Fwd: [SSRI-Research] 20% volunteers drop out after suicide in Eli Lilly's duloxetine trial

[Guest guest]

JustSayNo

Thu, 12 Feb 2004 20:48:41 -0000

[sSRI-Research] 20% volunteers drop out after suicide in Eli Lilly's

duloxetine trial

 

Janet Woodcock; Mark McClellan MD; Robert Temple MD; Russell Katz

MD; Thomas Laughren

Cc: Daniel Troy; Thomas Insel MD; Tommy Thompson; Warren Rumble

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting openness and full disclosure

http://www.ahrp.org

 

FYI

 

The Associated Press reports that nearly a fifth of the volunteers

testing Eli Lilly's antidepressant drug, duloxetine, dropped out

after Traci Johnson, a 19-year old student committed suicide at a

company laboratory. " Three participants in the study in Indianapolis

and 16 volunteers in Evansville have quit. " See:

http://abcnews.go.com/wire/US/ap20040212_723.html

 

The Philadelphia Inquirer reports (below) that " the Institutional

Review Board (IRB), a body of the Indiana University School of

Medicine, which has been monitoring the clinical trial, moved to

tighten the duloxetine study. " And the Inquirer reports that

IRB " ordered Lilly to accept no new subjects for the trial, ordered

an independent psychiatrist to evaluate the current subjects, and

required that they sign a new consent form. "

 

Did the FDA approved informed consent form signed by Ms. Johnson and

the other subjects disclose the fact that there had been 4 suicides

in prior duloxetine clinical trials?

 

The New York Times finally saw fit to report the suicide of this

healthy volunteer but buried the report on p. A30. The report

provides Eli Lilly an opportunity to present the company's spin. For

example, " the company did not believe that duloxetine ...caused the

suicide. " That assertion is premature, inasmuch as Lilly's chief

medical officer and former senior researcher at the National

Institute of Mental Health, Dr. Alan Breier, acknowledged that Ms.

Johnson had been screened by Lilly before the trial and found her not

to be " healthy and had no mental problem. " The test did require Ms.

Johnson and the other volunteers to take " larger than therapeutic

doses. " How then can the company exonerate the drug out of hand?

 

A classic example of PHARMA spin follows:

When confronted with the revelation that there were not one but 5

completed suicides in duloxetine clinical trials, a Lilly spokesman,

Robert Smith, is quoted stating: " The drug has been studied in 9,000

patients ....and we have not been able to discern any signal between

duloxetine and suicidal ideation. "

 

But when confronted with the revelation that there was a two-to three

fold increased incidence of suicidal ideation and suicidal acts by

children who tested antidepressants compared to those given a dummy

pill, drug manufacturers and FDA officials

claim--

" but there was no death from suicide in pediatric antidepressant

trials. "

See: www.ahrp.org

 

What did the FDA know and when did it know about the suicides? What,

if anything, does the FDA do to ensure that patients and volunteers

are protected from harmful drug tests?

 

 

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare

 

 

 

http://www.philly.com/mld/inquirer/news/local/7932602.htm

PHILADELPHIA INQUIRER

Feb 12, 2004

Drug test altered in wake of suicide

By Walter F. Naedele

 

 

Colleen Jacoby last spoke to Traci Johnson on Friday, the night

before Johnson is reported to have committed suicide.

 

" On the phone, she was laughing, she was happy, " Jacoby said of her

call from Northeast Philadelphia to her best friend in Indianapolis.

 

At 9 p.m. Saturday, a doctor at Indiana University Hospital

pronounced Johnson dead, a suicide, according to an incident report

from the Indianapolis Police Department.

 

Johnson, 19, a 2002 graduate of Bensalem High School, had been found

hanging by a scarf from a bathroom shower rod in the Lilly Laboratory

for Clinical Research.

 

Since early last month, after leaving studies at the Indiana Bible

College in Indianapolis, Johnson had been categorized a " healthy

subject " by Eli Lilly & Co. in a trial of the drug duloxetine, which

a spokesman for the pharmaceutical company said would be used to

treat depression and for urinary incontinence caused by stress.

 

Jacoby, 20, who lives in the Oxford Circle neighborhood of Northeast

Philadelphia, said that " 80 percent of [Johnson's] life, she was with

me; we were her second family. "

 

Johnson " would never hang herself, " Jacoby said. " Never, ever. She

was full of life. "

 

David Shaffer, an Eli Lilly spokesman in Indianapolis, said that four

of more than 8,500 people in previous trials of duloxetine had

committed suicide.

 

But, he said in an interview yesterday, they were " studies of people

who actually had depression. "

 

" And that rate is in line with what you'd expect in a population of

that size who were depressed, " and who weren't taking the drug, he

said.

 

Shaffer said Johnson's trial consisted of healthy persons " in which

the patient doesn't know, the doctor doesn't know, whether they're on

the medication or sugar pills. " There are about 100 subjects

currently.

 

Johnson had been given duloxetine early last month but was taking

sugar pills at the time of death, Shaffer said. He called this " a

high-dose study. "

 

" It's higher than the dose we expect to be used in clinical practice,

once the drug is approved and doctors are using it in the real world. "

 

Yesterday, the Institutional Review Board, a body of the Indiana

University School of Medicine, which has been monitoring the clinical

trial, moved to tighten the duloxetine study.

 

Shaffer said the board ordered Lilly to accept no new subjects for

the trial, ordered an independent psychiatrist to evaluate the

current subjects, and required that they sign a new consent form.

 

The Lilly spokesman said that enrollment for this trial was completed

before Johnson's death, that the subjects had undergone psychiatric

evaluation before the trial, and that the new form asks their consent

in light of the apparent suicide.

 

Shaffer said that " the steps that the [review board] took, we feel,

are appropriate in this case. "

 

Jacoby said she and Johnson had been friends since grammar school,

and longtime members of the Greater Church of Philadelphia, a

nondenominational Pentecostal church in Kensington.

 

The Rev. Joel Barnaby, the pastor there, said that since Johnson's

death, the young woman's relatives " just walk around numb. They're

just devastated. "

 

He said they " come to me and lean on my shoulder and [ask], 'How did

this happen to our little girl?' "

 

Barnaby said that Johnson came to him last year, asking for names of

Bible schools.

 

" I asked why, and she said, 'Because I want to sharpen my skills and

understanding of the Scriptures, so that I could be a vessel of honor

that the Lord might use.' "

 

 

----

------

----

Contact staff writer Walter F. Naedele at 215-345-7768 or

wnaedele.

 

 

----

------

---- http://www.nytimes.com/2004/02/12/health/12SUIC.html?

pagewanted==print & positi

on=THE NEW YORK TIMES

February 12, 2004

 

Student, 19, in Trial of New Antidepressant Commits Suicide

By GARDINER HARRIS

 

A 19-year-old college student who had shown no outward signs of

depression killed herself over the weekend at an Eli Lilly & Company

laboratory in Indianapolis where she had been participating in a

company drug trial for an experimental antidepressant.

 

The student, Traci Johnson, was one of 25 healthy patients at an Eli

Lilly clinic who were being given larger than therapeutic doses of

duloxetine, which will be known as Cymbalta if it is introduced as an

antidepressant. Four days before her death, Ms. Johnson was taken off

Cymbalta and given a placebo.

 

While Eli Lilly asserted that it had properly screened Ms. Johnson

before the study started to ensure that she was healthy and had no

mental problems, her death is being used by critics of a popular

class of antidepressants to bolster their case that the widely used

drugs carry the risk of suicidal tendencies for a small number of

people, particularly young people.

 

Four other patients who were given the drug during earlier trials

also committed suicide, the company said. The drug is being tested

not only as an antidepressant but also as a possible treatment for

stress urinary incontinence.

 

Ms. Johnson's death came less than a week after a federal advisory

panel concluded that the Food and Drug Administration should issue

stronger warnings to doctors that this class of antidepressants may

be linked to suicide and violent behavior in children and teenagers.

 

A review board has told Eli Lilly to stop entering new patients into

the trial, and to have all the current participants evaluated by an

independent psychiatrist.

 

Robert Smith, a Lilly spokesman, said the company did not believe

that duloxetine, the drug's generic name, caused the suicide.

 

" This drug has been studied in 9,000 patients, in depressed and

nondepressed healthy people, and we have not been able to discern any

signal between duloxetine and suicide or suicidal ideation, " Mr.

Smith said.

 

Ms. Johnson had not shown signs of depression, distress or mood

swings throughout about a month in the trial, said Dr. Alan Breier,

Lilly's chief medical officer.

 

Patients who abruptly stop therapy with some antidepressants often

experience withdrawal symptoms that can include severe agitation,

unusual dreams and night sweats. This is especially true of

antidepressants like Paxil, made by GlaxoSmithKline, that leave the

bloodstream quickly. Cymbalta also leaves the blood stream quickly.

 

Dr. Breier said Ms. Johnson did not appear to be suffering any

withdrawal symptoms. He said the company might never be able to

answer why Ms. Johnson killed herself.

 

" Most people who commit suicide in the general population leave

people asking these kinds of questions, " Dr. Breier said. " And just

because this happens while someone is taking a drug doesn't mean the

drug caused it. "

 

Ms. Johnson did not leave a suicide note. She hanged herself in a

shower stall Saturday night in the bathroom of Lilly's dormlike

laboratory on the top two floors of the Indiana University Medical

Center.

 

She had been attending nearby Indiana Bible College but left school

to participate in the study because it paid $150 a day plus meals.

 

Whether antidepressants cause some people to commit suicide was an

issue that flared briefly in the early 1990's but had been largely

dismissed by mainstream researchers until last summer. That is when

GlaxoSmithKline warned that a series of studies had found that

children and teenagers given Paxil were more likely to attempt or

think about suicide than those given a placebo.

 

Wyeth soon followed with a warning suggesting that its

antidepressant, Effexor, should not be given to children. British and

American drug regulators set to work studying the problem. The

British soon concluded that most antidepressants in this class should

not be used in children and teenagers since they have not proved

effective in that population and could be linked to suicide.

 

The F.D.A. continues to study the issue, said Susan Cruzan, an agency

spokeswoman. The agency is aware of Ms. Johnson's death and will

evaluate its implications once the agency receives all of the needed

information about it, Ms. Cruzan said.

 

 

Copyright 2004 The New York Times Company

 

FAIR USE NOTICE: This may contain copyrighted (© ) material the use

of which has not always been specifically authorized by the copyright

owner. Such material is made available to advance understanding of

ecological, political, human rights, economic, democracy, scientific,

moral, ethical, and social justice issues, etc. It is believed that

this constitutes a 'fair use' of any such copyrighted material as

provided for in section 107 of the US Copyright Law. In accordance

with Title 17 U.S.C. Section 107, this material is distributed

without profit to those who have expressed a prior general interest

in receiving similar information for research and educational

purposes.

 

 

 

 

 

 

Finance: Get your refund fast by filing online