Letters from Grassley: Grassley to NIH Why No Disclosure on Resolved Conflicts of Interest at Baylor

Senator Charles Grassley’s (R-IA) latest letter to the NIH follows an article in The Chronicle of Higher Education that noted several academics with alleged research conflicts. In particular, he cited Dr. Christie Ballantyne of the Baylor College of Medicine, who received over $34,000 for consulting with Merck about the Vytorin cholesterol pill. Mr. Grassley saw this as a concern because Dr. Ballantyne was also listed on several NIH grants concerning cardiovascular studies (here’s one).

At issue for the Senator was a concern regarding undisclosed financial conflicts of interest among academics who simultaneously receive grants from the National Institutes of Health and payments from drug makers for research or speaking.

Dr. Ballantyne and other physicians carried out crucial research on ways to emphasize lower cholesterol. In a March 2006 news release from Merck and Schering-Plough, he is quoted as saying Vytorin was “significantly better than (Pfizer’s) Lipitor,” while acknowledging the need for further studies “to confirm these findings.”

When the Enhance study was completed in 2006, it showed the Vytoryn lowered cholesterol better than Zocor (one of two drugs comprising Vytorin that was, by then, available as a cheaper generic). The study failed to show better results in preventing plaque build-up in arteries. As a result, Vytorin sales plunged amid the controversy.

Dr. Ballantyne’s case however did not warrant explicit disclosure because NIH only asks the university to certify that any conflict is being “managed, reduced, or eliminated,” not specific disclosure of industry payments. Contrary to this notion, Mr. Grassley claimed that Baylor should have reported to NIH that Ballantyne received more than $10,000 from a company.

Lori E. Williams, a Baylor spokeswoman, noted that the Baylor College of Medicine was confident that its rules guard against any financial conflict of interest, and therefore saw no need to tell the NIH of payments by Merck to Christie M. Ballantyne. Once again, Mr. Grassley’s tireless efforts seem to hopelessly discredit the work of a valuable physician for a policy that was obviously followed.

Other critics, such as former NIH director Elias Zerhouni, acknowledged that “the problem is our current system of managing conflicts.” This quote is irrelevant to Dr. Ballantyne considering Baylor explicitly stated they were “managing” his conflicts, if any ever existed, closely.

Consequently, Mr. Grassley’s letter—or that of his staffer Paul Thacker—is clearly misguided.  In lectures, Dr. Ballantyne himself has always pointed out that the benefits of adding Schering-Plough’s Zetia to Zocor are unknown.  He even went as far as saying that he had “no interest in helping a company to increase market demand,” nor was the topic ever a “purpose of advisory meetings.”

Interestingly, the timing of Mr. Grassley’s letter came shortly after an amended lawsuit was filed by the Schering-Plough pension plan alleging that executives at the drug maker suspected back in 2005 that the Enhance study was a flop. (see the complaint)

Regardless of these other issues outside of Dr. Ballantyne’s specific research, Senator Grassley’s letter is uncalled for and unnecessary. While it is important that government oversight exists regarding grants given to academic medical institutions, there must be a level of trust and responsibility at those institutions to manage the recipients of those grants. Just because something appears to be a conflict does not warrant a threat or need for clarification by Mr. Grassley, especially and specifically when such an institution is already monitoring the matter.

Instead of wasting time trying to discredit work that saves the lives of patients, Senator Grassley should be working on more ways to give grants to physicians like Dr. Ballantyne to help Americans lower their cholesterol. If Mr. Grassley continues to hinder research and scare physicians from their work, the whole country is going to be in the emergency room for heart attacks that could have been prevented by research Dr. Ballantyne could have been carrying out.

Disclosure: I am a principal in Rockpointe Corporation, and the Potomac Center for Medical Education.  Our company has in the past received educational grants from Merck Schering Plough.

I have personally worked with Dr. Ballantyne on educational programs since 1996 and find him to be one of the most trust worthy and honorable scientists in cardiology and considerably more honorable than some of his critics.

Senator Grassley: Letter to Francis Collins Director National Institutes of Health