The sealed Prozac data from Eli Lilly also came from my investigations of the company as a medical expert in product liability suits. The British Medical Journal [BMJ] recently obtained the sealed documents from an anonymous source and released them to the FDA and the U.S. Congress.
This is message #1 from: BOUCHY CLAUDE
November 13, 1990 10:49
To: THOMPSON LEIGH, WEINSTEIN ALLAN J, ZERBE ROBERT L
CC: MAYR GERHARD, TAUREL SYDNEY, WEBER HANS J
RE: ADVERSE DRUG EVENT REPORTING-SUICIDE FLUOXETINE
Hans Weber and I have problems with the directions our safety people are
getting from the corporate group (Drug Epidemiology Unit) and requesting that
we change the identification of events as they are reported by the physicians.
- GEB-FLM039(DEN #GE90100350A). On this one, our safety staff is requested to
change the event term "suicide attempt (as reported by the pshysician) to
- GEB-FLM025(DEN #GE 90090427A). On this one, it is requested that we change
from "suicidal ideation" to "depression".
Hans has medical problems with these directions and I have great concerns
about it. I do not think I could explain to the BGA, to a judge, to a reporter
or even my family why we would do this especially on the sensitive
issue of suicide and suicide ideation. At least not with the explanations
that have been given to our staff so far. I am quoting "When an overdose
is taken in a suicide attempt, our Research Physicians prefer to list the
event term overdose" even if "when tracking suicides, we always look at all overd
ose and suicide attempt reports".
This issue has been argued back and forth for about a month between Bad Homborg
and Indy, therefore I am bringing it to your attention and await your
November 14, 1990 06:47
To: THOMPSON LEIGH
CC: MAYR GEHARD, TAUREL SYDNEY, WEBER HANS J,
WEINSTEIN ALLAN J, ZERBE ROBERT L
November 14, 1990 05:58
RE:ADVERSE EVENT REPORTING – SUICIDE FLUOXETINE
Thank you very much for your prompt answer and your detailed explanation. Hans
and I rediscussed the issue in depth.
Our point is the following: the physician has reported a suicide attempt. Do we
have the right to change it to some terminology which we may consider to be more
specific e.g. overdose, but which is not free from ambiguity and could be
regarded as inaccurate or misleading?
The term overdose is not free from ambiguity because there are clearly forms
of overdose which are not related to suicide attempts, for instance wrong
dose prescribed or dispensed error on the part of the patient etc … In fact
and perhaps more importantly, the dictionaries we have looked at [medical
dictionaries and non-medical] fail to associate [not to mention equal] the
concept of overdose with suicide attempt.
In addition, it can be argued that the event term overdose is inaccurate or
misleading because in this case the patient attempted suicide by taking
an overdose of barbituates and tricyclics and not, I repeat not, of fluoxetine.
Finally, on a very simple and non-scientific basis, I personally wonder whether
we are really helping the credibility of the excellent ADE system by calling
overdose what a physician reports as suicide attempt and by calling depression
what the physician is reporting as suicide ideation. We fully realize that there
is no code in our DSM system for suicide ideation but it could be argued by
people who have little sympathy to the company or by regulatory authorities
that it is not a responsible way to deal with an issue which is getting so
much attention in the scientific and in the general press. It could also be
argued that the term depression is not specific in this case.
Of course, at the end of the day, we will do what we are told to do but Hans
and I felt that we had to bring these points to your attention.
- they’re messing with the medical reporting in a clinical trial
- they’re worried that Prozac will look like it causes suicidal thinking
- they’re manipulating the outcome of the study to hide serious adverse events
My reaction to these emails is mixed. On the one hand it’s disillusioning to see this kind of blatant corruption so early in the game. On the other hand, after so much speculation about what went on in the background, it’s confirming to read it there in black and white – almost a relief. But mainly, these people were messing with reporting suicide attempts – the worst side effect of all. They knew what they were denying, what it meant, and their reflex was to hide it in the word-play of reporting – change the data. A crime is being contemplated, one actually soon committed. And all of this is going on less than a year before the FDA Hearing on Prozac and suicidality in September 1991 where the freshly appointed Chairman of Emory Psychiatry, Dr. Charlie Nemeroff, will testify as Eli Lilly’s star witness – making his debut with a lie:
September 20, 1991
"I would suggest to you that I have as little confidence in these anecdotal reports as I do in the anecdotal report of Teicher, and that, in fact, there is no substitute for controlled prospective double-blind clinical trials…"
"In conclusion, there is simply no scientific evidence whatsoever, no placebo-controlled double-blind study that has established a cause-and-effect relationship between antidepressant pharmacotherapy of any class and suicidal acts or ideation."
"As Drs. Potter and Fawcett have suggested, limiting the availability of antidepressants could have a very profound adverse effect in terms of increasing the morbidity and, in fact, mortality associated with untreated depression."
Dr. Charles Nemeroff, Professor and Chair
Department of Psychiatry
Emory University, Atlanta Georgia