[SSRI-Research] : PROZAC: 27 Deaths During Clinical Trials/50,000 Linked to the Drug

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PROZAC: 27 Deaths During Clinical Trials/50,000 Linked to the Drug

 

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.

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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.

 

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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.

 

 

 

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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

 

 

 

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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.

 

 

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