Lack Of Deployment Health Monitoring Obscures New Anthrax Vaccine Safety Performance: As controversial and divisive as the anthrax shot has been, it would be valuable to ascertain if Bioport's new production lots are conforming to the much higher reaction levels acknowledged on its revised package insert. Complying with health monitoring requirements would help establish just how well or poorly the new production lots are performing. Prior to implementing the Anthrax Vaccine Immunization Program in 1998, Secretary Cohen established four conditions, one being a shot tracking system. If the Pentagon does not comply with health monitoring legislation, such shot tracking provides inadequate information because DoD does not track adverse reactions. In a few cases blood drawn for physical exams has validated that previously healthy servicemembers developed autoimmune problems after taking the shot. Their experience fortifies the argument for pre-deployment exams required by law. As in Gulf War I, there will be those who get vaccines and do not deploy. Since some of those individuals also got sick, exams and blood draws can contribute to early awareness of problems, unclouded by toxic battlefield exposures. Although the approximately 2000 reported reactions in the FDA's Vaccine Adverse Event Reporting System (VAERS) makes the anthrax vaccine the most reactogenic shot on the market, VAERS alone is inadequate to assess the safety performance of the new lots. The data now shows both old and new lot reactions. Also, a Harvard study of the mid-1970's swine flu reaction reporting indicates military members report at only one-seventh the rate of civilians, perhaps a reflection of both a healthier population and more reticent culture. Finally, former FDA Director David Kessler has stated that VAERS data may represent as little as one percent of the real reaction picture. Again, because of such limitations, pre- and postdeployment health exams and blood draws may yield a more accurate picture of anthrax vaccine safety. Pre- and post-deployment exams and blood draws become more important as risks increase with new force health protection polices that may interact with other problematic prescriptions such as lariam and GO pills. Smallpox Inoculation Complications Are Currently Invisible To Congress: Service members are receiving smallpox inoculations from an expired and thus technically adulterated stockpile the FDA re-licensed in October 2002. The Pentagon initiated this program in the midst of significant public resistance by civilian health professionals against the smallpox policy to protect first responders. Many servicemembers have not had both anthrax and smallpox vaccines simultaneously. The Senate Veterans Affairs Committee wrote DoD on February 14, 2003 requesting information on the percentage of deploying troops receiving these two vaccines, the incidence of adverse events, and the number of exemptions. Pyridostigmine Bromide Problems Could Easily Be Repeated: There are many unanswered questions about the FDA's recent approval of the Anti-Nerve Gas Pill Pyridostigmine Bromide (PB) as a prêtreatment for exposure to the nerve agent Soman. Had PB remained an experimental or investigational drug for nerve gas pretreatment, the military would have had to give soldiers informed consent and the option of whether to take it, or invoke a direct order from the President. By fully licensing PB, FDA saved the President and Congress political liability, not lives, by allowing the military to avoid giving troops a choice. Documents and scientific studies conducted over the last 12 years (such as the 1999 RAND report and the 2000 Institute of Medicine analysis) have clearly shown PB is both experimental and harmful. The Department of Defense and the Department of Veterans Affairs have both concluded through previous studies that PB could not be ruled out as a factor in Gulf War veteran illnesses. In fact, Congress banned DoD's use of the substance in an amendment to the FY '99 Defense Authorization Bill unless it was approved for use by a Presidential waiver. While the drug may be approved for civilians who have the neuromuscular disease myasthenia gravis, it has never been shown to be effective or safe for the military application against Soman. This drug is especially problematic for the following reasons: 1. PB's dosing for effectiveness should be variable in each individual and would require individual evaluation due to the genetics and the size of the person receiving the dose. 2. PB is known to cause muscle damage in animal studies with even one dose. 3. PB can increase the adverse effects of Sarin nerve gas. 4. Researchers have shown that PB, with simultaneous exposures to combinations of DEET, permethrin, sarin, or jet fuel, causes brain and testicular injury in animal experiments. Thus, in allowing this use, the FDA, DOD, Congress, and the President are permitting a questionable protection against Soman and increasing the likelihood that troops will be more susceptible to Sarin. It is possible that those who made the decision think they have chosen the lesser of two evils with the troops' protection in mind. But a decision that ignores the facts about the risks of PB is irresponsible policy-making. It is unfortunate that the FDA has approved PB when it is known to have harmed veterans of the last Gulf War. Once again our government is putting soldiers in another type of "Harms Way," which could have been prevented. FDA's ruling is most likely the impetus for soldiers saving their sperm prior to deployment. The very least the Pentagon should have done is to give preand post-deployment exams and blood draws that may allow for analysis of PB effects on health. New Pentagon "Limited Access" Medical Record Policy Creates a Climate for Hiding Malpractice And Exacerbates Servicemember Mistrust of Military Medicine: One of the intents of Public Law 105-85, Section 765, is to improve future access to medical records. But the Department of Defense is turning this provision on its ear by instituting its January 2003 Health Information Privacy Regulation. Particularly counterproductive is language that enables medical malpractice by denying servicemembers the information necessary to hold military physicians or clinicians accountable for substandard care. This language reads: C11.1.2. Unreviewable Grounds for Denial. Subject to paragraph C11.1.4., a Lack of accountability has been the hallmark of DoD's Anthrax Vaccine Immunization Program. In May 1999 the Army's top immunologist exhorted colleagues against continuing anthrax shots in cases of a clear contraindication. Unfortunately, there are still current examples of service members who developed significant and unresolved health complications after receiving anthrax shots and who now are being told they must risk worsening their conditions by taking the shot again. The AVIP was touted as a “Commander's Program" that forced line officers to play doctor. However, five years later most commanders and many military health professionals are still unaware of Army medical guidance on identifying and screening out individuals at risk for reactions. Thus, commanders are forcing some service members to jeopardize their health, and the Pentagon's Health Privacy regulation could allow such actions to go uninvestigated and unpunished. The Feres Doctrine Shields DoD from Liability for Medical Malpractice and Related Cover-Ups. Pentagon memos obtained by Congressional investigation of the anthrax vaccine program revealed statements that the Feres Doctrine did not apply when care standards were not met. This reality was best exemplified by the 2001 conviction of the Army anesthesiologist who caused the death of a Marine colonel's daughter. For this malpractice and related Army cover up, the doctor was court-martialed only due to the intervention of the Commandant of the Marine Corps. The doctor was sentenced to dismissal from the service, and is still licensed to practice medicine. The Marine colonel whose daughter died expressed hopes through his attorney that "no military family will have to strain, struggle and suffer as they did in order to learn what medical care was actually provided to a family member at a military medical facility." DoD must revisit its Health Privacy Regulation and ensure that the restriction on medical record access is adjusted to comply fully with PL 105-85 intentions to improve future access to medical records for service members and those who need to know. Recommendations 1. Congress should send a letter from the subcommittee to the Secretary of Defense insisting on immediate full compliance with health monitoring requirements of Public Law 105-85 and identifying accountability consequences. 2. Service members should be given a copy of the manufacturer package insert for each immunization and pharmaceutical they receive so they can know what reactions to look for. 3. Military doctors, nurses and corpsmen should all be given continuing education on the 26page guidance written by Engler, Pittman and Grabenstein on when to waive vaccines for those at risk of severe reactions. 4. The Subcommittee should communicate to DoD and introduce legislation, if appropriate, that assures the right of military patients and their family members to obtain complete and unhindered access to their medical records. Further Considerations Regarding Inadequate Force Health Protection Impacts on the Department of Veterans Affairs The need for the DoD to adhere to Public Law 105-85 is even more important given that the Veterans Administration (VA) increasing patient workloads, under-funding, and continuing disconnects between DoD and VA health information systems. As with Gulf War I, the VA will shoulder the burden of learning about mystery illnesses from toxic battlefield exposures and/or from force health protection drugs and vaccines. To illustrate the challenges already faced by the VA, I have attached charts presented last week by the Vietnam Veterans of America to the House and Senate Veterans' Affairs Committees. Given these VA challenges, Congress must force DoD to make it easier for service members to trace potential ailments to deployment events rather than stand in the way of accurate diagnosis and effective treatments as has been done with veterans from the first Gulf War. Complying with the requirements of Public Law 105-85 is simply the right Pentagon policy to maintain the trust of service members and their families. Conclusion Effective Force Health Protection measures should be characterized by the following: A) They should not be "FORCED" B) They should enhance service member HEALTH before and after deployment, and not unnecessarily risk their health C) They should be designed to offer PROTECTION for service members, not protection for military medical clinicians responsible for questionable health policies and practices Public Law 105-85 meets these criteria except for experimentation allowances, and it is my hope that service members will benefit from DoD's full implementation of the provisions of this law. Mr. Chairman, I again thank you for the privilege of submitting this statement. I hope the committee finds the analysis useful, and I stand ready to assist in further efforts to improve health care management for fellow citizens in the armed forces. |