Continuing his crusade to end all collaboration between physicians and industry, and in doings so, chilling the progress of research and discovery in medicine, David Rothman, PhD, wrote a commentary about academic medical centers’ conflict of interest policies. The commentary, which was published in the Journal of the American Medical Association (JAMA), discussed how “a number of academic medical centers (AMCs) have taken the lead in implementing new policies that more strictly manage the relationships between physicians and industry during the past 4 years.”
We have previously summarized many of these changes (Harvard, Minnesota, Wisconsin, Yale, Stanford, Michigan), which include “new measures to prohibit accepting gifts, food, and drug samples and restricting faculty consulting and speaking arrangements.” In light of these measures, Rothman recognizes that there is still a heated debate about these changes, with some feeling that they “are long overdue, and others complaining that the policies sully their reputations and reduce their income.”
He also acknowledges that because these “measures break new ground, uncertainties about their short- and long-term consequences are widespread.” Given this uncertainty, you would think that a member of academia, whose mission is to remain objective in searching for evidence, would call for more research to gain a better understanding of the wide ranging impact these policies could have and the unintended consequences and harm that are likely to result (i.e. MIT study).
Not surprisingly however, Rothman instead says that rather than do more research about the consequences of misguided conflict of interest (COI) policies, it would just be “simpler, more equitable, and more effective if all AMCs adopted $0 thresholds for all faculty, staff, and adjuncts.” He offers no empirical evidence or logical reasoning to how he arrived at such a conclusion, also not surprising, since to date, no evidence has been produced suggesting that physician-industry relationships have caused any harm to patients.
Commentary
Given the various changes in AMC policies listed above, Rothman uses this commentary to discuss what he believes are “accomplishments at the leading institutions and evaluate prospects for future change.” Other than these institutions actually adopting or changing COI policies, he does not explain why this stands as an accomplishment. Have these policies improved patient care? Have they led to more discoveries of new drugs or treatments? How many more lives have they saved now that these policies are in place? Does the public trust AMCs more now than before?
The clear problem that Rothman identifies about COI policies, but strategically underscores, is that “Implementing conflict of interest policies demands substantial time and resources, as well as a deep commitment to effective oversight.” While many justify COI policies as a way to ensure professionalism and to keep public trust, others argue that they also serve to reduce health care costs. On the latter point, critics of industry-physician collaboration believe that physicians who work with industry can lead to overprescribing, extra tests, use of brand name drugs, and other things that lead to increased costs.
But how does creating a COI police state at an AMC reduce health care costs? As Rothman recognizes, “issuing a policy is merely the first step; next come the appointment and staffing of a faculty/administration committee that, together with an expanded compliance office, answers faculty queries, investigates violations, reviews disclosure forms, and develops and implements individual management plans that must become embedded in the institutions’ governance and culture.” This all costs significant amounts of money on not only resources, but also training and compliance.
Based on the extremely limited budgets of most AMCs already, coupled with the threat that AMCs will prevent industry-funded research, grants or continuing medical education (CME), how can the overwhelming majority of these institutions expect to pay for all of this? Rothman does not answer that question.
Discussion
To Rothman, COI policies should exist at AMCs to show “a deep sense of professional values and by the conviction that, left unregulated, industry marketing practices undermine patient well-being and scientific integrity.” He neglects however another equally, if not more important sense of professional value: the need for physicians to learn continuously about new advances and research to improve patient outcomes, and a duty to educate and train others with that information.
By focusing solely on what he sees as beneficial for patients, Rothman himself undermines patient well-being and scientific integrity by not realizing that patients will be the first to suffer when physicians can no longer collaborate with industry to discover new breakthroughs and treatments to continue the progress in medicine America has enjoyed for decades. Patient well-being will also suffer from biased proposals such as Rothman’s because once physician-industry collaboration begins to decrease, the training and education of physicians will be insufficient and inadequate to deal with the revolutionary pace of medicine and science. Doctors, who barely have enough time to see patients presently, will simply fall behind the standard of care in many areas because critics like Rothman want to impede the flow of truthful and valuable scientific information between physicians and industry.
Despite these contradictions, Rothman’s commentary reads more like a warning: since industry Web sites are reporting payments to physicians, there is the potential that an AMC may be the subject of “unflattering media coverage, and no institution wants to receive an inquiry from a senator’s office about a faculty physician’s ties to industry, which almost inevitably produces reputation-damaging media coverage.” But Rothman too quickly forgets that AMCs are constantly under a microscope on a number of unflattering media and legal issues such as malpractice, adverse events, clinical trials, research protocol, hospital borne infections, and so on.
While physician-industry payments are a popular topic in the media now, they are no more unflattering than the issues previously stated. Yet we still have hundreds of thousands of deaths in hospitals and AMCs from adverse events and hospital acquired infections. Why should AMC resources and staff be filling out and reading COI forms when they could be fixing real problems of life and death instead?
Essentially, Rothman reasons that AMCs should fear working with industry and should adopt his $0 threshold because “such an inquiry into payments may adversely affect funding from the National Institutes of Health and even spur investigations by state attorneys general.” This reasoning is both counterintuitive and counterproductive. The purpose of NIH funding is to bring tangible medical discoveries to the market for patients, and without the interaction and collaboration of industry, the chances of this happening are minimal. You can’t just have NIH funding and no industry support. And you can’t have industry support and no clinical trials or testing. This is why we need collaboration. Moreover, if an individual researcher is found in violation of COI policies, it is highly likely that only that person will be restricted from NIH funding, and not the institution as a whole.
Consequently, Rothman discusses a number of specific prohibitions and policies in place, most of which are reasonable. These include prohibition of gifts and food from industry. However, Rothman’s suggestion that there is “extensive literature on the effect of gifts on physician decision making” is inappropriate. There is only one such article by Wazana, that did not even use clinical outcomes to show if such gifts were harming patients. In other words, the study was meaningless.
Another problem with Rothman’s portrayal of such policies is that he does not explain the role of physicians on speakers’ bureaus adequately. Speakers are not salespeople because they use company slides. FDA requires, by law, that speakers must use slides from companies that the agency has approved to ensure that adequate risk/benefit information is included, there is no discussion of off-label use, and only clinical evidence is being presented.
In addition, Rothman’s suggestion that samples be “less frequently used, and detached from interactions between the drug representative and the physician” is also problematic. Many of these samples are given to doctors for the explicit purpose of giving to patients who do not have sufficient financial resources. Samples are also useful for doctors to test a patient’s tolerance and monitor for any side effects before deciding a specific and costly treatment.
Conclusion
Rothman’s commentary presents assumptions stated as fact, and uses a clear framing bias to suggest that physician-industry collaboration must be eliminated or heavily regulated. Throughout his entire commentary, he does not mention one benefit, of the thousands that have come from physician-industry collaboration (ones that he himself has probably personally benefited from i.e. vaccination). His ideas are not only problematic because of their extreme view and lack of objectivity in evaluating the significant role industry plays in advancing medicine and improving patient care, they are also conflicted. Specifically, Dr. Rothman is the president and a board member of the Institute on Medicine as a Profession (IMAP), which is funded by George Soros, a philanthropist with a very liberal agenda.
Ultimately, transparency is important, and AMCs should continue enforcing and creating policies that promote transparency to ensure a high sense of professionalism and public trust in academic institutions. This does not mean however, as Dr. Rothman suggests, that these measures should completely abolish physician-industry collaboration. Policies must strike the proper balance to ensure ethical collaboration without hindering innovation and creating obstacles. Since the consequences of these policies are unknown and will likely be widespread, AMCs have a duty to the public to first determine whether more harm than good will come from COI policies, and the potential negative consequences they could have on patient outcomes and physician training and knowledge.