Fwd: Healthy 19 year old volunteer commits suicide at Eli Lilly laboratory

[Guest guest]

DARocksMom

Tue, 10 Feb 2004 11:24:34 EST

Fwd: Healthy 19 year old volunteer commits suicide at Eli Lilly

laboratory

 

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

 

Promoting openness and full disclosure

 

http://www.ahrp.org

 

 

FYI

 

 

The Indianapolis Star reports (below) that Traci Johnson, a 19 year old

 

healthy

 

volunteer, one of 25 local paid volunteers committed suicide by hanging

 

while

 

testing Lilly's drug, Duloxetine, at Lilly's Laboratory for Clinical

 

Research.

 

Duloxetine is the main ingredient in two new Lilly drugs: the

 

antidepressant,

 

Cymbalta, and an incontinence drug.

 

 

Since 1990, the suicide link to antidepressant drugs has been the source of

 

an acrimonious debate. Eli Lilly's strategy (and that of the other SSRI

 

manufacturers)

 

has been to deny, deny, deny any and all reports linking Prozac to suicide.

 

 

The Star reports " Lilly said Monday it does not believe the drug,

 

duloxetine,

 

was related to the death of Johnson, who was a former student at Indiana

 

Bible College. Toxicology test results are expected in about a month. "

 

 

Most recently the debate shifted to evidence linking the antidepressants to

 

a

 

two-to-three fold increased risks of suicidal behavior in children. The

 

British

 

medicines authority took action to protect children from these drugs'

 

hazards,

 

banning all but one for use in children.

 

Documents are posted on the AHRP website: www.ahrp.org

 

 

For unexplained reasons, the FDA has continued to drag its feet and has

 

delayed any

 

action to protect children. Antidepressant drugs are the blockbusters of the

 

drug

 

industry. Under pressure to act, FDA convened an advisory committee meeting

 

to review

 

the evidence--but announced that no votes or action would be taken.

 

 

On Feb. 2, 2004, 62 families testified about the hazards these drugs pose

 

for children.

 

Parents described the loss (or near loss) of their children to suicide after

 

being

 

prescribed an antidepressant.

 

 

However, the FDA refused to allow scientific experts who have vital

 

information from

 

presenting their analyses to the committee for consideration. The committee

 

recommended

 

action: warning labels to alert doctors and the public about the potential

 

hazards of

 

antidepressants for children. See:

 

http://www.ahrp.org/infomail/04/02/04.html

 

 

The Alliance for Human Research Protection (AHRP) held a press briefing at

 

which 6 scientists were given an opportunity to present publicly their

 

documented analyses from published and unpublished sources. See:

 

http://www.ahrp.org/risks/SSRIsuicide0204.html

 

 

See links to original, documented evidence of the actual incidence of

 

violent and suicidal behavior in children who tested the drugs in company

 

controlled clinical trials. See:

 

http://www.ahrp.org/risks/SSRI0204/Healy.ppt

 

 

See also: Critical court documents re suicide risk courtesy of

 

" Let them eat Prozac " :

 

http://www.healyprozac.com/Trials/CriticalDocs/default.htm

 

 

 

Contact: Vera Hassner Sharav

 

Tel: 212-595-8974

 

e-mail: veracare

 

 

~~~~~~~~~~~~~~

 

http://www.indystar.com/articles/7/119246-5807-092.html

 

 

Woman participating in Lilly trial hangs self

 

Coroner will examine whether experimental drug played possible part in

 

19-year-old's suicide.

 

 

By J.K. Wall and John Tuohy

 

jk.wall

 

February 9, 2004

 

 

A toxicology test will determine whether narcotics played a role in the

 

suicide of a 19-year-old woman who was participating in clinical trials for

 

a new drug that Eli Lilly and Co. hopes to launch this year.

 

 

Traci Johnson, Bensalem, Pa., hanged herself Saturday night in the Lilly

 

Laboratory for Clinical Research by tying a scarf to a bathroom shower rod,

 

according to the Indianapolis Police Department.

 

 

While the toxicology test is standard procedure in the investigation of

 

suicides by the Marion County coroner, it could have huge implications for

 

Lilly if it is determined that the trial drug -- or removal from it --

 

played a role in the woman's suicide.

 

 

Lilly said Monday it does not believe the drug, duloxetine, was related to

 

the death of Johnson, who was a former student at Indiana Bible College.

 

Toxicology test results are expected in about a month.

 

 

Duloxetine is key to future business prospects of Lilly. It is the main

 

ingredient in Cymbalta, an anti-depressant drug, and in a stress urinary

 

incontinence treatment, both of which are moving toward final approval by

 

the U.S. Food and Drug Administration.

 

 

However, incidents such as the suicide of a clinical trial participant often

 

draw questions from the FDA and can delay the federal approval needed to

 

bring a drug to market.

 

 

In earlier statements, Lilly has said it expects the FDA to approve

 

duloxetine to treat both depression and incontinence in 2004. Analysts have

 

predicted sales of each could near $200 million this year. They bill

 

Cymbalta as a potential blockbuster that could top $2 billion in sales by

 

2008.

 

 

Lilly spokesman Rob Smith would not say which use of the drug was the

 

subject of Johnson's trials. However, the trial cycled the participants

 

between doses of duloxetine and a placebo. At the time of her death, Smith

 

said, Johnson was taking placebo.

 

 

" Based upon our initial review, we do not believe at this time that the

 

design or conduct of the study is related to the death, " Smith said. He said

 

Lilly would continue looking into the matter, but added that " there's

 

nothing to suggest that this is anything but an isolated incident. "

 

Lappin, the Indianapolis police detective who investigated Johnson's

 

death, said she did not leave a note, making her motive undetermined. " I

 

talked to her friends. They all said, 'She was chipper,' " Lappin said.

 

 

A nurse found Johnson's body around 8:20 p.m. Saturday at the Lilly Lab,

 

which occupies the fifth and sixth floors of an outpatient center on the

 

campus of the Indiana University Medical School.

 

 

Lilly's clinical trial is one that tests " healthy volunteers, " who do not

 

have depression or incontinence, in order to evaluate how the human body

 

metabolizes the drug and to examine proper dosages and side effects.

 

 

The FDA had requested Lilly to conduct this latest safety test, even though

 

duloxetine has been tested on more than 9,000 people to date, Smith said. He

 

added that the FDA had not asked for the study for any suicide risk.

 

 

Johnson joined the trial in early January, staying overnight at the clinic,

 

but with the freedom to come and go. She received $150 a day plus meals,

 

Smith said. She was one of about 25 local volunteers, and one of about 100

 

nationally.

 

 

Johnson's parents could not be reached Monday by phone. Smith said that

 

Lilly had told them of Johnson's death over the weekend.

 

 

" It's a real tragedy. We really feel sorry, " Smith said. " We extend our

 

deepest condolences to her family. "

 

 

Lilly will not halt its clinical trial of duloxetine, Smith said, because

 

the company does not believe the drug is putting participants in danger. But

 

Lilly did conduct additional monitoring of the other participants after

 

Johnson's death.

 

 

Smith said Lilly would make a formal report to the FDA and similar

 

international regulatory agencies later this week.

 

 

Similar incidents have sparked lawsuits against some companies, according to

 

two clinical trial experts at the University of Southern California. And

 

those lawsuits sometimes have led companies to suspend their clinical

 

trials, said Peter Pressman, clinical physician at the Keck School of

 

Medicine, and Roger Clemens, a professor of molecular toxicology at School

 

of Pharmacy.

 

 

But both Pressman and Clemens noted the regulatory protocol for the safety

 

tests in which Johnson was involved requires an abundance of safeguards

 

standardized by an international organization.

 

 

Lilly screens participants at the Lilly Labs with physical and mental exams.

 

In safety tests, the company also must make sure that participants do not

 

have the disease or condition that is treated by the drug being tested.

 

Participants must sign consent forms after receiving explanations of a

 

drug's potential side effects and risks in both technical and layman's

 

terms.

 

 

" It's more careful, it's more thoughtful -- almost to a fault -- than most

 

people realize, " Pressman said.

 

 

Clemens, who worked on clinical trials for more than 20 years, primarily in

 

the food industry, said he had never seen a death related specifically to a

 

drug.

 

 

" It's rare, " he said. " There may be a lot that you could criticize about the

 

pharmacological industry, but this is one area where it's very difficult. "

 

 

Star reporter Tom Spalding contributed to this story.

 

 

Call Star reporter J.K. Wall at (317) 444-6287.

 

 

Charles Medawar

 

Social Audit Ltd

 

P.O. Box 111

 

London NW1 8XG UK

 

TEL/FAX +44 (0)20 7586 7771

 

charles

 

http://www.socialaudit.org.uk

 

 

 

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