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Second, it is Violently Opposed... Third, it is Accepted as being Self-Evident." - Arthur Schopenhauer (1778-1860)
By Jennifer Tierney
Feb 13, 2004
Concerned about Objectivity of FDA Panel Members Six members of the FDA Advisory Committee panel members have (financial) ties to the pharmaceutical industry February, 13 2004 To: Peter J. Pitts, Associate Commissioner for External Relations, Office of the Commissioner, Phone: 301-827-3330, Fax: 301-827-3052 To: Scott Gottlieb, M.D., Senior Advisor for Medical Technology, Office of the Commissioner, Phone: 301-827-5259, Voicemail: 888-991-7667 To: Theresa Toigo, Office of Special Health Issues - Director, Phone: 301-827-4460, Fax: 301-443-4555 To: JoAnn Minor, M.S., Cancer Liaison Progam, Phone: 301-827-4460, Fax: 301-443-4555
Department of Health and Human Services
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. Andrew Leon and Neil Ryan were FDA appointed voting members of
the February 2, 2004 advisory panel. Did not Drs. Leon and Ryan, 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. 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 from the drug company
itself [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.” 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'
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. 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 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 (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
By Jennifer Tierney
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