The New York Times (pg. C1)  [Printer-friendly version]
April 16, 2008

MERCK WROTE DRUG STUDIES FOR DOCTORS

By Stephanie Saul

The 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?"

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," 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?"

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.