to the Subcommittee on Criminal Justice, Drug Policy, and Human Resources of the Committee on Government Reform U.S. House of Representatives

RE: HEPATITIS B VACCINE

Submitted by Jane Orient, M.D.

June 14, 1999

Mr. Chairman and Members of the Subcommittee:

My name is Jane Orient, M.D. I am a practicing internist from Tucson, Arizona, and serve as the Executive Director of the Association of American Physicians & Surgeons ("AAPS"). AAPS is a nationwide organization of physicians devoted to defending the sanctity of the patient-physician relationship. AAPS revenue is derived almost exclusively from membership dues. We receive no government funding, foundation grants, or revenue from vaccine manufacturers. No members of our governing body (the Board of Directors), have a conflict of interest because of a position with an agency making vaccine policy or any entity deriving profits from mandatory vaccines. AAPS thanks this Committee and Chairman Mica for leaving the record open for a longer period to permit an opportunity to review the hearing transcript, written testimony, and raw data from the Vaccine Adverse Event Reporting System (VAERS).

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. Or there may be a simple disinclination to cause problems for one member's agenda in the expectation that that member will reciprocate.

Once a vaccine is mandated for children, the manufacturer and the physician administering the vaccine are substantially relieved of liability for adverse effects. 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."

Should a physician advise against a mandated vaccine, he faces increased legal liability should the patient acquire the disease. Moreover, he may risk his very livelihood if he is dependent upon income from"health plans" that use vaccine compliance as a measure of "quality." It is perhaps not surprising, although still reprehensible, that physicians sometimes behave in a very callous manner toward parents who question the need for certain vaccines.

Federal policy of mandating vaccines marks a profound change in the concept of public health. 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. With hepatitis B vaccine, the case for mandatory immunization with few exemptions is far less persuasive than with smallpox or polio vaccines, which protected against highly lethal or disabling, relatively common, and easily transmissible diseases. An intelligent and conscientious physician might well recommend AGAINST hepatitis B vaccine, especially in newborns, unless a baby is at unusual risk because of an infected mother or household contact or membership in a population in which disease is common.

AAPS awaits the release of full information concerning the licensure of hepatitis B vaccine and the mandate for newborn immunizations, as requested under the Freedom of Information Act by the National Vaccine Information Center. It is imperative that independent scientists have the opportunity to review the raw data. In the meantime, 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 this 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 data; publications by governmental, pro-vaccine, and anti-vaccine groups; and a sample of the medical literature leads to the following conclusions:

VAERS contains 25,000 reports related to hepatitis B vaccine, about one-third of which were serious enough to lead to an emergency room visit,hospitalization, or death. It is often assumed that only 10% of reactions are reported. (This committee has heard testimony about persons being actively discouraged from reporting, even if they are aware of the reporting system.) Thus, if there have been some 80,000 serious adverse reactions associated with 20 million doses of vaccine, the risk is about 4 in 1000. (This calculation depends on many assumptions.

Moreover, many of the patients experiencing temporally associated adverse reactions had simultaneously received more than one vaccine. Nevertheless, a better estimate has not been put forth.)

It should be noted that a less than 1 in 1,000,000 purely hypothetical risk may be used to justify costly federal regulations on highly useful products that are used voluntarily.

The CDC admits that the results of ongoing studies on a potential association of hepatitis B vaccine and demyelinating diseases such as multiple sclerosis are not yet available.

ØThere may be large genetic differences in susceptibility to vaccine adverse effects. The committee has been told that serious reported adverse effects seem restricted to Caucasians. Yet the oft-cited long-term safety study was conducted in Alaskan natives, and many studies involved Asians.

In adults, 77% of the reactions involve women, who are generally more susceptible to autoimmune diseases. This deserves serious study, not off-hand dismissal ("nurses always over-report"). Universal immunization could lead to disproportionate injury to susceptible populations, who might also be the least affected by the disease one is trying to prevent.

ØStriking increases in chronic illnesses have occurred in temporal association with an increase in vaccination rates. 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. There is no explanation for this increase. The temporal association, although not probative, is suggestive and demands intense investigation.

Instead of following up on earlier, foreign studies suggesting a greater-than-chance association, the CDC, through vaccine mandates, is obliterating the control group (unvaccinated children). Dr. Classen testified concerning his opinion that hepatitis Bvaccine could precipitate diabetes mellitus. Of note, VAERS contains more than 4,000 reports of abdominal symptoms that could have been due to pancreatitis, which was probably not specifically sought and thus missed if present.

ØHepatitis B vaccine as a cause of sudden infant death has not been ruled out. The mere observation that the incidence of SIDS has decreased while hepatitis B immunization rates have increased proves nothing whatsoever. In other contexts, the Back to Sleep campaign is credited with a dramatic fall in SIDS; the fall might have been much greater without hepatitis B immunizations. The presence of findings such as brain edema in healthy infants who die very soon after receiving hepatitis B vaccine is profoundly disturbing, especially in view of the frequency of neurologicsymptoms in the VAERS. Does SIDS occur on the day after hepatitis Bvaccine with a greater-than-expected frequency? Does it occur at a younger-than-expected age? Are the autopsy findings different in babies who just received the vaccine? The fact that vaccine just happens to be given during the time period that babies are most likely to die of SIDS complicates the analysis. Also, there are a number of other confounding variables (sleep position, socioeconomic status, and possibly smoking behavior).

The data in VAERS are probably too incomplete to answer the questions. A very detailed statistical analysis and an aggressive attempt to obtain more complete information are urgently needed. Glib reassurance, based on the secular trends shown to this Committee, is dangerous.

CONCLUSIONS

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).

AAPS would specifically oppose the campaign for universal immunization against hepatitis B, even if the above did not apply, because the safety of the vaccine is in question.