Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

Sunday, January 24, 2016

JAMA JUMPS THE SHARK

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 article
on 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.

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.

Thank you for your workDr. Carroll. I have had personal experience with self serving JAMA editors. One even ignored patient harms and was rewarded with the plum assignment of a chief trustee at a large educational institution.

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