Nice try, Abbott

On Monday I described as “desperate” Abbott’s attempt to seek FDA approval for Xinlay, a drug that the company’s own trials showed not to be effective. Sure enough, the FDA review panel voted 13-0 not to recommend approval. The Wall Street Journal referred to the panel’s assessment as “scathing” and quoted the FDA’s statistical reviewer Shenghui Tang as saying that Abbott’s pooled-analysis approach “violated well-established standards for clinical trials.”

Abbott justified it’s attempt to get the drug approved for advanced prostate disease by saying,

“We had a body of data that shows that the drug is doing something for patients with a miserable terminal condition”

September 14, 2005

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