no leg to stand on…

Posted on Saturday 6 August 2011

So I get home from a three week trip to Hawaii and fire up my real computer. There are two Google Alerts from today blinking at the top of my email list:
Ghostwriting – how does academic medicine justify it?
Speaking of Medicine [PLOS Blog]
by Jocalyn Clark
August 5th, 2011

We’re always interested at PLoS Medicine in different perspectives on the ghostwriting problem. Following considerable news coverage of our recent Stern and Lemmens paper on legal liability for ghostwriting, another article, this one by Jonathan Leo and colleagues (who have previously written for us on the lack of ghostwriting policies in major US medical schools), has appeared in Society. In it they offer some explanations for why ghostwriting is “allowed” in academic medicine.

The parts I found most intriguing were their examples of how academic medicine is complicit. We all know that in the “publish or perish” environment of medical academia publications are currency, which must help explain why many academic guest authors receive no monetary payment at all for their unethical and dishonest collusion with pharma that allows them to take (academic) credit for papers they didn’t write. But don’t institutions expect their faculty and members to publish ethically and in the best interest of patients?

Apparently not. One particular example cited by Leo and colleagues, involving the widely-prescribed Paxil (paroxetine; an SSRI antidepressant), jumped out at me: they describe allegations that an American Psychiatric Press (APP) textbook called “Recognition and Treatment of Psychiatric Disorders,” ostensibly authored by leading psychiatrists Charles Nemeroff and Alan Schatzberg, was actually ghostwritten by writers employed by the manufacturer of Paxil, GlaxoSmithKline, who paid the writing firm US$120,000.  An earlier draft of the text written by the paid medical writers is on the website of the US-based Project on Government Oversight.

What’s astonishing is not that the institutions and publishers deny the involvement of GSK-paid ghostwriters (they don’t), but that they accept and justify the ghostwriting because the authors “signed off on the final copy.” Leo and colleagues quote James Scully, Medical Director for the American Psychiatric Association: “The book was reviewed for any potential bias (among other things) by eight independent reviewers, and there was no undue influence on the content from industry or any other outside source.” The psychiatrist Daniel Carlat, in his New York Times blog last year, on the other hand, called the textbook “an advertisement for Paxil.”

That medical academia finds these types of arrangements acceptable is, I think, at the heart of the problem of ghostwriting. But for anyone who has been a student or trainee in medical academia─subject to strict codes of conduct prohibiting plagiarism etc. ─ this apparent double-standard will strike as more than a little ironic. Clearly we need to address this hypocrisy. I love the analogy Leo and colleagues draw, so I quote from their article directly:
    A college professor determines one of his graduate students handed in a paper largely written by someone else. After being confronted, the student acknowledges that indeed someone else wrote the paper. The student then says, “I approved the final copy, and had eight classmates look over the paper and they all vouch for its unbiased conclusions.”
NIH’s Plan for Public Disclosure Is Getting Help from Senator Grassley
August 5th, 2011

One of the best of our government agencies, the National Institutes of Health (NIH), is getting some well-deserved help from Senator Chuck Grassley (R-IA). In recent years, Senator Grassley exposed several academic physicians for taking large amounts of money from companies with a direct financial interest in their research, some of it funded by the NIH. The list reads like a who’s who in academic research:
  • Dr. Charlie Nemeroff, former Chair of the Psychiatry Department at Emory University, who failed to report hundreds of thousands of dollars in payments from GlaxoSmithKline while researching that same company’s drugs with an NIH grant.  Dr. Nemeroff was bounced from Emory and has now taken over the Chair of Psychiatry at the University of Miami.
  • Dr. Alan Schatzberg, former Chair of the Psychiatry Department at Stanford University received an NIH grant to study a drug while partially owning a company that was seeking FDA approval of said drug. An NIH oversight group recommended that Stanford’s clinical trial on mifepristone be “terminated immediately and permanently.”  The recommendation was made because of concerns over conflicts of interest, patient safety and other issues.
  • Dr. Joseph Biederman and two other researchers at Harvard University failed to report almost a million dollars each in outside income while heading up several NIH grants. Harvard later disciplined the three physicians.
A government requirement for public disclosure would obviously make these secret payments more difficult – and that’s just what the NIH is trying to do. A new regulation proposed by the Department of Health and Human Services would deal with investigators’ financial arrangements by requiring these arrangements to be disclosed on a publicly accessible website if those arrangements created a conflict of interest. Good step by the NIH! But, as reported by Meredith Wadman of the journal Nature, the NIH’s new regulation is being blocked by the Office of Management and Budget (OMB), discrediting the Obama administration’s boast about a new era of transparency in the federal government. Senator Grassley wrote yesterday to Jacob Lew, the OMB director, that he was concerned by this story:
    I am troubled that taxpayers cannot learn about the outside income of the researchers whom the taxpayers are funding, and this flies in the face of President Obama’s call for more transparency in the government. The public’s business should be public…. I urge OMB to follow through and approve a rule that includes a publicly available website.
In his letter, Senator Grassley requested all records related to the OMB’s weakening of the proposed conflict-of-interest rule. He also asked to see all calendar meetings for Administrator Cass Sunstein, OMB Office of Information and Regulatory Affairs, from May 1, 2010, to the present. “Transparency is a backstop against research that’s compromised by doctors’ self-interest, to the detriment of consumers,” Grassley said in a statement. In a letter three weeks ago, POGO pressed OMB Director Lew to drop his agency’s resistance to the proposed new requirement for public disclosure. POGO is meeting in a few days with some of those in OMB who are working on this rule. We’ll be sure to inform readers of this blog post what happens.
Tomorrow, I have three things on my agenda: Pick up my dogs from the Kennel; Pick up my new Jeep [to replace my truck that was stolen the night before we left on the trip]; and then read every link in each of these articles from PLoS and POGO. While I was gone, I read and reread Dr. Marcia Angell’s two articles in the New York Review of books, and the letters in response:
Dr. Angell writes a stinging indictment of Psychiatry and the modern turn to psychopharmacology. She sees psychiatry as way off base right now. In ‘The Illusions of Psychiatry’: An Exchange, several prominent Psychiatrists acknowledge the problems, but go on to defend the specialty and its current directions. I think that’s a mistake. While I agree that some of the anti-medication current in many recent writings may go too far, in my opinion, it’s not the place of psychiatrists to defend anything right now. That’s for later, if and when we’ve restored some credibility to our scientific processes and literature, when our evidence is based on genuine science. Right now, right-thinking psychiatrists need to focus on clearing out the forces among us that have made our specialty a target of mockery. Dr. Angello ends her second installment with:
    The books by Irving Kirsch, Robert Whitaker, and Daniel Carlat are powerful indictments of the way psychiatry is now practiced. They document the “frenzy” of diagnosis, the overuse of drugs with sometimes devastating side effects, and widespread conflicts of interest. Critics of these books might argue, as Nancy Andreasen implied in her paper on the loss of brain tissue with long-term antipsychotic treatment, that the side effects are the price that must be paid to relieve the suffering caused by mental illness. If we knew that the benefits of psychoactive drugs outweighed their harms, that would be a strong argument, since there is no doubt that many people suffer grievously from mental illness. But as Kirsch, Whitaker, and Carlat argue convincingly, that expectation may be wrong.

    At the very least, we need to stop thinking of psychoactive drugs as the best, and often the only, treatment for mental illness or emotional distress. Both psychotherapy and exercise have been shown to be as effective as drugs for depression, and their effects are longer-lasting, but unfortunately, there is no industry to push these alternatives and Americans have come to believe that pills must be more potent. More research is needed to study alternatives to psychoactive drugs, and the results should be included in medical education.

    In particular, we need to rethink the care of troubled children. Here the problem is often troubled families in troubled circumstances. Treatment directed at these environmental conditions—such as one-on-one tutoring to help parents cope or after-school centers for the children—should be studied and compared with drug treatment. In the long run, such alternatives would probably be less expensive. Our reliance on psychoactive drugs, seemingly for all of life’s discontents, tends to close off other options. In view of the risks and questionable long-term effectiveness of drugs, we need to do better. Above all, we should remember the time-honored medical dictum: first, do no harm (primum non nocere).
Who wants to argue with that? Not me. I’d rather join forces with the efforts in those first two pieces [PLoS and POGO]  to end ghostwriting and insist on transparency in our scientific literature. With the likes of Nemeroff, Schatzberg, Biederman, and many others prominently in our midst, we haven’t got a leg to stand on in defense of anything…
    August 6, 2011 | 8:23 AM

    Welcome back! I’m so sorry to read about the theft of your truck – that’s pretty stressful!

    Thanks for pointing to these two most recent publications. They are important foundational pieces and lead to a number of critical questions.

    I’ve been reading with interest the growing dissatisfaction of US psychiatry by UK, Canadian and Australian/New Zealand physicians, and I wonder if external forces won’t be the key drivers to force fundamental change?

    The time also seems ripe for another iteration of the Flexner report to address patient harm, safety and ethics in medical school curricula and in physician practice, research and leadership. If organized psychiatry doesn’t self impose reformation, it will indeed come from external sources, and those with the most skin in the game i.e. money, power, control and influence over the profession, may well come from the international community of physicians. Otherwise, patients, lacking any real organized clout, will continue to take it on the chin (or in the brain), and the corporate overlords (pharma, insurers, device makers, for-profit care goods and services) will increasingly define what psychiatry is and how it is practiced.

    And the dog that doesn’t bark? That would be building local, regional and national cultures in the US that are founded and sustained on the ye old principles of Enlightenment: tolerance, respect, mutual aid, the valuing of education, science & the classical virtues, and the recognition of diversity as desirable and valuable.

    There will never be effective and humane community based services until there exist healthy communities. Those are exceedingly rare in the US.

    August 11, 2011 | 12:49 PM

    I just stumbled across your blog. Wow. Makes me feel guilty for not blogging enough myself on these issues. Please keep it up – your perspective is great. I also have beein involved with mental health treatment of kids across recent decades, and so have similar perspectives on whether these drugs and diagnoses are warranted at all, and whether they are effective at all.

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