When questioned last week by The Chronicle, the National Institutes of Health declined to comment on the cases of 14 university-affiliated physicians who took money from the drug maker Merck as part of the company's plan to promote its controversial anti-cholesterol drug Vytorin. Now Sen. Charles E. Grassley of Iowa is demanding that the NIH give some answers.
Senator Grassley, the top-ranking Republican on the U.S. Senate Finance Committee, wrote on Monday to Francis S. Collins, director of the NIH, saying he was "troubled" by the payments and wanted an explanation by November 16 as to how the agency would handle the matter.
The Chronicle, in an article this week, cited a letter from Merck to Senate investigators showing that Merck paid more than $400,000 to the 14 doctors as part of a strategy to sell Vytorin even though the company's own internal tests showed the drug, with several billion dollars in sales, was not significantly better than far cheaper alternatives for most patients.
Senator Grassley told Dr. Collins he was especially concerned that the Baylor College of Medicine said it saw no need to inform the NIH of the payments to one of its doctors, Christie M. Ballantyne, even though Dr. Ballantyne was also involved with several NIH grants that concern cardiovascular studies. A spokeswoman for the Baylor College of Medicine, Lori E. Williams, told The Chronicle that her institution felt it needed to tell the NIH about the matter only if it believed Dr. Ballantyne "had a relevant NIH grant."
When asked about the payments from Merck, Ms. Williams had said that the college's Conflict of Interest Committee reviewed all NIH grants involving Dr. Ballantyne "from 2007 and the years just prior in which human subjects were involved. None of these," she said, "involved any validating of any drugs produced by any company."
Senator Grassley said in his letter to Dr. Collins that Baylor, under NIH regulations, should have told the NIH that Dr. Ballantyne received more than $10,000 from a single company.
Dr. Ballantyne collected more than $34,000 from Merck during the company's program of payments, which ran from November 2007 to March 2008. At least four other university doctors paid by Merck during that period also had NIH grants in the same year. Spokesmen at some of the other universities told The Chronicle they found no financial conflicts or relied on the doctors or others to judge whether the physicians' work with Merck conflicted with their research for the NIH.
In the case of David E. Cohen, an associate professor of medicine at Harvard Medical School who was paid $50,488 by Merck, a university spokesman said the doctor's "financial interest in Merck was, in his judgment, not relevant to his NIH-funded research, and accordingly, under hospital policy and NIH regulations, it did not need to be disclosed in connection with his NIH grants."
In the case of Antonio M. Gotto Jr., dean of Weill Cornell Medical College, who was paid $27,146 by Merck, a university spokesman said the university counsel "determined that there was no conflict of interest with Dr. Gotto's advisory relationship with Merck and his role as institutional representative on Weill Cornell's NIH General Clinical Research Center grant."—Paul Basken