News in brief - March 7, 2005

FDA forms drug safety board - Resistant HIV case in N.Y. - Stroke reduction - Smoking cessation program adds years to life - Treatment for partners of patients with STDs reduces recurrence

FDA forms drug safety board

In response to recent criticism over its ability to ensure the safety of the nation's prescription drugs, the Food and Drug Administration is establishing an independent advisory board to monitor the safety of medications after they are on the market.

The Drug Safety Oversight Board is being put in place to help provide emerging information on the risks and benefits of available medications to physicians and their patients, said Health and Human Services Secretary Michael Leavitt, MD, when announcing the new board Feb. 15.

The board, which will be made up of FDA staff and medical experts from other HHS agencies and government departments, will oversee the management of drug safety issues within the FDA's Center for Drug Evaluation and Research. The board also will consult with other experts and patient and consumer groups, according to the FDA.

In addition, the agency will take steps to ensure that emerging drug safety data are quickly made available, said Acting FDA Commissioner Lester M. Crawford, DVM, PhD. The agency is proposing that a new consumer-friendly "Drug Watch" Web site be developed that allows easy access to new information.

One-page information sheets for physicians and other health care professionals also will be made available for all drugs on FDA's Drug Watch and for all drugs with Medication Guides. The information sheets will contain the most important new information for safe and effective use of a medication, according to the FDA.

The FDA's actions came on the eve of a three-day hearing by two agency advisory panels on the safety of Cox-2 inhibitors. The hearing was called in the wake of the withdrawal last fall of the pain medication Vioxx, and resulting concerns raised about related drugs including Celebrex and Bextra.

Resistant HIV case in N.Y.

A highly resistant strain of HIV that proceeds rapidly to AIDS has been diagnosed in a New York City man, the city health department announced Feb. 11.

The diagnosed strain of HIV is resistant to three of the four classes of commonly prescribed anti-retroviral medications. The infected man, who had not been treated previously for HIV, was a methamphetamine user and said he had unprotected anal intercourse with numerous partners, thus raising the possibility that infections could spread beyond this single case.

The infection appeared to be recent, said health department officials. While drug resistance is increasingly common among patients who have been treated for HIV, cases that are resistant to three strains are rare in previously untreated patients.

Although AIDS usually occurs more than 10 years after initial infection with HIV, in the case of the New York City patient, elevation to AIDS probably occurred within two to three months after the initial infection.

"This case is a wake-up call," said New York City Health Commissioner Thomas R. Frieden, MD, MPH. "The community successfully reduced its risk of HIV in the 1980s, and it must do so again to stop the devastation of HIV/AIDS and the spread of drug-resistant strains."

The health department issued a health alert to physicians, hospitals and other health care professionals asking them to test all newly diagnosed, previously untreated patients for anti-HIV drug susceptibility.

Stroke reduction

Preventing gum disease also could significantly improve chances of avoiding vascular problems, according to a new study published in the Feb. 8 issue of the American Heart Assn.'s journal Circulation.

Although previous studies have suggested a relationship between periodontal disease and vascular disease, surrogate markers for gum disease, such as tooth loss or gum pocket depth, were used. This is the first study to examine the microbiology of periodontal infection and positively connect it to arterioscleroses, the researchers said.

"Because gum infections are preventable and treatable, taking care of your oral health could very well have a significant impact on your cardiovascular health," said Moise Desvarieux, MD, PhD, assistant professor of epidemiology at Columbia University Medical Center's Mailman School of Public Health and lead author of the study.

Columbia researchers measured the bacteria levels in the mouths of 657 people who had no history of stroke or myocardial infarction. They also measured the thickness of the subjects' carotid arteries. The researchers found that people with a higher level of the specific bacteria that causes periodontal disease also had an increased carotid artery thickness, even after taking other cardiovascular risk factors into account.

Smoking cessation program adds years to life

Participation in a smoking cessation program with strong physician participation, a dozen group behavior modification sessions and nicotine replacement therapy was associated with a significant reduction in mortality that was even more significant if participants actually quit smoking, according to a study published in the Feb. 15 issue of the Annals of Internal Medicine.

Researchers randomized smokers who presented with asymptomatic airway obstruction to receive either usual care or the more intensive smoking cessation program. Those in usual care had an 18% increased risk of dying within 14 years of the intervention. In both groups, death rates among those who quit intermittently or quit long term were nearly half that of those who never stopped smoking.

Authors of the paper suggested that this demonstrated the significant impact that such programs can have even without making significant numbers of people quit long term.

"One might have thought this program was not working, because only 20% or so of the people who were enrolled in it quit smoking continuously," said John E. Connett, PhD, study group leader and professor of biostatistics at the University of Minnesota School of Public Health. "However, quitting had such a statistically large impact on the overall population that even though many people quit and started smoking again, as long as they were smoke-free for periods of time, they had better outcomes than those who continued to smoke."

Treatment for partners of patients with STDs reduces recurrence

Patients with gonorrhea or chlamydial infection benefit from being given medication for their partners as well as for themselves, according to a study published in the Feb. 17 New England Journal of Medicine.

Researchers at the University of Washington National Institutes of Health STD Cooperative Research Center and the Centers for Disease Control and Prevention's Division of STD Prevention randomized patients diagnosed with these STDs to one of two interventions.

One group received the usual advice that their partners should come in as well. Those in the other group were offered medication for their partner or the option of having a staff member contact the partners directly and offer medication without a clinical examination.

After five months, only 3% of patients in the intervention group returned with a recurrent gonorrhea infection, while 11% in the usual care group did so. The intervention had less impact on chlamydia, although it was still significant, with 11% of the intervention group returning with another infection. Thirteen percent of the control group did so.

An accompanying editorial advocated that immediate access to antibiotics could stem the spread of sexually transmitted diseases.

"Traditional approaches to informing partners -- in which the patients themselves must notify their sexual partners, who are then expected to seek medication evaluation and treatment -- simply do not work well enough," said Emily Ebelding, MD, MPH, lead author on the editorial and associated professor at Johns Hopkins University School of Medicine.