Medical Colleges And Universities Are Urged To Adopt New Guidelines On Conflicts Of Interest
3 CommentsBy Ed Silverman // February 28th, 2008 // 7:17 pm
The Association of American Medical Colleges and the Association of American Universities have just issued a report that, they hope, will provide a “roadmap” for medical schools, teaching hospitals, and major research universities to “identify, evaluate, and manage financial conflicts of interest in research that involves human research subjects.” (This is the report).
The groups note that recommendations were issued in 2001 and 2002, but concerns remains, especially in the wake of a scandal at the National Institutes of Health and and as academic institutions expand their relationships with industry. But a recent study revealed that, as of 2006, just 38 percent of the medical schools surveyed had policies addressing institutional conflicts of interest.
And so they issued these recommendations: accelerate the development of COI policies that cover the financial interests of faculty, institutions and their officials, including deans, department chairs, and division chiefs; implement a reporting, evaluation and management process for both individual and institutional financial COI, that includes a review system involving a standing internal committee or an external review entity, and complete the development and implementation of institutional COI policies in the next two years.
In a statement, Chuck Grassley, the Iowa Republican and Senate Finance Committee member who has investigated the topic, commended the groups: “These associations are setting worthy goals that ought to get the attention of America’s universities. Institutions need to be far more rigorous in monitoring the outside income of university researchers and faculty members from pharmaceutical drug and device companies. There’s evidence that this money can affect the objectivity and validity of research work, and the public deserves to know the facts in considering any potential conflicts of interest.”
Kyoto27
Looking back:
Was it any surprise that the May 9, 2007 vote on the Durbin Amendent –to reduce financial conflict of interest in FDA Advisory Panels ended as follows:
YEAS: 47
NAYS: 47
NO VOTE: 6
How much would you bet Ed that that vote was not just an accident? As long as votes can be bought like that, and as long as Congress and our regulatory authorities keep their head in the sand…we should not be surprised by the naked corruption and moral decay that is becoming a growing part of the American landscape.
Meanwhile, thank you Ed for keeping the Kleig Lights on –which helps keep the streets safer.
someone
This is a good first, albeit, small step in the right direction. However, it does not do enough. One would certainly hope that the AMA goes a bit further and ask that unless physicians can verify the raw data from the clinical trial by accessing all of it, and unless they truly actually write the final report/study then they should not allow their name to appear on it. Otherwise they should have to face the consequences.
This was actually recently suggested at a rather large International physician association.
This is the only way to increase and maintain the science portion of our healthcare. If we do not mandate integrity, marketing seems to be able to negotiate a price for it - the patients lose..
Tony Frost
The recommendations made here are not delivered in an impactful manner. Moreover, the advisory committee consisted only of university admiistrators, and not of clinical investigators, industrial sponsors or national regulators, all of whom would like clarity and harmonized practices throughout the research community. Simple, useful rules have been missed, e.g.,:
1. The investigator in a clinical trial cannot also be the patient’s usual clinical care-giver.
2. Clinical investigators, to the extent of the study being conducted at their site, should be included in Box 15 (or 14) of Form 1571 under the IND regulations.
3. Data safety monitoring boards should report directly to Institutional Review Boards.
4. Informed consent documents are the responsibility of Institutional Review Boards, and not the FDA where there is no idea of the local situation of the patients.
Rules such as these would be practical, unambiguous, and consistent.