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Health Highlights: April 2, 2009
Health Highlights: April 2, 2009Here are some of the latest health as well as health examination news developments, compiled by editors of HealthDay: FDA Panel Finds Recent Diabetes Drug Poses No Heart Risk A U.S. Food as well as 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 break on whether to recommend approval for the injectable medication because of its likely link to thyroid tumors.
The Danish drug maker has asked the FDA to approve liraglutide for millions of patients with class 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 as well as mice. The panel voted 8 to 5 that liraglutide did not appear to hasten heart attack as well as other problems seen with similar drugs in recent years. The FDA isn't required to follow the panel's advice, though it usually does. Denmark-based Novo Nordisk is one of more than a dozen companies developing recent 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 as well as 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 possess enough data to be reasonably confident of safety in humans for long-term take," said Dr. Peter Savage, of the National Institutes of Health. Liraglutide is among the earliest to go before the FDA's panel of diabetes experts since the agency issued recent safety guidelines for diabetes treatments final 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 recent guidelines, it primarily studied the drug in otherwise wholesome 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 total picture of the drug's side effects. Incase 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. ----- House Passes Tobacco Regulation Bill A bill to give the U.S. Food as well as 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, as well as supporters believe it will be successful despite opposition from tobacco-state senators, the Associated Press reported. The Obama administration supports the legislation. Final 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 as well as Tobacco Control Act was welcomed by many health examination groups. including the American Health examination Association. "This legislation is critical to combat smoking-related diseases as well as help get cigarettes out of the hands of kids 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 as well as 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 halt tens of thousands of expected deaths." ----- 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 as well as a class 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, as well as advanced colorectal cancer. ----- 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 using the 2-milligram dose of bapineuzumab, but no health risks were noted in patients using lower doses (0.5 milligrams or 1 milligram) of the drug, the Associated Press reported. Drug developer Elan as well as 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 as well as the feedback from the Safety Monitoring Committee made it cloudless that continued development of the highest dose was not advisable. The decision to remove the highest dose from development lowers risk to patients, as well as it as well as helps to lower 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. ----- Evenflo High Chairs Recalled Faulty screws that could cause infants to fall or choke possess 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 possess been more than 300 reports of seatbacks detaching or reclining unexpectedly. There possess as well as 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 as well as 2892351A. The model number is located on a pale label on the seatback. The CPSC said consumers with these high chairs should halt using them as well as contact Evenflo at (800) 233-5921 between 8 a.m. as well as 5 p.m. ET, Monday through Friday, CBS News reported. ----- Journal Retracts Gene Therapy/Diabetes Study A study that claimed gene therapy led to remission of Class 1 diabetes in rats as well as 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 as well as a fifth author is deceased. In the study, the researchers said they created a gene designed to make an insulin-like artificial. After the gene was given to rodents with Class 1 diabetes, they no longer suffered from the disease, according to the study. At the time, the researchers said this technique may prove effective in people. However, after the study was published, diabetes experts told the AP that it wasn't cloudless the gene therapy would work in humans. ----- Health examination Groups Must Sever Industry Ties: Article Professional health examination groups must "wean" themselves from drug as well as health examination device industry financial support as well as ties, a group of prominent physicians as well as researchers write in the April 1 issue of the Journal of the American Health examination Association. They urged health examination associations to adopt stricter conflict-of-interest guidelines that go beyond requiring disclosure of financial links to companies. The group as well as wants health examination associations to forbid members who receive industry money from serving in leadership positions as well as on influential committees, The Recent York Times reported. The group as well as called for a ban on corporate money for things such as souvenir pens, tote bags as well as sponsorship of committees that develop clinically substantial guidelines as well as training programs. The authors of the article said it would be difficult to achieve these reforms, but such action is essential incase health examination groups want to maintain their scientific integrity as well as the trust of their patients, The Times reported.
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