Drug ‘Reports’ Found to be Faked

June 22, 2009

22 June (TORONTO STAR) – From the creation of fake academic journals, to bogus stories submitted to real journals, to falsified results in some of academia’s most respected publications – the pharmaceutical industry has been rocked by allegations that the world’s biggest drug companies put public relations above public safety.

by STUART LAIDLAW
The Toronto Star

As consumer advocate Peter Lurie put it recently: “I’ve seen no shortage of creativity emanating from the marketing departments of drug companies.”

The allegations have come to light thanks to lawsuits in the United States and Australia seeking compensation for drug costs that the plaintiffs claim were too high.  The suits allege the drug companies skewed academic investigations into their products, thereby driving up the price they could charge.

Trudo Lemmens, an associate professor of medical law at the University of Toronto, says it should not be left to the civil courts to uncover what he calls “publishing as marketing.”

“You have to ask yourself, why isn’t there more regulatory control?”

Lemmens would like to see tougher conflict-of-interest rules and more oversight of how drug trials are conducted, and the results published.

Some of the drugs involved in the lawsuits – including Vioxx and Fosamax – were later found to have adverse, and even deadly, side effects. Others, such as Zetia and Vytorin, were later found to be no more effective than much cheaper alternatives.

Merck & Co., maker of those drugs, has steadfastly defended its policies and products.

“We believe the companies acted responsibly and appropriately and we intend to defend this lawsuit vigorously,” Ron Rogers, a spokesman for Merck, told the Star in an email statement.

Ely Lilly also defended its policies and products. “Plaintiffs are releasing one-sided, cherry-picked documents obtained in discovery to selected news media in an effort to try their cases (there),” spokeswoman Marni Lemons told Bloomberg.

“Lilly remains prepared to defend ourselves against all of these allegations in the appropriate venue, a court of law.”

Some of the recent allegations:

  • Company documents released in Australia during a civil suit there suggest that Merck & Co. allegedly paid publishing company Elsevier to print nine fake academic journals, including Australasian Journal of Bone and Joint Medicine, without revealing their link to the drugs giant. Thirteen more journals were in the works, The Scientist magazine reports.
  • A Philadelphia lawsuit brought by the Pennsylvania Employees Benefit Trust Fund charges that Merck and Schering-Plough Corp., which Merck is merging with, suppressed evidence that two of their medicines, Zetia and Vytorin, are no better at reducing cholesterol than much cheaper alternatives, Bloomberg reported.
  • Ely Lilly & Co. employees allegedly acted as ghostwriters for academic journal articles that were favourable to the company’s products, according to company documents unsealed as part of a lawsuit brought against the company by insurers and pension funds seeking to recoup money spent on Lilly drugs.
  • Merck and Pfizer Inc. have faced claims they used ghostwriters as part of their marketing plans, Bloomberg reports. Last year, Merck agreed to pay $58 million (U.S.) to 29 states to resolve claims that its advertisements for painkiller Vioxx hid the drug’s health risks. It also agreed to stop ghostwriting articles.
  • To test the integrity of a publication called The Open Information Science Journal, Cornell University student Philip Davis and Kent Anderson of the New England Journal of Medicine, submitted a fake manuscript – generated by a computer program to be purposely nonsensical – at the end of January. The “open information” journal offered to publish the article if the pair agreed to pay an $800 publishing fee. The editor later resigned.
  • Pfizer paid $60 million to 33 states in October to settle claims it improperly marketed its Bextra and Celebrex pain relievers.
  • In December 2005, the prestigious New England Journal of Medicine took the unusual step of publishing an online editorial accusing Merck of suppressing data that showed a greater risk of heart attack among people taking Vioxx than was already known. The year before, Vioxx was removed from the market after previous studies identified the heart attack risk.

In January, The New England Journal of Medicine and the Journal of the American Dental Association published studies linking Fosamax to such side effects as esophageal cancer and jaw bone die-off. Both Vioxx and Fosamax figure prominently and favourably in the Australasian Journal of Bone and Joint Medicine linked to Merck.

Lurie, deputy director of the public health research group at the consumer advocacy non-profit Public Citizen, reviewed two issues of the Australasian Journal of Bone and Joint Medicine for The Scientist. He concluded there was little evidence to show the publication’s connections to Merck.

“To the jaundiced eye, (the journal) might be detected for what it is: marketing,” he told the magazine. “Many doctors would fail to identify that and might be influenced by what they read.”

Elsevier, which also publishes some of academia’s most respected journals including The Lancet, recently announced changes to its policies on such matters but refused to disclose how much Merck paid it for the Australasian journals – a position Merck supported.

“Merck agrees with Elsevier about the importance of appropriate disclosure of financial support, and we remain committed to providing journals with the information that permits such disclosures to be made,” Rogers says in his email.

Lemmens says there has been some progress in the United States on the issue, including “sunshine laws” requiring any conflicts of interest be revealed to those who ask, and a series of congressional hearings being held into how drug trials are conducted and reported.

He is studying how the field can be better regulated in Canada, saying professional bodies already overseeing the conduct of doctors and researchers could be involved.

Researchers, he says, are often under intense pressure to publish as many academic articles as possible and can be tempted by offers of help from ghostwriters and the companies whose products they are researching.

“It plays into the publish or perish culture,” he says.

As well, he says, there is great academic prestige for a researcher to have his or her name on an article in a top journal – something that accepting a ghostwritten article can help a researcher achieve.

The practice, however, is not new. A study in the Journal of the American Medical Association in 1998 found 11 per cent of articles in a series of top-rated journals had been ghostwritten.

Mississippi State University bioethicist Barton Moffatt predicts doctors who allow their names to be put on ghostwritten articles may one day find themselves being fired over the practice, adding that many in academia now see the practice as plagiarism.

Lemmens says he would fail any student who handed in a ghostwritten article, adding that universities cracking down on student plagiarism need to pay closer attention to faculty, as well.

“It is clearly false representation, which is academic misconduct. If we don’t do something about it (ghostwriting), it’s hard to tell the students it is wrong.”

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