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Ruth Holladay
Student's suicide cries out to FDA for drug warnings

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Drug trial participant recruiting questioned
Holladay: Student's suicide cries out to FDA for drug warnings

 
February 15, 2004
 

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

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