Tests done at the now bankrupt Cetero Research lab in Houston to assure the safety of drugs seeking FDA approval were, in many cases, fraudulent, according to an investigation by Rob Garver and Charles Seife at ProPublica.
In a long story that appeared last week, they reported that "about 100 drugs, including sophisticated chemotherapy compounds and addictive prescription painkillers, had been approved for sale in the United States at least in part on the strength of Cetero Houston's tainted tests."
Astonishingly, Garver and Seife reported that the FDA has apparently not taken any action on the drugs that were approved on the basis of fraudulent testing, and it has not even revealed what those drugs are. "To this day, the agency refuses to disclose the names of the drugs it is reassessing, on the grounds that doing so would expose "confidential commercial information." ProPublica reported that it had identified five drugs that used Cetero tests to help win FDA approval. And yesterday, the reporters said they had identified a sixth.
Why hasn't the FDA disclosed which drugs are affected? "We believe that this did not rise to the level where the public should be notified," an FDA official told ProPublica. "We felt it would result in misunderstanding and inappropriate actions."
In other words, the American public isn't smart enough to understand it. Rather than protecting us from the drugs, the agency is choosing to protect us from ourselves, I suppose.
This is a disturbing story. And an important one. I'm glad Garver and Seife are continuing to work on the story, uncovering what information they can about the potentially compromised drugs. And I hope they will stay with it.
-Paul Raeburn
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