January 29, 2007, 8:30 p.m. GMT
(In the United States via Internet: 12:30 p.m. PST;
2:30 p.m. CST; 3:30 p.m. EST)
Documents Reveal Academic “Thought Leaders” Hired by Drug Maker Promoted Paxil for Children and Adolescents Despite Clinical Trials Showing the Drug Was Ineffective and Unsafe
On Monday, January 29, 2007, BBC-One will air “Secrets of the Drug Trials,” a program detailing the investigation by reporter Shelley Jofre, which reveals how “one of Britain’s biggest drug companies misled doctors into prescribing the antidepressant Seroxat (known as Paxil in the US) to teenagers, even after one of its own clinical trials indicated that they were more likely to become suicidal after taking it.” This program is Panorama’s fourth in a series involving the selective serotonin reuptake inhibitor (SSRI) Paxil.
- Academics serving as spokespersons for the pharmaceutical
- Medical journal articles ghostwritten by PR companies
working for industry and academics lending their names to the process
- Promotion of drugs as more effective than they
are, while downplaying side effects
See the British Medical Journal’s review of the program: “Inside big pharma’s box of tricks”
Ms. Jofre’s October 2002 program “The Secrets of Seroxat” launched a firestorm of controversy and generated an unprecedented 65,000 telephone calls and emails to BBC in response. British regulators thereafter appointed a panel of experts to examine Paxil studies for treatment emergent suicidal behavior.
On June 10, 2003, the regulators announced that a review of the Paxil studies showed that the drug failed to demonstrate efficacy and showed “an increase in the risk of harmful outcomes including episodes of self-harm and potentially suicidal behavior in the [Paxil] group compared to placebo.” Six months later, on December 10, 2003, U.K. regulators announced they would contra-indicate the use of most antidepressants in children and adolescents in the UK. The US FDA followed suit the following year, in 2004, instructing manufacturers of antidepressants to include a “black box” warning regarding the increased risk of suicidality in children and adolescents.
Many of the documents in the BBC’s upcoming program were obtained through a consumer fraud class-action lawsuit filed by Baum Hedlund. The lawsuit, which is pending in a California court, was filed on June 21, 2004, against Paxil’s maker, GlaxoSmithKline (GSK) alleging the company suppressed evidence of Paxil’s failed efficacy and increased risk of suicidality in children and adolescents.
For the past two and a half years, Baum Hedlund has amassed and reviewed hundreds of thousands of pages of documents and taken numerous depositions of GSK employees and academic “thought leaders” hired by GSK to promote Paxil. Although virtually every document produced by GSK is stamped “confidential,” Baum Hedlund attorneys were able to get some of the documents out from under confidentiality seal by court order or by getting GSK to concede that the documents were not properly labeled confidential trade secrets to begin with.
A Baum Hedlund attorney was interviewed for the program.
- Baum Hedlund’s consumer fraud class action lawsuit against GSK
- Baum Hedlund’s National Class Action Filed Against Drug-Maker For Paxil-induced Suicides in Youths
- Lancet “Depressing Research”
- “Facing the Evidence: antidepressant treatment in children and adolescents”
- NEJM “A Black-Box Warning for Antidepressants in Children?” by Thomas B. Newman, M.D., M.P.H.
- Articles re ghostwriting, academics and pharmaceutical industry
- “The SSRI Trials in Children: Disturbing Implications for Academic Medicine” by Jonathan Leo, PhD