Glaxo-Smith-Kline Settles Paxil Suit Out of
Court
http://www.counterpunch.org/giombetti0723.html
July 23, 2002
Glaxo Raises White Flag, Settles Paxil Trial Appeal, and Pays Up
by Rick Giombetti
In a bombshell comparable to the recent belated revelation of the disaster that
hormone replacement therapy has been, I have learned that Paxil manufacturer
Glaxo-Smith-Kline (GSK) has secretly settled its appeal of the ruling in the
Paxil trial last year.
GSK was sued in federal district court in Cheyenne by family members of Donald
Schell, the Gillette, Wyoming man who killed his wife, daughter, granddaughter
and then himself on February 13, 1998 after two days on the pharmaceutical
giant's anti-anxiety/depression drug Paxil. The plaintiff's position was that
Paxil was the primary cause of Donald Schell's actions in the murder-suicide.
The jury agreed and the judge in the trial rejected GSK's challenge of the
validity of the scientific data presented to the jury by the plaintiff's. As a
public service I will be publishing the crucial expert testimony and cross
examination of British psychiatrist and psychiatric historian David Healy soon.
GSK appealed the verdict in the case in Denver, but recently gave up, I have
been told by Healy. The deal in the appeal settlement GSK made with the
plaintiff's calls for the company getting all of its documents back, and a set
of confidentiality statements from the plaintiffs side to not release anymore
details of the case not already in the public domain. This is an important
development in the history of psychiatric medicine. The jury verdict forced GSK
to cave in to the demands of the Medicines Control Agency, the British
government agency that regulates prescription drugs, that it place a suicide
warning on Paxil. GSK has had to place a suicide warning on Paxil in Britain for
about a year now. Now the question remains will this same warning ever make it
over to this side of the Atlantic, with as much publicity as the hormone
replacement story has gotten? Not likely, I believe, but I hope I am wrong.
Even though there isn't a widely publicized suicide warning being given for
Paxil, or any other drug in its class, known as "Selective Serotonin Reuptake
Inhibitors," or "SSRI's," it's not like there is a complete information black
out about these newer generation psychiatric drugs in consumer prescription drug
guides.
For example, in the recently published 10th edition of The Pill Book, it warns
patients taking SSRI's (i.e. Celexa, Luvox, Paxil, Prozac and Zoloft) that "The
possibility of suicide exists in severely depressed patients and may be present
until the condition is significantly improved. Severely depressed people should
be allowed to carry only small quantities of SSRI's to limit the risk of
overdose." The term "overdose" can just as easily be read as "killing
themselves." Also, "As many as 1/3 of people taking an SSRI experience anxiety,
sleepnessness and nervousness." In other words all the symptoms that can push a
depressed person over the edge and into a suicide attempt. Finally, the recently
published 5th edition of The Physicians' Desk Reference Pocket Guide to
Prescription Drugs warns patients consdering taking the SSRI known as Zoloft
"May also cause mental or emotional symptoms such as: Abnormal dreams or
thoughts, aggressiveness, exagerated feeling well-being, depersonalization
("unreal" feeling), hallucinations, impaired concentration, memory loss,
paranoia, rapid mood shifts, SUICIDAL THOUGHTS, tooth-grinding, WORSENED
DEPRESSION (emphasis is the authors)."
Now why on Earth are pharmaceutical companies allowed to get away with marketing
these drugs as "anti-depresants," or "anti-anxiety" agents when they can produce
in patients exactly what they are supposd to treat at such high rates? This is
the deeper question about the mass marketing of these drugs the mass media is
simply avoiding by a combination of cowardice, laziness and just outright
ignorance in reporting on these issues.
Rick Giombetti is a freelance writer who. lives in Seattle. Visit
his website at:
http://rjgiombetti.blogspot.com/. He can be reached at:
rickjgio@speakeasy.net
Source:
http://www.canoe.ca/EdmontonNews/33n1.html
'My son is not a monster'
A young man goes on a bloody rampage - is there a connection to a drug he
was taking?
By Doug Beazley -- Edmonton Sun
About a month ago, Kenny came home. This was after the prescriptions, the
therapy, the psych report, the nightmares and crying jags. On the mend, more or
less, and ready to leave the safe confines of Alberta Hospital and be reunited
with his family - for weekends, at least. But it's still there, all of it, in
the back of his head. The blood and the screaming, his hand on the knife,
running, squatting in the bushes in the darkness. He'll hear music he knows, or
pass by a place he's been before, and remember the friends he tried to kill.
"He's doing better. He sleeps," said Kenny's mother. "We know it wasn't him that
was responsible - I know it's the thing families always say after something like
this happens. He didn't know himself at first, whether it was something inside
him he didn't know he had, which made him do what he did. He'd ask me, 'Mom, how
could I do that?' And I'd keep telling him, `It wasn't you.'
"Because if it was, what would that make him? A monster? My son is not a
monster."
'Kenny' isn't the boy's real name, but everything else in this story is told
just as it happened. First, a little background. Kenny was a shy, troubled
16-year-old with a history of depression. He had no reported violent tendencies,
no dissociative episodes, no sleepwalking. About six months before the night in
question, he saw a doctor to treat the depression; he was put on Paxil, a
prescription antidepressant, 20 mg daily dose.
In June 2001, Kenny tried to slash his wrists. The dosage was upped from 20 to
30, and then to 40 mg after he was released from hospital. During this period,
according to his mom, Kenny started having "strange" thoughts - violent ones.
"He'd think about hurting people, thoughts he'd never had before," she said. "He
knew this little boy, maybe 12, a friend of a friend. (Kenny) remembers wanting
to beat him up, for no reason. This was after they increased his dose."
Leeanne Wampler, 17, was Kenny's best friend, an artistic type like himself.
They hung out together almost constantly. During the early summer of 2001, Kenny
was staying at Leeanne's house with her mother Deb and her little sister Maddie,
12. The night of July 31, Kenny and the Wamplers were camped out on the family
couch, near Borden Park, watching TV. Kenny had consumed some marijuana and a
little alcohol. Maddie went down to the basement to play Nintendo. Moments
later, Kenny rose and went into the kitchen, then followed Maddie downstairs.
The screaming started seconds later. Deb raced downstairs to find Kenny crouched
over her young daughter, pinning down the terrified girl as he raised a 20-cm
butcher knife in one blood-grimed hand. Mother and attacker flew at each other.
They grappled, slipping and stumbling on the bloody floor, while Kenny shifted
the knife and started plunging it underhand into the woman's abdomen.
Deb felt something hot burst in her midsection and collapsed next to the phone.
While she called 911, Kenny moved up the stairs to start cutting into Leeanne.
"Stop it! Stop it! Please stop!" - Deb Wampler on the 911 tape - "Oh my God,
he's stabbing us ... my daughter ..." The ambulance made it in time, the
Wamplers lived. Kenny's court-ordered psychological assessment, which found no
provocation for the assault, concluded that Kenny was schizophrenic and that the
"rapidly increased dose in antidepressant may have contributed to the acute
psychotic break ..." that caused the attack.
After Kenny turned himself in to Edmonton cops a few hours after the attack, he
baffled the investigating officer with his utter lack of emotion, his inability
to offer any explanation - even an irrational one - for his actions. "Police
know all the motives for trying to kill someone. Money, sex, jealousy," said Det.
Mark Anstey. "Here, there was nothing. He just ... did it. I'd never seen
anything like it."
A devoted father and grandfather
But the cops in Gillette, Wyoming, have seen something a lot like it. Gillette
is where Donald Schell, 60, shot and killed his wife, their daughter and
granddaughter, and finally himself on Feb. 13, 1998. Schell also had a history
of depression; he'd been on several different drugs for the condition. He had no
obvious marital problems, was reportedly devoted to his daughter and
granddaughter. When he died, he'd been taking Paxil for just two days. On June
7, 2001, Schell's relatives won a precedent-setting $6.4-million settlement
against Paxil's manufacturer, Smith-KlineBeecham (now GlaxoSmithKline PLC). The
jury found that Paxil - the eighth most-prescribed medication in Canada as of
last year - could, in rare cases, cause someone to become suicidal or violent.
It also found the pillmaker 80% responsible for the deaths.
As a direct result of the Schell case, the Wamplers are now pursuing a lawsuit
against GlaxoSmith-Kline, using the same Texas law firm that represented
Schell's survivors.
The star witness for the plaintiffs was Dr. David Healy, author of The
Antidepressant Era - a history of psychiatric drug therapy - and director of the
department of psychiatric medicine at the University of Wales College of
Medicine.
GlaxoSmithKline (GSK) abandoned an appeal and settled with the plaintiffs for an
undisclosed sum - meaning, said Healy, that most of the data he cited during the
case to prove Paxil's side-effects has been sealed from public view. "The
company, rather naively, was very keen to get all of this stuff back," said
Healy, referring to secret GSK documents used in the Schell case listing the
results of Paxil tests on more than 2,000 healthy volunteers. Healy said those
tests showed the drug caused symptoms ranging from insomnia to anxiety to
attempted suicide for some test subjects.
Healy himself conducted several clinical trials for GSK, two of them on
paroxetine, the chemical word for Paxil. And while Healy uses drugs like Paxil
in his own practice, he said he thinks it's time for the manufacturer to
pointedly warn prescribing physicians the drug can cause heightened states of
agitation in some users - states he claims can lead to acts of self-destruction
or violence. "I believe that if Mr. Schell didn't have the Paxil that he had
been given, that he would be alive today and so would his family," Healy told
the court during the Schell case.
The question of warning doctors about Paxil's side-effects was a key point in
the Schell case. The Paxil product monograph, revised last April, says the drug
is not recommended for patients "hypersensitive" to it, and suggests a link
between the drug and "manic" reactions among depressed patients.
Drugs affect chemicals in the brain
The monograph mentions a suicide risk only in connection with cases of
depression, not in connection with Paxil treatment itself. It also recommends
against prescribing Paxil to anyone under age 18, adding that the "safety and
efficacy" of Paxil on under-18s hasn't been established. Paxil is part of a
family of prescription drugs - which includes Zoloft, Luvox and Prozac - called
'selective serotonin reuptake inhibitors', or SSRIs. They work by preventing
neurons from reabsorbing serotonin, a chemical the brain makes that controls
mood, among other things. Healy said his review of GSK documents indicates the
company's own research found the drug made some of the subjects - as many as one
in four - extremely agitated. This heightened agitation, he suggested to the
court, is "exactly the kind of condition that will lead to violent, suicidal and
homicidal behaviour." "There is a vast amount of inconvenient data that is
unpublished," Healy told the court.
He also noted that while several cases involving Paxil have achieved prominence,
his research work with Zoloft, manufactured by drug giant Pfizer, found familiar
results: two of the healthy volunteers for that drug trial became "very, very
suicidal" as a result. "The problem with the SSRI group of drugs is that they
can cause some people to become agitated ... mental turmoil," Healy told the
court. "The range of side-effects from Paxil is the same as the range of
side-effects from Prozac (and from) Zoloft and the other SSRIs. "I am not a
psychotherapist hostile to drug treatment. I use SSRI antidepressants to treat
people who are depressed. I believe in order to treat people properly, I need to
let them know about the hazards of these drugs as well as the good points."
GSK's lawyer in the Schell case pointed out, correctly, that the research hasn't
proven that Paxil promotes suicide or violent aggression. He also hammered home
the point that Schell was already clinically depressed when he started taking
the drug, and argued that the medication hadn't had time to take effect when he
opted to kill his family and himself. "The real tragedy is Paxil didn't have a
chance to do its job and save lives," said lawyer Charles Preuss. "Paxil could
have saved four lives in Gillette."
In a statement issued to The Edmonton Sun last week, GSK said that Paxil "is a
highly-effective treatment with a well-established safety profile, that has
helped tens of millions of patients around the world lead fuller, happier, more
productive lives." GSK also dismisses a secondary claim being made in several
other pending lawsuits against the company - that patients who stop taking Paxil
all at once suffer severe withdrawal symptoms. "There is no valid scientific
evidence that any SSRIs, including Paxil, lead to addiction," said the GSK
statement.
There's a whole lot at stake here. Worldwide sales of Paxil were worth an
estimated $4.5 billion Cdn last year. Beyond the effect that negative publicity
might have on sales, there's the fact that, already, hundreds of potential
plaintiffs have come forward to a handful of U.S. and Canadian law firms to
launch suits of their own.
The damage to GSK, and to other SSRI manufacturers, could be in the tens of
millions of dollars - or beyond. "My office has been contacted by over 4,000
people on this," said Karen Barth, a Los Angeles lawyer whose firm is handling a
large number of SSRI-related lawsuits. "More than 700 people have retained us on
Paxil alone. And we're working with other lawyers who have hundreds of clients
of their own. The Schell case opened a whole lot of doors for a lot of people."
Comments? Write me at
dbeazley@edm.sunpub.com
