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Science News Update

Week of May 20, 1998


American Medical Association Science News Updates are made available to the public after 3 p.m. Central time (U.S.) on the first four Tuesdays of each month. We keep some back issues on this issue and have a list of available releases.


THIS WEEK'S CONTENTS

JAMA REPORTS


EDUCATION AND HEALTH STATUS PREDICTORS OF ALTERNATIVE MEDICINE USAGE
Dissatisfaction with conventional medicine not a primary factor

CHICAGO—Being more educated and having a less-than-optimum health status are predictors of who will likely use alternative medicine, according to an article in the May 20 issue of The Journal of the American Medical Association (JAMA).

In addition, alternative medicine users tend to hold a philosophical orientation toward health that can be described as holistic and are more likely to have had some type of transformational experience that changed their world view in a significant way, according to John A. Astin, Ph.D., a researcher at Stanford University's School of Medicine in Palo Alto, Calif. Astin surveyed 1,035 randomly selected people from throughout the U.S. for the study.

Respondents were asked whether they had experienced any of a list of 26 health-related problems within the past year. They were then asked to list the three most "bothersome" or "serious" ones. The top five responses were: back problems (19.7 percent); allergies (16.6 percent); sprains/muscle strains (15.7 percent); digestive problems (14.5 percent); and lung problems, pneumonia or respiratory infections (13 percent).

Astin writes: "Forty percent of respondents reported using some form of alternative health care during the past year. The top four treatment categories were chiropractic (15.7 percent); lifestyle diet (8 percent); exercise/movement (7.2 percent); and relaxation (6.9 percent). The most frequently cited health problems treated with alternative therapies were chronic pain (37 percent); anxiety, chronic fatigue syndrome and 'other health condition' (31 percent each); sprains/muscle strains (26 percent); addictive problems and arthritis (both 25 percent); and headaches (24 percent)."

Astin adds: "Although certain alternative therapies tended to be used more frequently, a broad range of alternatives were, in fact, being used for the majority of health problems. For example, although chiropractic care represented close to 50 percent of all alternative treatments used for headaches, individuals also reported using acupuncture, homeopathy, megavitamins, spiritual healing, lifestyle diets, relaxation, massage, folk medicine, exercise, psychotherapy and art/music therapy to treat this health problem."

Astin discovered that negative attitudes/experiences with conventional medicine were not predictive of alternative health care use. Racial/ethnic differences also did not predict use of alternative medicine. Use was found across all racial/ethnic groups. No significant differences were found with respect to sex. Forty-one percent of women and 39 percent of men reported use of alternative health care. Neither income nor age predicted use, either, he writes.

Of the sample surveyed, only 4.4 percent was categorized as relying primarily on alternative forms of health care. He writes that this population has a distrust of conventional physicians and hospitals and a dissatisfaction with conventional practitioners, different than the group using alternative medicine in conjunction with conventional medicine.

The most frequently cited benefits from alternative medicine by the entire sampling included getting relief from symptoms; pain or discomfort is less or goes away; feeling better; and the treatment works better for particular health problems than standard medicine's; and the treatment promotes health rather than just focusing on illness."

Astin writes: "As policymakers and health care professionals continue to debate reforms of the present health care system, it seems important to understand why a significant portion of the population is going outside mainstream biomedicine to treat a variety of illnesses and to maintain their general health and well-being."
(JAMA. 1998;279:1548-1553)

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U.S. DRUG SAFETY MONITORING MUST BE EXPANDED
Commentary calls for pharmaceutical companies to provide funding for enhanced safety program

CHICAGO—The nation needs an office of drug safety with the authority, independence, funding, and legal mandate to undertake all the responsibilities of drug safety monitoring, according to a commentary in the May 20 issue of The Journal of the American Medical Association (JAMA).

Thomas J. Moore of the Center for Health Policy Research at George Washington University Medical Center in Washington, D.C., and colleagues, note that an estimated 1.5 million people require hospitalization and 100,000 die each year because of injuries linked to prescription drugs. Overall, 51 percent of approved drugs have serious adverse effects which are not detected prior to approval. They point out that the diet drug fenfluramine was approved 24 years before studies on heart valve damage prompted the Food and Drug Administration (FDA) to pull it from the market.

The authors write that an effective program to protect the American public from the health risks of marketed drugs should address four specific tasks:

Estimating the number and cause of serious injuries and deaths. Without this information, it is impossible to determine if serious injuries associated with adverse effects of prescription drugs are declining, or if an epidemic of drug-induced injury may be taking place. The authors write: "It makes no more sense to monitor drug safety without knowing the extent of serious injuries than to have a National Highway Transportation Safety Administration operating without information about automobile accidents, or a Federal Aviation Administration not knowing how many airplane crashes have occurred."

Identifying new serious reactions. The FDA's Division of Pharmacovigilance and Epidemiology (DPE) devotes most of its staff and resources to this task. Reports of adverse reactions to recently marketed drugs are collected from consumers, physicians, pharmacists, nurses, and other health professionals. But the authors point out that the FDA estimates only about one percent of adverse events are ever reported. And they add: "A spontaneous reporting system also cannot capture adverse effects that manifest themselves as a disease with high prevalence or with a long delay between exposure and clinical manifestations. Cancer is the classic example."

Monitoring the effect of previous safety alerts. The FDA has no organized program to check whether important warning messages about product labeling about drug use are being heeded. But the limited information available suggests that some warnings are not received, or have little effect. The authors write: "It is important to discover why important safety warnings are not being heeded. Are 'Dear Doctor' letters and label changes being lost in the avalanche of pharmaceutical marketing and advertising information being sent to the physician's office? Or do physicians disbelieve the message?"

Operating an early-warning system. Rather than waiting passively for spontaneous reports of adverse reactions, the authors say active surveillance is needed to check for sensitive indicators of possible problems: "In particular, regular monitoring is needed to check for drug involvement in reported cases of birth defects, agranulocytosis, a disorder primarily caused by drugs, and aplastic anemia, which is frequently caused by drugs. So many drugs--including tricyclic antidepressants, agents for migraine headaches, diet drugs, class I antiarrhythmics, non-sedating antihistamines, and cardiac glycosides--have been linked to arrhythmia and other cardiac effects that a cardiac early-warning system may also be warranted."

The authors propose that funding for an expanded drug safety program should come from user fees collected from pharmaceutical companies: "The drug industry should be no less liable for the costs of its safety regulation than the nuclear power industry, which pays for the full costs of the Nuclear Regulatory Commission. Even if the pharmaceutical industry, already the nation's most profitable as measured by return on investment, passes on the whole burden to consumers, the added cost would be small. Just one penny per prescription would yield approximately $24 million for an enhanced drug safety monitoring program."

They conclude: "This investment in drug safety has the potential to save thousands of lives and prevent tens of thousands of serious injuries every year."
(JAMA. 1998; 279:1571-1573)

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