You’ll remember the many - many - many - many Rezulin Taken Off Market Years After It Caused the First Of Over 60 Deaths times that I’ve offered the many disturbing facts about this drug, from its testing by physicians from Warner-Lambert, its manufacturer, to the many deaths and liver failures that it has caused (each "many" is a different link by the by) .
Lately, it has been reported that an FDA physician is threatened with dismissal for releasing documents to Congress that demonstrated the many dangers that Rezulin posed to patients.
Dr. Robert I. Misbin has been involved in the sad history of Rezulin He examined the results of the tests during the original trials before the FDA approved the drug and supported the expansion of its recommended use twice.
However, since January of this year, he and four other FDA physicians have been recommending the removal of the drug from the market. They have cited the 89 reported liver failures and 61 deaths that are directly related to the use of Rezulin.
What is causing Misbin such grief is that he released to Congress copies of e-mail detailing his and the other physician’s concerns about the drug as well as the replies for their superiors. This, the agency declares this constitutes “inappropriate release of information to individuals outside the FDA.”
Now, the FDA has initiated an investigation into Misbin’s actions in regard to public exposure of the dangers of the drug. The depth of their intent to discipline him is in the fact that he was barred from bringing any witnesses to an interrogation by the FDA’s internal affairs investigator. The investigator also flatly refused to put his questions into writing.
The one man who should be investigated is Dr. Murray Lumpkin, director of the FDA’s Center for Drug Evaluation and Research. Lumpkin is the one man in the FDA responsible for assuring the agency reviews and approves new drugs more quickly than ever before (read before 1995 after the Republicans won their revolution and America lost its decency). As the point man for this so-called “fast track approval”, Lumpkin in Oct. of 1996 stripped another FDA physician, Dr. John L. Gueriguian, of further involvement in the reviews of the drug, after he cited the potential liver and heart toxicity and, in a written review, recommended that the drug be rejected. In point of fact, Geuriguian was relieved of his duties not because of any shortcomings on his part but at the direct request of Warner-Lambert executives who complained of his negative comments about the drug. Lumpkin’s answer to the deeply negative review was to simply lose the report and handed the review over to other, more pliant researchers who were, as well, approved by Warner-Lambert’s executives. The document, it has now been discovered, was simply wiped from agency files.
Even faced with reports from Britain that the Medicines Control Agency in London (the equivalent of the FDA) that they were highly recommending that the drug be taken off the market based on even more deaths and liver failures in Japan and Europe, Lumpkin saw no reason for action. Even the refusal of the drug company licensed to sell the drug in Europe, Glaxo-Wellcome, withdrew the drug from the market, Lumpkin continued to defend the drug’s use in the United States.
Hoping to cover all of their bases, Warner-Lambert proceeded to relabel the drug four different times, each time recommending more frequent and more thorough liver tests both before and during the regime of taking the drug. Each time the label was reworded, more reports of deaths and liver failures followed. Each time, Lumpkin and Warner-Lambert defended the drug and discounted the deadly effects by claiming that the reports were being blown out of proportion.
In any event, Dr. Misbin now faces the end of his career within the FDA not because he caused even one death but because he attempted to inform Congress of the dangers of a drug when his superior was doing all in his power to insure that the drug remained on the market regardless of the damages it was causing. As even Misbin admits in a March 14 e-mail to his boss, “The ‘inappropriate release of information to individuals outside the FDA’ could undermine [public] trust and should be the subject of a timely and vigorous investigation...But had FDA been equally vigorous in dealing with the Rezulin problem, we would not be at the impasse that we currently face.”
Happily, Dr. Sidney M. Wolfe of the Ralph Nader group Public Citizen, has asked the FDA to file criminal charges against Warner-Lambert for the manner in which the company classified and basically hid the earliest known cases of death and liver failures in the report which led to the approval of the drug in 1997. (1, 2, 3, 4)
Today, March 21, we have learned that the drug Rezulin has now been removed from the market entirely at the request of the FDA and the National Institute of Health. To say the least, it’s about time. (5 )
To add injury to the many deaths already on the consciences of those in Congress, the FDA and the White House who allowed and encouraged this abomination (the first of many more, you can be certain), the FDA is now admitting that Rezulin may have caused damage to the hearts of many of the patients using it. ( 6 )
All of you who voted Republican because you fell for their bulls**t bumper sticker slogan “smaller government”, I hope you rest easier than the families of the victims of your stupidity.
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