Pressure’s building on the Office of Management and Budget to give a status update after Nature blog reported earlier this week that OMB may have tossed a rule proposed by NIH last year that would tighten conflict of interest reporting rules for biomedical researchers and institutions. Yesterday, Sen. Charles Grassley wrote to the Administration asking for documents related to the decision, and saying to rollback the rule “flies in the face” of its own transparency promise (hat tip Pharmalot).
In the spirit of disclosure, we supported the NIH rule in public comments with the Pew Prescription Project last year, and defended it here when university associations took aim at it late last summer. Despite progress among academic medical centers in tightening individual conflict policies, many AMCs still do not publicly disclose faculty ties to drug companies, and schools and investigators are left making the call if and what to report.
Meanwhile, media reports and industry-based disclosures like the Propublica ‘Dollars for Docs’ database show that millions of dollars are still moving from drug company to doctors’ hands. When those doctors are also doing tax-payer funded research that guides clinical practice and prescribing, we think the NIH–and the public–should know.
I talked to Dr. Sidney Wolfe of Public Citizen yesterday about the rule, the flap around conflict of interest at FDA, and just how hard it is to find an unconflicted expert around here.
PS: Many academic medical centers have strengthened or implemented better disclosure policies recently. And we have the Physician Payments Sunshine Act coming down the line. So why was this NIH rule needed? Where does its rollback leave us?
SW: Just think about the Dollars for Docs. Before a website like that (which only has data from the eight companies that currently disclose) you needed to go to each of the eight companies’ websites, instead of being able to get all of the information on a specific doctor at one place. Instead of having to write to every academic medical center, [the NIH rule] would put it in a user-friendly place subject to analysis.
And academic medicine revolted against it. They don’t want this, they don’t want medical students to easily out find what’s going on. Because if you are a med student, you may have a different view of your instructor who’s positive toward a therapy if you find out he or she is getting a considerable amount of money from the company who makes it.
There’s little doubt as to why the academy pushed against this rule. They don’t want people to believe members of their faculty have a bias. Of course, many still have to disclose it, but now it requires leafing through papers, or waiting for a FOIA request.
PS: What happened? Is this about budget woes, or pressure from industry and the universities?
SW: Nothing has happened yet. But from what [Nature reporter] Meredith Wadman reported, it certainly pushes away from what should have been now been finalized.
No one is disputing there is a big glitch in this process. I doubt whether out of a clear blue sky, [OMB's] Cass Sunstein says, Oh, that is not a good idea. I assume he read the letters, and he may be just more ideologically attune to academic medicine and those trying to fend off what was originally proposed by the government 15 months ago.
PS: Conflict of interest rules at FDA are also in the news after Commissioner Hamburg said at a Public Citizen meeting this week said that limiting financial conflicts has made it hard to fill advisory boards. But Health News Review and Project on Government Oversight offer lists of independent experts, and say the rule is not to blame. Is this a real problem?
SW: There’s no doubt that it’s more difficult to find someone without a conflict, but it’s obviously very important to do so, because these decisions are best made by people who don’t have a conflict of interest. The advisory committee I serve on, the Drug Safety and Risk Management Advisory Committee, had some empty slots, but the slots have all been filled now.
I don’t think there have been any committees that have not met because of unfilled slots. One could argue that having tougher conflict laws and missing two or three people on a committee actually makes the decision-making better. This decision-making is too important to be polluted with a conflict of interest.
There are two questions, and it’s not clear which Commissioner Hamburg was referring to.
Question A: Does someone get put on a committee or not?
and Question B is: Even if they are on a committee, should this person be recused from a given meeting? Someone with a conflict can also be given a “waiver,” but this happens much less than it used to six, eight, 10 years ago.
PS: NIH has rules around advisors’ conflicts, too. To be an NIH reviewer, one must receive less than $10,000 from an involved company per year, as I understand it. Do you know if NIH has similar vacancies, or problems finding unconflicted experts?
SW: NIH reviewers pretty much have a final say, whereas we are just advisors to the FDA. I doubt seriously that NIH will tell you that they have a very difficult time finding enough reviewers. And if it’s a little more difficult, remember, the whole purpose is to be as unfettered as possible. So it’s worth the extra effort.
interviewed by Kate Petersen, PostScript blogger