+19 Year Old Healthy, Normal Woman Kills Self During Clinical Trial

First paragraph reads: “Toxicology test will determine whether drugs played a role in the suicide of a 19-year-old woman who was participating in clinical trials for a new medication that Eli Lilly and Co. hopes to launch this year.”

Paragraph 12 reads: “Lilly’s clinical trial is one that tests “healthy volunteers,” who do not have depression, in order to evaluate how the human body metabolizes the drug and to examine proper dosages and side effects.”

http://www.indystar.com/articles/7/119357-4527-102.html

Woman in Lilly clinical trial hangs herself
Coroner will consider whether drugs played a possible part in 19-year-old’s suicide.

By J.K. Wall and John Tuohy
jk.wall@indystar.com
February 10, 2004
A toxicology test will determine whether drugs played a role in the suicide of a 19-year-old woman who was participating in clinical trials for a new medication that Eli Lilly and Co. hopes to launch this year.
Traci Johnson, whose pastor and family in Bensalem, Pa., described her as upbeat and devout, hanged herself Saturday night in the Lilly Laboratory for Clinical Research, according to the Indianapolis Police Department. She reportedly used a scarf tied to a bathroom shower rod.
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. Toxicology test results are expected in about a month.
Lilly said Monday it does not believe the drug, duloxetine, was related to the death of Johnson, who attended Indiana Bible College through December. But Johnson’s family and friends said it is inconceivable that the tender-hearted teenager would have killed herself.
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 Johnson’s death, Smith said, she was on a 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 at this time “there’s nothing to suggest that this is anything but an isolated incident.”
Todd Lappin, the Indianapolis police detective who investigated Johnson’s death, said she did not leave a note, making her motive unclear. “I talked to her friends. They all said, ‘She was chipper,’ ” Lappin said.
When asked whether he thought duloxetine contributed to Johnson’s death, her pastor, Joel Barnaby, said, “Abolsutely. This is a testing drug. . . . This girl is not a girl that had any type of suicidal ideation. She is a bubbly person with a positive personality.”
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 that Lilly 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. FDA officials could not be reached by phone late Monday.
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 — money that relatives said she planned to use to return to college.
Smith said there were about 25 local volunteers participating in the trial and about 75 more across the country.
Johnson’s mother, reached by phone Monday night, declined to be quoted for this story. Smith said that Lilly informed Johnson’s family of her 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 the 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.
Star reporter Tom Spalding contributed to this story.
Call Star reporter J.K. Wall at (317) 444-6287.

Woman Commits Suicide While Testing  New Antidepressant

Was Traci Johnson Driven To Suicide By Antidepressants?

That’s A Trade Secret, Say US Officials

To view original story click here.

 By Jeanne Lenzer and Nicholas Pyke

 The Independent – UK

©2005 Independent News & Media (UK) Ltd.

When the body of a 19-year-old student, Traci Johnson, was found hanging from a shower rod in the laboratories of pharmaceuticals giant Eli Lilly, US officials were quick to announce that the death could not be linked to a new anti-depressant drug she was helping to test.   During her stay at the hotel-cum-clinic in Indiana known as the Lilly Lab, Johnson had been taking part in trials for a secret new formula called Cymbalta, a chemical cousin of Prozac, which the company hoped would guarantee huge profits for years to come.   For the drugs giant, her death on 7 February last year was an “isolated tragedy” that did not prevent it from pressing ahead with the Cymbalta trials. It is now on sale in the US and – under another name – in Europe and the UK.   But for the scientific community it was another warning bell about a class of medicines already under scrutiny for possible ties to suicide. After all, Johnson was not depressed. Far from it. She enrolled in the clinical trial as a healthy volunteer in order to earn money to pay for her college tuition. Anyone with signs of depression was excluded.   Now, medical researchers attempting to establish the truth about Cymbalta are asking why her disturbing and very public suicide is completely absent from the official record, at least as it is released to academics and the public. According to an investigation by The Independent on Sunday, this and at least four other suicides by volunteers have been hidden by the US regulators, the Food and Drug Administration (FDA).   As the FDA admits, even a young woman’s death counts as a commercial secret in the world of pharmaceuticals.   Last week, the IoS reported how vital data on prescription medicines found in millions of British homes has been suppressed by the US authorities, even though the information could potentially save lives. As a result, medical specialists say they have been unable to assess the true risks of big-name products such as painkillers Vioxx (now withdrawn) and Neurofen.   It is hard to overestimate the importance of Cymbalta to Eli Lilly. Prozac, the popular antidepressant that accounted for a quarter of the company’s $10bn revenues in 2000, went off-patent in August 2001, causing a bruising financial reaction on Wall Street. In just one day, the company’s stock plunged by almost a third.   The replacement was supposed to be Cymbalta, which financial analysts predicted would bring in a whopping $2bn in sales.   Lilly defended its drug, saying that 4,142 depressed patients had taken Cymbalta and the deaths represent a 0.097% suicide rate. Besides, it said, it is the underlying depression – not the drug – that causes sufferers to become suicidal.   With so much at stake, the FDA sent experts to Indianapolis to investigate. When they announced that Cymbalta “couldn’t be linked to her death”, her family was outraged. According to the Johnson family spokesperson, Pastor Joel Barnaby, FDA officials never spoke to them.   National headlines following the FDA ruling were unequivocal. The Associated Press ran an article entitled, “FDA clears Lilly drug in suicide”. And six months after Johnson’s death, the FDA approved the drug for the treatment of depressed patients. Cymbalta, which has the chemical name duloxetine, is also sold for “stress urinary incontinence” in Europe and the UK under the trade name Yentreve.   Beginning in January, the IoS started filing US Freedom of Information Act requests for all safety data relating to the drug’s use. The FDA responded with its Adverse Events Reporting System (Aers) database, which shows 13 suicides reported among patients taking duloxetine and about 41 deaths. Five suicides are notably absent from the information supplied by the FDA; that of Johnson and the four patients who committed suicide while enrolled in clinical trials of Cymbalta.   The FDA has a good reason not to release any information about these five patients: they don’t have to. In fact, it’s against the law, according to Dr Robert Temple, its director of medical policy. In an exclusive interview with the IoS, he said that some of the data filed by Lilly is considered commercially protected information.   When asked whether the FDA would release all the data from anti-depressant trials analysed by the FDA to a researcher, Dr Temple said his belief is that “the answer is clearly no”. That, he said, is something “only Congress can change”.   Dr David Graham, associate safety director at the FDA, agreed with Dr Temple that it would take action by Congress to make data available that are currently considered trade secrets. “Most of us think of trade secrets as a manufacturing process or the names of certain ingredients, but here, deaths are being considered trade secrets.”   Following revelations that drug companies were not publishing negative data, Eli Lilly won praise for its announcement that it would disclose all clinically relevant trial data on its website. The company has stated that it will disclose “all medical research results that are significant to patients, health care providers or payer – whether favourable or unfavourable to a Lilly product”.   The company posts clinical trials results on its freely available clinical trials website (www.lillytrials.com). Data from seven trials of duloxetine are posted, but these show a total of two deaths associated with duloxetine, and no reported suicides. Lilly says that it is “on track” to post all clinical data by 1 July 2005.   A spokesman for Eli Lilly, David Shaffer, said some of the studies are still in progress and that the suicides would be reported when the studies are completed, the data is reviewed and, if applicable, they have been published in a peer-reviewed scientific journal. Other suicides occurred in depression studies “run by another company”. Two cases from a completed study will be posted by 1 July, he said.   Dr Jerome Hoffman, professor of medicine and emergency medicine at the University of California at Los Angeles said, “Like Dr Temple, I don’t know whether this one young woman’s death was related to this drug, nor do I believe that it’s possible for anyone to determine that with certainty.”   But he said it was “unconscionable” that “the FDA appears to be prevented by law from carrying out what we all surely believe is its primary role in this process, which is to safeguard the interests of the public.   “The fact that the law not only does not make this a requirement – of the drug company itself, no less of the FDA – but that it actually makes it forbidden, clearly turns the function of this government agency on its head: from protector of the public health, to protector of industry.”