Jennifer Tierney

Kernersville, NC

 

February 13, 2004

 

Peter J. Pitts

Associate Commissioner for External Relations

Office of the Commissioner

Phone: 301-827-3330
F
ax: 301-827-3052

Email: Peter.Pitts@fda.gov

Scott Gottlieb, M.D
Senior Advisor for Medical Technology
Office of the Commissioner
Phone: 301-827-5259
Voicemail: 888-991-7667
Email: scott.gottlieb@fda.gov

Theresa Toigo
Office of Special Health Issues - Director
Phone: 301-827-4460
Fax: 301-443-4555 
Email:
ttoigo@oc.fda.gov 

JoAnn Minor, M.S.
Cancer Liaison Progam
Phone: 301-827-4460
Fax: 301-443-4555

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 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 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. . . ,” concluding that “it would have been preferable to have included adequate ascertainment in the first place.”

http://www.fda.gov/ohrms/dockets/ac/04/briefing/4006B1_03_background%20memo%2001-05-04.pdf

 

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

 

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.”