CHEMOTHERAPY AND INFORMED CONSENT

Most cancer specialists (oncologists) prescribe chemotherapy drugs for unproved purposes, according to a new survey. This is not the first time the practice called "off-label" prescribing has been shown to be widespread. In fact, it is generally condoned by physicians in all medical specialties. Some off-label uses are relatively benign. For instance, if a new drug shows a "response" in some study participants in whom the standard drugs have failed to control the cancer, the doctor may then prescribe it to people with an earlier stage of the same form of cancer. Other off-label uses are costly, life-threatening, and highly toxic. The best-known example is bone marrow transplant, now called stem cell rescue, for the treatment of advanced breast cancer. Stem cell rescue has been available for years, though it has never been proven superior to high-dose chemotherapy. In short, off-label use may be based on an educated guess at efficacy, not on a formal study.

Off-label use raises an issue which is problematic even for people taking chemotherapy drugs of proven efficacy--informed consent. People often do not understand how benefit is determined in clinical trials. And rare is the doctor who would voluntarily offer an honest explanation. The average cancer patient might reasonably assume that the oncologist who quotes a "20% response rate," means that the drug produced a remission in 20% of the people taking it. But the term response rate simply means that the tumor shrank, not necessarily that it disappeared. (The FDA defines response as reduction by 50% or more in all measurable tumors for 28 days or more.) In other words, response rate does not mean that 20% lived longer or had a better quality of life. Another measurement of benefit is disease-free survival. This merely refers to the longer period of time the new drug-treated study participants went without a recurrence, as compared to the control group. It does not mean prolonged life. As Ralph Moss, Ph.D., author of Questioning Chemotherapy (Brooklyn, New York: Equinox Press, 1995), explains, "One can die at exactly the same time [as someone who did not receive the drug], yet have a wonderful increase in 'disease-free survival'."

Unfortunately, too much chemotherapy is given in response to the cancer patients need for hope. Too often, there is an unspoken but very real possibility that the new drug may merely prolong the dying time while destroying the quality of remaining life. In 1985, Dr. John Cairns, professor of microbiology at Harvard University School of Public Health, wrote, "The National Cancer Institute estimates that more than 200,000 patients receive chemotherapy in the U.S. each year. For a dangerous and technologically exacting form of treatment, these are disturbing figures, particularly since the benefit for most categories of patients has yet to be established. Furthermore, the number of patients who are being cured can hardly amount to more than a few percent of those who are treated."

Today, about 400,000 people receive chemotherapy each year in the U.S., but chemotherapy's curative potential has changed little in the 12 years since Dr. Cairns wrote his Scientific American article entitled "The Treatment of Disease and the War Against Cancer." Thus, it is not surprising that desperation was the reason given by oncologists for their extensive off-label use in the new survey conducted by Roper Starch and financed by the American Cancer Society and Amgen Corporation, a biotech company that makes cancer drugs. A representative sample of 200 practicing oncologists participated. The survey never questioned the doctors about whether they informed their patients about the exact nature of off-label prescribing. Nor did the survey questions indicate any impulse to determine whether the practice actually improved patient care. Instead, the questions were geared to show how the FDA is a stumbling block for physicians. For example, 74% of the oncologists said they agreed with this statement: "FDA rules about off-label information stand in the way of doctors' efforts to get the most current information available about cancer treatments."

The timing and design of this survey appears calculated to fan the anti-FDA mood of Congress, now bent on undermining the agency's authority. A bill currently before the Senate, The FDA Modernization and Accountability Act of 1997, would permit drug companies to advertise and otherwise promote off-label uses to doctors. Several studies have clearly demonstrated that many doctors are misled by drug company advertising. Thus, allowing the manufacturers to advertise drugs for unproved uses would only exacerbate the problem. One of the more alarming findings from the new survey was the 73% of oncologists who disagreed with the statement, "Off-label information provided by pharmaceutical firms could be misleading and therefore should be prohibited." Currently, the FDA can restrict misleading drug company advertising, though it has no authority over physicians' prescribing practices.

The Patients' Coalition, of which the Center for Medical Consumers is a member, opposes the pending legislation because it contains numerous provisions that pose a significant threat to the health of all consumers. Among other measures, the bill would lower the standards for new drug approval and create major conflicts of interest by allowing medical device manufacturers to select, hire and pay for-profit companies to review and approve their product.

Amgen's interest in giving drug companies free-rein in their promotional activities is understandable. But the off-label survey's other sponsor, the American Cancer Society, purports to serve the interest of people with cancer. You can help in the fight against drug company promotion of off-label drug use by urging your House and Senate representatives to oppose passage of the FDA Modernization and Accountability Act of 1997.

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