By PAUL THACKER
Well, they're finally out. What is it, a year, a year and a half, since they were promised? And let's not forget Cass Sunstein bumbling his way into the matter, and grabbing the attention of Senator Charles Grassley (R-IA) who nudged Cass into getting his act together.
Anyway, POGO has gotten an embargoed edition of the National Institutes of Health (NIH) rules on conflicts on interest [update: read them here], and we're ripping through them now. Here are the changes the NIH proposed:
Expanding the scope of the regulations to include SBIR/STTR [Small Business Technology Transfer Program/Small Business Innovation Research Program] Phase I applications.
Amending the definition of SFI [significant financial interest] to include a de minimus threshold of $5,000 for disclosure that generally applies to payments and/or equity interests as well as any equity interest in non-publicly traded entities.
Excluding income from government agencies of institution of higher education for seminars, lectures, teaching or service on advisory or review panels.
Expanding Investigator disclosure requirements to include SFIs that are related to an Investigator’s institutional responsibilities, with Institutions responsible for determining whether a disclosed SFI relates to the research for which PHS [Public Health Service] funding is sought and constitutes an FCOI.
Enhancing the information on an FCOI [financial conflict of interest] reported by the Institution to the PHS Awarding Component to include the information required under the 1995 regulations plus the value of the financial interest or a statement that a value cannot be readily determined, the nature of the FCOI, a description of how the FCOI relates to PHS-funded research, and key elements of the Institution’s management plant.
Requiring that before spending funds for PHS-supported research, an Institution shall post on a publicly accessible Web site information on SFIs of senior/key personnel that the Institution determines are related to the PHS-funded research and constitute an FCOI.
Remember, in the old rules, the only thing that had to be done was that the university had to tell the NIH that the researcher had a financial conflict and that it was being managed. That was it.
The new rule that is published at the Federal Register is extremely difficult to understand. What is new? It seems to be buried.
So what questions should you ask NIH Director Francis Collins?
QUESTIONS FOR DR. COLLINS:
- Who will disclose the significant financial interests of the researchers? Will it be the universities or the NIH?
- What exactly will be disclosed? Will there be exact amounts or levels? And how will the levels be done—in $10,000 increments? (Remember, Alan Schatzberg had $6 million in shares in a company)
- What will be the penalties for not disclosing? (Remember, the only thing that has happened thus far is that Dr. Charles Nemeroff had a grant temporarily shut down, as did Dr. Alan Schatzberg)
- Universities must now make a management plan to deal with the financial conflicts of the researcher. Will this plan be public? Will it be published on a website, or do you have to FOIA it? (This is critical, guys. How do you get the management plan to see if it’s being followed?!)
- How will universities deal with institutional conflicts?
BACKGROUND
These changes started moving forward back in 2008. At that time, Senator Grassley started hammering the NIH for funding researchers who had failed to report outside income from corporations.
I was the lead investigator on this matter, and we moved to fix the matter with the Physician Payments Sunshine Act, which was passed during healthcare reform. When we first introduced the legislation, I was uncertain if it would pass, and so I created a backstop by calling in HHS personnel to also fix their regulations.
If the Sunshine Act didn’t pass, at least we would get changes to the federal regulations. Below are some of the key investigations that led to passage of the Sunshine Act and the new regs out of HHS.
- Dr. Charlie Nemeroff, former Chair of the Psychiatry Department at Emory University, who failed to report hundreds of thousands of dollars in payments from GlaxoSmithKline while researching that same company’s drugs with an NIH grant. Dr. Nemeroff was bounced from Emory and has now taken over the Chair of Psychiatry at the University of Miami.
- Dr. Alan Schatzberg, former Chair of the Psychiatry Department at Stanford University received an NIH grant to study a drug while partially owning a company that was seeking FDA approval of said drug. An NIH oversight group recommended that Stanford’s clinical trial on mifepristone be “terminated immediately and permanently.” The recommendation was made because of concerns over conflicts of interest, patient safety and other issues.
- Dr. Joseph Biederman and two other researchers at Harvard University failed to report almost a million dollars each in outside income while heading up several NIH grants. Harvard later disciplined the three physicians.
Paul Thacker is a POGO Investigator.
about time
Posted by: big tilly | Aug 23, 2011 at 09:43 AM