The Committee is not satisfied that the conventional medical community as symbolized by NIH has fully explored the potential that exists in unconventional medical practices. Many routine and effective medical procedures now considered commonplace were once considered unconventional and counter indicated. Cancer radiation therapy is such a procedure that is now commonplace but once was considered to be quackery. In order to more adequately explore these unconventional medical practices the Committee requests that NIH establish within the Office of the Director an office to fully investigate and validate these practices. The Committee further directs that the NIH convene and establish an advisory panel to screen and select the procedures for investigation and to recommend a research program to fully test the most promising unconventional medical practices.[2]

Under the NIH Revitalization Act of 1993, OAM was subsequently established in the Office of the Director of the NIH.[3] An important effect of this enactment was to predicate the existence of the Office on statutory authority rather than a directive from a congressional committee, thus according the Office more permanence as a governmental unit. The Act charges OAM with facilitating the evaluation of alternative medical treatments, including acupuncture and Oriental medicine, homeopathic medicine, and physical manipulation therapies and requires the Secretary of NIH to establish an advisory council to advise the Director of the Office.[4] The OAM must also establish an information clearinghouse to exchange information with the public about alternative medicine and support research training in this field.[5]

The legislative history of the Act reflects Congress' intent that research fellowships for training should support program and analysis, as well as clinical research. Concerning the ongoing efforts of OAM to develop a plan for research activities at NIH in the field of alternative medicine, Congress also intends that the Office coordinate its work with that in other nations and pay particular attention to activities that emphasize ethnomedicine. Further, Congress expects OAM to develop databases in functional support of both research and information transfer.[6] By the end of 1994, the Office had awarded forty-two grants for research concerning specific alternative modalities and two additional awards for exploratory centers in alternative medical research (Appendix 6).

From an initial appropriation of $2 million for fiscal year 1992 funding for the Office has increased to $5.4 million for fiscal year 1995.[7] In its report concerning the fiscal year 1995 appropriation for the Office, the Senate Appropriations Committee anticipates that OAM will expand the number of field investigations of alternative treatments and provide additional scientific investigators who would be available to travel to conduct preliminary medical investigations into these treatments. The committee also urges the advisory council to the Director to develop an operating budget and long-term strategic plan for the Office.[8] Further, the committee contemplates the establishment of a data base in alternative medicine along the following lines:

The purpose of the data base is to bring together all the existing data and literature on alternative medicine and develop organized, systematic, and up-to-date reviews of the relevant scientific data. The data base should prepare and maintain a register of randomized controlled trials and other research efforts in this area, and should also contain a compilation of basic and clinical research relevant to alternative and complementary medicine. This review of the literature should also be made available to health care providers and consumers.[9]


B. Regulation of Dietary Supplements
In January of 1994, the FDA promulgated regulations under the Nutrition Labeling and Education Act concerning dietary supplements such as vitamins, minerals, herbs, and other similar substances.[10] Among other matters, the new regulations prescribe standards to govern nutritional labeling and nutrient content and health claims made by manufacturers on the labels or in the labeling of dietary supplements. The provisions regarding health claims for dietary supplements remain controversial and are treated in the succeeding discussion.

Under the new regulations, the FDA will hold health claims made by manufacturers of dietary supplements to the same statutory standard that applies to food in conventional form. The essence of that standard is the need for "significant scientific agreement" to support the claim:

FDA will promulgate regulations authorizing a health claim only when it determines, based on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence.[11]

The FDA characterized its decision concerning the applicable scientific standard for regulating dietary supplements as "one of the most significant issues" involving the regulations.[12] In rejecting the application of a more lenient standard for assessing health claims, such as the "existence of substantial scientific evidence," the agency indicated that allowance of a health claim on the basis of substantial scientific evidence where significant scientific agreement about the validity of the claim does not exist, "would be inconsistent with Congress' desire to ensure that health claims that are made on food, including dietary supplements, are scientifically valid.''[13]

Underlying its choice of the "significant scientific agreement" standard for assessing health claims was the agency's concern that if it allowed claims in the market place whose validity had not been established, this would undercut the credibility of valid health claims and perpetuate the type of confusion among consumers that Congress intended to correct in enacting the Nutrition Labeling and Education Act of 1990. In the view of the FDA, adoption of the same standard to assess health claims for dietary supplements as that applied to food in conventional form would "strike the proper balance between the congressional concern for consumer fraud, public health, and sound science, on the one hand, and the desire to provide the consumer with information on the other.''[14]

In implementing this standard, the FDA maintains that significant scientific agreement does not require unanimous scientific consensus concerning the validity of a health claim. At the same time, the agency concedes the "somewhat subjective" nature of the standard and indicates that in practice it will be "necessary to consider both the extent of agreement and the nature of the disagreementon case-by-case basis.''[15]

Another important and controversial issue concerning health claims under the regulations is the extent to which the new rules apply to the use or display of literature (including advertising) that does not physically appear on the label of a dietary supplement, but which contains a health claim about the product. From the FDA's perspective, the key issue is whether the literature effectively can be deemed part of the labeling of the product:

FDA advises that the provisions of this regulation pertain only to a product's label and labeling. This regulation does nothing to censor the content of books, magazines, or advertising. However, firms sometimes choose to use such material as labeling for their products, and if used as such, the material would be subject to this regulation. For example, sometimes firms copy an article from a magazine and display that article with a product that is offered for sale. Under such circumstances, the article would be part of the labeling of that product. What is significant to note is that these regulations in no way limit what articles may be published, or what books may be printed. They limit only the claims that may be made in the labeling of food products.[16]

The FDA also sought to allay consumer apprehension that the agency was plotting to ban all dietary supplements or that the regulations would have the effect of limiting the availability of supplements by restricting the amount of health information on product labels and thereby diminish marketability. According to the agency:

There is no basis for virtually all the concerns raised in the comments about the availability of dietary supplements. Nothing in these regulations will make them unavailable to consumers. These regulations focus only on ensuring that health claims, if made on the labels or in the labeling of dietary supplements, are scientifically valid and understandable. Thus, the availability of dietary supplements will not be affected by these regulations. While it is likely that some claims may have to be removed from product labeling as a result of this final rule, the products themselves can continue to be marketed.

It is true that prohibiting the use of claims that have not been authorized by FDA may have an adverse impact on the marketability of some products. However, any such impact is outweighed by the need to assure consumers that the claims that are made in labeling are scientifically valid, and that they can rely on such claims. In fact, the only products whose marketability will ultimately suffer under these regulations will be those whose labeling has borne claims that cannot be supported by the available scientific evidence.[17]

Continuing controversy concerning the FDA's dietary supplement regulations, however, prompted the enactment of the Dietary Supplement Health and Education Act of 1994.[18] In its favorable report on the Senate version of this legislation, the Senate Committee on Labor and Human Resources criticized FDA's regulatory approach toward dietary supplements:

Despite the fact that the scientific literature increasingly reveals the potential health benefits of dietary supplements, the Food and Drug Administration has pursued a regulatory agenda which discourages their use by citizens seeking to improve their health through dietary supplementation. In fact, the FDA has had a long history of bias against dietary supplements...[and] has pursued a heavy-handed enforcement agenda against dietary supplements for over 30 years. The agency's approach has forced the Congress to intervene on two previous occasions, and yet again with the adoption of [the Senate bill].[19]

In its final form, the Dietary Supplement Health and Education Act of 1994 ultimately reflected a legislative compromise that was necessary to ensure passage of the measure in the House of Representatives and to accommodate the interests, on the one hand, of supplement manufacturers and many consumers for greater autonomy for the dietary supplement industry and, on the other hand, of proponents of continuing regulatory control by the FDA to ensure the safety of supplements for consumers. Under the new law, a dietary supplement will be deemed adulterated if, among other reasons, it presents a "significant or unreasonable risk of illness or injury." The government would bear the burden of proving that the supplement is adulterated. Moreover, a person against whom the government is contemplating a civil enforcement proceeding on this ground must be given prior notice and an opportunity to present views concerning the intended proceeding.

The law also accords a manufacturer of a dietary supplement some latitude in making a truthful, nonmisleading statement on the label of the product concerning the benefit and function of the ingredients contained in the supplement. For example, the manufacturer could claim a benefit relating to a classical nutrient deficiency disease and disclose the prevalence of the disease in the United States or describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans. A statement along these lines, however, would also have to contain a prominent disclaimer that the statement itself has not been evaluated by the FDA. Further, a manufacturer who wishes to make a statement on the label concerning the benefits of the supplement must notify the FDA no later than thirty days after first marketing the product that the statement is being made.[21]

Concerning the use or display of literature containing health claims for dietary supplements, the law permits retailers and wholesalers of supplements to display an independent, third-party publication (e.g., an article, a chapter in a book, or abstract of a scientific study) concerning a supplement in connection with the sale of the product, if the publication:

(1) is not false or misleading;

(2) does not promote a particular manufacturer or brand of a dietary supplement;

(3) is displayed so as to present a balanced view of the available scientific information on dietary supplements;

(4) when displayed in an establishment, is physically separate from the dietary supplement; and

(5) does not have appended to it any information by sticker or any other method.

If the preceding requirements are met, the publication will not be deemed to be part of the "labeling" for the product. These requirements apply to the display of literature in connection with the sale of a dietary supplement and do not apply to or restrict the sale of books or other publications by a retailer or wholesaler as part of his or her business. Moreover, the burden of proof is on the government to establish that an article or other publication is "false or misleading."[22]

New dietary supplements, which are those not marketed in the United States before October 15, 1994, may be marketed without prior approval by the FDA as long as there is a history of use or other evidence which establishes a reasonable expectation that the product is safe. At least 75 days before marketing, however, supplement manufacturers must submit information to the agency regarding the safety of the product. The FDA may take action in response to a public petition to establish conditions for the safe use of the supplement. [23]

The law establishes an independent Commission on Dietary Supplement Labels appointed by the President. The members of the Commission must have expertise and experience regarding dietary supplements and be without bias on the issue of supplements. The Commission is charged with studying and making recommendations to the President and Congress within the next two years concerning the regulation of labeling claims for dietary supplements, including the use of literature in connection with the sale of these products and the procedure for evaluation of manufacturers' claims. Current FDA regulations regarding dietary supplements could remain in force no more than four years from the date of enactment of the 1994 law, pending submission of the Commission's report and promulgation of new regulations by the FDA within two years after the report.[24]

The law also creates an Office of Dietary Supplements in the National Institutes of Health to explore the potential role of supplements in improving health care and to promote the scientific study of the benefits of supplements in maintaining health and preventing chronic disease and other health-related conditions. Among other specific functions, the Office must conduct and coordinate scientific research within NIH concerning the extent to which supplements can limit or reduce the risk of such diseases as heart disease, cancer, birth defects, osteoporosis, cataracts, or prostatism. Further, the Office must compile a data base of scientific research on dietary supplements and individual nutrients. The law appropriates $5 million for this new governmental unit.[25]


C. Health Care Reform
In 1993-1994, the 103rd Congress was unable to enact legislation to overhaul the nation's health care system.[26] While a variety of health care measures were introduced during the legislative session, substantial attention was focused initially on the Health Security Act (HSA) proposed by the Clinton Administration.[27] Although the HSA reflected a finding that any reform of the health care system should afford individuals a meaningful opportunity to choose among a range of health care providers and a purpose to promote this choice,[28] the bill did not explicitly address the practice or access rights of the alternative health care community.

Among other provisions, the HSA would have established a comprehensive benefit package to cover the "services of health professionals" and defined such services as those provided by a "physician" or those that "would be [described as physician services] if provided by a physician, but are provided by another person who is legally authorized to provide such services in the State in which the services are provided."[29] This ambiguous language could be construed narrowly to authorize only those services rendered by nonphysician providers to whom a physician lawfully delegates medical duties, such as a nurse or a physician assistant. Alternatively, and perhaps in view of the all-encompassing definition of the practice of medicine under most state medical practice acts,[30] the legislative text could be read as permitting the use of an alternative health care service (e.g., acupuncture or naturopathy) if authorized by state law, even though that service might also be provided by a physician.

Coverage for alternative modalities under the HSA was further obscured by provisions in the bill that excluded services which were not "medically necessary or appropriate" and that authorized a National Health Board to determine by regulation which services were consistent with this standard.[31] Given the current investigational status of acupuncture under federal law [32] and the marginal recognition of alternative modalities by the medical and insurance industries generally, the likelihood that this board would mandate coverage for alternative treatments as "medically necessary or appropriate" seemed doubtful, at least in the short term.

Congressional interest concerning the extent to which the Administration intended to include alternative therapies under the HSA arose even before formal introduction of the legislation, as evidenced by the following exchange during hearings before the Senate Committee on Labor and Human Resources in 1993:

Senator Pell....Madam Secretary, [of Health and Human Services] I am a strong believer in alternative medicine, new medical techniques. Thanks to the creativity of a member of this committee, Senator Harkin, we have an Office of Alternative Medicine. I was curious how its work is planned to be phased into the health plan.

Secretary Shalala. One of the wonderful things about that Office of Alternative Medicine is it will over time change our attitudes and the kinds of medicines and approaches we use to medicine, that we use as part of health care. And as those things are folded in, the health professionals in the various plans, I am sure, will use them.

What we are doing with that rigorous new office is to do both the thinking and the review and to make more visible the results of the office. But I have no reason to believe that the health professionals in this country, on being presented an alternative way of improving the health of an individual, would not incorporate many of those proposals. [33]

Senator Harkin....I do not know what is going to be in the plan, but if it is just going to sort of obliquely refer to alternative methods and practitioners, I think it is going to be deficient. I think it has to incorporate them fully into the plan, and I hope it will do so.[34]

Continuing uncertainty concerning coverage for alternative health care under the HSA prompted a written inquiry about this issue in 1994 from Senator Barbara Mikulski to the Secretary of Health and Human Services.[35] In her written response, the Secretary indicated that:

...the Health Security Act does not specify the type of provider who can be reimbursed for offering a particular covered service. Nor does the Health Security Act require plans to offer access to specific types of providers. However, the Act does state that any health care provider licensed and authorized by a State to provide a service is eligible to render covered services, and those services when medically necessary or appropriate are eligible for reimbursement.

You are also correct in your understanding that the Health Security Act does not require prior approval or referral by a physician in order to get access to any specific covered service such as acupuncture or other alternative health care services. However, some plans, such as managed care plans, may choose to rely on a gatekeeper or prior approval for referral, as they do today.

The intent of the Act is to encourage efficient delivery of care through private health insurance. It is our hope that as we change incentives for insurance plans to deliver care more effectively, plans will be encouraged to select those services and professionals that efficiently promote health.[36]

As a result of successful lobbying by the chiropractic community, which argued that patients should have the freedom to choose their own providers, the House Ways and Means Committee, on June 30, 1994, approved a version of the HSA with language that restricted the right of a managed-care network to exclude any health care provider willing to meet the network's qualifications and to accept its fees. The Committee's version also expanded Medicare coverage to include payment for x-rays necessary for chiropractic services.


D. Access to Medical Treatment Act
On May 19, 1994, Senator Thomas Daschle, along with five cosponsors, introduced the "Access to Medical Treatment Act" in the United States Senate.[38] This bill, which was not enacted, sought to provide health care consumers with increased access to alternative treatments and to allow greater opportunity for the trial of alternative treatments that may prove to be effective.[39] In particular, the legislation was designed to facilitate conditional access by health care consumers to food, drugs, devices, and procedures that might otherwise be delayed from authorized use by the lengthy and expensive FDA approval process. According to Senator Daschle:

The intent of my legislation is merely to extend freedom of choice to medical consumers under controlled situations. I believe that individuals, especially individuals who face life-threatening afflictions for which conventional treatments have proven ineffective, should have the option of trying an alternative treatment, so long as they have been informed of the nature of the treatment and are aware that it has not been approved by the FDA. This is a choice that is rightly left to the consumer, and not dictated by the Federal Government.[40]

To implement this legislative intent, the bill generally authorized an individual to be treated by specified health care providers (i.e., a medical doctor, osteopath, chiropractor, or naturopath) with any method of medical treatment that the individual desires.41 "Treatment," in this context, was defined as the use of any food, drug, device, or procedure.[42] The right to treatment, however, was subject to the following conditions:

(1) the health practitioner must agree to treat the individual;

(2) the administration of the treatment must be within the scope of practice of the practitioner;

(3) there must be no evidence that the treatment, when taken as prescribed, is a danger to the individual;[43]

(4) if the treatment involves a food, drug, or device that has not been approved by the FDA, then the individual must be informed of this fact and the food, drug, or device (or accompanying information) must contain a warning concerning the absence of FDA approval and the assumption of risk by the individual;

the individual must be informed regarding the nature of the treatment (i.e., its contents, reasonably foreseeable side effects, and results of past applications);

no claim may be made regarding the efficacy of the treatment, except that the practitioner may report treatment results in recognized journals or at seminars, conventions, or similar meetings as long as the practitioner will not gain financially as a result of the claim apart from any reimbursement received from the patient; and the individual must sign an informed consent form indicating his or her permission to be treated.[44]

The bill allowed the interstate delivery of medication or equipment for use in treatments authorized by the legislation and prohibited state licensing boards from denying, suspending, or revoking the license of a covered practitioner solely because the practitioner provides treatment permitted by the bill.[45] If a practitioner violated the requirements of the legislation, the practitioner would lose the benefits of the protection accorded by the bill and be subject to any other applicable law or regulation. [46]

During Senate hearings concerning the Access to Medical Treatment Act, opponents of the legislation alleged, among other things, that the absence in the bill of any requirement for scientific testing of treatments for safety prior to actual use could expose patients to dangerous products and undermine the bill's requirement that a patient give "informed" consent before treatment. Opponents also expressed concern that the bill failed to preserve FDA's enforcement authority in this subject area, would undermine efforts by the Office of Alternative Medicine to assess the safety and effectiveness of alternative treatments, and potentially exposed patients to quackery.[47]

Supporters of the bill argued, however, that there is already substantial risk present in many conventional treatments, a firm scientific basis for many approved medical procedures does not exist, treatments authorized by the bill would be administered by licensed providers who would remain subject to malpractice liability for faulty practice, and the health interests of consumers actually would be enhanced by accommodating a patient's desire to choose his or her form of health care treatment.[48] The legislation was further supported by testimony from a German physician who indicated that many of the same objections to the bill were also made when Germany passed legislation in 1978 establishing a regulatory framework for alternative medicine in that country:

At the time the bill was being debated in our congress, critics made all kinds of insupportable claims that the public would suffer harm or fail to use effective conventional therapies. After more than 15 years of experience, these criticisms have proven to be wrong.

The medication law of 1978 was also important in that the government decided to acknowledge the following. First, freedom in one's choice of therapy by the doctor and the right of self-determination by the patient should be guaranteed. Second, the existence and equal justification of various lines of therapeutics should be expressly recognized. And, third, health authorities are obliged to take into consideration the state of scientific knowledge of each line of therapy or different schools of medicine when advising the public or practitioners about their benefits.

In addition, it was also agreed upon that in all matters of medical treatment it was ultimately the obligation of each physician to listen to his conscience when considering treatment for his patients. However, he must also be able to give plausible reasons for his choice of treatment to his patients by being informed of the merits and risks associated with any treatment he may elect to use.[49]

A bill identical to that offered by Senator Daschle was introduced in the House of Representatives on May 25, 1994, by Delegate Eleanor Norton of the District of Columbia and referred to the House Committee on Energy and Commerce.50 Similar legislation was also introduced by Congressman Peter DeFazio on June 30, 1994, and referred to the same committee.[51] No further legislative action was taken on either of these bills. Congressman's DeFazio's legislation was virtually identical to these other measures with the following exceptions:

(1) The health care practitioner would be allowed to administer a method of treatment if there is no evidence that the treatment is a "serious harm" to the patient (the Daschle and Norton bills refer to "danger" to the patient);[52]

(2) The bill explicitly contemplated the use of "controlled drugs" for which there is a currently accepted medical use (the Daschle and Norton bills are silent regarding the use of controlled drugs);[53]

(3) State licensing boards are broadly prohibited from taking "any disciplinary sanctions" against a health care practitioner who provides treatment authorized by the bill (the Daschle and Norton bills would only prohibit a state board from denying, suspending, or revoking a license and do not address other possible forms of disciplinary action against a practitioner);[54] and

(4) Imposition of sanctions for violating the bill was made more difficult by requiring that the penalty provision would apply only if the practitioner "knowingly, willingly, or with gross negligence" violates the provisions of the legislation (the Daschle and Norton bills are silent concerning the degree of the practitioner's personal knowledge or negligence).[55]