DOES AMERICAN PSYCHIATRY MATTER?

DOES AMERICAN PSYCHIATRY MATTER?

The blogmeister of 1boringoldman.com has done it again. A semi-retired psychiatrist in rural Georgia, he has done more than anyone to document the follies and the ethical challenges of contemporary American psychiatry. His site is required reading for all who care about behavioral health issues.

In his latest posting he compared the domain of American psychiatry to Yugoslavia. Cast Melvin Sabshin as Marshal Tito. Sabshin was the medical director of the American Psychiatric Association in the late 1970s, the period leading up to DSM-III. Tito and Sabshin each strong-armed a confederation of sorts but failed to deal with the conflicts beneath the surface. Both leaders were faced with the prospect of their domains disintegrating – Tito’s at the hands of Moscow and Sabshin’s at the hands of insurance companies. Both persuaded wary stakeholders to sign on to a compromise, for want of anything better and fearing a worse outcome.

The domain of psychiatry hasn’t yet reached the stage of ethnic cleansing and genocide that we saw in Yugoslavia after Tito’s death, but it is well on the way. One only has to look at the vicious response of the American Psychiatric Association leaders to Allen Frances and other critics of DSM-5. The APA president in 2009, Alan Schatzberg from Stanford, went out of his way to smear Dr. Frances and Robert Spitzer, the architects of DSM-IV and DSM-III because he had no credible scientific response to their criticisms of the directions DSM-5 is taking. He was joined in this low act by David Kupfer and Darrel Regier, who are directing the DSM-5 effort. Where is the comity, Comrades? Where are the shared values? Why is the APA holed up in a bunker?

Then we have the unsavory sight of the APA lawyers threatening a blogfrauchen in the U.K. with a SLAPP lawsuit for alleged infringement on the APA’s intellectual property – as though the APA owns psychiatric classification! Talk about chutzpah. So now the confederation Sabshin cobbled together is breaking up and the stakeholders are starting to go their separate ways – psychologists, counselors, social workers, patient advocacy groups, even many psychiatrists. Christopher Lane in Psychology Today has said American psychiatry is facing “Civil War” over its diagnostic manual. Even an international psychiatric journal like British Journal of Psychiatry is distancing itself from DSM-5 and there is talk of abandoning DSM-5 for the next ICD classification.

Why is American psychiatry self destructing? Because the grand bargain forged in 1980 with DSM-III was a sham from the get-go and the promised benefits of diagnostic reliability have not materialized. They knew all along that reliability was a poor substitute for validity, but they settled for half a loaf. That compromise led us into the epistemologic quagmire of today, where there is no solid ground for clinical decisions or clinical research progress or drug development. A stunning absence from the DSMs to date is any statement about treatment. That compromise also led us to diagnostic inflation, which Pharma embraced. Pharma quickly filled the vacuum with experimercials that pretended to be real clinical science, and in the process diverted precious clinical research infrastructure away from genuinely important questions. Just look at the clinical trials er, experimercials, mill operating out of Massachusetts General Hospital at Harvard University.

What lies ahead? Stakeholders are going to vote with their feet. DSM-5 is likely to be a footnote in the history of psychiatric classification. The APA will become even less relevant than it is today, much like the American Medical Association, which now commands the loyalty of maybe 30% of U.S. physicians. Mel Sabshin will turn in his grave, the APA will lose revenue, ICD-11 will become the dominant classification of psychiatric disorders, and the quagmire will continue until a new synthesis arises from the ashes. If Yugoslavia is any kind of model, don’t hold your breath.

SELF INFLICTED DAMAGE

SELF INFLICTED DAMAGE

The American Psychiatric Association (APA) is in the news again for bad public relations: worse than bad, actually – appalling. Locked in a bunker mentality, they have moved to stifle advance criticism of their flagship initiative, DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition), which is a work in progress. Lawyers for the APA have threatened the owner of a UK blog that served as a discussion forum for issues affected by DSM-5 and other, international psychiatric classifications. The blog, named dsm5watch was considered authoritative and accurate. If you go to this site now you will find that it has been deleted.

As recounted this week by Allen Frances, MD, the editor of the last published DSM edition, the blog’s owner, Suzy Chapman, told him, ”On December 22, I was stunned to receive two emails from the Licensing and Permissions department of American Psychiatric Publishing, claiming that the domain name my site operates under was infringing upon the DSM 5 trademark in violation of United States Trademark Law and that my unauthorized actions may subject me to contributory infringement liability including increased damages for willful infringement. I was told to cease and desist immediately all use of the DSM 5 mark and to provide documentation within ten days confirming I had done so."

"Given my limited resources compared with APA's deep pockets, I had no choice but to comply and was forced to change my site's domain name to dxrevisionwatch. Hits to the new site have plummeted dramatically and it will take months for traffic to recover - just at the time when crucial DSM 5 decisions are being made."

In effect, the APA, acting not through its medical or scientific officers but through its wholly owned publishing house, has attempted a SLAPP maneuver. SLAPP is the acronym for strategic lawsuit against public participation. What kind of leadership does this signal in a major professional organization?

The normal remit of professional medical societies is stewardship of professional values and ethics. That is why these societies are accorded deference and respect on matters of clinical guidelines, health policy and public education. Even when, like the Institute of Medicine of the National Academy of Sciences, they tolerate compromised members, they can generally hope to retain the public trust.

One reason for this assurance is that they are expected as a matter of professional duty to avoid conflicts of interest – personal and financial. The APA, however, has an enormous conflict in this case: it counts on millions of dollars in revenue from sales of the DSM volumes and it is under siege currently for perceived scientific and clinical weaknesses of the DSM-5 that is due to be released next year. Professional criticism is running so high that over 10,000 interested parties have signed a petition for the APA to reconsider planned changes. There is even talk of abandoning DSM-5 in favor of the ICD system (International Classification of Diseases), which is a WHO initiative.

The APA doesn’t own psychiatric classification and diagnostic criteria. When the field allows the APA to take the initiative for revisions of the DSM, it is with the understanding that the work will be conducted in the public interest rather than in the commercial interest of the APA itself, which is said to derive over $5 million annually in profits from DSM sales. The public interest and the public trust are served by transparency and open discussion, not by contrived SLAPP threats.

It is bad enough that the APA resorts to this legal artifice to stifle public discussion. When they do it through their lawyers and business entities rather than through their medical and scientific officers, they sink to a lower level yet. The parallels with corporate sleaze that we have discussed so often on this blog are obvious. For shame.

...THEM OR YOUR LYING EYES?

…THEM OR YOUR LYING EYES?

A few days ago I discussed stonewalling by the American Psychiatric Association over charges that they were partners in a ghostwritten textbook. The issue resonated with many people, including Daniel Carlat, John Nardo, the POGO blog, Alison Bass, Ed Silverman, and others. The APA has not seen its way clear to releasing key documents that might clear up the charges. By stonewalling, the APA just does more damage to its image and credibility. They come across as uninterested in transparency, and they appear to be fighting a rearguard action to defend the indefensible.

What kind of key documents could the APA have released? In our letter last January we suggested several, including the contract involving the American Psychiatric Press, the medical communications company (Scientific Therapeutics Information, Inc. or STI), the grant-giving drug company, the professional writers, and the nominal authors of the allegedly ghostwritten book. What might the contract have told us? Well, it probably looks a lot like this contract, which involves the same medical communications company, the same drug company, and one of the same professional writers, Sally Laden. It was developed right around the same time as the textbook was planned, and it is for a ghostwritten journal article promoting the infamous Paxil Study 329. Look carefully at this contract and you will be in no doubt about who did the essential work of writing and framing the article or about whether the corporation had control over the content. Now ask yourselves, if the contract for the textbook doesn’t look like this then why ever would the APA want to suppress it? That behavior just makes people conclude that the contract for the textbook does look like this contract and that the APA knows it has plenty to hide.

A first principle of cover-ups and stonewalling is that everyone needs to be on the same page with the cover story. When they are not, the façade collapses and the actors come across like the Three Stooges, all heading for the door at the same time. Today, thanks to the sleuthing of Phyllis Vine at Mental Illness Watch, we saw the stooges exposed in their clumsiness. Phyllis Vine discovered material on the corporate website of STI that has them featuring the textbook in the ‘portfolio’ that aims to attract new business to the company. Juxtapose that with the adjacent claim that STI’s skills are to "develop, write, edit, and submit a high-quality article to your target audience." Now is there any doubt about how this game is played? Now is there any doubt about whether the APA has come clean?

Well, if there were any remaining doubt it has been removed by another development: All the materials describing the STI ‘portfolio’ have been removed from the company’s website. Fortunately, Phyllis Vine had captured it here, and so did Daniel Carlat through the Wayback machine. It was picked up some more by Mickey Nardo today. It looks like the APA is going to have more explaining to do.

As the old Groucho Marx line goes, Who you gonna believe, them or your lying eyes?

Bernard Carroll

WHO YOU GONNA BELIEVE?

WHO YOU GONNA BELIEVE?

Ghostwriting Charges and Stonewalling at the American Psychiatric Association

The American Psychiatric Association came under a searchlight this past December over allegations of ghostwriting. The story originated with a public letter from Project on Government Oversight (POGO) to the Director of NIH, and it was picked up by Duff Wilson writing in the New York Times. The book was Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care. The named authors were Charles Nemeroff, now chairman of psychiatry at the University of Miami, and Alan Schatzberg, formerly chairman of psychiatry at Stanford University. Both are well known for ethical controversy – see here and here. Soon, these allegations were being dissected in the blogosphere, with stellar contributions from Daniel Carlat, 1boringoldman, Ed Silverman, and Alison Bass.

The APA and its publishing arm, known as American Psychiatric Press, Inc. or APPI, came to the defense of the two prominent academic authors over the ghostwriting charge. In particular, an APA employee named Mark Moran authored a denial of the charge in the January 2011 issue of the APA news magazine, Psychiatric News. As the controversy played out, letters from attorneys demanded retractions, and partial qualifications of the original story appeared in the New York Times and on the POGO weblog. There was never any doubt that the heavy lifting was done by a pair of professional writers employed by a medical communications company under a financial grant from a drug company. Nemeroff defended his role by averring that he ‘scrutinized’ the work product of the professional writers. Threatening letters from lawyers for Nemeroff and Schatzberg were publicized, and the APA weighed in.

The coup de grâce was administered by blogger Daniel Carlat’s withering review of the book’s artful construction to highlight the use of the sponsoring company’s antidepressant and anti-anxiety drug in primary care, while muting important information about the drug’s liabilities. Nevertheless, the APA held to its legalistic stance in defense of the ‘authors.’ This behavior is counterproductive for professional medical organizations, as I have discussed before, because it misses the ethical forest for the legal trees.

Now comes the good part. In response to the piece by Mark Moran in Psychiatric News, Leemon McHenry prevailed on Robert Rubin and myself to write with him to the magazine’s editors. Leemon is a faculty member in the Department of Philosophy at California State University, Northridge. He also has experience evaluating legal documents arising in litigation over antidepressant drugs. Robert Rubin has partnered with me in outing several notable ethics compromises involving Nemeroff and Schatzberg, going back as far as 2002, though we always call ourselves equal opportunity critics.

Our letter sent in late January to Dr. Carolyn Robinowitz, the Interim Editor of Psychiatric News, has been posted today on the POGO site. In our letter, we challenged much of Mr. Moran’s defense, and we called attention to what WASN’T in the public domain, despite all the claims and counterclaims. Essentially, the partial qualifications of the original reports that appeared in The New York Times and in the letter to NIH from POGO resulted from the inconclusiveness of some of the documents. We called on the APA to come clean with the release of all relevant materials, in the interest of transparency.

For instance, what WASN’T known were the specifics of the contract involving the corporation, the (ahem) authors, the publisher (APPI), and the medical communications company. Or the money flow to the ‘authors’ from the contract in addition to their royalties. Or the legal release form transferring ownership of the work product to the ‘authors’ and APPI. Or the corporation’s planned marketing activities, given that the corporation ordered 10,000 copies of the book. Or the correspondence among all parties that might reveal who actually did what.

Leemon McHenry’s perspective is that this hidden layer of documents may well be available if they could be unsealed in pending litigation. Naturally, corporations and their attorneys strive to keep the information hidden. But our general point is that the APA has a different duty – which is to transparency rather than to stonewalling. Did the APA do that? Sadly, no, they did not. Here is the curt reply from the Executive Editor Catherine Brown denying publication of our letter after a delay of almost 8 weeks. Now that’s what I call stonewalling.

INSEL and NEMEROFF - WHAT SANCTIONS?

INSEL and NEMEROFF – WHAT SANCTIONS?

Thomas Insel, Director of NIMH, has another posting in his own defense on his official blog today. He has been widely criticized lately for the appearance of cronyism in his relationship with Charles Nemeroff. For the past three months, Insel has been trying to put some distance between himself and Nemeroff, but the public isn’t buying it. I have called his statements disingenuous here and here. Dr. Insel’s statements today are equally disingenuous. Negative reactions are already appearing from those familiar with Nemeroff’s history.

There is no argument that Nemeroff was instrumental in Insel’s move to Emory in 1994, that Nemeroff was Insel’s department chairman at Emory, that Nemeroff helped Insel again when Insel’s initial term as director of the Yerkes laboratory at Emory was not renewed in 1999, or that Nemeroff lobbied for Insel’s appointment as NIMH Director in 2002. There is no argument that Insel and Nemeroff have given glowing public recommendations of each other, or that they have a record of cozy personal communications. There is no doubt that Pascal Goldschmidt at Miami sought and received a recommendation from Insel before hiring Nemeroff last year or that Insel went out of his way to put a personal gloss on the official NIH position regarding Nemeroff’s eligibility for grant funding if he left Emory. These are matters about which Dr. Insel prevaricates today in his blog.

Continuing his prevarication, Dr. Insel today also avoids confronting the issue of Nemeroff’s continuing service on NIMH review committees under Insel’s watch during the period that he was under sanction by Emory University, and banned from participating in NIH grants – before he relocated to Miami. Nemeroff’s curriculum vitae on the U Miami website states that he is a member of the NIMH Review Group, Interventions Committee for Adult Mood and Anxiety Disorders (ITAV), 7/1/2006 - 6/30/2010. This means Insel allowed Nemeroff to continue in that peer review role even though he was banned by Emory from association with NIH grants. The question is why? And what does that tell us about Insel's judgement?

It gets worse. During the period that Nemeroff was at Emory and under sanction vis à vis NIH grants, he continued to function as operational director of a NIMH-funded program administered by the American Psychiatric Association (APA). It is inconceivable that Insel was not aware of this arrangement. The APA program is known as Research Colloquium for Junior Investigators, and it is funded through NIMH project # 5R13MH064074-10. For the past few years Nemeroff, as Chair of the APA Committee on Research Training, has directed this program. The nominal Principal Investigator is Darrel Regier, who is the Executive Director of the American Psychiatric Institute for Research and Education (APIRE). At the session in New Orleans during the annual APA meeting last month, one of the featured speakers was Bruce Cuthbert, PhD, one of Insel’s principal lieutenants. In God’s name, why is the APA fronting the compromised Nemeroff as a role model to junior investigators, and why does NIMH/Insel allow this unsavory arrangement to continue? Could it be that Nemeroff’s crony Alan Schatzberg, the outgoing president of the APA, ran interference for his friend? And what will the new APA president Carol A. Bernstein do about it?

And then there is the issue of Nemeroff’s appointment to two new NIMH review committees just recently. Dr. Insel prevaricates again about his awareness or approval of those actions. As reported by Paul Basken in the Chronicle of Higher Education, “An NIH spokesman, John T. Burklow, answering written questions about the matter, confirmed Dr. Nemeroff's full eligibility for agency activities and said he will begin serving this coming week on two scientific panels that review NIH grant applications.” Here again, Dr. Insel seems to be trying to help his crony Nemeroff to get back into circulation after his fall from grace at Emory.

Emory University went through the wringer to discipline Nemeroff, at long last, in 2008. The actions of Insel in running interference for Nemeroff’s rehabilitation must leave Emory perplexed. Are Dr. Insel’s statements today disingenuous? You bet. Isn’t it time for the adults at NIH to step in and end this farce?

New DSM Task Force Members' Ties to Pharmaceutical Companies

The latest reminder of the pervasiveness of financial entanglements among physicians and medical researchers and health care corporations comes from a story in US News and World Report. The topic was how the American Psychiatric Association is attempting to make the development of the new edition of The Diagnostic and Statistical Manual of Mental Disorders the "most transparent" ever. The impetus behind the new transparency may have been criticism that the last edition was written by a group of authors heavily financially entangled with health care corporations (see post here, based on early reports of the results of this article: Cosgrove L, Krimsky S, Vijayaraghavan M et al. Financial ties between DSM-IV panel members and the pharmaceutical industry. Psychother Psychosom 2006; 75: 154-160, available here).

This time around, pledging to avoid even the appearance of conflicts, the APA has instituted screening procedures for the 27 members of its DSM task force, asking them for detailed financial information about stocks, honoraria, and consulting fees from drug interests.

Yet the summaries of the disclosure statements that were recently released to the public are remarkably spare [see them here]; they show only the existence of corporate connections, not their dollar amount or their duration. The result is a document that even an APA board member suggested is not very revealing. In a 2006 memo to the board obtained by U.S. News, William Carpenter wrote: 'Simple listing of all relationships is not very informative and does not identify potential conflicts that may need to be resolved.'

Critics say the limited information violates the spirit of disclosure. 'There is disclosure, and then there is disclosure,' says Daniel Carlat, a psychiatrist and former consultant to drug companies [and blogger on the Carlat Psychiatry Blog]. "There is a big difference between $500,000 and $500. It is one thing to disclose in a generic way, to say that a psychiatrist has had some consulting with a company, but that doesn't tell you a number of things.'

Furthermore, the disclosure appears incomplete in many ways. There were errors by the task force members.

Dilip Jeste, a professor of psychiatry at the University of California-San Diego, had consulting ties that did not appear on his disclosure form. Yet during the reporting year of 2003, he was a consultant to Pfizer and AstraZeneca and received honoraria from Pfizer, according to documents. Jeste called the error 'unintentional,' saying he had relied on memory. The APA said that Jeste would submit a new disclosure. APA President Carolyn Robinowitz said that task force nominees 'were on the honor system' and acknowledged that the association had made no effort to check their accuracy.

There were errors by the APA.

The APA itself erred in its public summary for Jan Fawcett, a professor of psychiatry at the University of New Mexico and chair of the DSM's mood disorders work group. The summary lists no directorships or corporate positions for Fawcett. But a 2005 sec filing shows that he was a member of the board of directors for Berman Health and Media, a company that is poised to 'exploit opportunities in the female sexual medicine industry.' [He has since resigned from the board.] The APA said that Fawcett had disclosed the connections in private filings but that its staffers accidentally omitted them from the public disclosure form.

It's funny that the errors always seem to be of omission, not commission.

Also, task force members who received funding from medical education and communication companies (MECCs), that were, in turn, funded by drug companies, did not disclose the latter funding.

David Kupfer, the task force chair, reported multiple consulting arrangements with communications companies that 'sponsored pharmaceutical meetings & editorial work.' His public form, however, does not reveal that income from two of these companies, Prescott Communications and Innovative Medical Education, came from work for Forrest Pharmaceuticals and Pfizer, respectively. The APA said Kupfer did not need to disclose the ties because he was not paid directly by drug companies.

The APA actually not only required disclosing conflicts of interests, it required that "members pledged to limit their aggregate income from pharmaceutical sources to $10,000 a year. If their income exceeded that amount, they were required to reduce it or sever ties." On the other hand, "critics say that loopholes weaken the policy. One is that task force members can undertake new financial arrangements after being appointed. Second, task force members are not asked to disclose 'unrestricted research grants,' which often go straight to one's department or institution."

Given that the reporting may have been incomplete, it is striking that 18 of 27 (two thirds of the) members of the Task Force reported financial ties to the pharmaceutical industry, and that many of these reported multiple kinds of ties, and/or ties to multiple companies. Given how influential the DSM is on the mental health practice, and given how expansions of definitions of mental illness provide new opportunities to develop costly treatments for them, it is disturbing that the group who will develop the new DSM has had such extensive past relationships with the pharmaceutical industry.

ADDENDUM (2 January, 2008) - See also coverage of this case in Integrity in Science Watch (2 January, 2008 issue when up), and PharmaLot.

Financial Relationships Among Authors of the Psychiatric Diagnostic and Statistical Manual and Pharmaceutical Companies

A new study about conflicts of interest affecting the writing of important medical texts has been widely reported in the media, although the study is not yet available (as far as I can tell, on the web).

Based on New York Times and Washington Post reports, the study was a cross-sectional study of the prevalence of financial links to pharmaceutical companies among the authors of the latest (1994) full edition of the American Psychiatric Association's Diagnostic and Statistical Manual (DSM). This text is the authoritative guide to the definitions of psychiatric diseases. Apparently, the investigators searched through publicly available data, including "legal files, patent records, conflicts-of-interest databases and journal articles," covering 1989 to 2004, according to the Times. From these records, they were not able to determine the time course of the authors financial connections to the drug companies.

They found that 95/170, 56% of authors had some financial relationship to at least one pharmaceutical company from 1989 to 2004. They found higher prevalences of such relationships among authors "who worked on sections of the manual devoted to severe mental illnesses, like schizophrenia...," according to the Times.

The Post reported that "Darrel Regier, director of the association's division of research, said that concerns over disclosure are a relatively recent phenomenon, which may be why the last edition, published in 1994, did not note them. Regier and John Kane, an expert on schizophrenia who worked on the last edition, agreed with the need for transparency but said financial ties with industry should not undermine public confidence in the conclusions of its experts. Kane has been a consultant to drug companies including Abbott Laboratories, Eli Lilly, Janssen and Pfizer Inc. 'It shouldn't be assumed there is a true conflict of interest,' said Kane, who said his panel's conclusions were driven only by science. 'To me, a conflict of interest implies that someone's judgment is going to be influenced by this relationship, and that is not necessarily the case....'

Furthermore, again per the Post, "at least one psychiatrist who worked on the current manual criticized the analysis. Nancy Andreasen of the University of Iowa, who headed the schizophrenia team, called the new analysis "very flawed" because it did not distinguish researchers who had ties to industry while serving on the panel from those who formed such ties afterward."

In summary, Sheldon Krinsky, a study author, said, "When someone is establishing a clinical guideline for the bible of psychiatric diagnosis, I would argue they should have no affiliation with the drug companies in those areas where the companies could benefit from those decisions."

There is reason to be concerned that the data in this study may have reflected financial relationships that did not occur at the time the authors worked on the manual. Yet no better data about the time course of these relationships may have been available from public sources. In retrospect, one could criticize the study investigators for not directly querying the DSM authors about their financial relationships. But would all the authors have answered them? And would an academic institutional review board approved such a study?

It may very well be true that DSM authors with financial ties to drug companies honestly believed that these ties did not bias their work. On the other hand, some cognitive psychologists have found that people do not believe that conflicts of interest affect their thinking, yet such effects may occur, but not be consciously acknowledged. A recent op-ed article in the New York Times summarizing this work stated, "research suggests that decision-makers don't realize just how easily and often their objectivity is compromised. The human brain knows many tricks that allow it to consider evidence, weigh facts and still reach precisely the conclusion it favors."

Finally, and again commenting without having seen the actual research paper, in thinking about conflicts of interest, one has to consider all the parties involved. This leads to questions including: Did the editors and publishers of the DSM try to limit the involvement of authors with conflicts? Were the authors under pressure from their academic institutions to develop more financial ties with pharmaceutical companies to help "support their salaries?" Did the pharmaceutical companies develop the ties to the authors because of their work with DSM, or for entirely unrelated reasons?