The case against Darvon, which was FDA-approved in 1957 and abruptly withdrawn in 2010, is confusing. Dr. Sidney Wolfe, author of Worst Pills, Best Pills and a health lobbyist connected to Ralph Nader, has wanted Darvon banned from the market for decades, claiming links to suicide, heart arrhythmia, and other serious problems. His petitions to have the drug banned were rejected in 1978 and 2006, and it wasn't until November 2010, months after Wolfe's appointment to the FDA's Drug Safety and Risk Management Committee, that the drug was finally pulled from the market.
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| Here is a link to what Dr. Wolfe has to say. This video was posted on the day of the FDA vote (Nov. 19, 2010) and is short on evidence against Darvon. |
Several doctors I know have complained that they used Darvon effectively for years without incident, and were bewildered as to why it was banned. I found it curious that not only were Wolfe's petitions rejected twice, but the FDA voted to remove the drug by a margin of 14-12, certainly not an overwhelming majority.
I read this memorandum by Dr. Wolfe, which he submitted to the FDA Center for Drug Evaluation and Research one day before the vote on Darvon. It certainly is heavy on implication and warnings, but there is very little conclusive evidence that Darvon users who did not have prior cardiovascular problems and did not overdose suffered from any unusual symptoms while using Darvon.
Thankfully, Darvon is not a groundbreaking cancer drug, and its loss from the market, while annoying, will likely not transform lives. However, it is frustrating to think that one lobbyist's obsession (Dr. Wolfe never actually practiced medicine) could remove people's ability to make educated choices about which medicines they would like to use. Particularly when that removal is based on shabby evidence.
Postscript: I am happy to be back and looking forward to continuing to take on the FDA! Also, welcome to readers from urbansurvival.com! George Ure always has interesting perspectives and I so appreciate his mentioning the FDA Monitor!
