Aussie Civil Suit Uncovers Fake Medical Journals
Testimony Accuses Merck of Paying for Scientific Journal Lookalikes for Vioxx
By LAUREN COX and JOSEPH BROWNSTEIN
ABC News Medical Unit
May 14, 2009— http://abcnews.go.com/print?id=7577646
An ongoing class-action trial against Merck & Co has unearthed a series of controversial marketing techniques that have roiled the international science community -- including the creation of phony medical journals full of favorable studies of Merck's drugs.
The trail in Australia, one of many held worldwide over Merck's recalled drug Vioxx, has opened a trove of internal material from the company related to how it promoted the blockbuster arthritis drug that, before its recall in 2004 generated more than $2 billion in sales a year.
Vioxx has been linked to many thousands of strokes and heart attacks including, Plaintiffs claim, that of some 1,000 Australians, according to court documents. The plaintiffs in the case have presented evidence revealing a range of sales tactics from a bizarre motivational Vioxx music video for the sales staff set to the melody of Ricky Martin's "She Bangs" to an internal Merck list of physicians with "anti-Merck" medical views to be "neutralized."
But the news that Merck paid the renowned scientific publisher Elsevier to produce publications designed to look like independent scientific journals with names such as "The Australasian Journal of Bone and Joint Medicine" has led to some of the most-far reaching professional fallout from the trial. Elsevier disclosed six other phony "Australasian Journals" last week.
Scientific journals are supposed to be doctors' independent, non-biased source of the latest information about diseases and drugs. This is the first evidence that a drug maker has tried to co-opt the peer reviewed medical journal process by creating their own journals.
The elite Journal of the American Medical Association published an editorial calling for universal reform, citing evidence from Vioxx class action lawsuits that the that the New Jersey-based drug company "manipulated" vital safety details about Vioxx before submitting articles for peer review and paid doctors to act as "ghostwriters" for articles produced mostly by Merck employees.
According to evidence at the Australian trial, Merck didn't even bother to consult the medical experts published in their "journal." Some of the doctors listed as honorary board members in the fake publication called The Australasian Journal of Bone and Joint Medicine, have said they never agreed to be part of the so-called journal, and were never given any articles to review. The Scientist magazine has obtained two of the phony journals here, and here.
"I saw a copy of it years ago, somewhere, and I saw my name on it," said Dr. Ego Seeman, professor of medicine, at the University of Melbourne at Austin Health. "The pure fact that my name was on it without me being contacted, invited or involved was very upsetting."
Seeman said he twice called the editor listed on the publication to get his name off of the journal, and he called to warn one of his colleagues he saw on the list of honorary editorial board members: Dr. Philip Sambrook who is the president of the Australian and New Zealand Bone and Mineral Society.
"I was never invited to be on the advisory committee. It was never made known to me directly that I was on it. I was never consulted about the scientific content or its validity," said Seeman. "They just put my name on it, boom."
Dr. James Bertouch, chairman of rheumatology at Sydney's Prince of Wales Hospital, told of surprise and confusion at discovering his name on The Australasian Journal of Bone and Joint Medicine to the Australian Federal Court on last week, according to reporting by The Australian.
The journals listed subscription charges, distributed it to doctors and listed editorial staff, yet published no new content, did no new peer reviews, and printed no mention of Merck for several years of the publication. The journals also displayed the imprint of a branch of Elsevier, Excerpta Medica.
Elsevier, the world's largest publisher of medical journals, also reacted with anger at the news. "We think this practice is wrong and we're doing everything that we possibly can to make sure it doesn't happen again," said Tom Reller, director of corporate relations at Elsevier.
Reller said what was contained in the Australasian Journal of Bone and Joint Medicine is usually found in so-called "article compilation products" -- essentially marketing materials printed to inform doctors about a specific topic.
"Article compilation products are quite common, but they have to disclose the sponsor and they shouldn't be called 'Journals of.' That absolutely should not have happened," said Reller.
Elsevier has started a company-wide investigation of its 2,000 scientific journals and the much smaller commercial reprint division to see whether other fakes were published.
Merck, which has been inundated with suits over Vioxx, declined to elaborate on the journals, referring questions to Elsevier. Ronald Rogers, a Merck spokesman, said in an e-mail that "sometimes in high-visibility litigation, information is taken out of context and misstatements end up in the press."
The Australian class action suit has also brought to light a list of leading doctors and researchers with notes on their potential for prescribing Vioxx or speaking about the drug. Pharma companies routinely pay doctors to speak about their drugs to other professionals.
Notes on a prominent Philadelphia rheumatologist, listed him as "Not quite anti-Merck; major advocate for Searle/Pfizer&willingness to speak for Merck when VIOXX is launched; however, suspicious of his relationship of the Searle/Pfizer camp."
Then underneath the doctor's name on the memo submitted at trial is printed "NEUTRALIZED" in bold letters. The plaintiff testimony claims that the term "neutralize" meant to discredit these doctors.
But Rogers in the e-mail said "neutralizing" meant "providing the physician with scientific data in the hope of bringing a physician who is an advocate of a competing medication back to a neutral position."
"'Neutralized' means simply that the information has been provided," he wrote.
Of Merck's actions on Vioxx, Rogers said, "We believe that our strategy and our actions have been responsible...our strategy has been consistent from day one.
What's at Stake in the Vioxx Testimony
Merck's Vioxx sales strategy ended when the company withdrew the painkiller from the U.S. market in September 2004 citing safety concerns that the drug caused heart problems and increased the risk for heart attacks.
In the years since Vioxx prescriptions stopped, Merck has defended thousands of civil cases charging that the drug company was responsible for heart attacks -- losing some key billion-dollar claims but winning others, according to reporting by the New York Times.
Seeman said he's just happy that the phony journals have been exposed. But he also notes that such a marketing strategy threatened an intangible yet crucial commodity in his field: reputation of scientific integrity.
"Having my name there [on the board] makes me indirectly responsible for the validity of the content. It's a gross abuse," he said.
"Among scientists, the most important thing that we have is the credibility with our peers," said Seeman. What Merck did is "careless&it's showing no care or respect for the scientists' need for independence and credibility."
The Australian trail, which began in Melbourne on March 30, continues.