[Ip-health] US: Merck Wrote Drug Studies for Doctors

[Riaz K Tayob]

If there is 'fraud' (since ghost writing is widespread) would this
invalidate patent applications for other types of medications?

rt,,

US: Merck Wrote Drug Studies for Doctors


by STEPHANIE SAUL, The New York Times
April 16th, 2008

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
=93External author?=94

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=92s 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=92s published research, because the ghostwriting practice appears
to be widespread.

=93It almost calls into question all legitimate research that=92s been
conducted by the pharmaceutical industry with the academic physician,=94
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=92s 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=92s conclusion that the authors do little of
the actual research or analysis.

The final work is the product of the doctor and =93accurately reflects his
or her opinion,=94 said a Merck lawyer, James C. Fitzpatrick.

And at least one of the doctors whose published research was questioned
in Wednesday=92s article, Dr. Steven H. Ferris, a New York
Universitypsychiatry professor, said the notion that the article bearing
his name was ghostwritten was =93simply false.=94 He said it was =93egregio=
us=94
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.

=93It 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,=94 the editorial said.

The editorial called upon medical journal editors to require each author
to report his or her specific contributions to articles. =93Journal
editors also bear some of the responsibility for enabling companies to
manipulate publications,=94 the editorial said.

JAMA itself published one of the Vioxx studies that was cited in Dr.
Ross=92s article.

In that case, in 2002, a Merck scientist was listed as the lead author.
But Dr. Catherine D. DeAngelis, JAMA=92s 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.

=93I consider that being scammed,=94 Dr. DeAngelis said. =93But 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?=94

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=92s 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=92 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=92s progression.

The draft of the paper, dated August 2003, identified the lead writer as
=93External author?=94 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=92s 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=92s 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.

=93It=92s simply false that we didn=92t contribute to the final publication=
,=94
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.

=93The 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,=94 Dr. Kirby=92s 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. =93Currently, we have in place prohibitions
against this,=94 Dr. Meador-Woodruff said.