5/24/2000 – Questions Persist Concerning Prozac’s Role in Suicide Risk

The former US Surgeon General, Dr. C. Everett Koop has joined
in the current concern over SSRI medications and suicide, and
posts this on his site, drkoop.com.
————-

Questions Persist Concerning Prozac’s Role in Suicide Risk

May 11, 2000

Lee Hickling
drkoop.com Health News

The question of whether Prozac, the most-prescribed
antidepressant, can make some patients more likely to commit
suicide just won’t go away, despite repeated and categorical
rebuttals by the drug’s manufacturer, Eli Lilly and Co.

Based on his experience as a suicide counselor and
investigator, Dr. Ronald W. Maris, director of the Center for the
Study of Suicide at the University of South Carolina, is firmly
convinced that a risk exists.

Research done in Wales by Dr. David Healy, director of the
University of Wales’ North Wales Department of Psychological
Medicine, appears to show a cause-and-effect relationship
between Zoloft (sertraline) and the emergence of suicidal
thinking in a group of physically and mentally healthy adult
volunteers. Zoloft, like Prozac (fluoxetine), is a selective
serotonin
uptake inhibitor (SSRI). Healy has completed a similar study with
Prozac, but its results have not yet been published.

A spokesman for Lilly said today, “There is no scientific evidence
to establish a link between Prozac and suicide.” He cited a l991
study by a Food and Drug Administration advisory panel, which
unanimously agreed that there was “no credible evidence of a
causal link between the use of antidepressants, including
Prozac, and violent behavior.”

Even the drug’s critics agree that the effect, which the company
says does not exist, occurs in only a small number of cases –
fewer than 1 percent. Maris said that although the incidence is
very low, when it happens it is such a serious matter that doctors
should be very careful in prescribing Prozac, and extremely
watchful when they do.

Maris said the danger is greatest during the first week or two of
Prozac use, when some patients who were already at risk for
suicide have a rare reaction that makes them feel energized and
more ready to act on their self-destructive impulses. There is
another dangerous time later, when a patient, who had been
virtually immobilized by deep depression, still entertains suicidal
thoughts. At this time, the drug has moderated their depression
enough to make them able to carry out these thoughts.

Healy’s study showed a similar pattern, and left him convinced
that a direct link exists between SSRIs and the emergence of
suicidal thinking in people who had never had such thoughts. He
is not the first medical researcher to suspect such a reaction. Dr.
Martin Teicher of Harvard Medical School reported in 1990 that
he and his colleagues had observed suicidal thoughts emerging
in six patients who were taking Prozac. Other researchers and
clinicians began reporting that they saw it too.

Serotonin is a relatively simple chemical that is vital to the
brain’s
regulation of a great many body functions — sleep, appetite, and
even more basic activities such as muscular activity, breathing
and blood circulation. Abnormal serotonin levels have been
blamed for a large number of mental and physical problems,
including depression, obsessive-compulsive disorder and panic
disorder.

Prozac and the other SSRIs have been prescribed for all those
problems and more, and have produced dramatic improvement
in a majority of cases. “Prozac is a valuable drug,” Maris said.
“For every horror story, there are thousands of persons who say
their lives were saved by it.”

But he said, doctors need to be much more careful about
prescribing it. They should investigate the patient’s history,
particularly the psychological history, to see if there have been
any indications of suicidal thought or other instability, and then
should monitor each patient very carefully. He said that is not
always done.

Because any physician can prescribe Prozac, and general
practitioners, primary care doctors and specialists in other areas
might not be as alert for danger signs as a psychiatrist might be,
Maris said Lilly should have warned doctors about Prozac’s
dangers.

The company did not do that. According to a Boston Globe story
earlier this week, internal Lilly documents show that in 1990,
corporate executives pressured Lilly scientists to alter records
on physicians’ experiences with Prozac. They changed mentions
of suicide attempts to “overdose” and of suicidal thoughts to
“depression.”

Some of Lilly’s own studies were cited by the German equivalent
of the Food and Drug Administration, delaying Prozac’s approval
there. They showed that previously nonsuicidal patients who
took the drug had five times the rate of suicide or suicide
attempts as patients on older antidepressants. When the drug
was approved for sale in Germany, a warning was required on
the label. The label warned that the drug’s use carried a risk of
suicide, and recommended that sedatives be given along with it.

The Globe said figures in Lilly internal documents showed that
in early clinical trials, 1 in 100 previously nonsuicidal patients
who took Prozac became anxious and agitated, and either
attempted or committed suicide during the studies.

Some of the previously unknown information that Eli Lilly
possessed about the drug has come to light during civil trials in
which the company was sued for wrongful deaths following
suicides, or during criminal trials in which defense lawyers
argued that Prozac caused a defendant’s violent and homicidal
behavior.

Maris has been an expert witness in a number of trials, including
one in Hawaii last year in which Healy also testified. William D.
Forsyth Sr., a retired businessman, stabbed his wife 17 times
and then stabbed himself to death. He had been taking Prozac
for 10 days. His family brought a wrongful death suit against Lilly,
claiming that the company knew Prozac could make some
people violent or suicidal, and failed to notify physicians about it.

The plaintiffs wanted $1 million in damages and the addition of a
warning statement to the Prozac label. A jury found for the
defendant, Lilly. So far, Lilly has won every Prozac-related civil
suit against it, more than 100 and possibly 200. The number is
difficult to verify because most did not go to trial. Some — Lilly
says only a few — were settled out of court to avoid the expense
of defending them.

In criminal cases up to now, prosecutors, frequently with the help
of expert witnesses suggested by the company, have been able
to obtain convictions despite defense claims that the drug had
turned a previously stable and nonviolent person into a
murderer.

The most often-prescribed antidepression drug in the world,
Prozac has been Lilly’s major moneymaker ever since it was
introduced in 1988. Its sales, however, have been falling, for
which the company’s annual report blames “changes in
wholesaler purchasing patterns and intense competition.” Four
years ago, it accounted for more than one-third of Lilly’s total
sales. Last year it represented just over one-quarter.

The company’s patents on Prozac will start to expire next year. A
patent has been granted for its successor, R-fluoxetine, which
Lilly will make and market. In the patent application, which the
Boston Globe obtained, the company said the new drug will
decrease such side effects such as headaches, anxiety and
insomnia, and also “inner restlessness (akathisia), suicidal
thoughts and self-mutilation.”

Akathisia, an overwhelming physical and mental restlessness,
has been cited by physicians and researchers as a frequent
side effect in the cases in which they believe Prozac is causing
violent, impulsive and sometimes suicidal behavior. Teicher,
who pioneered research on the question, observed it in a
number of Prozac patients who attempted or committed suicide.

Teicher is one of the developers of the “new Prozac,”
R-fluoxetine, and a co-owner of the patent.

THIS POSTING CAN BE FOUND AT

http://www.drkoop.com/news/stories/may/prozac.html

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