I found this report very worrying. This situation, if true, certainly seems to be compromising academic and ethical integrity.
It's worth pointing out that the 'funder' and the 'sponsor' are not always the same. In my experience, we seek external funding for research, but the funder is not the sponsor. That position is usually taken by the employing organisation (in my case a university). The sponsor is then responsible for the conduct of the research, so if any negligent or non-negligent harm were to be caused, they would be liable.
Maybe we just have more ethical funders in the UK: they want results from the research they pay for, but I don't think they demand control over the data or the dissemination of results.
I would have thought that 'ghost-writing' articles could be seen as research misconduct - see the Committee on Publication Ethics data available at:
http://bmj.bmjjournals.com/talks/ 

Dr. Andrew Symon
Senior Lecturer
School of Nursing & Midwifery
University of Dundee


>>> [log in to unmask] 27/05/2005 16:27:02 >>>


----- Original Message ----- 
From: Roy Poses 
To: [log in to unmask] 
Sent: Friday, May 27, 2005 4:21 PM
Subject: NEJM study of contracts between medical schools and corporate research sponsors


I urge you to look at a very important study of the ethics of clinical research that just appeared in the New England Journal of Medicine.
The study is on the web here, and its full citation is: Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352: 21. 
I have put a brief summary of the results, with comments, on the Health Care Renewal blog.  The specific posting is here.
In short, this is the first systematic study showing that many medical schools are willing to sign contracts with corporate research sponsors that give the sponsors significant ability to manipulate the design, analysis, and interpretation of clinical research so that the results are likely to be in the sponsors' favor.
For example, 50% of medical schools surveyed would acquiesce to a contract provision that allows ghost-writing, specifically allowing the sponsor to write manuscripts reporting clinical trial results, and only allow the university based investigators to "suggest" changes.  
This study raises major questions about the validity of published clinical research, and the governance of medical schools, their parent universities, and their academic medical centers.  Although the study was done in the US, given that many sponsors and clinical trials are international, and given that ghost-writing has been identified in the UK as well as the US, these questions likely have global implications. 

Roy M. Poses MD

Brown University Center for Primary Care and Prevention
Memorial Hospital of Rhode Island
111 Brewster St.
Pawtucket  RI  02860
401 729-3400
fax 401 729-2494
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