UK: BBC Aired Secrets of the Drug Trials on Panorama

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>From: " Isabella " <isabellathomas@...>

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http://news.bbc.co.uk/2/hi/programmes/panorama/6291773.stm

BBC Aired " Secrets of the Drug Trials " on Panorama

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 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 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: " 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, GlaxoKline (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 Barth Menzies was interviewed for

the program.

The program can be viewed online by going to

http://news.bbc.co.uk/2/hi/programmes/panorama/6291773.stm

Viewers may comment on the program by going to

http://news.bbc.co.uk/1/hi/programmes/panorama/discuss_panorama/default.stm