Letter from three Congresswomen to the Secretaries of Defense and Health and Human Services -- 29 Nov 1999
Washington, D.C. 20515
November 29, 1999
The Honorable William
Cohen
Secretary
Department of Defense
1000 Defense, The
Pentagon
Washington, D.C. 20301
The Honorable Donna
Shalala
Secretary
Department of Health and Human Services
200
Independence Avenue, SW
Washington, D.C. 20201
Dear Secretaries Cohen and Shalala:
We are writing to express our serious concern about the Department of Defense's (DOD) initiative to mandate vaccination of all 1.4 million active duty and 900,000 Selected Reserve personnel against anthrax without a study of long-term effects of the vaccine, particularly with respect to women of child-beating age.
These vaccinations axe forcing our nation's military personnel to:·
For women, particularly those of childbearing age, this is of particular concern.
In requiring the vaccination of military personnel, DoD and Food and Drug Administration (FDA) witnesses before Congress note that the anthrax vaccine was first licensed and approved by the FDA in 1970. Based on its approved label at the time, DoD has appropriately adopted the policy that "pregnant women should not receive this vaccine."
However, women that would like to become pregnant and have children are not allowed the option of opting out. This is the case despite the fact that FDA is preparing to revise its drug labeling to recognize that "[f]ertility, pregnancy, and lactation are a clinical continuum, therefore it would be logical and useful to address these situations in the same section of the labeling" (FDA "Concept Paper on Pregnancy Labeling", May 20, 1999).
Despite assertions that the "vaccine is as safe as most common vaccines" (testimony by Charles Cragin, Principal Deputy Assistance Secretary of Defense for Reserve Affairs, September 29, 1999), there is no definitive evidence this is the case. In fact, the General Accounting Office (GAO) has repeatedly noted that "[t]he long term safety of the vaccine has not yet been studied" and "[n]o studies have been done to determine the optimum number of doses of the anthrax vaccine" (see GAO testimony dated April 29, 1999, and July 21, 1999).
A DoD website whose purpose is to inform military personnel about the anthrax vaccine also states that "[i]n nearly 30 years of licensed use there is no evidence that indicates any adverse reproductive effects including fertility or birth defects." This is accurate only because there have been no studies on the long-term impact of the anthrax vaccine -including the vaccine's effects on fertility, both male and female, and birth defects. Lack of evidence due to lack of research does not mean that problems do not exist.
If DoD is relying completely on the lack of self-reporting of the adverse reproductive effects to make such claims, they are far from scientific. Women have not been involved in receiving the anthrax vaccine in anything close to the number of men. There are numerous concerns with self-reporting that have been well documented by both the FDA and GAO. Moreover, reporting in the past has never focused on women's health, fertility, reproduction or birth defects, although FDA is looking to improve in the area of data collection in the future.
In the three DoD studies that have been conducted regarding the short-term reactions that military personnel have had with respect to the anthrax vaccine, the GAO notes that "[d]ata from these efforts show that women reported twice the rate of reactions than men for both local (e.g., swelling) and systematic (e.g., malaise and chills) reactions. In addition, a higher proportion of women than men reported making an outpatient medical visit after a vaccination, and more than twice the percentage of women reported that they missed one or more duty shifts after their vaccinations than did men" (GAO Testimony, July 21, 1999).
As Dr. Murray Lumpkin, Deputy Center Director at the Center for Drug Evaluation and Research recently said, "I think.., one of the things we have learned this century is that drugs carry with them risks, and one of the real challenges that we have as regulators, we have as the health care community, and we have as individual patients is how do you balance those wonderful benefits that many drugs give us and the often very, very real, very, very serious risks that the drugs can carry."
In balancing risks versus benefits, women in this country certainly have a right to be particularly concerned about the impact of drugs and biologics. With particular respect to the issue of the use of drugs in women who are pregnant or lactating, Dr. Lumpkin adds, "If you think about it, this is a group and this is a situation where, as a community, we probably want to know the most... We're talking about the next generation here. What is the effect on the mother? What is the effect on the child? But yet, it's an area where we all agree, we have very, very little knowledge."
With this in mind, we urge DoD to consider revising its mandatory requirement that all military personnel receive the anthrax vaccination, particularly women of child-bearing age. In light of the fact that it will take seven or eight years to fully immunize all 1.4 million active duty and 900,000 Select Reserve personnel against anthrax, we recommend DoD consider making the anthrax vaccination program voluntary, particularly for women of child-bearing age.
In the meantime, we urge DoD to work with the Department of Health and Human Services (HHS) to, as recommended by the GAO, "design and conduct a study on possible long-term side effects of the anthrax vaccine and develop a communications plan to provide servicemembers information on the status of this effort." We recommend that such a study address the particular impact on women's health, including fertility, pregnancy, birth outcomes, lactation and child development.
Thank you for your time and attention to this important matter impacting our nation's military personnel.
Sincerely,
DIANA DEGETTE
Member
of Congress
ANNA ESHOO
Member of
Congress
TAMMY BALDWIN
Member
of Congress