“Collaboration among industry, government, and medicine in the pursuit of clinical research is critical to driving scientific progress, particularly as industry increasingly replaces government as the primary source of research funding.” With a statement that shows such ardent and obvious support for the need of industry support in clinical research, why is the Center for Health & Pharmaceutical Law & Policy at the Seton Hall Law School which authored that statement, trying to hurt American medicine by deterring researchers from participating in such studies?
In their recently issued a 62-page paper, (written by attorneys) they suggest greater oversight of the financial relationships with doctors in research.
The recommendations by the Seaton Hall attorneys included:
– The federal government should bar payments solely for a referral to a trial; payment tied to screening potential trial participants, and bonuses for recruiting or retaining a certain number of participants.
– The federal government should also prohibit compensation for research in the form of an equity interest in the sponsor of a clinical trial.
– Federal policy should specify certain conflicts, such as stock holdings, that will disqualify a researcher from serving as an investigator.
– Review and management of investigator or institutional conflicts prior to the time that research begins should be mandated by regulation and subject to contemporaneous government oversight.
– Before research begins, research sponsors should report to the FDA and recipients of federal grants should report to the granting federal agency relevant equity and ownership interests as well as all payments…to the investigator and the investigator’s institution or practice group by the company whose product is under review in the clinical trial.
Our concern is that the impact of such ideas will eventually send business and industry elsewhere, and clinical investigations will be exclusively conducted outside of the U.S.
As a result, the recommendations set forth in this White Paper will only turn physicians away from carrying out such studies because the compensation they receive will be inadequate for the risks they will have to take. Such a consequence will impact the critical experience that fellows, medical students, and physicians need to keep patients informed of new treatments, devices, and medicine.
This recent scrutiny of clinical trials follows the trend of health care reform advocates who believe that the health care industry—namely pharmaceutical and device companies—should change the way they do business to fix the health care system.
Last time we checked, cancer survival rates have increased dramatically, heart disease treatment has improved significantly, and breakthroughs in other diseases such as AIDS and HIV are not what is causing our health care system to fail, nor are the clinical trials that support such advances.
Moreover, trying to pass off the relatively minimal “media coverage, government reports, and academic literature” on the nature of conflicts of interest between medicine and industry in treatment, medical education, and scientific publication as “pervasive,” is a gross exaggeration.
We would like to know exactly what “substantial conflicts in clinical research remain unaddressed.” While some instances have certainly been captured by these mediums, we agree that greater transparency is needed but, allowing such information to tarnish medicine, researchers and physicians is simply wrong.
While the extent to which doctors are compensated for their participation in clinical trials is certainly of importance to academic medical centers, patients, and the general public, government oversight is not necessary when these institutions and industry can bring about such changes. And most already have.
So what if “the number of trials has increased, industry funds a larger proportion of research, and more research now occurs in physicians’ private offices?” Where are the federal funds to match more trials to find cures for chronic diseases and life threatening illnesses? There was only $8.2 billion in the stimulus which was passed almost a year ago, and now suddenly politicians changed their priority about where money comes from to help make safe drugs and devices?
While the Paper certainly brings to light all of the potential weaknesses inherent in clinical trials, their only idea to reduce such weaknesses is to control payments for conducting such studies. But even there suggestions are vague.
For example, they recommend that holdings by investigators or their immediate family members should be barred. Yet they state that “Compelling circumstances may justify individuals with such interests to perform consulting services on matters related to the trial.” Are we to believe that such a process is going to increase the number of clinical trials conducted, and speed up the process of drug approval? Who is going to define “compelling circumstances,” a government appointed unelected official?
We certainly agree that all clinical investigators should be transparent and identify or manage their financial relationships between industry and physicians. Online databases to enter such data are a great idea, as long as the process is uniform and clearly explained to all researchers and health care providers across all institutions. Institutional review boards (IRBs) or committees at academic medical centers are also great ideas to manage and evaluate relationships between industry and physician-investigators, so long as they do not unnecessarily result in delayed trials, which inevitably hurt patients.
Greater transparency is something we applaud for clinical investigations because these researchers have nothing to hide about their involvement in such trials: they simply want to help advance medicine and science to make patients healthier.
Conflicts?
We all have a financial interest in the outcome of something. The farmer has an interest in selling his corn, regardless of the chemicals he uses to grow it or spray it with to keep bugs away. The paper company has an interest in selling products to companies even when we know it hurts the environment. The automobile industry has an interest—as do all associated industries—in selling cars, even though more than 50,000 people a year die in car accidents. So then why is it any different for a clinical investigator to “have financial interests in the outcome of the research or stand to gain substantially from conducting a clinical trial,” when it will actually helps patients and save lives?
Claiming that such financial interests “may affect their judgment throughout the conduct of the trial … such as enrolling and recruiting individuals to participate as research subjects” is problematic.
Clinical investigators are enrolling people into these studies to test drugs and devices that will determine whether medicine can help save millions of lives. In a sense, for both enrollees and investigators—both of which are compensated for their participation—clinical trials represent a sacrifice to help save others.
In fact, the White Paper itself recognized that “negative consequences may exist when compensation for research is so inadequate that it discourages physicians and institutions from conducting research at all.” They even cited a “recent New York Times article, which reported that the “great majority” of oncologists decline to participate in clinical trials because “[t]hey make little or nothing on trials and, in fact, often lose money.”
Changing payments for clinical trials has nothing to do with “ensuring that a physician’s decision to conduct clinical research, as well as his or her decision to recommend that a particular patient participate in a clinical trial, is grounded in reasons unrelated to investigator compensation.”
Medicine is by far one of the most complex and expensive businesses in the world—it makes up 17% of our GDP. Besides overhead costs, staff, resources, insurance, and the risk of being sued, doctors are overworked, underpaid, and constantly being controlled by new regulations and laws that lead to defensive medicine and an abandonment to practice areas such as primary care. Mean while they barely have a chance to keep up with the breakthroughs that industries provide while they are treating patients. To make the assertion that an investigator is choosing to take his or her time away from her practice, and risk their career for reasons other than advancing science and helping gain valuable experience is unfounded.
Conclusion
The White Paper recommends that the benchmark for compensation for physician services for research should be comparable payment for time and services for treatment. While this recommendation includes delineated reimbursement for all other expenses, including tests or interviews to screen patients, time seeking informed consent, tracking of enrollee participation, training, and data collection and reporting, it still poses a problem that will move the business of medicine elsewhere.
As the Paper itself states, “at present, the government provides little guidance or oversight of compensation for clinical research, or other conflicts that arise from the financial relationships between industry and investigators and institutions.” Changing such an establishment can only harm “the collaboration between industry and medicine in the arena of clinical research is critical to driving scientific progress.”
A collaboration that the paper asserts “leads to the production of drugs and devices to prevent, diagnose, and cure illness, as well as innovations that prolong the lives and improve the quality of life of seriously ill patients.” Why would we change such a relationship now, when as the paper also states, “investigators, both inside and outside of academic medical centers, depend on industry funds to advance clinical research to break new barriers in patient care?”