3 Comments

  1. Thomas C. Ardoline
    November 19, 2010 @ 4:39 pm

    Dr. Wolfe.

    As a retired Senior Health Policy Fellow from the United States Air Force I am utterly bewildered that your studies cited consistently fail to address quality of life. I have to live, and to live knowing that when I can no longer walk in the grocery store that there is relief at hand. To ignore that outcome vs risk is ludicrous.

    My physician and cardiologist are quite comfortable knowing that I can live with the aid of this medication. So many other medications are far riskier but produce a physiologically noteworthy outcome. Those medications have this notable outcome to balance against the risk.

    Not having a dreadful fear of waking up or engaging my day IS a noteworthy outcome that more than balances a far higher risik than propoxophene presents.

    You have forced me into a stronger series of opioids etc that no one will prescribe on a chronic basis.

    This decission will lead to suicides as did the decission to remove VIOXX some years ago. Patient’s begged to have it reinstated. What kind of people are you???

    Please go do some good in someone else’s life. I am an educated, freeborn, land owning American. This is my decission, not the government’s or some increasingly powerful quasi-governmental agencies such as Public Citizen.

    Thank you for your good work.

    Thomas C. Ardoline

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  2. Terence Mix
    November 26, 2010 @ 12:34 pm

    The FDA’s decision to order Darvon and other propoxyphene-containing products removed from the market on November 19, 2010, comes 5 YEARS after the pain reliever had been banned in Great Britain and a YEAR AND A HALF after it was withdrawn by all other members of the European Union. While other countries were taking strong regulatory steps to protect their citizens, the FDA’s reaction had been to simply increase the warnings on its risks. Darvon and its sister drugs have had a long history of drug addiction, suicide and cardiac problems since first entering the market in 1957. My question is this – why should it take 53 years to determine that a drug should not be on the market?

    This history is not unique. On October 8, 2010, the FDA announced that Abbott Laboratories would be withdrawing Meridia from the American market, 9 months after the weight-loss drug was removed by the European Union. Earlier, the FDA had only strengthened the warning on the drug’s labeling, cautioning its users about the risk of heart attacks and strokes. On September 23, 2010, the FDA decided to allow Avandia to remain on the market, while the European Medicines Agency decided to pull the plug on the drug in Europe. These decisions are somewhat reminiscent of the history involving the drug, Cylert, which was withdrawn by the FDA in 2005 because it was causing severe liver damage to children taking it for ADHD – eight years after it was withdrawn by Great Britain.

    This pattern of increasing warnings while other countries are removing drugs that do not belong on the market is only a small sample of why our FDA and its oversight of drugs is no longer the gold standard of the world. Meanwhile, thousands of Americans are dying unnecessarily. As many as 230,000 per year die in the United States as a result of an adverse reaction to prescription and/or nonprescription drugs – a number that can be cut in half.

    Changes need to be made and they need to happen now. And it has got to start by eliminating the insanity of drug companies conducting their own premarket studies rather than an impartial entity, such as the National Institutes of Health. For everyone who is in agreement with taking some action, I would urge you to go to the website, http://www.FDAreformpetition.com and sign my petition to Congress demanding a change. Only if the citizens of this country speak in a strong and unified voice will we catch the attention of Congress and impress upon it the need for such a change.

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  3. Charli
    December 4, 2010 @ 4:05 pm

    As a person suffering from Chronic pain I wonder what happens to all those who used the drug knowing the risk and who it worked for? There are not alot of “bullets” to help with pain. I know I’ve been through a lot of different meds trying to find something that works. I tried Neurotin and almost died yet it’s still be prescribed to people. Most meds have side effects that can kill but if someone is informed then I don’t see the problem. It has to be OUR choice as to what we’re willing to risk.

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