Eli Lilly Knew About Prozac Induced Suicidality

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[sSRI-Research] File - Eli Lilly Knew About Prozac Induced

Suicidality

 

 

 

 

Eli Lilly Internal Documents - Lilly Knew About Prozac Induced

Suicidality

 

http://www.baumhedlundlaw.com/media/timeline.html

 

Below is the time-line presented to the jury in the Forsyth v. Eli

Lilly Trial. It was presented during closing arguments by the plaintiffs.

It lists Lilly's internal documents. The plaintiffs allege that it shows

that Lilly knew about Prozac-induced suicidality and violence (even

before Prozac was approved for marketing in the United States) and that

this was withheld from the public.

 

 

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1 Aug. 1978 - Team Meeting Minutes - " There have been a fairly large

number of reports of adverse reactions . . . Another depressed patient

developed psychosis . . . Akathisia and restlessness were reported in

some patients. " Exhibit 30 (2nd page, end of 2nd paragraph)

2 May 1984 - BGA Comments - " During the treatment with the preparation

(Prozac) 16 suicide attempts were made, 2 of these with success. As

patients with a risk of suicide were excluded from the studies, it is

probable that this high proportion can be attributed to an action of the

preparation (Prozac) . . . " Exhibit 42 (page 3, 6th paragraph)

3 Jan. 1985 - Lilly receives reasons why the BGA will reject Lilly

registration, one of which was because of " SUICIDAL RISK. " With

instructions for " IMMEDIATE FOLLOW-UP ON ALL KEY OPINION LEADERS ON

THE BGA

COMMISSION FOR SELECTED VISITATION NEXT WEEK. " Exhibit 53

4 March 29, 1985 - " Benefit/Risk Considerations " - " The incidence

rate (suicide) under fluoxetine (Prozac) therefore purely mathematically

is 5.6 times higher than under the other active medication imipramine. "

.. . . " The benefits vs. risks considerations for fluoxetine (Prozac)

currently does not fall clearly in favor of the benefits. Therefore, it

is of the greatest importance that it be determined whether there is a

particular subgroup of patients who respond better to fluoxetine

(Prozac) than to imipramine, so that the higher incidence of suicide

attempts

may be tolerable. " Exhibit 58 (pages 18 & 22)

5 June 1986 - Draft of Proposed PRECAUTIONS and ADVERSE REACTIONS

Sections of the Prozac Package Insert - " Mania and psychosis may be

precipitated in susceptible patients by antidepressant therapy. "

Exhibit 5

(1st page) (never included in actual inserts)

6 Aug. 1989 - Additional Feedback Regarding the Fluoxetine (Prozac)

Review by the Commission A (Germany) - " 3. The counterindication because

of acute suicidality should become a warning whereby the physicians

should be advised that in the absence of sedation, the risk of higher

suicidality should be taken into account. " Exhibit 88

7 Nov. 17, 1989 - Letter to sales representatives on article about

Prozac-induced akathisia authored by Dr. Lipinski and others. " In the

article the authors voice their suspicion that `the triad of symptoms'

(anxiety, nervousness, and insomnia) reflects the syndrome of akathisia,

`which, in their view is apparently related to fluoxetine (Prozac)

therapy. " But the sales people are warned: " Use of this information in

product discussions may violate federal law. " Exhibit 91 (1st page, 2nd

paragraph and 2nd page, last sentence)

8 Jan. 1990 - PROZAC and SELF-DIRECTED VIOLENCE - " We have just

received a pre-print of an article (not a letter to ed.) Which we

understand

is to appear in the February 1990 AMERICAN JOURNAL OF PSYCHIATRY

suggesting that Prozac can induce severe, intense, obsessional suicidal

ideation. " . . . " Exhibit 94

9 Jan. 30, 1990 - Letter to sales representatives giving the sales

people a " heads-up " on the forthcoming Teicher article regarding Prozac

and Suicide and instructing them as follows: " Because these issues

(suicide) are not part of our current marketing plan, you should not

initiate

discussions on these articles. ... " Again, because these issues are not

part of our current marketing plan, discussions should not be initiated

by you. " Exhibit 15 (bottom of second page)

10 Feb 1990 - Teicher article published " Emergence of Intense Suicidal

Preoccupation During Fluoxetine (PROZAC) Treatment " - " The purpose of

this report is to suggest the surprising possibility that fluoxetine

(Prozac) may induce suicidal ideation in some patients. " . . . " In our

experience, this side effect has occurred in 3.5% of patients receiving

fluoxetine (Prozac) . . . " Exhibit 95

11 February 7, 1990 - Leigh Thompson Memo - " Anything that happens in

the UK (England) can threaten this drug (Prozac) in the US and

worldwide. We are now expending enormous efforts fending off attacks

because of

(1) relationship to murder and (2) inducing suicidal ideation. " Exhibit

97

12 February 7, 1990 - Leigh Thompson Memo - " I am concerned about

reports I get re UK attitude toward Prozac safety. Leber (FDA)

suggested a

few minute ago we using CSM database to compare Prozac aggression and

suicidal ideation with other antidepressants in UK. Although he is a fan

of Prozac and believes a lot of this is garbage, he is clearly a

political creature and will have to respond to pressures. I hope Patrick

realizes that Lilly can go down the tubes if we lose Prozac and just one

event in the UK can cost us that. " Exhibit 98

13 June 1990 - Letter to Lilly by concerned doctor - " I am writing to

inform Eli Lilly Company that a disturbing number of suicides or

suicide attempts associated with Prozac has come to my attention over the

last several months. " I am concerned that the association with Prozac may

be more than coincidental. " . . . " There appears to be growing concern

that Prozac may somehow trigger a suicidal preoccupation in a small

subset of patients and that their families should be warned of this

potential risk. It is certainly possible that some of the cases

reported are

" coincidence " in that the depressed person may have attempted suicide

independently of Prozac. However, some of these cases appear to be in

patients taking Prozac for reasons other than depression. " Exhibit 102

(2nd page)

14 July 18, 1990 - Memo regarding call from Paul Leber at the FDA.

" Paul Leber called yesterday; I contacted him at 6:15 am this morning and

half-hour conversation, very, very pleasant . . . " " The call was about

suicide. " . . . " He asked that we FAX nothing to him unless he has

agreed before hand. " " Paul (Leber) is taking a position in talking with

outside folks today that Lilly and FDA working together on the suicide

issue and following closely the postmarketing events, but that there are

no denominators and the best that can be done is to put a `cap' on the

number of events. " Exhibit 104 (top of 1st page and bottom of 2nd page)

15 August 3, 1990 - Letter to sales representatives regarding reports

of suicidal ideation/behavior possibly associated with PROZAC therapy.

" This information is not intended to replace our current promotional

strategy but is being provided to enable you to respond to physicians

when appropriate. You should not initiate discussion on these issues nor

use this letter in detailing. However, if asked to comment on these

issues by a health care professional, you should: 1. Reassure the health

care professional that no casual relationship has been established

between suicidal ideation and PROZAC therapy. " Exhibit 17 (bottom of

1st page

and top of 2nd page)

16 August 31, 1990 - " Dear Doctor " letter assuring them that there is

no " causal relationship between Prozac and suicidality (ideation or

acts). " Exhibit 22

17 September 12, 1990 - Lilly memo between Max Talbot and Leigh

Thompson- Talbot says " One possible strategy if FDA presses for an

additional

labeling change vis-a-vis suicide is a class-wide (i.e. ALL

antidepressants) cautionary note; however we should take this position

only as a

last resort. " Thompson replies: " that report MUST move swiftly through

approval and to Dr. Leber's (FDA) hands - - he is our defender. " Exhibit

109

18 September 14, 1990 - Lilly memo between John Heiligenstein (Lilly)

and Leigh Thompson - Heiligenstein says: " We feel caution should be

exercised in a statement that " suicidality and hostile acts in patients

taking Prozac reflect the patient's disorder and not a causal

relationship to Prozac - - - - Postmarketing reports are increasingly

fuzzy and we

have assigned `Yes, reasonably related' on several reports. " . . . " You

may want to note that trials were not intended to address issue of

suicidality. " Exhibit 110

19 September 25, 1990 - Minutes of Lilly Meeting with FDA - discuss

doing an in-hospital rechallenge of patients who met predefined criteria

for suicidal acts and ideation and agrees to " analyze international

data relating to suicide. " Exhibit 112

20 October 2, 1990 - Memo to Lilly employee Leigh Thompson to Lilly

employee Robert Zerbe regarding an upcoming Prozac symposium in which the

issue of suicidality is discussed. " Then the question is what to do

with the `big' numbers on suicidality. If the report numbers are shown

next to those for nausea, they seem small. " Exhibit 113 (2nd page.)

21 November 7, 1990 - Leigh Thompson memo - " I'd suggest that

priorities are: (1) protect Prozac " . . . Exhibit 116

22 November 13, 1990 - Memo from Claude Bouchy (Lilly Germany) to

Leigh Thompson Re: Adverse Drug Event Reporting - Suicide Fluoxetine - In

response to Lilly's request that he (Bouchy) change the event " suicidal

ideation " to " depression, " Bouchy writes: " Hans (another Lilly employee

in Germany) has medical problems with these directions and I have great

concerns about it. I do not think I could explain to the BGA, a judge,

to a reporter or even to my family why we would do this especially on

the sensitive issue of suicide and suicidal ideation. " Exhibit 117

23 November 14, 1990 - Second memo from Claude Bouchy (Lilly Germany)

to Leigh Thompson Re: Adverse Drug Event Reporting - Suicide Fluoxetine

in which he states: " I personally wonder whether we are really helping

the credibility of an excellent ADE system by calling overdose what a

physician reports as suicide attempt and by calling depression what a

physician is reporting as suicide ideation. " Exhibit 118

24 April 15, 1991 - Memo to Leigh Thompson called " Upcoming TV

appearance " Section I. " MESSAGE GOALS - Whatever questions you are

asked or

direction the interview take, the three points we want to establish are:

2. `It's in the disease, not the drug.'; Section III `If pressed, or as

a postscript to the above, then make the point that absolutely no

evidence indicates that PROZAC as a cause of such behavior (violence and

suicide).', and `Prozac defense . . . There is simply no medical or

scientific merit to the argument. " Exhibit 123

25 April 23, 1991 - Leigh Thompson Memo re 20/20 Show in which he

admits that on the issue of suicidality " I did NOT share the European

data

AT ALL. " and " She attacked on us hiding data by dividing up reports by

many COSTART terms. She had numbers for suicide, overdose, intentional

overdose, unintentional overdose and said they came to 1200 (or 1400)

total suicides - - so we went around on OD not necessarily being suicide

and COSTART, etc. " Exhibit 124 (bottom of 1st page and 4th paragraph of

2nd page)

26 May 15, 1991 - FDA Meeting to Discuss Fluoxetine Rechallenge

Protocol - " we agreed to have the rechallenge protocol ready to go by

September 1, 1991 Exhibit 125

27 August 1991 - Dr. David Healy's Article " Antidepressant Induced

Suicidal Ideation " - " These two cases suggest that the emergence of

suicidal ideation on antidepressants cannot always be attributed to a

lifting

of psychomotor retardation but rather that the ideas may in some

instances be produced by antidepressants. " Exhibit 126

28 October 29, 1991 - Lilly prepared draft for Dr. Beasley entitled

" Suggested Reply Points to Oswald, Healy & Creaney " in which he

acknowledges that item 3 of the HAMD is an insensitive measure of

suicidality

and states: " There was no specific rating scale for akathisia included in

the trial designs for the studies reported, so the only source of data

would be adverse event reports. Akathisia is a subjective phenomenon

and hence would rely on patients volunteering information. " Exhibit 130

(2nd page)

29 December 1991 - Dr. Rothschild's Article " Re-exposure to Fluoxetine

After Serious Suicide Attempts by Three Patients: The Role of

Akathisia " - " This is the first report, to our knowledge, of patients

restarted

on fluoxetine (Prozac) after a previous suicide attempt during

fluoxetine treatment. " . . . " When re-exposed to fluoxetine, the

patients again

developed akathisia and suicidal ideation. The suicidal feelings abated

when the akathisia was treated by the discontinuation of the fluoxetine

(Prozac) or the addition of propranolol. " Exhibit 131

(Cross-examination)

30 January 23, 1992 - Lilly memo regarding upcoming meeting with

Taiwanese doctors (Drs. Lu and Ko) to discuss the report on their study

results entitled " suicidal attempts and fluoxetine (Prozac) treatment. "

Exhibit 133

31 April 8, 1992 - Weinstein (Lilly employee) Report - " Mission

Accomplished. Professor Lu will not present or publish his fluoxetine

(Prozac) vs. maprotiline suicidality data. " Exhibit 144

32 March 3, 1993 - Forsyth's deaths

33 1994 - Dr. David Healy's Article " The Fluoxetine and Suicide

Controversy " - Dr. Healy concludes: " In the opinion of this author, the

volume of case reports and other studies is sufficient to demonstrate

that

antidepressants and antipsychotics may induce suicidal ideation in

certain individuals under certain conditions. " Exhibit 153

34 1995 - Dr. Jick's Study " Antidepressants and Suicide " - " The

results indicate that only fluoxetine (Prozac) has a rate that seems

to be

substantially higher than that of the other antidepressants. " Exhibit 155

35 June 1998 - Dr. Roger Lane's article " SSRI-Induced Extrapyramidal

Side-Effects and Akathisia; Implications for Treatment " appears in the

Journal of Psychopharmacology. " SSRI-induced akathisia is a relatively

rare but is frequently unrecognized when it does occur. " . . . " The

precise definition of akathisia is a matter of controversy, as is the

relative importance of the objective and subjective aspects of the

disorder.

Is akathisia a movement disorder or an intense and uncomfortable mental

state . . . " " It may be less of a question of patients experiencing

fluoxetine (Prozac)-induced suicidal ideation, than patients feeling that

`death is a welcome result' when the acutely discomforting symptoms of

akathisia are experienced on top of already distressing disorders. "

 

 

 

 

 

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