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.

676 total views, 1 views today

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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6/9/2000 – 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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5/24/2000 – Falling Off Prozac

This appears today on the ABC News website at
http://abcnews.go.com/sections/living/DailyNews/ssri000524.html

Falling Off Prozac

Doctors and Patients Unaware of Withdrawal Side Effects

By Robin Eisner

N E W Y O R K, May 24 — Tara Calhoun wanted to kill herself.

The then-48-year-old mother of two from Norman, Okla., had
forgotten to take her small dose of Paxil, an antidepressant
prescription medication.

But her suicidal feelings were not a return to symptoms of
depression, her doctor said. Rather, they were withdrawal
symptoms from seven months on a drug that had altered her
brain chemistry.

Calhoun’s reaction to ending her treatment with a serotonin
booster — drugs that increase the neurotransmitter serotonin in
the brain to treat depression, panic disorder and compulsive
behavior — was extreme but not unique.

Up to 85 percent of patients who take these kinds of drugs may
have some type of symptom when they stop, studies say.
Symptoms include balance problems, nausea, flu-like
symptoms, tingling and electric shock sensations, vivid dreams,
nervousness and melancholy.

The problem, doctors now are saying, is that patients and even
other doctors may not be aware that stopping these drugs, which
are among the top 10 best-selling pills in the United States, may
be causing the symptoms. Patients, they say, may unnecessarily
continue taking the drugs after they try to stop because the
symptoms of withdrawal may scare them into thinking they are
still suffering from the bad feelings they had — such as
depression — when they first started taking the drug.

Many doctors and patients also may not know that to end
treatment, levels of the drug should be tapered off while under a
doctor’s care.

The Way to Stop
According to recent research in the Journal of Clinical Psychiatry,
as many as 70 percent of general practitioners and 30 percent of
psychiatrists do not know about the side effects of ending
serotonin-boosting drugs. Of those who do know, only 20
percent of psychiatrists and 17 percent of general practitioners
caution their patients about the proper way to slowly lower the
levels of these drugs to come off them.

“Getting off these drugs properly is an issue that is
underappreciated,” says Dr. Alexander Bodkin, director of the
clinical psychopharmacology research program at McLean
Hospital, a teaching affiliate of Harvard Medical School located in
Belmont, Mass. “These drugs are being prescribed without the
full knowledge of how they should be monitored.”

Pharmaceutical companies place the responsibility of proper
prescribing on the doctor. “The decision about how long a
patient should be on treatment and how treatment should be
stopped is a highly individual one between the physician and
patient,” says Brian Jones, a spokesman for SmithKline
Beecham of Philadelphia, the manufacturer of Paxil.

Lifesavers, But Also Overprescribed
While these serotonin boosters can be life-savers for people
who suffer from severe depression, panic disorder and
obsessive-compulsive illnesses, and could offer help to
thousands of others on a long-term basis, psychiatrists and
doctors acknowledge that not everyone taking them should
necessarily be on them and that stopping might be a problem.

The numbers tell the story. Prozac, manufactured by Eli Lilly &
Co., of Indianapolis, Ind., has been on the market since 1988
and is the third best-selling drug in the country, according to IMS
Healthcare, a healthcare information company in Plymouth
Meeting, Mass. Zoloft, made by Pfizer Inc., of New York City, was
introduced in 1992 and is seventh. Paxil, available since 1993, is
ninth.

But the down side of these popular drugs has only recently been
addressed.”We are only beginning to see concerns about these
drugs like what inevitably happened with other so-called miracle
drugs over time,” says Dr. Joseph Glenmullen, a clinical
instructor of psychiatry at Harvard Medical School in Cambridge,
Mass., and author of the recently published book Prozac
Backlash.

“People during last century have wanted to take drugs that will
make them feel better, such as Valium, amphetamines and
cocaine elixirs, but it takes time to see the side effects of these
quick cures,” he says.

Glenmullen says today the serotonin boosters are being
prescribed for more and more moderate conditions, but that they
should be reserved for people who are truly debilitated by their
mental illness.

Once Taken, Forever Stuck?
And once on a drug, Glenmullen says, many people who don’t
really need it for the long haul have trouble getting off. When the
dosage is lowered, he says, it can be difficult to determine
whether it’s the symptoms of the disorder returning or the side
effects of withdrawal.

“If a doctor is unaware of these withdrawal symptoms, they
might put the patient back on the drug or another one and this
can go on for years,” Glenmullen says. Doctors also sometimes
switch patients to other serotonin drugs when these
discontinuation effects occur.

Calhoun’s story about stopping Paxil is cautionary. At the time
she forgot her medication, she had been trying to get off the drug
for six months, after being hospitalized from what she calls the
side effects of the drug — inability to sleep, constant suicidal
thoughts and chemical sensitivity.

Her general practitioner had prescribed Paxil when Calhoun had
told him she was feeling anxious upon losing a job. She worried
about supporting her two children. She says her doctor had not
told her about potential adverse effects of the drug. Nor did he
tell her the appropriate way to stop taking the medication.

Eventually, another doctor, who agreed she was suffering from
serious side and withdrawal effects, gradually lowered her
dosage.

Today, Calhoun has been off the drug for a year and a half, has
two jobs and counsels people getting weaned from serotonin
boosters. “When I felt the suicidal feelings that day I forgot the
drug, I realized that it was not me that was crazy, but…the
changing level of the drug inside my brain,” Calhoun says.

Stopping Serotonin Boosters
Each person will respond differently to stopping serotonin
boosters, or selective serotonin reuptake inhibitors (SSRI),
doctors say.

While many people experience no problem stopping the drug,
some people will have side effects from lowering the dosage,
since the brain has become used to certain levels of serotonin.

Medical research indicates that it is easier to get off Prozac than
Paxil. That’s because Prozac lasts longer in the body. So when
dosages are cut back, withdrawal effects are minimized.

Doctors caution no one should stop taking their drug cold turkey
and that use should be tapered off.

“A doctor should communicate with a patient at least once a
month when they are on these drugs,” says Dr. Bruce Bagley,
president of the American Academy of Family Physicians.

“I tell patients that they may need to be on these drugs for at
least six months to see an improvement, but you must talk to
them to see if conditions in their life have changed to warrant
considering ending the drug treatment.”

SSRIs act by increasing the amount of the neurotransmitter
serotonin available to the brain. Exactly how they work to treat all
the disorders for which they are prescribed is unknown, but
serotonin is a chemical that allows neurons in the brain to
communicate with each other. Over time, the drug changes the
way the neurons respond, according to Jerrold Rosenbaum, a
psychiatrist at Harvard Medical School.

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5/15/2000 – PROZAC, ZOLOFT, MAYHEM & SUICIDE

The revelations contained in this press release from Vickery and
Waldner are remarkable. It is being sent to major news media
today, Monday, May 15th. Mark
===============================

FOR IMMEDIATE RELEASE:
PROZAC, ZOLOFT, MAYHEM & SUICIDE
Teicher & Cole – Together Again and Still Sounding the Alarm

The February 1990 article by Harvard psychiatrists Martin
Teicher and Jonathan Cole (along with their colleague nurse
Carol Glod) brought the issue of Prozac/SSRI induced suicidality
to the public consciousness. The article spawned immediate
regulatory interest and a whirlwind of publicity in the popular
media.

Primed by company spin doctors, Lilly top scientist Leigh
Thompson blamed the publicity on the Scientologists and the
suicides on the underlying disease of depression. It was a
good public relations tactic, and it has been an effective
products liability stratagem for over a decade.

However, after ten years more experience, on May 7, 2000, in a
rare interview with the Boston Globe, Dr. Teicher said that he
stood by his work, and that the ability of Prozac to induce suicide
in a minority of patients “is a real phenomenon.” Meanwhile, on
April 28, 2000, Dr. Cole, who has been described by Pfizer
experts as a “pioneer” in the field of psychopharmacology,
signed a sworn declaration in a federal wrongful death case
concerning the tragic suicide of a 13 year old boy, only seven
days after he began taking Zoloft promotional samples. Dr. Cole
wrote:

In 1990 I co-authored an article with my colleague Martin Teicher
. . . Our purpose in writing this article was to alert the
profession
to an alarming, probable drug side effect which we had
observed. . . . The SSRI drugs, as a class, clearly have the
potential to cause, and in reasonable medical probability or
certainty do cause, akathisia in some patients. . . . they may also
cause emotional blunting or disregulation. Either of these
conditions could, and probably do, trigger or contribute to violent
or suicidal behavior. . . .

A side effect that occurs in a relatively small percentage of
patients, such as the treatment emergent suicidality which Dr.
Teicher, Nurse Glod and I reported on in 1990, is not likely to be
detectable in a standard RCT [clinical trial] or measured by a
relative risk calculation. That does not mean, however, that the
side effect is not real, not dangerous, and not caused by the
drug.

Although the drug companies continue to deny the existence of
this phenomenon in public and in court, in a 1986 report to the
FDA, Pfizer quietly admitted that “drug-induced activation is a
plausible explanation for the emergence of suicidal behavior in
our patient #4 . . .”, an 8 year old boy who mutilated his feet with
a
razor blade and tried to strangle himself with a necktie. And
Lilly? Well, it paid $90 million for a patent, the ostensible
usefulness of which is that it reduces a few really troublesome
side effects of the original Prozac: “nervousness, anxiety,
insomnia, inner restlessness (akathisia), suicidal thoughts, self
mutilation [and] manic behavior” .

A peer-reviewed journal article this month recounts the
experiences of two healthy, non-depressed volunteers who
became actively suicidal within two weeks of taking Zoloft.
Harvard psychiatrist Joe Glenmullen’s powerfully endorsed but
provocative book, PROZAC BACKLASH, continues to receive
wide public interest and to engender industry obloquy. And the
FDA? Hopefully, they are working right now on a proper warning
for Prozac II, and the entire class of SSRI drugs.

Vickery & Waldner May 11, 2000
www.justiceseekers.com Houston, Texas

——–
ENDNOTES

Teicher, Glod, Cole, Emergence of intense suicidal
preoccupation during fluoxetine treatment. Am.J.Psychiatry
1990: 147: 207-210.
——
Dr. Thompson’s coaching came via a memo dated April 15,
1991 from the now current executive VP of Lilly, Mitch Daniels. It
was introduced into evidence as Px 123 in the case of Forsyth v.
Eli Lilly. Lilly’s hardball litigation tactics through the years
are
well covered in the Lilly’s legal tactics disarmed legions of
Prozac lawyers article by Indianapolis reporter Jeff Swiatek,
available online at the paper’s website, www.starnews.com. and
ours, www.justiceseekers.com.
——–
Leah Garnett, Prozac revisited: As drug gets remade, concerns
about suicide surface, available online at the paper’s website,
www.boston.com and ours, www.justiceseekers.com.
——–
“Q. Is Dr. [Jonathan] Cole a man of considerable stature and
reputation in the field of neuropsychopharmacology in this
country?

A. He’s one of the pioneers of the field.”

March 29, 2000 deposition of retained Pfizer expert
witness,pre-eminent suicidologist and psychopharmacologist, J.
John Mann, M.D. in case of Miller v. Pfizer, No. 99-2326 KHV
(United States District Court, Kansas). Another Pfizer expert, Dr.
Daniel Casey, not coincidentally the chairman of the 1991 FDA
advisory committee that considered this issue, agreed with Dr.
Mann’s description of Dr. Cole’s professional standing.
——-
The term “RCT” refers to randomized, clinical trial. The industry,
which has never conducted such a study to test the hypothesis
that SSRI drugs induce suicidality, nevertheless argues in Court
that only such tests are truly “scientific.” All other opinions, no
matter who renders them or what they base them upon, are
merely “junk”. The Declaration is being filed in federal court in
Kansas City in the case of Miller v. Pfizer, docket number
99-2326 KHV. The case is set for trial before Judge Kathryn
Vratil and jury on July 18, 2000. A copy of Dr. Cole’s
Declaration
is posted on our website, www.justiceseekers.com. Matt Miller’s
story, “He Never Said Goodbye” is available at
www.drugawareness.org and on our site,
www.justiceseekers.com.
——-
Report, Suicide-Related Behavior in Children and Adolescents
in the Sertraline OCD Clinical Development Program, Pfizer, Inc.
(May 23, 1996), Pfizer Exhibit #40 in Miller v. Pfizer pretrial
motions. It based its determination of causality on the clinical
judgment of its own investigator and its scientists’ review of
published “anecdotal case reports” in a 1991 article.
——–
U.S. Patent 5,708,035
——–
Healy, Emergence of antidepressant induced suicidality, Primary
Care Psychiatry 2000, Vol.6 No. 1.

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5/9/2000 – Prozac Revisited

http://www.boston.com/dailyglobe2/128/nation/Prozac_revisited+
.shtml

Prozac revisited
As drug gets remade, concerns about suicides surface

By Leah R. Garnett, Globe Staff, 5/7/2000

Just as the 14-year patent on Prozac is about to expire and the
drug’s maker, Eli Lilly and Co., is preparing to launch a new
version, a body of evidence has come to light revealing the
antidepressant’s dark side.

The company’s internal documents, some dating to the
mid-1980s, as well as government applications and patents,
indicate that the pharmaceutical giant has known for years that
its best-selling drug could cause suicidal reactions in a small
but significant number of patients. The reports could become
critical as Lilly seeks government approval for its new Prozac.

Among the findings:

– Internal documents show that in 1990, Lilly scientists were
pressured by corporate executives to alter records on physician
experiences with Prozac, changing mentions of suicide attempt
to “overdose” and suicidal thoughts to “depression.”

– Three years before Prozac received approval by the US Food
and Drug Administration in late 1987, the German BGA, that
country’s FDA equivalent, had such serious reservations about
Prozac’s safety that it refused to approve the antidepressant
based on Lilly’s studies showing that previously nonsuicidal
patients who took the drug had a fivefold higher rate of suicides
and suicide attempts than those on older antidepressants, and
a threefold higher rate than those taking placebos.

– Lilly’s own figures, in reports made available to the Globe,
indicate that 1 in 100 previously nonsuicidal patients who took
the drug in early clinical trials developed a severe form of anxiety
and agitation called akathisia, causing them to attempt or
commit suicide during the studies.

– Though Lilly has steadfastly defended the drug’s safety and
downplayed studies linking Prozac to suicide, the patent for the
new Prozac, R-fluoxetine, expected to be marketed by Lilly
beginning in 2002, notes that the new version will not produce
several existing side effects including “akathisia, suicidal
thoughts, and self-mutilation,” which the patent calls “one of its
more significant side effects.”

– A McLean Hospital researcher and associate professor at
Harvard Medical School, Dr. Martin Teicher, whose early 1990s
studies linked Prozac to akathisia and suicide, is a co-inventor of
the new Prozac, which Lilly plans to market, along with Timothy J.
Barberich, the CEO of Sepracor Inc., a Marlborough drug
company, and James W. Young.

– A just-published book, “Prozac Backlash,” by a Cambridge
psychiatrist, Dr. Joseph Glenmullen, has drawn Lilly’s ire for
discussing Prozac’s link to suicide, tics, withdrawal symptoms,
and other side effects of Prozac and similar antidepressants.

Lilly officials continue to defend the drug’s effectiveness, saying
its track record is borne out by the fact it is still the most widely
prescribed drug of its kind. In a written statement, Jeff Newton, a
Lilly spokesman, said: “There is no credible evidence that
establishes a causal link between Prozac and violent or suicidal
behavior. There is, to the contrary, scientific evidence showing
that Prozac and medicines like it actually protect against such
behaviors.”

Using figures on Prozac both from Lilly and independent
research, however, Dr. David Healy, an expert on the brain’s
serotonin system and director of the North Wales Department of
Psychological Medicine at the University of Wales, estimated that
“probably 50,000 people have committed suicide on Prozac
since its launch, over and above the number who would have
done so if left untreated.”

Healy, meanwhile, is conducting a new study that he says is the
first of its kind, giving antidepressants to healthy people to study
possible links to suicide. The results are expected to be
published in June.

Prozac’s success is certainly unquestioned. The introduction of
the drug to the US market in the late 1980s changed the way
Americans viewed their most intimate emotions and limitations.
Billed as a wonder drug to combat depression by boosting
levels of the brain chemical serotonin, Prozac and others like it
were also said to remedy a host of human frailties from poor
self-esteem and concentration to fear of rejection.

By the end of last year, more than 35 million people worldwide
were using the drug, which provided Lilly with more than 25
percent of its $10 billion in 1999 revenue.

Yet the problems with Prozac were known even before it was
introduced to the US market. Figures in a 1984 Lilly document
indicated that akathisia, the severe agitation that can lead to
suicide, occurs in at least 1 percent of patients, a level
considered a “frequent” event, and as such must be disclosed in
a company’s product literature and package inserts. But there is
no such disclosure in Prozac’s US literature, and it is not clear
whether the FDA panel charged with approving Prozac simply
overlooked or did not have access to certain critical data of
Lilly’s.

As a result, researchers say that most US doctors do not know to
warn patients of the potentially dangerous effect which,
according to published literature on the topic, can be alleviated
with sedatives or by going off the drug.

German regulators, who eventually approved Prozac for use in
that country, require a warning label about the risk of suicide and
suggest the concurrent use of sedatives when necessary.

Akathisia is listed in Lilly’s US product literature, but as an
infrequent event in Prozac users. No mention is made of its
potential relationship to suicide.

A relationship, however, was found in a Globe search of US
patents. The patent for the new Prozac or R-fluoxetine (US Patent
no. 5,708,035), which Lilly will market after the existing patent
expires in 2001, contains a wealth of information about the
original Prozac. According to the patent, the new Prozac will
decrease side effects of the existing Prozac such as headaches,
nervousness, anxiety, and insomnia, as well as “inner
restlessness (akathisia), suicidal thoughts and self-mutilation” –
the same effect Lilly has contended has not occurred in any
substantial way in some 200 lawsuits against it over the past
decade. Most of the suits were settled out of court and the terms
kept confidential.

A 1990 communique

In an electronic communique obtained by author Glenmullen
dated Nov. 13, 1990, from Claude Bouchy, a Lilly employee in
Germany, to three Lilly corporate executives at the company’s
Indianapolis headquarters, Bouchy says he and a colleague
“have problems with the directions our safety people are getting
from the corporate group (Drug Epidemiology Unit) and
requesting that we change the identification of events as they are
reported by the physicians. . . . Our safety staff is requested to
change the event term `suicide attempt’ [as reported by the
physician] to `overdose.’ ”

Bouchy continued that “. . . it is requested that we change . . .
`suicidal ideation’ to `depression.’ ”

And then Bouchy makes an appeal to his US Lilly colleagues: “I
do not think I could explain to the BGA, to a judge, to a reporter or
even to my family why we would do this especially on the
sensitive issue of suicide and suicide ideation. At least not with
the explanations that have been given to our staff so far.”

Lilly has also aggressively sought to discredit researchers who
published data linking its product to suicide. One of its early
targets was Dr. Martin Teicher, an associate professor of
psychiatry at Harvard Medical School and a McLean Hospital
researcher, who wrote a crucial paper on the link between
suicide and Prozac in 1990; he found that 3.5 percent of patients
put on Prozac either attempt or commit suicide due to severe
agitation from akathisia. As a result of Lilly’s campaign, many in
the psychiatric community say they believe Teicher has
distanced himself from his original work. But in a rare interview
with the Globe, Teicher said that he stood by his work, and that
the ability of Prozac to induce suicide in a minority of patients “is
a real phenomenon.”

Teicher, Barberich, and Young filed their patent for the new
Prozac in August 1993, the same year Teicher published another
report, this one in the journal Drug Safety titled “Antidepressant
Drugs and the Emergence of Suicidal Tendencies.”

The paper was a direct challenge to data reported in the March
1991 issue of the Journal of Clinical Psychiatry by Drs. Maurizio
Fava and Jerrold Rosenbaum of Massachusetts General
Hospital. Their study found no significant difference in “suicidal
ideation” in patients treated with fluoxetine compared to those
receiving other antidepressants.

Teicher wrote in his 1993 paper that Fava and Rosenbaum’s
statistics were flawed. Using Fava and Rosenbaum’s data,
Teicher came to the opposite conclusion: namely, that patients
on Prozac were at least three times more likely to become
suicidal than those on older antidepressants.

The FDA came up with similar results even before Teicher
published his 1993 data. Dr. David Graham, chief of the FDA’s
Epidemiology Branch, wrote on Sept. 11, 1990, that Lilly’s data
on suicide and Prozac, as well as the Fava and Rosenbaum
study, were insufficient to prove that Prozac was safe. In an
internal FDA memo, Graham wrote: “Because of apparent
large-scale underreporting, the firm’s analysis cannot be
considered as proving that fluoxetine and violent behavior are
unrelated.”

“Prozac Backlash”

Now a decade later, Lilly has targeted Dr. Joseph Glenmullen,
whose book “Prozac Backlash” has apparently incensed Lilly
executives.

Glenmullen, a clinical instructor in psychiatry at Harvard Medical
School and a clinician at the Harvard University Health Services,
says he wrote the book because he was alarmed by the number
of patients who were reporting severe side effects from the
serotonin-boosting antidepressants including Prozac, Paxil,
Zoloft, and Luvox. “The two most upsetting side effects were
patients becoming suicidal on the drugs, and the development
of disfiguring facial tics,” he said in an interview.

After obtaining hundreds of pages of FDA documents through
the Freedom of Information Act, as well as internal Lilly memos
that are part of the public record in lawsuits filed against the drug
company, Glenmullen wrote that Lilly had tried to downplay side
effects of Prozac for years.

Lilly alerted newspapers and TV stations to the book and began
a campaign to discredit the author, saying that Harvard Medical
School professors were unfamiliar with his work and didn’t
recognize his name. Glenmullen, a graduate of Harvard Medical
School, is one of 415 clinical instructors in medicine at Harvard.

Blast from a critic

Chief among Glenmullen’s critics is Mass. General’s
Rosenbaum, a professor of psychiatry at Harvard Medical
School, who, in a written statement sent to the Globe calls
“Prozac Backlash” a “dishonest book” that is ” manipulative” and
“mischievous.”

But Rosenbaum’s objectivity has also been questioned. Not only
was his 1991 study on Prozac and suicide criticized by at least
two sets of researchers as well as the FDA, documents obtained
by the Globe show that Rosenbaum’s relationship to Lilly is a
cozy one: he has served as a Prozac researcher and sat on a
marketing advisory panel for Lilly before Prozac was launched.

When asked in an interview why he was speaking out against
Glenmullen’s book, Rosenbaum said that the suicide
controversy was “old news” and that the book presents the
information as new research. He noted that akathisia is “pretty
rare” and that “it doesn’t occur more than in people given a
placebo.”

But because there is no official reporting system for drug side
effects, no one knows how common drug side effects are, said
Larry Sasich, a research analyst at Public Citizen in Washington,
D.C.

“There is no active surveillance system to look at adverse
events,” he said. “Unless something very unfortunate happens
and a large number of people are harmed in a unique way, no
one is going to look at it; nobody ever puts two and two together.”

Sepracor’s patent

On April 12, the Federal Trade Commission opened the way for
Lilly to market Teicher’s, Barberich’s, and Young’s new Prozac,
for which Sepracor holds the patent. The new Prozac,
R-fluoxetine, is a modified form of an ingredient found in Prozac,
which, according to Sepracor, not only has fewer side effects but
more potential uses and benefits than the original.

In making the decision, the FTC rejected arguments from its
lawyers and the generic drug industry that the agreement unfairly
limits generic Prozac competition.

According to a Sepracor press release dated April 13, the
company will receive an upfront payment and license fee of $20
million from Lilly and an additional $70 million based on the
progression of the drug. Sepracor will receive royalties, and in
exchange, Lilly will get the exclusive world rights to R-fluoxetine
for all indications and uses. Lilly will be responsible for the
development of the drug, regulatory submissions, product
manufacturing, marketing and sales, according to the release.

Glenmullen wonders whether the new Prozac will, in fact, be little
more than an effort to prolong the life of a product with a
soon-to-expire patent.

Although it is touted as having fewer side effects, no one knows
what effects may surface once large numbers of people begin
taking it for months or years. In the epilogue to his book, he
simply says: “Like any new drug, it too will be an ongoing
experiment.”

This story ran on page A01 of the Boston Globe on 5/7/2000. ©
Copyright 2000 Globe Newspaper Company.

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The Aftermath of Antidepressants

The Aftermath Of Prozac, Zoloft, Luvox, Fen-Phen, & Many Other Serotonergic Drugs

By Ann Blake-Tracy – Executive Director,
International Coalition For Drug Awareness

Ann Blake-Tracy has specialized for 10 years in adverse reactions to serotonergic medications. She is the executive director of the International Coalition for Drug Awareness (www.drugawareness.org) and author of the book PROZAC:PANACEA OR PANDORA?

WARNING: IT SHOULD BE NOTED THAT A GRADUAL TAPERING OFF OF MEDICATIONS IS SAFEST WITHDRAWAL METHOD TO AVOID SERIOUS WITHDRAWAL EFFECTS

Often there is the terrible withdrawal associated with the SSRIs. Unless patients are warned to come very slowly off these drugs by shaving minuscule amounts off their pills each day, as opposed to cutting them in half or taking a pill every other day, they can go into terrible withdrawal which is generally delayed several months. This withdrawal includes bouts of overwhelming depression, terrible insomnia and fatigue, and can include life-threatening physical effects, psychosis, or violent outbursts.

Note: Keep in mind that these drugs are all serotonergic agents and clones or “copy cat” drugs of Prozac – the first SSRI antidepressant introduced to the market in America. Basically what applies to one, applies to the others. For instance we have more data out on Prozac because it has been around longer, but as the mode of action is the same for all of these meds the effects will be the same for the other drugs on this list as it is for Prozac. If we are discussing one drug, similar effects would be expected from any other company’s version of the drug. In fact it would be more honest to give them the titles of Prozac #1, Prozac #2,Prozac #3, etc. rather than the brand names they have been given, from the second clone, Zoloft, to the latest Prozac clone, Celexa.

My concern is that each new SSRI introduced seems to be a little stronger on serotonin reuptake and therefore potentially more dangerous. And the all too common practice of going from one SSRI to another blocks additional receptors and magnifies the harmful effects of these medications. It is crucial to learn that according to medical research the theory behind this group of drugs is invalid. Known as serotonin reuptake inhibitors. They are designed to block serotonin in the brain, thereby increasing brain levels of this neurotransmitter. Yet for three decades researchers have been intensely interested in serotonin because LSD and PCP produce their psychedelic effects by mimicking serotonin. Elevated serotonin is found in: psychosis or schizophrenia, mood disorders, organic brain disease, mental retardation, autism and Alzheimer’s. While low levels of the metabolism of serotonin (which also produces high serotonin), are found in those with: depression, anxiety, suicide, violence, arson, substance abuse, insomnia, violent nightmares, impulsive behavior, reckless driving, exhibitionism, hostility, argumentative behavior, etc. The drugs increase serotonin and decrease the metabolism of serotonin leading to any and all of the above results. This information is extremely crucial for patients and physicians to learn as soon as possible. We have a high rate of use of these drugs nationwide. Raising serotonin and lowering the metabolism of serotonin in such a large number of people can produce very serious, widespread and long term problems for all of society.

So why are we now in the 90’s being told that increased serotonin is good for us? Is it because it is good for the pocketbooks of the manufacturers? One manufacturer is running full page newspaper and magazine ads and half hour TV infomercials to bring in over $7 million daily, while on the other hand they are settling Prozac suicide cases for huge amounts of money in exchange for silence from victim’s families on the details of those settlements. The silence in the court cases insures that the drug will be allowed to finish out its patent time, thus bringing in the highest possible profits for the company. They know that with $7 million coming in daily, they can afford to settle a large number of lawsuits and still come out “smelling like a rose” financially.

Eli Lilly has been sued for Prozac related deaths in numerous state and federal courts with most of these cases being settled or dismissed – many were dismissed due to the unethical manipulation of the Wesbecker verdict
(see time line for details).

We have witnessed no decrease in suicide, but increases in murder/suicide, suicide, unwed pregnancies, domestic violence, manic-depression, MS, hypoglycemia, diabetes, bankruptcies, divorce, mothers (parents) killing children, road rage, school shootings, cancer, Chronic Fatigue Syndrome, and Fibromyalgia since these serotonergic drugs have become so popular and I relate it directly to the effects of these drugs.

The death toll has continued to climb drastically since I wrote PROZAC: PANACEA OR PANDORA? Some of the cases you may be familiar with are:

1. Mr. and Mrs. Phil Hartman (Zoloft), Prozac was found in the van of Mark Barton, the Atlanta day trader, who recently killed his family and others in a shooting spree before taking his own life;
2. Neal Furrow, in LA Jewish school shooting was reported to have been court ordered to be on Prozac along with several other medications;
3. The Salt Lake Family History Library shooting;
4. School shootings in Littleton, Colorado (Luvox), Atlanta, Georgia, Springfield, Oregon (Prozac), and Caldwell, Idaho;
5. Another boy in Pocatello, ID in 1998 who in seizure activity from Zoloft had a stand off at the school;
6. 15 year old Chris Shanahan (Paxil) in Rigby, ID who out of the blue killed a woman;
7. The shooting at the lottery in Connecticut last spring by Matthew Beck (Luvox) that left five dead in a murder/suicide;
8. The New York City Subway bombing by Edward Leary (Prozac);
9. Nick Mansies (Paxil) in New Jersey who was convicted of killing a little boy who was selling cookies door to door;
10. In Orange County, CA Dana Sue Gray (Paxil) who co-workers described as a very caring nurse killed several elderly people;
11. Officer Stephen Christian (Prozac) one of the finest officers on the Dallas Police force, who ran into a police substation shooting at fellow officers and was killed;
12. 13 year old Chris Fetters (Prozac) in Iowa who killed her favorite aunt;
13. David Rothman (Prozac) killed two co-workers and himself at the Dept. of Agriculture in Ingelwood, CA;
14. Williams Evans (Zoloft) shot one co-worker at the Ohio Bureau of Employment Services before shooting himself in Columbus, OH;
15. Winatchee, WA where 43 people were wrongfully imprisoned in a false accusation of sexual abuse “witch hunt” fury started by a child under the influence of Prozac and Paxil;
16. Christopher Vasquez (Zoloft) killed Michael Morrow in Central Park;
17. Megan Hogg (Prozac) duct taped the mouths and noses of her three little girls and took a handful of pills; Vera Espinoza (Prozac) in Randolph, VT shot her small son and daughter before shooting herself;
18. An elderly man (Prozac) in Layton, UT axed his wife and daughter to death;
19. Margaret Kastanis (Prozac) used a knife and hammer to kill her three children before stabbing herself to death;
20. An elderly man (Paxil) in Dallas, TX strangled his wife before shooting himself twice in the chest;
21. Larramie Huntzinger (Zoloft) blacked out and ran his car into three young girls killing two in Salt Lake City, UT;
22. Mary Hinkelman (Prozac), a nurse in Baroda, MI shot her two small daughters and her sister before shooting herself;
23. Lisa Fox (Prozac) shot her small son and her dog before shooting herself in Brighton, MI;
24. Debi Louselle (Zoloft) shot daughter and then herself in Salt Lake City, UT;
25. A father in Wyoming shot his wife, daughter and baby grand-daughter then himself after only days on Paxil;
26. A mother (Prozac) in Pleasant Grove, UT killed her 17 year old son with a sledge hammer while he slept before she attempted suicide by drinking Drano;
27. Larry Butz, a superintendent of schools in Ames, IA shot his wife, son and daughter before shooting himself – many cases pending in court are not mentioned.

This is only a handful of MANY, MANY more cases – there would not be room for anything else if I continued listing the cases.

A few additional famous victims: Princess Di (Prozac) and Dodi Fayed -via their driver Henri Paul (Prozac), Monica Lewinsky (Prozac, Zoloft, Effexor, Serzone and Phen-Fen), Chris Farley (Prozac), Pres. Clinton’s ex-partner Jim Mc Dougal (Prozac), Abby Hoffman (Prozac), Del Shannon (Prozac), Danielle Steele’s son (Prozac), INXS singer Michael Hutchence (Prozac), Sarah – Dutchess of York (Phen-Fen)

The latest figures show Prozac has about 44,000 adverse reports filed with the FDA. Out of those reports there are about 2,500 deaths with the large majority of them linked to suicide or violence.

The suicide statistics relating to women are shocking. According to the CDC there are about 30,000 suicides yearly in the United States. Out of those about 6,000 are women – a ratio of about 4.3 to 1, male to female. About twice as many women as men are treated for depression demonstrating that generally men are more than 8 times as lethal in their suicidal gestures as women. Women were known to use less lethal means until the SSRI antidepressants hit the market. But on Prozac and Paxil, women committed 40% of the suicides – many were strikingly violent and clearly leaving no
means for rescue. (Remember that because Prozac was the first of this group of drugs its track record gives us a vision of what is to come with other serotonergic antidepressants, especially when they are so powerful in the reuptake of serotonin.)

TIME LINE OF CRITICAL INFORMATION DISCOVERED SINCE THE BOOK:

*NOTE: Any documents beginning with PZ are Lilly documents on Prozac which have been ferreted out by attorneys and are now being used in lawsuits against the drug company. (Christian vs. Eli Lilly, by Vickery & Waldner, Houston, TX)

* Mid 1950’s: Dr. Felix Sulman began his research on those who suffer from high serotonin levels because of an inability to metabolize serotonin. He found that serotonin is a stress neuro-hormone leading even rabbits, the most docile of creatures, to be aggressive. He coined the term “serotonin irritation syndrome.” He found that those who were unable to break down serotonin would have the levels increase. They were in effect being poisoned by the serotonin produced by their own bodies, the irritation victims suffered from migraines, hot flashes, irritability, sleeplessness, pains around the heart, difficulty in breathing, a worsening of bronchial complaints, irrational tension and anxiety. . . horrifying nightmares. It also caused his volunteers to sleep badly – that is, always on the edge of consciousness so that they were not properly rested – and to wake after only a few hours of sleep.” (sleep apnea) He also found it caused pregnant women to abort.
* October, 1977: Slater, et.al., Inhibition of REM Sleep by Fluoxetine, a Specific Inhibitor of Serotonin Uptake, October 1977, at p. 385 – Prozac was found to affect sleep habits, specifically to suppress deep sleep, which the scientists call REM (rapid eye movement) sleep in cats. By the fourth day of drug treatment the cats receiving the larger doses, which had been friendly for years, began to growl and hiss. After cessation of the drug treatment, the cats returned to their usual friendly behavior in a week or two; those on the higher doses recovering more slowly. – – 1977: [PZ 1298 1999] “A total of six dogs from the high dose group were removed from treatment … due to severe occurrences of either aggressive behavior, ataxia, or anorexia.”]
* July 31, 1978: [PZ1061 1025-28, July 31, 1978] Human subjects began to be used by Lilly in controlled clinical trials. The first group of patients showed no improvement in their depression, but there were a “large number of reports of adverse reactions.” The first human to receive Prozac experienced “dystonia resembling an extrapyramidal reaction” – an uncontrollable, Parkinson-like shaking or trembling.
* July 23, 1979 [PZ 1297 969] The clinical studies in depression showed that “some patients have converted from severe depression to agitation within a few days; in one case the agitation was marked and the patient had to be taken off drug. In future studies the use of benzodiazepines to control the agitation will be permitted.”
* August 3, 1979: The clinical trials excluded patients who had serious suicidal risk. [E.g. control #001519, IND Protocol No. 14, August 3, 1979; PZ1135 695, July 2, 1986 memorandum of Dr. Wernicke].
* December 17, 1984: [PZ 65 449, report of Lilly to FDA] Lilly reported to the FDA that benzodiazepines and other sedatives were given with Prozac throughout the clinical trials. This was to help offset the stimulant effect of the drug. In a memorandum of Lilly scientist Charles Beasley [PZ 541 2007-08] issues of “agitation vs. sedation” and concomitant sedative medications like benzodiazepines (to control the agitation) are discussed. Concerns are that agitation in a suicidal patient can induce suicide.
* March 3, 1986 Lilly controlled the flow of information to the FDA and decided that suicide data on Prozac should not be evaluated, “in the safety-update for the FDA the number of suicides and suicide attempts will not be especially evaluated.” [PZ 879 1966, March 3, 1986 telex]
* September 12, 1986: German BGA very concerned with the risk of suicide and ultimately approved Prozac on the condition that physicians be warned of the risk of suicide and told to consider using sedatives and closely monitor patients. [PZ 878 1383, report of Lilly consultant Pohlmeier; PZ 2467 299, September 12, 1986] Lilly actually warned physicians in Germany and other countries that this measure “can be necessary” to minimize the risk of suicide, [PZ 1341 402, December 6, 1989 German warning; PZ 2469 490]
* February 7, 1990: In response to the Harvard study, Teicher, et al., Lilly’s top scientist, Leigh Thompson, told his fellow executives that “Lilly can go down the tubes if we lose Prozac”. [PZ 1941 827, February 7, 1990]. In the ensuing months Dr. Thompson spoke frequently with his principal FDA regulator about the issue, once at 6:15 in the morning. [PZ 391 1959, July 18, 1990]. Lilly later described the man as “our defender”. [PZ1941 2256, September 12, 1990]
* May 29, 1990, Lilly added “suicidal ideation” in the section dealing with post-marketing reports. [PZ883 562, July 26, 1990 memorandum]
* September 14, 1990: Contrary to the advice of his staff, Dr. Thompson told the Eli Lilly Board of Directors that suicide and hostile acts were probably, caused by the patients’ underlying disorders rather than Prozac. [PZ542 2101, September 14, 1990; PZ4002 889, Board Minutes]. The staff was concerned because they knew that this issue was never studied during the clinical trials.
* September 11, 1990: Note from Dr. Bruce Stadel, Chief of the Epidemiology Branch, attaching an analysis done by Dr. David Graham, Section Chief within the Epidemiology Branch, of Lilly’s July 17, 1990 submission to the FDA on the Prozac/suicidality/violence issue. The following factors were (a) brought to the attention of those in the higher echelons of the FDA, but (b) ignored, discounted or “trashed” by them: #1 Lilly’s analysis improperly excluded 76 out of 97 suicides; as Dr. Stadel expressed it, “[i]t is inappropriate in a safety analysis to exclude such a large proportion of case”; #2 Lilly admitted that its clinical trials “were not designed for the prospective evaluation of suicidality” and that “[i]n these trials, patients with current suicidal ideation were excluded”; #3 Lilly admitted that the HAMD-3 rating scale it used to assess suicidality in clinical trials was inadequate; and that Lilly’s statements about violence only demonstrated “how great under-reporting is” and that “[t]he actual data showed a higher percentage of treatment-emergent suicidality among fluoxetine (2.9% than tricyclic (0.8%) patients . . . [which percentage] was similar to that reported by Teicher.”
* July 1, 1992: A study lead by Dr. Lorne Brandes of the Manatoba Institute of Cell Biology in Winnipeg, Canada was published in CANCER RESEARCH linking the two most popular anti-depressants, Elavil and Prozac to cancer.
* 1994: A study headed by Howard Markell published in The Journal of Pediatrics showed LSD flashbacks and LSD reactions induced by Prozac.
* June 9, 1994: The New York Review of Books article by Dr. Sherwin Nuland slams Peter Kramer for pushing Prozac in his book Listening to Prozac. He pointed out that all docs are taught in med school this little poem about serotonin: “This man was addicted to moanin’, confusion, edema, and groanin’, intestinal rushes, great tricolored blushes, and died from too much serotonin.” He listed constriction of lungs and intestines, diarrhea, wheezing, flushing, mental confusion, tightening of bronchioles, and lessening conscious control over behavior from increases in serotonin. “Moreover, . . . it is still too early to arrive at a reliable estimate of possible dangers that may appear in the long term,” and 15% dropped out of the clinical trials on Prozac because of adverse reactions. He also discussed the similarity of serotonin to the psychedelics like LSD and PCP.
* November, 1994: Krystal JH, Webb E, Cooney N, et al., “Specificity of Ethanol-like Effects Elicited in Serotonergic and Noradrenergic Mechanisms,” ARCHIVES OF GENERAL PSYCHIATRY, Vol. 51, Issue 11, pgs 898-911, 1994 demonstrated that an increase in brain levels of either of two neurotransmitters, serotonin or noradrenalin, produces:
#1 a craving for alcohol,
#2 anger,
#3 anxiety.
They found this to be especially true for those who have a history of alcoholism. An increase serotonin in turn increases noradrenalin. Numerous reports have been made by reformed alcoholics who are being “driven” to alcohol again after being prescribed a serotonergic drug. And many other patients who had no previous history of alcoholism have continued to report an “overwhelming compulsion” to drink while using these drugs.

A few personal accounts:

#1 A young woman, a recovering alcoholic, reported that during the eight month period she had been using Prozac she found it necessary to attend AA meetings every day in order to fight off the strong compulsions to begin drinking again.
#2 In the Southeastern United States a middle aged psychologist, also a recovering alcoholic, after being prescribed Prozac, found herself needing to attend AA meetings morning, noon, and night to keep from destroying the sobriety she had achieved.
#3 A young father, who was Mormon and had never before in his life used alcohol, found himself drinking Ever Clear and exhibiting bizarre as well as violent behavior, after being prescribed Prozac and Ritalin.
#4 A young mother who had never used alcohol before began drinking large amounts within weeks of being prescribed Prozac and quickly found herself committed to a mental institution due to the psychotic behavior that resulted. Added to her Prozac prescription were anti-psychotic meds and electric shock treatments. She then began to experience seizures and was started on anti-seizure meds.
#5 A concerned neighbor reported her friend was drinking straight Vodka on a regular basis after being prescribed Zoloft. #6 A daughter reported her father, sober for 15 years, began drinking again on Prozac.

* December, 1994: Not guilty verdict on Wesbecker wrongful death suit against Lilly’s Prozac.
* Treatment emergent suicidality with Prozac has been demonstrated to be two to three times higher than any other anti-depressant. (Jick, et al., Antidepressants and Suicide)
* May, 1995: Judge John Potter who presided over the Wesbecker case filed documents to demand that Lilly be forced to disclose the secret deal they made with the plaintiffs to withhold very damaging evidence in exchange for settlement. In his pleading to the court Potter stated, “Lilly sought to buy not just the verdict, but the court’s judgment as well.” Potter accused Lilly of “giving the verdict the widest possible publicity” accompanied by the claim that Lilly had “proven in a court of law that Prozac was safe.” Furious with Lilly’s attempt to turn his courtroom into an advertising agency for Prozac, he claims his motion reflects “the court’s duty to protect the integrity of the judicial system.” He believes, as do prominent legal ethicists, that a full and open disclosure of the terms of the settlement is a necessary public safety issue.
* July, 1997: Mayo Clinic found that the increased serotonin, which produces blood clotting, was causing a gummy glossy substance to build up on heart valves. Dr. Heidi Connolly with the Divisions of Cardiovascular Diseases and Internal Medicine, who headed the study stated, “We do know that fenfluramine and phentermine [Fen-Phen] alter the way the brain chemical serotonin is metabolized, and serotonin that circulates in the blood can cause valve injury.” Fenfluramine produces a rapid release of serotonin, inhibits serotonin reuptake, and may also have receptor agonist activity. The study’s revelations should send a loud and very clear warning throughout the medical community concerning all serotonergic medications.
* August 25, 1997: Letter to Ann Blake-Tracy, “I caught the last part of your presentation on Radio Station KEX, Portland, while flipping through the dial last night. I was flabbergasted to hear you speak of the horrible potential side effects from Prozac, which I have been taking for approximately four years, particularly since I have been diagnosed recently with cardiomyalgia, severe artery disease, congestive heart failure and also Fibromyalgia. (I was a very “well” person prior to taking the Prozac and am now exhausted all the time, with horrible aching joints and considerable pain and a massive heart problem.) The adverse cardiovascular effects from Prozac, the one drug in this class of drugs out long enough to have somewhat of track record, are listed in the drug information sheet put out by the manufacturer. The “frequent” effects listed are hemorrhage and hypertension. The “infrequent” effects include very serious adverse effects: congestive heart failure, myocardial infarct, tachycardia, angina pectoris, arrhythmia, hypotension, migraine syncope and vascular headache.
* September, 1997: Redux and Phen-Fen were pulled from the market.
* October 20, 1997: Dr. Candace Pert, Research Professor at Georgetown University Medical Center, past head of the brain chemistry department at the National Institute of Health, and author of the new book, MOLECULES OF EMOTION, sounded an alarm in TIME, October 20. She stated, “I am alarmed at the monster that Johns Hopkins neuroscientist Solomon Snyder and I created when we discovered the simple binding assay for drug receptors 25 years ago. Prozac and other antidepressant serotonin-receptor-active compounds may also cause cardiovascular problems in some susceptible people after long-term use, which has become common practice despite the lack of safety studies.”
As we are being led to believe these drugs produce effects only in the brain, Dr. Pert accuses the medical profession of oversimplifying the action of these drugs and adds that “the public is being misinformed about the precision of these selective serotonin-uptake inhibitors.” It is critical that both physicians and patients be made aware of these adverse physical reactions. She points out that the medical profession not only oversimplifies the action of these drugs in the brain, but “ignores the body as if it exists merely to carry the head around!” And that, “these molecules of emotion regulate every aspect of our physiology.” The body plays a very significant role in how we feel and act the way we do. This fact can no longer be ignored. Serotonin and serotonin receptors exist throughout the body, as well as the brain, and every aspect of the body’s physiology is affected by these serotonergic medications. In fact approximately 90% of the body’s serotonin is produced in the intestinal tract. According to Dr. Michael Gershon of New York’s Columbia Presbyterian, this is the reason why Prozac produces so many gastrointestinal side effects.
* March, 1998: Two new studies published. One that shows Prozac so strongly inhibits one particular serotonin receptor that this produces both obesity and seizures and the other discusses the blockage of muscle and neuronal nicotinic acetylcholine receptors indicating interactions between the serotonergic and cholinergic systems in the central nervous system.
* April, 1998: Our next generation of guinea pigs – one month before a 15 year old on Prozac, Kip Kinkel, in Springfield OR killed his parents and two classmates the American Psychiatric Association and the American Academy of Pediatric Psychiatrists asked the FDA to consider the serotonergic antidepressants for use in children as young as two and drugs for anxiety, aggression and manic depression in babies only one month old! The use of Prozac among young children ages 6 – 12 has increased an alarming 400% from 1995 (51.000 new prescriptions) to 1996 (203,000 new prescriptions).
* June, 1999: CLINICAL PSYCHIATRY NEWS reported that Dr. Malcolm Bowers a psychiatrist at Yale has found that physicians are not paying enough attention to patient factors that could make initiation of SSRIs dangerous. He found that “SSRI-induced psychosis has accounted for 8% of all general hospital psychiatric admissions over a recent 14-month period.” And “What is surprising is that this particular group of side effects is really underplayed.” (The 8% figure represents over 150,000 SSRI induced psychotic breaks per year!!!!!!!)

WARNING: Children so often get coughs and colds, yet using a cough or cold medication with dextromethorphan could cause the serotonin syndrome, a very serious and potentially fatal adverse reaction and/or produce PCP reactions.

Serotonin syndrome remains an often misdiagnosed or unrecognized fatal reaction due to the medical profession being so uninformed about this drug-induced disorder.

Developing brains are far more vulnerable than adult brains and brain damage generally becomes more apparent after the brain is fully developed, rather than immediately. Increases in cortisol produce brain damage while medical research shows that one single 30mg dose of Prozac DOUBLES the level of cortisol. This drastic increase in cortisol causes a multitude of serious physical reactions including impairment of linear growth, as well as impairing the development and regeneration of the liver, kidneys, muscles, etc. In light of so many unspeakable tragedies, I have grown weary of all the silly philosophical discussions we have heard since Kramer’s LISTENING TO PROZAC came out. Patients are dying or having their health destroyed mentally as well as physically (when do we begin to discuss the very serious physical side effects associated with high levels of serotonin?). These patients and their families are frantically searching for answers while this research sits right under our noses and could easily be made available to them. The widespread use of Prozac and its clones is not a statement of either their safety or their effectiveness. It is a statement about the effectiveness of an infinite marketing budget and incredible advertising campaign! These drugs have very serious physical side effects, as well as dangerous psychiatric side effects.

To prevent further tragedy this medical research must be acknowledged and addressed in headline news without delay rather than remain buried in seldom read medical research documents as has been the case in the past with other mind- altering medications, once thought to be safe, which were subsequently prohibited by law, i.e. LSD, PCP, cocaine, etc.

PRAISE FOR PROZAC: PANACEA OR PANDORA?

“I started having bad reactions . . . Oct ’96 I found Prozac to be causing joint and muscle pain itself . . . signs of Cushing’s Syndrome. . . I was very pro-Prozac until last October and wouldn’t have listened to anything said against it until I got problems (thought it was saving my life, while all the time it was insidiously and interested but quite skeptical. However, since reading it and having suffered so many problems with Prozac, I have come to the conclusion that the book is brilliant, and a life-line as far as I am concerned. I tried to fault the research and reasoning, but could not and still can’t. I would like to extend my thanks to you for your heroic stance on this enormously important issue. I have tremendous respect and admiration for your hard work, determination and courage in pursuing this subject so vigorously, against so much powerful opposition for the benefit of people like me. Your integrity puts many, if not most doctors and psychiatrists to shame. It is reassuring to find that there are a few people who are prepared to fight for the truth for the benefit of mankind.” Oct. 1998 note from a British nurse

“PROZAC: PANACEA OR PANDORA? is an incredible compilation of medical data that will lay the groundwork to educate other professionals and the general public about the new SSRI antidepressants – Prozac, Zoloft, Paxil, Luvox, Effexor and Serzone.” (Jeff Wise, psychologist, Salt Lake County Drug and Alcohol Abuse )

“In 15 years of reading books on drugs I have never read a book with more information or so well documented as PROZAC: PANACEA OR PANDORA?” (Dr. Kevin Millet, Bountiful, UT)

“As I lecture to physicians nationwide on the medical use of psychoactive drugs PROZAC: PANACEA OR PANDORA? always accompanies me in my brief case.” (Dr. Bruce Woolley, neuropsychopharmacologist, Brigham Young University)

“I found PROZAC: PANACEA OR PANDORA? fascinating reading and the most complete analysis of the various factors pertaining to the Prozac controversy.” (Attorney Donald Sokol, Susanville, CA)

“PROZAC: PANACEA OR PANDORA? literally saved my life, and if I’d known about it a year earlier, could have saved me untold grief and agony as well. It is the only collated, comprehensive source I know of for this information , . . .. this book described everything that had happened to me in great detail, gave scientific reasons why it happened, backed it all up with solid research, included testimonials from hundreds of others in the same situation, it immaculately details, explains, and refers one to the latest research on a whole hornet’s nest of ‘atypical’ side-and/or after-effects from the use of these antidepressants. It also contains information on how to reduce the severity of problems encountered while starting on or going off these meds.” (Nick Jameson, Prozac patient)

“Magnificent! This text is a monument to Ann Tracy’s tenacity and love for her fellow human beings.” (Dr. Paul Kennedy, N.J.)

“PROZAC: PANACEA OR PANDORA? has not left one question about these drugs unanswered! Ann Tracy has covered them all.” (Margaret McCaffery, N.Y. who lost her daughter, a neurosurgeon, in a Prozac suicide)

“The work Ann Blake-Tracy is doing is very important and she is truly a heroine.” (Dr. Candace Pert, Washington, DC, one of the two developers of the serotonin binding process which made possible the development of the serotonergic drugs. Dr. Pert has boldly stated, speaking of these serotonergic medications, “I am alarmed at the monsters I created!”)

WARNING: In sharing this information about adverse reactions to antidepressants I always recommend that you also give reference to my CD on safe withdrawal, Help! I Can’t Get Off My Antidepressant!, so that we do not have more people dropping off these drugs too quickly – a move which I have warned from the beginning can be even more dangerous than staying on the drugs!

The FDA also now warns that any abrupt change in dose of an antidepressant can produce suicide, hostility or psychosis. And these reactions can either come on very rapidly or even be delayed for months depending upon the adverse effects upon sleep patterns when the withdrawal is rapid! You can find the CD on safe and effective withdrawal helps here: http://store.drugawareness.org/

Learn More
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Withdrawing from Paxil has been a Nightmare

“Feelings of suicide and hopelessness are worse now than ever.”

 

I liked your comments on Prozac, Paxil, and Zoloft. I have been on Paxil since 1995, and it has been a nightmare. I am slowly getting off the drug on my own, without telling my doctor. Believe me, I am cutting back VERY slowly because of how long I have been on it. I have gotten worse over the years, and not better, and have told my doctor so, but to no avail. Feelings of suicide and hopelessness are worse now than ever.

I know that many people wish there was a drug that really would help without the incredible side effects, such as weight gain, etc. By the way, I have gone from 180 (my ideal weight) to 240 pounds during the time I have been on Paxil. That in itself is depressing.

Tom Gadowski
27627 El Capitan Dr.
Warren, MI 48092-3078
(810) 751-6791

5/2/2000

This is Survivor Story number 23.
Total number of stories in current database is 96

 

 

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5/1/2000 – PA Suit blames Prozac for suicide try

Suit blames Prozac for suicide try

By Jeff Swiatek

The Indianapolis Star

Last updated 11:58 PM, EST, Monday, May 01, 2000

A Pennsylvania woman and her husband have sued Eli Lilly and Co., charging
that Prozac caused the woman to attempt suicide in 1997.

The lawsuit, filed Friday in federal court in Pittsburgh, says Diane V.
Cassidy was prescribed Prozac by her family doctor in July of 1997 for weight
loss.

Three weeks later, Cassidy checked into a motel, slit her wrists and took an
overdose of a drug that damaged her brain, the lawsuit says.

Cassidy, 47, survived, but is brain-damaged and requires constant care, the
lawsuit says.

A co-plaintiff is Cassidy’s husband of 29 years, Melvin J. Cassidy. They live
in Monroeville, Pa.

Lilly spokesman Edward A. West said, “Prozac had nothing do with this woman’s
situation.” He added, “There is a real serious question about whether there
was a suicide attempt or not.”

The 23-page initial complaint asks for $4.84 million to cover medical
expenses, lost wages and life-care needs. Intangible damages also are sought.

The lawsuit accuses the Indianapolis drugmaker of negligence for not warning
doctors that Prozac can cause suicidal behavior in some patients.

Prozac, the nation’s top-selling antidepressant, is not federally approved as
a weight-loss drug, but the lawsuit says Lilly “has either actively or
tacitly encouraged doctors to prescribe Prozac for weight loss.”

The lawsuit joins a dwindling number of fewer than 10 product-liability
claims over Prozac. Five years ago, there were more than 150 claims. Most
have been dismissed, dropped or settled.

Handling the Pittsburgh lawsuit are Greensburg, Pa., attorney Lawrence D.
Kerr and Houston attorney Andy Vickery, who has three other Prozac lawsuits
pending against Lilly.

722 total views, 1 views today

Nurse Tells of Horrors after Gaining Weight on Prozac

“Prozac is a dangerous drug!!!!! It has changed my body, my health, my financial status, influenced my marital status and almost destroyed me.”

 

Hi Ann Blake-Tracy,

Tomorrow will be 77 days off Prozac.

I feel relieved and elated that I have made it this far…and feel good. I hope my story can help some of the readers, as I have been on a real rollercoaster ride with this drug.

Let me start at the beginning. I have been prescribed and have taken sporadically antidepressant drugs for about 29 years. I have been diagnosed as bipolar but have neither manic episodes or deep depression. I do have time to time mild depression which causes some anxiety in my day to day living.

Three years ago a psychiatrist, seeing me for 10 minutes as a requirement as an adjunct to my one on one therapy with my therapist, prescribed Prozac. I was started on 20mg per day and within 1 day could feel it “kicking in” and making the world tolerable again. I immediately felt that I had really needed this drug..and why did I wait so long to feel better….as the weeks wore on however, the initial good feelings for my fellow man were replaced by transient feelings of anxiety…feeling that I couldn’t cope with things, situations… and an ongoing feeling that I didn’t want to deal with anything anymore.

I also started to gain weight…..mostly craving fast food and sweets…..at the end of 3 years I have gained 65 pounds and have the appearance of a cushinoid patient with upper body weight, buffalo hump, facial weight. I look different..I don’t look healthy. I also quit a job that I had for 7 years and started job hopping…had 4 jobs in one year. Financially..somehow I went from good credit…to bad credit with my 2nd mortgage becoming a reality to get my life back. I also divorced a husband of 26 years and remarried…but I believe that was a good choice. Would I have made different choices without the Prozac….I don’t know…….I weaned myself off the drug after reading your book and feel so much better mentally…..I have started another job and have stuck to it…I feel I have myself back again.

The only problem is the weight…..I can’t seem to get it off………Do you have any suggestions on diet types for this problem? I know the Cortisol is directly at fault…does it continue??? How do we stop it? I am a nurse and have been trying to research it on my own…what I have found is disheartening…..effects may last 2 years…….any suggestions….

I have also sent your book to my daughter who was also on Prozac..and my other daughter on Paxil….. Both are off the drugs after weaning…and doing better…..Prozac is a dangerous drug!!!!! It has changed my body, my health, my financial status, influenced my marital status…..and almost destroyed me……Please write back on any suggestions you may have on diet to crack this weight..I am 52 years old.
———–

Note from Ann Blake-Tracy:

Whatever you do as an ex-SSRI user, DO NOT try the high protein diet craze that is making a come back in spite of destroying the health of so many in the 1970’s! Ex-SSRI users are becoming EXTREMELY ill trying to follow this diet. I personally believe the reason for that is that the serotonergic drugs, while impairing one’s ability to break down serotonin, also impair one’s ability to metabolize proteins. This would make high protein diets very dangerous for them. Good nutrition, walking, sufficient water intake, proper sleep, and good fats Vs bad fats have always been the keys to weight loss. Check out Udo Erasmus’ book, “Fats the Heal, Fats that Kill” at www.edoerasmus.com.

Susan in Michigan

4/17/2000

This is Survivor Story number 24.
Total number of stories in current database is 96

648 total views, 2 views today