Health: Latest Findings

By Alice Park Monday, July 12, 2010

    • DRUG SAFETY
    They're Approved, But Are They Safe?
    No drug can ever be 100 % safe, but a series of studies published in late June raises questions about how researchers gather data on the safety and effectiveness of medications and how the Food and Drug Administration (FDA) analyzes this material before approving a drug.

    Two new trials question the safety of the popular diabetes drug Avandia (rosiglitazone) by showing that the blood-sugar-controlling medication raises the risk of heart disease in Type 2 diabetes patients. The results confirm previous data on the potentially fatal risks of a drug that has been widely used since 1999.

    Similar concerns were raised with respect to another best-selling class of drugs, the cholesterol-lowering medications known as statins. The studies disputed whether statins can actually reduce disease-free patients' risk of dying from a first-time heart attack.

    In both cases, the new data add to years-old concerns about the drugs. Safety questions over Avandia, distributed by GlaxoSmithKline, emerged in 2007, when Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, published a meta-analysis showing that patients using Avandia had higher risks of heart attack and heart-disease-related death than those taking a placebo or another diabetes drug. In an update of that paper, Nissen now reports that Avandia is associated with a 28% rise in heart-attack risk. A second study comparing Avandia with a diabetes drug, Actos, in the same class, found that while both lowered blood sugar, Avandia caused significantly more heart attacks, strokes and deaths than its competitor. "It's frustrating to see a drug this hazardous still being aggressively marketed," says Nissen, and particularly to people who already face elevated risk of heart disease. Since 2007, Avandia has carried a black-box warning — the strongest alert the FDA uses — on its label, but on July 13 and 14, an agency committee will meet to review the latest safety data and discuss whether any additional regulatory action is needed.

    The question of risks vs. benefits also applies to drugs for treating heart disease. Although statins have been proved to lower the risks of heart attack, stroke and death in patients who have already had a heart event, it's not clear whether they deliver the same benefit in otherwise healthy but high-risk populations. Some past studies have suggested they do — and millions of healthy patients are currently taking statins — but new analyses recently concluded that statins failed to prolong life in healthy, high-risk people (see strip at left).

    The back-and-forth over both drugs only highlights the fact that sometimes the most compelling scientific data on a new drug emerge after it hits the shelves.

    FROM THE LABS
    Bigger IVF Babies
    Thousands of babies are born via in vitro fertilization (IVF) each year, and researchers are still learning about the developmental impacts of their provenance. Scientists from the U.K. report that in vitro maturation, in which doctors help immature eggs obtained from a woman's ovaries develop more fully before fertilization, can result in babies who are 6% to 9% larger and pregnancies that are longer than those begun with standard IVF, in which eggs are already mature when they are removed. Bigger babies can lead to early miscarriage or higher risk of cesarean section.

    Fit Body, Keen Mind
    Can physical activity in youth lead to mental sharpness in old age? In a study of 9,344 women over age 65, those who reported being physically active as teens enjoyed the lowest rates of cognitive decline: they were 35% less likely to experience early signs of dementia than women who had been sedentary. Even late starters who didn't hit the gym until their 30s or their 50s lowered their risk of age-related intellectual decline.

    DATA SET

    26th
    Rank of the U.S. among 89 countries in "positive feelings" — a measure of a population's happiness — despite being No. 1 in GDP per capita

    80%
    Percentage of 98 female medical students surveyed in the U.K. who said they would freeze their eggs to delay starting a family

    Sources: AIM; European Society of Human Reproduction and Embryology conference (2); JAGS; JAMA; JPSP