The Wall Street Journal-20080131-Article on Avandia Study Was Leaked to Glaxo

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Article on Avandia Study Was Leaked to Glaxo

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Weeks before an influential article was published last year in the New England Journal of Medicine linking the diabetes drug Avandia to a risk of heart attacks, a physician helping peer-review the article broke the Journal's confidentiality rules and leaked a copy to the drug's maker, GlaxoSmithKline PLC.

The advance copy helped Glaxo prepare its public response, though the company said yesterday it was already discussing Avandia's potential heart-attack risks with the Food and Drug Administration at the time.

Seventeen days before the article was published in May 2007, Steven Haffner, a professor of internal medicine at the University of Texas Health Science Center at San Antonio, faxed a copy to a GlaxoSmithKline employee he knew from working on an earlier clinical trial of the drug, Glaxo confirmed yesterday, after the scientific journal Nature and Republican Sen. Charles Grassley of Iowa made the matter public.

Dr. Haffner's move is likely to raise questions about how medical journals and peer reviewers vet potentially market-moving information about pharmaceuticals and health-care companies. Publication of the article in the New England Journal of Medicine on May 21, 2007, led to a sharp drop in Glaxo's stock price and a similar plunge in sales of Avandia.

"Why I sent it is a mystery," a Nature article published yesterday quotes Dr. Haffner as saying. "I don't really understand it. I wasn't feeling well. It was a bad judgment."

Dr. Haffner didn't return phone calls seeking comment. Dr. Haffner had financial ties to Glaxo, including getting paid for giving speeches for the company, Glaxo said. Sen. Grassley, citing FDA documents, said Glaxo has paid Dr. Haffner about $75,000 in consulting fees and speaking honorariums since 1999.

In an email, a spokeswoman for the New England Journal of Medicine said: "We consider the peer-review process to be confidential. Any breach of ethics by a reviewer would be taken very seriously by the editors, but would be handled as a private matter."

Glaxo spokeswoman Nancy Pekarek confirmed that Dr. Haffner sent the article to the Glaxo employee, Alexander Cobitz, on May 3. She said Dr. Haffner wanted Glaxo to provide input on the study, but that Glaxo declined to. Glaxo didn't inform the New England Journal that it had a copy of the study, she said. Ms. Pekarek said Mr. Cobitz declined to comment.

Ms. Pekarek said no senior Glaxo executives traded stock based on their advance notice of the imminent publication. She said the company doesn't have information "immediately available on stock trading by all people within the company during that time frame."

Medical journals don't normally give companies advance copies of papers concerning their drugs. Steven Nissen, a cardiologist with the Cleveland Clinic who wrote the study linking Avandia to heart-attack risks, said he didn't give Glaxo an advance copy. Soon after Dr. Nissen's study was published, Glaxo began defending Avandia by referring to a clinical trial called Record. Preliminary results from that trial showed that Avandia was as safe as other diabetes treatments, Glaxo said at the time.

Glaxo made the decision to examine preliminary results from Record in mid-May, after it had the advance copy of Dr. Nissen's study, Ms. Pekarek said. Glaxo made this decision in conjunction with outside clinicians helping oversee Record, she said. She said Dr. Nissen's study was just one factor contributing to the decision to examine preliminary results of the study. Scientists don't normally like to look at what a clinical trial is showing until it is complete, as that can bias the eventual outcome of the trial.

Ms. Pekarek said Glaxo at the time was already discussing Avandia's possible risks with the FDA; Glaxo's desire to answer the FDA's questions was the primary factor motivating the company to examine preliminary results of Record, she said.

Sen. Grassley, who has been investigating Glaxo's handling of Avandia, said yesterday that he has sent a letter to Glaxo asking it to detail what action, if any, Glaxo took after receiving an advanced copy of the study. He asked Glaxo to provide details of when it began examining the Record results.

In his study, Dr. Nissen reviewed 42 previous clinical trials of Avandia and concluded that patients taking Avandia had a 43% higher risk of suffering a heart attack than those taking other oral diabetes medicines or placebo pills.

In November, under pressure from the FDA, Glaxo agreed to add a "black-box" warning to Avandia's label describing Dr. Nissen's findings.