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

http://www.abcnews.go.com/wire/US/ap20040212_1907.html

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 spirits.

"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)

LILLY COVER UP OF SUICIDE WITH SSRI, DUPLICITY OF PSYCH-PHARM CARTEL

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 fredbaughmanmd@cox.net 619 440 8236 , 9/13/99

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

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.