FDA Finally Approves Controversial RU-486
By William T. Elliott, MD, FACP
The FDA has approved mifepristone for early medical abortion. The drug, known for years as RU-486, represents perhaps the most controversial, and certainly the most politicized drug the agency has ever approved. Mifepristone was originally submitted to the FDA over four years ago, but negotiations regarding restrictions on usage of the drug held up approval for years. The FDA’s decision to approve was accompanied by a list of restrictions on use of the drug, although not as many as originally proposed. The major restriction is that the drug will not be available in pharmacies, only directly through a doctor’s office. Doctors will need to sign a statement certifying that they have met certain requirements before they will receive the drug. Danco Laboratories, the New York firm that will market and distribute the medication, assures doctors that submitted information will never be made public. The FDA also initially suggested that only physicians who perform surgical abortions would be approved to use the drug, but later backed off that requirement, instead requiring that doctors be able to assess gestational age of the pregnancy and diagnose ectopic pregnancy. If the drug is ineffective, doctors should be prepared to perform a surgical abortion themselves or refer the patient to someone who can. Mifepristone works by blocking progesterone receptors, which causes the endometrium to break down. Two days after taking mifepristone, misoprostol (200 mg) is given orally to begin contractions. The drug combination may be used up to seven weeks after the last menstrual period. Mifepristone will be marketed under the trade name Mifeprex.
Selective serotonin reuptake inhibitors (SSRI) are effective first-line therapy for severe premenstrual syndrome, according to a recent meta-analysis. A review of 15 studies showed the drugs to be effective for treating both physical and mental symptoms. Intermittent therapy was also effective and side effects were uncommon (Lancet 2000;356:1131-1136). SSRIs include paroxitine (Paxil), fluoxitine (Prozac), sertraline (Zoloft), fluvoxamine (Luvox), and citalopram (Celexa). Lilly has been the first drug company to take advantage of this market niche with the recent approval of fluoxetine under the trade name Serafem for this indication.
Despite testimonials from celebrities such as Larry King, garlic is only moderately effective at best in reducing cholesterol. Pooled data of 13 randomized, placebo controlled trials in patients with cholesterol counts over 200 mg/dL suggested that garlic may lower cholesterol by about 16 points. However, when the trials were controlled for dietary changes during the study period, there was no significant difference between garlic and placebo. Researchers suggest that garlic is not an efficient way to decrease serum cholesterol levels (Ann Intern Med 2000;133:420-429).
Sexual dysfunction is common in women who have undergone oophorectomy. A recent study and accompanying editorial suggest that testosterone replacement along with estrogen replacement may be beneficial in normalizing sexual function. Seventy-five women who had undergone oophorectomy and hysterectomy received conjugated estrogens (at least 0.625 mg per day orally) and, in random order, placebo, 150 µg of testosterone, and 300 µg of testosterone per day transdermally for 12 weeks each. Although there was significant placebo effect, women who were treated with testosterone noted improved sexual function and psychological well being, with higher doses being more effective (N Engl J Med 2000;343:682-688).
Congress is considering allowing patients to import medications that have been purchased in other countries. But PhRMA, the Pharmaceutical Research and Manufacturers of American, an organization that represents the pharmaceutical industry, is responding with both barrels. The legislation is being considered because of the often large differential between the cost of drugs in this country and the cost of the same drug over the border in Canada or Mexico. But PhRMA is responding by suggesting such legislation would open this country to mislabeled, adulterated, expired, or even counterfeited prescriptions. The agency has also recruited 11 former FDA commissioners to lobby Capitol Hill on their behalf, and has spent millions on media ads asking consumers to write their representatives in Congress to ask them to oppose the bill.
Antibiotic resistance is on the rise, with strains of new multi-resistant "superbugs" being found worldwide on a regular basis. Overuse of antibiotics is considered the major reason for the appearance of these microbes. Canada started a campaign in 1997 to reduce the use of oral antibiotics, and their efforts have been remarkably successful with an 11% reduction in antibiotic use in the last five years. Factoring projected growth in the use of antibiotics, the reduction is closer to 20%. Several large healthcare firms in this country are joining together to begin a large-scale surveillance project to better assess the magnitude of the problem. The new group will be called the Global Advisory on Antibiotic Resistance Data and includes members from pharmaceutical giants Bristol-Myers Squibb, SmithKline Beecham, and others. Once the scope of the problem is known, actions can be planned to combat it.
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