Letter from AAPS - - originally found:
[on the AAPS web site: click to goto]

1601 N. Tucson Blvd. Suite 9
Tucson, AZ 85716-3450
Phone: (800) 635-1196
Hotline: (800) 419-4777
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

and

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 anticipated.

(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 one.

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 available.

(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 estimate?

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 response.

Sincerely yours,

Jane M. Orient, M.D.
Executive Director

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.
Regarding Vaccines
December 1999

Issue 1
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 vaccines.
Response 1
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.

Issue 2
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.
Response 2
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 goals.
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.

Issue 3
Many questions have been raised about the use of hepatitis B vaccine in groups at low risk for the disease....
Response 3
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 controlled.
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.

Issue 4
There is also increasing concern about the safety and efficacy of the vaccines so mandated. The rotavirus vaccine is a case in point
Response 4
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.