Saturday, January 25, 2014

WINDY CITY BLUES

WINDY CITY BLUES

There is an academic ethics mess brewing in the windy city… at The University of Chicago. It involves a start-up Chicago corporation, a star statistician in the medical school, seed money in the form of NIH research grants, the American Psychiatric Association, and the chairman of the APA’s DSM-5 Task Force. It involves the appearance of self-interested bias in the DSM-5 process. It involves a recidivist pattern of failure to disclose material conflict of interest. And it involves academic journal editors (JAMA and JAMA Psychiatry) who did not do the right thing when the perps were outed.

I broke the story on this site back in November, right after a confession appeared on-line in JAMA Psychiatry by the gang of five perps (Robert Gibbons, Ellen Frank, David Kupfer, Paul Pilkonis, and David Weiss) . Indeed, it was I who had alerted the journal. Others have since weighed in here and here and here, for instance. The definitive summary and Timeline were the work of Dr. John M. (Mickey) Nardo here. Of course, readers of JAMA Psychiatry would never know that the authors were outed. The editors (Howard Bauchner for JAMA and Joseph Coyle for JAMA Psychiatry) allowed the authors to make it seem like they were making a spontaneous admission of nondisclosure, and they acquiesced in the withholding of key information that I had given to the journal.

It gets worse. We now know that the chair of the DSM-5 Task Force (Dr. David Kupfer) failed to disclose his financial conflict of interest on at least 4 occasions (#s 13, 15, 16, 19 in the Nardo Timeline). On two of those occasions he was representing the DSM-5 team and the APA! These lapses undermine his repeated assurances that COI issues were under control in DSM-5. If the chairman of the DSM-5 Task Force does not have his own act together concerning COI disclosures, then what are his assurances worth? Nevertheless, the APA released a statement that tried to whitewash Dr. Kupfer’s nondisclosures. They need to recalibrate their ethical compass.

The methods adopted in this affair are classic: Peddle unproven psychiatric screening scales backed up by black box statistics (a distressing specialty of Dr. Gibbons); publish a glowing report in JAMA Psychiatry, which you have infiltrated (Ellen Frank and Robert Gibbons are on the editorial board); get your corporate people inside the DSM-5 process (David Kupfer, Robert Gibbons, Paul Pilkonis); slant the DSM-5 process to endorse, however weakly, the kind of products you intend to market; start a corporation without telling anybody and establish a website  with advance marketing that touts your new academic publication in JAMA Psychiatry while highlighting Dr. Kupfer’s key role in DSM-5; loudly proclaim (see page 4) the advent of population-wide screening but before doing any serious field trials or acknowledging that most positive screens will be false positives. This is the usual dodgy hand waving of wannabe entrepreneurs, whose vision is obscured by dollar signs. Oh, and did I mention regulatory capture of NIMH for over $11 million in funding while not producing a product worth a tinker’s damn?

In response to all this adverse commentary, the authors and the journal editors have gone to radio silence. They must be hoping it will blow over.  If anything, their silence has provoked even more searchlight questions that focus on what is happening at The University of Chicago.

For instance, who is bankrolling this start-up corporation? Last summer they brought on board an executive named Yehuda Cohen who is a mover and shaker in Chicago business circles. I am sure he doesn’t work for peanuts. He set up a website that must be staffed to respond to queries from consumers and professionals. Plus, the corporate office appears to be located in prime commercial space at 217 N Jefferson #600, Chicago IL 60661; phone 312-878-6490. E-mail: info@adaptivetestingtechnologies.com (from the website: you can find a picture of the neighborhood on Google). So, they are racking up significant operating expenses already. Heaven forfend that these expenses might be covered directly or indirectly by their NIMH funding! Are the responsible administrators at NIMH and at The University of Chicago looking and auditing?

It is also unclear whether they have a sound or even a legal business plan. Where will the high powered computing needed for their expansive applications be conducted? Do they have a computing facility at the corporate office? Or do they intend to perform the commercial computing through the NIH-supported Center for Health Statistics at The University of Chicago, which Dr. Gibbons personally directs? If so, did the University sign off on that plan? Is NIH aware of the plan?

In late November I asked NIH about the ownership of the data bases and algorithms on which the corporation relies for the business plan. I received a reply from NIH outlining the applicable federal policy and stating “We understand that the data are deposited and made available to the community per request through the Center for Health Statistics.” That had to be what Dr. Gibbons told them. Notice that no mention was made of the algorithms. I have replied to NIH, asking them to clarify the status of the algorithms, without which the data bases alone are of little use. I also pointed out to NIH that there is no mention of this public access option in any of the publications from these authors or on the corporate website. This situation is typical of the dissembling style we have seen before from Dr. Gibbons and Dr. Kupfer – lacking in candor and transparency.

The more one looks, the more questions arise. Is The University of Chicago being taken for a ride? Is NIMH being taken for a ride? Are we all being taken for a ride? Can we please have some transparency here? Can we please have some psychometric standards here? Will the APA step up to the plate? Will NIH step up to the plate? Will The University of Chicago step up to the plate?



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