By MARYA ZILBERBERG, MD, MPH
I want to digress from our recent focus on methods and talk a bit about conflict of interest (COI for short). There has been a lot in the press lately about doctors taking money from the biopharmaceutical manufacturers, and doctors inserting unnecessary hardware into patients’ hearts and spines. All of this has been happening against the background of a low hum of an ongoing discussion of what constitutes a COI, how much is too much and for what (for example, can a doc who takes research and education dollars from a manufacturer with an interest in anticoagulation sit on a committee that develops the guidelines for prevention of thromboembolic disease?), and how to mitigate these ubiquitous and pesky COIs.
In some ways watching this discussion has been amusing, while in others it has been downright sad. Medical journals, while insisting that advertising money is OK to take (presumably because the editorial and marketing offices are separated by some sort of a fire wall), though professional societies should not be able to take this tainted education money. Professional societies, on the other hand, are running away from the accusations by tightening their continuing medical education (CME) criteria and scrambling to replace the lavish budgets derived from pharma to develop their coveted evidence-based practice guidelines. And while all the pots are calling all the kettles black, academic researchers are being barred from collaborating with the industry on research projects, and industry researchers are being precluded from presenting their data at professional society meetings. While all the time the public is being whipped into lather about these alleged systematic transgressions, and forced to cheer for the ensuing retribution.
But, like many things in life, and especially stuff that we discuss on this blog, this issue is neither black nor white. Don’t take me wrong: I am not condoning the egregious excesses of greed demonstrated by some members of my hallowed profession. If you have been reading my blog for some time, you know that I do not dispute the shameful reality of many breeches of public trust. I am an ardent supporter of exposing these breeches and of harsh punishments that they deserve. This is not what I am talking about here.
I am much more concerned about the one-sided story that we have been hearing about pharma-academic collaborations. Because of the persecutory nature of public opinion, some institutions are now shying away from such collaborations. This attitude is akin to navigating a treacherous road while looking in the rear-view mirror. Yes, there have been transgressions, yes there has been greed and even scientific fraud in the name of money. Does this mean that we need to stop everything and come up with an entirely new way of managing these risks? Absolutely! Does this mean that we have to get rid of all pharma-academic collaborations? Absolutely not! In my humble opinion, erecting non-scaleable walls between these two groups is a big mistake. Here is why.
First, let me make a disclaimer: I do have active ongoing collaborations with multiple manufacturers. I do not take speaking or other promotional money, but limit myself to consulting and research grant funding. I also do a good deal of unfunded research, and I have never taken a penny for any of my blogging or blogging-related activities. And here is the crux of the matter: In this world of über-subspecialization, with the expertise being demographically and geographically diffuse, how can we afford not to collaborate across different types of organizations with different types of capabilities? Can we really afford to leave all of therapeutic development in the hands of organizations whose overarching purpose is to make money? And equally importantly, can we afford to continue this fragmented model of medical development without any thought to integration of the needs of all of the stake holders? I think not. Just as we are reaping the fruit of electronic medical record development in isolation from the end-user, so this isolation of research effort will lead to even less coherence in medicine. And unless we are ready to socialize our entire healthcare system, it seems naïve to expect that this one sector will acquiesce and start working outside of our coveted free market for the good of humankind alone.
My readers know that I am not an industry apologist. On the contrary, I have said many times that there has been bad behavior across all the sectors of healthcare, starting with biopharma. But if we want to advance rather than stagnate and regress, we need robust collaborations. We also need higher ethical standards and greater professionalism to keep public’s health as our top priority.
There is COI everywhere, and, while financial COI is most visible, it is the more hidden COI that is most insidious. An hidden COI can be intellectual, reputational, ego-driven, career-mediated, etc. It is incumbent on us all in this complex world to ask questions and mitigate any ill effects of any cognitive biases, including those created by COI. Ultimately, as I have begun to realize of late, nothing will replace an educated and empowered patient: This is the only model that can provide appropriate checks and balances for our oftentimes misaligned and perverse incentives, both academic and economic.
Marya Zilberberg, MD, MPH, is a physician health services researcher with a specific interest in healthcare-associated complications and a broad interest in the state of our healthcare system. She is the Founder and President of EviMed Research Group, LLC, a consultancy specializing in epidemiology, health services and outcomes research. She is also a professor of Epidemiology at the University of Massachusetts, Amherst. Dr. Zilberberg is a member of multiple journal editorial boards and is frequently invited to speak about evidence-based medicine, research methods and healthcare-associated complications. She blogs about healthcare at Healthcare, etc.
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I agree that there may be good reasons for “pharma-academic” collaboration, but one can collaborate with someone else without money being exchanged. Much of the “collaboration” that raises questions entails a pharma (or device, biotech, or health care IT) company paying the collaborator.
Furthermore, there have been many cases in which those on the pharma side were paying to advance marketing, not science. Take a look at Forest Pharmaceuticals Lexapro marketing plan (see this post on Health Care Renewal for link to whole document: http://hcrenewal.blogspot.com/2009/09/lexapro-marketing-plan-was-meant-to.html ) and see how marketers regard academic key opinion leaders, CME delivered at academic organizations, writing of scholarly papers, etc as part of marketing. Also see the documentation of Neurontin marketing plans in which research and publication were considered key parts of marketing (Health Care Renewal post here: http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html, based on Annals of Internal Medicine article here: http://www.annals.org/content/145/4/284.full) Although some pharma payments for basic science research may strictly support development of new products, there is reason to suspect nearly all commercial payments supporting clinical research, epidemiologic and public health research, and medical and health care education are really meant to support marketing.
Maybe therapeutic development should not be left only in the “hands of organizations whose overaching purpose is to make money,” but do we want to put medical education and clinical, epidemiological and public health research into the hands of such companies?
Finally, although doctors and medical and health care academics can be influenced by many factors, there ought to be a big distinction between being paid by marketers who get big incentives to increase revenue from specific products and influence from people and organizations whose purposes may be more diffuse.
Thanks to everyone for your comments. I agree that this is not a straightforward issue and, as such, does not have a neat and straightforward answer. All I am asserting is that in the context of our healthcare system, which we as voters have decided to keep within the market model, we need to come up with ways of collaborating with integrity. I truly believe that isolationism will lead to yet more useless and expensive toys that do nothing for public’s health.
I do also want to note that, to their credit, pharma funds a lot of disease state research, not just specific drug treatments. And this is a part of the equation that in my mind provides the greatest value to the public by giving us the opportunity to understand better diseases, their risk factors and potential points for intervention.
Let me just say something here, as I find this post to be a bit two sided in its intent to “clarify” the role of industry with medical care. At the end of the day, as a physician, you either do what is right, or you do what is convenient and benefits your wallet. Because what is right does NOT have a profit motive. Yes, we as doctors make money, and more than the average citizen in this country will make in a year, maybe two. BUT, if you do your job responsibly and ethically, no one will come behind you and raise questions that have viability to challenge your agenda. And having taken money from industry raises questions until it silences challenges. It is that simple. As I wrote at the post about dementia from a day or two ago, quoting another physician who wrote about this conflict, industry is about profit, until proven otherwise. Being a doctor is about care. The two do not mix. It is oil and water. Don’t believe me, just pay attention to those who try to mix the two.
Just my opinion, I could be wrong.
Many medical school faculty who publish clinical articles, present at medical conferences and get interviewed by the news media are subject matter experts on newer, more expensive brand name drugs. The doctors are probably sincere in their convictions and drug company’s have the financial resources to help disseminate these doctors’ opinions. Unfortunately, it’s a bit like only listening to broadcasting from CNN or FOX news. We are saturating the airwaves with information about new drugs, while very little is published, or said, about therapeutic advantages of older generics.
How do we know when someone crosses the line? Even more difficult, if you believe in invisible hands, how can you tell when subtle economic pressures are guiding decisions? In many ways I am less concerned about out and out crooks than I am about people who are convinced they are doing the right thing, and just happen to be making money for it.
Steve
Excellent and fearless as usual doc!