Few Universities File Conflict Of Interest Reports
5 CommentsBy Ed Silverman // November 19th, 2009 // 8:18 am
Few universities file required reports to the National Institutes of Health about financial conflicts held by their researchers, and even when such conflicts are reported, universities rarely require researchers to eliminate or reduce conflicts, The New York Times reports.
The paper writes that a report showing that 90 percent of universities relied solely on researchers to decide whether the money they made in consulting and other relationships with drug and device makers was relevant to their government-financed research (here is the report).
Moreover, half of universities don’t ask faculty members to disclose the amount of money or stock made from drug and device makers, and so the report concludes the potential for extensive conflicts with their government-financed research is often known only to the researchers themselves, the Times writes.
The Times reminds us that researchers are required to report to their universities any outside income that may conflict with government-financed research, and a lot of that comes from the NIH. Federal rules also require universities to manage conflicts. Sally Rockey, the NIH acting deputy director for extramural research, tells the paper that the agency announced in May it was considering changes to its conflicts of interest rules and the report recommendations would be considered.
The issue has received considerable attention due to a series of ongoing investigations by Chuck Grassley, an Iowa Republican on the Senate Finance Committee.
Photo thanks to Jerome Kassirer, author of ‘On The Take’
patrons99
This is an argument for repeal of the Bayh-Dole Act or the University and Small Business Patent Procedures Act which was codified in 35 U.S.C. §200 and implemented by 37 C.F.R. 401. This act reversed the presumption of title. Bayh-Dole permits a university, small business, or non-profit institution to elect to pursue ownership of an invention in preference to the government. A strong argument can be made that an unintended consequence of the conflicts of interest created by the Bayh-Dole Act and PDUFA (“Prescription Drug User Fee Act”) is the loss of integrity of clinical research in this country.
bullls23
such a mess.
BP Observer
Not at all a surprise. The major academic institutions that house most of the KOLs who receive big money really don’t want to know. In addition, since some of the biggest money contributors to academic research are the Big Pharma companies and they don’t want this cash stream to end, they don’t want to bite the hand that feeds them. The only way this will ever come to light is if they are required to reveal by enforcement of law.
martin brown
yea, the report sums it up. its a mess
Outside the Box
BP Observer is right but I would go further.
Much of the true innovation in research comes from these same institutions and turn into the bright new small biotechs from which big pharma is increasingly obtaining its pipeline - and this is another business process that nobody wants to end because (as patrons99 points out) these scientists have a huge vested interest in seeing their research turn into IP and profit.
At the innovation end of the market I don’t think these things constitute a conflict of interest that is harmless - quite the reverse. Where I think the potentially harmful conflicts exist is in the work done on existing products already owned and sold by big pharma.
Is there an option where the category of work being done can determine whether conflicts have to be disclosed? Work on products in research up to and including phase 2 would not constitute a conflict as up to this stage the product is really still a high risk research project. If the product is in phase 3 or later (for any indication and not just the one being researched) then the researchers must disclose all conflicts - by force of law.