Prozac (Fluoxetine)

"Looking back, it sometimes seems that instead of asking, Who among famous figures might have suffered from what we call depression?, it might be more accurate to ask, Who didn't? From Caesar to Churchill, who described his dark moods as a black dog that hounded him, many of even the strongest leaders have struggled with profound bouts of melancholy. Indeed, in the pre-PROZAC view the condition was often seen to be inevitable and all encompassing...
Lilly researchers collaborated to develop a compound known as fluoxetine hydrochloride, the active ingredient in the drug now known as PROZAC. The availability of fluoxetine allowed researchers to prove the hypothesis that a selective serotonin reuptake inhibitor (SSRI) could treat depression. Many doctors now believe that one thing that may cause depression is an imbalance of serotonin, a naturally occurring chemical in the body.
PROZAC, approved in late 1987 and first marketed in the United States in early 1988, has helped revolutionize the treatment of depression. Although, as we have seen, other depression-fighting drugs had been available since the 1950s, PROZAC produced fewer of the significant drawbacks most commonly associated with older medications. Today PROZAC is the world's most widely prescribed antidepressant. It has been prescribed for more than 38 million people in more than 100 countries, including 22 million in the United States alone."
- pp. 21 & 34, The Journey Continues: The Story of Prozac by Eli Lilly and Company (2000)

"I was first diagnosed with major depression in 1983 at the age of six, and started on the older form of tricyclic antidepressants. In 1988, when I was twelve years old, my doctor started me on Prozac, touting it as a miracle drug that would finally cure my stubborn feelings of depression stemming from early childhood trauma.
Once on Prozac, the relatively mild depression I felt mixed with a new and terrifying anxiety that I had never experienced previously. When I reported this anxiety to my doctor, he simply upped my dose of Prozac. I immediately began to experience insomnia, for which I was given a mild sedative to help me sleep at night. I felt a horrific inner restlessness, a feeling of wanting to jump out of my skin, that I now know is called akasthisia.
For about two years, my dosage of Prozac was continually being raised in hopes that it would finally start to work. From the beginning, I began to suffer from brief but regular periods of racing thoughts that I could not control. All this anxiety and restlessness was simply attributed to my worsening "illness." I began to have intense thoughts of cutting myself, killing myself. It occurred to me that I should act on my thoughts of self-mutilation, and began to slice my wrists and forearms with razors. This too, was chalked up to my advancing mental illness, and I began a long downward spiral of hospitalizations, which fed the feelings of depression and anxiety. In 1991, at age sixteen, while taking Zoloft, I made my first bona fide suicide attempt, swallowing an entire bottle of painkillers. I cannot even recall the reason for doing so. I became completely unable to control feelings of terror and rage that seemed to come out of nowhere, surpassing any teen angst or depression that I had ever heard of.
In 1993, at the age of eighteen, I decided to take matters into my own hands as a legal adult, and to get off the antidepressants for good. Since stopping SSRI medications over a decade ago, I have never again self- mutilated, had suicidal thoughts, or entered the hospital. The suicidality simply vanished! For me, this is clear proof that the drugs must have played some kind of role in my suicidality and self-mutilation. In the past decade, not only am I not suicidal, but I have managed to travel the world, get an M.A. degree in political science from Georgetown University, and become an active participant in my society."
- Leah Harris of the National Association for Rights Protection and Advocacy (NARPA), presented to the Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee, hosted by the Food & Drug Administration

"A 19-year old woman seemed partly phobic and partly psychotic with hints of an eating disorder as well as depression. She had previously had a variety of medications and occasional suicidal thoughts. Over the course of two weeks on a mixture of Prozac and the anti-psychotic perphenazine, she became paranoid, depressed, irritable and developed "disturbing self destructive thoughts". Her Prozac was increased and her perphenazine reduced because she showed signs of akathisia, but she became more depressed and preoccupied with thoughts of death. When her Prozac was increased further, she became actively suicidal. After a further increase in Prozac to 80 mg per day, she became violent and self-mutilating. When Prozac was finally discontinued, her self-destructive urges eased and she subsequently improved markedly."
-p. 96, Let Them Eat Prozac by Dr. David Healy (2003)

"In the early 1990s, when Prozac's dangerous effects surfaced in the media, the FDA asked a special committee to look into the matter of suicidality and violence. On important issues that come to public attention, the FDA often turns to an advisory committee, a panel of "independent" - meaning outside the FDA- "blue ribbon" experts...
Who were the blue-ribbon, independent experts on the Prozac panel? There were nine doctors, five of whose financial duties to the pharmaceutical industry- including the manufacturers of serotonin boosters- required the FDA to "waive" its own standards regarding conflicts of interest. In addition, six consultants were appointed to advice the panel. Four tf the six consultants required conflict-of-interest waivers. Among the committee members receiving waivers was Dr. David Dunner of the Department of Psychiatry and Behavioral Sciences at the University of Washington in Seattle. Dunner had been a lead investigator for Eli Lilly in one of the four Prozac placebo-controlled clinical studies which Lilly submitted to the FDA to win approval to market the drug. Among the consultants receiving waivers was Dr. Stewart Montgomery of the Department of Psychiatry, St. Mary's Hospital Medical School in London, England. Montgomery, too, had been a principal investigator for Eli Lilly in a study of Prozac...
Also at the hearing was Martin Teicher, the Harvard psychiatrist whose case reports helped bring the issue of suicidality and violence to national attention. Remarkably, although four doctors representing Eli Lilly had been scheduled to make formal presentations to the committee, Dr. Teicher was not... [After an audience member asked to hear from Dr. Teicher, he was given the opportunity to] briefly summarize the clinical experience with Prozac inducing suicide and violence, proposed several mechanisms by which the drug might do so, and said he had data showing that Prozac is associated with a "threefold" higher incidence of suicidality than other antidepressants. But Dr. Teicher was not able to present the data. Presiding over the hearing was the panel's chairman, Dr. Daniel Casey, a strong drug proponent from Oregon Health Sciences University in Portland. As Teicher spoke, Casey repeatedly cut him off, admonishing him to keep his comments "brief" and "focused"...
Wanting to present the data to the committee, Teicher asked, "May I show you a couple of slides?"
"I would rather not...," responded Casey.
Shortly thereafter, the committee agreed, voting unanimously that the anti-depressants do not cause suicide and violence. This was the unanimous, "no credible evidence" vote that was widely publicized.
But in another vote, the committee considered adding a warning to the guidelines for prescribing antidepressants based upon what they had heard at the hearing. In spite of the many conflicts of interest, the committee was deeply divided. Several committee members pressed for a warning. One of the m drafted a proposed warning that red, "In a small number of patients, depressive symptoms have worsened during therapy, including the emergence of suicidal thoughts and attempts...
Here,, again Dr. Paul Leber of the FDA weighed in. "We almost have that [kind of warning] in labeling now, " said Leber. He was referring to a statement in the precautions section of the product information for antidepressants stating that "the possibility of a suicide attempt is inherent in depression." Committee members argued with Leber: This was not the same as warning doctors that suicidality could emerge or worsen after drug treatment was initiated. Leber raised concern that even a general warning for antidepressants would hurt Prozac in particular: "It is sort of a no-win situation for Prozac, because it has been in the public eye".
Despite the conflicts of interest, one-third of the panel members voted for a warning, while two-thirds voted against one. This was the deeply divided vote, the strongly held, one-third minority opinion in spite of the many conflicts of interest. This vote was not highly publicized after the hearing."
-pp. 156- 160, Prozac Backlash by Joseph Glenmullen, M.D. (2000)

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