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NIH Toughens Rules On Baylor College Of Medicine [Houston Chronicle]

From Houston Chronicle (TX) (January 21, 2010)

Jan. 21--Baylor College of Medicine researchers are facing tougher federal financial disclosure requirements after the National Institutes of Health learned the Houston school failed to tell them about a cardiologist’s $34,000 consulting deal with a drug company.

The agency determined Baylor’s corporate conflict-of-interest policies were not in compliance with regulations, which require institutions report any potential conflicts of interest involving doctors while conducting research funded by the NIH.

Baylor’s initial response to questions "raised serious concerns regarding BCM’s compliance" with regulations governing such financial conflicts, NIH director Francis S. Collins wrote in a Jan. 14 letter to Sen. Charles Grassley, R-Iowa, who called for the inquiry following a newspaper report on universities not reporting employees’ acceptance of drug company money.

Case not reported to NIH

Grassley singled out Baylor as a particular concern because of the case involving cardiologist Dr. Christine Ballantyne, which was reported in The Chronicle of Higher Education last year. He was among 14 university-affiliated doctors in the article who received money as part of a plan by the drug company Merck to promote its anti-cholesterol drug Vytorin.

Ballantyne followed Baylor’s disclosure and conflict-of-interest policies, but in what Baylor spokeswoman Lori Williams said was an oversight, the medical school didn’t report his disclosure to the NIH.

Under the NIH’s new requirements of Baylor, the school must now provide a specific assurance letter and documentation that researchers on all currently funded and new grant awards are in compliance with agency policies. Collins wrote that the condition will continue until Baylor can demonstrate compliance.

The NIH took the unusual action after also asking Baylor to conduct a review of financial disclosures involving every active grant awarded since 2004 to assess what conflicts of interest were not reported.

Baylor officials would not say how or why the school’s policy was out of line with NIH standards, first put in place in 1995. Baylor’s policy was rewritten to specifically follow the NIH after concern arose late last year, Williams said.

"We have been and are continuing to work directly with the NIH on this issue and are confident we are responding to every suggestion that has been made and every request for additional information," Williams said.

The journal Nature reported that this is only the second time the NIH has imposed additional conditions on an institution’s grants as a result of it not disclosing a conflict of interest.

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Posted: January 2010