10/15/2000 – Attention: Legal action in Paxil withdrawal

Victims suffering withdrawal symptoms from Paxil are
encouraged to contact the attorneys who are currently
prosecuting a civil action suit (a wrongful death of a father
and his two children) against SmithKline Beecham, the
drug’s manufacturer. On August 18, 2000, three California
attorneys brought suit against SmithKline Beecham in Santa
Clara County Superior Court alleging that the drug maker has
kept hidden the addictive traits of Paxil in order to enhance the
drug’s worldwide sales, which now comes to approximately
$2 billion annually.

In the lawsuit it is alleged that SmithKline Beecham has
intentionally understated the drug’s addictive traits. (To say
the least!) And the plaintiffs in this suit have asked the court
to compel SmithKline Beecham to divulge all they know about
that hazard to the federal Food & Drug Administration. This is
being done with the intention that proper warning labels about
withdrawal might be included with Paxil prescriptions in the
future to warn new patients of this adverse effect.

Victims of Paxil withdrawal are encouraged to contact the
attorneys in order that statements can be obtained and
evidence put before the court that the alleged harm is very
real. Any of the three attorneys handling the case can be
contacted. They are as follows:

(1) Donald J. Farber, e-mail: (n3dgt@…)
(2) Vince D. Nguyen, e-mail: (lawvdn@…)
(3) Skip Murgatroyd e-mail (skip-tracy@…)

They will need a complete description of the victim’s problems
with Paxil, including particularly “whether or not the victim was
warned on the drug’s addictive characteristics when the drug
was initially prescribed.” (Most likely to be featured on the
television program “It’s a Miracle” if they were warned about
withdrawal when Paxil or any other SSRI was prescribed!)
And they will need to detail the circumstances surrounding
the victim’s discovery of the withdrawal problem.

The attorneys do emphasize that reporting the problem to
them will not result in damage awards to the reporting parties,
but that any success in the lawsuit they are currently pursuing
will ultimately hopefully result in warnings for all future Paxil
users – the warning you did not get.

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org

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6/3/2000 – Prozac-induced death of child via impaired liver function

Finally reports are being made of deaths of children due to the toxicity
associated with Prozac. Below is an abstract on the death of a child due to
Prozac (fluoxetine). If you have not read my article entitled “The Next
Generation of Medical Guinea Pigs – Our Prozac, Zoloft and Paxil Babies” be
sure to do so. It is on our website and was published in the summer of 1998
and warns of the deadly effects of this liver enzyme system and children on
the SSRIs.

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org
__________________________________

“Fluoxetine-related death in a child with cytochrome P- 450 2D6 genetic
deficiency” Sallee FR, DeVane CL, Ferrell RE J Child
Adolesc Psychopharmacol 10(1):27-34 (2000)

ABSTRACT:

The clinical course of a 9-year-old diagnosed with attention-deficit
hyperactivity disorder, obsessive-compulsive disorder, and Tourette’s
disorder and treated with a combination of methylphenidate, clonidine, and
fluoxetine is described. The patient experienced over a 10-month period,
signs and symptoms suggestive of metabolic toxicity marked by bouts of
gastrointestinal distress, low-grade fever, incoordination, and
disorientation. Generalized seizures were observed, and the patient lapsed
into status epilepticus followed by cardiac arrest and subsequently
expired. At autopsy, blood, brain, and other tissue concentrations of
fluoxetine and norfluoxetine were several-fold higher than expected based on
literature reports for overdose situations. The medical examiner’s report
indicated death caused by fluoxetine toxicity. As the child’s adoptive
parents controlled medication access, they were investigated by social
welfare agencies. Further genetic testing of autopsy tissue revealed the
presence of a gene defect at the cytochrome P450 CYP2D locus, which results
in poor metabolism of fluoxetine. As a result of this and other evidence, the
investigation of the adoptive parents was terminated. This is the first
report of a fluoxetine-related death in a child with a confirmed genetic
polymorphism of the CYP2D6 gene that results in impaired drug metabolism.
Issues relevant to child and adolescent psychopharmacology arising from this
case are discussed.

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6/14/2000 – PROZAC – New directions: Science, money drive a makeover

This article which ran in the Boston Globe last Sunday does a
good job of demonstrating the awkward position the makers of
New Prozac are in- defending the new Prozac without offending
its new partner, Eli Lilly.

http://www.boston.com/dailyglobe2/163/nation/Science_money_
drive_a_makeover+.shtml

PROZAC – New directions
Science, money drive a makeover
By Mitchell Zuckoff, Globe Staff, 6/11/2000

This is a story about a drug that changed the world, the bravery of
rats, the evolution of a psychiatrist, the Jekyll and Hyde nature of
man-made chemicals, the Church of Scientology, and the
impulses that lead some people to kill.

It is also about money. Lots of money.
——
In 1848, Louis Pasteur discovered that some molecules can
exist in mirror forms – the same chemical composition can build
shapes that curve one way or another, said to be left – or
right-handed.
Natural molecules come in only one shape, but the procedures
for creating manmade molecules create both left- and
right-handed forms at the same time. Sold as the
antidepressant drug Prozac, fluoxetine include the two shapes,
called isomers, pictured below.
Because the different isomers are difficult to separate, the FDA
allows drug companies to include both in medicines, as long as
the less-functional isomer is not harmful. Isolating R-fluoxetine
could yield a more effective drug with fewer side effects.
The drug is Prozac, and its resume is lore: Introduced by Eli Lilly
and Co. in 1988 as the first notable new antidepressant in two
decades, it lifted the spirits of millions and became shorthand
for the search for answers in convenient pill form.
Yet its triumphs have been clouded by persistent accusations,
denied by Lilly, that a small but significant percentage of Prozac
users suffer a side effect that runs counter to the drug’s intent:
intense agitation that in rare cases explodes into violence,
suicide, or both.
Now, as the familiar green-and-white pill approaches the
humbling status of a generic drug in 2004, along comes a new
drug derived from Prozac – ostensibly without the dangerous
side effects – that is designed to take Prozac’s place in the
medicine cabinet and on Lilly’s billion-dollar balance sheet.
And along with that new drug comes a most unexpected
helpmate for Lilly: a Harvard psychiatrist named Martin H.
Teicher, who in the space of a decade has taken an
extraordinary journey.
Once Prozac’s most prominent critic – author of the first scientific
paper to wave the red flag of suicide and violence Teicher is now
enjoying what he calls a ”wonderfully ironic” role as co-inventor
of the Prozac replacement drug.
With a high-flying Massachusetts drug firm acting as
middleman, Teicher stands to grow rich from Lilly, despite its
continued rejection of his conclusions about suicide. If the new
Prozac clears ongoing trials and proves even moderately
successful compared to its predecessor, Teicher could
supplement his associate professor’s salary by more than $5
million a year.
At the same time, Teicher’s decade-old observations about
Prozac’s dangers have resurfaced in a very awkward way for Lilly.
The drug patent obtained by Teicher and his co-inventors says
the new Prozac is free from the suicide side effect, and last week
that claim became the basis for a federal fraud lawsuit against
Lilly. The lawsuit essentially accuses Lilly of denying any
Prozac-suicide link on the one hand, yet buying an exclusive
license for a patent that says otherwise.
For perspective, imagine that car-safety crusader Ralph Nader
identifies a major safety flaw in, say, the braking system used in
all cars. The automakers deny that the flaw exists. Nader then
invents a device that fixes the flaw and offers it to the
automakers. Despite denying the problem, they pay him millions
for it.
Now substitute Teicher and Lilly in those roles, and that’s what
makes this a uniquely American tale about the pursuit of
knowledge, the pursuit of profits, and the arranged marriages
that sometimes bring them together.

The psychiatrist’s den
Teicher’s office at the Harvard-affiliated McLean Hospital in
Belmont has all the trappings of a psychiatrist’s den. There is the
leather couch, the bursting bookcase, and the wall of diplomas –
PhD from Johns Hopkins in 1977, MD four years later from Yale
University. A clock chimes to mark the passing hours.
There are personal touches, too: a jar on a shelf jokingly labeled
”Ashes of former students”; and a quote on the wall from
Voltaire, ”No problem can withstand the assault of sustained
thinking.” A plaque commemorating one of Teicher’s two
Prozac-related patents hangs over his desk. There are two
paintings, one of a sad clown and the other of a frightened child.
They were painted by the psychiatrist’s mother.
Teicher, 49, is a suit-and-tie native of New York’s endless
suburb, Long Island. Divorced, he lives in Waltham; after the
divorce, his ex-wife took a job as a cancer researcher for none
other than Lilly, which Teicher calls ”an odd happenstance of
coincidence.”
He does not seek publicity; would-be interviewers have to run a
gantlet of McLean public relations officials. Once he agrees to
talk, however, Teicher is gracious, if seemingly detached from
the subject that could make him rich and, in certain circles,
famous.
”This is just one small part of what I do, a minor offshoot,”
Teicher says quietly, preferring to talk about his recent work on
attention-deficit and hyperactivity disorders.
In fact, a McLean-supplied biographical sketch that lists 58 of his
publications between 1976 and 2000 does not include the
scientific paper that set him on the Prozac path, and for which he
is arguably most widely known: ”Emergence of Intense Suicidal
Preoccupation During Fluoxetine (Prozac) Treatment.”
Its absence notwithstanding, there is no denying the paper’s
impact.
Just four pages, it was written by Teicher, a nurse named Carol
Glod (who has since earned a doctorate), and fellow Harvard
psychiatrist Jonathan O. Cole. It was published in February 1990
in the prestigious American Journal of Psychiatry.
In the dry language of academia, the paper describes six
depressed patients, ages 19 to 62, five of whom had considered
killing themselves in the past but none of whom had recent
suicidal thoughts.
The authors detail how all six became powerfully suicidal –
stricken by a ”state more intense, obsessive, and violent than
anything they previously had experienced” – within weeks of
beginning Prozac treatment, and remained so for anywhere from
three days to three months after discontinuing the drug. One put
a loaded gun to her head, and another had to be restrained to
prevent self-mutilation. None committed suicide.
With the imprimatur of Harvard psychiatry, the paper was
received by many as proof of the anecdotal and media reports
that flourished in the years after Prozac’s introduction.
Among the most dramatic was the story of Joseph Wesbecker, a
deeply disturbed Kentucky printing-press operator who in 1989
walked into his workplace and killed eight people, then himself.
Wesbecker had begun taking Prozac weeks earlier, and its
effects had alarmed his psychiatrist, who unsuccessfully urged
Wesbecker to discontinue the drug just days before the carnage.
Prozac doubters seized on Teicher’s paper to press the US Food
and Drug Administration to ban, or at least investigate, Prozac
and similar antidepressants.
That is where the Church of Scientology fits in. The most ardent
Prozac critics were members of a group affiliated with
Scientology, which was founded by science-fiction writer L. Ron
Hubbard, in part based on his hatred of psychiatry.
The group trumpeted Teicher’s paper and blanketed the media
with claims that Prozac was a ”killer drug.” In one press release
the group stated that ”the numbers of persons who have been
driven or are being driven suicidal or homicidal by Prozac is
astronomical.” It was one of many subtle and not-so-subtle
distortions of Teicher’s paper.
Teicher and his coauthors had written that the dangerous side
effect was observed in 3.5 percent of all their patients, and the
Scientologists extrapolated that figure to the entire population of
Prozac users. It was a leap Teicher says had no basis in
science and left him deeply frustrated.
Teicher says his contact with the Scientologists was limited to
one phone call in which he complained they were distorting his
data. Yet, he says, he suffered ”guilt by association,” despite the
fact that he always believed Prozac was a valuable addition to
the psychiatrist’s toolbox, ”a breakthrough” drug that simply
needed to be monitored closely for troubling side effects.
But, for the most part, all anyone heard was that Teicher had
linked Prozac to suicide, and the Scientologists were citing him
as their most potent ally.
The psychiatric community circled the wagons to oppose the
Scientologists’ attacks on Prozac and the entire profession,
sweeping up Teicher in what he called a ”strange, surreal”
process. Lilly fought back as well, offering studies and scientists
to challenge Teicher’s work and sending out press releases of
their own to counter the criticism.
A climax of sorts was reached in 1991, when the FDA dismissed
any link between suicide and Prozac or similar antidepressants.
A nine-member panel of experts voted unanimously that there
was ”no credible evidence” of any association, and split 6-3
against requiring a stronger warning label.
In the aftermath, critics disparaged the panel – ”a kangaroo
court,” in the words of one lawyer who has pending lawsuits
against Lilly – as riven by conflicts of interest and armed with
flawed data from the company’s clinical studies. Lilly also came
under fire.
”Lilly’s efforts to discredit clinicians, scientists, and
journalists
trying to foster greater discussions, research, and awareness of
this side effect is one of the most disgraceful chapters in
American corporate history,” said Harvard psychiatrist Joseph
Glenmullen, author of the new book ”Prozac Backlash,” which
focuses in part on tendency toward suicide.
Still, the FDA’s finding has been the cornerstone of Lilly’s
defense of Prozac in public and the courts.
Lilly officials declined several requests for interviews, but in a
written statement the company restated the 1991 FDA decision:
”There is no scientific evidence that establishes a link between
Prozac and violent or suicidal behavior.”
Today, Teicher looks back on the early 1990s with what seems
like preternatural equanimity: ”It was a good life lesson. I
basically did fine.”
Asked to define the lesson, he says: ”What I learned from all this
is I cared much less what people thought. … There are always
going to be colleagues who disagree with me about this. A
definitive study hasn’t been done. Maybe 20 years from now
there will be a clear answer, but maybe not.”

Partners looking for `cure’
What his critics did not know was that Teicher, since early 1992,
had been working on what might be called a ”cure” for the
problems he saw in Prozac.
By all accounts, that turn of events began one morning when a
bear of a man named Timothy J. Barberich was reading The
Wall Street Journal. He came across a story about the Prozac
controversy that mentioned Teicher’s work.
Barberich was not just any reader, though. He had parlayed his
undergraduate chemistry degree into founder, chairman, and
chief executive of an upstart drug company called Sepracor Inc.,
in Marlborough, half an hour west of Teicher’s office.
Barberich and one of his top scientists, James W. Young,
decided to call Teicher to talk about a chemical process
Sepracor had developed to reformulate existing drugs by
removing unwanted side effects. By the early 1990s, the
company had targeted 40 or so already-approved drugs –
including Prozac – that it hoped to improve, patent, and then
market on its own or in partnership with the old drugs’ owner.
Teicher, as it turns out, had been studying the science of that
process in his laboratory, feeding different chemical substances
to rats and sending them into a maze. In early 1992, Teicher and
Sepracor struck a deal under which the company would fund
about $150,000 of research in his lab.
To understand what happened next requires a painless
chemistry lesson, first taught in the 1800s by Louis Pasteur.
Pasteur discovered that most man-made chemical compounds –
prescription drugs, for instance – exist at a microscopic level as
twins, called isomers. Although the twins are chemically
identical, each one is not the mirror image of the other.
In some drugs, only one of the twins provides the benefits, fitting
into chemical receptors in the body to flip switches on or off to
fight illness. The other twin does not fit the same receptors, so it
is free to wander through the body. Sometimes it goes looking
for trouble. That is, causing side effects.
The most dramatic example was the 1960s drug thalidomide,
one of whose twins was the good Dr. Jekyll, effectively
decreasing morning sickness in pregnant women. The other
was the evil Mr. Hyde, a chemical monster that caused horrible
birth defects.
Until the last 20 years or so, it was difficult to separate the twins

and sometimes, both twins have problems of their own – so
government regulators allowed drugmakers to sell medicines
including both, as long as the side effects were not terrible.
That was Lilly’s argument for Prozac, which allows brain cells to
bathe more freely in a chemical called serotonin, which affects
mood and emotion. To this day, despite millions of prescriptions
for the drug, scientists are not certain precisely how Prozac
works, but it is generally believed that the added serotonin in a
brain on Prozac lessens depression.
Lilly acknowledges that the current formula also can cause side
effects including non-life-threatening ailments such as
headaches, anxiety, tremors, and sexual dysfunction. But not
suicidal tendencies.
Teicher and Sepracor set out to find a way to keep the good parts
of Prozac, or improve it, while eliminating the bad. Within six
months of starting his work, Teicher and Sepracor officials say,
he recognized which of the Prozac twins was the one most worth
keeping.
Teicher noticed that when he gave his rats the part of Prozac that
would be considered the ”good” twin – known chemically as
R-fluoxetine – the rodents bravely explored the more dangerous,
exposed parts of the maze, spending less time anxiously
scurrying to the enclosed, protected areas.
It took a lot more work, lots more rats, and five more years to get
a patent, during which both Teicher and Sepracor experienced
bumps in the road. Teicher weathered an embarrassing state
medical board investigation into allegations, eventually
dismissed, of sexual misconduct with a patient. Sepracor,
meanwhile, was frustrating stockholders with yearly losses.
Eventually, though, Teicher and the two Sepracor officials,
Barberich and Young, succeeded in patenting their discovery,
receiving one in 1997 and the second in 1998.
The patents tout their drug’s effectiveness as an antidepressant
and appetite suppressant, an anxiety reliever, and a potential
treatment for migraine headaches, chronic pain, and
obsessive-compulsive disorders. Its residual effects leave the
body sooner than the existing Prozac, the patent says, allowing
doctors to try other drugs more quickly if it proves ineffective.
Lilly has no problem with any of that. But then comes the patent
language that has caused the current uproar: ”The adverse
affects (sic) which are decreased by administering the [new
version of Prozac] include but are not limited to headaches,
nervousness, anxiety, insomnia, inner restlessness (akathisia),
suicidal thoughts and self-mutilation.”
And so, with one swing of a patent examiner’s approval stamp,
Lilly’s decade-long denials about suicidality ran headlong into
the claims of a promising new drug that Lilly was eager to buy.

Difficulty protecting Lilly
Teicher refers questions about the patent to Sepracor, and
Barberich finds himself in the awkward position of defending the
new Prozac without offending his powerful partner, Lilly.
First, Barberich downplays the issue: ”I don’t want to get my
patent disallowed, but it’s not as if you have any evidence for
what you’re claiming in the broadest sense. … There’s no court of
truth that these patents go through. I believe that they, Lilly, are
correct.”
Then, he hedges: ”Marty Teicher may be right, Eli Lilly may be
right, and the FDA may be right, and we still wouldn’t have any
idea whether [the new drug] eliminates a problem that we’re not
sure exists.”
Although Lilly officials would not discuss the patent, their
statement sought to put distance between Lilly and the
damaging patent language: ”Lilly had no input nor provided
content for the patent application. Not all the `side effects’ listed
in the patent are scientifically demonstrated facts. … Teicher’s
article was a series of anecdotal reports, and his suggestions of
a `possibility’ of a causal relationship have been refuted by
multiple … studies that have demonstrated no increased risk of
suicide associated with Prozac use.”
Barberich also said Lilly had no role in the patent. He said the
Indianapolis-based drugmaker opened talks with Sepracor only
after the patent was certain to be approved.
He also said there were no discussions with Lilly about the
suicide issue when Lilly purchased exclusive rights to the patent
in late 1998. The deal gives Sepracor $20 million up front – due
to be paid by the end of this month – plus another $70 million if
the drug gets FDA approval, as anticipated within the next two
years.
If that approval comes, the real money for Sepracor, Teicher, and
McLean Hospital could start rolling in as early as 2002. ”It’s
likely
it’s going to be a big drug. It’s just a question of how big,”
Barberich said.
Under the terms of the deal with Lilly, Sepracor gets about 10
percent of sales. McLean gets 10 percent of that, of which the
hospital gets half, Teicher personally gets one-quarter and his
laboratory gets one-quarter.
Prozac revenues for Lilly were $2.6 billion last year. If the new
Prozac becomes a $2 billion-a-year drug, Sepracor would get
$200 million a year, of which McLean gets $10 million, and
Teicher and his lab each would receive $5 million.
Back in his office, Teicher acknowledges that he finds himself
thinking about the money sometimes. He said a need for money
prompted him to stop seeing patients two years ago, so he
could focus on ”entrepreneurial” activities to fund his son’s
college education.
He also thinks about the potential conflict involved in prescribing
and lecturing about a drug in which he has a large financial
stake, but he expects to handle that by simply disclosing his
interest.
Teicher says he spends almost no time thinking about a patent
on his wall that says he was right all along, and even less time
thinking about vindication.
”I’m not sure vindication will ever come,” he says. ”I’m not sure
I
need it or want it.”

This story ran on page A1 of the Boston Globe on 6/11/2000.
© Copyright 2000 Globe Newspaper Company.

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6/14/2000 – Paxil Causes Brain Atropy

Thanks to Ian Goddard for forwarding us this information on Paxil and brain
atropy.

Paxil Causes Brain Atropy

This is a major finding: the thalamus in children
taking Paxil was observed to shrink after 12 weeks.
This is portrayed as a good thing, since the study
claims that the thalamus of OCD patients is too
large and 12 weeks of treatment shrunk the brain
region to normal size. Even if such atrophy after
12 weeks is beneficial (a big “if”!!), what happens
after 50, 100, 200 or more weeks of brain atrophy?

Here’s the abstract. Following that is a remarkable
reply I got from one of the authors of the study.

======================================================
Arch Gen Psychiatry 2000 May;57(5):449-56

Decrease in thalamic volumes of pediatric patients with
obsessive-compulsive disorder who are taking paroxetine.

Gilbert AR, Moore GJ, Keshavan MS, Paulson LA,
Narula V, Mac Master FP, Stewart CM, Rosenberg DR

Department of Psychiatry, Wayne State University School
of Medicine, Detroit, Mich, USA.

BACKGROUND: Thalamic dysfunction has been implicated
in obsessive-compulsive disorder (OCD). While OCD
frequently has its onset during childhood, to our
knowledge, no prior study has measured neuroanatomical
changes in the thalamus of patients with OCD near the
onset of illness, and before and after treatment.
METHODS: Volumetric magnetic resonance imaging studies
were conducted in 21 psychotropic drug-naive children,
aged 8 to 17 years, with OCD and 21 case-matched healthy
comparison subjects. Magnetic resonance imaging studies
were also conducted in 10 of the 21 patients with OCD
after 12 weeks of monotherapy with the selective
serotonin reuptake inhibitor, paroxetine hydrochloride.
RESULTS: Thalamic volumes were significantly greater
in treatment-naive patients with OCD than in controls
but declined significantly after paroxetine monotherapy
to levels comparable with those of controls. Decrease
in thalamic volume in patients with OCD was associated
with reduction in OCD symptom severity. CONCLUSIONS:
Our findings provide new evidence of thalamic
abnormalities in pediatric OCD and further suggest
that paroxetine treatment may be paralleled by a
reduction in thalamic volume. These reductions may,
however, not be specific to paroxetine treatment and
could be due to a more general treatment response,
and/or spontaneous improvement in symptoms. Our
findings are preliminary given the small sample size
and our inability to measure discrete thalamic nuclei.

http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_u
ids=10807485&dopt=Abstract
========================================================

From Dr. David Rosenberg, an author of above study:

At 05:07 PM 5/8/00 -0400, you wrote:
>Hello Doctor Rosenberg,
>
>I just read your study in the May issue if the Archives
>of Clinical Psychiatry. I think it could prove to be a
>real breakthrough. The question I have is what’s the
>cause of the observed reduction of thalamus volume?
>Could it be a result of cell death or the loss of
>cell mass? If not that, than what other cause?
>
>Thank you for your time and attention.
>
>– Ian Goddard
>

At this point it’s not clear although we have several hypotheses. We saw a
differential maturation of thalamic volume in OCD patients and controls that
might reflect a neural network dysplasia with a possible reduction in
synaptic pruning in OCD pts vs controls (the normal pruning of neural
elements during peripubertal period). Cell death or loss of cell mass is
one possibility, probably best looked at in post-mortem studies. We recently
published a priority communication in biological psychiatry (february 2000)
showing decreased NAA/Cho +Cr levels suggestive of possible neuronal
dysfunction (NAA is thought to be a marker of neuronal viability); however,
more recent analysis also suggests potential choline abnormalities. Finally,
the thalamus is a densely serotonergic region and possible aberrations in
development could lead to altered volume. This was a surprising finding,
clearly requires replication with larger samples; also, our inability to
measure subdivisions of the thalamus: we are working on a new program that
allows us to do this and we hope to delineate whether medial regions (which
we would hypothesize) would be more affected)

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6/14/2000 – Suit Blames Fen-Phen for Murder-Suicide

At times I get so busy with all of these cases that I forget that not all of
you are aware of what is happening. I must apologize for not sending this out
sooner.

This is a case that has been filed against the makers of Fen-Phen in a
murder/suicide situation – another caring mother who took the life of her son
and attempted to kill her other son before killing herself. It happened in
the withdrawal from Fen-Phen.

This company jerked these drugs off the market so quickly leaving so many in
serious “cold turkey” withdrawal situations that were possibly more dangerous
than the possible heart and lung damage. I remain convinced that this case is
one of MANY MANY more cases that went unnoticed as everyone focused on heart
and lung damage with these diet pills and ignored the most alarming reports
of brain damage that occurs within days of using the drugs.

I repeat once again, no matter what substance one is using to increase
serotonin, you can produce psychotic breaks leading to out of character
behavior.

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org

APBnews.com April 13, 2000, Thursday

Copyright 2000 APB Online, Inc.
APBnews.com

April 13, 2000, Thursday

Suit Blames Fen-Phen for Murder-Suicide

By Steve Waterstrat

SPOKANE, Wash.

A man who lost his wife and a 6-year-old son in a murder-suicide claims
that the diet drug fen-phen caused the violence that also left another
son wounded.

But Bill Etter, the attorney for the doctor named in the suit, said Debra
Eik stopped taking the combination months before her death and had shown
no negative side effects.

Spokane resident Ed Eik claims that his wife suffered major personality
changes during her treatment. On Nov. 1, 1997, Debra Eik drove to a
remote road in the South Spokane Valley with her sons and shot the boys
before turning the gun on herself. Brandon Eik died, but Brian, 11,
survived and used his mother’s cellular phone to call for help.

The combination fen-phen, or fenfluramine-phentermine, was recalled by
the U.S. Food and Drug Administration in July 1997, primarily due to its
links to heart-valve damage. Debra Eik was prescribed Pondimin and
Ionamin, brand names for the fen-phen combination.

‘There was something else going on’

While the manufacturers face billions of dollars in claims for deaths and
injuries allegedly caused by fen-phen, Etter said he could find no
precedent in the country for anyone linking the drug combination to such
a drastic psychological reaction.

“This whole situation with the mother and her two boys is an absolute
tragedy,” Etter said. “But it’s a bit of a reach to try to link it to a
diet drug taken months beforehand. There was something else going on.”

The lawsuit, filed in Spokane County Superior Court, seeks unspecified
damages from four drug companies and from Eik’s physician, Dr. Milan
Jeckle.

Etter told APBnews.com that the doctor’s last prescription of fen-phen
for Eik was for a two-week dosage, and it was given six months before the
shooting. Jeckle treated Eik from late March 1997 to May 1997.

Husband: Personality changed

Etter also said that a review of the doctor’s records showed that Eik did
not complain of any bad side effects.

“For her last visit, the doctor’s report said that the patient ‘Feels
great, no side effects.’ There was nothing negative at all,” Etter said.

The lawsuit itself acknowledges that the shooting took place six months
after the final prescription. But in the suit, Ed Eik claims that the
prescribed drugs caused his wife “to sustain mental and emotional
distress and illness leading to major personality and behavioral changes.
These changes resulted in her shooting her sons … and her own death by
suicide.”

Etter said his legal job is not to defend fen-phen itself. But he does
believe that his client did a prudent and responsible job of prescribing
the drug in short-term doses and monitoring his patients. Debra Eik
received three two-week prescriptions.

“This was so he could make sure the drug was working for his patients,
and so he could watch for any potential side effects,” Etter said.

Manufacturers are named

Eik’s attorneys, from the Seattle law firm Chemnick, Moen and
Greenstreet, refused to comment on the lawsuit.

The suit also names American Home Products Corp., Wyeth-Ayers
Laboratories Inc., A.H. Robins Co., and Medeva Pharmaceuticals as
co-defendants. American Home Products was the major producer of fen-phen
and is involved in a nationwide class action suit over the drug.

No dollar amount is mentioned in the lawsuit, in accordance with
Washington state laws on civil suits. Etter said he expects the plaintiff
to ask for several million dollars. No trial date has been set, but Etter
said he expected the trial to be held in the summer of 2001.

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6/13/2000 – Quandary Over Prozac – Boston Globe Editorial

http://search.boston.com/globe.vts

A BOSTON GLOBE EDITORIAL

The Prozac Question

Eli Lilly, manufacturer of the highly successful antidepressant drug Prozac,
wants to have it both ways. While it has always insisted that the drug does
not cause even a tiny percentage of its users to contemplate suicide, it also
wants to sell an updated version of Prozac with a patent which states
specifically that one of its advantages over the original is that it is less
likely to cause suicidal thoughts.

Now the firm has been caught in this contradiction by a Houston lawyer whose
clients unsuccessfully sued Lilly after their father killed his wife and then
himself while on the drug. By the time of the trial last year, Lilly had
bought rights to the new patent, boasting of its superiority over Lilly’s
original Prozac, whose patents expire in 2004.

The lawyer says his clients would have gotten a fairer trial if Lilly had
come forward with that language, and he is now asking a federal court for a
new trial. His clients deserve that chance, and the Food and Drug
Administration should ask Lilly why, in light of the language in its new
patent, it is not warning current Prozac users about suicidal thoughts.

Even if it had been aware of the new patent language, the jury might still
have exonerated the drug manufacturer. Prozac is hailed by many health
professionals for treating often debilitating depression and actually
preventing suicides. And while a small percentage of Prozac users have
committed suicide, it is not easy to prove that it was the drug and not the
underlying illness that was the cause.

Lilly, for its part, notes that a separate company developed the new version
of Prozac and wrote the patent language for it before Lilly acquired the
patent. And Lilly says ”not all of the `side effects’ listed in the patent
are scientifically demonstrated facts.” But why should a patent have been
issued for a new version of Prozac if it does not reduce side effects like
suicidal thoughts?

The FDA should reopen the question of whether the patent language on the new
Prozac is not a warning that users and prescribers of the original Prozac
should have been receiving all along. The patent’s message should also be
conveyed to a jury in a second trial of the Houston lawyer’s case.

This story ran on page A26 of the Boston Globe on 6/13/2000.
© Copyright 2000 Globe Newspaper Company.

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6/10/2000 – Boston Globe carries story on Forsyth suit

http://199.97.97.16/contWriter/yhd7/2000/06/08/medic/8169-0102-pat_nytimes.h
tml

Eli Lilly Sued By Family Of Prozac User Who Killed Wife, Self

Mitchell Zuckoff
c.2000 The Boston Globe

Opening a new front in the battle over Prozac and suicide, the family of
a man who killed his wife then himself while taking the drug are accusing
Eli Lilly and Co. of fraud for allegedly concealing damaging details about
its blockbuster antidepressant.

In a federal lawsuit filed in Hawaii, the family of William Forsyth
claims that Lilly “committed a fraud on the court” by failing to tell the
family’s lawyers about a patent that claims a new version of the drug
eliminates side effects of the existing Prozac, including violent and
suicidal thoughts among a small percentage of users.

Despite consistently denying any link between Prozac and suicide,
Lilly has purchased an exclusive license to market the new drug from a
Massachusetts company that owns the patent.

The suit says Lilly actively concealed the potentially explosive
patent language during a trial last year over Prozac’s alleged role in the
couple’s deaths. The trial ended with a verdict in Lilly’s favor; the family
has appealed.

“Lilly wanted a verdict that it could herald in the marketplace as
being the definitive vindication of their claims, and they were willing to
get it by withholding important information from the judge and jury,” said
Houston lawyer Andy Vickery, who represents the dead couple’s adult
children.

Vickery said he decided to file the lawsuit after reading a May 7
report in The Boston Globe in which the patent language for the new drug was
publicly disclosed for the first time.

A spokesman for Lilly declined comment on the suit Wednesday, saying
the company had not seen it.

Whatever the outcome, the lawsuit seems certain to fuel a revival of
a longstanding dispute over the Indianapolis drug company’s efforts to blunt
criticism of the popular antidepressant, a green-and-white capsule that has
earned the company billions of dollars and become a totem of modern life.

“To me the new patent can be compared to the tobacco papers. It’s a
pharmaceutical company document that acknowledges this dangerous side effect
which has been downplayed by Eli Lilly and other pharmaceutical companies for
a decade,” said Dr. Joseph Glenmullen, a Cambridge, Mass. psychiatrist whose
new book, “Prozac Backlash,” has helped to trigger the renewed controversy.

Lilly has built its defense of Prozac on a 1991 finding by the U.S.
Food and Drug Administration that there is no credible evidence linking
Prozac to suicide. Glenmullen and others have challenged that finding,
alleging it was based on flawed clinical testing and marred by conflicts of
interest among several members of the FDA’s panel of outside experts.

Though sales have slipped somewhat in recent years as other
antidepressants entered the market, more than 35 million people worldwide
have taken Prozac. Lilly derived more than 25 percent of its $10 billion in
revenues last year from the drug.

The lawsuit, filed Wednesday in U.S. District Court in Honolulu,
also focuses attention on the new drug, which Lilly hopes will extend its
antidepressant franchise after the last Prozac patents expire in 2004.

The key patent for the new drug was obtained in 1998 by two
officials at Sepracor Inc., a Marlborough, Mass. drug company, along with Dr.
Martin H. Teicher, an associate professor of psychiatry at Harvard University
who works at McLean Hospital in Belmont, Mass.

The patent brought Teicher full circle in the Prozac debate: He had
ignited the decade-long controversy over suicidality with a 1990 paper about
sudden, self-destructive tendencies among patients who had recently begun
taking Prozac.

The patent describes an antidepressant derived from Prozac that, the
inventors claim, is formulated in such a way as to decrease the current
drug’s adverse effects, ranging from headaches and nervousness to “intense
violent suicidal thoughts and self-mutiliation.” That claim is based on
Teicher’s paper.

Although that patent language directly contradicts Lilly’s longtime
position on Prozac, the Indianapolis-based drug company clearly saw great
value in the drug described in the patent.

In December 1998, Lilly paid Sepracor $20 million for exclusive
rights to the patent, a portion of which went to Teicher and McLean. Lilly
also promised the inventors $70 million in milestone payments depending on
the new drug’s progress through ongoing clinical trials, and a percentage of
sales if the drug is ultimately approved and sold.

Three months after that deal was struck, in March 1999, a federal
jury in Honolulu began hearing a civil lawsuit Vickery filed on behalf of
the two adult children of the late William and June Forsyth.

A wealthy couple, married for 37 years, the Forsyths had been going
through a rough patch in their marriage in late 1992 and early 1993. William
Forsyth, 63, began suffering panic attacks, and in February 1993 his doctor
prescribed Prozac. After feeling wonderful the first day, Forsyth underwent a
change for the worse and admitted himself to a psychiatric hospital. After a
week, while continuing to take Prozac, he checked himself out.

On March 3, 1993, 11 days after he began taking Prozac, Forsyth
fatally stabbed his wife multiple times with a serrated kitchen knife then
impaled himself on the blade. Their children blamed the drug for what they
said were their father’s completely uncharacteristic acts.

Of some 200 lawsuits filed against Lilly claiming the use of Prozac
led to suicide or violence, the Forsyth case was only the second to yield a
verdict. Lilly settled many of the others, and the only other one to reach a
jury, in 1994, was widely reported to have been a victory for the company. In
fact, it was settled in a secret agreement between Lilly and the plaintiffs.

Lilly obtained its long-sought courtroom victory in the Forsyth case
when the jury said the drug could not be held responsible for the
murder-suicide. In the suit filed Wednesday, however, the Forsyths’ children
claim the victory for Lilly was tainted by the failure to disclose its link
to the new Prozac patent and should be set aside for a new trial.

A key element of Lilly’s defense was its claim that if Forsyth
suffered from the severe form of agitation his children claim led to the
deaths, he would have experienced inner and outer restlessness. No one at the
psychiatric hospital noticed restlessness in Forsyth before his release, and
Lilly’s lawyers and expert witnesses used that to refute his children’s case.

In the patent, however, the side-effect is described purely as inner
restlessless, a condition known as akathisia. Vickery said that difference
is crucial because, if the patent had been disclosed at the trial, it would
have been a powerful answer to Lilly’s argument that outer restlessness –
characterized by relentless fidgeting – was required as evidence of the
side-effect. It also might have challenged Lilly’s overall claims about
suicide, he said.

For instance, a top Lilly scientist, Dr. Gary Tollefson, testified
during the trial that it was his opinion “that there is absolutely no
medically sound evidence of an association between any antidepressant
medicine, including Prozac, and the induction of suicidal ideation
(thoughts) or violence.”

The new patent language, and Lilly’s purchase of exclusive rights to
the invention, might have convinced the jury otherwise, Vickery said.

—-
(The Boston Globe Web site is at http://www.boston.com/globe/

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6/9/2000 – Prozac Fraud – Motion Filed in Forsyth Case

June 8, 2000
FOR IMMEDIATE RELEASE Baum, Hedlund, Aristei, Guilford & Downey
12100 Wilshire Blvd., Ste. 950
Los Angeles, CA 90025
Contact: Robin McCall
bhagd@…
Day: (800) 827-0087 or (310) 207-3233
Night: (818) 558-5964
www.bhagd.com/media/prozacinformation.html
PROZAC MAKER, ELI LILLY AND COMPANY, COMMITTED FRAUD ON HAWAII COURT BY
CONCEALING CRUCIAL EVIDENCE AT TRIAL, FAMILY IN NEWLY FILED LAWSUIT ALLEGE

June 8, 2000, Hawaii — The plaintiffs in one of the only Prozac cases to
ever go to trial filed a new lawsuit yesterday against the pharmaceutical
giant and Prozac drug maker, Eli Lilly and Company. The new lawsuit
alleges Lilly committed fraud on a Hawaii Court by concealing potentially
damaging patent language for a new and improved Prozac during their civil
trial last year over Prozac’s alleged role in their parents’ deaths. That
trial ended in a verdict in Lilly’s favor. (An appeal is currently pending
in the Ninth Circuit Court of Appeals.)

The plaintiffs, Susan Forsyth, of California and her brother, William
Forsyth Jr., of Maui, have requested that the verdict be set aside based on
the alleged fraud. The Forsyths’ first suit alleged that, while under the
influence of Prozac, their father, a successful businessman and retiree
living on the island of Maui, stabbed his wife (their mother) to death and
then committed suicide by impaling himself on a kitchen knife after being
on Prozac for 10 days.

The new lawsuit alleges that, “unbeknownst to plaintiffs or their counsel
at the time that case went to trial, Eli Lilly and Company had recently
agreed to pay $90 million for exclusive rights to a patent for a new
formulation of the Prozac molecule which would reduce the following
side-effects of the original Prozac: “nervousness, anxiety, insomnia, inner
restlessness (akathisia), suicidal thoughts, self mutilation [and] manic
behavior,” the very side effects which plaintiffs’ claimed occurred with
their father and resulted in the brutal deaths of both parents.

MORE – MORE – MORE

The new suit alleges that an “in-house patent lawyer for Eli Lilly and
Company sat mutely in the courtroom during key portions of the Forsyth
trial without advising the Court or opposing counsel of these facts or
correcting the mis-impression created by Eli Lilly and Company’s trial
counsel and its witnesses.”

Attorney, Karen A. Barth, of the Los Angeles law firm, Baum, Hedlund,
Aristei, Guilford & Downey, represents the Forsyths along with Andy Vickery
of the Texas firm, Vickery & Waldner. Karen Barth stated of the new action:

“It is incredible that, on the one hand, Lilly vehemently argues to a
federal judge and jury that Prozac does not cause suicide and/or violence
(or akathisia which is a known precursor to suicide) while on the other,
pays $90 million for a patent for a ‘new and improved Prozac,’ which
clearly acknowledges Prozac’s propensity to increase the risk of suicide
and violent behavior and to cause akathisia! Lilly has consistently blamed
the individuals taking Prozac for these adverse reactions rather than
acknowlege any connection to Prozac.

“The new patent is an admission by Eli Lilly that the original Prozac
causes these side effects. If Lilly denies this, they’ve paid $90 million
for an invalid patent. (For a patent of a new product to be accepted, it
must be something new and useful. The ‘useful’ part of this patent is
reduced side effects.)”

FACT SHEET FOLLOWS

YOU CAN FIND THE NEW COMPLAINT AT:

WWW.BHAGD.COM/MEDIA/PROZACINFORMATION.HTML

# # # The Forsyths lawsuit contains the following claims, among others:

1. Under the influence of Prozac, the Forsyth plaintiffs’ father stabbed
their mother numerous times before impaling himself on a kitchen knife.
When the Forsyth children sought justice for these wrongful deaths in this
Court, Eli Lilly and Company repeatedly represented to this Court and to
its Jury that suicide is not a side effect of Prozac, and that Mr. Forsyth
could not have had a drug-induced “akathisia” because this condition
requires both “inner” feelings of restlessness and outward manifestations
of motor movement.

2. Unbeknownst to plaintiffs or their counsel at the time that case went to
trial, Eli Lilly and Company had recently agreed to pay $90 million for
exclusive rights to a patent for a new formulation of the Prozac molecule
which would reduce the following side-effects of the original Prozac:
“nervousness, anxiety, insomnia, inner restlessness (akathisia), suicidal
thoughts, self mutilation [and] manic behavior.”

3. In-house patent counsel for Eli Lilly and Company sat mutely in the
courtroom without advising the Court or opposing counsel of these facts or
correcting the mis-impression created by Eli Lilly and Company’s trial
counsel and its witnesses. Under the prevailing case law in this Circuit,
this conduct constitutes a “fraud on the Court” and mandates that the
Court’s prior judgment be set aside. See Pumphrey v. K.W. Thompson Tool
Co., 62 F.3rd 1128 (9th Cir. 1995) (affirming trial judge’s decision in
independent action to set aside defense verdict and judgment in products
liability, wrongful death, case based on fraud on the court).

14. Several months prior to the trial of the action, Lilly purchased the
exclusive license to U.S. Patent No. 5,708,035 (“the patent”) from
Sepracor, Inc. (fn3 Sepracor Inc. is a specialty pharmaceutical company with
a unique strategy to develop and commercialize potentially improved versions
of widely-prescribed drugs referred to as Improved Chemical Entities (ICEs).
Sepracor’s ICE Pharmaceuticals are differentiated, proprietary, single-isomer
or active-metabolite versions of currently marketed drugs.) The patent
abstract states: “A method and composition are disclosed utilizing the pure
R(-) isomer of fluoxetine which is a potent antidepressant and appetite
suppressant substantially free of adverse effects.” As further explained in
the Background section of the patent: “This invention relates to a novel
composition of matter containing optically pure R (-) fluoxetine. This
composition possesses potent antidepressant and appetite suppressant activity
as a serotonin uptake inhibitor while avoiding the usual adverse effects
associated with the racemic mixture of fluoxetine.” The adverse effects
listed include thoseexact same adverse effects that were at issue in trial
of the action, i.e.,
akathisia and suicidal thoughts and behavior, and mutilation; side effects
which Lilly consistently and repeatedly told the Court and jury did not
exist. As set forth below, such a position by Lilly during the trial of
the action was a fraud on this Court.

15. Though, during discovery of the underlying case, Plaintiffs
specifically asked for such information such as that contained in the
patent, Lilly never supplemented its discovery responses to provide such
information.

16. In December 1998, Lilly entered into an agreement to pay approximately
$90 million for the exclusive license to U.S. Patent 5,708,035. A true and
correct copy of the patent [is] available online from the U.S. Patent Office
at www.uspto.gov. On its company website at www.lilly.com, Lilly announced
its intention to market this new type of Prozac. [ ]

17. As exclusive licensee, to enforce patent rights against third parties,
Lilly must necessarily stand in privity with the inventors with respect to
their representations to the Patent Office, particularly representations
about “usefulness” which could affect the validity of the patent. See e.g.
Abbott Laboratories v. Diamedix Corp., 33 U.S.P.Q.2d 1771, 47 F.3d 1128
(Fed.Cir. 1995). (fn6 A licensee who is adverse to the inventor or
patent owner can challenge the validity of the patent. Lear, Inc. v.
Adkins, 395 U.S. 653 (1969). But to enforce the patent, Lilly must
necessarily accept the fact that its statutory usefulness hinges on
reducing these side effects of Prozac.)

18. Further, Lilly acknowledged, adopted and ratified the information
contained within the patent in its 1999 Annual Report: “And, pending U.S.
Federal Trade Commission approval, we’re in-licensing Sepracor’s
R-fluoxetine, a compound that may offer broader efficacy and fewer side
effects than existing therapies.” (Emphasis added).

19. Under the Patent Act there are two essential requirements for
patentability of an invention, i.e. it must be both “new” and “useful.” 35
USC §101. As the patent itself demonstrates, fluoxetine is a racemic
mixture or stereo-isomer. What this means in lay terms is that the Prozac
molecule is like a pair of gloves, with both a right hand and a left hand.
The patent discloses a method for separating the stereo-isomer and creating a
one-handed or R(-) version of fluoxetine, i.e. with only one of the two
isomers. This is what is “new.”

20. What the patent claims as “useful” is the propensity of the new R(-)
fluoxetine molecule to reduce side effects. The side effects which the
patent claims will be reduced include: “nervousness, anxiety, insomnia,
inner restlessness (akathisia), suicidal thoughts, self mutilation [and]
manic behavior.”

21. A Lilly in-house patent lawyer was present in the courtroom during
portions of the trial of the Forsyth case, including the opening statements
and some of the testimony. Although he did not appear as trial counsel,
he was nonetheless an “officer of the court” for fraud on the court
purposes. See Pumphrey, supra at 1132.

22. In the trial of the wrongful death case, Lilly defended against the
general causation contentions, i.e. that Prozac causes some people to
become violent or suicidal, by arguing that any violent or suicidal
thoughts experienced by people on Prozac was because of their underlying
depression or other life “stressors.” It specifically and repeatedly
represented in both testimony and argument that treatment emergent
suicidality was not a side effect of Prozac.

23. Neither Mr. Norman nor other Lilly counsel ever brought it to the
attention of the Court or Jury that Lilly had agreed to pay $90 million for
a patent, whose validity hinges on the truthfulness of the notion that
“akathisia, suicidal thoughts [and] self-mutilation” are side effects of
Prozac. Rather, they allowed the mis-impression to continue.

29. Lilly is no stranger to claims that it has “protected Prozac”, inter
alia, by conduct which could be branded as a “fraud on the court.” Potter v.
Eli Lilly & Co., 926 S.W.2d 449Ky.1996) was a writ of prohibition case
against Judge John Potter, the trial judge of the first Prozac/wrongful death
case to go to trial in this country. The case resulted in a defense verdict.
Judge Potter entered a final judgment which stated “dismissed pursuant to
jury verdict.” However, when he learned later that there had been a
mid-trial secret settlement, that evidence had been withheld from the jury,
and that the attorneys for both parties had misrepresented facts to him
concerning their dealings, Judge Potter issued a show cause order, requiring
the parties to demonstrate why the judgment should not be modified to read
“dismissed as settled.” The judgment was ultimately
corrected to “dismissed as settled” as Judge Potter had proposed in the
first place.

The Kentucky Supreme Court, citing Hazel-Atlas Glass Co. v. Hartford Empire
Co., 322 U.S. 238 (1944) held that, not only did the judge have the right,
but, indeed, he had the duty to investigate a potential fraud on his court.
It wrote:

“there was a serious lack of candor with the trial court and there may
have been deception, bad faith conduct, abuse of the judicial process or
perhaps even fraud.” Id. at 454.

See also Winkler v. Eli Lilly & Co., 101 F.3d 1196, 1203 (7th Cir. 1996).

30. Plaintiffs did not discover the fraud on this Court until it came to
their attention via a May 7, 2000 article in the Boston Globe newspaper
entitled “Prozac Revisited”.

32. One of two things must be true. Either “inner restlessness
(akathisia), suicidal thoughts, [and] self-mutilation” are side effects of
the original Prozac, or Lilly has paid $90 million for an invention that
is not “useful” and a patent that is not valid. But regardless of which
one it is, by knowingly adducing evidence and making arguments which
created a false impression, and knowingly withholding the patent from
discovery supplementation, Lilly has perpetrated a fraud upon this Court.

33. Thus, based upon the foregoing, a fraud was committed on this Court. The
nature of this fraud was such that it harmed “the integrity of the judicial
process” within the meaning of Pumphrey v. K.W. Thompson Tool Co., 62 F.3rd
1128, 1132-33 (9th Cir. 1995).

34. Accordingly, the Judgment entered in the action entitled Susan K.
Forsyth, individually and as Personal Representative of the Estates of
June M. Forsyth and William D. Forsyth, and William D. Forsyth, Jr. v. Eli
Lilly and Company, Case No. 95-00185ACK should be set aside and a new trial
should be ordered.

PRAYER

WHEREFORE, Plaintiffs pray judgment against defendant Eli Lilly and
Company, as follows:

1. That the Judgment entered in the action entitled Susan K. Forsyth,
individually and as Personal Representative of the Estates of June M.
Forsyth and William D. Forsyth, and William D. Forsyth, Jr. v. Eli Lilly
and Company, Case No. 95-00185ACK be set aside and a new trial ordered.

2. An award for reasonable attorneys’ fees, including all attorneys’
fees incurred in the trial of the action entitled Susan K. Forsyth,
individually and as Personal Representative of the Estates of June M.
Forsyth and William D. Forsyth, and William D. Forsyth, Jr. v. Eli Lilly
and Company, Case No. 95-00185ACK.

3. An award of costs incurred in the underlying trial and herein;

4. An award of such other and further relief as the court deems just and
equitable.

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6/2/2000 – Use of Sertraline Linked to Suicidality

Use of Sertraline Linked to Suicidality

LONDON, May 30 (Reuters Health) – The use of sertraline might
prompt some patients to commit suicide, a UK researcher
warns based on a study of healthy volunteers.

In a double-blind, randomized crossover study, Dr. David Healy
of the University of Wales College of Medicine compared the
effects of two selective serotonin reuptake inhibitors (SSRIs) in
20 individuals, ages 28 to 52, who had no history of psychiatric
illness.

The study aimed to monitor the effects of the drugs on the state
of well being and “in particular the serenic effect that appears
associated with the use of SSRIs,” Dr. Healy writes in the June
issue of Primary Care Psychiatry.

Subjects received either reboxetine (marketed as Edronax in the
UK and as Vestra in the US), 4 mg q.d. for 5 days and increased
to 4 mg b.i.d. if tolerated, or sertraline (Zoloft), 50 mg q.d. for 5
days, increased to 100 mg b.i.d. if tolerated. Treatment lasted for
a total of 2 weeks, followed by a 2-week washout period and
then crossover to the opposite arm.

None of the subjects had suicidal ideation on reboxetine
although two reported depression, Dr. Healy found. “In contrast,
two developed suicidal thoughts on sertraline,” he writes. Within
a few days of treatment both of these patients reported feeling
restless and “fidgety.”

There is “no easy means of explaining what happened other
than by invoking an SSRI-induced suicidality,” Dr. Nealy writes.
“The mechanism…appears to have been a combination of
akathisia and emotional blunting, as well as other features
suggestive of an automatism.”

He points out that the risk of drug-induced problems in
nondepressed volunteers is of concern because
“antidepressants are commonly prescribed for stress reactions.”

Prim Care Psychiatry 2000;6:25-28.

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6/1/2000 – Direct to consumer advertising

It is my opinion that one of the most frightening and dangerous practices in
American medicine today is this direct to consumer advertising. Advertising
of tobacco products has been banned, yet they are allowed to advertise
prescription drugs? Where is the logic?

Clearly many who have had their lives destroyed by the SSRIs would not have
ever taken the first pill had it not been for direct to consumer ads leading
them to believe that someone coming back to Prozac would be young, slender,
and athletic, rather than old and worn out, overweight and bloated, and
barely able to move or function. Or the Paxil ad leading them to believe the
drug would help them “come into life” rather than being honest about the drug
helping them come into the “afterlife” thanks to the very deadly effects of
Paxil.

It is my opinion that these drug company ads are the most perfect example of
the biblical prophesy about our day when they would call evil “good” and good
“evil.”

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org
___________________________________

http://www.washingtonpost.com/wp-dyn/articles/A56322-2000May12.html

With TV Spots, Drug Firms Aim At Patients’ Role

By Susan Okie
Washington Post Staff Writer
Monday, May 22, 2000 ; A01

In an animated television commercial for the anti-anxiety drug Buspar, a
woman sweeps her list of woes–worry, sleeplessness, muscle aches,
irritability–into the trash.

In one for Prilosec, a long-acting heartburn remedy, smiling people play or
recline on the faces of giant clocks.

And in a commercial for the antihistamine Zyrtec, a man with “indoor and
outdoor allergies” is sniffle-free as he flies a toy plane around his yard.

A pill can fix whatever ails you: That’s the message that makers of these
and other heavily advertised prescription drugs seem to be sending American
consumers. For years, pharmaceutical companies promoted
such medicines exclusively to doctors, since they wrote the prescriptions and
thus determined sales. But in the last decade, as managed care has limited
the drugs that doctors can choose from health plans’ formularies and as
consumers have demanded more say in their treatment, some companies have
dramatically shifted their marketing strategy.

Now, for a growing number of drugs, the patient is the target.
Direct-to-consumer advertising for prescription medicines increased nearly
20-fold during the 1990s. Last year, U.S. drug companies spent almost
$1.9 billion urging consumers to try prescription remedies for conditions
ranging from allergies and baldness to diabetes and high cholesterol. Of that
total, $1.1 billion was spent on television commercials, the fastest-growing
medium for advertising prescription medicines. The goal is to send patients
to the doctor demanding a brand-name drug, even if they have to pay for it
themselves.

“There are a lot of forces now that are basically pushing the decision-making
back to the consumer,” said Jim Daly, general manager for respiratory and
anti-infective marketing at Glaxo Wellcome, the top-spending company for
consumer advertising of prescription drugs.

Sabrina Smith of Arlington is the kind of consumer these companies are
trying to reach. Smith, 32, suffers from hay fever and is allergic to her two
cats. She has tried five different prescription medicines in the last two
years in response to TV commercials, with little success.

Drug ads “really grab my attention,” she said. “Why is it that I trust them
so much more than any other ad? . . . My allergies are so bad that I just get
desperate.” When a commercial mentioned a drug’s side effects, she added, “I
used to not even hear them, because I’d think, ‘Oh my God, here’s something
else that might help me.’ ”

Sales figures for heavily promoted drugs suggest that the strategy works.
U.S. sales for the antihistamine Claritin, No. 1 in direct consumer
advertising, were $2.3 billion last year; Prilosec, one of the top five, had
$3.8 billion in sales. But whether such advertising is good for patients–and
for the U.S. health care system–are hotly debated questions.

Advocates say the ads alert people to new treatments and open up discussion
of once-forbidden topics such as impotence or depression. Critics charge that
the ads play down medicines’ risks, contribute to steeply rising prescription
drug costs and encourage Americans to believe that pills–rather than
lifestyle changes or other nondrug interventions–are invariably the
treatment of choice.

“The aim is to sell a product,” said Barbara Mintzes, a public health
researcher at the University of British Columbia’s Centre for Health Services
and Policy Research. She noted that the United States and
New Zealand are the only countries that allow direct-to-consumer advertising
of prescription drugs, although Canada is considering such a policy. “It
doesn’t give [consumers] an overview of what’s available and whether it’s the
most appropriate treatment or the best value for money,” Mintzes said.

Although most prescription drug advertising still focuses on doctors, the
number of medicines being promoted to patients is growing. Many drugs
marketed in this way are for problems that are more bothersome than
dangerous: allergy symptoms, baldness, acne, migraine headaches. But
medicines for serious, chronic illnesses such as diabetes and asthma are
promoted, as well.

“Even on TV, we’re talking about over 40 drugs” advertised to consumers, said
Nancy M. Ostrove, chief of the division of drug
marketing, advertising and communications at the Food and Drug
Administration’s Center for Drug Evaluation and Research. “It’s
easily over 100 if you count print [advertising] too.”

The boom in television ads began in August 1997, after the FDA issued a
“guidance” that made it easier for companies to craft commercials that
complied with agency regulations. Previously, every broadcast advertisement
linking a drug with a condition had to state the medicine’s potential side
effects and tell consumers how to get a copy of the product labeling. The new
guidance allowed TV and radio ads to mention only major risks and to list
four sources–“your doctor,” a toll-free number, a Web site and a concurrent
print ad–for people who wanted additional information.

In the three years since the guidance, television ads for drugs have
proliferated–and quite a few have run afoul of the FDA for lack of balance,
incomplete information or misleading claims.

Drug commercials need not be preapproved by the agency. Companies must send a
copy to the FDA whenever a new TV ad (or any other prescription drug ad)
debuts. Ostrove said her staff of 15 reviewers was responsible for screening
about 30,000 pieces of promotional material last year, including more than
100 television commercials. Even though TV ads for drugs are a top priority,
misleading ads have sometimes reached millions of viewers before FDA staffers
saw them and picked up violations.

According to an FDA official, 50 prescription drugs have been promoted on TV
or radio since August 1997. In the same period, the agency has sent 23
regulatory letters to drug companies for advertisements that violated FDA
rules. That total doesn’t include violations found in so-called reminder ads,
which the agency counts separately. (Reminder ads mention a drug’s name but
must not specify what it’s for, and they are not required to list its side
effects.)

So far this year, two companies have received letters about TV commercials
that violated FDA regulations. The offending ads
were for the heartburn remedy Prevacid and the anti-allergy nasal spray
Flonase.

“Sometimes [companies] will argue with us, but generally they pull the ads,”
Ostrove said. “In some cases we have asked for
remedial advertisements.”

Daly of Glaxo Wellcome, which makes Flonase, said the FDA’s position on
direct-to-consumer advertising is still evolving and often difficult for
companies to predict. “It is far from black and white, in terms of what
claims and what fair balance the agency feels comfortable with,” he said.

Every prescription drug ad contains some variation of the phrase “ask your
doctor”–and physicians say that’s just what patients are doing. As a result,
direct-to-consumer advertising is shifting the agenda of many doctor-patient
encounters and influencing treatment decisions.

“One-fifth or one-sixth of the patients that I see either come in with an
advertisement that they’re holding or mention something that they’ve seen,”
said Michael S. Wilkes, a professor of medicine at the
University of California at Los Angeles who has published studies on the
impact of consumer advertising.

About 75 percent to 80 percent of the time, a patient who asks for a
specific drug receives it, according to several surveys. “The physician
doesn’t want to disappoint patients,” Wilkes said. “It takes time to answer,
to argue or to reeducate somebody. [Doctors] don’t want to be perceived as
cheap or cutting corners.”

A selection of Washington area doctors said drug advertisements sometimes
prompt patients to seek treatment for serious problems that they might
otherwise have ignored.

“If they come in and say, ‘I’m anxious or depressed and I’d like to consider
medication,’ it just makes talking about it so much easier,” said Bryan J.
Arling, who practices internal medicine in the District.

But doctors also complained that responding to requests for specific drugs
takes up time that might be better used discussing lifestyle changes or other
issues. “[Patients] all say, ‘Well, it [the drug] is paid for by my insurance
plan,’ ” said Ronald E. Greger, a family physician in Gaithersburg. “It’s
going to take the doctor time to explain why an alternative might be better.
. . . If I’m going to get paid $38 or $48 for the visit, I can just give you
the [drug] that you really wanted in two minutes and you’re going to leave
happy.”

The explosion in consumer advertising is contributing to rising health care
costs. Americans spent more than $100 billion on prescription medicines last
year, about 10 cents in every health care dollar. The average cost of a
prescription rose 11.6 percent last year–partly because of increasing
research and development costs, but also because of hefty promotion budgets.
Drugs advertised to consumers tend to be among the newest and most expensive
on the market, and ads may woo patients away from cheaper generic drugs.

There’s indirect evidence that consumer advertising also increases visits to
the doctor and medical testing. For example, in the year after an advertising
campaign for Fosamax, an osteoporosis treatment, patient visits for
osteoporosis evaluations almost doubled, according to the market research
firm IMS Health Inc. In the first nine months of 1998, according to a survey
by Scott-Levin, a drug-marketing research firm, total patient visits rose by
only 2 percent compared with the same period in 1997, but visits for hair
loss doubled and visits for smoking cessation more than tripled. Drugs for
baldness and to help smokers quit were being heavily promoted at the time.

Daly of Glaxo Wellcome said consumer advertising motivates people to seek
help for problems–such as migraine, allergies or irritable bowel
syndrome–that many doctors tend to minimize and treat in a limited way. “I
think it’s an empowering message . . . that the condition you have is real,
it’s not psychosomatic, it’s not in your head, there’s a biological basis and
there are effective treatments available,” he said.

Smith, the Arlington woman, recalled one occasion when a drug ad provoked a
valuable exchange with her doctor. She saw a commercial for Zyban, an
antidepressant marketed for people who want to quit
smoking.

Smith, who was a longtime smoker, asked her doctor at Kaiser Permanente, an
HMO, about the drug. “He said, ‘Well, that’s a lot
of money, and it usually doesn’t work,’ ” she recalled. Instead, the doctor
suggested she try a nicotine patch and a smoking-cessation program at a local
hospital. She did–and she hasn’t smoked since.

Cathy Alphin of Springfield, another Kaiser Permanente member, believes drug
advertisements have made her a more knowledgeable patient. Alphin said seeing
such ads prompted her to ask her doctor about alternative treatments for her
chronic sinusitis.

Drug ads directed her to pharmaceutical company Web sites, which she learned
to check regularly for new treatments and rebate offers. From there, she
began to surf other health sites to address her medical questions. “Now I go
out and look on the Web,” she said. “I’m responsible to be an informed
consumer.”

© 2000 The Washington Post Company

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