Saturday, June 29, 2013

The Pharmapologists' Ballad: Same Song, Second Verse

In the immediately last post, I noted the staying power of the old rationalizations repeated by clinicians found with their hands in the Pharma till, that of course those big bucks for speakers' fees, etc. could not possibly influence their prescribing habits. The subject of this post is how the same old dirge, in the version trotted out by defenders of the status quo relationships between academic medicine and industry, continues to get sung even in the face of massive contrary evidence.

Our pal Dr. Roy Poses at Health Care Renewal blog called attention to a set of papers in the latest JAMA Internal Medicine that included a viewpoint by Dr. Susan Desmond-Hellman, chancellor of the UC-San Francisco health science campus. The paper is worth walking through point by point because it illustrates so many of the old canards that still afflict our thinking about relationships between medicine and industry.

Before I do the walk-through, let me get to the bottom line. Dr. Desmond-Hellman apparently wishes to have robust, positive relationships between academic medicine and the pharmaceutical and biotech industries. I want exactly the same thing, as I have stressed in earlier posts. No one imagines that somehow, academic medicine can simply proceed on its own and ignore the essential role of industry in making new drugs available to patients. No one imagines that either side can do its best work if deprived of the insights and ideas that could come from a productive exchange with the other. What's left to argue about, therefore, is the ground rules by which such a positive relationship for the future could be created. We pharmascolds say that the current system is broken, and only by frankly admitting this could we then go forward and create something that really works for the benefit of patients and the public health. The pharmapologists insists that everything is just peachy as it is, and the best move forward would be for us pharmascolds simply to shut up.

So now for the walk-through. First step: who is this person anyway? For background on Dr. Desmond-Hellman we go back to an earlier Health Care Renewal post:
This post makes two points. First, while the present viewpoint refers modestly to the author's "16 years of employment in the pharmaceutical and biotechnology sector (at Bristol-Myers Squibb and Genentech) prior to returning to academia," it fails to note that during her time at Genentech, she held a president's role that paid somewhere between $7M and $11M annually. So this is not exactly a mere employee of the industry. Second, by the usual measures of such things, her background in academic medicine is notably skimpy--her number of papers reportedly published, for example, would ordinarily not earn a junior faculty promotion from assistant to associate professor. So her being hired as Chancellor (i.e., big boss) at UCSF was hardly an example of a solid academic physician coming home to her roots; it was more a matter of, "Let's see if we can attract a really high roller in industry to come run our shop, and see if we can't get our hands on some of those big industry bucks."

Next step: denounce the pharmascold "pundits." While admitting coyly that this places her in a bit of an awkward position as a would-be pundit herself, Dr. Desmond-Hellman begins by attacking the "pundits" who suggest that the industry may not have the purest or noblest motives. Interestingly she picks on one particular pundit, Dr. Ben Goldacre of the UK, whose book, Bad Pharma, I recently reviewed here:

Now Dr. Goldacre is an interesting "pundit" to target, especially coming from a person who holds an MPH degree and so who supposedly knows something about epidemiology and research methods. You can kick about a lot of what he write in his book, but one thing you can't kick about is his evidence base--he seeks out the most careful, systematic reviews available in the literature to support every point he makes, and when he can find no such studies, he tells you. By contrast, Dr. Desmond-Hellman's viewpoint consists of one unsupported anecdote after another, basically saying: I have spent a lot of years working with industry; the people I worked with are really fine people; where's the beef?

Next step: appear even-handed. Dr. Desmond-Hellman now has to defend her bona fides and so proclaims, "I readily appreciate both the opportunities and the threats to private-public partnerships with industry." Great--she is going to admit that it's not all roses and there are thorns here as well. Except she doesn't. It turns out that all the threats, as we'll see in a minute, are on the academic side, and she makes abundantly clear her immediate conclusion that "I strongly believe that the benefits--the enhanced ability to ameliorate disease, extend life, and improve health--outweigh the risks." It's typical of her strategy that she explicitly lists the benefits, even as mom-and-apple-pie generalities, but says nothing about what the "risks" might be--when push comes to shove, she apparently cannot think of any.

Next step: attack bias in research. Next we encounter an argumentative strategy that we've looked at in the past in considerable detail, for example:
Briefly, this refrain in the chorus goes: Investigator bias is a ubiquitous problem in research; financial conflicts of interest with industry are merely one of many forms of investigator bias; therefore financial COI fades into insignificance as a concern about academic-industry partnerships. Let's study this for a minute (besides referring to all the refutations of this flawed line of argument from the previous posts).

As an individual academic-medicine investigator, I may have a strongly held belief that the earth is flat. This gives me a strong and pervasive bias. When I do a study, I will selectively seek out evidence showing that the earth is flat and tend to dismiss data showing that it isn't. Given a choice of things to study, my interests will gravitate toward flat-earth issues. My published papers, if the editors allow it to get through, will contain a variety of statements tending in a flat-earth direction. And so on.

There are also many things that won't happen. I cannot assure anyone will give me funding for flat-earth research. I cannot assure that if I get funding, I won't be the only one; there will be a whole stable of investigators all studying flat-earth matters. I cannot hire expert science writers to draft all of my published papers for me to aid them through the editorial review process and to assure that things about flat-earth are slipped in at every possible point in the manuscript. I cannot afford to buy tens of thousands of dollars of reprints of my published articles, making it more likely that journal editors will be swayed to print them. I cannot afford to hold international "consensus" conferences at glitzy five-star hotels, in which all the high rollers in the field are paid big bucks to come and proclaim how flat-earth thinking is the new best thing in medicine. I cannot donate millions fo dollars to medical specialty societies to assure that when they write their guidelines on a clinical subject, they'll be sure that paid consultants to flat-earth thinking dominate the panel and write flat-earth-friendly clinical practice guidelines, which will then be imposed on practitioners as "evidence-based." And so on and so on.

There is a big difference, in short, between investigator bias, and well-funded investigator bias.

Final step: call for more transparency and reduced bias across the board. Since according to this chorus, financial COI is just one of many forms of investigator bias, the solution is better quality research across the board; no reason to single out industry funding as in any way more problematic. Plus of course do a bit of hand-waving toward improving matters: "In addition, we must ensure that communication of research findings is robust and clear."

The answer to this canard is well provided in an accompanying editorial by Drs Robert Steinbrook and Rita F. Redberg:
Drs. Steinbrook and Redberg do what Dr. Desmond-Hellman ought to have done at the get-go if she wanted to be taken seriously-- they note the existing problems: "But in our view, any path forward must include the urgent restoration of trust in industry-funded research. On Wikipedia, there is a remarkable list of the 20 largest legal settlements reached between the US Department of Justice and pharmaceutical companies..."

A common theme is these largest legal settlements, many of which we've reviewed in this blog, is the systematic and deliberate failure of the drug industry to communicate research findings in a "robust and clear" way, so long as obfuscating produces higher profits. Anyone who imagines that we don't have to recognize this sorry track record, and start off any proposal for improved academic-medicine/industry relations by indicating precisely how we are going to avoid these pitfalls in the future, has a lot of explaining to do. Singing the same old song won't cut it.


A. Patrick Jonas, MD said...

Thanks, Howard, for a robust and thought-provoking post. Our profession has to continually review our ethical sensitivity in these challenging times.

Mickey Nardo said...

Well put. Listening to Desmond-Hellmann on some of her many videos, she speaks business-ese as her native language, hardly sounding like either a physician or an academic. In between her careful phrases and upbeat delivery, it sounds like she wants California to let her turn UCSF into an integral piece of the Biotechnical industry. Her leverage is funding of course, and she wields her sword like a seasoned veteran. She actually feels dangerous to me...