Post by Mech on Feb 28, 2004 21:35:48 GMT -5
Antidepressant Or Anti-Existant -
Government Drug Testing Program = DEATH
From: [PagPawnt]@yahoogroups.com
Until two weeks ago 19-year-old Traci Johnson, who is from Bensalem, Pa., was a Bible student at Indiana Bible College in Indianapolis.
Her family and friends would describe her as upbeat personality on campus, an active volunteer and someone who loved life.
But early this year, she suspended her studies to earn money to enable her continue. On January 8th she agreed to join with 100 volunteeres taking a new anti-depressant drug duloxetine. She was paid $150 a day.
Hundreds of college students like Traci are recruited to become human research subjects by campus notices, e-mails, Web sites, fliers and word of mouth.
On Feb. 7, Traci walked into a shower unit in her room at the on-campus Lilly Laboratory for Clinical Research, tied a scarf to a bathroom shower rod, and hung herself according to the Indianapolis Police Department.
She was one of 25 local healthy volunteers taking higher-than-normal doses of duloxetine, a compound developed by Lilly to treat incontinence and depression.
Even as arrangements for the teenager's burial were underway, her mother Peggy Johnson, recalled noticed something odd in telephone conversations with her daughter after Johnson entered the drug trial. She would call and say, 'My heart feels funny' or 'I feel funny today.' Peggy described some of the telephone conversations as being real silly and lightheaded."
The drug maker has been ordered to stop taking new patients for the trial. Traci's death was the fifth person to committ suicide on the trial.
But, Eli Lilly & Co. says it does not expect the projected summer launch of its experimental antidepressant Cymbalta (duloxetine) to be delayed by the suicide, according to The Wall Street Journal. It's business as usual.
Eli Lilly are in final testing stages of a chemical compound called duloxetine as the main ingredient in Cymbalta, a potential blockbuster that could earn lilly over $2 billion in sales in the next four years.
Eli Lilly's chief medical officer, Dr. Alan Brier said, "Just because this h appens while someone is taking a drug doesn't mean the drug caused it."
Lilly spokesman Rob Smith said: "At this time, there is nothing to suggest the conduct of the study led to this tragic event. That was not the most forthcoming statement.
The clinical trial was cycling the participants between doses of duloxetine and a placebo. Patients at the clinic were being given larger than therapeutic doses of duloxetine.
Lilly spokesman Rob Smith said that at the time of her death Johnson was taking placebo. She hung herself after 4.5 days of withdrawl symptoms from duloxetine in the incontinence variety of medication.
That raises serious questions of negligence. There are known problems with suicides caused by withdrawals from anti-depressants - let alone from withdrawals from the high doses Traci was administered. To design a study with built in withdrawals -without extremely close monitoring in the days immediately after would be negligent. Traci would not have been told she was coming off mediaction.
There needs to be a thorough investigation which is prepared to bring charges of criminal negligence or even manslaughter if the facts warrant.
Just five days before Traci's death families from around the nation who've had deadly experiences with anti-depressant drugs attended a Food and Drug Administration hearing and persuaded the agency to urge doctors to warn patients that for some people -- especially children, adolescents and young adults -- anti-depressants can trigger suicide.
Van Syckel testified at the Feb. 2 FDA hearings, because her teenage daughter had made two suicide attempts while on anti-depressants.
Syckel says: "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. It is almost like God chose an angel because this has been very slow moving."
Government Drug Testing Program = DEATH
From: [PagPawnt]@yahoogroups.com
Until two weeks ago 19-year-old Traci Johnson, who is from Bensalem, Pa., was a Bible student at Indiana Bible College in Indianapolis.
Her family and friends would describe her as upbeat personality on campus, an active volunteer and someone who loved life.
But early this year, she suspended her studies to earn money to enable her continue. On January 8th she agreed to join with 100 volunteeres taking a new anti-depressant drug duloxetine. She was paid $150 a day.
Hundreds of college students like Traci are recruited to become human research subjects by campus notices, e-mails, Web sites, fliers and word of mouth.
On Feb. 7, Traci walked into a shower unit in her room at the on-campus Lilly Laboratory for Clinical Research, tied a scarf to a bathroom shower rod, and hung herself according to the Indianapolis Police Department.
She was one of 25 local healthy volunteers taking higher-than-normal doses of duloxetine, a compound developed by Lilly to treat incontinence and depression.
Even as arrangements for the teenager's burial were underway, her mother Peggy Johnson, recalled noticed something odd in telephone conversations with her daughter after Johnson entered the drug trial. She would call and say, 'My heart feels funny' or 'I feel funny today.' Peggy described some of the telephone conversations as being real silly and lightheaded."
The drug maker has been ordered to stop taking new patients for the trial. Traci's death was the fifth person to committ suicide on the trial.
But, Eli Lilly & Co. says it does not expect the projected summer launch of its experimental antidepressant Cymbalta (duloxetine) to be delayed by the suicide, according to The Wall Street Journal. It's business as usual.
Eli Lilly are in final testing stages of a chemical compound called duloxetine as the main ingredient in Cymbalta, a potential blockbuster that could earn lilly over $2 billion in sales in the next four years.
Eli Lilly's chief medical officer, Dr. Alan Brier said, "Just because this h appens while someone is taking a drug doesn't mean the drug caused it."
Lilly spokesman Rob Smith said: "At this time, there is nothing to suggest the conduct of the study led to this tragic event. That was not the most forthcoming statement.
The clinical trial was cycling the participants between doses of duloxetine and a placebo. Patients at the clinic were being given larger than therapeutic doses of duloxetine.
Lilly spokesman Rob Smith said that at the time of her death Johnson was taking placebo. She hung herself after 4.5 days of withdrawl symptoms from duloxetine in the incontinence variety of medication.
That raises serious questions of negligence. There are known problems with suicides caused by withdrawals from anti-depressants - let alone from withdrawals from the high doses Traci was administered. To design a study with built in withdrawals -without extremely close monitoring in the days immediately after would be negligent. Traci would not have been told she was coming off mediaction.
There needs to be a thorough investigation which is prepared to bring charges of criminal negligence or even manslaughter if the facts warrant.
Just five days before Traci's death families from around the nation who've had deadly experiences with anti-depressant drugs attended a Food and Drug Administration hearing and persuaded the agency to urge doctors to warn patients that for some people -- especially children, adolescents and young adults -- anti-depressants can trigger suicide.
Van Syckel testified at the Feb. 2 FDA hearings, because her teenage daughter had made two suicide attempts while on anti-depressants.
Syckel says: "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. It is almost like God chose an angel because this has been very slow moving."