"All Truth passes through Three Stages: First, it is Ridiculed...|
Second, it is Violently Opposed...
Third, it is Accepted as being Self-Evident."
- Arthur Schopenhauer (1778-1860)
By Thomas G. Whittle and Richard Wieland
Aug 21, 1999
The Story Behind Prozac
the KILLER DRUG
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
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
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."
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.
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.
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
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.
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.
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
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.
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
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
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.
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"
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
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."
evidence, however, has made clear what the FDA committee was unable or
unwilling to see: that Prozac causes suicidal ideation and senseless
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.
FDA Commissioner David Kessler for comment. The commissioner was not in
and he did not return our call.
By Thomas G. Whittle and Richard Wieland
Aug 21, 1999