Will Avandia Be Yanked Off the Market?
The Food and Drug Administration will meet this week to decide the fate of the blockbuster diabetes drug Avandia, U.S. News's Deborah Kotz reports. But Avandia's fate may already be decided—if the meeting materials posted by the FDA are any indication. While some prominent researchers (including those at the FDA) have demonstrated that Avandia is associated with an increased risk of strokes, heart attacks, and heart-related deaths, clinical trials conducted by manufacturer GlaxoSmithKline have found no increase in cardiovascular risks.
Here's the rub: When Thomas Marciniak, an FDA medical team leader, analyzed one of the recent GSK-sponsored trials, he discovered that the company had made mistakes in its data analysis and that increased heart risks were indeed present in Avandia users. In some cases, the researchers who conducted the so-called "Record" study, one of the trials cited by GSK, failed to count heart attacks and hospitalizations as heart-related conditions and didn't investigate some deaths in Avandia users to see whether they may have been caused by the drug. In a memo posted on the FDA website, Marciniak called the study "inadequately designed" and alleged it was conducted to reassure the public of the drug's safety even though the data suggested otherwise.
Another analysis comparing Avandia with Actos, the only other diabetes drug in the same class, found that the likelihood of major heart events like heart attacks or strokes "tended to be less" with Actos and "tended to be greater" with Avandia, according to FDA statistician Bradley McEvoy. [Read more: Will Avandia Be Yanked Off the Market?]
Going Gaga for 'Circle' Contact Lenses? 5 Celebrity Trends That Could Harm Your Health
Lindsay Lohan drinks too much, Michael Jackson was allegedly addicted to painkillers, and Keira Knightley and Jennifer Aniston smoke—in real life and in movies. Sure, we're used to celebrities exhibiting self-destructive behaviors, and most of us are too wise to light up or down a bottle of tequila because our favorite stars do, U.S. News's Deborah Kotz writes. But all too often, famous folks engage in "healthful" or seemingly benign practices that could actually jeopardize the health of those who do follow their lead.
The use of cosmetic contact lenses that extend beyond the iris giving the appearance of larger eyes has come into fashion, thanks to Lady Gaga, who displayed the look in her "Bad Romance" music video. But these drugstore circle lenses—which come in various colors like violet and teal—can cause a host of eye problems. The American Academy of Ophthalmology issued a warning on Wednesday against the lenses stating that "inflammation and pain can occur from improperly fitted, over-the-counter lenses and lead to more serious problems, including corneal abrasions and blinding infections." Though illegal in the U.S., they're still widely available for purchase over the internet, if you don't mind putting your vision at risk, Kotz writes.
Another example: Suzanne Somers and "bioidentical" hormones. After being diagnosed with breast cancer, Somers declined conventional treatments like chemotherapy and tamoxifen. And she continued to take bioidentical hormones (identical in structure to what's naturally made by the body) like estrogen despite the fact that oncologists routinely tell breast cancer patients to stay away from estrogen, since it can fuel the growth of the most common kind of tumor. Somers extolled the health benefits of bioidentical hormones for lifelong disease prevention on Oprah, much to the chagrin of many medical professionals. For example, Susan Love, a breast cancer surgeon and author of Dr. Susan Love's Breast Book, said Somers is taking a "crazy" approach to breast cancer prevention. Somers herself admitted her practices were controversial. "[My doctor] told me I could die, but here I am eight years later doing just fine," Somers told U.S. News in an interview last year to promote her book on the subject. [Read more: Going Gaga for 'Circle' Contact Lenses? 5 Celebrity Trends That Could Harm Your Health.]