AAPS Letter to CDC
And their reply posted below it.
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Association of American Physicians
and Surgeons, Inc.
A Voice for Private Physicians Since 1943
Omnia pro aegroto
December 21, 1999
Jeffrey P. Koplan, M.D., M.P.H., Director
Department of Health and Human Services
Public Health Service
Centers for Disease Control and Prevention
Atlanta, GA 30333
The Honorable Donna Shalala
Department of Health and Human Services
200 Independence Ave. SW
Washington, DC 20201
Dear Drs. Koplan and Shalala:
This is in response to Dr. Koplan's letter of December 8, which replied
to our July 21 letter to Dr. Shalala.
We thank you for your letter. However, it leaves some issues unanswered
and raises others.
(1) We are glad that you agree (Response 1) that all parents need to be
informed about the risks and benefits of vaccines. We would be interested
to know the specifics of your activities to improve performance in this
area, which is often lacking at present.
(2) You state (in Response 1) that "multiple studies [are] underway
to address questions raised about the safety of various vaccines."
Please provide information concerning which vaccines are being studied,
the questions being addressed, the funding sources, and when results are
(3) You state (in Response 2) that "control of infectious diseases
by a State within its borders is a constitutional right of
sovereignty." Further, you note that the Federal government makes
"recommendations." We have asked you to recommend that state
health departments place a moratorium on mandatory vaccines. Apparently,
you are denying our request. If that is your intention, we ask you to
state so explicitly. Further, please provide details as to incentives
provided by the Federal government for states to comply with the
recommendations (for example, the release of Federal funds for various
programs such as welfare).
(4) You state (also in Response 2) that "the CDC is not aware of any
'threats' made to parents who do not consent to having their children
immunized." Our Association, however, is aware of such threats,
which can be difficult to document because parents fear further
harassment and physicians fear governmental reprisals. It would be
extremely helpful for the Department of HHS and the CDC to state that
such threats are inappropriate, and that parents have the right to refuse
vaccines (which is simply the reciprocal of the physician's duty to
obtain informed consent). Will you make such a statement?
(5) In response # 3, you state that "several studies have documented
high rates of early childhood hepatitis B virus transmission among
children born in the United States to mothers who are not infected.
Before hepatitis B vaccine was given universally to infants, each year
there were approximately 33,000 infants and children infected who were
not exposed to hepatitis B virus-infected mothers."
Please cite the references for these statements. Note that this 33,000
figure grossly contradicts CDC report number 56, issued April, 1996,
which states that 85 cases of hepatitis B were reported in children under
the age of 15 in 1993, and that the rate was 21% lower than in 1992. If
90% of infected children are asymptomatic, then the true incidence was
about 850 in 1993 and about 1100 in 1992. According to the Healthy People
2000 Review, the number of chronic infections in infants was 6,012 in
1987; 3,003 in 1990; 2,234 in 1991; and 2,464 in 1992 and 1993. According
to the same report, only 16% of children age 19-35 months had received 3
doses of hepatitis B vaccine in 1993. Can you reconcile these figures?
Can you provide a reference for serological studies to identify chronic
infection in asymptomatic children?
According to the CDC, there were 3,780 deaths in 1997 from ALL forms of
viral hepatitis in ALL age groups combined. The report does not give an
estimate of how many of these deaths were due to hepatitis B in persons
who contracted this disease in infancy and childhood from noninfected
mothers. Do you have such an estimate? And is this report correct? If
not, has a retraction been published?
In order to help physicians advise parents and patients concerning the
risks and benefits of hepatitis B vaccine, the CDC should provide tables
and graphs of the annual age-related incidence of acute and chronic
hepatitis B over the past several decades, along with figures for
percentage of the population vaccinated in each age group, and
information concerning the distribution of risk factors (including
vertical transmission, household contacts, sexual activity, occupational
exposure, etc.). If extrapolations are being used to estimate incidence,
then the methodology should be described. Is such a table available at
present? If so, we would appreciate the citation so that we may direct
our members to it. If not, we hope that the CDC will prepare
We would also appreciate a reference for the statement that "the CDC
has estimated that one-third of the chronic hepatitis B virus infections
in the United States come from such infected infants and young
children," preferably from the peer-reviewed medical literature if
(6) We are well aware of the deficiencies of the VAERS reports (Response
3). In addition to the ones that you named, there is significant
underreporting. What percentage of actual reactions are reported, in the
CDC's estimation, and what method is used to arrive at this
We would also like to know what sort of follow-up is done on reports of
serious adverse reactions. Is the information gleaned from such
investigations available for inspection and analysis?
(7) Concerning the ongoing studies of possible long-term consequences, we
would draw your attention to a statement by Dr. Samuel Katz of Duke
University, a member of the Advisory Commission on Childhood Vaccines
(ACCV): "[D]espite the need for funds and the quest for them over
the past several years, we still have no budget to develop a program
specifically for long term assessment of vaccine safety." Dr. Katz
suggests designating a portion of funds from the vaccine compensation
Trust Fund to answer questions "that currently remain unanswered
because of the cost, logistics and inability to conduct long term
studies. To answer charges such as autism, multiple sclerosis and other
autoimmune disease allegedly due to vaccines, only studies such as these
will provide reliable scientifically valid data."
Are the Department of HHS and the CDC planning to ask Congress to fund
more studies on vaccine safety? If so, will care be taken to address
concerns about potential conflicts of interest arising from relationships
between investigators and manufacturers?
A recommendation that affects the health of all of America's children
requires the most thoughtful scrutiny, especially when it is so often the
basis for state mandates. Physicians and concerned parents throughout the
nation are troubled by questions such as the above and await your prompt
Jane M. Orient, M.D.
Reply from CDC to above letter
Centers for Disease Control and Prevention
Comments to Issues Raised by
the Association of American Physicians and Surgeons, Inc.
The Association of American Physicians is deeply concerned that federal
vaccine policy results in the violation of informed consent, and is based
on incomplete studies of efficacy and potential adverse effects of the
The National Childhood Vaccine Injury Act (42 USC 300aa-26) requires that
all health professionals who administer vaccines discuss the known
benefits and risks with parents and guardians of children receiving the
vaccine and provide parents and guardians with the Vaccine Information
Statement (VIS) prepared by the Centers for Disease Control and
Prevention (CDC). This statement includes information about the vaccine,
the disease it is preventing, the contraindications to vaccination, and
adverse events that have been documented to be associated with the
vaccine. As new scientific information is accumulated regarding a
vaccine, the VIS may be changed and there is a public comment period for
each new or revised VIS. The specific requirements for informed consent
are determined by State law. We are aware that the VIS is not always
provided, as required, and we are working with professional medical
societies such as the American Academy of Pediatrics to improve
compliance and to assure that all parents are appropriately informed
about the benefits and risks of vaccination.
Although extensive studies involving thousands of persons are required to
demonstrate both safety and effectiveness of a vaccine before it is
licensed, research and monitoring are subsequently necessary to identify
very rare safety issues, which may only arise or be detected following
vaccination of millions of persons. These rare side effects may not come
to light before licensure or, if noted, the evidence may not be adequate
to prove that a reported health event in preclinical trials is due to the
vaccine. This surveillance and targeted research extends to all reported
adverse reactions potentially due to vaccination, regardless of the
length of time that has elapsed from administration of the vaccine. At
present, there are multiple studies underway to address questions raised
about the safety of various vaccines.
If children do not receive all the mandated vaccines, because of their
beliefs or individual medical circumstances, they may be deprived of
their liberty to associate with others or of their supposed
"right" to a public education. Parents may give
"consent" to the vaccine under duress, such as the threat of
having their children taken from them.
Control of infectious diseases by a State within its borders is a
constitutional right of sovereignty. The Federal government does not
promulgate school entry laws; such laws are passed under the States'
authority. The Federal government does, however, recommend vaccines based
on advice received from the Advisory Committee on Immunization Practices
(ACIP). The Federal government may also recommend strategies that States
can use to increase vaccination rates to achieve disease prevention
All States have exemptions to vaccination for medical conditions that are
known to increase the risk of an adverse reaction; 48 States have
exemptions for religious beliefs and 15 States have exemptions for
philosophical beliefs. CDC is not aware of any "threats" made
to parents who do not consent to having their children immunized.
High rates of vaccination coverage have several advantages to families
and society. First, vaccination protects children against a range of
serious and, sometimes, fatal diseases. Secondly, in communities where
vaccination coverage is high, there is decreased transmission agents that
cause disease resulting in "community immunity," which protects
even those children who are not vaccinated or who cannot be vaccinated
because of medical contraindications.
Many questions have been raised about the use of hepatitis B vaccine in
groups at low risk for the disease....
Several studies have documented high rates of early childhood hepatitis B
virus transmission among children born in the United States to mothers
who are not infected. Before hepatitis B vaccine was given universally to
infants, each year there were approximately 33,000 infants and children
infected who were not exposed to hepatitis B virus-infected mothers.
Other than for infants born to hepatitis B virus-infected pregnant women
who are tested prior to delivery, which does not always happen, there is
no way to identify and selectively vaccinate most of those children who
will acquire hepatitis B virus infection in early childhood. More than 90
percent of young children who become infected with hepatitis B virus are
asymptomatic and, therefore, would not be reported. Hepatitis B
virus-infected children are at greatest risk of chronic infection, and
they contribute disproportionately to the number of adults with chronic
hepatitis B, cirrhosis, and liver cancer. CDC has estimated that
one-third of the chronic hepatitis B virus infections in the United
States come from such infected infants and young children. If childhood
infections are not prevented, especially the early childhood infections,
hepatitis B liver disease in the United States cannot be effectively
Reported cases of possible adverse events related to vaccines are tracked
by CDC and the Food and Drug Administration (FDA) through the Vaccine
Adverse Event Reporting System (VAERS). The VAERS system is unique in
that there is no other drug monitoring system on the market as extensive
as VAERS. This system provides "signals" for further
investigation and research; however, VAERS numbers are not reflective of
actual side effects associated with vaccines and cannot be used in this
way. The numbers quoted in the constituent's correspondence are
misleading in that VAERS accepts ALL reports, regardless of whether the
report is causally related to receipt of a vaccine or a chance occurrence
unrelated to the vaccine. VAERS data are available to the public and are
often misinterpreted. The vast majority of deaths reported to VAERS and
investigated by FDA are found to be related to other health conditions
unrelated to vaccination. To date, anaphylaxis is the only serious
adverse event for which scientific data indicate a causal relationship
with hepatitis B vaccine, and no deaths from anaphylaxis have been
reported in the United States.
In addition to VAERS, CDC's Vaccine Safety Data-Link Project provides the
ability to conduct carefully controlled studies of potential
vaccine-adverse events among persons enrolled in certain managed care
plans. For example, this system was used to determine that no association
exists between rubella vaccination and arthritis. Similarly, ongoing
studies are analyzing whether an association exists between hepatitis B
vaccination and SIDS, multiple sclerosis, or diabetes mellitus.
There is also increasing concern about the safety and efficacy of the
vaccines so mandated. The rotavirus vaccine is a case in point
The Federal government is very concerned that the vaccine program be as
safe as possible so that disease can be prevented with the least possible
risk. Changes in the vaccination schedule such as the transition to
inactivated polio virus vaccine and to acellular pertussis vaccine
demonstrate that commitment to the safest program, even at increased
costs. At its October 1999 meeting, the ACIP recommended that Rotashield,
the only U.S.-licensed rotavirns vaccine, no longer be recommended for
infants in the United States. This action is based on the results of an
expedited review of scientific data presented to the ACIP by CDC in
cooperation with FDA, the National Institutes of Heath, and Public Health
Service officials, along with Wyeth-Lederle. Use of the vaccine was
suspended in July pending the data review by the ACIP.