Web registry for drug studies to begin Oct. 1

[Guest guest]

http://www.indystar.com/articles/6/176960-4886-223.html

Web registry for drug studies to begin Oct. 1

Trade group says it will post trial results that are submitted by pharmaceutical

firms.

Star and news service report

September 8, 2004

The Pharmaceutical Research and Manufacturers of America, the trade group

representing drug companies such as Pfizer Inc. and Merck & Co, plans to publish

members' drug studies on a Web site starting Oct. 1.

The announcement of the voluntary registry comes two days before a U.S. House

panel meets to discuss antidepressant trials. The hearing was sparked by New

York Attorney General Eliot Spitzer's suit against GlaxoKline Plc in June,

in which he accused the company of hiding study data suggesting its

antidepressant Paxil might increase suicide risk in children.

The Washington-based trade group, known as PhRMA, has faced public pressure to

get drugmakers to disclose the results of all product trials, not just those

that are positive. Since Spitzer filed the lawsuit, Glaxo, Merck and Eli Lilly

and Co. announced plans to expand how much study data they disclose.

" While it has been designed with the physician in mind, there is nothing to

preclude the public from seeing the information as well, " Alan Goldhammer,

PhRMA's associate vice president for regulatory affairs, said in a conference

call with reporters. " It seems like a lot of people want access to this data for

a lot of different reasons. "

Doctors currently rely on peer-reviewed medical journals and conferences to get

information on drugs. The data presented through those channels is often

filtered for financial gain, doctors have said.

Results from studies conducted since October 2002 on approved drugs will get

posted, with the drugmakers' permission, on www.clinicalstudyresults.org. Each

drug entry will include the drugmaker's name, a link to the FDA-approved label,

a bibliography of published studies and links to printed articles, and a summary

of unpublished studies.

Caroline Loew, PhRMA's vice president of scientific and regulatory affairs, said

in the call that the creation of the Web site wasn't " a direct response to the

congressional environment, " but rather " one of many concrete steps we are taking

to make sure the data is transparent. " She said member companies don't want

mandatory rules enacted.

The trade group isn't sure how many drugs will be listed when the Web site

launches next month, PhRMA spokesman Court Rosen said.

Editors from major medical journals worldwide are expected this week to place

new requirements on studies they will consider for publication, according to The

Wall Street Journal. The editors are expected to require that studies be

disclosed in a trial database before they will be considered for publication,

according to the newspaper.

The American Medical Association, the largest group representing U.S. doctors,

also approved a measure in June urging the United States to require

pharmaceutical companies to disclose all drug study results, including negative

findings. The AMA has been working with the Department of Health and Human

Services to hash out details for a regulated registry of trials.

In 2002, researchers spent about $5.6 billion on clinical trials involving human

subjects. More than 80 percent of the funding was provided by device- and

drugmakers, the AMA said.

Glaxo vowed to post trial results on a Web site shortly after Spitzer filed suit

in June. Glaxo, Europe's largest drugmaker, settled the Spitzer suit in August

for $2.5 million. The Web site, which went live Sept. 1, contains more than 50

studies for one drug, the diabetes treatment Avandia.

Lilly in August promised to disclose the results of all human experiments it

sponsors on a Web site that will launch before the end of the year.

Lilly's site will include trial data on experimental drugs, while PhRMA's Web

site will contain information only on medicines approved for sale in the United

States.

[Guest guest]

http://www.indystar.com/articles/6/176960-4886-223.html

Web registry for drug studies to begin Oct. 1

Trade group says it will post trial results that are submitted by pharmaceutical

firms.

Star and news service report

September 8, 2004

The Pharmaceutical Research and Manufacturers of America, the trade group

representing drug companies such as Pfizer Inc. and Merck & Co, plans to publish

members' drug studies on a Web site starting Oct. 1.

The announcement of the voluntary registry comes two days before a U.S. House

panel meets to discuss antidepressant trials. The hearing was sparked by New

York Attorney General Eliot Spitzer's suit against GlaxoKline Plc in June,

in which he accused the company of hiding study data suggesting its

antidepressant Paxil might increase suicide risk in children.

The Washington-based trade group, known as PhRMA, has faced public pressure to

get drugmakers to disclose the results of all product trials, not just those

that are positive. Since Spitzer filed the lawsuit, Glaxo, Merck and Eli Lilly

and Co. announced plans to expand how much study data they disclose.

" While it has been designed with the physician in mind, there is nothing to

preclude the public from seeing the information as well, " Alan Goldhammer,

PhRMA's associate vice president for regulatory affairs, said in a conference

call with reporters. " It seems like a lot of people want access to this data for

a lot of different reasons. "

Doctors currently rely on peer-reviewed medical journals and conferences to get

information on drugs. The data presented through those channels is often

filtered for financial gain, doctors have said.

Results from studies conducted since October 2002 on approved drugs will get

posted, with the drugmakers' permission, on www.clinicalstudyresults.org. Each

drug entry will include the drugmaker's name, a link to the FDA-approved label,

a bibliography of published studies and links to printed articles, and a summary

of unpublished studies.

Caroline Loew, PhRMA's vice president of scientific and regulatory affairs, said

in the call that the creation of the Web site wasn't " a direct response to the

congressional environment, " but rather " one of many concrete steps we are taking

to make sure the data is transparent. " She said member companies don't want

mandatory rules enacted.

The trade group isn't sure how many drugs will be listed when the Web site

launches next month, PhRMA spokesman Court Rosen said.

Editors from major medical journals worldwide are expected this week to place

new requirements on studies they will consider for publication, according to The

Wall Street Journal. The editors are expected to require that studies be

disclosed in a trial database before they will be considered for publication,

according to the newspaper.

The American Medical Association, the largest group representing U.S. doctors,

also approved a measure in June urging the United States to require

pharmaceutical companies to disclose all drug study results, including negative

findings. The AMA has been working with the Department of Health and Human

Services to hash out details for a regulated registry of trials.

In 2002, researchers spent about $5.6 billion on clinical trials involving human

subjects. More than 80 percent of the funding was provided by device- and

drugmakers, the AMA said.

Glaxo vowed to post trial results on a Web site shortly after Spitzer filed suit

in June. Glaxo, Europe's largest drugmaker, settled the Spitzer suit in August

for $2.5 million. The Web site, which went live Sept. 1, contains more than 50

studies for one drug, the diabetes treatment Avandia.

Lilly in August promised to disclose the results of all human experiments it

sponsors on a Web site that will launch before the end of the year.

Lilly's site will include trial data on experimental drugs, while PhRMA's Web

site will contain information only on medicines approved for sale in the United

States.

[Guest guest]

http://www.indystar.com/articles/6/176960-4886-223.html

Web registry for drug studies to begin Oct. 1

Trade group says it will post trial results that are submitted by pharmaceutical

firms.

Star and news service report

September 8, 2004

The Pharmaceutical Research and Manufacturers of America, the trade group

representing drug companies such as Pfizer Inc. and Merck & Co, plans to publish

members' drug studies on a Web site starting Oct. 1.

The announcement of the voluntary registry comes two days before a U.S. House

panel meets to discuss antidepressant trials. The hearing was sparked by New

York Attorney General Eliot Spitzer's suit against GlaxoKline Plc in June,

in which he accused the company of hiding study data suggesting its

antidepressant Paxil might increase suicide risk in children.

The Washington-based trade group, known as PhRMA, has faced public pressure to

get drugmakers to disclose the results of all product trials, not just those

that are positive. Since Spitzer filed the lawsuit, Glaxo, Merck and Eli Lilly

and Co. announced plans to expand how much study data they disclose.

" While it has been designed with the physician in mind, there is nothing to

preclude the public from seeing the information as well, " Alan Goldhammer,

PhRMA's associate vice president for regulatory affairs, said in a conference

call with reporters. " It seems like a lot of people want access to this data for

a lot of different reasons. "

Doctors currently rely on peer-reviewed medical journals and conferences to get

information on drugs. The data presented through those channels is often

filtered for financial gain, doctors have said.

Results from studies conducted since October 2002 on approved drugs will get

posted, with the drugmakers' permission, on www.clinicalstudyresults.org. Each

drug entry will include the drugmaker's name, a link to the FDA-approved label,

a bibliography of published studies and links to printed articles, and a summary

of unpublished studies.

Caroline Loew, PhRMA's vice president of scientific and regulatory affairs, said

in the call that the creation of the Web site wasn't " a direct response to the

congressional environment, " but rather " one of many concrete steps we are taking

to make sure the data is transparent. " She said member companies don't want

mandatory rules enacted.

The trade group isn't sure how many drugs will be listed when the Web site

launches next month, PhRMA spokesman Court Rosen said.

Editors from major medical journals worldwide are expected this week to place

new requirements on studies they will consider for publication, according to The

Wall Street Journal. The editors are expected to require that studies be

disclosed in a trial database before they will be considered for publication,

according to the newspaper.

The American Medical Association, the largest group representing U.S. doctors,

also approved a measure in June urging the United States to require

pharmaceutical companies to disclose all drug study results, including negative

findings. The AMA has been working with the Department of Health and Human

Services to hash out details for a regulated registry of trials.

In 2002, researchers spent about $5.6 billion on clinical trials involving human

subjects. More than 80 percent of the funding was provided by device- and

drugmakers, the AMA said.

Glaxo vowed to post trial results on a Web site shortly after Spitzer filed suit

in June. Glaxo, Europe's largest drugmaker, settled the Spitzer suit in August

for $2.5 million. The Web site, which went live Sept. 1, contains more than 50

studies for one drug, the diabetes treatment Avandia.

Lilly in August promised to disclose the results of all human experiments it

sponsors on a Web site that will launch before the end of the year.

Lilly's site will include trial data on experimental drugs, while PhRMA's Web

site will contain information only on medicines approved for sale in the United

States.

[Guest guest]

http://www.indystar.com/articles/6/176960-4886-223.html

Web registry for drug studies to begin Oct. 1

Trade group says it will post trial results that are submitted by pharmaceutical

firms.

Star and news service report

September 8, 2004

The Pharmaceutical Research and Manufacturers of America, the trade group

representing drug companies such as Pfizer Inc. and Merck & Co, plans to publish

members' drug studies on a Web site starting Oct. 1.

The announcement of the voluntary registry comes two days before a U.S. House

panel meets to discuss antidepressant trials. The hearing was sparked by New

York Attorney General Eliot Spitzer's suit against GlaxoKline Plc in June,

in which he accused the company of hiding study data suggesting its

antidepressant Paxil might increase suicide risk in children.

The Washington-based trade group, known as PhRMA, has faced public pressure to

get drugmakers to disclose the results of all product trials, not just those

that are positive. Since Spitzer filed the lawsuit, Glaxo, Merck and Eli Lilly

and Co. announced plans to expand how much study data they disclose.

" While it has been designed with the physician in mind, there is nothing to

preclude the public from seeing the information as well, " Alan Goldhammer,

PhRMA's associate vice president for regulatory affairs, said in a conference

call with reporters. " It seems like a lot of people want access to this data for

a lot of different reasons. "

Doctors currently rely on peer-reviewed medical journals and conferences to get

information on drugs. The data presented through those channels is often

filtered for financial gain, doctors have said.

Results from studies conducted since October 2002 on approved drugs will get

posted, with the drugmakers' permission, on www.clinicalstudyresults.org. Each

drug entry will include the drugmaker's name, a link to the FDA-approved label,

a bibliography of published studies and links to printed articles, and a summary

of unpublished studies.

Caroline Loew, PhRMA's vice president of scientific and regulatory affairs, said

in the call that the creation of the Web site wasn't " a direct response to the

congressional environment, " but rather " one of many concrete steps we are taking

to make sure the data is transparent. " She said member companies don't want

mandatory rules enacted.

The trade group isn't sure how many drugs will be listed when the Web site

launches next month, PhRMA spokesman Court Rosen said.

Editors from major medical journals worldwide are expected this week to place

new requirements on studies they will consider for publication, according to The

Wall Street Journal. The editors are expected to require that studies be

disclosed in a trial database before they will be considered for publication,

according to the newspaper.

The American Medical Association, the largest group representing U.S. doctors,

also approved a measure in June urging the United States to require

pharmaceutical companies to disclose all drug study results, including negative

findings. The AMA has been working with the Department of Health and Human

Services to hash out details for a regulated registry of trials.

In 2002, researchers spent about $5.6 billion on clinical trials involving human

subjects. More than 80 percent of the funding was provided by device- and

drugmakers, the AMA said.

Glaxo vowed to post trial results on a Web site shortly after Spitzer filed suit

in June. Glaxo, Europe's largest drugmaker, settled the Spitzer suit in August

for $2.5 million. The Web site, which went live Sept. 1, contains more than 50

studies for one drug, the diabetes treatment Avandia.

Lilly in August promised to disclose the results of all human experiments it

sponsors on a Web site that will launch before the end of the year.

Lilly's site will include trial data on experimental drugs, while PhRMA's Web

site will contain information only on medicines approved for sale in the United

States.