in indelible ink…

Posted on Saturday 6 February 2016

When I mentioned the sponsorship of the STAT Morning Rounds page [explanation?…], George Dawson implied in a comment that my radar was perhaps set too low:
What would you call it if I gave a lecture for CME, unrelated to prescribing but it was sponsored by Big Pharma – even though I had nothing to do with the business end of it? I would definitely get listed in Open Payments web site.
And I had just written about the Annals of Internal Medicine editor going after Ben Goldacre’s COMPare for noting that the a priori outcome variables in one of their papers had changed in the published version [protest too much…]. I don’t have anything to say more about either of those things because he’s right, I don’t really know where either boundary ought to be set – and perhaps that is my whole point.

There was a time when pharmaceutical sponsorship of all kind of things was common, even desirable. I didn’t actually think much about it back then – seeing it as a service provided by one member of the medical community to another. They gave us an endless stream of pens, cheesy models if knees and brains, note pads, prescription pads. F. Netter’s drawings in C.I.B.A. pamphlet’s were the gold standard for anatomical illustration – much revered. But I honestly didn’t know which company made which drug. A friend once quipped that the only drug company we all really knew was SKF, because they made the diet pills we took as med students to cram for exams [embarrassingly true in the mythic 60s].

I know that when I read the NYT article about the Senate investigation in 2008 [Top Psychiatrist Didn’t Report Drug Makers’ Pay], that was the first time I’d ever heard of Speaker’s Bureaus. But by then, there were lots of things I’d never heard of – CROs [Contract Research Organizations] that actually did the Clinical Trials, KOLs [Key Opinion Leaders] and KOL Managers:
As pharmaceutical and life-sciences companies search for the most effective, efficient ways to manage collaboration with the physicians who conduct research, write articles, or speak on their behalf, relationship management of the interaction with these elite physicians, or key opinion leaders [KOLs], has ultimately emerged as an individual business discipline. Similar to CRM, KOL management is an essential component for marketers and medical staff throughout the life-cycle process of a specific drug or product.
[NOTE: CRM stands for Customer Relationship Management]

By sustaining a business process that creates and maintains meaningful and collaborative relationships between KOLs and business functions from marketing to medical affairs, pharmaceutical and life-sciences companies can experience increased share of voice and accelerated adoptions at the global, national, and regional levels. A CEO of a major pharmaceuticals company recently told a group of analysts that effectively managing KOL relationships was essential to companies’ future products and market expansion.

As physicians strive to choose from a myriad of drug options for their patients, they often turn to fellow key opinion leading physicians for knowledge and advice on specific drugs. Key opinion leaders possess a unique credibility, as their validity often stems from years of industry experience and medical affiliations. As a result, pharmaceutical and life-sciences companies have begun relying heavily on key opinion leaders to help establish the knowledge base about their drugs and expand their markets throughout all stages of life-cycle management.
And as we learned from first the Propublica Dollars for Docs database and later from the Open Payments web site, there are plenty of physicians on the PHARMA payroll to manage.

So I take George’s point, and I don’t mean that sarcastically. My radar just doesn’t work anymore. When I think about it, Megan’s Morning Rounds PhRMA and Johnson & Johnson sponsorship is more along the lines of what I recall from the past. It’s open and I expect [hope] that her clarification is on the up and up [explanation?…]. I’m sure that there are many hypotheticals that I wouldn’t have a clue how to classify, how to decide which side of the line they fall on. People like Dr. Nemeroff and the other ultra-KOLs on Senator Grassley’s list made that part easy. They were so far south of the border that the line drew itself. And there are plenty of others where that’s true.

I come from an era when even the possibility or appearance of a Conflict of Interest was exclusionary. I did a lot of speaking during my years. And though it was to trainees, graduate students, and peer groups in my own and other mental health specialties, I didn’t ask for honoraria, and if it appeared, I donated it back to the sponsoring organization. I did accept room and board if it was out of town. That wouldn’t have worked had I been on the circuit, but I wasn’t. Saying it now sounds kind of prissy, hyper-moral, maybe even pseudo-moral. But I was just following the lead of my own role models. I really liked talking about things I had learned, and I almost always came away from those talks having learned something myself. It was kind of like this blog – a way of collecting my thoughts. Nothing makes you think about things so much as the possibility of saying it out loud to others. I wouldn’t necessarily push that approach on anyone else. It just is what worked for me.

So I expect that anything I said about drawing a line that marked the limits between acceptable and unacceptable COI policies would be idiosyncratic, anachronistic, or some other five dollar word. But I would stand behind the fact that that the line needs to be drawn – not in the sand, but in indelible ink. And I don’t much agree with the idea of exceptions. I would much prefer the part that I think George objects to – 100% transparency. I’d rather they list all industry payments and connections publicly, and let the decision about whether they are benign or malignant come after the fact. And that’s based on how often people have found ways to use exceptions to hide all kind of things. Admittedly, there are people who will indict any industry involvement or payment, but we’re not all that way. And the people who push for transparency aren’t the cause of the problem – that blame falls on our colleagues who have abused the system, or allowed themselves to be used. I appreciate Megan’s quick, non-defensive clarification as what I was asking for. But I still think the editors response to COMPare was uncalled for. I know Megan of Morning Rounds and Ed Silverman of Pharmalot have to support themselves, and industry sponsorship is an obvious direction to look. But in a modern world, the burden of proof falls on their shoulders – proof that they’re not under the influence of some version of a KOL Manager. It’s just that kind of world now…
  1.  
    jamzo
    February 6, 2016 | 1:57 PM
     

    seems pretty clear to me

    “if they are paying you they are sponsoring you”
    “if they pay for your research, they are sponsoring you”
    “if they pay you to speak, they are sponsoring you”

    Sponsor (commercial) – Wikipedia, the free encyclopedia
    https://en.wikipedia.org/wiki/Sponsor_(commercial)
    Wikipedia

    To sponsor something is to support an event, activity, person, or organization financially or through the provision of products or services. A sponsor is the individual or group that provides the support, similar to a benefactor.

    they are supporting you financially because what they are supporting is aligned with their interests (commercial goals, political goals, charitable goals)

    it is only confusing when the person being sponsored says “yea i know they are supporting me making this speech, doing this research, consulting on this project but it does not mean i am aligned with their (commercial or political) goals

    i don’t care if you speak to Goldman sachs executives or physicians at a pharma event, it is ok, but don’t tell me that they their goals are not advanced by sponsoring your activity

  2.  
    Bernard Carroll
    February 6, 2016 | 3:32 PM
     

    Back in 2008 the BMJ ran a piece titled “Should the drug industry work with key opinion leaders? Yes.” [Buckwell, C: BMJ 2008; 336: 1404. (21 June)]. Here is what I had to say in response (PubMed ID: 2483898).

    “HOW IT REALLY WORKS
    Buckwell pleads for an idealised state of transparent relations between the industry and key opinion leaders. The reality is different. Here is a description from an internationally recognised clinical scientist about his experience with the industry. I respect his confidentiality and that of the corporation. My colleague’s experience is not atypical.

    “When [the company] first began trumpeting the success of [their drug], I was asked to be on their speakers’ bureau. In a large audience … I departed from the script I was given for the published data to note that the effect size … was significantly lower than the [alternative treatments]. Since most [of the audience] had no idea what “effect size” is, I gave a brief explanation. That evening I received a phone call in my hotel room from [the company’s] director of the program. He chastised me for being off message and warned me not to make these intrusive statements. I told him that I did not work for [the company], and that presumably I was asked to give these talks because I was a respected researcher in the field and had participated in some of the early trials of their drug, including meetings to develop a protocol for their FDA submissions. I repeated my performance the next day, and was never asked to talk for them again.”

    Over the years I have given many talks sponsored by corporations, but I gave my talk, using my slides, and choosing my topic. These presentations were designed for educational impact, and the company’s drugs were never the central focus. They were extremely popular. About five years ago I was informed that henceforth I must use the company’s topics and slides, with no deviations allowed. The corporate material provided was mediocre in quality and infomercial in tone. That is when I stopped giving company-sponsored lectures in the US.”

    Dr. Mickey mentioned drawing a line. There are some lines that one just doesn’t want to cross, like these two examples. As the saying goes, when you sup with the devil, use a long spoon.


    [from 1bom: see also Should the drug industry work with key opinion leaders? No]

  3.  
    February 6, 2016 | 6:41 PM
     

    I don’t think it is confusing either.

    I expect to be paid for my work. That may be a disruptive comment in a world where companies expect physicians to work for free.

    If somebody says – show up here and talk about whatever you want and we will pay you x number of dollars for it, I might consider it. I don’t really care who they are. I am not naive enough to think that a pharmaceutical company cares about me or my career outside of that event. As Dr. Carroll points out I am going to avoid any three ring circuses and probably events that don’t target people who know what I know (the feedback from generalists is just too predictably deplorable).

    At least I might have done that in the past – but not now that I would be listed in one of the physician shaming databases.

    Of course there are any number of venues where I can present what I know for free. In many of those venues, the pharmaceutical companies will be “sponsoring” the medical or non-medical organization running it, but certainly not me.

    The millionaires and billionaires who run medicine in this country seem to have even more leverage in getting physicians to work for free. Apparently it is unethical to get paid.

  4.  
    Ferrell Varner
    February 7, 2016 | 6:51 AM
     

    Data transparency would solve most of this. Wouldn’t it?

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