[SSRI-Research] Prozac And The Medical Industrial Complex

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SSRI-Research

 

9 May 2004 19:21:18 -0000

[sSRI-Research] File - Only 286 people were used as a basis for

Prozac's approval

 

 

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 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

 

 

 

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.

 

 

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