This caught my attention: an article appeared in the Wall Street Journal on February 2 of this year, about a new anti-clot drug that will compete with Plavix.  There were problems with the drug being given a “clean bill of health” by the review committee.  TWO WEEKS LATER, Wall Street Journal carried a story that the chief cardiologist in the study (who had been critical of the drug) had been “disinvited” to serve on the committee.  Read the reports–draw your own conclusions.  I have posted my thoughts after each article.

February 2, 2009

FDA Panel May Recommend High Fence Around Lilly Clot Drug

Lilly’s new anti-clot drug, Prasugrel, is not being given a clean bill of health before the FDA makes their final decision, after 2 delays for approval in 2008. This ‘innovative but risky’ medication has potential serious bleeding complications that should restrict its use. Some say more studies are needed to assure that the benefits outweigh the risks.

Dr. Gardner’s comments: This drug is going to compete with Plavix, a $7 billion-per-year blockbuster used after a stroke or heart attack to prevent future clots. Approximately 1/3 of patients on Plavix get very little benefit, according to recent studies. I’m not aware that any of my patients that have been put on Plavix by another physician who were informed that there is only a 2/3 chance of it helping. I don’t know if they will be informed of the increased bleeding risk of Prasugrel if they are placed on it. Fortunately, there are other products outside of drugs that have a better safety profile—they just aren’t marketed by pharmaceutical companies with big marketing budgets, and aren’t given permission to indicate its true use if they have not been cleared by the FDA’s committees.

Then, TWO WEEKS LATER, this appeared:

February 24, 2009

FDA Says It Erred on Doctor

Lilly presented another drug, Prasugrel, to the FDA for approval. This would compete with the $7 Billion-per-year drug, Plavix. A cardiologist from Cedars-Sinai Heart Institute in Los Angeles, Dr. Kaul, was disinvited to serve on the committee making the final decision for this drug just days before the committee met. The FDA apologizes for this error, saying lower-level officials made the decision without informing top officials. This occurred after Lilly questioned the inclusion of this cardiologist, who has written several papers critical of the new drug.

Dr. Gardner’s comments: Here we have another example how fragile the system is for the clearance of new drugs into our supply chain. It sounds like the metaphorical jury that excludes all non-drinkers from judging a drunken-driving offense in the justice system. Folks, here’s another reason to look at all non-drug alternatives before chancing prescription use.