Life Science Compliance Update

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17 posts from October 2008

October 31, 2008

Conflict of Interest Inquisition: Scary Implications

The national press has been implying that interactions between physicians and pharmaceutical companies are sinister.   The tactic has evidently been to scare patients and show that politicians can come to the rescue.  Yet the effect of this approach may be much scarier than the supposed problem they're shining the limelight on.

 Paul Rubin, Emory Professor of Economics and Law, wrote in the Atlanta Journal Constitution this week that:

..there is no evidence at all that any of the alleged interactions between doctors and pharmaceutical companies has had any harmful effect on any patient. Here is a direct quote from one of the leading articles on the issue: “No study used patient outcome measures.” In other words, no one has actually looked at the effect of pharmaceutical marketing on the welfare of patients. Indeed, some of the researchers writing in this area profess not to care about patient outcomes. In an interchange I had with two authors in this tradition (in the Journal of the American Medical Association) they said that “this fact [that pharmaceutical promotion influenced physicians’ drug choices] rather than the possible merits of the choices themselves, should concern us as physicians.” So we have a set of policies based on an unproven assumption.

The article gives an interesting perspective on the Nemeroff situation at Emory.  To clarify this statement, according to the reports Nemeroff failed to follow an agreement that was made with NIH to disclose conflicts of interest, thus he failed to comply with the rules.   Rubin points out that this focus on conflict of interest will push physician researchers to avoid seeking NIH grants, thus less basic research.

Frank Lichtenberg, a health economist at Columbia University, has shown that newer drugs tend to reduce total health care costs and improve patient outcomes better than older drugs. The policies at issue here may reduce the availability and use of newer drugs because they will make it more difficult for academic physicians to undertake research on drugs and for physicians to learn about newer drugs that are developed. If this happens, patients will suffer — a perverse outcome for policies ostensibly designed to improve patient care.

Now this is a scary scenario

Atlanta Journal Constitution: If politician’s war on drugs continue, patients will suffer

October 29, 2008

AMA CEJA: Round 2

This past summer the AMA CEJA committee proposed elimination of commercial support of CME. This was soundly rejected by the AMA Membership.

The AMA Committee on Ethical and Judicial Affairs and the AMA Council on Medical Education are now joining up to write companion reports on commercial support for medical education for the House of Delegates meeting in June of 2009. 

This proposal, to begin the process, will be presented at the AMA House of Delegate Interim Meeting, November 8-11, in Orlando, Florida.

Joint Report of the Council on Ethical and Judicial Affairs and the Council on Medical Education

CEJA Report 1-A-08, “Industry Support for Professional Education in Medicine” - Update (Informational)

The CEJA committee understands that the last version of the 2008 CEJA report received input that was significantly in favor of referral back to the committee. (Translation: almost everyone thought it was a bad idea.) CEJA was urged to more fully address potential different implications for different stakeholders in medical education and seek further input from stakeholders.

In view of these concerns, the Council on Ethical and Judicial Affairs and the Council on Medical Education (CME) discussed the issues raised by CEJA Report 1 (A-08) and concluded that those issues can best be addressed by the two Councils working together.  Each committee has unique roles and responsibilities to take advantage of their differing areas of expertise and focus.

CEJA and CME appreciate the unique roles and responsibilities of each Council. To take maximum advantage of their differing areas of expertise and focus, the Councils will develop complementary, companion reports that provide ethical analysis and recommended guidelines (CEJA) and empirical analysis of existing strong practices and strategic recommendations for implementing ethical guidelines (CME). It is CEJA and CME’s intention to present these reports to the House at its 2009 Annual Meeting.

To help inform their work, CEJA and CME will jointly solicit focused commentary on key issues relating to commercial support for medical education. Invitations to comment will be extended to interested stakeholders, including consumer/patient advocates as well as professional organizations, through an open call for response posted on the AMA website. The comment period will open immediately following the 2008 Interim Meeting.

To ensure effective collaboration, the Councils’ respective work processes and products will be coordinated by a small joint work group composed of the Chair and Vice Chair of CEJA, the Chair and Chair-Elect of CME, and at least one additional member of each Council. The work group members will serve as representatives of and liaisons to their respective Councils.

It is encouraging that the AMA committees are opening up the process for input.  The last CEJA report was poorly thought out and only served to incense large constituencies at the AMA.  We applaud the AMA for opening up the process.

We anticipate seeing a more balanced statement from the AMA committees this go around.

AMA 2008  Interim Meeting

Full Agenda

CEJA – CME informational report

IOM Report: The Workings of the Crystal Ball

Earlier this summer we had written AAMC and Prescription Project --Telling the Future  about how the Prescription Project had received advance copies of the AAMC Taskforce on Industry Support for Medical Education report from which the Prescription Project wrote their implementation tool kit (released in advance of the AAMC report).  Also, we asked how was the NY Times able to write a story about the report for the Sunday newspaper in advance of the release of the report? 

It was told to me by several members of the Taskforce that all copies were “strictly” confidential.   At the time I had not put two and two together.  The AAMC Taskforce was funded by the Josiah Macy, Jr. Foundation.   This is the same Macy Foundation that brought us the Macy Conference - Missed Opportunity.  The mystery is over.

So what does this have to do with IOM?  Last week I attended a conference in which one of the speakers is member of the the Institute of Medicine report on Conflict of Interest in Medical Research, Education and Practice committee and he was going on and on about how the IOM works and about their meetings, and how the report is written.  It was impressive; the levels of review that the report goes through. 

At the end of the presentation, he mentioned that it is IOM policy that the sponsors get 10 days to review the reports prior to their release to the public.

The sponsors of the IOM report include “The Macy Foundation.”  So in March 2009 when the report is expected, we can look forward to journal articles, press releases, press kits, kits for universities, NY Times articles … all geared to a specific agenda.

Now we know the mystery of the crystal ball.

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