cache of story removed from the coast - re Stan Kutcher

[Guest guest]

Stan Kutcher involved in controversial drug test

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

Lberal candidate for Halifax co-authored problematic Paxil study

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 Keller, then the chair of the Psychiatry department at Brown University, proposed to the drug company Kline Beechman a study of the use of Paxil for the treatment of adolescent depression. In 2000, Kline Beechman merged with Glaxo Wellcome to become GlaxoKline. 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 GlaxoKline 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 GlaxoKline 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.

[Guest guest]

Damn good article, shame they pulled it. I wonder

why they did pull it? Slamming politicians is open season in the

USA at least.

On 4/30/2011 4:51 AM, jeremy9282 wrote:

Stan Kutcher

involved in controversial drug test

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

Lberal candidate for Halifax co-authored

problematic Paxil study

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 Keller, then the

chair of the Psychiatry department at Brown University,

proposed to the drug company Kline Beechman a study of

the use of Paxil for the treatment of adolescent

depression. In 2000, Kline Beechman merged with Glaxo

Wellcome to become GlaxoKline.

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

GlaxoKline 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 GlaxoKline

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.