Glaxo Is Testing Paxil on 7-Year-Olds Despite Well Known Suicide Risks

The only word for this news is “Criminal!” I hope they are watching these children 24-7 to keep them from committingsuicide or homicide while in the study. I recall the seven year old boy on Paxil I worked with who wanted to cut the baby out of his mother’s belly and the 17 year old who impulsively jumped off an overpass in front of a semi-truck to end his life. Then there was the 10 year old brother and 15 year old sister, both on Paxil, who stabbed their 7 year old brother and buried him in the back yard. Sounds like a great drug for kids, doesn’t it?
I just finished a court report (I have been testifying as an expert in these cases for almost two decades) on a Paxil case and noted that 18 of the listed side effects were indicators of mania. If Glaxo had labeled those effects for what really are instead of the labels they gave those reactions then no one would be surprised to know that in children the rate of Bipolar Disorder increased 4000% from 1996-2004.
As for Paxil being beneficial apparently someone missed the news that came out just over two years ago where the original studies done on SSRI antidepressants finally surfaced – many the FDA had never seen – indicating that the drugs offer no more benefit than a placebo. So if even the worst drugs perform better than placebo, where does that leave the SSRI antidepressants?
Ann Blake-Tracy, Executive Director
International Coalition for Drug Awareness
www.drugawareness.orgwww.ssristories.drugawareness.org

Glaxo Is Testing Paxil on 7-Year-Olds Despite WellKnown Suicide Risks

By Jim Edwards | May 21, 2010

It was established years ago that Paxil carries a risk of suicide in children and teens, but GlaxoSmithKline (GSK) has for the last 18 months been conducting a study of the antidepressant in kids as young as seven — in Japan. It’s not clear why the company would want to draw more attention to its already controversial pill, but it appears as if GSK might be hoping to see a reduced suicide risk in a small population of users — a result the company could use to cast doubt on the Paxil-equals-teen-suicide meme that dominates discussion of the drug.

GSK didn’t immediately respond to a request for comment. A staffer on GSK’s trials hotline confirmed the study was ongoing, however. The drug carries a “black box” warning on its patient information sheet, warning doctors and consumers that the antidepressant is twice as likely to generate lethal thoughts than a placebo.

The trial criteria listed on ClinicalTrials.gov, however, provide an interesting lesson in how managers can carefully design drug trials designed to flatter their products — something good companies don’t do.

The primary aim of the study is not to find out why Paxil makes some children kill themselves. Rather, it’s yet another efficacy study, which the drug doesn’t need because it was approved years ago — we already know the drug works.

Paxil is being tested against a placebo, so the results won’t be very surprising — even terrible drugs work better than sugar pills.

To what degree Paxil triggers suicide is only a secondary aim of the study. If the results suggest a lower suicide risk, expect GSK to play them up. If they’re bad, expect the company to dismiss them in favor of the primary endpoint results.

About 130 children have been enrolled, according to ClinicalTrials.gov, which puts about 65 patients in each arm. That means the results won’t be too statistically robust — there only need to be two or three outlier results to skew the numbers by several percentage points.

The trial will wrap up in September.

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PAXIL: Catholic Priest Commits Suicide: IN Lawsuit

Paragraph three reads:  “Father Rick Tucker, who took Paxil because he was upset about the way his parish ignored a child abuse scandal, may have committed suicide because of side effects from the drug and not the stress from the cover-up, a federal judge ruled. Judge David H. Hamilton of Indiana’s federal court found that Tucker’s sister Debra could sue GSK over the death of her brother, who shot himself to death in September 2002.”

http://industry.bnet.com/pharma/10007579/glaxo-paxil-and-the-catholic-church-sex-abuse-cover-up-drug-implicated-in-suicide-of-priest/

Glaxo, Paxil and the Catholic Church Sex Abuse Cover-up: Drug Implicated in Suicide of Priest

By Jim Edwards | Apr 7, 2010

GlaxoSmithKline (GSK), which was already the focus of controversy over whether it ignored thesuicide risk of its antidepressant Paxil, has found itself linked to the Catholic Church’s cover-up of child abuse in the death of a priest who took the drug.

The case seems bound to become a further PR headache for GSK, which in 2008 was accused of obscuring the suicide risk of Paxil in studies for 15 years.

Father Rick Tucker, who took Paxil because he was upset about the way his parish ignored a child abuse scandal, may have committed suicide because of side effects from the drug and not the stress from the cover-up, a federal judge ruled. Judge David H. Hamilton of Indiana’s federal court found that Tucker’s sister Debra could sue GSK over the death of her brother, who shot himself to death inSeptember 2002.

The Tucker case stems from 1966, when Debra Tucker was 10 years old and attended the St. Lawrence Parish church in the Diocese of Lafayette-in-Indiana. At the same time, Rick attended St. Mary’s Seminary in the same parish. Between 1966 and 1968, Debra was raped two to four times a month by St. Lawrence’s children’s choir instruction, a lay employee of the church, she alleges. In1968, Tucker had an abortion at the abuser’s behest, and then her family  including Rick, who had no idea what was going on  moved house and the abuse stopped. Debra remained in the area and over the years the abuser painted her house and attended the funerals of both her parents, she alleges.

In July 2000, after Debra discovered that the abuser had also allegedly assaulted his own children, she attended a meeting with Father Tucker, St. Lawrence’s Monsignor Robert Sell and other church officials. She claims that Sell and the church agreed to ensure that the abuser had no further contact with children in the parish and in return she would not sue the church.

After learning that Sell and the church allegedly did nothing about the man, Debra Tucker sued for breach of contract in a separate case not involving GSK.

The parish dragged its feet over the lawsuit, and as Father Tucker waited for word over whether his employers would settle his sister’s case, he became increasingly anxious. He was also worried about an upcoming audit by the diocese because, the judge wrote, he had “advanced himself some monies” and the Church would discover these “irregularities.”

However, his anxieties were misplaced: the audit did not uncover any irregularities in Father Tucker’s bookkeeping, the ruling says. The Tucker family’s lawyer said that the amounts involved were in the $50 range  and thus proof that Father Tucker’s anxiety was a product of the drug and not the situation he was in.

After taking Paxil, Tucker went into a sudden depressive tailspin. His diary for Aug. 30, 2002, just two days after he was prescribed the pill, says:

“Things have gotten behind and I do not know how to catch up. I want to live, but I want out of the pain. I feel like I am in an ocean and I can’t swim to the top for air. . . . I can see no way out of it. I know that if I follow through with the thoughts that come to my mind, there will be people hurt. … Debra I am sorry.”

Father Tucker killed himself on Sept. 18.

Debra Tucker alleges in her complaint against GSK that the company knew as early as 1990 thatPaxil potentially had an increased risk of suicide, and that the company failed to warn patients of the risk of akathisia, psychosis or violent self harm. Akathisia is a profound state of anxiety in which patients, unable to rest, believe they are doomed.

GSK had asked the judge to summarily dismiss the case based because the expert witnesses who testified that Father Tucker’s death was triggered by the Paxil and not the other stresses in his life were inadequate. The judge ruled there was a case to answer.

GSK and Msgr. Sell did not immediately respond to emails and a voicemail requesting comment. I’ve decided not to name the alleged abuser  although his name is published in Debra Tucker’s complaint against the church because I could not reach him for comment.

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