In rapid succession, I received three email alerts today. The first was of a blog post from Dr. Bernard Carroll who argued the obvious point that the physicians who have repeatedly sold out to Pharmaceutical Companies have skirted their egregious ethical violations using legalistic arguments and claims of benign oversights [whoops!], avoiding appropriate censure by the profession.
| IMPEACHMENT: IT’S ABOUT THE INSTITUTION, NOT THE PERSON Healthcare Renewal by Bernard Carroll MD December 08, 2010 |
| What this means for us in medicine is that legalistic charges and defenses are not the right way to go in exposing and ejecting bad actors from our field. In the highly publicized cases of ethical compromise over the past few years, our group disapproval, when there was any at all, generally has run on two parallel tracks. The first is legalistic, and it favors the bad actors, who flaunt their constitutional protections with the taunt, prove it. The second ground of disapproval is esthetic, based on the tackiness of the bad actors’ behaviors – regardless of technical legalities, what they do is an affront and an insult to professional standards and mores. When we look at how recent incidents in medicine actually played out, however, we see a disconnect. The bad actors have narrowed the debate to the first ground of disapproval, while forcing the second off limits. In this strategy, they have received conscious or unconscious assistance from the professional establishment. The focus has been on legal technicalities involving the bad actors rather on preserving the dignity and credibility of high offices in academic medicine… |
The next email alert pointed to the Corrections section of the New York Times, obviously the target of the very legalistic nickle and dime harangues Dr.Carroll was predicting – focusing on the trees and away from the forest [for the article – Drug Maker Wrote Book Under 2 Doctors’ Names, Documents Say]. In a recent post, Dr. Danny Carlat wrote, "Rumor has it that Schatzberg is sicking his attorneys on anyone who dares to suggest what seems to be crystal clear based on the documents" [Nemeroff and Schatzberg’s “Textbook” Pushed Paxil]. Looks like he was right about that.
| Corrections New York Times December 8, 2010 |
| A headline on Nov. 30 with an article about SmithKline Beecham’s role in the publication of a book about treating psychiatric disorders overstated SmithKline’s actions. While documents show that SmithKline [now known as GlaxoSmithKline] hired a writing company for the book, they do not indicate that the company wrote the book for the authors, Dr. Charles B. Nemeroff and Dr. Alan F. Schatzberg. The article also described incorrectly, in some editions, events outlined in a letter from the writing company to Dr. Nemeroff. The correspondence proposed a timeline for the writing company to furnish the doctors and SmithKline with draft text and final page proofs for approval; the letter did not say that the company had already provided those materials for final approval. And the article misstated the context under which Dr. David A. Kessler, the former commissioner of the Food and Drug Administration, commented about the book’s production. The letter and other documents were described to him; he did not personally review the documents. |
The third email alert was of today’s powerful editorial in the journal, Nature:
| Give up the ghosts Nature by Paul Thacker 08 December 2010 |
| The spectral fingerprints of a big drug company have once again been found all over academic publications. Documents released last week by a watchdog group based in Washington DC raise concerns about the role of writers paid by GlaxoSmithKline (GSK) in works attributed to psychiatric researchers at a number of US institutions. They add to the drumbeat of allegations in recent years indicating that such ghostwriting — in which articles contain substantial portions written by someone who is not listed as an author — is endemic in the biomedical literature. The documents were made available as a result of litigation over GSK’s antidepressant Paxil [paroxetine] and were pounced on by the Project on Government Oversight, which raised concerns about authorship of a research article, journal editorial and textbook. |
| … |
| All the academic authors involved in this case have been recipients of US National Institutes of Health [NIH] funding; all but one still are. The NIH may argue, rightly, that the ghostwritten publications did not use its money. It will also note, correctly, that this in an issue that demands far broader action. Both are beside the point. Money is fungible, and rarely do the studies and intellectual output of senior researchers divide neatly into industry-funded and taxpayer-funded work. If its grantees are not playing by the rules, the NIH is tarred and public trust is damaged. So, how clear are the rules on ghostwriting? A study last year found that just 10 out of 50 top US academic medical centres had explicit, web-accessible policies that prohibit the practice. Another three banned ghostwriting in practice without naming it as such. |
| Discussing the issue of ghostwriting a year ago, Francis Collins, the NIH director, said publicly that he was “shocked” that “people would allow their names to be used on articles they did not write, that were written for them, particularly by companies that have something to gain by the way the data is presented”. Many will share that shock, but, unlike Collins, few are in a position to do something about it. The agency is “considering how best to address and ensure” greater transparency and accountability as its grantees develop and author articles, Sally Rockey, NIH chief of extramural research, told Nature in an e-mail last week. A good start would be for the NIH to require all institutions that take its funds to articulate, publicize and vigorously enforce a clear ban on ghostwriting. Other funders should follow suit. Without such a clear signal, and the willingness to give a ban teeth, this troubling ghost will linger at the feast. |
One might wonder why people [like me] keep posting on this same topic – over and over. Is it vindictiveness? or some kind of idée fixe? nothing else to do? Well, there’s another loud explanation. These ghosts won’t give up! In the case of these particular doctors, there’s a string of ethical malfeasance that stretches back for decades – failures to report Conflicts of Interest; failure to report outside Pharmaceutical income; working directly for Drug Manufacturers whose drugs they are studying with NIMH Grants; publishing under their own names material prepared by Pharmaceutical Company hired ghost-writers; recommending treatments they have direct financial interest in; the list seems never ending – a fertile syllabus for a whole course on medical ethics violations. Yet they keep on keeping on.
As for Dr. Nemeroff, he is yesterday’s news. The adverse findings by ACCME about his program serve as a reminder to corporate sponsors and CME companies that Dr. Nemeroff is so compromised by now that he has lost effectiveness as a front man for Pharma. Indeed, he is so toxic that he now glows in the dark.
At this juncture in American Medicine, there is no room for this kind of intrusion by the Pharmaceutical Industry or this level of ethical lapse. While I agree with Paul Thacker that the N.I.H. needs to act now to require grantees to be pristine in adhering to traditional medical ethics, I would add that the Pharmaceutical Industry needs to be held to a similar standard. And those people responsible for infractions should be punished directly. The companies have every right to profit from their enterprise, but if they can’t play it straight, they need to get out [or be sent out] of the game. This is now the business of organized medicine [A.M.A., A.P.A.], the N.I.H. [N.I.M.H.], the F.D.A., H.H.S., PHARMA itself, and the D.O.J.
Who do Alan Schatzberg and Charles Nemeroff think they are fooling? If you examine the draft written by the ghostwriting company, there are entire paragraphs and even tables that appear in the published book.
The lawyer with POGO found some and explained this in the latest letter.
http://www.pogo.org/pogo-files/letters/public-health/ph-iis-20101208.html
Who do Alan Schatzberg and Charles Nemeroff think they are fooling?
Their own consciences [rudimentary organs that the are]…