Jennifer
Tierney |
February 13, 2004 |
|
|
|
| Peter
J. Pitts Associate
Commissioner for External Relations Office
of the Commissioner
Phone:
301-827-3330 Email: Peter.Pitts@fda.gov |
Scott
Gottlieb, M.D |
| Theresa
Toigo |
JoAnn
Minor, M.S. Email: jminor@oc.fda.gov |
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
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.
Paul 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
Y from the drug company itself Y [and] I would like to see other data that would support
that.” Another panelist stated that
“[w]e agree the data are not great quality data.” Dr. Claghorn stated that allegations of Prozac
suicidality “may be quite valid.”
[1]
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.
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. Paul
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. John 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 GlaxoSmithKline 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
Finally,
as mentioned above, two members of the ACNP task force were members of the
FDA advisory committee on February 2 (Andrew C. Leon and Neil D. Ryan). 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.
Frankly, 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.
David 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,
Jennifer
Tierney
cc:
February 2, 2004 PDAC panel members
February
2, 2004 PDAC open public hearing speakers
Members
of Congress
Media
Jame`
Tierney
Kim
Witczak
Eric
Swan
Dawn
Rider (ASPIRE)
Cynthia
Brockman
Mark
Taylor
Donna
Taylor
Steven
Cole
Dr.
David Healy
Dr.
Joseph Glenmullen
Vera
Sharav (Alliance for Human Research Protection)
Richard
Brook (MIND)
Andy
Bell (BBC)
Baum
Hedlund
[1] The Beasley analysis was criticized as well. For instance, one scientist wrote to the editor of the British Medical Journal that Beasley=s meta-analysis “is bedecked with impressive seeming, eponymous statistics, but it makes no sense to present probability values to three decimal places, nor confidence intervals, when comparing one patient with three patients. What was needed was a critical assessment, independent of the manufacturers, that included assessment of the quality of data collection B and not Eli Lilly=s employees deciding which clinical comments should be ‘eliminated.’” In another criticism of the analysis, a Pfizer physician called the conclusions of the Beasley paper “invalid.”