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

October 26, 2003

Hi Friends:

This is such an excellent book.

Just me... Jan

Encourage One Another

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Breggin MD: Prozac: A Second Opinion

(author of: " TALKING BACK TO PROZAC: What Doctor's

Aren't Telling You About Today's Most

Controversial Drug " )

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.

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Worthless Clinical Trials

Dr. 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 ph 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.

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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.

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

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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.

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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.

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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

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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.

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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

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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.

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Cancer

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

anti-depressants, enhance tumor growth.

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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.

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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, ph 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

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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 considered

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

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Correspondence:

Null, PhD

P.O. Box 918 Planetarium Station

New York, New York 10024 USA

212-799-1246

References

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

.

http://www.tldp.com

info@...

360-385-6021

360-385-0699 (fax)

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October 26, 2003