These reports of inexplicable suicides were alarming to members of the committee. "Is it possible that this medication has an effect, an action that results in spontaneous, impulsive, self destructive behavior that is different from that which occurs from a clinical depression?," Congressman Ted Strickland (D-OH), who has a PhD in psychology, asked.
"I know of no clinical concept of depression that has an instantaneous onset and what we've heard described are people who are emotionally," Rep Strickland said, "psychologically healthy with none of the clinical signs of depression spontaneously doing something to themselves."
"So I'm wondering," he concluded, "if we are dealing here with something other than depression, and that we ought to recognize that."
The FDA Office of Drug Safety keeps a monthly cumulative count of psychiatric adverse event reports in AERS. According to Dr Janet Woodcock, Director of the Center for Drug Evaluation and Research, at the hearing, as of November 30, 2002, AERS contained 3,104 reports with at least one reported psychiatric event.
The FDA is aware of 173 reports of suicide in association with Accutane, she told the panel. She noted that the FDA had requested quarterly summaries of psychiatric events from Roche and said the most recent summary through August 2002 indicated approximately 6,000 additional reports that include psychiatric events
Because the 173 cases of suicides ware based on self reporting, experts say that figure is highly suspect and that being as few as 1% of suicides are reported as adverse events, it could mean that the actual number of suicides may be as high as 17,000.
During his December 11, 2002 statement to the committee, Congressman Stupak pointed the finger of blame directly at the FDA when stating:
"Accutane is a powerful, dangerous drug with devastating consequences for some patients. The birth defects caused by Accutane are horrific. The FDA's response to the birth defects and psychiatric events has been inadequate, irresponsible and unacceptable. Thousands of babies, teenagers, and young adults have died prematurely.
"While the FDA has been aware of the birth defects since at least 1982 and the psychiatric injuries since 1985, their responsibility to protect the public has been inconsistent and without direction."
There is no debate about whether Accutane is a moneymaker. According to the Associated Press on August 21, 2006, patients usually take it for up to a year at a cost of $10 to $15 per day. And in the December 11, 2002 hearing, Congressman Stupak turned the attention of the committee to Roche's conduct of putting profits before people and stated:
"They have done everything possible to prevent the American people from learning of the psychiatric injuries and deaths associated with Accutane. Even, today ... Roche will deny any casual effect of Accutane with the abortions, deaths, and suicides caused by their product."
"We cannot allow the drug manufacturer and the FDA to continue to turn a blind eye to the lives lost, families devastated and dreams dashed by an acne drug," he said.
"The American people, our children," he said, "are not collateral damage in the scheme of corporate profits!"
Information for injured parties can be found at Lawyers and Settlements.com
http://www.lawyersandsettlements.com/
Evelyn Pringle
evelyn.pringle@sbcglobal.net
"I know of no clinical concept of depression that has an instantaneous onset and what we've heard described are people who are emotionally," Rep Strickland said, "psychologically healthy with none of the clinical signs of depression spontaneously doing something to themselves."
"So I'm wondering," he concluded, "if we are dealing here with something other than depression, and that we ought to recognize that."
The FDA Office of Drug Safety keeps a monthly cumulative count of psychiatric adverse event reports in AERS. According to Dr Janet Woodcock, Director of the Center for Drug Evaluation and Research, at the hearing, as of November 30, 2002, AERS contained 3,104 reports with at least one reported psychiatric event.
Because the 173 cases of suicides ware based on self reporting, experts say that figure is highly suspect and that being as few as 1% of suicides are reported as adverse events, it could mean that the actual number of suicides may be as high as 17,000.
During his December 11, 2002 statement to the committee, Congressman Stupak pointed the finger of blame directly at the FDA when stating:
"Accutane is a powerful, dangerous drug with devastating consequences for some patients. The birth defects caused by Accutane are horrific. The FDA's response to the birth defects and psychiatric events has been inadequate, irresponsible and unacceptable. Thousands of babies, teenagers, and young adults have died prematurely.
"While the FDA has been aware of the birth defects since at least 1982 and the psychiatric injuries since 1985, their responsibility to protect the public has been inconsistent and without direction."
There is no debate about whether Accutane is a moneymaker. According to the Associated Press on August 21, 2006, patients usually take it for up to a year at a cost of $10 to $15 per day. And in the December 11, 2002 hearing, Congressman Stupak turned the attention of the committee to Roche's conduct of putting profits before people and stated:
"They have done everything possible to prevent the American people from learning of the psychiatric injuries and deaths associated with Accutane. Even, today ... Roche will deny any casual effect of Accutane with the abortions, deaths, and suicides caused by their product."
"We cannot allow the drug manufacturer and the FDA to continue to turn a blind eye to the lives lost, families devastated and dreams dashed by an acne drug," he said.
"The American people, our children," he said, "are not collateral damage in the scheme of corporate profits!"
Information for injured parties can be found at Lawyers and Settlements.com
http://www.lawyersandsettlements.com/
Evelyn Pringle
evelyn.pringle@sbcglobal.net
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