Thursday, November 21, 2013

WHEN IS DISCLOSURE NOT DISCLOSURE?



WHEN IS DISCLOSURE NOT DISCLOSURE?

Hint: When it is made by the Chairman of the DSM-5 Task Force.

Here is a case study in conflict of interest (COI). A remarkable confession has just appeared by a group of 5 prominent academics, writing in the journal JAMA Psychiatry. Having been outed to the Editors, they now admit to concealing pertinent financial information. One of the five is David J. Kupfer, MD, chairman of the DSM-5 Task Force and past chairman of the department of psychiatry at The University of Pittsburgh. The others are from Pittsburgh, Minnesota, and Chicago.

With millions in funding from NIMH, these folks have been developing new approaches to testing for anxiety and depression. The technical details are not important for this story. What matters is that they have clearly set their sights on a large market for diagnostic screening, epidemiological research, and clinical practice. They have recently published promotional reports talking up three products and projecting major applications – but before taking care of the nuts and bolts of scale development.

Their major report in JAMA Psychiatry contained a disclosure to the effect that they might at some time in the future consider commercial development of their depression scale. This disclosure was phony. We now know that, in lieu of frankly disclosing a major COI, they opted for a disingenuous, dissembling statement that was economical with the truth.

I thought the content of their report was sub-par, and the journal published a letter from me to that effect. They responded to my criticism with hand waving, and they tried to impugn me for bias related to my own (disclosed) COI. This foolish, ad hominem tactic aimed to divert attention from the substance of my critique – for which they had no adequate response.

As I am not a person who suffers fools or insults gladly, their evasive response caused me to do some checking. I quickly learned that the gang of five are shareholders in a private corporation. Before their paper was accepted by JAMA Psychiatry, the corporation was incorporated in Delaware and soon after registered to do business in Illinois. Those facts were not disclosed in the original report or in the published letter of Reply to me. These omissions were acknowledged in the notice of Failure to Report that appeared on-line today.

It gets worse. Other things that I learned – and that I communicated to the journal – make it clear that the corporate train had left the station in advance of the letter of Reply. For instance, a professional operations and management executive (Mr. Yehuda Cohen) had joined the corporation. He had established the corporate website, where he was featured as a principal, along with the gang of five. The website also displayed a professionally crafted Privacy Policy, dated ahead of the letter of Reply. This document identified what appears to be a commercial business address for the corporation. The notice of Failure to Disclose is silent on these facts.

So, the published notice of Failure to Disclose still withholds pertinent information, which makes a mockery of the weasel words that they have not released any tests for commercial or professional use. Not yet, they haven’t. But they are under way, make no mistake. This prevarication creates the impression of a habitual lack of transparency. Considering that I gave the journal all this information, one has to be surprised that JAMA Psychiatry went along with this prevarication. Plus, would it have killed them to apologize for their foolish attempt to smear me, as I requested? In correspondence with me, the Editor in Chief of JAMA didn’t want to go there, and he refused to publish my letter that detailed the facts, citing the most specious of grounds. The Editor of JAMA Psychiatry has ducked for cover when I faulted him for publishing the ad hominem material in the first place.

This deplorable episode casts a pall on the repeated assurances by Dr. Kupfer that COI issues were under control in the DSM-5 process. If the chairman of the DSM-5 Task Force doesn’t have his own act together, then what are his assurances worth? The new instruments proposed by this corporation bear an eerie resemblance to cross-cutting dimensional measures that were promoted for DSM-5 but that didn’t make the final cut. As far as I know, Dr. Kupfer didn’t declare his interest in this corporation for scrutiny vis à vis DSM-5.

Another lesson is that even Failure to Report notices can be weasel documents. I fault the Editors of JAMA Psychiatry, Joseph Coyle, MD, and of JAMA, Howard Bauchner, MD, for the non-rigorous standard they applied to the notice of Failure to Disclose. They acquiesced in another dissembling response.

Yet another lesson is that all authors are accountable for the accuracy of disclosure statements. Some of these authors might claim they relied on the lead author and president of the corporation, Robert Gibbons, PhD, a statistician at The University of Chicago, to make sure everything was kosher. Big mistake – just like the infamous case of the Nemeroff-led Cyberonics – vagus nerve stimulation review that failed to disclose that the academic authors (ahem) were paid consultants of the corporation. When your name is on the byline, be sure you cover the bases for your own protection, and don’t squawk when you are called out.

Finally, where is NIMH in all of this? Since when are public NIMH funds to be treated as commercial seed money? Who actually owns the algorithms and data bases on which the Gibbons corporation relies for its commercial aspirations? Why are they not publicly accessible? Is Thomas Insel on top of this?



8 comments:

Anonymous said...

"We apologize to the editors and readers of JAMA Psychiatry for our failure to fully disclose our financial interests"

is equivalent to

"We apologize to the editors and readers of JAMA Psychiatry for our lying about our financial interests"

no?

Anonymous said...

Nice job Dr. Carroll. These bastards had to be outed.

Anonymous said...

Absolutely disgusting. But yes, good work!

Nancy Wilson said...

"Is Thomas Insel on top of this?"

I asked him. We'll see if he responds.

Based on past experience, Dr. Insel tends to show up a day late and a dollar short.

Mickey Nardo MD said...

It's a bit hard to parse out the hierarchy of crimes and misdemeanors involved here. There's non-disclosure of financial entanglement for starters. Then there's Dr. Kupfer's commercial entrepreneurialism while leading the DSM-Task Force. And, of course, there's his advocating for the Dimensional Diagnoses towards which this screening psychometric is obviously aimed. But this ["Their major report in JAMA Psychiatry contained a disclosure to the effect that they might at some time in the future consider commercial development of their depression scale"] was simply a lie, told to JAMA Psychiatry and the rest of us, on purpose. The commercial development was well down the road already.

Looking back at Dr. Carroll's original letter []Not Ready for Prime Time] and the authors' response [Not Ready for Prime Time—Reply], they never really got around to responding to his critique.

So besides the conflict of interest and other issues along the way, the fact remains that these tests are still "not ready for prime time" nor are they likely to be in the future. I guess we'll have to fall back to taking histories from our patients after all...

Anonymous said...

Don't you have an Office for Research Integrity in the US? Can this matter be referred?

Bernard Carroll said...

Thank you, Anonymous. Yes, the matter was referred informally to the director of NIH and to the director of NIMH last week. They were asked to look into the propriety of Gibbons and Kupfer and the rest using the products of NIMH-funded research for the exclusive use of their private corporation.

The Federal administrators can make the formal referral to ORI.

Nic Stuart said...

We have been here before, in the 1970s. Szasz, Goffman, Rosenhan etc,We were resoundingly defeated. Via the DSM III. Once psychiatry realises it is going to be defeated, it will fight back with twice as much desperation and with quadruple the money. We have not seen this just yet. Power corrupts and is incorrigible. Good luck guys...