Saturday, November 3, 2012

Roses (and Thorns) by Any Other Name: ACRE's New "Guidelines"

I have blogged at length about the Association of Clinical Researchers and Educators (ACRE), the primary outlet for pharmapologist sentiments, for example:

ACRE has now come out with what seems alternatively to be called either a "statement" or "guidelines" on "relationships between physicians and industry":

(Side note: I looked for this statement first on ACRE's own website and found that their latest posted news release was dated mid-2011, so I'm not sure what's up with them, but for all I can tell this statement is legit.)

If you want to cut to the chase and read the statement directly, not the summary of it in the press release, you can go to:
The summary says that this is to be published in the journal Endocrine Practice, which is not exactly a high-impact journal, but leave that aside. Corresponding author is Dr. Michael A. Weber of SUNY-Downstate, with our old friends Drs. Tom Stossel, Avi Markowitz, and philosopher Lance Stell among the writing committee.

OK, so why should a pharmascold blog like this one devote (virtual) ink to anything coming out of ACRE? I decided it might be instructive to see what happens when this organization attempts to be positive and actually issue a set of practical guidelines. Think of an analogy with the Romney campaign. Romney had it easy early on when all he had to do was attack "Obamacare." Then things got tougher when unkind folks asked him what his own health plan consisted of. When forced to come up with concrete policy proposals, Romney suddenly discovered that he actually agreed with some parts of the Affordable Care Act. So one might ask whether any similar "aha" moments might emerge from ACRE's recent efforts.

Let's quickly review ACRE's track record. Perhaps guided by in-house philosopher Stell, ACRE has never been content to quibble about the details of the ethics of the Pharma-medicine relationship. They have always gone for the jugular, attacking the core assumptions of the pharmascold position (if I may caricature it that way for brevity).

What are those assumptions? Folks like me always start with a collection of ideas:
  • Conflict of interest
  • Professionalism
  • Trust (alleging that conflicts threaten patient and public trust in medicine)
ACRE's previous publications take aim at every one of these, as we've reviewed in previous posts. There are no worries about financial conflicts of interest, because COI is ubiquitous in science and medicine so no reason to worry about one form of it. Professionalism is an outmoded sentiment. There's no empirical evidence that anyone's trust in medicine is diminished when docs fill their pockets with industry cash.

So, having trashed all the more usual ethical assumptions on which one could base guidelines for physician-industry interactions, and which in fact were relied on by folks like the IOM, NIH, and AAMC in their proposed guidelines, what can ACRE come up with?

Their summary statement seems to be: "While there may be strengths and weaknesses to [current] approaches [to regulate these relationships], the best course is a middle road: one that values transparency of such relationships, but does not harm patients or slow innovation in the process."

They then begin their statement with a substatement: "The vast majority of collaborations between physicians and industry has added considerably to improved patient care.  Moreover, these collaborations have been conducted with integrity and commitment.  Critics of these collaborations have raised concerns, largely speculative and theoretical, that have created complicated and counterproductive regulations and rules regarding these relationships."

This sounds like the old ACRE, trashing the pharmascold position as based solely on theoretical concerns when everyone knows that in the real world, nothing but benefits flow from the exchange of cash between docs and industry. And in fact, a good deal of the verbiage in the actual statement consists of a long list of all the advantages to science and patient care provided by industry and strong relationships between medicine and industry. But wait...

Here are some comments culled from the summary review, which reflect the language in the statement itself:

On medical societies: "Accordingly, ACRE recommended that leaders of medical societies have a strong obligation to create internal operational procedures ... to ensure corporate support does not create inappropriate endorsements of industry products.  ... societies should be proactive in protecting themselves and their corporate supporters against the appearance of inappropriate endorsements."

On CME: "Faculty should create their own talks"

On publishing: "Cannot prevent or delay publication of unfavorable results... Begin before outlines of article or any drafts are written ... 'ghostwriting' should be avoided and the use of external writing agencies or 'editorial assistance' should be undertaken with great care..."

On travel expenses for meeting attendance: "Travel support to attend a meeting as a member of the audience, not the faculty, should be declined...Acceptance of travel support must not be linked in any way to prescribing performance or other support of the sponsor’s products"

On consulting/advising: "Avoid giving the impression of primarily defending industry interests"

  • As I noted, ACRE's past publications have ruthlessly trashed the ideas of COI, professionalism, and concern about public trust. But their new statement/guidelines offers no alternative set of principles on which ethical conclusions might be based. And many observers would note that the above-quoted recommendations make no sense at all unless one implicitly assumes concerns about COI, professionalism, and breaches of trust.
  • Put another way, whenever the principal actors in ACRE have allowed us to peek behind the curtain to see what basic philosophy motivates them, we see some version of economism, or a faith that the unregulated free market will solve all human problems (see This proposed set of guidelines is inconsistent with that philosophy. If the market did not want ghostwriting to exist, it would not be so profitable and hence so commonplace. So the guidelines represent a tacit admission that the marketplace cannot solve all these problems on its own, and that the unregulated marketplace indeed creates problems for medicine.
  • ACRE's champions have always insisted that pharmascolds have blown a very few anecdotes way out of proportion, to claim that problems at the Pharma-medicine interface are serious and widespread. But if you look at what this blog has repeatedly documented, and then look at what ACRE's guidelines call for, you see that behavior that their own guidelines criticize occurs commonly. So these guidelines represent a tacit admission by ACRE that their past dismissal of these problems is ill-founded.
 ACRE ends this new statement by saying that while they agree with transparency and disclosure (again, why, if they reject concerns such as trust, professionalism, and conflicts of interest): "ACRE rejects the terms 'conflict of interest' [and] 'competing interests'...ACRE strongly believes that 'acknowledgement of support' is more appropriate and should be used in making disclosures of financial relationships by physician educators and researchers." All right, so they want to call it by that name, but the ethical concerns seem to be pretty much the same when you drill down. 

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