Ghostwriters Used in Vioxx Studies, Article Says

[RedEarth]

Source: nyt

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 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

.........

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,” Dr. Ross said, whose article, written with colleagues, was published Wednesday in JAMA, the journal of the American Medical Assocation.



Read more: http://www.nytimes.com/2008/04/15/business/15cnd-vioxx.html?ex=1208923200&en=a5966f18042c2fc8&ei=5065&partner=MYWAY

[OhioChick]

1. Nice. n/t

[Clear Blue Sky]

2. Typical

The physicians who contributed the most patients to the clinical trials usually get their names on the papers. The pharma company writes the paper, although with input and oversight from the physicians. Typical physician doesn't have the time or inclination to write the actual paper. This is almost always acknowledged in the paper or footnotes.

No different than some celebrity writing a book and it's actually written by a ghostwriter.

[mhatrw]

19. That's not what the article says.

The Journal of the American Medical Association

http://jama.ama-assn.org/cgi/content/full/299/15/1800

Guest Authorship and Ghostwriting in Publications Related to Rofecoxib

A Case Study of Industry Documents From Rofecoxib Litigation

Joseph S. Ross, MD, MHS; Kevin P. Hill, MD, MHS; David S. Egilman, MD, MPH; Harlan M. Krumholz, MD, SM

JAMA. 2008;299(15):1800-1812.

ABSTRACT ...

Data Synthesis Approximately 250 documents were relevant to our review. For the publication of clinical trials, documents were found describing Merck employees working either independently or in collaboration with medical publishing companies to prepare manuscripts and subsequently recruiting external, academically affiliated investigators to be authors. Recruited authors were frequently placed in the first and second positions of the authorship list. For the publication of scientific review papers, documents were found describing Merck marketing employees developing plans for manuscripts, contracting with medical publishing companies to ghostwrite manuscripts, and recruiting external, academically affiliated investigators to be authors. Recruited authors were commonly the sole author on the manuscript and offered honoraria for their participation. Among 96 relevant published articles, we found that 92% (22 of 24) of clinical trial articles published a disclosure of Merck's financial support, but only 50% (36 of 72) of review articles published either a disclosure of Merck sponsorship or a disclosure of whether the author had received any financial compensation from the company.

Conclusions This case-study review of industry documents demonstrates that clinical trial manuscripts related to rofecoxib were authored by sponsor employees but often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support. ...

This case-study review of industry documents related to rofecoxib demonstrates that Merck used a systematic strategy to facilitate the publication of guest authored and ghost written medical literature. Articles related to rofecoxib were frequently authored by Merck employees but attributed first authorship to external, academically affiliated investigators who did not always disclose financial support from Merck, although financial support of the study was nearly always provided. Similarly, review articles related to rofecoxib were frequently prepared by unacknowledged authors employed by medical publishing companies and attributed authorship to investigators who often did not disclose financial support from Merck. ...

However, the instances for which we did identify before and after manuscript drafts, such as for protocol 078, we found scant documentary evidence that the recruited authors were involved in the design or conduct of the study or made substantive contributions to the manuscript beyond minor editing. ... Nevertheless, although we cannot conclude that each of the external, academically affiliated investigators attributed authorship for their respective trial or review article made no substantive contributions to the study design or manuscript preparation, the authorship pattern observed within these documents suggests there was a widespread practice of inappropriately attributing authorship to academic authors and a failure to disclose relevant financial relationships. ...

Finally, this case-study review is based on documents from a single company related to a single medication. We cannot determine if the authorship pattern we observed for clinical trial and review articles related to rofecoxib also would be observed in articles describing other Merck products or the products of other pharmaceutical companies. However, given the reported prevalence of guest authorship and ghostwriting among the most prestigious medical journals and that similar authorship patterns were identified using documents produced during litigation surrounding both gabapentin and sertraline, it is reasonable to expect that the authorship practices observed in this case study may be used by other pharmaceutical companies as well. A recent press account seems to confirm as much, as does the presence of an industry specializing in medical writing. ...

[geomon666]

3. A pharmaceutical company lied about its' product?

Well I'd say color me surprised if I weren't already blue from being dead from all of these drugs.

[Bozita]

4. Just like GWB's AUTObiography, written by Karen Hughes after the first ghostwriter was fired ...

... for failure to properly adulate.

"A Charge To Keep"

The reviews at Amazon are hilarious.

The NYT article is anything but.

[maddezmom]

5. Maker of Vioxx Is Accused of Deception

Maker of Vioxx Is Accused of Deception

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Who's Blogging» Links to this article
By David Brown
Washington Post Staff Writer
Wednesday, April 16, 2008; Page A01

Two teams of researchers with access to thousands of documents gathered for lawsuits over the painkiller Vioxx allege that Merck waged a campaign of deception to promote its drug, moving slowly to warn of possible hazards while at the same time dressing up in-house studies as the work of independent academic researchers.

The reports in today's Journal of the American Medical Association in effect accuse one of the world's biggest pharmaceutical makers of various forms of scientific fraud.

One study alleges that Merck gave the Food and Drug Administration an incomplete accounting of deaths in a clinical trial of Vioxx in people with mild dementia. Federal regulators eventually received the data, which added to growing evidence that Vioxx increased the risk of heart attacks and strokes.

Simultaneously, Merck was using what the JAMA authors call "guest authorship and ghostwriting" to make it appear that research done by its employees or contractors was the work of scientists at medical schools and universities. That presumably gave the findings more credibility when they were published, in medical journals, boosting Vioxx's profile in the crowded painkiller market.

more:http://www.washingtonpost.com/wp-dyn/content/article/2008/04/15/AR2008041502086.html?hpid=moreheadlines

[Supersedeas]

11. thanks for the link -- note the lack of coverage on the network distributors of Big Pharm Ads

[Lance_Boyle]

6. Nobody ever wondered before why CROs have Medical Writing depts?

Talk about willful blindness! This has been standard since the rise of companies like Quintiles, Parexel, etc. The drugcos pay them to conduct the studies, write the papers, schmooze the "Principal Investigators" (to entice them to sign their names to the pre-written papers full of predetermined results), and get the product to market. There has been precious little "honest research" out of the Clinical Trials racket for a decade or more. Industry/Academic partnerships are an even more fraudulent scam.

[bemildred]

7. Look, our health care system is corrupt.

There is no fixing it, we need to junk it and start over.

[underpants]

8. More from the article. The diabolical lengths that corporations go to is no longer a surprise

from Blair Mountain to Walmart and Taco Bell hiring dumpster divers to Monsantos outrageous behavior and rewriting of its history are more indicative than out of the norm

----------

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.



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.

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.

[Supersedeas]

9. will the networks that receive big Ad $$'s from big Pharm bother to touch this news??

[womanofthehills]

10. P & G did this also with the osteo drug Acetonal

check this out - my friend can barely walk after using this drug based on bought research

http://www.slate.com/id/2133061/

[mhatrw]

12. Merck Wrote Drug Studies for Doctors

Source: 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.

Read more: http://www.nytimes.com/2008/04/16/business/16vioxx.html

---

What a surprise!

[gratuitous]

13. It "almost" calls into question industry research

"Almost," but not quite. I'm sure this was just one bad apple. Shouldn't spoil the whole bunch. Surely there's no need for the government to get involved, or for any outside review to be instituted. I mean, any drug company that consistently sold a poisonous product would to out of business sooner or later, and just because a handful of men would make a shitload of money in the meantime, that's no reason to suspect that they'd routinely jigger their research.

Let mean, petty, greedy, selfish people act on their worst impulses, because the Holy Magic of the Free Market will make it all come out right in the end.

[mhatrw]

14. The Journal of the American Medical Association calls this a "case study."

http://jama.ama-assn.org/cgi/content/full/299/15/1800

Guest Authorship and Ghostwriting in Publications Related to Rofecoxib

A Case Study of Industry Documents From Rofecoxib Litigation

...

Conclusions This case-study review of industry documents demonstrates that clinical trial manuscripts related to rofecoxib were authored by sponsor employees but often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support.

[thecrow]

17. Unfortunately, they sold it to me....and I had a stroke

Now my attorneys have talked me into accepting their settlement, but I don't knnow if I would have agreed to that if I had read this first. In the suit, Merck asks you if you have any internet information about Vioxx or have you read any newspaper articles. My injury was before they even changed the labeling, and at that time my health insurance company was pushing Vioxx for any kind of pain you had. These Merck people should be given the same strokes and heart attacks that we, the trusting public, received. Maybe then they'd care what they put on the market.

[hvn_nbr_2]

18. The sun "almost" rose this morning

The boy king is "almost" an idiot and a war criminal.

[greiner3]

15. Nothing will happen of substance;

Merck got away with mass murder and besides, wall street loves 'em.

[tanyev]

16. Time for all these "external authors" to lose their medical licenses.

[OKthatsIT]

20. Damn..I sure am glad I dont need medicine

(knocks on wood)

[mhatrw]

21. me, too.

A whole lot of knocking going on.