Women's Health Initiative: The largest research study ever funded by the National Institutes of Health may be headed for trouble.
The study, involving 160,000 women and 14 years of work, was designed to make up for years of neglect on women's health. But in November, a committee of the Institute of Medicine expressed great skepticism in the merits of the study, setting up a battle this year that might curb the ambitious effort. The Institute of Medicine was asked by the Congress to analyze the study after concerns emerged over its size, complexity and cost.
The project is supposed to test strategies to prevent breast cancer, cardiovascular disease and osteoporosis. The Institute of Medicine's biggest criticism was of the part of the study that seeks to determine whether a low-fat diet reduces the risk of breast and colon/rectal cancer.
* Health Care Reform: While a comprehensive national health plan may not go into effect until 1995, the fighting will begin in earnest this year.
In the meantime, many other changes will take place this year as industry prepares for the inevitable. Look for mergers galore among hospitals, doctors and health plans.
* Vitamin Supplements: The war between the Food and Drug Administration and vitamin manufacturers will continue.
The FDA announced last month that dietary supplements will remain widely available, but said that it will soon regulate claims on the labels for the first time. Expect continued protest from the industry. "Once those regulations go into effect, dietary supplement consumers will be put in the dark about the benefits of dietary supplements . . ." said Jerry Kessler, president of the Nutritional Health Alliance in New York.
* Breast Implants: Will the FDA bow to pressure on breast implants? After placing a moratorium on the use of silicone breast implants, except as part of a federal study, the FDA is under pressure to reverse itself and allow unregulated use of the products.
In a December issue of the Journal of the American Medical Assn., AMA experts blasted the FDA's caution on implants and said: "This anxiety is not warranted based on current scientific events." The AMA said it supports continued use of implants for reconstruction \o7 and \f7 augmentation.
But research on the potential dangers of breast implants is highly contradictory. And FDA Commissioner David Kessler, responding in same issue, said the AMA's position fails to acknowledge physicians' responsibility to provide patients with adequate information.
In an editorial, JAMA editor George D. Lundberg said: "The resulting brouhaha should be interesting. In the silicone mess, there's plenty of blame to go around."