Drug companies ghostwriting research
Posted: Mon Apr 21, 2008 4:31 pm
Research ghostwriting common, insiders say
Drug companies seek recognized authors
By Jonathan Bor, Sun reporter, April 18, 2008
The news this week that Merck & Co. conducted research on its own drug and paid prominent scientists to lend their names to the studies came as no surprise to many people in medicine.
Researchers and ethicists say scientists are often paid to be listed as authors of ghostwritten studies in scientific journals, a practice they say undermines the public's already sagging confidence in research.
"We've got to stop this," said Dr. Catherine D. DeAngelis, editor of the Journal of the American Medical Association, which had an article on the topic this week. "People are being hurt. We've given away our profession."
DeAngelis, a pediatrician who was vice dean for academic affairs at Johns Hopkins School of Medicine, said she was often approached while on the faculty to put her name on research that she hadn't conducted.
In some cases, callers representing drug companies assured her little work would be required and said she could refer to a draft by a professional writing firm.
"I was approached many times until they realized I wasn't biting," DeAngelis said.
Articles in JAMA this week charged that Merck conducted its own studies on the pain pill Vioxx, then hired a company to ghostwrite reports for medical journals that appeared under the names of scientists who did little of the research.
Merck didn't disclose the involvement of the ghostwriters, according to the articles, which were based on company documents that surfaced in Vioxx lawsuits. The arthritis drug went on the market in 1999 and became a blockbuster before Merck withdrew it in 2004 after studies showed it was linked to a higher risk of heart attack and stroke.
In an editorial, DeAngelis and deputy editor Phil. B. Fontanarosa wrote that the practices of ghostwriting and "guest authorship" are examples of how the medical profession has been "inundated with profound influence from the pharmaceutical and medical device industries."
Merck defended the research and criticized JAMA for not allowing Merck to respond to the allegations before publication.
"We are disappointed that such false and misleading statements about Merck from trial lawyers have made their way into a medical journal," the company said in a prepared statement.
One of the scientists listed as an author has disputed the contention that he did little work - saying that he reviewed the records of almost 200 patients.
An industry group, the Pharmaceutical Research and Manufacturers Association of America, said that "it is essential for clinical trials to be conducted as ethically as possible" but disputed any inference that company-sponsored studies are inherently biased.
The group said the U.S. Food and Drug Administration acts as a check by reviewing protocols, data and conclusions.
It's understandable that drug companies sponsor studies on drugs they developed, DeAngelis said in an interview. "It's the drug companies that discover these drugs, and thank God somebody does," she said.
But she said it's dishonest for companies to hire doctors to lend prestige to studies they had little role in, and to hide the participation of outside firms that do much of the writing and apply the drug company's spin.
The editorial proposed that all authors disclose their contributions and that anybody who helped write the article but didn't qualify for authorship be listed in acknowledgments. It also proposed that any editor who allows for-profit companies "to manipulate his or her journal must be relieved of the editorship."
The articles struck a chord with Dr. Jean Sealey, a retired professor from Weill Cornell Medical College in New York. Last year, she said, a London-based consulting firm that helps drug companies publish research invited her to "author" an article for a coming conference of the American Society for Hypertension.
Sealey, a noted authority on hypertension, said two things surprised her about the offer: The conference was only a week away, and she had never heard of the drug, much less conducted any research on it:
"I knew nothing about this drug, and I didn't really know how to pronounce it. Clearly they just wanted my name."
The offer came in a series of e-mails, then in a phone call. Sealey said the line went dead when she asked whether she'd have access to the data, and she never heard from the company again.
"Every time I hear something about this field, I get shocked," she said.
Dr. Troyen Brennan, former director of the physicians' organization at Boston's Brigham and Women's Hospital, brought the issue to light in a piece he wrote in 1994 for the New England Journal of Medicine.
He said a prominent public relations firm, Edelman Medical Communications, offered him $2,500 to write an editorial about antihistamines and other drugs with sedative effects.
Brennan, who could not be reached for this article, said at the time that the company wanted to help him with the task by supplying him with an editorial it had commissioned for another journal. He said he rejected the offer.
Dr. Jerome Kassirer, editor of the New England Journal of Medicine from 1991 to 1999, said companies that draft research articles on their own drugs "necessarily bias the article in favor of their products, which may or may not be the best product for the patients."
And he said doctors who sign their names to studies they didn't actively participate in are "unprofessional to the very least and unethical at the very worst."
Kassirer said the practice of hiring consulting firms to write a first draft of review articles - which pull together studies on a drug - is particularly dangerous. That's because the firm can cherry-pick studies that reflect favorably on the drug and leave out ones that don't. An author who writes the final draft may be unaware of the omissions, he said.
Ruth Faden, director of the Hopkins bioethics institute, said the standard should be clear for any scientist asked to put his or her name to an article.
"If I have not contributed in a significant intellectual way to the science being reported or the review of analysis being reported, then I ought not be an author of that manuscript," she said.
Faden said the writing of a first draft is a serious matter because it helps shape what's presented in the final article: "Other authors who come in afterwards may do so without complete awareness they are working in that frame."
At Johns Hopkins, honorary authorship "is unacceptable and should be actively discouraged," according to policy, said Dr. Julie Gottlieb, Hopkins assistant dean for policy administration.
Drug companies seek recognized authors
By Jonathan Bor, Sun reporter, April 18, 2008
The news this week that Merck & Co. conducted research on its own drug and paid prominent scientists to lend their names to the studies came as no surprise to many people in medicine.
Researchers and ethicists say scientists are often paid to be listed as authors of ghostwritten studies in scientific journals, a practice they say undermines the public's already sagging confidence in research.
"We've got to stop this," said Dr. Catherine D. DeAngelis, editor of the Journal of the American Medical Association, which had an article on the topic this week. "People are being hurt. We've given away our profession."
DeAngelis, a pediatrician who was vice dean for academic affairs at Johns Hopkins School of Medicine, said she was often approached while on the faculty to put her name on research that she hadn't conducted.
In some cases, callers representing drug companies assured her little work would be required and said she could refer to a draft by a professional writing firm.
"I was approached many times until they realized I wasn't biting," DeAngelis said.
Articles in JAMA this week charged that Merck conducted its own studies on the pain pill Vioxx, then hired a company to ghostwrite reports for medical journals that appeared under the names of scientists who did little of the research.
Merck didn't disclose the involvement of the ghostwriters, according to the articles, which were based on company documents that surfaced in Vioxx lawsuits. The arthritis drug went on the market in 1999 and became a blockbuster before Merck withdrew it in 2004 after studies showed it was linked to a higher risk of heart attack and stroke.
In an editorial, DeAngelis and deputy editor Phil. B. Fontanarosa wrote that the practices of ghostwriting and "guest authorship" are examples of how the medical profession has been "inundated with profound influence from the pharmaceutical and medical device industries."
Merck defended the research and criticized JAMA for not allowing Merck to respond to the allegations before publication.
"We are disappointed that such false and misleading statements about Merck from trial lawyers have made their way into a medical journal," the company said in a prepared statement.
One of the scientists listed as an author has disputed the contention that he did little work - saying that he reviewed the records of almost 200 patients.
An industry group, the Pharmaceutical Research and Manufacturers Association of America, said that "it is essential for clinical trials to be conducted as ethically as possible" but disputed any inference that company-sponsored studies are inherently biased.
The group said the U.S. Food and Drug Administration acts as a check by reviewing protocols, data and conclusions.
It's understandable that drug companies sponsor studies on drugs they developed, DeAngelis said in an interview. "It's the drug companies that discover these drugs, and thank God somebody does," she said.
But she said it's dishonest for companies to hire doctors to lend prestige to studies they had little role in, and to hide the participation of outside firms that do much of the writing and apply the drug company's spin.
The editorial proposed that all authors disclose their contributions and that anybody who helped write the article but didn't qualify for authorship be listed in acknowledgments. It also proposed that any editor who allows for-profit companies "to manipulate his or her journal must be relieved of the editorship."
The articles struck a chord with Dr. Jean Sealey, a retired professor from Weill Cornell Medical College in New York. Last year, she said, a London-based consulting firm that helps drug companies publish research invited her to "author" an article for a coming conference of the American Society for Hypertension.
Sealey, a noted authority on hypertension, said two things surprised her about the offer: The conference was only a week away, and she had never heard of the drug, much less conducted any research on it:
"I knew nothing about this drug, and I didn't really know how to pronounce it. Clearly they just wanted my name."
The offer came in a series of e-mails, then in a phone call. Sealey said the line went dead when she asked whether she'd have access to the data, and she never heard from the company again.
"Every time I hear something about this field, I get shocked," she said.
Dr. Troyen Brennan, former director of the physicians' organization at Boston's Brigham and Women's Hospital, brought the issue to light in a piece he wrote in 1994 for the New England Journal of Medicine.
He said a prominent public relations firm, Edelman Medical Communications, offered him $2,500 to write an editorial about antihistamines and other drugs with sedative effects.
Brennan, who could not be reached for this article, said at the time that the company wanted to help him with the task by supplying him with an editorial it had commissioned for another journal. He said he rejected the offer.
Dr. Jerome Kassirer, editor of the New England Journal of Medicine from 1991 to 1999, said companies that draft research articles on their own drugs "necessarily bias the article in favor of their products, which may or may not be the best product for the patients."
And he said doctors who sign their names to studies they didn't actively participate in are "unprofessional to the very least and unethical at the very worst."
Kassirer said the practice of hiring consulting firms to write a first draft of review articles - which pull together studies on a drug - is particularly dangerous. That's because the firm can cherry-pick studies that reflect favorably on the drug and leave out ones that don't. An author who writes the final draft may be unaware of the omissions, he said.
Ruth Faden, director of the Hopkins bioethics institute, said the standard should be clear for any scientist asked to put his or her name to an article.
"If I have not contributed in a significant intellectual way to the science being reported or the review of analysis being reported, then I ought not be an author of that manuscript," she said.
Faden said the writing of a first draft is a serious matter because it helps shape what's presented in the final article: "Other authors who come in afterwards may do so without complete awareness they are working in that frame."
At Johns Hopkins, honorary authorship "is unacceptable and should be actively discouraged," according to policy, said Dr. Julie Gottlieb, Hopkins assistant dean for policy administration.