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B The Endangered Physician-Scientist: Opportunities for Revitalization Emerge Leon E. Rosenberg Professor, Department of Molecular Biology, Princeton University and Timothy J. I.ey Alan A. and Edith L. Wolfe Professor Department of Internal Medicine, Washington University School of Medicine _ ~ n 1979 Wyngaarden wrote that physician-investigators (now genera ally called physician-scientists and defined as M.D.s or M.D./Ph.D.s _ ~ whose principal professional activity is research) were an endangered species (Wyngaarden, 1979~. This conclusion was based on an examina- tion of trends at the NIH concerning postdoctoral research fellows, re- search-career-development awardees, and research-project-grant-princi- pal investigators. Only now, more than 20 years later, has this prescient albeit unwelcome truth been widely accepted. No single publication or lecture overcame the denial and dismissal of Wyngaarden's message. Rather, it has taken work by several individuals (Ahrens, 1992; Gill, 1984; Goldstein and Brown, 1997; Rosenberg, 1999, 2000; Schechter, 1998; Thompson and Moskowitz, 1997; Williams et al., 1997) and an impressive number of organizations, including the Institute of Medicine (Kelley and Randolph, 1994), the NIH Director's Panel on Clinical Research (Nathan, 1998), the National Research Council's Committee on National Needs for Biomedical and Behavioral Research (NRC, 2000), the American Medical 1A number of individuals generously provided us with information for this report: Marc Horowitz, Ruth Kirschstein, Burton Shapiro, and Judith Vaitukaitis of the National Insti- tutes of Health; Andrew Quon of American Association of Medical Colleges; Carl Rhodes of the Howard Hughes Medical Institute; and Hui Wen Chan and Tamara Zemlo of the Federation of American Societies for Experimental Biology. 60

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APPENDIX B 61 Association (AMA, 1996), the Association of American Medical Colleges (AAMC, 1999), and the Federation of American Societies for Experimen- tal Biology (Zemlo et al., 2000) to achieve consensus that a serious prob- lem exists. EVIDENCE FOR ENDANGERMENT There are threats to the physician-scientist career path throughout its length and breadth. ∑ During the 1990s there was a progressive, statistically significant decline in the intention of matriculating and graduating medical students to pursue a research career. This decline was noted at the most research- intensive medical schools as well as those with less research activity. A distinctly smaller fraction of female students, who now constitute about 49 percent of all medical students, expressed stronger research intentions than did their male counterparts (Guelich et al., under review). ∑ During the 1990s progressively fewer M.D.s obtained postdoctoral research training positions from NIH (Rosenberg, 1999~. This conclusion was reached by summing all of NIH's training mechanisms for M.D.s (T32, F32, K04, K08~. ∑ In the past several years there has been a decline in the number of first-time M.D. applicants for research project grants, a trend not observed for M.D./Ph.D.s or for Ph.D.s (Rosenberg, 1999~. ∑ M.D.s constitute a progressively smaller fraction of members of chartered NIH review panels, a trend that has been ongoing for 20 years (Zemlo et al., 2000~. ∑ There has been a progressive shift toward older age of M.D. princi- pal investigators supported by NIH. In 1977, 56 percent of NIH principal investigators with the M.D. degree were less than 45 years old. In 1997 this fraction had fallen to 44 percent (Zemlo et al., 2000~. ∑ Since the 1970s the number of Ph.D.s applying for NIH grants has grown much faster than the number of M.D. applicants. Whereas M.D.s and M.D./Ph.D.s made up 43 percent of NIH principal investigators in 1970, they account for less than 30 percent now, despite having a success rate indistinguishable from that for Ph.D. applicants (Rosenberg, 1999; Zemlo et al., 2000~. ∑ The total number of physicians engaged in research has declined over the past 15 years, while the total number in practice has increased dramatically; He percentage of all physicians engaged in research has, therefore, decreased sharply over this period of time (Zemlo et al., 2000~.

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62 APPENDIX B TWO GENERAL MECHANISMS FOR BECOMING A PHYSICIAN-SCIENTIST The historical pathway to becoming a physician-scientist is the post- doctoral (or "late bloomer") one. These M.D.s become seriously interested in research during their clinical residency (two to three years) and sub- specialty years (two to three years). This interest is then pursued during an additional three to six years devoted exclusively, or nearly so, to labo- ratory, patient-oriented, or epidemiologic study. In contrast, the second pathway starts at medical school matriculation, when candidates enroll in combined M.D./Ph.D. programs leading to receipt of both degrees in seven to eight years. These pathways differ in many ways other than when the career choice is made. First, the late-bloomer pool remains far larger than that of the M.D./Ph.D.; M.D.s still account for about 70 percent of physician- scientists serving as principal investigators on NIH research project grants. Second, M.D./Ph.D.s generally complete their formal education with a much smaller debt burden than do those with an M.D. degree only, because M.D./Ph.D students usually receive tuition and stipend support from the NIH or other agencies. Third, the kind of research these two groups do tend to differ. M.D./Ph.D. students frequently perform their thesis work in basic science departments, which are naturally focused on basic research. Their initial research topic is often not influenced by clini- cal experiences. M.D. postdoctoral candidates, on the other hand, gener- ally select a research topic based on their own experience with sick people. This results in a far higher fraction of late bloomers being engaged in disease-oriented and/or patient-oriented research. Fourth, the number of people seeking the M.D./Ph.D. route is growing, whereas the number of late bloomers is declining, making this subset the truly endangered one. WHY PHYSICIAN-SCIENTISTS MATTER How important to the health of the public is this endangerment of physician-scientists? What is the proof that they matter? A definitive an- swer to these provocative questions could be obtained by permitting phy- sician-scientists to disappear over the next generation and then assessing the impact on health research, health care, and health status. We hope this Swiftian knockout experiment will be rejected in favor of reasoned argu- ments. First, physician-scientists continue to make major contributions to health research. If one takes the Nobel Prize in physiology or medicine as the ultimate emblem of scientific distinction, M.D.s have done well, gar- nering about 50 percent of all such awards during the past 50 years. Let us

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APPENDIX B 63 mention just a few of the discoveries these Nobelists and others have made. Physician-scientists doing basic or disease-oriented research have discovered oncogenes, the low-density lipoprotein receptor, priors, HIV, pulmonary surfactant, and the genes responsible for cystic fibrosis and Huntington's disease. Those doing patient-oriented or epidemiologic in- vestigation have pioneered in the eradication of smallpox; the near eradi- cation of polio; the cure of childhood leukemia, Hodgkin's disease, and testicular cancer; the development of open heart surgery and of organ and bone marrow transplantation; and the elucidation of means to decrease mortality due to heart attacks and strokes. Based on this past performance there is every reason to expect that physician-scientists will make equally important contributions in the new millennium. Second, whereas medical school education is not aimed at teaching one how to obtain scientific answers, it is the ideal place to raise a wide range of questions about health and disease that can be answered only through basic or applied research. It is the questions that physician-scien- tists ask because of their involvement with sick patients that distinguish their approach to research, and that make them critical members of the health research workforce. These questions should be even more robust in the postgenomic era, and more capable of being answered. Third, the bridge between bedside and bench depends on bidirec- tional traffic and communication. Physician-scientists are in an ideal posi- tion to communicate and collaborate with Ph.D. scientists on one side and with health care providers on the other. They can make the strongest case for the clinical relevance of basic research to legislators, advocates, and health agencies. Without physician-scientists the bridge will weaken, per- haps even collapse. This would have serious implications for the funding of health and medical research because the public supports such invest- ments in the hope of securing longer, healthier lives they want to see science translated into cures. The public supports medical science not for what it is, but what it is for. REASONS FOR ENDANGERMENT Why is the physician-scientist career path in decline just when scien- tific opportunities to diagnose, treat, cure, and prevent disease have never been greater? This paradox has many explanations, which affect all par- ticipants in the pathway and all stages of development. College students interested in medicine are too often advised that they can become either a physician or a scientist but not both unless they are superstars who can be accepted by the M.D./Ph.D. programs at medical school, which enroll only about 2 percent of all medical students. Medical school admission committees reinforce this view in that they tend neither to try to recruit

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64 APPENDIX B students with experience or interest in research nor to indicate that it is plausible and exciting to be a physician and a scientist. Thus most ma- triculating medical students focus exclusively on becoming clinicians. The opportunity for medical students to try their hand at research varies widely. A few schools require all their students to conduct a re- search project and to write a doctoral thesis. At such schools as many as 50 percent of medical students take a year out to do research, but these patterns are the exception, not the rule. Most students at most medical schools have no research experience. They graduate with a great deal of information about sick people and a great deal of debt, now averaging nearly $90,000. After graduation, exposure to research depends on the specialty chosen and even more the subspecialty. These are the critical years for the late bloomer. Such individuals require lengthy, rigorous research experience equivalent to a Ph.D. in either laboratory, patient- oriented, or epidemiologic research. Too often the subspecialty fellow- ships provide scientific training that is too narrow, too abbreviated, and too superficial to provide a foundation for a long research career. Too often the stipends are insufficient to meet individual or family responsi- bilities and repay enormous medical school loans. For those intrepid enough to soldier on and achieve faculty status, the challenges continue, and perhaps grow even larger. One must have pro- tected time to establish an independent research program, usually at least 75 percent of effort in the first three to five years. Such protection is required to obtain research grant funds and build a team. Such protection is now very difficult to find in clinical departments, particularly in this era of managed care with its resultant demands to see more patients so that the clinical earrungs that most departments depend on will be maintained. Once having risen to the status of an established investigator with ad- vanced faculty status, it remains necessary to obtain and re-obtain exter- nal funds from NIH or other sponsors in an environment that is extremely competitive. The emotional and structural barriers just described are daunting. If we are to revitalize the physician-scientist career path and refill the hu- man pipeline, these barriers must be lowered or better still, removed, so that the decisions made by would-be physician-scientists will be tilted toward the great excitement they can have doing science in the name of health. EMERGING OPPORTUNITIES We are encouraged by a series of recent developments aimed at offer- ing incentives and removing disincentives.

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APPENDIX B 65 ∑ The Clinical Research Enhancement Act, signed into federal law in 2000, finds that "clinical research is critical to the advancement of scien- tific knowledge and to the development of cures and improved treatment for disease." It provides for "increasing the involvement of the NIH in clinical research." Among its many provisions the Act directs the NIH to establish a broad extramural loan repayment program (LRP) for M.D.s engaged in training in clinical research. This program was initiated in 2002, and will provide a maximum of $35,000 per year of loan repayment plus the taxes on this "income" for up to three years of training. Clinical research is defined broadly so that a large number of M.D.s with identifi- able NIH support will be eligible for funding through competitive re- view. The total number of awards in the first year was 250, growing to at least 500 in later years. ∑ Two other extramural loan repayment programs was initiated in 2002, as well. One is for individuals engaged in basic or clinical pediatric research. The other is for members of disadvantaged minorities engaged in minority health disparities research. The financial terms of these pro- grams will be identical to that of the Clinical Research Enhancement Act loan repayment programs. The number of individuals to be recruited has not yet been set (M. Horowitz, personal communication, 2001~. ∑ The NIH also supports focused loan repayment programs for train- ees in the intramural program working in any of four areas of special need: AIDS; underrepresented minorities doing clinical research; contra- ceptive and infertility research; and general research. There are currently 152 individuals in these programs. The financial terms of these awards are identical to those described above ~ M. Horowitz, personal communi- cation, 2001~. ∑ In response to recommendations of the Director's Panel on Clinical Research and the Clinical Research Enhancement Act the NIH has estab- lished three new mechanisms aimed at enhancing the career development of physician-scientists doing patient-oriented research. The Mentored Patient-Oriented Research Career Development Award (K23) provides five years of salary and research support to a current total of 279 awarders. It is aimed at young investigators in transition from fellowship to junior faculty. The Mid-Career Investigator in Patient-Oriented Research Award (K24) provides "protected research time to . . . clinical investigators by relieving them of patient care and administrative responsibilities." It is a five-year award currently held by 158 people. The Institutional Curricu- lum Award (K30) aims "to provide didactic multidisciplinary training in the fundamentals of clinical research." There are currently 55 such pro- grams supported, and new ones are being considered a Vaitukaitis, per- sonal communication, 2001~.

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66 . APPENDIX B The Medical Scientist Training program (MSTP) of the NIH has slowly increased in size. In 1996 the program supported 833 M.D. /Ph.D. students at 33 medical schools. In 2001, 927 students were supported at 39 schools (B. Shapiro, personal communication, 2001~. ∑ The NIH has been authorized by the FY2001 appropriation to in- crease He salary cap on its research grants from $141,000 to $157,000. ∑ In 2001 He Howard Hughes Medical Institute appointed 5 to 10 new investigators who conducted patient-oriented research. Nominees at He assistant, associate, or full investigator levels were considered from medical schools, hospitals, and schools of public health. Most of those appointed held the M.D. or the M.D./Ph.D. degrees (C. Rhodes, personal communication, 2001~. ∑ A growing list of not-for-profit agencies, now numbering at least 12, provide support for the training and career development of physician- scientists (Chan and Zemlo, 2001~(see Table B.1) in three categories: fellowships; awards to junior faculty; and awards to senior faculty. The newest sponsors on this roster are the Doris Duke Charitable Trust and He Damon Runyon Fund. ∑ A growing number of academic institutions (e.g., Duke, Harvard, Johns Hopkins, Yale, UCLA, and Washington University) have devel- TABLE B.1 Nonprofit Organizations Supporting Training and Career Development of Physician-Scientists Stage of Support Offered Fellow Junior Senior Organization Faculty Faculty American Cancer Society American Federation for Aging Research X American Gastroenterologic Association American Lung Association American Society of Hematology Berlex Foundation Burroughs Wellcome Fund Damon Runyon Fund Doris Duke Charitable Trust Leukemia and Lymphoma Society National Foundation for Infectious Diseases Rockefeller Brothers Fund X X X X X X X X X X X X X X X X X SOURCE: Modified from Chan and Zemlo (2001). The list should be seen as illustrative rather than comprehensive.

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APPENDIX B 67 aped degree-granting postdoctoral programs in clinical research for M.D.s. Some of these programs offer a Ph.D. in clinical science; others offer master's degrees. These multiyear programs combine didactic and mentored research experience. ∑ The Association for Patient-Oriented Research was established in 1999 and has already had two annual meetings at which research directly involving patients has been presented by investigators from departments of medicine, surgery, pediatrics, and psychiatry. This association now has more than 300 members from the United States and abroad. RECOMMENDATIONS This list of opportunities demonstrates that some of the key players in the health research enterprise recogruze the imperative to revitalize the physician-scientist career pathway. These steps are good ones and we hope will catalyze other actions by these and other participants. But much more must be done. For example, doubling the number of students in the MSTP program (as recommended by the Federation of American Societ- ies for Experimental Biology) is justified by the large applicant pool and the positive outcome of those so trained. But this action alone will not solve the problem of M.D.s doing clinical research with patients. A larger and broader NIH loan repayment program for M.D. post- doctorals in both the intramural and extramural programs of the NIH would further mitigate this key economic disincentive. Such a program should support M.D.s training in basic as well as applied research, be- cause such diversity of training will enhance the contributions made by future physician-scientists. In like fashion, tuition relief for medical stu- dents taking a full year out of medical school to do research would be an inducement for more students to get this early kind of exposure. Nonmonetary efforts are also important for revitalizing the pathway. Medical schools can take steps to make it clear that an interest in research is one of the qualities sought in their applicants and can strive to reduce the gender gap in research intentions between male and female medical students. Successful academic physician-scientists must make it an ongo- ing priority to talk with students and residents about the excitement and gratification they have experienced doing research. The NIH and the Na- tional Research Council should define national goals for the number of physician-scientists needed in the long term and develop a national data- base to continuously monitor key trends concerning physician-scientists. It has taken a generation for the endangerment of physician-scientists to be acknowledged. It will take at least another generation to restore the physician-scientist cadre to its rightful size and diversity. Just as medical

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68 APPENDIX B research is viewed as a national priority that offers hope to sick people, revitalizing the physician-scientists career paw should be viewed as a national priority Mat offers hope for the continued success of medical research. REFERENCES Ahrens, E. H., Jr. 1992. The Crisis in Clinical Research, Overcoming Institutional Obstacles, p. 236. New York: Oxford University Press. American Medical Association. 1996. Proceedings of the Conference on Clinical Research: Ad- dressing the Future in a Changing Environment. Chicago, IL: AMA Press. Association of American Medical Colleges. 1999. Breaking the Scientific BottleneckóClinical Research: A National Call to Action. Washington, D.C.: Association of American Medical Colleges. Chan, H. W., and T. R. Zemlo. 2001. Summary of research foundation support for the training and career development of physician-scientists. Federation of American Societies for Experimental Biology. Gill, G. N. 1984. The end of the physician-scientist? American Scholar 53:353-368. Goldstein, J. L., and M. S. Brown. 1997. The clinical investigator: bewitched, bothered, and bewilderedóbut still beloved. Journal of Clinical Investigation 12:2803-2812. Guelich, J. M., B. H. Singer, M. C. Castro, and L. E. Rosenberg. Under review. A gender gap in the next generation of physician-scientists: Medical student interest and par- ticipation in research. Nathan, D. G. 1998. Clinical research, perceptions, reality, and proposed solutions. Journal of the American Medical Association 16:1427-1431. National Research Council. 1994. Careers in Clinical Research, Obstacles and Opportunities. W. N. Kelley and M. A. Randolph, eds. Washington, D.C.: National Academy Press. National Research Council. 2000. Addressing the Nation's Changing Needs for Biomedical and Behavioral Scientists. Washington, D.C.: National Academy Press. Rosenberg, L. E. 1999. The physician-scientists: An essential arid fragile link in the medi- cal research chain. Journal of Clinical Investigation 103:1621-1626. Rosenberg, L. E. 2000. Young physician-scientists: Internal medicine's challenge. Annals of Internal Medicine 133:832. Schechter, A. N. 1998. The crisis in clinical research. Journal of the American Medical Associa- tion 16:1440-1442. Thompson, J. N., and J. Moskowitz. 1997. Preventing the extinction of the clinical research ecosystem. Journal of the American Medical Association 3:241-245. Williams, G. H., D. W. Wara, and P. Carbone. 1997. Funding for patient-oriented research. Journal of the American Medical Association 3:227-231. Wyngaarden, J. B. 1979. The clinical investigator as an endangered species. New England Journal of Medicine 23:1254-1259. Zemlo, T. R., H. H. Garrison, N. C. Partridge, and T. J. Ley. 2000. The physician-scientist: career issues and challenges at the year 2000. FASEB Journal 14:221-230.