Drug-Free School Zone?! JUST SAY NO TO PROZAC FOR CHILDREN.

[Guest guest]

SSRI-Research@

Sun, 08 Jan 2006 17:20:50 -0000

[sSRI-Research] " Drug-Free School Zone " ?! " JUST SAY NO " TO

PROZAC FOR CHILDREN.

 

 

 

 

 

Eli Lilly Internal Documents - Lilly Knew About Prozac Induced

Suicidality

 

Below is the time-line presented to the jury in the Forsyth v. Eli

Lilly Trial. It was presented during closing arguments by the

plaintiffs. It lists Lilly's internal documents. The plaintiffs

allege that it shows that Lilly knew about Prozac-induced suicidality

and violence (even before Prozac was approved for marketing in the

United States) and that this was withheld from the public.

 

-- http://www.baumhedlundlaw.com/media/timeline.html

 

 

 

 

----

 

Peter Breggin MD: Prozac: A Second Opinion

 

Only 286 people were used as a basis for Prozac's approval

 

-- http://www.tldp.com/issue/162/162psych.htm

 

Prozac is one of the most heavily prescribed psychiatric drugs in use

today, but there are good reasons to challenge its popularity. While

this medication is primarily prescribed as an antidepressant, it is

itself associated with depression, and other severe side effects,

such as nervous system damage. What's more, its use has been

implicated in suicides and homicides. To understand why this drug was

approved in the first place and how the public became brainwashed

into embracing it, we must first investigate cover-ups during the

testing phase and then look at the powerful interest groups behind

its promotion.

 

Worthless Clinical Trials

 

Dr. Peter Breggin, author of Talking Back to Prozac: What Doctors

Aren't Telling You About Today's Most Controversial Drug, believes

strongly that Prozac should never have been approved. He backs up his

assertion with a multiplicity of reasons.

 

First, studies were performed by the manufacturer's own hand-picked

doctors who chose to ignore evidence of Prozac's stimulant

properties. Patients becoming agitated were administered sedatives,

such as Klonopin, Ativan, Xanax, and Valium. This fact in itself,

Breggin says, invalidates the studies, because whatever effect the

patients were experiencing was not provided by Prozac alone.

Basically, Breggin argues, the FDA should have said, We're approving

Prozac in combination with addictive sedatives.14

 

Second, researchers lied about the number of people tested. Eli

Lilly, the manufacturer, claims that thousands of people received

Prozac in controlled clinical trials during its testing phase. In

actuality, the numbers were far lower, since those who failed to

complete the studies due to negative side effects were never

accounted for. FDA material, derived via the Freedom of

Information Act, shows that up to 50% of the test patients dropped

out of the studies because of serious side effects. In his book,28

Dr. Breggin reports that, in the final analysis, only 286 people were

used as a basis for Prozac's approval. Significantly, Lilly has never

challenged this information. They've had me under oath in court,

Breggin says, and they haven't contested a single word that I've

written in the book.14

 

Third, tests purposefully excluded the kinds of patients who would

later receive Prozac those who are suicidal, psychotic, and afflicted

with other emotional/mental disorders. Even now, Breggin reminds us,

Lilly could easily study how many people have attempted or committed

suicide since the drug's release:

 

One of the easiest things to study is whether your patients are alive

or not. It's much easier to study that than whether they've gotten

over their depression. That's a hard thing to judge. How do you know

somebody's feeling better or not feeling better? It's very

complicated. But it's very easy to see if a person made a suicide

attempt or if a person committed suicide...Lilly excluded all suicidal

patients from its outpatient studies that were used for the approval

of the drug. They also excluded patients who were psychotic, who had

all kinds of problems for which the drug nonetheless

is now given.14(tk)

 

We are now reaping the consequences of irresponsible approval. Dr.

Breggin has testified as a medical expert in an ongoing lawsuit, the

case of Joseph Wesbecker, who, while taking Prozac, shot 20 people,

killing eight of them and then himself. The data in that trial

indicate that Lilly knew beforehand that patients taking Prozac were

having much higher suicide attempt rates than patients taking placebos

or other drugs.

 

 

The Medical Industrial Complex

 

Why did Eli Lilly and the FDA use trickery to approve a drug it knew

to be ineffective and unsafe? Breggin says this happened because

psychiatry is part of the medical industrial complex, which, like any

industry, is looking to sell products:

 

One way to look at this is to consider the industrialization of

suffering. Getting Prozac from a doctor is very similar to getting a

Ford or a Toyota from a car dealer. We are at the end point of an

industrialized process with a product. Now, psychiatrists are like

salesmen in the car showroom. We go to a psychiatrist and he's going

to try and sell us a car, only the car in this case is a psychiatric

drug, and very frequently it's going to be Prozac.... The FDA is

influenced by what the manufacturers do and what the manufacturer

tells them.14(tk)

 

Prozac is not the first pharmaceutical to be questioned after FDA

authorization. Hundreds of drugs that initially pass their tests end

up having major label changes i.e., a major new warning has to be made

or wind up being withdrawn. In the field of psychiatry, the rate is

especially high. During the time Prozac was approved, about 16 other

psychiatric drugs passed

inspection, and nine of these have since had major label changes.

Breggin says that the FDA reveals the truth of the matter to

physicians, but not to the public: A few months ago, he reports, I

attended a full day's seminar put on by the FDA where they were openly

admitting this.... They had a black poster there that said, Once a

drug is approved, is it safe? No, it's not!' They were making the

point that many drugs turn out to be very dangerous after approval.14

 

There are a number of reasons why dangerous effects of medications

are not known early on. One is that the individual studies performed

by the FDA usually have a hundred patients or less. Four thousand

patients may be tested as 40 groups of 100. According to Breggin, this

means that scientists are less likely to notice a reaction in one patient:

 

They may think, Jane got depressed when she took Prozac but she was

probably going to get more depressed anyway. In 40 different studies,

40 or more people may be missed. Perhaps a fatal reaction shows up

once in 5,000,000. That's a lot of fatalities but it may not show up

at all in a group of 5000. Or it may be missed. Eli Lilly was

developing a drug for the treatment of a liver disorder. A couple of

people died from this drug but it was missed in the early stages of

the study. So, it's very easy for things to get through.14

 

In addition, FDA doctors have close affiliations with drug companies.

Paul Leiber, who approves psycho-pharmacological drugs at the FDA, is

known to have friendly communication with Lilly. Breggin states, This

guy is a friend to Prozac. One statement I found in the Lilly material

even says so. You have some real issues here having to do with the

collaborative kind of relationship. 14

 

There are always doctors who can be easily bought. When violence and

suicide were related to Prozac at FDA-held hearings, Breggin reports

that most of the doctors who were making the judgment at the hearing

were taking money from drug companies. One consultant, who supported

Prozac in court, was getting paid huge sums by Lilly to write a paper

on the subject. Another doctor who voted in favor of the drug was paid

by Lilly to tour the country and make speeches on its safety and

benefits. Dozens of them are getting paid by Lilly and doing clinical

research for them. Nonetheless, they think they can sit fairly in

judgment about whether Prozac is harmful or not.14

 

Breggin stresses that it all comes back to the fact that organized

psychiatry is part of a medical industrial complex. It is out to push

drugs, not ethics, he feels. It's not science but a myth. They're part

of industry. They're no more objective than doctors who work for

tobacco companies and say tobacco doesn't cause cancer.14

 

 

Side Effects of Prozac

 

Overstimulation

 

Prozac acts like a stimulant, and some of its side effects are thus

the same as those of amphetamines. Breggin explains that the major

adverse effects of the amphetamines like those of Prozac are

exaggerations of the desired effects, specifically stimulation,

including insomnia, anxiety, and hyperactivity....As is now commonly

done with Prozac, amphetamines were often prescribed along with a

sedative to relieve overstimulation.29

 

Overstimulating the central nervous system can cause a wide range of

symptoms, including agitation, anxiety, nervousness, increased

headaches, sweating, nightmares, insomnia, weight loss, and loss of

appetite. Two common manifestations of overstimulation are akathisia

and agitation, discussed below.

 

Akathisia The term akathisia refers to a need to move about. A person

feels driven to shuffle his or her feet, or to stand up and walk

around. At the same time, there is an inner sense of anxiety or

irritability, like chalk going down a chalkboard, only it's your

spine.14 The feeling can be mild or torturous.

 

Agitation Prozac can produce extreme feelings of agitation, often

associated with akathisia. Studies have shown 30 to 40% of people on

Prozac, even when some of them are taking sedatives, get agitated or

get akathisia. Both of these conditions are associated with violence

and suicide because they are related to a breakdown of impulse control.

 

 

Psychosis

 

When overstimulation becomes extreme, a patient's nervousness reaches

psychotic proportions. People become manic and do outlandish things.

They start directing traffic naked, or spending all their money.

Extreme overstimulation can ruin lives. People can become paranoid and

extremely dangerous to others, as well as bizarrely depressed and

compulsively suicidal. This effect was noted in FDA controlled studies

that were only four to six weeks long. Out of the 286 people who

finished the short-term studies, 1% became psychotic. Actually, the

rate may be higher than 1% since these were such short, controlled

studies, and the population of people studied was so narrow. As

mentioned earlier, the people chosen for the study

were carefully screened to exclude those with a history of being

manic depressive, schizophrenic, or suicidal. As a result, one can see

that the craziness people experienced was strongly associated with the

drug.

 

 

Depression

 

Depression is an aftereffect of overstimulation. While researching

FDA materials on Prozac, Breggin discovered that Lilly knew Prozac

caused depression and that, in fact, the company initially reported it:

 

Lilly admitted on paper, in its final statement about the drug's side

effects, that it commonly caused patients to get depressed. Then it

got scratched out at the FDA, along with a whole bunch of other

things. It went from being common,' and being scratched out, to not

even appearing under uncommon.' It just disappeared from the label.14

 

In other words, the manufacturer admitted that Prozac causes the very

thing it is supposed to cure. Ultimately, this places patients in

jeopardy. Breggin explains:

 

[People] start taking the drug, and in the beginning they feel

better. Maybe, after all, because it's just good to get a drug. They

feel like, wow, I'm doing something for myself. Or maybe the drug

gives them a burst of energy. Stimulants will do that. They will make

people feel energized. Then they get more depressed. They get suicidal

feelings. They don't know the drug hasn't been tested on suicidal

patients. They don't know that Eli Lilly once listed depression as an

effect of the drug. And so they end up thinking

they need more Prozac, and their doctor agrees. When that fails to

work, they end up eventually getting shock treatment, never knowing

that if they hadn't been started on Prozac they might never have

gotten so severely depressed.14

 

 

Tardive Dystonia and Tardive Dyskinesia

 

There have been reports of serious nerve damage with Prozac. Some

former users charge that Prozac has essentially wrecked their nervous

systems, leaving them with permanent disabilities such as tardive

dystonia, a condition in which muscles tense up involuntarily, or

tardive dyskinesia, in which there is involuntary movement.

 

Many psychiatric drugs, such as Haldol and Thorazine, are recognized

as causing tardive dyskinesia (TD) in roughly one out of five

long-term users, and warnings are contained in the manufacturers'

prescribing information cautioning against this permanent brain damage

caused by the drugs. But no such warning is provided with Prozac by

the manufacturer. The Prozac package insert does note that users of

the drug have developed dystonia and dyskinesia, but it contains no

suggestion that these conditions could become permanent. Current

medical knowledge holds that the permanent damage of TD is not

expected to develop until the person has been on the psychiatric drug

for a year or more, hence the name tardive (meaning late developing).

With Prozac, however, the condition can develop rapidly and without

warning.

 

Tardive dystonia and dyskinesia are conditions that should not be

taken lightly, because they can stigmatize a person for life. The

movements and postures associated with these conditions can look

bizarre, and may make a person seem quite mentally ill when in fact

his or her movements are side effects of medications intended to

alleviate mental illness. These symptoms can persist long after the

person has come off the drug, and in some cases they never remit at

all because parts of the brain that control muscle function have been

destroyed by the drug.

 

 

Sexual Dysfunction

 

Prozac affects serotonin levels and may therefore cause sexual

dysfunction. Men may find themselves unable to ejaculate or get an

erection, and women may have difficulty obtaining an orgasm. One study

showed this problem to occur in half the people using the medication.

Breggin says the percentage may be even higher, noting that many

people taking Prozac won't complain about sexual dysfunction because

this drug tends to make them less interested in other people. In fact,

Breggin terms Prozac an anti-empathy

drug for this reason. Even those in psychiatry who praise the drug,

Breggin points out, admit that it reduces sensitivity. That, of

course, can reduce sexual interest, and diminish whether you care

about having a sexual problem.14

 

Again, when Lilly studied this matter for the FDA, reports Breggin,

they found only a small amount of people were having sexual

dysfunctions. Then after the drug was approved, they found out that

they were wrong and that a very large percentage of people were having

this particular problem.14

 

 

Skin Rashes

 

Several kinds of rashes are associated with Prozac use. At the most

serious extreme, rashes that appear reflect serious immunological

disorders, such as lupus erythematosus or serum sickness, which is

accompanied by fever, chills, and an abnormal white blood cell count.

A few deaths have been associated with Prozac-induced skin rashes.

 

 

Cancer

 

Animal studies show that Prozac, as well as a number of other

anti-depressants, enhance tumor growth.

 

 

Biochemical Imbalance

 

If you don't have a biochemical imbalance before starting Prozac, you

certainly will have one once you are on it! Prozac has been shown to

have drastic effects on the brain's serotonergic system. Serotonin is

a neurotransmitter, or chemical messenger, that normally connects to

receptor sites and fires nerves. Prozac prevents serotonin from being

removed from the active place where it's working in the brain. It

keeps the sparks alive longer, and as a result, a lot of excess firing

takes place. The brain doesn't like all the overstimulation and

eliminates 30-40% or more of receptors. The brain, in effect, is

saying, I'm not going to have receptors for all this serotonin. It's a

compensatory mechanism for the overstimulation. Receptors can be

compared to catcher's mitts. The balls being thrown are like

serotonin. After awhile the brain just eliminates its catcher's mitts.

It says, I'm catching too much serotonin. I'm going

to get rid of my catcher's mitts.

 

Eli Lilly knew about the disappearance of receptors from their

laboratory experiments. What they failed to study, however, was

whether or not receptors ever come back. The experiment, which would

have been simple to perform, could have consisted of stopping the

drug, waiting a couple of weeks, sacrificing some of the animals, and

then seeing if their brains had come back to normal. The information

could also have been indirectly gleaned from performing spinal taps on

human beings before and after they had taken Prozac, to see if the

breakdown products indicated that the brain returns to normal. Neither

of these approaches were ever attempted. Obviously, Lilly is not

concerned with this issue.

 

 

Dependency

 

Since Prozac's release, millions of Americans have come to depend on

it and to believe that their lives are better because of it.

Concerning this reality, Breggin says:

 

First of all, I don't think Prozac should have been approved. But now

that it's out there it shouldn't be taken away from anybody who thinks

that it's helping them. People should be warned, however, about its

dangerous effects. If, for example, Joseph Wesbecker committed a mass

murder while on Prozac, then we're weighing the potential good of the

drug against some real disasters.

 

The other issue to look at is why people like to take drugs. The fact

that so many people feel helped by this drug doesn't necessarily mean

you or I would feel helped.

 

Evidence from the FDA trials suggests that this is a very poor drug.

Even a New York Times article recently said that follow-up studies

show Prozac as not very effective.

 

But when you give something to people and tell them it's a miracle,

they'll believe it.... Also, the drug does have stimulant effects. And

while we no longer believe that stimulants should be given for

depression, certainly people can feel like it's helping them.14

 

 

Overcoming Depression Without Drugs

 

At the core of the problem are psychiatric theories that limit the

range of acceptable human behavior. So emotional upsets are onsidered

diseases. When a child is anxious or can't concentrate in school, it

is called a disease. If someone is sad or depressed, it's called a

disease. Breggin says that counter to current dogma, there are real

reasons for emotional pain, and ways of becoming healthy that do not

involve drugs:

 

I think that depression comes from many different sources. I think

anybody who is depressed should have a medical evaluation. There are

tests for whether your blood sugar is functioning normally, whether

you have diabetes, whether you have hypothyroid disease, whether you

have Cushing's disease, whether your nutrition is poor, and whether

you need to improve your nutrition. So, general health matters.

 

While there are some diseases, on occasion, that can make a person

anxious, afraid, or depressed, it's far, far more likely that the

sources of human suffering at any given moment come from something

other than a psychiatric disease.... Most people become depressed

because of their life experiences. Life is very difficult. Life is

full of tragedy. From childhood on, people are exposed to a great many

stresses. Women, in particular, become depressed more often than men

and have good reason. It's harder for them to get many of their

desires fulfilled. It's often harder for them to make a relationship

feel satisfying. It's harder for them to have the same achievements in

the career arena. Almost anyone I talk with about being depressed has

a reason somewhere along the line for why their view of life

is filled with hopelessness.

 

Breggin feels that coming out of a depression involves understanding

what has gone into your life that has led up to your being depressed

and what ideas you have about life that aren't helping you to live

better, as well as learning new principles that are more positive and

creative. What I try to provide, he says, and what I think every good

therapist tries to provide, is a warm, supportive, encouraging

relationship to help a person rebuild hope and confidence in

themselves, to rebuild an idea about how to live life.

 

Breggin believes that a holistic approach to treating depression

allows a patient the opportunity to look at his or her life, and to

choose to live in a new and far better way. Depression, in that light,

is viewed as a signal that something is wrong, something is not

understood, or some values are not being fulfilled. While drugs can

jerk people out of their depression, they fail to help them deal with

life. Unfortunately, Breggin says, drugs are out there and millions

are taking them. Now, they are a basic part of American

life and it is really a matter of following the dollars back to the

drug companies and to organized psychiatry.14

 

 

Correspondence:

 

Gary Null, PhD

P.O. Box 918 Planetarium Station

New York, New York 10024 USA

212-799-1246

 

 

References

 

14. Gary Null interview with Dr. Peter Breggin, Nov. 9, 1994.

 

© 1983-2002 Townsend Letter for Doctors and Patients

.

http://www.tldp.com

info

360-385-6021

360-385-0699 (fax)

 

----

--------------

 

International Journal of Risk & Safety in Medicine 16 (2003/2004) 31-

49 31

IOS Press

 

Suicidality, violence and mania caused by selective serotonin reuptake

inhibitors (SSRIs): A review and analysis

 

Peter R. Breggin MD

101 East State Street, No. 112, Ithaca, NY 14850, USA

 

http://www.breggin.com/31-49.pdf

 

----

 

 

THE STORY BEHIND PROZAC... the KILLER DRUG

by Thomas G. Whittle and Richard Wieland

http://www.pnc.com.au/~cafmr/newsl/prozac.html

 

 

In the face of ever-mounting evidence of the dangers of the

psychiatric drug Prozac, the Food and Drug Administration (FDA) has

balked at moving against the antidepressant which has accumulated more

adverse reaction reports than any other substance in the 24-year

history of the FDA's adverse drug reaction reporting system.

 

Based on documents recently obtained by FREEDOM under the Freedom of

Information Act, as of September 16, 1993, 28,623 reports of adverse

reactions to Prozac had been received by the FDA.

 

These included such effects as delirium, hallucinations, convulsions,

violent hostility, aggression, psychosis, 1,885 suicide attempts and

1,734 deaths - 1,089 by suicide.

 

 

27 DEATHS DURING CLINICAL TRIALS

 

Additional documents obtained under the Freedom of Information Act

reveal that both Eli Lilly and Co., manufacturer of Prozac, and

officials of the FDA were aware that at least 27 deaths had been

linked to Prozac's use before the drug was released.

 

One of the documents shows that as of October 15, 1987, two months

before Prozac was allowed on the market, there had already been 15

suicides linked to it - six by overdose, four by gunshot, three by

hanging and two by drowning.

 

A total of 12 other deaths are also described in the document,

provided by Lilly to the FDA.

 

Despite the startling information about these 27 fatalities - a

substance has been recalled from the market (1) with as few as two

deaths - FDA officials failed to prevent Prozac from being released.

Instead, it was given final FDA approval on December 29, 1987.

 

 

1986 SAFETY REVIEW WARNED OF PROZAC'S DANGERS

 

Another document obtained under the Freedom of Information Act, dated

March 23, 1986, is a safety review of Prozac by the FDA's Richard

Kapit, who observed that " fluoxetine [Prozac] may exacerbate certain

depressive symptoms and signs. "

 

Kapit, a medical doctor, noted, " Certain clinical risks of mild to

moderate severity did appear to be associated with the use of

fluoxetine, as determined by a review of the safety data in this NDA

(2) submission. These potential risks include intensification of the

vegetative (3) signs and symptoms of depression. "

 

The 1986 FDA safety review also discovered that Lilly had failed to

report information about the onset of psychotic episodes in people

during Prozac's testing. No action was taken against the drug maker,

however.

 

Kapit concluded his safety review with this warning: " It is suggested

that labeling be developed which advises physicians about possible

exacerbation of the vegetative manifestations of depressive

illness.... If the drug is marketed, post-marketing studies should be

required to assess more precisely the severity of these potential risks. "

 

As early as 1986, in other words, long before Prozac was approved for

public consumption, evidence existed which linked Prozac to worsened

symptoms of depression and the onset of psychotic episodes - a fact

underscored by the 1,089 suicides as of September 16, 1993, along with

many episodes of senseless violence, homicide and even multiple murder.

 

Despite these deaths and Kapit's warning, today's Prozac bottle fails

to carry an adequate warning of the drug's dangers.

 

The FDA had another opportunity to act in the public interest in

September 1991, when its Psychopharmacologic Drugs Advisory Committee

held a hearing to review evidence showing links between Prozac and

similar psychiatric drugs and psychotic, violent acts.

 

For over three hours, more than two dozen Prozac victims or their

surviving family members recounted horror stories linking the drug to

multiple murders, suicide, attempted suicide, self-mutilation,

psychosis and other nightmarish effects.

 

The committee, however, ignored this information and voted against

this information and voted against relabeling Prozac to carry a proper

warning of its dangers.

 

 

CORRUPT RELATIONSHIP WITH DRUG COMPANIES

 

A lengthy investigation by FREEDOM and the Citizens Commission on

Human Rights has linked the FDA committee's failure to protect the

public from the dangers of Prozac to improper relationships between

its members and the drug companies which they are mandated to oversee.

 

At least five out of 10 of the members on the FDA's

Psychopharmacologic Drugs Advisory Committee had conflicts of interest

based on business dealings with manufacturers of antidepressant drugs

- including Lilly - totaling a minimum of $1,108,587.

 

In a memorandum for the public record, committee member David Dunner

of the University of Washington, prior to participating in the

hearing, had agreed to report any possible conflicts of interest to

the committee. He made the startling acknowledgment in his disclosure

statement that he had two $100,000 studies pending with Lilly. Also,

though Dunner reported having received approximately $100,000 to

conduct an ongoing study of a drug called Paroxetine, he made no

mention of the fact that this study also included Prozac.

 

Dunner also failed to report that he had been paid in the past to

conduct clinical trials of Prozac. In one instance, he conducted a

clinical trial for Prozac involving 100 people. The results of these

tests were submitted by Lilly with its New Drug Application, seeking

FDA approval of Prozac.

 

One day after the hearing, panelist Dunner was scheduled to speak at

a Lilly-sponsored seminar in Pittsburgh on " depressive disorders, "

with two similar events following shortly thereafter.

 

Dunner had already appeared at five such seminars and, at the time of

the hearing, knew he was scheduled to attend three more. Despite this,

and despite his financial connection to Lilly, he easily convinced the

FDA he had " no pending commitments at the present time " which would

represent a conflict of interest.

 

Five days after the committee rendered its pro-Prozac opinion, Dunner

received yet another Lilly grant; this one for a NEW study on the

effects of Prozac on sleep patterns. Research has brought to light

that Lilly has showered some $1.4 million on Dunner since 1982.

 

 

DRUG COMPANY STRATEGY: DESTROY THE CRITICS

 

After Prozac's harmful effects began to be exposed, the reaction of

Lilly was rabid and in alignment with the strategy of the

Pharmaceutical Manufacturers Association (PMA): to destroy all critics.

 

As cited in John Pekkanen's THE AMERICAN CONNECTION: PROFITEERING AND

POLITICKING IN THE " ETHICAL " DRUG INDUSTRY, " There are many different

divisions in the PMA, and files and background enough to attack

almost any allegation made against the drug industry. And that is

precisely what the PMA does. It does not defend the industry against

charges, it attacks the person making them. "

 

Thus, Lilly's Richard Wood and Mitch Daniels (4) declared war against

those who attacked Prozac.

 

Lilly is a major financial supporter of the PMA; Eugene Step,

longtime right-hand man of Richard Wood, sat on the PMA's board and

several PMA committees. Faced with sharp criticism of Prozac's dangers

which also cast an unfavorable light on similar antidepressants by

other manufacturers, the all-out attack was intensified.

 

One of Lilly's reactions consisted of issuing a statement that it

would indemnify doctors " against claims, liabilities or expenses,

arising from personal injury alleged to have been caused by Prozac. "

This was a testimonial to the mind-set that the amount of cash to be

gained through drug sales would offset the costs of any litigation.

 

To pump up sales, Lilly launched a massive campaign to a) popularize

" depression " as a modern illness for which a miracle cure was

available and b) vilify any opposition.

 

 

DAMAGE CONTROL

 

In its efforts to silence mounting public demand that the FDA order

Prozac off the market, Lilly turned to its public relations firm,

Burson Marstellar, to handle damage control on the bad publicity which

continued to envelop the killer drug.

 

In May 1990, Thomas D. Bell, an aide to then Vice President Dan

Quayle and one of his leading advisers, became vice chairman and chief

executive officer of Burston Marsteller's Washington, D.C., office and

subsequently acquired the Lilly account.

 

During his tenure as vice president, Quayle chaired the controversial

White House Council on Competitiveness which worked closely with the

Pharmaceutical Manufacturers Association to push through

administrative measures allowing the FDA to speed up its approval

process for new drugs. One of the provisions allowed the FDA to use

non-government scientific experts under contract to the FDA to review

pending drug applications. Critics have charged that this measure was

tantamount to the FDA relinquishing drug oversight to the drug makers

themselves.

 

Also at the Washington office of Burson Marsteller was Executive Vice

President Wayne Pines. Prior to signing on with the controversial PR

firm, Pines had been FDA associate commissioner for public affairs

from 1972 to 1982.

 

While helping to oversee the Lilly account, Pines continued to

maintain his many FDA connections, including his friendship with FDA

Commissioner David Kessler.

 

In yet another example of the FDA's incestuous relationship with

Lilly, Jim O'Hara recently assumed a position as spokesman for the FDA

following a 2 1/2-year stint with Burson Marsteller, handling " media

relations " for Lilly.

 

In " media relations, " O'Hara had spent the better part of two years

devising defensive measures for Prozac and Lilly, personally calling

dozens of reporters around the country in efforts to sell stories

attacking Prozac's critics.

 

Considering such ties, it is no surprise that the FDA has refused to

take effective action against Prozac.

 

 

FRAUDULENT NATURE OF CLINICAL TRIALS

 

Other documents released under the Freedom of Information Act show

the fraudulent nature of Prozac's clinical trials which led to FDA

approval of the drug. According to an FDA document dated March 28,

1985, guidelines constructed by Lilly for the clinical trials excluded

the reporting of " adverse experiences caused by depression. "

 

The FDA report admitted this skewed the results, stating: " NOTE: The

exhortation to exclude experiences caused by depression may have

altered the relative frequencies of many adverse experiences. Each

investigator would have had his own idea of what depressive

experiences might comprise resulting in a lack of generalizability

from one investigator to the next. Not surprisingly, many

antidepressants... do produce adverse effects which are known to be

symptoms of different kinds of depressions (e.g., insomnia,

nausea, anxiety, tension, restlessness) leading to a possible

under-representation of these effects. "

 

The subsequent under-reporting of adverse effects during the clinical

trials caused the scientific data on Prozac to be inaccurate, if not

completely fraudulent. Nevertheless, the FDA's Psychopharmacologic

Drugs Advisory Committee relied upon this information to assert that

Prozac was " safe " and " effective. "

 

Empirical evidence, however, has made clear what the FDA committee

was unable or unwilling to see: that Prozac causes suicidal ideation

and senseless violence.

 

Other FOIA documents show still more examples of agency officials

going to bat for Lilly.

 

In 1985, after tests of Prozac found the drug not to be significantly

more effective than the placebo, an FDA statistician suggested to

Lilly that the test results be evaluated differently - causing the

results to come out more favorably for Prozac.

 

And in August 1991, shortly before the FDA hearing on Prozac, a

document shows that the FDA executive Paul Leber, concerned about " the

large volume of reports of all kinds on Prozac (more than 15,000), "

pressured personnel in charge of the agency's adverse reaction

reporting system to discount the large number of reports of adverse

reactions to Prozac as " of limited value. "

 

 

THE RESULT: SUICIDES, HOMICIDES AND SENSELESS VIOLENCE

 

As a result of the FDA's actions and inactions, a powerful, mind-

altering chemical has been liberally dispensed for nearly six years,

triggering the highest number of adverse reactions for any

prescription drug - 10 times that of Halcion, for example, a

psychiatric drug which has been banned in the United Kingdom due to

its adverse effects but which is still available in the United States.

 

Eli Lilly and Co. was called and asked to provide its current

statistics regarding the adverse reactions to Prozac, including

deaths, as well as an explanation regarding the large number of

reactions. Lilly was also asked whether it would take the drug off the

market if deaths linked to the drug reached a certain number - say

50,000 or so. Lilly spokesman Ed West refused to comment.

 

FREEDOM called FDA Commissioner David Kessler for comment. The

commissioner was not in and he did not return our call.

----

 

 

PROZAC: CAUSING PHYSICAL DAMAGE

by Church of Scientology, International

 

Individual case histories and medical studies have shown that Prozac

harms the brain and the body.

 

The Physician's Desk Reference Family Guide to Prescription Drugs

lists side effects reported by Prozac users: heart attack, impotence,

hair loss, cataracts, kidney disorders, hepatitis, arthritis, breast

cysts, breast pain, convulsions, coma, migraine headache, bronchitis,

pneumonia, deafness, duodenal ulcer, stomach ulcer, gallstones, pelvic

pain, inability to control bowel movements, painful sexual intercourse

for women, urinary tract disorders, eye bleeding, spitting blood and

vomiting blood.

 

Clinical Pharmacy, for example, contained an article discussing " a

patient with no prior history of epilepsy who experienced a seizure

shortly after initiation of fluoxetine [Prozac] therapy. " (1) The

author concluded, " The temporal sequence of drug administration and

seizure occurrence and the reliability of the witness's account of the

episode suggest a possible relationship between the seizure episode

and fluoxetine therapy. " ...

 

1. Jeffrey J. Weber, Pharm.D., " Seizure Activity Associated with

Fluoxetine Therapy, " April, 1989.

 

----

 

The story behind Prozac is another typical example of how poisonous

and ineffective drugs are approved and protected in the United States

by the Drug Trust's important ally, the Food and Drug Administration.

Unfortunately, as in most other countries whose health matters are

controlled by the international drug cartelists, Australia's drug

evaluation and approval procedures are also a sham - because

decisions are based on research data supplied or financed by the

pharmaceutical companies, an industry that has a disgusting

reputation of fraudulent drug research and testing.

 

 

----

 

 

CAFMR Newsletter - Spring-Summer 1994 - Campaign Against Fraudulent

Medical Research, P.O. Box 234, Lawson NSW 2783, Australia. Phone +61

(0)2-4758-6822. URL: www.pnc.com.au/~cafmr

 

 

----

 

 

Reference & Notes to " The Story Behind Prozac " :

 

1. The amino acid L-tryptophan was recalled by the FDA in 1989 after

being linked with two deaths.

 

2. New Drug Application.

 

3. " Functioning involuntarily or unconsciously. " From DORLAND'S

ILLUSTRATED MEDICAL DICTIONARY (Philadelphia: 24th edition, 1965).

 

4. Wood was Lilly's chairman of the board and CEO; Daniels is

president of Lilly's North American pharmaceutical operations.

 

------------------------------

 

FDA SSRI Withdrawal - Suicide Warning

-- www.fda.gov/cder/drug/advisory/SSRI200507.htm

 

Please report your adverse effects from SSRIs

-- www.fda.gov/medwatch/report/consumer/consumer.htm

 

Links:

-- http://health.SSRI-Research/links/

 

Files:

-- http://health.SSRI-Research

 

" We live in an era in which 98% of pharmaceutical preparations have

no proven beneficial effects, in which the pharmaceutical industry

has created the fourth largest cause of death herself, the side

effects of medication, with the sole purpose of creating new markets

for its products. " -- Matthias Rath, M.D., 1999.

-- http://www4.dr-rath-foundation.org/

 

 

" JUST SAY NO " TO PROZAC FOR CHILDREN

 

 

 

 

 

 

 

 

Drug-Free School Zone? Just Say NO to Prozac for Children.