Ensnared by an Undercover Investigation, Drug Study Reviewer Halts Many of Its Review Operations

April 28, 2009
Category: Uncategorized

A previous Pulse of Health Freedom issue mentioned the uncover operations of the Government Accountability Office (GAO) which ensnared Coast IRB, LLC, of Colorado Springs. The GAO created a fake medical study of a fake product to see whether for-profit review boards adequately supervised medical trials. Two firms turned it down but Coast IRB took it.

Coast IRB has now voluntarily halted many of its review operations at the FDA’s request. Up to 300 trials could be affected. The company has issued a statement that it caught the “sting” internally and had launched an internal investigation.
In the wake of an adolescent’s death in a gene therapy drug trial, the safety of human volunteers in clinical trials has come under increasing scrutiny, and many are worried about the objectivity of the results presented to the FDA.

The influence of vested interests, particularly in medical research, is also of great concern. Educators like John Abramson, MD, author of Overdosed America, have clearly documented that vested interests skew medical school education, medical research, medical journal publication, and clinical practice guidelines. When guidelines become mandatory or coercive, which is the current direction the government and insurers are taking, it gives vested interests a chance directly to control medical care. All Americans deserve an objective assessment of their potential treatment options in order to make an informed decision about their health.

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