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Posted on 10/26/2001 8:46:39 PM PDT by Bump in the night

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

We, the Undersigned, demand a Grand Jury Investigation into serious misconduct concerning Prozac on the part of Eli Lilly, the drug’s manufacturer. Specifically, we assert that Eli Lilly has known of and engaged in the suppression of the truth concerning the drug’s ability to cause suicide and suicidal ideation. We assert that Eli Lilly has knowingly and fraudulently concealed facts surrounding its drug’s 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, "…some 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, "…in future studies the use of benzodiazepines to control the agitation will be permitted.” From that point on, Lilly's trial subjects were put on tranquillizers 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 examing 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 patient’s disorders. Yet, Lilly’s 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 akathesia; the company asserted that the link between akathesia and suicide is questionable.

· Lilly's internal documents of that time show that public criticism was threatening the drug’s success. Some were coming out of the UK.

· An internal memo from Leigh Thompson, one of Lilly’s chief scientists, stated, "Anything that happens in the UK 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 [suicidal behaviour].”

· 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.”

(All points outlined above are supported by documented findings published in The Guardian; “They said it was safe”; 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; “As drug gets remade, concerns about suicides surface”; Boston Globe, 5/7/2000)

3. In September 1991, an advisory committee of the FDA cleared Prozac. “Suicidal ideation" and "violent behaviours" were added to the label as "reported, but not proven." (Robert Bourguignon MD; “Problems with Prozac”; 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 Evidence” in which he stated that antidepressants, Prozac included, can 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 Office’s own admissions, reported FDA Adverse Drug Events only reflect an estimated 1%, to a conservative 10% of actual events, and “are unlikely to be representative of the much larger number of unreported events.” (“Adverse Drug Events – the Magnitude of Health Risk is Uncertain Because of Limited Incidence Date”, 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; “As drug gets remade, concerns about suicides surface”; 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 Lilly’s 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, “Our safety staff is requested to change the event term `suicide attempt' [as reported by the physician] to `overdose.' " He added, “...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-mutilation…one of its more significant side effects." This is the same effect Lilly has repeatedly denied to have occurred 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 1990’s 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 Tendencies”, 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 US 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 Lilly’s and the FDA’s 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 it…

“All truth passes through three stages: First it is Ridiculed.
Second, it is Violently Opposed. Third, it is Accepted as being Self-Evident.”
- Arthur Schopenhauer (1778-1860)

Respectfully Yours,

Sincerely,

The Undersigned

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