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Healthy Skepticism Library item: 14494

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Emory Creates New Conflict Oversight, Announces New Disclosure Requirements
PharmaLive 2008 Oct 13
http://pharmalive.com/news/index.cfm?articleID=577722&categoryid=9&newsletter=1


Full text:

Emory University announced today it has created a new University-wide central office to oversee administration and enforcement of conflict of interest (COI) policies.

The institution also informed Emory researchers of new financial disclosure regulations that will apply to investigators on new and pending National Institutes of Health (NIH) grants.

Emory’s provost and executive vice president for academic affairs, Earl Lewis, PhD, and executive vice president for health affairs, Fred Sanfilippo, MD, PhD, said the oversight move has been discussed for months as the scale of research at the institution has grown dramatically. Last year, for the first time, sponsored research at Emory passed the $400 million mark.

“We understand the need for integrity in research. We believe creating oversight of conflict of interest issues in a new central office will help us ensure strong conflict of interest policies and procedures University-wide,” Lewis and Sanfilippo said. The new office will report to David Wynes, PhD, vice president for research administration at Emory.

Although Emory’s School of Medicine continues to have the most sponsored research of any division at Emory, growing numbers of studies are also found in Emory College, the Rollins School of Public Health, the Woodruff School of Nursing, the Yerkes National Primate Research Center, and elsewhere at Emory. COI administration has been based in the School of Medicine since the inception of such research protocols in the mid- 1990s.

Wynes wrote to Emory researchers last Friday to notify them of new disclosure requirements related to new and pending NIH grants. The full text of the letter is posted at http://www.osp.emory.edu.

In other recent actions, Emory announced that:

Dr. Charles Nemeroff, professor of psychiatry and behavioral sciences, is voluntarily stepping aside as principal investigator or co-investigator on all NIH grants at Emory, pending resolution of the COI questions raised by Senator Charles Grassley (R-Iowa).

Dr. Steven Levy has been appointed acting chair of the department, again pending resolution of the COI issues raised by Senator Grassley. Nemeroff had earlier announced that he was stepping down voluntarily as department chair until the current questions are resolved.

Emory officials are currently conducting an internal review of the allegations raised by Senator Grassley and have promised a fair, thorough, and evenhanded investigation of these claims.

Dr. Nemeroff is cooperating with the investigation and has assured Emory officials that: “To the best of my knowledge, I have followed the appropriate University regulations concerning financial disclosures. I have dedicated my career to translating research findings into improvements in clinical practice in patients with severe mental illness. I will cooperate fully and work with Emory to respond to the alleged conflicts of interest issues raised by Senator Grassley and his staff.”

 

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Cases of wilful misrepresentation are a rarity in medical advertising. For every advertisement in which nonexistent doctors are called on to testify or deliberately irrelevant references are bunched up in [fine print], you will find a hundred or more whose greatest offenses are unquestioning enthusiasm and the skill to communicate it.

The best defence the physician can muster against this kind of advertising is a healthy skepticism and a willingness, not always apparent in the past, to do his homework. He must cultivate a flair for spotting the logical loophole, the invalid clinical trial, the unreliable or meaningless testimonial, the unneeded improvement and the unlikely claim. Above all, he must develop greater resistance to the lure of the fashionable and the new.
- Pierre R. Garai (advertising executive) 1963