Wednesday, January 04, 2006

Stunning example of corruption in the clinical trials cartel

On the continuing saga of troubles at SFBC International, a for-profit clinical research organization (CRO) that runs clinical trials for pharmaceutical companies, last posted on by colleague Roy Poses here:

Let's see what today's news holds: Sen. Grassley opens probe of abuses at this CRO and the top officers quit before "showtime"; safety issues; death and injury; complaints by over 100 doctors about the improprieties in the industry documented by Bloomberg's; conflicts of interest; unlicenced doctors as president & chair; non-lawyers running the legal department; non-CPA CEO's listing themselves as CPA's in SEC filings; $15 million mansions; "inappropriate" behavior with trial subjects followed by threats to deport them.

Do we have all the bases of medical corruption covered here in this one story? It seems so. Absolutely amazing. The pharmaceutical industry still wonders why they've lost credibility with the public regarding integrity. It would be interesting to know which companies contracted with the CRO in this little story, and what drugs were involved. In an initial glance at the company website this information is not apparent.

Ironically, this same CRO industry found that a person like me doesn't have enough experience. Or perhaps they don't want honest Medical Informatics specialists around. Perhaps we'd be seen as putting a damper on the ability to lie, cheat, steal, and conduct other types of biomedical mayhem.

2 top officers quit clinical-trial firm in inquiry

Posted on Wed, Jan. 04, 2006
By Kerry Dooley Young and David Evans

The top two officials at SFBC International Inc., the Miami-based drug-testing company at the center of a U.S. Senate probe, quit after investigators sought to interview them.

Lisa Krinsky resigned as president and chairman, and Arnold Hantman retired as chief executive officer, the company said in a statement yesterday. SFBC's shares had fallen 61 percent since Nov. 1, the day before Bloomberg News reported on deaths and injuries that occurred in experimental-drug studies across the United States.

... SFBC is trying to regain investor confidence after Miami officials forced it to remove beds in its main clinical-trial center because of safety issues, Canadian officials probed a tuberculosis outbreak in a Montreal drug trial.

Krinsky, 43, was to meet with the staff of Sen. Charles Grassley (R., Iowa) next Wednesday as a result of an inquiry by the Senate Finance Committee chairman into drug-trial safety issues. No date had been set for a meeting requested by Grassley's staff with Hantman, 69.

... Krinsky and Hantman no longer have offices at the company and could not be reached for comment, spokesman Michael York said.

... Bloomberg's Nov. 2 article reported details of deaths and injuries in tests of experimental drugs across the United States. More than 100 doctors, government officials, scientists and participants said the drug-testing industry inadequately protected people.

The report also disclosed conflicts of interest in the industry. One company that was paid to monitor the safety of participants in some SFBC clinical trials was owned by the wife of a company executive.

... Krinsky, whom SFBC refers to as a medical doctor, is a graduate of Spartan Medical School in the Caribbean island of St. Lucia and not a licensed doctor. Krinsky and the former director of legal affairs, Gerald Seifer, who isn't a lawyer, share a $15 million home they bought last year.

Seifer resigned Dec. 19 after an investigation found he engaged in "inappropriate" behavior with trial subjects, the company said. Prior to his resignation, Seifer was placed on 30 days paid leave after a report from two law firms hired by SFBC's board found that a witness heard Seifer threaten to have research subjects deported, the company said.

Hantman, referred to in company filings with the Securities and Exchange Commission as a CPA, is not licensed as a certified public accountant...Hantman, Seifer and Krinsky were among SFBC's founders.

-- SS

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