Monday, December 20, 2010

Why we need collaborations across healthcare sectors

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 rearview 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.


  1. I agree that it is not a black and white issue and we cannot end all collaborations with the industry. However, one other issue raised by industry involvement is that other areas of research that do not benefit corporations but can be beneficial to consumers are not financially supported and less enticing for researchers. For example, research of generic products like wheatgrass that can be very beneficial for consumers will be under studied as there is no funding coming in for this unless companies have something to gain from this.

    Corporate agenda then drives academic research...if there was a way to create a pool for research and democratically set priority for research projects that bring highest good to maximum stakeholders...

  2. While its not black or white, there are some practices which are clearly black. Gifts to docs is one. As soon as I was in my own practice (over 10 years now) I would not let any drug-company c--p in my office. I told my office manager that we could afford to buy our own pens etc.

    Banning these activities is different than addressing collaboration issues. For those I think it really goes back to the way the science is done, or rather spun vs done. One boon to pharma that hurts the consumer is the absurd insisence on using placebo controls. Who cares if a medication is better than placebo. What matters is if it works better than what is already out there. Imagine if the military tested new weapons against placebo weapons, plastic look-alikes that did nothing. Or if Apple tested their new computers against an abacus. That would be ludicrous, yet for a new drug to be approved it just has to work better than a sugar pill. If the bar was raised for approval then I think the collaborations would be more fruitful.

  3. I agree with your overall tone, however:

    1) Patients as police is a second line defense only. They should not be relied upon as the primary filters. Yes, for transparency, but they are ill equipped for the most part to handle task, and is too imperfect a model to use as backstop.

    2) Moral Licensing: Declarations of COI may inadvertently soften "defenses" and produce the opposite of intended effects, mainly dulling i/o heightening perception radars.

    Companies want to contribute, outstanding. Not a new idea, let them contribute to a public-private entity that will blindly allocate funds to research or CME endeavors in domains of their choice--DM, Dementia, wt loss/obesity. If they want to advance their agendas in subjects that support their investments, this is a purposeful ROI scheme.


  4. Shalini, Joe, Brad, thanks for your comments -- I largely agree with them all. My central point is that we cannot abandon the quest to optimize these partnerships, whatever that optimization may look like. The ultimate goal is to do better by the public and their health. But there is also a contradiction when we want pharma to be in it purely for altruism, when everyone else wants to make money on the healthcare system. My personal opinion is that our nation's health should not be for sale. But the pragmatist in me, having seen the outcome of the attempted healthcare "reform" does not think that the nation is ready for the more rational model. Hence, we need to work with what we've got and create better systems.

  5. I think that changes in the testing will improve collaboration. Right now pharma can make big bucks by creating "me-too" drugs and then spinning the study results. That doesn't serve anyone's interest in the long-term, even that of the drug companies. If new drugs had to be rigorously compared against existing treatments then drug companies would shift their research into new treatments instead of absurd "innovations", for example Pristiq.

  6. Thanks, Joe. What do you think of the competition argument that is used to justify me-twos that are not superior?

  7. Marya,

    "But there is also a contradiction when we want pharma to be in it purely for altruism, when everyone else wants to make money on the healthcare system."

    Pharma is not alone in the microscopic dissection. MCOs (MLRs, regs), Hospitals (reduced DSH, market basket updates), devices (taxes, scrutiny), DME (scrutiny, bidding), etc., are all undergoing change. They are in a for profit world and must pharma. This is the new reality, and a new equilibrium is evolving in which pharma will be a participant in the behavior change. Part of that process is a reexamination of profit seeking, regs, COI, et al.

    I dont feel Pharma is unique. Every player can make the same argument, in various shades of gray, ie, "we are unique," we must be accorded certain privileged exceptions."

    My two cents.

    BTW, like your blog--ran across it and plan to be a regular reader.