Lisa Rosenbaum's final installment of her three-part conflict of interest series in the NEJM is out and full text is available online for free. My associations and observations in response to the first two can be found here and here. As a student of bias and rhetoric, reading Dr. Rosenbaum's series has been a breath of fresh air both on its own merit, but also relative to the grim anti-industry and anti-physician bias that permeates the popular press and medical settings these days. The hypocritical nature of many of these comments was always obvious to me, but there was only very qualified support for anyone who did not see all physicians (especially psychiatrists) as tools of the pharmaceutical industry. But the types of moral and ethical biases that Rosenbaum highlights goes far beyond the issue of free lunch from a pharmaceutical rep. It shakes the very foundation of a system of evaluation based on weak empirical evidence or pure politics as I have pointed out many times on this blog. At some level it is such a stunning expansion of many of the old NEJM editorials, it seems surrealistic that these articles have been published. But on the other hand, the page below this last article invites readers to participate in a poll on the ".....suitability of three potential authors to review articles for the Journal." Combined with the fact that these articles have a series editor that suggests to me that this may be all part of a social media-like initiative to attract interest to the NEJM. On that basis, I expect a full gamut of future authors including the more typical opinions equating the appearance of conflict of interest with conflict of interest and suggesting zero tolerance for contact with industry.
This article starts out with commentary on the medical school "anti-pharma animus". The organization of American medical students apparently grades medical schools on the basis of how free from pharmaceutical company influence their conflict of interest policies and environment are. She gives a quote from a medical student to illustrate the mind-set involved in at least some members of this movement, namely the need for "pure" information to medical students. Some early critics of Rosenbaum's article cite this as anecdotal data but that misses the point. Her point is that this kind of mind-set exists and it is one of a number of mind-sets that makes the ethical climate around conflict of interest an unreasonable one. She also points out that the rhetoric associated with this statement clearly indicates that this is a moral argument and at that point the psychology of moral arguments may apply. From the perspective of medical education, is it better to take an insular approach and suggest that all research can be assessed by looking at the funding source or should medical students be taught to read and critique research independent of funding source? A study quoted one of Rosenbaum's previous article suggests that internists are able to look at research abstracts and classify them according to research rigor, but that the introduction of funding source forces a re-evaluation with a bias against industry funded research.
The article progresses to talk about the psychology of moral argumentation at that point and a set of arguments that I have summarized in the table above. I think it is also instructive to address one of the early arguments about the Rosenbaum essays and that has to do with evidence and the use of evidence in arguments. In order to look at that, it requires a quick look at the type or argument, whether it is a scientific or non-scientific argument and whether the corresponding type of evidence exists. I think there is no doubt that Rosenbaum's arguments are moral arguments rather than scientific ones. As such they seek to address the ethical climate around conflict of interest.
There are two aspects of the concept of ethical climate that are missing from Rosenbaum's analysis. The first is the ethical climate as a way to control physicians. The best example during my career has been managed care and the research that supported it. Like today's collaborative care research, the early managed care research was focused on the idea that it was more "cost-effective" than fee-for-service or treatment as usual. In both cases (collaborative care and managed care), the research was generally done by advocates of the proposed methods. Thirty years later, any objective analysis on the effect of managed care on psychiatric services will show that it has been devastatingly negative. Bed capacity has been shut down, the criteria for inpatient care is "dangerousness" rather than any specific medical indication, people are clearly discharged from hospitals based on optimizing meager DRG based payments rather than medical indications, detoxification and addiction services have practically been eliminated from most hospitals, only a small percentage of hospitals have psychiatric services, state hospital systems have also been shut down, and the only place where psychiatric care has increased has been county jails and prisons. That entire system wide change for the worse was based on a moral argument of cost-effectiveness rather than scientific research. Once that ethical landscape was established physicians could simply be shouted down with the slogan: "Times have changed - you are no longer in charge." I doubt that any physician who heard that slogan was ever in charge of anything. It was political rhetoric, designed to elicit an emotional reaction in the people taking over and the physicians they ultimately came to control. Nobody thought that cost effectiveness was the same thing as cost shifting to correctional systems.
The second aspect is the explicit control of physicians by managed care companies and a conflict of interest that greatly exceeds that of any other industry. Rosenbaum's three articles are all focused on the pharmaceutical or medical device industries. There is no mention of the managed care industry or its spinoffs, despite the fact that it controls the medical care of over 80% of Americans. As I have consistently pointed out, the theoretical concerns of the affiliations of authors on research papers about drugs or medical devices is nothing compared with a managed care company that tells your physician that you need to be discharged from a hospital or use a particular medicine that the physician is not recommending. In the case of psychiatric care, that company is free to make even more life altering decisions such as denying a patient with a drug addiction any functional detox services, deciding that a patient with significant suicide risks can be treated on an outpatient basis, or maintaining a person in a disabled state with minimal treatment options for a complete recovery. The regulatory environment that concentrates that much power in an industry that can generate profits by denying care is a complex story, but it all started with an ethical environment that blamed physicians for the high cost of health care. That physicianscold environment has too many elements in common with the pharmascold environment to ignore. In both cases there is a predominate moral bias that greatly oversimplifies the problem and at least in the case of managed care leads to clear long term adverse consequences.
The good news is that these articles have been published along with the evidence that moral reasoning can be seriously flawed and associated with biases. Rosenbaum's focus has clearly been on the relationship between physicians and the pharmaceutical or medical device industry. She has discussed her personal experience as a Cardiologist and how it has affected her largely in terms of interventions, statin therapy, and as a potential consultant to the industry. Psychiatry has been an easier target for the same biases and rhetoric that she lists in her article. I pointed it out in a Washington Post article where the narrative was clearly skewed to fit the idea that psychiatry was corrupted by Big Pharma and attempting to make it easier to diagnose depression in order to sell more antidepressants. That article included selected information to make it seem like the American Psychiatric Association was the only professional organization to make advertising profits from Big Pharma. The suggested quid pro quo for advertising revenue should be absurd to anyone familiar with advertising but it was not to this reporter. But the real issue was that the DSM does not recommend treatment anyway and the majority (80%) prescribers who treat depression don't use a DSM-5 or even care about what it says. Less formal approaches adopt a similar scolding moralistic tone toward psychiatry that is possible only by ignoring the deficiencies in other medical fields and idealizing them while devaluing psychiatry.
I think that Rosenbaum's articles are must reads, especially for psychiatrists who may be unfamiliar with rhetoric, moral reasoning, and politics. That may be why physicians in general have been inept in mounting any kind of a counterattack against political strategies that work by changing the ethical climate. These articles provide some points for discussion. Watching the counterattacks will also be instructive.
George Dawson, MD, DFAPA
1: Rosenbaum L. Beyond moral outrage--weighing the trade-offs of COI regulation. N Engl J Med. 2015 May 21;372(21):2064-8. doi: 10.1056/NEJMms1502498. PubMed PMID: 25992752.