Bruce Psaty

Liver-Damaging Effects of Cholesterol Drug Zetia Hidden by Merck, FDA Documents Reveal

Documents on the FDA Web site reveal that pharmaceutical companies Merck and Schering-Plough conducted numerous safety studies on the popular cholesterol drug Zetia but did not publish the results, which suggested that the...

Dark Cloud Over Amylin

Does the diabetes drug Byetta cause a dangerous swelling of the pancreas? Worries that Byetta might harm the pancreas have dogged the drug's makers, biotech Amylin Pharmaceuticals (nasdaq: ) and drug giant Eli Lilly (nyse: ),...

Researchers: Merck Vioxx study was for marketing

TRENTON, N.J. A 1999 Merck & Co. study of its since-withdrawn painkiller Vioxx, touted to participating doctors and patients as meant to show whether Vioxx caused fewer stomach problems than another drug, was primarily a...

Merck Delayed Release of Clinical Study Revealing Failure of Vytorin Cholesterol Drug

The long-awaited release of the results from a clinical trial of Merck and Schering-Plough's cholesterol drug Vytorin has renewed allegations that the companies deliberately delayed in making the study data public."It is easy...

Trial Intensifies Concerns About Safety of Vytorin

In a clinical trial, the cholesterol-lowering drug Vytorin did not help people with heart-valve disease avoid further heart problems but did appear to increase their risk of cancer, scientists reported Monday. The scientists...

All Over but the Litigation for Merck

by Martha Rosenberg Page 1 of 2 page(s) Even as Merck seeks closure on its Vioxx nightmare by paying $4.85 billion to tens of thousands of plaintiffs who took the painkiller--not that it did anything wrong--the bad ink continues. Merck transposed its own clinical study results of 34 deaths in the...

FDA plans look inside medical records

To sniff out possible safety problems with drugs and medical devices, the Food and Drug Administration is going to start mining millions of medical records. Not yours, but maybe the ones your hospital has. Nancy Marshall Genzer reports. FDA logo (U.S. Food and Drug Administration) More on Health...

Scrutiny of drug safety to get boost

FDA seeks to cut deadly side effects NEW YORK TIMES NEWS SERVICE and ASSOCIATED PRESS WASHINGTON – Chastened by repeated instances in which popular medicines proved deadly, federal health officials announced a major effort yesterday to use information on Medicare claims to assess the risks of...

Has Merck Learned Anything from Vioxx and Vytorin?

It's getting tough to find any Merck drug that can hold up to scrutiny. Merck transposed its own clinical study results of 34 deaths in the Vioxx group and 12 in the placebo group to 29 deaths in the Vioxx group and 17 in the placebo group when it submitted data to the FDA, write Bruce Psaty, MD,...

Vioxx makers knew of drug’s dangers three years before recall

Seattle Times | Apr 15, 2008 By Kyung M. Song The maker of the controversial arthritis drug Vioxx knew of dangers associated with it for as many as three years before a massive nationwide recall, but withheld the information from federal officials and played down the number of deaths associated...

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