Drug oversight by sham
If you have wondered why so many FDA-approved pharmaceuticals have been withdrawn after approval, perhaps one answer is sham clinical trials. At a Congressional hearing on March 26, a Colorado company reportedly drew scorn over its record. Coast Independent Review Board was snared when federal investigators devised a study trial for a make-believe product. While two other companies refused to approve the sham design, Coast did approve the nonexistent product, Adhesiabloc, and the non-existent researchers.
Review of medical products has shifted from academic institutions to commercial entities such as Coast, and during the same period, the evidence of fraud or ineptitude in the process has increased dramatically. Patients have died during trials and drugs have been approved for patient use improvidently. Coast, for example, reviewed 356 study proposals over a five-year period, and during that time it rejected only one: one wonders just how defective that proposal must have been. Meanwhile, the company's revenue has jumped since 2004 to $9.3 million dollars in 2008.
Although Coast's chief executive was combative and truculent in response to this unwanted attention, his two competitors called the study design Coast had approved "awful" and "a piece of junk". Coast received a warning letter after a separate FDA investigation in 2008.