Re: Serious Flaw in FDA's Complex Regulatory Structure

[Guest guest]

This state of affairs is relatively new for the FDA, isn't it? It seems to

me that during Reagan's presidency, the balance began to shift toward

" getting potentially life-saving drugs to market more quickly. " Prior to

that time, public welfare was more emphasized. I don't know if any of the

folks on this list are old enough to remember Thalidomide. Quite a few

pregnant women in Europe used that drug -- I forget what it was for --

and their children were born with grotesque physical defects. The

" thalidomide babies " were rare in the United States, because the FDA was

skeptical of the drug's safety, and withheld approval. So it's the last 25

years that the balance of power has shifted toward easy, quick approvals,

and away from caution based on public welfare. gertie

Serious Flaw in FDA's Complex Regulatory Structure

>

> FYI

>

> ALLIANCE FOR HUMAN RESEARCH PROTECTION

> Promoting Openness and Full Disclosure

> http://www.ahrp.org

>

> Bloomberg News reports that New York State Attorney General Eliot Spitzer

> requested information from Pfizer about the promotion of some of its drugs

> for unapproved uses-the recalled diabetes drug, Rezulin and the

> antidepressant, Zoloft were named.

>

> In what is surely the understatement of the decade, FDA's director of the

> Center for Drug Evaluation and Research (CDER) acknowledged:

>

> " Our current drug approval system has demonstrated that we don't always

> understand the full magnitude of drug risks prior to approval of drug

> products. "

>

> The FDA is under intense criticism following disclosure that the agency

time

> and again failed to detect evidence of lethal drug hazards or to issue

> appropriate Black Box warnings to protect the public when such hazards

were

> identified by the agency's own experts-has led senior FDA officials to

> scramble for cover. The Washington Post and New York Times report that

FDA

> officials have made several announcements to demonstrate a willingness to

> concede imperfection.

>

> See: Marc Kaufman and A. Masters. FDA pledges to listen to

> dissenting scientists

>

>

> The Washington Post

> Saturday, November 06, 2004

> http://www.washingtonpost.com/wp-dyn/articles/A29124-2004Nov5.html

>

> However, none of the proposed measures would address the inherent

overriding

> problems that plague the agency. An insightful, hard hitting editorial in

> The Lancet points to an essential problem that the agency fails to

address:

> " The inherent precedence that licensing of new drugs takes over safety

> evaluation is

> a serious flaw in FDA's complex regulatory structure. "

>

> FDA's failure to identify and to warn the public about the " full magnitude

> of drug risks " is rooted in the fact that the FDA has given priority to

the

> business interests of pharmaceutical companies--rather than public safety

> issues. Indeed, the agency has left the Office of Drug Safety without a

> director for over a year. The FDA has failed to fulfill its mission by

> pretending not to know that drug companies were concealing lethal side

> effects because disclosing the " full magnitude of drug risks " is risky for

> business.

>

> The FDA has yet to act or even to respond to AHRP's complaint about the

> failure of Pfizer to comply with FDA's suicide disclosure requirements in

a

> two page advertisement for its antidepressant, Zoloft, in The New York

Times

> Magazine (October 24, 2004).

>

> Public announcements do not substitute for enforcement of safety

> requirements. When a public oversight agency fails to perform its

> mission--protecting the public from hazardous drugs--its leadership must

be

> held accountable and a thorough overhaul is called for.

>

> The foremost objective must be to rid the drug evaluation process of

> conflicts of interest. Conflict of interest is like graft--it can't be

> contained-if tolerated, it corrupts the entire enterprise.

>

> The FDA announced that it would contract the Institute of Medicine to

> convene a panel to assess FDA's handling of dangerous side effects.

Unless

> that panel is free of conflicts of interest, its assessment will not be

> credible.

>

>

> Unless there is zero tolerance for conflicts of interest in the drug

safety

> assessment process and unless the process becomes transparent--public

health

> is in jeopardy. To ensure that the drug review and approval process is

not

> tainted--all voting members on FDA's advisory committees must be free of

> conflicts of interest. All FDA's consultants' financial ties to industry

> must be disclosed. No more waivers of financial disclosure.

>

> Contact: Vera Hassner Sharav

> 212-595-8974

> veracare@...

>

> BLOOMBERG NEWS

>

> Pfizer Says New York's Spitzer Requests Information

> (Update2) 2004-11-05 19:21 (New York)

> By Ostrow and Marni Leff Kottle

>

> Nov. 5 (Bloomberg) -- Pfizer Inc., the world's largest drugmaker, said

New

> York State Attorney General Eliot Spitzer requested information about the

> promotion of some of its drugs for unapproved uses.

>

> Pfizer, based in New York, said Connecticut Attorney General

> Blumenthal also requested materials on so-called ``off-label'' promotion

of

> its Zoloft antidepressant. The company disclosed the probes in a

regulatory

> filing. Doctors sometimes prescribe medications for applications that

> haven't been approved by U.S. regulators. While such use is legal,

> promotion of drugs for off-label use isn't.

>

> Pfizer's Warner-Lambert unit in May agreed to pay more than $430 million

to

> settle U.S. charges that it promoted its Neurontin epilepsy drug for

> unapproved uses.

>

> Pfizer spokesman Fitzhenry said he couldn't provide additional

comment

> beyond the filing. Shares of Pfizer declined 27 cents to $28.79 as of

4:17

> p.m. in New York Stock Exchange composite trading. They have fallen 19

> percent this year. Pfizer also said it has given the Justice Department

and

> the U.S. Securities and Exchange Commission information related to an

> internal investigation the company is conducting in Croatia. The inquiry

> involves ``certain potentially improper payments made in connection with

> foreign sales activities in Croatia,'' Pfizer said in the filing.

>

> Fitzhenry said he couldn't provide further details. The U.S. Attorney's

> office for the District of land told Pfizer in an Oct. 13 letter that

> it has closed its investigation related to sales of the Rezulin diabetes

> drug, according to the filing. Pfizer acquired Rezulin when it bought

> Warner-Lambert

> in 2000. Rezulin has been the subject of personal-injury lawsuits,

claiming

> the drug damaged some patients' livers. The drug was taken off the market

> in 2000. Pfizer in last year's fourth quarter had $955 million in costs

as

> it set aside money to resolve claims over Rezulin.

>

> --With reporting by Decker in Washington.

> Editors: Simison, Todd.

>

>

> FAIR USE NOTICE:

> This may contain copyrighted (© ) material the use of which has not always

> been specifically authorized by the copyright owner. Such material is

made

> available for educational purposes, to advance understanding of human

> rights, democracy, scientific, moral, ethical, and social justice issues,

> etc. It is believed that this constitutes a 'fair use' of any such

> copyrighted material as provided for in Title 17 U.S.C. section 107 of the

> US Copyright Law. This material is distributed without profit.

>

>

>

>

>

>

>

[Guest guest]

This state of affairs is relatively new for the FDA, isn't it? It seems to

me that during Reagan's presidency, the balance began to shift toward

" getting potentially life-saving drugs to market more quickly. " Prior to

that time, public welfare was more emphasized. I don't know if any of the

folks on this list are old enough to remember Thalidomide. Quite a few

pregnant women in Europe used that drug -- I forget what it was for --

and their children were born with grotesque physical defects. The

" thalidomide babies " were rare in the United States, because the FDA was

skeptical of the drug's safety, and withheld approval. So it's the last 25

years that the balance of power has shifted toward easy, quick approvals,

and away from caution based on public welfare. gertie

Serious Flaw in FDA's Complex Regulatory Structure

>

> FYI

>

> ALLIANCE FOR HUMAN RESEARCH PROTECTION

> Promoting Openness and Full Disclosure

> http://www.ahrp.org

>

> Bloomberg News reports that New York State Attorney General Eliot Spitzer

> requested information from Pfizer about the promotion of some of its drugs

> for unapproved uses-the recalled diabetes drug, Rezulin and the

> antidepressant, Zoloft were named.

>

> In what is surely the understatement of the decade, FDA's director of the

> Center for Drug Evaluation and Research (CDER) acknowledged:

>

> " Our current drug approval system has demonstrated that we don't always

> understand the full magnitude of drug risks prior to approval of drug

> products. "

>

> The FDA is under intense criticism following disclosure that the agency

time

> and again failed to detect evidence of lethal drug hazards or to issue

> appropriate Black Box warnings to protect the public when such hazards

were

> identified by the agency's own experts-has led senior FDA officials to

> scramble for cover. The Washington Post and New York Times report that

FDA

> officials have made several announcements to demonstrate a willingness to

> concede imperfection.

>

> See: Marc Kaufman and A. Masters. FDA pledges to listen to

> dissenting scientists

>

>

> The Washington Post

> Saturday, November 06, 2004

> http://www.washingtonpost.com/wp-dyn/articles/A29124-2004Nov5.html

>

> However, none of the proposed measures would address the inherent

overriding

> problems that plague the agency. An insightful, hard hitting editorial in

> The Lancet points to an essential problem that the agency fails to

address:

> " The inherent precedence that licensing of new drugs takes over safety

> evaluation is

> a serious flaw in FDA's complex regulatory structure. "

>

> FDA's failure to identify and to warn the public about the " full magnitude

> of drug risks " is rooted in the fact that the FDA has given priority to

the

> business interests of pharmaceutical companies--rather than public safety

> issues. Indeed, the agency has left the Office of Drug Safety without a

> director for over a year. The FDA has failed to fulfill its mission by

> pretending not to know that drug companies were concealing lethal side

> effects because disclosing the " full magnitude of drug risks " is risky for

> business.

>

> The FDA has yet to act or even to respond to AHRP's complaint about the

> failure of Pfizer to comply with FDA's suicide disclosure requirements in

a

> two page advertisement for its antidepressant, Zoloft, in The New York

Times

> Magazine (October 24, 2004).

>

> Public announcements do not substitute for enforcement of safety

> requirements. When a public oversight agency fails to perform its

> mission--protecting the public from hazardous drugs--its leadership must

be

> held accountable and a thorough overhaul is called for.

>

> The foremost objective must be to rid the drug evaluation process of

> conflicts of interest. Conflict of interest is like graft--it can't be

> contained-if tolerated, it corrupts the entire enterprise.

>

> The FDA announced that it would contract the Institute of Medicine to

> convene a panel to assess FDA's handling of dangerous side effects.

Unless

> that panel is free of conflicts of interest, its assessment will not be

> credible.

>

>

> Unless there is zero tolerance for conflicts of interest in the drug

safety

> assessment process and unless the process becomes transparent--public

health

> is in jeopardy. To ensure that the drug review and approval process is

not

> tainted--all voting members on FDA's advisory committees must be free of

> conflicts of interest. All FDA's consultants' financial ties to industry

> must be disclosed. No more waivers of financial disclosure.

>

> Contact: Vera Hassner Sharav

> 212-595-8974

> veracare@...

>

> BLOOMBERG NEWS

>

> Pfizer Says New York's Spitzer Requests Information

> (Update2) 2004-11-05 19:21 (New York)

> By Ostrow and Marni Leff Kottle

>

> Nov. 5 (Bloomberg) -- Pfizer Inc., the world's largest drugmaker, said

New

> York State Attorney General Eliot Spitzer requested information about the

> promotion of some of its drugs for unapproved uses.

>

> Pfizer, based in New York, said Connecticut Attorney General

> Blumenthal also requested materials on so-called ``off-label'' promotion

of

> its Zoloft antidepressant. The company disclosed the probes in a

regulatory

> filing. Doctors sometimes prescribe medications for applications that

> haven't been approved by U.S. regulators. While such use is legal,

> promotion of drugs for off-label use isn't.

>

> Pfizer's Warner-Lambert unit in May agreed to pay more than $430 million

to

> settle U.S. charges that it promoted its Neurontin epilepsy drug for

> unapproved uses.

>

> Pfizer spokesman Fitzhenry said he couldn't provide additional

comment

> beyond the filing. Shares of Pfizer declined 27 cents to $28.79 as of

4:17

> p.m. in New York Stock Exchange composite trading. They have fallen 19

> percent this year. Pfizer also said it has given the Justice Department

and

> the U.S. Securities and Exchange Commission information related to an

> internal investigation the company is conducting in Croatia. The inquiry

> involves ``certain potentially improper payments made in connection with

> foreign sales activities in Croatia,'' Pfizer said in the filing.

>

> Fitzhenry said he couldn't provide further details. The U.S. Attorney's

> office for the District of land told Pfizer in an Oct. 13 letter that

> it has closed its investigation related to sales of the Rezulin diabetes

> drug, according to the filing. Pfizer acquired Rezulin when it bought

> Warner-Lambert

> in 2000. Rezulin has been the subject of personal-injury lawsuits,

claiming

> the drug damaged some patients' livers. The drug was taken off the market

> in 2000. Pfizer in last year's fourth quarter had $955 million in costs

as

> it set aside money to resolve claims over Rezulin.

>

> --With reporting by Decker in Washington.

> Editors: Simison, Todd.

>

>

> FAIR USE NOTICE:

> This may contain copyrighted (© ) material the use of which has not always

> been specifically authorized by the copyright owner. Such material is

made

> available for educational purposes, to advance understanding of human

> rights, democracy, scientific, moral, ethical, and social justice issues,

> etc. It is believed that this constitutes a 'fair use' of any such

> copyrighted material as provided for in Title 17 U.S.C. section 107 of the

> US Copyright Law. This material is distributed without profit.

>

>

>

>

>

>

>

[Guest guest]

Gertie,

It was the Clinton's (democrats) whose campaign into Washington included

promises to ease regulations over approval of drugs in 1992 - and so they

did. They also ran as did Kerry and (democrats), with promises of

finding " cures " for our ills. This is a synonymous term for funding more

tax dollars into drug discoveries. It was in the Reagan (Republican)

era that laws were changed and medical schools were allowed to share in

profits from drugs and discoveries made in their institutions. Before that,

the drug companies reaped all profits and schools were suppose to be

intellectual, academic institutions, in the pursuit of truth, not profit.

This destroyed the objectivity and academic freedom of scientists to speak

honestly against things such as bad drugs. Nixon (Republican)

would take credit for drastically increasing research funding. McGovern

(democrats) was the first politician I am aware of to very overtly use his

political power in the promotion of drugs - the cholesterol lowering

medications. But the greatest contributor of all was Lyndon

(democrats) in his Great Society programs, most particularly Medicare that

made medicine a very financially lucrative profession, not simply for

doctors but the peripheral components such as hospitals and drug companies.

This combined with the wave of corporations paying medical insurance

benefits, removed market forces that would otherwise have contained costs

and profits. As profits grew, so did power structures of those who loved

money as the root of all evil. The 90's has been labeled the decade of

greed because it was by that time, that the money lords had taken full rule.

For those who think changes are going to occur at the FDA, I would suggest

reading the economist Stigler and his capture theory of regulation.

He postulated that regulatory agencies will inevitably develop to be servers

of the industries they are suppose to be regulating.

Serious Flaw in FDA's Complex Regulatory

> Structure

>

>

>>

>> FYI

>>

>> ALLIANCE FOR HUMAN RESEARCH PROTECTION

>> Promoting Openness and Full Disclosure

>> http://www.ahrp.org

>>

>> Bloomberg News reports that New York State Attorney General Eliot Spitzer

>> requested information from Pfizer about the promotion of some of its

>> drugs

>> for unapproved uses-the recalled diabetes drug, Rezulin and the

>> antidepressant, Zoloft were named.

>>

>> In what is surely the understatement of the decade, FDA's director of the

>> Center for Drug Evaluation and Research (CDER) acknowledged:

>>

>> " Our current drug approval system has demonstrated that we don't always

>> understand the full magnitude of drug risks prior to approval of drug

>> products. "

>>

>> The FDA is under intense criticism following disclosure that the agency

> time

>> and again failed to detect evidence of lethal drug hazards or to issue

>> appropriate Black Box warnings to protect the public when such hazards

> were

>> identified by the agency's own experts-has led senior FDA officials to

>> scramble for cover. The Washington Post and New York Times report that

> FDA

>> officials have made several announcements to demonstrate a willingness to

>> concede imperfection.

>>

>> See: Marc Kaufman and A. Masters. FDA pledges to listen to

>> dissenting scientists

>>

>>

>> The Washington Post

>> Saturday, November 06, 2004

>> http://www.washingtonpost.com/wp-dyn/articles/A29124-2004Nov5.html

>>

>> However, none of the proposed measures would address the inherent

> overriding

>> problems that plague the agency. An insightful, hard hitting editorial

>> in

>> The Lancet points to an essential problem that the agency fails to

> address:

>> " The inherent precedence that licensing of new drugs takes over safety

>> evaluation is

>> a serious flaw in FDA's complex regulatory structure. "

>>

>> FDA's failure to identify and to warn the public about the " full

>> magnitude

>> of drug risks " is rooted in the fact that the FDA has given priority to

> the

>> business interests of pharmaceutical companies--rather than public safety

>> issues. Indeed, the agency has left the Office of Drug Safety without a

>> director for over a year. The FDA has failed to fulfill its mission by

>> pretending not to know that drug companies were concealing lethal side

>> effects because disclosing the " full magnitude of drug risks " is risky for

>> business.

>>

>> The FDA has yet to act or even to respond to AHRP's complaint about the

>> failure of Pfizer to comply with FDA's suicide disclosure requirements in

> a

>> two page advertisement for its antidepressant, Zoloft, in The New York

> Times

>> Magazine (October 24, 2004).

>>

>> Public announcements do not substitute for enforcement of safety

>> requirements. When a public oversight agency fails to perform its

>> mission--protecting the public from hazardous drugs--its leadership must

> be

>> held accountable and a thorough overhaul is called for.

>>

>> The foremost objective must be to rid the drug evaluation process of

>> conflicts of interest. Conflict of interest is like graft--it can't be

>> contained-if tolerated, it corrupts the entire enterprise.

>>

>> The FDA announced that it would contract the Institute of Medicine to

>> convene a panel to assess FDA's handling of dangerous side effects.

> Unless

>> that panel is free of conflicts of interest, its assessment will not be

>> credible.

>>

>>

>> Unless there is zero tolerance for conflicts of interest in the drug

> safety

>> assessment process and unless the process becomes transparent--public

> health

>> is in jeopardy. To ensure that the drug review and approval process is

> not

>> tainted--all voting members on FDA's advisory committees must be free of

>> conflicts of interest. All FDA's consultants' financial ties to industry

>> must be disclosed. No more waivers of financial disclosure.

>>

>> Contact: Vera Hassner Sharav

>> 212-595-8974

>> veracare@...

>>

>> BLOOMBERG NEWS

>>

>> Pfizer Says New York's Spitzer Requests Information

>> (Update2) 2004-11-05 19:21 (New York)

>> By Ostrow and Marni Leff Kottle

>>

>> Nov. 5 (Bloomberg) -- Pfizer Inc., the world's largest drugmaker, said

> New

>> York State Attorney General Eliot Spitzer requested information about the

>> promotion of some of its drugs for unapproved uses.

>>

>> Pfizer, based in New York, said Connecticut Attorney General

>> Blumenthal also requested materials on so-called ``off-label'' promotion

> of

>> its Zoloft antidepressant. The company disclosed the probes in a

> regulatory

>> filing. Doctors sometimes prescribe medications for applications that

>> haven't been approved by U.S. regulators. While such use is legal,

>> promotion of drugs for off-label use isn't.

>>

>> Pfizer's Warner-Lambert unit in May agreed to pay more than $430 million

> to

>> settle U.S. charges that it promoted its Neurontin epilepsy drug for

>> unapproved uses.

>>

>> Pfizer spokesman Fitzhenry said he couldn't provide additional

> comment

>> beyond the filing. Shares of Pfizer declined 27 cents to $28.79 as of

> 4:17

>> p.m. in New York Stock Exchange composite trading. They have fallen 19

>> percent this year. Pfizer also said it has given the Justice Department

> and

>> the U.S. Securities and Exchange Commission information related to an

>> internal investigation the company is conducting in Croatia. The inquiry

>> involves ``certain potentially improper payments made in connection with

>> foreign sales activities in Croatia,'' Pfizer said in the filing.

>>

>> Fitzhenry said he couldn't provide further details. The U.S. Attorney's

>> office for the District of land told Pfizer in an Oct. 13 letter

>> that

>> it has closed its investigation related to sales of the Rezulin diabetes

>> drug, according to the filing. Pfizer acquired Rezulin when it bought

>> Warner-Lambert

>> in 2000. Rezulin has been the subject of personal-injury lawsuits,

> claiming

>> the drug damaged some patients' livers. The drug was taken off the

>> market

>> in 2000. Pfizer in last year's fourth quarter had $955 million in costs

> as

>> it set aside money to resolve claims over Rezulin.

>>

>> --With reporting by Decker in Washington.

>> Editors: Simison, Todd.

>>

>>

>> FAIR USE NOTICE:

>> This may contain copyrighted (© ) material the use of which has not

>> always

>> been specifically authorized by the copyright owner. Such material is

> made

>> available for educational purposes, to advance understanding of human

>> rights, democracy, scientific, moral, ethical, and social justice issues,

>> etc. It is believed that this constitutes a 'fair use' of any such

>> copyrighted material as provided for in Title 17 U.S.C. section 107 of

>> the

>> US Copyright Law. This material is distributed without profit.

>>

>>

>>

>>

>>

>>

>>

[Guest guest]

That's interesting -- I knew it was a bit back in recent history, and I just

assumed it was the Reagan legacy, but it is interesting it was Clinton's regime

that eased the approval process for pharmaceuticals.

Serious Flaw in FDA's Complex Regulatory

> Structure

>

>

>>

>> FYI

>>

>> ALLIANCE FOR HUMAN RESEARCH PROTECTION

>> Promoting Openness and Full Disclosure

>> http://www.ahrp.org

>>

>> Bloomberg News reports that New York State Attorney General Eliot Spitzer

>> requested information from Pfizer about the promotion of some of its

>> drugs

>> for unapproved uses-the recalled diabetes drug, Rezulin and the

>> antidepressant, Zoloft were named.

>>

>> In what is surely the understatement of the decade, FDA's director of the

>> Center for Drug Evaluation and Research (CDER) acknowledged:

>>

>> " Our current drug approval system has demonstrated that we don't always

>> understand the full magnitude of drug risks prior to approval of drug

>> products. "

>>

>> The FDA is under intense criticism following disclosure that the agency

> time

>> and again failed to detect evidence of lethal drug hazards or to issue

>> appropriate Black Box warnings to protect the public when such hazards

> were

>> identified by the agency's own experts-has led senior FDA officials to

>> scramble for cover. The Washington Post and New York Times report that

> FDA

>> officials have made several announcements to demonstrate a willingness to

>> concede imperfection.

>>

>> See: Marc Kaufman and A. Masters. FDA pledges to listen to

>> dissenting scientists

>>

>>

>> The Washington Post

>> Saturday, November 06, 2004

>> http://www.washingtonpost.com/wp-dyn/articles/A29124-2004Nov5.html

>>

>> However, none of the proposed measures would address the inherent

> overriding

>> problems that plague the agency. An insightful, hard hitting editorial

>> in

>> The Lancet points to an essential problem that the agency fails to

> address:

>> " The inherent precedence that licensing of new drugs takes over safety

>> evaluation is

>> a serious flaw in FDA's complex regulatory structure. "

>>

>> FDA's failure to identify and to warn the public about the " full

>> magnitude

>> of drug risks " is rooted in the fact that the FDA has given priority to

> the

>> business interests of pharmaceutical companies--rather than public safety

>> issues. Indeed, the agency has left the Office of Drug Safety without a

>> director for over a year. The FDA has failed to fulfill its mission by

>> pretending not to know that drug companies were concealing lethal side

>> effects because disclosing the " full magnitude of drug risks " is risky for

>> business.

>>

>> The FDA has yet to act or even to respond to AHRP's complaint about the

>> failure of Pfizer to comply with FDA's suicide disclosure requirements in

> a

>> two page advertisement for its antidepressant, Zoloft, in The New York

> Times

>> Magazine (October 24, 2004).

>>

>> Public announcements do not substitute for enforcement of safety

>> requirements. When a public oversight agency fails to perform its

>> mission--protecting the public from hazardous drugs--its leadership must

> be

>> held accountable and a thorough overhaul is called for.

>>

>> The foremost objective must be to rid the drug evaluation process of

>> conflicts of interest. Conflict of interest is like graft--it can't be

>> contained-if tolerated, it corrupts the entire enterprise.

>>

>> The FDA announced that it would contract the Institute of Medicine to

>> convene a panel to assess FDA's handling of dangerous side effects.

> Unless

>> that panel is free of conflicts of interest, its assessment will not be

>> credible.

>>

>>

>> Unless there is zero tolerance for conflicts of interest in the drug

> safety

>> assessment process and unless the process becomes transparent--public

> health

>> is in jeopardy. To ensure that the drug review and approval process is

> not

>> tainted--all voting members on FDA's advisory committees must be free of

>> conflicts of interest. All FDA's consultants' financial ties to industry

>> must be disclosed. No more waivers of financial disclosure.

>>

>> Contact: Vera Hassner Sharav

>> 212-595-8974

>> veracare@...

>>

>> BLOOMBERG NEWS

>>

>> Pfizer Says New York's Spitzer Requests Information

>> (Update2) 2004-11-05 19:21 (New York)

>> By Ostrow and Marni Leff Kottle

>>

>> Nov. 5 (Bloomberg) -- Pfizer Inc., the world's largest drugmaker, said

> New

>> York State Attorney General Eliot Spitzer requested information about the

>> promotion of some of its drugs for unapproved uses.

>>

>> Pfizer, based in New York, said Connecticut Attorney General

>> Blumenthal also requested materials on so-called ``off-label'' promotion

> of

>> its Zoloft antidepressant. The company disclosed the probes in a

> regulatory

>> filing. Doctors sometimes prescribe medications for applications that

>> haven't been approved by U.S. regulators. While such use is legal,

>> promotion of drugs for off-label use isn't.

>>

>> Pfizer's Warner-Lambert unit in May agreed to pay more than $430 million

> to

>> settle U.S. charges that it promoted its Neurontin epilepsy drug for

>> unapproved uses.

>>

>> Pfizer spokesman Fitzhenry said he couldn't provide additional

> comment

>> beyond the filing. Shares of Pfizer declined 27 cents to $28.79 as of

> 4:17

>> p.m. in New York Stock Exchange composite trading. They have fallen 19

>> percent this year. Pfizer also said it has given the Justice Department

> and

>> the U.S. Securities and Exchange Commission information related to an

>> internal investigation the company is conducting in Croatia. The inquiry

>> involves ``certain potentially improper payments made in connection with

>> foreign sales activities in Croatia,'' Pfizer said in the filing.

>>

>> Fitzhenry said he couldn't provide further details. The U.S. Attorney's

>> office for the District of land told Pfizer in an Oct. 13 letter

>> that

>> it has closed its investigation related to sales of the Rezulin diabetes

>> drug, according to the filing. Pfizer acquired Rezulin when it bought

>> Warner-Lambert

>> in 2000. Rezulin has been the subject of personal-injury lawsuits,

> claiming

>> the drug damaged some patients' livers. The drug was taken off the

>> market

>> in 2000. Pfizer in last year's fourth quarter had $955 million in costs

> as

>> it set aside money to resolve claims over Rezulin.

>>

>> --With reporting by Decker in Washington.

>> Editors: Simison, Todd.

>>

>>

>> FAIR USE NOTICE:

>> This may contain copyrighted (© ) material the use of which has not

>> always

>> been specifically authorized by the copyright owner. Such material is

> made

>> available for educational purposes, to advance understanding of human

>> rights, democracy, scientific, moral, ethical, and social justice issues,

>> etc. It is believed that this constitutes a 'fair use' of any such

>> copyrighted material as provided for in Title 17 U.S.C. section 107 of

>> the

>> US Copyright Law. This material is distributed without profit.

>>

>>

>>

>>

>>

>>

>>

[Guest guest]

That's interesting -- I knew it was a bit back in recent history, and I just

assumed it was the Reagan legacy, but it is interesting it was Clinton's regime

that eased the approval process for pharmaceuticals.

Serious Flaw in FDA's Complex Regulatory

> Structure

>

>

>>

>> FYI

>>

>> ALLIANCE FOR HUMAN RESEARCH PROTECTION

>> Promoting Openness and Full Disclosure

>> http://www.ahrp.org

>>

>> Bloomberg News reports that New York State Attorney General Eliot Spitzer

>> requested information from Pfizer about the promotion of some of its

>> drugs

>> for unapproved uses-the recalled diabetes drug, Rezulin and the

>> antidepressant, Zoloft were named.

>>

>> In what is surely the understatement of the decade, FDA's director of the

>> Center for Drug Evaluation and Research (CDER) acknowledged:

>>

>> " Our current drug approval system has demonstrated that we don't always

>> understand the full magnitude of drug risks prior to approval of drug

>> products. "

>>

>> The FDA is under intense criticism following disclosure that the agency

> time

>> and again failed to detect evidence of lethal drug hazards or to issue

>> appropriate Black Box warnings to protect the public when such hazards

> were

>> identified by the agency's own experts-has led senior FDA officials to

>> scramble for cover. The Washington Post and New York Times report that

> FDA

>> officials have made several announcements to demonstrate a willingness to

>> concede imperfection.

>>

>> See: Marc Kaufman and A. Masters. FDA pledges to listen to

>> dissenting scientists

>>

>>

>> The Washington Post

>> Saturday, November 06, 2004

>> http://www.washingtonpost.com/wp-dyn/articles/A29124-2004Nov5.html

>>

>> However, none of the proposed measures would address the inherent

> overriding

>> problems that plague the agency. An insightful, hard hitting editorial

>> in

>> The Lancet points to an essential problem that the agency fails to

> address:

>> " The inherent precedence that licensing of new drugs takes over safety

>> evaluation is

>> a serious flaw in FDA's complex regulatory structure. "

>>

>> FDA's failure to identify and to warn the public about the " full

>> magnitude

>> of drug risks " is rooted in the fact that the FDA has given priority to

> the

>> business interests of pharmaceutical companies--rather than public safety

>> issues. Indeed, the agency has left the Office of Drug Safety without a

>> director for over a year. The FDA has failed to fulfill its mission by

>> pretending not to know that drug companies were concealing lethal side

>> effects because disclosing the " full magnitude of drug risks " is risky for

>> business.

>>

>> The FDA has yet to act or even to respond to AHRP's complaint about the

>> failure of Pfizer to comply with FDA's suicide disclosure requirements in

> a

>> two page advertisement for its antidepressant, Zoloft, in The New York

> Times

>> Magazine (October 24, 2004).

>>

>> Public announcements do not substitute for enforcement of safety

>> requirements. When a public oversight agency fails to perform its

>> mission--protecting the public from hazardous drugs--its leadership must

> be

>> held accountable and a thorough overhaul is called for.

>>

>> The foremost objective must be to rid the drug evaluation process of

>> conflicts of interest. Conflict of interest is like graft--it can't be

>> contained-if tolerated, it corrupts the entire enterprise.

>>

>> The FDA announced that it would contract the Institute of Medicine to

>> convene a panel to assess FDA's handling of dangerous side effects.

> Unless

>> that panel is free of conflicts of interest, its assessment will not be

>> credible.

>>

>>

>> Unless there is zero tolerance for conflicts of interest in the drug

> safety

>> assessment process and unless the process becomes transparent--public

> health

>> is in jeopardy. To ensure that the drug review and approval process is

> not

>> tainted--all voting members on FDA's advisory committees must be free of

>> conflicts of interest. All FDA's consultants' financial ties to industry

>> must be disclosed. No more waivers of financial disclosure.

>>

>> Contact: Vera Hassner Sharav

>> 212-595-8974

>> veracare@...

>>

>> BLOOMBERG NEWS

>>

>> Pfizer Says New York's Spitzer Requests Information

>> (Update2) 2004-11-05 19:21 (New York)

>> By Ostrow and Marni Leff Kottle

>>

>> Nov. 5 (Bloomberg) -- Pfizer Inc., the world's largest drugmaker, said

> New

>> York State Attorney General Eliot Spitzer requested information about the

>> promotion of some of its drugs for unapproved uses.

>>

>> Pfizer, based in New York, said Connecticut Attorney General

>> Blumenthal also requested materials on so-called ``off-label'' promotion

> of

>> its Zoloft antidepressant. The company disclosed the probes in a

> regulatory

>> filing. Doctors sometimes prescribe medications for applications that

>> haven't been approved by U.S. regulators. While such use is legal,

>> promotion of drugs for off-label use isn't.

>>

>> Pfizer's Warner-Lambert unit in May agreed to pay more than $430 million

> to

>> settle U.S. charges that it promoted its Neurontin epilepsy drug for

>> unapproved uses.

>>

>> Pfizer spokesman Fitzhenry said he couldn't provide additional

> comment

>> beyond the filing. Shares of Pfizer declined 27 cents to $28.79 as of

> 4:17

>> p.m. in New York Stock Exchange composite trading. They have fallen 19

>> percent this year. Pfizer also said it has given the Justice Department

> and

>> the U.S. Securities and Exchange Commission information related to an

>> internal investigation the company is conducting in Croatia. The inquiry

>> involves ``certain potentially improper payments made in connection with

>> foreign sales activities in Croatia,'' Pfizer said in the filing.

>>

>> Fitzhenry said he couldn't provide further details. The U.S. Attorney's

>> office for the District of land told Pfizer in an Oct. 13 letter

>> that

>> it has closed its investigation related to sales of the Rezulin diabetes

>> drug, according to the filing. Pfizer acquired Rezulin when it bought

>> Warner-Lambert

>> in 2000. Rezulin has been the subject of personal-injury lawsuits,

> claiming

>> the drug damaged some patients' livers. The drug was taken off the

>> market

>> in 2000. Pfizer in last year's fourth quarter had $955 million in costs

> as

>> it set aside money to resolve claims over Rezulin.

>>

>> --With reporting by Decker in Washington.

>> Editors: Simison, Todd.

>>

>>

>> FAIR USE NOTICE:

>> This may contain copyrighted (© ) material the use of which has not

>> always

>> been specifically authorized by the copyright owner. Such material is

> made

>> available for educational purposes, to advance understanding of human

>> rights, democracy, scientific, moral, ethical, and social justice issues,

>> etc. It is believed that this constitutes a 'fair use' of any such

>> copyrighted material as provided for in Title 17 U.S.C. section 107 of

>> the

>> US Copyright Law. This material is distributed without profit.

>>

>>

>>

>>

>>

>>

>>

[Guest guest]

That's interesting -- I knew it was a bit back in recent history, and I just

assumed it was the Reagan legacy, but it is interesting it was Clinton's regime

that eased the approval process for pharmaceuticals.

Serious Flaw in FDA's Complex Regulatory

> Structure

>

>

>>

>> FYI

>>

>> ALLIANCE FOR HUMAN RESEARCH PROTECTION

>> Promoting Openness and Full Disclosure

>> http://www.ahrp.org

>>

>> Bloomberg News reports that New York State Attorney General Eliot Spitzer

>> requested information from Pfizer about the promotion of some of its

>> drugs

>> for unapproved uses-the recalled diabetes drug, Rezulin and the

>> antidepressant, Zoloft were named.

>>

>> In what is surely the understatement of the decade, FDA's director of the

>> Center for Drug Evaluation and Research (CDER) acknowledged:

>>

>> " Our current drug approval system has demonstrated that we don't always

>> understand the full magnitude of drug risks prior to approval of drug

>> products. "

>>

>> The FDA is under intense criticism following disclosure that the agency

> time

>> and again failed to detect evidence of lethal drug hazards or to issue

>> appropriate Black Box warnings to protect the public when such hazards

> were

>> identified by the agency's own experts-has led senior FDA officials to

>> scramble for cover. The Washington Post and New York Times report that

> FDA

>> officials have made several announcements to demonstrate a willingness to

>> concede imperfection.

>>

>> See: Marc Kaufman and A. Masters. FDA pledges to listen to

>> dissenting scientists

>>

>>

>> The Washington Post

>> Saturday, November 06, 2004

>> http://www.washingtonpost.com/wp-dyn/articles/A29124-2004Nov5.html

>>

>> However, none of the proposed measures would address the inherent

> overriding

>> problems that plague the agency. An insightful, hard hitting editorial

>> in

>> The Lancet points to an essential problem that the agency fails to

> address:

>> " The inherent precedence that licensing of new drugs takes over safety

>> evaluation is

>> a serious flaw in FDA's complex regulatory structure. "

>>

>> FDA's failure to identify and to warn the public about the " full

>> magnitude

>> of drug risks " is rooted in the fact that the FDA has given priority to

> the

>> business interests of pharmaceutical companies--rather than public safety

>> issues. Indeed, the agency has left the Office of Drug Safety without a

>> director for over a year. The FDA has failed to fulfill its mission by

>> pretending not to know that drug companies were concealing lethal side

>> effects because disclosing the " full magnitude of drug risks " is risky for

>> business.

>>

>> The FDA has yet to act or even to respond to AHRP's complaint about the

>> failure of Pfizer to comply with FDA's suicide disclosure requirements in

> a

>> two page advertisement for its antidepressant, Zoloft, in The New York

> Times

>> Magazine (October 24, 2004).

>>

>> Public announcements do not substitute for enforcement of safety

>> requirements. When a public oversight agency fails to perform its

>> mission--protecting the public from hazardous drugs--its leadership must

> be

>> held accountable and a thorough overhaul is called for.

>>

>> The foremost objective must be to rid the drug evaluation process of

>> conflicts of interest. Conflict of interest is like graft--it can't be

>> contained-if tolerated, it corrupts the entire enterprise.

>>

>> The FDA announced that it would contract the Institute of Medicine to

>> convene a panel to assess FDA's handling of dangerous side effects.

> Unless

>> that panel is free of conflicts of interest, its assessment will not be

>> credible.

>>

>>

>> Unless there is zero tolerance for conflicts of interest in the drug

> safety

>> assessment process and unless the process becomes transparent--public

> health

>> is in jeopardy. To ensure that the drug review and approval process is

> not

>> tainted--all voting members on FDA's advisory committees must be free of

>> conflicts of interest. All FDA's consultants' financial ties to industry

>> must be disclosed. No more waivers of financial disclosure.

>>

>> Contact: Vera Hassner Sharav

>> 212-595-8974

>> veracare@...

>>

>> BLOOMBERG NEWS

>>

>> Pfizer Says New York's Spitzer Requests Information

>> (Update2) 2004-11-05 19:21 (New York)

>> By Ostrow and Marni Leff Kottle

>>

>> Nov. 5 (Bloomberg) -- Pfizer Inc., the world's largest drugmaker, said

> New

>> York State Attorney General Eliot Spitzer requested information about the

>> promotion of some of its drugs for unapproved uses.

>>

>> Pfizer, based in New York, said Connecticut Attorney General

>> Blumenthal also requested materials on so-called ``off-label'' promotion

> of

>> its Zoloft antidepressant. The company disclosed the probes in a

> regulatory

>> filing. Doctors sometimes prescribe medications for applications that

>> haven't been approved by U.S. regulators. While such use is legal,

>> promotion of drugs for off-label use isn't.

>>

>> Pfizer's Warner-Lambert unit in May agreed to pay more than $430 million

> to

>> settle U.S. charges that it promoted its Neurontin epilepsy drug for

>> unapproved uses.

>>

>> Pfizer spokesman Fitzhenry said he couldn't provide additional

> comment

>> beyond the filing. Shares of Pfizer declined 27 cents to $28.79 as of

> 4:17

>> p.m. in New York Stock Exchange composite trading. They have fallen 19

>> percent this year. Pfizer also said it has given the Justice Department

> and

>> the U.S. Securities and Exchange Commission information related to an

>> internal investigation the company is conducting in Croatia. The inquiry

>> involves ``certain potentially improper payments made in connection with

>> foreign sales activities in Croatia,'' Pfizer said in the filing.

>>

>> Fitzhenry said he couldn't provide further details. The U.S. Attorney's

>> office for the District of land told Pfizer in an Oct. 13 letter

>> that

>> it has closed its investigation related to sales of the Rezulin diabetes

>> drug, according to the filing. Pfizer acquired Rezulin when it bought

>> Warner-Lambert

>> in 2000. Rezulin has been the subject of personal-injury lawsuits,

> claiming

>> the drug damaged some patients' livers. The drug was taken off the

>> market

>> in 2000. Pfizer in last year's fourth quarter had $955 million in costs

> as

>> it set aside money to resolve claims over Rezulin.

>>

>> --With reporting by Decker in Washington.

>> Editors: Simison, Todd.

>>

>>

>> FAIR USE NOTICE:

>> This may contain copyrighted (© ) material the use of which has not

>> always

>> been specifically authorized by the copyright owner. Such material is

> made

>> available for educational purposes, to advance understanding of human

>> rights, democracy, scientific, moral, ethical, and social justice issues,

>> etc. It is believed that this constitutes a 'fair use' of any such

>> copyrighted material as provided for in Title 17 U.S.C. section 107 of

>> the

>> US Copyright Law. This material is distributed without profit.

>>

>>

>>

>>

>>

>>

>>

[Guest guest]

That's interesting -- I knew it was a bit back in recent history, and I just

assumed it was the Reagan legacy, but it is interesting it was Clinton's regime

that eased the approval process for pharmaceuticals.

Serious Flaw in FDA's Complex Regulatory

> Structure

>

>

>>

>> FYI

>>

>> ALLIANCE FOR HUMAN RESEARCH PROTECTION

>> Promoting Openness and Full Disclosure

>> http://www.ahrp.org

>>

>> Bloomberg News reports that New York State Attorney General Eliot Spitzer

>> requested information from Pfizer about the promotion of some of its

>> drugs

>> for unapproved uses-the recalled diabetes drug, Rezulin and the

>> antidepressant, Zoloft were named.

>>

>> In what is surely the understatement of the decade, FDA's director of the

>> Center for Drug Evaluation and Research (CDER) acknowledged:

>>

>> " Our current drug approval system has demonstrated that we don't always

>> understand the full magnitude of drug risks prior to approval of drug

>> products. "

>>

>> The FDA is under intense criticism following disclosure that the agency

> time

>> and again failed to detect evidence of lethal drug hazards or to issue

>> appropriate Black Box warnings to protect the public when such hazards

> were

>> identified by the agency's own experts-has led senior FDA officials to

>> scramble for cover. The Washington Post and New York Times report that

> FDA

>> officials have made several announcements to demonstrate a willingness to

>> concede imperfection.

>>

>> See: Marc Kaufman and A. Masters. FDA pledges to listen to

>> dissenting scientists

>>

>>

>> The Washington Post

>> Saturday, November 06, 2004

>> http://www.washingtonpost.com/wp-dyn/articles/A29124-2004Nov5.html

>>

>> However, none of the proposed measures would address the inherent

> overriding

>> problems that plague the agency. An insightful, hard hitting editorial

>> in

>> The Lancet points to an essential problem that the agency fails to

> address:

>> " The inherent precedence that licensing of new drugs takes over safety

>> evaluation is

>> a serious flaw in FDA's complex regulatory structure. "

>>

>> FDA's failure to identify and to warn the public about the " full

>> magnitude

>> of drug risks " is rooted in the fact that the FDA has given priority to

> the

>> business interests of pharmaceutical companies--rather than public safety

>> issues. Indeed, the agency has left the Office of Drug Safety without a

>> director for over a year. The FDA has failed to fulfill its mission by

>> pretending not to know that drug companies were concealing lethal side

>> effects because disclosing the " full magnitude of drug risks " is risky for

>> business.

>>

>> The FDA has yet to act or even to respond to AHRP's complaint about the

>> failure of Pfizer to comply with FDA's suicide disclosure requirements in

> a

>> two page advertisement for its antidepressant, Zoloft, in The New York

> Times

>> Magazine (October 24, 2004).

>>

>> Public announcements do not substitute for enforcement of safety

>> requirements. When a public oversight agency fails to perform its

>> mission--protecting the public from hazardous drugs--its leadership must

> be

>> held accountable and a thorough overhaul is called for.

>>

>> The foremost objective must be to rid the drug evaluation process of

>> conflicts of interest. Conflict of interest is like graft--it can't be

>> contained-if tolerated, it corrupts the entire enterprise.

>>

>> The FDA announced that it would contract the Institute of Medicine to

>> convene a panel to assess FDA's handling of dangerous side effects.

> Unless

>> that panel is free of conflicts of interest, its assessment will not be

>> credible.

>>

>>

>> Unless there is zero tolerance for conflicts of interest in the drug

> safety

>> assessment process and unless the process becomes transparent--public

> health

>> is in jeopardy. To ensure that the drug review and approval process is

> not

>> tainted--all voting members on FDA's advisory committees must be free of

>> conflicts of interest. All FDA's consultants' financial ties to industry

>> must be disclosed. No more waivers of financial disclosure.

>>

>> Contact: Vera Hassner Sharav

>> 212-595-8974

>> veracare@...

>>

>> BLOOMBERG NEWS

>>

>> Pfizer Says New York's Spitzer Requests Information

>> (Update2) 2004-11-05 19:21 (New York)

>> By Ostrow and Marni Leff Kottle

>>

>> Nov. 5 (Bloomberg) -- Pfizer Inc., the world's largest drugmaker, said

> New

>> York State Attorney General Eliot Spitzer requested information about the

>> promotion of some of its drugs for unapproved uses.

>>

>> Pfizer, based in New York, said Connecticut Attorney General

>> Blumenthal also requested materials on so-called ``off-label'' promotion

> of

>> its Zoloft antidepressant. The company disclosed the probes in a

> regulatory

>> filing. Doctors sometimes prescribe medications for applications that

>> haven't been approved by U.S. regulators. While such use is legal,

>> promotion of drugs for off-label use isn't.

>>

>> Pfizer's Warner-Lambert unit in May agreed to pay more than $430 million

> to

>> settle U.S. charges that it promoted its Neurontin epilepsy drug for

>> unapproved uses.

>>

>> Pfizer spokesman Fitzhenry said he couldn't provide additional

> comment

>> beyond the filing. Shares of Pfizer declined 27 cents to $28.79 as of

> 4:17

>> p.m. in New York Stock Exchange composite trading. They have fallen 19

>> percent this year. Pfizer also said it has given the Justice Department

> and

>> the U.S. Securities and Exchange Commission information related to an

>> internal investigation the company is conducting in Croatia. The inquiry

>> involves ``certain potentially improper payments made in connection with

>> foreign sales activities in Croatia,'' Pfizer said in the filing.

>>

>> Fitzhenry said he couldn't provide further details. The U.S. Attorney's

>> office for the District of land told Pfizer in an Oct. 13 letter

>> that

>> it has closed its investigation related to sales of the Rezulin diabetes

>> drug, according to the filing. Pfizer acquired Rezulin when it bought

>> Warner-Lambert

>> in 2000. Rezulin has been the subject of personal-injury lawsuits,

> claiming

>> the drug damaged some patients' livers. The drug was taken off the

>> market

>> in 2000. Pfizer in last year's fourth quarter had $955 million in costs

> as

>> it set aside money to resolve claims over Rezulin.

>>

>> --With reporting by Decker in Washington.

>> Editors: Simison, Todd.

>>

>>

>> FAIR USE NOTICE:

>> This may contain copyrighted (© ) material the use of which has not

>> always

>> been specifically authorized by the copyright owner. Such material is

> made

>> available for educational purposes, to advance understanding of human

>> rights, democracy, scientific, moral, ethical, and social justice issues,

>> etc. It is believed that this constitutes a 'fair use' of any such

>> copyrighted material as provided for in Title 17 U.S.C. section 107 of

>> the

>> US Copyright Law. This material is distributed without profit.

>>

>>

>>

>>

>>

>>

>>

[Guest guest]

Don't forget that AIDS activist groups and advocates for other catastrophic

diseases pushed hard for easing the approval proces, with the rationale that

people were dying due to the sluggish approval system which took years for

life-saving drugs to get to market. Leave it to pharma to apply that to all

drugs in the approval pipeline, as well as expanding the definition of

'life-saving.' I'm sure they would argue that any ssri is a 'life-saving'

drug. All of the good things that were intended by deregulating the

approval process had unintended applications, and pharma was sure to twist

it to thier advantage.

>From: " cateh " <ccsh@...>

>Reply-SSRI medications

><SSRI medications >

>Subject: Re: Serious Flaw in FDA's Complex Regulatory

>Structure

>Date: Tue, 9 Nov 2004 21:53:33 -0500

>

[Guest guest]

Don't forget that AIDS activist groups and advocates for other catastrophic

diseases pushed hard for easing the approval proces, with the rationale that

people were dying due to the sluggish approval system which took years for

life-saving drugs to get to market. Leave it to pharma to apply that to all

drugs in the approval pipeline, as well as expanding the definition of

'life-saving.' I'm sure they would argue that any ssri is a 'life-saving'

drug. All of the good things that were intended by deregulating the

approval process had unintended applications, and pharma was sure to twist

it to thier advantage.

>From: " cateh " <ccsh@...>

>Reply-SSRI medications

><SSRI medications >

>Subject: Re: Serious Flaw in FDA's Complex Regulatory

>Structure

>Date: Tue, 9 Nov 2004 21:53:33 -0500

>

[Guest guest]

Good point! This is where 'regulation' falls short because you can't

really rely on protocol because ultimately there will be shortcomings

to the protocol either way; by making drug approval easier and by

making it more difficult. If it's any consolation, I think that many

people across many different sectors of society are facing these

kinds of dilemmas. I don't know what the solution is.

> Don't forget that AIDS activist groups and advocates for other

catastrophic

> diseases pushed hard for easing the approval proces, with the

rationale that

> people were dying due to the sluggish approval system which took

years for

> life-saving drugs to get to market. Leave it to pharma to apply

that to all

> drugs in the approval pipeline, as well as expanding the definition

of

> 'life-saving.' I'm sure they would argue that any ssri is a 'life-

saving'

> drug. All of the good things that were intended by deregulating

the

> approval process had unintended applications, and pharma was sure

to twist

> it to thier advantage.

>

> >From: " cateh " <ccsh@e...>

> >Reply-SSRI medications

> ><SSRI medications >

> >Subject: Re: Serious Flaw in FDA's Complex

Regulatory

> >Structure

> >Date: Tue, 9 Nov 2004 21:53:33 -0500

> >

>

>

>

>