Wednesday, November 4, 2009

Conflict of interest in healthcare research

I have been in San Diego for nearly an entire week, and am eagerly getting ready to head back to my beloved New England tomorrow after I chair my last session in the morning on the extra-pulmonary complications of critical illness. Guess what my talk is on? That's right, C diff.

A hot topic at this meeting of the American College of Chest Physicians (affectionately known as Chest) has been conflicts of interest. Yesterday I chaired and spoke at a session talking about what good collaborations look like between the Industry and Academia. Today there was a fascinating session on a related topic, which included talks from Catherine DeAngelis, the Editor-in-Chief of JAMA, as well as Richard Irwin, the Editor-in-Chief of the journal Chest, and two other speakers: Jim Roach, MD, representing the Industry point of view, and Ian Nathanson, MD, who is a part of the Chest COI working group. Although all speakers attempted to be balanced, the sum total amounted, as one would expect, to at least some Industry bashing and finger-pointing. It is interesting to me that, while people do not hesitate, appropriately, to include all fraud and result falsification, they usually conflate these into the "Evils of the Industry", regardless of the funding received by those defrauding the system. Also, what is not mentioned are the denominators of this potential relationship of fraud with manufacturers. The story is usually told thusly: 1). Look at the proportion of research funded by private vs. public funds (~85% of all clinical research, according to Dr. DeAngelis). 2). Look at the systematic reviews that indicate that Industry-sponsored trials are more likely to show results favorable to the product in question (true, but could this be because Industry-funded studies are designed with more precision? Or perhaps it is because of the nature of our regulatory process: early phase studies shed light on what can be expected, and the later phase studies merely build on that information. It is possible that our regulatory path promotes lack of equipoise, but that is a discussion for a different time). 3). Here are a bunch of case studies of fraud that we have uncovered (usually quite a few from the Industry, but also a number not funded by private dollars), 4). Therefore, the fraud is a big problem with Industry-funded work.

If I were structuring a scientific argument in this manner, I would be accused of using ecological data for hypothesis testing. The leaps of faith required are considerable. I do not wish to minimize the abominable behavior exhibited by those with a considerable monetary interest at stake, or by those that have benefitted at the trough: their lack of ethics and concern for the public has brought public cynicism and apprehension about everything we do. However, it is not OK to mitigate this terrible situation by singling out only the most visible potential culprit, made visible simply because of the volume (denominator) of work it supports. This tactic reeks of scape goating for personal gain -- so as to divert the spot light from transgressions of other stake holders, no matter how egregious.

The reason that manufacturers present an easy target is that they have in the past been unethical in so many visible cases. Another reason is that the source of the conflict of interest that exists for the Industry and investigators they fund -- money given for work that will advance the cause of the particular technology the company owns and benefits from financially --is particularly easy to identify. To be sure, we do need to deal with this source of COI carefully if we do not want to lose our credibility completely as the scientific community. At the same time, turning this process into a witch hunt is a mistake. Barring Industry scientists from presenting their work in a CME forum at professional society meetings, fro example, runs counter to the transparency mandate of authorship guidelines. Further, it denigrates the achievements of often prominent and dedicated scientists, and assumes guilt until innocence is proven.

In so many ways, this reactive stance is a response to the Congress's interest in the issue, and the mad rush to deal with it surely reflects an earnest attempt to clean our house. While I salute journals and societies for addressing this difficult issue, if some of the parties are locked out of the discussion, the attempts will look like and amount to nothing more than window dressing. Unless we are willing to overhaul completely how we do medicine in this country and take out the profit motive altogether for everyone (this is in fact my preferred solution, but given how difficult it has been to pass even the current anemic public option, universal socialized healthcare system does not stand a chance), it is critical to be inclusive and to find the most sensible and well thought-out solution to this visible violation of public trust.

2 comments:

  1. If health care is the problem, insurance is not the cause and government is not the answer.
    .
    Of those "50 million," that lack insurance there were 45,000 who died without health care.
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    WITH health care, 98,000 died FROM health care because of malpractice.
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    The question is do we want to trust that largest corporation in the world, the U.S. Government. Do not expect house calls anytime soon.
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    We have seen how well the government delivers on its promises and its bureaucracies pursue the money without giving us benefits on so many levels.
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    Imagine another 111 bureacracies that only ultimately must listen to the Secretary of the Treasury - another "service" of which is the IRS.
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    http://theprogressivecapitalist.blogspot.com/2009/10/affordable-health-care-for-america-act.html
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    That blog of mine above has several .pdf connections (HR. 3962 and two summaries, a few videos, and page references for new taxes and other mandates).
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    If you cannot use the link, google "Progressive Capitalist H.R. 3962."
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    If you believe the promises of this bill, you have to deal with the lie that it fosters competition with a government option called the "Public Option" and establishes the government as a monopoly making its own rules. Don't worry. You'll run out of "rich" soon enough.
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    We have at least a $12 trillion economy of which at least $1.8 trillion is spent on health care.
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    If you read the bill, there are plenty of opportunities to soak the middle class, if you do not mind the 1.6 million made jobless.
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    REPUBLICAN Affordable Health Care For America Act
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    MAKING HEALTH Care Affordable For EVERY AmeriCAN
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    http://thehill.com/images/stories/whitepapers/pdf/ainsfloor_01_xml.pdf

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  2. John,

    Thanks for your comment. I agree that it is not insurance companies that are the problem, though not sure if gov't is NOT the answer. The problem is that healthcare is just another market to get rich off, and this promotes overuse and inappropriate use that ultimately harms the society, which is what we are seeing today. I am coming to the realization that when it comes to health, rather than disease and medicine, we are indeed focusing on the wrong solutions. We need to clean up the rest of our lives even more urgently than healthcare, though unless the profit motive is taken out of it, there will be no sustainable solution.

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