Ghostwriting and Medical Fraud
Can any medical research studies be trusted?
Posted Oct 16, 2010
"Much of what medical researchers conclude in their studies is misleading, exaggerated, or flat-out wrong," writes David H. Freedman in November's Atlantic Monthly. "So why are doctors—to a striking extent—still drawing upon misinformation in their everyday practice?"
Freedman's hard-hitting article, "Lies, Damned Lies, and Medical Science," concentrates on the work and findings of Dr. John Ioannidis, a medical professor in Greece who has "spent his career challenging his peers by exposing their bad science." Far from being dismissed as a maverick or crank, Dr. Ioannidis is highly sought after. "His work has been widely accepted by the medical community," Freedman writes. "It has been published in the field's top journals, where it is heavily cited; and he is a big draw at conferences." One of his articles for PLoS Medicine, on bias in clinical trials, is the most downloaded in the journal's history.
The real shock of Dr. Ioannidis' work? He charges that "as much as 90 percent of the published medical information that doctors rely on is flawed."
The Greek professor's underlying goal, the Atlantic reports, is to shed an uncompromising spotlight on just how often—and how much—drug companies have been "manipulating published research to make their drugs look good." This issue was, you may recall, the subject of my last post, following news that the Public Library of Science (PLoS) and New York Times had successfully lobbied for the release of 1,500 documents that the drug-maker Wyeth commissioned to boost its spotty product, Prempro. Prempro, a Hormone Replacement Therapy (HRT), has been shown to increase women's risk of breast cancer, stroke, and dementia. Beyond that, the journal and newspaper discovered that Wyeth not only had fabricated evidence about its treatment, but also had paid a ghostwriting agency to create and plant vast amounts of that "evidence" on the drug-maker's behalf. (The documents are freely available here.)
To the evidence uncovered by the Atlantic, Guardian, New York Times, and PLoS, we can also add GlaxoSmithKline's highly incriminating document CASPPER, short for "Case Study Publications for Peer Review," which the drug-maker seems to have chosen as the name of its shell company because it brought to mind the cartoon ghost Casper, as in "CASPPER, the friendly ghost-writing agency."
A confidential brochure published by GSK's Philadelphia office and circulated "for consultant use only," CASPPER makes clear that the drug maker's "PAXIL Product Management" team had "budgeted for 50 articles in 2000" (p. 11). That was the year, incidentally, the corporation spent more than $92 million on an ad campaign to promote social anxiety disorder, following the medical truism that one must first sell the disease before pitching the product advertised as treating it. Among other things, the CASPPER brochure indicates a strong preoccupation with devising and planting favorable articles about Paxil, the first of the SSRI antidepressants to be given an FDA license for the treatment of social anxiety disorder (March 1999). Other confidential documents that colleagues have sent me indicate that GSK internally was concerned about 1-in-5 patients reporting significant side effects from Paxil within weeks of starting treatment on it in their clinical trials.
According to the Associated Press, which covered this scandal when it broke last year, GlaxoSmithKline "used [the] sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants." "Manuscript preparation can be a time-consuming task," the company recognizes in its brochure, while "CASPPER coordinates these responsibilities for contributing physicians" (p. 8).
Working with professors and researchers with names in the field, even to the point of mimicking their personal styles, CASPPER committed to crafting positive-sounding data in such a way that the professor would be willing to add his or her name to the fabricated article. After dogged effort targeting and revising for journals, the shell company would then be responsible for placing said article in prominent publications.
According to Policy and Medicine, "Articles from the company's [ghostwriting] program [did indeed] appear in five journals between 2000 and 2002, including the American Journal of Psychiatry and the Journal of the American Academy of Child and Adolescent Psychiatry."
In the case of Wyeth and GlaxoSmithKline, who've been caught red-handed with their ghostwriting agencies, the fabrication of medical evidence amounts to widespread, certifiable fraud. A spokeswoman for Glaxo's London office even is on record as saying, "The published articles noted any assistance to the main authors," which is supposed to sound reassuring, I guess, though readers of the American Journal of Psychiatry expecting good data clearly wouldn't have known the extent of the drug company's involvement in crafting more or less the entire article. The same spokeswoman is quoted as adding that the ghostwriting program "was not heavily used and was discontinued a number of years ago."
So we can all breathe a sigh of relief that medical fraud is over, right? Wrong. For starters, there's Wyeth's 1,500-document ghostwritten archive, which the drug company has been required to make available to the public. The Wyeth Ghostwriting Archive constitutes an example of medical fraud on a massive scale.
According to the Guardian, moreover, DesignWrite, the medical communications company that Wyeth hired, "boasts that over 12 years they have planned, created, and/or managed hundreds of advisory boards, a thousand abstracts and posters, 500 clinical papers, over 10,000 speakers' bureau programmes, over 200 satellite symposia, 60 international programmes, dozens of websites, and a broad array of ancillary printed and electronic materials."
And what about seemingly milder infractions and distortions of evidence?
"Wasn't it possible," Dr. Ioannidis is reported as asking his colleagues in the Atlantic article, "that drug companies were carefully selecting the topics of their studies—for example, comparing their new drugs against those already known to be inferior to others on the market—so that they were ahead of the game even before the data juggling began? Maybe sometimes it's the questions that are biased, not the answers."
"Though the results of drug studies often make newspaper headlines," concludes Freedman at the Atlantic, "you have to wonder whether they prove anything at all. Indeed, given the breadth of the potential problems raised at the meeting, can any medical-research studies be trusted?"
It's a bleak and troubling question, and in his last post for "Mad in America," his excellent PT blog, Robert Whitaker came last week to the same conclusion: "Research in this country is financed by pharmaceutical firms that can't be trusted to conduct honest science."
Houston, we have a problem.