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Drug racket

FDA ready to loosen rules for clinical trials, allowing drug companies to make them up as they go along

Tuesday, July 11, 2006 by: NewsTarget
Tags: drug racket, junk science, clinical trials


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(NewsTarget) The U.S. Food and Drug Administration (FDA) announced today that drug makers will soon be able to conduct "adaptive" clinical trials that will allow researchers to change details of the study midway through.

Under the FDA's new guidelines, pharmaceutical companies conducting drug studies would no longer be required to follow the current rules, under which patients and physicians in drug trials do not know the results until the trial is complete. Those guidelines were put in place to prevent doctors and patients from purposely affecting the outcome of a study.

However, the FDA's new "adaptive" trials would allow drug makers to see early trial results midway through, permitting researchers to change study participants, or drop the study entirely if the drug seems ineffective. The new guidelines are aimed at reducing the cost of bringing new drugs to the market.

"These new approaches to clinical trials can result in trial designs that tell us more about safety and benefits of drugs, in potentially shorter time frames, exposing fewer people to experimental treatments," said Dr. Scott Gottlieb, deputy FDA commissioner of medical and scientific affairs.

"It may also be true that making decisions during a trial's course can increase the rate of making an erroneous decision," Gottlieb said. He also acknowledged that the newer designs could lead to "complicated decisions and uncertainty about the best approach for data analysis."

Critics of the FDA view the new guidelines as an opportunity for drug companies to more easily manipulate and falsify study findings to bring ineffective or dangerous drugs to the market simply to make a profit. With fraudulent clinical trials already commonplace, the new FDA rules would appear to make it even easier for drug companies to engineer clinical trials to produce any desired outcome.

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