Twitter
BLN RSS
Add to Google




http://www.wikio.com






News, Blogs,
Information, and Analysis

Rogue Government
What Really Happened
Deadline Live
Cryptogon
Vigilant Citizen
Raw Story
Dprogram
Citizens for Legit Gov.
Information Clearing House
American Free Press
Global Research
The Peoples Voice
Tom Burghardt
Uncover The News
All Gov.
Media Monarchy
Information Liberation
TPM Muckraker
Mike Chambers
F. William Engdahl
Tony Cartalucci
Cryptome
Narco News
Media Matters
Uruknet
Corbett Report
Common Dreams
Alternet
Antiwar
Aftermath News
Steve Quayle
Wayne Madsen
Truth Out
Lew Rockwell
Dissident Voice
Morph City
Sovereign Independent
Before It's News
News With Views
Jeff Rense
Revolt Of The Plebs
Strike The Root
Peter Chamberlin
12160
Michael Snyder
Old Thinker News
Activist Post
Common Dreams
Empire Burlesque
CNS News
IntelliBreifs
Intel Trends
Electric Politics
Stop The Lie
Amy de Miceli
Crooks and Liars
Rumor Mill News
The Resident
Aangirfan
OpEDNews
The Brad Blog
Conspiracy Archive
Foreign Policy Journal
Counter Punch
August Review
Buzzflash
Truth Is Treason
Reason
Real News Network
VOA News
Huffington Post
World Net Daily
Drudge Report
Newsmax
Boing Boing
Short News
Small Government Times
Capitol Hill Blue
Global Post
The Blotch
Wide Awake News
Intel Hub
Amped Status
NewsWires
Breaking News
Yahoo!-Top Headlines
Yahoo!-Full Coverage
AP-National News
UPI
Reuters
WorldNews.com
7am.com
1st Headlines
My Way - News
Ananova.com
Lycos News - Breaking
CNews - Top News
Sky News
Guardian Unlimited
Newswire - Salon.com
NewsNow.co.uk
news-spider.com
Community News Aggregators
Reddit
Digg
Business / Economics
Gold & Silver Prices
Seeking Alpha
Market Watch
Bloomberg
Wall Street Journal
RTT News
CNN Money
Forbes
Business Week
Funny Money Report
Market Oracle
Money Morning
My Budget 360
The Street
Shadow Stats
Economist
Financial Times
Fortune Magazine
Kitco
Gold Eagle
Max Keiser
321 Gold
Stock Charts
Zero Hedge
Washingtons's Blog
The Daily Reckoning
Energy Business Review
Milplex / Intel / Defense
Public Intelligence
Spacewar News
Danger Room
Washington Technology
Defense Industry Daily
Global Security
Geopolitical Monitor
Global Intelligence Report
Defense Link
Stratfor
Space War
Jane's
Defense Tech
Strategy Page
Military Info Tech
Health & Environment
Natural News
Prevent Disease
Health Wyze
Major US Newspapers
New York Times
New York Post
New York Daily News
Washington Post
Washington Times
L.A. Times
USA Today
Science / Tech News
Wired
Sites And Blogs
Blast Magazine
PHYSorg
Science Daily
Popular Science
Tech Eye
Engadget
New Scientist
DVice
Technovelgy
Singularity Hub
H+ Magazine
Science Magazine
Seed Magazine
CBR Online
Science News
SlashDot
Scientific American
Spectrum IEEE
Technology Review
io9
ZD Net
Technology News
The Register
Tech News World
VNU Net






Directive 21

Directive 21



Home Security



AddThis Feed Button
Add to Technorati Favorites
Valid XHTML 1.0 Transitional






Merck Wrote Drug Studies For Doctors
Published on 2008-04-16 00:00:00
AddThis Social Bookmark Button

Source: NY 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.