Corporate Integrity? Professionalism? Give Us a Break

"The rich are different from you and me."
"Yes, they have less integrity."

I'll return at the end to this exchange that never happened between F. Scott Fitzgerald and Ernest Hemingway. The thread begins, however, with this post by our friend Dr. Roy Poses on Health Care Renewal: http://hcrenewal.blogspot.com/2012/11/phony-consulting-and-royalty-agreements.html

Dr. Poses reviews the recent legal difficulties of the firm Orthofix, which seems to be headquartered down in my neck of the woods, in Lewisville, TX. Orthofix makes stuff that orthopedists implant in patients and so getting surgeons to choose their products over competitors' is huge for Orthofix profits. Some of the wrongdoing occurred in a subsidiary company, Blackstone Medical, which Orthofix bought out in 2006.

Some of the legal issues, in four separate legal actions, are summarized in a Bloomberg News release:
http://www.bloomberg.com/news/2012-11-02/orthofix-will-pay-u-s-30-million-to-settle-kickbacks.html
Others came from an SEC news release that Dr. Poses quotes.

Not to get overly fancy about which legal action is which, basically Orthofix was implicated in all of the following:

• Having to pay a total of $121.4M to the Feds in all the actions combined
• Paying docs sham consulting fees and kickbacks for using Orthofix products
• Paying bribes to Mexican government officials to obtain sales contracts with Mexican government-owned hospitals

Health Care Renewal has made a big deal of how drug and device companies repeatedly are caught violating laws and committing fraud, but they pay fines that amount to small percentages of their total take on the products they were peddling illegally, and have no real financial incentive not to do it again, which they then routinely do. Dr. Poses has stated that until executives of these companies do jail time we can expect this behavior to continue. So it is therefore worthy of particular note that in this case, the behavior was apparently so egregious that 5 Orthofix employees, including a vice president, have pleaded guilty to criminal charges in the kickback allegations.

What do we mean by "egregious"? Well, even if you are now jaded by all the repeated accounts of company wrongdoing, this stuff may get your attention. Here's the partial rundown:

• Docs were paid as much as $8000/month under fictitious consulting agreements, and some were awarded phony research grants for up to $18,000
• Blackstone sales tactics routinely included wining and dining docs, taking them to strip clubs, and paying for prostitutes
• One Blackstone female sales manager was urged by two surgeons whom she took to a strip club to disrobe and join the strippers on stage--after she complied, she was demoted but not fired
• The bribes paid to Mexican government officials were referred to in Orthofix documents as "chocolates," but consisted of cash, laptop computers, TVs, and appliances given directly to the officials or via front companies

Somewhere in the mix of all the legal actions back and forth, there was mention of Orthofix being forced to agree to a corporate integrity pact with the Feds. One has to wonder what possible meaning an "integrity" agreement could have in this type of situation. It is sort of like going to the local garbage dump and getting them to sign a "smell nice"" agreement.

That brings us back to the non-quote with which I began. We would like to talk about corporate integrity, on the industry side, and professionalism on the physicians' side. What does corporate integrity mean when companies act in the way that Orthofix has--apparently as a standard business arrangement? What does professionalism mean when a company offers strippers and prostitutes as well as funny money to surgeons, and expects that this will gain them points with their customers, instead of enraging and offending the surgeons? ("We've already established what you are; we're just haggling over the price"?) And what does professionalism mean when a company assumes that surgeons will find these offers attractive and acceptable--and the surgeons, in fact, do accept them, eagerly?

Well, it turns out that one problem we may be facing here is that both the corporate leaders and their surgeon-customers are wealthy. And going back to Health Care Renewal again:
http://hcrenewal.blogspot.com/2012/07/quantitating-corruption-of-finance.html
--we're reminded that there is starting to be a body of experimental and survey literature that documents a general trend of rich folks to be less honest and more likely to feel entitled to bend the rules in their favor than average people.

This is the opposite of what the popular political discourse proclaims. When we hear mention of "entitlement programs," we are not likely to think of corporate welfare for the rich, but rather of programs that aid the poor and middle class, and make those nasty people into bad folks who feel "entitled" to things they did not properly earn. But the available research suggests that it's rather those who grew up under privilege that somehow are conditioned to believe that they earned every bit of that advantage and that they can expect it to keep rolling in. (Which is what F. Scott Fitzgerald, in the legitimate quote, actually did say about the rich.)

So I conclude that for some corporations to develop integrity, and for some physicians to develop professionalism, would require a dose of anti-entitlement pills. The drug company that seeks to market that particular product might get my blessing.

A Non-Psychiatrist Dares to Comment on Psychiatry

I have occasionally posted about the controversy aroused by the American Psychiatric Association's (APA)forthcoming DSM-V classification of mental illnesses, for example:
http://brodyhooked.blogspot.com/2009/07/more-on-psychiatrys-dsm-v-mess.html
http://brodyhooked.blogspot.com/2009/06/will-psychiatrys-dsm-v-be-huge-growth.html
http://brodyhooked.blogspot.com/2012/01/from-health-care-renewal-egregious.html

I will now offer a further comment based on two posts, first, Dr. Bernard Carroll over on Health Care Renewal:
http://hcrenewal.blogspot.com/2012/11/does-american-psychiatry-matter.html
--who in turn cites the 1 Boring Old Man blog run by a retired psychiatrist:
http://1boringoldman.com/index.php/2012/11/02/cest-la-vie/

The short form of these two posts is that the APA has antagonized so many folks with the way they have mishandled the DSM-V business that they risk making both DSM-V and themselves irrelevant to mental health, and that smart people will ignore DSM-V and turn elsewhere for classifications of mental illness.

What follows is my attempt to synthesize some important ideas from these two recent posts, and I'll use the excuse that even though I am not a psychiatrist, the other two bloggers are, and so I am simply trying to pass along what they have said.

1 Boring Old Man recalls what it was like to practice psychiatry in the 1970s and 1980s. He recalls that a thousand flowers bloomed. There were many disparate, incompatible theories and schools of psychiatry--and that was good. Psychiatrists read Freud and benefited from the reading, but very few were the cardboard-caricarture Freudians that now are derided and are trotted out as the excuse as to why psychiatry had to reform itself. When the DSM-III (the first modern version) came out, most psychiatrists realized why it had been created, and basically supported the idea that some sort of standard diagnostic approach was necessary; but hardly anyone found it clinically useful. The eclectic mix of disparate schools and theories was confusing to the statisticians and epidemiologists, but a rich mine ideas for the psychiatrist who had to confront a wide variety of symptoms in a wide variety of people. The eclectic mix gave them the freedom to do what worked best under any given circumstance.

This state of affairs, these psychiatrists say, has evolved from toolbox to straitjacket as the new DSM-V seems a further attempt to impose a rigid orthodoxy on the field that stresses brain biology and drug treatment--so much so that many are now saying they'll have none of it and the APA can go take a hike.

Okay, now I'll add my own ideas. When eclecticism is working for a field, and people decide to throw out the eclecticism and replace it with something clinically much less helpful, that's bad. What this blog is mostly concerned about is the impact of industry-driven commercialization on medicine. So the next question is, how much of this bad stuff can be traced to drug industry influence.

In a previous post:
http://brodyhooked.blogspot.com/2010/05/whitakers-anatomy-of-epidemic.html
--I recounted journalist Robert Whitaker's history of the APA (in his Anatomy of an Epidemic) giving the specific dates (between 1974 and 1980) when the APA decided they had major problems on their hands, that those problems could be solved by a big influx of Pharma dollars, and that their policies therefore should shift to make APA an extremely Pharma-friendly venue. The above-listed posts further document how the new DSM-V appears to be an even bolder move toward allowing the Pharma fox to guard the psychiatric-diagnosis henhouse, in ways that maximize industry profits and the drugging of patients with even mild symptoms.

So does this shift in the DSM, that results in a further flight from clinical utility, have something to do with Pharma influence? Yes.

Let's Do It Again: Latest Federal Settlement (Boehringer Ingelheim)

We are back to our standard form, to report the latest incident of a drug firm settling with the Feds over alleged lawbreaking:

Drug company: Boehringer Ingelheim
Drugs involved: Combivent (ipratropium/albuterol), Micardis (telmisartan), Aggrenox (aspirin/dipyridamole)
Amount of settlement: $95M
Settlement equals what percentage of one year's sales of the drug?: I could quickly locate annual US sales figures only for two of the drugs in 2010, Micardis and Combivent; the settlement amount is 4% of that combined figure.
Did the company admit wrongdoing? Yes/No: Of course not
Link to detailed news coverage:
http://www.washingtonpost.com/business/pharmaceutical-company-to-pay-95m-to-settle-allegations-of-improper-promotion/2012/10/25/ef595032-1ee1-11e2-8817-41b9a7aaabc7_story.html
http://articles.courant.com/2012-10-26/business/hc-boehringer-ingelheim-fraud-20121026_1_hypertension-drug-civil-settlement-risk-of-heart-attacks

This is such small potatoes in the balance sheet of a big drug firm, less than $100M, that it's hardly worth even mentioning, except that the Feds claimed that besides evidence for off-label promotion which amounted to lying about the drug's effectiveness, the company also engaged in paying kickbacks to docs for prescribing the drugs. Not surprising to any regular readers of this blog, the kickbacks consisted of payment for serving on advisory boards, speaker panels, speakers' training programs, and consultancies.

The company, in denying any wrongdoing, commented that industry standards had recently changed, that the company was cooperating fully, and that they had entered into a supposed integrity agreement. Given the frequency with which other drug companies in the past have entered into such agreements and then repeatedly re-violated, one can be forgiven for skepticism that this amounts to any significant deterrent.

Hat tip to our Health Care Renewal friends for tipping us off:
http://hcrenewal.blogspot.com/2012/10/just-another-day-at-office-boehringer.html

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:
http://brodyhooked.blogspot.com/2012/01/another-planet-heard-from-sunshine-law.html
http://brodyhooked.blogspot.com/2010/04/encounters-with-dr-tom-stossel.html
http://brodyhooked.blogspot.com/2010/02/another-county-heard-from-acre.html

ACRE has now come out with what seems alternatively to be called either a "statement" or "guidelines" on "relationships between physicians and industry":
http://www.policymed.com/2012/11/association-of-clinical-researchers-and-educators-releases-statement-on-relationships-between-physicians-and-industry.html

(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:
http://aace.metapress.com/content/k12021244705x03w/fulltext.pdf
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"

Comments:

• 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 http://brodyhooked.blogspot.com/2011/11/shameless-commerce-division-new-book.html). 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.