A BIPARTISAN bill introduced in both the Senate and House would allow consumers to use treatments not currently approved by the Food and Drug Administration (FDA). The Access to Medical Treatment Act is needed to stop the legal harassment many alternative practitioners face from the FDA and state medical boards, says Candace Campbell, executive director of the American Preventive Medical Association.
For example, the bill would help end a Texas physician's 12-year battle with the FDA. Stanislaw Burzynski, a physician who immigrated from Poland to pursue innovative cancer treatments, has been indicted for treating patients with a nonapproved drug. Patients have testified on Dr. Burzynski's behalf, citing anecdotal evidence that his treatment works and that, unlike toxic treatments, his does not hurt anybody. Burzynski notes that he has faced more resistance to alternative treatments in the US than in Communist Poland.
The bill specifies that individuals can be treated by a health-care practitioner with any medical treatment the individual desires, or that is authorized by the individual's legal representative, if: (1) the practitioner agrees to treat the individual; and (2) the administration of such treatment does not violate state licensing laws. It does not apply to religious treatment, since state medical-practice acts do not consider religious treatment the practice of medicine. Nor does the bill mandate that insurers must pay for nonapproved treatments, although insurers may choose to do so upon passage of the bill.
The bill's critics claim it would expose consumers to possibly dangerous treatments. They argue that in order to protect consumers from dangerous drugs, all drugs should go through the FDA's approval process before consumer use. But alternative practitioners argue that the approval process is too costly for many alternative treatments, since botanicals cannot be patented. The total cost of taking a new drug to the market in the US is close to $400 million; it takes nearly 15 years to complete the process. Alternative practitioners say the process favors large pharmaceutical companies.
The bill does not pave the way for charlatans to sell snake oil, as opponents suggest. "In fact, the bill includes significant consumer-protection and disclosure provisions," says Michael Cohen, associate professor of law at Widener University in Harrisburg, Pa. It permits only treatments provided by legally authorized providers and that do not unreasonably and significantly threaten patient health. It incorporates informed-consent requirements by requiring that practitioners notify consumers of risks and benefits and that such treatments do not yet have FDA approval. It also prohibits false or misleading labeling and forbids commercial advertising. These provisions offer greater consumer protection than is currently available.
With more than one-third of Americans using alternative health care, Congress should hold hearings on the the bill soon. Fourteen senators have endorsed the Senate version (S 1035), including sponsor Tom Daschle (D) of South Dakota and cosponsors Bob Dole (R) of Kansas, Tom Harkin (D) of Iowa, and Orrin Hatch (R) of Utah. The House bill, HR 2019 has 34 endorsers, including sponsor Peter DeFazio (D) of Oregon and cosponsors Joe Barton (R) and Henry Bonilia (R) of Texas, and Andrew Jacobs (D) of Indiana.
Americans want the freedom to choose treatments that have not been blessed by the FDA. Let them decide how much consumer protection they want from the FDA, and just how much freedom and responsibility they want for themselves.