Darvon, Darvocet and Propoxyphene Recall-A case study in the power and influence of BIg Pharma
Darvon, Darvocet and the generic Propoxyphene are bad drugs that should have been taken off the market a long time ago. Efforts to ban the drug began more than thirty (30) years ago. Yes, I said 30. The truth is they never were very good drugs to begin with. There were animal studies that signalled heart problems even before the drug was first approved. The fact that they were allowed to remain on the market for so many years is a case study in the unbridled power and influence of Big Pharma over Congress and the FDA. For an excellent chronology of the efforts to get propoxyphene (Darvon and Darvocet) removed from the market, see Public Citizen's Report.
Sidney M. Wolfe, M.D., Director of the Health Research Group at Public Citizen testified at the 2009 FDA hearings on Propoxyphene. This is what he said:
There is little doubt that were propoxyphene and propoxyphene-containing products to come before these committees today for approval, based on what is now known, they would be rejected because of one of the most unfavorable benefit-to-risk ratios ever seen for a drug. This is not to say that there was insufficient evidence for a ban 30 years ago when we first petitioned the Food and Drug Administration (FDA) to withdraw the approval. But the forceful and successful war then waged by Lilly in opposition to such a ban tended to drown out evidence of minimal benefit and rapidly growing evidence of life-threatening, often lethal harm.
The entirety of his testimony lays out a grim scenario of deaths directly related to the use of propoxyphene.
Another notable expert, Dr. Steven B. Karch also testified before the FDA panel. Dr. Karch is a former medical examiner in San Francisco where he investigated deaths related to drug toxicity. He also wrote a textbook, Karch's Pathology of Drug Abuse in which a section is specificallly devoted to propoxyphene-related deaths.
Dr. Karch laid out the case for banning the drug, in saying:
(1) It is a dangerous drug: Large amounts are rapidly absorbed from the GI tract very quickly, making attempted suicide difficult to treat.
(2) Even modest amounts of this drug can cause lethal cardiac arrhythmias in any individual with an undiagnosed hERG genetic polymorphism.
(3) Use of propoxyphene can lead to toxic levels of antibiotics and anticonvulsants
(4) The drug is not particularly effective. For far less money, patients would get more pain relief if they took aspirin or acetaminophen.
Yet, rather than immediately recalling the drug from the market and thereby preventing more needless deaths, the FDA inexplicably called for stricter warnings. When, In November 2010 the FDA finally pulled Darvon off the market, Dr. Sidney Wolfe issued a statement calling for a Congressional Investigation of the FDA and estimating that the FDA's delay cost 1000-2000 lives.
According to Dr. Wolfe,
The FDA's pitiful excuse that it needed to order a human study to find that "the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities" before deciding whether to ban propoxyphene only emphasizes how out-of-step the agency is with the rest of the world - which already had enough human evidence of death and near-death in tens of thousands of people to act accordingly.
In a study on dogs published 31 years ago, researchers at Lilly, the discoverer of propoxyphene, stated that "cardiac conduction depression may be a factor in some of the [human] cardiac toxicities associated with propoxyphene overdose." This study examined the same kind of function measured in the human study now being put forth by the FDA as a justification for belatedly banning propoxyphene.
We will ask for and support a congressional investigation into whom in the FDA, specifically in the Center for Drug Evaluation and Research, was responsible for the loss of so many lives in this country. It is clear that long before today, many drug safety experts in the Office of Surveillance and Epidemiology had decided the drug should be removed from the market.
Dr. Wolfe was a severe critic of the FDA under the Bush Administration, decrying in 2006 that the FDA had embarked upon an "unprecedented assault on the American public.
Only time will tell whether any such Congressional investigation will ever take place. I have my doubts given the current state of political affairs in this country. I would love to be proven wrong.
