US: Merck Wrote Drug Studies for Doctors

Publisher Name: 
The New York Times
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 Universitypsychiatry
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.

AMP Section Name:Pharmaceuticals