Friday, April 03, 2009

Health Headlines - April 3

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.

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