The challenges of academic physician-scientists in gastroenterology and hepatology: From managing indebtedness, securing grants, to managing conflicts

TY - JOUR

T1 - The challenges of academic physician-scientists in gastroenterology and hepatology

T2 - From managing indebtedness, securing grants, to managing conflicts

AU - Camilleri, Michael

N1 - Funding Information: Michael Camilleri M.D., Editor This work is supported in part by grants from the National Institutes of Health (RO1 DK 54681 and K 24 DK 02638) Ever since Wyngaarden 1 espoused the prediction that academic physician-scientists would become an endangered species, we have observed the intermittent pleas from authoritative bodies and Nobel laureates in Medicine 2 to ensure the species is maintained. With the focus of this journal on the interests of clinical gastroenterologists and hepatologists, it is important to analyze the opportunities available and the remaining challenges faced by the academic gastroenterologists and hepatologists who perform research that Brown and Goldstein would say passes the “handshake test”. 2 They perform research with live human beings, not only tissues or cell lines, animal models, or more basic techniques that are consistent with a broader definition of “clinical” research. More than ever before, we perceive the need for integrating medical scientific breakthroughs into clinical practice. This requires talented and dedicated handshake-based clinical investigators. The National Institutes of Health provide a spectrum of opportunities to support the preservation of the species. 3 The K23, K24, and K30 programs and the new extramural Loan Repayment Program for clinical researchers address some of the needs of physician-scientists. Early stages of research careers and didactic training in clinical research are supported through the K23 and K30 programs. Opportunities for mid-career clinician-scientists to provide mentorship are supported through the K24 program. The Loan Repayment Program provides financial incentives through the Clinical Research Enhancement Act: up to $35,000 per year (plus a 39% adjustment for taxes) for 2 or more years toward repaying educational loans are available for scientists who conduct clinical research. 4,5 This program will benefit 250 scientists per year. Recently, Wolf has called on medical schools, which are the primary cause of increasing debt among physician-scientists, to provide loan-forgiveness programs for individuals who conduct extended periods in postgraduate research. 6 This is all very positive, and the leadership of the NIH and the support of the public should be recognized by academia. So, you might ask, what are the challenges faced by clinician-scientists? Three seem to be of great significance and are actually interrelated. First is the acquisition of stable RO1 funding. The funding, nature, and actual conduct of the research continue to provide significant challenges. Clinical research is expensive, and the pace at which research can be conducted with appropriate sample sizes and meaningful endpoints requires the investigator to seek federal funding. The acquisition of preliminary data to develop a convincing application in the face of stiff competition is an arduous task; mentorship is crucial for the effective use of the resources from a K23 or R03 award (e.g., for a focused clinical research trial). Experience at the NIH in the last 30 years shows that M.D.s are much less likely to resubmit revised federal grant applications once initial submissions are unsuccessful. Early success is crucial because institutional or university support is limited or, in the current fiscal climate, withdrawn from those unable to “convert” from the K23 (with its very limited support of indirect funding to the university) to the RO1. RO1 is the sine qua non for academic advancement in the research arena, much favored by university authorities because of the coveted indirect funding. So many talented researchers move from academia to practice or the corporate world when there is a setback in the career development plan. Even in academic centers, reduced reimbursement for clinical activities leads the department chief to require more time in the endoscopy room, while the grant is prepared for resubmission. A successful outcome brings the investigator back on track; a grant review that says “approved but not funded” often leads to the reality check: clinical/educator track in the academic center, or a new career in practice or industry. For the successful grant recipients, there are significant challenges in the actual performance of clinical research, and delays result from the important regulations designed to protect human subjects. At my institution, the review process often involves a sequence of in-series (rather than in-parallel) reviews by the different review bodies. These might include a divisional/departmental research committee, radiation safety committee, institutional review board, biospecimens committee, or general clinical research center's advisory committee, followed by its implementation groups (flow chart, in-service for nursing support, data safety monitoring plan and patient advocacy review, and inclusion of minorities). For research involving contracts with industry sponsors, legal, intellectual property, and medical/industry relations' review are also required and, thankfully, these proceed in parallel with the other reviews. The protocol writing, meeting with the biostatistician, and finalizing the protocol for submission takes a meager 2 weeks in my laboratory. The regulatory review and approval process, on the other hand, takes up to 6 months. One requires determination and an incredibly tough skin to weave one's way through the forms, contingencies, recommendations (sometimes contradictory between well-meaning committees), responses, and revisions. Yet the toughest part of this uphill climb is still only starting! Clinical research can only be as successful as the recruitment of participants, which is often a function of the resources available to the research team. This leads to the second major challenge to clinician-scientists: the limited availability of funds to supplement the federal or foundation grants and the limited number of effective mentors in patient-oriented research. Much has been written about the lack of supplementation. The NIH K24 awards have provided a lifeline to support the time of the mentor, but only limited support is provided through the K23 and K24 awards for infrastructure or research costs of the mentees. Therefore, it is inevitable that the mentor and mentee involved in “handshake research” find it necessary to develop relationships with corporate sponsors. “Industry” provides opportunities for new mechanistic insights through novel medications, devices, and diagnostic or measurement technologies. Advances in the new biologies of genomics, imaging, and molecular biology are crucial to the success of patient-oriented investigation, in some instances to achieving success with NIH RO1 applications. In some fields of study, the need for this diversified portfolio allowing symbiotic relationships between federal and corporate sponsorship of patient-oriented research was established many years ago, e.g., by the National Cancer Institute. This is a plea for similar creative approaches to be brought to the fields of gastroenterology and hepatology. The NCI has shown that this approach brings clinician investigators into the field and provides mechanisms to expand their opportunities and funding. My personal experience as a K24 recipient is that I need to find $75,000 to $100,000 per year for each M.D. fellow on the NIH T32 training grant or K23-supported junior faculty who entrusts me with the responsibility of being his or her mentor in patient-oriented research. Carefully developed relationships with corporate sponsors provide a way to support the infrastructure, environment, and materials (e.g., novel pharmaceuticals) required for appropriate and successful mentoring. Yet this approach delivers a third challenge to the physician-scientist: the potential for conflict of interest. According to Dr. David Korn, of the Division of Biomedical and Health Sciences Research at the Association of American Medical Colleges, “Conflicts of interest are ubiquitous and inevitable in academic life, indeed, in all professional life. The challenge for academic medicine is not to eradicate them, which is fanciful and would be inimical to public policy goals, but to recognize and manage them sensibly and effectively.” 7 The public policy goals include the Bayh-Dole law, which empowers educational institutions, including not-for-profit organizations, to retain ownerships in patents developed with federal funding. Conflicts arise because individuals and institutions receive royalties or own equity in the company developing the invention. An even more common type of conflict arises when the physician-scientist is invited to participate in advisory boards, educational programs, or phase III protocol development for pharmaceuticals or devices. This work provides the academic with grants for support of research or a supplemental income that is used to pay off debts for medical education, or to partly redress the balance between income from their salaries as academics and the potential income in private practice. Such consulting may present further conflict if the physician-scientist or colleagues in the same laboratory or institution are evaluating the same or a competing medication or device concurrently. A personal financial conflict of interest is clearly intolerable when there is any risk to the patient or it could be perceived that decisions taken by the investigator were not guided solely by the best interests of the patient. Potential conflicts in research are most apparent when they apply to human research (defined by any protocol that requires review and approval by an institutional review board, including medical records and human biospecimen research 8 ). Conflicts also arise when non-human research performed by the investigator involves equity or licensed technology to which monetary value has been assigned. Several precautionary measures can address and manage these conflicts; this will be discussed in a future editorial. In summary, academic gastroenterologists and hepatologists performing “handshake” research face several challenges as they push the frontiers of medical innovation and navigate an increasingly complex regulatory environment. They experience tension whenever there is a setback in the career plan and the family advocates for a change to the more lucrative and potentially more comfortable lifestyle with an equally important career in clinical practice or in the corporate world. Mentorship and support are key to the preservation of the species of clinician investigators. The impact and immense contribution of programs established by the NIH will be apparent as more well-trained young investigators embark on careers in patient-oriented research. Creative approaches are needed to increase the funding available for the conduct of clinical trials and research: combined federal and corporate sponsorship programs should be developed to support patient-oriented research, mentoring, staff training, and clinical trials. The clinical investigator is indeed bewitched, bothered, and bewildered—but still beloved 2 at this and other journals.

PY - 2003/5/1

Y1 - 2003/5/1

UR - http://www.scopus.com/inward/record.url?scp=0141961621&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0141961621&partnerID=8YFLogxK

U2 - 10.1016/S1542-3565(03)70029-9

DO - 10.1016/S1542-3565(03)70029-9

M3 - Editorial

C2 - 15017484

AN - SCOPUS:0141961621

SN - 1542-3565

VL - 1

SP - 153

EP - 155

JO - Clinical Gastroenterology and Hepatology

JF - Clinical Gastroenterology and Hepatology

IS - 3

ER -