Please make sure you've signed this: Prozac Petition

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Prozac Petition/Eli Lilly

http://www.petitiononline.com/lilpro/

 

The Office of the Surgeon General of the United States; The Department

of Health & Human Services; The Federal Bureau of Investigations and The

Justice Department

 

We, the Undersigned, demand a Grand Jury Investigation into serious

misconduct concerning Prozac on the part of Eli Lilly, the drug¹s

manufacturer. Specifically, we assert that Eli Lilly has known of and

engaged in the suppression of the truth concerning the drug¹s ability to

cause suicide and suicidal ideation. We assert that Eli Lilly has knowingly

and fraudulently concealed facts surrounding its drug¹s deadly side effects.

Documented findings of cover-ups supporting our demand include, but are not

limited to, the following:

 

· Eli Lilly has known Prozac (fluoxetine) causes akathisia, defined as an

extreme subjective feeling of inner restlessness. This condition has long

been known to be caused by antipsychotic drugs and recognized as leading to

suicidal and homicidal-suicidal feelings. Lilly's own internal documents

show the condition was identified in association with Prozac as early as

1978.

 

· August 2, 1978, when only three trials were underway, minutes of a

meeting of the Fluoxetine (Prozac) Project Team read: " 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. " A similar meeting held 10 days earlier stated, " Šsome

patients have converted from severe depression to agitation within a few

days; in one case the agitation was marked and the patient had to be taken

off [the] drug. " The minutes further state, " Šin future studies the use of

benzodiazepines to control the agitation will be permitted.² From that point

on, Lilly's trial subjects were put on tranquilizers to get them over the

akathisia experienced by some in the early days on the drug. Those who

developed akathisia or who had any suicidal tendencies were excluded from

the trial data on the basis that they would otherwise obscure the results of

the drug's success in treating depression.

 

· Lilly internal documents, May 25, 1984 ­ Upon examining Prozac trial

results, the German licensing authority (the Bundes Gesundheit Amt (BGA))

issued a letter stating: " During the treatment with the preparation

[Prozac], 16 suicide attempts were made, two 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]. "

 

· January 1985, the Germans told Lilly that they would not license the

drug, citing " suicidal risk " as one of the reasons for their decision.

Lilly's scientists continued trying to persuade the BGA to grant a license,

but focused most of their efforts on the US. By August 1989, it was clear to

Lilly that the BGA would demand that Prozac carry a warning to General

Practitioners (GPs) that they should be aware of the risk of suicide unless

they gave patients sedation along with Prozac. A warning of a " risk of

suicide " finally went on the German package insert in 1992. It also stated,

" For his/her own safety, the patient must be sufficiently observed, until

the antidepressive effect of Fluctin [Prozac] sets in. Taking an additional

sedative may be necessary. "

 

· During the licensing process in the US Lilly did not tell the FDA of

the German concerns.

 

· Lilly has repeatedly attempted to suggest suicidality reflects

patient¹s disorders. Yet, Lilly¹s own scientist, John Heiligenstein, wrote

in an internal memo on September 14, 1990: " 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'. Post-marketing reports [reports from GPs of suicides and

violence in patients on the drug] are increasingly fuzzy and we have

assigned, 'Yes, reasonably related', on several reports.

 

· This Heiligenstein memo was written two years after Prozac was granted

a license by the FDA, and just months after a study report by Martin

Teicher, Jonathan Cole and Carol Glod was published. According to the study,

6 patients with a history of depression became violently suicidal in a way

that surprised themselves and their doctors while on the drug. The report

noted that suicidal thoughts occurred within days or weeks of going on

Prozac, or of having the dosage increased beyond a certain level, and that

such thoughts disappeared when the patient stopped taking the drug. Lilly

insisted that Prozac did not cause akathisia; the company asserted that the

link between akathisia and suicide is questionable.

 

· Lilly's internal documents of that time show that public criticism was

threatening the drug¹s success. Some were coming out of the UK.

 

· An internal memo from Leigh Thompson, one of Lilly¹s chief scientists,

stated, " Anything that happens in the UK can threaten this drug [Prozac] in

the US and worldwideŠ " " We are now expending enormous efforts fending off

attacks because of 1) relationship to murder and 2) inducing suicidal

ideation [suicidal behaviour].²

 

· Another memo from Thompson ran: " I am concerned about reports I get re

UK attitude toward Prozac safety. Leber [Dr Paul Leber of the FDA] suggested

a few minutes ago we use CSM [british Committee on Safety of Medicines]

database to compare Prozac aggression and suicidal ideation with other

antidepressants in the 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 [probably a Lilly employee, but not

identified fully in the memo] realizes that Lilly can go down the tubes if

we lose Prozac, and just one event in the UK can cost us that.²

 

(All points outlined above are supported by documented findings published in

The Guardian; ³They said it was safe²; Sarah Boseley; October 30, 1999)

 

 

FURTHER SUPPORTING EVIDENCE:

 

1.As cited above, in 1990, Martin Teicher et al, of Harvard Medical School,

reported six cases of " intense suicidal preoccupation " in patients who had

been prescribed the drug. According to the authors, " none of these patients

had ever experienced a similar state during treatment with any other

psychotropic drug. " (American Journal of Psychiatry, February 1990)

 

2. Dr. David Graham, chief of the FDA's Epidemiology Branch, wrote on Sept.

11, 1990, that Lilly's data on suicide and Prozac, and data garnered from a

study by Drs. Maurizio Fava and Jerrold Rosenbaum of Massachusetts General

Hospital (citing no significant difference in " suicidal ideation " in

patients treated with fluoxetine compared to those receiving other

antidepressants) was insufficient to prove that Prozac was safe. In an

internal FDA memo, Graham wrote: " Because of apparent large-scale

underreporting, the firm's analysis cannot be considered as proving that

fluoxetine and violent behavior are unrelated. " Rosenbaum's objectivity has

been questioned. Not only was his study on Prozac and suicide criticized by

at least two sets of researchers as well as the FDA, but also documents

obtained by The Boston Globe illustrate Rosenbaum's questionable

relationship to Lilly. He has served as a Prozac researcher and sat on a

marketing advisory panel for Lilly before Prozac was launched. (Leah R.

Garnett; ³As drug gets remade, concerns about suicides surface²; Boston

Globe, 5/7/2000)

 

3. In September 1991, an advisory committee of the FDA cleared Prozac.

³Suicidal ideation " and " violent behaviours " were added to the label as

" reported, but not proven. " (Robert Bourguignon MD; ³Problems with Prozac²;

http://www.camtech.net.au/malam/reports/prozac.htm)

 

4. In 1994, David Healy (then consultant to Eli Lilly) published an

article entitled " The Fluoxetine and Suicide Controversy, a Review of the

Evidence² in which he stated that antidepressants, Prozac included, could

indeed induce suicidal behaviour. (CNS Drugs, March 1994)

 

5. The FDA's adverse event reporting system (AERS) reveals 28,623 Prozac

adverse events (ADEs) (Garnered from data gathered via Freedom of

Information Act):

· 63% of 1,734 deaths reported - 1,089 - were attributed to suicides.

· Suicide attempts numbered 1,885.

· Over 10% of the total 28,623 ADEs reported were attributed to suicides

and suicide attempts.

 

6. By the Government Accounting Office¹s own admissions, reported FDA

Adverse Drug Events only reflect an estimated 1%, to a conservative 10% of

actual events, and ³are unlikely to be representative of the much larger

number of unreported events.² (³Adverse Drug Events ­ the Magnitude of

Health Risk is Uncertain Because of Limited Incidence Date², Jan. 2000;

GAO/HEHS-00-21) Given this lack of actual data, Prozac numbers could be

projected to be in the area of 10,890 deaths by suicide and 18,850 suicide

attempts at 10% reporting. At 1% reporting, 108,900 suicides and 188,500

suicide attempts could be projected.

 

7. Recent studies reveal over 50,000 deaths related to Prozac and

estimate that between 7% and 10% of individuals exposed to Prozac will have

some kind of adverse reaction. (The Boston Globe; " As drug gets remade,

concerns about suicides surface " ; Leah R. Garnett, Globe Staff; May 7, 2000;

© Copyright 2000 Globe Newspaper Company)

 

8. According to internal documents and other documented material made

available to The Boston Globe, (Leah R. Garnett, Globe Staff; ³As drug gets

remade, concerns about suicides surface²; The Boston Globe, 5/7/2000):

 

· In 1990, Lilly scientists were pressured by corporate executives to

alter records on physician experiences with Prozac, changing mentions of

suicide attempts to " overdose " and suicidal thoughts to " depression. " In an

electronic communiqué (obtained by author Dr. Joseph Glenmullen, Prozac

Backlash) from Claude Bouchy, a Lilly employee in Germany, to three Lilly

corporate executives at Lilly¹s Indianapolis headquarters, dated November

13, 1990: Bouchy says he and a colleague " 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. . . " He further reported, ³Our safety staff is

requested to change the event term `suicide attempt' [as reported by the

physician] to `overdose.' " He added, ³...it is requested that we change . .

.. `suicidal ideation' to `depression.' " He informed his US Lilly

colleagues: " I do not think I could explain to the BGA, to 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. At least not with the

explanations that have been given to our staff so far. "

 

· Three years before Prozac received approval by the US Food and Drug

Administration in late 1987, the German BGA had such serious reservations

about Prozac's safety that it refused to approve the antidepressant based on

Lilly's studies showing that previously non-suicidal patients who took the

drug had a fivefold higher rate of suicides and suicide attempts than those

on older antidepressants, and a threefold higher rate than those taking

placebos.

 

· Lilly's own figures indicate that 1 in 100 previously non-suicidal

patients who took the drug in early clinical trials developed a severe form

of anxiety and agitation called akathisia, causing them to attempt or commit

suicide during the studies.

 

· A patent for a new Prozac (US Patent no. 5,708,035), R-fluoxetine,

expected to be marketed by Lilly beginning in 2002, (as of the 2000 Globe

report) states the new version will not produce several existing side

effects including " akathisia, suicidal thoughts, and self-mutilationŠone of

its more significant side effects. " This is the same effect Lilly has

repeatedly denied to occur in any substantial way in some 200 lawsuits

against them over the past decade. Most of the suits were settled out of

court and the terms kept confidential.

 

· Lilly will pay Sepracor, Inc., who holds the patent for the new Prozac,

an upfront payment and license fee of $20 million and an additional $70

million based on the progression of the drug. Lilly will have exclusive

world rights to the drug, will be responsible for development, product

manufacturing, regulatory submissions, and marketing and sales ­ Sepracor to

receive royalties according to a Sepracor press release dated April 13.

 

· Dr. Martin Teicher, whose early 1990¹s studies linked Prozac to

akathisia and suicide, is a co-inventor of the new Prozac, along with

Timothy J. Barberich, the CEO of Sepracor Inc., (a Marlborough drug

company), and James W. Young. They filed their patent in August 1993, the

same year Teicher published " Antidepressant Drugs and the Emergence of

Suicidal Tendencies², which concluded that patients on Prozac were at least

three times more likely to become suicidal than those on older

antidepressants. (Journal Drug Safety)

 

· Figures in a 1984 Lilly document indicated that akathisia, the severe

agitation that can lead to suicide, occurs in at least 1 percent of

patients, a level considered a " frequent " event, and as such must be

disclosed in a company's product literature and package inserts. But there

is no such disclosure in Prozac's United States literature. Akathisia is

listed in Lilly's US product literature, but as an infrequent event in

Prozac users. No mention is made of its potential relationship to suicide.

 

In conclusion, we believe the FDA and Eli Lilly must be held accountable as

to their negligent, fraudulent and cover-up activities concerning this

deadly drug. Given the above cited findings, we firmly believe that it is

only through a Grand Jury Investigation that the rights of the unsuspecting

American consuming public can be best served, that unconscionable future

suffering may be averted, and many lives saved. We, the undersigned, most

earnestly request that a thorough investigation into Eli Lilly¹s and the

FDA¹s practices concerning Prozac, both past and present, be vigorously

pursued as per the powers vested in you to do so. Countless innocent lives

depend on itŠ

 

³All truth passes through three stages: First it is ridiculed.

Second, it is Violently Opposed. Third, it is Accepted as being

Self-Evident.²

- Arthur Schopenhauer (1778-1860)

 

Respectfully Yours,

 

The Undersigned

 

 

Click Here to Sign Petition :

http://www.petitiononline.com/lilpro/

 

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The Eli Lilly & Prozac Petition to The Office of the Surgeon General of the

United States; The Department of Health & Human Services; The Federal Bureau

of Investigations and The Justice Department was created by SSRI-Crusaders

and written by Mary Collissa Weber, Douglas and Sandi Payne.