With the president’s family friend, Dr. Andrew Von Eschenbach, M.D., being recently appointed to head the U.S. Food and Drug Administration, (“You are doing a great job Eschenbachy!”), perhaps the time has come to consider the privatization of the FDA? The FDA has found itself embroiled in a number of political controversies recently such as the “Plan B” Day After contraceptive imbroglio. It seems the “gate keepers” at the FDA may be more concerned with political, than medical correctness.
On February 28, 20096, Public Citizen, a public “watch dog” group filed a petition with Dr. Eschenbach requesting the FDA to remove Propoxyphene (“Darvon", "Darvocet,"" Wygesic”) from the market as the United Kingdom did over a year ago. According to the British, “It has not been possible to identify any patient group in whom the risk-benefit [ratio] may be positive.” The complete petition and summary of medical data supporting Public Citizen’s petition can be found at www.worstpills.org.
Eli Lilly & Co. introduced propoxyphene in 1957. According to the Federal Drug Abuse Warning Network (“DAWN”), which collects autopsy records from medical examiners, 5.6% of all drug related deaths in the United States for the past 19 years involved Propoxyphene. Between 1981 and 1992, 2,110 people died of accidental deaths related to the use of Propoxyphene. Propoxyphene is habit forming and frequently causes withdrawal symptoms on a sudden stop in use.
Propoxyphene in person’s body morphs into norpropoxyphene, a highly toxic metabolite, which causes cardiac depression and sometimes fatal cardiac arrhythmias.
The elderly are particularly susceptible to adverse events from use of propoxyphene, but are among the most widely prescribed, particularly those in institutionalized settings. The drug has had adverse affects on the central nervous systems of the aged. The elderly using the drugs have a 2.4 times greater chance of requiring hospitalization, emergency room services or death than those who do not.
Interestingly, Public Citizen petitioned the Department of Health and Human Services for the banning of propoxyphene in 1978. H.E.W., relying on representations of Eli Lilly that it would undertake an “education” program related to the drug, denied the request. The education program was reportedly little more than a marketing campaign and was not effective in controlling the use of the drug. Eli Lilly no longer owns the drug having sold its interests to aaiPharma, a generic drug company..
Public Citizen has been in the forefront of alerting the public to dangerous drugs including raising issues with the FDA over Vioxx, Effedra, Bextra, Baycol, Propasil and others. Perhaps we should turn this function over to Public Citizen who apparently has a stronger concern for the protection of consumer interests in the regulation of drugs than our more politicized agencies. We could of course keep for the FDA the function of approving the names of drugs to protect the consumer . See Mathews, “When a Drug Maker Creates A New Pill, Uncle Sam Vets The Name,” WSJ (March 17, 2006).
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