PROZAC The LEGAL Killer

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.