A Sokal Hoax for Docs

Via Ezra Klein, a revealing anecdote about the power of “thought leadership:”

In the early 1970s, a group of medical researchers decided to study an unusual question. How would a medical audience respond to a lecture that was completely devoid of content, yet delivered with authority by a convincing phony? To find out, the authors hired a distinguished-looking actor and gave him the name Dr. Myron L. Fox. They fabricated an impressive CV for Dr. Fox and billed him as an expert in mathematics and human behavior. Finally, they provided him with a fake lecture composed largely of impressive-sounding gibberish, and had him deliver the lecture wearing a white coat to three medical audiences under the title “Mathematical Game Theory as Applied to Physician Education.” At the end of the lecture, the audience members filled out a questionnaire.

The responses were overwhelmingly positive. The audience members described Dr. Fox as “extremely articulate” and “captivating.” One said he delivered “a very dramatic presentation.” After one lecture, 90 percent of the audience members said they had found the lecture by Dr. Fox “stimulating.” Over all, almost every member of every audience loved Dr. Fox’s lecture, despite the fact that, as the authors write, it was delivered by an actor “programmed to teach charismatically and nonsubstantively on a topic about which he knew nothing.”

It’s one more rationale for more disclosure of sources of influence in the medical profession . . . and ostensibly more objective, “algorithmic” authorities.

Originally posted at Concurring Opinions. Photo credit, Jerry Angelica.

Shine On: Lessons for Disclosure of Industry Payments to Physicians from New Empirical Research on Sarbanes-Oxley’s Conflict of Interest Disclosure Requirement

Woodcut, 16th or 17th Century

In Placebo Ethics: A Study in Securities Disclosure Arbitrage, an interesting (and very readable) article published earlier this year in the Virginia Law Review, Usha Rodrigues and Mike Stegemoller present the results of their empirical research into Section 406 of the Sarbanes-Oxley Act of 2002, which “requires companies to disclose their codes of ethics (or explain why they do not have them), and then to disclose any waivers from that code granted to top corporate officers.”  Briefly, Rodrigues and Stegemoller found that “at least for related-party transactions, firms regularly engage in a kind of ‘disclosure arbitrage,’ neglecting to disclose ethics waivers at the time when transactions occur (in violation of Section 406 of Sarbanes-Oxley),” but complying with a regulation requiring disclosure of such transactions in their year-end proxy statements.  Rodrigues and Stegemoller’s observations about Section 406 have relevance beyond securities law including (and of particular interest to readers of this blog) to recent efforts to regulate conflicts of interest in medicine through disclosure of relationships between physicians and the pharmaceutical and medical device industries.

For several years, a small number of states have required drug and device companies to report their relationships with physicians practicing in those states.  Section 6002 of the Patient Protection and Affordable Care Act takes it to the next level, requiring “drug, device, biological, or medical supply” companies to report all of the payments they make to physicians and teaching hospitals in all of the 50 states.  The Secretary of Health and Human Services is required to make the payment information public “through an Internet website,” in a form that is clear, understandable, and searchable, and in a format that is easily aggregated and downloaded.  While drug and device companies do not need to submit their first reports under PPACA until March 31, 2013, those reports are to include all payments made to physicians and teaching hospitals in 2012.  As a result, drug and device companies are hard at work right now putting systems in place to accomplish the information gathering and organizing that nationwide reporting will require.

In a number of important ways, the disclosure regime established by PPACA comports with Rodrigues and Stegemoller’s findings and recommendations.  First, having found that disclosure via company websites (as is allowed under Section 406 of Sarbanes-Oxley) has a number of downsides, they recommend that disclosure be made through EDGAR, the SEC’s consolidated, easy-to-use, indefinitely accessible database.  As Duff Wilson reports here, several companies have begun disclosing the payments they make to physicians on their own websites and downsides similar to those pointed out by Rodrigues and Stegemoller have been noted.  For one, a patient interested in learning more about a given doctor’s relationships with industry would have to search each company’s website individually and then compile the results.  The companies have not made this easy to do; most use formats that make it very difficult to aggregate or analyze the data they report.  PPACA’s HHS-run website will solve these problems.

Relatedly, Rodrigues and Stegemoller found that, given the chance, companies will choose to bury “unsavory related-party transactions” “in the rubble of sundry disclosures.”  This pitfall, too, should be avoided under PPACA’s disclosure regime.  (If anything, the statute is too lean-and-mean, providing that payments be labeled with bare descriptors like “consulting fees” and “gift.”)

Finally, Rodrigues and Stegemoller suggest that one of the problems with Section 406 of Sarbanes-Oxley is that it sets forth a “soft” disclosure requirement; a company is permitted to determine for itself what its code of ethics permits or does not permit and, a fortiori, under what circumstances a (disclosable) waiver of that code will be required.  Predictably, this leads to “companies evad[ing] illegality by watering down their codes to such a degree that they no longer forbid the very Enron-style conflicts of interest that led to the adoption of Section 406.”     Section 6602 of PPACA, by contrast, sets forth a “hard” disclosure requirement.  Companies have to disclose all payments, not just those that they have determined create a conflict of interest.

There is one concern raised by Rodrigues and Stegemoller with regard to Section 406 of Sarbanes-Oxley that may apply to Section 6602 of PPACA — the problem of enforcement (or lack thereof).  They note that “the basic consequence of underenforcement is the imposition of disclosure requirements on paper that are ignored in real life.”  Overlapping disclosure requirements (such as those that Rodrigues and Stegemoller exploited to conduct their research) are one way to determine whether required disclosures are made.  With regard to physician payments, a valuable cross check would be provided by the draft Public Health Service conflict regulations’ requirement that any significant financial interest that (1) is still held by a principal investigator or senior/key person, (2) is related to government-funded research, and (3) is a financial conflict of interest must be disclosed to the public via the world wide web; the disclosures that physician-investigators must make to medical journals will also serve this function.

Finding an Understanding Between Doctors and Patients

Photo by baslow via Flickr

A general perception has been that doctors choose their profession over their patients. The perception takes shape as medical professionals sometimes choose to protect their profession over the chance to improve the quality of medical care– whether doctors refusing to report a colleague’s mistake or perhaps even hindering the efforts of a doctor rating system.

So when medical mistakes occur and possible lawsuits are on the horizon, it’s no shock that medical professionals sometimes fail to own up to their mistakes–implementing instead a code of silence about the case to avoid or limit liability.  In a critical time when patients or family members are looking for answers, doctors can be unavailable to provide it for them. It would also not be a shock if, after any such information could be helpful to the patient, doctors did so under the advice of counsel.

However, a study has been recently reported by the NY Times which suggests that perhaps silence may not be the most prudent approach.  According the NY Times,

Since 2001, the University of Michigan Health System has handled patient injuries by initiating discussions with patients and families, conducting internal investigations and offering apologies with offers of compensation should those investigations reveal medical errors. To examine the repercussions of such an open disclosure with compensation policy, researchers analyzed the number of claims and lawsuits filed against the hospital system between 1995 and 2007, comparing data from before and after the policy took effect.

Contrary to fears that such transparency might worsen litigation, the researchers found that there were actually fewer lawsuits and claims after the hospital began its disclosure with compensation program. Moreover, the hospital system’s liability costs for lawsuits, patient compensation and legal fees dropped, and claims in general were resolved faster than ever before.

While it may seem counter-intuitive to admit fault from a litigation standpoint, these efforts at transparency and an acknowledgment have actually decreased the number of lawsuits.  Richard C. Boothman, who devised and carried out the disclosure program, says, “[w]hen you break that paradigm of litigation and give patients the chance to understand the human element of the other side — of the doctor and what they are struggling with — you find that people are far more forgiving and understanding than has been typically assumed.”

It’s an interesting proposition,  disclosure and accountability as both a means to litigation loss reduction and changing negative perceptions of the profession. In revealing the doctor’s ordeal– in disclosing the fault, one may move forward towards greater understanding between patients and doctors.

It’s also worth noting that additional disclosure methods are being studied.  The Wall Street Journal reports a study about a project, known as OpenNotes, where doctors share their notes with their patients electronically.  While doctors do complain that the OpenNotes may be burdensome, there are those who think it it may be worth the additional burden because it shows– perhaps whether or not the handwriting is decipherable–that doctors are willing to take the extra time to attempt to keep them informed.

But of course, it would better if patients actually understood their doctors. But this would be in stark contrast to a recent study we wrote about here on HRW last week. The study showed a woeful lack of communication (and a wide gap in perception) between hospital staff physicians and “their” patients:

• Only 18% of patients knew their main doctor by name.
• Sixty-seven per cent of doctors believed their patients knew them by name.
• Fifty-seven per cent of patients knew their diagnosis.
• Seventy-seven per cent of doctors believed their patients knew their diagnosis.
• Fifty-eight per cent of patients thought that physicians always explained things in a comprehensible way.
• Twenty-one per cent of doctors stated they always provided explanations of some kind.
• Sixty-six per cent of patients reported receiving a new medication in the hospital, 90% noted never being told of any adverse effects of these medications.
• Ninety-eight per cent of doctors stated that they at least sometimes discussed their patients’ fears and anxieties.
• Fifty-four per cent of patients said their doctors never did this.

Sunlight is a Weak Disinfectant

Palace Guard with Two Leopards, Jean-Joseph Benjamin Constant (1845-19020

One of the most robust “memes” in contemporary law is the power of disclosure. In health law, disclosure comes up again and again: patients need to give “informed” consent, insurers are supposed to explain their policies clearly, and conflicts of interest, when not proscribed, should at the very least be exposed. But there are growing challenges to the disclosure meme, both within health law and without.

George Lowenstein and Peter Ubel note some problems with disclosure approaches in this article on the weaknesses of behavioral economics generally:

It seems that every week a new book or major newspaper article appears showing that irrational decision-making helped cause the housing bubble or the rise in health care costs. Such insights draw on behavioral economics, an increasingly popular field that incorporates elements from psychology to explain why people make seemingly irrational decisions, at least according to traditional economic theory and its emphasis on rational choice. . . . But the field has its limits. As policymakers use it to devise programs, it’s becoming clear that behavioral economics is being asked to solve problems it wasn’t meant to address.

[T]ake conflicts of interest in medicine. Despite volumes of research showing that pharmaceutical industry gifts distort decisions by doctors, the medical establishment has not mustered the will to bar such thinly disguised bribes, and the health care reform act fails to outlaw them. Instead, much like food labeling, the act includes “sunshine” provisions that will simply make information about these gifts available to the public. We have shifted the burden from industry, which has the power to change the way it does business, to the relatively uninformed and powerless consumer.

The same pattern can be seen in health care reform itself. The act promises to achieve the admirable goal of insuring most Americans, yet it fails to address the more fundamental problem of health care costs. . . . [T]he act tries to lower costs by promoting incentive programs that reward healthy behaviors. . . . [But s]tudies show that preventive medicine, even when it works, rarely saves money.

At its worst, disclosure can become merely pro forma; as Kafka (via Trudo Lemmens) puts it, “Leopards break into the temple and drink to the dregs what is in the sacrificial pitchers; this is repeated over and over again; finally it can be calculated in advance, and it becomes part of the ceremony.” Omri Ben-Shahar has argued that disclosure is one of many aspects of consumer protection law with little real impact on individual welfare. As Amelia Flood reports,

Ben-Shahar, who spent last summer studying all the mandated disclosure statutes in Illinois, Michigan and California, argues that consumer protection advocates have gotten it wrong when it comes to mandating information access for consumers. He says consumers get lost in a sea of technical language, unread disclaimers and long-shot lawsuits. . . . According to Ben-Shahar, disclosures are of more use to consumer ratings groups like Zagat and Consumer’s Digest than they are to most consumers.

So perhaps there is some hope here: third-party aggregators and raters might use disclosures as part of an overall effort to rate various hospitals or doctors. The question then becomes–who shall pay (and rate) the raters? One irony here is that doctor rating sites have themselves been accused of being insufficiently transparent about the ways in which they evaluate physicians. New York Attorney General Cuomo even pursued the matter. His office eventually settled with insurers who ran rating sites. They pledged to “fully disclose to consumers and physicians all aspects of their ranking system.”

What’s the lesson here? First, that consumers are, by and large, too busy to process piecemeal disclosures by professionals like physicians and other health care providers. Second, third party raters can fill some of this information gap by aggregating information. Third, this process of aggregation and rating itself will likely need to be closely supervised by a good-faith regulator, lest it fail to take into account the full range of interests (and quality of information) proper for the task.