When one thinks of ghost writing, they may conjure up thoughts of secret writers and scheming in the background with some nefarious plan in mind. Or an attorney who has his team preparing his important last minute brief, never giving thought of assigning credit to any of the contributors. That is why it was so unusual for the New York Times to run a story alleging that drug companies had essentially paid two authors eleven years ago to put their names on a medical handbook, written by unacknowledged authors. The problem with the story is everything was acknowledged in the preface of the handbook.
The book, entitled “Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care,” published in 1999 , listed two distinguished authors—Charles Nemeroff, who chairs the psychiatry department at the University of Miami medical school, and Alan Schatzberg, who was chair of the psychiatry department at the Stanford University School of Medicine from 1991 until recently.
The preface of the book acknowledges an “unrestricted educational grant” from SmithKline Beechman (now GlaxoSmithKline). It also acknowledges Scientific Therapeutics Information (STI) and Diane M. Coniglio for “editorial assistance.”
After reviewing unsealed materials the Times received from the Los Angeles law firm of Baum Hedlund as part of discovery in lawsuits against GlaxoSmithKline, involving Paxil, the article asserted that the books preface insufficiently acknowledged the role of GSK and STI. The article however does not mention that this lawsuit was filed by a whistleblower under the qui tam provision, and that both the law firm and whistleblower stand to benefit significantly by any evidence of wrongdoing by the company. What were the financial motivations of the lawyers sending this information to the Times?
Despite failing to mention this important detail, the Times asserts that “SmithKline Beecham, actually had much more involvement than the book described.” Specifically, they allege that the documents show that “the grant paid for a writing company to develop the outline and text for the two named authors, and then the writing company said it planned to show three drafts directly to the pharmaceutical company for comments and “sign-off” and page proofs for “final approval.”
Leemon B. McHenry, a bioethicist with California State University, Northridge, who is a hired consultant for the plaintiff’s law firm, told the Times that many similar documents remain sealed, and claimed that this was “only the tip of the iceberg.”
Kevin G. Colgan, a spokesman for GlaxoSmithKline, disagreed. He insisted that the company’s role in producing the book was described accurately in its preface.
The “book has never been in wide circulation and has not been sold for a few years.” It sold about 26,000 copies, including 10,000 bought by SmithKline Beecham for American family doctors and 10,000 purchased by the Dutch pharmaceutical company Organon. The authors together received a 15 percent royalty on sales of $120,000 sales, or about $18,000. Estimating the time it takes to write a 200 plus page book, the authors roughly made $15 per hour, not exactly what pay one expects from a story writing as if the doctors are living “Lifestyles of the Rich and Famous”. This figure does not take into account the time spent by the eight independent reviewers.
Consequently, disclosure standards have changed in the 12 years since the book was published. The Times article doesn’t emphasize this sufficiently. Today, industry funding for medical writing and research is much more restricted. PhRMA itself issued its first Code of Ethics in 2002. It was widely praised at the time. The Code was extensively revised and made more restrictive in 2008.
The claims that the Times advance are misguided and skeptical. The handbook was published by two highly respected, albeit somewhat controversial psychiatric authorities over a decade ago, ancient news. In 2008, Emory University imposed a two-year ban on Dr. Nemeroff receiving NIH grants after a Senate inquiry found that he had failed to disclose at least $1.2 million in industry financing over seven years from pharmaceutical companies, including GlaxoSmithKline. Dr. Schatzberg was accused of similar disclosure of payments issues by Senator Grassley but was subsequently exonerated. Senator Grassley also inquired with Stanford about ghost writing but no evidence was ever found. Former Grassley staffer Paul Thacker who is the source of this NY Times article was fully aware of that fact.
Since no one has set forth any claims other than improper attribution of funding and editorial assistance, presumably then, the effort to produce this handbook led to a good quality project and everybody wins. The psychiatrists assure the quality, and they enhance their visibility and reputations. The writers improve clarity. The readers get good information. To the same extent that if some products discussed in the book along with competitive products and were sold by Smith Kline Beecham, the company benefits. If there is no inappropriate promotion of Smith Kline Beecham products, nobody gets hurt.
The “story” doesn’t contain a shred of evidence to contradict that possibility. Instead, this story represents another synergy between activists like Paul Thacker and journalists who fail to objectively investigate the whole issue, or fairly report such information. What sells papers is in the “best interest” of journalists, and advancing activists’ agenda to discredit industry and please their ideologically like-minded sponsors and their legal clients appears to be the only interest news sources are considering these days on this issue.
The article does a poor job trying to maintain neutrality and violates many journalistic principles. It only quotes liberals and industry critics, none of which are “experts” in publishing or psychiatry. What authorizes them to weigh in—other than to throw around one of the most muddled epithet slogans—on “ghostwriting?” The answer is that lawyers just want to use these insinuations to influence juries.
But did any of the critics actually read the book? Criticizing literary involvement of industry sponsors is a better idea once one has established that the finished work is in some way incomplete, inaccurate, or unlawful (i.e. off-label promotion). From the “experts” identified in the Times article it appears that no such claims are advanced and no one has read or even used the book. Had this been responsible, objective reporting, the author would have sought commentary from relevant experts in the field to determine first whether the book makes erroneous or hazardous recommendations, especially related to drug dosing.
For all we know, the book could have saved thousands of lives.
American Psychiatric Association
In response to the Times story, the American Psychiatric Association (APA) issued a press release asserting that the handbook was “reviewed for bias by eight physicians and not ghostwritten by a pharmaceutical company,” and appropriately identified editorial assistance from STI and funding of through an unrestricted grant from GSK. APA asserted that “the pharmaceutical company had no rights to approval on the editorial content, nor would any of us have granted them that authority.”
Project on Government Oversight
The Times story also arose because the Project on Government Oversight (POGO) sent a letter to the National Institutes of Health (NIH) Director Dr. Francis Collins asserting that NIH needs to make regulations to prohibit ghostwriting. The letter, a product of the investigative work of Paul Thacker, former staffer of Senator Charles Grassley (R-IA), essentially alleges that ghostwriting is a prevalent practice, and that researchers receiving federal funding through NIH grants that participate in ghostwriting or have in the past, should be banned from federal health research funding.
Background
According to Dr. Schatzberg, the materials in question were not a textbook, rather it was a handbook or primer for primary care physicians. In response to the allegations that this was a “ghostwritten” book, Dr. Nemeroff and Dr. Schatzberg responded to questions by e-mail last week and emphasized the “unrestricted” nature of the grant from the drug maker to develop the book and said they did most of the work.
Dr. Schatzberg firmly maintained that SmithKlineBeecham “had no involvement in content,” and that “An unrestricted grant does not give the company any right of sign-off on content and in fact they had no sign-off in content.” Dr. Nemeroff said he and Dr. Schatzberg “conceptualized this book, wrote the original outline and worked on all of the content.”
Despite their assertions, the issue raised by POGO and the Times stems from a letter dated Feb. 4, 1997, documenting the relationship between Dr. Nemeroff, GSK and STI. A review of this letter indicated that STI had developed “a complete content outline” for Dr. Nemeroff’s comment and had “begun development of the text.” The outline is pretty bare bones, and uncontroversial.
Although Dr. Schatzberg had not seen the 1997 letter to Dr. Nemeroff, he asserted that it was merely “a theoretical proposal that bears little, if any relationship to what actually happened.” Dr. Nemeroff further maintained that he and Dr. Schatzberg “scrutinized every page and rewrote and edited as we deemed necessary,” keeping control of the final draft.
In its press release, APA clarified that the “letter showed a timeline for development of the book by the editorial service but did not show that the book was “ghostwritten” by the company.” From APA’s perspective, they recognized that the “timeline and details in the letter were never approved by APPI or the authors, and a contract between the authors and APPI was not executed until 2 years after the letter.” As Dr. Schatzberg explained, the letter mentions a delivery of the book by August 1997. However, this was not the final arrangement. He noted that they did not negotiate a contract with APPI until 1998 and that was signed in 1999, around the time when the book was actually completed. Accordingly, Dr. Schatzberg asserted that “there is little relationship of the 1997 letter to the reality of what occurred.”
“This type of editorial assistance was quite common, especially the use of editorial experts to compile and check facts in books on pharmacology,” said Ron McMillen, chief executive of American Psychiatric Publishing. “To say the book was ghostwritten is not true. Our contracts hold the authors responsible for the content.”
McMillen added, “Every book APPI publishes is peer-reviewed by medical doctors. In this case, the APPI editors got five separate reviews and the American Medical Association, which co-published the book, got three more. All of them were favorable,” McMillen said. The use of APPI should come as no surprise, especially given that Dr. Schatzberg has published over 15 books with APPI, and the publisher had knowledge from the start that GSK was providing support and STI was providing editorial assistance.
But the Times tries to discount this information by quoting Dr. Bernard Lo, a medical ethicist and chairman of an Institute of Medicine group that wrote a 2009 report on conflicts of interest. After reviewing the documents, Dr. Lo an expert on all things concerning (no need for facts) ethics asserted that the grant did not sound “unrestricted,” and that it appeared as though the company had “ultimate control.” Consequently, the Times maintains that this is the first “book among publications, namely medical journal articles, that have been criticized in recent years for hidden drug industry influence, colloquially known as ghostwriting.”
Discussion
McMillen reviewed files on the book this week and found no evidence of influence by the writing company or GlaxoSmithKline. However, he told the Times that he was unaware of the plan outlined in the two-page letter to Dr. Nemeroff, and that this would have “showed more involvement than we would accept.”
Nevertheless, McMillen was quoted in the APA news release asserting that the kind of editorial assistance the handbook got was “quite common, especially the use of editorial experts to compile and check facts in books on pharmacology.” He further asserted that, “To say the book was ghostwritten is not true. Our contracts hold the authors responsible for the content.”
The letter published by The Times indicated the “sponsor” would review drafts throughout the process, but the publisher’s records show no signs of influence from the company, McMillen said. In fact, there were more than 500 suggested corrections on the part of reviewers and all revisions were made to the manuscript that APPI published.
One important detail that was left out of the Times article and POGO letter was some background for the book. Dr. Schatzberg noted that he and Dr. Nemeroff came up with the idea for the handbook after publishing an actual psychopharmacology textbook for psychiatrists. Their idea came long before there was any pharmaceutical interest in distributing it. Dr. Nemeroff said the book was written to fill an unmet need in educating family doctors and primary care physicians on how to provide adequate treatment for people with mental illness. He added that the book “remains quite accurate and relevant to clinical practice today.”
When the authors decided to move forward with the idea of a primer and received funding, STI provided some editorial and outline assistance and specific contributors from STI were duly and appropriately noted. Dr. Schatzberg further asserted that given the standards in 1999, the disclosures for the handbook were appropriate then, and would still be today. Accordingly, he emphasized that any implication that he or Dr. Nemeroff did not write the handbook is not accurate.
These assertions however were discounted by Dr. David A. Kessler, former commissioner of the Food and Drug Administration, who reviewed the documents, and believed that the entire handbook was essentially ghostwritten.
Conclusion
Changes in journals, professional societies, and academic medical centers to prohibit ghostwriting and require disclosure of payments have been widespread over the past several years. As Dr. Lo acknowledged, ghostwriting has receded in recent years with tougher standards.
Nonetheless, to ensure public trust in medicine, transparency is always welcomed with physician-industry collaboration. While the letters published this week may appear to show an aspect of ghostwriting, it appears clear from Dr. Nemeroff and Schatzberg’s comments that such conduct is misstated.
Before proposing any changes to their grant system, the NIH should consider that plaintiff attorneys are largely behind this sudden move to disclose ghost writing. These attorneys can then discredit those physicians and their research in court. Given this fact, one may not consider calls for banning funding for those who worked on papers with writers in the pasts and were arbitrarily assigned the label of “ghost writing” a purely altruistic goal.
No one doubts that the practice of ghostwriting raises concerns about bias since the authors may not be appropriately acknowledged however, more attention needs to be paid to the entire writing of medical literature process. As in almost all professions, many people take different roles in producing finished products.
In Congress, staffers, attorneys, interns, and lobbyists help write laws, but their names do not appear on the bills, only the original sponsors and co-sponsors do. Sure, you can look up who the staffers may be, but you do not know what their interests are, other than maybe what party they are work for.
As long as researchers continue to adequately acknowledge whose idea it was, who were authors on the project, collaboration between industry and researchers to produce educational materials should be a priority because such relationships help teach and inform physicians how to help better treat patients.