ZOLOFT: NY Judge to Allow Zoloft Defense in Assault Case

Paragraphs two and three read: “The attorney for Coram resident Brandon Hampson says he plans to argue that his client became violent and beat Lisa Essling on Aug. 25, 2006, because he stopped taking the popular antidepressant Zoloft days before the attack.”

“Nassau County District Court Judge Rhonda Fischer said Friday that she will allow a defense witness to testify that withdrawl from the antidepressant can cause a person to become aggressive.”

http://www.newsday.com/ny-judge-to-allow-zoloft-defense-in-assault-case-1.1388026

NY judge to allow “Zoloft defense” in assault case

August 22, 2009 By The Associated Press

HEMPSTEAD, N.Y. (AP) A Long Island judge has said she will allow a man accused of punching and kicking his former girlfriend to use the so-called “Zoloft defense.”

The attorney for Coram resident Brandon Hampson says he plans to argue that his client became violent and beat Lisa Essling on Aug. 25, 2006, because he stopped taking the popular antidepressant Zoloft days before the attack.

Nassau County District Court Judge Rhonda Fischer said Friday that she will allow a defense witness to testify that withdrawl from the antidepressant can cause a person to become aggressive.

Prosecutors say they strongly disagree with the court’s decision.

Zoloft manufacturer Pfizer Inc. has said there’s not evidence to suggest that discontinuing the drug can cause violent behavior.

___

Information from: Newsday, http://www.newsday.com

Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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ANTIDEPRESSANTS: Police Stop Man From Committing Suicide: England

Paragraphs two and three read: “The attorney for Coram resident Brandon Hampson says he plans to argue that his client became violent and beat Lisa Essling on Aug. 25, 2006, because he stopped taking the popular antidepressant Zoloft days before the attack.”

“Nassau County District Court Judge Rhonda Fischer said Friday that she will allow a defense witness to testify that withdrawl from the antidepressant can cause a person to become aggressive.”

http://www.newsday.com/ny-judge-to-allow-zoloft-defense-in-assault-case-1.1388026

NY judge to allow “Zoloft defense” in assault case

August 22, 2009 By The Associated Press

HEMPSTEAD, N.Y. (AP) A Long Island judge has said she will allow a man accused of punching and kicking his former girlfriend to use the so-called “Zoloft defense.”

The attorney for Coram resident Brandon Hampson says he plans to argue that his client became violent and beat Lisa Essling on Aug. 25, 2006, because he stopped taking the popular antidepressant Zoloft days before the attack.

Nassau County District Court Judge Rhonda Fischer said Friday that she will allow a defense witness to testify that withdrawl from the antidepressant can cause a person to become aggressive.

Prosecutors say they strongly disagree with the court’s decision.

Zoloft manufacturer Pfizer Inc. has said there’s not evidence to suggest that discontinuing the drug can cause violent behavior.

___

Information from: Newsday, http://www.newsday.com

Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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4/23/2001 – Matt Miller's Zoloft tragedy featured in UK article

When Depression Turns Deadly:
Can Antidepressants Transform Despair into Suicide?

ANNE McILROY
THE GLOBE AND MAIL
Saturday, April 21, 2001

www.globeandmail.com

When Matt Miller’s family moved to a bigger house in a new neighbourhood in
Kansas City, Mo., the athletic 13-year-old with thick blond hair found that
he couldn’t penetrate the cliques at his new school. He was a nobody, an
outsider.

“He was angry at us, he was angry at the school, his grades suffered. He
wasn’t himself,” said his father, Mark Miller.

The boy’s teachers recommended that he see a psychiatrist, who prescribed
Zoloft, an antidepressant in the same chemical family as Prozac.
The doctor said it would help Matt’s mood, make him feel better about
himself. The boy started taking the pills and seemed to be in good spirits
for a few days.

But then he began showing signs of intense nervousness and agitation. He
couldn’t sit still, his father remembers. He kept kicking people under the
table. His eyes were sunken and he couldn’t sleep, yet he had a restless
energy.

After six days on the drug, on July 28, 1997, Matt hanged himself in his
bedroom closet.

“Suicide always takes you by surprise, but no one could have imagined that
Matt would have done that,” Miller said in an interview. “There was no
previous attempt, no serious threat of it, no note, no premeditation.
“It was a very impulsive act I am convinced was brought about by the
stimulant nature of the drug.”

Miller has launched a lawsuit against Pfizer Inc., which makes Zoloft. He is
one of about 200 people who have sued — so far unsuccessfully — the makers
of Prozac and similar products. The plaintiffs contend that the drugs, known
as selective serotonin reuptake inhibitors, caused their loved ones to kill
themselves and, in some cases, hurt or kill others as well.
One of the few cases to go to trial so far was that of William Forsyth, a
63-year-old wealthy Hawaii businessman who stabbed to death his wife of 37
years and then killed himself in 1993. At the time, he had been taking
Prozac for 11 days for panic attacks.

In 1999, a jury in the civil lawsuit cleared Prozac of liability in the
deaths. Forsyth’s adult children began another suit last year accusing Eli
Lilly and Co., the maker of the drug, of covering up damaging details about
the antidepressant.

Chief among the scientific experts who have given people, including Miller
and Forsyth’s children, reason to believe that a link may exist between
antidepressants and suicide is Dr. David Healy, whom Miller has engaged as
an expert witness in his suit.

Healy is a well-known British psychiatrist who argues that Prozac and
similar drugs may trigger suicide in some patients, and that there should be
warning labels on the products.

To Miller, Healy is a hero, a crusading scientist with the guts and
credibility to challenge the powerful, multinational drug companies in an
era in which many researchers and institutions depend on them for funding.
But discussing the down side of Prozac does not appear to have been a good
career move. Healy’s blunt expression of his views may have cost him a job
at the Centre for Addiction and Mental Health, a teaching hospital
associated with the University of Toronto. The centre had been recruiting
him for months, but last year rescinded his written job offer after he gave
a speech warning that Prozac may trigger suicide in some patients.

Eli Lilly Canada Inc. is a major corporate donor to the centre, but
university and hospital officials say their decision had nothing to do with
wanting to please the drug company or to avoid damaging future fundraising
efforts. They say their reasons are confidential.
Healy says the only explanation he was offered was that his lecture
“solidified” the view that he was not a good fit.

For Eli Lilly’s part, it points out that a U.S. Food and Drug Administration
panel of experts voted six to three against requiring Prozac to carry a
suicide-risk warning label. In September of 1991, the FDA concluded that
there was no credible evidence of a causal link between the use of
antidepressant drugs, including Prozac, and suicides or violent behaviour.
And a paper published in March of 1991 by Jerrold Rosenbaum of Massachusetts
General Hospital found that patients on Prozac were not prone to suicide any
more than patients on other medication.

Eli Lilly said, in a written response to questions from The Globe and Mail:
“There is, to the contrary, published scientific evidence showing that
Prozac and medicines like it actually protect against such behaviour —
reducing aggressive and suicidal thoughts and behaviour.”

When Prozac was introduced in the late 1980s, it was billed as a wonder drug
that could combat depression with far fewer risks than previous medications,
including the danger of an overdose or problems when mixed with alcohol.
Prozac and drugs like it — Zoloft, Paxil and Luvox — were said to help
with emotional limitations such as low self-esteem and fear of rejection.
Prozac was a commercial as well as a medical miracle, sold to an estimated
40 million people worldwide since it hit the market.

The drug boosts levels of the neurotransmitter serotonin, which seems to
improve the mood of patients. But within a few years of Prozac’s launch came
hints that it brought out a dark side in a small fraction of users.
Martin Teicher, a researcher at Harvard University, published an article in
the American Journal of Psychiatry in 1990 that discussed six cases in which
patients became intensely preoccupied with suicide after taking the drug.
Other scientists also found a potential link between Prozac and suicide.

Healy says in one of his published papers that Eli Lilly scientists
collaborated with the FDA on designing an experiment that would measure how
serious the problem was, but they then decided against conducting it.
Instead, in 1991, Eli Lilly published an analysis of data taken from
existing trials. Its conclusion? There was no increase of suicidal thoughts
or suicide among depressed patients taking Prozac.

But Healy says in the paper that data from only about one-eighth of the
patients in the clinical trials were included. No mention was made that some
had been prescribed a sedative that may have alleviated an intense nervous
state that can lead to suicide, which is called akathisia, he says.
The analysis also did not point out that 5 per cent of patients dropped out
of the studies because they were anxious and agitated and may have been
suffering from akathisia, Healy says.

Another document, dated Nov. 13, 1990, shows that company scientists were
pressured by executives to soften physicians’ reports of suicidal thoughts
or suicide attempts, according to Harvard psychiatrist Joseph Glenmullen,
who obtained the document and is author of the book Prozac Backlash.
Additional evidence about the potential risks can be found in the patent for
a second-generation Prozac pill, which Eli Lilly has licensed. The patent
says the new and improved Prozac would decrease side effects including:
“nervousness, anxiety, and insomnia,” as well as “inner restlessness
(akathisia), suicidal thoughts and self-mutilation.”

But at the same time, Eli Lilly says these symptoms are not associated in
any significant way with taking the current version of Prozac.
The new Prozac — which incidentally was co-developed by Teicher, one of the
drug’s early critics — isn’t yet on the market, Last year, Healy published a
study in the journal Primary Care Psychiatry that said two of 20 healthy
volunteers taking an antidepressant in the same family as Prozac reported
feeling suicidal.

But by his calculations, probably 40,000 people have committed suicide while
on Prozac since its launch, above and beyond the number who would have taken
their own lives if their condition had been left untreated.

The German government now requires warning labels, and Britain is
considering them. Canada and the United States do not.
Healy says he is not opposed to Prozac and thinks that it can do a lot of
good. But he says it is unethical and irresponsible not to warn doctors
about the potential dangers, and believes Eli Lilly chose not to do so to
maximize profits.

He says family doctors seem to be increasingly prescribing Prozac and other
antidepressants to children and now to women complaining of severe
premenstrual symptoms, yet patients in North America do not have to be told
about the potential risks.

Eli Lilly and the other drug companies argue that depression, not
antidepressants, are to blame for suicides. Pfizer is trying to have Healy
barred from testifying in the Miller case, questioning his credibility as an
expert witness.

So what are Canadian consumers to think? Jacques Bradwejn, chairman of the
psychiatry department at the University of Ottawa, says he has reviewed the
literature and agrees with the FDA and Eli Lilly that there is no evidence
that Prozac and similar drugs cause more suicides than would have occurred
if patients had not been treated.

But a small number of patients — even as many as 1 per cent — may fall
into a nervous state that could trigger suicide, he said, adding that more
research is needed to better understand the problem.

While Prozac may be overprescribed for patients who are not truly ill,
Bradwejn worries that the message that the Prozac is dangerous will do more
harm than good for those who are moderately to severely depressed.
“If the message is too alarmist, it could have a very negative effect on
Canadians.”

DEPTHS OF DESPAIR

A study by Dr. David Healy found that two of 20 healthy volunteers taking a
selective serotonin reuptake inhibitor in the same family as Prozac reported
suicidal feelings. This is the story of one of those people, a 30-year-old
woman who didn’t know what drug she was taking, as recorded in the study.
“On the Friday she telephoned early in the morning, distressed and tearful
from the previous night. Her conversation was garbled. She described almost
going out and killing herself. . .

“The night previously she had felt complete blackness all around her. . . .
She felt hopeless and alone. It seemed that all she could do was to follow a
thought that had been planted in her brain by some alien force.
“She suddenly decided she should go and throw herself in front of a car,
that this was the only answer. It was as if there was nothing out there
apart from the car. . . . She didn’t think of her partner or child. She was
walking out the door when the phone went. This stopped the tunnel of
suicidal ideation.

“She later became distraught at what she had nearly done and guilty that she
had not thought of her family.”

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3/17/2001 – Doctor Links Viagra to Five Cases of Blindness

I have made the statement before that Viagra is a very dangerous drug and the
only good thing about it is that it will give Pfizer the funds they need to
pay off all of their Zoloft wrongful death suits while it remains to be seen
which new Pfizer drug will bring in the funds to pay off all of the Viagra
damage suits.

It appears the serious physical effects have begun to surface in spite of
most major drug company’s ability to suppress this type of information.

A Washington State man claimed Viagra drove him to attack a woman with a
hammer soon after the drug was released. And I just investigated the case of
a police officer who committed a murder/suicide while on Viagra. It will be
interesting to see how many more reports begin to come in as the public
becomes more aware of the serious effects of this new wonder drug.

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

http://dailynews.yahoo.com/htx/nm/20010312/hl/viagra_blind_1.html

Monday March 12 12:07 PM ET

Doctor Links Viagra to Five Cases of Blindness

By Edward Tobin

NEW YORK (Reuters) – A US ophthalmologist says there
appears to be a very small risk that men taking the
impotence drug Viagra could suffer permanent vision
loss, but the firm that makes the drug on Friday
played down the reported threat.

Howard Pomeranz, director of neuro-ophthalmology at
the University of Maryland Medical Center, said he
knows of five men across the United States who were
diagnosed with permanent vision loss by doctors after
taking the impotence drug. More than 10 million people
have taken the drug since it was approved in 1998.

The condition, called ischemic optic neuropathy, is
caused after blood flow is cut off to the optic nerve
in the eyeball. It usually occurs in people with
diabetes, hypertension and other vascular disorders.

A spokesman for Pfizer Inc., which makes Viagra,
dismissed Pomeranz’s observations, which were first
presented at the American Academy of Ophthalmology
Conference in Dallas in November. The company
spokesman told Reuters that the three-year old product
is not a threat to its users.

“From all clinical experience with Viagra, there have
been no cases of treatment-related blindness reported,
and reports of serious visual problems have been
extremely rare,” said Geoff Cook, the Pfizer
spokesman.

Viagra, which is available in 100 countries, is known
to cause some temporary vision problems such as
blue/green color distortions in some patients.

Blood Flow To Optic Nerve Constricted

Pomeranz said the five men diagnosed with the
condition after taking Viagra had a low cup-to-disk
ratio, which is a way doctors measure the small
circular indentation where the optic nerve connects to
the eyeball.

The low cup-to-disk ratio means that the blood vessels
and nerves are tightly bundled together into the small
space in the back of the eye, according to a
University of Maryland release about the issue.

“We know that Viagra regulates a chemical in the body
to constrict the arteries. The constriction may cut
off the blood flow to the optic nerve, especially in
people with a low cup-to-disk ratio, where the blood
vessels and nerves are tightly bundled,” Pomeranz
said in the release.

Pfizer’s Cook associated potential permanent visual
damage with the known risk factors for men taking the
drug, such as diabetes, and not the drug itself.

“In the population of men who take Viagra, many men
with diabetes and other conditions have significant
associations with long term visual problems,” he
said.

The US Food and Drug Administration (FDA), which
reviews reports of drug side effects, said it had not
received any complaints of sudden blindness in
patients taking Viagra.

“We do not have any reports of people losing their
sight like that,” FDA spokeswoman Susan Cruzan said.

“We would take any such reports seriously, and we
encourage health professionals to submit any such
information to us,” she added.

Leonard Yaffe, analyst with Banc of America
Securities, said more information was needed before
evaluating what effect the report would have on
Pfizer. “I’d want to know how often the men were
taking the drug, for how long a period of time?” he
said. “You need to know a lot more than these five
guys had this problem.”

Pomeranz, who is also assistant professor of
ophthalmology and neurology at the University of
Maryland School of Medicine, called for more research
into the matter.

“People who take Viagra who have this particular
configuration of their optic nerve at least need to be
aware that this is a potential problem that may occur
if they use this medication,” he said. “Whether this
is a significant increased risk, I don’t have the
statistics to back that up.”

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02/15/2001 – Doctors Say Drug Trial's Approval was Backdated

Pfizer, makers of Zoloft and Viagra cannot seem to stay out of trouble
lately. This is one of several messes they have found themselves caught in
around the world lately. I thought all of you who barely survived your bouts
with Zoloft would be interested.

Not that Pfizer is the only drug company out there doing this type of thing.
They just got caught. I have learned over the last decade of doing research
on these issues that most drug companies would not blink an eye in deciding
to do the same. They are so often caught in such underhanded dealings that I
wonder why they are allowed to continue business.

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

http://www.washingtonpost.com/wp-dyn/articles/A63515-2001Jan15.html

Doctors Say Drug Trial’s Approval was Backdated

THW WASHINGTON POST

By Joe Stephens
Washington Post Staff Writer
Tuesday, January 16, 2001; Page A01

The Nigerian doctor who supervised a 1996 Pfizer Inc. drug experiment on
desperately ill children said in an interview that his office created a
backdated ethics approval document that the American pharmaceutical company
later used to satisfy U.S. regulators and to justify its conduct of the
human testing.

Abdulhamid Isa Dutse, the physician who oversaw the test of the antibiotic
Trovan on children with meningitis, said the letter may have been written as
long as a year after the test was completed when Pfizer officials asked him
for proof the test was reviewed by a Nigerian ethics board. Nigerian
officials are now examining the roles played by Dutse and others in
conducting the American company’s drug trial, which was the subject of an
investigation by The Washington Post.

Pfizer spokesman Andy McCormick said last week that he was unaware of
possible irregularities in the Nigerian ethics approval document. “We are
currently investigating it. We are cooperating with the authorities in
Nigeria,” he said.

The New York-based company gave the letter to the U.S. Food and Drug
Administration in 1997 during an audit of records supporting its application
to use Trovan for treatment of children during a meningitis epidemic. U.S.
regulations require that if a company intends to use foreign medical
research to support a drug application, the experiments must be reviewed and
formally approved in advance by an ethics committee.

FDA officials last week declined to comment on the Pfizer case, but one
official said it is a violation of federal law to knowingly submit false
documents to a government regulatory agency.

Typed on the letterhead of the Aminu Kano Teaching Hospital and dated March
28, 1996 — six days before Pfizer’s experiment began — the letter said the
hospital ethics committee had reviewed the plan to test Trovan on 100
children with meningitis and found the protocol to be “adequate.” The letter
gave permission for the test to proceed.

But Sadiq S. Wali, the hospital’s medical director, recently told The
Washington Post the document was “a lie.” He said the hospital had no ethics
committee at the time Pfizer’s test was underway and did not organize it —
or create the letterhead stationery bearing his name that was used in the
approval letter — until months later.

“The hospital is quite clear: We had no ethical committee,” he said in a
telephone interview.

Reached by telephone in Kano last week, Dutse said it was “possible” that
the approval letter was drafted up to a year after the trial.

Dutse, who was listed as Pfizer’s “principal investigator,” said he felt
that the letter reflected the informal approval he had obtained from three
doctors, who reviewed Pfizer’s test plans and told him they saw no ethical
problems. No records were prepared at the time, he said.

But one of the doctors Dutse cited, Idris Mohammed, last week disputed
Dutse’s account. Reached in London, Mohammed said: “There was no ethical
committee at the time of the trial, none met, and no approval was properly
given for the trial.”

In fact, Mohammed said that he challenged the legality of Pfizer’s
experiment while it was underway and that he demanded unsuccessfully to see
documents proving it had been properly authorized.

“You shouldn’t try an experiment in an epidemic,” said Mohammed, a medical
professor who now heads the Nigerian federal immunization program. “You
needed to give these patients something that was proven.”

Mohammed said that in 1996 he took his concerns to a senior official in the
Nigerian government — then controlled by a military dictator, Gen. Sani
Abacha — but was overruled.

Since the experiment, Pfizer repeatedly has cited the Nigerian committee’s
approval as proof its experiment was ethical. The testing was carried out on
children and infants during a record-breaking meningitis epidemic that
killed more than 15,000 Africans.

The Post’s Dec. 17 article recounted how Pfizer physicians tested the
company’s then-unapproved antibiotic in the impoverished northern Nigerian
state of Kano. The drug was later associated with liver damage and deaths in
the United States and its use was restricted.

Pfizer described the Nigerian test as a humanitarian venture, but medical
specialists and international aid workers attacked it as unethical and
challenged the company’s claim that the children knew they were part of an
experiment.

Pfizer officials have said that the Nigerian ethics committee approved
giving some Nigerian children an oral formulation of the antibiotic instead
of a fast-acting intravenous version used in U.S. meningitis tests.

A Pfizer spokeswoman also said the ethics committee decided there was no
need to warn Nigerian parents that young lab animals given Trovan-class
antibiotics had suffered joint damage. American parents were told of the lab
animal results in a subsequent Trovan trial.

After receiving a copy of the ethics approval letter from The Post, Wali
said he confronted Dutse and the doctor “did admit to me he was wrong,”
although he provided few specifics.

Tim Menakaya, Nigeria’s health minister, said he had appointed a federal
investigative panel charged with determining whether the trial was conducted
legally and, if so, whether the experiment was “morally right.”

“I am investigating all of it,” Menakaya said.

The probe is headed by Abdulsalami Nasidi, a senior health official who said
that he, like Mohammed, considered the experiment to have been unethical in
1996 but failed in attempts to block it.

“It is a very serious problem; procedures were not followed,” Nasidi said.
“We are going to get to the root of the problem.”

Nasidi said that his investigation, whose findings will be forwarded to
Nigerian President Olusegun Obasanjo, failed in initial attempts to locate
“detailed evidence” that Pfizer’s investigators had secured the needed
authorization before launching the experiment. Dutse said he spent two days
last week addressing a closed session of the panel.

The Post’s investigation has generated a flurry of stories in the Nigerian
press, which have reported that “widespread condemnation rages.” Editorials
have called for international investigations, federal lawsuits and criminal
prosecutions.

Nigerian newspapers — always fiery and at times less than entirely
factual — have quoted parents who contend their children had serious
disabilities or died after treatment.

“The government has a duty to tell us whether our children were used as
guinea pigs and, if so, who committed such criminality and who is liable,”
said the Vanguard newspaper.

© 2001 The Washington Post Company

~~~~~~~~~~~~

Pfizer accused of irregularities during clinical trial in Nigeria

THE GUARDIAN
Sarah Boseley, health editor
Wednesday January 17, 2001

http://www.guardianunlimited.co.uk/international/story/0,3604,423222,00.html

An inquiry is under way in Nigeria into allegations that the multinational
pharmaceuticals company Pfizer used an experimental drug on sick children
during a major outbreak of meningitis, without official approval.
Yesterday the Nigerian doctor employed by Pfizer to run the clinical trial
in Kano said that the letter certifying approval by the ethics committee at
the hospital where the children were treated was probably written a year
after the experiment took place.
Pfizer admitted last night that there did “appear to be possible documentary
irregularities” and said they were co-operating fully with the inquiry.
Pfizer sent a team in to Kano at very short notice in 1996, when it heard of
the outbreak of spinal meningitis. The company wanted to test the efficacy
of its new drug Trovan on children, and such outbreaks in the west are now
relatively rare……

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