Healthy Skepticism Library item: 12638

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Saul S.
Doctor Accused of Leak to Drug Maker
The New York Times 2008 Jan 30
http://www.nytimes.com/2008/01/30/business/30cnd-censure.html

Full text:

A key member of the Senate said Wednesday that a prominent diabetes expert leaked an unpublished and confidential medical journal article to GlaxoSmithKline last year, tipping the company to the imminent publication of safety questions involving the company’s diabetes drug Avandia.

The doctor, Steven M. Haffner of the University of Texas Health Science Center in San Antonio, faxed the article to the drug maker after agreeing to read it as part of the peer-review process for the New England Journal of Medicine, according to a statement Wednesday by Senator Charles E. Grassley.

“The most troubling aspect of this situation is that the integrity of another aspect of the scientific process is called into question – scientific peer review,” Mr. Grassley’s statement said. The peer-review process, he said, is meant to ensure “that other scientists will judge a study’s quality before it is made public.”

Mr. Grassley, the ranking Republican on the Finance Committee and a long-time critic of business dealings between doctors and drug companies, also released a copy of a letter he sent to GlaxoSmithKline in which he asked what action the company took after receiving the letter.

Dr. Haffner has not responded to phone calls and e-mail messages seeking comment, including calls and messages so far today.

An article on the matter that was published online Wednesday by the journal Nature quoted Dr. Haffner. “Why I sent it is a mystery,” the quote says. “I don’t really understand it. I wasn’t feeling well. It was bad judgment.”

A spokeswoman for GlaxoSmithKline, Nancy Pekarek, said that Dr. Haffner had sent the article to the company on May 3, more than two weeks before the article was published in the New England Journal. He “expressed concerns and questions regarding the methodology of the analysis, and sent the article to GSK for advice from experienced statisticians,” she said.

But Ms. Pekarek said the company did not provide comments or any other input. “We believe GSK acted appropriately and responsibly in responding to the situation.”

Under the New England Journal’s rules, reviewers are prohibited from disclosing an article’s contents before they are published, as a way of protecting the intellectual property of scientists who submit articles.

A spokeswoman for the New England Journal of Medicine, said the journal was aware of the allegations against Dr. Haffner. “Any breach of ethics by a reviewer would be taken very seriously by the editors, but would be handled as a private matter,” the Journal said in an e-mailed statement.

Besides violating the New England Journal’s rules, disclosing a pending article would also be considered a breach of professional ethics, according to Dr. Jerry Avorn, a professor of medicine at Harvard Medical School. Dr. Avorn said that he was not familiar with the specific allegations against Dr. Haffner.

Dr. Haffner has previously disclosed that he has conducted research and served as a paid speaker for Glaxo. Mr. Grassley said that Dr. Haffner had received $75,000 in consulting and speaking fees from GlaxoSmithKline since 1999.

As part of its normal pre-publication review process, the New England Journal had asked Dr. Haffner last year to vet the article, which had been submitted for publication by Dr. Steven E. Nissen of the Cleveland Clinic. The article, a pooled analysis of Avandia studies, was published in late May and suggested that the diabetes drug increased heart attack risks by more than 40 percent in patients.

Dr. Nissen, the chief of cardiovascular medicine at the clinic, said Wednesday that he was disappointed in Dr. Haffner’s decision to send the article to GlaxoSmithKline.

“The integrity of the scientific review process is really very important in medicine,” Dr. Nissen said. “The last thing I would have ever expected was that a respected reviewer for a prestigious journal would have, within hours of receiving a review, give it to a pharmaceutical company.”

The article and subsequent criticism of the drug, as well as placement of a black box warning on the drug’s label ordered by the Food and Drug Administration, have helped drive down Avandia’s sales by more than half from their level in 2006, when sales exceeded $3 billion worldwide.

Receiving an early copy of the article could have given GlaxoSmithKline time to mount a campaign refuting the article’s findings. Within days of Dr. Nissen’s article appearing, the company began citing the interim results of another study, called Record, that did not support his findings.

But Ms. Pekarek said that even before receiving the Nissen article from Dr. Haffner the company had been weighing whether to look at preliminary results of the Record study, which was still underway. Those internal deliberations, she said, were based on the company’s own internal findings of an increased heart attack risk from Avandia.

Ms. Pekarek said the additional knowledge that an article critical of the drug’s safety was soon to be published increased the urgency of looking at the interim Record results.

Dr. Haffner, who had been involved in a major clinical study of Avandia, called Adopt, that found the drug worked better at controlling blood sugar than two other common treatments, was quoted last year in the online medical publication theheart.org as critical of the publication of Dr. Nissen’s study and of editorials that supported it in two other journals.

“The three major medical journals are becoming more like British tabloid newspapers – all they lack is a bare-chested woman on page 3,” Dr. Haffner was quoted as saying.

Last year the New England Journal sanctioned another physician, Dr. Martin B. Leon, for commenting on a study before its publication. Dr. Leon, who was a reviewer of a journal article on the effectiveness of heart stents, disclosed at a medical conference that the study’s findings were negative before the article appeared. As a result, the journal barred Dr. Leon from reviewing articles for five years, and said he could not submit commentary for publication in the journal during that period.