March 1, 1999

Representative Dale Van Vyven
Chairman, Health Committee
Ohio House of Representatives
77 South High Street
Columbus, Ohio 43266

Dear Representative Van Vyven:

I have been asked by Kristine M. Severyn for testimony regarding hepatitis B vaccination. Dr. Severyn is doing excellent work on behalf of the children of Ohio and of our nation and I am honored to add my voice to hers in a plea for reason and objectivity regarding vaccination policy in the U.S.

I am a physician in private general practice, having received my M.D. degree in 1966 from Albert Einstein College of Medicine in New York City.

For 29 years I have privately and independently pursued a study of vaccinations and vaccine policy. I have served as an expert witness in court trials concerning vaccinations and have submitted medical opinions in cases of vaccine-damaged children adjudicated under the National Vaccine Injury Compensation Program. I was an invited speaker at the First International Public Conference on Vaccinations sponsored by the National Vaccine Information Center in Alexandria, Virginia in September 1997.

I am one of the two physician-signers of the cover letter to the 16-page special report "Hepatitis B Vaccine: The Untold Story" which the National Vaccine Information Center sent out recently to 55,000 U.S. pediatricians. The report was also sent to 8,000 state and federal legislators and to 1500 media outlets in the United States.

In October 1998 I was invited to speak at a special workshop on vaccinations in Manchester, New Hampshire where a citizens’ initiative to roll back the hepatitis B vaccine mandate is under way.

As a private physician with no ties to any academic or government institution, I am free to give voice to my conscience without the usual constraints that group affiliation confers. In what follows I am motivated simply to express the truth as I see it, by a deep concern for the long term health of our nation’s children.

The present growing distrust of vaccinations by concerned parents nationwide is a grassroots movement that will not go away because it springs from a very real source: from a frequency of acute and chronic adverse effects of vaccinations far greater than is being officially acknowledged. This grassroots movement is only bound to increase until its concerns are acknowledged and dealt with in a scientifically objective and forthright manner.

In 1979 the Centers for Disease Control stated: "Vaccinations are recommended and administered to millions of children and other individuals each year on the presumption (emphasis mine) that the benefits far outweigh the risks. The benefit side of the equation is straightforward: vaccinations can prevent serious disease. The risk side is not as straightforward since it includes factors that are known and others that may exist but have not yet been discovered. It is necessary, therefore, to maintain surveillance of potential risks of vaccination to continually reevaluate whether individual vaccinations are, on balance, good for people."

The above clear statement of purpose to monitor vaccine safety has unfortunately been totally eclipsed by our nations’ enormous intellectual, bureaucratic and economic commitment to vaccination as the method to eradicate illness.

This commitment has made it virtually impossible to achieve an open, fair and unbiased risk-benefit evaluation of any vaccination in use today. With a conflict of interest of this magnitude, the pressures that exist to maintain the momentum of our national vaccine initiative and to avoid "alarming the public" overshadow by far those voices who might question the wisdom of such a one-sided and politicized health agenda.

In addition, severe constraints are placed on the media in the name of "responsible journalism" with the result that the American public very seldom hears both sides of the vaccination story, and comes to have an unquestioning faith in vaccinations as our greatest hope against future imagined disease plagues. In this fear-based scenario, the questioning voice of reason is drowned out amid the hysteria surrounding the emerging "killer infections" which are such a favorite media topic.

This propagation of fear by the media and by its sources in the public health industry has resulted in a growth of power of this industry far beyond the usual checks and balances of our democracy.

One aspect of this power is the ability of many state health departments to legally mandate a new vaccination for all children completely bypassing any discussion or deliberation in that state’s legislature. In a democracy this cannot and must not be.

Practicing physicians and the general public rely on the monitoring capacity and the scientific objectivity of the C.D.C., the F.D.A. and the health departments of our 50 states to alert us to the very real risks of vaccinations in use today, and to provide us with as accurate an assessment of that risk, both acute and chronic, as is scientifically possible.

In fact, the C.D.C. has retreated utterly from its 1979 statement quoted above emphasizing the importance of vaccine safety monitoring.

It is extremely regrettable, but no exaggeration to say that with regard to informing physicians and the public on vaccine safety, the responsible agencies have failed the American people.

In support of this assertion, I cite the following facts:

1. In 1994 a special committee of the Institute of Medicine of the National Academy of Sciences published a comprehensive review of vaccine safety which had been commissioned by federal law. Of five possible and plausible adverse effects of the hepatitis B vaccination which the committee investigated, they were unable to come to any conclusion for four of them because they found to their dismay that the relevant research had not been done!

Why aren’t the agencies responsible for vaccine safety commissioning such research? For the fifth adverse effect, anaphylactic shock, the committee concluded that the evidence positively established a causal relation to the hepatitis B vaccination.

2. In contrast to the lack of research on the adverse effects of hepatitis B vaccination found by the Institute of Medicine, the National Vaccine Information Center in its recent special report on hepatitis B vaccination sites 38 reports in the international medical literature, some dating back to 1987, that hepatitis B vaccination is causing chronic autoimmune and neurological disease in children and adults.

3. In July 1998, 15,000 French citizens filed a class action lawsuit against the French government accusing it of understating the risks of hepatitis B vaccine and of exaggerating its benefits for the average person. In October 1998 the French government declared a moratorium on hepatitis B vaccination in public schools while it evaluates more carefully the true risk-benefit profile of the vaccine.

4. Since July 1990, 17,497 cases of hospitalizations, injuries and deaths in America following hepatitis B vaccination have been reported to the Vaccine Adverse Event Reporting System (VAERS) of the U.S. government. This figure includes 146 deaths in individuals after receiving only hepatitis B vaccine without any other vaccines, including 73 deaths in children under 14 years old.

In 1996 alone there were 872 serious adverse events in children under 14 years old reported to VAERS. 658 of those injuries were following hepatitis B vaccination in combination with other vaccinations and 214 of these injuries were after hepatitis B vaccination alone. In these children under 14 years old, there were 35 deaths after hepatitis B vaccination in combination and 13 deaths after hepatitis B vaccination alone, for a total of 48 deaths. Compare these statistics with the total number of hepatitis B cases nationwide reported that same year (1996) in children under 14, just 279, and the conclusion is obvious that the risks of hepatitis B vaccination far outweigh its benefits.

In those infants who died under one month of age, most of the deaths are classified as Sudden Infant Death Syndrome (SIDS). However, in the past this syndrome has never struck infants so young, and SIDS is officially defined as beginning only after one month of age.

With 6,000 children dying of SIDS every year, we have no idea how many of these deaths are actually caused by hepatitis B vaccination. Though the Vaccine Adverse Event Reporting system was created by federal law to permit a more accurate assessment of the risks of vaccination, and although the raw data it generates is analyzed, the individual reports of injury or death are rarely, if ever, investigated. If one factors in that fewer than 10% of physicians report adverse reactions to vaccines because we are taught to regard them as merely "temporally related", as only a coincidence, it would be quite plausible to say that the risks of hepatitis B vaccination clearly outweigh its benefits for 99% of the children who receive it.

5. The best way to determine the risk-benefit profile of any vaccination is well known and in theory is quite simple: Take a group of vaccinated children and compare them with a matched group of unvaccinated children. If the groups are well-matched and large enough and the length of time the children are observed following vaccination long enough, then such a study is deemed the "gold standard" of vaccine research because its data is as accurate a reflection as medical research is capable of achieving of how vaccinations are actually affecting our nation’s children.

Incredible as it sounds, such a common-sense controlled study comparing vaccinated to unvaccinated children has never been done in America for any vaccination.

This means that mass vaccination is essentially a large-scale experiment on our nation’s children.

6. A critical point which is never mentioned by those advocating mandatory vaccination of children is that children’s health has declined significantly since 1960 when vaccines began to be widely used. According to the National Health Interview Survey conducted annually by the National Center for Health Statistics since 1957, a shocking 31% of U.S. children today have a chronic health problem , 18% of children require special health care or related services and 6.7% of children have a significant disability due to a chronic physical or mental condition. Respiratory allergies, asthma and learning disabilities are the most common of these.

Three controlled studies comparing vaccinated to unvaccinated children in England and New Zealand have shown that the vaccinated children have significantly more asthma, ear infections, hospitalizations and inflammatory bowel disease than their unvaccinated cohorts.

Since vaccinations have a lasting effect on the immune system, and since it is known that many vaccines shift the balance of the immune system away from its acutely-reacting "Th1" side and toward its chronically-reacting "Th2" side , it is a very plausible scenario that vaccines are contributing greatly to the large-scale and unprecedented increase in chronic conditions such as allergies, asthma, diabetes and a wide range of neurological dysfunctions including learning disabilities, attention deficit disorder, seizures and autism in U.S. children today.

The shocking facts that 31% of U.S. children today suffer from a chronic condition and that the rate of disability from such chronic conditions in children has seen nearly a fourfold increase since 1960 ought to seriously challenge our medical research establishment.

But, far from taking a proactive approach toward these disturbing facts, our medical establishment remains curiously uninterested in children’s chronic diseases and instead continues to pursue its narrow focus of using vaccines to eradicate every possible acute childhood illness, even those like hepatitis B and chicken pox which pose no threat to 99% of children.

The idea that illnesses exist in an ecological balance like everything else in nature and that eradicating acute diseases could very likely upset the balance and cause chronic disease to increase is not seriously considered or pursued in medical science today. Whenever any evidence pointing in this direction is published, usually in the international medical literature, it is usually dismissed out of hand by American physicians or angrily repudiated with the implication that such research is "irresponsible" because it might cause the American public to lose trust in our vaccination program.

With such a total commitment of our medical community to a policy of universal vaccination, is it any wonder that new and potentially upsetting discoveries relating to the role of vaccinations in the alarming prevalence of chronic illness in our children are never seriously considered much less pursued?

When the Institute of Medicine published its Federally mandated reports on vaccine safety in 1991 and 1994, their disturbing conclusion was that there is very little data on vaccine safety because the necessary research is simply not being done.

7. Eugene Robin, M.D., Emeritus Professor of Medicine from Stanford Medical School is one of the world’s leading experts on risk/benefit analysis in medicine. He authored the definitive book on the subject, Matters of Life and Death: Risks vs. Benefits of Medical Care.

In a statement at the First International Public Conference on Vaccination in September, 1997, Dr. Robin said the following:

"…The scientists who develop vaccines should be given great credit and respect for their pioneering work. But it must be recognized that once a promising vaccine is available, that should be the beginning and not the end of the process.

Accurate assessment of the risk/benefit ratio of the vaccine by means of a … controlled clinical trial should be obligatory. An educational process involving the public should be mandatory in which the risks and uncertainties are described as well as the potential benefits.

So, what can we ‘teach’ the public if we ourselves, the medical scientific community, have not done the proper and required studies?

A true process of informed choice would, for example, raise grave questions about the vaccination of young children for hepatitis B.

We must be honest and admit that we do not know the impact of administering multiple, different vaccines on very young children or, indeed, on anyone."

8. My final comments are drawn from my 27 years of experience as a general practitioner of medicine. Twenty-three of those years were in a rural farming community in upstate New York where as many as 50% of my pediatric patients were unvaccinated due to their parents’ conscientious personal choice.

When I started my practice I believed, as I had been taught in medical school, that the benefits of vaccinations outweighed the risks. I also believed that the right of parental choice in vaccinations ought to be respected.

For 23 years I had the opportunity to observe my young patients grow from infancy to young adulthood and to appraise their overall health and vitality. It was out of this experience that my present views took shape. I observed that my unvaccinated children were healthier, hardier and more robust than their vaccinated peers. Allergies, asthma and pallor and behavioral and attentional disturbances were clearly more common in my young patients who were vaccinated.

My unvaccinated patients, on the other hand, did not suffer from infectious diseases with any greater frequency or severity than their vaccinated peers: their immune systems generally handled these challenges very well.

Conclusion
Like all science, medicine has radically changed many of its views over time. What seems wise and prudent today may be totally repudiated a decade or two later.

Vaccinations are powerful medical tools which impact human immune systems to achieve the desired effect of preventing certain infectious disease manifestations.

In the early 1900’s when diphtheria and whooping cough were life-threatening, the uncritical acceptance and implementation of vaccination was understandable and perhaps unavoidable. Today, when far more children suffer from allergies and other chronic immune system disorders than from life-threatening infectious diseases, it is neither reasonable nor prudent to persist in presuming that the benefit of any vaccination outweighs its risk.

When the medical scientific community makes a total and one-sided commitment to any public policy, no matter how noble its intentions, then vigorous debate and fact-finding tend to be neglected.

The facts on hepatitis B brought out by Dr. Severyn and by the special 16-page report of the National Vaccine Information Center deserve our very careful consideration. They indicate that the risk of hepatitis B vaccination outweighs its benefit for the vast majority of American children today.

When these facts are ignored, and when vital medical research on the safety and adverse effects of hepatitis B vaccine is left undone, then the truth suffers, our children suffer and we all suffer.

Yours,
Philip Incao, M.D.