Health Highlights: Nov. 4, 2011
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
High Doses of Bone Drug May Boost Cancer Risk
Newly-released data suggests that administering high doses of a bone growth product to patients undergoing spinal fusion may increase their risk of cancer, an expert says.
The data was collected in a clinical trial conducted by Medtronic when it sought U.S. Food and Drug Administration approval of a higher-dose formulation of its bone growth product Infuse, The New York Times reported.
The FDA rejected the higher-dose version, called Amplify, due to concerns about cancer risks.
Data from the Medtronic clinical trial showed that spinal fusion patients who received Amplify had a much higher number of cancers than those who received a bone graft, Stanford University's Dr. Eugene J. Carragee said Thursday at a national meeting of the North American Spine Society, The Times reported.
These study findings are important for patients who receive Infuse, which contains the same active ingredient as Amplify and is often given in levels much higher than the recommended doses, Carragee said.
Medtronic has given a $2.5 million grant to Yale University researchers to review data on the safety and effectiveness of Infuse. The findings are expected to be released next year, The Times reported.
Glaxo to Pay $3 Billion to Settle Investigations
In order to settle several long-running criminal and civil investigations, GlaxoSmithKline PLC says it will pay $3 billion to the U.S. government.
The company has faced allegations that it marketed some drugs illegally and defrauded the Medicaid program. The final terms of the settlement, one of the largest of its kind, are still under negotiation. The company said it expects to make the payment next year, the Wall Street Journal reported.
The investigations included a Justice Department probe into Glaxo's development and marketing of the diabetes drug Avandia. After being linked to heart attacks, the drug was taken off the market in Europe and restricted in the U.S.
The Glaxo settlement is one of the largest in a series of settlements the U.S. government has reached with drug companies in an effort to halt illegal marketing practices, the Wall Street Journal reported.
But drug industry critics say the amounts paid in such settlements are small compared to the profits companies made through illegal marketing.
"It's a speed bump," Kevin Outterson, co-director of the health-law program at Boston University, told the Wall Street Journal. "It's a cost of doing business."
Drug Take-Back Day Collects Nearly 200 Tons of Medications
Americans turned in more than 188.5 tons of unwanted or expired prescription medications on the Drug Enforcement Administration's third National Prescription Drug Take-Back Day on Oct. 29.
The DEA set up 5,327 sites around the country to collect the medications, the Associated Press reported.
During the three Take-Back Days held over the past 13 months, nearly 500 tons of medications have been collected for safe disposal.
The response shows the need to develop a convenient way to help people get rid of unwanted or expired prescription drugs, which otherwise could end up in the hands of abusers or pollute the environment, according to DEA Administrator Michele Leonhart, the AP reported.
Strengthen Chantix Warnings: Study
Warnings about the risks of suicidal behavior and depression associated with the stop-smoking drug Chantix need to be strengthened, according to a new study.
It concluded that the psychological risks of Chantix (varenicline) exceed those of nicotine replacement drugs and the rival stop-smoking drug Zyban (bupropion), ABC News reported.
The study was published today in the journal PLoS One.
"Among all the treatments we have for smoking cessation, Chantix is the worst," Dr. Curt Furberg, a professor of public health sciences at Wake Forest Baptist Medical Center and one of the study's authors, told ABC News.
"The FDA's own data show that Chantix is more dangerous than other treatments to stop smoking," he noted.
But an FDA spokeswoman said the drug is a safe and effective way to help smokers kick the habit, ABC News reported.
Last week, the agency said two federally-funded clinical trials involving a total of more than 26,000 patients showed that Chantix did not increase depression and suicidal thoughts compared with other stop-smoking treatments.
Chantix was approved by the FDA in 2006. The agency in 2009 placed a "black box" warning label on Chantix and Zyban to alert doctors and patients about the risk of depression, hostility and suicidal thoughts associated with the drugs.
Posted: November 2011