In February 2018, lawyers asked the U.S. Attorney’s Office in Boston to reopen a criminal case against Forest Pharmaceuticals. The lawyers in Washington cited new information about how the company misrepresented Lexapro. The information surfaced in recent court filings.
Forest Pharmaceuticals had pleaded guilty in 2010 to criminal charges. The federal government said that the company illegally promoted the use of Lexapro and Celexa in children. Charges included obstructing justice and distributing an unapproved drug in interstate commerce. Forest also pleaded guilty to distributing an unbranded drug in interstate commerce.
Forest Pharmaceuticals agreed to pay more than $313 million in penalties and fines. The company is a subsidiary of Forest Laboratories.
The U.S. Attorney in Boston had joined a civil case filed by whistleblowers. Federal prosecutors also brought a criminal complaint.
The federal government accused Forest of hiding the results of a study. The study found Celexa to be ineffective and dangerous for children. Forest also allegedly paid kickbacks to doctors to get them to prescribe the drugs.
Federal prosecutors said that Forest promoted Lexapro and Celexa for off-label use in children for more than five years. Off-label refers to uses for drugs other than those approved by the U.S. Food and Drug Administration.
At the time of the offenses, the FDA had not approved either drug for patients under 18. The FDA later approved Lexapro for younger patients.
Forest Uses Positive Study to Promote Celexa and Lexapro
The U.S. Attorney in Massachusetts said in a civil complaint that Forest misled doctors. The company touted only the results of a positive study on the use of Celexa for children. It failed to disclose that another study had negative results.
The negative study found that Celexa was no more effective in treating depression than a placebo. The study also found that three times as many children taking Celexa attempted or thought about suicide as those taking a placebo.
Celexa and Lexapro are closely related drugs. Forest acquired Celexa in 1998. As Celexa was close to losing its patent, Forest created Lexapro in 2002. The company developed Lexapro by changing the molecular structure of Celexa.
Forest researchers performed two studies on each drug for use in children. Each drug had one positive and one negative study. In 2002, Forest submitted the two Celexa studies to the FDA as part of an application to allow Celexa for pediatric patients. The FDA denied that application.
FDA Requires Suicide Black Box Warning
In March 2004, the FDA issued a public health advisory. It required the makers of Celexa and Lexapro to add a warning to their labels.
The warning recommended closely watching patients for worsening depression or suicidal behavior.
Months later, the FDA told drugmakers to add a black box warning to the drugs’ labels. A black box warning is the most serious kind of warning the agency requires.
The black box warning alerted doctors about the possibility of suicidal behavior in children and adolescents who took the drugs.
Still, in 2009, the FDA approved Lexapro for pediatric patients. It based its decision on the positive study for Lexapro and the positive study for Celexa. The FDA noted the similarities between the two drugs.
Forest Hides Negative Study
Forest hid the results of a negative Celexa study from everyone but the FDA and its top executives, according to a government complaint.
Even doctors hired to promote the drugs, Forest’s sales staff and the company’s Professional Affairs Department were kept in the dark. The Professional Affairs Department is supposed to give balanced information to doctors who ask for data about drugs.
Forest’s pediatric researchers didn’t know about the negative study, either. These researchers include a doctor who made presentations to professional groups about the positive study.
The doctor was the main author of the positive study. She also was chair of an education program for doctors on treating pediatric depression.
The positive study was promoted at 20 additional medical education teleconferences. Because the doctor didn’t know about the negative study, her presentations stated that there were no negative studies on pediatric use of Celexa.
Doctor Kickbacks and Promotional Programs for Children
Forest also paid kickbacks to doctors to get them to prescribe Celexa and Lexapro, according to a federal complaint. Payments to doctors included restaurant gift certificates, lavish entertainment and grants.
Forest paid more than 19,000 medical professionals to attend local and regional “advisory boards.” Each participant was paid $500, according to the civil complaint. The advisory boards were intended to generate revenue by getting doctors to prescribe Celexa and Lexapro.
Forest created clinical studies to encourage prescribing the drugs, too. In one, the company targeted 2,000 doctors. Forest paid each participant up to $1,500. Participation involved prescribing the drugs to up to 10 patients each.
Federal prosecutors said Forest also told its Celexa sales representatives to call child psychiatrists and pediatricians. Forest organized promotional programs with titles like “Adolescent Depression,” “Adolescent Treatment of Depression” and “Uses of Celexa in Children.”
Please seek the advice of a medical professional before making health care decisions.