Government Sanctioned Degradation and Exploitation of Children

[Guest guest]

Government Sanctioned Degradation and Exploitation of Children

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org/cms/

FYI

The following confirms to us that the U.S. government (specifically,

in this case, the FDA) and licensed academic and/or commercial

laboratories that test drugs in human subjects have descended into a

moral abyss.

FDA " bioethicist " Dr. Sara Bodkind, told the President's Council on

Bioethics ( December 2005) that under the 1997 law--FDA Modernization

Act-- " if the FDA issued a request for pediatric studies and if those

studies were designed and approved by the FDA and they were

completed, then the sponsor could get an additional six-month period

of market protection, not only in the specific drug that they tested

in children but in the entire moiety, in any preparation that used

that particular chemical. "

In other words, FDAMA opened the flood gates for drug testing to be

done on children: the financial incentives were doubled: that is, a

six month patent extension exclusivity, and the drug's market was

expanded to include children.

This " public gtood " was " accomplished " by encouraging manufacturers

and their paid academic pharmacologists to exploit children's

vulnerability in mostly non-therapeutic risky drug experiments.

Dr. Bodkind stated:

" So sildenafil, for example, is now tested for pulmonary hypertension

in children, but it's the compound that's known as Viagra. So if

that company were to get six months of exclusivity, then it would

apply to all of the products and all the uses of that moiety. So

this was a very important incentive to encourage pediatric research.

And that was I guess commonly called " the carrot. " See:

http://www.bioethics.gov/transcripts/dec05/session4.html

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

FAIR USE NOTICE

This email contains copyrighted material the use of which has not

always been specifically authorized by the copyright owner. I am

making such material available in my efforts to advance understanding

of environmental, political, human rights, economic, democracy,

scientific, and social justice issues, etc.

I believe this constitutes a 'fair use' of any such copyrighted

material as provided for in section 107 of the US Copyright Law. In

accordance with Title 17 U.S.C. Section 107, the material in this

email is distributed without profit to those who have expressed a

prior interest in receiving the included information

for research and educational purposes. For more information go to:

http://www.law.cornell.edu/uscode/17/107.shtml

If you wish to use copyrighted material from this update for purposes

of your own that go beyond 'fair use', you must obtain permission

from the copyright owner.

_______________________________________________

[Guest guest]

Government Sanctioned Degradation and Exploitation of Children

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org/cms/

FYI

The following confirms to us that the U.S. government (specifically,

in this case, the FDA) and licensed academic and/or commercial

laboratories that test drugs in human subjects have descended into a

moral abyss.

FDA " bioethicist " Dr. Sara Bodkind, told the President's Council on

Bioethics ( December 2005) that under the 1997 law--FDA Modernization

Act-- " if the FDA issued a request for pediatric studies and if those

studies were designed and approved by the FDA and they were

completed, then the sponsor could get an additional six-month period

of market protection, not only in the specific drug that they tested

in children but in the entire moiety, in any preparation that used

that particular chemical. "

In other words, FDAMA opened the flood gates for drug testing to be

done on children: the financial incentives were doubled: that is, a

six month patent extension exclusivity, and the drug's market was

expanded to include children.

This " public gtood " was " accomplished " by encouraging manufacturers

and their paid academic pharmacologists to exploit children's

vulnerability in mostly non-therapeutic risky drug experiments.

Dr. Bodkind stated:

" So sildenafil, for example, is now tested for pulmonary hypertension

in children, but it's the compound that's known as Viagra. So if

that company were to get six months of exclusivity, then it would

apply to all of the products and all the uses of that moiety. So

this was a very important incentive to encourage pediatric research.

And that was I guess commonly called " the carrot. " See:

http://www.bioethics.gov/transcripts/dec05/session4.html

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

FAIR USE NOTICE

This email contains copyrighted material the use of which has not

always been specifically authorized by the copyright owner. I am

making such material available in my efforts to advance understanding

of environmental, political, human rights, economic, democracy,

scientific, and social justice issues, etc.

I believe this constitutes a 'fair use' of any such copyrighted

material as provided for in section 107 of the US Copyright Law. In

accordance with Title 17 U.S.C. Section 107, the material in this

email is distributed without profit to those who have expressed a

prior interest in receiving the included information

for research and educational purposes. For more information go to:

http://www.law.cornell.edu/uscode/17/107.shtml

If you wish to use copyrighted material from this update for purposes

of your own that go beyond 'fair use', you must obtain permission

from the copyright owner.

_______________________________________________

[Guest guest]

Government Sanctioned Degradation and Exploitation of Children

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org/cms/

FYI

The following confirms to us that the U.S. government (specifically,

in this case, the FDA) and licensed academic and/or commercial

laboratories that test drugs in human subjects have descended into a

moral abyss.

FDA " bioethicist " Dr. Sara Bodkind, told the President's Council on

Bioethics ( December 2005) that under the 1997 law--FDA Modernization

Act-- " if the FDA issued a request for pediatric studies and if those

studies were designed and approved by the FDA and they were

completed, then the sponsor could get an additional six-month period

of market protection, not only in the specific drug that they tested

in children but in the entire moiety, in any preparation that used

that particular chemical. "

In other words, FDAMA opened the flood gates for drug testing to be

done on children: the financial incentives were doubled: that is, a

six month patent extension exclusivity, and the drug's market was

expanded to include children.

This " public gtood " was " accomplished " by encouraging manufacturers

and their paid academic pharmacologists to exploit children's

vulnerability in mostly non-therapeutic risky drug experiments.

Dr. Bodkind stated:

" So sildenafil, for example, is now tested for pulmonary hypertension

in children, but it's the compound that's known as Viagra. So if

that company were to get six months of exclusivity, then it would

apply to all of the products and all the uses of that moiety. So

this was a very important incentive to encourage pediatric research.

And that was I guess commonly called " the carrot. " See:

http://www.bioethics.gov/transcripts/dec05/session4.html

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

FAIR USE NOTICE

This email contains copyrighted material the use of which has not

always been specifically authorized by the copyright owner. I am

making such material available in my efforts to advance understanding

of environmental, political, human rights, economic, democracy,

scientific, and social justice issues, etc.

I believe this constitutes a 'fair use' of any such copyrighted

material as provided for in section 107 of the US Copyright Law. In

accordance with Title 17 U.S.C. Section 107, the material in this

email is distributed without profit to those who have expressed a

prior interest in receiving the included information

for research and educational purposes. For more information go to:

http://www.law.cornell.edu/uscode/17/107.shtml

If you wish to use copyrighted material from this update for purposes

of your own that go beyond 'fair use', you must obtain permission

from the copyright owner.

_______________________________________________

[Guest guest]

Government Sanctioned Degradation and Exploitation of Children

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org/cms/

FYI

The following confirms to us that the U.S. government (specifically,

in this case, the FDA) and licensed academic and/or commercial

laboratories that test drugs in human subjects have descended into a

moral abyss.

FDA " bioethicist " Dr. Sara Bodkind, told the President's Council on

Bioethics ( December 2005) that under the 1997 law--FDA Modernization

Act-- " if the FDA issued a request for pediatric studies and if those

studies were designed and approved by the FDA and they were

completed, then the sponsor could get an additional six-month period

of market protection, not only in the specific drug that they tested

in children but in the entire moiety, in any preparation that used

that particular chemical. "

In other words, FDAMA opened the flood gates for drug testing to be

done on children: the financial incentives were doubled: that is, a

six month patent extension exclusivity, and the drug's market was

expanded to include children.

This " public gtood " was " accomplished " by encouraging manufacturers

and their paid academic pharmacologists to exploit children's

vulnerability in mostly non-therapeutic risky drug experiments.

Dr. Bodkind stated:

" So sildenafil, for example, is now tested for pulmonary hypertension

in children, but it's the compound that's known as Viagra. So if

that company were to get six months of exclusivity, then it would

apply to all of the products and all the uses of that moiety. So

this was a very important incentive to encourage pediatric research.

And that was I guess commonly called " the carrot. " See:

http://www.bioethics.gov/transcripts/dec05/session4.html

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

FAIR USE NOTICE

This email contains copyrighted material the use of which has not

always been specifically authorized by the copyright owner. I am

making such material available in my efforts to advance understanding

of environmental, political, human rights, economic, democracy,

scientific, and social justice issues, etc.

I believe this constitutes a 'fair use' of any such copyrighted

material as provided for in section 107 of the US Copyright Law. In

accordance with Title 17 U.S.C. Section 107, the material in this

email is distributed without profit to those who have expressed a

prior interest in receiving the included information

for research and educational purposes. For more information go to:

http://www.law.cornell.edu/uscode/17/107.shtml

If you wish to use copyrighted material from this update for purposes

of your own that go beyond 'fair use', you must obtain permission

from the copyright owner.

_______________________________________________