Tag Archives: Disease

Yet another fallacy is destroyed. Cholesterol is actually GOOD for you.

It’s the jolting headline that will make your taste buds jump for joy. Foods high in cholesterol may not be bad for your heart after all. After years of warning consumers to cut down on cholesterol, found in eggs, shellfish, butter and beef, the nutrition community has come full circle.

A new draft of a report from the Dietary Guidelines Advisory Committee contains a monumental shift in warnings first issued nearly four decades ago, suggesting that cholesterol no longer needs to be viewed as a “nutrient of concern.”

The announcement is viewed as vindication for Nina Teicholz, author of the 2014 best-selling book “The Big Fat Surprise: Why Butter, Meat, and Cheese Belong in a Healthy Diet.” Teicholz broke with conventional wisdom and angered many in the medical community by writing that through years of research, she concluded that not only was cholesterol wrongly linked to heart disease, but foods high in saturated fats, such as butter, eggs and beef, were also falsely labeled as heart unhealthy. The former vegetarian now practices what she preaches and has changed the way she and her family eat. Breakfast consists of eggs and bacon; cheese is a staple, as is lard. Gone are foods high in carbs and sugar. Teicholz invited Yahoo News into her kitchen just days before the stunning announcement from the nutrition advisory panel and predicted that more findings like these would be coming soon.

Hahnemann and study of drugs: What they dont teach you in college. (More background thinking to the Mallorca Seminar)

398869_10151814864274148_1123956388_nHahnemann’s objection to the physiological approach to the study of drug-actions seemed to lie in the fact that the moment an attempt to establish the action of the drug from its supposed physiological effects, one was entering into a mystery that would give rise to various conflicting ideas and theories.

That is why the Homoeopathic Materia Medica consists of the collective statements of perceptible reactions of the healthy human body, recorded in the words of the persons acted upon by drugs and eschews all concepts, physiological and pathological and thus admits no misinterpretations with changing medical terminology, altered biological concep­tions and newer scientific attitudes.

In so far as Hahnemann’s method remains on the plane of description of observations, it attains TOTAL stability to the extent that the observations are correct. When orthodox medicine attempts to “explain”, whenever these explanations are premature, each newly discovered fact will cause a shifting of emphasis and a conse­quent appearance of progress that is more of change than an advance; whereas the essentially descriptive view-point tends to account for the relative stability of Hahnemanns Materia Medica and his doctrine in general. And has done so for nearly 2 centuries.

However,there are many who, while affiliating with Hahnemann in his work, accepting the law of cure and the theory of drug provings, nevertheless are inclined towards the thought that a more thorough knowledge of the effects of drugs upon the organism should be established, more so than that which comes through the perceptible signs and symptoms caused by the drug. Further they want to explain that the modus operandi of the drug action has the capability of producing certain prominent physiological effects, or in other words, pathological alterations in the tissues.

We must ask why Hahnemann practically ignored these possible changes in tissues, and instead depended entirely upon the symptoms which provers recorded. We may note that this physiological approach to the study of drug-actions necessarily leads to the pathologising of remedies. The study of pathology and pathological anatomy shows how the study of connection of symptoms in the patient may greatly facilitate the discovery of symptoms by showing their mental connection, dependence and succession just as the study of physiology enables us to grasp the pheno­mena of healthy persons. This study aims at integrating all the symptoms into harmonious whole. But it would have been completely successful were our present knowledge of remedial actions perfect. However as the matter stands, neither physiological concepts nor the pathological symptoms completely cover the totality of symptoms in diseased conditions of the human organism, though these methods (e.g., physiological and pathological), no doubt help us greatly to marshal the facts in an orderly manner and to retain them in memory.

These methods of study attempt to grasp the conceptual whole, which are never co-extensive with the perceptual whole,

It is a fact that as yet there is not one single remedy in the whole of materia medica whose physiological action is completely understood and this being the case it becomes at once apparent that we cannot base our knowledge of drug-action upon that which we do not know or at least know very imperfectly. Then too, the study of the physio­logical effects of the drug to the entire disregard of indivi­dual symptoms necessarily leads to the pathologising of our materia medica.

study-drugs-300x225Thus, when one studies the action of a drug. only from the effects to which he finds or supposes that he finds it to produce upon the tissues and organs he natura­lly concludes that when we find those alterations of tissues present in a manner similar to that which was supposed to be accomplished by the drug under consideration, that such a drug is the remedy regardless of any individual symptoms.

This leads to adoption of specific methods, which being once established everything pertaining to the pathogenesis which does not fall within the circle of this established specific drug-action is thrown away and cannot be considered of any more account;

It may be asserted without hesitation that whenever a remedy has been received as a specific in the sense which I have just mentioned, it has proved a curse both to the remedy and the physician as well. It is simply an impossi­bility for the action of any one remedy to be brought into any single recognised physiological or pathological process, at least in our day and without imperfect knowledge of drug-action. The continued study of drug-action upon this basis may give us eventually so perfect a knowledge of drug patho-genesy and disease pathology, if I may use such a term, that we may be able to establish a system of therapeutics based upon physiological action of drugs. That time has not yet come and it is very probably in the far distant future.

Our present knowledge of the pathology is not and can never be a guide to the administration of remedies. Object as we may, it is an undoubted fact that is becoming more apparent that we cannot understand the action of a drug from any other standpoint than that of the individual symptomology. We may theorise to as to the conditions which give rise to the symptomology; it is perhaps eminently proper that we should do so, but when it comes to the application of the drug itself itself we should not allow any theory that we may hold to stand against the indications that may be given by pure symptomatology. As the same rule holds good here as elsewhere in the study of various branches of medicine, that is, while extremes are sometimes useful in leading us to the consideration of effects, nevertheless they are seldom a safe guide in the study of either diseases or drug-actions.

It may be pointed out in this connection, that the so-called Hahnemannians of to day who ignore physiology and pathology in their study are found to be making the most ludicrous mistakes in their treatment of diseases, mistakes that might be avoided by a very simple knowledge of the other two important sciences which they leave entirely out of the question. On the other hand there may be a class of men who claim for themselves the title of homoeopathic physicians, but who have no knowledge whatever of symptomatology and never studied their materia medica carefully, but go upon the assumption that they possess a perfect knowledge of the physiological effects of the drugs and of pathological effects in disease; and they are found to be prescribing certain drugs for certain conditions under any and all circumstances regardless of the symptomatology or indeed regardless of any specific ideas whatsoever excepting only those relating to the pathological effects of the drug itself. It is very evi­dent that such physicians are liable to err; and that there is not one who does not make mistakes at times in his supposed knowledge of the physiological effects of drugs. He therefore stands upon an uncertain ground and is neither scientific nor safe in his methods of practice.

It may be concluded therefore that the physiological effects of a drug must ever be, so far as known, the scientific basis of our knowledge of drug-action, and we should lend every energy to increase this knowledge and at the same time, we should realise how weak and lame we are in this direction before accepting as a fact that which almost every physician has established as unsatisfactory if he has given the matter any thought at all. This is why the theory expounded by Hahnemann in the early days of drug study holds equally good today, that symtomatology is the only safe language of a drug-action, wherein we are never liable to make a mistake and upon which we can at all times depend. One who closely follows the symptomatology of the drug and the patient we shall more nearly arrive at the indi­viduality of the drug and the patient.

We should not ignore the very important rela­tion that exists between the homoeopathic materia medica and physiology, but at the same we should not allow the relationship to become so great as to blind us to the true and only scientific method of drug-study: symptomatology, the science of semiology.

 

Hahnemann’s concept of Illness. (Background thinking for the Mallorca Seminar)

palma roomHahnemann’s concept of Illness

(Click here for details of the Mallorca Seminar)

Hahnemann believed that the signs and symptoms of a case of illness represented an attempt by the body to heal itself. According to this view, the signs and symptoms do not represent the illness, but rather the reaction of the person to his illness. The illness and the reaction to illness are separate. Therefore Hahnemann reasoned that physician should administer that medicine to the patient which produced in the healthy signs and symptoms similar to those of the patient. In this manner the natural attempt of the body to heal itself would be re­inforced, rather than neutralised or interfered with. Hahne­mann called this treatment of illness with medicines which produced in the healthy symptoms similar to those of the ill>Homoeopathy (Homois: Similar; Pathos: suffering).

Nature of Cure in illness

If an ill person receives no treatment, he either dies, remains chronically ill or recovers. If he recovers, his pattern of re­covery is like that of all sick persons and separate from his particular disease. As people become ill, old symptoms of previous illness often reappear. The symptoms move from non-vital organs, like the nose and throat, to more vital organs, like the kidneys and lungs. Then there is a period of crisis. Following this crisis, one by one and in reverse order of their appearance, the symptoms move from vital to less vital organs until the patient is well again. This natural response is called auto therapy.

Under homoeopathic treatment an identical response usually follows, rather than the abrupt disappearance of symptoms or the introduction of new symptoms which often follows other types of treatment.

Homoeopathy, from its inception has been based on an inclusive, descriptive attitude towards the patient and the medicine and the response of the patient is equally inclusive in relation to the natural course his illness would have taken without treatment. After he has made his initial, descriptive inclusive analysis of the patient and the medicine, the homoeopathic physician may then indulge in analytic specula­tion. Throughout the 19th century until the present time the majority of scientists have been analytically oriented after accepting as relevant only the information which fits within their particular scheme. In contrast to this Hahnemannian approach to science was pre-Newtonian. It was the same, non-mechanical, descriptive manner in which Cuvier described the botanical kingdom or Dana, the mineralogical world. Or at the other end of the time-scale the same manner in which the present-day physicists are following up Anderson’s discovery in 1938 of sub-nuclear particles and of the fourth great revolution in physics of the world of sub-nuclear energies.

An ultra-mechanistic view-point is characterised by the usual mechanistic concepts, and in addition, it also includes at least the acceptance of a causal, unpredictable, unstable phenomena whose wholes are greater than the sum of their parts. The observer must attempt to be completely inclusive and unbiased in his approach to a field of interest. He must accept the totality of the relationships that make it up. This total approach is called “Holism”. As a result of a total or holistic view of all the phenomena in a field, certain data may be found to co-exist with each other. Jung calls the temporal co-existence “synchronicity”.

Let us now consider the application of this ultra-mechanistic view point in the field of modern physics:

The skeleton of the physical universe in the 19th century was considered to consist of six unrelated functions, viz., 1. Space; 2. Time; 3. Matter; 4. Energy; 5. Gravity; 6. Inertia.

Over a period of 50 years Einstein gradually related each of these functions with each other by means of ingeniously derived formula e.g.,

 (a)      Integration of space and time in his conception of fourth dimension.

 (b)      Matter and Energy are interchangeable as evident by the equation: Energy =mass x velocity of light squared (by application of Planck’s Quantum Theory to the transmission of light).

(c)   In Einstein’s special Theory of Relativity he showed that space-time-energy and Matter are interchangeable, e.g., Mass of a body is a function of its motion. At the speed of light a body would have no weight at all. .

[d] In his gravitational field physics theory Einstein showed that all matter is surrounded by a gravitational field and that inertia is a function of this field. From this it follows that the space is curved, since matter travels in response to this curved field pattern.

(e) Shortly before his death Einstein announced his unified field theory in which he attempted to unite all six com­ponents of our universe in one continuum.

The new physics is concerned with specific, discontinuous energies which are basically uncertain and within certain relative areas are woven together in an acausal, unpredictable manner throughout a space-time-matter-energy-gravity-intertia continuum. It views the universe in an ultra-mechanistic, holistic, descriptive manner.

Homoeopathy is also concerned with the specific, discon­tinuous action of dynamized sub-atomic energies whose action is uncertain and statistical rather than analytic.

The homoeopathic approach to the patient and medicine is descriptively inclusive and holistic.

In future, homoeopathy may take its place as a pioneer approach in medicine toward a therapeutic psycho-somatic synthesis.

 

THE U.S. MEDICAL SYSTEM IS THE NATION’S NUMBER ONE KILLER

 

 

By Rob Pell
March 11, 2013
NewsWithViews.com

Ideas for reducing unnecessary, preventable deaths in this country have been in the news a lot lately. Where shall we begin? Annual gun related homicides total about 11,000 and automobile fatalities are about 35,000 per year.

Would you be surprised to learn that the leading cause of death in the US appears to be the medical system itself. This is the startling conclusion reached in a report published by medical researchers: Gary Null, PhD; Carolyn Dean MD, ND; Martin Feldman, MD; Debora Rasio, MD; and Dorothy Smith, PhD.

Deaths resulting from inadvertent, adverse effects or complications from medical treatment or diagnostic proceedures are known as Iatrogenisis, meaning: Brought forth by a healer (from the Greek iatros, healer).Their report places the number of annnual iatrgenic (brought forth by a healer) deaths in the US at 783,936.

Hippocrates is often regarded as the father of western medicine and 98% of American medical students swear to some form of the Hippocratic Oath before practicing medicine. One of the underlying principals of the Oath is: “first, do no harm.” I’m not sure if that’s sad or ironic.

The largest single contributor to iatrogenic deaths are prescription drugs, being used as directed. According to a report issued by Medical News Today, over 4 billion prescriptions were written for drugs in America in 2011 . That’s an average of over 13 for each man, woman and child. The average number of prescriptions written annually for a senior citizen is 28 per year. That doesn’t include over- the-counter medications or vaccines. If these drugs could successfully treat and cure disease, the United States would have the healthiest inhabitants on the planet.

The possible adverse reaction warnings on TV drug commercials have become a punch line for comedian’s routines, but, life-threatening side-effects are no laughing matter. Common side-effects of individual drugs are well publicized but it’s impossible for physicians or pharmacists to reliably predict what possible side-effects will occur when combining three, four, 13 or 28 different drugs.

I was recently saddened to read the obituary of one of my customers, a strongly-built Military Veteran in his mid-seventies, who appeared to me to be in excellent health five years ago. His son told me that he had reviewed his Dad’s prescriptions with him and was shocked to discover that 9 of the 12 drugs his father was taking had been prescribed to treat side-effects from one of the other drugs. His father was found dead, lying on the floor of his residence. No autopsy was performed.

The Journal of the American Medical Association (JAMA) published a study by Dr. Barbara Starfield, an MD with a Master’s degree in Public Health, revealing the extremely poor performance of the United States health care system in a number of areas.

One of Starfield’s main concerns is the lack of systematic recording and studying of adverse events stemming from prescription drugs. If a patient dies, there is no routine procedure to notify their physician, even if the patient is autopsied. Therefore, there is almost no way for the average doctor to link a patient’s death to a possible adverse reaction to a prescribed medication.

This is especially troubling because another article published in JAMA concluded prescription drugs, being used as directed, cause about 106,000 deaths a year and over two million serious injuries annually in the U.S. This makes prescription drugs the single largest factor in deaths induced by the medical establishment.

Nationally, only about 20% of all deaths are subject to investigation by a coronor or medical examiner. If the cause of death was made certain in all cases by autopsy, I’m quite sure that the number of deaths actually caused by prescription drugs, being used as directed, would dwarf the 106,000 per year the JAMA report acknowleged.

I’ve seen enough to believe that in many cases Big-Pharma is far more concerned with creating repeat, lifetime customers rather than finding cures. Joining the drug companies, the FDA and insurance companies are the kingpins behind this profit-driven business model. Some call doctors well-meaning, unsuspecting pawns of Big-Pharma. Others call them street level pushers for FDA sanctioned drug cartels. Either way, the kingpins couldn’t do it without medical doctors helping them complete the drug delivery system.

Due to concerns about dangerous side-effects from long-term use, many prescription drugs were, at one time, specifically prescribed only for short-term use Now, just a few years later, many of the same drugs are routinely prescribed, indefinitely, for the rest of your life.

Further, the Null-Dean report showed that the number of people exposed to unnecessary hospitalization annually is 8.9 million per year. This is cause for concern because a 2008 study issued by the Office of Inspector General for the Department of Health and Human Services, reported that one in seven Medicare beneficiaries who is hospitalized will be harmed as a result of the medical care they receive in the hospital.

Prescription drugs and hospital visits are very risky business. Unlike with other more well publicized causes of death, simply taking greater personal responsibility for our own health and well-being could save hundreds of thousands of lives every year. Unfortunately, more gun or traffic laws will do nothing to save us from what is actually the Nation’s number one killer, the U.S.medical system.

Treating cancer with dissimilar disease

By Dr. Guillermo Zamora, a surgeon UAG, Homeopath (Dhom. Med) by the Institute for Homoeopathic Medicine.

Herpes

For those who question the strength of the inductive method of reasoning applied to medicine proposed by Hahnemann, put as an example if not its antithesis, if it is unduly partial observation of an event, the report that for several days been going on for the journal Public Library of Science Pathogens [1] and has been published in various journals, conferences, websites, and magazines [2].

This report mentions that a genetically modified virus [“oncolytic” herpes simplex virus (HSV)] has been created, and is able to block the spread of ovarian cancer and breast cancer in mice. It seems important to mention that different sources of conventional medicine, have been saying this for several years.

Chief Scientist, Professor Gabriella Campadelli-Fiume, University of Bologna in Italy, said: “Many laboratories worldwide are using more specific viruses as weapons against cancer cells, called oncolytic viruses.”

“Safety concerns prevailed so far, and all oncolytic herpes virus now in clinical trials are weakened viruses, effective only against a fraction of tumors.”

“We were the first to obtain a reprogrammed herpes virus to enter positive tumor cells, unable to infect other cells, but retains the same ability to kill in order that the wild-type HSV.”

According to Dr. Kevin Harrington, Institute of Cancer Research in London, who is leading oncolytic virotherapy studies [3], has been obtained “success” in up to 93% of cases in which the virus (and other viruses such as reovirus and adenovirus) has been modified to not infect healthy tissue (?) and according to the studies could become successful treatment in the fight against head and neck cancer.

With FDA approval, studies (including multicenter) are carried out in different phases using intratumoral injection in order to evaluate the response of colony stimulating factor-granulocyte macrophage [JS1/34.5-/47-/granulocyte -macrophage colony-stimulating factor (GM-CSF)] in different types of advanced cancer. Studies may include combinations of chemotherapy with cyclophosphamide, docetaxel, 3-AP Triapine (3-aminopyridine-2-carboxaldehyde thiosemicarbazone), radiation therapy, or combined chemoradiation in which studies show is “synergy” between all therapies. Side effects such as anemia, nausea, and fatigue are often reported, and neutropenia. One speaks of proviral states as vascular endothelial growth factor (vascular endothelial growth factor or VEGF) during which the reovirus can replicate oncolytic administered systemically in the endothelium, thereby inducing immune-mediated vascular collapse with significant antitumor properties.

Many studies show how are you amazing results with proven results in the treatment of certain cancers. However, the long term effects of drug-biological treatments, dependence and the tendency to acquire another disease state or immune weakness, are some maxims that should worry us. No medical intervention or treatment should be given without a long period of experimentation and testing (*). A Hahnemann It took eight years before he started dealing with Homoeopathy. There are many books, documents and writings and research experiments on the reactions, similarities, and results before he carefully follow each step with your therapy.

(*) This warning applies also for studies with the name “Homoeopathy” is conducted for cancer treatment (for example the protocol Banerji Homeopathic Research Foundation), especially when real has not been practiced homeopathy for decades for most of the “homeopathic”.

Something that has not been taken into account is that one thing is the infectious agent with whom you work for any purpose, and one is the reaction-disease so mild, moderate or severe body generates all contacts that agent. Any modified agent however, can not be discriminative enough not to cause a reaction in the center of the life force (wherever it is), as we saw with the immediate side effects reported as anemia, nausea, fatigue and neutropenia.

The experimental study is developed with the herpes virus, derived from observation (as I said at the beginning, unduly partial) that people with cancer and at the same time acquire or come into contact with people infected with the herpes virus appear stop development of its initial cancerous state, and even reverse it [4]. (I translate an extract of the reference number 4 on the history of oncolytic therapy, for the convenience of our readers)

“It seems that the use of viruses in cancer treatment was not the result of some insightful theory of alternative therapy, but rather only derived from the observation that, occasionally, cancer patients who contracted an infectious disease had brief periods clinical remission. “

So, we put a lot of attention. We must not lose the entire complex under which certain conditions are favoring the experimental subjects, who were either inmunosuprime (even when it is intended to search a localized immune response), or causes them to weaken their disease through chemo and / or radiation while trying to “attack” the tumor with the modified virus. This means that protocols require that artificially weaken, suppress or maintain and produce a susceptibility to opportunistic infectious miasm widely known, but enough to make it amended as yet unknown. With this, it will be predicted drug dependence or ultimately death because desarmonizado balance that sustains life. We will see later why.

This herpes and cancer research leads me to remember what Hahnemann had observed about through simple inductance and I would have liked to have been taken into account by the researchers (or perhaps if they knew about it?). This would comment that we do not object to people using their preferred therapy or oppose personal opinions. What we would like is that these observations are considered under Baconian establish a new era in science as applied to medicine.

I can not leave out, mention the fact that prior experimentation on animals has serious drawbacks, including:

  • Animals can not express subjective symptoms produced during the experiment.
  • Infective agents (read infecting agent perspective Hahnemanniana) act differently in each species.
  • Humans and animals react differently to these infectious agents.
  • There are substances in animals may be harmless, while for men can be highly toxic and vice versa.
  • Man or animal (host) can act as a reservoir and in turn so individualized in each body of each species cause changes (mutations) to infective agents making them more potent complexes, reactivándolos (eg after attenuated) or increasing their virulence ( **).

(**) Vaccines may also be applied to the same vial containing three viruses or vaccines contaminated with unknown viruses. [5, 6.7 to cite some references, but there is enough hemerography about]

As I mentioned before and want to accept it or not researchers oncolytic viral therapy (they did not know, did not understand, did not care or did purposely. No) [4], for almost 200 years, Hahnemann had already observed in As regards to the reaction-disease, three circumstances where two dissimilar diseases coexist in the body of a human being, I quote two of those three circumstances with some of his remarks and references:

Aphorism § 38, Organon, 6th. edition

“II. – New to dissimilar disease is the strongest. – In this case the disease under which the patient lived primitively, being the weakest, will be arrested and suspended by the emergence of stronger, until it cross its course or be cured, then the old reappears uncured.

  • “As noted Tulpius 72 two children suffering from some form of epilepsy, were free of attacks after being infested with ringworm (instep), but as soon as the eruption of epilepsy head disappeared again as before. (72 Obs., lib. i, obs. 8)

 

  • Scabies, as noted Schopf 73 submitted scurvy disappeared, but after it healed, that reappeared. (72 Obs., lib. i, obs. 8)

 

  • So also remained stationary pulmonary tuberculosis patient being attacked by a violent typhus, but continued their march after typhus ran its course. 74   (74 Chevalier, in Hufeland’s Neuesten Annalen der Französiche, Heiljunde, ii, p. 192)

 

  • When the measles and smallpox together dominate, and both attack the same child, measles-existing, generally is contained by smallpox appeared later; measles does not end until it ends its course smallpox, but not uncommon it happens that the smallpox infection is suspended for four days by the supervening of measles, after which scaling complete your smallpox, as observed by Manget. 76 (76 In Edimb. Med Comment., Pt. I, I)

 

  • So with all dissimilar diseases, the strongest stops development of the weakest (if not complicated which is rare in acute diseases), but never a cure to the other. “(My emphasis)

 

The aphorism § 40, 6th Organon. Editing refers to a combined response (or response miasmatic disease combined mutant)

“III. – The new disease, after he had worked a long time in the body, finally joins that is unlike the former, and forms with it a complex disease, so that each occupies a special location in the body, ie organs peculiarly adapted to it and only that particular location belongs, while leaving the remaining organs other disease that is unlike … For two dissimilar diseases can not be destroyed, can not be cured to one another … not However, there have also been major epidemics of this kind, in which two dissimilar acute and, in rare cases, have occurred simultaneously in one and the same body, and combined, as it were, for a short time with each other … then, though not completely incurable, but can be transformed into health with very great difficulty. “

  • “Rainey 86 witnessed the simultaneous occurrence of measles and smallpox in two girls. (86 Edinb. Med Comment, iii, p. 480)
  • J. Maurice 87 throughout its practice observed only two cases of this kind. (87 in Phys Med and Journ., 1,805)
  • Similar cases are found in the works of Ettmüller 88 and in the writings of some others. (88 Opera, ii, pi, chap. 10)
  • Lencker 89 vaccine was go full term together with measles and purple. (89 Hufeland’s Journal, X v ii) “

 

This latter circumstance applies for malnourished patients, and / or with certain addictions, and / or debilitating conditions, and / or in immunosuppressed patients, etc. A clear example of this would be all diseases “new” appearance as acquired immunodeficiency syndrome (AIDS), in which you can combine various diseases caused by two or more types of the herpes family (***) and microorganisms and other viral, bacterial, fungal, etc..

(***) In the last 100 years have discovered 8 different types of herpes.

1.-TYPE herpes simplex virus I.

2.-Herpes Simplex Virus Type II

3.-varicella-zoster virus.

4.-Epstein-Barr virus.

5.-CITAMEGALOVIRUS.

6.-herpesvirus-6-6-B AY. (HHV-6)

7.-herpesvirus 7 (HHV-7)

8.-human herpesvirus 8 (Kaposi’s sarcoma)

If we reflect the foregoing, we find that Hahnemann makes complete observations (and NO partial), deep and detailed the circumstances between two dissimilar diseases coexist, including the aftermath of the same, so we can see that the inductance in science, observe the experienced (even from the same accident or toxicity), helps predict the outcome of an event. Take into account the principles established by Hahnemann in the Organon for experimentation and the coexistence of two dissimilar diseases is not a minor thing. Accept and understand our limitations, our achievements, and the consequences of such applications in medicine is vital to our future and wellbeing.

References

[1] http://www.plospathogens.org/

[2] Huffingtonpost, Herpes Virus Could Be Key To Breast And Ovarian Cancer Treatment, The Huffington Post UK | Posted: 31/01/2013 22:16 GMT

GM virus blocks spread of cancer, Press Association – Thu, Jan 31, 2013, yahoo news.

Herpes virus, “new weapon” against cancer Join BBC Science, August 2, 2010 – 13:39 GMT

The herpes virus shows promise in treating breast cancer, Isaude, Science and Technology, published on 26/10/2011 at 13h58: 00

HERPES VIRUS SHOWS PROMISE IN TREATING EARLY TRIPLE-NEGATIVE BREAST CANCER Oncolytic viral therapy shows great potential for treating an aggressive form of breast cancer, News from the Clinical Congress, Yuman Fong, MD, FACS Sepideh Gholami, MD, Monday, October 24, 1:00 pm

[3] Donnelly, OG., Errington-Mais, F., Prestwich, R., Harrington, K., Pandha, H., Vile, R. & Melcher, AA. (2012) Recent Clinical Experience with oncolytic Viruses Current Pharmaceutical Biotechnology, Vol.13 (9), pp.1834-1841, ISSN: 1389-2010.

Adair, RA., Roulstone, V., Scott, KJ., Morgan, R., Nuovo, GJ., Fuller, M., Beirne, D., West, EJ., Jennings, VA., Rose, A., et al. (2012) Cell Carriage, Delivery, and Selective Replication of an oncolytic virus in Tumor in Patients Science Translational Medicine, Vol.4 (138), ISSN: 1946-6234.

Karapanagiotou, MS., Roulstone, V., Twigger, K., Ball, M., Tanay, M., Nutting, C., Newbold, K., Gore, ME., Larkin, J., Syrigos, KN., et al. (2012) Phase I / II trial of carboplatin and paclitaxel chemotherapy in combination with intravenous oncolytic reovirus in patients with Advanced Malignancies. Clin Cancer Res, Vol.18 (7), pp.2080-2089, ISSN: 1078-0432 .

Simpson, GR., Horvath, A., Annels, NE., Pencavel, T., Metcalf, S., Seth, R., Peschard, P., Price, T., Coffin, RS., Mostafid, H., et al. (2012) Combination of a fusogenic glycoprotein, pro-drug activation and oncolytic HSV as an intravesical therapy for bladder cancer Surface British Journal of Cancer, Vol.106 (3), pp.496-507, ISSN: 0007-0920 .

Kottke, T., Chester, J., Ilett, E., Thompson, J., Diaz, R., Coffey, M. Selby, P., Nuovo, G., Pulido, J., Mukhopadhyay, D., et al. (2011) Precise Scheduling of Chemotherapy Primes VEGF-producing Tumors for Successful Systemic oncolytic virotherapy MOL THER, Vol.19 (10), pp.1802-1812, ISSN: 1525-0016.

Heinemann, L., Simpson, GR., Boxall, A., Kottke, T., Relph, KL., Vile, R., Melcher, A., Prestwich, R., Harrington, KJ., Morgan, R., et al. (2011) Synergistic effects of oncolytic reovirus and docetaxel chemotherapy in prostate cancer BMC CANCER, Vol.11 ISSN: 1471-2407.

Touchefeu, Y., Vassaux, G. & Harrington, KJ. (2011) oncolytic viruses in radiation oncology Radiother Oncol, vol.99 (3), pp.262-270, ISSN: 0167-8140.

Ilett, EJ., Barcena, M., Errington-Mais, F., Griffin, S., Harrington, KJ., Pandha, HS., Coffey, M., Selby, PJ., Limpens, RWAL., Mommaas, M . et al. (2011) Internalization of oncolytic Reovirus by Human Dendritic Cell Carriers from the Virus Neutralization Protects Clin Cancer Res, Vol.17 (9), pp.2767-2776, ISSN: 1078-0432.

Willmon, C., Diaz, RM., Wongthida, P., Galivo, F., Kottke, T., Thompson, J., Albelda, S., Harrington, K., Melcher, A. & Vile, R. (2011) Vesicular Stomatitis Virus-induced Suppressor Cells Immune Antagonism Between Intratumoral oncolytic Generate Virus and Cyclophosphamide Mol Ther, Vol.19 (1), pp.140-149, ISSN: 1525-0016.

Senzer, NN., Kaufman, HL., Amatruda, T., Nemunaitis, M., Reid, T., Daniels, G., Gonzalez, R., Glaspy, J., Whitman, E., Harrington, K., et al. (2009) Phase II Clinical Trial of a Granulocyte-macrophage colony-stimulating factor-Encoding, Second-Generation oncolytic herpesvirus in unresectable Patients With Metastatic Melanoma J CLIN ONCOL, Vol.27 (34), pp.5763-5771, ISSN: 0732-183x.

Harrington, KJ. (2010) Topical treatment for oral Cancers Winners and Losers and oncolytic adenoviruses: who should be down in the mouth? GENE THER, Vol.17 (12), pp.1421-1422, ISSN: 0969-7128.

Harrington, KJ., Hingorani, M., Tanay, MA., Hickey, J., Bhide, SA., Clarke, PM., Renouf, LC., Thway, K., Sibtain, A., McNeish, IA., et al. (2010) Phase I / II Study of oncolytic HSVGM-CSF in Combination with Cisplatin in Untreated Radiotherapy and Stage III / IV Squamous Cell Cancer of the Head and Neck Clin Cancer Res, Vol.16 (15), pp.4005 -4015, ISSN: 1078-0432.

Merron, A., Baril, P., Martin-Duque, P., de la Vieja, A., Tran, L., Briat, A., Harrington, KJ., McNeish, IA. & Vassaux, G. (2010 ) Assessment of the Na / I symporter gene as a reporter to visualize oncolytic adenovirus propagation in peritoneal Tumours Eur J Nucl Med MOL I, Vol.37 (7), pp.1377-1385, ISSN: 1619-7070.

Kottke, T., Hall, G., Pulido, J., Diaz, RM., Thompson, J., Chong, H., Selby, P., Coffey, M., Pandha, H., Chester, J., et al. (2010) Antiangiogenic cancer therapy combined with oncolytic virotherapy leads to regression of tumors in mice Established J CLIN INVEST, Vol.120 (5), pp.1551-1560, ISSN: 0021-9738.

Harrington, KJ., Vile, RG., Melcher, A., Chester, J. & Pandha, HS. (2010) Clinical trials with oncolytic reovirus: moving beyond phase I into combinations with standard therapeutics. Cytokine Growth Factor Rev, Vol.21 (2-3), pp.91-98.

Senzer, NN., Kaufman, HL., Amatruda, T., Nemunaitis, M., Reid, T., Daniels, G., Gonzalez, R., Glaspy, J., Whitman, E., Harrington, K., et al. (2009) Phase II Clinical Trial of a Granulocyte-macrophage colony-stimulating factor-Encoding, Second-Generation oncolytic herpesvirus in unresectable Patients With Metastatic Melanoma J CLIN ONCOL, Vol.27 (34), pp.5763-5771, ISSN: 0732-183x.

Willmon, C., Harrington, K. Kottke, T., Prestwich, R. Melcher, A. & Vile, R. (2009) Cell Carriers for oncolytic Viruses: Fed Ex for Cancer Therapy MOL THER, Vol.17 (10), pp.1667-1676, ISSN: 1525-0016.

Prestwich, RJ., Errington, F., Steele, LP., Ilett, EJ., Morgan, RSM., Harrington, KJ., Pandha, HS., Selby, PJ., Vile, RG. & Melcher, AA. (2009) Reciprocal Human Dendritic Cell-Induced Natural Killer Cell Interactions Following Antitumor Activity Tumor Cell Reovirus Infection by oncolytic J Immunol, Vol.183 (7), pp.4312-4321, ISSN: 0022-1767.

Pandha, HS., Heinemann, L., Simpson, GR., Melcher, A., Prestwich, R., Errington, F., Coffey, M., Harrington, KJ. & Morgan, R. (2009) Synergistic Effects of oncolytic Reovirus and Cisplatin Chemotherapy in Murine Malignant Melanoma CLIN CANCER RES, Vol.15 (19), pp.6158-6166, ISSN: 1078-0432.

Prestwich, RJ., Errington, F., Diaz, RM., Pandha, HS., Harrington, KJ., Melcher, AA. & Vile, RG. (2009) The Case of oncolytic Viruses Versus the Immune System: Waiting on the Judgment of Solomon HUM GENE THER, Vol.20 (10), pp.1119-1132, ISSN: 1043-0342.

Prestwich, RJ., Ilett, EJ., Errington, F., Diaz, RM., Steele, LP., Kottke, T., Thompson, J., Galivo, F., Harrington, KJ., Pandha, HS., et al. (2009) Immune-Mediated Antitumor Activity of Reovirus Is Required for Therapy and Is Independent of Direct Viral Replication Oncolysis and CLIN CANCER RES, Vol.15 (13), pp.4374-4381, ISSN: 1078-0432.

Pandha, H., Melcher, A., Harrington, K. & Vile, R. (2009) oncolytic Viruses: Time to Compare, Contrast, and Combine? MOL THER, Vol.17 (6), pp.934-935, ISSN: 1525-0016.

Ilett, EJ., Prestwich, RJ., Kottke, T., Errington, F., Thompson, JM., Harrington, KJ., Pandha, HS., Coffey, M., Selby, PJ., Vile, RG., et al. (2009) Dendritic cells and T cells deliver Tumour killing oncolytic DESPITE reovirus for pre-existing anti-viral immunity Gene Ther, Vol.16 (5), pp.689-699, ISSN: 0969-7128.

Kottke, T., Thompson, J., Diaz, RM., Pulido, J., Willmon, C., Coffey, M., Selby, P., Melcher, A., Harrington, K. & Vile, RG. (2009) Improved Systemic Delivery of Established Tumors to Reovirus oncolytic Using Preconditioning with Cyclophosphamide-Mediated Treg Modulation and Interleukin-2 Clin Cancer Res, Vol.15 (2), pp.561-569, ISSN: 1078 – 0432.

Prestwich, RJ., Errington, F., Ilett, EJ., Morgan, RSM., Scott, KJ., Kottke, T., Thompson, J., Morrison, EE., Harrington, KJ., Pandha, HS., et al. (2008) Tumor Infection by oncolytic Reovirus Primes Adaptive Antitumor Immunity CLIN CANCER RES, Vol.14 (22), pp.7358-7366, ISSN: 1078-0432.

Prestwich, RJ., Harrington, KJ., Pandha, HS., Vile, RG., Melcher, AA. & Errington, F. (2008) oncolytic viruses: a novel form of immunotherapy EXPERT ANTICANC REV, Vol.8 (10), pp.1581-1588, ISSN: 1473-7140.

Harrington, KJ., Melcher, A., Vassaux, G., Pandha, HS. & Vile, RG. (2008) Exploiting Synergies Between radiation and oncolytic viruses. Curr Opin Mol Ther, Vol.10 (4), pp.362-370, ISSN: 1464-8431.

Prestwich, RJ., Harrington, KJ., Vile, RG. & Melcher, AA. (2008) immunotherapeutic potential of oncolytic virotherapy LANCET ONCOL, Vol.9 (7), pp.610-612, ISSN: 1470-2045.

Kottke, T., Galivo, F., Wongthida, P., Diaz, RM., Thompson, J., Jevremovic, D., Barber, GN., Hall, G., Chester, J., Selby, P., et al. (2008) Treg depletion-enhanced IL-2 therapy of treatment Facilitates Established tumors delivered systemically using oncolytic virus Mol Ther, Vol.16 (7), pp.1217-1226, ISSN: 1525-0016.

White, CL., Twigger, KR., Vidal, L., De Bono, JS., Coffey, M., Heinemann, L., Morgan, R., Merrick, A., Errington, F., Vile, RG. , et al. (2008) Characterization of the adaptive and innate immune response to intravenous oncolytic reovirus (Dearing type 3) during a phase I clinical trial. Gene Ther, Vol.15 (12), pp.911-920.

Qiao, J., Kottke, T., Willmon, C., Galivo, F., Wongthida, P., Diaz, RM., Thompson, J., Ryno, P., Barber, GN., Chester, J., et al. (2008) Purging metastases in lymphoid organs using a combination of antigen-nonspecific adoptive T cell therapy, immunotherapy and virotherapy oncolytic Nat Med, Vol.14 (1), pp.37-44, ISSN: 1078-8956.

Hu, JC., Coffin, RS., Davis, CJ., Graham, NJ., Groves, N., Guest, PJ., Harrington, KJ., James, ND., Love, CA., McNeish, I., et al. (2006) A phase I study of OncoVEXGM-CSF, a second-generation oncolytic herpes simplex virus expressing granulocyte macrophage colony-stimulating factor. Clin Cancer Res, Vol.12 (22), pp.6737-6747, ISSN: 1078-0432.

[4] NATURE, Molecular Therapy (2007) 15 4, 651-659 doi: 10.10, “History of oncolytic Viruses: Genesis to Genetic Engineering”, Elizabeth Kelly and Stephen J Russell:

“It Appears That the use of viruses in the treatment of cancer was not the result of some perspicacious theory of an alternative therapy but Rather stemmed from the observation just That, occasionally, Contracted cancer patients who went into an infectious disease brief periods of clinical remission . “

[5] Modulation of immune responses during canine distemper virus infection: implications for therapeutic and vaccine development, Céspedes PF *, P Cruz, CO Navarro, Faculty of Veterinary and Animal Sciences, Laboratory of Animal Virology, University of Chile , Santiago, Chile. Arch Med Vet 42, 15-28 (2010):

“This last statement is based on evidence of the ability of the attenuated vaccine virus to revert to virulence so fleeting and cause lethal encephalitis in dogs following immunization and, similarly, a multisystem box of 90-100% morbidity and lethality in ferrets blacklegged (Mustela putorius furo) (Summers and Appel 1994, von Messling et al 2003). “

[6] Reverse Genetics for Live Attenuated Virus Vaccine Development Kun Yao, * and Zaishi Wang

“… An attenuated virus can still replicate in the Vaccinated Individuals, Therefore, the virus has the potential to revert to virulent phenotypes. Moreover, some of live vaccines can be Transmitted from the person to non immunized Vaccinated Individuals … “

“These are particularly important safety Concerns for Certain human RNA human parainfluenza viruses Such as virus (PIV), respiratory syncytial virus (RSV) and HIV, since viruses These RNA, RNA-dependent RNA Whose polymerases do not have a proofreading function and a high Could Occur During mutation rate virus replication. “

[7] Altered Virulence of Vaccine Strains of Measles Virus after Prolonged Replication in Human Tissue, Alexandra Valsamakis et al, J Virol. October 1999, 73 (10): 8791-8797.

The levels of Deception in Medicine

shock1

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The Health Hazards of Disease Prevention

 The vaccination policy and the Code of Practice of the Joint Committee on

Vaccination and Immunisation (JCVI): are they at odds?

Lucija Tomljenovic, PhD

 

Neural Dynamics Research Group, Dept. of Ophthalmology and Visual Sciences, University of British

Columbia, 828 W. 10th Ave, Vancouver, BC, V5Z 1L8, lucijat77@gmail.com

Introduction

No pharmaceutical drug is devoid of risks from adverse reactions and vaccines are no exception. According to the world’s leading drug regulatory authority, the US Food and Drug Administration (FDA), vaccines represent a special category of drugs in that they are generally given to healthy individuals and often to prevent a disease to which an individual may never be exposed [1]. This, according to the FDA, places extra emphasis on vaccine safety. Universally, regulatory authorities are responsible for ensuring that new vaccines go through proper scientific evaluation before they are approved. An equal responsibility rests on the medical profession to promote vaccinations but only with those vaccines whose safety and efficacy has been demonstrated to be statistically significant. Furthermore, vaccination is a medical intervention and as such, it should be carried out with the full consent of those who are being subjected to it. This necessitates an objective disclosure of the known or foreseeable risks and benefits and, where applicable, a description of alternative courses of treatment. In cases where children and infants are involved, full consent with regards to vaccination should be given by the parents.

Deliberately concealing information from the parents for the sole purpose of getting them to comply with an “official” vaccination schedule could thus be considered as a form of ethical violation or misconduct. Official documents obtained from the UK Department of Health (DH) and the Joint Committee on Vaccination and Immunisation (JCVI) reveal that the British health authorities have been engaging in such practice for the last 30 years, apparently for the sole purpose of protecting the national vaccination program.

Here I present the documentation which appears to show that the JCVI made continuous efforts to withhold critical data on severe adverse reactions and contraindications to vaccinations to both parents and health practitioners in order to reach overall vaccination rates which they deemed were necessary for “herd immunity”, a concept which with regards to vaccination, and contrary to prevalent beliefs, does not rest on solid scientific evidence as will be explained. As a result of such vaccination policy promoted by the JCVI and the DH, many children have been vaccinated without their parents being disclosed the critical information about demonstrated risks of serious adverse reactions, one that the JCVI appeared to have been fully aware of. It would also appear that, by withholding this information, the JCVI/DH neglected the right of individuals to make an informed consent concerning vaccination. By doing so, the JCVI/DH may have violated not only International Guidelines for Medical Ethics (i.e., Helsinki Declaration and the International Code of Medical Ethics) [2] but also, their own Code of Practice (http://www.dh.gov.uk/prod_consum_dh/groups/ dh_digitalassets/@dh/@ab/documents/digitalasset/dh_115363.pdf).

The transcripts of the JCVI meetings also show that some of the Committee members had extensive ties to pharmaceutical companies and that the JCVI frequently co-operated with vaccine manufacturers on strategies aimed at boosting vaccine uptake. Some of the meetings at which such controversial items were discussed were not intended to be publicly available, as the transcripts were only released later, through the Freedom of Information Act (FOI). These particular meetings are denoted in the transcripts as “commercial in confidence”, and reveal a clear and disturbing lack of transparency, as some of the information was removed from the text (i.e., the names of the participants) prior to transcript release under the FOI section at the JCVI website (for example, JCVI CSM/DH (Committee on the Safety of Medicines/Department of Health) Joint Committee on Adverse Reactions Minutes 1986-1992; http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306).

 

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 Assertions

In summary, the transcripts of the JCVI/DH meetings from the period from 1983 to 2010 appear to show that:

1)   Instead of reacting appropriately by re-examining existing vaccination policies when safety concerns over specific vaccines were identified by their own investigations, the JCVI either a) took no action, b) skewed or selectively removed unfavourable safety data from public reports and c) made intensive efforts to reassure both the public and the authorities in the safety of respective vaccines;

2) Significantly restricted contraindication to vaccination criteria in order to increase vaccination rates despite outstanding and unresolved safety issues;

3)   On multiple occasions requested from vaccine manufacturers to make specific amendments to their data sheets, when these were in conflict with JCVI’s official advices on immunisations;

4) Persistently relied on methodologically dubious studies, while dismissing independent research, to promote vaccine policies;

5)  Persistently and categorically downplayed safety concerns while over-inflating vaccine benefits;

6)   Promoted and elaborated a plan for introducing new vaccines of questionable efficacy and safety into the routine paediatric schedule, on the assumption that the licenses would eventually be granted;

7)   Actively discouraged research on vaccine safety issues;

8)   Deliberately  took  advantage  of  parents’  trust  and  lack  of  relevant  knowledge  on vaccinations in order to promote a scientifically unsupported immunisation program which could put certain children at risk of severe long-term neurological damage;

Notably, all of these actions appear to violate the JCVI’s own Code of Practice (http:// www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/ dh_115363.pdf).

 

 

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 Evidence

I here provide the evidence in support of each of the above assertions. (Note: emphasis added throughout the text as underlined are by the author unless otherwise indicated)

1)   Instead of  reacting  appropriately  by  re-examining  existing  vaccination  policies when   safety  concerns  over  specific  vaccines  were  identified  by  their  own investigations, the JCVI either a) took no action, b) skewed or selectively removed unfavourable safety data from public reports and/or c) made intensive efforts to reassure both the public and the authorities in the safety of respective vaccines.

As early as 1981, the JCVI had substantial documentation which associated the measles vaccine with serious adverse reactions including death and long-term adverse neurological outcomes.  At  the  JCVI  meeting  held  on  9th     April  1981   (http://www.dh.gov.uk/ab/ DH_095169), in discussing a paper that summarised all the reports of adverse reactions to the CSM, the following was noted:

(5.b.) Adverse Reactions to measles vaccine

“All reports since 1970 of encephalitis, encephalopathy or sudden death shortly after vaccination had been reviewed; 60 patients were involved of whom 8 had died, 36 had made an apparent complete recovery and 16 were left with permanent sequelae. The high proportion of deaths and patients with sequelae was surprising in comparison with the findings of the NCES [National Childhood Encephalopathy Study].”(5.b. Adverse Reactions to measles vaccine)

By 1983, the JCVI appeared to have had more evidence that the measles vaccine could cause encephalitis associated with “severe handicap” in a subset of vulnerable children. At the JCVI meeting on 17th   of June 1983 (http://www.dh.gov.uk/ab/JCVI/DH_120115), the Committee on Safety of Medicines (CSM) received 66 reports of suspected adverse reactions to measles vaccines over the period January 1982 to April 1983. According to the transcript of the meeting:

(7. Suspected adverse reactions to measles vaccine: recent reports to the CSM)

“These included three cases of encephalitis; on follow-up, two of these patients were left one year later with severe handicap and the third patient, after a year, appeared to be developmentally normal.”

By the end of 1981 serious safety concerns have also been raised with regards to another routine  paediatric  vaccine,  the  whooping  cough  vaccine. At  the  meeting  held  on  3rd November 1981 (http://www.dh.gov.uk/ab/DH_095169) in section 5 on Whooping Cough:

(5.d. Comments on Professor Stewart’s letter)

“Professor Gilliatt observed that in the Meade Panel Study one-third of children with brain damage were not admitted to hospital. In both the Meade and Dudgeon studies there were examples of children who had a fit soon after vaccination which was followed by a fit at a later time and then followed by cessation of development. It was very difficult to assess this as a random event.”

Furthermore:

“The Chairman concluded that much was not known about the natural history of brain damage in the young.”

In  spite  of  this,  three  years  later,  at  the  meeting  on  25th     of  April  1986  (http://

www.dh.gov.uk/ab/DH_095169), the JCVI concluded their discussion on suspected adverse

 

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reactions for the period 19th   September 1985 to 15th   of January 1986 with the  following statement:

(11.4)

“The Committee agreed to a suggestion from the Chairman that in future it would accept reports on adverse reactions as “for information” only.” [their emphasis added-quotation marks]

It is somewhat perplexing why the JCVI adopted what appears to be a rather passive approach to vaccine safety, in light of the severe adverse reactions that were reported at that meeting. These included cot deaths, convulsions and anaphylaxis (11.4).

The JCVI appeared to have had other solutions for dealing with vaccine safety concerns. In a “commercial in confidence” CSM/JCVI/Joint Sub-Committee on Adverse Reactions to Vaccination and  Immunisation  (ARVI)  meeting  on  7th    February  1986   (http://www.dh.gov.uk/en/FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306), in a discussion about a surveillance study on adverse reactions to two measles vaccines, the members noted that:

“…results showed that 70 per cent of children were well after receiving Attenuvax and 61 per cent after receiving Rimevax. If children with mild general reactions were added to those who were apparently well then the numbers associated with Attenuvax were 85 per cent and those with Rimevax 80 per cent.” (7.1 PHLS [Public Health Laboratory Service] surveillance of adverse reactions to two measles vaccine (Rimevax and Attenuvax))

In other words, even skewing the data by adding cases of mild reactions to those who were “apparently” well, did far from producing a reassuring statistic in favour of the safety of the measles vaccines, as it still implied a rate of 15-20% of vaccine-associated serious adverse reactions (as opposed to 30-39% of mild-to-serious adverse reactions in total). After further discussion on this topic:

“…it was agreed there was now enough information to stop the study.”

While at the same time, there appeared to be no incentive to reconsider the current immunisation policy,  in  fact,  it  seemed  more  reasonable  to  conclude  that  some  of  the suspected adverse reactions to measles vaccine:

“…were unlikely to be associated with the use of measles vaccine and were more likely to be temper tantrums.” (7.2 Suspected adverse reactions to measles vaccine: a summary of recent reports to the CS, June 1983 to September 1985)

The summary of suspected adverse reactions to DTP vaccine administered alone or with oral polio (OPV)  during  the  period  19th    September  1985  to  15th    January  1986,  presented  at  the  same “confidential”  meeting  (CSM/JCVI/Joint  Sub-Committee  ARVI,  7th     February  1986)  were  more difficult to ascribe to “temper tantrums”:

(9.(1))

“Ninety such adverse reactions have been registered. These included six patients with convulsions, one a patient with abnormal fever following vaccination and one patient with apparent cerebral irritability; in addition two cot deaths were reported. (i) Case No.

154043 A three-month  old  boy  who  after  his  first  dose  of Trivax AD  and  OPV  on  17

September 1985 was found dead 18 hours after immunisation….(ii) Case No. 154080 A

three-month old girl who received her first dose of Trivax and OPV on the 19 September

1985 and was found dead on the night of 21/22 September 1985. No initial adverse reaction

to vaccination was reported and the cause of death was stated as SIDS.” [sudden infant

death syndrome]

By mid to the late 1980s, the JCVI had become increasingly concerned about publicly associating the terms          “death” and/or “brain damage” with the word “vaccine”, because of the negative

4

 

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 repercussions they perceived this would have on vaccination policy (CSM/JCVI/Joint Sub-Committee ARVI  meetings  on  7th    February  1986;  3rd    October  1986;   http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306). Such concerns were also exacerbated by the increasing burden of litigations about pertussis vaccine-suspected injuries (JCVI meeting on 22nd      April 1988; 20th   October 1988; http:// www.dh.gov.uk/ab/DH_095169), and the possibility that vaccination could be linked to some cases of SIDS, as evident from the Reports on Yellow Cards quoted above.

At the meeting on 22nd  April 1988 (http://www.dh.gov.uk/ab/DH_095169), in an ongoing discussion about the Loveday v Renton litigation, the Chairman:

“…reminded members that they had asked for a list of documents disclosed. JCVI (88)1 provided such a list, but it should not be made public. Dr Salisbury said that the Department’s solicitors had advised that a part of the section on whooping cough in the revised Memorandum was in conflict with the judgement in the above-mentioned case. They had recommended that any statement on the risk of neurological reaction should avoid any estimate of the size of the risk of death or permanent brain damage. Dr Salisbury said that paragraph 3.4.1c of the section on whooping cough in the Memorandum had been modified accordingly and this modification was tabled. Professor Miller observed that the conclusion to be reached from the judgment of the Court and from the assessment of the scientific evidence of risk of neurological reactions and their consequences, were not necessarily the same. The legal judgement was that there is insufficient evidence, on the balance of probabilities that the vaccine causes permanent damage to allow any claim for damages to succeed. The JCVI was concerned with the implications of scientific assessment of the evidence for vaccine policy purposes. On this basis he was content to quote the figure for attributable risk of serious neurological illness without giving a figure for the risk of permanent damage, which was consistent with the conclusion of the NCES quoted in the Whooping Cough Report 1981.”(Item 5, page 4 – Loveday v Renton)

The extent of the JCVI’s concerns with the implications of scientific assessment of vaccine safety on vaccine policy explains why they were opposed to any long-term surveillance for severe neurological disorders following vaccination. In fact, as it will be shown below in greater detail, the CSM/JCVI/ARVI considered such studies “unreasonable” and paradoxically, ARVI even “deprecated the use of the term ‘brain damage’” (CSM/JCVI/Joint Sub-Committee ARVI meeting held on 7th    February  1986; h t t p : / / w w w . d h . g o v . u k / e n / F r e e d o m O f I n f o r m a t i  o  n / Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306).

In 1989, 10 years prior to the “controversial” Lancet report by Wakefield et al. [3], the JCVI appeared to have been fully aware of the outcomes of the investigation carried out by the National Institute for Biological Standards and Control (NIBSC), which unequivocally established a link between the mumps component of the MMR vaccine (the Urabe-9 strain) and cases of vaccine- induced meningitis/encephalitis. In response to this, the JCVI appeared to have actively engaged in skewing and censoring data available to the public, continued to use the Urabe-9 containing MMR vaccines and made intensive efforts to reassure both the public and the authorities of the safety of all MMR vaccines.

According to the transcript of the JCVI meeting on 3rd   November 1989 (http://www.dh.gov.uk/ab/ DH_095169), the causal agent of vaccine-induced meningitis/encephalitis was unequivocally identified:

(9. ARVI Committee – Minutes of meeting 6 October 1989 (JCVI (89)25)

“Prof Collee expressed gratitude to the NIBSC for the progress it achieved in developing techniques to identify wild and vaccine virus strains. Dr Schild reported that NIBSC was now able to distinguish clearly the wild strains from each of the two vaccines, and isolates from CSF clearly showed Urabe in all three cases believed to be associated with vaccine-although it should not be assumed that Jeryl-Lynn is not capable of the same result. Professor Collee added that no mumps vaccine could be said to be void of risk. Dr Schild said NIBSC would be happy to continue analysing samples.”

 

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 In the following meeting on 17th  September 1990, the JCVI CSM/DH Joint Sub-Committee on Adverse Reactions (http://www.dh.gov.uk/ab/JCVI/DH_095294), on reviewing the adverse reactions to the MMR vaccine reported on Yellow Cards, applied the following criteria to the assessments:

(6.3.1.)

Definite=Virus isolated from CSF [cerebrospinal fluid], time course of 14-28 days; Possible/probable=Cells isolated from CSF, no virus in CSF, acceptable time course” [their emphasis added-underlined]

The transcript then states:

“It was noted that there were 10 definite cases of meningitis/encephalitis.” Both definite and probable cases were then discussed in some detail: (6.3.4.)

“It  was  noted  that  the  mumps  viruses  obtained  from  two  out  of  three  cases  from Nottingham were sequenced and shown to be vaccine related. The patients had all been vaccinated from different batches and did not live close to each other.”

At the 17th  September 1990 meeting (http://www.dh.gov.uk/ab/JCVI/DH_095294), the JCVI CSM/DH Joint Sub-Committee on Adverse Reactions did recognize the need to do a follow- up analyses for long-term neurological outcomes in all cases of  meningitis/encephalitis associated with the MMR vaccine. It was also recognized that  the current avenues for adverse reactions reporting (via the Yellow Card, the British  Paediatric Surveillance Unit (BPSU) scheme, directly to Communicable Disease Surveillance Centre (CDSC) and through Laboratory reports) were inadequate for  detailed  epidemiological evaluations. The JCVI CSM/DH Joint Sub-Committee then stated that:

(6.4)

“In order to further validate vaccine related illnesses, fuller studies would be required.” Despite these unresolved safety issues, the conclusion reached at the meeting was that:

(6.7)

“There should be no change in the present recommendations or supply of MMR vaccine on the evidence available to us at the present time.”

Thus, instead of re-evaluating the vaccination policy, at least until safety concerns were fully  evaluated,  the  JCVI  choose  to  support  the  existing  policy  based  on  incomplete evidence that was available at that time.

Furthermore,  at  the  17th      September  1990  meeting   (http://www.dh.gov.uk/ab/JCVI/ DH_095294), the JCVI appeared to have been fully aware of increasing numbers of cases of mumps vaccine-associated aseptic meningitis occurring in Japan, since at the time of the meeting, they had been presented with a draft of a  study by Sugiura et al. [4].

The Japanese study found that among 630,157 recipients of the MMR vaccine containing the Urabe-9 mumps vaccine, there were at least 311 meningitis cases suspected to be vaccine- related. In 96 of these 311 cases, mumps virus related to the vaccine was isolated from the CSF. Sugiura et al. [4] noted that this was an unusually high incidence of vaccine-related adverse outcomes, which they had attributed in part to “adverse media publicity”. Nonetheless, the fact that in almost one third of the cases, the vaccine strain had been isolated from the CSF of children, suggests that safety concerns over the MMR were warranted. Indeed, in 1993 the Japanese suspended the use of the MMR vaccines containing the Urabe strain due to it causing a high incidence of aseptic meningitis, and reverted to the use of monovalent measles, mumps and rubella vaccines. According to Japanese Health Authorities, the withdrawal of the MMR had not caused an increase in deaths from wild

 

 

 

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 measles infection. Noteworthy, in a BBC news report (http://news.bbc.co.uk/2/hi/asia- pacific/1808316.stm), a spokesperson for the Japan’s Health Ministry stated that:

“…more children had died from the disease during the period when MMR was being used.” In reference to the Japanese study, the JCVI transcript specifically states:

(6.6)

“The paper confirmed information from Japan previously disclosed to ARVI.”

This suggests that the JCVI knew for some time that the Urabe-9 vaccine was causing problems and yet, did not consider the possibility to temporarily suspend its use.

Furthermore, four months prior to the 17th    September 1990 meeting, at the JCVI 4th    May  1990 meeting (http://www.dh.gov.uk/ab/DH_095169), ARVI expressed concerns regarding the  reports from Japan. The major reason for these concerns was not that the JCVI/ARVI were in  favour of using the Urabe-9 vaccine which was now associated with increased risk of meningitis/encephalitis in children, but rather:

(9.1.)

“Professor Banatvala was concerned about the possibility of the Japanese experience being published widely in the UK, and urged the gathering of information on the various episodes from all MMR manufacturers.”

ARVI also reached a rather surprising conclusion that:

“The Japanese experience may be due to different reporting/investigating criteria or other local factors.”

However, if this were the case, “the Japanese experience” would have been an isolated event. That this was not the case can be clearly seen from further readings of the JCVI 4th   May 1990 meeting transcript (http://www.dh.gov.uk/ab/DH_095169):

(9.3.a.)

“Dr  Thores  spoke  to  the  letter,  JCVI/90/10,  from  Dr  McIntyre.  He  highlighted  SHHD [Scottish Home and Health Department] concern about the Canadian decision not to use Urabe strain vaccine, the cases of neurological complications in Japan, the seeming bias of the UK adverse reactions towards Scotland, and the continued use of vaccine distribution figures as the denominator when calculating adverse reaction rates.”

In spite of this, instead of re-evaluating or suspending the existing MMR vaccination policy due to safety concerns, the JCVI called for a specific and concentrated effort aimed at counteracting the growing public and health authorities’ concern over the safety of the Urabe-9 MMR vaccines.

(9.3.c.)

“Professor Peckham told the Committee that she was aware of three districts changing from use of Urabe to Jeryl Lynn vaccine, and therefore the Committee needed to reassure authorities of the safety of all MMR vaccines.”

Hence, it appears that the JCVI’s solution to the growing problem regarding the MMR vaccine safety issues was to provide as little information as possible to health practitioners, in order to preserve the JCVI’s vaccination policy. If this assumption is correct, does it suggest that the JCVI was more concerned about boosting vaccine uptake than child safety?

(9.3.e.)

“The Chairman asked the Committee if it thought necessary to draw up a statement about

MMR.”

 

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 (9.3.g.)

“Professor Hull suggested a simple sheet with ARVI’s evaluation of the vaccines. This would let  doctors know  that  an  expert committee had looked at the situation and perhaps reassure them.”

What appears to be a rather inadequate handling of the MMR safety concerns on behalf of the JCVI did not make the problem go away. Only a year later, at 1st    November  1991 meeting  (http://www.dh.gov.uk/ab/JCVI/DH_095050),  unable  to  resolve  the  continuing MMR safety issues the JCVI turned to vaccine manufacturers for help:

(7.1 Report on MMR)

“On adverse reactions to the vaccine, the most worrying reports had been studies which showed problems with the Urabe vaccine, particularly Mumps Meningitis. Reports had also come from overseas countries, Canada being the most helpful….of 67 reported cases between October 1988 and August 1990, 38 children had definite or probable Aseptic Meningitis and one Encephalitis. Te n of these were definitely caused by the vaccine, and a further 29 were probably caused by the vaccine. Of these 39 children, 37 were followed up at 12 months. 33 (or 89%) were neuro-developmentally normal. Of the remaining four, two had neuro-developmental problems before being given MMR, one had behaviour problems and one had a cerebral astrocytoma. There had been eight reports of nerve deafness although one was pre-MMR; six needed further investigation. The over-all picture was that there were 3.7 cases per 100,000 doses of Urabe vaccine and no cases reported with the Jeryl Lynn vaccine. However, the MSD [Merck Sharp and Dohme] vaccine was generally not well accepted because of pain at the injection site. Urabe is the most reactogenic vaccine but some data suggested that it may also be the most immunogenic. It was impossible to make a firm decision about this until all information had been collected.”

(Note: it ought to be asked why the UK health authorities thought it was appropriate to vaccinate children with neurodevelopmental problems and cerebral astrocytoma with a vaccine that had caused substantial worries to them over its association with adverse reactions affecting the brain).

(7.2 Discussions with Manufacturers)

“Dr Salisbury reported on his recent meetings with Merieux, MSD and SKB [Smithkline Beecham]. Information was shared and details of adverse events discussed. The manufacturers  felt  that  the  Department’s  line-that  is,  surveying  adverse  events  and checking immunogenicity-was correct.”

Again, the JCVI appeared to have adopted a passive approach to the problem and made no apparent efforts to identify specific sub-groups of children who may have been more prone to adverse reactions to the MMR. At the meeting that followed on 1st   May 1992 (http:// www.dh.gov.uk/ab/JCVI/DH_095050), the same conclusions were reiterated in light of the continuing MMR crisis, with an additional concern that the actual number  of vaccine- associated  aseptic  meningitis  cases  might  have  been  higher,  due  to   suspected underreporting:

(7.4 Report of North Herts Immunogenicity Study (Dr Elizabeth Miller))

“The report of a cluster of CSF mumps virus positive cases in Nottingham had caused concern that national surveillance may have been underreporting the incidence of cases; a meeting had been held to discuss the Nottingham situation and the national data….In Nottingham all children with febrile convulsions were lumbar punctured, unlike some other areas from where reports had been received (Preston and Ashford) .The Committee agreed that no conclusion could be reached until the full immunogenicity results were available as well as the full analysis of the Nottingham and other data.”

In the meantime, no changes were made to the immunisation policies. Would a seemingly passive approach to child health and safety, suggest that the JCVI in essence agreed to the fact that during the surveillance for the purposes of “for information only”, some cases of

 

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suspected  vaccine-induced  convulsions,  meningitis/encephalitis  and  deaths  in  children would just have to be tolerated?

Note also that for using the same technique of lumbar puncture, 18 years later, Dr Andrew Wakefield  who  investigated  a  consecutive  series  of  children  with  chronic  enterocolitis  and regressive developmental disorder which appeared to have been linked to MMR vaccination, was charged and found unfit to practice medicine by the UK General Medical Council (GMC).  According to the GMC hearing, lumbar puncture in children with MMR-suspected adverse neurological outcome was apparently ”not clinically indicated” (http://www.gmc-uk.org/static/documents/content/ Wakefield   Smith_Murch.pdf).

In July 1992, the data from Nottingham became available, nonetheless, it took another two months before the JCVI and the DH finally decided to take action, apparently not so much because of safety concerns but more so because of the legal advice given to the manufacturers by their lawyers in response to which the manufacturers decided to stop producing the Urabe-9 containing MMR vaccines. According to the transcript of the JCVI meeting on 6th    November 1992  (http:// www.dh.gov.uk/ab/JCVI/DH_095050):

(8.1 Report to Sub-Committee on SEAR/CSM: Dr David Salisbury)

“In August, Department of Health officials met with MCA [Medicines Control Agency] and the manufacturers. At the end of August SKB, acting on the advice of their lawyers, decided to stop producing vaccine and advise licensing authorities world wide accordingly; the Department had, therefore, to act quickly.”

Thus, only when the alarm was sounded by the manufacturers’ lawyers did the DH sense that the matters regarding the safety of the MMR vaccine required some urgency. In addition, it appears that the principal preoccupation of the European Authorities was how to preserve global vaccine policies in face of the Urabe-9 scandal.

“On the 3 and 4 September the Chief Medical Officers of European Community countries were advised in confidence of the situation at a routine meeting. ARGOS/SEAR [Sub- Committee on Safety, Efficiency (SEAR) and the Adverse Reaction Group of SEAR (ARGOS)] agreed on 4 September that no action would be taken to revoke the manufacturer’s license as a change of purchasing policy was to be made by the Department; revoking the license would have caused a world-wide vaccine crisis.”

The actual rate of aseptic meningitis after the MMR vaccination was discussed later on the JCVI 6th

November 1992 meeting agenda (http://www.dh.gov.uk/ab/JCVI/DH_095050):

(8.7 Risk of aseptic meningitis after MMR vaccination in UK children: Dr Elizabeth Miller)

“The overall risk of this complication in the UK was 1 per 10,000 immunised children but, in Nottingham, this had increased to 1 in 4,000. Tests in Canada in 1989 had associated the Urabe vaccine with meningitis. The linking of laboratory records of CSE samples with district computer databases on immunisation had been very effective. The Committee was told that all the countries which had had a choice had switched from the Urabe to Jeryl Lynn;”

What is rather astonishing is that the four-year old Canadian concerns over the safety profile of the MMR vaccine (which had been confirmed in 1989), were apparently ignored by the JCVI or at least, not given much credence. While the Canadian Health Authorities suspended the use of the Urabe-9

MMR in 1988, the UK introduced it along with a vigorous promotional campaign. In a confidential meeting of the JCVI Working Party on the introduction of measles, mumps, rubella (MMR) vaccine on 11th  February 1988 (http://www.dh.gov.uk/ab/JCVI/DH_095297):

(5. MMR vaccination in Canada)

“Members read a report of cases of mumps encephalitis which had been associated with MMR vaccine containing the URABE strain of the mumps virus. The Canadian authorities had suspended the licences of MMR vaccines containing the URABE strain, but Dr Salisbury considered that the data on which the decision had been based was slender.”

 

 

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 The JCVI also had a specific plan to combat any adverse publicity in case any of this “confidential” information was to reach the public:

“A statement would be prepared in anticipation of any adverse publicity which might arise.”

(7. Publicity)

“A paper prepared by the MMR Publicity Group was presented, by Mr Flaherty and Mr Reid, for the Group to discuss and to approve the general approach it contained. Dr Ross considered that the priority was to get the message across to doctors, health visitors and nurses.”

Finally, the JCVI also had a number of funding strategies in place to promote the introduction of the MMR:

(9. Funding situation)

“£800,000 had been set aside for publicity and £1.4 million had been set aside to cover the period October 1988 – March 1989 to assist health authorities with increased vaccine costs, the education of professionals and for the re-programming of child computers. Members noted that the Statement of Fees and Allowances would need altering to include item of service payment for MMR.”

This latter strategy was further refined on the JCVI Working Party on the introduction of MMR vaccine following meeting, on 17th  May 1988 (http://www.dh.gov.uk/ab/JCVI/DH_095297):

(3. Matters Arising)

“Dr McGuiness suggested that instead of an item of service payment GPs might be paid according to their immunization rates.”

In spite of carefully elaborated advertising and substantial investments, the JCVI did not entirely succeed  in  countering  public  concerns  over  vaccine  safety,  as  on  6th    October  1989  (http:// www.dh.gov.uk/ab/JCVI/DH_095294):

(5.2.6)

“The meeting’s further sadness was expressed over the press reports, which could have harmful implications and unnecessarily damage public confidence in vaccines.”

Regrettably, similar sadness was apparently not expressed by the JCVI members over a report of a vaccine-suspected death of a 16 month old child, which was discussed at the same meeting. Rather:

(5.2.4)

“This was a fiscal case and as such was highly confidential. Doubts were expressed about the cause of death, and while it was not possible to give clear judgement, it was felt that there was unlikely to have been a causal relationship with the vaccine and that this was an unusual case.”

Science should be based on facts and experimental evidence, not feelings.

As for the alleged “slender” Canadian data on safety hazards of the SKF (Smith Kline and French) Urabe MMR vaccine, in a confidential JCVI CSM/DH Joint Sub-committee on Adverse Reactions meeting  on  7th    March  1990  (http://www.dh.gov.uk/ab/JCVI/DH_095294)  the  following   was disclosed:

(6. Adverse reactions to MMR vaccine)

“In Canada, the MSD vaccine had been used exclusively [Jeryl Lynn strain-containing MMR]. Following the introduction of SKF product, the cases of meningoencephalitis had been

 

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 reported. When distribution of the SKF vaccine was halted, no further cases of meningoencephalitis were reported.”

Yet, from this clear evidence, the JCVI derived a conclusion that somewhat seems to defy logic:

“It was suggested that, due to different reaction criteria and methods of data collection, reporting in different countries should not be compared.”

In summary, the JCVI endorsed and promoted a policy of vaccinating every child in the UK with the Urabe-9 MMR vaccine, in spite of the evidence that this would have caused a greater risk of encephalitis in children, when compared to the alternative Jeryl Lynn version of the MMR. It was only under pressure from a potential legal action that the JCVI and DH decided that it was due time “to act quickly” and withdraw the Urabe MMR from use in routine vaccinations.

2)   Significantly restricted contraindication to vaccination criteria in order to increase vaccination rates despite outstanding and unresolved safety issues.

Already in the early 1980s, the public confidence in the safety of the whooping cough (pertussis) vaccine has been eroded and since the uptake of the vaccine was relatively low, the JCVI sought ways to improve immunisation rates. According to Sir Charles Stuart-Harris, at  the  JCVI  meeting  on  3rd     November  1981  (http://www.dh.gov.uk/ab/DH_095169)  in section 5 on Whooping Cough:

(5.c. Whooping Cough Vaccination Campaign)

“…a 40% uptake of the vaccine ensured continuance of the disease; the uptake rate had to be improved.”

The transcripts of the JCVI meetings from 1981 to 1986 indicate that the Committee did not know what was the risk/benefit balance of whooping cough vaccination in children who were potentially more at risk of vaccine associated-adverse outcomes. In spite of this, the JCVI went on with restricting contraindication criteria so that more children could be vaccinated. The JCVI also seemed to have been more preoccupied with protecting the “reputation of the vaccine” rather than protecting potentially vulnerable individuals, as the former served a basis for defining certain contraindication criteria.

In 1981, a Working Group on Contra-indications to Whooping Cough Vaccination had been set up because ARVI, which had been asked by the JCVI to consider contraindication to whooping cough vaccine, had not been able to reach an appropriate agreement on this issue. At a beginning of the meeting of this Working Group on 1st    May 1981  (http:// www.dh.gov.uk/ab/JCVI/DH_120115), it was noted that:

“It was extremely important that the present meeting should reach an agreed conclusion because the reports on whooping cough were to be published on the 12 May, and it was desirable for any new contra-indications to be ready as soon as possible after this date.”

and:

“When considering the question of contraindications, the general principle to be borne in mind was that the right balance had to be struck between the need to keep acceptance rates for vaccination as high as possible and the need to protect groups of children who had an increased risk of adverse reaction to vaccination.”

Assuming that the whooping cough vaccine is effective in preventing whooping cough, this principle indeed appears to be sound. Curiously however, one of the first items to be discussed under this agenda was that of respiratory illnesses and whether these should be regarded as a contraindication to whooping cough vaccination. Some members thought that respiratory illnesses ought to be deleted from the list of contraindications. Others however:

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 “…thought that the reference to respiratory disease was not really a contra-indication; rather it was a move to protect the reputation of whooping cough vaccination by avoiding an association between vaccination and SIDS.”

Since apparently:

“Respiratory illness was often associated with SIDS, and therefore the reference to respiratory disease was a wise precaution to prevent SIDS and whooping cough vaccination being associated.”

Next:

“Professor Miller stressed the need to maintain public confidence in the vaccine and said there was a need to prevent children with epilepsy being vaccinated in order to avoid an apparent association between vaccination and fits.”

In addition:

“The Chairman asked members to consider “History of seizures, convulsions, or cerebral irritation in the neonatal period”. Professor Hull said that this contra-indication would include children with disguised brain damage; this was good for the reputation of the vaccine in that it prevented an apparent association between vaccination and the discovery of brain damage.”

It is somewhat perplexing why in discussing contraindication to whooping cough vaccination, the Working Group members entrusted with an “extremely important” task to reach a prompt agreement on this issue, appeared to have been more concerned about the reputation  of  the  whooping  cough  vaccine,  rather  than  the  risk/benefit  balance  of whooping cough vaccination in children who were potentially more at risk of vaccine associated-adverse outcomes, especially since:

“It was agreed that the risk/benefit balance in this group of children was not known.” Nonetheless, Dr Griffiths in referring to a paper from the US, in which children with a history of convulsions were immunised against whooping cough and then followed up noted that:

“…this data did show a slightly increased risk of convulsions following vaccination in children with a previous history of convulsions.”

In the ensuing discussion, members also considered whether a family history of epilepsy or other diseases of the central nervous system should be regarded as a contraindication to whooping cough vaccination and:

“There was general agreement that including other diseases of the central nervous system was unnecessarily restrictive, and that this particular contra-indication should be deleted.”

Whether such contraindications were indeed “unnecessarily restrictive” and whether the need to rush an agreement on this issue was justified in the light of the data available at that time, remains questionable following the observations made by Professor Gilliatt at the  subsequent  meeting  held  on  3rd    November  1981   (http://www.dh.gov.uk/ab/ DH_095169):

(5.d. Comments on Professor Stewart’s letter)

“In both the Meade and Dudgeon studies there were examples of children who had a fit soon after vaccination which was followed by a fit at a later time and then followed by cessation of development. It was very difficult to assess this as a random event…The Chairman concluded that much was not known about the natural history of brain damage in the young.”

On 30th   January 1986 at the Joint Working Party of the British Paediatric Association (BPA) and the JCVI Liaison group meeting (http://www.dh.gov.uk/ab/JCVI/DH_120115), concerns

 

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 were expressed over the low rates of whooping cough vaccination due to contraindications which may have exempted children who had a family history of seizures. In discussing cases in whom whooping cough vaccination is not absolutely contraindicated but who require special consideration as to its advisability (item 4.8):

“Professor Gillliatt said that there had been a paper published recently in America, History of  convulsions  and  the  use  of  pertussis  vaccine.  Harrison  C  Stetler  et  al.  Journal  of Pediatrics 1985; vol 107; pages 175-179 which indicated that there was a quite high incidence of a family history of convulsions among the first degree relatives of children who had febrile convulsions. Members observed that changing this recommendation might decrease the number of children available for vaccination against whooping cough.”

By November 1986, the JCVI had a quite remarkable solution to deal with the “problem” of reduced uptake of the pertussis vaccine: the suggestion was to alter the advice on contraindication criteria.

According to the transcript of the 7th  November 1986 JCVI meeting (section 3.5.2a; http:// www.dh.gov.uk/ab/DH_095169),  the  groups  of  children  in  whom  the  advisability  of Whooping Cough vaccination required special consideration included:

i)          Children with a documented history of cerebral damage in the neonatal period.

ii)          Children with a personal history of convulsions.

iii)         Children whose parents or siblings have a history of idiopathic epilepsy.

iv)         Children with developmental delay thought to be due to a neurological defect.

v)         Children with neurological disease. It is further noted in the same transcript that:

“There was considerable discussion on 3.5.2(a)”

the details of which had not been given but:

“it was finally agreed that for (iii),  it should be stressed that the risk was very slight and that (iv) and (v) should be combined under “children with neurological conditions which are stable” and “not a contraindication”, ie in 3.5.4.” [their emphasis added-underlined]

Based on no apparent scientific evidence the JCVI claimed that neurodevelopmental delays or neurological disorders were in fact stable conditions and as such, unlikely to be exacerbated by vaccinations. It would appear that the sole purpose of this potentially misleading claim was to reassure parents, who otherwise might have been deterred from vaccinating their child against pertussis, of the safety of pertussis vaccination. The same would apply to the JCVI statement regarding the alleged “very slight” risk of adverse reactions in children with family history of idiopathic epilepsy.

One has to wonder whether the notes of the “commercial in confidence” CSM/JCVI/Joint Sub- Committee ARVI meeting on 3rd   October 1986, later obtained through FOI (which discussed among other “not be disclosed” items, suspected adverse reactions to DTP vaccines given alone or with OPV ;       http://ww w .dh.go v .uk/en/Fr eedo mO f Inf o r matio n/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306), would have had the same “reassuring” effect on parents had they been made publicly available at that time, or promoted with the same vigour as the vaccination campaigns:

“During the current period [13th   May 1986 to the 11th   September 1986] 95 suspected adverse reactions were reported. These included:

i)Death 151828. A 16 month old girl who two days after her first dose of DTP in mid-July 1985 was found to have a fever and a possible respiratory tract infection. Two days later

 

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she had a major fit and was admitted to hospital where further convulsions occurred. Further fits occurred at the end of July 1985 and she died on the 1st   of August probably from pneumococcal septicaemia. This patient had a family history of idiopathic epilepsy.“ This case has been reported to previous meetings of ARVI.

ii)There were 8 reports of convulsions following vaccination including 165236, a patient who was in status epilepticus within hours of receiving her third dose of triple vaccine.” (7. Summary of Suspected Adverse Reactions to Vaccines, a.)

It should be noted that the adverse reactions from OPV alone were no less severe and in fact more easily specifically attributed to the polio vaccine:

“A six month old girl who developed recipient vaccine-associated poliomyelitis 30 days after receiving her first dose of oral polio vaccine.” (7. Summary of Suspected Adverse Reactions to Vaccines, c.)

At the same meeting, the CSM/JCVI/Joint Sub-Committee ARVI discussed the results of a National Childhood Encephalopathy Study (NCES) as these were the subject of court proceedings on pertussis vaccine-related injury that were ongoing at that time:

(5.1.1.)

“The working party had established that the final number of cases in the NCES was 1,167.

39 cases had received triple vaccine in the week prior to the onset of their neurological

illness (9 with infantile spasms, 18 with convulsions, and 12 with encephalopathies). These

vaccine-associated  cases  included  5  patients  (4  with  convulsions  and  1  with  infantile

spasms) who had a history of neurological events before immunisation which indicates

possible prior abnormality.”

Again, one has to wonder whether these five patients also fitted in the JCVI’s criteria of “stable” neurological conditions. The apparently lenient attitude with regards to vaccine safety on behalf of the JCVI is perplexing, particularly in light of their admission which followed the brief discussion about the significance of the NCES findings the CSM/JCVI/Joint Sub-Committee ARVI:

(5.1.3.c.)

“From the above there is reason to believe that the increased relative risk of prolonged convulsions after DTP was a real one.”

Is this supposed to be a reassuring statement for all those children with prior family history of epilepsy or those suffering from “stable” neurological disorders, who as a result of the JCVI’s decision to shrink the contraindication criteria, no longer had a choice to opt out from pertussis vaccination? In further “reassurance”, the following was noted in the transcript of the CSM/JCVI/ Joint Sub-Committee ARVI meeting on 3rd  October 1986 (http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306):

(5.1.5.)

“Queries had been raised with regard to long-term sequelae after vaccine-associated encephalopathy…Among 12 children with encephalopathy there were 2 deaths, and 5 children with impairment of varying severity at 1 year. The relative risk for an acute vaccine-associated illness (convulsions or encephalopathy) was 3.3, and was similar irrespective of degree of impairment.”

Thus, according to the JCVI’s own admission, not only was the risk of DTP-associated neurological complications a real one, it also appeared to be a relatively high risk.

A somewhat lenient approach to contraindication criteria was also used with vaccines other than

DTP in order to boost vaccination rates.

(12. BPA/JCVI Working Group)

 

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 “In the matter of alleged egg allergy and measles vaccine, it was noted that although it was possible to amend the advice contained in the Memorandum ‘Immunisation against Infectious Disease’, it was also desirable to encourage manufacturers to change the advice in their data sheets.” (Meeting on 25 April 1986; http://www.dh.gov.uk/ab/DH_095169)

In other words, the JCVI appeared to be rather unwilling to change their own advice in the Memorandum and instead suggested that manufacturers should be “encouraged” to do so. The following Section (3) indicates that the JCVI elaborated a very simple solution for boosting vaccine uptake in face of impediments posed by contraindication criteria: restrict the contraindication criteria, rewrite information in the Memorandum and ask the pharmaceutical companies to change their data sheets as to “avoid confusion” and possible legal action.

3)   On multiple occasions requested from vaccine manufacturers to make specific amendments to their data sheets, when these were in conflict with the JCVI’s official advice on immunisations.

That boosting vaccine uptake appeared to be the major force driving the JCVI’s decision process, can be inferred from their request to the manufacturer of the MMR vaccine Merieux to modify the data sheet information related to contraindication to adverse effects, at the 1st  May 1987 meeting (http://www.dh.gov.uk/ab/DH_095169). Apparently, it was not sufficient to amend existing information on immunisation in their Memorandum to Infectious Diseases, it was also necessary to make that information concordant with the advices stated on manufacturer’s data sheets:

(7.2 Report of the meeting of the Working Party held on 25 February 1987)

“It was also noted that the data sheet for the Merieux MMR vaccine contra-indicated the use of the vaccine in children with a past or family history of convulsions. Medicines Division would be asked to approach Merieux to ascertain whether they would be willing to adopt appropriate modification to this data sheet.”

At a later meeting on 23rd   October 1987 (http://www.dh.gov.uk/ab/DH_095169), the JCVI also pressed for a change in the pertussis vaccine licensing details from the manufacturers, in spite of a pertussis vaccine-suspected injury litigation that was ongoing at that time. The Chairman of the JCVI approached the Association of British  Pharmaceutical Industries to resolve this issue. The notes on this meeting state that:

(15.2)

“The meeting considered revised contra-indications to pertussis vaccine in parallel with those at present published; ARVI was aware of the potential difficulties in relaxing the contra-indications to pertussis vaccine and suggested that the papers be sent to the CSM and also to the manufacturers. The latter, in a written response, replied that it was not possible at present to change the product license details whilst litigation was in progress.”

The “potential difficulties” that ARVI was concerned about were related to the ongoing pertussis litigation (this becomes more evident from the notes of a confidential meeting on

6th   July 1987 cited further below). Unable to get the manufacturers to comply with their request, the JCVI turned to the Solicitors Branch in the Department of Health and Social Security (DHSS), to seek advice over:

“…the difficulty of reconciling revised contra-indications to pertussis vaccine with advice issued by the manufacturers.”(18. Meeting of the Chairman of the JCVI and the Association of  British  Pharmaceutical  Industries;  JCVI  meeting  23rd    October  1987;                                                       http:// www.dh.gov.uk/ab/DH_095169)

The advice from the Solicitors was that:

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 “…such a discrepancy was not a problem for the JCVI whose function was to give advice to medical profession in the light of the best available knowledge.”(19. Memorandum “Immunisation  Against  Infectious  Disease;  JCVI  meeting  23rd      October  1987;   http:// www.dh.gov.uk/ab/DH_095169)

Notably, the “difficulty of reconciling revised contra-indications to pertussis vaccine” had been previously discussed by the CSM/JCVI/Joint Sub-Committee ARVI, on 6th   July 1987, in yet another meeting that was noted as “commercial” and “in confidence”.

According to this transcript which has been obtained through FOI (http://www.dh.gov.uk/ en/FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306):

“The Chairman reminded members that the proceedings, papers, and information before them were confidential and should not be disclosed.”

The same transcript also reveals the reason why the JCVI made great efforts to obtain the manufacturers’ compliance to their request to amend the data sheets on the pertussis vaccine and why,  failing  that, they sought help from the DHSS Solicitors. It was not necessarily because their policy was ethically and scientifically sound, but possibly because they were anxious about potential legal repercussions.

(Note that the names of the participants have been redacted from the transcript prior to its release under the FOI section at the JCVI website, so that the comments made are un- attributable to particular members):

(6.4 JCVI’s revised contra-indications to pertussis vaccine)

“The Chairman stated that JCVI had produced more permissive guidance on contra- indications to pertussis immunisation and that the revised contra-indications, shortly to appear in the next version of the Memorandum ‘Immunisation against Infectious Disease’ would not conform with the manufacturers data sheet. This might lead to confusion for general practitioners and other vaccinators and there might be legal problems.                                 commented that both the JCVI and the JCVI/BPA Working Party had tried to improve guidelines to give specific contra-indications but an attempt should be made to reconcile these with data sheets and product licenses. Delay in the new Memorandum might be worthwhile in order to obtain manufacturers agreement to changes in data sheets and also to  give  the  BNF  [British  National  Formulary]  the  opportunity  to  change  its  advice.

                agreed with                and welcomed the clearer advice from JCVI on pertussis contraindications which he endorsed.”

The  discussion  that  followed  seems  to  indicate  that ARVI  was  indeed  nervous  about potential legal implications, as apparently, they tried to evade having any responsibility on this matter:

             commented there was no need for JCVI advice to change but there should be awareness  of  the  implications  of  change.                    

suggested  a  meeting  with  the

manufacturers to discuss the changes in an attempt to seek common ground.                         

commented that it was not ARVI’s responsibility to dismantle other groups instructions.

              noted that ARVI had responsibilities to both JCVI and CSM and asked that pertussis

section of the revised Memorandum should be submitted to the CSM for endorsement and

then to the Licensing Authority to discuss with manufacturers so that the data sheets and

the  Memorandum  would  be  compatible.                    

suggested  that  advice  should  be

followed and that members should submit their comments in writing to the Chairman.

                hoped that there could be informal discussion with the manufacturers of areas

of agreement or debate and                    noted that the new pertussis guidelines would be

produced at a time of a continuing pertussis litigation.                     asked if there was likely

to be a change in pertussis vaccine in the near future as this might promote difficulties if

the contra-indications were also to change.                 agreed that the pertussis section should

be sent to CSM….”

 

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 The following “commercial in confidence” CSM/JCVI/Joint Sub-Committee ARVI meeting held on 2nd October 1987 (http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306), reveals how the CSM dealt with the burden of responsibility over the revised pertussis contraindications issue:

(6.4 JCVI’s Revised Contra-indications to Pertussis Vaccine)

“_________reported that the discrepancy between JCVI recommendations and manufacturers product licenses had been discussed at CSM who had upheld JCVI’s right to issue advice to the profession.”

               reported  that  a  meeting  was  shortly  to  be  held  with  the  Pharmaceutical Industry to find common ground on issues such as this.                                           stated that DHSS Solicitors views  of  this  discrepancy  had  been  sought  and  had  been  advised  that  there  was  no obligation on JCVI’s views to conform with the manufacturers product licenses when those views represented the advice of expert medical opinion.”

We see here that unlike the manufacturers, the CSM had endorsed the proposed revisions of contraindications to pertussis vaccine and their view was held by the DHSS Solicitors as superior to that of the vaccine Licensing Authority. This indeed is the case, since in the UK licensing process when applying for a licence, the pharmaceutical company will first submit a file to the Medicines and Healthcare products Regulatory Agency (MHRA) and the CSM within the MHRA will then review the application and produce an independent assessment. Following that, the CSM will issue a recommendation to the Licensing Authority that a licence is granted (http://www.ukmi.nhs.uk/ Med_info/licensing_process.pdf).

The CSM’s competence as a body of medical experts and the reliability of their advice can be assessed from the notes of the preceding “commercial in confidence” CSM/JCVI/Joint Sub-Committee  ARVI  meeting,  held  on  6th    July  1987   (http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306):

(6.1 Whooping cough)

“In conjunction with Tabled Paper 1 and an unnumbered agenda paper the Secretary summarised the present position regarding the Loveday litigation for the benefit of new members. He  explained  that in February the CSM had called for ARVI’s advice about updating the statement made in the 1981 report on Whooping Cough (HMSO) about a possible link between DTP immunisation and serious neurological illness. It had been hoped that by this means ‘discovery’ of all the relevant JCVI, CSM and ARVI documentation on whooping cough vaccine could be avoided. However, by the time                                                            could report a revised statement to CSM (see minutes of February 1987 meeting) it was already clear that nothing could be done to avoid ‘discovery’. Subsequently, the Chairman of CSM asked ARVI to keep a watching brief on the situation, and to let the Main Committee know if at any time it was thought possible to modify further the statement.”

The contents of the controversial statement that the CSM appeared to be eager to modify, in order to avoid potential legal consequences, have been disclosed to the JCVI/Joint Sub- Committee ARVI members on “commercial in confidence” meeting on 6th    February 1987 ob t a i n e d  t h rou gh  FOI  ( http://ww w.dh.g o v.uk/en/F r eedo mO f Inf o r matio n/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306):

The notes of that meeting in the section “7.1 Whooping cough vaccine –CSM advice” read: “No scientifically unassailable link has been established between DTP immunisation and serious neurological illness but we have come to conclusion, on the basis of all present evidence, that there is a prima facie case that such a link may exist. We would also agree that the evidence suggests that the vaccine causes convulsions in some children.”

 

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 Thus, the “best available knowledge” on which the CSM “upheld the JCVI’s right to issue advice to the profession on restricting contraindication to pertussis vaccination can be summarized as follows:

Both the CSM and the JCVI/Joint Sub-Committee ARVI seemed to have been fully aware of the fact that the pertussis vaccine could cause convulsions and adverse serious neurological outcomes in a sub-set of children. Apparently, the CSM and the JCVI/Joint Sub-Committee ARVI have then attempted to avoid “‘discovery’ of all the relevant JCVI, CSM and ARVI documentation”. Does this suggest that the top UK authorities responsible for sound vaccination policies were not as much concerned about putting certain children at risk of serious vaccine-induced neurological harm, as they were of legal repercussions that might have followed in the event that any of the “relevant” documents were to reach the public?

Finally, rather than being in line with public health interests, those responsible for the safety of medicines and sound vaccination practices appeared to have been more aligned with the interests of vaccine manufacturers. This is implied by the following discussion from the transcript of the “commercial in confidence” CSM/JCVI/Joint Sub-Committee ARVI meeting  held  on  6th    June  1986   (http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306), at which members of the US Centers for Disease Control (CDC) were also present. In discussing the significance of the NCES report on pertussis vaccine injury it was noted:

(6. Litigation and pertussis vaccination)

“6.1            referred to the June issue of the American Journal of Diseases of Childhood. He said that between 18 and 22 million doses of DPT were manufactured annually in the United States prior to the difficulties concerning whooping cough vaccine and litigation… Since 1985, the price of the vaccine has risen from 40 cents per dose to $ [unreadable] per dose in 1986 and it is expected to rise to $11 per dose. Litigation claims per year have risen from virtually nil in 1978/79 to over 219 in 1985, claiming [unreadable] billion US dollars, and  litigation  suits  follow  a  similar  pattern.  The  total  amount  claimed  has  likewise increased greatly.”

“6.2            said that out of court settlements had not been included in these figures. It was difficult to protect manufacturers against such heavy compensation claims. The situation had been aggravated by an organisation called ‘Dissatisfied Parents Together’. The Hawkins Congressional Commission suggested that claimants might go into a system with a Panel and if accepted would be given an award of $1 million or alternatively accept court settlement. There was also a Bill before the American Government which suggested that punitive damage be done away with and that damages for pain and suffering only be awarded.”

Over the subsequent years the trend of restricting contraindications criteria by the JCVI in order  to  increase  vaccination  rates  continued.  On  20th    October  1988   (http:// www.dh.gov.uk/ab/DH_095169):

(6.2 Health Education Authority (HEA) publications on MMR)

“Members pointed out that the Data Sheet for MMR vaccine suggested that it should not be given before the age of 15 months and also that the vaccine should be given subcutaneously (and not by deep subcutaneous or intramuscular injection as suggested in the Memorandum). The difficulties of changing the Data Sheets to agree with the advice in the Memorandum “Immunisation Against Infectious Disease” were discussed.”

What also continued is the JCVI’s confidential meetings with vaccine manufacturers, which appeared to be focused on vaccine policy and business rather than child health and safety. In reference to the meeting of the Chairman of the JCVI and the Association of British Pharmaceutical Industries, the transcript of the JCVI meeting on 23rd  October 1987 (http:// www.dh.gov.uk/ab/DH_095169) states:

“Also discussed was the availability of scarce vaccines and the introduction of new vaccines into more regular use. The question of financial support for training members of the health

 

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 service in immunisation was also discussed.” (18. Meeting of the Chairman of the JCVI and the Association of British Pharmaceutical Industries)  It ought to be asked why the Chairman of the JCVI deemed as appropriate for members of health services to be financially supported by the vaccine manufacturers.

On further relations between the JCVI and vaccine manufacturers, the transcript of the

JCVI meeting on 4th  May 1990 (http://www.dh.gov.uk/ab/DH_095169) reveals that:

(2. iv.)

“The Chairman said that Departmental officials had recently met vaccine manufacturers who were keen to be informed, in confidence, of the outcome of JCVI discussions which might affect their own plans. Agreement was sought from the committee on the appropriateness of a summary of such discussions, cleared by the Chairman, being provided to manufacturers. The Committee agreed to this. In connection with this Professor Hull brought to the Committee’s attention a recent letter he had received from a GP, the contents of which indicated, and the Chairman and committee agreed, a continuing communication problem on the relationship between JCVI advice and manufacturer’s data sheets. Dr Salisbury said he was aware of this particular correspondence.”

Incidentally, this is the same Professor Hull who, 8 years later, on 6th    July 1998,  was prompted to write to Professor Zuckerman at the Royal Free Hospital in London, to express his concern about the work of Dr Andrew Wakefield, who investigated the histories of 12 children with regressive autism and gastrointestinal symptoms that appeared to be linked to the MMR vaccine (http://www.circare.org/autism/hull_zuckerman_19980706.pdf).

In summary, by making persistent efforts in restricting vaccination contraindication criteria, so  that  more  children  could  be  vaccinated,  the  JCVI  appeared  to  have  prioritized vaccination policy over vaccine safety. In doing so, both the JCVI and the CSM (which actively supported the JCVI’s amendments) may have shown a disregard for the safety of children. Furthermore, together with ARVI and the CSM, the JCVI attempted to avoid “’discovery’ of all the relevant documentation” and thus perhaps evade potential legal repercussions. By seemingly siding with vaccine manufacturers rather than public health interests, the CSM/JCVI appear to have signally failed their fiduciary duty to protect individuals from vaccines of questionable safety and thus possibly shown incompetence in their role in the public health service.

4)   Persistently  relied  on  methodologically  dubious  studies,  while  dismissing independent research, to promote vaccine policies.

Over the years, the JCVI has consistently promoted the MMR vaccine as safe, based on studies that have proven to be either irrelevant, inconclusive, or methodologically questionable. There was also a marked tendency by the JCVI to rely on epidemiological work to support the MMR policy. For example, in a discussion of a population-based study by Fombonne and Chakrabarti [5], which found no link between the MMR vaccine and autism, at the JCVI meeting on 2nd   November 2001 (http://www.dh.gov.uk/ab/JCVI/DH_095044):

(7.1)

“The Committee agreed that this data from Dr Fombonne was persuasive and indicated that the frequency of regressive autism appeared not to have increased.”

The problem with epidemiological studies is that they only test for “association” and not “causation”, thus providing unreliable estimates of true risks. Regarding the alleged safety of the MMR vaccine, the most comprehensive independent evaluation done on this subject, by the Cochrane Review (October 2005, http://www2.cochrane.org/reviews/en/ab004407.html), is hardly reassuring.

 

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 Although the Cochrane Review found no significant evidence of an involvement of the MMR with either autism or Crohn’s disease, none of the 31 studies included in the review met the Cochrane Collaboration’s methodological criteria.

In fact, one of the major conclusions from the Cochrane’s 2005 MMR review was:

“The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post- marketing, are largely inadequate.”

More specifically, referring to the 2001 Fombonne and Chakrabarti study which the JCVI regarded as “persuasive” in disproving the link between the MMR vaccine and autism, the Cochrane review made the following remark:

“The number and possible impact of biases in this study was so high that interpretation of the results is impossible.”

While historically, the JCVI tended to be quick in accepting those studies which dismissed safety concerns over the MMR or other vaccines, it was inert in accepting those which indicated that concerns were warranted. At the JCVI meeting on 1st   November 2002 (http://www.dh.gov.uk/ab/ JCVI/DH_095044), the members discussed recent scientific research on the MMR where:

“The Committee was provided with recent research published on the safety of MMR, in particular the link with inflammatory bowel disease and autism. The following papers had undergone review by experts:

1.  “Neuro-immunopathogenesis  in  Autism”  V  Singh.  New  Foundation  of  Biology  2001,

447-458.

2. Abnormal measles-mumps-rubella antibodies and CNS auto-immunity in children with autism. V Singh et al. Biomedical Science 2002; 9; 359-364

3. Small intestinal enteropathy with epithelial IgG and complement deposition in children with regressive autism. Torrente et al. Molecular Psychiatry 2002; 7(4);375-382

4. Development of an “allelic discrimination” type assay to differentiate between the strain origin of measles virus detected in intestinal tissue of children with ileocolonic lymphonodular hyperplasia and concomitant development disorder. O Sheils et al. Abstract presented at the Pathological Society of Great Britain and Ireland in July 2002.

5.  Review  article:  the  concept  of  entero-colonic  encephalopathy,  autism  and  opioid receptor ligand. A Wakefield et al. Alimentary Pharmacology and Theraputics 2002; 16:

663-674.” (10.2 Recent scientific research)

The conclusions were:

“that this new evidence did not alter the CSM view: there was no evidence to support a causal link between MMR vaccine and autism and bowel disease. JCVI found the papers helpful and expressed its strong support for the conclusion reached by the CSM.”

As it will be evident from Section 8), the JCVI attitude towards vaccine safety, particularly the MMR, has not changed and to this day, the Committee still regards it as safe. On the other hand, independent research is accumulating to suggest otherwise. Only a year after the 1st   November

2002 JCVI meeting, Singh and Jensen found more evidence to support an aetiological role of the measles virus component of the MMR vaccine in autism [6]. Using enzyme-linked immunosorbent assay, Singh and Jensen found that children with autism, unlike their siblings or normal children, had significantly elevated levels of measles antibodies in their sera. Antibodies against rubella and mumps did not significantly differ between these groups of children, however, immunoblotting screen against measles vaccine virus (source Merck&Co) showed that 43 out of 52 (83%) autistic children, but none of the 30 normal children or 15 siblings of autistic children, had antibodies against the measles vaccine virus. Since none of the children in Singh and Jensen study had any prior  history  of  measles  rash  or  wild  type  measles  infection,  but  they  all  have  had  their immunisation with the MMR, the authors concluded [6]:

 

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 “This  vaccine  in  a  small  population  of  genetically  predisposed  children  may  perhaps manifest an atypical measles infection that does not yield a clinical rash but produces neurologic symptoms similar to those seen in children with autism.”

and

“Although more research is necessary to uncover the etiology of autism, the hyperimmune response  to  measles  virus  might  indicate  virus  reactivation  that  triggers  a  misguided humoral immune response in children with the disorder.”

Finally, far from being “discredited” and “flawed” as suggested in latest editorials published in the BMJ [7], the “Wakefield’s hypothesis”, which indicates that there is “a pattern of colitis and ileal- lymphoidnodular hyperplasia in children with developmental disorders” [3], is now supported by more independent research [8-12]. Notably, several respectable publications suggest that the principal findings of the Wakefield’s 1998 Lancet study should not be discarded nor ignored. For example:

Quigley and Hurley [13]:

“Wakefield et al. are to be congratulated on opening yet another window onto the ever- broadening spectrum of gut/brain interactions. Their findings raise many challenging questions that should provoke further much-needed research in this area, research that may provide true grounds for optimism for affected patients and their families.”

Most recently, at the meeting on 2nd   February 2011 (http://www.dh.gov.uk/ab/JCVI/DH_123529), the  JCVI  dismissed  the  relevance  of  a  paper  by  world-renowned  autoimmunologists  Professor Yehuda Shoenfeld and Nancy Agmon-Levin [14], which raised serious concerns about the role of vaccine adjuvants in vaccine-related autoimmune conditions.

(XII. Papers for information and any other business, 61.)

“The  committee  discussed  a  review  paper  by  Shoenfeld  and  Agmon-Levin  (2010)  on

autoimmune/inflammatory syndrome induced by adjuvants, in particular on the role of adjuvants in the pathogenesis of four conditions: siliconosis, the Gulf war syndrome (GWS), the macrophagic myofasciitis syndrome (MMF) and post-vaccination phenomena. The committee considered that the paper did not provide convincing data on the role of adjuvants in these four ‘enigmatic’ medical conditions and that the review did not raise safety concerns about the use of adjuvants.”

5)   Persistently  and  categorically  downplayed  safety  concerns  while  overinflating vaccine benefits.

The sharp increase in litigation claims over pertussis vaccine injury between 1978/79-1985, presented an additional challenge for the CSM/JCVI/Joint Sub-Committee ARVI, as increased efforts were now needed to reassure the public in the safety of the pertussis vaccine.

In the transcript of the “commercial in confidence” CSM/JCVI/Joint Sub-Committee ARVI meeting  held  on  7th     February  1986  (http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306), ARVI made the following comments on a confidential paper:

(Item  5.1  ARVI’s  comments  on                vaccine damage”) paper     “Whooping cough disease, vaccination,

             deprecated the use of the term ‘brain damage’ which the public might consider as a permanent entity. The public may not also understand the significance of febrile convulsions.”

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 Are we to assume that ARVI had not been aware of a certain controversial statement made by the CSM in the 1981 in a report on Whooping Cough about a possible link between DTP immunisation and serious neurological illness?:

“No scientifically unassailable link has been established between DTP immunisation and serious neurological illness but we have come to conclusion, on the basis of all present evidence, that there is a prima facie case that such a link may exist.” (JCVI/Joint Sub- Committee ARVI “commercial in confidence” meeting on 6th   February 1987, section “7.1

Whooping cough vaccine –CSM advice”; http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306)

Perhaps the reason why ARVI “deprecated the use of brain damage” is because of their firm belief that vaccines could not be associated with such events. Apparently, the possibility that vaccination could cause permanent brain damage must have been considered as an outrageous assertion, so much so that it did not even deserve scientific scrutiny. In fact, following a discussion on a proposal for the surveillance of severe neurological disorders in infancy and their relationship to pertussis va ccin e  on  7 th    F e b r u a r y  1 9 8 6  ( http://ww w.dh.go v.uk/en/Fr eedo mO f Inf o r matio n/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306), CSM/JCVI/Joint  Sub- Committee ARVI jointly concluded that:

(6.5.1)

“It was considered unreasonable to ask paediatricians to report for a period of six years.” Under the same agenda, the CSM/JCVI/Joint Sub-Committee ARVI also decided that:

(6.5.1)

“No attempt would be made to study serious neurological disease arising from pertussis and other infectious diseases.”

Obviously without such a standard, it would have been quite impossible to assess whether vaccination against pertussis caused more severe brain damage than natural pertussis infection. If concerns about pertussis vaccination were indeed unsupported and only a product of an inexpert “perception of the public” as ARVI’s statements would led us to believe, then surely such a study would have just reinforced the notion that vaccines are safe. However, it appears that according to the CSM/JCVI/Joint Sub-Committee ARVI’s problem-solving rationale, instead of encouraging further research, it seemed more acceptable to downplay safety concerns over possible vaccine-injury, which then justified their decision to take no further investigation into the matter. Unwillingness to carry out this specific research is perplexing indeed, in light of what was noted at the 3rd  November

1981 meeting (http://www.dh.gov.uk/ab/DH_095169) in section 5 on Whooping Cough:

(5.d. Comments on Professor Stewart’s letter)

“Professor Gilliatt observed that in the Meade Panel Study one-third of children with brain damage were not admitted to hospital. In both the Meade and Dudgeon studies there were examples of children who had a fit soon after vaccination which was followed by a fit at a later time and then followed by cessation of development. It was very difficult to assess this as a random event…The Chairman concluded that much was not known about the natural history of brain damage in the young.”

Are we meant to believe that “cessation of development” following episodes of vaccine-associated fits does not fit into the category of “permanent entity” and/or “brain damage”?

As for the public’s alleged misunderstanding on the significance of febrile convulsions, the transcript notes of the “commercial in confidence” CSM/JCVI/Joint Sub-Committee ARVI meeting  held  on  6th    June  1986   (http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306) are particularly enlightening:

In discussing the significance of the NCES report on pertussis vaccine injury:

(5.2 Encephalopathy)

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 “The report used the NCES estimation of relative risk of 3:1, it was estimated that one third of such cases have permanent handicap one year from their onset (as derived from the NCES).”

(5.3 Complex Febrile Convulsions)

“These were defined as being of more than 10 minutes in duration, or repetitive over 24 hours…Va ccine could cause such seizures and it was believed that 10 per cent of such complex seizures could result in permanent handicap…”

Perhaps the public would have been better acquainted with the significance of febrile convulsions and the fact that pertussis vaccine could cause them, had not:

“The Chairman reminded members that the proceedings, papers and information before them [were] confidential and should not be disclosed.”

Paradoxically,  at  the  prior  meeting  on  7th    February  1986   (http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306), at which ARVI stated it “deprecated the use of the term brain damage”, the CSM/ JCVI/Joint Sub-Committee ARVI acknowledged:

(6.5.1)

“that the NCES may have missed cases of severe neurological disease which progressed to handicap among children who were not admitted to hospital.”

Going  back  to  the  meeting  that  followed,  on  6th    June  1986   (http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306):

(5.7)

“In the general discussion which followed, some members of the Committee felt that the report [referring to the American Medical Association (AMA) panel report on Pertussis Vaccine Injury, published in JAMA 1985; vol 254, pages 3083-3084] not only accepted the fact that vaccine damage was a real phenomenon but implied (by the way it was written) that it was commoner than was believed to be the case in the UK.”

Notably, according to the notes of the “commercial in confidence” CSM/JCVI/Joint Sub- Co mmittee  ARVI  m e e t i n g  o n  3rd    O c t o b e r  1 9 8 6  ( http://ww w.dh.g o v.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306), the AMA panel report had been prepared:

(5.2)

“…with the particular intention of providing information for legislators as to what type of vaccine-associated event might require compensation, if Federal compensation for presumed vaccine injury were to be introduced.”

Perhaps it is because of this that the CSM/JCVI/Joint Sub-Committee ARVI:

(5.2)

“…agreed that the document contained a number of assertions which could not be accepted.”

One has to wonder whether such assertions unacceptable to the CSM/JCVI/Joint Sub- Committee ARVI include:

“…the fact that vaccine damage was real a phenomenon” and “commoner than was believed to be the case in the UK.” (CSM/JCVI/Joint Sub-Committee ARVI meeting on 6th Ju n e  1 9 8 6 ;  i t e m  5 . 7 ;  http://ww w.dh.go v.uk/en/F r eedo mO f Inf o r matio n/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306)

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Other than perceiving health hazards associated with certain vaccines as a danger to overall routine immunisations, the JCVI felt that certain health professionals were also negatively affecting the vaccination policy by exercising more caution with regards to contraindication criteria than the JCVI deemed appropriate (for a remainder of the JCVI’s position with regards to contraindication criteria refer back to Sections 2) and 3)). In a Summary Report on an investigation of failure to reach a measles immunisation uptake in the Maidstone Health Authority, at the Joint Working Party of the BPA and the JCVI Liaison group  meeting  on  30th    September  1986  (FOI  release,  86/3rd    meeting;   http:// w w w . d h . g o v . u k / e n / F r e e d o m O f I n f o r m a t  i  o n / Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4140335),  the  member whose name was erased from the transcript commented that:

(7.)

“…the paper described a position which was still bedevilled by false contra-indications to measles vaccination.”

Apparently,

             commented that often parents wanted the vaccine given but were dissuaded by health service staff.                  stressed the need for training of health professionals and the Chairman considered that the ‘responsible person’ in each district (quoted in previous circulars) should organise such a training.” (7. Measles vaccination: Summary Report on an investigation of failure to reach a measles immunisation uptake in the Maidstone Health Authority)

In a later meeting (JCVI 7th  November 1986; http://www.dh.gov.uk/ab/DH_095169):

(9. BPA/JCVI Working Group)

“Members agreed that the most disturbing feature was that a minority of health professionals could exert a disproportionally bad effect on a campaign.”

What the JCVI’s perception of a “responsible person” might be, is perhaps best understood in the light of their bewildering leniency towards vaccine safety and a seeming tendency to align with the manufacturers’ interests more than those of public health.

By 18th   November, the JCVI had an elaborate strategy to improve measles vaccine uptake (as  documented  in  the  transcript  of  the  JCVI  meeting  on  1st      May  1987;   http:// www.dh.gov.uk/ab/DH_095169), which included:

(discussion about a PHLS meeting on 18th  November on the uptake of measles vaccine)

“GP clinics where immunisations were given should be more attractive and use every opportunity of attendance at clinics to offer immunisation; this is especially important for deprived families.”

It was also recommended that:

“Regional  and  District  Health  Authorities  (DHAs)  should  be  accountable  for  their vaccination performance.”

Since:

“All the members agreed that accountability with regard to immunisation was most important. The Chairman is summing up said that immunisation was a most important NHS Policy and that recommendation before them, after editing, should be put to the NHS Management  Board  and  then  promulgated  to  the  NHS  with  a  separate  copy  to  the nominated persons in the districts.”

That “immunisation was a most important NHS Policy” is also implied in a discussion on whooping cough at the JCVI meeting on 3rd    November 1981  (http://www.dh.gov.uk/ab/ DH_095169):

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(5.d. Comments on Professor Stewart’s letter)

“The meeting then considered Professor Stewart’s paper on deaths from whooping cough in Great Britain (JCVI(81)12). Dr Williams, referring to page 5 of the paper, said that deaths from whooping cough tended to be under-notified…On the other hand, at times of outbreaks of whooping cough the disease tended to be over-notified; this had the effect of lowering fatality ratio.”

In the ensuing discussion:

“The Chairman concluded that it would probably not be wise for the Committee to make a formal reply to this paper. (Members also thought that controversial replies to correspondence to the medical journals might not add support to the whooping cough vaccination campaign.)”

In the following years, the members of ARVI continued to “express anxieties” over eroding confidence of the public in pertussis and other vaccines. In a Joint Sub-Committee ARVI meeting on 8th    March 1988, the members recommended that a monitoring system  for vaccine reactions should be set up, which would cope with any vaccine related “adverse publicity”  (item  7,  Adverse  Reactions  Surveillance;   http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306; note that this meeting was incorrectly noted as March 1998 rather than March 1988).

While the public appeared to have lost the confidence in the safety of the pertussis vaccine by the mid 80s, in 1989, the JCVI was still debating on whether or not the pertussis vaccine caused permanent brain damage. Referring to the NCES report it was generally accepted by the JCVI that if the vaccine led to severe neurological outcomes, it did so very rarely (JCVI meeting  on  3rd    November  1989;  http://www.dh.gov.uk/ab/DH_095169).  Finally,  it  was agreed  that  the  statistical  data  of  attributable  risk  should  be  removed  from   the Memorandum since, according to Dr Salisbury:

“If the public was given a risk ratio — any ratio — they would still see it as a scientifically proven risk. It was therefore preferable not to use insecure figures if possible but to stress the benefits from vaccination.” (12.1 Whooping cough – article by Dr A H Griffith in Vaccine etc JCVI (89)32)

Regarding  the  alleged  overall  “benefits  from  vaccination”,  it  is  worth  mentioning  that  in  a discussion  about  Diphtheria  outbreaks  in  immunised  populations  on  22nd    April  1988  (http:// www.dh.gov.uk/ab/DH_095169), the JCVI acknowledged that these do in fact:

(16.1)

“occur in well-immunised populations…”

In  addition,  the  decision  to  include  mumps  in  the  routine  vaccination  schedule  with  the introduction of the MMR in 1988 goes against JCVI’s own past advice, as evidenced by a discussion about the usefulness of the mumps vaccine in the JCVI meeting on 11th   December 1974 (http:// www.dh.gov.uk/ab/JCVI/DH_095052):

(10.)

“The Committee agreed that there was no need to introduce routine vaccination against mumps.”

because

“complications from the disease were rare.”

Granted, opinions can change with time as new scientific evidence becomes available. Even so, the arguments are against routine mumps vaccination. Mumps in adults but not in children can cause mumps orchitis, a serious condition which may result in male sterility. Mumps outbreaks in older

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 individuals increased in frequency since the introduction of the MMR into the routine schedule, most likely because of the poor effectiveness of the mumps component of the vaccine.

In a comprehensive assessment on mumps orchitis in the post-vaccine era, which included epidemiologic, clinical, therapeutic, and follow-up studies and outcomes of 609 patients, Ternavasio-de la Vega et al. [15] reported:

“Mumps  orchitis  is  the  most  common  complication  of  mumps  infection  in  young postpubertal males. Testicular compromise is characterized by an abrupt onset of unilateral or bilateral marked scrotal swelling and pain, accompanied by constitutional symptoms and fever. Immunization programs against mumps have reduced the number of reported cases and influenced their age distribution. Since the introduction of mumps vaccine in 1967 (the year the first mumps vaccine was licensed in the United States), a shift in the age of peak incidence of mumps from children aged 5-9 years, in the prevaccine era, to children and young adults aged 10-24 years has been observed. Serious complications have appeared as a consequence because of the higher rate of sequelae among the older age-group. The principal complication of acute mumps orchitis is the atrophy of germinal epithelium with spermatogenesis arrest, which in turns leads to male sterility.”

The evidence for the poor effectiveness of the mumps vaccine has recently been reported by

Castilla et al. [16]:

“This study adds to the literature showing moderate effectiveness of the mumps vaccine containing the Jeryl Lynn strain, which seems to be related with early and progressive waning immunity. This effect, seen in children vaccinated with both one and two doses, makes it difficult to control the disease even when high vaccination coverage is achieved, and leaves open the possibility that outbreaks will occur when the infection is reintroduced.”

“Our results indicate that this effect of waning immunity begins early, as seen in the fact that 3 or more years after the second dose of MMR vaccine, the risk of mumps was 10 times higher. This increased risk does not appear to be linear, but rather is accentuatedover time.”

Hence, routine mumps vaccination has shifted a childhood disease to adolescents and young adults, groups with a higher incidence of adverse long-term complications and sequelae. By contrast, the benefits of naturally acquired immunity against mumps in early childhood are life-long protection against mumps and its serious complications later in life.

Curiously,  at  the  meeting  held  on  17th    September  1990   (http://www.dh.gov.uk/ab/JCVI/ DH_095294), the JCVI also acknowledged the consequences of shifting mumps infections to older age groups:

(6.5)

“It was noted that the introduction of mumps immunisation could in theory shift the age specific infection rates to the older age groups in whom the complications were greater;”

However, the Committee concluded:

“…nevertheless, the gains from the progressive reduction in mumps illnesses outweigh such concerns.”

It would appear that in following the JCVI’s line of reasoning, one must conclude that the alleged benefit of eradicating mumps in young males where the illness is mild and “complications are rare”, outweighs the risk of male sterility.

Similar to mumps, the complications from rubella early in childhood are minimal, hence it may be argued that vaccination against both rubella and mumps are of little clinical benefit to a child. Serious complications from rubella may occur in a developing foetus of a pregnant woman who has contracted rubella during her first trimester. In such cases a child may be born with congenital rubella  syndrome  (CRS),  involving  multiple  congenital  abnormalities.  The  risk  of  CRS  can  be reduced either by making sure all women have caught rubella as children or by vaccinating those

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 who have not prior to puberty. Hence, the current JCVI’s policy of vaccinating every child, male and female, against rubella does not appear to be justified.

Finally, apart from “no need to introduce routine vaccination against mumps” , the decision to introduce the MMR into a routine schedule was in conflict with the JCVI’s past concerns about risks associated with simultaneous administration of multiple live vaccines. Curiously, the MMR vaccine developed by MSD was first licensed in the UK in 1972, but not marketed until 1988. An indication as to why it took 16 years to introduce it in to a schedule may be found in the same meeting which discussed  the  usefulness  of  the  mumps  vaccine  (JCVI  meeting,  11th    December  1974;  http:// www.dh.gov.uk/ab/JCVI/DH_095052):

(11 Simultaneous administration of live vaccines (CHCS(VI)14))

“The Chairman refereed to the 3 vaccines which had been licensed for Merck Sharp and Dohme and asked for comments on the company’s claim that these could be administered simultaneously with live poliovirus vaccine. This use of the vaccine appeared to conflict with the Committee’s published advice and they had to consider (a) whether this advice should be changed and (b) if the vaccine concerned viz MMR, Biavax and Measles and Rubella virus vaccine and live MSD could be given with live poliovirus vaccine. Professor Dick and Dr Warin pointed out that an interval in the administration of live vaccines had been advocated in view of the probability of adverse reactions and because of the recent publicity surrounding adverse reactions. The Committee agreed that it would be inopportune to change the guidance that an interval of at least 3 weeks should be allowed to elapse between the administration of any 2 live vaccines whichever came first.”

Perhaps unknown to most lay people as well as medical professionals is the issue of vaccine contaminants which is somewhat inherent to the vaccine production process. In this regard, one particular item discussed under the section 3.4. Ruminant and Human Materials used in Vaccine Manufacture, at the JCVI meeting on 4th   May 2001 (http://www.dh.gov.uk/ab/JCVI/DH_095044), deserves special emphasis:

(3.4.1)

“This  report  was  provided  for  information.  The  Committee  asked  by  which  date  the vaccines already distributed would no longer include any whose production process may have involved the use of potentially BSE [Bovine spongiform encephalopathy] infected Category 1 or 2 material. The Committee was told that Category 1 material was only used at the master seed/working seed stage of the manufacture of a very few vaccines, not in routine vaccine production itself. Many vaccines are produced from master seeds which were manufactured many years ago…Master seed material often antedated the BSE epidemic in the UK, and was diluted many fold to the extent that any exposure to infected material, if ever present, would be remote.”

How many people would feel comfortable with taking medicinal products derived from potentially BSE-contaminated material? As to why such vaccines continued to be used:

(3.4.1)

“There is reluctance to establish new master seeds for vaccines which have long history of use because such a change could possibly change the vaccine characteristics which may adversely impact safety and efficacy.”

Indeed, removing sources of possible BSE contamination from vaccine manufacture would have no doubt “impacted safety”; it would have made vaccines safer.

Curiously, when asked by the JCVI:

(3.4.3)

“…to consider whether it would be possible to put the information it had summarised on vaccine manufacturing and excipients in vaccines into the public domain; the MCA would consult their lawyers on this point.”

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 If there was no risk of contracting BSE from a vaccine, then why did the MCA have to consult their lawyers “on this point”?

At the same meeting, on 4th  May 2001 (http://www.dh.gov.uk/ab/JCVI/DH_095044), the Committee discussed:

(4.5.1)

“… suspected adverse reactions categorised as serious to DTP/Hib, polio, BCG, hepatitis A and B vaccines over the last three years. The data was based on Yellow Card reports received by the MCA.”

and it showed the following:

“i. DTP/Hib – the overall pattern and type of suspected reactions in 2000 were similar to previous years, with the exception of an increase in the number of respiratory reactions. Most of the increase appeared to be due to an increase in number of SIDS (5) and apnoea type reactions (14) being reported.

ii. Polio – The types of suspected reactions reported in 2000 were on the whole similar to previous years. The only differences appeared to be an increase in the number of cardiovascular, eye and respiratory reactions reported.

iii. BCG – Overall the types of suspected reactions reported were similar with the exception of an increase in number of cardiovascular reactions in 1999 and musculo-skeletal reactions in 2000.

iv. Hepatitis B – The types of suspected reactions reported on the whole had been similar, with a notable decrease in the number of serious cardiovascular, eye, immune system, musculo-skeletal and neurological reactions being reported.

v. Hepatitis A – The types of suspected reactions being reported were on the whole fairly similar.  However,  there  were  three  notable  differences:  a  significant  increase  in  the number of cardiovascular and musculo-skeletal reactions reported in 2000, and a significant increase in the number of immune system disorder reactions reported in 1999. All these type of reactions were recognised side effects of this vaccine.”

(4.5.2)

“Overall, there were no new safety issues identified.”

Perhaps these were not new issues, just old persisting ones. Nonetheless, in all but one case (Hepatitis B), the number of serious adverse reactions appeared to have increased and in some cases this was not only significant but also a “recognised side effect of this vaccine” (Hepatitis A). In spite of this:

(4.5.2)

“The Committee was not persuaded given all the inherent uncertainties of spontaneous reporting that there were significant problems developing.”

If anything, the Committee previously appeared to have acknowledged that there were problems with underreporting of adverse reactions to vaccines. In a Report of North Herts Immunogenicity Study on the 1st  May 1992 meeting (http://www.dh.gov.uk/ab/JCVI/DH_095050), it was noted that “the report of a cluster of CSF mumps virus positive cases in Nottingham had caused concern that national surveillance may have been underreporting the incidence of cases…”

As noted in the following Section (6), the Yellow Cards are a passive surveillance system, not routinely used by the GPs and hence, data on adverse reactions obtained through Yellow Card reports are likely to be an underestimate of the true rate of these events.

Finally, since the principal rationale for shaping vaccine recommendations and policies according to the JCVI was to keep vaccination rates as high as possible so that presumably, “herd immunity”

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 would be achieved, it would seem fair at this point to question exactly how well has this concept been  established?  The  theory  behind  vaccine-mediated  “herd  immunity”  appears  sound,  it maintains that vaccination of a significant portion of a population (herd), will provide a measure of protection for individuals who have not developed immunity. Obviously, transmission of a disease to the point where it would reach an epidemic is expected to be countered in a population where most individuals are thought to be immune. However, the concept of vaccine-mediated “herd immunity” is based on the assumption that vaccines are effective in conferring immunity to the individual.  If  this  were  so,  then  how  does  one  explain  outbreaks  of  infectious  diseases  in populations where over 95% of individuals have been vaccinated?

Gustafson et al. [17] “An outbreak of measles occurred among adolescents in Corpus Christi, Texas, in the spring of 1985, even though vaccination requirements for school attendance had been thoroughly enforced. Serum samples from 1806 students at two secondary schools were obtained eight days after the onset of the first case. Only 4.1 % of these students (74 of 1806) lacked detectable antibody to measles according to enzyme- linked immunosorbent assay, and more than 99 % had records of vaccination with live measles vaccine…After the survey, none of the 1732 seropositive students contracted measles.  Fourteen  of  74  seronegative  students,  all  of  whom  had  been  vaccinated, contracted measles. In addition, three seronegative students seroconverted without experiencing any symptoms. We conclude that outbreaks of measles can occur in secondary schools, even when more than 99 percent of the students have been vaccinated and more than 95 percent are immune”

(Note that if the measles vaccine was effective in providing herd-protection, then the <5% of children in this study who did not seroconvert would still have had protection from contracting measles. The whole premise on achieving high vaccination rates rest on the assumption that the herd  will  protect  those  vulnerable  individuals  who  have  not  been  vaccinated,  or  do  not seroconvert.)

Hersh et al. [18] “In early 1988 an outbreak of 84 measles cases occurred at a college in Colorado in which over 98 percent of students had documentation of adequate measles immunity (physician diagnosed measles, receipt of live measles vaccine on or after the first birthday, or serologic evidence of immunity) due to an immunization requirement effect since 1986.”

Tugwell et al. [19] “A chickenpox outbreak occurred in a school in which 97% of students without a prior history of chickenpox were vaccinated. Students vaccinated >5 years before the outbreak were at risk for breakthrough disease.”

It would thus appear that these vaccines only provide waning immunity, not herd immunity, as already well established in the case of the mumps vaccine by Castilla et al. [16] This often has the effect of shifting a relatively mild childhood disease to older age groups of children or young adults, in whom complications and sequelae from the disease are much more severe [15].

6)   Promoted and elaborated a plan for introducing new vaccines of questionable efficacy  and safety into the routine paediatric schedule, on the assumption that the licenses would eventually be granted.

On 7th   May1999 (http://www.dh.gov.uk/ab/JCVI/DH_095050), the JCVI met to discuss the use  of  the  new  conjugate  Group  C  meningococcal  vaccines. At  the  beginning  of  the meeting, Professor Hull, the Chairman:

“…reminded members that the minutes and proceedings of the JCVI were confidential. Politically and clinically sensitive material was dealt with by the Committee…”

It was further emphasised:

(8. Meningococcal meningitis, i.)

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“This  was  the  main  agenda  item  for  the  meeting.  Much  information  had  been  made available and important decisions were required of the Committee, particularly about the introduction of meningococcal Group C conjugate vaccine, of which three brands would soon become available. Any decision would be dependent on the granting of product licenses and the wording of those licenses and, during the discussion, the Committee had to act on the assumption that licenses would be granted. The MCA was responsible for the safety, efficacy and quality of vaccines. The question for consideration by the Committee was how it would recommend that the vaccine should be introduced.”

The Committee members were also once again:

“…reminded that this issue, and the papers presented, was extremely sensitive, commercially and politically. It was requested that confidentiality be maintained.”

The Chairman had then asked for any declarations of interest:

“Professor Cartwright was involved in manufacturers’ studies on the vaccines, including health trials. Dr Goldblatt was involved in one company-sponsored study and had provided a clinical expert report to the MCA for one manufacturer. Dr Jones was involved in trials for two of the companies involved. Dr Schild said that NIBSC was evaluating the vaccines.”

In spite of these substantial conflicts of interests:

“There were no objections to these members continuing to take part in the meeting and it was agreed that they would be able to provide a valuable input to the discussion in common interest.”

We are only left to speculate as to what such “common interest” might have been, between the JCVI and the pharmaceutical industry, bearing in mind several past instances where  the  Chairman  of  the  JCVI  met  with  the Association  of  British  Pharmaceutical Industries to discuss:

“…the availability of scarce vaccines and the introduction of new vaccines into more regular use. The question of financial support for training members of the health service in immunisation was also discussed.” (18. Meeting of the Chairman of the JCVI and the Association of British Pharmaceutical Industries, JCVI meeting on 23rd  October 1987; http:// www.dh.gov.uk/ab/DH_095169)

or where:

“The Chairman said that Departmental officials had recently met vaccine manufacturers who were keen to be informed, in confidence, of the outcome of JCVI discussions which might affect their own plans.” (2.iv. JCVI meeting on 4th  May 1990 (http://www.dh.gov.uk/ ab/DH_095169)

The apparent close ties between the pharmaceutical industry, JCVI and the DH perhaps explain why the DH funded studies were not adequately designed to detect long-term vaccine-related adverse outcomes. In discussing 8.4.1 Meningococcal C Conjugate (MCC) Vaccine Evaluation Programme, at the 7th   May1999 JCVI meeting (http://www.dh.gov.uk/ ab/JCVI/DH_095050), Dr Elizabeth Miller reported:

(i.)

“Papers  providing  data  on  the  new  vaccines’ safety  and  efficacy  and  data  from  the Department of Health funded studies were looked at; no other country had conducted similar studies. The Medicines Control Agency had also gathered lots of information and NIBSC was evaluating the vaccines. The data provided to the Committee related to the Wyeth product, which would be the first to become available. All available ADR [adverse reactions] data was included; the follow-up of ADRs had been up to the end of 4 to 6 weeks.”

It should be obvious that long-term adverse reactions cannot be identified if a study is not designed to detect them (and quite predictably there were none, since the DH funded

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 studies showed that the MCC vaccines were well tolerated, section 8.4.1. vii., 7th  May1999

JCVI meeting; http://www.dh.gov.uk/ab/JCVI/DH_095050). The reason for such omissions

in study design are bewildering, given the past safety issues with the measles vaccine,

where several children “were left one year later with severe handicap.” (7. Suspected

adverse reactions to measles vaccine: recent reports to the CSM, JCVI meeting on 17th   of

June 1983; http://www.dh.gov.uk/ab/JCVI/DH_120115)

Not  only  did  the  safety  of  the  new,  soon-to-be  introduced  MCC  vaccine  remain questionable, but also:

(ii.)

“There was no good evidence for the efficacy of the meningococcal Group C conjugate vaccine, only the surrogate of antibodies compared with those known to be protective against invasive disease. To actually test the efficacy on the conjugate vaccine it would be necessary to introduce the vaccine and then conduct a Phase III or Phase IV study to test efficacy; this would be very difficult to do and would delay introduction by 3-5 years.”

In the ensuing discussion we are told that the JCVI:

(iii.)

“…felt that it was important to plan the programme now and confirmation that the vaccines were equally effective could follow.”

In other words, the JCVI and the DH were actively working on a plan to introduce a vaccine with no demonstrable safety or efficacy into a routine paediatric schedule. Apparently, those responsible for sound safe and effective immunisation policies concluded that it was “very difficult” to conduct the necessary trials and they felt that this would unnecessarily delay the introduction of the MCC vaccine into a routine immunisation schedule.

What should have been considered by the JCVI is that vaccines represent a special category of drugs, generally given to healthy individuals and often to prevent a disease to which an individual may never be exposed [1]. Because of this, according to the US FDA, significant emphasis should be placed on vaccine safety  [1]. Thus, If there are uncertain benefits from a vaccine, only a small level of risk of adverse effects may be acceptable. If the benefits are certain, then a greater risk of side effects may be tolerated.  However, neither of these two points would have applied in the case of the MCC introduction programme, since there is absolutely no clinical benefit to a child from a vaccine that has neither been proven to be safe nor effective. The only “benefit” from such a programme would have been more in line with certain “common interests” rather than public health.

What followed at the 7th   May 1999 meeting (http://www.dh.gov.uk/ab/JCVI/DH_095050), was a discussion on priority groups to whom the MCC vaccine should be offered, in which Dr Smithson made a following remark:

(ix.)

“…there was very little to chose between the priority age groups but suggested that infants were easier to target.”

Finally, the Committee concluded that:

(x.)

“…if sufficient vaccine was available, all children should have it…”

In  the  following  meeting,  held  on  21st    January  2000  (http://www.dh.gov.uk/ab/JCVI/ DH_095050),  in  section  6.4  Meningococcal  C   Conjugate  (MCC)  Vaccine  Evaluation Programme, Dr Elizabeth Miller reported that several safety studies indicated that the new vaccine was not a cause for concern. Although,

(6.4.4)

 

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 “… headache, particularly if it was associated with muscle stiffness inevitably raised fears of actual meningitis, although the vaccine could not cause this.”

Furthermore:

(6.4.6)

“The Committee noted that this information would not have been available without the co- operation of the manufacturers. This had given everyone much more confidence in the vaccine programme and was a unique co-operation.”

In  the  following  meeting,  on  9th    October  2000   (http://www.dh.gov.uk/ab/JCVI/ DH_095050), the Committee was given an update on the safety profile of the MCC vaccine:

(7.6.2)

“The Working Party had received data available and had concluded that an association between MenC vaccine and seizures had not been proven. There had been 14 deaths reported. (2 further deaths had since been reported: 7 of the deaths were SIDS, 2 were meningitis B, 3 were in children with underlying conditions 1 was pneumococcal septicaemia, 1 was infantile encephalitis, 1 bronchiolitis and 1 child collapsed one month after immunisation with no cause of death being found).The Working Party believed that the deaths were all explained by other causes and that the vaccine was most unlikely to be implicated. By 21 September 2000, there had been 8.300 reports of 17,000 ADRs (1 ADR pern2,000 doses). The profiles were the same for each brand of vaccine.”

Note that the Working Party “believed” that the vaccine was not implicated. An even firmer belief in MCC vaccine safety was held by the JCVI:

(7.6.3)

“The Committee did feel that the MCA statement that there was “no evidence that the vaccine caused meningitis” was far too light: the vaccine categorically did not cause meningitis. The MCA Meningitis Working Party would consider this issue further…”

How the JCVI could claim with such definite certainty that the newly introduced and poorly tested MCC vaccine could not cause meningitis is not clear from the transcript. Amongst those who did not share  similar  views  with  regards  to  vaccine  safety  are Alexander  Harris  Injury  and Accident Solicitors and their clients, families whose children appear to have suffered severe long-term health  pr o blems  f o llo wing  MCC  v accinatio n.  F r o m  their  webs ite  ( http:// www.alexanderharris.co.uk/OurWork/ProductLiability/MeningitisCVaccine/Pages/default.aspx), we learn that safety concerns about MCC vaccine were first raised by the media (and not the UK health authorities) and that:

“Some 16,527 adverse reactions from 7,742 patients had been reported by GPs to the Medicines Control Agency through the Yellow Card reporting system. As well as reactions at the site of the injection such as swelling and soreness were other long-term reports which included seizures and 12 deaths.”

This appears to be consistent with the data reported at the JCVI 9th  October 2000 meeting. Further, the Solicitors made an important observation:

“The Yellow card reporting system is not routinely used by most GPs and healthcare professionals and as such the figures for adverse reactions are likely to be an underestimate. Despite the known under-reporting, the number of adverse reactions reported for Meningitis C vaccine is the highest for any vaccine within the UK immunisation programme.”

7)

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 8)   Actively discouraged research on vaccine safety issues.

On 14th  October 1985 a letter was issued to Dr Derek Zutshi (DHSS), from a member affiliated with the London School of Hygiene and Tropical Medicine at the University of London, whose name was erased from the copy of the letter prior its FOI release (http://www.dh.gov.uk/prod_consum_dh/ groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4140359.pdf):

“Dear Derek

Enclosed are comments on the estimates of vaccination-associated SIDS as presented at the recent ARVI meeting. I hope they prove helpful.

Let me add that this is a complicated problem, but one that I would be interested to pursue in the future.”

In three pages, the author of the letter made several comments on “Tabled Paper 1, (Appendix to ARVI/85/34)”, titled “Note on the estimation of sudden infant deaths expected to occur by chance after immunization”, authored by Paul EM Fine from the London School of Hygiene and Tropical Medicine. A balanced critical overview was given on three key points relevant to Paul EM Fine’s estimation of SIDS: “method used”, “data used” and “assumptions made”, outlining both strengths and limitations. In a final note, the author concluded:

“These brief comments  indicate a number of problems which arise in estimating the number of SIDS deaths expected to arise by chance, within 24 hours of vaccination, if there were no causal association between them. Some of these problems favour overestimation and others favour underestimation by the methods used in the DHSS note. Given the nature and direction of the biases, it is probable that the estimates presented in the DHSS note are of the correct order of magnitude. On the other hand, given the importance of the subject, a more thorough examination of the subject seems appropriate.”

Copies of this letter appear to have been forwarded to Dr M Graveney (DHSS) and Professor RW Gilliatt (JCVI).

Two months later, on 13th   December 1985, on the University of Nottingham, Department of Child Health’s letterhead, a member whose name was erased from the copy of the letter released under FOI   (http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/ digitalasset/dh_4140362.pdf), also wrote to Dr Derek Zutshi, to express his grave concerns about potential further investigations into the relation between vaccination and SIDS:

“Dear Derek

I showed the Tabled Paper 1, (Appendix to ARVI/85/34) to Richard Madeley [Department of Community Medicine and Epidemiology, University of Nottingham Medical School] and he kindly prepared the enclosed observations. I agree with everything that he has said. As you know, at the meeting I had grave misgivings about the exercise and of the assumptions that were made.”

In the following section, “Re: Note on the estimation of sudden infant deaths expected to occur by chance after immunisation”, apparently from the author of the “enclosed observations”, Richard Madeley, several reasons are given for his own misgivings “about the exercise”, some of which appear to be sound, such as:

(3. The hypothesis that immunisation may cause SIDS)

“c. Most deaths from SIDS occur before the age of four months2, when first immunisation takes place.”

(note, this still does not exclude the possibility that some cases of SIDS may be vaccine-related)  while others appear not as sound:

“d. There is no foolproof method of discrediting the hypothesis by statistical or epidemiological methods. On the contrary, there is a danger of getting drawn into a lengthy

 

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 argument about numbers which neither side could win, thus giving more credibility to the hypothesis than it deserves.”

(it ought to be noted that in the realm of science, a hypothesis can only be proven or disproven by experimental evidence and not by personal opinions)

In his “Final Comments and Conclusions” the author stated:

“For those reasons, I think it would be extremely unwise for the DHSS to get involved in any type of epidemiological work on this hypothesis. The hypothesis seems most unlikely on grounds of basic scientific reasoning, and such evidence as already exists points in the opposite direction.”

“To go ahead in these circumstances would endow upon the hypothesis a respectability which it does not deserve. It is impossible to disprove through numbers. To try to do so, using flawed assumptions, as in the memorandum of the DHSS Statistics Division, weakens the position.”

Indeed, epidemiological work would not be the most appropriate way to address the possibility that SIDS could be causally related to vaccination given that epidemiological studies only test for “association” and not “causation”. However, case control studies as well as post-mortem lab analysis should have been considered as viable alternatives to further research. Such as:

Ottaviani et al. [20] “Herein we report the case of a 3-month-old female infant dying suddenly and unexpectedly shortly after being given a hexavalent vaccination. Examination of the brainstem on serial sections revealed bilateral hypoplasia of the arcuate nucleus. The cardiac conduction system presented persistent fetal dispersion and resorptive degeneration. This case offers a unique insight into the possible role of hexavalent vaccine in triggering a lethal outcome in a vulnerable baby. Any case of sudden unexpected death occurring perinatally and in infancy, especially soon after a vaccination, should always undergo a full necropsy study according to our guidelines.”

“The identification of a possible pathological basis of reflexogenic mechanisms in sudden, unexpected infant death necessarily requires examination of the brainstem nuclei and of the cardiac conduction system on serial sections.”

The senior author of this study, Professor Luigi Matturri is a member of the European Medicines Agency (EMEA) Pathologists Panel for evaluation of SUD (sudden unexpected death) cases reported for hexavalent vaccines. In a review by EMEA cited in the Introduction of the study, of five reports of unexplained deaths in children which occurred within 24 hours of vaccination with a hexavalent vaccine, panels of experts (including pathologists with the experience in the field of vaccines and SIDS), investigated whether there might have been a link between the vaccines and the deaths observed:

“The EMEA’s conclusions were that the causes of death remained unexplained. SIDS, viral infection, metabolic disorders, allergic reactions or airway obstruction were plausible but were not definitely proven to have been the cause of death [4]. However, to the best of our knowledge, during the mentioned post-mortem investigations, little, if any, attention was paid to examination of the brainstem and the cardiacconduction systems on serial sections, nor  was  the  possibility  of  a  triggering  role  of  the  vaccine  in  the  lethal  outcome considered.”

In addition, in responding to numerous criticisms of their study Unexplained cases of sudden infant death shortly after hexavalent vaccination [21] Zinka et al. noted [22]:

“(ad 6) The main problem is that vaccination specialists have failed for decades to establish any tests or other criteria to find out if adverse events are linked to vaccinations or not. To our knowledge they did not even try hard—why?!”

“(1) A precise  description  of  the  mechanism  leading  to  serious  adverse  events  after hexavalent vaccination is not the task of forensic pathology. This would be the job of vaccination specialists, and actually this job should have been done before phase 1 and phase 2 studies in order to get valid data on the drug safety.”

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In summary, it may be inferred from here that the real reason why causality is rarely (if ever) established by scientific investigations into vaccine-related serious adverse outcomes is because it is assumed that: a) they don’t happen and b) the study is not designed to detect them. This may further suggest that vaccines are not proven to be safe but are only assumed to be safe. Indeed, according to the US FDA “Historically, the non-clinical safety assessment for preventive vaccines has often not included toxicity studies in animal models. This is because vaccines have not been viewed as inherently toxic” [1].

9)   Deliberately took advantage of parent’s trust and lack of relevant knowledge on vaccinations  in  order  to  promote  a  scientifically  unsupported  immunisation program which could put certain children at risk of severe long-term neurological damage.

Recently  the  DH  announced  that  there  would  be  a  significant  change  in  the  current  UK immunisation schedule, following the October 2010 meeting at which the JCVI recommended that children be vaccinated against six diseases at the same time. This would be through receiving three vaccines (Hib/MenC, MMR and pneumococcal) in one visit rather than getting the first vaccine at 12 months of age and the second two at 13 months of age. According to a letter sent by the Chief Medical Officer Professor Dame Sally Davies to local GPs(http://www.dh.gov.uk/en/ Publicationsandstatistics/Lettersandcirculars/Professionalletters/Chiefmedicalofficerletters/ DH_121748), this new “simplified” immunisation policy is to be implemented “as soon as practicable”.  Furthermore,  according  to  a  BBC  news  report  on  22nd    November  2010  (http:// www.bbc.co.uk/news/health-11809967), the purpose for vaccinating against 6  diseases  at one single appointment is “to boost vaccine uptake”, which has apparently been low ever since safety concerns regarding the MMR vaccine had been raised in public following the study of Wakefield et al. in 1998 [3]. Despite continued public concerns on the overall safety of the MMR and its possible link to autistic regression and other severe neurological outcomes, the  DH spokesperson stated (http://www.dh.gov.uk/en/MediaCentre/Statements/DH_122026):

Independent scientific research has shown that providing these vaccines at the same time is safe, effective and more convenient for parents.”

I have requested from the UK DH to show me these independent data. The request was granted, and much more than that. First to the independent data: they are not independent.

The study by Miller et al. [23], referenced by the DH states in the acknowledgments:

“This is an independent report funded by the Policy Research Programme in the Department of Health, UK, grant 039/031.”

As for the safety assessment:

“For safety, proportions of children with erythema, swelling or tenderness at site of injection,  or  fever  or  other  systemic  symptoms  for  7  days  after  immunization  were compared between regimens. No adverse consequences for either safety or immunogenicity were demonstrated when MCC/Hib was given concomitantly with

PCV and MMR at 12 months of age or separately at 12 and 13 months of age.”

Thus the vaccine was “demonstrated safe” based on a 7 day follow-up and monitoring for largely local reactions. Not only is this an appalling example of a vaccine safety study, it is the only study quoted by the DH and JCVI in support of their decision to implement a new vaccine schedule. This is evident from a Possible simplification of the childhood vaccination schedule report (http:// www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/ dh_121799.pdf), issued by the JCVI Secretariat in October 2010, which states:

(4.)

 

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 “In June 2009, JCVI considered a pre-publication clinical trial paper from Miller et. al. that showed that co-administration did not adversely affect the immune response elicited by the vaccines. In addition, no safety concerns around co-administration were identified.”

The JCVI report further states:

(Annex A, Background)

“In June 2009 the Joint Committee on Vaccination and Immunisation concluded that there is no scientific reason to keep the combined Hib and Meningitis C vaccine (currently given at 12 months) and the MMR and pneumococcal vaccines (given at 13 months) separate.”

The “no scientific reason” is grossly misleading. Once again, it should be obvious that safety concerns cannot be identified if the study is not designed to detect them. Autistic regression is known to occur gradually over periods of weeks to many months. In spite of this, the vast majority of studies which are presumed to provide conclusive evidence on the safety of vaccines, have short follow ups and focus almost exclusively upon acute near-immediate events [23-29].

In addition, the fact that in 2008 The US federal Advisory Committee on Immunization Practices (ACIP) voted to withdraw their initial recommendation for the use of measles, mumps, rubella, and varicella vaccine (MMRV, marketed by Merck & Co., Inc. as ProQuad) as the vaccine of choice for vaccination of infants, because it was associated with double the risk of febrile seizures when compared to the MMR, shows that there is indeed solid reason for concern over simultaneous administration of multiple vaccines. Proquad contains only four vaccines in combination, not six. The research from The Vaccine Safety Datalink (VSD), considered by the ACIP, evaluated the incidence of febrile seizures in 43,000 children between the ages of 12 and 23 months who had been vaccinated with ProQuad and 315,000 who had received two separate MMR and varicella vaccines. Within 7 to 10 days after vaccination, those given ProQuad suffered twice as many seizures (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5710a3.htm):

“The preliminary results indicated a rate of febrile seizure of nine per 10,000 vaccinations among MMRV vaccine recipients compared with four per 10,000 vaccinations among MMR vaccine and varicella vaccine recipients.”

The multivalent vaccine Hexavac was also recently withdrawn following a recommendation from the EMEA (http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2009/12/ WC500017695.pdf) “as a precautionary measure“, due to its poor effectiveness. Safety concerns have also been raised over administration of hexavalent vaccines by Ottaviani et al. [20] and Zinka et al. [21] the latter, following five cases of infant deaths in Germany in 2005 (all occurring within

48 hrs of vaccination). The post-mortem analysis of six children aged 4-17 months (5 of whom were vaccinated with Hexavac and one with another hexavalent vaccine, Infanrix Hexa) reported by Zinka et al. [21], revealed abnormal pathologic findings particularly affecting the nervous system. Although there is no conclusive proof that these deaths were directly caused by vaccination, the authors felt it was:

“…important to inform vaccinating physicians and pediatricians as well as parents about such possibly fatal complications after application of hexavalent vaccines.”

In spite of these relevant findings, no mention of these two studies is found in the DH and the JCVI reports regarding the introduction of the new “simplified” and “improved” schedule.

Other than the paper by Miller et al. [23], the DH also provided me with the official report on their research on parents’ attitudes to the possibility of administering the Hib/MenC, PCV and MMR vaccines on a single occasion. Following their initial consideration of the draft paper by Miller et al., in 2009, the JCVI did recognize the need to seek parent’s opinion on the proposed “6 in 1” program before making any changes to the current schedule. In February 2010, the DH initiated this research and subsequently published it in a document Childhood immunisation programme: Attitudinal research into combining 12 and 13 month immunisations which is now available on the DH website at:

http://www.dh.gov.uk/en/Publichealth/Immunisation/Marketresearch/index.htm

 

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 http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_122329.pdf

What the Attitudinal research found was that parent’s knowledge on childhood’s current immunisation timetable, particularly around 12 and 13 months, was generally low and apparently, the DH and the JCVI are content with keeping it that way, in order to preserve the national vaccination program. The DH and the JCVI concluded that informing parents of the changes would be “unwise” because it would create unnecessary panic. In order to prevent this, the health officials need to be instructed on how to “reassure” parents in the safety of vaccines, especially the MMR.

According to the Attitudinal research report, parents generally trusted the schedule and the NHS, however, some had reservations about the MMR, particularly if it was to be combined with other vaccines. Specifically, the Research Management Summary on Behalf of the DH from a Possible simplification of the childhood vaccination schedule report (http://www.dh.gov.uk/ prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_121799.pdf), issued by the JCVI Secretariat, states that:

“While the principle of combining vaccinations and/or giving more than one at the same time  appeared  largely  to  be  accepted,  if  one  of  these  is  MMR,  views  can change.” (Conclusions and Recommendations: 2.)

In light of this explicit concern, the DH report noted:

“The combined schedule at 12 and 13 months was regarded with mixed feelings; if it is introduced, the way in which it is communicated will have a significant impact on how it is received. Given low awareness of the immunisation schedule, parents are unlikely to notice the change until informed about it.” [their emphasis added-italicised] (Conclusions and Recommendations: 3.)

They further elaborated on this particular finding:

“When the combined schedule was presented to parents first (before seeing the current schedule), very few identified the appointment at a year of age as different or worthy of comment. Parents’ problems and worries only came to the surface when the combined option was explicitly presented as a change to the schedule. Those in areas where the combined schedule is apparently already being given accepted it without question. When parents were told that the new schedule involves giving MMR and PCV at the same time as another vaccine, some changed their views, including some of those who were otherwise accepting of MMR.” (Conclusions and Recommendations: 4.)

On the basis of the above observations the DH concluded that it is best to keep parents ignorant of the proposed changes, in order to avoid what they deemed as “unwarranted anxiety”, as this would most likely lead to reduced immunisation rates:

Offering parents a choice between the two schedules could generate more questions than answers, and seems unwise. It might also risk compromising current understanding of the vaccination schedule as ‘just what happens’, and reframing it as optional, which could reduce vaccine uptake.” (Conclusions and Recommendations: 5.)

Consistent with their past legacy that apparently puts priority on the preservation of the vaccination program rather than the safety of an individual, the British Health Authorities consider it “unwise” that parents should have a choice as to how immunisations are to be carried out. So much so that special action is needed to assure that their efforts in promoting vaccination are not hampered. In particular, to the DH it “seems sensible” to, somehow, camouflage the change in the vaccination schedule in order to prevent what they deem as “unwarranted anxiety”.

“It is also clear that offering parents detailed information, and flagging up changes, can generate anxiety where it is not warranted. In light of this, it seems sensible to introduce the  combined  schedule  as  far  as  possible  without  announcing  it  explicitly  as  a change.” (Conclusions and Recommendations: 6.)

 

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Indeed, the DH offers an elaborate strategy for addressing parental concerns about the “improved”and “simplified” vaccination program:

“If the combined immunisation is introduced, some parents will have questions about it, and health professionals, especially health visitors and practice nurses, will be their first port of call for information. Health professionals will have an important part to play in informing and reassuring parents, and they will need to provide consistent answers; any variation  between  what  they  say  is  likely  to  create  a  sense  of  unease  among parents.” (Conclusions and Recommendations: 7.)

In revealing further details on how the health staff should approach those parents who may have concerns over the safety of the MMR vaccine, the DH advises:

“Health professionals will need to be ready to reassure parents that…

• combining vaccinations into one appointment and giving three at a time is entirely safe

• the fact that MMR is one of these makes no difference, because MMR is safe

• there is a good reason for the change: though the current system is effective and safe, changing it will be an improvement

• there are significant benefits to baby and parent in having one fewer appointment and reduced distress”

It should be obvious that any a priori exclusion of possible adverse effects from vaccines which is not based on valid scientific evidence but rather, a belief system is not by definition scientific. Rather, it reflects a disturbing trend to view anything associated with vaccines and vaccine policy as sacred and beyond scientific scrutiny. The need to protect the UK government-mandated vaccination program against any reasonable doubt, in the absence of any truly independent scientific evidence and despite a) CSM/JCVI/ARVI’s own records discussed under Sections 1)-3) & 5) which show that vaccines, including measles and the MMR are not “entirely safe” and b) the government’s own concession that the MMR can in fact cause permanent brain damage (in the case of Robert Fletcher who in August 2010 received £90,000 payout for epilepsy and severe mental retardation that he suffered following the MMR jab; http://www.bbc.co.uk/news/uk-england- merseyside-11125343), is even more disturbing.

If vaccines are indeed entirely safe as the DH and the JCVI claim, why do they feel they need to hide information from parents and health professionals?

Perhaps “combining vaccinations into one appointment and giving three at a time is” not “entirely safe”

As a reminder (JCVI meeting, 11th  December 1974; http://www.dh.gov.uk/ab/JCVI/DH_095052):

(11 Simultaneous administration of live vaccines (CHCS(VI)14))

“Professor Dick and Dr Warin pointed out that an interval in the administration of live vaccines had been advocated in view of the probability of adverse reactions and because of the recent publicity surrounding adverse reactions. The Committee agreed that it would be inopportune to change the guidance that an interval of at least 3 weeks should be allowed to elapse between the administration of any 2 live vaccines whichever came first.”

The above would explain the need to censor certain information as well as why the JCVI went to great lengths in devising a special strategy with which such a task would be achieved:

“Given continued sensitivity about MMR, any negative news coverage will have a significant impact. Health professionals will be the front line in combating this, and will need to be kept fully informed on the latest information from JCVI and DH to prevent any contradictions  or  confusion,  and  to  ensure  that  they  are  equipped  to  reassure parents.” (Conclusions and Recommendations: 9.)

 

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The choice of words is rather peculiar here, it appears as if the DH and the JCVI are preparing for war. Their choice of weapons includes “educating” health professionals with what appears to be highly  censored  information,  since  numerous  truly  independent  studies  which  raised  safety concerns in the scientific community (particularly about the MMR vaccine), were simply dismissed by the JCVI (see Section 4). Both the JCVI and the DH opted instead for the methodologically dubious study by Miller et al. [23] as their only evidence to promote the new “improved” and “simplified” immunisation program. This obvious information bias is to be promulgated by the JCVI/ DH to the health profession.

Furthermore, according to the DH, it is not only important to censor information given to both parents and health professionals, the way in which this information is to be communicated is also very important.

“It is important that the information given by health professionals is pitched at the right level. The JCVI information prompted questions among many respondents, but was useful for reassuring some, particularly those with a more pragmatic view of immunisation. Information at this level needs to be carefully tailored by health professionals according to the attitudes of individual parents.”

The  corresponding  section  from  the  Attitudinal  research  report  (http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_122329.pdf) adds:

“If in doubt, we would suggest keeping it simple, as outlined above.” (D Conclusions; 3. Dealing with questions about the change to a combined schedule)

Since some disclosure to the parents on adverse events associated with the combined schedule is necessary, it is further regarded that in spite of some:

“…diverging views on when the sheet should be given to parents; on balance it seems wise to hand it out immediately before vaccination, so that parents feel they have been given advance warning, but do not dwell on the content to the extent that they begin to worry.” (D Conclusions; 4. The tear-off sheet on side effects)

The idea of “keeping it simple” was also welcomed by the health professionals. Indeed, as already discussed in Section 5), the public may not understand correctly the significance of febrile convulsions. Nor would anyone want the public to dwell extensively on associations between the words “vaccine” and “death” or “permanent brain damage”.

One has to wonder whether parents who to this day continue to trust the British Health Authorities on matters of immunisation, would still have the same opinion if crucial facts on vaccine-associated adverse events discussed in “commercial” and “in confidence” CSM/JCVI/Joint Sub-Committee ARVI meetings were fully disclosed to them:

From the Attitudinal research report (pg 22):

“To  my  eyes  these  things  have  all  been  tried  and  tested,  the medical people studied for years, they tried all of this stuff. They obviously know getting these things correctly so my trust is in their hands really at the end of the day.”

From a discussion on a proposal for the surveillance of severe neurological disorders in infancy and their relationship to pertussis vaccine, 7th    February 1986, CSM/JCVI/Joint Sub-Committee  ARVI

( h t t p : / / w w w . d h . g o v . u k / e n / F r e e d o m O f I n f o r m a t i o n /  Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306):

(6.5.1)

“It was considered unreasonable to ask paediatricians to report for a period of six years.” “No attempt would be made to study serious neurological disease arising from pertussis and other infectious diseases.”

From Miller et al. [23]

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 “For safety, proportions of children with erythema, swelling or tenderness at site of injection,  or  fever  or  other  systemic  symptoms  for  7  days  after  immunization  were compared between regimens.”

From the JCVI meeting held on 3rd  November 1981 (http://www.dh.gov.uk/ab/DH_095169):

(5.d. Comments on Professor Stewart’s letter)

“Professor Gilliatt observed that in the Meade Panel Study one-third of children with brain damage were not admitted to hospital. In both the Meade and Dudgeon studies there were examples of children who had a fit soon after vaccination which was followed by a fit at a later time and then followed by cessation of development. It was very difficult to assess this as a random event…The Chairman concluded that much was not known about the natural history of brain damage in the young.”

From the Attitudinal research report (pg 22):

“…the diseases must be serious and pose a risk – ‘the NHS wouldn’t put children through it [so young] if it wasn’t necessary.”

From the JCVI meeting on 11th  December 1974 (http://www.dh.gov.uk/ab/JCVI/DH_095052):

(10.)

“…mumps vaccine was unnecessary because complications from the disease were rare. The Committee agreed that there was no need to introduce routine vaccination against mumps.”

From a discussion on a proposal for the surveillance of severe neurological disorders in infancy and their relationship to pertussis vaccine, 7th    February 1986, CSM/JCVI/Joint Sub-Committee  ARVI ( h t t p : / / w w w . d h . g o v . u k / e n / F r e e d o m O f I n f o r m a t i o n /  Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306):

(6.5.1)

“No attempt would be made to study serious neurological disease arising from pertussis and other infectious diseases.”

From the Attitudinal research report (pg 23):

“They’re in the book and they say you should do them, I think if I don’t do them then that’s wrong. They know what they’re doing.”

From the “commercial in confidence” CSM/JCVI/Joint Sub-Committee ARVI meeting, held on 5th  October 1984 (http://www.dh.gov.uk/ab/JCVI/DH_095294):

(9.)

“Fetal damage after accidental polio vaccination of an immune mother. Barton AE et al. Journal of the RCGP 1984: 34: p. 390-394

Dr Smith observed that the termination of the pregnancy at 20 weeks in this case report was not related to the administration of oral poliovaccine (OPV).”

Note: how such conclusion could be reached remains unclear since:

“However, the foetus was reported to have signs of infection with poliovirus in the nervous system although no similar event had been previously seen after vaccination.”

From the Attitudinal research report (pg 23):

“I don’t think they would put something into a child that is not good for them.”

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 “I put my hands in the medical profession and they do a good enough job for me and I trust them.”

“Surely they wouldn’t give these injections if they felt they would harm?”

“I do think it’s a good thing. You want to try and protect your children so if that’s what they’re suggesting they have to have done you should trust your health professionals.”

“Because they’re recommended you kind of trust the doctors to guide you.”

From the “commercial in confidence” CSM/JCVI/Joint Sub-Committee ARVI meeting, held on  6 th    J u l y  1 9 8 7  ( http://ww w.dh.g o v.uk/en/F r eedo mO f Inf o r matio n/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306):

(6.1 Whooping cough)

“He explained that in February the CSM had called for ARVI’s advice about updating the statement made in the 1981 report on Whooping Cough (HMSO) about a possible link between DTP immunisation and serious neurological illness. It had been hoped that by this means ‘discovery’ of all the relevant JCVI, CSM and ARVI documentation on whooping cough vaccine could be avoided.”

From  the  JCVI/Joint  Sub-Committee ARVI  “commercial  in  confidence”  meeting  on  6th

February 1987, section “7.1 Whooping cough vaccine –CSM advice” (contents of the statement that CSM wished  to  mo dif y;  http://ww w.dh.g o v.uk/en/F r eedo mO f Inf o r matio n/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306):

“No scientifically unassailable link has been established between DTP immunisation and serious neurological illness but we have come to conclusion, on the basis of all present evidence, that there is a prima facie case that such a link may exist. We would also agree that the evidence suggests that the vaccine causes convulsions in some children.”

From the CSM/JCVI/Joint Sub-Committee ARVI “commercial in confidence meeting on 3rd   October

1986                   ( http://ww w .dh.go v .uk/en/Fr eedo mO f Inf o r matio n/

Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306):

(5.1.3.c.)

“From the above there is reason to believe that the increased relative risk of prolonged convulsions after DTP was a real one.”

From the JCVI meeting on 3rd  November 1989 (http://www.dh.gov.uk/ab/DH_095169):

(9. ARVI Committee – Minutes of meeting 6 October 1989 (JCVI (89)25)

“Dr Schild reported that NIBSC was now able to distinguish clearly the wild strains from each of the two vaccines, and isolates from CSF clearly showed Urabe in all three cases believed to be associated with vaccine-although it should not be assumed that Jeryl-Lynn is not capable of the same result.”

From the JCVI meeting on 7th  May 1999 (http://www.dh.gov.uk/ab/JCVI/DH_095050):

(8. Meningococcal meningitis, i.)

“Committee members were reminded that this issue, and the papers presented, was extremely sensitive, commercially and politically. It was requested that confidentiality be maintained. The Chairman asked for any declarations of interest. Professor Cartwright was involved in manufacturers’ studies on the vaccines, including health trials. Dr Goldblatt was

 

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 involved in one company-sponsored study and had provided a clinical expert report to the MCA for one manufacturer. Dr Jones was involved in trials for two of the companies involved. Dr Schild said that NIBSC was evaluating the vaccines.

“There were no objections to these members continuing to take part in the meeting and it was agreed that they would be able to provide a valuable input to the discussion in common interest.”

From  a  discussion  of  the  8.4.1  Meningococcal  C  Conjugate  (MCC)  Vaccine  Evaluation

Programme, at the 7th  May1999 JCVI meeting (http://www.dh.gov.uk/ab/JCVI/DH_095050):

(ii.)

“There was no good evidence for the efficacy of the meningococcal Group C conjugate vaccine, only the surrogate of antibodies compared with those known to be protective against invasive disease. To actually test the efficacy on the conjugate vaccine it would be necessary to introduce the vaccine and then conduct a Phase III or Phase IV study to test efficacy; this would be very difficult to do and would delay introduction by 3-5 years.”

(iii.)

“It was felt that it was important to plan the programme now and confirmation that the vaccines were equally effective could follow.”

Standards of Conduct

Finally, a reader may wish to assess the presented data on JCVI vaccination policies against the

JCVI’s  own  Code  of  Practice  (http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_115363.pdf) which states:

(Responsibilities of Committee and Sub-committee members):

(30)“All members of the Committee and its Sub-committees (‘members’) must demonstrate high standards of conduct.”

(31)“In exercising their duties, members must observe the ‘Seven Principles of Public Life’ set out by the Committee on Standards in Public Life (the Nolan Committee):

Selflessness: Holders of public office should take decisions solely in terms of the public interest. They should not do so in order to gain financial or other material benefits for themselves, their family, or their friends

Integrity: Holders of public office should not place themselves under any financial or other obligation to outside individuals or organisations that might influence them in the performance of their official duties.

Objectivity:  In  carrying  out  public  business,  including  making  public  appointments, awarding contracts, or recommending individuals for rewards and benefits, holders of public office should make choices on merit.

Accountability: Holders of public office are accountable for their decisions and actions to the public and must submit themselves to whatever scrutiny is appropriate to their office.

Openness: Holders of public office should be as open as possible about all the decisions and actions that they take. They should give reasons for their decisions and restrict information only when the wider public interest clearly demands.

 

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Honesty: Holders of public office have a duty to declare any private interests relating to their public duties and to take steps to resolve any conflicts arising in a way that protects the public interest.

Leadership: Holders of public office should promote and support these principles by leadership and example.”

(Conflicts of Interests)

(39) Personal pecuniary8 interest

“If a member has in the last 12 months received, or plans to receive a financial payment or other benefit from a business or representative body relating to vaccines or any other product or service that could be under consideration by JCVI or a Sub-committee including:

• holding a directorship, or other paid position

carrying out consultancy or fee paid work

• having shareholdings or other beneficial interests

• receiving expenses (e.g. travel to, or registration for, conferences) and hospitality the member must declare this interest.

If this interest is specific to an agenda item and the payment or other benefit is connected specifically with the product under consideration, the member will be required to absent him/herself from the discussion and any subsequent vote.”

Summary

In conclusion, by apparently prioritizing vaccination policy over vaccine safety, the JCVI, the DH and the Committee on Safety of Medicines (CSM) may have shown a disregard for the safety of children. Through selective data reporting, the JCVI in conjunction with the DH, has promulgated information relating to vaccine safety that may be inaccurate and potentially misleading, thereby making it impossible for the parents to make a fully informed consent regarding vaccination. Furthermore, by 1) apparently misleading patients about the true risks of adverse reactions as to gain their consent for the administration of the treatment and 2) seemingly siding with vaccine manufacturers rather than public health interests, the JCVI and the CSM appear to have signally failed their fiduciary duty to protect individuals from vaccines of questionable safety. If these provisional conclusions are indeed correct, then the information presented here may help us in understanding the UK government’s and the JCVI’s official position on vaccine damage, that is, one of persistent denial.

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The Health Hazards of Disease Prevention

 References

 

[1]      Food  and  Drug Administration  (FDA).  Workshop  on  Non-clinical  Safety  Evaluation  of  Preventative Vaccines:  Recent  Advances  and  Regulatory  Considerations.  2002.  http://www.fda.gov/downloads/ bio lo gicsblo o dvaccines/newsevents/wo r ksho psmeetingsco nf erences/transcr iptsminutes/ ucm054459.pdf, last accessed May 30 2011.

[2]      World Medical Association (WMA). WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. 2011. http://www.wma.net/en/30publications/10policies/b3/, last accessed June 4 2011.

[3]      Wakefield AJ, Murch SH, Anthony A, Linnell J, Casson DM, Malik M, et al.  Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 1998; 351 (9103): 637-41.

[4]      Sugiura A, Yamada A. Aseptic meningitis as a complication of mumps vaccination. Pediatr Infect Dis J

1991; 10(3): 209-13.

[5]      Fombonne E, Chakrabarti S. No evidence for a new variant of measles-mumps-rubella-induced autism.

Pediatrics 2001; 108(4): E58.

[6]      Singh VK, Jensen RL. Elevated levels of measles antibodies in children with autism. Pediatr Neurol 2003;

28(4): 292-4.

[7]      Godlee F, Smith J, Marcovitch H. Wakefield’s article linking MMR vaccine and autism was fraudulent.

BMJ 2011; 342: c7452.

[8]      Balzola F, Barbon V, Repici A, Rizzetto M, Clauser D, Gandione M, et al. Panenteric IBD-like disease in a patient with regressive autism shown for the first time by the wireless capsule enteroscopy: another piece in the jigsaw of this gut-brain syndrome? Am J Gastroenterol 2005; 100(4): 979-81.

[9]      Balzola F., et al. Beneficial behavioural effects of IBD therapy and gluten/casein-free diet in an Italian cohort of patients with autistic enterocolitis followed over one year. Gastroenterology 2006; 130 (Suppl.

2): S1364 A-21.

[10]    Balzola F., et al. Autistic enterocolitis: confirmation of a new inflammatory bowel disease in an Italian cohort of patients. Gastroenterology 2005; 128 (suppl.2): A-303.

[11]    Chen B, Girgis S, El-Matary W. Childhood autism and eosinophilic colitis. Digestion 2010; 81(2): 127-9. [12]  Krigsman  A,  Boris  M,  Goldblatt  A,  Stott  C.  Clinical  Presentation  and   Histologic  Findings  at Ileocolonoscopy in Children with Autistic Spectrum Disorder and Chronic Gastrointestinal  Symptoms. Autism Insights 2010; 2: 1-11.

[13]    Quigley EM, Hurley D. Autism and the gastrointestinal tract. Am J Gastroenterol 2000; 95(9): 2154-6.

[14]    Shoenfeld Y, Agmon-Levin N. ‘ASIA’ – Autoimmune/inflammatory syndrome induced by  adjuvants. J Autoimmun. 2011; 36(1): 4-8.

[15]    Ternavasio-de la Vega HG, Boronat M, Ojeda A, Garcia-Delgado Y, Angel-Moreno A, Carranza-Rodriguez C, et al. Mumps orchitis in the post-vaccine era (1967-2009): a single-center series of 67 patients and review of clinical outcome and trends. Medicine (Baltimore) 2010; 89(2): 96-116.

[16]    Castilla J, Garcia Cenoz M, Arriazu M, Fernandez-Alonso M, Martinez-Artola V, Etxeberria J,  et al. Effectiveness of Jeryl Lynn-containing vaccine in Spanish children. Vaccine 2009; 27(15): 2089-93.

[17]    Gustafson TL, Lievens AW, Brunell PA, Moellenberg RG, Buttery CM, Sehulster LM. Measles outbreak in a fully immunized secondary-school population. N Engl J Med 1987; 316(13): 771-4.

[18]    Hersh BS, Markowitz LE, Hoffman RE, Hoff DR, Doran MJ, Fleishman JC, et al. A Measles Outbreak at a College with a Prematriculation Immunization Requirement. American Joumal of Public Health 1991; 81 (3): 360-4.

[19]    Tugwell BD, Lee LE, Gillette H, Lorber EM, Hedberg K, Cieslak PR. Chickenpox outbreak  in a highly vaccinated school population. Pediatrics 2004; 113(3 Pt 1): 455-9.

[20]    Ottaviani G, Lavezzi AM, Matturri L. Sudden infant death syndrome (SIDS) shortly after  hexavalent vaccination: another pathology in suspected SIDS? Virchows Arch 2006; 448(1): 100-4.

[21]    Zinka B, Rauch E, Buettner A, Rueff F, Penning R. Unexplained cases of sudden infant death shortly after hexavalent vaccination. Vaccine 2006; 24(31-32): 5779-80.

 

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BSEM March 2011

The Health Hazards of Disease Prevention

 [22]    Zinka B, Penning R. Unexplained cases of sudden infant death shortly after hexavalent  vaccination.

Letter to Editor. Response to the comment by H.J. Schmitt et al. Vaccine 2006; 24: 5785–6.

[23]    Miller E, Andrews N, Waight P, Findlow H, Ashton L, England A, et al. Safety and immunogenicity of co- administering a combined meningococcal serogroup C and  Haemophilus influenzae type b conjugate vaccine with 7-valent pneumococcal conjugate vaccine and measles, mumps and rubella vaccine at 12 months of age. Clin Vaccine Immunol 2011; 18(3): 367–72.

[24]    Kaplan SL, Lauer BA, Ward MA, Wiedermann BL, Boyer KM, Dukes CM, et al. Immunogenicity and safety of Haemophilus influenzae type b-tetanus protein conjugate vaccine alone or mixed with diphtheria- tetanus-pertussis vaccine in infants. J Pediatr 1994; 124(2): 323-7.

[25]    Plennevaux E, Blatter M, Cornish MJ, Go K, Kirby D, Wali M, et al. Influenza A (H1N1) 2009 two-dose immunization of US children: an observer-blinded, randomized, placebo-controlled trial. Vaccine 2011;

29(8): 1569-75.

[26]    Li G, Zhang H, Zhou W, Ye Q, Li F, Wang H, et al. Safety and immunogenicity of a diphtheria, tetanus, acellular pertussis and Haemophilus influenzae Type b combination  vaccine compared with separate administration of licensed equivalent vaccines in Chinese infants and toddlers for primary and booster immunization. Vaccine 2010; 28(25): 4215-23.

[27]    Marchant CD, Miller JM, Marshall GS, Blatter M, Aris E, Friedland LR, et al. Randomized trial to assess immunogenicity and safety of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in infants. Pediatr Infect Dis J 2009; 29(1): 48-52.

[28]    Kanra  G,  Viviani  S,  Yurdakok  K,  Ozmert  E,  Yalcin  S,  Baldini  A,  et  al.  Safety,  tolerability  and immunogenicity of a Haemophilus influenzae type b vaccine containing aluminum phosphate adjuvant administered at 2, 3 and 4 months of age. Turk J Pediatr 1999; 41(4): 421-7.

[29]    Kim KH, Lee H, Chung EH, Kang JH, Kim JH, Kim JS, et al. Immunogenicity and safety of two different

Haemophilus influenzae type b conjugate vaccines in Korean infants. J Korean Med Sci 2008;  23(6):

929-36.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

45

THE MEDICAL TIME BOMB OF IMMUNIZATION AGAINST DISEASE

The greatest threat of childhood diseases lies in the dangerous and ineffectual efforts made to prevent them 

by ROBERT S. MENDELSOHN, M.D.

I know, as I write about the dangers of mass immunisation, that it is a concept that you may find difficult to accept. Immunizations have been so artfully and aggressively marketed that most parents believe them to be the “miracle” that has eliminated many once-feared diseases. Consequently, for anyone to oppose them borders on the foolhardy. For a paediatrician to attack what has become the “bread and butter” of paediatric practice is equivalent to a priest’s denying the infallibility of the pope.

Knowing that, I can only hope that you will keep an open mind while I present my case. Much of what you have been led to believe about immunizations simply isn’t true. I not only have grave misgivings about them; if I were to follow my deep convictions in writing this chapter, I would urge you to reject all inoculations for your child. I won’t do that, because parents in about half the states have lost the right to make that choice. Doctors, not politicians, have successfully lobbied for laws that force parents to immunize their children as a prerequisite for admission to school.

Even in those states, though, you may be able to persuade your paediatrician to eliminate the pertussis (whooping cough) component from the DPT vaccine. This immunization, which appears to be the most threatening of them all, is the subject of so much controversy that many doctors are becoming nervous about giving it, fearing malpractice suits. They should be nervous, because in a recent Chicago case a child damaged by a pertussis inoculation received a $5.5 million settlement award. If your doctor is in that state of mind, exploit his fear, be-cause your child’s health is at stake.

Although I administered them my-self during my early years of practice, I have become a steadfast opponent of mass inoculation because of the myriad hazards they present. The subject is so vast and complex that it deserves a book of its own. Consequently, I must be content here with summarizing my objections to the fanatic zeal with which pediatricians blindly shoot foreign proteins into the body of your child without knowing what eventual damage they may cause.

Here is the core of my concern:

I. There is no convincing scientific evidence that mass inoculations can be credited with eliminating any childhood disease. While it is true that some once common childhood diseases have diminished or disappeared since inoculations were introduced, no one really knows why, although improved living conditions may be the reason. If immunizations were responsible for the diminishing or disappearance of these diseases in the United States, one must ask why they disappeared simultaneously in Europe, where mass immunizations did not take place.

2. It is commonly believed that the Salk vaccine was responsible for halting the polio epidemics that plagued American children in the 19405 and 1950s. If so, why did the epidemics also end in Europe, where polio vaccine was not so extensively used? Of greater current relevance, why is the Sabin virus vaccine still being administered to children when Dr. Jonas Salk, who pioneered the first vaccine, points out that Sabin vaccine is now causing most of the polio cases that appear. Continuing to force this vaccine on children is irrational medical behaviour that simply confirms my contention that doctors consistently repeat their mistakes. With the polio vaccine we are witnessing a rerun of the medical reluctance to abandon the smallpox vaccination, which remained as the only source of smallpox-related deaths for three decades after the disease had disappeared.

Think of it! For thirty years kids died from smallpox vaccinations even though no longer threatened by the disease.

3. There are significant risks associated with every immunization and numerous contraindications that may make it dangerous for the Shots to be given to your child. Yet doctors administer them routinely, usually without warning parents of the hazards and without determining whether the immunization is contraindicated for the child. No child should be immunized without making that determination, yet small armies of children are routinely lined up in clinics to receive a shot in the arm with no questions asked by their parents!

While the myriad short-term hazards of most immunizations are known (but rarely explained), no one knows the long term consequences of injecting foreign proteins into the body of your child. Even more shocking is the fact that no one is making any structured effort to find out.

5. There is growing suspicion that immunization against relatively harm-less childhood diseases may be responsible for the dramatic increase in auto-immune diseases since mass inoculations were introduced. These are fearful diseases such as cancer, leukemia. rheumatoid arthritis, multiple sclerosis, Lou Gehrig’s disease, lupus erythematosus, and the Guillain-Barre syndrome. An autoimmune disease can be explained simply as one in which the body’s defense mechanisms cannot distinguish between foreign invaders and ordinary body tissues, with the consequence that the body begins to destroy itself. Have we traded mumps and measles for cancer and leukemia?

I have emphasized these concerns because it is probable that your paediatrician will not advise you about them. At the 1982 Forum of the American Academy of Pediatrics (AAP), a resolution was proposed that would have helped insure that parents would be informed about the risks and benefits of immunizations. The resolution urged that the “ALA? make available in clear, concise language information which a reasonable parent would want to know about the benefits and risks of routine immunizations, the risks of vaccine preventable diseases and the management of common adverse reactions to immunizations.” Apparently the doctors assembled did not believe that “reasonable parents” were entitled to this kind of in-formation because they rejected the resolution!

The bitter controversy over immunizations that is now raging within the medical profession has not escaped the attention of the media. Increasing numbers of parents are rejecting immunizations for their children and facing the legal consequences of doing so. Parents whose children have been permanently damaged by vaccines are no longer accepting this as fate but are filing malpractice suits against the manufacturers and the doctors who administered the vaccine. Some manufacturers have actually stopped making vaccines, and the lists of contraindications to their use are being expanded by the remaining manufacturers, year by year. Meanwhile, because routine immunizations that bring patients back for repeated office calls, are the bread and butter of their specialty, paediatricians continue to defend them to the death.

The question parents should be asking is: Whose death?

As a parent, only you can decide whether to reject immunizations or risk accepting them for your child. Let me urge you, though-before your child is immunized-to arm yourself with the facts about the potential risks and benefits and demand that your paediatrician defend the immunizations that he recommends. If you decide that you don’t want to have your child immunized, but your state laws say you must, write to me, and I may be able to offer suggestions on how you can regain your freedom of choice.

MUMPS

Mumps is a relatively innocuous viral disease, usually experienced in childhood, which causes swelling of one or both salivary glands (parotids), located just below and in front of the ears. Typical symptoms are a temperature of 100-l04 degrees, appetite loss, headache, and back pain. The gland swelling usually begins to diminish after two or three days and is gone by the sixth or seventh day. However, one gland may become affected first, and the second as much as 10-l2 days later. The infection of either side confers life-time immunity.

Mumps does not require medical treatment. If your child contracts the disease, encourage him to stay in bed for two or three days, feed him a soft diet and a lot of fluids, and use ice packs to reduce the swelling. If his headache is severe, administer modest quantities of whiskey or acetaminophen. Give ten drops of whiskey to a small baby and up to one-half teaspoon to a larger one. The dose can be repeated in one hour and again in another hour, if needed.

Most children are immunized against mumps along with measles and rubella in the MMR shot that is administered at about fifteen months of age. Paediatricians defend this immunization with the argument that, although mumps is not a serious disease in children, if they do not gain immunity as children they may contract mumps as adults. In that event there is a possibility that adult males may contract orchitis, a condition in which the disease affects the testicles. In rare instances this can produce sterility.

If total sterility as a consequence of orchitis were a significant threat, and if the mumps immunizations assured adult males that they would not contract it, I would be among those doctors who urge immunization. I’m not, because their argument makes no sense. Orchitis rarely causes sterility, and when it does, because only one testicle is usually affected, the sperm production capacity of the unaffected testicle could repopulate the world! And that’s not all. No one knows whether the mumps vaccination confers an immunity that lasts into the adult years. Consequently, there is an open question whether, when your child is immunized against mumps at fifteen months arid escapes this disease in childhood, he may suffer more serious consequences when he contracts it as an adult.

You won’t find paediatricians advertising them, but the side effects of the mumps vaccine can be severe. In some children it causes allergic reactions such as rash, itching, and bruising. It may also expose them to the effects of central nervous system involvement, including febrile seizures, unilateral nerve deafness, and encephalitis. These risks are minimal, true, but why should your child endure them at all to avoid an innocuous diseaze in childhood at the risk of contracting a more serious one as an adult?

MEASLES

Measles, also called rubeola or ‘English measles,” is a contagious viral disease that can ‘be contracted by touching an object used by an infected person. At the onset the victim feels tired, has a slight fever and pain in the head and back. His eyes redden and he may be sensitive to light. The fever rises until about the third or fourth day, when it reaches 103-104 degrees. Sometimes small white spots can be seen inside the mouth, and a rash of small pink spots appears below the hair line and behind the ears. This rash spreads downward to cover the body in about 36 hours. The pink spots may run together but fade away in about three or four days. Measles is contagious for seven or eight days, beginning three or four days be-fore the rash appears. Consequently, if one of your children contracts the disease, the others probably will have been exposed to it before you know the first I child is sick.

No treatment is required for measles other than bed rest, fluids to combat possible dehydration from fever, and calamine lotion or cornstarch baths to relieve the itching. If the child suffers from photophobia, the blinds in his bedroom should be lowered to darken the room. However, contrary to the popular myth, there is no danger of permanent blindness from this disease.

A vaccine to prevent measles is an-other element of the MMR inoculation given in early childhood. Doctors maintain that the inoculation is necessary to prevent measles encephalitis, which they say occurs about once in 1,000 cases. After decades of experience with measles, I question this statistic, and so do many other paediatricians. The incidence of 1/1,000 may be accurate for children who live in conditions of poverty and malnutrition, but in the middle-and upper-income brackets, if one excludes simple sleepiness from the measles itself, the incidence of true encephalitis is probably more like 1/10,000 or 1/100,000.

After frightening you with the unlikely possibility of measles encephalitis, your doctor can rarely be counted on to tell you of the dangers associated with the vaccine he uses to prevent it. The measles vaccine is associated with encephalopathy and with a series of other complications such as SSPE (subacute sclerosing panencephalitis), which causes hardening of the brain and is invariably fatal.

Other neurologic and sometimes fatal conditions associated with the measles vaccine include ataxia (inability to coordinate muscle movements), mental retardation, aseptic meningitis, seizure disorders, and hemiparesis (paralysis affecting one side of the body). Secondary complications associated with the vaccine may be even more frightening. They include encephalitis, juvenile-onset diabetes, Reye’s syndrome, and multiple sclerosis.

I would consider the risks associated with measles vaccination unacceptable even if there were convincing evidence that the vaccine works. There isn’t. While there has been a decline in the incidence of the disease, it began long before the vaccine was introduced. In 1958 there were about 800,000 cases of measles in the United States, but by 1962-the year before a vaccine appeared-the number of cases had dropped by 300,000. During the next four years, while children were being vaccinated with an ineffective and now abandoned “killed virus” vaccine, the number of cases dropped another 300,000. In 1900 there were 13.3 measles deaths per 100,000 population. By 1955, before the first measles shot, the death rate had declined 97.7 percent to only 0.03 deaths per 100,000.

Those numbers alone are dramatic evidence that measles was disappearing before the vaccine was introduced. If you fail to find them sufficiently convincing, consider this: in a 1978 survey of thirty states, more than half of the children who contracted measles had been adequately vaccinated. Moreover, according to the World Health Organization, the chances are about fifteen times greater that measles will be contracted by those vaccinated for them than by those who are not.

“Why,” you may ask, “in the face of these facts, do doctors continue to give the shots?” The answer may lie in an episode that occurred in California fourteen years after the measles vaccine was introduced. Los Angeles suffered a severe measles epidemic during that year, and parents were urged to vaccinate all children six months of age and older-despite a Public Health Service warning that vaccinating children below the age of one year was useless and potentially harmful.

Although Los Angeles doctors responded by routinely shooting measles vaccine into very kid they could get their hands on, several local physicians familiar with the suspected problems of immunologic failure and “slow virus” dangers chose not to vaccinate their own infant children. Unlike their patients, who weren’t told, they realized that “slow viruses” found in all live vaccines, and particularly in the measles vaccine, can hide in human tissue for years. They may emerge later in the form of encephalitis, multiple sclerosis, and as potential seeds for the development and growth of cancer.

One Los Angeles physician who refused to vaccinate his own seven-month-old baby said: “I’m worried about what happens when the vaccine virus may not only offer little protection against measles but may also stay around in the body, working in a way we don’t know much about.” His concern about the possibility of these consequences for his own child, however, did not cause him to stop vaccinating his infant patients. He rationalized this contradictory behaviour with the comment that “As a parent, I have the luxury of making a choice for my child. As a physician… legally and professionally I have to accept the recommendations of the profession, which is what we also had to do with the whole Swine Flu business.”

Perhaps it is time that lay parents and their children are granted the same luxury that doctors and their children enjoy.

RUBELLA

Commonly known as “German measles,” rubella is a non-threatening disease in children that does not require medical treatment.

The initial symptoms are fever and a slight cold, accompanied by a sore throat. You know it is something more when a rash appears on the face and scalp and spreads to the arms and body. The spots do not run together as they do with measles, and they usually fade away after two or three days. The victim should be encouraged to rest, and be given adequate fluids, but no other treatment is needed.

The threat posed by rubella is the possibility that it may cause damage to the fetus if a woman contracts the disease during the first trimester of her pregnancy. This fear is used to justify the immunization of all children, boys and girls, as part of the MMR inoculation. The merits of this vaccine are questionable for essentially the same reasons that apply to mumps inoculations. There is no need to protect children from this harmless disease, so the adverse reactions to the vaccine are unacceptable in terms of benefit to the child. They can include arthritis, arthralgia (painful joints), and polyneuritis, which produces pain, numbness, or tingling in the peripheral nerves. While these symptoms are usually temporary, they may last for several months and may not occur until as long as two months after the vaccination. Because of that time lapse, parents may not identify the cause when these symptoms reappear in their vaccinated child.

The greater danger of rubella vaccination is the possibility that it may deny expectant mothers the protection of natural immunity from the disease. By preventing rubella in childhood, immunization may actually increase the threat that women will contract rubella during their childbearing years. My concern on this score is shared by many doctors. In Connecticut a group of doctors, led by two eminent epidemiologists, have actually succeeded in getting rubella stricken from the list of legally required immunizations.

Study after study has demonstrated that many women immunized against rubella as children lack evidence of immunity in blood tests given during their adolescent years. Other tests have shown a high vaccine failure rate in children given rubella, measles, and mumps shots, either separately or in combined form. Finally, the crucial question yet to be answered is whether vaccine-induced immunity is as effective and long lasting as immunity from the natural disease of rubella. A large proportion of children show no evidence of immunity in blood tests given only four or five years after rubella vaccination.

The significance of this is both obvious and frightening. Rubella is a non threatening disease in childhood, and it confers natural immunity to those who contract it so they will not get it again as adults. Prior to the time that doctors began giving rubella vaccinations an estimated 85 percent of adults were naturally immune to the disease.

Today, because of immunization, the vast majority of women never acquire natural immunity. If their vaccine-induced immunity wears off, they may contract rubella while they are pregnant, with resulting damage to their unborn children.

Being a skeptical soul, I have always believed that the most reliable way to determine what people really believe is to observe what they do, not what they say. If the greatest threat of rubella is not to children, but to the fetus yet unborn, pregnant women should be protected against rubella by making certain that their obstetricians won’t give them the disease. Yet, in a California survey reported in the Journal of the American Medical Association, more than 90 percent of the obstetrician-gynecologists refused to be vaccinated. If doctors themselves are afraid of the vaccine, why on earth should the law require that you and other parents allow them to administer it to your kids?

WHOOPING COUGH

Whooping cough (pertussis) is an extremely contagious bacterial disease that is usually transmitted through the air by an infected person.

The incubation period is seven to fourteen days. The initial symptoms are indistinguishable from those of a common cold: a runny nose, sneezing, listlessness and loss of appetite, some tearing in the eyes, and sometimes a mild fever.

As the disease progresses, the victim develops a severe cough at night. Later it appears during the day as well. Within a week to ten days after the first symptoms appear the cough will become paroxysmal. The child may cough a dozen times with each breath, and his face may darken to a bluish or purple hue. Each coughing bout ends with a whopping intake of breath, which accounts for the popular name for the disease. Vomiting is often an additional symptom of the disease.

Whooping cough can strike within any age group, but more than half of all victims are below two years of age. It can be serious and even life-threatening, particularly in infants. Infected persons can transmit the disease to others for about a month after the appearance of the initial symptoms, so it is important that they be isolated, especially from other children.

If your child contracts whooping cough, there is no specific treatment that your doctor can provide, nor is there any you can apply at home, other than to encourage your child to rest and to provide comfort and consolation. Cough suppressants are sometimes used, but they rarely help very much and I don’t recommend them. However, if an infant contracts the disease, you should consult a doctor because hospital care may be required. The primary threats to babies are exhaustion from coughing and pneumonia. Very young infants have even been known to suffer cracked ribs from the severe coughing bouts.

Immunisation against pertussis is given along with vaccines for diphtheria and tetanus in the DPT inoculation. Although the vaccine has been used for decades, it is one of the most controversial of immunizations. Doubts persist about its effectiveness, and many doctors share my concern that the potentially damaging side effects of the vaccine may outweigh the alleged benefits.

Dr. Gordon T. Stewart, head of the department of community medicine at the University of Glasgow, Scotland, is one of the most vigorous critics of the pertussis vaccine. He says he supported the inoculation before 1974 but then began to observe outbreaks of pertussis in children who had been vaccinated. “Now, in Glasgow,” he says, “30 per-cent of our whooping cough cases are occurring in vaccinated patients. This leads me to believe that the vaccine is not alt that protective.”

As is the case with other infectious diseases, mortality had begun to decline before the vaccine became available. The vaccine was not introduced until about 1936, but mortality from the disease had already been declining steadily since 1900 or earlier. According to Stewart, “the decline in pertussis mortality was 80 percent before the vaccine was ever used.” He shares my view that the key factor in controlling whooping cough is probably not the vaccine but improvement in the living conditions of potential victims.

The common side effects of the pertussis vaccine, acknowledged by JAMA, are fever, crying bouts, a shock-like state, and local skin effects such as swelling, redness, and pain. Less frequent but more serious side effects include convulsions and permanent brain damage resulting in mental retardation. The vaccine has also been linked to Sudden Infant Death Syndrome (SIDS). In 1978-79, during an expansion of the Tennessee childhood immunization program, eight cases of SIDS were reported immediately following routine DPT immunization.

Estimates of the number of those vaccinated with the pertussis vaccine who are protected from the disease range from 50 percent to 80 percent. According to JAMA. reported cases of whooping cough in the United States total an average of 1,000–3,000 per year and deaths five to twenty per year.

DIPHTHERIA

Although it was one of the most feared of childhood diseases in Grandma’s day, diphtheria has now almost disappeared. Only 5 cases were reported in the United States in 1980. Most doctors insist that the decline is due to immunization with the DPT vaccine, but there is ample evidence that the incidence of diphtheria was already diminishing before a vaccine became available.

Diphtheria is a highly contagious bacterial disease that is spread by the coughing and sneezing of infected persons or by handling items that they have touched. The incubation period f6r the disease is two to five days, and the first symptoms are a sore throat, headache, nausea, coughing, and a fever of l00-l04 degrees. As the disease progresses, dirty-white patches can be observed on the tonsils and in the throat. They cause swelling in the throat and larynx that makes swallowing difficult and, in severe cases, may obstruct breathing to the point that the victim chokes to death. The disease requires medical attention and can be treated with antibiotics such as penicillin or erythromycin.

Today your child has about as much chance of contracting diphtheria as she does of being bitten by a cobra. Yet millions of children are immunized against it with repeated injections at two, four, six, and eighteen months and then given a booster shot when they enter school. This despite evidence over more than a dozen years from rare outbreaks of the disease that children who have been immunized fare no better than those who have not. During a 1969 outbreak of diphtheria in Chicago the city board of health reported that four of the sixteen victims had been fully immunized against the disease and five others had received one or more doses of the vaccine. Two of the latter showed evidence of full immunity. A report on another outbreak in which three people died revealed that one of the fatal cases and fourteen of twenty-three carriers had been fully immunized.

Episodes such as these shatter the argument that immunization can be credited with eliminating diphtheria or any of the other once common childhood diseases. If immunization deserved the credit, how do its defenders explain this? Only about half the states have legal requirements for immunization against infectious diseases, and the percentage of children immunized varies from state to state. As a consequence, tens of thousands-perhaps millions-of children in areas where medical services are limited and paediatricians almost nonexistent were never immunized against infectious diseases and therefore should be vulnerable to them. Yet the incidence of infectious diseases does not correlate in any respect with whether a state has legally mandated mass immunization or not.

In view of the rarity of the disease, the effective antibiotic treatment now available, the questionable effectiveness of the vaccine, the multimillion dollar annual cost of administering it, and the ever-present potential for harmful, long-term effects from this or any other vaccine, I consider continued mass immunization against diphtheria indefensible. I grant that no significant harmful effects from the vaccine have been identified, but that doesn’t mean they aren’t there. In the half century that the vaccine has been used no research has ever been undertaken to determine what the long-term effects of the vaccine may be!

CHICKEN POX

This is my favourite childhood disease, first because it is relatively innocuous and second because it is one of the few for which no pharmaceutical manufacturer has yet marketed a vaccine. That second reason may be short-lived, though, because as this is written there are reports that a chicken pox vaccine soon may appear.

Chicken pox is a communicable viral infection that is very common in children. The first signs of the disease are usually a slight fever, headache, backache, and loss of appetite.

After a day or two, small red spots appear, and within a few hours they enlarge and become blisters. Ultimately a scab forms that peels off, usually within a week or two. This process is accompanied by severe itching, and the child should be encouraged not to scratch the sores. Calamine lotion may be applied, or cornstarch baths given, to relieve the itching.

It is not necessary to seek medical treatment for chicken pox. The patient should be encouraged to rest and to drink a lot of fluids to prevent dehydration from the fever.

The incubation period for chicken pox is from two to three weeks, and the disease is contagious for about two weeks, beginning two days after the rash appears. The child should be isolated during this period to avoid spreading the disease to others.

TUBERCULOSIS

Parents should have the right to assume, and most do assume, that the tests their doctor gives their child will I produce an accurate result.

The tuberculin skin test is but one example of a medical test procedure in which that is definitely not the case. Even the American Academy of Pediatrics, which rarely has anything negative to say about procedures that its members routinely employ, has issued a policy statement that is critical of this test. According to that statement,

Several recent studies have cast doubt on the sensitivity of some screening tests for tuberculosis. Indeed a panel assembled by the Bureau of Biologics has recommended to manufacturers that each lot be tested in fifty known positive patients to assure that preparations that are marketed are potent enough to identify everyone with active tuberculosis. However, since many of these studies have not been conducted in a randomized, double-blind fashion and/or have included many simultaneously administered skin tests (thus the possibility of suppression of reactions), interpretation of the tests is difficult.

That statement concludes, “Screening tests for tuberculosis are not perfect, and physicians must be aware of the possibility that some false negative as well as positive reactions may be obtained.”

In short, your child may have tuberculosis even though there is a negative reading on his tuberculin test. Or he may not have it but display a positive skin test that says he does. With many doctors, this can lead to some devastating consequences. Almost certainly, if this happens to your child, he will be exposed to needless hazardous radiation from one or more x-rays of his chest. The doctor may then place him on dangerous drugs such as isoniazid for months or years “to prevent the development of tuberculosis.” Even the AMA has recognized that doctors have indiscriminately over prescribed isoniazid. That’s shameful, because of the drug’s long list of side effects on the nervous system, gastrointestinal system, blood, bone marrow, skin, and endocrine glands. Also not to be overlooked is the danger that your child may become a pariah in your neighborhood because of the lingering fear of this infectious disease.

I am convinced that the potential consequences of a positive tuberculin skin test are more dangerous than the threat of the disease. I believe parents should reject the test unless they have specific knowledge that their child has been in contact with someone who has the disease.

SUDDEN INFANT DEATH SYNDROME (SIDS)

The dreadful possibility that they may awaken some morning to find their baby dead in his crib is a fear that lurks in the mind of many parents. Medical science has yet to pinpoint the cause of SIDS, but the most popular explanation among researchers appears to be that the central nervous system is affected so that the involuntary act of breathing is suppressed.

That is a logical explanation, but it leaves unanswered the question: What caused the malfunction in the central nervous system? My suspicion, which is shared by others in my profession, is that the nearly 10,000 SIDS deaths that occur in the United States each year are related to one or more of the vaccines that are routinely given children. The pertussis vaccine is the most likely villain, but it could also be one or more of the others.

Dr. William Torch, of the University of Nevada School of Medicine at Reno, has issued a report suggesting that the DPT shot may be responsible for SIDS cases. He found that two-thirds of 103 children who died of SIDS had been immunized with DPT vaccine in the three weeks before their deaths, many dying within a day after getting the shot. He asserts that this was not mere coincidence, concluding that a “causal relationship is suggested” in at least some cases of DIPT vaccine and crib death. Also on record are the Tennessee deaths, referred to earlier. In that case the manufacturers of the vaccine, following intervention by the U.S. surgeon general, recalled all unused doses of this batch of vaccine.

Expectant mothers who are concerned about SIDS should bear in mind the importance of breastfeeding to avoid this and other serious ailments. There is evidence that breastfed babies are less susceptible to allergies, respiratory disease, gastroenteritis, hypocalcaemia, obesity, multiple sclerosis, and SIDS. One study of the scientific literature about SIDS concluded that “Breast-feeding can be seen as a common block to the myriad pathways to SIDS.”

POLIOMYELITIS

No one who lived through the 1940s and saw photos of children in iron lungs, saw a ‘President of the United States confined to his wheel-chair by this dread disease, and was for forbidden to use public beaches for fear of catching polio can forget the fear that prevailed at the time. Polio is virtually nonexistent today, but much of that fear persists, and there is a popular belief that immunization can be credited with eliminating the disease. That’s not surprising, considering the high-powered campaign that promoted the vaccine, but the fact is that no credible scientific evidence exists that the vaccine caused polio to disappear. As noted earlier, it also disappeared in other parts of the world where the vaccine was not so extensively used.

What is important to parents of this generation is the evidence that points to mass inoculation against polio as the cause of most remaining cases of the disease. In September 1977 Jonas Salk, the developer of the killed polio virus vaccine, testified along with other scientists to that effect. He said that most of the handful of polio cases which had occurred in the US since the 197Os probably were the by-product of the live polio vaccine that is in standard use in the United States.

Meanwhile, there is an ongoing debate among the immunologists regarding the relative risks of killed virus vs. live virus vaccine. Supporters of the killed virus vaccine maintain that it is the presence of live virus organisms in the other product that is responsible for the polio cases that occasionally appear. Supporters of the live virus type argue that the killed virus vaccine offers inadequate protections and actually increases the susceptibility of those vaccinated.

This offers me a rare opportunity to be comfortably neutral. .I believe that both factions are right and that use of either of the vaccines will increase, not diminish, the possibility that your child will contract the disease.

In short, it appears that the most effective way to protect your child from polio is to make sure that he doesn’t get the vaccine!

East West Journal November 1984. (Also a chapter in  How To Raise a Healthy Child In Spite of Your Doctor)

American Medical Revolutions

Sunday, March 18th 2012 at 4:00 pm by Sayer Ji, founder

American Medical Revolutions

About 170 years ago our ancestors forced the repeal of licensing laws which had created a monopoly over the practice of medicine for orthodox physicians. Ordinary people, farmers, artisans, tradesmen and others got together and forced politicians to act on their behalf. They were tired of bloodletting, and harsh medications like mercury compounds that ruined their teeth and weakened their bodies. They opted for kinder and gentler alternatives with lower casualty rates, particularly the newly introduced homeopathy. They were impressed that tiny doses of medicine were able to cure cholera much better than the massive doses used by orthodox physicians.

Homeopathy, introduced in America in 1825, was a brand new medical discipline developed by a German physician named Samuel Hanhemann (1744-1843). He was disillusioned with the results of medical practices of his day. He stopped practicing and began to study the effects of medicine on a healthy person, himself. He tried quinine, a very popular medication, first. It caused symptoms of malaria, the disease which it was able to cure. Similarly mercury produced symptoms of syphilis on which it had therapeutic effects. This experimental evidence lead to an assumption: substances which produce symptoms in healthy people can have a curative effect on sick people who experience the same symptoms. Extensive experimentation with his family and friends resulted in collection of the symptomology of 27 medications. With this information he was able to investigate the validity of his hypothesis.

Returning to the practice of medicine he found that clinical experience validated his hypothesis. By this means his hypothesis became a theory in accordance with scientific methodology. Ultimately, confirmed by other investigators, it became the law of similars.

Subsequently experimentation with varying doses disclosed that small amounts of medicines had more effect on the diseases of patients than large amounts. This experimental evidence led him to conclude that his medications were stimulating the inherent healing powers of his patients. They were getting well without the damaging side effects of excessive amounts of medicines.

Many orthodox physicians in Germany, observing Hahnemann’s successes, sought training in the application of the new doctrines and began to practice homeopathy-generating a new school of medicine in the process. It became popular all across Europe. Homeopathic physicians began treating the royalty and nobility of Europe.

Homeopathic physicians didn’t try to find the cause of diseases. They spent a lot of time identifying symptoms in consider-able detail since each patient was considered to be unique. The symptoms defined the disease. Matching the symptoms of the patient with the symptoms associated with medications was not an easy job. Intelligence, training and dedication were required to achieve the full benefits of homeopathic technology. Ultimately some homeopaths limited themselves to the use of low potency medications while the most effective practitioners used the high potency variety, those with the highest dilutions.

Hahnemann did not claim to have discovered the law of similars. The therapeutic systems of empiric physicians in ancient Greece and Paracelsus had included this theory. The important discovery that medicinal substances could be more active at high dilutions was his alone and he was vilified because of it. Those whose incomes depended on the sale of large quantities of drugs found it economically damaging. Orthodox physicians, whose use of excessive amounts of mercury caused their patients to lose teeth and deteriorate physically, hated it as a serious threat to their physical safety as well as their professional reputation. But many physicians trained in the orthodox tradition abandoned it and took up the practice of homeopathy with great success.

Success of homeopathic treatments with camphor, copper sulfate and Veratrum album, recommended by Hahnemann during the Asiatic cholera epidemic in Europe in 1832, firmly established homeopathy in France. When Hahnemann arrived in Paris in 1835 he was granted a license to practice medicine within 6 month. He subsequently cured the Marquess of Anglesea of tic deleureux which French physicians had been trying unsuccessfully to cure for 20 years. After losing prestige and patients to the homeopaths, member of the French National Academy of Medicine called them knaves, ignoramuses, charlatans and quacks. Nevertheless orthodox physicians adopted camphor, copper sulfate and Veratrum album as remedies for cholera.

American homeopaths were as successful treating cholera in the 1830s as the French homeopaths. They added to their reputation when in 1878 a yellow fever epidemic spread from New Orleans into the Mississippi Valley with alarming death rates: 4,600 of 27,000 cases in New Orleans, 5,000 out of 18,500 cases in Memphis with a total of 15,934 death out of 74,265 cases reported in the Mississippi Valley. Homeopathic physicians in New Orleans had treated 1,945 cases with loss of 110. In the rest of the south they had treated 1,969 cases with loss of 151–7.7%. The overall death rate for reported cases in the south was at least 16%. The French Government awarded a gold medal to a French homeopath for his work during the New Orleans epidemic. Homeopaths were popular!

Insurance companies began offering reduced rates to persons employing homeopathic physicians and homeopathic life insurance companies were being chartered. In 1870 the Homeopathic Life Office of New York reported that it had sold 7,927 policies to followers of homeopathy and 2,258 to other; 84 deaths in the first category and 66 in the second justified the lower premiums charged to the former.

As a result of these successes by 1892, homeopaths in the United Stated controlled about 110 hospitals, 145 dispensaries, 62 orphan asylums and old peoples homes, over 30 nursing homes and sanitaria and 16 insane asylums.

In 1889 the Westborough, Massachusetts insane asylum was run by homeopaths and the Springfield Republican reported that the cost of maintenance is much less and recoveries and general success greater than in allopathic asylums.

Meanwhile competing medical technologies and an oversupply of physicians drastically reduced the income and status of about 110,000 orthodox physicians. An average one earned $750 per year in 1900 and about 40 per year committed suicide because of financial difficulties. But about 15,000 homeopathic physicians prospered and 26 schools of homeopathy flourished at the end of the century. Unsuspecting homeopaths, fully occupied with their lucrative practices, gave grudging support to their own organization not realizing that they were in danger.

Orthodox physicians at the American Medical Association (AMA) plotted their downfall. The first objective was reduction in the number of medical schools and medical students. This had been a cherished goal since 1846 when the founding convention of the AMA occurred.

Politically astute George Simmons, M.D. who graduated from Hahnemann Medical College of Chicago in 1882 and later attended Rush Medical School, was appointed secretary of the AMA and editor of its journal (JAMA) in 1899. Soon thereafter he was appointed secretary of a committee to consider reorganization. In 1901 a reorganized AMA changed from a loose federation of independent professionals into a political powerhouse. The reorganization substantially reduced the influence of individual physicians who had been objecting to unethical drug company advertising.

In 1904 the AMA established a Permanent Council on Medical Education. In 1905 the Council arranged a conference of state medical licensing boards to review the status of medical education and set standards for medical schools. A temporary standard required four years of high school and 4 years of medical school and examination of graduates by state boards before licensing. In 1906, the committee inspected 160 medical schools, grading 82–A, 46–B and 32–C. Fifty schools agreed to require 1 year of college sciences courses for admission.

In 1907 Arthur D. Bevan, M.D., the Council’s chairman, convinced Henry Pritchard, former President of MIT, who now headed the Carnegie Foundation, to sponsor a study of medical education. That Foundation, founded in 1905 with the objective of upgrading the status of college teachers and creating a uniform system of higher education, was a logical ally. In November of that year the trustees approved the proposed study and Pritchard hired Abraham Flexner, an educator who had graduated from Johns Hopkins University, to work on the project.

Flexner headed for his alma mater’s medical school, which he used as his standard of comparison. Accompanied by Nathan Caldwell, M.D., who replaced Bevan as Chairman of AMA’s Council on Medical Education, Flexner made a comprehensive survey of medical schools in 1910. His opinions of most of the schools he visited and evaluated were not flattering. Harvard University was incensed at his opinion of their medical school which had been reorganized by Charles Elliot in 1870.

Flexner was convinced, probably by Dr. Caldwell, that Hahnemann and homeopathy were frauds, since this was the official opinion of the AMA which denied that homeopathy possessed therapeutic efficacy. Flexner also bought the opinion of William Osler, M.D. that “sectarian allopathy and homeopathy” were yielding to the new scientific medicine.

Flexner’s famous report, coauthored by Nathan Caldwell, caused substantial changes. It started a process that empowered the AMA, disorganized the homeopaths and forced the closure of homeopathic medical schools. Even though John D. Rockefeller favored homeopathy and repeatedly insisted that it be sup-ported, all of his money was spent on “scientific medicine”. Frederick Gates who was influential in disbursing Rockefeller’s money wrote that Hahnemann was in-sane. John D., Jr. told his father that the homeopaths were integrating with the allopaths. Letter requests for funds from one homeopathic school were said to have been unanswered.

Scientific medicine was designed to be capital intensive. Requirements for teaching it increased costs beyond the capability of students to support the schools with tuition and fees. As a result schools, unable to supplement their income from other sources like grants and bequests, were forced to close or consolidate. In 1910 the number of medical schools was reduced from 166 to 131. Only 63 were left in 1929. In the 1930s and 1940s, 11 homeopathic schools closed. After 1930 even the Hahnemann Medical College of Philadelphia was teaching allopathic medicine except for one or two classes of homeopathy.

New laws gave the AMA the power to control what the schools taught. Curricula were heavy in the sciences, but there was only minimal training in nutrition and pharmacology. Physicians who used to make up their own remedies began to rely on pharmaceutical company formulations and for information on drugs. Production of physicians was substantially reduced. Competing medical sects, whose members had totaled less than 10% of all physicians, were all but emasculated.

Evidently our present unsatisfactory situation came about because the frustrated monopolists of the 1820s found a way to put themselves back in the driver’s seat. They convinced upper and middle class people that they were scientists who could bring the benefits of science to their patients. At least $300 million ($600 million according to Harris Coulter’s The Divided Legacy) contributed by wealthy donors, supplemented by an unknown amount funneled through the JAMA by the pharmaceutical industry and other advertisers, helped them regain control. At a time when one dollar bought a 10-hour day’s work, this was an irresistible flood that carried the orthodox physicians back into power and supported the monopoly for almost a hundred years.

Once in control, efforts to reduce competition and increase income have been unceasing. Physicians who practice alternative medicine, in competition with regular physicians, are subject to harassment. In the state of Washington about 30% of them are being harassed at this time. Those who make substantial advancements in medical science often find the Federal Government moving against them. The FDA and FTC have used taxpayer money to suppress new technology in a number of cases. Even State legislators have cooperated, in cases where other means failed,

The purpose of the new licensing laws was to protect the public but, in fact, monopolized medical care, according to reports, has been killing over 200,000 of us every year and promises to bankrupt the country. These laws are used to prevent free public access to less lethal, more effective and less expensive therapies. As Daniel Haley so eloquently wrote, in Politics in Healing, “we don’t need government protection from things that can’t hurt us”.

Medical science should be a search for the truth and many medical scientists have spent their lives in this search. Unfortunately scientific medicine, as practiced by the medical monopoly during the last century, has rejected the discoveries of a number of medical scientists. Too many promising technologies have been consigned to the dust bin of history. As a result, medical services are much more expensive than they should be and lower in quality than they could be. Less suppression and more competition can make people healthier at lower cost.

One hundred years of suppression of advancements in medical science is enough. Even physicians have been victimized. Their expensive schools don’t teach them about the suppressed science and give them inadequate training in nutrition and therapeutics. We can do without the high prices and poor care. Let’s recover and apply the suppressed technology and reward, rather than discourage, innovations that promise lower costs and better quality care. Replace the medical monopoly with laws guaranteeing freedom of choice in medical care.

Again in 2008, as in the 1830s, orthodox medicine is killing lots of people and creating lots of invalids. The exorbitant price of $2 trillion a year is too much. We owe it to ourselves and our descendants to reintroduce competition into the medical marketplace. Forcing the repeal of the Medical Practices Act will be a good start. The Access to Medical Treatment Act proposed in the 2000 session of Congress might also be resurrected.

– Jack Phillips

Giardiasis

2010 Florida

Female patient age 27  presented with Giardia in the form of the following symptoms.

General feeling of malaise and intense weakness..

Diarrhoea, watery, frequent, unpleasant smelling and fast spluttery discharge. Abominal cramps after eating. A noted symptom was that the patient could no longer drink her customary hot or iced tea as it made the cramps and diarrhoea worse.

Causation was unknown, except had a brief sexual relationship with a male with anal sex involved 3 to 4 weeks previously.

Lab test confirmed Giardia lamblia parasite.

A look in the P & W Therapeutic Pocket book suggested two remedies to look at for comparison. China and Veratrum. After careful analysis, China was selected as it fitted more closely with the patients state.

 

The patient was given one dose of the China 0/1 in the office, and told to take another two doses that same day, and then take one dose a day for 4 days when I would see her again.

Follow up. 5 days later. Cramps gone, evacuations was just one watery stool a day…still weak but not feeling unwell. Prescribed 1 dose of sulphur 0/1 daily for three days. On follow up patient was clear of all symptoms but still a little weak. continued sulphur 0/1 for 7 days.

Patient was discharged on follow up.

 

Soldier acquitted in AIDS assault case after HIV tests shown to be completely bogus

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An Army sergeant who was falsely accused of being HIV positive, and who spent 240 days in pretrial custody as a result, has officially been acquitted of the charges levied against him. Thanks to the efforts of the Office of Medical and Scientific Justice(OMSJ), a private investigative agency that focuses on medical and scientific fraud, Sgt. “TD,” who was arrested in 2011 for HIV-related criminal charges, has been vindicated of his HIV-positive status, which has also caused the legitimacy of HIV tests to once again be called into question.

A former girlfriend of Sgt. TD, as well as three other women, reportedly pressed charges against the man after several ELISA (enzyme-linked immunosorbent assay), Western Blot, and viral load tests revealed that he was allegedly HIV-positive. Based on these tests and on affirmations by both a doctor’s diagnosis and a soldier’s signed confession, each of the women claimed that Sgt. TD exposed them to HIV without disclosing that he was infected, which is said to constitute aggravated assault.

Initially, it appeared as though Sgt. TD had no defense, and would have to potentially serve 37 years in federal prison for his alleged crime. But after Sgt. TD’s attorneys asked OMSJ for help on the case, to which the group agreed, it was eventually shown that each of the HIV tests conducted, including Western Blot, the so-called “gold standard” of HIV tests, could not be relied upon for absolute accuracy in light of the numerous outside factors that may have tainted their results.

“The underlying diagnosis of being HIV-positive was unreliable, and the reason it was unreliable is because the tests used […] the standard tests for claiming that someone is infected with HIV, if you really dissect them, they don’t do that,” said attorney David Steele Esq., who observed the trial and recently spoke about it with radio host Celia Farber and Dr. David Rasnick, Ph.D.

“There was a significant doubt whether or not TD was infected with HIV. He was totally healthy. This is a man with no symptoms. And if there was a doubt on whether he was infected with HIV, obviously he could not be convicted of transmitting that allegedly fatal virus to people.”

You can listen to the entire audio of Steele’s interview here: http://www.omsj.org/2012/PRN-SgtTD.mp3

Sgt. TD’s HIV tests invalid due to vaccines he was forced to receive

One of the primary factors that is known to affect the legitimacy of popular and widely-accepted HIV tests is vaccines. And Sgt. TD had reportedly received a battery of vaccinations around the time when his HIV tests, many of which are known to produce false positives to begin with, were conducted. This key piece of information was used in Sgt. TD’s defense to help acquit him of the charges filed against him.

But the fact that these vaccines, which were not named, are linked to false positives says a whole lot about the reliability of HIV tests in general. Not only are most Americans compliant with the vaccination schedules put out by the likes of the U.S. Centers for Disease Control and Prevention (CDC), which increase their chances of having a false positive, but many of them are likely exposed to other factors that contaminate the results of HIV tests.

HIV tests, after all, do not even test for the presence of the actual HIV virus, but rather the antibodies that the body would produce in response to it. As a result, roughly 50 percent of all HIV tests that show up positive are phony, according to a 2010 study published in the Journal of the American Medical Association (JAMA). And certain vaccines are responsible for causing a nearly 90 percent false positive rate for HIV tests (http://www.naturalnews.com/029236_HIV_vaccine.html).

How many individuals have been illegitimately imprisoned due to false HIV-positives?

The legal ramifications for individuals that fail to disclose their HIV-positive status to sexual partners are severe, as the courts consider this to be attempted murder. But with the integrity of HIV tests called into question, it begs the question as to how many other people besides Sgt. TD have been falsely imprisoned.

While Sgt. TD spent only 240 days in prison before his trial, he could have spent several decades there if the OMSJ had not pointed out the problems with HIV tests. Many others, including Andre Davis, a professional wrestler who was recently sentenced to 32 years in prison for failing to disclose his allegedly HIV-positive status (http://www.usatoday.com), have not received the same legal benefit of the doubt.

For more on the Sgt. TD case, check out this Robert Scott Bell interview with attorney David Steele: http://www.omsj.org/2012/RSBSteele3.mp3

Sources for this article include:

http://www.omsj.org/issues/ustd

 

http://www.naturalnews.com/036043_AIDS_assault_soldier_acquitted.html