Lead author Jordan J. Cohen, M.D., of the Association of American Medical Colleges (AAMC), Washington, D.C., presented the article today at a JAMA media briefing on medical research.
Dr. Cohen and co-author Elisa K. Siegel, A.B., of the AAMC, examined the status of medical research at academic medical centers.
"The present era offers more promise for progress in medical research than ever before. Contemporary science has deciphered the human genome, discovered some of the potential of stem cells, and unleashed the power of information technologies. Any one of these three historic scientific achievements would have the potential to effect a fundamental transformation in medicine; their confluence has created unprecedented opportunity for spectacular breakthroughs in human health."
The authors write that despite this promise for progress, many challenges await medical research:
- The need to manage high (and often unreasonable) public expectations for lifesaving discoveries.
- The need to maintain public trust despite the suspicions aroused by financial conflicts of interest.
- The need to sustain the cultural norms of academe while partnering with industry to promote technology transfer.
- The obstacles to recruiting and retaining physician-scientists to pursue translational research.
- The widening gap between the costs of research and available funding sources.
- The unfunded mandates with which investigators and institutions must comply.
- The need to transform an academic reward structure built to encourage individual scientists to pursue their own ideas into one that fosters teams of collaborating investigators to pursue "big science".
Promoting Public Understanding
"Having raised expectations with tantalizing promises of scientific breakthroughs, the research community has an obligation to help the public understand the process of medical research and the often uneven and incremental pace of progress that characterizes most medical discoveries," the authors write. "Academic medical centers, as sources of much of the advances in medicine, have a special role to play in managing the public's expectations and can do so by ensuring that public communications about their research developments are tempered with realistic assessments of their practical impact."
Managing Financial Conflicts of Interest
Financial conflicts of interest on the part of investigators and their institutions have the potential both to undermine the integrity of the scientific process and to compromise the safe conduct of human research. "According to a 2004 AAMC survey, the academic medicine community has made substantial progress in moving beyond the minimum requirements prescribed by federal regulations to strengthen the safeguards against conflicts of interest in human research. However, this survey also revealed that the academic medicine community still has more work to do to establish a uniformly robust set of policies and procedures. … Sustaining public trust in the medical research enterprise will, at minimum, require continued efforts to identify and address ways to improve the protection of human research subjects and to buttress the management of financial conflicts of interest."
Maintaining Academic Values
According to the authors, examples of the potentially damaging effects of academic-industry relationships include real or perceived pressures to relax scientific standards, inducements to become advocates (or shills) for industry, suppression of nonoptimal research results, incomplete or misleading descriptions and interpretations of trial results, and premature termination of clinical trials. "Academic medical centers and their industry partners must be willing to adopt more uniform, more robust, and more transparent standards governing their relationships if the mutual benefits of those relationships are to be sustained."
Sustaining Research Funding
In recent years, the growth of federal funding for medical research has decreased, with the NIH's budget growing by less than the rate of inflation. Compounding this restrictive fiscal climate are the increasing costs of modern science and of complying with the ever-increasing burden of government regulations.
"The White House Office of Science and Technology Policy and Office of Management and Budget have undertaken a cross-agency initiative to identify more efficient business models and to streamline agency requirements for federally sponsored research, giving rise to some hope that the federal government will at least partially restore the balance of responsibility that formerly characterized the historic federal-academic partnership in the country's research enterprise. If some relief is not forthcoming, some institutions may find it impossible to sustain their sponsored research programs."
"Academic medical centers face many difficult challenges in pursuing their research mission, and the interconnectedness of those challenges magnifies the difficulty. The ability to nurture and sustain a vibrant clinical research workforce in the future is heavily dependent on the ability to shift the academic culture and reward system away from the traditional paradigm focused on the individual investigator in favor of one that is more collaborative, team-based, and interdisciplinary," the authors write.
"The ability to sustain financial support for medical research in the face of constrained federal and state budgets is heavily dependent on managing unrealistic public expectations and on maintaining public trust. The ability to benefit optimally from the growing relationships with industry is heavily dependent on remaining true to fundamental academic values, including the safety of human subjects research, the integrity of the scientific process, and the free exchange of research results. The degree to which medical schools and teaching hospitals are successful in meeting these challenges will determine the degree to which the historic promise of modern medical science will be realized," the authors conclude.
(JAMA. 2005; 294:1367 - 1372. Available pre-embargo to the media at www.jamamedia.org.)
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JAMA