The National Institutes of Health has ordered tougher financial disclosures on all grant applications from Baylor College of Medicine, saying that an investigation has raised “serious concerns” about the college’s compliance with regulations governing corporate conflicts of interest.
The NIH also asked the medical college, in Houston, to review all of its grant awards from the agency dating back to 2004 to reassess all financial relations between its scientists and outside drug companies.
The NIH began investigating Baylor College of Medicine and several other institutions after a Chronicle article last October listed 14 physicians affiliated with a dozen universities who had collected more than $400,000 from the makers of the anti-cholesterol drug Vytorin as part of a campaign to encourage the use of the medication.
The medical college’s responses to that inquiry “raised serious concerns regarding BCM’s compliance” with regulations governing financial conflicts of interest, Francis S. Collins, the NIH director, said in a letter this month to Congress.
The NIH informed the institution last month that the agency would impose “special award conditions” on all future grants, said Lori E. Williams, a college spokeswoman. Both Ms. Williams and an NIH spokesman declined to provide details of problems at Baylor College of Medicine beyond those identified in the Vytorin case.
The imposition of “special award conditions” affects both the application and the payment processes for NIH grants, and includes a requirement that the institution list for the NIH all participants in a project and describe any potential financial conflicts.
Reliance on Trust
It is possible that such conditions could affect the timing or the success rate of future applications, although both NIH and college officials declined to say what the effects might be. Under regular conditions, the NIH usually accepts an institution’s assurance that it has checked for possible financial conflicts of interest on its grant applications and has taken steps to mitigate and conflicts that may exist.
Baylor College of Medicine is cooperating with the new NIH requirements and hasn’t had any grants lost or delayed as a result of the new procedures, Ms. Williams said.
Restrictions on outside financing could pose problems for the medical college, which severed most ties with Baylor University in 1969. (Talks of a new affiliation between the medical college and the Baptist university have recently started, however.)
The medical college has been in financial distress since 2004. It relied on the NIH for more than $221-million in federal grant money in the most recent fiscal year.
Baylor College of Medicine reported that the value of its endowment fell to $778-million in the 2009 fiscal year, down 18 percent from a year earlier. It lost a total of $323-million between 2004 and 2009, according to calculations by Moshe Y. Vardi, a professor of computational engineering at Rice University, which until recently was discussing a merger with the medical school. Mr. Vardi lobbied against such a merger, and used those numbers to support his case.
Investigation of Payments
The data cited in the Chronicle article, listing payments to physicians, was provided to U.S. Senate investigators by Merck & Company and the Schering-Plough Corporation, the makers of Vytorin. The doctors who spoke favorably of Vytorin included Christie M. Ballantyne, of Baylor College of Medicine, who collected $34,472 during a five-month period beginning in November 2007.
Some other institutions listed by the drug makers have resolved questions about possible conflicts of interest. Dr. Collins, in the letter addressed to Sen. Charles E. Grassley, Republican of Iowa, expressed satisfaction with answers the NIH had received from two other institutions—Vanderbilt University and Weill Cornell Medical College—where researchers had active NIH grants during the same five-month period in which they were receiving money from Merck and Schering-Plough.
Sergio Fazio, a professor of medicine at Vanderbilt, received $82,260, and Antonio M. Gotto Jr., dean of Weill Cornell, got $27,146. Vanderbilt and Weill Cornell both told NIH investigators that they had determined the payments to their doctors “were not related to NIH-supported research,” Dr. Collins told Mr. Grassley, the top-ranking Republican on the Senate Finance Committee.
But Dr. Collins said NIH investigators are still seeking complete responses from the University of California at Davis. Ishwarlal Jialal, a professor of internal medicine there, was paid $25,808 by Merck and Schering-Plough.
A spokesman at Davis, David Ong, said that the NIH had “requested additional clarification about university policy and process,” and that the university expects to provide a follow-up response in the coming week.
Questions Over Drug’s Effectiveness
Dr. Ballantyne, a professor of medicine at Baylor, was paid by Merck and Schering-Plough at the same time he had at least two NIH grants to study the effects of drug treatments on atherosclerosis and cardiovascular disease.
The two companies issued a news release in March 2006 that quoted Dr. Ballantyne as saying Vytorin was “significantly better than Lipitor,” a statin drug made by Pfizer, for lowering cholesterol. But in January 2008, Merck released study data that had been held internally for two years showing that Vytorin didn’t significantly outperform a far cheaper generic alternative for most patients in preventing the buildup of plaque in the arteries, which can lead to heart attack and stroke.
Dr. Ballantyne told The Chronicle that interactions between companies and university researchers are so complex that an outsider trying to assess bias “can easily come to very wrong conclusions from looking at just some of the facts.” He said he has a “very strong family history of cardiovascular disease,” and that he has dedicated his career to helping patients rather than companies.
Baylor College of Medicine had not previously informed the NIH of the corporate payments to Dr. Ballantyne, Ms. Williams said, because it believed it needed to tell the agency only that some type of conflict of interest had been identified and that it had been “either reduced, managed or eliminated.”
Federal regulations, however, impose additional reporting requirements on researchers who collect more than $10,000 in a year from an outside company while also holding an NIH grant. Audits in recent years by the inspector general of the Department of Health and Human Services have repeatedly criticized both universities and the NIH for paying too little attention to rules governing financial conflicts of interest.
Bringing Conflicts to Light
The NIH is in the process of drafting new rules to toughen its financial reporting requirements on universities, “and not have these kinds of conflicts so easily hidden away,” Dr. Collins said in an interview last week with The Chronicle.
But the NIH doesn’t regard itself as an enforcement agency and doesn’t plan to change the basic understanding that universities have primarily responsibility for guarding against financial conflicts, Dr. Collins said.
Senator Grassley, however, said he’s concerned that new NIH regulations will have a limited effect if they are not accompanied by tougher enforcement. The NIH “has a responsibility to turn every lever it can to bring about transparency and accountability,” he said.
Baylor College of Medicine, meanwhile, is working to improve its own practices for handling financial conflicts of interest, Ms. Williams said. Before learning last month that the institution faced new grant-application conditions, she said, college officials had already begun “the process of changing our policy and procedure to comply with NIH standards.”