Healthy Skepticism Library item: 7991

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: media release

McCall R.
BBC to Air 'Secrets of the Drug Trials' on Panorama
Baum Hedlund 2007 Jan 26
http://web.archive.org/web/20071213202205/http://www.baumhedlundlaw.com/media/ssri/PaxilConsumerFraudClassAction/BBCPanorama-Secretsofthedrugtrials.htm

Full text:

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

January 29, 2007, 8:30 p.m. GMT
(In the United States via the Internet:

12:30 p.m. PST; 2:30 p.m. CST; 3:30 p.m. EST)

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 third in a series involving the selective serotonin reuptake inhibitor (SSRI) Paxil. http://www.bbc.co.uk/bbcone/listings/programme.shtml?day=monday&service_id=4165&filename=20070129/20070129_2030_4223_21585_30

The BBC program touches on a number of important issues, such as:

Academics serving as spokespersons for the pharmaceutical industry;
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 (below): “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.

Baum Hedlund attorney and partner Karen Barth Menzies was interviewed for the program.

The program can be viewed online by going to http://news.bbc.co.uk/1/programmes/panorama/default.stm

Viewers may comment on the program by going to: http://news.bbc.co.uk/1/hi/programmes/panorama/discuss_panorama/default.stm

Link to Baum Hedlund’s consumer fraud class action lawsuit against GSK
http://www.baumhedlundlaw.com/media/ssri/PaxilConsumerFraudClassAction/PaxilConsumerFraudClassAction.htm
http://www.baumhedlundlaw.com/media/ssri/PaxilConsumerFraudClassAction/GSKConsumerFraudComplaint.pdf
Link to Lancet “Depressing Research”
http://www.baumhedlundlaw.com/media/ssri/PaxilConsumerFraudClassAction/Lancet%20-%20Depressing%20Research.pdf
Link to CMAJ “Facing the Evidence: antidepressant treatment in children and adolescents”
http://www.cmaj.ca/cgi/reprint/170/4/489
Link to NEJM “A Black-Box Warning for Antidepressants in Children?” by Thomas B. Newman, M.D., M.P.H. http://www.baumhedlundlaw.com/media/ssri/PaxilConsumerFraudClassAction/Newman%20-%20A%20BlackBox%20Warning%20for%20Antidepressants%20in%20Children.pdf
Links to articles re ghostwriting, academics and pharmaceutical industry.
http://psychrights.org/Research/Digest/Science4Sale/Science4Sale.htm
About Baum Hedlund:

Baum Hedlund has the longest track-record handling SSRI antidepressant litigation having litigated over 3,000 antidepressant cases in the past 16 years. Karen Barth Menzies, Baum Hedlund partner, has been at the forefront of the SSRI-antidepressant litigation for more than a decade. She is currently the lead attorney on dozens of Paxil suicide cases and antidepressant birth defect cases. Karen and her firm have successfully defeated preemption arguments in a number of cases, including Motus v. Pfizer and Witczak v. Pfizer. Ms. Barth Menzies has testified three times before the FDA and also before the California State Senate regarding the risk of suicide in children, adolescents and adults taking antidepressants. In 2004 Karen was awarded Lawyer of the Year by Lawyer’s Weekly USA and California Lawyer of the Year by California Lawyer magazine. In 2005 she was named one of The National Law Journal’s Top 40 Under 40 and in 2006 she was named Consumer Attorney of the Year Finalist by Consumer Attorneys of California. She is the author of many articles related to SSRI antidepressants.

http://www.baumhedlundlaw.com/attorneys/karenbarthmenzies.htm