Remember in February when I said to expect a recall of the diabetes drug Avandia - well the FDA finally released its report in advance of a panel that will be held next week to make the final decision.

The findings are not good for Avandia maker GlaxoSmithKline. The FDA had withheld judgement until now because the clnical trials carried out by GSK had shown no risk, even though recent independent studies  showed a risk of heart problems and death among those who take it. But a review of those GSK studies show what could be called gross negligence in design and analysis. 

The clinical trials DID show increased heart problems among those who received the yet unapproved drug, but the statistical analysis methods used by the drugmaker only showed the good about their new blockbuster, and hid the bad. They also didn't include enough patients in the trials and other methodology issues.

If the FDA doesn't pull the drug there will be a number of surprised health professionals who are wondering how it got approved without a more thorough review in the first place.