- This is a newsletter that just went out to our Drugawareness
E-group and I knew you would all be interested in this late breaking news
on the antidepressant front as well.
- Also, if any of you carried the story last Wednesday
on Prozac being good for children you should know that both Dr. Emslie
and Dr. March have major confilcts of interest and therefore, never should
have been allowed to do this study. On top of that, in reading the results
of the study there was NO evidence that Prozac was beneficial unless you
call what they found as beneficial: a DOUBLING of the suicide rate and
a suicide attempt rate FIVE TIMES GREATER on Prozac than placebo. So, I
ask again, where was the evidence of any benefit? And why was none of that
reported to the public?
- For additional information contact:
- 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
Office Number: 801-282-5282
- 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 applies 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 www.drugawareness.org
- Glaxo Faces Criminal Action In Britain Over
- By Paul Durman and Dominic Rushe
Times Online - UK
- 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
- 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."
- 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."
- 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."
- Glaxo May Face Prosecution Over Anti-Depressant
- 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,"
- 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.