One More Reason Why We Die When Taking Needed Medication

Its money over safety. Organizations who do this must be heavily punished or put out of business. Corporate executives who condone or know and do nothing need to go to jail. I hate it when executives resign, like that atones for what he/she did. Corporations care not one percent for the lives they ruin, unless they have to pay, then they say they care.



http://www.nytimes.com/2009/03/27/business/27clinic.html?ref=health

An Overseer of Trials in Medicine Draws Fire

By BARRY MEIER
Published: March 26, 2009

A Colorado company that drug and medical device makers pay to oversee patient safety during clinical trials drew scorn Thursday at a Congressional hearing on whether such companies adequately supervise medical trials.

The company, Coast Independent Review Board, of Colorado Springs, was recently snared when undercover federal investigators created a sham medical study to see how closely companies like Coast evaluate the studies they are paid to review. Two of Coast’s competitors refused to approve the study’s design. But Coast approved a trial, involving a make-believe surgical product called Adhesiabloc and researchers who did not exist.

“Where was the due diligence of your company?” demanded Representative Bart Stupak, a Michigan Democrat and chairman of the panel, the House Energy and Commerce Committee’s oversight and investigations subcommittee.

Coast’s chief executive, Daniel Dueber, who had issued press releases before the hearing that accused government officials of carrying out an “extensive fraud” against his company, maintained a combative attitude at the hearing.

He said he could not imagine why anyone would design a fake trial. “I cannot believe that my government did this to me and my company,” Mr. Dueber said. “It is unconscionable.”

The hearing follows incidents in recent years in which patients have died during clinical trials or companies have submitted fraudulent data to the Food and Drug Administration to get new medical products approved. During this period, the oversight of clinical trial safety has shifted from academic medical institutions to commercial firms like Coast.

There is growing concern that commercial review boards may too easily accommodate drug and device companies that pay for their services. Some critics also say that companies will shop for an accommodating oversight board after their research plans are rejected by more stringent reviewers.

Over a five-year period, Coast reviewed 356 study proposals and rejected only one, according to data presented at the hearing. Meanwhile, since 2004 the company’s revenue has more than doubled, to $9.3 million in 2008.

In a report presented at Thursday’s hearing, officials of the Government Accountability Office, a research arm of Congress, said they had found that the commercial review system was vulnerable to manipulation. It was G.A.O. investigators who set up the Adhesiabloc sting.

In responding to undercover solicitations from G.A.O. investigators, two other companies — Argus Independent Review Board, of Tucson, and Fox Commercial Institutional Review Board, of Springfield, Ill. — refused to approve the Adhesiabloc plan. In their responses, they called the trial design “awful,” and “a piece of junk,” according to the G.A.O.

After a separate F.D.A. inspection last year, Coast received an agency warning letter after officials discovered it had used an unqualified person to approve an advertisement to recruit trial subjects for a different, real study. That approval had come, the F.D.A. letter said, after qualified reviewers working for Coast had found the advertisement unacceptable.

An F.D.A. official said at Thursday’s hearing that Coast had subsequently submitted a plan to improve its procedures. Mr. Dueber said Thursday that Coast also revised its procedures in response to the G.A.O. investigation.

Another focus of Thursday’s hearing was whether the F.D.A. and the Department of Health and Human Services, which also has a role in overseeing clinical trials, have been doing their jobs to protect patients.

In another part of the G.A.O. operation discussed at the hearing, investigators last year created a fictitious clinical trial oversight company and registered it with the department.

Representative Joe L. Barton, Republican of Texas, asked at the hearing why federal regulators had not yet put companies like Coast out of business, saying the company ought to be “kicked out of the door.”

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