Health Highlights: April 2, 2009
April 3 -- Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
FDA Panel Finds New Diabetes Drug Poses No Heart Risk
A U.S. Food and Drug Administration advisory panel said Thursday that an experimental diabetes drug from Novo Nordisk does not appear to carry heart risks, but its members were split on whether to recommend approval for the injectable medication because of its possible link to thyroid tumors.
The Danish drug maker has asked the FDA to approve liraglutide for millions of patients with type 2 diabetes, which has been shown to lower blood sugar levels while reducing weight, making it unique among diabetes medications.
According to the Associated Press, the panelists voted 6 to 6 on whether the drug should be approved because research has shown it caused cancerous thyroid tumors in rats and mice. The panel voted 8 to 5 that liraglutide did not appear to hasten heart attack and other problems seen with similar drugs in recent years.
The FDA is not required to follow the panel's advice, though it usually does.
Denmark-based Novo Nordisk is one of more than a dozen companies developing new therapies to compete in the $5.1 billion U.S. diabetes drug market, the wire service reported.
FDA scientists stressed that most drug studies are discontinued after showing findings similar to the rat and mice studies conducted with liraglutide.
"It is very rare for a drug that has caused tumors in two species, in both genders at clinically relevant exposures, to be approved," said FDA drug reviewer Karen Mahoney.Novo Nordisk argued that while their drug spurs tumor growth in rodent cells, there is no comparable reaction in humans. But that reasoning failed to convince a majority of panelists.
"I just don't think we have enough data to be reasonably confident of safety in humans for long-term use," said Dr. Peter Savage, of the National Institutes of Health.
Liraglutide is among the first to go before the FDA's panel of diabetes experts since the agency issued new safety guidelines for diabetes treatments last year. The more cautious stance followed a 2007 controversy surrounding figures suggesting GlaxoSmithKline's blockbuster pill Avandia increased the risk of heart attack.
Because Novo Nordisk conducted its tests before the FDA issued the new guidelines, it primarily studied the drug in otherwise healthy diabetes patients in their 50s, excluding patients with elevated heart risks, the wire service reported. The FDA now requires companies to study high-risk patients, including the elderly, to give a more complete picture of the drug's side effects.
If approved, Novo Nordisk plans to the market the drug under the name Victoza. A decision is expected in the coming weeks, according to the AP.
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House Passes Tobacco Regulation Bill
A bill to give the U.S. Food and Drug Administration regulatory powers over the tobacco industry was passed by the House in a 298-112 vote Thursday.
The Senate takes up its version of the bill later this month, and supporters believe it will be successful despite opposition from tobacco-state senators, the Associated Press reported.
The Obama administration supports the legislation. Last year, the Bush administration threatened to veto a House-passed measure to give the FDA the power to regulate tobacco.
Thursday's House vote on the Family Smoking Prevention and Tobacco Control Act was welcomed by many medical groups. including the American Medical Association.
"This legislation is critical to combat smoking-related diseases and help get cigarettes out of the hands of children by giving the FDA needed regulatory authority over tobacco products," AMA President Dr. Nancy Nielsen said in a news release.
"This legislation is a major victory for those of us who prize the health of this nation over the profits of tobacco companies, American Thoracic Society President-elect Dr. J. Randall Curtis said in a news release. "We applaud the House for passing the bill and hope that the Senate will move it through quickly so that President Obama can sign it into law as he has already indicated he would. Swift action could prevent tens of thousands of future deaths."
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Pfizer Halts Breast Cancer Drug Study
A phase 3 clinical trial of the drug Sutent as a treatment for advanced breast cancer has been stopped, because the drug was no more effective than the chemotherapy drug capecitabine, Pfizer Inc. announced Thursday.
The study included 455 patients who failed previous treatment with other drugs. They received either Sutent or capecitabine, which is sold under the brand name Xeloda by Roche Holding Ltd., the Wall Street Journal reported.
Pfizer canceled the study after an independent monitoring committee concluded continued treatment with Sutent wouldn't offer any additional benefit over Xeloda.
The company said five other studies of Sutent as a treatment for advanced breast cancer are continuing, the Wall Street Journal reported. Sutent is currently approved in the United States to treat kidney cancer and a type of gastrointestinal cancer.
Other studies are assessing Sutent as a treatment for a number of cancers -- prostate cancer, liver cancer, non-small-cell lung cancer, and advanced colorectal cancer.
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Study Eliminates Highest Dose of Alzheimer's Drug
The highest dose of an experimental drug to treat Alzheimer's disease has been eliminated from a study, because patients experienced an increased risk of brain inflammation from water retention.
The problem was seen in patients taking the 2-milligram dose of bapineuzumab, but no health risks were noted in patients taking lower doses (0.5 milligrams or 1 milligram) of the drug, the Associated Press reported.
Drug developer Elan and partner Wyeth say this adjustment to the clinical trial won't affect their efforts to pursue government approval of bapineuzumab.
"Our review of the safety data and the feedback from the Safety Monitoring Committee made it clear that continued development of the highest dose was not advisable. The decision to remove the highest dose from development reduces risk to patients, and it also helps to reduce risk to the overall development effort," said Elan President Carlos Paya, the AP reported.
Several hundred patients who had been receiving or scheduled to receive the highest dose will be removed from the trials or switched to lower doses.
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Evenflo High Chairs Recalled
Faulty screws that could cause infants to fall or choke have prompted the recall of more than 640,000 high chairs sold by Evenflo, the U.S. Consumer Product Safety Commission said Thursday.
The agency said there have been more than 300 reports of seatbacks detaching or reclining unexpectedly. There have also been reports of screws falling out of the Chinese-made chairs, CBS News reported.
The voluntary recall covers all Evenflo Envision high chairs, including model numbers 2891321, 2891321A, 2891333, 2891351, 2891351A, 2891365, 2891375, 2891403, 2891403A, 2891466, 2891466A, 2891478, 2891536, 2891536A, 2891573, 2891586, 2892351 and 2892351A. The model number is located on a white label on the seatback.
The CPSC said consumers with these high chairs should stop using them and contact Evenflo at (800) 233-5921 between 8 a.m. and 5 p.m. ET, Monday through Friday, CBS News reported.
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Journal Retracts Gene Therapy/Diabetes Study
A study that claimed gene therapy led to remission of Type 1 diabetes in rats and mice has been retracted by the journal Nature at the request of three of the five authors.
The researchers asked for the retraction because they couldn't reproduce the results of their study, which was published more than eight years ago, said the Associated Press. A fourth author insists the results are still valid and a fifth author is deceased.
In the study, the researchers said they created a gene designed to produce an insulin-like chemical. After the gene was given to rodents with Type 1 diabetes, they no longer suffered from the disease, according to the study. At the time, the researchers said this technique might prove effective in people.
However, after the study was published, diabetes experts told the AP that it wasn't clear the gene therapy would work in humans.
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Medical Groups Must Sever Industry Ties: Article
Professional medical groups must "wean" themselves from drug and medical device industry financial support and ties, a group of prominent physicians and researchers write in the April 1 issue of the Journal of the American Medical Association.
They urged medical associations to adopt stricter conflict-of-interest guidelines that go beyond requiring disclosure of financial links to companies. The group also wants medical associations to forbid members who receive industry money from serving in leadership positions and on influential committees, The New York Times reported.
The group also called for a ban on corporate money for things such as souvenir pens, tote bags and sponsorship of committees that develop clinically important guidelines and training programs.
The authors of the article said it would be difficult to achieve these reforms, but such action is necessary if medical groups want to maintain their scientific integrity and the trust of their patients, The Times reported.