The Miami Herald
December 2, 2010 Thursday
UM prof accused of submitting ghostwritten textbook
By JOHN DORSCHNER; jdorschner@MiamiHerald.com
December 2 2010

A national watchdog group has accused a University of Miami psychiatrist, Charles Nemeroff, of listing himself as a co-author of a textbook that was ghostwritten by a writing company and paid for by a major drug maker.
The Washington-based Project on Government Oversight has written a letter to the National Institutes of Health complaining about three publications, including Nemeroff’s, in which a marketing firm, Scientific Therapeutics Information, performed ghostwriting about drug benefits that was paid for by a company now known as GlaxoSmithKline.
Nemeroff and the book’s publisher, the American Psychiatric Association, emphatically denied the charge.
The book, Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care, was published in 1999, when Nemeroff was at Emory University. The co-author was listed as Alan F. Schatzberg, then chairman of psychiatry at the Stanford University.
“A draft of the textbook states that it was sponsored by GSK and written by Diane M. Coniglio and Sally K. Laden of STI,” POGO wrote. “In a letter addressed to Dr. Nemeroff, Ms. Laden provided an updated status of the textbook. Her timeline states that she wrote the first draft, which was then sent to Drs. Nemeroff and Schatzberg, the publisher, and GlaxoSmithKline. The timeline also notes that GSK was given all three drafts, and was sent page proofs for final approval.”
The POGO letter, dated Monday, was based on documents recently released in a lawsuit against GlaxoSmithKline. The documents, independently obtained by The New York Times, were the subject of a Monday article, “Drug Maker Wrote Book Under 2 Doctors Names, Documents Say.”
In a statement to The Herald, Nemeroff wrote: “. . . Schatzberg and I conceptualized this project and developed an outline . . . long before there was any involvement from a pharmaceutical company. Diane Coniglio . . . provided editorial assistance and expanded on the outline, and she was acknowledged in the preface.
“Such editorial assistants can provide help with such tasks as tracking down references and the like, but certainly do not have the clinical expertise or experience to put such a volume together.” Nemeroff called accusations of ghostwriting “blatantly false and inaccurate.”
“In the two years that elapsed between the 1997 letter from Ms. Laden and the finalization of the book and the contract with the publisher, I do not recall Dr. Schatzberg nor I having any contact with any SmithKline Beecham personnel concerning its content,” Nemeroff stated.
“With each successive draft, we scrutinized every page and rewrote and edited as we deemed necessary. The final product reflects this process. An unrestricted educational grant assumes that we had control of the final product and that was indeed the case. In view of the reference to sponsor comments in the letter, I would guess that they would have had to review the content to comply with [Food and Drug Administration] regulations on a pharmaceutical company distributing a publication, but this is hardly my area of expertise.
“Finally, it is important to note that the book was peer reviewed by multiple outside experts No questions of bias were raised.”
The APA posted a statement on its website Wednesday, saying the book was “was written by the two authors, reviewed for bias by eight physicians and not ghostwritten by a pharmaceutical company as suggested in an article in The New York Times.”
The letter from Scientific Therapeutics to Nemeroff did not use the term “ghostwriting” but referred to “developing” the drafts to be submitted to the named authors and the drug maker.
“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 in the APA statement. “To say the book was ghostwritten is not true. . . .
“Every book we publish is peer reviewed by medical doctors.” In this case, eight experts saw the manuscript and made “favorable” comments. “There were more than 500 suggested corrections on the part of reviewers and all revisions were made to the [published] manuscript.”
The book noted that it had been partly financed from an unrestricted educational grant from SmithKline Beecham, as the company was then known, and mentioned the assistance of the editorial company.
The POGO letter to NIH, written by Danielle Brian and Paul Thacker, says, “We are writing to urge that NIH curb the practice of ghostwriting in academia” by withholding NIH funds from those that have work ghostwritten for them.
“We have discovered that the NIH gave $66.8 million in grants over the last five years to a handful of researchers who used ghostwriters for scientific publications,” the POGO leaders wrote, and suggested that NIH action could swiftly stop the practice.
The letter said Nemeroff and co-author Schatzberg have received $23.3 million in NIH grants over the past five years.
Thursday UM Dean Pascal Goldschmidt issued a statement: “It is unfortunate that two individuals who have contributed so much to the medical discipline of psychiatry, Drs. Charles Nemeroff and Alan Schatzberg, and to the health of so many patients with dreadful psychiatric illnesses here in the U.S. and beyond, are exposed to such an unreliable and unfounded challenge to their reputation.”
The POGO letter and accompanying court documents can be found at pogo.org . The APA response is in the newsroom portion of psych.org.