The report by the New York Times today that a 1999 medical text authored by Dr. Charles Nemeroff and by Dr. Alan Schatzberg was ghostwritten and financed by a pharmaceutical firm seems—at first glance—to tell of a new level of corruption within American medicine. “To ghostwrite an entire textbook is a new level of chutzpah,” former FDA commissioner David Kessler told the New York Times. “I’ve never heard of that before.”
But, in fact, this ghostwriting revelation simply hints at a much larger, pervasive problem, which is that financial bias profoundly affects the authorship of psychiatric textbooks at every turn. And it is quite easy to document that this is so.
In its article, the New York Times reported that SmithKline Beecham (now part of GlaxoSmithKline) had provided Nemeroff, who today is chairman of psychiatry at the University of Miami medical school, and Schatzberg, who was chairman of psychiatry at Stanford University Medical School from 1991 to 2009, with an “unrestricted educational grant” to author Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care. But SmithKline Beecham also paid a writing company, Scientific Therapeutics Information, to develop an outline for the book and—apparently—to actually write the text. Once the ghostwritten book was published, SmithKline Beecham purchased 10,000 copies for distribution to American family physicians.
This is indeed egregious. But the larger problem is this: Commercial interests influence the writing of most psychiatric texts.
First, psychiatric textbooks are regularly authored by leading psychiatrists at academic medical centers, many of whom are paid by pharmaceutical companies for their work as “advisors, consultants, and speakers.” Thus, while writing a particular textbook, they may not be receiving any money from a pharmaceutical company, they still have an ongoing financial relationship with the makers of psychiatric medications. As such, they have a financial reason for writing about psychiatric medications in a way that promotes their use.
Second, psychiatry as a field naturally has reason to promote the safety and efficacy of psychiatric medications. After all, this is the field’s main product today. Psychiatrists have turned into psychopharmacologists, and you can’t expect the leaders in the field to author texts that might question the fundamental merits of that product.
In my book Anatomy of an Epidemic, I investigated this storytelling process. In the first sections of the book, I reported on a number of studies funded by the National Institute of Mental Health, the World Health Organization, and other governmental agencies that told of unmedicated psychiatric patients doing better over the long-term than those who stayed on the drugs. In the latter part of the book, I investigated whether these studies were ever written about in psychiatric texts. Here’s what I found: None of the studies was discussed at any length, and in the few instances when one of the studies was mentioned in a textbook, the authors spun the results to protect the image of the drugs.
For instance, Martin Harrow, a researcher from the University of Illinois College of Medicine, reported in 2007 on the 15-year outcomes of a group of schizophrenia patients he had been following since the early 1980s. Forty percent of the patients off antipsychotic medications were in recovery at the end of 15 years, versus five percent of those on medication. He also reported on the 15-year outcomes of patients with milder psychotic disorders, and once again it was those off antipsychotics that were doing much better.
Now, this is the best longitudinal study of modern schizophrenia outcomes that we have today. This was an important NIMH-funded study. So how did the authors of the 2009 edition of the American Psychiatric Association’s Textbook of Psychiatry deal with it? They mentioned the study in passing, but they didn’t detail the actual results. They didn’t report that the recovery rate for unmedicated patients was eight times higher than for the medicated patients; instead the authors simply wrote that Harrow’s study revealed that there are some schizophrenia patients who are “able to function without the benefit of continuous antipsychotic treatment.”
This was spinning at its best. The authors came up with a sentence that told of the “benefit of continuous antipsychotic treatment.”
Now, let’s put the pieces of this larger storytelling process together. As is fairly well known now, the published scientific literature on the clinical testing of psychiatric medications during the past 20 years does not accurately portray the efficacy and safety of those drugs. Trials were biased by design, results were spun, articles were ghostwritten, and negative results went unpublished. As such, the source literature is corrupted, and that tainted literature then serves as the source material for authors who write psychiatric texts. Then those authors—when confronted with an upsetting study like Harrow’s—add their own layer of spin.
The New York Times article tells of a ghostwritten book, and observers—like former FDA commissioner David Kessler—express their shock. But it’s really not so out-of-step with larger storytelling forces that have been at work in psychiatry for some time.
Update on the "ghostwriting" controversy (posted January 5, 2011)
There has been some continuing controversy regarding the New York Times November 29 story cited above, which was titled "Drug Maker Hired Writing Company for Doctors' Book, Documents Say."
Here is a review of the controversy. We can look at the documents that triggered it; the response by attorneys for Nemeroff and Schatzberg, and their denials that the textbook was ghostwritten; the correction issued by the New York Times; and finally the response by the Project on Government Oversight, which obtained the documents that served as the basis for the New York Times article.
The first key document is dated February 4, 1997. It is a letter from Scientific Therapeutics Information (STI) to Charles Nemeroff. STI had received an "eduycational grant" from SmithKline Beecham to develop this publication, which was a textbook titled "Primary Care Handbook of Psychopharmacology." In the letter, STI's Sally Laden provides Dr. Nemeroff with "an update on the status of this project. We have begun development of the text, and Diane Coniglio, PharmD is the primary technical writer and project manager. I will be working closely with Diane at all times and will serve as technical editor."
STI lays out a timeline for completion of the book, in which it is stated that three drafts will be sent to Dr. Nemeroff and Dr. Schatzberg for their review, and to the sponsor, SmithKline Beecham for its review. The letter noted that STI had developed "a complete content outline" for Nemeroff and Schatzberg to comment on. As you can see from this letter, there is an understanding--at least at this point--that the project is underway, and STI will be writing the drafts.
The second document is a preliminary draft of the first 49 pages of the book, dated February 21, 1997. In this draft, the text is said to have been "authored" by Schatzberg and Nemeroff, and "developed" by Diane Coniglio and Sally Laden of Scientific Therapeutics. The intro to the draft states: "This publication is prepared under an educational grant from SmithKline Beecham Pharmaceuticals by Scientific Therapeutics Information, Inc."
POGO, in its postings on the matter, noted how many passages in the draft written by STI were then published in very similar form in the book authored by Schatzberg and Nemeroff. However, POGO noted that Nemeroff and Schatzberg, in the book, "only thank STI for 'editorial assistance' and GSK for 'providing an unrestricted educational grant.' " POGO, in a November 29 letter to the National Institutes of Health, stated that "the fact that STI wrote the first draft undermines Drs. Nemeroff and Schatzberg's assertion that STI provided mere 'editorial assistance,' " and thus STI's writers should have been listed as co-authors.
The response by attorneys for Schatzberg and Nemeroff
In response to the article published by the New York Times and by POGO's posting of documents on the web, attorneys for Dr. Schatzberg and Dr. Nemeroff, in a series of letters, demanded that POGO issue a retraction. In their letters (the correspondence can be traced by scrolling to the bottom of this posting), the attorneys state that it is "false" that STI "ghostwrote" the textbook, and that it was 'false" that "STI wrote the first draft," and that it was "false" that GlaxoSmithKline Beecham "was given all three drafts, and was sent page proofs for final approval."
The attorneys state that STI's Feb. 4 letter, which set out the proposed timelines and milestones, "does not recite the actual terms upon which Dr. Nemeroff and his co-author were retained to write the book," and that the timelines and the detailing of the specific roles of STI and the authors "were not finalized until early 1999, on terms quite different from those set out in the STI letter." As for the fact that passages in the draft written by STI show up in similar form in the book, an attorney for Dr. Schatzberg stated that STI's role was "to support the authors of the book," and that "given the editorial support that is expressly acknowledged in the preface to the Book, it is entirely unremarkable that some paragraphs from the preliminary draft have survived the addition of further content, rewriting, and editing."
In sum, the attorneys for Schatzberg and Nemeroff are asserting that the documents written by STI in February of 1997, which--by their tone and language--indicate that an arrangement for STI to write the text is already in place, give a mistaken picture of what actually happened. They are asserting that a new arrangement was made, in which Dr. Nemeroff and Dr. Schatzberg authored the textbook, with editorial support from STI. GlaxoSmithKline Beecham provided funding for the project through an "unrestricted" educational grant, and Schatzberg and Nemeroff didn't send the text to GlaxoSmithKline for final approval. The fact that passages in the first draft written by STI were very similar to passages in the book written by Schatzberg and Nemeroff is "entirely unremarkable" and not indicative of any ghostwriting arrangement.
The New York Times' Correction
On December 8, The New York Times issued a correction in regards to its article. It stated that "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 Times noted that the documents provided a timeline for presenting the drafts to GlaxoSmithKline, but did not "say that the company had already provided those materials for final approval." The Times also noted that former FDA Commissioner David Kessler had not reviewed the documents when he commented about the book's production, expressing his shock that an entire text had been ghostwritten.
POGO, for its part, has basically stood by its story. It wrote, in an amended letter to the NIH, that "STI authored entire portions of a physician handbook, Recognition and Treatment of Psychiatric Disorders, for Drs. Alan Schatzberg of Stanford Medical Center and Charles Nemeroff." POGO did state however, in its amended letter, that "based on the evidence available to POGO at this time, the nature and extent of GlaxoSmikthKline's actual involvement [in reviewing the text] is undetermined."
That's where the controversy stands today. Perhaps more clarifying details will come out in the future.