O/T COI-Feeling Heat Over Financial Conflicts, NIH Mulls New Rules for Grantees

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December 8, 2008, 10:01 am

Feeling Heat Over Financial Conflicts, NIH Mulls New Rules for

Grantees

Posted by E. Knight

Wall Street Journal Blogs - New York,NY,USA

http://blogs.wsj.com/health/2008/12/08/feeling-heat-over-financial-

conflicts-nih-mulls-new-rules-for-grantees/

The NIH, under fire from Congress for failing to crack down on

unreported financial conflicts of interest among academic

researchers receiving federal grants, came out with a plan to do

something about the problem on Friday. But it's going to take a

while.

Under current NIH rules, researchers are required to inform their

universities about any " significant financial interests " they hold

in research financed by the NIH. The threshold for income is

$10,000. In turn universities are obliged to inform the NIH of the

steps they've taken to manage, reduce or eliminate conflicts of

interest.

Critics charge the NIH hasn't being policing the university

researchers closely enough. In October, the NIH suspended a five-

year, $9.3 million grant to Emory, after Senator Chuck Grassley (R.,

Iowa) raised questions about drug industry payments to the chair of

the med school's psychiatry department.

At a Friday meeting of a committee advising the head of NIH, Sally

Rockey, the NIH's acting deputy director for extramural research,

highlighted parts of the regulations under review. Among the

questions being asked? Should researchers be required to disclose

all their sources of income if they get an NIH grant? Does the

definition of " significant financial interests " need to be changed?

And should universities be required to disclose the nature of the

conflicts of interest in their reports to the NIH? At present they

don't.

We watched a webcast of the event and the opinions differed among

committee members. One way to get a clearer picture of the sources

of researchers' income could be to take a peek their tax returns,

suggested one member — apparently in jest. " Do you want us to go

there? " he asked. Such a requirement would be " nuts " and create more

bureaucracy without solving any problems, he added.

Still, there seemed to be a consensus more needs to be done — at the

very least to avoid the perception by Congress and general public

that the NIH is ducking the issue.

For starters the NIH will tell the world that is proposing to make

some changes. Outside parties, including researchers, universities,

companies and individuals will have sixty days to chime in. Armed

with the feedback, the NIH can then start drafting new regulations.

" It'll be six months to a year before we can act on this, " said

Raynard Kington, the NIH's acting director. In the meantime, Kington

said the NIH would be " aggressive " in cracking down on research

institutions found flouting the existing rules.

Photo of the Capitol Dome by alykat via Flickr

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Deja Vu Again,

It has been only 18 years since the publication of " Are Scientific

Misconduct and Conflicts of Interest Hazardous to our Health? House

Report 101-688. 101st Congress, 2nd Session. 10 SEP 1990. " ,

coauthored by Rep. Pelosi, the Speaker of the House, to reform

the corrupted NIH system. It is sad to see the NIH is still playing

the same tune of " aggressive " cracking down after doing nothing for

more than two decades.

Comment by E.I. Cantekin - December 8, 2008 at 12:28 pm

At the NIH in the late '70s, there were very strict regulations

regarding outside consulting activities, particularly relating to

what was termed honoraria. Basically, you could't really work as an

outside consultant, but under some tightly regulated conditions, you

could receive honoraria.

————

In the 80s, they liberalized things a little. You still weren't

allowed to consult overtly, but you could receive more money in your

honorarium. A common subterfuge was a pharmaceutical company paying

your way to give a talk somewhere, then to pay you a generous

honorarium for giving the talk.

————

And the government instituted a program wherein a government

employee could share in the financial value of intellectual property

developed by the

employee. These measures were taken to retain gifted and productive

scientists, rather than losing them to the private sector.

Universities started also to do the same sort of things.

————

It's fairly apparent that things have gotten way more liberal, with

respect to what government employees are permitted to do. Government

and University employees are permitted, it seems, to work as private

consultants to all manner of private organizations, most prominently

pharmaceutical and biotech companies.

————

It would also appear that things have begun to run out of control.

This sort of thing is now a problem in everything from arthritis to

cholesterol to erectile dysfunction.

————

Maybe it will be worth it if it really does do something to

accelerate the

pace of discovery and development of new, more effective treatments.

The

willy-nilly dash for cash. But there will certainly be a price to be

paid, and

collateral damage to be endured.

Comment by the Hope & the Hype in Research - December 9, 2008 at

12:37 am

We have received NIH funding for over 20 years. When we present our

work at a national meeting, we are always asked if there is a

conflict of financial interest in this work. For most of us,

checking the box is our testament of truth. We could not live with

ourselves if we did otherwise. Why be in research? Unethical

behavior does not help anyone - it never does - it always backfires.

We can learn from the ones who were liars.

Comment by Prof. Tristram-Nagle - December 9, 2008 at

12:30 pm

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