The New York Times
February 26, 2009
By BARRY MEIER and BENEDICT CAREY
The Justice Department charged the drug maker Forest Laboratories on Wednesday with defrauding the government of millions of dollars by illegally marketing the popular antidepressants Celexa and Lexapro for unapproved uses in children and teenagers.
In a civil complaint filed by the United States attorney’s office in Boston, federal prosecutors alleged that former top executives at Forest concealed for several years a clinical study that showed that the drugs were not effective in children and might even pose risks to them, including causing some to become suicidal.
From 2001 to 2004, Forest heavily promoted results from another clinical trial it had financed that showed that the drugs were effective, without disclosing the negative study to those researchers, its own medical advisers or its sales representatives, the complaint said.
An official of Forest, which is based in Manhattan, said the company’s lawyers were reviewing the complaint and did not have an immediate comment. Celexa and Lexapro are two versions of the same drug, citalopram. The drugs are currently approved by the Food and Drug Administration only for adults.
By failing to disclose the negative trial results, prosecutors said in the complaint, “Forest told prescribing physicians a half-truth and thereby prevented them and the public from having all potentially available information when making decisions about how to treat a serious medical condition in pediatric patients.”
Doctors are free to prescribe drugs to patients, including children, for whom those drugs are not approved by federal regulators. But it is illegal for companies to actively promote such uses.
The filing follows a long-running federal investigation that began with complaints filed by two former company officials. Under the civil charges brought against Forest, the government is seeking to recover up to three times the amount of money spent by federal programs to pay for pediatric prescriptions of Celexa and Lexapro, but did not specify a figure.
Prosecutors also charged that Forest paid kickbacks, in the form of baseball tickets and gift certificates to expensive restaurants, to doctors who prescribed its drugs, and provided some doctors with paid vacations. The complaint also charges that the company separately ran so-called seeding studies, or trials that were really marketing efforts to promote the drugs’ use by doctors.
Forest’s stock fell in late afternoon trading, after news of the lawsuit began to circulate, ending down more than 5 percent, at $23.14.
Currently, drug makers are required to disclose the results of all their clinical trials. But the issues surrounding Forest’s marketing of Celexa and Lexapro date to before those rules were in place.
Lexapro is Forest’s biggest product, with total sales of $2.3 billion in 2008. Last year, the company submitted new clinical data to the F.D.A. seeking approval for the drug’s use in the treatment of depression in adolescents.
According to court papers, Forest was aware of two studies started in the late 1990s to help win F.D.A. approval for the use of Celexa to treat depression in children.
One study was conducted by Dr. Karen D. Wagner, a child psychiatrist at the University of Texas Medical Branch at Galveston. The other study was conducted by H. Lundbeck, the Danish drug company that developed citalopram, Celexa’s active ingredient.
In 2002, Forest submitted results from Dr. Wagner’s study, which were positive, and those from the Lundbeck study, which were negative, to the F.D.A.
Based on the Lundbeck findings, regulators rejected pediatric approval for Celexa, finding that the report was “a clearly negative study that provides no support for the efficacy of citalopram” in children. The agency, however, did not disclose the study’s results because Forest had submitted them confidentially.
But by 2001, several top Forest executives, including the company’s current president, Dr. Lawrence Olanoff, were aware of Lundbeck’s negative results, prosecutors stated. For the next three years, those executives did not disclose those results within the company or to outside researchers like Dr. Wagner, who worked closely with it, the complaint stated.
In 2002, as Celexa faced generic competition, Forest began to market Lexapro, another version of citalopram.
In court papers, prosecutors said that the existence of the Lundbeck study first came to public light when The New York Times published an article about it. Three days after that article was published in June 2004, Forest acknowledged the study as well as an another, earlier trial that also failed to show any benefits of Lexapro as a depression treatment for children.
Antidepressants approved for adults continue to be widely used by doctors to treat children. But those drugs, including Celexa and Lexapro, all now carry a prominent “black box” warning that the drugs could cause suicidal thinking or behavior in some children.
In an analysis last year, Dr. Erick H. Turner, a senior scholar at the Center for Ethics in Health Care at Oregon Health and Science University, found that most antidepressant makers had in the past failed to report negative findings, or tried to cast a positive light on their findings, to make their drugs appear more effective in adults.