On the propriety of collaborations between academicians and the pharmaceutical industry: an alternate viewpoint. (2007)

Giovanni Fava convincingly summarizes the many reasons why the relationships between the for-profit industries and academicians - as well as physicians more generally - are very serious matters and may adversely affect both society's confidence in the medical profession and the integrity of the evidence base that helps to guide selection of treatments. As my own experiences are those of an academician who does several different kinds of work with the pharmaceutical industry, I will generally limit my comments to this area.

After decades of denial and minimization, there are now sufficient data the impact of unmanaged conflicts of interest to justify the conclusion that speaking for, advising/consulting, and doing research with pharmaceutical industry can influence opinion leaders' evaluations of the industry's products. Most often the nature of this effect is a positive bias, which can result in overvaluation of a treatment's strengths and underappreciation of that therapy's limitations. The net result of such bias could be overly favorable presentations at meetings and/or insufficiently critical interpretation of results or conclusions in manuscripts, which ultimately could result in greater use of that treatment and higher profits for the manufacturer.

Fava has correctly pointed to a number of notorious cases involving purportedly unreported conflicts of interest that have been an embarrassment to the broader academic community, with several recent cases specifically involving psychiatry. Although the initial public presentations of these scandals often did not fairly reflect the facts of the cases, there is the growing public perception that all collaborations between academicians and the pharmaceutical industry are unseemly and, at best, suspect. For these reasons and more, academicians must examine their relations with the pharmaceutical industry with much greater scrutiny than ever before, and think much more carefully about the potential for conflicts of interest and strategies to manage such conflicts.

Before turning to our more specific areas of agreement and disagreement, it is important to clarify that the pharmaceutical industry is a heavily regulated business, which does produce medications that can save lives and reduce human suffering; few of our currently used psychiatric medications have been developed by alternate (i.e., governmental, academic, or not-for-profit) agencies. When practicing within ethical guidelines, it is not inherently a conflict of interest for an academician to earn income from working with a drug company. Such financial relationships do have the potential to cause conflicts of interest, however, and as such they must either be avoided (as suggested by Fava) or properly managed (the approach that I recommend)

One factor that complicates debates such as this is that accepted ethical guidelines for managing potential conflicts of interest are continually changing. Thus, when the standards of today are applied to work completed a decade ago, it should be no surprise that a large proportion of academicians appear to fall short of the standard. And, no doubt, the same will be true when the standards of 2017 are applied to work performed today.

I fully agree with Fava that effective management of the potential for conflicts of interest represents one of the major challenges facing academic medicine in the 21st century. Moreover, I feel strongly that we must come to terms with these issues in order for collaborations between academicians and industry to continue, which I believe offers the best opportunities for development of improved therapeutics. As I have written about previously (1,2), however, the pharmaceutical industry is not a monolithic evil and, despite being in business to earn profits for stockholders, all of the companies and the vast majority of people who work in the pharmaceutical business want to develop - and sell - new and improved products that really do help humanity. And, although it is true that new (patent-protected) medications are too expensive for many people and a large proportion of publicly funded health care agencies, it is also true that - without first introducing these new drugs on patent - there would be no newer generation generic medications after patents expire.

As is often the case in polemical papers, Fava focuses the side of this issue and does not give proper credit to the legitimate contributions of the pharmaceutical industry to improved public health and the potential benefits that can result from academic-industry collaborations (e.g., improved research designs, research pharmacogenomics, development of biomarkers, etc.), if the potential for conflicts of interest is properly managed. Although I share Fava's disdain for the practice of selective publication (i.e., suppression of negative studies), I do not think that it is fair to describe as pathetic the industry's efforts to create study registries and to make all data from all relevant trials available for meta-analysis. Nor do I view the potential benefits of longer-term antidepressants for patients with highly recurrent forms of depression to be propaganda.

Giovanni Fava also largely fails to deal with the potentially deleterious effects that noncontractual or uncompensated conflicting interests can have scientific matters, such as those related to different schools of thought, sociopolitical positions, interpersonal rivalries, or even spiritual, religious, or quasi-religious beliefs, which are virtually never acknowledged and also have shown to have potential effects both professional relations and the design, interpretation, presentation, and publication of research results. As one example, it should be recognized that academicians who strongly believe that the pharmaceutical industry conducts shoddy research often provide negatively biased evaluations of industry-sponsored studies.

With respect to management of potential conflicts of interest, who in 2007 can argue against full disclosure and transparency? To take such an untenable position would reflect both ignorance of the data and insensitivity to the issues involving public trust. In fact, in order to avoid even the appearance of trying to conceal ties with industry, I (along with most colleagues that I know who do work with the pharmaceutical industry) have begun to report all financial relationships in all manuscripts, regardless of relevance of the paper to the pharmaceutical industry.

I also agree with Fava that expert consensus panels should include individuals (clinicians, researchers, and patients and their family members) with no industry ties, although I disagree with the notion that individuals with such ties should be systematically excluded. Parenthetically, the fact that 100% of the DSM-IV panelists for mood disorders and schizophrenia had some industry relationships reflects the ubiquity of these relationships in the 1990s, not the systematic exclusion of those without such ties.

As one of the so-called gatekeepers at the industry sponsored symposia at the American Psychiatric Association's annual meetings, I can report that there is no pressure whatsoever to pick faculty from a select oligarchy of colleagues who work with industry (we are, in fact, strongly encouraged to recruit a very diverse faculty for these presentations). Our other continuing medical education (CME) talks are independently reviewed to ensure a lack of commercial bias and, unless the talk is explicitly promotional (i.e., clearly labeled as such), the rules are clear: industry representatives must keep their hands off the material. Although I am not immune to commercial bias, I am fairly certain that I have a greater risk of unrecognized bias when presenting work that I have performed and findings that are consistent with my clinical beliefs. Consistent with this view, although it is true that industry sponsorship does have an effect study outcome (e.g., 3,4), it is also true that - in work not sponsored by the pharmaceutical industry - much larger effects have been associated with an investigator's allegiance to particular models of psychotherapy (5).

With respect to advising and consulting, I cannot see how the public health could be benefited by mandates that prevent the pharmaceutical industry from utilizing the input of experts. At one point, Fava wonders out loud: wouldn't the pharmaceutical industry want to hear the opinion of someone - like himself - with an unbiased opinion? I am sure that they would and often do. But, given Fava's stated position, wouldn't he have to decline the invitation or, if he it, wouldn't he no longer qualify as an unbiased advisor?

I likewise disagree with the merits of prioritizing governmental research funding for investigators with no industry ties. Could a system that arbitrarily excludes some of the best and brightest scientists actually result in better science? In this case, the remedy may be much worse than the malady.

I admire the stand taken by Fava, as well as his disciplined adherence to a personal code of conduct that eschews industry support. There are legitimate differences of opinion here and I would not be surprised if our disagreements herein might be mirrored by similar differences in sociopolitical world views. I am glad that there is such a diversity of opinion this matter and remain optimistic that the dialogue between those who are and are not interested in working with industry will lead to better ways of managing the very real potential for conflicts of interest and ultimately will result in better treatments for our patients.