Lilly duloxetine drug trial–19 Quit after a suicide – Philadelphia Inquirer

Lilly duloxetine drug trial–19 Quit after a suicide – Philadelphia Inquirer

Fri, 13 Feb 2004

19-year old Teri Johnson’s suicide occurred one week after an FDA advisory committee had urged the FDA to issue warnings about prescribing antidepressant drugs for children under 18 because of an increased risk in suicide. The FDA has yet to act upon its own advisory committee recommendations. Below are two press reports providing additional information.

* Dr. Joseph Glenmullen, a Harvard University psychiatrist, the author of Prozac Backlash, and an expert psychopharmacologists, told The Indianapolis Star that Teri Johnson’s suicide, her lack of depression, her young age, and the time she had been off the drug suggests she was vulnerable to suicidal thoughts. “She’s still a teenager. It does look that children or adolescents might be even more vulnerable to (suicidal thoughts while taking antidepressants).”

Today, the Ind. Star reports: “A packed inner-city church said goodbye Thursday to one of its best-loved members, a 19-year-old woman known for unstoppable optimism while working with youths in one of Philadelphia’s more troubled neighborhoods. http://www.indystar.com/articles/8/120422-7218-009.html

The Philadelphia Inquirer reports that after the suicide, the Evansville, Ind “site management decided to pull out from the [duloxetine] study." No further explanation was given.

The Inquirer reported that on Wednesday, David Shaffer, a Lilly spokesman, said that “over the years, there had been four other suicides in trials of duloxetine, but only among the more than 8,500 subjects who already had been diagnosed with depression.”

On Thursday “Shaffer said he had misspoken and that “more than 8,500″ was the total number of trial subjects, both depressed and not depressed.” The Ind. Star reports that 4,142 patients were depressed. This raises further questions about who the four other subjects who committed suicide during duloxetine tests were.

Schaeffer claimed he “was uncertain how many took part in each study and how long the studies had been under way.” If the company is uncertain about such basic information about the trials how reliable is Lilly’s claim, “duloxetine was not associated with Johnson’s death”?

On Thursday, the Indianapolis Star reported: "Johnson’s trial was a “high-dose” variety. From the time Johnson began the trial in early January, her dosages were increased gradually to a peak, then gradually reduced until she was given placebo.”

This raises a fundamental ethical question: Why are teenagers put at increased risks of harm in "high dose" drug tests when it is no secret that most severe adverse drug reactions occur when doses are increased.

The Star further reports that “Lilly was barred Tuesday from enrolling any new participants in its duloxetine study in Indianapolis at the Lilly Laboratory for Clinical Research on the Indiana University Medical Center campus. The order was issued by the Institutional Review Board, which oversees all Lilly research on the campus.”

* Dr. Gelnmullen was one of 6 scientists who presented their original analyses of evidence linking antidepression drugs to serious risks for children, at a press briefing convened by The Alliance for Human Research Protection (AHRP). See: http://www.ahrp.org/risks/SSRIsuicide0204.php

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http://www.philly.com/mld/inquirer/news/local/7941952.htm?template=contentModules/printstory.jsp
PHILADELPHIA INQUIRER
Posted on Fri, Feb. 13, 2004

19 quit Lilly drug trial after a death

By Walter F. Naedele

Nineteen of 99 people in a clinical trial of an antidepressant have left after a Bensalem woman in the study hanged herself Saturday, Eli Lilly & Co. said yesterday.

Traci Johnson, 19, a 2002 graduate of Bensalem High School, was found hanging by a scarf from a bathroom shower rod at the Lilly Laboratory for Clinical Research in Indianapolis.

Johnson was buried yesterday in Resurrection Cemetery in Bensalem after a funeral at the Greater Church of Philadelphia in Kensington, where she was a youth leader.

Johnson had been a first-year student at the Indiana Bible College, but she left in January to become a subject in the Lilly study of duloxetine.

The chemical is intended to treat depression and urinary incontinence caused by stress.

David Shaffer, a Lilly spokesman, said three of Johnson’s 25 fellow subjects at the Indianapolis site had left the study.

Shaffer said 16 people at a trial site in Evansville, Ind., also had left the program when “the site management decided to pull out from the study.”

Shaffer declined to identify the management or the specific site.

“No other participants in any of the other sites have chosen to withdraw” from the clinical trials of duloxetine, he said.

On Wednesday, Shaffer said that over the years, there had been four other suicides in trials of duloxetine, but only among the more than 8,500 subjects who already had been diagnosed with depression.

Yesterday, Shaffer said he had misspoken and that “more than 8,500” was the total number of trial subjects, both depressed and not depressed.

He was uncertain how many took part in each study and how long the studies had been under way.

Lilly has said it believes duloxetine was not associated with Johnson’s death.

Before it can be marketed, he said, the Lilly drug needs to be approved by the U.S. Food and Drug Administration.

Yesterday, FDA spokeswoman Susan Cruzan said the agency “couldn’t really address the [Lilly] drug trials specifically” in light of Johnson’s death. “But FDA does have a process for reviewing reports of death associated with use of a drug in a clinical trial. We’ll review all the information and evaluate its implications.”

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

© 2004 Philadelphia Inquirer and wire service sources. All Rights Reserved.

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http://www.indystar.com/articles/9/119961-3639-031.html
Indianapolis Star
Death fuels fallout in drug trial
20% of patients exit Lilly’s study for duloxetine after girl’s suicide

By J.K. Wall
February 12, 2004

Eli Lilly and Co. said Wednesday that nearly one-fifth of the participants in a clinical trial for its new anti-depression and anti-incontinence drug have dropped out of the study after one test subject committed suicide over the weekend.

At the same time, Lilly acknowledged that four other suicides have occurred during several years of clinical trials on the drug duloxetine.

However, the other suicides were among patients with depression, unlike Traci Johnson, who hanged herself Saturday while participating in a trial involving what Lilly described as “healthy” volunteers.

That difference has led antidepressant watchdogs from around the country to seize on Johnson’s death, saying the facts point to the drug as a possible cause. But Lilly officials reiterated Wednesday that they do not believe duloxetine played a part in the suicide and that duloxetine has been proven safe to treat patients with depression.

“It’s a sad fact, it’s a tragic fact, that sometimes these patients commit suicide,” Lilly spokesman Rob Smith said.

The rate of suicide for depressed patients taking duloxetine is lower than for those taking a placebo. It’s also 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.

Of the 4,142 depressed patients who participated in Lilly’s duloxetine studies, 0.097 percent committed suicide. The rate for SSRIs is 1.5 percent, according to numbers cited by British drug regulators.

Those facts didn’t stop three participants in the study in Indianapolis and one whole center in Evansville — which was studying 16 people — from quitting the study. Smith said the 19 departures dropped the population in Lilly’s study from about 100 to about 80.

“We clearly anticipated that a number of patients would not continue the study,” Smith said, adding that the company would still have enough participants to complete the study.

Lilly was barred Tuesday from enrolling any new participants in its duloxetine study in Indianapolis at the Lilly Laboratory for Clinical Research on the Indiana University Medical Center campus. The order was issued by the Institutional Review Board, which oversees all Lilly research on the campus.

Johnson, 19, was one of about 25 healthy volunteers in the Indianapolis study. Lilly said those volunteers did not have depression and were participating in a study testing the effects of higher than normal doses of duloxetine.

Johnson reportedly hanged herself using a scarf tied to a shower rod in her bathroom at the hotel-like Lilly Lab.

Her death came to light the week after an advisory committee to the Food and Drug Administration recommended that the regulatory body discourage the prescription of antidepressants for children under 18 because of an increased risk in suicide.

In December, Great Britain’s version of the FDA told doctors to stop prescribing antidepressants to patients under 18 after it concluded that the drugs caused suicide rates two to three times the rate for patients on placebo.

Dr. Joe Glenmullen, a clinical instructor of psychiatry at Harvard Medical School, said Wednesday that Johnson’s lack of depression, her young age, and the time she had been off the drug suggests she was vulnerable to suicidal thoughts.

“She’s still a teenager,” Glenmullen said of Johnson. “It does look that children or adolescents might be even more vulnerable to (suicidal thoughts while taking antidepressants).”

Glenmullen, who wrote a book in 2000 attacking another Lilly antidepressant, Prozac, said that the rate at which duloxetine breaks down in the body is similar to the rate for Paxil and Effexor, which in 2003 were the subject of “Dear Doctor” letters issued by their respective makers, GlaxoSmithKline and Wyeth. The letters warned of the increased risk of suicide in teens.

Paxil, Effexor and a third drug, Zoloft, all have high rates of withdrawal symptoms, between 60 percent and 70 percent, which can also include suicide. Glenmullen said patients taking antidepressants are most vulnerable to suicidal thoughts three to 10 days after they cease the medication.

At the time of her death, Johnson had been on placebo for four days. “It could have been a double whammy, really, if she had became suicidal when she was on the drug, and then came off of it,” Glenmullen said.

Johnson’s trial was a “high-dose” variety, Smith said. From the time Johnson began the trial in early January, her dosages were increased gradually to a peak, then gradually reduced until she was given placebo.

“She was weaned off the drug,” Smith said.

The FDA has asked for such high-dosage tests recently to test whether patients have difficulty metabolizing antidepressants.

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

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