Nissen's analysis seemed to show that the drug worked at clearing out artery plaque, but an analysis by Jean-Claude Tardif of the Montreal Heart Institute, who collected the ultrasound data, was inconclusive.
Glaxo's own analysis of the drug, which the company shared with the FDA, said Avandia increases the risk of heart attack by about 30%.
But the regulators had received a similar analysis, from drug maker GlaxoSmithKline (nyse: GSK - news - people ), more than a year before.
GlaxoSmithKline's own analysis of its diabetes drug Avandia showed that the medicine increased the risk of heart attacks by a third.
In the past three months the FDA has slapped cautionary labels on sleeping pills and yanked Novartis' constipation drug Zelnorm after that company's analysis showed heart problems.
In the past three months the FDA has slapped cautionary labels on sleeping pills and yanked Novartis (nyse: NVS - news - people )' constipation drug Zelnorm after that company's analysis showed heart problems.
He argues courts are ill-equipped to subject drug manufacturers to after-the-fact analysis.
At the time scientists inside and outside the EPA unanimously agreed that the test posed negligible risk. (I wrote the analysis submitted by the Food and Drug Administration.) No new genetic material had been added--only a single gene whose function was well known had been removed--and the organism was obviously harmless.
The findings of the study are published in The Lancet medical journal, alongside an analysis of all other trials of the drug from the past 20 years.
On Tuesday, I wrote about an analysis of how often the Food and Drug Administration follows the advice of its expert advisory panels on whether or not to approve a new drug.
Second, much of the media coverage totally ignored the fact that the paper was just talking about the U.K. and not anywhere else (The paper is titled Drug harms in the UK: a multicriteria decision analysis ).
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In a letter sent to the head of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, Wolfe outlined a statistical analysis he had done of a 1999 Pfizer-funded test of Celebrex as a preventative for Alzheimer's disease that had just been made available on an industry Web site of clinical trial results.
Researchers in the Canadian Network for Observational Drug Effect Studies (CNODES) performed a retrospective observational analysis of administrative databases in Canada, the UK and the US containing more than 2 million patients newly treated with statins. 59, 636 of the subjects already had chronic kidney disease.
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The technique of pooling disparate clinical trials, called meta-analysis, has become the most powerful weapon of drug safety researchers.
One of the most prominent statisticians in the U.S. is taking issue with an analysis that claims there is no credible evidence the cholesterol drug Vytorin increases the risk of cancer death.
Novartis is appealing, submitting an analysis from 22 gastrointestinal specialists who found no link between the drug and the surgeries.
The company also said it had shared this data with European regulatory authorities and the U.S. Food and Drug Administration, and that the information had been included in its regulatory analysis.
In 2005 and 2006, GSK secretly conducted an analysis of the cardiovascular safety of Avandia and concluded that the drug increased the risk of heart attacks and related events by about 30%.
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GlaxoSmithKline 's Avandia was the best-selling diabetes drug in the world until Steven Nissen of the Cleveland Clinic published an analysis of clinical trial data that showed a heightened risk of heart attacks, strokes and cardiovascular death for patients on the drug.
It was an analysis of published clinical trials that raised the first big questions about drug-coated stents causing heart attacks in rare cases.
"Even if you accept the analysis, it doesn't mean everybody drops dead because of the drug, " he says.
The problem was that analysis did not look at the panels that dealt with most of the drug approvals.
Bextra, a drug that was similar to Vioxx, was linked to heart problems by one such analysis and has since been pulled from the market for serious skin side effects.
Zelnorm, a Novartis drug for painful bowel symptoms, was pulled from the market because of another meta-analysis that showed an increased risk of heart attacks.
At the very best, the first hints of these problems came from a re-analysis of data--an unreliable technique--two years after the drug had been on the market.
This leads to my second issue with the McKinsey analysis, and this refers to the new hurdles that exist for a new drug to be a commercial success.
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Analysis of tissue from mice killed during the course of the experiment showed that the drug was having its intended effect.
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Unfortunately for weight loss drugs, clinical researchers tend to favor an analysis that includes those who stop therapy precisely because it is tougher and harder for drug companies to game.
Huang is now turning his focus beyond gamers to a host of new customers that will need number-crunching power: oil companies doing deep-sea seismic analysis, Wall Street banks modeling portfolio risk and biologists visualizing molecular structures to find drug target sites.
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