Why is the New England Journal of Medicine Scolding "Pharmascolds"?

I, a normally quiet blogger on this site, was disquieted by what may be a backlash aimed at quashing the anti-conflict-of-interest movement.

Lisa Rosenbaum just published her second of three treatises in the highly prestigious New England Journal of Medine, scolding "pharmascolds" (see Conflicts of Interest: Understanding Bias — The Case for Careful Study). "Pharmascolds" is the term Rosenbaum and others use for those of us at Health Care Renewal, the Institute of Medicine, and countless medical journals and institutions.  Why?  Because we dare assert there is great danger when providers practice though saddled by (potential) conflicts of interests in medicine.  Such conflicts are created when physicians (up to 94% of us, according to Rosenbaum's research), other health care providers in practice, and health care organizations accept, not only gifts and trinkets, but also large, sometimes clandestine consulting fees and other arrangements from pharma and device companies, all the while providing direct patient care using the companies' products.

Rosenbaum and others say we pharmascolds are essentially self-righteous and obstructionist, holding back the progress of medical science.  In this article, she seems to claim that not proving direct patient harm from a specific questionable financial arrangement with a company whose product we may therefore more likely prescribe, speak well of, or publish (pseudo)evidence supporting the use of, is enough of a reason to justify the arrangement. 

Wouldn't that be the same as saying, "Until you actually crash into another car while texting, it's ok to text while driving, even if it's distracting."?

Rosenbaum uses mainly anecdote to prove her point, and appeals to a little-quoted, but still important, heuristic/bias called "moral liscensing."  Rosenbaum describes the phenomenon correctly: "once disclosure [of a conflict of interest] gets the weight [of guilt] off your chest, you feel liberated and may feel licensed to behave immorally."  True.  But then Rosenbaum seems to support non-disclosure of acts that create conflicts of interest, because disclosure doesn't decrease the acts themselves.

Rosenbaum goes further. At the same time as she supports non-disclosure of conflicts, she attempts to paint those who accept conflict-generating arrangements and keep them clandestine as victims--afraid to "come out of the closet" because doing so is socially taboo, though the activity is not wrong. 

I beg to differ.  For certain acts, potential conflicts, and actual conflicts, it seems to me that mere disclosure of the act or conflict shouldn't relieve one of the guilt associated with the act or conflict.  It also seems disclosure of a conflict should not make a speaker seem more credible to his/her audience because of its disclosure, though some research Rosenbaum quotes seems to show that disclosure improves credibility. 

Perhaps the stronger argument for disclosure is to disqualify people from activities that should be prohibited for people in conflict, as well as to warn people away from engaging in questionable activities that would result in conflicts. 

In an unbelievable twist of logic, Rosenbaum seems to be arguing in this article for more, not less of these questionable activities, in the interest of advancing science, until we prove patients are directly hurt by them, i.e., we have a "wreck."  Heck, let's get rid of traffic lights too, while we're at it.  People have eyes. We should trust them. They should be able to avoid accidents voluntarily, on their own.

In short, how could Dr. Rosenbaum not see that the best solution for the "problem" of conflicts of interests is avoidance when possible?  One can't help but wonder if she and the Journal aren't blinded by the shimmer and pull of powerful, influential organizations, ones so shiny, so strong, and so ubiquitous that resistance is just too hard for her, the Journal, and for 94% of us.

Conflicts of interest should be avoided.  Society has accepted that improved health will result not just from secondary prevention (e.g., not texting while driving after one has had an accident from the activity), but also from primary prevention (not texting while driving, even before an accident occurs). 

Wally R. Smith, MD

1:59 PM

Administrators at Pepper Spray U Found to Have Violated Medical Professor's Academic Freedom

There they, the management of University of California - Davis, go again.

The Wilkes and Hoffman Op-Ed Questioning A University Sponsored Aggressive Prostate Cancer Screening Program

According to the Los Angeles Times, and a post in Inside Higher Ed, the trouble began when Dr Michael Wilkes, a professor of medicine at University of California - Davis, and Jerome Hoffman, a professor of emergency medicine, wrote an op-ed in the San Francisco Chronicle in 2010 questioning the wisdom of a program run by UC-Davis promoting aggressive screening for prostate cancer with the PSA test.  They brought up problems with using PSA for screening that have been known for a while, including the poor ability of the test to detect cancer, the inability of the test or of prostate biopsy performed in response to the test to differentiate aggressive prostate cancer from cancer that will not progress, which is more common, the risks of such biopsies, and the poor effectiveness of available prostate cancer treatments, compared with the frequency with which they produce harms.  All these issues have again been brought to the fore by US Preventive Services Taskforce's latest recommendations not to screen for prostate cancer, based on similar concerns.

Not only did Wilkes and Hoffman question the basis for the university sponsored program's aggressiveness, they speculated that it might have to do with money.  The program was sponsored not only by UC-Davis but by the American Urological Association Foundation.  In fact, that foundation's current corporate sponsors include:  Astellas Pharma, Inc., Endo Pharmaceuticals, Ferring Pharmaceuticals, Intuitive Surgical, Inc., Pfizer, Inc., and Qualigen, Inc., although the op-ed did not specifically list its commercial support.

The University Slap(p?)s Back

Nonetheless, per the Inside Higher Ed post,

Michael Wilkes received an e-mail from an administrator at the University of California at Davis. Wilkes, a professor at the medical school, was told that he would no longer lead a program sequence that taught better patient care, and support for a Hungarian student exchange program he headed would be withdrawn.

Within weeks, Wilkes was told that he would be removed as director of global health for the UC Davis Health System. He also received letters from the university’s health system counsel suggesting that the university could potentially sue him for defamation over the op-ed.

Again, this occurred despite the facts that many distinguished people have questioned the wisdom of aggressive prostate cancer screening, and that this particular prostate cancer program was supported by an organization that in turn is supported by money from pharmaceutical devices and drug companies that may stand to gain from selling drugs and devices related to screening for prostate cancer, and the diagnosis and treatment of such cancer. Wilkes and Hoffman were raising valid clinical and policy concerns about the public actions of a government-supported university, in my humble opinion.

Thus the university lawyer's apparent threat of defamation suits thus appears to be a SLAPP, a threat of strategic litigation against public participation. In California, a 1993 law provides recourse for people who have been threatened with SLAPPs (look here).

The Faculty Committee Responds

Regardless, Prof Wilkes filed an internal complaint, and again, per Inside Higher Ed,

Now, a committee on academic freedom at the university that investigated allegations of intimidation and harassment against Wilkes has found them to be true. The faculty committee said in its report, a copy of which was obtained by Inside Higher Ed, that the actions of the university administrators cast doubt on its ability to be a 'truthful and accountable purveyor of knowledge and services.'

The group has asked the dean and other top officials at the university’s school of medicine to write letters of apology to the professor, admit to errors of judgment, stop proposed disciplinary actions against him and take steps to prevent future violations of academic freedom. This week, representatives of the university’s Academic Senate are expected to vote on similar resolutions against the administrators.

Now, according to the LA Times,

The next step is up to campus Executive Vice Chancellor Ralph Hexter, who in consultation with Chancellor Linda P.B. Katehi is expected to decide by fall whether to impose any discipline on the medical school executives, campus officials said.

Good luck with that.

The Context at UC-Davis

I would be surprised if any such punishment occurs. After all, UC-Davis has a record of not tolerating dissent, but tolerating administrators who suppress such dissent.  We have previously discussed:
- How the UC-Davis police infamously pepper sprayed peaceful student demonstrators, apparently at least partially in response to Chancellor Katehi's vague orders to clear the campus (see post here).
- A subsequent report blamed this incident on incompetent, or worse leadership by Katehi's administration, but so far it is not obvious that this has lead to any changes (see post here).
- How UC-Davis adminstrators tried to punish a medical student who got in a dispute with an overly officious student who apparently was "monitoring" his actions on an email list server, apparently on behalf of the administration, invoking "professionalism" as if that meant blind obedience to academic administrators (see post here).

Furthemore, Chancellor Katehi has a record of her own relationships to industry.  Here we noted that she sits on the board of a large publishing conglomerate that includes a medical education and communication company (a MECC) as a subsidy.  So I suspect she may not rush to punish subordinate executives because they suppressed criticism of the role of commercial money in medical academics.

Summary

So UC-Davis seems to be another academic medical institution run by people more interested in bringing in commercial support than the academic medical mission, including the support of free speech and academic freedom.  Its case is another example of how leadership that seems hostile to the mission in one instance is likely to be hostile to the mission in other instances.

Here I summarized what I believe to be the real threats against professionalism in the academic medical context.  As we have said again and again, true health care reform would encourage leadership who understand the mission and will put its support ahead of financial concerns and ahead of their own self-interest.

See also posts in the Health News Review blog, and the University Diaries blog.

3:39 PM

Dartmouth's Governance and Wall Street

While the money spent on health care in the US continues to increase, care becomes less accessible and its quality becomes more dubious.  Most public health care discourse seems at a loss to explain how we can keep spending more to get less.

Of many possible explanations, one that has become more credible is continuing erosion of health care stewardship.  The boards of trustees of health care organizations, those charged with their stewardship, seem increasingly preoccupied with self-interest rather than the health care mission.  As more information about how such boards currently operate sneaks into public view, the problems appear more serious and salient.

New information about the governance of Dartmouth College, an issue we have followed since 2007, is illustrative.

The Case So Far

The problems at Dartmouth were notable because in many ways its governance was superior to that of many US higher educational and health care institutions.  At the time we first stumbled on these problems, Dartmouth was unusual in that nearly half of its board of trustees were elected by alumni, rather than being self-appointed.  That made its governance both more representative  and more accountable. 

In 2007, however, a dispute was ongoing about the extent that the institution's board of trustees ought to represent the alumni at large, or instead, ought to be a self-elected body not clearly accountable to anyone else.  The unelected, or "charter" board members were pushing to increases their numbers.  In 2007, what really got our attention was the stated rationale for this push towards less representative and accountable governance. Mr Charles Haldeman, then the chairman of the board of trustees, announced a smaller proportion of elected trustees would ensure that the board "has the broad range of backgrounds, skills, expertise, and fundraising capabilities needed," and that the board members would possess "even more diverse backgrounds."  However, despite his appeal to diversity, Mr Haldeman seemed most intent on reducing "divisiveness," especially dissent that challenged his own authority.  At the time, we thought his argument for more diversity to reduce dissent and increase his own authority seemed Orwellian.

Yet when we examined the backgrounds of the self-appointed trustees, we found that they exhibited little diversity. Furthermore, rather than resembling followers of Ingsoc, they resembled more the group that the radical left traditionally reviled.  Remarkably, three-quarters (6/8) were leaders of the finance sector, of what is popularly called "Wall Street." In 2007, they seemed not very diverse, but why the majority should be in the financial sector, and what implications that had, was then obscure.

After the fall of Lehman Brothers and the onset of the global financial collapse/ great recession, the implications of this Wall Street majority on the board of an institution of higher education became more troubling.  Since 2008, growing concerns about the extent that finance is driven by a "greed is good" culture increasingly suggest that domination of university, medical school, or hospital boards by leaders in the finance sector may increasingly divorce boards from the missions which they are supposed to uphold.

Yet in 2008, the unelected "charter" members of the Dartmouth board succeeded in increasing their numbers, and hence their proportion of total board seats.  The new board was no more diverse.  Of its 13 charter members, 9 were from finance, and one more was the CEO of a corporation with a major finance subsidiary.  (Look here.)  By 2009, the charter board members had succeeded in ousting a dissident alumni-elected member, labeling him a member of a "radical cabal," and rewriting a board loyalty oath apparently to discourage further dissent.  (Look here.)

All this spoke to the increasing power of the culture of finance among members of the board.  Perhaps, though, there were reasons that the financial majority on the board wanted to suppress dissent other than to make themselves more comfortable with their own dominant culture,  In 2010, as the global financial crisis continued, "Educational Endowments and the Financial Crisis: Social Costs and Systemic Risks in the Shadow Banking System," published by the Center for Social Philanthropy, Tellus Institute, focused on how prominent educational institutions, including Dartmouth College, came to invest much of their endowments in risky, illiquid "alternative" investments, the sort provided by the "shadow banking system."  (See this post.)  The report noted extensive conflicts of interest on the Dartmouth board involving trustees who were also leaders of finance.  Their firms, it turned out, were managing a substantial fraction of the money in the college's endowment.  Half of the charter trustees were also being paid to manage the finances of the institution for whose stewardship they were responsible. 

Trustees of non-profit organizations are supposed to exhibit a duty of loyalty, that is, they "must give undivided allegiance when making decisions affecting the organization."  (For a summary of their duties, look here.)   In 2010, I noted, "letting a board member's firm manage millions of dollars worth of the institution's endowment portfolio seems an obvious violation of the duty of loyalty."  So, "these sorts of conflicts of interest may be another 'missing link' explaining why the leadership and governance of health care organizations has gone so far astray."  I then posited, "as disclosure continues, maybe enough outrage will ensue so that improved leadership and governance will become possible.

The Friends of Eleazar Wheelock Charge Corruption

Now there seems to be more outrage.  Last month, the dissident Dartblog broke the story of a letter sent in February, 2012 to the New Hampshire Attorney General by an anonymous group called the "Friends of Eleazar Wheelock."  (Wheelock was the founder of the college.)  To the the letter was appended a report that included an even more extensive list of conflicts of interest affecting Dartmouth trustees, the college's Finance Committee and Investment Committees, and their friends and relatives. 

The letter also added

The mismanagement extends beyond the investments and endowment. 1) Over a period of seven years The College engaged Lehman Brothers in six 'interest rate swaps' totaling $550 million dollars. The current value of these 'swaps' is now in excess of two hundred million dollars. That is what Dartmouth owes on these bets. These losses are not reported in the College’s financial statements. 2) The College’s 'cash' was invested in six hedge funds. Up to 40% of it was lost. Again, this was not reported. This comprises grant money for research, advances to faculty, and other working capital which should have been invested in the safest of money market instruments. 3) over 50% of the endowment is invested with Trustees, Investment Committee members, or their friends.

The report summary stated,

The pattern that the Dartmouth trustees and members of the Endowment/Investment committee have engaged in for decades is clear. That pattern is that a donor/investment manager’s pledge to support Dartmouth is reciprocated with an investment of ever increasing proportions in the donor’s firm, lending the credibility of an Ivy League institution to the firm. The investment returns are of little import; most of these alum/donor/investment manager returns are average to poor.

It rhetorically asked how the college came into

the grip of a club of investment manager alums who have invested almost six hundred million dollars in their very own funds and directed over one billion dollars to their friends? And who have taken almost one hundred million dollars in fees to manage the endowment, often with poor results culminating in the twenty three per cent loss in 2008 and the worst performance of all the Ivies in 2011?

The letter charged that there has been a

quiet takeover of this great College by a cabal of external, wealthy alumni/ae of the college. They have mortgaged the College’s future through borrowing heavily in the tax exempt marketplace under NH HEFA (Health and Education Facilities Authority). They have simultaneously directed the College’s three billion dollar endowment to themselves, their firms, and their friends. They have furthered their own self-interest at the expense of the College and the Upper Valley. They have abused the non-profit status of Dartmouth College. They have enriched themselves through managing and directing Dartmouth’s three billion dollar endowment. In all cases they have taken gargantuan fund management fees through 'Private Equity', 'Venture Capital', and 'Hedge Funds' investments which they, themselves, manage and are the owners of.

Summary

A post on the American Thinker blog noted that the letter alleged "corruption." It is impossible to tell whether these expanded allegations will result in any charges, much less convictions. The state Attorney General is currently looking into this (see Reuters). Certainly, the allegations are at least of ethical corruption as it is defined by Transparency International, "abuse of entrusted power for private gain."

The revelations since 2007 (and I could argue beginning with my finding that the majority of the supposedly "diverse" charter trustees were leaders of finance) first raised questions whether Dartmouth governance's was attentive to the mission, then, whether it was conflicted, and now, whether it is corrupt.

That these questions can be credibly raised about one of our most prestigious institutions of higher education and health care demonstrates the depth of our health care crisis. It also demonstrates how the health care crisis seems inextricably linked to the financial crisis, and to a fundamental crisis about our society and its commitment to democracy and fairness.

A fair and thorough enquiry about the mess at Dartmouth, resulting in clear actions to uphold the institution's mission and ethics, and, if applicable, the law, would start us down the path of true health care reform.

However, if this just gets swept under the rug, we will not have reached the bottom of our descent.

ADDENDUM (2 June, 2012) - Note that Dartmouth's most recent President, Jim Yong Kim, who was appointed by and served under the Trustees in question above, is now President of the World Bank (see this LA Times article.)

See also comments in the University Diaries blog.

1:18 PM

Yale, Van Gogh's "The Night Cafe" and Personal Property: What's Mine is Mine, and What's Yours is Mine

At Healthcare Renewal and at numerous other healthcare blogs, we write about academic and industry conflicts of interest, malfeasance, and other topics in the hopes that there are leaders within organizations who might correct the wrongs that result from such conflicts and behaviors. (That is, when it is not those same leaders behind the scandals in question.)

Our efforts are based on the assumption (perhaps, more correctly, a hope) that the problems within organizations are not organic and ideological, and that they are in some fashion amenable to correction internally and externally via exposure to sunlight.

What if we're wrong?

A story caught my eye about my Medical Informatics alma mater. A Frenchman, Pierre Konowaloff, is suing Yale for return of a famous Van Gogh painting that was confiscated from his family in the early 1900's by totalitarians, psychopaths who created what proved to be one of the most oppressive and murderous regimes in history (the Soviet Union).

In return, Mr. Konowaloff was countersued by Yale.

Yale alleges that the confiscation of the painting by the Soviets was A-OK because "international law was not violated" [by the confiscation - ed.], therefore Yale has legitimate and unchallengeable dibs on the painting.

"International law" was not violated? This response is beyond stunning.

I had to retrieve my jaw from the floor after reading the story:

Wall Street Journal
June 3, 2009

Yale Sued Over Van Gogh Painting Seized by Soviets

By JOSEPH PEREIRA

A descendant of the onetime owner of a famed Van Gogh painting has sued Yale University in an effort to reclaim the artwork from the Ivy League school.

In a lawsuit filed in U.S. District Court in New Haven, Conn., Pierre Konowaloff alleged that the university should have known the painting—"The Night Café"—had been confiscated from his great-grandfather, Ivan Morozov, a Russian industrialist and aristocrat, during the Communist takeover of Russia in the early 1900s.

The 1888 painting was subsequently sold by the Soviet government to a European gallery. Stephen Carlton Clark, a Yale alumnus, bought the painting from a gallery in New York in the early 1930s and bequeathed it to Yale in 1961.

In his suit, Mr. Konowaloff, who lives in France, accuses the university of engaging "in a policy of willful ignorance" that amounts to "art laundering," and asks the court to declare him the rightful owner. Aware of Mr. Konowaloff's intention to claim the painting, Yale filed a lawsuit of its own last March in federal court in New Haven.

In its suit, Yale asserted ownership of "The Night Café," claiming that the nationalization of the painting by Communist Russia -- while at odds with capitalism -- did not violate international law. Yale stated in its lawsuit that "it was accepted at the time, as it is now, that the sales by the Soviet government were valid, as were later acquisitions of the paintings."

In other words, rather than doing the right thing, Yale is claiming that the theft of personal property by the Soviets was OK by them. (While Yale is well known to have a culture far to the left and many of its leaders and faculty probably sympathize with communists, Hitler also "nationalized" the artwork and other property of individuals. Would Yale find those actions in accordance with "International law?" One can only wonder.)

Van Gogh's "The Night Cafe"

Now, if this were a one-off event, it would not be as illustrative of a systematic ethical decay that I fear exists in the hallowed Ivy halls. However, Yale has recently been fined $7.6 million after an investigation by NIH, NSF, DOD and others into misuse of research money by faculty. I wrote about that event at "Lux et Veritas, or Trust But Verify? Yale discovers eDiscovery", and the powerpoint from within Yale outlining the issues was eye-opening.

Here is a synopsis of the outcome:

Yale University Pays $7.6 Million to Resolve False Claims Act Allegations (PDF)

—excerpted from U.S. Dept. of Justice press release, Dec. 23, 2008

Yale University has entered into a civil settlement agreement with the federal government in which it will pay $7.6 million to resolve allegations that it violated the False Claims Act and the common law in the management of federally-funded research grants awarded to the university between January 2000 and December 2006. The grant awards were made by approximately 30 federal agencies and entities, including NIH, NSF, DOE, DOD, and NASA.

The investigation focused on allegations involving two types of mischarges to federal grants. Both types of mischarges arose as violations of the basic principle that recipients of federal grants are allowed to charge to each grant account only “allocable” costs, which are costs that relate to the specific objectives of that grant project.

The first allegation involved cost transfers and the requirement that costs transferred to a federal grant account must be allocable to that particular grant account. The settlement resolves allegations that some Yale researchers at times improperly transferred charges to a federal grant account to which those charges were not allocable. Researchers allegedly were motivated to carry out these wrongful transfers when the federal grant was near its expiration date and they needed to spend down the remaining grant funds. Federal regulations require that unspent grant funds be returned to the government.

The second allegation involved salary charges and the requirement that charges to federal grant accounts for researcher time and effort must reflect actual time and effort spent on a particular grant. It was alleged that some Yale researchers submitted time and effort reports, for summer salary paid from federal grants, that wrongfully charged 100 percent of their summer effort to federal grants when, in fact, the researchers expended significant effort on unrelated work.

Researchers allegedly were motivated to carry out these wrongful salary charges by the fact that they are not paid their academic-year salary by Yale during the summer. The only salary received by these researchers during the summer was the result of the effort they charged to federal grants. Absent the alleged grant mischarges, the researchers would not have been paid.

The $7.6 million payment comprises two components: $3.8 million in actual damages for the false claims, and $3.8 million assessed as penalties for the false claims.

Taxpayer money was used as they pleased until caught. What's mine is mine, and what's yours is mine.

Yale's clinical operations have seen federal investigation once before which I wrote about at "Insufficient IT Management Depth Results in Justice Dept. Investigation, Millions of Dollars in Fines." That story was more about IT incompetence rather than malfeasance, however.

I've had my own personal experiences with these "what's mine is mine, and what's yours is mine" property-rights attitudes at Yale. Perry Miller, Director of Informatics, Kenneth Kidd, Professor of Genetics, and Carolyn Slayman, Deputy Dean for Academic and Scientific Affairs, waged a rather one-sided and extortionary battle to misappropriate my intellectual property, a computer program I'd authored as faculty, assisted by a lawyer in Yale's Office of General Counsel -- who for good measure was in fact unauthorized to practice law in Connecticut at that time. Ex-colleague faculty Richard Shiffman "purged" me, Stalin style, by telling recruiters who called that I didn't exist - one of those recruiters, unfortunately for him, happened to be a detective I retained. I wrote up the story in detail at this site. Dr. Kidd in particular was a principal in the now-defunct Human Diversity Genome Project in which he and others promised indigenous tribes their genetic materials would not be misappropriated for others' gain and profit. (I found that position risible considering my circumstances. Kidd's research raised further issues as I wrote at "Informed consent, exploitation and developing a SNP panel for forensic identification of individuals.")

University officials right up to President Richard Levin (in the WSJ recently lamenting the decrease in the value of Yale's endowment from $24 billion to $17 billion), said they could do nothing to help me, even though I was being badgered for my software and actually blackmailed (through denial of confirmation of my training and faculty time at Yale to potential employers).

You would think a university with an endowment in the billions of dollars could have protected its own junior faculty from senior faculty predators, and you'd also think it could return a Van Gogh to the heir of a man who had it stolen by thugs who later murdered tens of millions of their own citizens.

Ironically, when I was Yale School of Medicine junior faculty in Yale Center for Medical Informatics, I was charged with teaching postdoctoral fellows about NIH ethics guidelines. The tenured senior faculty I was working for just didn't have the time.

Now, I may simply be a "disgruntled former Yale faculty member" after nearly having my career destroyed by these people in what was the most disappointing experience in my life, bar none, but the pattern of "what's mine is mine, and what's yours is mine" seems to be all too commonplace in Yale's case. From Bloomberg's coverage of the same Van Gogh story:

Yale Sued Over Van Gogh Work By Man Claiming to be Russian Heir

June 4, 2009
By Cary O’Reilly

... Konowaloff’s claim is the latest litigation accusing Yale of improperly possessing artwork or historic artifacts. The Republic of Peru sued Yale in December seeking a collection of artifacts excavated from Machu Picchu and other sites by university scientists and researchers.

I'd written about Machu Picchu here:

... Peripherally related in the scientific sense but perhaps closely related in the ethical and ideological sense, I've just discovered via a recent newspaper that Yale has some additional problems of late regarding property: "Peru demands return of Machu Picchu treasures by Yale", Miami Herald, July 25, 2007, by Tyler Bridges (now a Peruvian resident). Yale apparently went so far as to interpret the laws of a foreign nation, which is, of course, Yale's right as a sovereign entity, the People's Republic of Yale, it would seem:

Key documents include a 1912 Peruvian decree stating that Peru reserved the right to request the objects' return, and a 1916 letter that [Yale professor/explorer Bingham] wrote to the National Geographic Society about the artifacts from the 1914-15 expedition. ''Now they do not belong to us, but to the Peruvian government, who allowed us to take them out of the country on condition that they be returned in 18 months,'' Bingham wrote. Yale officials have said that Peruvian law in force in 1912 does not require the university to return objects from Bingham's expedition that year.

Perhaps less credible is this additional allegation from Bloomberg:

... Yale and a secretive student society known as the Order of Skull & Bones were sued in February by the descendants of the 19th century Apache Indian warrior Geronimo. The family claims a group of Yale students may have stolen some of Geronimo’s remains in 1918 and taken them to Yale’s campus. The university denies the allegation and says it has no connection to Skull & Bones.

Then there's Yale's Taliban Man incident per John Fund at the WSJ. The former deputy foreign secretary of the Taliban was taken as a student at Yale in 2006 while at the same time the school blocked ROTC training from its campus and argued for the right of its law school to exclude military recruiters.

I fear other Ivy universities also lack a sense of basic ethics, both at the individual faculty level and collectively, i.e., including the leadership. I'd written about the ghastly events regarding the Duke lacrosse team affair at "A Truly Appalling Lawsuit Against Duke University." Harvard Medical Schools's own ombud had written an article in JAMA in the late 1990's entitled "Authorship: the coin of the realm, the source of complaints", outlining the commonality of fights over IP between faculty and students, and admitted in a response to my Letter to the Editor that this could not be prevented by administration (which in my view translates to, "the administration's worse than the faculty in this regard.")

Others at Healthcare Renewal and related blogs have written about ethical lapses at other major universities as well.

In summary, if both the majority of the faculty as well as the administration of our major universities never learned as children about respecting others' property, and pass these attitudes along to future academics and future captains of industry, the bloggers will be unable to teach them very much. We will continue on a course of periodic academic and industry healthcare (and other) scandals of increasing scale, along with the wasted talent, resources and opportunity these scandals represent.

-- SS

Addendum: after such a grim report, I thought I'd throw in something pleasant. Here is a friend I feed at the nearby park, one of six, in fact, Mute Swan cygnets (babies). The parents like me so much, they've offered me food in return - lovely clumps of fresh tender grass, which to them is a delicacy:

Cygnus olor - click to greatly enlarge these adorable fuzzballs

It's a great picture, but it's not a Van Gogh. Since I once worked at Yale, however, let's hope they don't claim the photo is theirs.

-- SS

6/10/09 Addendum:

Remarkably, there is apparently someone in the health IT community who was offended by the posting of the photo of the cygnet I feed (done, of course, as "comic relief"), as I have been informed. One can only wonder if violations of intellectual property and civil rights by universities, or patent safety concerns by faulty EHR's cause equal offense.

12:28 PM

In Defense of Psychiatric Diagnoses and Treatments

In Defense of Psychiatric Diagnoses and Treatments

The Boston Globe is out today with a story about conflicts of interest involving American Psychiatric Association guidelines for treating depression, mania, and schizophrenia – disorders for which the market in medications is said to be $25 billion annually. Conflicts abound, it seems, and the consequent implication is that industry influence has led to guidelines that “focus heavily on medications and give relatively little attention to nondrug treatments.”

The lead author of a forthcoming analysis, Lisa Cosgrove from the University of Massachusetts is quoted in the Globe as saying “…the lack of biological tests for mental disorders renders psychiatry especially vulnerable to industry influence." Maybe so, but it’s not just psychiatry. And this new study should not be taken to invalidate psychiatric diagnoses or to undermine the efficacy of psychiatric treatments.

The existence of disease is not predicated on having a biological test. It’s nice when we do have one, but there are many disorders throughout medicine, not just in psychiatry, for which there is no conclusively defining biological test. Think migraine. Think multiple sclerosis. Think chronic pain.

There is a distinguished tradition of clinical research, going back to the late 1950s, wherein disorders like depression, mania, and schizophrenia were studied for their genetic profiles, their clinically meaningful subtypes, their biological correlates, and their responses to treatments. This bottom-up approach yielded useful theories, which in turn led to better theories and to new treatments for depression, mania, and schizophrenia. Like any other branch of science, clinical science has a self-correcting function that distinguishes it from pseudo-science and propaganda. So, we welcome new theories even though most will not survive, and we welcome new diagnostic proposals and we welcome potential new treatments. All are subject to the test of independent confirmation, and nobody is surprised when many fall away.

Since around 1990 that tradition has been corrupted by Pharma and Pharma’s money. There is no shortage of examples regularly in the news. Academic key opinion leaders lost their ethical compass and, with or without a figleaf, devolved into spokespersons for industry. One is reminded of Julien Benda’s term la trahison des clercs. Instead of moving on from undistinguished and problematic new drugs, key opinion leaders work with the marketing departments of Pharma to promote and defend the brand. Remember the PsychNetters? Of course, psychiatry is not the only medical specialty corrupted in this way. Stents, anybody? Orthopedic devices, anybody?

Lost in the marketeering and propaganda since around 1990 is the discipline of clinical therapeutics. As one commentator put it, if there is no way to confirm biologically the existence of disease, then “…we cannot confirm with much confidence that this or that treatment treats mental disease.” It actually is possible to identify effective treatments for mental disease. We did it with lithium. We did it with the early antidepressant drugs. And we did it with the early antipsychotic drugs. There was room for improvement in all of these, but make no mistake – they were dramatic positive developments. Most of the work in the past 20 years, however, put marketing first and clinical therapeutics second. Humbug aside, the goal was not to improve the management of depression or mania or schizophrenia but to jump whatever bar the FDA was setting in order to get a product on the market. Indeed, the really hard clinical research issues were studiously avoided. Along the way, the clinical research enterprise became dominated by academic and for-profit contract research organizations in which, to put it gently, standards of recruitment of patients apparently suffered, so that response rates in placebo-treated patients skyrocketed. As a result, proving that a drug does work became harder, and the overall drug advantage over placebo in treating depression came into serious question. In effect, the corruption of clinical research standards has brought us to an epistemologic quagmire about the efficacy of today’s most popular antidepressant drugs.

As for the charge that psychiatrists and primary care physicians just throw drugs at mental health problems, that is nothing new. It is a reflection of the professional pragmatism that permeates medical practice. Think back to the 1950s when the new wonder drugs called antibiotics were handed out like Pez, mostly for people who did not really need them and who would not benefit from them. The working principle was misguided simplicity and pragmatism, which minimized and discounted the risks. Even today the over-use of antibiotics remains a public health concern. Just as in the 1950s patients with nonspecific upper respiratory symptoms were “given the benefit of the doubt” and were prescribed an antibiotic on the reasoning that it might help them while probably not hurting them, so today patients with nondescript depressive or anxiety symptoms are prescribed an SSRI drug on the same reasoning. The cost of this approach in wasted money, in unnecessary side effects, and in unproductive clinical management is non-trivial.

So, the issues are more nuanced than today’s Boston Globe story would suggest. For good and for ill, psychiatry is not so very different from the rest of medicine. Corruption and compromise respect no subspecialty boundaries. We can have reliable and valid knowledge of disease without a biological test. We can show efficacy of treatments for disorders that lack a biological test. But when simplistic pragmatism and cutting corners dominate in therapeutics and in clinical trials, then we are in trouble.

4:41 PM