Mandating Vaccines: Government Practicing Medicine
Without a License?
Jane M. Orient, M.D.
The issue of mandatory vaccines is becoming increasingly
important: Dozens of Americans have given testimony to Congressional committees about adverse
effects (including death) of vaccines, particularly in children; military personnel are being
court-martialed for refusing required anthrax vaccinations; etc. And yet, the public health
establishment in this country has not only downplayed the adverse effects and complications of
vaccines, insisting that vaccines are safe and effective, but it continues to support mandatory
Dr. Jane Orient --- who spoke at the Doctors for Disaster Preparedness
(DDP) meeting on this subject and submitted a statement to the Subcommittee on Criminal Justice,
Drug Policy and Human Resources of the House Government Reform Committee on behalf of AAPS, June 14,
1999 --- was invited to write this column for the benefit of AAPS (http://www.aapsonline.org/aaps/)
members and the readers of the Medical Sentinel.
The Source of Mandates
By means of vaccine policy, which was previously discussed in these pages,(1) the federal
government is effectively making critical medical decisions for an entire generation of American
children. The mechanism is a public-private partnership. "Recommendations" issue from the
Advisory Committee on Immunization Practices (ACIP), a small group whose members have incestuous
ties(2) 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.
ACIP recommendations frequently become mandatory through actions of state legislatures, or
through state health departments to which legislatures have delegated such authority. State policy
is generally enforced by school districts, which set requirements for school attendance. Some
children, as reported by ABC's 20/20, are being home schooled because they have not received
all the required vaccines.
An Inversion of Medical Ethics and a Reversal of Public
Mandates have a profound effect on medical practice. Once a vaccine is mandated for children, the
manufacturer and the physician administering the vaccine are substantially relieved of liability for
adverse effects.(3) The relationship of patient and physician is shattered: 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." Instead, he is applying the new population-based ethic in which the interests of
the individual patient may be sacrificed to the "needs of society."
If a physician advises against a mandated vaccine, he faces increased legal liability if the
patient is infected with the disease. In addition, he may risk his very livelihood if he is
dependent upon income from "health plans" that use vaccine compliance as a measure of
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. I have even heard
reports of physicians threatening to call Child Protective Services to remove the child from
parental custody if a parent refused a vaccine --- even after the child had screamed inconsolably
for hours after each of the first two doses. The federal policy of mandating vaccines marks a
monumental 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 deprived of his liberty to associate with others, or even of his supposed right to a public
education, simply because of being unimmunized. Yet, if a child is uninfected, his unprotected
status is not a threat to anyone else. On the other hand, immunization of a child who is already
infected (or who becomes infected in spite of the vaccine) is of no protective value to anyone. This
represents a reversal of the earlier policy of preventing exposure to infectious agents. In fact, it
takes exposure --- as to contaminated needles or promiscuous sex --- as a given, while begging the
question of whether protection against hepatitis B has any overall effect on morbidity or mortality
in a population that also exposes itself to worse hazards.
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,
easily transmissible diseases. Most physicians probably recommended immunizing most patients against
these diseases, while defending their authority to give contrary advice.(4) In contrast, an informed
and conscientious physician might frequently advise 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, physicians are still morally obligated to seek
informed consent and to provide 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."(5) 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."(6) However, relevant studies have not
been done to investigate whether the temporal association of vaccine with serious side effects is
purely coincidental or not.
The Vaccine Adverse Event Reporting System (VAERS), established by the CDC and the FDA, contains
about 25,000 reports of adverse reactions associated with hepatitis B vaccine, or to a vaccine
cocktail that included hepatitis B.* About one-third of the reactions were serious enough to result
in an emergency room visit or hospitalization, and there were 440 deaths, including about 180
attributed to Sudden Infant Death Syndrome or SIDS.
More than 20 million persons are said to have received the vaccine in the United States.(7) Thus,
there are about 4 serious reported reactions for every 10,000 persons receiving the vaccine.
If only one-tenth of the reactions are reported to VAERS, as is often assumed, there are about 4
serious adverse events for every 1,000 persons receiving vaccine. This is not an unreasonable
estimate of the degree of underreporting with a passive reporting system. Moreover, Congress
heard testimony concerning medical students who were told not to report suspected adverse
events.(8) Dr. Harold Margolis, a CDC hepatitis expert, told Congress that the incidence of SIDS
has decreased at the same time that infant immunization rates have increased.(9) In other contexts,
the Back to Sleep campaign is credited with a dramatic fall in SIDS; it is possible that the
decrease might have been greater without hepatitis B immunizations.
Data in VAERS are too limited to answer such questions as this: Does SIDS occur on the day after
hepatitis B vaccine 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 (in other words, was
SIDS truly the cause of death)? The fact that the 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
of the parents).
The presence of findings such as brain edema in healthy infants who die very soon after receiving
hepatitis B vaccine is worrisome, especially in view of the frequency of neurologic symptoms in the
In nearly 20 percent of VAERS reports, the first of eight listed side effects suggests central
nervous system involvement. Examining just the first of eight listed effects shows about 4,600
involving such symptoms as prolonged screaming, agitation, apnea, ataxia, visual disturbances,
convulsions, tremors, twitches, an abnormal cry, hypotonia, hypertonia, abnormal sensations, stupor,
somnolence, neck rigidity, paralysis, confusion, and oculogyric crisis. The last is a striking
feature of post-encephalitic Parkinson's disease, or it may occur as a dystonic reaction to certain
drugs such as phenothiazines.
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. Post-marketing
surveillance in the first three years after licensure showed Guillain Barré syndrome was reported
significantly more often than expected, with a relative risk between 1.3 and 2.8. Of possibly
greater interest is the fact the observed number of convulsions was only 6 to 20 percent of the
expected number, suggesting underreporting by a factor of 5 to 17. If optic neuritis and transverse
myelitis were underreported by this amount, complete ascertainment probably would have demonstrated
a significant increase in the vaccinated population.(10)
The question of an association between apparent increases in behavioral disorders (such as autism
and attention deficit/hyperactivity disorder) and the increasing number of childhood vaccines has
been raised, primarily by parents, but I am not aware of appropriate studies addressing the issue.
Asthma and insulin-dependent diabetes mellitus, causes of lifelong morbidity and frequent
premature death, have increased substantially, with childhood asthma nearly doubling,(11) 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. Barthelow Classen testified concerning his studies, which suggest that hepatitis B and other
vaccines could increase the incidence of diabetes mellitus.(12,13) 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.
Risk vs. Benefit
For each individual, the risk of a serious adverse vaccine reaction (not known but possibly as
high as 4 per 1,000) must be weighed against the risk of disease. (Note that a risk as low as 1 per
1,000,000 may be cause for regulatory action in the case of involuntary risks, and 1 in 10,000 for
voluntary risks.) In the United States, seroprevalence for hepatitis B surface antigen, a sign of a
chronic carrier state, is between 0.1 and 0.5 percent (1 to 5 per 1,000) in normal populations,
compared with up to 20 percent in the Far East and some tropical countries, and 30 percent in
needle-using drug addicts or persons with Down's syndrome, leukemia, or chronic renal disease
requiring dialysis, among others.(14) Thus, for a member of the "normal" population, the
risk of serious adverse reaction to the vaccine is probably of the same order of magnitude as the
lifetime risk of becoming a chronic carrier for hepatitis B. Although the carrier state may
disqualify the individual from certain occupations, only a small percentage of carriers develop
chronic active hepatitis, cirrhosis, or liver cancer.
Overall, the annual incidence of hepatitis B in the U.S. is currently about 4 per 100,000.(15)
The risk for most young children is far less. In 1996, the number of deaths from viral hepatitis (of
all types) reported in children under the age of 14 was 11, and in children under the age of 1 year
was 1.(16) The number of reported cases of hepatitis B in children under age 14 was 85 in 1993(17)
and 279 in 1996, according to CDC figures, or between 2 and 6 per million.
There may be a genetic predisposition to adverse effects. Although much of the vaccine testing
was done in Alaskan natives and Asians, adverse events in the United States have been predominantly
among Caucasians.(8) Nearly 80 percent of adverse events associated with hepatitis B vaccine alone
involve women, who are more susceptible to autoimmune reactions. This female predominance deserves
serious study, not off-hand dismissal ("nurses tend to over report," said a CDC
official).(18) 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.
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. Indeed,
evidence is accumulating that serious adverse reactions are being ignored. Although this article has
focused on hepatitis B vaccine, similar questions should be raised about others as well.
1. Schlafly R. Official vaccine policy flawed. Medical Sentinel 1999; 4(3):106-108.
2. See, for example, the verbatim transcripts of the Advisory Committee on Immunization Practices
(ACIP) Conference convening at 8:45 a.m. on Wednesday, February 17, 1999, at the Atlanta Marriott
North Central, Atlanta, GA.
3. Background information on VICP [Vaccine Injury Compensation Program]. Health Resources and
Services Administration, Department of Health and Human Services, Bureau of Health Professions. See
4. Elsten AW. Mass immunization. The Freeman 1960;10(8):30-34, reprinted as AAPS pamphlet no. 1065,
5. Hepatitis B vaccine and hepatitis B immune globulin: what you need to know before you or your
child gets the vaccine. CDC, U.S. Department of Health and Human Services, Hep B-5/1/96.
6. Information after immunizations. Arizona Department of Health Services.
7. CDC. Hepatitis B vaccine - frequently asked questions. See
8. Dunbar B. Hearing before the Subcommittee on Criminal Justice, Drug Policy and Human Resources of
the House Government Reform Committee, May 18, 1999, transcript by Federal News Service.
9. Margolis H. Hearing before the Subcommittee on Criminal Justice, Drug Policy and Human Resources
of the House Government Reform Committee, May 18, 1999, posted at
10. Shaw FE, Graham DJ, Guess HA, et al. Postmarketing surveillance for neurologic adverse events
reported after hepatitis B vaccination: experience of the first three years. Am J Epidemiol
11. Asthma Prevention Program of the National Center for Environmental Health, Centers for Disease
Control and Prevention At-a-Glance 1999. www.cdc.gov/nceh/programs/asthma/ataglance/asthmaag2.htm.
12. Classen JB. Hearing before the Subcommittee on Criminal Justice, Drug Policy and Human Resources
of the House Government Reform Committee, May 18, 1999, transcript by Federal News Service.
13. Classen JB, Classen JC. Hemophilus vaccine and increased IDDM, causal relationship likely. eBMJ
318(7192):1169-1172, May 7, 1999, www.bmj.com/cgi/eletters/318/7192/1169.
14. Dienstag JL, Isselbacher KJ. Acute viral hepatitis. Harrison's Principles of Internal Medicine
ed. 13, New York: McGraw-Hill, 1994, pp. 1458-1478.
15. CDC. Fastats A-Z, updated 5/14/99. See www.cdc.gov/nchswww/fastats/hepatitis.htm.
16. Table 10, National Vital Statistics Report 1998;47(9):51.
17. Hepatitis Surveillance, Viral Hepatitis Surveillance Program 1993, report # 56, CDC, April,
18. Belkin M. Hearing before the Subcommittee on Criminal Justice, Drug Policy and Human Resources
of the House Government Reform Committee, May 18, 1999, transcript by Federal News Service.
* A copy of this data base is available on request from email@example.com. Compressed, the
file is about 8 megabytes and may take half an hour to download.
Dr. Orient is the Executive Director of the Association of American Physicians and Surgeons
(AAPS), 1601 N. Tucson Blvd., Suite 9, Tucson, AZ 85716. (800) 635-1196, http://www.aapsonline.org.
This article was published in the Medical Sentinel 1999;4(5):166-168. Copyright © 1999
Association of American Physicians and Surgeons (AAPS).