Session I | Session II
Comprehensive Medical Care for Bioterrorism Exposure-Are We Making Evidence-Based Decisions? What Are the Research Needs? -- Hearing Before the House Committee on Government Reform -- November 14, 2001
Dan Burton (R-IN), Chairman; Henry Waxman (D-CA), Ranking Member; William Lacy Clay, Jr. (D-MO); Elijah Cummings (D-MD); Benjamin Gilman (R-NY); Dennis Kucinich (D-OH); Steven LaTourette (R-OH); Ron Lewis (R-KY); Stephen Lynch (D-MA); Constance Morella (R-MD); Major Owens (D-NY); Bernard Sanders (I-VT); Christopher Shays (R-CT); and Diane Watson (D-CA).
Panel One: Major General John Parker, U.S. Army Medical Research Institute for Infectious Diseases, U.S. Department of Defense (DoD); Stephen Straus, M.D., Director, National Center on Complementary and Alternative Medicine (NCCAM), National Institutes of Health (NIH); Carole Heilman, Ph.D., Director, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), NIH; Andrea Meyerhoff, M.D., Director, Anti-Terrorism Programs, Center for Biologics Research and Review, Food and Drug Administration (FDA); William Egan, FDA.
Panel Two: Wayne Jonas, M.D., Director, Samueli Institute for Information Biology; H. Reg. McDaniel, M.D., Director of Research, Fisher Institute of Medical Research and Medical Director, Mannatech, Inc.; Sherwood Gorbach, M.D.,Tufts University; Richard Klasco, M.D., Medical Director, Micromedex, Inc.
Purpose of Hearing: The purpose of the hearing was to discuss the current state of medical knowledge regarding the efficacy of vaccines and the use of complementary and alternative therapies as treatments for exposures to biological agents.
Opening Statements: During his opening statement, Chairman Burton expressed his concern about the availability of inaccurate information that is posted on the Internet about alternative treatments for exposure to anthrax and smallpox. Chairman Burton applauded the dietary supplement industry's efforts to educate the public about the fact that there are no dietary supplements that can cure anthrax. He emphasized that it is important for patients who have been exposed to biological agents to follow their doctors advice regarding the use of conventional treatments since more research on alternative therapies is necessary. Chairman Burton expressed his concern about the side effects that arise from the anthrax vaccine. He cited a recent Institute of Medicine (IOM) report which reported that vaccines have significant shortcomings. Mr. Burton wanted to know about the evidence of the safety and efficacy of vaccines and of alternative therapies, such as homeopathy and nutritional supplements. He cautioned about the development of vaccines for every biological agent, and he urged researchers to "keep an open mind" about theories that they may be unconventional.
Representative Waxman said that we must be prepared for biological attacks by having adequate stockpiles of vaccines and distribution systems. He said that the public needs to understand the side effects of vaccines and post-exposure treatments. Mr. Waxman expressed support for continued research on treatments and prevention of biological exposures. He also said that it is necessary for any new treatments to meet strict scientific standards for safety and efficacy.
In his opening statement, Representative Sanders said that he was concerned about the confusion within the medical community about the most appropriate treatment for anthrax. Mr. Sanders was concerned about the adequacy of the public health infrastructure and access to bioterrorism treatments for people who are poor or uninsured.
During the witness testimony, Representative Gilman was given an opportunity to provide an opening statement. Mr. Gilman indicated that we need to know more about anthrax and that health professionals need to be better prepared for future biological attacks.
Statements of Witnesses and Questions:
Panel I: Major General Parker discussed evidence obtained from animal models that demonstrates the efficacy of vaccines against cutaneous anthrax. He also mentioned that the DoD is at the advanced stages of research on vaccines for smallpox and tularemia. Major General Parker outlined a research gap in the area of aerosol exposures. He indicated that limited facilities and trained personnel exist that have the capacity to test aerosol exposures with animal models. Major General Parker also highlighted DoD's efforts to train military medical personnel about appropriate treatments for biological attacks.
During his testimony, Dr. Straus expressed his support for the current steps that public health agencies are taking to combat bioterrorism. At this point, there is no scientific basis to determine whether alternative therapies could help victims of biological attacks. Dr. Straus indicated that alternative therapies must be studied through animal models in order to determine if they are safe and effective. Since current evidence about the safety and efficacy of alternative therapies is inadequate, it is necessary to trust the current body of knowledge.
Dr. Heilman outlined NIAID research efforts in the area of anthrax and smallpox. She indicated that NIAID is conducting research on the efficacy of diluted smallpox vaccine. Dr. Heilman mentioned that NIAID is accelerating efforts to identify antiviral drugs that will be effective in treating smallpox. She indicated that NIH has taken a lead role in the development of a protocol that would allow cidofovir (an antiviral drug) to be used in emergency situations for the treatment of smallpox. Dr. Heilman also told the Committee that NIAID is working with DoD on the development of the "next generation" anthrax vaccine. In the next few weeks, NIH will announce new initiatives to expand basic and applied research on bioterrorism.
Chairman Burton cited a DoD manual which states that vaccines exist for 14 biological agents. However, the anthrax vaccine is the only one that has received FDA approval. Chairman Burton asked Major General Parker for an explanation of this discrepancy. Major General Parker told the Committee that the 14 vaccines are in Investigational New Drug (IND) phase in the FDA drug approval process.
Chairman Burton cited evidence that supports homeopathic remedies for tularemia and asked why Federal agencies have not done research to capitalize on this evidence. Dr. Meyerhoff said that the FDA considers drugs that sponsors bring to the agency's attention. FDA has not received any applications for approval of homeopathic remedies. Chairman Burton asked Dr. Meyerhoff if FDA only accepts applications from pharmaceutical companies. Dr. Meyerhoff responded that FDA accepts applications from a variety of entities.
Representative Kucinich asked if FDA is interested in alternative or complementary therapies for biological attacks. Dr. Meyerhoff indicated that FDA would consider approval of such therapies if it receives an application for consideration. Mr. Kucinich asked if FDA can initiate research on alternative therapies. Dr. Meyerhoff explained that FDA has limited involvement in the drug development process because its regulatory responsibilities could pose a conflict of interest.
Representative Kucinich asked Dr. Straus if NCCAM is prepared to bring forward alternative treatments against biological attacks. Dr. Straus indicated that NCCAM would be happy to receive and consider any applications for research related to biological attacks. He also told the Committee that "in the absence of good evidence of safety and efficacy," he would not use alternative therapies especially if there is a possibility that they would interfere with the use of drugs that are known to be safe and effective. Mr. Kucinich discussed his concerns about reports that vaccines could not completely prevent biological exposures. He said, "NCCAM should have plan B ready in the event that vaccines and conventional approaches do not work."
Representative Morella asked Dr. Meyerhoff if there are any treatments available today that could not be administered to a victim of a biological attack because of FDA regulations. Dr. Meyerhoff said that a number of products are approved or under IND.
Chairman Burton asked Major General Parker what would happen if troops were given antibiotics. Major General Parker said that 20 percent of the troops would likely experience side effects. Chairman Burton asked Major General Parker if he thought that the vaccine, with its side effects, was a good tradeoff. Major General Parker said "I personally feel that that's a good trade-off, compared to the risk of contracting anthrax, or the pulmonary anthrax."
Chairman Burton asked Dr. Straus if complementary and alternative medicine (CAM) therapies exist to improve immune responses to infectious diseases. Dr. Straus said that there are some therapies that have been tested on lab animals, but it is unclear if the results of these studies are "clinically meaningful for people who have infectious diseases." Chairman Burton also asked Dr. Straus if any dietary supplements exist that would improve immune responses to infectious diseases. Dr. Straus indicated that there is no good evidence to suggest that dietary supplements have an impact upon immune responses. He indicated that NCCAM and the National Cancer Institute are planning an anti-oxidant workshop to explore the relationship between some anti-oxidants and cancer. Chairman Burton asked if NCCAM is supporting any research on the use of homeopathic remedies in response to infectious diseases. Dr. Straus discussed research on the use of dietary approaches against diseases such as HIV and Hepatitis.
Chairman Burton asked if existing research alternative therapies for tularemia should be considered by NCCAM. Dr. Straus said that effective antibiotics for tularemia already exist. He would like to see serial animal model studies on alternative therapies before they are administered to people. Chairman Burton asked Dr. Straus if it would make sense to use alternative therapies in the event that there is a shortage of antibiotics or vaccines. Dr. Straus told the Committee that it would be "problematic to give untested, unproven therapies to the populace." Chairman Burton asked Dr. Straus if NCCAM would do research on homeopathic treatments to supplement existing treatments. Dr. Straus reiterated that he would be happy to consider any applications for this type of research.
Chairman Burton asked if NCCAM is conducting research on regimens used in India and China. Dr. Straus told the Committee that NCCAM has invited Asian investigators to apply for research funding and he has personally met with the Minister of Traditional Medicine in India. On the day of the hearing, NCCAM held a workshop with the National University in Singapore. Dr. Straus also mentioned that NCCAM is planning a workshop in India, which will give American investigators an opportunity to meet with investigators and practitioners of Ayurvedic medicine. He also indicated that NCCAM is considering a homeopathy study on cancer.
Representative Morella asked about the amount of time it takes to develop drugs. Dr. Heilman explained that it takes a great deal of time to get from the efficacy stage to the drug approval process. Ms. Morella asked if the FDA process slows down product development. Dr. Meyerhoff told the Committee that FDA seeks to streamline certain points of development and that increased dialogue at the onset of the approval process helps to reduce the amount of time that is required. Dr. Straus said that investigators have a responsibility not to harm patients and not to make people sick. This responsibility results in a time-consuming process that cannot be overlooked.
Chairman Burton indicated that there is currently not enough smallpox vaccine to combat a major outbreak. He wanted to know if the Federal agencies are looking at approaches to treat people who may not be vaccinated. Dr. Heilman said that NIAID has conducted a study on cydofovir. This drug has shown potent activity against smallpox and related viruses in animal models. NIH has taken the lead in developing a protocol that would allow cidofovir to be used in emergency situations for the treatment of smallpox. This drug is now in the IND phase. Dr. Straus said that it is possible that natural materials exist that could act as a substitute for smallpox vaccine, however, these materials have not yet been discovered. If the materials are discovered, NCCAM would support research of these products on animal models.
Chairman Burton said that we are facing a terrorist threat right now and expressed his concern that homeopathic theories are not being explored by Federal agencies. Mr. Burton said that if we had an epidemic right now, we would only be prepared to help 5 million people. Dr. Heilman explained that NIAID is conducting a smallpox vaccine dilution study which could help to make the vaccine available to more people.
Representative Watson asked if the Federal Government is doing a better job of training emergency room personnel to diagnose biological agents. Dr. Heilman explained that CDC is trying to improve training on biological agent diagnosis for infectious disease doctors. She also said that the Infectious Disease Society of America (IDSA) has made great efforts to educate infectious disease doctors about symptoms and treatments of infections caused by bioterrorist agents.
Panel II: Dr. Jonas discussed his research on homeopathic therapies for tularemia His research indicated that homeopathic therapies "reduced the mortality of lethal exposure to tularemia by 22 percent in mice." This approach could be used for partial protection of affected individuals if vaccines are not available. Dr. Jonas said that literature exists which indicates that some low-dose homeopathic preparations can provide partial protection against exposure to chemical agents. Dr. Jonas indicated that his data must be considered preliminary and that more research is required. Dr. Jonas also said that the Federal investments in research must be broader.
Dr. McDaniel discussed research on glyconutrients and glycobiology, which is a dietary approach to dealing with biological agents. Dr. McDaniel said that his research has shown that glyconutrients can destroy bacteria and viruses in animal cell cultures. Thus, he believes that glyconutrients could be effective against bioterrorist agents.
Dr. Gorbach discussed his research on the use of probiotics, which is a dietary supplement for prevention of side effects associated with antibiotic use for prevention of anthrax. Dr. Gorbach indicated that intestinal tract problems are the most common side effects of antibiotic use. Dr. Gorbach said that probiotics could be used to replace healthy bacteria that is lost as a result of antibiotic use and would reduce intestinal tract problems. Dr. Gorbach indicated that more research is needed to determine if probiotics would reduce intestinal tract problems resulting from the use of cipro for anthrax exposure.
Dr. Glasco discussed a decision support technology which has been developed by his company, Micromedex, Inc. The technology is a CD-Rom which gives medical personnel immediate access to information on agents that could be related to biological attacks.
Chairman Burton expressed frustration that Federal agencies have a narrow approach and point of view toward CAM. He asked Dr. Jonas why Federal agencies are closed minded about considering CAM therapies against biological attacks. Dr. Jonas said that Federal agencies are very conservative and careful about the public health messages that they convey. Dr. Jonas also said that agencies are reluctant to support such research because there are some CAM practitioners that promote CAM without providing evidence. He also said that most of the funding for research comes from Federal agencies, which represent conservative scientific views.
Chairman Burton said that Dr. Straus' views are similar to those of CDC and FDA. He said that Dr. Straus' views on CAM are very conservative. Dr. Jonas said that he understands Dr. Straus' position and he indicated that NIH is doing more than it would have done if NCCAM had never been created. Dr. Jonas said that we need to make sure that experienced CAM practitioners work in places like NCCAM. Chairman Burton said that he will tell Secretary of Health and Human Services, Tommy Thompson, to ensure that CAM practitioners are working in places like NCCAM and that CAM practitioners should serve as members of its Advisory Council.
Dr. McDaniel said that Government officials do not like to consider unconventional therapies because the agencies will be blamed if they turn out to be dangerous. Dr. McDaniel also said that research is very expensive; thus, agencies are reluctant to support studies that may not be successful. Dr. Gorbach indicated that he has received several NIH grants for other research that he is conducting. However, all of his probiotics grant applications have been rejected. He said that NIH review committees and study sections do not believe in this kind of research. Even if NIH puts out a request for applications in this area, applications will get rejected in study sections.
Chairman Burton asked Dr. Jonas to explain the success rate of homeopathy. Dr. Jonas said that homeopathy is twice as effective as a placebo. Although the conventional medical community is critical of this research, NIH is supporting some projects. Chairman Burton asked Dr. Jonas if the White House should have a senior advisor to coordinate CAM throughout the world. Dr. Jonas agreed that the White House should have such an advisor that will work to integrate CAM into mainstream medical practice.
Dr. Jonas said that the Federal Government should not fund all CAM research. There are few incentives for the private sector to enter into this type of research. We need to look into patent laws, FDA regulations, and tax incentives to encourage more people to pursue CAM research. Chairman Burton asked the panelists to submit any suggestions to him on approaches for increasing CAM research.
Prepared by Dina Dariotis, OD/OLPA, November 15, 2001