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FDA leaves tainted Generic Drugs in Stores

Think twice before taking a generic drug. The Supreme Court recently voted with two pro-corporate, anti-citizen decisions to overturn jury verdicts that had awarded damages to Gladys Mensing and Karen Bartlett, both of whom developed painful, life-altering injuries from generic versions of brand-name drugs. The high court voted 5-4 in each case that generic drug makers are not to be held accountable when the drugs they make injure people. Now comes word that the FDA has failed to remove fraudulently tested generic drugs from the market or even to announce to the public when it discovers such a problem.

It is more than a little disconcerting to discover this fact of the FDA’s negligence and/or incompetence, especially as the agency actively promotes generic drugs on its web site while at the same time it submits  amicus briefs to the highest court in support of insulating generic drug makers from liability when they hurt U.S. citizens.

If you’ve taken generic Ibuprofen recently, or sophisticated versions of generic chemotherapy drugs, for two examples, you may not have been getting what you paid for or expected. Were the drugs you took even safe? Who knows? Not the United States Food & Drug Administration.

In 2011, the FDA announced that several years’ worth of studies from a major drug research lab might be worthless, or worse. More than 80 percent of the drugs the lab had “researched” were generic.

On May 3, 2010, FDA raided the Houston office of drug company researcher, Cetero Research. A now retired FDA agent, Patrick Stone, led a team that investigated a former employee’s charge that the company had falsified records and manipulated test data.

Presented with evidence, the testing facility’s president, Chinna Pamidi, promptly admitted
that much of the lab’s work was fake. Stone recalled that Pamadi said, “You got us.”

The FDA determined that the lab’s violations were “egregious,” and said studies conducted there between April 2005 and August 2009 might be worthless.

Complicated chemotherapy compounds and addictive prescription painkillers were some of the 100 drugs that had been approved for sale in the U.S. at least partly on the legitimacy of Cetero’s “research.” Fully 81 were generic versions of brand-name drugs which Cetero scientists had been entrusted to examine for equivalency. One of these generic drugs was ibuprofen, sold as gelatin capsules by one of the U.S.’s biggest grocery chains for months before the FDA had even received assurance they were safe.

But the FDA also claimed the rest were new medications that required so much research to win approval that Cetero’s tests were rarely crucial. Are we to believe this?

Meanwhile, as the FDA investigated and ordered re-tests, the European equivalent of that agency pulled seven drugs from the market.

The FDA says it has no evidence that any of the drugs were unsafe or that any patient has been harmed. The FDA has also never named the drugs, claiming that to do so would reveal trade secrets. Really? So trade secrets are more important than drug safety or efficacy? Does the agency work for corporations or for citizens, and could it be any more transparent in its support of corporations at the expense of citizens?

Are we to believe that this is a rare situation for the FDA? How many other times has such a thing occurred? The agency is badly underfunded and understaffed for the huge responsibility that it has to monitor drug safety and efficacy. So why doesn’t the agency err on the side of safety rather than on the side of corporate profits?

Instead of treating us like adults and giving us the necessary information and letting us decide matters related to our own health, the agency decided to handle the matter with virtually no public disclosure of what it had discovered. It pulled none of the drugs from the market, even temporarily, letting consumers take the ibuprofen and other medicines it no longer knew were safe and/or effective. Some of those drugs remain on the market today.

See the propublica.org story

Stay tuned. . .

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