[drugawareness] Glaxo Faces Criminal Action in Britain Over ‘Suicide’ Pills

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atracyphd2

Mon, 7 Jun 2004 03:00:57 EDT

[drugawareness] Glaxo Faces Criminal Action in Britain Ove

r ‘Suicide’ Pills

 

 

Four days ago I sent you the news that the NY Attorney General had filed a

suit against GlaxoSmithKline over Paxil and in that message I made the following

statement: " United Kingdom has been considering criminal charges against this

company for almost a year for this same exact reason. With this action by the

state of New York will we see them now act on that as well? "

 

And today we have that answer in VERY bold headlines stating it the way it

is: " Glaxo may face prosecution over antidepressant " or " Glaxo faces criminal

action in Britain over ‘suicide’ pills " - exactly what I have said for 15

years, although " murder/suicide pills " may have been a better fit.

 

Paxil was the worst of the SSRIs until Celexa hit the market - as if you can

pick one out as one's worst poison? They all work the same way and they all

produce the same results - some may take a day or two longer is all. But I

predict that Effexor will be the next to bite the dust because it is such a

nasty

drug. When they marketed it as " Prozac with a kick " they were not kidding!

 

Anyway I don't think anyone would want to be in the shoes of Glaxo

spokeswoman Mary Ann Rhyne right now. The end of May Italian police announced

they want

4000 doctors and 273 Glaxo employees put on trial. Then the NY Attorney

General last week, Canada issued their strong warning against this group of

drugs a

day or two later, and now Britian plans to file criminal charges. Talk about

a public relations nightmare! They are being hit from the four corners of the

earth!

 

Considering how many lives I have seen lost to this drug, or lives destroyed

as a result, or people addicted to it in terrible withdrawal, I have no

compassion for Glaxo. The old saying, " You reap what you sow " certainly applys

in

this case.

 

 

Ann Blake Tracy, Ph.D.

Executive Director, International Coalition For Drug Awareness

Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare

& audio tape on safe withdrawal: " Help! I Can't Get

Off My Antidepressant! "

 

Order Number: 800-280-0730

Website: www.drugawareness.org

 

 

http://business.timesonline.co.uk/article/0,,8209-1135320,00.html

 

June 06, 2004

 

Glaxo faces criminal action in Britain over ‘suicide’ pills

 

Paul Durman and Dominic Rushe

 

GLAXO SMITH KLINE is facing a potential criminal prosecution for allegedly

failing to inform British health regulators about the suicide risks associated

with Seroxat, its blockbuster anti-depressant. Officials at the Medicines and

Healthcare Products Regulatory Agency (MHRA) launched an investigation into

Glaxo because of concerns that Britain’s biggest pharmaceutical group had

withheld important data from clinical trials.

 

This showed that Seroxat could cause an increased risk of suicide and “

self-harm†if prescribed to depressed teenagers.

 

The MHRA and the Committee on Safety of Medicines only received full details

of the trials in May last year. Within two weeks, the MHRA announced a ban on

giving Seroxat to children under 18 — the first regulator in the world to take

such a step. Shortly afterwards, the US Food and Drug Administration issued

similar, though less categorical, advice to doctors.

 

The MHRA investigation is expected to report its findings shortly. This

weekend the MHRA said it “treats very seriously any failure to comply with the

law.

Last year, the MHRA announced that it would investigate Glaxo to make sure

the company had complied with its legal obligations under UK and European

law.â€

 

Drug companies are obliged to report new evidence that changes the balance of

risks and benefits of using their products.

 

Depending on its findings, the MHRA could choose to prosecute either Glaxo as

a company or go after named individuals. If found guilty, the penalties could

include fines or imprisonment.

 

The MHRA action comes when Glaxo is still reeling from allegations last week

that it had “engaged in repeated and persistent fraud by misrepresenting,

concealing and otherwise failing to disclose†important information about the

safety and efficacy of Seroxat, which is known as Paxil in America. The company

must defend itself against a lawsuit from Eliot Spitzer, the New York

attorney-general who first came to prominence after taking on the abuses of Wall

Street

banks during the technology boom.

 

Jean-Pierre Garnier, Glaxo’s chief executive, insisted the firm had provided

regulators with all trial data. “We are a high-integrity company,†he said.

“

We know what the rules are and we follow them. We have a policy of publishing

our negative data to the authorities.â€

 

The British case rests on some of the same evidence as that of the New York

lawsuit.

 

Garnier said it could be dangerous to change medical advice based on a single

clinical study. “Sometimes you have to wait for all studies to come in before

you have some sort of conclusion.â€

 

 

http://www.reuters.co.uk/newsPackageArticle.jhtml?type=businessNews &

storyID=524209 & section=finance

 

Glaxo may face prosecution over antidepressant

 

Sun 6 June, 2004 12:49

 

LONDON (Reuters) - GlaxoSmithKline may face prosecution for allegedly not

informing health authorities about suicide risks associated with its

antidepressant Seroxat, The Sunday Times has reported.

 

Europe's largest drugmaker is already facing charges by New York Attorney

General Eliot Spitzer over the use of the drug, sold in the United States as

Paxil, on children.

 

The Sunday Times said the Medicines and Healthcare Products Regulatory Agency

(MHRA) had begun an investigation because of fears that Glaxo held back

important information from clinical trials.

 

The information indicated that Seroxat may cause a greater risk of suicide

and " self-harm " if given to depressed teenagers, the paper said.

 

A spokeswoman for MHRA -- the government's watchdog on drug safety --

confirmed it was investigating Glaxo on the Seroxat issue.

 

" The MHRA treats very seriously any failure to comply with the law. Last

year, MHRA announced that they would investigate (Glaxo) to establish whether

they

had complied with their legal obligations under UK and European law, " she

said.

 

" The investigation is ongoing and will report shortly, " she added. She did

not elaborate.

 

A Glaxo spokesman declined to comment.

 

The use of Seroxat and other similar drugs to treat children is under medical

scrutiny because of worries about higher suicide risks, leading U.S. and

British regulators to issue warnings against using it for patients under the age

of 18.

 

Spitzer filed a lawsuit against Glaxo on Wednesday over charges that it

fraudulently concealed studies showing that the antidepressant may not work when

used to treat children and could lead to suicidal behaviour.

 

" The company suppressed the negative results of the other studies, which

failed to demonstrate that Paxil is effective and which suggested a possible

increase risk of suicidal thinking and acts, " Spitzer said. This amounted to

" repeated and persistent fraud, " he said.

 

Glaxo spokeswoman Mary Ann Rhyne said on Wednesday that the company

disseminated information about all its trials either in medical journals or at

public

scientific meetings as well as to regulatory agencies.

 

The Sunday Times said the MHRA may choose to prosecute Glaxo or go after

specific individuals at the company.

 

 

 

 

 

 

 

 

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