JAMA Disclosure Case: Conflicts Abound

 

When Catherine DeAngelis, M.D., of The Journal of the American Medical Association (JAMA) attacked Professor Leo, a little known neuro-anotomy professor at Lincoln Memorial University, in Harrogate, Tennesse, for publishing a letter in The British Medical Journal (BMJ), it set off a chain reaction.

Professor Leo had posted a letter to the editor on the BMJ website on 5 March 2009, stating that Robert Robinson, M.D.’s failure to include Forest Laboratories in his financial disclosures, indicated that crucially important information was selectively omitted by researchers with conflicts of interest.

The original research article focused on antidepressant use in stroke patients, in which Professor Leo pointed out that Dr. Robinson apparently failed to note his financial relationship with the drug company whose product was studied.

In response, University of Iowa psychiatrist, Dr. Robert Robinson, who authored the 2008 study, recently published online his letter rebutting Professor Leo.  Within this letter, Dr. Robinson admitted that “he failed, in the study, to disclose payments from Forest Laboratories, the maker of Lexapro, and that his study found that Lexapro was effective in helping to prevent depression in stroke victims.”  (The failure to disclose – which amounted to two talks – did not change the outcome of the trial and the science which was peer-reviewed remains valid.)

Dr. Robinson continued in his letter by apologizing “to the editors and readers of JAMA for not accurately remembering the dates of two talks that Forest sponsored and two talks that Pfizer sponsored in my incomplete disclosure letter to JAMA.”

He set the record straight by acknowledging the financial conflict.  Defending himself further, he noted that “since 2004, I had not received a penny from Forest Laboratories nor did I have any contact with anyone from Forest’s corporate headquarters.”  Moreover, he stressed that the study published in JAMA regarding the prevention of depression was entirely funded by the National Institute of Mental Health (NIMH).

Dr. Robinson then explained how Professor Leo claimed that since the research was not designed for head-to-head comparison, the comparison of drugs should not be published.  But this is where Dr. Robinson jabbed back at Professor Leo for having an “ideological-based mission,” and noting that “Dr. Leo should have disclosed that he is on the Board of Directors of the International Center for the Study of Psychiatry and Psychology.”

Apparently, this group is against the use of psychiatric medicines, which presented a preconceived bias by Professor Leo to expose even minor discrepancies in psychiatric research that supports the use of neuro-pharmaceuticals.

In response, “Leo says he resigned as a Board member of the psychiatry center two years ago, although he acknowledged the center’s Web site continues to list him as a member.”  He also says “he isn’t against all psychiatric drugs.”

Alternatively, Dr. Robinson concluded his letter by noting that since Professor Leo’s omission from the published study of being a Board member in this era of transparency, is so critical that his public criticism of others is germane based on his preconceived biases.

In the end, Dr. Robinson posed the question of why BMJ would have published the Leo letter without checking with JAMA to see if an investigation or failure to disclose letter was underway, since it created unfair media coverage of Dr. Robinson’s “relationship (or more accurately, lack of relationship) with Forest Laboratories.”

Interestingly, in this new era of transparency, it seems that forgetting what one did five years ago or this afternoon, is all relevant to the conflicts of interest police.

This is exactly why conflicts of interest policies at journals must be more flexible, agile, and individually focused.  For doctors like Robinson who have not had a direct connection to industry in five years, policies should reflect this separation.

Not every physician is going into a revolving door from hospital, medical school, and industry.

Instead, physicians are using varied experiences to supplement their pay, and to gain valuable clinical research and consulting experience to advance their treatment and services to provide better quality healthcare for their patients.

This chain of reaction created by a “no-name” doctor is a perfect example of why conflicts of interest policies must not be extreme (as they presently are), because physicians whose expertise are demanded, and whose knowledge and experience provide innovative developments, almost always have involvement in professional associations, or speaking events.

While disclosure is certainly required, the stigma associated with acknowledging such involvement can be burdensome, as Dr. Robinson notes in his letter.

What if doctors were to adopt the Obama policy, in other words, where members of his Administration cannot have lobbied for the past two years, and after leaving the Administration, cannot lobby for two more years on any issues that pose conflicts?

But then again, Obama still has a lot of unfilled positions – is this because of this policy?  Has he not already issued exceptions to these conflicts of interest?  Are not a lot of those positions going to be filled with a lot of people with little experience, or mostly academics who lack the insight into “being in the trenches?”

How would a policy like this play out in the medical field where research and science are in the highest demand ever, there is a large and growing shortage of physicians, and the healthcare system is failing?

Are physicians going to be banned from research and clinical studies, because they forget they were once on a board, or because they were on the board in the first place?  Have we forgotten the value professional associations with industry and others provide to advancing research and clinical studies?

The answer is there is no end to this, conflicts abound and not all perceived conflicts are actual conflicts. 

There is a lot of fear from academic physicians being banned from publication for disagreeing with a journal or exposing their faults.  Academic physicians and researchers serve as slaves to the journals.  Publish or perish, their careers are basically decided by the quantity and quality of the journals they publish in. 

Several large journals have adopted “perceived conflicts of interest” as their criteria for rejecting or accepting authors. 

As long as journal editors have the license to call a dean and threaten a ban on his faculty or institution on all future publications (as the JAMA editors did with Professor Leo and his Dean), the need for reforming journals grows day by day.

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