FDA Official Alleges Pressure to Suppress Vioxx Findings
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A Food and Drug Administration official who sought to estimate the harm done to patients by side effects of the painkiller Vioxx said yesterday that his supervisors tried to suppress his conclusions, according to Sen.
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Ina series of testy e-mail exchanges with his bosses, a federal drug-safety reviewer contends that an effort to publish his study demonstrating the dangers of Vioxx was delayed and demeaned
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Merck &amp; Co. forced one of its researchers to remove her name from a study linking Vioxx to heart attacks, then criticized the findings before ultimately pulling the arthritis drug from the market last fall, two of the scientist's colleagues say.
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A drug manufacturer and the Food and Drug Administration failed the public by not heeding the warning signs associated with Vioxx, and Congress should investigate their actions, a Cleveland Clinic cardiologist said Wednesday.
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Senator Charles E. Grassley charged on Friday that top federal drug regulators intend to suppress a study on the safety of Celebrex and Bextra.
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WASHINGTON -- Merck &amp; Co., which stopped selling its blockbuster Vioxx drug due to heart problems caused by the painkiller, manipulated the design of a key study for a new painkiller to minimize its cardiovascular risks and increase chances of approval, a federal whistle-blower says.
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U.S. drug safety regulators are coming under fire for their response to years of suspicions, confirmed last week, that arthritis drug Vioxx increased the risks of heart attacks and strokes.
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Safety problems with Vioxx could have been detected in months rather than years if the Food and Drug Administration had been able to sift through health-care information already compiled privately on one in three Americans.
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The U.S. Food and Drug Administration denied charges it tried to suppress a safety official's findings that painkiller Vioxx, which was pulled from the market last week, raised heart attack risks.
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Just days before a medical journal was to publish a Food and Drug Administration-sponsored study that raised concerns about the safety of the arthritis drug Vioxx, an FDA official
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Merck (MRK) officials on Wednesday called a press conference to reiterate that they did not believe until last month that Vioxx raised users&#39; risk of heart attacks or strokes.
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Congress has been investigating the FDA&#39;s decisions in both the Vioxx and antidepressant cases. The probes have focused on agency reviewers who warned about potential problems but claimed their research was ignored or suppressed by other officials.
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A leading U.S. Senate Republican  this week demanded internal documents from Merck & Co. Inc.  MRK.N that could answer questions about the company's  interaction with U.S. regulators over its arthritis drug Vioxx.
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A US Food and Drug Administration official said Friday &quot;we categorically reject&quot; accusations the agency has failed to protect the public against dangerous drugs.
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WASHINGTON -- A veteran Food and Drug Administration safety officer yesterday told a Senate hearing inquiring into the abrupt recall of the arthritis drug Vioxx that five other widely used drugs should be either withdrawn or sharply restricted because they have dangerous side effects.
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The Food and Drug Administration has given a whistle-blower scientist permission to publish data indicating that as many as 139,000 people had heart attacks that may be linked to Vioxx, the scientist's lawyer said Monday.
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An official of the Food and Drug Administration said Friday "we categorically reject" accusations the agency has done a poor job of protecting the public against dangerous drugs.