Risk Vs Benefit Arguement

Wednesday, April 25, 2012

Vaccines: Analysing the Risk Vs Benefit Arguement

Vaccines: Analysing the Risk Vs Benefit Arguement - Jagannath Chatterjee

When I started my campaign, sometime in 1985, on the internet from 2001, doctors responded by saying that vaccine safety was beyond question, they were as safe as water. Later as I intensified my campaign and cited peer reviewed published material on risks from vaccines, they modified their stance to; well all medications have some risk. Now they fall back upon the risk-benefit analysis meaning that the benefits outweigh the risks. Today I will touch on this topic in a generalised fashion so that all can comprehend what I am trying to say.

Human rights

I will start with the human rights aspect. Human rights aspect laws framed after World War II atrocities cover not only medical research/interventions but also therapy. According to them there should be full disclosure for all medical prescriptions and procedures and that the subject has the choice to accept the risk or refuse, that is the patient decides what is suitable for her or him. This is blatantly violated by medical practitioners who feel that it is they who should take the decisions. In case of informed consent on matters of vaccines, in developing countries there is no disclosure though there is a hint in immunisation procedure training manuals that healthworkers should inform parents that there are risks involved which is not done. In case of developed countries there is only token standardised leaflets that do not reveal the full story.

Doctors usually avoid talking on the issue of informed consent. They will stare at you as if you are an alien from another planet if you even broach the subject. But I have been a little persistent. Indian doctors whom I have talked to/corresponded with say that even hinting about a risk might prompt parents not to vaccinate their children. This, according to them will severely compromise the vaccination rates. This is a damning statement. So it seems vaccination targets are more important than the life or health of the children. Parents deserve to know the risks that their children face, whom they have conceived and nurtured for nine months in their womb, on those their entire dreams and aspirantions rest, when they are being administered vaccines, singly or in combination.

Risks from vaccines

Now about the risks from vaccines. I have pointed out again and again that vaccine risk is a taboo subject that is always avoided, by manufacturers, policy makers and the medical fraternity. When I complained to the WHO patient safety unit about what they were doing to address the subject of ascertaining vaccine risks they replied that the department is never allotted the required funds to do so. This is the same with the FDA which licences most vaccines. GAVI & PATH did not even feel the need to answer my queries on the subject. It has recently been revealed that the FDA does not have the required cutting edge research laboratory to conduct credible vaccine safety tests. In an article in "Investigate Hers" - a family magazine from New Zealand, Merck employees have complained that the vaccine safety team employed by Merck is not adequately qualified and that Merck too has not appropriately upgraded its laboratories. They said this was undermining the credibility of Merck, a prominent vaccine MNC.

Vaccine testing procedures are highly questionable

In case of vaccine testing the onus is primarily on the manufacturer. The procedures followed are highly questionable. The vaccines are tested on hand picked healthy children while in real life vaccines are administered indiscriminately to vulnerable, sick, underweight, preterm, immune compromised infants, a fact pointed out and raised by senior pediatrician Dr T Jacob John in India. In these tests the vaccinated children are compared to another group who are either vaccinated with another similar vaccine, with other highly reactogenic vaccines or with the vaccine ingredients minus the antigen. This is so the studies can safely declare, "no significant changes were noticed in the vaccinated children vis a vis control groups". The vaccinated children are observed for usually for 14 days, as pointed out by Dr Sherri Tenpenny, or for that number of days till the after effects start appearing. This is a skulduggery that is an insult to the very procedure. Cases of deaths or very severe adverse effects are often excluded citing that other extraneous factors were behind them. For example, in the rotavirus vaccine clinical trial it was observed that the vaccinated children suffered from respiratory tract infections. However this was ignored as "the vaccine could not have possibly caused that". So these trials are more about hiding vaccine risks rather than trying to identify them.

Fair and accurate monitoring of vaccines after licensing is not done

There is a rule stating that there should a monitoring mechanism after the vaccine is licenced and released. However this mechanism is very tardy to say the least. There is neither the political will nor the medical endeavour to ensure fair and accurate monitoring. In case of the OPV, the IMA in India made the shocking declaration that doctors were advised to ignore and not report cases of paralysis caused by the vaccine. It goes to the credit of the then IMA chief functionaries led by Dr S K Mittal that such a monitoring was done and it revealed that on an average 500 to 600 cases of Vaccine Attributed Paralytic Polio occur every year. The IMA also reported that the OPV was causing cases of Acute Flaccid Paralysis (a condition indistinguishable from polio) to skyrocket and that a vaccine strain virus had attained virulence and was circulating in the population. While the IMA quoted a figure of 30,000 AFP cases, the JSA reported 1,25,000 up to 2007 and The Telgraph science correspondent G S Mudur indicated a figure of 3,00,000.

Doctors and health care workers are programmed not to report adverse vaccine effects

The IMA demanded identification, treatment and rehabilitation of the tens of thousands of victims of the Oral Polio Vaccine but the health ministry did not pay heed and the matter was allowed to die down. I have reported recently how the cases of intestinal intussusception (an extremely painful condition that may require immediate surgery or lead to death) and intestinal bleeding in children following the rotavirus vaccines are being observed but not reported because it could "scare other doctors" and also hinder the process of including this vaccine into the government schedule. The doctors are thus programmed not to report vaccine adverse effects. They are not informed or taught about serious vaccine risks in their textbooks or are told that serious events are next to negligible. They are also not always knowledgeable about whom to report and are often afraid to do so fearing reprisals from their associations. Only deaths immediately following the vaccines which are brought to the notice of the press ever get reported. But in almost 100% of the cases they are dubbed as "coincidence" or blamed on "program errors" and the vaccine is exonerated. Health care workers will not report vaccine adverse effects as the entire blame is usually put on them and they are punished.

Vaccine adverse effects do not occur immediately but may take weeks or months before manifesting

Vaccine adverse effects do not occur immediately but may take weeks or months before manifesting as the process is often slow and insidious though the end result may be catastrophic. Doctors investigating vaccines say that even acute reactions may take from five months to five years to manifest. Thus it becomes very easy to dissociate the event from the vaccine and the cases end up by being termed idiopathic or "cause unknown". Vaccine long term effects may span the lifetime particularly as the inflammatory process set in motion does not stop. Many of the vaccine ingredients lodge themselves permanently in the tissues, fat cells and the brain and continue to inflict a steady and progressive damage permanently. Attenuated live viruses introduced by vaccines may stay dormant for long periods, often mutate, and can become virulent when the immune system becomes weak due to any reason. As vaccines adversely affect the immune system viruses and bacteria present in humans that were not virulent earlier are today causing diseases, for example the Hib, which has coexisted since centuries with humans without any averse effect, but which has become virulent and is now causing meningitis and pneumonia in some immune compromised children and for which yet another vaccine has been devised and is being forced upon the population of mostly developing countries .

Animal and human genetic material contamination in vaccines

The other very dangerous aspect involves animal and human genetic material contamination in vaccines. Such contamination is inevitable, cannot be controlled, and cannot always be traced as our knowledge about zoonotic (animal) viruses is very limited. Till date, despite the intention not to identify the viruses, there have been traced 100 or so monkey viruses, bovine and avian leukemia viruses, porcine viruses, cytomegaloviruses, the foamy virus and so on in vaccines. No research has been done on their presence, continuation in the human body and mutation or their incorporation into the human genome. SV 40, the Simian Virus, the only one researched into for a short time before the researcher was ticked off and the research stopped, is known to be behind many forms of tumours and cancers in the human body. It is also known to be transmitted to the new generation as it has contaminated the human sperm and most probably breast milk as well. Junk DNA and RNA poses a graver threat as they can incorporate into the human genome by a process known as reverse transcriptase. According to medical scientists this form of threat is the most dangerous that vaccines pose but serious concerns raised by medical scientists are being ignored.

Knowledgeable parents who do their own research genuinely worry about vaccines because of many reasons;

1. The nature of vaccine ingredients that are highly toxic in nature

2. How these toxins interact with themselves in a process called synergistic toxicity is never studied

3. The child is given not one but many vaccines

4. Often the vaccines are administered simultaneously

5. The safety aspects of such simultenous administrations are rarely studied

6. The complaints of parents of adverse reactions following vaccines go unheeded and they are often mocked at or threatened for raising the subject

7. Parents today know that vaccine adverse effects may take a long time to appear

8. Whether infants, a category with almost no liver activity, with immature immune systems and low kidney efficacy can really tolerate even one single vaccine shot. Studies in other mammalian species have revealed that they cannot.

9. Vaccine shots have grown in number from 5 earlier to 70 shots of 16 different vaccines, up to 45 of them mandated in the United States

10. Vaccine damage is extremely expensive to address and families go bankrupt trying to take care of their children

11. Doctors do not understand autism and other developmental disorders in children fully and they are programmed to treat them as purely psychological and behavioral disorders of genetic origin. As a result the parents have to research and treat their own children. Doctors who go against the grain and try to biomedically treat these children are being persecuted and branded as quacks.

12. The children suffer from lack of communication and so cannot express their pain and discomfort. They cannot take care of themselves, fall behind in their studies, rebel and run away, throw serious tantrums that are difficult to control, suffer repetative behaviour patterns, and thus are avoided by teachers and nannies and the burden entirely falls on the mother who suffers endlesslly.

13. The presence of such a child in the family causes familial tensions resulting in divorces and separation. There are cases of mothers killing their own children and committing suicide unable to bear the trauma.

14. Compensation is not given, or is extremely difficult to obtain (only in developed countries is compensation even considered) as the procedure goes against the interest of the victims and the scientific apparatus have set conditions that almost negate any chance of compensation. There are cases where the judges have understood the situation but have said that their hands are tied, and have described vaccines as "unavoidably risky".

15. The parents cannot sue the vaccine manufacturers because of an 1986 law passed by Parliamentarian Bill Frist and supported by Ronald Reagan that indemnifies vaccine manufacturers from law suits.

16. Even then $ 2 billion has been compensated so far to select cases, 83 of them for vaccine induced autism as per expert testimony of those very officials who under oath admit to vaccine damage while negating them otherwise.

17. Even then officials will not admit that vaccines cause autism by offering the explanation that the court awards were for "autism like symptoms' and not autism which is strange as autism is till now a symptomatic disorder.

18. Recent law passed in California has waived parental consent for vaccinating 12 year old children against sexually induced illness, like vaccines for HPV and Hep-B. Other states threaten to follow suit.

19. All efforts are being made to mandate vaccines for school and college admissions and parental exemptions are being made more and more difficult to obtain.

20. There is a revolving door between health institutions and vaccine manufacturers. Dr Julie Gerberding, Head of CDC who had steamrolled many a call for enquiry into vaccine safety, today heads the vaccine division of Merck. Dr Thomas Verstraeten of the CDC is today with GSK. Dr Paul Offit of the Childrens Hospital of Philadelphia has joined the IOM, USA. Many health officials and vaccine industry employees have joined the vaccine wing of the Bill & Melinda Gates Foundation.

21. Vaccine decisions are often taken by politicians or beurocrats who are influenced by money paid into election funds by vaccine manufacturers.

22. Published studies on vaccine safety and efficacy are conducted by doctors and scientists with conflicts of interest, which are often not declared but later found out through public and activist investigations.

23. Medical journals have their functions conducted by donations from the pharmaceutical industry which severely dilutes their credibility.

24. Pro vaccine books wriiten by doctors and pro vaccine articles or studies in journals are procured in bulk by vaccine manufacturers which are then distributed free to doctors and policy makers involved with vaccines to influence their opinion and to prove that vaccines are scientific.

25. Institutions who form vaccination schedules are heavily financed by vaccine manufacturers and their office buildings built by them or their annual events sponsored by vaccine manufacturers. Individual doctors are also suitably rewarded in the guise of foreign fully paid jaunts for continuing education or gifts to influence their decisions.

26. Latest genetic studies into origins of autism have clearly stated that cases of genetic mutations have been observed which could be due to external, termed environmental, toxins. The Joachim Hallmayer study this September 2011 has doubted the theory being pushed that autism is genetic.The Hallmayer study is the largest done so far conducted upon 900 twins.

27. It is a fact that pediatricians depend entirely on vaccines and the resultant illnesses for their income. Unless this issue is settled we are not going to see any perceivable shift in vaccine policy in the near future.

So the overall picture is that vaccine safety is not even low rung priority of any of the stakeholders, except for the public for whom it is the one and only priority. In India, I have had access to meeting records where vaccine policies are discussed and I can declare that vaccine safety is not usually even touched upon. The whole thrust is on introducing new vaccines and of ways to finance the decisions. India's latest Draft National Immunisation Policy seeks to sanction all vaccines available in the market, a move that has been strongly opposed by doctors and policy makers who say that such a move is due to the pressure from agencies like the Bill & Melinda Gates Foundation and the international vaccine MNCs. A petition signed by doctors and medical scientists has been submitted to the Health Ministry against this policy.

Vaccine effectiveness has been questioned in published literature. According to a published study in medpage, vaccine induced antibodies do not necessarily translate into immunity. Cases of measles, whooping cough and mumps outbreaks in fully vaccinated children have been reported in many countries. Vaccine preventible disease outbreaks are blamed on non vaccinated children without releasing key information about the disease outbreak in vaccinated children. The herd immunity argument used to push vaccines into the maximum number of children has been questioned as it is not based upon scientific evaluation. Whereas countries such as Japan and Sweden concede cases of vaccine adverse effects and pay compensation, those vaccines continue to be administered in other countries. Vaccine batches rejected in developed countries are not destroyed but shipped to developing countries. Currently a large batch of a flu vaccine associated with risks is being considered to be shipped elsewhere. Companies have reportedly even intentionally shipped infected ingredients of vaccines so as to cause global outbreaks of diseases mandating further vaccines (the Baxter incident).

Thus we are compelled to come to the conclusion that the risk vs benefit anlaysis that the vaccine lobby tom-toms to promote this highly controversial procedure is, to put it very mildly and politely, seriously flawed.

All that I have commented upon here has been published in various books, journals and is also available on the internet. I have merely collated the information to create awareness about vaccine risks. Parents are advised to do their own research before deciding to vaccinate their children. Always remember, as stated by Dr Ajay Gambhir of India, past Vice President of IAP, and a good friend of mine, that you have a choice and that no one can infringe upon your rights to forcefully vaccinate your child. If that is done please hire a lawyer, file a case of assault in the police station in whose jurisdiction the area falls against the doctor or institution involved and bring the matter to the notice of the IMA, IAP or the Health Department (You can go to their websites to get the contact numbers). There is no law in India mandating vaccines. The government and also the IAP merely recommends vaccines and tries to pursuade parents to vaccinate their children through the media and by employing celebrities to send out the message.

http://currenthealthscenario.blogspot.in/2012/04/vaccines-analysing-risk-vs-benefit.html

Studies comparing vaccinated to unvaccinated populations

Tetyana Obukhanych, Ph.D. (Immunology) explains:

To date, no studies comparing total health outcomes of vaccinated versus unvaccinated children have been done by the medical establishment. In fact, to carry out a study that would give the most definitive answer (i.e., long-term total health outcome in the prospective randomized placebo-controlled trial of the whole vaccination schedule) is considered unethical by the establishment’s code of research bioethics.

Whereas association-type studies of health outcomes in groups who have already made the choice to vaccinate (or not) are ethical to perform, the interpretation of data from such studies might be prone (or construed to be prone) to reporting bias or other confounders, thus further fueling rather than resolving the vaccine debate. (FAQ)

The following is taken in part from Public Testimony of Dr. Heather Rice at the Vermont Department of Health hearing on Act 157, 10/19/2012:

No study of health outcomes of vaccinated people versus unvaccinated has ever been conducted in the U.S. by CDC or any other agency in the 50 years or more of an accelerating schedule of vaccinations.

However, a German study published in 2011 compared the health outcomes of 94 unvaccinated children versus 13,359 vaccinated children (Dtsch Arztebl Int. 2011 February; 108(7): 99–104.”Vaccination Status and Health in Children and Adolescents; Findings of the German Health Interview and Examination Survey for Children and Adolescents (KiGGS).” (pdf of article – pdf of replies). Because the number of unvaccinated children included in the analysis is so small, statistical evaluation is nearly impossible. However, the study did show that unvaccinated human children in two of the three age groups under investigation showed fewer infections and atopic disorders than those who were vaccinated, and none of the unvaccinated children younger than 10 had developed asthma. KIGGS_Fig2

This study was based on data collected during the German Health Interview and Examination Survey for Children and Adolescents (KiGGS) and was conducted from May 2003 to May 2006 by the Robert Koch Institute. The objective of the interview and examination survey was to collect representative data on the health status of children and adolescents aged up to 17 years. In total, 17 641 children and adolescents (8656 girls, 8985 boys) and their parents participated in the study but only 13,453 (76%) were included in the presented, published analysis.

comparison vaccinated-unvaccinated Additionally, there is an ongoing survey in Germany with currently 12,583 participants and the results of this survey show that unvaccinated children are far less affected by common diseases than vaccinated children.The results are presented in the bar chart above and complete data and study results are linked here. The data is compared to the national German KIGGS health study of the children in the general population. Most of the respondents to the survey were from the U.S.A. The data was collected from parents with vaccine-free children via an internet questionnaire by vaccineinjury.info and Andreas Bachmair, a German classical homeopathic practitioner. The independent study is self-funded and is not sponsored by a large “credible” non-profit or government health organization with political and financial conflicts of interest; hence Bachmair relies on Google ads and donations for revenue. Each one of the studied cases are actual cases with medical documentation. Three other studies had similar results according to Bachmair and are reported below.

Salzburger Study

Results: of 1004 unvaccinated children, had

Asthma, 0% (8-12% in the normal population)

A-topic dermatitis 1.2% (10-20% in the normal population)

Allergies 3% (25% in the normal population)

ADHD 0.79% (5-10%) in children

Longterm Study in Guinea-Bissau (1 Kristensen I, Aaby P, Jensen H.:“Routine vaccinations and child survival: follow up study in Guinea-Bissau, West Africa”, BMJ 2000; 321: 1435–41)

The children of 15,000 mothers were observed from 1990 to 1996 for 5 years.

Result: the death rate in vaccinated children against diphtheria, tetanus and whooping cough is twice as high as the unvaccinated children (10.5% versus 4.7%).

New Zealand Survey (1992) (http://www.ias.org.nz)

The study involved 254 children. In which 133 children were vaccinated and 121 remained unvaccinated.

Result:

Symptom	vaccinated	unvaccinated
Asthma	20 (15%)	4 (3%)
Eczema or allergic rashes	43 (32%)	16 (13%)
Chronic otitis	26 (20%)	8 (7%)
Recurrent tonsillitis	11 (8%)	3 (2%)
Shortness of breath and sudden infant death syndrome	9 (7%)	2 (2%)
Hyperactivity	10 (8%)	1 (1%)

Another study by the Division of Pediatric Infectious Diseases, University of Louisville School of Medicine, Louisville, Kentucky used data from a previous Vaccine Safety Datalink study of thimerosal exposure looking at 42 neuropsychological outcomes and ran it through multivariable regression models which were specifically constructed to assess the impact of “timeliness” of vaccination (receipt within 30 days of recommended age) on neuropsychological outcomes after adjustment for potential confounders. The authors, Smith and Woods, controlled for cumulative ethylmercury exposure, without providing any explanation – even though ethylmercury would have been associated with receipt of 3 of the 4 vaccines in the analysis (hepatitis B, DPT and Hib). The authors concluded that, “timely vaccination during infancy has no adverse effect on neuropsychological outcomes 7 to 10 years later.” (link to article – link to reply letters)