[e-drug] BBC Panorame to air "Secrets of the Drug Trials" Jan 29 on GSK and Paxil

["Robin McCall" <RMcCall@BaumHedlundLaw.com>]

E-DRUG: BBC Panorame to air "Secrets of the Drug Trials" Jan 29 Re GSK and
Paxil
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BBC to Air "Secrets of the Drug Trials" on Panorama - Jan. 29, 2007 (Re GSK
and Paxil)

January 26, 2007
FOR IMMEDIATE RELEASE

Baum Hedlund 
12100 Wilshire Blvd., Ste. 950
Los Angeles, CA 90025
Contact: Robin McCall, Media Relations
Day: (800) 827-0087 or (310) 207-3233 Email:RMcCall@BaumHedlundLaw.com
<mailto:RMcCall@BaumHedlundLaw.com> 
www.baumhedlundlaw.com <http://www.baumhedlundlaw.com> 

BBC to Air "Secrets of the Drug Trials" on Panorama

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,  8:30 p.m. GMT,  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=nday&service_idA65&;
filename 070129/20070129_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/Paxil
ConsumerFraudClassAction.htm
	
http://www.baumhedlundlaw.com/media/ssri/PaxilConsumerFraudClassAction/GSKCo
nsumerFraudComplaint.pdf 
*	Link to Lancet "Depressing Research" 
http://www.baumhedlundlaw.com/media/ssri/PaxilConsumerFraudClassAction/Lance
t%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/Newma
n%20-%20A%20BlackBox%20Warning%20for%20Antidepressants%20in%20Children.pdf 
*	Links to articles re ghostwriting, academics and
pharmaceuticalindustry. 
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

_____  

Inside big pharma's box of tricks
Collier BMJ.2007; 334: 209 

January 27, 2007

Views & reviews 
REVIEW OF THE WEEK

Joe Collier, professor of medicines policy and consultant in clinical
pharmacology, St George's Hospital and Medical School, London

Joe Collier is impressed by a BBC documentary about the marketing of
paroxetine.

The list of examples of big pharma's trickery seems endless (even though
many of those employed in it are of the highest calibre and of
unquestionable integrity). Indeed, it is as though, in the marketing arm of
some drug companies, mischief is institutionalised. But much of this is
recognised, and the adverse effects of drug companies could be countered by
alert regulators, scientists, prescribers, and the medical press. All too
often, however, these checks fail. There is even evidence that, in some
cases, these counter-forces collude with industry and so compound its
indiscretions. It is this area, the interplay between industry and some of
the would-be counter-forces, that Panorama's "The Secrets of Seroxat" seeks
to tackle.

Panorama has been investigating drug companies' behaviour for years, and
this inquiry is its third involving selective serotonin reuptake inhibitors
(SSRIs), and in particular Seroxat (paroxetine), since 2002.

It deals primarily with GlaxoSmithKline's history as it relates to the
development of paroxetine for the treatment of children with depression.

Drawn into the frame are opinion formers and medical journals, and the
picture painted is one of a conspiracy orchestrated by the company in which
doctors have been misled, regulators duped, journals exposed, and children
harmed.

The story is said to be based on information gained from "secret" company
files made available through court cases and freedom of information
regulations. It starts with the company discovering the results of trials it
has commissioned to investigate the value of paroxetine in the treatment of
adolescent depression: the product was found to be no more effective than
placebo and able to cause serious psychological side effects such as self
harm, suicidal thoughts, and suicidal attempts.

At the time the company had wanted to license the drug for use in depressed
children but privately realised that with such information an application
would be unsuccessful. The inquiry then tells of how the company is claimed
to have "written up" the trial for publication, bought and manipulated
(apparently willingly) opinion formers, worked to promote the product for
use in children (although it was not, and never has been, licensed for such
use), and distorted information about the safety and efficacy of the drug in
letters to prescribers, in advice to their sales force, and in messages to
the media.

The programme covers many areas, and claims that there was a failure by the
company to reveal material about Seroxat to the regulatory authorities and a
failure by the regulatory authorities to recognise and respond to the
various problems with due speed. But these are areas in which Panorama has
investigated before. It is the pursuit of media manipulation that now gets
particular attention. The inquiry claims that the manufacturer, through its
agencies, "ghost wrote" the major trial that was subsequently published in
the Journal of the American Academy of Child and Adolescent Psychiatry, and
how that in the "writing" data were distorted to maximise the known benefits
and minimise known harms.

It also reports that key named authors of the paper do not appear to have
critically read the report; how the journal editors had failed to spot the
distortions (although at least one other medical journal had been concerned
enough to reject the article earlier); how key opinion formers "promoting"
the product were so close to the company financially and intellectually that
they could not possibly offer independent advice; and how drug company
spokespeople simply lied to the media when pressed about the product's side
effects.

If these claims are well founded, patients deserve better. Panorama has made
its contribution by telling this story. It has reminded us again of a social
contract involving drug producers, drug prescribers, drug regulators, and
information suppliers. In a properly functioning society, openness and
honesty should be assumed and certain standards of behaviour expected.
Indeed, in an ideal world, drug companies should be trusted. It has to be
recognised that not all activities can be controlled through legislation;
rather they rely on good practice and honesty and a will not to cheat
patients.

It does seem to be the case that regulatory authorities now appear to be
more prepared to tackle these issues and prescribers now have greater
insights into drug company behaviour and have every reason to be vigilant.
For their part, professional bodies must start to look seriously at how
their members behave and bring to book those who mislead (or collude in
misleading) others about drug properties.

The new players to enter the equation are the medical journals. These
provide a crucial conduit between drug companies and society at large as
they publish original papers, opinion pieces, and, of course, advertisements
for drugs.

Many are suspicious of the media, but as is often the case it is the media
(and typically Panorama) that will have been important in prompting much
needed change. It seems silly that we should need the media to shame us into
altering our ways; surely we should be proactive and get there first.

_____  

This press release with links online:

http://www.baumhedlundlaw.com/media/ssri/PaxilConsumerFraudClassAction/BBCPa
norama-Secretsofthedrugtrials.htm

Robin McCall
Director of Media Relations
Baum Hedlund
RMcCall@BaumHedlundLaw.com