Fwd: [SSRI-Research] The Lilly Suicides - Richard DeGrandpre

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[sSRI-Research] The Lilly Suicides - Richard DeGrandpre

 

The Lilly Suicides - Richard DeGrandpre

 

http://prozacspotlight.org/lilly/

 

 

The Witness

 

In the final days of the 20th century, a North Wales psychiatrist named David

Healy conducted a curious study, and with more than a curious result. Twenty

volunteers with no history of psychiatric problems were recruited, half of whom

were given the drug Zoloft, an antidepressant from the Prozac family of drugs

known as the SSRIs, or " selective serotonin reuptake inhibitors. " The other half

were given an antidepressant that, unlike Zoloft and Prozac, does not

selectively target the brain chemical serotonin. Each group took their

respective drug for two weeks and then, shortly thereafter, switched to the

other.

Healy had designed his " healthy volunteer study " to compare the psychological

experience of being on a serotonin antidepressant versus a non-serotonin

antidepressant, but before he knew it, two of his volunteers became dangerously

agitated and suicidal. Both were taking the SSRI drug. The adverse reactions

couldn't easily be blamed on psychological instability - these were healthy

volunteers. And the rate of 10 percent made it clear that such results were not

so rare as to be incidental.

 

Healy was surprised at the effect, but he would not stay surprised. Some months

later, when serving as an expert witness in a civil action against Zoloft's

manufacturer, Pfizer, Healy obtained access to the company archives. There he

discovered an unpublished study from the 1980s in which healthy female

volunteers were given either Zoloft or a placebo. The study was canceled four

days later, after all those taking Zoloft began complaining of agitation and

apprehension. Healy's case was not so bad; in fact, some of his volunteers rated

Zoloft positively. Of the two who did not, one was a 30-year-old woman who,

within two weeks of starting the drug, became obsessed with the idea that she

should throw herself in front of a car. " It was as if there was nothing out

there apart from the car which she was going to throw herself under, " Healy

reported. " She didn't think of her partner or child. "

 

The Zoloft case was not Healy's first involvement in a civil action against an

SSRI manufacturer. Earlier, he had been involved in a wrongful death suit

against Eli Lilly, the maker of the much celebrated SSRI drug, Prozac. An

internationally renowned psychiatrist as well as a historian of psychiatric

medicine, Healy's recruitment onto the plaintiffs' side was a small but

significant victory. Prior to his involvement as an expert witness, Healy had

already raised a number of questions about the SSRIs, including the possibility

that they might produce agitation and other problems with an unusual frequency,

sometimes leading to suicide. Healy was also ideal because he's not a radical,

nor an outsider; he has done research and consulting for various drug companies,

and has himself prescribed SSRIs and other psychiatric drugs. In fact, he had

been consulted on several SSRI suicide cases in which he had concluded that the

SSRIs were not at fault.

 

This view changed, however, with the case of William Forsyth.

 

The Victims

 

William Forsyth met and married his wife June in 1955. After two years of

military service in West Germany, Bill and June moved to Los Angeles, where Bill

had grown up. After arriving, Bill started a rental car business, and the couple

had two kids, Susan and Bill Jr. The business and other investments continued to

grow, and in 1986 the Forsyths cashed in. Four years later, Bill and June

retired to Maui, the Hawaiian island that their son called home. Bill was 61 at

the time. June was 54.

 

Despite the romance of a new life, the transition was difficult for Bill

Forsyth. Personal difficulties led to marital difficulties. Marriage counseling

seemed to help, though, and by the next year there was a general sense that Bill

was on the mend. Three years after the move to Hawaii, however, with Bill still

feeling unsettled, a local psychiatrist prescribed Prozac. The psychiatrist, who

had been seeing Bill since the previous year, did not believe Bill to be either

seriously depressed or suicidal.

 

After his first day on the drug, Bill was feeling as you might expect if

you've read Peter Kramer's Listening to Prozac - he was " better than well. " The

next day, however, he felt horrible, and for the first time put himself under

hospital care. Ten days later, Bill felt well enough to leave the hospital, but

was still taking Prozac. Everyone seemed to agree that he was doing better, and

the family scheduled a boat trip for the next day. When his parents failed to

show up that afternoon, Bill Jr. went to their home, where he found both his

parents lying dead in a pool of blood. Eleven days after starting on Prozac,

Bill Forsyth had taken a serrated knife from the kitchen and stabbed his wife 15

times. He had then taken the knife, fixed it to a chair, and impaled himself on

it.

 

Depressed people sometimes do desperate things. Yet these were senseless

acts that were simply unimaginable to those who knew Bill Forsyth. For his two

grown children, the only possible explanation was the drug. They decided to sue.

 

The Forsyth case was not the first wrongful death suit to be brought

against Eli Lilly. By the fall of 1994, a year after the Forsyth murder-suicide,

there were already 160 cases filed against Lilly, linking Prozac to homicides,

suicides, and other violence. Many of these cases were dismissed; others ended

with cash settlements. But Lilly had not lost a Prozac case, and was determined

to keep it that way. By the mid-1990s, Prozac sales were worth $2 billion per

year, or about a third of all Lilly's income.

 

In March 1999, with Susan and Bill Jr. refusing to settle, the Forsyth

case finally made it to trial in United States District Court in Honolulu. " I

know that with all their power and money I don't have much of a chance, " said

Susan at the time, " but I feel like I have to try. " With David Healy serving as

an expert witness, the Forsyth's lawyers went on to argue that the Prozac family

of drugs can produce a kind of psychological hijacking - a bizarre and

nightmarish syndrome marked by suicidal thoughts, extreme agitation, emotional

blunting, and a craving for death. They also argued that the company knew of

these risks and, instead of warning doctors to look out for them, worked

vigilantly to sweep them under the rug.

 

 

 

The Evidence

 

Though Prozac is one of the world's best-known commodities, its most

terrifying potential side effect, " akathisia, " remains virtually unknown.

Akathisia has been described as a unique form of inner torture that, prior to

the development of psychiatric drugs, probably never existed. Knowledge of the

side effect, however, has been around for a while. In 1978, 10 years before

" fluoxetine " would be brought to the US market and become the bestseller known

as Prozac, initial clinical trails had already warned of akathisia and other

problems. Minutes from Lilly's Prozac project team in that year noted that,

" Some patients have converted from severe depression to agitation within a few

days; in one case the agitation was marked and the patient had to be taken off

[the] drug . . . There have been a fairly large number of reports of adverse

reactions. "

 

As the Forsyth case and others would go on to reveal, Lilly's internal

records revealed considerable awareness within the company. A letter sent to

them from the British Committee on Safety of Medicines in 1984 reads: " During

the treatment with [Prozac] 16 suicide attempts were made, two of these with

success. As patients with a risk of suicide were excluded from the studies, it

is probable that this high proportion can be attributed to an action of the

preparation. " Similar concern was expressed by German authorities in 1985, where

Prozac is sold as " Fluctin, " and with required warnings of possible akathisia

and suicide. A Lilly document dated from March of that year even quantifies the

problem, suggesting a rate of suicide for Prozac 5.6 times higher than for the

antidepressants that were popular before the rise of the SSRIs - the tricyclics.

" The benefits vs. risks considerations for fluoxetine [Prozac] currently does

not fall clearly in favor of the benefits, " the document

concludes. By 1986, clinical-trial studies comparing Prozac with other

antidepressants showed a rate of 12.5 suicides per 1,000 users compared to only

3.8 per 1,000 on older, non-SSRI antidepressants, and 2.5 per 1,000 on placebos.

 

After Prozac's entry into the market in 1988, reports quickly surfaced to

confirm that the beast Lilly saw in the laboratory had now, without warning,

been unleashed upon the public. In 1990, a report appeared in the American

Journal of Psychiatry on the " Emergence of Intense Suicidal Preoccupation During

Fluoxetine Treatment. " Two Harvard psychiatrists and a registered nurse

described cases in which patients developed serious preoccupations with suicide

soon after being given Prozac. " We were especially surprised to witness the

emergence of intense, obsessive, and violent suicidal thoughts in these

patients, " they commented. " It was also remarkable how violent these thoughts

were. Two patients fantasized, for the first time, about killing themselves with

a gun, and one patient actually placed a loaded gun to her head. One patient

needed to be physically restrained to prevent self-mutilation. "

 

Two years later, in July 1992, another article appeared, this time in the

Archives of General Psychiatry. Again, the article had two senior researchers

among its authors, one of whom was a leading expert on akathisia. The

psychiatrists stressed in the report that, prior to going on Prozac, none of

their patients had a history of significant suicidal behavior. " All described

their distress [while on Prozac] as an intense and novel somatic-emotional

state; all reported an urge to pace that paralleled the intensity of the

distress; all experienced suicidal thoughts at the peak of their restless

agitation; and all experienced a remission of their agitation, restlessness,

pacing urge, and suicidality after the fluoxetine [Prozac] was discontinued. "

 

The finding that these problems emerge soon after an SSRI drug is taken,

and then disappear soon after the drug is withdrawn, provides compelling

evidence that the problem is often the drug and not, as the makers of SSRIs have

insisted, the depression. Anthony Rothschild and Carol Locke, also of Harvard

Medical School, reported three such cases in the Journal of Clinical Psychiatry

in 1991. All three individuals had previously attempted suicide while being

treated with Prozac - in fact, each had jumped from great heights and had

managed to survive. In turn, all three had been put back on Prozac, only to

complain of the same strange desire to kill themselves.

 

" I tried to kill myself because of these anxiety symptoms. It was not so

much the depression, " said one of the individuals, a 25-year-old woman. Another,

a 47-year-old man, complained that " this is exactly what happened the last time

I was on [Prozac], and I feel like jumping off a cliff again. " Reflecting on

these cases, the Harvard researchers stressed that patients need to know that

such overwhelming symptoms are the side effects of medication, and are

treatable. " Our patients had concluded their illness had taken such a dramatic

turn for the worse that life was no longer worth living. "

 

 

The Reckoning

 

Michael Grinfeld summed up Lilly's legal situation well, and

prophetically, writing in California Lawyer magazine in 1998: " Lilly may

eventually face a court judgment in a Prozac case, but it has succeeded beyond

all expectations in postponing that day. " Indeed it has. On April 2, 1999,

despite David Healy's testimony and the surfacing of the Lilly papers, the jury

in the Forsyth trial found in favor of Eli Lilly. In the eyes of the jury,

Prozac did not cause Bill Forsyth to kill his wife and then himself.

 

While Lilly has continued to survive all legal challenges to date,

not all plaintiffs' cases involving the SSRIs have ended in defeat. In May 2001,

Australian David Hawkins was freed from prison after a supreme court judge said

it was " overwhelmingly probable " that Hawkins would not have killed his wife or

attempted suicide had he not been using Zoloft. In another 2001 case, a Wyoming

court found against GlaxoSmithKline, maker of the SSRI Paxil. The jury found

that Paxil can cause some individuals to commit suicide and homicide, and had

done exactly that in the case of 60-year-old Donald Schell. After complaining of

anxiety, stress, and possible depression, Schell had been prescribed Paxil by

his family doctor. Two days later, Schell shot to death his wife, his daughter,

his infant granddaughter, and then himself. David Hawkins, too, had committed

homicide after his first two days of SSRI treatment.

 

Stories like these litter the communities of North America and

Europe, most of them concealed behind the confusion and secrecy that so often

mark sudden family tragedies. By the spring of 1999, 2,000 suicides by Prozac

users had been reported to the Food and Drug Administration, at least a quarter

of which appeared to be linked to agitation and akathisia. According to the

FDA's own estimate, only about one percent of serious side effects are ever

reported on its " adverse event system. " This means that, as David Healy has

concluded, as many as 50,000 akathisia-related suicides had taken place by 1999.

The total estimate for all SSRIs would of course be much larger.

 

In the face of such statistics, and with the loss of their exclusive

patent on fluoxetine, Lilly announced in December 2001 that they planned to

bring another antidepressant to market late in 2002. Not surprisingly, the new

drug, duloxetine, does not selectively target serotonin. The SSRIs, once hailed

as a revolution in the treatment of depression, are now in the process of being

phased out. Oddly, this is making way for pharmaceuticals that act in

essentially the same way as the drugs that the SSRIs originally replaced. Given

this backward trend, one is left to wonder whether all the death and misery

linked to the SSRIs might have been for naught. If so, a final conclusion seems

unavoidable: that next to big tobacco and the marketing of cigarettes, the

selling of the SSRIs is perhaps the deadliest marketing scandal of the 20th

century.

 

Richard DeGrandpre is the author of Ritalin Nation (1999) and

Digitopia (2001), and is currently writing a history of drugs in the 20th

century. For his full report on " The Lilly Suicides, "

 

From the May/June 2002 issue of Adbusters magazine.