Last Updated Apr 14, 2011 7:55 PM EDT
Many, many execs and reps at Forest will be sweating in their cars and cubicles today as a result. You can download a copy of the complaint yourself here.
The complaint alleges that Forest promoted its anti-depressants for pediatric use without FDA approval, and paid kickbacks to doctors to encourage prescriptions. The complaint also alleges that the company hid a negative study that later was used by the FDA in a decision to give both drugs black box warnings.
Here's a digest of some of the more juicy sections of the complaint:
The whistleblower plaintiffs are Christopher Gobble, former employee of Forest, and Joseph Piacentile, a resident of New Jersey whose employment is not given. UPDATE: American Lawyer identifies Piacentile as a doctor-turned-professional-whistleblower. Interesting story.
The company duped the media, allegedly:
Forest coordinated the "placement" of news stories about the positive Wagner data in numerous national and media outlets.(Wagner is University of Texas child psychiatrist Karen Wagner. A study done by the drug company Lundbeck, a Forest partner, was negative.) The complaint alleges that Forest set about poisoning CME sessions with biased data by using only the Wagner study:
Forest arranged for Dr. Wagner to give promotional presentations on the pediatric use of Celexa and to serve as the chair of a seven-city Continuing Medical Education ("CME") program on treating pediatric depression. Forest also sponsored 20 CME teleconferences that addressed the Wagner results.The company also allegedly set up educational calls to docs:
...Advisory board members represented, based on the Wagner data, that Celexa was safe for pediatric use even though, unbeknownst to them, the FDA had specifically rejected Forest's attempt to gain approval for such a claim because of the negative Lundbeck data.Forest lied to its own reps, the complaint alleges, by hiding the negative study:
During details to physicians, Forest's sales representatives made false or misleading representations by distributing off-label publications on the pediatric use of Celexa and Lexapro that did not include the negative Lundbeck data. Forest sales managers, also unaware of the Lundbeck data, directed the dissemination of these publications.Forest's professional affairs code says: "there is an ethical prohibition in 'cherry picking' studies that are favorable to Forest products."
So, who knew? When docs requested information on the drugs, Forest responded with letters describing only the positive data, the complaint states:
Several senior Forest executives -- including Lawrence Olanoff (then Forest's Chief Scientific Officer and its President), Ivan Gergel (Vice President of Clinical Development and Medical Affairs), and Amy Rubin (Director of Regulatory Affairs) -- reviewed the letters before the Professional Affairs Department disseminated them. All of these senior Forest executives knew about the negative Lundbeck data.Lundbeck wanted the data disclosed, but Forest execs prevailed in a decision to not disclose it. One Forest exec -- Dr. Lawrence Olanoff, then chief science officer -- even gave incorrect info to Congress, the complaint alleges:
Shortly before the FDA ordered the black box warning in September 2004, a Forest executive testified before Congress: "I want to emphasize that, because the FDA has not approved pediatric labelling of our products, Forest has always been scrupulous about not promoting the pediatric use of our antidepressant drugs, Celexa and Lexapro. That is the law and we follow it." In fact, Forest had been illegally promoting the use of Celexa and Lexapro throughouth the proceeding six years.The exec is not named. The complaint also includes information on 500,000 Forest sales details and thousands of call notes. Many of the off-label ones are quoted in the complaint.
One example: "[doctor] trying in children and asked if [Lexapro] could be dissolved in water for children. Told him to crush and put in apple sauce. Liked idea!"
Who was on Forest's payroll? This guy:
Dr Jeffrey Bostic of Massachussets General Hospital received $750,000 in payments from Forest for giving talks on use of these drugs in children.The company had 19,000 "advisory board" members and each consultant got $500.
Sales reps also used their promo money to bribe doctors into making prescriptions, the complaint states:
Prior to 2003, Forest sales representatives commonly spent their marketing money on fishing, golf, and spa outings for physicians, and on buying tickets to sporting events and the theater for physicians.There follows a list of specific trades in which docs were given things like St. Louis Cardinals tickets in exchange for implicit promises to write scrips.
One doc received a $1000 certificate to Alain Ducasse, one of the best (and most expensive) restaurants in New York.