JAMA LAYS AN EGG

Anne Cappola Bernard Carroll competing interest conflict of interest Garret FitzGerald JAMA

JAMA LAYS AN EGG

Unknown 5/01/2016 Komentar

JAMA LAYS AN EGG 

Three months ago I took JAMA to task over a Viewpoint opinion piece about conflict of interest. The authors proposed dancing around the reality of financial conflict of interest in medicine by talking instead about confluence of interest. I countered with a proposal for the term competing interests, which would not paper over the problem. In that post I also included a letter I had sent to JAMA in response to the opinion piece, but which JAMA had declined to publish. I questioned whether JAMA had deep sixed all the critical replies it received.

Now I can report that, in the April 26, 2016 print edition, JAMA has finally published one critical letter and a replyfrom the original authors. So JAMA didn’t deep six everything. This new correspondence appears 174 days after print publication and 214 days after on-line publication of the original Viewpoint article. That glacial delay is problematic – it disables meaningful dialogue.

The new critical letter is from a group in Europe, and it thoughtfully discusses weaknesses in the Viewpoint authored by Cappola and FitzGerald. These Viewpoint authors did not do justice to the critical letter in their reply. Moreover, they disclosed multiple potential competing interests, but they did not follow their own advice by clarifying why we should disregard those obvious competing interests. As we all know, the mere disclosure of competing interests does not by itself remove the problem. It can be a device for hiding in plain sight. Substantively, the reply from Cappola and FitzGerald is mostly hand waving and restatement of biased opinion, without real analysis or incisive thought.

The closing sentences of their reply letter illustrate these issues: “Everyone has biases. Rather than present these pejoratively, as a clash of values that undermines validity, it seems more constructive to mine the complexity of these biases, present them in an accessible fashion, and seek to determine whether they are confluent with the interests of patients, scientists, and regulators who might base their decisions on the results of a given piece of work.” The reference to complexity of biases concerns the matter of nonfinancial bias like fame and careerism in science. The reference to presenting biases in an accessible fashion concerns the ill-considered proposal to include a bias heat map on patients’ consent forms. This idea rightly was panned by the European critics. Meanwhile, where did the compromised and disgraced key opinion leaders disappear to in all this wishful thinking? Where did the corrupt corporations disappear to? They paid billions of dollars in penalties for felony crimes and plea-bargained settlements. They have been airbrushed out of the Cappola-FitzGerald narrative. These authors come across like Bambi confronting Godzilla.

If this is the best that an associate editor of JAMA and a fellow of the Royal Society can do then JAMA needs a fix. This effort is too little and much too late.

UPDATE 05-03-2016
Apparently the link to my earlier post is inoperative. My apologies. Here is a link that should work.
http://hcrenewal.blogspot.com/2016/01/jama-jumps-shark.html 

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JAMA JUMPS THE SHARK

Anne Cappola Bernard Carroll conflict of interest conflict of interest blog confluence of interest Garret FitzGerald JAMA

JAMA JUMPS THE SHARK

Unknown 1/25/2016 Komentar

JAMA JUMPS THE SHARK

Medical journals are supposed to promote professional values – scientific, social, and ethical. Quality matters, in each of these domains. Lately, however, highly ranked journals are failing in respect of ethics commentaries. Some editors seem happy to publicize or even to co-author commentaries that are dismissive of current ethics initiatives – like transparency of data reporting and disclosure of conflicts of interest (COI). That’s one way for journals to jump the shark in the race for ratings. They surely get attention and applause in some quarters – but those stunts are net negatives for the journals. Here is one example.

Last fall, JAMA went splashy with a sappy Viewpoint articleon conflict of interest by Anne R. Cappola and Garret A. FitzGerald. Anne Cappola is also an associate editor of JAMA– what a coincidence! The article was a Pollyanna piece by these two professors at Penn, promoting pushback on perceived pharmascolds, but really just papering over the problem of COI. The sappy formula? They declared conflict of interest to be a pejorative term that should be replaced by confluence of interest. This casuistry was backed up by wishful thinking and hortatory hand waving, weakly argued. Mostly, it gave the impression that the authors, presuming to speak for investigators generally, were offended by the increasing regulations for managing COI. Those developments have occurred at the Federal, institutional, and publication levels. Worse, the authors ignored the reality of recent corruption that led to those new regulations. That uncomfortable fact was airbrushed out of their discussion. In response, one critic of confluence of interest, writing on the COI blog, aptly raised a comparison to Wall Street: “The phrase also reminds me of a statement by then king-of-the-hill securities analyst Jack Grubman: “What used to be a conflict is now a synergy.” (Three years later Grubman was fined $15 million dollars and barred from the industry for life for what were apparently still considered COIs.)”

The Viewpoint article appeared on-line September 24, 2015, and four days later I sent a critical reply to JAMA. The printed version of the Viewpoint article appeared November 3, 2015, and on 4 December, 2015 I was notified that JAMA chose not to publish my letter to the editor. During the following six weeks, now nearly five months since it appeared, JAMA published no replies whatsoever to the Viewpoint article. Could it be that JAMA has deep sixed all the responses? That’s one way to manage bad publicity, but it is inconsistent with the standards we expect of a journal like JAMA. Here is the text of my letter to the editor of JAMA. Keep in mind that there is only so much one can say within a limit of 400 words and 5 references.

LETTER TO EDITOR, JAMA 09-28-2015            Text word count 389

                                                                                5 references

TITLE: CONFLICT OF INTEREST

In their recent Viewpoint (1), Anne Cappola and Garret FitzGerald recommended replacing the term conflict of interest (COI) with confluence of interest, declaring a pejorative connotation of the term conflict. A better suggestion would have been competing interest, which already is in wide use (2) and which does not paper over the problem. The authors did not frankly acknowledge the gravity of recent COI scandals that led to the situation they decry. Sadly, there are real, common, serious, and unacceptable conflicts of interest. Boundaries are needed, and the authors’ effort to weaken the boundaries is misguided.

Their case for re-framing COI more benignly as a confluence of interests is weakly argued. For instance, they warned of concern that current policies on COI “… might restrain innovation and delay translation of basic discoveries to clinical benefit.” (1) They produced no evidence for that speculative assertion, though they said it was a key reason for their endeavor. Moreover, COI policies do not demonize collaboration with industry. We once had an honorable tradition of interacting with industry while retaining our integrity as clinical scientists. That tradition broke down when academic investigators in many specialties were coöpted as key opinion leaders (KOLs) by the marketing departments of corporations. There followed an era of corruption in corporate-funded and KOL-managed continuing medical education and journal supplements; of experimercials disguised as KOL-initiated clinical trials (3); of rampant, biased ghostwriting, commissioned by corporations and often with cynical honorary KOL authorship; and of selective analyses of clinical trials data designed to exaggerate benefits, minimize harms, and maximize markets (4). We can readily agree with the Viewpoint authors that these practices had the effect of “biasing the interpretation of results, exposing patients to harm, and damaging the reputation of an institution and investigator” (1). Inevitably, those practices and individuals were exposed, which led to Congressional action and to staggering legal penalties (over $3 billion in the case of GlaxoSmithKline) (5). In response, COI policies were strengthened at the Federal and institutional levels and, of course, they now inconvenience everybody. Such is the way of bureaucracies. As we survey the aftermath, we should direct our annoyance to the many opportunistic investigators who entered into those compromised relationships with industry. It makes no sense now to shoot the messengers or to use sophistry in an attempt to define the problem away.

ACKNOWLEDGEMENTS

The author declares no competing financial interest or other conflict of interest.

REFERENCES

(1) Cappola AR, FitzGerald GA. Confluence, not conflict of interest: Name change necessary. JAMA. Published online September 24, 2015. doi:10.1001/jama.2015.12020.

(2) James A, Horton R, Collingridge D, McConnell J, Butcher J. The Lancet's policy on conflicts of interest––2004. Lancet. 2004; 363 (9402):2-3.

(3) Carroll BJ. Sertraline and the Cheshire cat in geriatric depression. American Journal of Psychiatry. 2004; 161(6): 1145-1146.

(4) LeNoury J, Nardo JM, Healy D, Jureidini J, Raven M, Tufanaru C, Abi-Jaoude E. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ. 2015;351:h4320.

(5) U.S. Department of Justice, Office of Public Affairs. GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data. July 2, 2012. http://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report Accessed 09-25-2015.

So, yes, Virginia, there is real COI and there is real corruption in medical science. You cannot make them go away by wishing them away. And, JAMA, if you allow your editors to promote divisive, weak, and problematic ethics positions, at least have the decency to allow debate.

Bernard Carroll.

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academic corruption conflict of interest evidence-based medicine institutional conflicts of interest NEJM pharmaceuticals physicians

Unknown 5/19/2015 Komentar

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

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