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Overseer of Medical Trials, Under FDA Pressure, Agrees to Suspension
Its true that when you do something wrong and lie about it, that the wrongdoing and truth bending will indeed come back to get you. The golden rule policy has come back to bite Coast, a medical trial company based in Colorado that approved a make-believe clinical trial run by doctors who did not exist, a New York Times article reported.
The sham clinical trial came to fruition after undercover federal agents prepared plans for a sham medical study involving a make-believe surgical product to see how closely companies like Coast evaluate the studies they are paid to review. There is a growing concern, the article reported, that these commercial review boards may too easily accomodate other companies that pay for their services.
For its part, Coast agreed to temporarily stop approving new clinical trials regulated by the F.D.A. until it had given the agency an acceptable plan of corrective actions. The F.D.A. is allowing trials now under way to continue, but Coast also agreed not to enroll any new patients in them until its corrective plan was approved.
For doctors, payers and patients, hearing news of these sham trials is frightening and creates a barrier of distrust between the providers and customers of products, medicines and health care. AllMed, an independent review organization, ensures that the advice it provides is clinically-based, not just on medicine and evidence, but on honesty, too.
To read the full article, click here: http://www.nytimes.com/2009/04/15/business/15device.html?ref=health


