Medical Journals Weigh Plan for Full Drug-Trial Disclosure

[Guest guest]

From yesterday's NY Times

Medical Journals Weigh Plan for Full Drug-Trial Disclosure

June 15, 2004

By BARRY MEIER

An organization of top medical journals is considering a

proposal that would require drug makers to register

clinical trials at their start in a public database in

order for results, whether successful or not, to be later

considered for publication, according to three people

working with the group.

Pharmaceutical companies are not generally required now to

disclose results of a trial or even whether one was

conducted. Some academic researchers have long argued that

fuller registries of drug trials are needed because

companies, as well as medical journals and scientists, tend

to spotlight only trials that show positive results.

The plan, if adopted by the organization, the International

Committee of Medical Journal Editors, is likely to put

pressure on pharmaceutical makers to disclose more about

the trials they run. The group includes 12 major medical

journals like The Journal of the American Medical

Association, The New England Journal of Medicine, The

Lancet and The ls of Internal Medicine.

The recent discussion among the journal editors about a

trial registry comes amid public controversy about clinical

trial data after the disclosures that the results of

antidepressant tests in children were not adequately

publicized.

Because the medical journals in the group are prestigious,

and publication of the results of a clinical trial in them

carries much weight, companies frequently use articles from

them as marketing tools to persuade doctors to prescribe a

drug. If the International Committee of Medical Journal

Editors adopts the proposal for a registry, drug companies

not wanting to participate could still seek to have their

research published in other less-prominent medical

journals, but the research might not get as much attention

from physicians.

A spokesman for the Pharmaceutical Research and

Manufacturers Association of America, a group representing

drug makers, said it was not aware of the proposal being

considered by medical journal editors to require

registration of trials, so it could not comment on it. In

the past, the group has not supported a registry, although

a few companies have adopted a registry.

Many drug companies without registries have noted that they

voluntarily disclose the results of all clinical trials

they conduct, either at scientific conferences or through

publications.

But critics say that there is no central registry where

clinical trials and their results are available, making it

difficult for researchers to track all studies that have

been done on a single drug.

Ideally, advocates of clinical trial registries say, such

databases would show when a trial was started, list its

objectives and then update that information with the

trial's results or the reason it was terminated.

A proposal to mandate trial registration as a prerequisite

for publication was discussed last week at a meeting of the

journal editors' group, said the three people working with

the organization who insisted on anonymity because, they

said, the proposal was still under discussion and because

the group was not planning to announce any change unless it

was adopted.

A decision could come in the summer, one person said.

In

a related development, policy makers at the American

Medical Association, which represents many of the nation's

doctors, are expected to vote as early as today on a

proposal that would urge the government to create a public

registry of clinical trials and their results, a spokesman

for the A.M.A. said.

Yesterday, GlaxoKline, the manufacturer of the

antidepressant Paxil, released on its company Web site the

reports of clinical tests of that drug in children and

adolescents suffering from psychological conditions

including depression.

The action follows a civil lawsuit filed this month by the

New York State attorney general, Eliot Spitzer, that

accused the company of misleading doctors by publicizing a

favorable study of Paxil for pediatric depression while

playing down other trials that showed the drug did not work

better than a placebo.

GlaxoKline officials have denied that they selectively

disclosed trial findings.

Regulators in this country and elsewhere are now scrambling

to review unpublished test data on Paxil and several other

popular antidepressants to see if the drugs pose dangers.

In a statement issued yesterday, Mr. Spitzer said that the

company's actions had not resolved his lawsuit but called

it a positive move. " This is a positive first step toward

changing a dangerous industry practice, " he said.

A decision by the International Committee of Medical

Journal Editors to consider for publication only clinical

trials that have been registered from the start would be

the organization's latest effort to push for greater

disclosure of data.

Two years ago, the group published a joint editorial

calling on companies to provide university researchers with

a greater role in designing trials and access to the

analysis of results. That same editorial also pointed to

the fact that the results of some trials were never

published.

" The results of the unfinished trial may be buried rather

than published if they are unfavorable to the sponsor's

product, " the editorial stated. " Such issues are not

theoretical. There have been a number of recent public

examples of such problems, and we suspect that many more go

unreported. "

But some academic researchers have also argued that medical

journals are themselves part of the problem, even if

unwittingly so. A growing number of studies have found that

clinical trials published in leading medical journals tend

to show positive results about the drug or medical devices

being tested, a phenomenon referred to as publication bias.

As a result, those researchers say, physicians who rely on

medical journals for information about drugs and medical

devices may get an incomplete view of their effectiveness

or safety because they may be unaware of other less

favorable or inconclusive studies.

In an interview this month, Dr. Alan Goldhammer, associate

vice president for regulatory affairs for the

Pharmaceutical Research and Manufacturers Association of

America, said that to date the organization had not

supported the idea of a public registry for clinical

trials. He said the association might reconsider its stance

in light of the antidepressant controversy.

Another trade group, the Association of the British

Pharmaceutical Industry, recommended to its members last

year that they voluntarily create trial registries. A

spokesman for the group said recently that 8 of its 80

members had created such databases.

http://www.nytimes.com/2004/06/15/business/15drug.html?ex=1088310454 & ei=1 & en=337\

056570253cfd5

[Guest guest]

From yesterday's NY Times

Medical Journals Weigh Plan for Full Drug-Trial Disclosure

June 15, 2004

By BARRY MEIER

An organization of top medical journals is considering a

proposal that would require drug makers to register

clinical trials at their start in a public database in

order for results, whether successful or not, to be later

considered for publication, according to three people

working with the group.

Pharmaceutical companies are not generally required now to

disclose results of a trial or even whether one was

conducted. Some academic researchers have long argued that

fuller registries of drug trials are needed because

companies, as well as medical journals and scientists, tend

to spotlight only trials that show positive results.

The plan, if adopted by the organization, the International

Committee of Medical Journal Editors, is likely to put

pressure on pharmaceutical makers to disclose more about

the trials they run. The group includes 12 major medical

journals like The Journal of the American Medical

Association, The New England Journal of Medicine, The

Lancet and The ls of Internal Medicine.

The recent discussion among the journal editors about a

trial registry comes amid public controversy about clinical

trial data after the disclosures that the results of

antidepressant tests in children were not adequately

publicized.

Because the medical journals in the group are prestigious,

and publication of the results of a clinical trial in them

carries much weight, companies frequently use articles from

them as marketing tools to persuade doctors to prescribe a

drug. If the International Committee of Medical Journal

Editors adopts the proposal for a registry, drug companies

not wanting to participate could still seek to have their

research published in other less-prominent medical

journals, but the research might not get as much attention

from physicians.

A spokesman for the Pharmaceutical Research and

Manufacturers Association of America, a group representing

drug makers, said it was not aware of the proposal being

considered by medical journal editors to require

registration of trials, so it could not comment on it. In

the past, the group has not supported a registry, although

a few companies have adopted a registry.

Many drug companies without registries have noted that they

voluntarily disclose the results of all clinical trials

they conduct, either at scientific conferences or through

publications.

But critics say that there is no central registry where

clinical trials and their results are available, making it

difficult for researchers to track all studies that have

been done on a single drug.

Ideally, advocates of clinical trial registries say, such

databases would show when a trial was started, list its

objectives and then update that information with the

trial's results or the reason it was terminated.

A proposal to mandate trial registration as a prerequisite

for publication was discussed last week at a meeting of the

journal editors' group, said the three people working with

the organization who insisted on anonymity because, they

said, the proposal was still under discussion and because

the group was not planning to announce any change unless it

was adopted.

A decision could come in the summer, one person said.

In

a related development, policy makers at the American

Medical Association, which represents many of the nation's

doctors, are expected to vote as early as today on a

proposal that would urge the government to create a public

registry of clinical trials and their results, a spokesman

for the A.M.A. said.

Yesterday, GlaxoKline, the manufacturer of the

antidepressant Paxil, released on its company Web site the

reports of clinical tests of that drug in children and

adolescents suffering from psychological conditions

including depression.

The action follows a civil lawsuit filed this month by the

New York State attorney general, Eliot Spitzer, that

accused the company of misleading doctors by publicizing a

favorable study of Paxil for pediatric depression while

playing down other trials that showed the drug did not work

better than a placebo.

GlaxoKline officials have denied that they selectively

disclosed trial findings.

Regulators in this country and elsewhere are now scrambling

to review unpublished test data on Paxil and several other

popular antidepressants to see if the drugs pose dangers.

In a statement issued yesterday, Mr. Spitzer said that the

company's actions had not resolved his lawsuit but called

it a positive move. " This is a positive first step toward

changing a dangerous industry practice, " he said.

A decision by the International Committee of Medical

Journal Editors to consider for publication only clinical

trials that have been registered from the start would be

the organization's latest effort to push for greater

disclosure of data.

Two years ago, the group published a joint editorial

calling on companies to provide university researchers with

a greater role in designing trials and access to the

analysis of results. That same editorial also pointed to

the fact that the results of some trials were never

published.

" The results of the unfinished trial may be buried rather

than published if they are unfavorable to the sponsor's

product, " the editorial stated. " Such issues are not

theoretical. There have been a number of recent public

examples of such problems, and we suspect that many more go

unreported. "

But some academic researchers have also argued that medical

journals are themselves part of the problem, even if

unwittingly so. A growing number of studies have found that

clinical trials published in leading medical journals tend

to show positive results about the drug or medical devices

being tested, a phenomenon referred to as publication bias.

As a result, those researchers say, physicians who rely on

medical journals for information about drugs and medical

devices may get an incomplete view of their effectiveness

or safety because they may be unaware of other less

favorable or inconclusive studies.

In an interview this month, Dr. Alan Goldhammer, associate

vice president for regulatory affairs for the

Pharmaceutical Research and Manufacturers Association of

America, said that to date the organization had not

supported the idea of a public registry for clinical

trials. He said the association might reconsider its stance

in light of the antidepressant controversy.

Another trade group, the Association of the British

Pharmaceutical Industry, recommended to its members last

year that they voluntarily create trial registries. A

spokesman for the group said recently that 8 of its 80

members had created such databases.

http://www.nytimes.com/2004/06/15/business/15drug.html?ex=1088310454 & ei=1 & en=337\

056570253cfd5

[Guest guest]

From yesterday's NY Times

Medical Journals Weigh Plan for Full Drug-Trial Disclosure

June 15, 2004

By BARRY MEIER

An organization of top medical journals is considering a

proposal that would require drug makers to register

clinical trials at their start in a public database in

order for results, whether successful or not, to be later

considered for publication, according to three people

working with the group.

Pharmaceutical companies are not generally required now to

disclose results of a trial or even whether one was

conducted. Some academic researchers have long argued that

fuller registries of drug trials are needed because

companies, as well as medical journals and scientists, tend

to spotlight only trials that show positive results.

The plan, if adopted by the organization, the International

Committee of Medical Journal Editors, is likely to put

pressure on pharmaceutical makers to disclose more about

the trials they run. The group includes 12 major medical

journals like The Journal of the American Medical

Association, The New England Journal of Medicine, The

Lancet and The ls of Internal Medicine.

The recent discussion among the journal editors about a

trial registry comes amid public controversy about clinical

trial data after the disclosures that the results of

antidepressant tests in children were not adequately

publicized.

Because the medical journals in the group are prestigious,

and publication of the results of a clinical trial in them

carries much weight, companies frequently use articles from

them as marketing tools to persuade doctors to prescribe a

drug. If the International Committee of Medical Journal

Editors adopts the proposal for a registry, drug companies

not wanting to participate could still seek to have their

research published in other less-prominent medical

journals, but the research might not get as much attention

from physicians.

A spokesman for the Pharmaceutical Research and

Manufacturers Association of America, a group representing

drug makers, said it was not aware of the proposal being

considered by medical journal editors to require

registration of trials, so it could not comment on it. In

the past, the group has not supported a registry, although

a few companies have adopted a registry.

Many drug companies without registries have noted that they

voluntarily disclose the results of all clinical trials

they conduct, either at scientific conferences or through

publications.

But critics say that there is no central registry where

clinical trials and their results are available, making it

difficult for researchers to track all studies that have

been done on a single drug.

Ideally, advocates of clinical trial registries say, such

databases would show when a trial was started, list its

objectives and then update that information with the

trial's results or the reason it was terminated.

A proposal to mandate trial registration as a prerequisite

for publication was discussed last week at a meeting of the

journal editors' group, said the three people working with

the organization who insisted on anonymity because, they

said, the proposal was still under discussion and because

the group was not planning to announce any change unless it

was adopted.

A decision could come in the summer, one person said.

In

a related development, policy makers at the American

Medical Association, which represents many of the nation's

doctors, are expected to vote as early as today on a

proposal that would urge the government to create a public

registry of clinical trials and their results, a spokesman

for the A.M.A. said.

Yesterday, GlaxoKline, the manufacturer of the

antidepressant Paxil, released on its company Web site the

reports of clinical tests of that drug in children and

adolescents suffering from psychological conditions

including depression.

The action follows a civil lawsuit filed this month by the

New York State attorney general, Eliot Spitzer, that

accused the company of misleading doctors by publicizing a

favorable study of Paxil for pediatric depression while

playing down other trials that showed the drug did not work

better than a placebo.

GlaxoKline officials have denied that they selectively

disclosed trial findings.

Regulators in this country and elsewhere are now scrambling

to review unpublished test data on Paxil and several other

popular antidepressants to see if the drugs pose dangers.

In a statement issued yesterday, Mr. Spitzer said that the

company's actions had not resolved his lawsuit but called

it a positive move. " This is a positive first step toward

changing a dangerous industry practice, " he said.

A decision by the International Committee of Medical

Journal Editors to consider for publication only clinical

trials that have been registered from the start would be

the organization's latest effort to push for greater

disclosure of data.

Two years ago, the group published a joint editorial

calling on companies to provide university researchers with

a greater role in designing trials and access to the

analysis of results. That same editorial also pointed to

the fact that the results of some trials were never

published.

" The results of the unfinished trial may be buried rather

than published if they are unfavorable to the sponsor's

product, " the editorial stated. " Such issues are not

theoretical. There have been a number of recent public

examples of such problems, and we suspect that many more go

unreported. "

But some academic researchers have also argued that medical

journals are themselves part of the problem, even if

unwittingly so. A growing number of studies have found that

clinical trials published in leading medical journals tend

to show positive results about the drug or medical devices

being tested, a phenomenon referred to as publication bias.

As a result, those researchers say, physicians who rely on

medical journals for information about drugs and medical

devices may get an incomplete view of their effectiveness

or safety because they may be unaware of other less

favorable or inconclusive studies.

In an interview this month, Dr. Alan Goldhammer, associate

vice president for regulatory affairs for the

Pharmaceutical Research and Manufacturers Association of

America, said that to date the organization had not

supported the idea of a public registry for clinical

trials. He said the association might reconsider its stance

in light of the antidepressant controversy.

Another trade group, the Association of the British

Pharmaceutical Industry, recommended to its members last

year that they voluntarily create trial registries. A

spokesman for the group said recently that 8 of its 80

members had created such databases.

http://www.nytimes.com/2004/06/15/business/15drug.html?ex=1088310454 & ei=1 & en=337\

056570253cfd5

[Guest guest]

From yesterday's NY Times

Medical Journals Weigh Plan for Full Drug-Trial Disclosure

June 15, 2004

By BARRY MEIER

An organization of top medical journals is considering a

proposal that would require drug makers to register

clinical trials at their start in a public database in

order for results, whether successful or not, to be later

considered for publication, according to three people

working with the group.

Pharmaceutical companies are not generally required now to

disclose results of a trial or even whether one was

conducted. Some academic researchers have long argued that

fuller registries of drug trials are needed because

companies, as well as medical journals and scientists, tend

to spotlight only trials that show positive results.

The plan, if adopted by the organization, the International

Committee of Medical Journal Editors, is likely to put

pressure on pharmaceutical makers to disclose more about

the trials they run. The group includes 12 major medical

journals like The Journal of the American Medical

Association, The New England Journal of Medicine, The

Lancet and The ls of Internal Medicine.

The recent discussion among the journal editors about a

trial registry comes amid public controversy about clinical

trial data after the disclosures that the results of

antidepressant tests in children were not adequately

publicized.

Because the medical journals in the group are prestigious,

and publication of the results of a clinical trial in them

carries much weight, companies frequently use articles from

them as marketing tools to persuade doctors to prescribe a

drug. If the International Committee of Medical Journal

Editors adopts the proposal for a registry, drug companies

not wanting to participate could still seek to have their

research published in other less-prominent medical

journals, but the research might not get as much attention

from physicians.

A spokesman for the Pharmaceutical Research and

Manufacturers Association of America, a group representing

drug makers, said it was not aware of the proposal being

considered by medical journal editors to require

registration of trials, so it could not comment on it. In

the past, the group has not supported a registry, although

a few companies have adopted a registry.

Many drug companies without registries have noted that they

voluntarily disclose the results of all clinical trials

they conduct, either at scientific conferences or through

publications.

But critics say that there is no central registry where

clinical trials and their results are available, making it

difficult for researchers to track all studies that have

been done on a single drug.

Ideally, advocates of clinical trial registries say, such

databases would show when a trial was started, list its

objectives and then update that information with the

trial's results or the reason it was terminated.

A proposal to mandate trial registration as a prerequisite

for publication was discussed last week at a meeting of the

journal editors' group, said the three people working with

the organization who insisted on anonymity because, they

said, the proposal was still under discussion and because

the group was not planning to announce any change unless it

was adopted.

A decision could come in the summer, one person said.

In

a related development, policy makers at the American

Medical Association, which represents many of the nation's

doctors, are expected to vote as early as today on a

proposal that would urge the government to create a public

registry of clinical trials and their results, a spokesman

for the A.M.A. said.

Yesterday, GlaxoKline, the manufacturer of the

antidepressant Paxil, released on its company Web site the

reports of clinical tests of that drug in children and

adolescents suffering from psychological conditions

including depression.

The action follows a civil lawsuit filed this month by the

New York State attorney general, Eliot Spitzer, that

accused the company of misleading doctors by publicizing a

favorable study of Paxil for pediatric depression while

playing down other trials that showed the drug did not work

better than a placebo.

GlaxoKline officials have denied that they selectively

disclosed trial findings.

Regulators in this country and elsewhere are now scrambling

to review unpublished test data on Paxil and several other

popular antidepressants to see if the drugs pose dangers.

In a statement issued yesterday, Mr. Spitzer said that the

company's actions had not resolved his lawsuit but called

it a positive move. " This is a positive first step toward

changing a dangerous industry practice, " he said.

A decision by the International Committee of Medical

Journal Editors to consider for publication only clinical

trials that have been registered from the start would be

the organization's latest effort to push for greater

disclosure of data.

Two years ago, the group published a joint editorial

calling on companies to provide university researchers with

a greater role in designing trials and access to the

analysis of results. That same editorial also pointed to

the fact that the results of some trials were never

published.

" The results of the unfinished trial may be buried rather

than published if they are unfavorable to the sponsor's

product, " the editorial stated. " Such issues are not

theoretical. There have been a number of recent public

examples of such problems, and we suspect that many more go

unreported. "

But some academic researchers have also argued that medical

journals are themselves part of the problem, even if

unwittingly so. A growing number of studies have found that

clinical trials published in leading medical journals tend

to show positive results about the drug or medical devices

being tested, a phenomenon referred to as publication bias.

As a result, those researchers say, physicians who rely on

medical journals for information about drugs and medical

devices may get an incomplete view of their effectiveness

or safety because they may be unaware of other less

favorable or inconclusive studies.

In an interview this month, Dr. Alan Goldhammer, associate

vice president for regulatory affairs for the

Pharmaceutical Research and Manufacturers Association of

America, said that to date the organization had not

supported the idea of a public registry for clinical

trials. He said the association might reconsider its stance

in light of the antidepressant controversy.

Another trade group, the Association of the British

Pharmaceutical Industry, recommended to its members last

year that they voluntarily create trial registries. A

spokesman for the group said recently that 8 of its 80

members had created such databases.

http://www.nytimes.com/2004/06/15/business/15drug.html?ex=1088310454 & ei=1 & en=337\

056570253cfd5