NIH grantees under the microscope?

Federal investigators are examining how the National Institutes of Health (NIH) oversees financial conflicts of interest among thousands of extramural scientists and grant recipients -- a decision biomedical research groups warn may lead to restrictions on industry-academic collaborations, ultimately inhibiting the translation of biomedical discoveries into therapies and diagnostics.

"There have to be interactions between those doing the research and those doing the translation," said David Korn, senior vice president for biomedical and health sciences research at the Association of American Medical Colleges (AAMC), which has prepared policy recommendations for academic and clinical researchers. If COI rules for extramural researchers are too Draconian, "you run the risk of interfering with" the search for cures and other health benefits, Korn told The Scientist.

"This is something we need to be very concerned about," said Howard Garrison, public affairs director at the Federation of American Societies for Experimental Biology, which has issued guidelines on industry interactions. "I would not want to see a situation where academic-industry collaborations are treated as something to be avoided or considered illicit, unwarranted, or bad," he told The Scientist.

In a March 23 letter made public last week (March 30), Department of Health and Human Services Inspector General Daniel R. Levinson said that the Office of the Inspector General (OIG) has started a study "to determine the extent to which the NIH oversees grantee institutions' financial conflict-of-interest issues."

The letter was addressed to Rep. Joe Barton (R-TX), ranking member of the House Committee on Energy and Commerce.

The topic was discussed in the pages of The Scientist in February.

At present, extramural researchers are not subject to the same federal laws and regulations that since 2005 have banned NIH staff and intramural scientists from consulting with or receiving other compensation from pharmaceutical and biotech companies. Rather, it is up to each university and research institute to establish and enforce COI guidelines and report infractions to NIH.

In his letter, Levinson also revealed that his office was re-examining 103 COI cases involving NIH intramural researchers, to determine whether further investigations are warranted.

The NIH had previously examined those cases following reports that numerous agency scientists and senior officials had received hundreds of thousands of dollars in consulting and other fees. Only one case, involving Trey Sunderland, former chief of the Geriatric Psychiatry Branch at the National Institute of Mental Health, ended in a successful conviction.

"We welcome the additional review," said NIH spokesman John Burklow. "We are confident in the process we used and the rigor in which we processed [investigations of intramural researchers] already," he told The Scientist.

However, not all officials are pleased with the NIH's previous efforts. "The NIH specializes in great science, not detective work, and it shows," Barton said in a statement. "I hope the inspector general's inquiry will finally sort things out so everyone can have confidence that the public's interest is being fully served."

"There is a giant hole in the way NIH conducted its investigation," said Ned Feder, an investigator with the Project on Government Oversight (POGO), which describes itself as an independent nonprofit group that exposes government corruption. "They were looking for documented evidence that the NIH had given its prior approval to paid consulting and other outside arrangements and not examining whether those arrangements actually created a conflict of interest," Feder told The Scientist.

Burklow and others said they unaware of any particular issue that may have triggered the IG's interested in extramural researchers. Donald White, spokesperson for the OIG, told The Scientist he had "no way of knowing" whether the decision to look into the NIH's oversight of conflicts of interest among extramural researchers will lead to any changes in rules about partnerships between academia and industry.

FASEB plans to release a set of COI proposals for NIH-funded extramural researchers during a summit in July with several dozen other research organizations.

Ted Agres
mail@the-scientist.com

Links within this article:

Financial Conflicts of Interest in Clinical Research -- AAMC
http://www.aamc.org/research/coi/start.htm

D. Korn and SH Ehringhaus, "NIH conflicts rules are not right for universities," Nature, April 14, 2005.
http://www.the-scientist.com/pubmed/15829935

T. Agres, "Code of conduct for industry cash: FASEB," The Scientist, July 17, 2006.
http://www.the-scientist.com/news/display/23966/

Letter from HHS Inspector General Daniel R. Levinson to Rep. Joe Barton, March 23, 2007
http://republicans.energycommerce.house.gov/108/news/03272007_DHHS.PDF


N. Feder, "Disclosure for extramural NIH researchers?" The Scientist, February 2007
http://www.the-scientist.com/article/display/43576/

Reminder of Financial Conflict of Interest Requirements for All NIH-Supported Institutions , Dec. 6, 2004
http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-05-013.html

T. Agres, "NIH bans all consulting," The Scientist, February 2, 2005
http://www.the-scientist.com/article/display/22586

Letter from NIH Director Elias A. Zerhouni to Rep. John Dingell, July 8, 2005
http://energycommerce.house.gov/Press_109/109-NIHltr-70805.pdf

T. Agres, "NIH defends consulting deals," The Scientist, January 23, 2004.
http://www.the-scientist.com/article/display/21953/

T. Agres, "Senior NIH researcher pleads guilty," The Scientist, December 11, 2006.
http://www.the-scientist.com/news/display/37502

HHS Inspector General to Reopen NIH Conflict-of-Interest Cases
http://republicans.energycommerce.house.gov/108/News/03302007_2126.htm

Project on Government Oversight
http://www.pogo.org