Senator Grassley has been investigating researchers of the NIH over alleged conflicts of interest at the Baylor College of Medicine (BCM) in Houston, Texas. Attention was brought to Baylor when an article in The Chronicle of Higher Education “pointed out several academics with alleged research conflicts, including Baylor’s Christie Ballantyne, who received over $34,000 for consulting with Merck about its Vytorin cholesterol pill.”
Once Senator Grassley got a hold of this information, he asked “NIH to investigate (see here), since Ballantyne was listed on several NIH grants concerning cardiovascular studies.” The issue at regarded whether researchers failed to comply with the agency’s conflict of interest policy.
NIH regulations state that any payment over $10,000 must be reported to the agency, and thus, Baylor should have reported to NIH that Ballantyne received more than $10,000 from a company.
Officials from Baylor however, stated that the rules “indicated there was no need to disclose the payments to the NIH.” As a result, the agency asked “Baylor to conduct a review and placed new conditions on Baylor researchers, requiring documentation that all new grants comply with NIH policies, according to a Jan. 14 letter from NIH Director Francis Collins to Senator Grassley (here is the letter).”
Director Collins wrote to Senator Grassley that the NIH conducted an investigation, and met with his staff to discuss the preliminary findings. Specifically, the investigation looked into whether 1) “significant financial interests, including any from Merck & Company and/or the Schering-Plough Corporation (Merck), were appropriately disclosed to the institution by the named invetigators; 2) the institituion reviewed investigator disclosures to determine whether a financial conflict-of-interest existed; and 3) any identified conflict was appropriately managed, reduce, or eliminated and reported to the NIH.”
As a result of this investigation, Weill Medical College of Cornell University and reported that “the investigators disclosed their financial interests from Merck and both institutions determined that the interests were not related to NIH-supported research.” Consequently, “those institutions did not identify any financial conflicts of interest to report to the NIH.”
Based on these findings, NIH Director Collins asserted that his agency would continue to engage with other grantees to obtain additional information, and the NIH has imposed “special award conditions on all BCM grant awards until BCM can assure the NIH that the detected deficiencies noted in their response have been appropriately addressed.”
Director Collins also asked BCM to “conduct a retrospective review of investigator financial disclosures for active NIH grant awards, for the period of 2004 to the present, to ensure that investigator financial interests were disclosed, reviewed and, where conflicts were identified, managed appropriately.”
Although investigators ultimately determined that the conflicts “were not related to NIH-supported research,” it is important to note that BCM will be making changes in response to the agency’s request.
Academic medical centers and researchers that work with industry provide a crucial relationship to advance medicine and treatments, which must be preserved. While this apparent mix-up should not be forgotten, the quick response of NIH and BCM to address this issue reveals the importance of having researchers continue working on both NIH Grants and with industry to develop the next generation of medicines.