Cardiologists have accused a small drug company of withholding data from a clinical trial showing that the company’s drug, meant to reduce the risk of heart attacks, increased the risk instead.
The cardiologists said that the company, Anthera Pharmaceuticals, did not turn over data to academic investigators, as it was required to do, for more than a year.
“Despite a contract that required transfer to the academic authors, the company stonewalled every attempt to acquire the data,” Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, said in an email on Tuesday.
Dr. Nissen was the senior author of a report on the data that was published online Monday by The Journal of the American Medical Association and presented at the annual meeting of the American Heart Association in Dallas. In unveiling the results there, the lead investigator, Dr. Stephen Nicholls, publicly admonished the company.
Dr. Colin Hislop, the chief medical officer at Anthera, denied the accusations, saying it simply took time to gather and organize the data. “I don’t think the timeline was particularly protracted, nor were we being difficult,” he said in an interview Tuesday.
Studies and lawsuits have shown that many clinical trial results, particularly negative ones, are not published. Critics say that hampers medical practice and violates an obligation to patients, who try experimental treatments in part to advance knowledge.
“We think that when you enter...
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Showing posts with label American Heart Association. Show all posts
Showing posts with label American Heart Association. Show all posts
Sunday, November 24, 2013
Doctors Say Heart Drug Raised Risk of an Attack
Wednesday, November 20, 2013
New obesity treatment guideline released
Insurance coverage for weight-related counseling, such as helping patients plan new menus with fewer calories or outline a realistic fitness program, could improve under this new recommendation. More importantly, the panel of physicians and weight researchers outlined which interventions are the most effective based on clinical trials. Doctors should treat patients who are obese — a BMI of 30 or above (180 pounds or more for a 5-foot-5 person — as well as those who are overweight with a BMI between 25 to 30 (150 to 180 pounds for a 5-foot-5 person) if they have certain heart disease risk factors such as type 2 diabetes, the guideline states. People at a healthy weight, or who are overweight without any health problems, should keep their weight steady. “It’s not just about body weight, but whether excess body weight is associated with medical conditions,” said Dr. Timothy Church, director of preventive medicine research at Pennington Biomedical Research Center, who was not involved in writing the guideline.
Doctors can offer drugs or bariatric surgery to help reverse obesity, but they should first try providing patients with intensive counseling to help them exercise and eat right.
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