Deadly Shell Game
Who said 40,000
deaths was a
the FDA. But
thats only the
|By Robert Daniels|
looked up into the face of who was holding the rifle. He was completely gone. There was just nothing there of what makes a person a person. He was gone. And I thought that soon, I would be even more gone than he.
So stated one of the surviving victims of Joseph Wesbecker, who shot and killed eight former co-workers and wounded 12 others at a Louisville, Kentucky, printing plant before taking his own life. Wesbecker, it was later learned, had a therapeutic level of Prozac in his blood at the time of the massacre on September 14, 1989.
After learning of this and other incidents of harm attributed to Prozac, members of the Citizens Commission on Human Rights (CCHR) launched an information campaign to educate the public about the drug. The Church of Scientology began publishing in Freedom the information CCHR found.
Our interest, said Rev. Heber Jentzsch, President of the Church of Scientology International, was solely in keeping people from being killed. We saw a serious problem and decided to act.
Prozac had already garnered an astonishing quantity of adverse reactions in its then-brief history on the market, and was well on its way to the highest number in the history of the FDAs adverse reaction reporting system. Indeed, it has held the leadership position in adverse reactions since not long after its release, with no other drug anywhere in the running. Even Valium, now widely known as an addictive, dangerous and frequently deadly street drug, saw only 7,000 adverse reaction reports in more than 20 years. Prozac, today on the market for just 10 years, has more than 40,000.
The agencys response to CCHRs reports of the drugs dangers and growing public concern was a 1991 review by its Psychopharmacological Drugs Advisory Committee.
But the review turned out to be nothing short of a whitewash. Dozens of Prozac victims or their surviving family members told the FDA committee of horror stories linking the drug to multiple murders, suicides and other nightmarish effects. Yet the panel voted to do nothing. It was later documented that at least five of the 10 committee members had conflicts of interest at the time they reviewed Prozac. But, it seemed, the FDAs cover-up was complete.
And what was Lillys response? Not to do anything about either the drug or the lives that were being destroyed. Instead, the motif was a familiar one: Kill the messenger.
The firm launched a multi-pronged, international and ultimately unsuccessful public relations offensive against both CCHR and the Church of Scientology. As documented in court records, it included both their own literature and messages carried by other media, most notably Time magazine.
More recently, the FDA took its protection of a deadly drug to a new low at the expense of the public good. In November 1996, the agency rubber-stamped Prozac for use in treating bulimia.
Before that year had even begun, the FDA had reportedly received more than 35,230 reports of adverse reactions to the drug. But no one at the agency was moved to action, even when the number shot past the 40,000 mark.
The result: Many parties went to the courts for justice after loss or injury of a loved one linked to the drug. Among them were the survivors and relatives of Joseph Wesbeckers onslaught.
Truth Slowly Emerges
One of the courts to which victims turned was in Louisville. Circuit Judge John W. Potter presided over the 1994 trial of Lilly in a lawsuit brought by survivors and relatives in the Wesbecker shootings, while scores of additional cases waited on the sidelines for the outcome of what was effectively the test case.
The Lilly legal team had gone through 10 weeks of trial and had managed to keep the plaintiffs from presenting evidence to the jury regarding Oraflex, a Lilly drug that had caused deadly liver damage in more than 70 people in the 1980s. Lilly had ultimately pleaded guilty to 25 counts of criminal misconduct in federal court. And it had also sidestepped vast amounts of evidence regarding Prozacs harmful effects, attributing it to what it called a smear campaign, devoid of truth. The picture presented by Lillys counsel was one of a drug company which went the extra mile to protect the public from any possibility of harm, in accordance with FDA regulations.
But the scenario changed dramatically on December 6, 1994. Lilly, it seemed, had pressed its luck too far. Having put psychiatrist Robert Granacher on the stand to testify at length about the drug manufacturers purportedly unassailable standards in research and testing, Lilly had unwittingly opened the Pandoras box of its trail of human misery. By putting a safety witness on the stand, the drug maker had gone over the top and, in Judge Potters view, made safety an issue in the trial.
He held a lengthy conference with counsel. The plaintiffs lawyers pressed for a ruling that the Oraflex evidence earlier barred from the case as irrelevant could be admitted and presented to the jury. The next day, Judge Potter granted the motion and Lilly was faced with what appeared to be certain doom. If Oraflex came out, who was to say that plaintiffs couldnt admit evidence of other deadly Lilly drugs: Darvon, connected to up to 4,000 fatalities in one year alone; DES, an artificial hormone now banned for use by pregnant women after it was found that it caused cancer in the offspring of mothers who had taken it; even LSD and heroin. A recess was called until the next day.
But the Oraflex evidence never came. The next day, plaintiffs curiously and without explanation rested their case, abandoning what they had fought so long to get.
Judge Potter queried both sides as to whether there had been a settlement; the lawyers claimed universally that this was not the case. The words didnt seem to ring true; and, as it turned out, they werent.
The case went to the jury for a decision without the Oraflex evidence being presented. The jury narrowly acquitted Lilly. The drug maker immediately touted the verdict as evidence that other complaints were also invalid without disclosing that a secret settlement had taken place.
It has since emerged that a substantial pre-verdict settlement took place between the plaintiffs and Lilly. (See Day of Reckoning, Freedom, Volume 29, Issue 2.) In September 1996, after receiving evidence of the secret payoffs, Judge Potter turned investigation of the matter over to the Kentucky Attorney Generals Office, empowering it to subpoena and interview witnesses under oath.
In March 1997, Lilly finally admitted what it had denied for more than two years: That there had been a secret settlement with the plaintiffs in the Prozac case. Judge Potter had suspected all along that his court had been fraudulently used by Lilly for public relations advantage. He changed the judgment from not guilty by reason of jury verdict to case dismissed as settled.
But there was still the question of how much Lilly had paid the victims of Wesbecker. Lilly appealed to the Kentucky Court of Appeals, again seeking to prevent the truth in this case the settlement amount from becoming public knowledge. The disclosure of that remains in contention and although the money paid to the plaintiffs may never emerge as an official statement from the drug manufacturer, knowledgeable estimates put it in eight figures and possibly as high as $20 million or the equivalent of three days profits from Prozac.
And in April 1997, the Kentucky Court of Appeals allowed the Kentucky Attorney Generals Office to proceed with its probe, specifically charging it with determining whether the parties in the case deceived Judge Potters court. Later that year, the matter was assigned to another judge for further investigation.
The Greater Tragedy
Observers close to the scene in Louisville said that Judge Potter pursued the action because he believed the secret deal in his courtroom needed to be made public due to the large number of outstanding civil damages cases believed to be in excess of 80 against Prozac.
Clearly, Lilly officials were afraid of the companys misbehavior catching up with them. The Louisville case, however, is shaping up to be one that Lilly cannot buy its way out of.
At this stage, the question is not whether matters will get worse for Lilly, but how much worse. The greater tragedy is that the deadly drug central to the case and other dangerous drugs that have come before the FDA have been turned loose on the public at large. The cost to the public in terms of human misery is, apparently, irrelevant; what matters is the money that can be raked in. With international sales in excess of $700 billion, and ever-larger amounts from that sum being dumped into the FDA to accelerate drug reviews, its hardly a strain to see that the bottom line is a dollar sign.
FDA officials should be called to task for their role in sanctioning and covering up the suffering and death that arise from broad use of harmful legal drugs. And if Congress is looking for a real task in government cleanup in this session, the FDA is a place to start.