~ Overview

The alternative pharmacological and biological treatments discussed in this chapter are an assortment of drugs and vaccines that have not yet been accepted by mainstream medicine. If and when they are accepted, many of these drugs and vaccines will fit into conventional medicine as it is practiced today. Thus, these treatments differ from other alternative health measures in this report because, by and large, they do not represent an entirely new theory or unified approach to health and disease.

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Despite their diversity, the alternative pharmacological approaches share some or all of the following themes:

• Unlike many mainstream drugs, most unconventional substances are believed to be nontoxic.

• Many are directed not toward eradicating a specific disease entity but toward ~stimulating the patient's immune system to fight the onslaught of a pathological condition or organism. Frequently, these methods may have to be tailored to individual patients to be effective.

• For other approaches, practitioners may postulate an entirely new defense system altogether.

• Other alternative substances are derived from old Native American herbal remedies or are turn-of-the-century remedies that were cast aside during the rapid advance of biomedicine.

Hundreds of alternative drugs and vaccines could have been included in this report. The ones that are included were chosen because they met one or more of the following criteria:

• Therapeutic promise. Available evidence suggests that they may be effective.

~ • Wide use. Because they are now used by many people, public health considerations indicate that they should be investigated. If any of these products prove harmful, that news needs to be spread quickly; if any prove effective, this should be officially recognized and they should be put to further use. An up-to-date example is the use of cartilage products for acquired immune deficiency syndrome (AIDS), cancer, and arthritis. Since a "60 Minutes" television program about them in late February 1993, some 50,000 Americans are currently reported to be taking shark cartilage even though properly designed trials have not yet been conducted. (Another consideration besides safety and effectiveness for the users is that demand for these products entails destroying many sharks.) Ozone is another example of a substance now being used widely--particularly as a self-medication in the AIDS community--without solid evidence of its usefulness.

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• Subject of controversy. Some other pharmacological or biological products have been the subject of long-standing controversies that need to be resolved. This point is particularly true for certain medicines derived from Native American remedies, such as the Hoxsey method and Essiac.~ • Former use or use elsewhere. Some products have been tested and well documented in the scientific literature but for various reasons have fallen by the wayside. An example is Coley's toxins, an immunotherapy for cancer that was developed at the turn of the century by a New York bone surgeon and which is currently being used in China and Germany. Similarly MTH-68, a nontoxic, biological vaccine, is reported to buttress the immune system against cancer. Another example is the use of a local anesthetic (often, novocaine) for neural therapy to combat chronic pain, allergies, and other problems; this approach is in wide use in Europe.

A major impediment to full investigation of alternative pharmacological treatments is the high expense of conducting the trials necessary to meet Food and Drug Administration (FDA) approval. Nearly every one of the few drugs that FDA approves each year is marketed by one of the major pharmaceutical companies. Nevertheless, even well-capitalized biotechnology firms have sometimes been driven out of the marketplace by the difficulty in meeting FDA requirements.

~Another problem for many alternative materials--such as herbs, nutrients, and common chemicals--is their lack of sponsorship. Because they are in the public domain and therefore inexpensive and not patentable, drug companies understandably lack interest in investing the enormous sums required for full trials. Therefore, most such alternatives lack both sponsors and funding for clinical trials of their safety and effectiveness.

Marketing most of the substances discussed in this chapter is not allowed by FDA on the basis of its interpretation of Title 21, article 355, of the U.S. Code, which states that unless a developer has presented "substantial evidence" of a drug's safety and efficacy, the FDA can deny approval for marketing that substance. "Substantial evidence" is defined as "adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved."

Many alternative medical practitioners have attempted to market new drugs or vaccines under this statute, but few have succeeded. The failure often occurs because "qualified experts" are defined as those who adhere to mainstream medical practices. To be an ~alternative practitioner has, until now, been reason enough to disqualify a person to evaluate the usefulness of the drug in question.

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Moreover, "clinical investigations" are generally interpreted to mean randomized, double-blind, placebo-controlled studies (see the "Research Methodologies" chapter) of the kind that only pharmaceutical companies and major medical centers can afford to conduct. This is true despite a declaration by Jay Moskowitz, former deputy director of the National Institutes of Health in September 1992, that "not all alternative medical practices are amenable to traditional scientific evaluation, and some may require development of new methods to evaluate their efficacy and safety." Thus, the reluctance of conventional medicine to accept for examination and possible use the materials assessed here appears to be tied to measuring them with the wrong yardstick.

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The remaining sections of this chapter deal with the existing research base for 14 specific treatments, future research opportunities for these 14 treatments, and key issues and recommendations that are relevant to all such biological and pharmacological treatments. ~Each treatment fits one or more of the criteria cited earlier--such as wide use, controversy, and therapeutic promise--and may require selection or development of appropriate methodologies for proper evaluation.