December 21, 1999
Jeffrey P. Koplan, M.D., M.P.H., Director
The Honorable Donna Shalala
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.
Jane M. Orient, M.D.