18. Is there a conflict of interest in vaccine policy decisions?



Vaccines are big business. Revenues from vaccines total more than $1 billion in the United States, $3 billion worldwide, going to $7 billion in the next few years. Vaccine manufacturers conduct their own research, and unfortunately, much of it is akin to the tobacco research funded by the tobacco companies. A study can "prove" cigarettes don't cause cancer or they can "prove" cigarettes do cause cancer, it all depends on how the research is designed. It's the same with vaccine research.

It is essential that independent researchers (independent of government grants, medical and drug company ties and political influence and pressure) do this research.

One of the most powerful revelations regarding conflict of interest has come out of Chairman Dan Burton's opening statement at the Committee on Government Reform's conference Thursday, June 15, 2000 1:00 PM 2154 Rayburn House Office Building Washington, DC 20515:

How confident in the safety and need for specific vaccines would doctors and parents be if they learned the following:

1. That members, including the Chair, of the FDA and CDC advisory committees who make these decisions own stock in drug companies that make vaccines.

2. That individuals on both advisory committees own patents for vaccines under consideration or affected by the decisions of the committee.

3. That three out of five of the members of the FDA's advisory committee who voted for the rotavirus vaccine had conflicts of interest that were waived.

4. That seven individuals of the 15 member FDA advisory committee were not present at the meeting, two others were excluded from the vote, and the remaining five were joined by five temporary voting members who all voted to license the product.

5. That the CDC grants conflict-of-interest waivers to every member of their advisory committee a year at a time, and allows full participation in the discussions leading up to a vote by every member, whether they have a financial stake in the decision or not.

6. That the CDC's advisory committee has no public members - no parents have a vote in whether or not a vaccine belongs on the childhood immunization schedule. The FDA's committee only has one public member.

These are just a few of the problems we found. "FACA: Conflicts of Interest and Vaccine Development: Preserving the Integrity of the Process" 

 http://www.house.gov/reform/hearings/
healthcare/00.06.15/index.htm

Jane Orient, M.D., executive director of the Association of American Physicians & Surgeons, has criticized the "incestuous ties" between the pharmaceutical companies and the regulatory agencies that make vaccine policy in the following address to the Subcommittee on Criminal Justice, Drug Policy, and Human Resources of the Committee on Government Reform US House of Representatives (June 14, 1999):

It is apparent that critical medical decisions for an entire generation of American children are being made by small committees whose members have incestuous ties with agencies that stand to gain power, or manufacturers that stand to gain enormous profits, from the policy that is made. Even if such members recuse themselves from specific votes, they are permitted to participate in discussions and thus influence the decision. Moreover, there is the potential for deal making ....

The relationship of patient and physician is dramatically altered: in administering the vaccine, the physician is serving as the agent of the state. To the extent that the physician simply complies without making an independent evaluation of the appropriateness of the vaccine for each patient, he is abdicating his responsibility under the Oath of Hippocrates to `prescribe regimen for the good of my patients according to my ability and my judgment and never do harm to anyone. "

... Traditionally, public health authorities restricted the liberties of individuals only in case of a clear and present danger to public health. For example, individuals infected with a transmissible disease were quarantined. Today, a child may be prevented from attending school or associating with others simply because of being unimmunized. If there is not an outbreak of disease and if the child is uninfected, his or her unimmunized state is not a threat to anyone. An abridgement of civil rights in such cases cannot be justified.

All coercive means for increasing the immunization rate should be immediately discontinued. Fully informed consent should be sought before vaccine is administered. This requires full and honest disclosure of the risks and uncertainties of the vaccine, in comparison with the risks of the disease.

Information given to parents about the Hepatitis B vaccine often does not meet the requirement for full disclosure. For example, it may state that "getting the disease is far more likely to cause serious illness than getting the vaccine. " This may be literally true, but it is seriously misleading if the risk of getting the disease is nearly zero (as is true for most American newborns). It may also be legalistically true that "no serious reactions have been known to occur due to the hepatitis B recombinant vaccine. " However, relevant studies have not been done to investigate whether the temporal association of vaccine with serious side effects is purely coincidental or not.

An independent review of the VAERS (Vaccine Adverse Event Reporting System Data); publications by governmental, pro-vaccine, and anti-vaccine groups; and a sample of the medical literature leads to the following conclusion:

For most children, the risk of a serious vaccine reaction may be 100 times greater than the risk of hepatitis B.

Asthma and insulin-dependent diabetes mellitus, causes of lifelong morbidity and frequent premature death, have nearly doubled in incidence since the introduction of many new, mandatory vaccines ....

Even more alarming is the huge increase in reports of autism and attention deficit/hyperactivity disorder, with devastating, life-long impacts. Much of this could be due to over-diagnosis (now rewarded by numerous government subsidies). The change in behavior that many parents observe related to vaccines could be coincidental, or it might reflect a desperate need to explain a disastrous occurrence. Nonetheless, the implications are so grave that immediate investigation is needed. Measles, mumps, rubella, hepatitis B, and the whole panoply of childhood diseases are afar less serious threat than having a large fraction (say 10%) of a generation afflicted with learning disability and/or uncontrollable aggressive behavior because of an impassioned crusade for universal vaccination.


Public policy regarding vaccines is fundamentally flawed. It is permeated by
conflicts of interest.. It is based on poor scientific methodology (including studies
that are too small too short and too limited in populations represented), which
is moreover, insulated from independent criticism. The evidence is far too poor to
warrant overriding the independent judgments of patients, parents, and attending
physicians, even if this were ethically or legally acceptable.

AAPS opposes federal mandates for vaccines, on principle, on the grounds that they are:
1. An unconstitutional expansion of the power of the federal government.
2. An unconstitutional delegation of power to a public private partnership.
3. An unconstitutional and destructive intrusion into the patient physician and parent-child relationships.
4. A violation of the Nuremberg Code in that they force individuals to have medical treatment against their will, or to participate in the functional equivalent of a vast experiment without fully informed consent.
5. A violation of rights to free speech and to the practice of one's religion (which may require one to keep oaths).

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