Translational Research: Under Assault From the Bottom Line

One of the disheartening aspects of becoming a senior medical administrator is that you have the opportunity to view the health-care system from two sides.

From the Presidential suite, it is clear that there is increasing chaos in health care in the United States, characterized by blowouts of expenditures, falling patterns of reimbursement, a government that doesn’t have a solution to paying the bills, an inflated pharmaceutical bottom line, a profession faced with increasing uncertainty (and potentially inadequate staffing numbers in cancer care), and a public that fears the increasing costs of health insurance and copays while continuing to demand every innovation and therapeutic option, irrespective of cost and effectiveness. The Affordable Care Act, while well intentioned, clearly isn’t “working”—with a key problem being the counterpunching from the “red” states that have refused to accept federal dollars for their underserved populations, often without having an alternative plan. (On the other hand, a colleague in California recently thanked me for paying tax dollars to help with health care in his state!)

Viewed from the clinic, it is increasingly challenging to achieve all one’s goals—there never seems to be enough time to spend on complex patients (and the reimbursement for truly complex care certainly doesn’t reflect the effort that we put in). Moreover, the level of documentation to appease the lobbyists and politicians has become ridiculous (and certainly does not provide the protections for patients that were initially intended), the electronic medical record is frequently not our friend (particularly if we wish to get home at a reasonable time in the evening), and the complexity of rules, regulations, and other challenges has made medicine a somewhat less appealing vocation to the tyro prior to medical school … and, thus, our numbers are falling.

Emerging Casualty

Against this background, a less obvious emerging casualty is the ability to do clinical and translational research. We all know about falling federal (and other) dollars to support peer-reviewed research. Having participated in the federal review process for more than 20 years, and having chaired both the National Cancer Institute (NCI) Cancer Clinical Investigations Review Committee and the Veterans Affairs Merit Review Board in Oncology, in addition to membership of the NCI Cancer Centers Support Review Committee, Clinical Oncology Study Section, U.S. Food and Drug Administration Oncologic Drugs Advisory Committee, and several other review boards, it is so obvious at a personal level that the quality of science has increased exponentially, in contradistinction to the amount of work being supported by federal dollars. It is actually upsetting to see so many superb grants that just don’t make it.

Beyond that, however, the situation is worrying at a more subtle level. I have noticed a disturbing trend in which young physicians, clearly influenced by their mentors who have found it increasingly challenging to secure support for research, are moving to much more pragmatic approaches to medicine. It seems to me that fewer trainees are making the commitment to laboratory training—a real shame, as laboratory discipline certainly influences one’s pattern of thinking as a clinician in many beneficial ways.

Downstream from that, fewer clinical investigators are attempting to take on the challenging role of the “triple threat”—ie, educator, scientist, and clinician—with many contenting themselves to restrict their research to cooperative group trials when feasible. The problem is that we really aren’t seeing the hike in trial accrual that this trend could bring, which may imply that less research is actually being carried out.

Adding to the Problem

In addition to the issues of funding deficits and deteriorating investigator morale (and/or numbers), we need to be aware that the focus on the bottom line is adding to the problem. The leaders of hospitals and clinical departments are spending a dramatically increasing proportion of the working day (and night) trying to figure out how to pay the bills.

There is no doubt that our politicians are casting an increasing focus on the role of hospitals and physicians in contributing to increasing costs of health care, thus moving the focus from their own inadequacies and lack of solutions, and their failures in other domains. As a consequence, reimbursements are falling, contracting mechanisms have increasing stringency, and a much tighter focus on value is correctly being placed.

That said, the ability to conduct research and to pay for it has become much more convoluted. In the past, the well-established NCI practice of cost-shifting to centers was recognized but tolerated, as there was a global view that the clinical and translational research embedded in our trials and clinical work contributed to the greater good, and actually improved the quality of care and downstream treatment results. Thus, the fact that NCI reimbursement (for expenses related to entering, treating, and following patients) didn’t come close to having a valid cost-accounting basis was offset by the perceived benefits for the participation of cancer centers, their staff, and patients.

In today’s health economy, that construct is decreasingly valid, which could ultimately lead to a system of clinical research that fails. In that situation, the only winner will be the pharmaceutical industry, which already is diverting an increasing proportion of eligible trial patients to studies that benefit their own agendas.

Looming Medical Tragedy

Senior health administrators have the responsibility of keeping their hospitals and systems financially viable, and their focus on the bottom line is not optional. Those who value clinical research are faced with a substantial challenge—viz., two sides of the House that seem not to value our work and its downstream medical progress.

If our nation’s health-care system, under the influence of this type of government, doesn’t address this critical problem soon, the recent increments in trial accrual will fall to the lowest levels in more than 50 years, and progress in investigator-initiated and cooperative group studies will grind to a halt. While the pharmaceutical industry seems to have a lien on most of the interesting new agents, loss of the ability to have dispassionate and nonconflicted testing of the usefulness of these products will be a medical tragedy. ■

Disclosure: Dr. Raghavan reported no potential conflicts of interest.

Disclaimer: This commentary represents the views of the author and may not necessarily reflect the views of ASCO.