FDA Encourages Physicians to Report Adverse Side Effects
Physicians or pharmacists who learn of adverse drug reactions can now use a simple form to report their finding to the Food and Drug Administration (FDA).
The MedWatch program — launched in June 1993 by the FDA, the American Medical Association, and other health organizations — provides a one-page form that health professionals can mail, fax, or send by modem to the FDA, Laurie Jones reports in American Medical News. FDA Commissioner David A. Kessler says that his organization and others are trying to spread the word about the program to help build a "nationwide network of practitioners" to enable the FDA to "conduct the epidemiological surveillance of drug and device related disease."
Despite recent increases in the reporting of adverse side effects, the FDA estimates that only 5 percent to 10 percent of occurrences are brought to its attention. Health professionals fail to report incidents of side effects because they do not have time, are not reminded to do so, are not sure what to report, fear liability, and do not receive feedback.
Giving health professionals recognition and feedback for reporting adverse reactions is a key to increasing compliance with the MedWatch program, emphasizes Donald R. Bennett, who directs the AMA's Division of Drugs and Toxicology. "We have to make sure," he says, "physicians know the information they provide doesn't fall into a black hole."
Persons wanting copies of the reporting form can call the FDA at 800-FDA-1088.
Unconventional Research Methods Needed for Acupuncture
Alternative medicine is "a field where there are still too few careful scientific studies, and where investigators haven't even agreed on what rules of evidence should apply," according to Consumer Reports. In a three-part series that began in January, Consumer Reports discusses unconventional treatment methods, especially acupuncture, homeopathy, and chiropractic — "treatments that seem to be truly at odds with Western medicine."
Acupuncture has been used in China for 2,500 years and more recently in the West. Even though Western scientists are unconvinced that acupuncture can cure everything its proponents claim, it may be the first alternative treatment to be accepted in mainstream medicine. All told, 9 million to 12 million acupuncture treatments are performed each year in the United States by an estimated 3,000 physicians and osteopaths and 7,000 nonphysicians.
Acupuncture is most widely used in the United States to control pain and treat addictions but has been reported useful for treating nausea and vomiting related to pregnancy, surgery, or chemotherapy.
Although several programs and studies back these positive effects, other claims — from treating gastritis to insomnia — remain unsupported. And U.S. scientists complain that the studies which have been done have faulty research designs. Because acupuncture treatment is based on personal traits, including sleep patterns and taste preferences, conventional research methods (in which all patients have the same diagnosis and treatment) may not be applicable to acupuncture, notes Consumer Reports. "Another inherent problem is that medical research is designed to test one treatment at a time, while acupuncture is often given in conjunction with other therapies."
It is difficult to test the effectiveness of acupuncture using the placebo-controlled, double-blind study, the standard by which pharmaceuticals are judged in the United States. But the article points out that acupuncture is more akin to surgical procedures, "which are not even tested in placebo-controlled trials for both practical and ethical reasons." Thus acupuncture research generally uses a single-blind design: Patients are unaware of which treatment they are receiving, and an outside evaluator interprets the results.
Some researchers have attempted using placebo techniques such as taping acupuncture needles to the skin. Consumer Reports acknowledges that such treatments have led to improvement, as happens in other placebo studies. But, the article points out, "these studies may suffer from a lack of credibility: It's likely the subjects know they're receiving an inactive treatment and have low expectations for the results."
In sham acupuncture, needles are applied to points other than the specified acupuncture points without patients' knowledge. The article reports that most studies suggest sham acupuncture is less effective than true acupuncture, but this research approach poses ethical questions. Some researchers point out it is "an invasive procedure with unknown effects." Representatives from the U.S. Food and Drug Administration (FDA) and National Institutes of Health Office of Alternative Medicine met early this year with the acupuncture community to discuss experimental research design that the FDA would find acceptable.
Reaching Out to Workers
Catholic healthcare facilities are not only reaching out to their communities, they are lending a helping hand to their employees as well. After two years of planning, St. Mary's Hospital, West Palm Beach, FL, recently launched the Employee Outreach Program.
St. Mary's employees can apply for assistance of up to $300 from the Employee Outreach Fund. "The monies can be granted either as a one-time loan or as a gift, depending upon the individual circumstances," writes Pat Keeler in the Messenger, St. Mary's employee newsletter.
To receive assistance, employees must have been employed for at least six months and must have exhausted their earned time off (ETO) resources. Checks are not payable to employees; instead they are earmarked for employees' special needs (e.g., rent or utilities). In 1993, 21 people received assistance (10 loans totaling $3,000 and 11 gifts totaling $3,300).
A unique feature of the Employee Outreach Program is that the hospital incurs no costs. The program is self-funding, using profits generated by events such as annual arts and crafts shows, talent reviews, and golf tournaments. In addition, employees can donate earned time off or personal illness bank hours to the Employee Outreach Program.
Copyright © 1994 by the Catholic Health Association of the United States
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