Aussie Civil Suit Uncovers Fake Medical Journals

May 14, 2009— -- An ongoing class-action trial against Merck & Co. has included claims of a series of controversial marketing techniques that have roiled the international science community -- including the creation of phony medical journals full of previously published studies favorable to Merck's drugs.

The trial in Australia, one of many held worldwide over Merck's recalled drug Vioxx, has opened what plaintiffs call 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, those 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 the renowned scientific publisher Elsevier produced Merck-sponsored 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. Both journals and drug companies such as Merck publically agree to follow international ethics committees' guidelines to keep the information in journals unbiased.

Just last April, the elite Journal of the American Medical Association published an editorial calling for universal reform in drug company collaborations with scientists, in light of evidence admitted in similar Vioxx class action lawsuits. The authors claimed 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.

But this case is the first to allege that a drug maker has tried to co-opt the peer reviewed medical journal process by creating their own journals.

Some of the doctors listed as honorary board members for 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."

Discovering a Bogus Medical Journal

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, distribution to doctors and listed editorial staff, yet published no original 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.

Trying to Fix Drug-Company Influence Over Medicine

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 plaintiffs in the Australian class action suit have also entered into evidence an internal Merck document that lists 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 increased the risk for heart attacks and strokes.

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 trial, which began in Melbourne on March 30, continues.