Testimony of Stephen E. Straus, M.D.

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Testimony
Before the Committee on Government Reform
United States House of Representatives

Comprehensive Medical Care for Bioterrorism Exposure - - Are We Making Evidenced Based Decisions?

Statement of
Stephen E. Straus, M.D.
Director, National Center for Complimentary and Alternative Medicine, National Institutes of Health,
HHS

For Release on Delivery
Expected at 1:00 pm
on Wednesday, November 14, 2001

Mr. Chairman and Members of the Committee:

As we sit here, our fellow Americans are confronted by the fearsome prospect of exposure to lethal biological weapons. In response, there is great interest in exploring every potential means of preventing or mitigating the health effects of such exposures to themselves and their loved ones. You invited my colleagues and me to comment on the potential value and wisdom of some of these approaches.

As a physician who for the past 25 years has specialized in the care of patients with severe and life-threatening infections, and as a public health official, I fully support the current CDC recommendations for managing potential exposure to and infection by anthrax. Moreover, I am impressed by the efforts already mounted at the Federal, State, and local levels in response to the intentional and malicious dissemination of anthrax spores. The success of current efforts to locate and disinfect contaminated sites and dispense effective antibiotics to those exposed is evidenced by the small numbers of infected persons and the even smaller numbers of serious illnesses or death that have resulted from such exposures. This has afforded us all some measure of comfort. To a great extent, we are able, as the President has urged, to pursue our normal activities.

In addition to the already proven means of detecting anthrax spores and preventing or treating exposures to them and other potential pathogens, there is the very real promise that research will reveal additional and even more effective strategies. Those efforts being mounted through the formidable scientific infrastructure of the National Institute of Allergy and Infectious Diseases will be summarized here today by my colleague Dr. Carole Heilman.

The specific question you asked me to address today, Mr. Chairman, in my capacity as Director of the National Center for Complementary and Alternative Medicine (NCCAM) is whether there are additional health tools and practices that could effectively serve as alternatives or as complements to the ones already implemented or forecast here by Dr. Heilman to prevent or treat diseases from biological weapons. In response to this, let me say first, that as public servants it would be unworthy and unwise of us to do anything but place our fullest confidence in those well-considered resources that our public health authorities have already summoned to meet the current national and personal threats.

Yet, we know that no measures, except for some vaccines, including the proven ones already being used, can totally prevent infection by virulent biological agents once they are deployed, and no words of comfort or medications are in themselves sufficient to fully allay the concerns that we may fall prey to such weapons. Understandably, people are seeking additional measures to safeguard their health and that of their loved ones. The issue is not whether there is justification for continuing concern, but whether the measures that some are promoting do anything more than prey upon people's fears and distract them from taking more prudent steps to protect themselves.

Some of the approaches now being considered by our frightened countryman are ones that were largely displaced by the emergence of scientific medicine. Before the articulation of the germ theory of disease in the late 19^th century and the subsequent development of vaccines and antibiotics, people sought protection from epidemic diseases through a variety of spiritual exercises and by ingesting natural products. It was believed that specific rituals and selected herbal extracts and tonics would, in current parlance, eliminate the offending pathogens or boost one's resistance to them. In fact, a characteristic shared by many of the traditional healing systems of indigenous peoples, such as Ayurvedic medicine, various forms of oriental medicine, and the more recently developed systems like Naturopathy, is an emphasis on maximizing the body's inherent capacity to heal itself.

While augmenting one's natural healing powers may prove beneficial for some illnesses, and is a focus of much work funded by NCCAM, there is no scientific basis to believe that this approach would be of much value in the context of virulent diseases incited by biological weapons. From the perspective of contemporary immunology, diseases like anthrax, smallpox, and tularemia exceed one's innate immunity to control them, and progress too rapidly for specific and protective antibody and lymphocyte responses to evolve. Simply stated, they can kill us before we can arm ourselves fully to defend against them.

As the eminent microbiologist Hans Zinnser concluded some 65 years ago in his acclaimed book entitled "Of Rats, Lice and History" the course of human history has been indelibly marked and shaped by plagues. Measles, yellow fever, cholera, bubonic plague, smallpox, typhus, syphilis and tuberculosis, and HIV in the current era, have exterminated native peoples and forced wholesale migrations of populations. Had the traditional healing rituals and natural products available to pre-20^th Century man been truly effective, our history would have been rather different. Through the availability of cleaner water, uncontaminated foodstuffs, and vaccines and antibiotics, human lifespan has increased by a greater proportion in the past century than through all recorded history up to that time.

Despite these impressive public health achievements, people still turn today to natural products hoping them to help mitigate infections. Among the most popular of these products for the American consumer is Echinacea, a widespread herbal medicine. Small studies suggest that it might lessen the severity of colds and the flu. Therefore, we in NCCAM are funding substantive and rigorous studies to determine whether the preliminary observations about Echinacea hold up. Nonetheless, even if Echinacea proves to mitigate simple viral respiratory infections that almost always resolve on their own, it would be a far stretch to believe that it could prevent or ameliorate highly virulent and disseminated bacterial or viral diseases with high mortality rates. We must discourage any assumption that products like Echinacea may serve in lieu of proven drugs like ciprofloxacin or doxycycline for people exposed to anthrax bacilli.

It may not even be prudent to combine such natural products with antibiotics because of the possibility that they would interfere with the proper metabolism and action of the drugs. An instructive example in this regard is the effect of the herb St. Johns wort on the metabolism of indinavir, a drug that has helped extend the lives of countless patients with HIV/AIDS. St. Johns wort accelerates removal of indinavir from the body, leaving drug levels that no longer are adequate to block the replication of the HIV virus.

Traditional healers of several Asian countries prescribed specific rituals, exercises, diets and herbal remedies for the treatment of virulent infections. Yet, there is no evidence that these were of any value. In Korea, for example, the primary approach to contagious diseases like typhoid and malaria involved spiritual exorcisms. Smallpox was especially feared and the deity Sonnim had to be assuaged if one hoped to resolve the disease. In India, relief required homage to the smallpox goddess Sitala.

Apparently, some ancient preventative strategies were more effective. From the time of the great Moslem physician Avicenna of the 10^th Century, Persians exposed their children to cows infected with cowpox to protect them from smallpox. Variolation with dried smallpox scabs was practiced in China and Korea centuries before Jenner proved the effectiveness and greater safety of classical vaccination. Since Jenner's time, immunity to infectious agents has been induced by administering small amounts of avirulent microbial components. This is the well-proven basis for routine immunizations, as for measles or polio, and which permitted the global eradication of natural smallpox in the 1970s.

The prophylactic benefits of exceedingly dilute substances are more in doubt than those of conventional vaccines. Starting with the use of ultra-high dilutions of belladonna to prevent scarlet fever in the late 18^th Century , there have been numerous claims that homeopathic medicine can prevent or treat infectious diseases. The premise of homeopathy is that 'like cures like', meaning that administration of infinitesimal quantities of a substance that in higher concentrations provokes specific symptoms, will eliminate those symptoms. Dilutions beyond those likely to leave even a single molecule of the original offending substance is often required to formulate a homeopathic treatment. In the 19^th century, practitioners of homeopathic medicine proposed that miniscule concentrations of killed anthrax or smallpox microbes could confer immunity to these infections. Although there have been studies of homeopathy's potential against infections, most prominently for veterinary diseases, as concluded even by experts in homeopathy in yesterday's Washington Post, the overall evidence of efficacy is lacking.

I mention the homeopathic approach here because products claiming activity against anthrax and smallpox are now experiencing a renaissance in the marketplace. Even though there is some doubt that these products could be effective, we cannot prove the claims to be entirely specious. It would be unethical and dangerous to withhold proven drugs and vaccines in order to see whether the homeopathic remedies protect people who become exposed. Exploration of such approaches should first involve careful studies in animals using contemporary methodologies to discern whether they hold any promise against diseases associated with biological weapons. In the interim, however, lacking any competent evidence that they work, the claims about these products are dangerous both to the individual who uses them and to the population in general who might become infected if some refuse standard treatments.

Another example of products being marketed by internet vendors to a frightened populace involves colloidal silver. Silver, like many substances, does possess antibacterial properties in vitro, rendering it a topical disinfectant. Its systemic use in humans, though, is limited by its toxicity. Even more serious illnesses and death were associated with exposure to heavy metals such as arsenic that was long included in popular remedies.

In conclusion, Mr. Chairman, we in NCCAM commit ourselves to apply exacting research methods to expand the repertoire of healthcare tools for countless medical conditions. We enjoy the generous support of the American people and appreciate the partnerships we have established with the other NIH institutes and centers and research agencies in this undertaking. In the instance of bioterrorism, however, the best approach is to manifest, as I do, an unwavering trust in the currently approved drugs and vaccines, and to not dissipate our energies or to distract the public by pursuing unproven remedies. The stakes are simply too high at this time to do otherwise.

I would be happy to take any questions you might have with regard to NCCAM and complementary and alternative responses to bioterrorism.