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[Fred A. Baughman Jr., MD:
It appears, has always appeared, that it
is something about the SSRIs--all of them. This even thought the more
cautious, not bought-and-paid-for Brits, are leaving Prozac--the number one
SSRI--on the market for kids. These observations from early Prozac
researcher, Jonathan Coles are always worth reading, and re-reading. This
is how good it gets in psychiatric drug research. (see the David Healy
interview of Jonathan Coles at the end of this article).]

Sent: Thursday, February 12, 2004 3:54 PM
Subject: Healthy Volunteer in Lilly’s Trials Sought Cash for School, Committed Suicide

Drug-Study Suicide Sought Cash for School
Woman Who Committed Suicide During Lilly Drug Study Was Trying to Earn
Money for College

The Associated Press

INDIANAPOLIS Feb. 12 – A college student who committed suicide while
testing a new antidepressant took part in the paid drug study to earn
money for another semester of classes, a school official said.
Traci Johnson, 19, hanged herself Saturday at Eli Lilly Co.’s hotel-like
research lab at the Indiana University Medical School. She had recently
stopped taking the pill, duloxetine, after about a one-month period, the
drug company said.

Her funeral was Thursday in Philadelphia, her hometown.

Her death came the same week the Food and Drug Administration held
hearings into whether an entire list of similar antidepressants can lead
to suicidal behavior in children and teenagers. Duloxetine was not one
of the drugs in that debate.

From the time Johnson began the trial in early January, her dosages of
the drug were increased gradually to a peak, then gradually reduced
until she was given a placebo. “She was weaned off the drug,” said Rob
Smith, a Lilly spokesman.

He said Johnson was staying overnight at the medical school, but was
free to come and go. Although she received medical attention daily and
was given a place to stay, the staff would have no reason to regularly
check on her room, Smith said.

The Rev. Talmadge French, dean of biblical studies at the Indiana Bible
College, said that Johnson enrolled in September as a freshman and was
well-liked by her classmates.

She worked part-time that first semester, but decided to forgo spring
classes so she could join the study on duloxetine.

“She evidently felt that she wanted to work more and raise more money
before she returned to classes. We had hoped that she would just come
and work out some financial arrangement, but she opted to take off and
work,” he said.

Johnson was getting $150 a day plus meals and was among 25 local
volunteers and 100 nationally who agreed to take part in the drug study.

Her suicide resulted in 19 of those 100 participants to drop out,
according to Smith. But he said their departures should have no impact
on the study’s results.

After her death was reported, a panel of IU doctors authorized by the
FDA to oversee medical research ordered Lilly to tell the remaining
participants at IU about her suicide and have them evaluated by an
independent psychiatrist.

Lilly has complied with that, said Pam Perry, an IU spokeswoman.
“Everything has been handled extremely well,” she said.

Lilly was also ordered not to accept new participants, but Smith said
the drug study was already full by the time the board issued its orders.

He reiterated Lilly’s view that duloxetine did not directly contribute
to Johnson’s suicide.

French said Johnson was a vivacious young woman at the school of about
300 students.

“I think everyone was stunned,” he said.

A friend of Johnson’s told The Philadelphia Inquirer that when she spoke
to her last, the day before her reported suicide, Johnson was in good

“On the phone, she was laughing, she was happy,” said Colleen Jacoby, a
friend of Johnson’s since grammar school.

Lilly has said it expects federal regulators this year to approve
applications to market duloxetine-based drugs, which treat depression
and incontinence. The antidepressant Cymbalta is widely expected to be a
blockbuster for Lilly, with some analysts forecasting sales could
eventually top $2 billion annually.

Lilly has acknowledged that four other suicides have occurred during
several years of duloxetine testing, but those cases involved patients
with depression.

The volunteers in the current trial were screened and had no outward
signs of depression or other illnesses, Smith said.

Lilly told this “healthy” group about the risks involved in taking the
drugs, but Smith said there has never been any indication the drug could
induce suicidal thoughts.

He also said the rate of suicide for depressed patients taking it is
lower than for those taking a placebo. It also is lower than the rate
for an older group of antidepressants known as SSRIs, or selective
serotonin reuptake inhibitors. Drugs such as Prozac, Paxil and Zoloft
are SSRIs.

The FDA opened hearings last week to determine whether such SSRIs deemed
safe to use by adults are suitable for children. An FDA advisory panel
urged that more specific warnings be given to parents and doctors until
the issue is settled.

British authorities last month declared that the drugs increase suicidal
thoughts in children and teens.

photo credit and caption: This is a photo of Traci Johnson, a
19-year-old from Bensalem, Pa., who committed suicide Saturday, Feb. 7,
2004, in an Eli Lilly and Co. research lab at the Indiana University
Medical School. Johnson was a volunteer testing a new anti-depressant
for Lilly, and had recently been weaned from a higher-than-normal dose
of the drug, the company said. Nearly a fifth of the volunteers testing
the antidepressant for Lilly have dropped out since Johnson’s suicide,
the drug maker said. (AP Photo/Greater Church of Philadelphia)


David Healy interview of Jonathan Cole (Director, Psychopharmacology
Research Centre, NIMH; Chair in Psychiatry, McLean Hospital), December 1994.

Excerpted by Fred A. Baughman Jr., MD 619 440 8236
, 9/13/99

p 258 Healy: What about a group of patients who may get worse on it

Cole: Yes. I’m one of the authors of the suicide paper.I didn’t realize it
would be quite that famous.p 259Yes, I have seen people, at least a
handful, that clearly got more agitated and got weird thoughts and suicidal
drive. Tony Rothschild.found three people who had jumped off something
while on fluoxetine, who didn’t kill themselves, and agreed to take it
again. He re-created the same desperate driven quality with fluoxetine.

Healy: Is it a form of akathesia”

Cole: I think it probably is but whether you get the neuromuscular form or
whether it’s purely psychic I don’t know. One patient.was so distressed by
a thought telling her to kill herself over and over again, .I told her to
take some Ativan and go to sleep and she did and within 36 hours it had
passed. At the end of it she said ‘gee, I’ve been depressed for 21 years,
and suicidal a lot but that was ridiculous.’ She thought it was clearly
different than anything she had ever experienced before which is why I put
her case and my name on the paper. Lilly doesn’t believe it.Plus about 1-2%
of the people on fluoxetine, and none of the people on trazodone, called up
and said I’ve got suicidal ideas that I haven’t had before and another 1-2%
phoned up and said I’ve got crazy ideas that I hadn’t had before.So I think
it’s rare and the drug has certainly prevented more suicides than it’s
cause. I don’t thin it’s a bad drug, I just think it does funny things
every once in a while.

p. 260 Cole: I got so pissed about Lilly saying ‘don’t you agree that
all the doctors know that fluoxetine doesn’t cause suicide’ that I did a
survey of everybody in the Mass. Psychiatric Society, who’d answer the
telephone about whether they had ever had or thought they’d had a patient
who had been made suicidal by fluoxetine, or whether they had heard of
anybody, and if they had, did they think they were prescribing less now than
they were before. You could make a case that if they had some personal
experience with fluoxetine in a patient who they thought got suicidal, they
were more likely to warn patient and be a little more gun shy.

Healy: Sometimes, ideas just get into popular consciousness and other times
they don’t. You would have thought that suicidal ideation would have killed
of fluoxetine but it hasn’t.

Cole: But the company probably did exactly the right thing which was to
stone wall and the FDA didn’t do anything. The company was publishing
meta-analyses of everything in the world – 800 patients in 6-week trials
with no increase in suicidal ideation.

p 261 Cole: The other wave I detect is that cognitive – behavior therapy
is rising in competition to drugs.There’s now been the three hospital’s
trial comparing cognitive therapy, interpersonal therapy, tofranil and
placebo. Tofranil is better but I keep wondering whether they didn’t do
something wrong, somewhere. They tried to train social workers to do these
therapies and I think there is a problem in skills transfers and because of
this I think the non-drug therapies didn’t do as well as they might have if
they had been done by people who had been trained to do them who thought it
was their favorite therapy therapeutic bias of therapist also of patient to
be considered.there was a funny business about the psychotherapies doing no
better than placebo and then in the last two weeks everybody got better -
like they had to p 262 please their therapists.There have been enough
other studies of cognitive therapies that I’m prepared to believe it works,
whatever the NIMH study shows.

If the behavioral therapies were able to be shown to give people increased,
inner strength to deal with life in the future, I would be impressed and be
inclined to refer patients more often than I am now. On the other hand,
behavior therapies are not cheap and not always readily accessible. They
end up being more expensive than pills. Pills are not cheap but they tend
more often to be paid for by insurances.

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