Federal prosecutors triumphantly announced the nation’s largest-ever health-care-fraud settlement last month, when the pharmaceutical maker GlaxoSmithKline admitted marketing its drugs for unapproved purposes.
Virtually unpublicized was a key detail: One of the central pieces of evidence in the case was a 2001 scientific journal article listing 22 authors, most of them university researchers, that was actually written by Glaxo-hired authors to overstate the benefits and understate the risks of a highly profitable Glaxo drug.
For years, critics had been pointing out flaws in that study of the drug, the antidepressant Paxil, and warning that the study’s recommendation of the use of Paxil on children had dangerously misrepresented data and hidden information indicating that the drug promoted suicidal behavior among teenagers.
And yet for years, the publisher of the article, the Journal of the American Academy of Child and Adolescent Psychiatry, and the universities whose researchers’ names were on it resisted calls to retract the study and publicly rebuke its “authors.” In the meantime, the government has continued to provide those researchers with millions of dollars in federal grant money.
Now Glaxo has admitted its guilt with regard to marketing Paxil and other drugs and agreed to pay a record $3-billion fine. The plea includes an admission that the Paxil study article was part of the fraud. And yet the universities, the journal, and the government are largely avoiding questions about whether they should finally take or force corrective or punitive action.
“At this moment I don’t have any comment,” Andrés S. Martin, a professor of psychiatry at Yale University and editor in chief of the journal, said in a brief telephone interview following the settlement, which was announced July 2.
Dr. Martin said his journal was still considering its options with regard to the article, which the journal published in July 2001. Asked how long the journal’s review of the article might take, Dr. Martin again declined to comment.
The article listed Martin B. Keller, then a professor of psychiatry and human behavior at Brown University, as its lead author. Other listed authors included Karen D. Wagner, then also at Brown and now a professor and vice chair of psychiatry and behavioral sciences at the University of Texas Medical Branch at Galveston, and David T. Feinberg, president of the UCLA Health System.
Yet e-mails and evidence uncovered through investigations long before the federal prosecution—including a 2007 documentary by the BBC and a 2008 book, Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial, by Alison Bass—and then the charges that Glaxo pleaded guilty to, show that the article constituted scientific fraud and that Dr. Keller relied on a Glaxo-hired author to draft it.
Brown University, under its previous president, Ruth J. Simmons, conducted an internal investigation of the Paxil study but declined to discuss its conclusions. Until Dr. Keller’s retirement this month, the university let him keep accepting federal grant money.
Brown’s new president, Christina H. Paxson, who took office on the same day the Glaxo settlement was announced, doesn’t see any reason for further action, a spokeswoman said. “The recent announcement by the U.S. Department of Justice did not suggest that any further reviews of the paper by the university are immediately warranted,” Darlene Trew Crist said in a written response. “We have no further statement to make at this time.”
Other universities with authors on the paper either declined to respond or gave similar answers. “After checking and double-checking, we’ll not be commenting,” said Raul Reyes, a spokesman at UTMB-Galveston. Dale Triber Tate, a spokeswoman for the University of California at Los Angeles, said Dr. Feinberg, too, had no comment.
‘A Target for Cheaters’
In the settlement announced last month, Glaxo agreed to plead guilty to two counts concerning the false marketing of Paxil and another antidepressant, Wellbutrin, and one count of failing to report safety data about Avandia, a diabetes drug.
Glaxo began selling Paxil in the United States in 1993 and reported sales of $11.7-billion between 1997 and 2005. Prescriptions for children “soared” after the publication of the study signed by Dr. Keller, Ms. Bass wrote, even though there was no strong evidence the drug actually helped children with depression.
Then British regulators warned in 2004 against prescribing Paxil to children, citing a study of 1,100 children that found those taking Paxil were nearly three times as likely to consider or attempt suicide as those given a placebo. Shortly afterward, the U.S. Food and Drug Administration issued a similar warning.
At the Justice Department’s news conference on July 2, William V. Corr, deputy secretary of the Department of Health and Human Services, called the prosecution of Glaxo a turning point in the government’s determination to halt criminal manipulation of medical research.
“For a long time,” Mr. Corr said, “our health-care system had been a target for cheaters who thought they could make an easy profit at the expense of public safety, taxpayers, and the millions of Americans who depend on programs like Medicare and Medicaid. But thanks to strong enforcement actions like those we have announced today, that equation is rapidly changing.”
Mr. Corr, however, declined a request to discuss whether the government could make such claims without anyone’s penalizing the university researchers found to have participated in the Glaxo fraud. The department instead made available an official, speaking on the condition of anonymity, who said the government had no legal authority to sanction any of the researchers—even though it had concluded they were part of an intentional criminal fraud—because the Glaxo study itself did not use federal money. The department is not seeking such authority from Congress, the official said.
Universities could act on their own to demand that the journal retract the article, said Fiona Godlee, editor in chief of BMJ, another leading medical journal. But, she said, “it is proving hard to get those who should do something to act.”
‘The Tip of the Iceberg’
Several of the authors on the Paxil paper are still bringing large federal grants to their universities. In addition to Dr. Keller, who is listed in the NIH database as holding two NIH grants, worth $1.4-million, the Glaxo study authors include Boris Birmaher and Neal D. Ryan, professors of psychiatry at the University of Pittsburgh, who together hold seven NIH grants, worth more than $6.5-million.
Graham J. Emslie, a professor of psychiatry at University of Texas Southwestern Medical Center at Dallas, has two NIH grants, worth more than $700,000, and Michael A. Strober, a professor of psychiatry at UCLA, has one grant, worth nearly $350,000. One other author, Gregory N. Clarke, a scientist at Kaiser Permanente Center for Health Research, has five NIH grants, worth more than $1.8-million. They and other authors did not respond to requests for comment.
The Department of Health and Human Services official who spoke anonymously said he considered the Glaxo case unique because of the federal guilty plea. Yet lawyers for patients alleging harm from medications have been highlighting a series of similar instances in recent years in which Glaxo and other drug companies have paid university researchers who have been willing to attach their names to studies that cast a favorable light on their products.
“This is just the tip of the iceberg,” said Leemon B. McHenry, a lecturer in philosophy and medical ethics at California State University at Northridge, who also serves as a research consultant at Baum, Hedlund, Aristei & Goldman, a Los Angeles law firm representing thousands of Paxil patients. “It just goes on and on and on.”
Correction, August 10, 2012, 11:34 a.m.: A caption under a photograph of Christina H. Paxson, president of Brown, mistakenly reported that Ms. Paxson had said that the university planned to take no further action as a result of the settlement. She has not said that; the photograph was removed and the story updated to reflect that a spokeswoman said Ms. Paxson saw no need for further action.
