U.S. drug safety reports linking an attention deficit drug to 20 deaths aren't enough for the Food and Drug Administration to follow Canada in taking the product off the market, the agency's director of medical policy said today.
Health Canada ordered the withdrawal yesterday of Adderall XR, made by Shire Pharmaceuticals Group Plc, based on its review of adverse-event reports previously given to the U.S. agency by the Basingstoke, England-based company. The drug is prescribed for children and adults with attention deficit hyperactivity disorder.
``The cases are not convincing evidence the drug is clearly responsible for these deaths,'' said Robert Temple, director of the FDA's office of medical policy, in an interview.
The drug, Shire's biggest product, will remain available in the U.S., its largest market, Temple said. House and Senate committees have been probing the FDA's monitoring of drug safety since antidepressants were linked to increased risk of suicide in children and Merck & Co. withdrew its Vioxx painkiller after a company study tied it to heart risks.
FDA Discouraged Withdrawal?
``Information conveyed to my staff suggests that during a recent Adderall meeting, one or more FDA employees requested that the Canadian government refrain from suspending the use of Adderall XR because there was concern that FDA could not handle another `drug safety crisis,''' Senate Finance Committee Chairman Charles Grassley, an Iowa Republican, said today in a letter to acting FDA Commissioner Lester Crawford.
Grassley requested details of meetings with Canadian officials concerning Adderall and related records and documents. A phone message left after normal business hours for FDA spokesman Brad Stone for comment on Grassley's letter wasn't immediately returned.
(Doesn't it make you sick?) -This info is from a Bloomberg article.
Thursday, February 10, 2005
Wednesday, February 09, 2005
More On Pittman Prozac Case From Ann Tracy and CNN
I hope you appreciate that statement as much as I do! This is an article on the Pittman case from CNN News. Note the following quote:
__________________________________
The boy's attorneys contend that Zoloft, a prescription drug manufactured by Pfizer, made him hallucinate and drove him to kill.
"He had these command hallucinations inside his head," Vickery said before the trial. "They didn't come externally. They came from inside his head: 'Kill, kill, kill.' "
The lawyers won a court fight to subpoena previously confidential drug test files from Pfizer and plan to use them in the trial.
If he is acquitted, some of the nation's largest drug makers could be exposed to future lawsuits linked to their antidepressants, possibly hurting sales.
________________________________
All I can say is that it could not happen to a more deserving group of folks!
Who gave them the right to harm so many with such deadly drugs?! Not even one of these tragedies is worth millions feeling "happy" for a while before they too crash into their own drug-induced nightmare. How can someone feeling good for a while compare to the pain and suffering of just this one little boy and his family?
As I have said over and over again, the research was there BEFORE these drugs were ever designed to demonstrate that they would become the nightmare they have become. For those of you who have read all of that documentation in my book, Prozac: Panacea or Pandora? - Our Serotonin Nightmare, you know that as well. There was no scientific reason whatsoever to ever develop and market these drugs.
Unfortunately lawsuits are our only recourse in this situation. Any of the rest of us would be charged with premeditated murder for what these companies have done in releasing and promoting these drugs.
Dr. Tracy
_________________
Ann Blake Tracy, Ph.D.,
Executive Director, International Coalition For Drug Awareness
Website: www.drugawareness.org
Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare & CD or audio tape on safe withdrawal: "Help! I Can't Get Off My Antidepressant!"
Order Number: 800-280-0730
________________________
http://www.cnn.com/2005/LAW/01/31/zoloft.killings/
Defense blames Zoloft as trial opens
Boy faces murder charges in deaths of grandparents
Monday, January 31, 2005 Posted: 10:48 PM EST (0348 GMT)
Christopher Pittman, 15, is charged as an adult with the murder of his grandparents.
CHARLESTON, South Carolina (CNN) -- Fifteen-year-old defendant Christopher
Pittman sighed and wiped his eyes as the prosecution argued Monday that the
shotgun deaths of his grandparents were crimes of "a dark heart, an evil heart."
But the minor's defense lawyer blamed the killings on the antidepressant drug
Zoloft, which Pittman was taking at the time, and called his client "a shy,
decent boy who was acting under the influence of a powerful, mind-altering
drug."
Pittman, who police say has confessed to the killings, is being tried as an
adult and could face 30 years to life in prison if convicted. "This is not a trial about Zoloft. ... Chris Pittman is on trial," prosecutor Barney Giese said in opening arguments. He said the boy, who was 12 at the time of the slayings, "knew what he was
doing was wrong, legally and morally."
Pittman's lawyer, Andy Vickery, said he plans to call a series of psychiatric
experts. "The defense, in this case, will focus on the fact Zoloft causes violence,"
Vickery said.
The first two prosecution witnesses were firemen who recounted how the bodies
of the grandparents, Joe Frank and Joy Pittman, were found in the ashes of their house after the murders on the night of November 28, 2001. The opening statements came shortly after nine women and three men were selected to serve on the jury in the double-murder trial. Wearing a tie but no coat, Pittman bowed his head during the jury selection, occasionally sighing, his fists clenched and held together.
Drug test files subpoenaed
Police have said Pittman gave them a written statement admitting he shotgunned his grandparents to death as they slept in bed, then used lighter fluid and candles to burn down their house before fleeing in a family vehicle.
If he is acquitted, some of the nation's largest drug makers could be exposed to future lawsuits linked to their antidepressants, possibly hurting sales. At the time of the killings, Christopher Pittman was living with his grandparents outside Chester, South Carolina. They had taken him in after he had run away from his parents' home in Florida and had spent about a week in a psychiatric treatment center. His father, Joe Pittman, said that shortly before the killings a South Carolina doctor gave Christopher a sample pack of Zoloft and doubled his dosage a
week later. Two days before the killings, according to court files, Christopher Pittman
got into a school bus fight with a younger boy. His grandparents then discussed
returning him to Florida.
The boy's attorneys contend that Zoloft, a prescription drug manufactured by Pfizer, made him hallucinate and drove him to kill. "He had these command hallucinations inside his head," Vickery said before the trial. "They didn't come externally. They came from inside his head: 'Kill, kill, kill.' "
The lawyers won a court fight to subpoena previously confidential drug test files from Pfizer and plan to use them in the trial. In testimony at a federal Food and Drug Administration hearing a year ago, Joe Pittman read a letter he said was written by his son. "Everything just kept getting worse, then I snapped and took everything out on my grandparents who I loved so much," said the letter. "When I was laying in my bed that night, I couldn't sleep, my voice kept echoing through my mind telling me to kill them until I got up, got the gun, went upstairs and pulled the trigger."
Pfizer officials declined to be interviewed but denied any connection between the drug and the deaths. The company said in a written statement: "There is no scientific evidence to suggest that Zoloft contributes to violent behavior in either adults or children." Zoloft is not recommended for use by children with depression. Yet it and other antidepressants are widely prescribed for younger patients and adults.
In October, the FDA announced there was a link between antidepressants such as Zoloft, Prozac and Paxil and suicidal actions or thoughts among some younger patients. The FDA asked the manufacturers to adopt a warning to alert doctors and parents to watch carefully for signs of anxiety, agitation and aggression, particularly when children and teenagers start taking these drugs.
But the FDA has never suggested there is any connection between the antidepressants and violent behavior toward others. Zoloft is in a class of anti-depressants known as selective serotonin reuptake inhibitors, or SSRIs, that increase the level of a brain chemical, serotonin.
In 2002, almost 11 million prescriptions were dispensed to patients under 18 for SSRIs and other newer antidepressants to treat depression and a host of other conditions, according to the FDA.
Trial moved to Charleston
Pittman's trial was moved to Charleston after both the judge and the prosecutor withdrew from the case for personal reasons. Judge Daniel Pieper has said he expects the trial to last about two weeks. The boy has been held in the state's juvenile facility for more than three years. In addition to the murder charges, Pittman also faces family court charges of arson. Under South Carolina law, a juvenile found guilty in family court can be held until he is 21. Prosecutors pressed successfully to try Pittman in adult court to seek a longer sentence. Speaking at a 2003 hearing, John Justice, the case's original prosecutor, said the killings were among the worst of his career. "This kid waited until his grandparents went to bed, went to sleep, came in, shot them in the face -- in the mouth -- with a shotgun," Justice said. "It's as cold and brutal an act as I've witnessed in 25 years of prosecuting."
CNN's Jim Polk contributed to this report
__________________________________
The boy's attorneys contend that Zoloft, a prescription drug manufactured by Pfizer, made him hallucinate and drove him to kill.
"He had these command hallucinations inside his head," Vickery said before the trial. "They didn't come externally. They came from inside his head: 'Kill, kill, kill.' "
The lawyers won a court fight to subpoena previously confidential drug test files from Pfizer and plan to use them in the trial.
If he is acquitted, some of the nation's largest drug makers could be exposed to future lawsuits linked to their antidepressants, possibly hurting sales.
________________________________
All I can say is that it could not happen to a more deserving group of folks!
Who gave them the right to harm so many with such deadly drugs?! Not even one of these tragedies is worth millions feeling "happy" for a while before they too crash into their own drug-induced nightmare. How can someone feeling good for a while compare to the pain and suffering of just this one little boy and his family?
As I have said over and over again, the research was there BEFORE these drugs were ever designed to demonstrate that they would become the nightmare they have become. For those of you who have read all of that documentation in my book, Prozac: Panacea or Pandora? - Our Serotonin Nightmare, you know that as well. There was no scientific reason whatsoever to ever develop and market these drugs.
Unfortunately lawsuits are our only recourse in this situation. Any of the rest of us would be charged with premeditated murder for what these companies have done in releasing and promoting these drugs.
Dr. Tracy
_________________
Ann Blake Tracy, Ph.D.,
Executive Director, International Coalition For Drug Awareness
Website: www.drugawareness.org
Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare & CD or audio tape on safe withdrawal: "Help! I Can't Get Off My Antidepressant!"
Order Number: 800-280-0730
________________________
http://www.cnn.com/2005/LAW/01/31/zoloft.killings/
Defense blames Zoloft as trial opens
Boy faces murder charges in deaths of grandparents
Monday, January 31, 2005 Posted: 10:48 PM EST (0348 GMT)
Christopher Pittman, 15, is charged as an adult with the murder of his grandparents.
CHARLESTON, South Carolina (CNN) -- Fifteen-year-old defendant Christopher
Pittman sighed and wiped his eyes as the prosecution argued Monday that the
shotgun deaths of his grandparents were crimes of "a dark heart, an evil heart."
But the minor's defense lawyer blamed the killings on the antidepressant drug
Zoloft, which Pittman was taking at the time, and called his client "a shy,
decent boy who was acting under the influence of a powerful, mind-altering
drug."
Pittman, who police say has confessed to the killings, is being tried as an
adult and could face 30 years to life in prison if convicted. "This is not a trial about Zoloft. ... Chris Pittman is on trial," prosecutor Barney Giese said in opening arguments. He said the boy, who was 12 at the time of the slayings, "knew what he was
doing was wrong, legally and morally."
Pittman's lawyer, Andy Vickery, said he plans to call a series of psychiatric
experts. "The defense, in this case, will focus on the fact Zoloft causes violence,"
Vickery said.
The first two prosecution witnesses were firemen who recounted how the bodies
of the grandparents, Joe Frank and Joy Pittman, were found in the ashes of their house after the murders on the night of November 28, 2001. The opening statements came shortly after nine women and three men were selected to serve on the jury in the double-murder trial. Wearing a tie but no coat, Pittman bowed his head during the jury selection, occasionally sighing, his fists clenched and held together.
Drug test files subpoenaed
Police have said Pittman gave them a written statement admitting he shotgunned his grandparents to death as they slept in bed, then used lighter fluid and candles to burn down their house before fleeing in a family vehicle.
If he is acquitted, some of the nation's largest drug makers could be exposed to future lawsuits linked to their antidepressants, possibly hurting sales. At the time of the killings, Christopher Pittman was living with his grandparents outside Chester, South Carolina. They had taken him in after he had run away from his parents' home in Florida and had spent about a week in a psychiatric treatment center. His father, Joe Pittman, said that shortly before the killings a South Carolina doctor gave Christopher a sample pack of Zoloft and doubled his dosage a
week later. Two days before the killings, according to court files, Christopher Pittman
got into a school bus fight with a younger boy. His grandparents then discussed
returning him to Florida.
The boy's attorneys contend that Zoloft, a prescription drug manufactured by Pfizer, made him hallucinate and drove him to kill. "He had these command hallucinations inside his head," Vickery said before the trial. "They didn't come externally. They came from inside his head: 'Kill, kill, kill.' "
The lawyers won a court fight to subpoena previously confidential drug test files from Pfizer and plan to use them in the trial. In testimony at a federal Food and Drug Administration hearing a year ago, Joe Pittman read a letter he said was written by his son. "Everything just kept getting worse, then I snapped and took everything out on my grandparents who I loved so much," said the letter. "When I was laying in my bed that night, I couldn't sleep, my voice kept echoing through my mind telling me to kill them until I got up, got the gun, went upstairs and pulled the trigger."
Pfizer officials declined to be interviewed but denied any connection between the drug and the deaths. The company said in a written statement: "There is no scientific evidence to suggest that Zoloft contributes to violent behavior in either adults or children." Zoloft is not recommended for use by children with depression. Yet it and other antidepressants are widely prescribed for younger patients and adults.
In October, the FDA announced there was a link between antidepressants such as Zoloft, Prozac and Paxil and suicidal actions or thoughts among some younger patients. The FDA asked the manufacturers to adopt a warning to alert doctors and parents to watch carefully for signs of anxiety, agitation and aggression, particularly when children and teenagers start taking these drugs.
But the FDA has never suggested there is any connection between the antidepressants and violent behavior toward others. Zoloft is in a class of anti-depressants known as selective serotonin reuptake inhibitors, or SSRIs, that increase the level of a brain chemical, serotonin.
In 2002, almost 11 million prescriptions were dispensed to patients under 18 for SSRIs and other newer antidepressants to treat depression and a host of other conditions, according to the FDA.
Trial moved to Charleston
Pittman's trial was moved to Charleston after both the judge and the prosecutor withdrew from the case for personal reasons. Judge Daniel Pieper has said he expects the trial to last about two weeks. The boy has been held in the state's juvenile facility for more than three years. In addition to the murder charges, Pittman also faces family court charges of arson. Under South Carolina law, a juvenile found guilty in family court can be held until he is 21. Prosecutors pressed successfully to try Pittman in adult court to seek a longer sentence. Speaking at a 2003 hearing, John Justice, the case's original prosecutor, said the killings were among the worst of his career. "This kid waited until his grandparents went to bed, went to sleep, came in, shot them in the face -- in the mouth -- with a shotgun," Justice said. "It's as cold and brutal an act as I've witnessed in 25 years of prosecuting."
CNN's Jim Polk contributed to this report
Monday, February 07, 2005
A Poem - Or Is It Prose? Or is it Prozac?
A great poem by Dean Blehert:
Kids shoot up their schools,
mothers drown their kids;
pretty new tablets (green, purple)
replace the shattered tablets of the law,
abetting Premedicated murder.
Kids shoot up their schools,
mothers drown their kids;
pretty new tablets (green, purple)
replace the shattered tablets of the law,
abetting Premedicated murder.
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