Drug risks hidden from public...

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http://www.canada.com/edmonton/edmontonjournal/story.asp?id=2E00FC1D-A3C8-467A-A\

66D-05EB5264E368

Drug risks hidden from public

Drug companies keep test failures quiet, medical journal says

Ê

Sharon Kirkey

CanWest News Service

Tuesday, February 17, 2004

OTTAWA - Pharmaceutical companies are deceiving patients and doctors by

keeping negative results from drug trials " locked in the filing cabinet, "

Can-ada's leading medical journal warns.

The Canadian Medical Association Journal says Health Canada is complicit in

this " file drawer phenomenon " by too often keeping quiet about buried

evidence that questions drug safety and effectiveness.

In an editorial published today, the CMAJ accuses drug companies of

silencing medical researchers by having them sign agreements that suppress

the release of negative findings in drug trials -- sometimes for as long as

a decade after the test results are in -- while positive findings are

promoted.

Most " negative studies " go unreported because they showed no beneficial

effects of the drug being tested. But some hold information that would hurt

the drug companies.

It takes $1 billion on average to bring a new drug to market, a huge

investment that " puts pressure on companies to suppress results that might

slow or extinguish sales, " the CMAJ says.

But by burying data, drug companies " deceive physicians, their patients and,

perhaps, shareholders. Worse, such concealment is a flagrant abuse of the

trust " patients put in doctors when they agree to be test subjects in

medical experiments.

A leading B.C. child psychiatrist has vowed never to do another drug-company

sponsored trial unless " drastic " changes are made. Three years ago, Dr. Jane

Garland was shown unpublished data that suggested the antidepressant Paxil

was ineffective in children -- but only after she had signed an agreement

prohibiting her from sharing the information with other doctors and

investigators for 10 years.

Garland, head of the Mood and Anxiety Disorders Clinic at British Columbia's

Children's and Women's Hospital, was about to do a study testing Paxil on

children with mood disorders when she was sent a confidential

" investigator's brochure " that summarized what GlaxoKline knew about

its drug.

Buried in the material were results from two studies that showed Paxil was

no more effective than a placebo, or sugar pill, in treating depression in

children.

At that time, the only study of Paxil in depressed children that had been

published suggested a benefit. None of the Paxil-like drugs have been

approved in Canada for use in anyone under 18, but they're increasingly

being prescribed to children as young as three for depression,

obsessive-compulsive disorder, social phobia and anxiety.

" My jaw dropped because I already signed a form saying I can't reveal

anything I'm about to see, " says Garland, whose commentary is one of several

articles on the burying of clinical evidence in today's CMAJ.

" I do the continuing medical education (for doctors). I run the specialty

clinic for the province. I teach students and residents and I have to tell

them that the medication works based on the one study published, and I'm not

allowed to mention that I've seen the other data. It felt terrible. "

The evidence came to light last summer, when GlaxoKline warned doctors

Paxil should not be given to children because several large trials also

found that two to three per cent of children taking the drug developed

suicidal thoughts while on the medication, twice as many as children on a

placebo.

Last month, Health Canada issued a public advisory about the increased risk

of suicide in children for all

SSRIs (Selective Serotonin Reuptake Inhibitors).

Garland says the safety data involving Paxil had been available at least

since the 1990s. She estimates 10,000 to 15,000 B.C. children are taking the

drugs.

In a written response to a request for an interview, the company said it

" began communicating results " from its pediatric studies in 1998 through

posters, abstracts and other publications.

" GSK takes very seriously our responsibility to provide health-care

professionals the information they need to prescribe medicines. We are

devoting significant time and energy to finalize the process of

communicating study results so that we have a sound and sustainable policy. "

But the problem of hidden drug information is much more widespread, says

CMAJ editor Dr. Hoey.

" It means that physicians who are prescribing these drugs may not have

complete information about how good the drug is, does it work or, equally

important, how safe is it, " Hoey said in an interview.

Drug companies have to make the results of all clinical trials available to

Health Canada to get initial approval for a drug, Hoey says. But there is no

requirement for the results to be published, or even made available to other

researchers.

A Health Canada spokeswoman said that information is owned by the drug

company.

Companies are required by law to report serious side effects to the

government. But the secrecy in the drug-approvals process and weak systems

for monitoring adverse drug reactions are also keeping unsafe medicines on

the market, U.K. and Canadian researchers report in the CMAJ.

Patient reports of drug reactions are often dismissed as " anecdotal or

unscientific, " the researchers say. In addition, Health Canada keeps

confidential any rejected applications to expand the use of a drug to

another patient group, such as giving drugs designed for adults to children.

Hoey says Health Canada should pressure all drug companies to follow the

lead of Merck-Frosst, which plans to publish the results of all clinical

trials, regardless of the outcome.

©ÊCopyright Ê2004ÊEdmonton Journal

_________________________________________________________________

Watch high-quality video with fast playback at MSN Video. Free!

http://click.atdmt.com/AVE/go/onm00200365ave/direct/01/

[Guest guest]

http://www.canada.com/edmonton/edmontonjournal/story.asp?id=2E00FC1D-A3C8-467A-A\

66D-05EB5264E368

Drug risks hidden from public

Drug companies keep test failures quiet, medical journal says

Ê

Sharon Kirkey

CanWest News Service

Tuesday, February 17, 2004

OTTAWA - Pharmaceutical companies are deceiving patients and doctors by

keeping negative results from drug trials " locked in the filing cabinet, "

Can-ada's leading medical journal warns.

The Canadian Medical Association Journal says Health Canada is complicit in

this " file drawer phenomenon " by too often keeping quiet about buried

evidence that questions drug safety and effectiveness.

In an editorial published today, the CMAJ accuses drug companies of

silencing medical researchers by having them sign agreements that suppress

the release of negative findings in drug trials -- sometimes for as long as

a decade after the test results are in -- while positive findings are

promoted.

Most " negative studies " go unreported because they showed no beneficial

effects of the drug being tested. But some hold information that would hurt

the drug companies.

It takes $1 billion on average to bring a new drug to market, a huge

investment that " puts pressure on companies to suppress results that might

slow or extinguish sales, " the CMAJ says.

But by burying data, drug companies " deceive physicians, their patients and,

perhaps, shareholders. Worse, such concealment is a flagrant abuse of the

trust " patients put in doctors when they agree to be test subjects in

medical experiments.

A leading B.C. child psychiatrist has vowed never to do another drug-company

sponsored trial unless " drastic " changes are made. Three years ago, Dr. Jane

Garland was shown unpublished data that suggested the antidepressant Paxil

was ineffective in children -- but only after she had signed an agreement

prohibiting her from sharing the information with other doctors and

investigators for 10 years.

Garland, head of the Mood and Anxiety Disorders Clinic at British Columbia's

Children's and Women's Hospital, was about to do a study testing Paxil on

children with mood disorders when she was sent a confidential

" investigator's brochure " that summarized what GlaxoKline knew about

its drug.

Buried in the material were results from two studies that showed Paxil was

no more effective than a placebo, or sugar pill, in treating depression in

children.

At that time, the only study of Paxil in depressed children that had been

published suggested a benefit. None of the Paxil-like drugs have been

approved in Canada for use in anyone under 18, but they're increasingly

being prescribed to children as young as three for depression,

obsessive-compulsive disorder, social phobia and anxiety.

" My jaw dropped because I already signed a form saying I can't reveal

anything I'm about to see, " says Garland, whose commentary is one of several

articles on the burying of clinical evidence in today's CMAJ.

" I do the continuing medical education (for doctors). I run the specialty

clinic for the province. I teach students and residents and I have to tell

them that the medication works based on the one study published, and I'm not

allowed to mention that I've seen the other data. It felt terrible. "

The evidence came to light last summer, when GlaxoKline warned doctors

Paxil should not be given to children because several large trials also

found that two to three per cent of children taking the drug developed

suicidal thoughts while on the medication, twice as many as children on a

placebo.

Last month, Health Canada issued a public advisory about the increased risk

of suicide in children for all

SSRIs (Selective Serotonin Reuptake Inhibitors).

Garland says the safety data involving Paxil had been available at least

since the 1990s. She estimates 10,000 to 15,000 B.C. children are taking the

drugs.

In a written response to a request for an interview, the company said it

" began communicating results " from its pediatric studies in 1998 through

posters, abstracts and other publications.

" GSK takes very seriously our responsibility to provide health-care

professionals the information they need to prescribe medicines. We are

devoting significant time and energy to finalize the process of

communicating study results so that we have a sound and sustainable policy. "

But the problem of hidden drug information is much more widespread, says

CMAJ editor Dr. Hoey.

" It means that physicians who are prescribing these drugs may not have

complete information about how good the drug is, does it work or, equally

important, how safe is it, " Hoey said in an interview.

Drug companies have to make the results of all clinical trials available to

Health Canada to get initial approval for a drug, Hoey says. But there is no

requirement for the results to be published, or even made available to other

researchers.

A Health Canada spokeswoman said that information is owned by the drug

company.

Companies are required by law to report serious side effects to the

government. But the secrecy in the drug-approvals process and weak systems

for monitoring adverse drug reactions are also keeping unsafe medicines on

the market, U.K. and Canadian researchers report in the CMAJ.

Patient reports of drug reactions are often dismissed as " anecdotal or

unscientific, " the researchers say. In addition, Health Canada keeps

confidential any rejected applications to expand the use of a drug to

another patient group, such as giving drugs designed for adults to children.

Hoey says Health Canada should pressure all drug companies to follow the

lead of Merck-Frosst, which plans to publish the results of all clinical

trials, regardless of the outcome.

©ÊCopyright Ê2004ÊEdmonton Journal

_________________________________________________________________

Watch high-quality video with fast playback at MSN Video. Free!

http://click.atdmt.com/AVE/go/onm00200365ave/direct/01/

[Guest guest]

http://www.canada.com/edmonton/edmontonjournal/story.asp?id=2E00FC1D-A3C8-467A-A\

66D-05EB5264E368

Drug risks hidden from public

Drug companies keep test failures quiet, medical journal says

Ê

Sharon Kirkey

CanWest News Service

Tuesday, February 17, 2004

OTTAWA - Pharmaceutical companies are deceiving patients and doctors by

keeping negative results from drug trials " locked in the filing cabinet, "

Can-ada's leading medical journal warns.

The Canadian Medical Association Journal says Health Canada is complicit in

this " file drawer phenomenon " by too often keeping quiet about buried

evidence that questions drug safety and effectiveness.

In an editorial published today, the CMAJ accuses drug companies of

silencing medical researchers by having them sign agreements that suppress

the release of negative findings in drug trials -- sometimes for as long as

a decade after the test results are in -- while positive findings are

promoted.

Most " negative studies " go unreported because they showed no beneficial

effects of the drug being tested. But some hold information that would hurt

the drug companies.

It takes $1 billion on average to bring a new drug to market, a huge

investment that " puts pressure on companies to suppress results that might

slow or extinguish sales, " the CMAJ says.

But by burying data, drug companies " deceive physicians, their patients and,

perhaps, shareholders. Worse, such concealment is a flagrant abuse of the

trust " patients put in doctors when they agree to be test subjects in

medical experiments.

A leading B.C. child psychiatrist has vowed never to do another drug-company

sponsored trial unless " drastic " changes are made. Three years ago, Dr. Jane

Garland was shown unpublished data that suggested the antidepressant Paxil

was ineffective in children -- but only after she had signed an agreement

prohibiting her from sharing the information with other doctors and

investigators for 10 years.

Garland, head of the Mood and Anxiety Disorders Clinic at British Columbia's

Children's and Women's Hospital, was about to do a study testing Paxil on

children with mood disorders when she was sent a confidential

" investigator's brochure " that summarized what GlaxoKline knew about

its drug.

Buried in the material were results from two studies that showed Paxil was

no more effective than a placebo, or sugar pill, in treating depression in

children.

At that time, the only study of Paxil in depressed children that had been

published suggested a benefit. None of the Paxil-like drugs have been

approved in Canada for use in anyone under 18, but they're increasingly

being prescribed to children as young as three for depression,

obsessive-compulsive disorder, social phobia and anxiety.

" My jaw dropped because I already signed a form saying I can't reveal

anything I'm about to see, " says Garland, whose commentary is one of several

articles on the burying of clinical evidence in today's CMAJ.

" I do the continuing medical education (for doctors). I run the specialty

clinic for the province. I teach students and residents and I have to tell

them that the medication works based on the one study published, and I'm not

allowed to mention that I've seen the other data. It felt terrible. "

The evidence came to light last summer, when GlaxoKline warned doctors

Paxil should not be given to children because several large trials also

found that two to three per cent of children taking the drug developed

suicidal thoughts while on the medication, twice as many as children on a

placebo.

Last month, Health Canada issued a public advisory about the increased risk

of suicide in children for all

SSRIs (Selective Serotonin Reuptake Inhibitors).

Garland says the safety data involving Paxil had been available at least

since the 1990s. She estimates 10,000 to 15,000 B.C. children are taking the

drugs.

In a written response to a request for an interview, the company said it

" began communicating results " from its pediatric studies in 1998 through

posters, abstracts and other publications.

" GSK takes very seriously our responsibility to provide health-care

professionals the information they need to prescribe medicines. We are

devoting significant time and energy to finalize the process of

communicating study results so that we have a sound and sustainable policy. "

But the problem of hidden drug information is much more widespread, says

CMAJ editor Dr. Hoey.

" It means that physicians who are prescribing these drugs may not have

complete information about how good the drug is, does it work or, equally

important, how safe is it, " Hoey said in an interview.

Drug companies have to make the results of all clinical trials available to

Health Canada to get initial approval for a drug, Hoey says. But there is no

requirement for the results to be published, or even made available to other

researchers.

A Health Canada spokeswoman said that information is owned by the drug

company.

Companies are required by law to report serious side effects to the

government. But the secrecy in the drug-approvals process and weak systems

for monitoring adverse drug reactions are also keeping unsafe medicines on

the market, U.K. and Canadian researchers report in the CMAJ.

Patient reports of drug reactions are often dismissed as " anecdotal or

unscientific, " the researchers say. In addition, Health Canada keeps

confidential any rejected applications to expand the use of a drug to

another patient group, such as giving drugs designed for adults to children.

Hoey says Health Canada should pressure all drug companies to follow the

lead of Merck-Frosst, which plans to publish the results of all clinical

trials, regardless of the outcome.

©ÊCopyright Ê2004ÊEdmonton Journal

_________________________________________________________________

Watch high-quality video with fast playback at MSN Video. Free!

http://click.atdmt.com/AVE/go/onm00200365ave/direct/01/

[Guest guest]

http://www.canada.com/edmonton/edmontonjournal/story.asp?id=2E00FC1D-A3C8-467A-A\

66D-05EB5264E368

Drug risks hidden from public

Drug companies keep test failures quiet, medical journal says

Ê

Sharon Kirkey

CanWest News Service

Tuesday, February 17, 2004

OTTAWA - Pharmaceutical companies are deceiving patients and doctors by

keeping negative results from drug trials " locked in the filing cabinet, "

Can-ada's leading medical journal warns.

The Canadian Medical Association Journal says Health Canada is complicit in

this " file drawer phenomenon " by too often keeping quiet about buried

evidence that questions drug safety and effectiveness.

In an editorial published today, the CMAJ accuses drug companies of

silencing medical researchers by having them sign agreements that suppress

the release of negative findings in drug trials -- sometimes for as long as

a decade after the test results are in -- while positive findings are

promoted.

Most " negative studies " go unreported because they showed no beneficial

effects of the drug being tested. But some hold information that would hurt

the drug companies.

It takes $1 billion on average to bring a new drug to market, a huge

investment that " puts pressure on companies to suppress results that might

slow or extinguish sales, " the CMAJ says.

But by burying data, drug companies " deceive physicians, their patients and,

perhaps, shareholders. Worse, such concealment is a flagrant abuse of the

trust " patients put in doctors when they agree to be test subjects in

medical experiments.

A leading B.C. child psychiatrist has vowed never to do another drug-company

sponsored trial unless " drastic " changes are made. Three years ago, Dr. Jane

Garland was shown unpublished data that suggested the antidepressant Paxil

was ineffective in children -- but only after she had signed an agreement

prohibiting her from sharing the information with other doctors and

investigators for 10 years.

Garland, head of the Mood and Anxiety Disorders Clinic at British Columbia's

Children's and Women's Hospital, was about to do a study testing Paxil on

children with mood disorders when she was sent a confidential

" investigator's brochure " that summarized what GlaxoKline knew about

its drug.

Buried in the material were results from two studies that showed Paxil was

no more effective than a placebo, or sugar pill, in treating depression in

children.

At that time, the only study of Paxil in depressed children that had been

published suggested a benefit. None of the Paxil-like drugs have been

approved in Canada for use in anyone under 18, but they're increasingly

being prescribed to children as young as three for depression,

obsessive-compulsive disorder, social phobia and anxiety.

" My jaw dropped because I already signed a form saying I can't reveal

anything I'm about to see, " says Garland, whose commentary is one of several

articles on the burying of clinical evidence in today's CMAJ.

" I do the continuing medical education (for doctors). I run the specialty

clinic for the province. I teach students and residents and I have to tell

them that the medication works based on the one study published, and I'm not

allowed to mention that I've seen the other data. It felt terrible. "

The evidence came to light last summer, when GlaxoKline warned doctors

Paxil should not be given to children because several large trials also

found that two to three per cent of children taking the drug developed

suicidal thoughts while on the medication, twice as many as children on a

placebo.

Last month, Health Canada issued a public advisory about the increased risk

of suicide in children for all

SSRIs (Selective Serotonin Reuptake Inhibitors).

Garland says the safety data involving Paxil had been available at least

since the 1990s. She estimates 10,000 to 15,000 B.C. children are taking the

drugs.

In a written response to a request for an interview, the company said it

" began communicating results " from its pediatric studies in 1998 through

posters, abstracts and other publications.

" GSK takes very seriously our responsibility to provide health-care

professionals the information they need to prescribe medicines. We are

devoting significant time and energy to finalize the process of

communicating study results so that we have a sound and sustainable policy. "

But the problem of hidden drug information is much more widespread, says

CMAJ editor Dr. Hoey.

" It means that physicians who are prescribing these drugs may not have

complete information about how good the drug is, does it work or, equally

important, how safe is it, " Hoey said in an interview.

Drug companies have to make the results of all clinical trials available to

Health Canada to get initial approval for a drug, Hoey says. But there is no

requirement for the results to be published, or even made available to other

researchers.

A Health Canada spokeswoman said that information is owned by the drug

company.

Companies are required by law to report serious side effects to the

government. But the secrecy in the drug-approvals process and weak systems

for monitoring adverse drug reactions are also keeping unsafe medicines on

the market, U.K. and Canadian researchers report in the CMAJ.

Patient reports of drug reactions are often dismissed as " anecdotal or

unscientific, " the researchers say. In addition, Health Canada keeps

confidential any rejected applications to expand the use of a drug to

another patient group, such as giving drugs designed for adults to children.

Hoey says Health Canada should pressure all drug companies to follow the

lead of Merck-Frosst, which plans to publish the results of all clinical

trials, regardless of the outcome.

©ÊCopyright Ê2004ÊEdmonton Journal

_________________________________________________________________

Watch high-quality video with fast playback at MSN Video. Free!

http://click.atdmt.com/AVE/go/onm00200365ave/direct/01/