In October, after examining the results of published and unpublished studies conducted by manufacturers of nine antidepressants-five selective serotonin reuptake inhibitors (SSRIs) and four "atypical" anti-depressants - on the use of the drugs in children and adolescents, the Food and Drug Administration (FDA) directed the drug companies to include a "black box" label warning about the increased risks of suicide in children. The new regulations apply to all antidepressants and are meant to increase prescribers' and caregivers' awareness. And a medication guide is scheduled to begin accompanying the drugs this month.
The broader question of whether drug manufacturers withheld information on the possible increased risk of suicide in young patients taking antidepressants also spurred change. As a result of the settlement of a suit brought by New York's attorney general against GlaxoSmithKline last June, the company agreed to publicly disclose the results of all of its clinical studies in a database called the "Clinical Trials Register."
In October, the pharmaceutical industry launched the online database http://www.clinicalstudyresults.com, where all manufacturers can-but are not obliged to-list results of their clinical studies. But if they don't, they'll have little chance of getting the results out to the medical community: a month earlier, the International Committee of Medical Journal Editors announced that its members agreed to require registration in a public access clinical trial registry as a condition of publication.
Has Medicare access to prescription medication gotten any better?
As a result of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Medicare beneficiaries were given a chance last June to enroll in one of over 30 Medicare-approved discount-card programs, most of which have an annual enrollment fee of $20 to $30. The results have been mixed.
According to a report by the Henry J. Kaiser Family Foundation, Medicare Drug Discount Cards: A Work in Progres s , some of the card programs do offer savings when compared with retail prices. But finding the right card can be frustrating and laborious, especially because the beneficiaries are older adults, whose capacity for plowing through massive administrative booklets, listening to lengthy explanations on Medicare's phone line ([800] 633-4227), or using the search tool "Prescription Drug and Other Assistance Programs" (available at http://www.medicare.gov) may be diminished.
The report also found that the mail-order pharmacy http://www.drugstore.com is a very competitive, simpler option for card-weary beneficiaries. Another option is to order medications from Canada, a practice that's a thorn in the side of pharmaceutical companies but which the FDA has yet to ban.
Obesity: a growing concern.
According to the Centers for Disease Control and Prevention, about 65% of Americans are either overweight or obese (and the rate of overweight children and adolescents is almost double what it was 20 years ago). A study in the October 2004 issue of Health Affairs reveals that between 1987 and 2001, the proportion of obese people in the United States increased by about 10%. And although health care costs among obese people in 1987 was 15% higher than that among people of normal weight, in 2001 it was 37% higher. Those costs stem primarily from the treatment of three diseases: diabetes, hyper-lipidemia, and heart disease.
Last March the FDA's Obesity Working Group called for a national public education campaign, the key message being "calories count." It's also advocating more information on the nutritional content of foods on labels and restaurant menus and more research into effective medical interventions (such as bariatric surgery, for which Medicare is considering easing eligibility requirements). For the complete report, go to http://www.fda.gov/oc/initiatives/obesity. -Dalia Sofer