Tuesday, October 27, 2009

Sen. Grassley Asks For NIH Briefing on Violative/Undisclosed Vytorin-Baylor Links

Pharmalot has a much wider story on all of this -- but I wanted to focus on this notion, that at least under the Bush-Cheney Administration, certain science institutions felt it was within their discretionary purview to wholly-ignore NIH rules, and thus, applicable law -- if the institution felt the regulation's aim was already being addressed by it.

Astonishing. H/T Ed -- and here is the Senator's full-text letter to NIH:

October 26, 2009

Via Electronic Transmission
Francis Collins, MD, PhD
National Institutes of Health
9000 Rockville Pike
Bethesda, MD 20892

Dear Director Collins:

First, let me congratulate you on your new position as Director at the National Institutes of Health (NIH/Agency). Over the last several years, I have been examining conflicts of interest at your Agency, and I am sure that we will enjoy working together on this important issue.

As a senior member of the United States Senate and the Ranking Member of the Committee on Finance (Committee), I have a duty under the Constitution to conduct oversight into the actions of executive branch agencies, including the activities of the NIH. In this capacity, I must ensure that NIH properly fulfills its mission to advance the public’s welfare and makes responsible use of the public funding provided for, among other things, biomedical studies. This research often forms the basis for action taken by the Medicare and Medicaid programs.

I was troubled by a front page article in today’s The Chronicle of Higher Education discussing several NIH grantees with conflicts of interest regarding their research. I was drawn to one passage noting that Dr. Christie M. Ballantyne of Baylor College of Medicine received over $34,000 for consulting with Merck regarding the cardiovascular drug Vytorin. At the same time, Dr. Ballantyne is on several NIH grants that concern cardiovascular studies. According to current NIH regulations, Baylor should have reported to NIH that Dr. Ballantyne had received more than $10,000 from a company. However, the article states explicitly that Baylor was “confident that its rules guard against any financial conflict of interest, saw no need to tell the NIH of payments by Merck to [Dr. Ballantyne].”

Accordingly, I request that NIH brief my staff on this issue and explain how they plan on handling these allegations. I have attached a copy of the article to this letter, for ease of review. I thank you again for your continued cooperation. If you have any questions please contact my Committee staff, Paul Thacker at (202) 224-4515. All formal correspondence should be sent electronically in PDF searchable format to Brian_Downey@finance-rep.senate.gov by no later than November 16, 2009.


United States Senator
Ranking Member,
Committee on Finance

[Emphasis supplied.]


Anonymous said...

on top of that:

Obama Sides With Investors in Merck Lawsuit!

Condor said...

Yep -- now in a post of its very own!

Thanks, and do stop back!


Anonymous said...

So, Adminstration approval for investors against Merck.

Since they will inherit it, I wonder what that will do for Merck's thoughts re:S/P investors and the Enhance debacle?

Condor said...

I suspect it will go down a lot like the Vioxx defense did (for old Merck): that is, tough talk -- at first from New Merck -- then a massive global settlement -- perhaps multiple billions -- to write the entire sordid episode off.

That will be yet another trinket for Ex-CEO Fred Hassan's "after departure, multi-billion dollar losses" charm bracelet. BTW, he has at least three separate trinkets on the bracelet, already (Bextra, Celebrex and the ENHANCE-related sales losses, proper). Still to come are the litigation losses caused by the allegedly delayed disclosures -- and (most likely) a host of other matters we will only learn about, after close.