Merck Writes Drug Studies for Doctors.

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April 16, 2008

 

Merck Wrote Drug Studies for Doctors

http://www.nytimes.com/2008/04/16/business/16vioxx.html?th & emc=thThe drug maker Merck

drafted dozens of research studies for a best-selling drug, then lined

up prestigious doctors to put their names on the reports before

publication, according to an article to be published Wednesday in a

leading medical journal.

The article, based on documents unearthed in lawsuits over the pain drug Vioxx,

provides a rare, detailed look in the industry practice of ghostwriting

medical research studies that are then published in academic journals.

The article cited one draft of a Vioxx research study that was still

in want of a big-name researcher, identifying the lead writer only as

“External author?â€

Vioxx was a best-selling drug before Merck took it off the market in

2004 over evidence linking it to heart attacks. Last fall, the company

agreed to a $4.85 billion settlement to resolve tens of thousands of

lawsuits filed by former Vioxx patients or their families.

The lead author of Wednesday’s article, Dr. Joseph S. Ross of the

Mount Sinai School of Medicine in New York, said a close look at the

Merck documents raised broad questions about the validity of much of

the drug industry’s published research, because the ghostwriting

practice appears to be widespread.

“It almost calls into question all legitimate research that’s been

conducted by the pharmaceutical industry with the academic physician,â€

said Dr. Ross, whose article, written with colleagues, was published

Wednesday in JAMA, The Journal of the American Medical Association. and posted Tuesday on the journal’s Web site.

Merck acknowledged on Tuesday that it sometimes hired outside

medical writers to draft research reports before handing them over to

the doctors whose names eventually appear on the publication. But the

company disputed the article’s conclusion that the authors do little of

the actual research or analysis.

The final work is the product of the doctor and “accurately reflects

his or her opinion,†said a Merck lawyer, James C. Fitzpatrick.

And at least one of the doctors whose published research was questioned in Wednesday’s article, Dr. Steven H. Ferris, a New York University psychiatry

professor, said the notion that the article bearing his name was

ghostwritten was “simply false.†He said it was “egregious†that Dr.

Ross and his colleagues had done no research besides mining the Merck

documents and reading the published journal articles.

In an editorial, JAMA said the analysis showed that Merck had apparently manipulated dozens of publications to promote Vioxx.

“It is clear that at least some of the authors played little direct

roles in the study or review, yet still allowed themselves to be named

as authors,†the editorial said.

The editorial called upon medical journal editors to require each

author to report his or her specific contributions to articles.

“Journal editors also bear some of the responsibility for enabling

companies to manipulate publications,†the editorial said.

JAMA itself published one of the Vioxx studies that was cited in Dr. Ross’s article..

In that case, in 2002, a Merck scientist was listed as the lead

author. But Dr. Catherine D. DeAngelis, JAMA’s editor, said in a

telephone interview on Tuesday that, even so, it was dishonest because

the authors did not fully disclose the role of a ghostwriter.

“I consider that being scammed,†Dr. DeAngelis said. “But is that

as serious as allowing someone to have a review article written by a

for-profit company and solicited and paid for by a for-profit company

and asking you to put your name on it after it was all done?â€

Although the role of pharmaceutical companies in influencing medical

journal articles has been questioned before, the Merck documents

provided the most comprehensive look at the practice yet, according to

one of the study’s four authors, Dr. David S. Egilman, a clinical

associate medical professor at Brown University.

In the Vioxx lawsuits, millions of Merck documents were supplied to

plaintiffs. Those documents were available to Dr. Egilman and Dr.. Ross

because they had served as consultants to plaintiffs’ lawyers in some

of those suits.

Combing through the documents, Dr. Ross and his colleagues unearthed

internal Merck e-mail messages and documents about 96 journal

publications, which included review articles and reports of clinical

studies. While the Ross team said it was not necessarily raising

questions about all 96 articles, it said that in many cases there was

scant evidence that the recruited authors made substantive

contributions.

One paper involved a study of Vioxx as a possible deterrent to Alzheimer’s progression.

The draft of the paper, dated August 2003, identified the lead

writer as “External author?†But when it was published in 2005 in the

journal Neuropsychopharmacology, the lead author was listed as Dr.. Leon

J. Thal, a well-known Alzheimer’s researcher at the University of

California, San Diego. Dr. Thal was killed in an airplane crash last

year.

The second author listed on the published Alzheimer’s paper, whose

name had not been on the draft, was Dr. Ferris, the New York University

professor. Dr. Ferris, reached by telephone Tuesday, said he had played

an active role in the research and he was substantially involved in

helping shape the final draft.

“It’s simply false that we didn’t contribute to the final publication,†Dr. Ferris said.

A third author, also not named on the initial draft, was Dr. Louis

Kirby, currently the medical director for the company Provista Life

Sciences. In an e-mail message on Tuesday, Dr. Kirby said that as a

clinical investigator for the study he had enrolled more patients, 109,

than any of the other researchers. He also said he made revisions to

the final document.

“The fact that the draft was written by a Merck employee for later

discussion by all the authors does not in and of itself constitute

ghostwriting,†Dr. Kirby’s e-mail message said.

The current editor of the journal Neuropsychopharmacology, Dr. James H. Meador-Woodruff, the chairman of psychiatry at the University of Alabama,

Birmingham, said he was not the editor in 2005 but planned to

investigate the accusations. “Currently, we have in place prohibitions

against this,†Dr. Meador-Woodruff said. Think Simply. Think Wisely. Curb Semantics. Speak the Truth.

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