5/15/2000 – Doctor lashes out in Prozac battle

The Boston Globe has wasted no time in doing a story based on
the Vickery & Waldner press release sent previously. Mark
——————

Doctor lashes out in Prozac battle

By Richard A. Knox, Globe Staff, 5/15/2000

Dr. Jonathan O. Cole, a Harvard psychiatrist who was one of the
first to suggest that Prozac and similar antidepressants could
precipitate suicide, is now criticizing drug companies and the US
Food and Drug Administration, saying they are failing to take the
problem seriously.

Cole made his complaint in support of a federal court lawsuit
that claims the drug Zoloft, a chemical cousin of Prozac, caused
a 13-year-old Kansas City youth to kill himself.

”I still believe our 1990 article was correct and it does happen,”
Cole said of the alleged suicide-antidepressant link that he and
other McLean Hospital researchers first suggested a decade
ago.

Although Cole had remained silent amid manufacturers’ efforts
to discredit his research, the Boston psychiatrist said he was
angered by the actions of Zoloft’s maker, Pfizer Inc., in fighting
the lawsuit brought by the family of Matthew Miller, the Missouri
teenager.

The youth had been taking Zoloft for only a week when he
hanged himself in his bedroom closet on July 28, 1997. His
parents insist he had never displayed suicidal tendencies and
had never been treated for behavioral problems. They say the
boy had been unusually restless and jumpy in the days before
his death – symptoms that Cole and other researchers say are
warning signs of alleged antidepressant-related suicides.

”Against this background … There is a clear prima facie case that
Zoloft caused Matthew Miller to commit suicide,” said Dr. David
Healy, a British researcher who is the family’s chief expert
witness.

Pfizer lawyers, calling Healy a practitioner of ”junk science,” are
asking Kansas City Federal District Court Judge Katheryn Vratil
to disallow Healy as an expert witness. Cole was recruited by the
Houston law firm representing the Miller family to vouch for
Healy’s scientific rigor.

Pfizer representatives say there is no credible scientific evidence
that Zoloft and related drugs precipitate suicide. Company
officials did not return telephone calls Friday seeking comment.

In the decade since Cole and Harvard colleagues first reported
on early cases of extreme agitation among people taking Prozac
and related antidepressants, use of these drugs – called
selective serotonin reuptake inhibitors, or SSRIs – has reached
84 million prescriptions a year.

The wholesale cost of SSRI prescriptions last year was $7
billion, a 15 percent jump from 1998, according to IMS Health, a
Pennsylvania research firm.

Moreover, US physicians are prescribing Prozac, Zoloft, and a
related drug called Paxil for ever-younger patients and for a
broadening list of disorders.

A University of Michigan researcher reported Friday in Boston
that nearly 2 percent of North Carolina children ages 6 to 14
received SSRI drugs in 1998. A growing number of physicians
are giving children prescriptions for SSRIs along with stimulants
such as Ritalin, the researcher said, despite the absence of any
studies supporting such use.

Dr. Jerry Rushton and his colleagues found that Prozac, Zoloft,
and Paxil are being used widely by children not only for
depression, but for school phobia, anxiety disorders,
bed-wetting, eating disorders, and attention deficit-hyperactivity
disorder. Their study was presented at the annual meeting of the
American Academy of Pediatrics and the Pediatric Academic
Societies.

While manufacturers have been successful so far in deflecting
criticism, opponents say the tide may be turning, due to lawsuits,
media reports, books, and statements from prominent scientists
such as Cole.

The Globe reported a week ago that Eli Lilly and Co., the maker
of Prozac, was aware more than a decade ago that suicidal
thoughts occurred in as many as 1 percent of patients who were
given the drug in early trials. Furthermore, the patent for a new
form of Prozac, invented by physicians at McLean Hospital in
Belmont and scientists at Marlborough-based Sepracor Inc.,
specifically mentions suicide as a possible side effect of the
original Prozac. Lily has embraced the new Prozac and plans to
market it within two years.

”I have seen patients and reviewed cases where an SSRI
unmistakably precipitated a driven preoccupation with suicide,”
said Cole, 74.

Such responses are unusual, Cole said, but they should be
taken more seriously by manufacturers and federal regulators.
”It’s a relatively small problem, but it exists,” he said in an
interview.

The problem, critics say, is that infrequent adverse effects are
magnified when millions of people take a drug every day. ”I
sense the scientific community is beginning to understand they
made a mistake in concluding that they could rule out suicide as
an adverse effect” from SSRI drugs, said Thomas J. Moore, a
drug industry critic at George Washington University in
Washington, D.C.

Nobody knows how many suicides have occurred among the
millions of people who have taken SSRI antidepressants.
Richard Ewing, a lawyer in a firm representing the Miller family,
said the FDA had recorded about 2,000 suicides between 1988
and 1997 that may have been related to the drugs, but says the
agency acknowledges that this is a small fraction of the probable
cases.

Healy, the British researcher, has estimated that as many as
50,000 suicides worldwide may be related to the drugs’ use.

Cole cited two studies by Texas researchers in 1993 and 1995
suggesting that about 1 in 200 patients reported having new
suicidal thoughts while on Prozac, while none did while taking
an older non-SSRI drug.

This rate ”sounds about right to me,” Cole said. It’s ”rare enough
to make most physicians not notice the effect, but common
enough to cause serious adverse effects, such as death by
suicide, in a few patients,” he said.

But Cole said no one has done the large-scale studies
necessary to pin down the frequency of SSRI-related suicides.
Such studies are not easy to do, since suicides are uncommon
events even among clinically depressed people and
researchers must distinguish those related to the underlying
depression from those preceded by the extreme agitation, called
akathisia.

”Although the manufacturers of SSRI drugs could and should
have done these studies, to my knowledge no manufacturer of
an SSRI drug has ever done a study where the primary outcome
of interest was to measure … suicidality” that emerged during
treatment, Cole said in a document filed with the federal court
Friday.

Cole also said an FDA advisory panel convened in 1991 to
consider the alleged SSRI-suicide link ”never came to grips with
the reality or non-reality of the phenomenon.”

But other researchers defend drug manufacturers and federal
officials for the way they have responded to studies suggesting a
suicide link. These include Dr. Anthony J. Rothschild of the
University of Massachusetts Medical School, who coauthored a
1991 study that the SSRI critics cite as evidence of a suicide
problem.

Rothschild and his colleagues administered Prozac to three
patients who had attempted suicide and found they developed
severe agitation and suicidal thoughts once again. Those
symptoms subsided when Prozac was withdrawn or when the
drug was countered by one with calming effects, according to the
study.

But Rothschild said he thinks Eli Lilly and Co., Prozac’s
manufacturer, and the FDA ”adequately addressed” the
concerns.

”The thing that disturbs me” about current SSRI critics,
Rothschild said, ”is the tone that suggests there’s almost a
conspiracy to cover up information and not do the right studies.”

This story ran on page A01 of the Boston Globe on 5/15/2000.
© Copyright 2000 Globe Newspaper Company.

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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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6/10/2000 – CBS Evening News Story on ADHD, Part II Tuesday

Monday evening CBS Evening News did a piece on the over
drugging of children in America. Sorry we did not get that
information to you sooner. Their summary is below. Hopefully
they will include a transcript of tonight’s piece on their site soon.
Tomorrow the news story is continued. Hope you can catch it.

Ann Blake-Tracy
____________________________

CBS Evening News

“On the HealthWatch, our Medical Correspondent Elizabeth
Kaledin will have the first of a two part report on the rising
number of kids being put on prescription drugs to treat Attention
Deficit Hyperactivity Disorder.

Tonight, Elizabeth will look at one Virginia school district where
an amazing 17% of the children are on medication to treat ADHD
and at a family in Texas that has weaned their child from
psychiatric drugs and has teamed with his teacher to shape his
behavior with no-nonsense discipline.”

Dan Rather

“P.S. On Tuesday’s CBS Evening News, we’ll have the second
part of our report on ADHD (Attention Deficit Hyperactivity
Disorder) and the medicating of our kids–in part two, Elizabeth
Kaledin will look at some of the alternatives to drugs. Please join
us.”

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5/8/2000 – Secret files protect dangerous doctors

Secret files protect dangerous doctors

HARTFORD, Conn. (AP) _ A little-known government database
tracking malpractice suits and disciplinary action against
physicians remains unavailable to the general public, and at
least one congressman says dangerous doctors have hidden
behind that shield of secrecy long enough.

But standing in his way is the American Medical Association and
a powerful medical lobby, The Hartford Courant reported in
weekend editions.

The newspaper, using a public version of the database which
does not have names or other identifying information,
nevertheless deduced the names of several doctors who have
repeatedly faced malpractice charges but continue to practice.
One such surgeon was nicknamed “Eric the Red” because of
the way his patients bled.

The Courant said it identified the doctors by comparing the
anonymous data in the database with court records, regulatory
files and other public records.

U.S. Rep. Thomas J. Bliley Jr., R-Va., chairman of the House
Commerce Committee, unsuccessfully championed legislation
this year that would have opened the National Practitioner Data
Bank to the public.

“Now is the time to open the data bank,” Bliley told The Courant.
“It is unconscionable that consumers have more comparative
information about the used car they purchase or the snack foods
they eat than the doctors in whose care they entrust their health
and well-being.”

Federal law prohibits anyone other than hospitals, health
maintenance organizations and licensing boards from using the
complete database.

In its Sunday editions, The Courant reported the Fairfax,
Va.-based data bank lists malpractice payments of $25 billion
against more than 100,000 doctors, or one of every six
physicians in the country.

At the top of list, the newspaper said, is Dr. Eric Scheffey, a
Houston orthopedic surgeon. The data bank shows Scheffey
involved in 29 malpractice payments totaling $8 million.

After the 1985 death of a back surgery patient, Scheffey’s medical
license was put on probation, but he was allowed to keep
practicing. The 1994 death of another patient resulted in five
more years’ probation from the Texas State Board of Medical
Examiners. He can still practice but cannot perform operations
without another surgeon present.

Residents in a hospital where Scheffey worked gave him the
“Eric the Red” nickname, court records show.

Scheffey could not be reached for comment Sunday. Phone
messages from The Associated Press were left with his
answering service, where an operator said he was unavailable
until Monday. Calls to a private listing went unanswered. He also
did not respond to several attempts by the newspaper to contact
him.

The AMA has fought to keep the data bank closed to the public,
arguing that malpractice payments are an unfair measure of a
doctor’s abilities.

“Even some of our nation’s finest physicians who specialize
high-risk cases are involved in settlements,” said AMA President
Thomas Reardon.

He said the data bank was intended to allow only regulators and
hospitals to flag problem doctors who move from state to state,
and the general public could misinterpret or overreact to the raw
information.

But the patients who must live with their doctor’s mistakes say
access to the bank is a matter of public safety.

Christine Hachey, a Scottsdale, Ariz., travel agent, said she was
not aware of any complaints against the eye doctor accused of
botching her surgery. Dr. Gary Hall, of Phoenix, had accumulated
more than two dozen malpractice payments totaling $5.3 million
before his state medical board prohibited him from performing a
certain type of surgery.

It came too late for Hachey, who now needs a large magnifying
glass to read. “This really makes me angry,” she told The
Courant upon learning of the data bank. “I never knew any of
this. I can’t believe the system is so secretive. How are you
supposed to know whether your doctor is any good?”

In a letter to The Courant, Hall said his insurance company had
settled cases “without my consent” and noted he had performed
25,000 radial keratotomy operations.

“Therefore, though the number of entries in the National
Practitioner Data Bank appears high, it still represents a very
small percentage of the total number of cases I performed,” he
wrote.

Copyright 1999 Associated Press. All rights reserved. This
material may not be published, broadcast, rewritten, or
redistributed.

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5/7/2000 – Anti-depressants get into water system

One more of my worst fears has just been confirmed. This is
exactly why I have allowed nothing but distilled or reverse
osmosis processed water into my home for years. It is also why I
have great concern over cities where the water is fluoridated.
With Prozac being 18% fluoride and it being a main ingredient in
Paxil, Luvox, Phen-Fen, etc. I am concerned that there may
possibly be a synergistic effect from the water that could throw
patients on these drugs into toxic reactions. My concern is that
no one has looked at this possibility with fluoride or any other of
the chemicals put into our city water supplies.

When it comes to drugs or chemicals and how they effect us and
our environment, society remains oblivious! We, like our
teenagers, tend to think we are invincible rather than human and
mortal.

Ann Blake-Tracy

Anti-depressants get into water system

May 7 2000 BRITAIN Roger Dobson

AN investigation is to be launched into the environmental effects
of pharmaceuticals amid new fears that tons of anti-
depressants and scores of other toxic drugs are polluting rivers,
threatening fish life and getting into drinking water.
Pharmaceutical companies are being given until the end of the
year to supply data on their drugs to the Environment Agency so
their impact can be researched.

Scientists in Europe have discovered that increasing numbers of
complex drugs – including heart medication, anti-depressants,
anti-epileptics, anti-cancer chemicals, cholesterol-lowering
medicines, sex hormones, antibiotics, hormone replacement,
aspirin, vitamins and ibuprofen – are surviving the human
digestive system, passing through sewage works and entering
rivers and the sea.

Dr Thomas Ternes, of Germany’s Institute for Water Research,
carried out sampling at one sewage works outfall and found 36
different drugs, plus five other compounds that had been
metabolised from them before they left the patient. Scientists are
blaming the drug pollution for some of the widespread and until
now unexplained mass deaths of tiny aquatic organisms. Some
drugs, especially anti-depressants, have also been found to
alter sperm levels and pawning patterns in aquatic life. Musks
and chemicals used in perfumes, and compounds from suntan
lotion, have been found to have accumulated in fish. Each year
in Britain about 600m prescription drugs and medicines are
dispensed.

Most of the research on environmental effects on drugs in rivers
has been done in Germany and Denmark; little has been carried
out in Britain. However, later this month at a world congress of
scientists in Brighton, the Environment Agency will lay down the
timetable for an investigation into the effects of the drugs. “We
have commissioned a review, which is due to be completed
within the next two weeks. There is limited data in Britain about
this issue and we don’t routinely monitor, said Dr Steve Killeen,
head of chemistry at the agency. “The report will make a series
of recommendations, including getting the pharmaceutical
industry to provide us with better information by the end of the
year. If we find that levels of drugs are causing environmental
damage, regulations are an option open to us.”

Stricter regulations could involve the need for more complex
sewage works to screen out the chemical compounds. A
conference to be held in America next month will also attempt to
quantify the problem for the first time. “Just about everything
people put into their mouth eventually gets into the water, said
Dr Christian Daughton, chief of environmental chemistry for the
US Environmental Protection Agency. “Serotonin, for example,
has been used to induce spawning in mollusks. Many
anti-depressants which are ending up in rivers are designed to
interfere with serotonin production in humans and may affect
spawning,” he said.

“Pharmaceuticals are perhaps also one of the reasons for
unexplained mass die-offs in some organisms that we see from
time to time.”

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5/7/2000 – Drugmaker: Breast Cancer Drug Linked to Death

Adverse Reaction
Drugmaker: Breast Cancer Drug Linked to Death

By Jessie Seyfer
The Associated Press

S A N F R A N C I S C O, May 5 — Pharmaceutical maker
Genentech Inc. has warned doctors that the breast cancer drug
Herceptin is linked to 15 deaths and 47 other adverse reactions
in patients.

In a letter to doctors sent Thursday, the company said the
adverse effects included allergic shock and extreme respiratory
distress.

“We sent the letter to oncologists to heighten their awareness
and educate them about infrequent adverse events that can
occur in certain patients,” Genentech spokesman Neil Cohen
said.

An estimated 23,000 patients have been treated with Herceptin.

Severe Reactions
Severe reactions to Herceptin had not occurred in clinical trials
before the drug gained Food and Drug Administration approval
in 1998, Cohen said.

But sometimes reactions can’t be foreseen in trials, he said.

“A lot of times you might see some safety issues once the drug
gets put into a larger patient population,” Cohen said.

Cohen said he didn’t know when the company first heard of the
deaths and reactions, but analysis had confirmed the link to
Herceptin.

Symptoms Seen Within 24 Hours
In nine of the 15 deaths, symptoms arose within 24 hours of the
time Herceptin was administered, according to the letter.

Genentech is working with the FDA to have the drug’s label
amended to reflect the new risks, Cohen said.

Herceptin is used to treat breast cancer patients that have too
many copies of the HER2 gene. A healthy version of this gene
produces a protein that signals cells to grow and multiply
normally. But in women with too much HER2, the breast cells
reproduce out of control and spread throughout the body.
Herceptin, an antibody, blocks excess HER2, shrinking and
eliminating tumors.

Copyright 2000 The Associated Press. All rights reserved. This
material may not be published, broadcast, rewritten or
redistributed.

http://www.abcnews.go.com/sections/living/DailyNews/breastca
ncer_drug0505.html

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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/

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Redux caused my Pulmonary Hypertension

“I had never been diagnosed with any of these things before taking Redux.”

 

Hi, My name is Bev and I took Redux for approximately 9 weeks ending with the drug recall 9/12/97. While on the drug I had a lot of symptoms of flushing especially in the face, dizziness when laying down where the room would spin around. I was told this was just getting use to the drug. I was more agitated than usual, but I did not notice any other physical problems until a few month off the drug when I had heart fluttering and what felt like skipping beats. I started having one flu like symptom one after another for about 9 months and was told I had bronchitis, sinusitis, asthma during this period. I never related any of this to the drug. During this time I had 3 echoes done two by the drug manufacturer since I was on a clinical trial and it showed that my valves had 3 valves with trivial insufficiency. I thought I got off pretty lucky.

However, by the close of the summer of 1998, (one year later) I was getting short of breath and having problems just driving to the store a few blocks away and stepping down on my feet, my ankles would hurt. There was some swelling but I believe I was hoping it was from arthritis. I also had trouble with tingling in my hands and feet almost like little needles poking you. I would toss and turn and have a difficult time falling asleep and when I did I would sometimes jump up feeling like I could get any air. I remember when we lit a fire in the fire place that winter that I went into a real allergy attack from the smoke. I was diagnose with dyspnea (shortness of breath) in 9/99. I had a scan done to see if I had an embolism and there was none. Blood work was completed and they check for arthritis and many other types of conditions and the only thing that was abnormal was my blood gases which said my oxygen was at 67 very low. I was suffering from confusion and forgetfulness. I had stopped menstruating for almost a year and then had terrible bleeding for 8 days straight. That has not finished with me yet. I am 53 years old and I know it should stop I hope soon. I was encouraged by friends to get another echo done but to have a stress echo done this time. I went to UC San Diego and had my echo performed and at that time it was discovered that my mitral valve was now mild and my tricuspid valve was moderate and that it appeared to be normal left ventricular systolic function but the right heart was now mildly enlarged and the baseline echocardiography suggests mild pulmonary hypertension with stress. The doctor wanted to perform a right heart Catherization soon and I went back there again for that procedure and to perform a sleep study. It was determined at that time that I did have pulmonary hypertension, but secondary to sleep apnea.

Now the problem is what caused it. I had never been diagnosed with any of these things before taking Redux so why would they all start to show up now. Anyway, now I must were a mask to bed every night that lets in enough air so I can breath. I believe that this is all related to taking that drug. I wonder how many others out there have had similar experiences.

Bev

5/5/2000

This is Survivor Story number 22.
Total number of stories in current database is 96

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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.

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