FDA Experts Recommend Gout Drug's Approval
An expert panel advising the U.S. Food and Drug Administration voted 14-1 on Tuesday to recommend that the full agency approve the Savient Pharmaceuticals drug Krystexxa (pegloticase), Dow Jones reported.
Last week, the FDA released documents saying that although the drug appeared to relieve the painful, swollen joints that characterize gout, it was concerned about the higher rate of cardiovascular side effects that surfaced during clinical testing.
About 24 percent of clinical trial participants who took Krystexxa had a serious adverse effect, compared with 12 percent of those who took a non-medicinal placebo. Six deaths were reported among those who took the drug, versus three deaths among those who didn't. But the FDA "noted that many of them had pre-existing heart conditions," the Associated Press reported.
The FDA has been reviewing the approval application from the drug's maker since December, the AP said.
Gout, which affects an estimated 8 million Americans, is caused by the buildup of too much uric acid in the body.
The full agency is not bound by the recommendations of its expert panels but usually follows them. The FDA's decision is expected by the end of July.
No Proof Anti-Aging Hormones Effective: AMA
There's no scientific proof that anti-aging hormones are effective, says the American Medical Association, which on Monday adopted a new policy on purported aging remedies.
For example, the AMA says, evidence indicates that long-term use of human growth hormone (HGH) to deal with aging-related issues might carry more risks, such as diabetes and tissue swelling, than benefits, the Associated Press reported.
The AMA says there's also no proof that hormones called bio-identicals are safer than traditional estrogen and progesterone products in treating menopause symptoms.
Those who promote the use of anti-aging hormones, the AMA says, need rigorous studies to support their claims, according to the AP report.
The new policy on products such as HGH, DHEA and testosterone was adopted at the group's annual meeting in Chicago.
FDA Targets Bogus Treatments for H1N1 Swine Flu
The U.S. Food and Drug Administration has sent more than 50 warning letters to Web sites selling illegal products that claim to diagnose, prevent, mitigate, treat or cure the H1N1 swine flu virus. As a result, more than 66 percent of the Web sites have removed the offending claims or products, the agency said.
The unapproved, uncleared or unauthorized products targeted by the FDA include:
- An electronic instrument that claimed to strengthen the immune system and prevent H1N1 virus-related symptoms.
- A shampoo that claimed to protect against the virus.
- A supplement that claimed to cure H1N1 infection within 4 to 8 hours.
- A dietary supplement that claimed to protect infants and children from contracting the H1N1 flu virus.
"Unapproved, uncleared or unauthorized products that claim to diagnose, mitigate, prevent, treat or cure the 2009 H1N1 flu are illegal and a potentially significant threat to the public health," the FDA said in a news release.
In addition to the warning letters, the agency identified the offending Web sites and products on the FDA Web site.
The agency "will consider further civil or criminal enforcement action against those Web sites that fail to resolve the violations cited in warning letters," the FDA said. "Actions could include seizure, injunction and criminal prosecution."
Experts Challenge Benefits of Moderate Alcohol Consumption
Some experts are questioning the common belief that moderate alcohol consumption contributes to good health, The New York Times reports.
Research has shown an association between moderate drinking and lower risk of death, but the skeptics point out that no study has ever proved a causal relationship between the two. They suggest that rather than making people healthy, moderate drinking is something typically done by healthy people.
"The moderate drinkers tend to do everything right -- they exercise, they don't smoke, they eat right and they drink moderately," Kaye Middleton Fillmore, a retired sociologist from the University of California, San Francisco, told the Times. "It's very hard to disentangle all of that, and that's a real problem."
"The bottom line is there has not been a single study done on moderate alcohol consumption and mortality outcomes that is a 'gold standard' kind of study -- the kind of randomized controlled clinical trial that we would be required to have in order to approve a new pharmaceutical agent in this country," Dr. Tim Naimi, an epidemiologist with the U.S. Centers for Disease Control and Prevention, told the Times.
Critics also expressed concerns about academic centers that accept money from the alcohol beverage industry to pay for studies, train students and publicize their findings.