Eli Lilly Ghostwrote Articles to Market Zyprexa, Files Show
Lilly employees also compiled a guide to hiring scientists to write favorable articles, complained to journal editors when publication was delayed and submitted rejected articles to other outlets, according to documents filed in drug-overpricing suits against the Indianapolis-based company, the largest manufacturer of psychiatric medicines.
Drugmakers use of ghostwriters has created “a huge body of medical literature that society cant trust,” said Carl Elliott, a University of Minnesota bioethicist who has written about the practice.
Lilly sought to make Zyprexa “the number one selling psychotropic in history,” according to a 2000 plan distributed to its product team. The memo was among more than 10,000 pages of internal documents unsealed last month in lawsuits by insurers and pension funds seeking to recoup money spent on the drug. They allege Lilly exaggerated Zyprexas effectiveness.
“Plaintiffs are releasing one-sided, cherry-picked documents obtained in discovery to selected news media in an effort to try their cases” there, said Lilly spokeswoman Marni Lemons. “Lilly remains prepared to defend ourselves against all of these allegations in the appropriate venue, a court of law.”
FDA Rules
The U.S. Food and Drug Administration doesnt have a guidance document or regulations specific to ghostwriting, said Karen Riley, an agency spokeswoman.
Lemons declined to answer specific questions about ghostwriting. There is no evidence in the unsealed documents that doctors were paid to sign off on the ghostwritten items.
“We believe these documents describe the marketing of a widely promoted and powerfully dangerous psychotropic medication,” said Thomas Sobol, lead attorney for the insurance plans. “Transparency is critically important.”
Lilly isnt the only drugmaker to use ghostwriters to win favorable play in medical journals. Merck & Co. and Pfizer Inc. also have faced claims they used ghostwriters as part of their marketing plans.
In May 2008, Whitehouse Station, New Jersey-based Merck agreed to pay $58 million to 29 states and to stop ghostwriting articles to resolve claims that its advertisements for the withdrawn painkiller Vioxx hid the drugs health risks.
Improper Marketing
Pfizer paid $60 million to 33 states in October to settle claims it improperly marketed its Bextra and Celebrex pain relievers. New York-based Pfizer agreed to halt off-label marketing of the medicines and stop ghostwriting about them. It withdrew Bextra in April 2005. Celebrex is still on the market.
“Every company, to some degree, has probably engaged in ghostwriting,” said Joseph Ross, an assistant professor at Mount Sinai School of Medicine in New York and the author of the JAMA paper on Mercks ghostwriting practices. “Its a challenging thing to discover without litigation, since its mutually beneficial to physicians and people within the industry to keep it under wraps.”
Untrustworthy
In 1996, Wyeth hired Excerpta Medica Inc., a New Jersey- based medical communications firm, to write 10 articles promoting drugs aimed at treating obesity, Elliott wrote in “Ghost Marketing: Pharmaceutical Companies and Ghostwritten Journal Articles,” published in 2007 in the journal Perspectives in Biology and Medicine.
Wyeth, which at the time was touting its fen-phen diet combination for weight loss, agreed to pay Excerpta $20,000 per article, according to Elliott.
“Wyeth kept each article under tight control, scrubbing drafts of any material that could damage sales,” he wrote. Pfizer is acquiring Madison, New Jersey-based Wyeth for $68 billion in cash and stock.
Doug Petkus, a spokesman for Wyeth, declined to immediately comment.