Stan Kutcher involved in controversial drug test
Lberal candidate for Halifax co-authored problematic Paxil study
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Posted by Tim Bousquet on Thu, Apr 28, 2011 at 8:23 AM
Stan Kutcher, the Liberal candidate for Halifax in Monday’s federal election, is running on his expertise as a doctor.
“I have a lot of experience in the health field,” says Kutcher, “in multiple areas: as a clinician, as a researcher, as associate dean of our medical school and in my work globally in my work with the World Health Organization, as someone who has worked to establish a number of national health institutions.”
But Kutcher’s experience as a clinician and researcher includes his involvement in a controversial drug test known as the Paxil 329 study, which was the subject of multiple lawsuits and explosive allegations of wrongdoing by researchers, and which ultimately changed the way medical research is conducted.
That study started in 1992, when Martin Keller, then the chair of the Psychiatry department at Brown University, proposed to the drug company SmithKline Beechman a study of the use of Paxil for the treatment of adolescent depression. In 2000, SmithKline Beechman merged with Glaxo Wellcome to become GlaxoSmithKline.
The drug trials took place between 1994 and 1997 at 12 research centres across North America, including the Dalhousie Medical School, where Kutcher oversaw the trials. It was a typical “double blind” study, with half the participants taking Paxil, and half taking a placebo. The results were published in 2001, with Kutcher as co-author.
But as documents later made public through the lawsuits demonstrate, the initial outcome measures in the study showed that there was no difference in therapeutic benefits between Paxil and the placebo, but those measures were changed to give Paxil a more favourable result.
“They essentially distorted the outcome measures, and essentially lied,” says Alison Bass, a former science reporter with the Boston *Globe* who broke the story and went on to write *Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial*, which examines the Paxil 329 study. “They also omitted information about adolescents who became suicidal on Paxil and withdrew from the study. And they miscoded those teenagers---they said they were non-compliant when in fact they had been withdrawn from the study because they became suicidal.”
Only in 2003, when a secretary at Brown leaked information to Bass, did the problems with the study became public. Afterwards, New York state attorney general Eliot Spitzer sued GlaxoSmithKline for fraud; that suit was settled out of court, but together with separate suits filed in Canada and California, hundreds of internal GSK documents were released. In Britain, the Committee on the Safety of
Medicine found that the incidence of suicidal thoughts in the Paxil group was double that of the placebo group.
Bass reported that in addition to his university salary, Keller, the lead author of the Paxil 329 study, was paid over a half-million dollars annually by drug companies, including GSK. Keller has since lost his job---”in large part I think because of the allegations in the book,” says Bass. Two other of the Paxil 329 authors have likewise lost their positions, but there’s no evidence any of the other co-authors, including Kutcher, have suffered professionally.
Kutcher was in the past paid by GlaxoSmithKline and other drug companies, but has not made the dollar amount of those payments public.
Kutcher says he stands by the Paxil 329 study. “I don’t think that study caused any particular controversy,” he says. “There certainly is a group of people who would like to cause a controversy around it, but science is nasty, brutish and long.”
Indeed, as co-author of a 2008 Canadian Academy of Child and Adolescent Psychiatry “Position Paper on Using SSRIs in Children and Adolescents,” Kutcher refers to “positive” results in the problematic Paxil 329 study and completely ignores negative results published in 2006 from further GSK-sponsored research on Paxil in treating depression in adolescents in which he was also involved.
Regardless, the Paxil 329 controversy has fundamentally changed the way drug research is conducted. Now, medical journals require all drug study protocols to be registered before the study begins, so that measures can’t later be changed. Also, American medical schools---but not Canadian---require that researchers enter all outside income from drug companies on a public database. As well, typically, although not always, published articles on drug trials now say what pharmaceutical firm paid for the study.
Lberal candidate for Halifax co-authored problematic Paxil study
http://webcache.googleusercontent.com/search?q=cache:dOdQCF35WccJ:www.thecoast.ca/RealityBites/archives/2011/04/28/stan-kutcher-involved-in-controversial-drug-study+Dr.+Stan+Kutcher+paxil+329&cd=1&hl=en&ct=clnk&gl=uk&source=www.google.co.uk
Posted by Tim Bousquet on Thu, Apr 28, 2011 at 8:23 AM
Stan Kutcher, the Liberal candidate for Halifax in Monday’s federal election, is running on his expertise as a doctor.
“I have a lot of experience in the health field,” says Kutcher, “in multiple areas: as a clinician, as a researcher, as associate dean of our medical school and in my work globally in my work with the World Health Organization, as someone who has worked to establish a number of national health institutions.”
But Kutcher’s experience as a clinician and researcher includes his involvement in a controversial drug test known as the Paxil 329 study, which was the subject of multiple lawsuits and explosive allegations of wrongdoing by researchers, and which ultimately changed the way medical research is conducted.
That study started in 1992, when Martin Keller, then the chair of the Psychiatry department at Brown University, proposed to the drug company SmithKline Beechman a study of the use of Paxil for the treatment of adolescent depression. In 2000, SmithKline Beechman merged with Glaxo Wellcome to become GlaxoSmithKline.
The drug trials took place between 1994 and 1997 at 12 research centres across North America, including the Dalhousie Medical School, where Kutcher oversaw the trials. It was a typical “double blind” study, with half the participants taking Paxil, and half taking a placebo. The results were published in 2001, with Kutcher as co-author.
But as documents later made public through the lawsuits demonstrate, the initial outcome measures in the study showed that there was no difference in therapeutic benefits between Paxil and the placebo, but those measures were changed to give Paxil a more favourable result.
“They essentially distorted the outcome measures, and essentially lied,” says Alison Bass, a former science reporter with the Boston *Globe* who broke the story and went on to write *Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial*, which examines the Paxil 329 study. “They also omitted information about adolescents who became suicidal on Paxil and withdrew from the study. And they miscoded those teenagers---they said they were non-compliant when in fact they had been withdrawn from the study because they became suicidal.”
Only in 2003, when a secretary at Brown leaked information to Bass, did the problems with the study became public. Afterwards, New York state attorney general Eliot Spitzer sued GlaxoSmithKline for fraud; that suit was settled out of court, but together with separate suits filed in Canada and California, hundreds of internal GSK documents were released. In Britain, the Committee on the Safety of
Medicine found that the incidence of suicidal thoughts in the Paxil group was double that of the placebo group.
Bass reported that in addition to his university salary, Keller, the lead author of the Paxil 329 study, was paid over a half-million dollars annually by drug companies, including GSK. Keller has since lost his job---”in large part I think because of the allegations in the book,” says Bass. Two other of the Paxil 329 authors have likewise lost their positions, but there’s no evidence any of the other co-authors, including Kutcher, have suffered professionally.
Kutcher was in the past paid by GlaxoSmithKline and other drug companies, but has not made the dollar amount of those payments public.
Kutcher says he stands by the Paxil 329 study. “I don’t think that study caused any particular controversy,” he says. “There certainly is a group of people who would like to cause a controversy around it, but science is nasty, brutish and long.”
Indeed, as co-author of a 2008 Canadian Academy of Child and Adolescent Psychiatry “Position Paper on Using SSRIs in Children and Adolescents,” Kutcher refers to “positive” results in the problematic Paxil 329 study and completely ignores negative results published in 2006 from further GSK-sponsored research on Paxil in treating depression in adolescents in which he was also involved.
Regardless, the Paxil 329 controversy has fundamentally changed the way drug research is conducted. Now, medical journals require all drug study protocols to be registered before the study begins, so that measures can’t later be changed. Also, American medical schools---but not Canadian---require that researchers enter all outside income from drug companies on a public database. As well, typically, although not always, published articles on drug trials now say what pharmaceutical firm paid for the study.
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