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http://www.vaccineinfo.net/issues/mediaarticles/nomandates.htm from
http://www.aapsonline.org./aaps/ )
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 vaccination programs.
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 Health Policy
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 "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. 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.
Vaccine Risks
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
VAERS.
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 overreport," 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.
Conclusions
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.
References
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
www.hrsa.dhhs.gov/bhpr/vicp/abdvic.htm.
4. Elsten AW. Mass immunization. The Freeman 1960;10(8):30-34,
reprinted as AAPS pamphlet no. 1065, Feb. 1999.
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
www.cdc.gov/ncidod/diseases/hepatitis/b/faqbvax.htm.
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
www.house.gov/reform/cj/hearings/5.18.99/index.htm.
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 1988;127:337-352.
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, 1996.
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
snavely@primenet.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).
