Published online 20 January 2010 | Nature | doi:10.1038/news.2010.17
Corrected online: 23 January 2010

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NIH scrutinizes drug-company payments at Baylor

Funding agency raises 'serious concerns' about conflicts of interest.

Baylor College of MedicineBaylor College of Medicine is revising its conflict-of-interest policy after NIH intervention.Baylor College of Medicine

Researchers at Baylor College of Medicine in Houston, Texas, are facing increased scrutiny of their grants by the US National Institutes of Health (NIH) following revelations that the university was not complying with the agency's financial conflict-of-interest policy.

It is only the second time that the NIH has ever taken such an action against a university. In 2008, the agency placed additional conditions on grants to Emory University in Atlanta, Georgia.

The NIH has struggled with conflict-of-interest issues since 2003, when The Los Angeles Times reported a pattern of financial conflicts of interest among its employees, which later triggered a congressional investigation. More recently, Senator Charles Grassley (Republican, Iowa) has been probing the agency's failure to police university-based grantees who fail to report payments from drug companies for consultancy work or for promoting drugs in talks to colleagues. His investigation into US$1.2 million in undisclosed payments to Emory psychiatrist Charles Nemeroff, for instance, led to the NIH suspending the university's $9.3-million clinical trial for depression, and requiring all grant applications from Emory to include details of investigators' financial conflicts.

The latest development at Baylor College of Medicine was sparked by an article in The Chronicle of Higher Education on 25 October 2009, which reported on payments that drug-maker Merck & Company, based in Whitehouse Station, New Jersey, had made to physicians to promote its anti-cholesterol drug Vytorin (ezetimibe and simvastatin) in 2007 and 2008. Prodded by Grassley, the NIH examined allegations related to Baylor cardiologist Christie Ballantyne.

Ballantyne, who declined to be interviewed by Nature for this article, has several NIH grants and had disclosed to Baylor the payments of more than $34,000 he received from Merck over five months, according to a later article in The Chronicle of Higher Education. But Baylor's own conflict-of-interest rules suggested that there was no need to disclose those payments to the NIH. The university now says that its rules did not comply with NIH policies.

“It seems pretty clear that the whole system for 'managing' conflicts and reporting financial ties has been very lax.”

Charles Grassley
Republican, Iowa

The NIH reviewed the matter, and on 17 December asked Baylor to conduct a review of financial disclosures from 2004 to the present. The agency also placed special conditions on Baylor grantees, requiring assurance letters and documentation that all new grants are in compliance with NIH policies. In a letter from NIH director Francis Collins to Grassley dated 14 January 2010, Collins writes that Baylor's response to the agency has "raised serious concerns" and that "NIH has imposed special award conditions on all BCM [Baylor College of Medicine] grant awards until BCM can assure the NIH that the detected deficiencies …have been appropriately addressed." Baylor spokeswoman Lori Williams says that the university has begun recrafting its policies to comply with the current NIH standards, which NIH first put in place in 1995.

"It seems pretty clear that the whole system for 'managing' conflicts and reporting financial ties has been very lax," Grassley said in a statement to Nature. "I've been urging the National Institutes of Health to flex its muscle and send a clear message to the grantee community that those days are over."

Not alone

Several NIH-funded researchers at Baylor told Nature that they had received e-mails from the university administration requesting financial disclosures on 23 December, but they were unaware that the NIH had singled out their institution. "It doesn't surprise me when the NIH keeps asking for paperwork, we get that all the time," says Baylor immunologist Tony Eissa. "We have other problems to worry about at Baylor," he added, referring to the institution's financial troubles and its struggle to build its own hospital after severing ties with The Methodist Hospital in Houston in 2004. Baylor received $213 million of NIH funding in 2008.

The NIH action at Baylor comes at a time when the agency is considering tightening the leash on university-based researchers by lowering its annual disclosure threshold of $10,000. Above this threshold, a payment from a single company to an NIH-funded researcher is considered significant enough to be reported as a potential conflict.

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In May 2009, the agency began a public consultation on updating those rules, which are expected to change this spring. The Association of American Medical Colleges, based in Washington DC, has suggested that the bar for disclosure to the NIH should be lowered to $5,000, and that all payments should be disclosed to the investigator's institution regardless of the payment size.

"This is another example of the impact that Senator Grassley and his investigations are having," says cardiologist Steven Nissen of the Cleveland Clinic in Ohio, who is a frequent critic of drug-company payments to physicians. "It's not an issue that affects only Baylor, but I am certain there are other examples," he adds.

Indeed, the NIH is also looking into whether the University of California at Davis, Sacramento, properly handled the potential conflict of interest related to cardiovascular pathologist Ishwarlal Jialal, who is also mentioned in the article in The Chronicle of Higher Education. Jialal, who served on Merck's advisory board and is also editor-in-chief of the journal Metabolic Syndrome and Related Disorders, says that he never received more than $10,000 from Merck in a single year and that he has always disclosed that to the university. 

Corrected:

Ishwarlal Jialal is a cardiovascular pathologist, not a cardiologist, as we stated in an earlier version of this story.
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