A Mother's Letter to FDA Officials

[Guest guest]

Tierney

jmt56@...

February 13, 2004

J. Pitts

Associate Commissioner for External Relations

Office of the Commissioner

Phone: 301-827-3330

Fax: 301-827-3052

Email: .Pitts@...

Gottlieb, M.D.

Senior Advisor for Medical Technology

Office of the Commissioner

Phone: 301-827-5259

Voicemail: 888-991-7667

Email: scott.gottlieb@...

Theresa Toigo

Office of Special Health Issues - Director

Phone: 301-827-4460

Fax: 301-443-4555

Email: ttoigo@...

JoAnn Minor, M.S.

Cancer Liaison Progam

Phone: 301-827-4460

Fax: 301-443-4555

Email: jminor@...

Department of Health and Human Services

Food and Drug Administration

600 Fishers Lane

Rockville, MD. 20857

Dear Mr. Pitts, Mr. Gottleib, Ms. Toigo, and Ms. Minor:

I would like to thank you for meeting with me and the other families who

have had negative and tragic experiences with the SSRI class of

antidepressants on Tuesday, February 3, 2004. As I mentioned during our

meeting, we felt the advisory panel listened to our concerns during the

February 2 hearing, but that individuals from the FDA (Drs. Temple, Katz,

and Laughren) did not. In fact, at every turn, they appeared to come to the

defense of the drugs and the companies that produce them.

Unfortunately, our concerns were amplified by the meeting on Tuesday. While

we felt the recipients of this letter were attentive to our concerns, Dr.

Temple’s comments and demeanor during the meeting left us feeling extremely

doubtful.

We are also concerned with the FDA’s refusal to allow Dr. Mosholder to

present his full analysis and conclusions, which reportedly were consistent

with the MHRA’s findings. Following our meeting, Mr. Pitts explained to me

that Dr. Mosholder was not permitted to do so

because he had reached a conclusion and therefore would not be unbiased. We

find this incredible given that Drs. Leon and Neil were FDA

appointed voting members of the February 2, 2004 advisory panel. Did not

Drs. Leon and , as part of the American College of

Neuropsychopharmacology (ACNP) task force, reach a conclusion when the ACNP

reported, just two weeks prior to the advisory committee meeting, that these

drugs are safe and effective in treating children?

It became clear to us during the meeting on Tuesday that, because the FDA (I

believe Drs. Temple and Laughren, in particular) failed to require SSRI

manufacturers to conduct further research following the 1991 PDAC, millions

of people have been placed at risk and God only knows how many people have

died as a result.

Some of us with knowledge of the history of these issues were shocked to

hear Dr. Temple state that the FDA did not pursue the risk of SSRIs in

relation to suicide following the September 20, 1991 PDAC because, according

to Dr. Temple, the “Beasley meta-analysis” put it to rest. This is

demonstrably false.

As a preliminary matter, the Beasley meta-analysis was published on

September 21, 1991, the day following the 1991 PDAC. During the 1991 PDAC,

the FDA stated that it did “not dismiss the possibility that antidepressants

in general or [Prozac] in particular may have the capacity to cause untoward

injurious behaviors and acts, and/or to intensify them,” but that Amore

research is needed.” Indeed, nine months later (in June 1992), the FDA told

Public Citizen that “these reports suggest a need for further study and

observation” and “there was a consensus [amongst members of the 1991 PDAC]

that more research is needed to further explore the relationship between

suicidality and the use of, not only Prozac, but other antidepressants as

well.”

Dr. Leber also pointed out during the 1991 PDAC, that Lilly “was asked

to develop plans to conduct new studies, including clinical trials and

epidemiological studies, studies that could provide more direct answers to

the questions that have been raised in the open session earlier.”

Moreover, several members of the 1991 PDAC complained about the scientific

unreliability of the data that was available and presented at that time.

For instance, the chairperson, Dr. Casey, stated that “I don’t feel I have

all the data.” Dr. Schooler stated: “I felt we were working with half a deck

of cards in terms of data.” Dr. Hellender expressed concern that the “large

data base we have looked at have been from the drug company itself and I

would like to see other data that would support that.” Another panelist

stated that “we agree the data are not great quality data.” Dr. Claghorn

stated that allegations of Prozac suicidality “may be quite valid.”

In summary, the conclusions of the committee were only as valid as the data

presented, which the panel criticized as “not great quality.”

Notwithstanding the significant concerns raised by the 1991 PDAC panel

members, further studies designed to address the suicide question were never

conducted by any SSRI producing company and the FDA never followed through

to make sure this happened. This is despite the fact that Lilly, in

conjunction with the FDA, discussed ways to study the issue further and even

devised a much more sensitive suicide scale that could and should have been

used to detect emergent suicidality in all future antidepressant clinical

trials. Ironically, Dr. Laughren, in his overview memo for the February 2

PDAC meeting stated: “One might reasonably ask why [there is a concern that

studies are not conducted in a manner to fully and adequately assess

patients for emergent suicidality] since, . . . signals for drug associated

suicidality did emerge. . ,” concluding that “it would have been preferable

to have included adequate ascertainment in the first place.”

Why was this not done in light of what transpired in 1991? We consider this

a grotesque failure on the part of both the drug companies and the FDA to

protect the public health. Even today, as the February 2, 2004, PDAC panel

members pointed out on Monday, the Columbia group’s re-analysis of the

existing trial data is unlikely to answer the questions about SSRI emergent

suicidality due to the poor quality of the data. In fact, one panel member

stated that it would be “an exercise in futility.” This is particularly

true if you take into consideration the drugs’ lack of efficacy. Indeed,

efficacy in relation to these drugs has been an issue for many years, even

in the adult population. Dr. Leber (formerly of the FDA) predicted

that the FDA would “come under attack” because it is “not as demanding as it

ought to be in regard to its standards for establishing the efficacy of

antidepressant drug products.”

We would also like to express our uneasiness about the Columbia University

connection to the re-analysis of the existing data and our understanding

that Dr. Mann will be involved in the process. Dr. Mann has

significant financial ties to the companies whose drugs are under scrutiny.

Dr. Mann has also been a defense expert witness for Pfizer and

GlaxoKline in litigation related to SSRIs on this very issue. He is

consistently relied upon by the companies as a spokesperson to counter the

claims that SSRIs cause suicide. Moreover, Mann was the co-chair

on the review conducted by the American College of Neuropsychopharmacology

(ACNP) which concluded (while admitting it did not possess all the data)

that the SSRIs are effective in treating children and do not pose a risk of

increased suicidality. (Nine out of ten of the ACNP “task force” members

have financial ties to the pharmaceutical companies in question and some of

the ACNP task force members were defending their own studies which found the

drugs safe and effective in children.)

Finally, as mentioned above, two members of the ACNP task force were members

of the FDA advisory committee on February 2 ( C. Leon and Neil D.

). This is very troubling to us. If members of this “task force” can

rush to make such bold conclusions knowing full well they do not have access

to all the data, how can they be expected to keep an open mind?

In conclusion, we believe there are those within the FDA who truly care

about our welfare, but something is awfully wrong here. ly, we have

little confidence in the current regime (Temple, Katz and Laughren) and do

not believe they have the necessary objectivity to oversee this process,

after all, it was their failure to ensure further research was conducted

that has placed millions of people at risk and potentially killed tens of

thousands of people, including children. How can you expect them to

objectively adjudicate a matter for which they are, in part, culpable? This

inherent conflict necessitates that these persons be removed from any

involvement in these proceedings if a truly objective determination is

desired.

Dr. Healy has advised me that he will be submitting the data Dr.

Temple requested in the next two to three weeks.

Again, thank you for meeting with us. We appreciate your attention to this

matter.

Sincerely,

Tierney

cc: February 2, 2004 PDAC panel members

February 2, 2004 PDAC open public hearing speakers

Members of Congress

Media

Jame` Tierney

Kim Witzack

Swan

Dawn Rider (ASPIRE)

Brockman

Mark

Donna

Cole

Dr. Healy

Dr. ph Glenmullen

Vera Sharav (Alliance for Human Research Protection)

Brook (MIND)

Andy Bell (BBC)

Baum Hedlund

_________________________________________________________________

Click, drag and drop. My MSN is the simple way to design your homepage.

http://click.atdmt.com/AVE/go/onm00200364ave/direct/01/

[Guest guest]

Tierney

jmt56@...

February 13, 2004

J. Pitts

Associate Commissioner for External Relations

Office of the Commissioner

Phone: 301-827-3330

Fax: 301-827-3052

Email: .Pitts@...

Gottlieb, M.D.

Senior Advisor for Medical Technology

Office of the Commissioner

Phone: 301-827-5259

Voicemail: 888-991-7667

Email: scott.gottlieb@...

Theresa Toigo

Office of Special Health Issues - Director

Phone: 301-827-4460

Fax: 301-443-4555

Email: ttoigo@...

JoAnn Minor, M.S.

Cancer Liaison Progam

Phone: 301-827-4460

Fax: 301-443-4555

Email: jminor@...

Department of Health and Human Services

Food and Drug Administration

600 Fishers Lane

Rockville, MD. 20857

Dear Mr. Pitts, Mr. Gottleib, Ms. Toigo, and Ms. Minor:

I would like to thank you for meeting with me and the other families who

have had negative and tragic experiences with the SSRI class of

antidepressants on Tuesday, February 3, 2004. As I mentioned during our

meeting, we felt the advisory panel listened to our concerns during the

February 2 hearing, but that individuals from the FDA (Drs. Temple, Katz,

and Laughren) did not. In fact, at every turn, they appeared to come to the

defense of the drugs and the companies that produce them.

Unfortunately, our concerns were amplified by the meeting on Tuesday. While

we felt the recipients of this letter were attentive to our concerns, Dr.

Temple’s comments and demeanor during the meeting left us feeling extremely

doubtful.

We are also concerned with the FDA’s refusal to allow Dr. Mosholder to

present his full analysis and conclusions, which reportedly were consistent

with the MHRA’s findings. Following our meeting, Mr. Pitts explained to me

that Dr. Mosholder was not permitted to do so

because he had reached a conclusion and therefore would not be unbiased. We

find this incredible given that Drs. Leon and Neil were FDA

appointed voting members of the February 2, 2004 advisory panel. Did not

Drs. Leon and , as part of the American College of

Neuropsychopharmacology (ACNP) task force, reach a conclusion when the ACNP

reported, just two weeks prior to the advisory committee meeting, that these

drugs are safe and effective in treating children?

It became clear to us during the meeting on Tuesday that, because the FDA (I

believe Drs. Temple and Laughren, in particular) failed to require SSRI

manufacturers to conduct further research following the 1991 PDAC, millions

of people have been placed at risk and God only knows how many people have

died as a result.

Some of us with knowledge of the history of these issues were shocked to

hear Dr. Temple state that the FDA did not pursue the risk of SSRIs in

relation to suicide following the September 20, 1991 PDAC because, according

to Dr. Temple, the “Beasley meta-analysis” put it to rest. This is

demonstrably false.

As a preliminary matter, the Beasley meta-analysis was published on

September 21, 1991, the day following the 1991 PDAC. During the 1991 PDAC,

the FDA stated that it did “not dismiss the possibility that antidepressants

in general or [Prozac] in particular may have the capacity to cause untoward

injurious behaviors and acts, and/or to intensify them,” but that Amore

research is needed.” Indeed, nine months later (in June 1992), the FDA told

Public Citizen that “these reports suggest a need for further study and

observation” and “there was a consensus [amongst members of the 1991 PDAC]

that more research is needed to further explore the relationship between

suicidality and the use of, not only Prozac, but other antidepressants as

well.”

Dr. Leber also pointed out during the 1991 PDAC, that Lilly “was asked

to develop plans to conduct new studies, including clinical trials and

epidemiological studies, studies that could provide more direct answers to

the questions that have been raised in the open session earlier.”

Moreover, several members of the 1991 PDAC complained about the scientific

unreliability of the data that was available and presented at that time.

For instance, the chairperson, Dr. Casey, stated that “I don’t feel I have

all the data.” Dr. Schooler stated: “I felt we were working with half a deck

of cards in terms of data.” Dr. Hellender expressed concern that the “large

data base we have looked at have been from the drug company itself and I

would like to see other data that would support that.” Another panelist

stated that “we agree the data are not great quality data.” Dr. Claghorn

stated that allegations of Prozac suicidality “may be quite valid.”

In summary, the conclusions of the committee were only as valid as the data

presented, which the panel criticized as “not great quality.”

Notwithstanding the significant concerns raised by the 1991 PDAC panel

members, further studies designed to address the suicide question were never

conducted by any SSRI producing company and the FDA never followed through

to make sure this happened. This is despite the fact that Lilly, in

conjunction with the FDA, discussed ways to study the issue further and even

devised a much more sensitive suicide scale that could and should have been

used to detect emergent suicidality in all future antidepressant clinical

trials. Ironically, Dr. Laughren, in his overview memo for the February 2

PDAC meeting stated: “One might reasonably ask why [there is a concern that

studies are not conducted in a manner to fully and adequately assess

patients for emergent suicidality] since, . . . signals for drug associated

suicidality did emerge. . ,” concluding that “it would have been preferable

to have included adequate ascertainment in the first place.”

Why was this not done in light of what transpired in 1991? We consider this

a grotesque failure on the part of both the drug companies and the FDA to

protect the public health. Even today, as the February 2, 2004, PDAC panel

members pointed out on Monday, the Columbia group’s re-analysis of the

existing trial data is unlikely to answer the questions about SSRI emergent

suicidality due to the poor quality of the data. In fact, one panel member

stated that it would be “an exercise in futility.” This is particularly

true if you take into consideration the drugs’ lack of efficacy. Indeed,

efficacy in relation to these drugs has been an issue for many years, even

in the adult population. Dr. Leber (formerly of the FDA) predicted

that the FDA would “come under attack” because it is “not as demanding as it

ought to be in regard to its standards for establishing the efficacy of

antidepressant drug products.”

We would also like to express our uneasiness about the Columbia University

connection to the re-analysis of the existing data and our understanding

that Dr. Mann will be involved in the process. Dr. Mann has

significant financial ties to the companies whose drugs are under scrutiny.

Dr. Mann has also been a defense expert witness for Pfizer and

GlaxoKline in litigation related to SSRIs on this very issue. He is

consistently relied upon by the companies as a spokesperson to counter the

claims that SSRIs cause suicide. Moreover, Mann was the co-chair

on the review conducted by the American College of Neuropsychopharmacology

(ACNP) which concluded (while admitting it did not possess all the data)

that the SSRIs are effective in treating children and do not pose a risk of

increased suicidality. (Nine out of ten of the ACNP “task force” members

have financial ties to the pharmaceutical companies in question and some of

the ACNP task force members were defending their own studies which found the

drugs safe and effective in children.)

Finally, as mentioned above, two members of the ACNP task force were members

of the FDA advisory committee on February 2 ( C. Leon and Neil D.

). This is very troubling to us. If members of this “task force” can

rush to make such bold conclusions knowing full well they do not have access

to all the data, how can they be expected to keep an open mind?

In conclusion, we believe there are those within the FDA who truly care

about our welfare, but something is awfully wrong here. ly, we have

little confidence in the current regime (Temple, Katz and Laughren) and do

not believe they have the necessary objectivity to oversee this process,

after all, it was their failure to ensure further research was conducted

that has placed millions of people at risk and potentially killed tens of

thousands of people, including children. How can you expect them to

objectively adjudicate a matter for which they are, in part, culpable? This

inherent conflict necessitates that these persons be removed from any

involvement in these proceedings if a truly objective determination is

desired.

Dr. Healy has advised me that he will be submitting the data Dr.

Temple requested in the next two to three weeks.

Again, thank you for meeting with us. We appreciate your attention to this

matter.

Sincerely,

Tierney

cc: February 2, 2004 PDAC panel members

February 2, 2004 PDAC open public hearing speakers

Members of Congress

Media

Jame` Tierney

Kim Witzack

Swan

Dawn Rider (ASPIRE)

Brockman

Mark

Donna

Cole

Dr. Healy

Dr. ph Glenmullen

Vera Sharav (Alliance for Human Research Protection)

Brook (MIND)

Andy Bell (BBC)

Baum Hedlund

_________________________________________________________________

Click, drag and drop. My MSN is the simple way to design your homepage.

http://click.atdmt.com/AVE/go/onm00200364ave/direct/01/

[Guest guest]

Tierney

jmt56@...

February 13, 2004

J. Pitts

Associate Commissioner for External Relations

Office of the Commissioner

Phone: 301-827-3330

Fax: 301-827-3052

Email: .Pitts@...

Gottlieb, M.D.

Senior Advisor for Medical Technology

Office of the Commissioner

Phone: 301-827-5259

Voicemail: 888-991-7667

Email: scott.gottlieb@...

Theresa Toigo

Office of Special Health Issues - Director

Phone: 301-827-4460

Fax: 301-443-4555

Email: ttoigo@...

JoAnn Minor, M.S.

Cancer Liaison Progam

Phone: 301-827-4460

Fax: 301-443-4555

Email: jminor@...

Department of Health and Human Services

Food and Drug Administration

600 Fishers Lane

Rockville, MD. 20857

Dear Mr. Pitts, Mr. Gottleib, Ms. Toigo, and Ms. Minor:

I would like to thank you for meeting with me and the other families who

have had negative and tragic experiences with the SSRI class of

antidepressants on Tuesday, February 3, 2004. As I mentioned during our

meeting, we felt the advisory panel listened to our concerns during the

February 2 hearing, but that individuals from the FDA (Drs. Temple, Katz,

and Laughren) did not. In fact, at every turn, they appeared to come to the

defense of the drugs and the companies that produce them.

Unfortunately, our concerns were amplified by the meeting on Tuesday. While

we felt the recipients of this letter were attentive to our concerns, Dr.

Temple’s comments and demeanor during the meeting left us feeling extremely

doubtful.

We are also concerned with the FDA’s refusal to allow Dr. Mosholder to

present his full analysis and conclusions, which reportedly were consistent

with the MHRA’s findings. Following our meeting, Mr. Pitts explained to me

that Dr. Mosholder was not permitted to do so

because he had reached a conclusion and therefore would not be unbiased. We

find this incredible given that Drs. Leon and Neil were FDA

appointed voting members of the February 2, 2004 advisory panel. Did not

Drs. Leon and , as part of the American College of

Neuropsychopharmacology (ACNP) task force, reach a conclusion when the ACNP

reported, just two weeks prior to the advisory committee meeting, that these

drugs are safe and effective in treating children?

It became clear to us during the meeting on Tuesday that, because the FDA (I

believe Drs. Temple and Laughren, in particular) failed to require SSRI

manufacturers to conduct further research following the 1991 PDAC, millions

of people have been placed at risk and God only knows how many people have

died as a result.

Some of us with knowledge of the history of these issues were shocked to

hear Dr. Temple state that the FDA did not pursue the risk of SSRIs in

relation to suicide following the September 20, 1991 PDAC because, according

to Dr. Temple, the “Beasley meta-analysis” put it to rest. This is

demonstrably false.

As a preliminary matter, the Beasley meta-analysis was published on

September 21, 1991, the day following the 1991 PDAC. During the 1991 PDAC,

the FDA stated that it did “not dismiss the possibility that antidepressants

in general or [Prozac] in particular may have the capacity to cause untoward

injurious behaviors and acts, and/or to intensify them,” but that Amore

research is needed.” Indeed, nine months later (in June 1992), the FDA told

Public Citizen that “these reports suggest a need for further study and

observation” and “there was a consensus [amongst members of the 1991 PDAC]

that more research is needed to further explore the relationship between

suicidality and the use of, not only Prozac, but other antidepressants as

well.”

Dr. Leber also pointed out during the 1991 PDAC, that Lilly “was asked

to develop plans to conduct new studies, including clinical trials and

epidemiological studies, studies that could provide more direct answers to

the questions that have been raised in the open session earlier.”

Moreover, several members of the 1991 PDAC complained about the scientific

unreliability of the data that was available and presented at that time.

For instance, the chairperson, Dr. Casey, stated that “I don’t feel I have

all the data.” Dr. Schooler stated: “I felt we were working with half a deck

of cards in terms of data.” Dr. Hellender expressed concern that the “large

data base we have looked at have been from the drug company itself and I

would like to see other data that would support that.” Another panelist

stated that “we agree the data are not great quality data.” Dr. Claghorn

stated that allegations of Prozac suicidality “may be quite valid.”

In summary, the conclusions of the committee were only as valid as the data

presented, which the panel criticized as “not great quality.”

Notwithstanding the significant concerns raised by the 1991 PDAC panel

members, further studies designed to address the suicide question were never

conducted by any SSRI producing company and the FDA never followed through

to make sure this happened. This is despite the fact that Lilly, in

conjunction with the FDA, discussed ways to study the issue further and even

devised a much more sensitive suicide scale that could and should have been

used to detect emergent suicidality in all future antidepressant clinical

trials. Ironically, Dr. Laughren, in his overview memo for the February 2

PDAC meeting stated: “One might reasonably ask why [there is a concern that

studies are not conducted in a manner to fully and adequately assess

patients for emergent suicidality] since, . . . signals for drug associated

suicidality did emerge. . ,” concluding that “it would have been preferable

to have included adequate ascertainment in the first place.”

Why was this not done in light of what transpired in 1991? We consider this

a grotesque failure on the part of both the drug companies and the FDA to

protect the public health. Even today, as the February 2, 2004, PDAC panel

members pointed out on Monday, the Columbia group’s re-analysis of the

existing trial data is unlikely to answer the questions about SSRI emergent

suicidality due to the poor quality of the data. In fact, one panel member

stated that it would be “an exercise in futility.” This is particularly

true if you take into consideration the drugs’ lack of efficacy. Indeed,

efficacy in relation to these drugs has been an issue for many years, even

in the adult population. Dr. Leber (formerly of the FDA) predicted

that the FDA would “come under attack” because it is “not as demanding as it

ought to be in regard to its standards for establishing the efficacy of

antidepressant drug products.”

We would also like to express our uneasiness about the Columbia University

connection to the re-analysis of the existing data and our understanding

that Dr. Mann will be involved in the process. Dr. Mann has

significant financial ties to the companies whose drugs are under scrutiny.

Dr. Mann has also been a defense expert witness for Pfizer and

GlaxoKline in litigation related to SSRIs on this very issue. He is

consistently relied upon by the companies as a spokesperson to counter the

claims that SSRIs cause suicide. Moreover, Mann was the co-chair

on the review conducted by the American College of Neuropsychopharmacology

(ACNP) which concluded (while admitting it did not possess all the data)

that the SSRIs are effective in treating children and do not pose a risk of

increased suicidality. (Nine out of ten of the ACNP “task force” members

have financial ties to the pharmaceutical companies in question and some of

the ACNP task force members were defending their own studies which found the

drugs safe and effective in children.)

Finally, as mentioned above, two members of the ACNP task force were members

of the FDA advisory committee on February 2 ( C. Leon and Neil D.

). This is very troubling to us. If members of this “task force” can

rush to make such bold conclusions knowing full well they do not have access

to all the data, how can they be expected to keep an open mind?

In conclusion, we believe there are those within the FDA who truly care

about our welfare, but something is awfully wrong here. ly, we have

little confidence in the current regime (Temple, Katz and Laughren) and do

not believe they have the necessary objectivity to oversee this process,

after all, it was their failure to ensure further research was conducted

that has placed millions of people at risk and potentially killed tens of

thousands of people, including children. How can you expect them to

objectively adjudicate a matter for which they are, in part, culpable? This

inherent conflict necessitates that these persons be removed from any

involvement in these proceedings if a truly objective determination is

desired.

Dr. Healy has advised me that he will be submitting the data Dr.

Temple requested in the next two to three weeks.

Again, thank you for meeting with us. We appreciate your attention to this

matter.

Sincerely,

Tierney

cc: February 2, 2004 PDAC panel members

February 2, 2004 PDAC open public hearing speakers

Members of Congress

Media

Jame` Tierney

Kim Witzack

Swan

Dawn Rider (ASPIRE)

Brockman

Mark

Donna

Cole

Dr. Healy

Dr. ph Glenmullen

Vera Sharav (Alliance for Human Research Protection)

Brook (MIND)

Andy Bell (BBC)

Baum Hedlund

_________________________________________________________________

Click, drag and drop. My MSN is the simple way to design your homepage.

http://click.atdmt.com/AVE/go/onm00200364ave/direct/01/

[Guest guest]

Tierney

jmt56@...

February 13, 2004

J. Pitts

Associate Commissioner for External Relations

Office of the Commissioner

Phone: 301-827-3330

Fax: 301-827-3052

Email: .Pitts@...

Gottlieb, M.D.

Senior Advisor for Medical Technology

Office of the Commissioner

Phone: 301-827-5259

Voicemail: 888-991-7667

Email: scott.gottlieb@...

Theresa Toigo

Office of Special Health Issues - Director

Phone: 301-827-4460

Fax: 301-443-4555

Email: ttoigo@...

JoAnn Minor, M.S.

Cancer Liaison Progam

Phone: 301-827-4460

Fax: 301-443-4555

Email: jminor@...

Department of Health and Human Services

Food and Drug Administration

600 Fishers Lane

Rockville, MD. 20857

Dear Mr. Pitts, Mr. Gottleib, Ms. Toigo, and Ms. Minor:

I would like to thank you for meeting with me and the other families who

have had negative and tragic experiences with the SSRI class of

antidepressants on Tuesday, February 3, 2004. As I mentioned during our

meeting, we felt the advisory panel listened to our concerns during the

February 2 hearing, but that individuals from the FDA (Drs. Temple, Katz,

and Laughren) did not. In fact, at every turn, they appeared to come to the

defense of the drugs and the companies that produce them.

Unfortunately, our concerns were amplified by the meeting on Tuesday. While

we felt the recipients of this letter were attentive to our concerns, Dr.

Temple’s comments and demeanor during the meeting left us feeling extremely

doubtful.

We are also concerned with the FDA’s refusal to allow Dr. Mosholder to

present his full analysis and conclusions, which reportedly were consistent

with the MHRA’s findings. Following our meeting, Mr. Pitts explained to me

that Dr. Mosholder was not permitted to do so

because he had reached a conclusion and therefore would not be unbiased. We

find this incredible given that Drs. Leon and Neil were FDA

appointed voting members of the February 2, 2004 advisory panel. Did not

Drs. Leon and , as part of the American College of

Neuropsychopharmacology (ACNP) task force, reach a conclusion when the ACNP

reported, just two weeks prior to the advisory committee meeting, that these

drugs are safe and effective in treating children?

It became clear to us during the meeting on Tuesday that, because the FDA (I

believe Drs. Temple and Laughren, in particular) failed to require SSRI

manufacturers to conduct further research following the 1991 PDAC, millions

of people have been placed at risk and God only knows how many people have

died as a result.

Some of us with knowledge of the history of these issues were shocked to

hear Dr. Temple state that the FDA did not pursue the risk of SSRIs in

relation to suicide following the September 20, 1991 PDAC because, according

to Dr. Temple, the “Beasley meta-analysis” put it to rest. This is

demonstrably false.

As a preliminary matter, the Beasley meta-analysis was published on

September 21, 1991, the day following the 1991 PDAC. During the 1991 PDAC,

the FDA stated that it did “not dismiss the possibility that antidepressants

in general or [Prozac] in particular may have the capacity to cause untoward

injurious behaviors and acts, and/or to intensify them,” but that Amore

research is needed.” Indeed, nine months later (in June 1992), the FDA told

Public Citizen that “these reports suggest a need for further study and

observation” and “there was a consensus [amongst members of the 1991 PDAC]

that more research is needed to further explore the relationship between

suicidality and the use of, not only Prozac, but other antidepressants as

well.”

Dr. Leber also pointed out during the 1991 PDAC, that Lilly “was asked

to develop plans to conduct new studies, including clinical trials and

epidemiological studies, studies that could provide more direct answers to

the questions that have been raised in the open session earlier.”

Moreover, several members of the 1991 PDAC complained about the scientific

unreliability of the data that was available and presented at that time.

For instance, the chairperson, Dr. Casey, stated that “I don’t feel I have

all the data.” Dr. Schooler stated: “I felt we were working with half a deck

of cards in terms of data.” Dr. Hellender expressed concern that the “large

data base we have looked at have been from the drug company itself and I

would like to see other data that would support that.” Another panelist

stated that “we agree the data are not great quality data.” Dr. Claghorn

stated that allegations of Prozac suicidality “may be quite valid.”

In summary, the conclusions of the committee were only as valid as the data

presented, which the panel criticized as “not great quality.”

Notwithstanding the significant concerns raised by the 1991 PDAC panel

members, further studies designed to address the suicide question were never

conducted by any SSRI producing company and the FDA never followed through

to make sure this happened. This is despite the fact that Lilly, in

conjunction with the FDA, discussed ways to study the issue further and even

devised a much more sensitive suicide scale that could and should have been

used to detect emergent suicidality in all future antidepressant clinical

trials. Ironically, Dr. Laughren, in his overview memo for the February 2

PDAC meeting stated: “One might reasonably ask why [there is a concern that

studies are not conducted in a manner to fully and adequately assess

patients for emergent suicidality] since, . . . signals for drug associated

suicidality did emerge. . ,” concluding that “it would have been preferable

to have included adequate ascertainment in the first place.”

Why was this not done in light of what transpired in 1991? We consider this

a grotesque failure on the part of both the drug companies and the FDA to

protect the public health. Even today, as the February 2, 2004, PDAC panel

members pointed out on Monday, the Columbia group’s re-analysis of the

existing trial data is unlikely to answer the questions about SSRI emergent

suicidality due to the poor quality of the data. In fact, one panel member

stated that it would be “an exercise in futility.” This is particularly

true if you take into consideration the drugs’ lack of efficacy. Indeed,

efficacy in relation to these drugs has been an issue for many years, even

in the adult population. Dr. Leber (formerly of the FDA) predicted

that the FDA would “come under attack” because it is “not as demanding as it

ought to be in regard to its standards for establishing the efficacy of

antidepressant drug products.”

We would also like to express our uneasiness about the Columbia University

connection to the re-analysis of the existing data and our understanding

that Dr. Mann will be involved in the process. Dr. Mann has

significant financial ties to the companies whose drugs are under scrutiny.

Dr. Mann has also been a defense expert witness for Pfizer and

GlaxoKline in litigation related to SSRIs on this very issue. He is

consistently relied upon by the companies as a spokesperson to counter the

claims that SSRIs cause suicide. Moreover, Mann was the co-chair

on the review conducted by the American College of Neuropsychopharmacology

(ACNP) which concluded (while admitting it did not possess all the data)

that the SSRIs are effective in treating children and do not pose a risk of

increased suicidality. (Nine out of ten of the ACNP “task force” members

have financial ties to the pharmaceutical companies in question and some of

the ACNP task force members were defending their own studies which found the

drugs safe and effective in children.)

Finally, as mentioned above, two members of the ACNP task force were members

of the FDA advisory committee on February 2 ( C. Leon and Neil D.

). This is very troubling to us. If members of this “task force” can

rush to make such bold conclusions knowing full well they do not have access

to all the data, how can they be expected to keep an open mind?

In conclusion, we believe there are those within the FDA who truly care

about our welfare, but something is awfully wrong here. ly, we have

little confidence in the current regime (Temple, Katz and Laughren) and do

not believe they have the necessary objectivity to oversee this process,

after all, it was their failure to ensure further research was conducted

that has placed millions of people at risk and potentially killed tens of

thousands of people, including children. How can you expect them to

objectively adjudicate a matter for which they are, in part, culpable? This

inherent conflict necessitates that these persons be removed from any

involvement in these proceedings if a truly objective determination is

desired.

Dr. Healy has advised me that he will be submitting the data Dr.

Temple requested in the next two to three weeks.

Again, thank you for meeting with us. We appreciate your attention to this

matter.

Sincerely,

Tierney

cc: February 2, 2004 PDAC panel members

February 2, 2004 PDAC open public hearing speakers

Members of Congress

Media

Jame` Tierney

Kim Witzack

Swan

Dawn Rider (ASPIRE)

Brockman

Mark

Donna

Cole

Dr. Healy

Dr. ph Glenmullen

Vera Sharav (Alliance for Human Research Protection)

Brook (MIND)

Andy Bell (BBC)

Baum Hedlund

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