February 15, 2004-Traci Johnson: Student's suicide cries out to FDA for drug warnings

[Guest guest]

> JustSayNo

> Tue, 3 Aug 2004 23:03:18 -0400

 

> [sSRI-Research] February 15, 2004-Traci

> Johnson: Student's suicide cries out to FDA for drug

> warnings

>

> Ruth Holladay

>

> Student's suicide cries out to FDA for drug warnings

>

> February 15, 2004

>

http://www.antidepressantsfacts.com/Traci-Johnson-duloxetine-FDA.htm

>

> The timing is, if nothing else, eerie.

>

> On Feb. 2, families from around the nation who've

> had bad or deadly experiences with anti-depressant

> drugs attended a hearing with the Food and Drug

> Administration in Bethesda, Md. Their goal? To

> persuade the agency to urge doctors to warn patients

> that for some people -- especially children,

> adolescents and young adults -- anti-depressants can

> trigger suicide.

>

> On Feb. 7, 19-year-old Traci Johnson, a former Bible

> student in Indianapolis, was found hanged in her

> room at the Lilly Clinic on the Indiana University

> Medical School campus. The Indianapolis Police

> Department termed her death a suicide. She was among

> 100 Eli Lilly and Co. drug-trial participants who

> had volunteered beginning Jan. 8 to take a new

> anti-depressant drug duloxetine. Johnson was paid

> $150 a day and planned to use the money to go back

> to school.

>

> Lilly thoroughly screened Johnson and others before

> the drug trials, says spokesman Rob Smith. She was

> evaluated physically and emotionally. Most

> importantly, she was deemed healthy, with no history

> of depression. In fact, her family and friends have

> described her as upbeat, an active volunteer and

> someone who loved life.

>

> Lisa Van Syckel, of Raritan Township, N.J., never

> met Traci Johnson, but she heard about her death

> early Tuesday in an e-mail flagged " urgent " from Dr.

> David Healy, a psychiatrist in the United Kingdom.

> In December, that nation banned the use of

> anti-depressants for people younger than 18. Healy

> led that charge, maintaining that young people are

> not helped by anti-depressants and in fact may be

> harmed.

>

> Van Syckel -- who testified at the Feb. 2 FDA

> hearings, the result of her teenage daughter's two

> suicide attempts while on anti-depressants -- sees

> Johnson's death as an omen. She and other activists,

> as well as Johnson's family and friends, are

> convinced Johnson died because of the effects of the

> drug on her mind and body. Toxicology tests won't be

> completed for four to six weeks.

>

> Lilly has acknowledged four suicides in past drug

> trials of duloxetine, but Johnson's death is a

> first, point out Van Syckel and others. That's

> because she was deemed healthy when she entered the

> trials; the others had been diagnosed as depressed.

>

> " Her faith in God, her love of life, her compassion

> for those on the street -- hers is a life that

> should never have been harmed, " Van Syckel says. " It

> is almost like God chose an angel because this

> (warning) has been very slow moving. "

>

> It's an emotional response, but emotion is

> appropriate -- given that an advisory panel to the

> FDA first urged the drug warning back in 1991, and

> the FDA did not act.

>

> Peter J. Pitts is the FDA's associate commissioner

> for external affairs. The former Indianapolis

> resident was at the Bethesda hearings. On Friday, he

> sounded a note of hope: " We are moving forward

> rapidly as to whether or not to change the warnings

> on these drugs. The (advisory) committee strongly

> recommended that we do that. We, by and large, take

> their recommendations. "

>

> Good. Because if the Feb. 2 testimony was not

> persuasive, then consider this:

>

> Traci Johnson was not old enough to legally drink a

> beer; she could not even rent a car. Yet she was

> deemed mature enough to decide to take an

> experimental drug on a daily basis.

>

> Side effects for similar drugs have been documented;

> they include extreme anxiety, says Dr. Joseph

> Glenmullen, a Harvard psychiatrist whose book

> " Prozac Backlash " in 2000 warned of possible

> suicides.

>

> Glenmullen is concerned that drug companies, and

> especially Lilly, market and protect drugs too

> aggressively. " Their priority should be to protect

> patients, not the drugs, " he says.

>

> That should also be the priority of the FDA, too.

>

> Ruth Holladay's column appears Sunday, Tuesday and

> Thursday. You can reach her at (317) 444-6405 or via

> e-mail at ruth.holladay

>

>

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