All of them, those in power, and those who want the power, would pamper us, if we agreed to overlook their crookedness by wilfully restricting our activities.
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After a whirlwind love affair with the media, fluoxetine's (Prozac's) fall from grace has been just as spectacular. Just over a year ago it was featured on the cover of Newsweek as a "wonder drug" that not only helped patients overcome major depression, but improved their social life, their careers, and their marriages. Patients testified on talk shows and in newspaper interviews that the drug made them feel even better than before they were sick.
A small case report of six patients who experienced intense suicidal ideation when taking the drug captured public attention when it was published in February 1990. Then the lawsuits began. The first was filed in June by a New York state woman who claimed that she cut herself over 100 times because fluoxetine caused her to have suicidal ideation. She blamed its manufacturer Eli Lilly & Co. of Indianapolis, charging that the drug wasn't properly tested and no warnings of suicidal ideation are listed on the labeling. As the trickle of lawsuits became a steady stream, the media began to carry "roundup" articles of all the cases they could get information about. One of the most publicized was that of a Louisville, Ky., man who went on a shooting spree at the printing plant where he had worked, killing eight, wounding 12, and then shooting himself. Joseph Wesbecker was taking fluoxetine at the time, and first the widows of three of the men killed, then Wesbecker's son, and eventually over 20 plaintiffs in the case have named the drug's manufacturer among those responsible.
To date, the most blatantly negative media coverage of the issue was the February 27 "Donahue" talk show titled "Prozac: Medication That Makes You Kill." Despite requests from the American Psychiatric Association, mental health organizations, and Eli Lilly, the producers of the program not only refused to have medical experts on the show, but even canceled the only two patients scheduled who had a favorable response to the drug. The two were not told they had been dropped from the show until they had flown to New York for the filming. A spokesperson for "Donahue," Karen Lippett, claimed the patients had never been scheduled by the show's producer but had been "chosen by Eli Lilly and instructed by Lilly's PR people." She said that Lilly had also offered to produce a psychiatrist for the program. When asked why the show refused Lilly's proposal as well as the APA's offer to supply a psychiatrist, Lippett said that having a psychiatrist on the show would not have fit the planned format. "What we wanted was a representative of the drug company because it was the drug that the show was about. The rationale was to look at the scattered, increasing number of reports around the country of the negative side effects of this drug," Lippett said.
Susan Dime-Meenan, executive director of the National Depressive and Manic Depressive Association, said she had 214 copies made of a videotape of the program to send to all the association's chapter heads in the United States and Canada to prepare them for the onslaught of calls from members. "We spent 68 hours straight on the phone answering calls from members frightened to death because they had seen the program," she said. "We kept telling them not to stop taking their medication without consulting their physician."
The four-year-old association has about 35,000 members, Dime-Meenan said. She estimates that about 95 per-cent are on antidepressants. "I felt we had come so far as an association in fighting the stigma of being diagnosed with a psychiatric illness," she said. "We are fortunate, those of us who suffer from depression, to have medication that works. But the stigma that was put in place by that program on people taking medication is a disaster."
The show's panel included a spokesman for the Citizens Commission on Human Rights (CCHR), an offshoot of the Church of Scientology; an attorney representing 20 to 30 plaintiffs in lawsuits involving the drug; the widow of rock star Del Shannon who was taking fluoxetine at the time he committed suicide; one of those wounded by Joseph Wesbecker; and two patients who blamed the drug for either suicidal ideation or homicidal ideation. One of the two patients on the panel is the national director of the Prozac Survival Support Group, recently formed by CCHR.
During the show, Donahue read a short statement by Lilly and mentioned several times that the company had been asked to send a representative to the show but had refused. The Psychiatric Times asked Marie Abbott of Eli Lilly to comment. "We haven't appeared on any television programs in keeping with the FDA (Food and Drug Administration) preference and our own policies to direct our communication only to medical professionals," she said. Lilly offered to recommend physicians who had tested the drug to appear on the show and suggested that the producers contact the FDA, Abbott said. When "Donahue" staff said they weren't interested, the company proposed that the show's producers choose a physician to be on the program. "Eventually, they refused to accept our calls," she said.
When "Donahue" producers turned down the APA's request to have a psychiatrist on the program to present a balanced approach, they told the APA it was because they were concerned that there would be a confrontation on the air between the physician and the spokesman for the Scientologists, according to Troy Thompson, M.D., Daniel Lieberman professor and chair of the department of psychiatry at the Jefferson Medical College in Philadelphia. Despite assurances by the APA that there would be no such confrontation and that the association would provide a nationally known and respected physician to talk about fluoxetine, the offer was rejected, he said. "They're concerned about their ratings, not about health care," Thompson said. "But I think a good confrontation between a reputable psychiatrist and a crazy Scientologist would have helped their ratings."
The tone of the show was highly emotional—sensational—and, at times, disjointed, as can be seen from this excerpt from the transcript in which Donahue fires quick questions to Leanne Westover, the widow of Del Shannon, and then, without a pause, switches to Jacquie Miller, one of those wounded in the Wesbecker shooting:
D: "And it was a handgun?"
W: "A rifle."
D: "A rifle. And you discovered the body."
(Turns to Miller) "Jacquie Miller—wow!—that you are walking around—"
M: "Yeah."
The program's transcript shows that Donahue repeatedly interrupted anyone in the audience or any caller who attempted to speak favorably about fluoxetine. When a neurochemist in the audience tried to talk about the research findings and said that the suicidal ideation was "not the drug. It's something else that's going on besides this," Donahue cut to a commercial promising to come back to the person, but did not.
The most disturbing statements made on the show came from Dennis H. Clarke, representing Scientology's CCHR, which has been outspoken in campaigning against psychiatry for years. Clarke said of fluoxetine: "There is a tremendous problem with this drug...in that people are killing themselves and making it appear to be accidents. They're running head-on into other individuals with their cars. They're running into bridge abutments and so on. And it appears to be accidents because the drug is producing in these people an obsessive violent need to kill and to be killed."
Clarke was not introduced with the rest of the panel when the show began. He shows up on page 5 of the program's 10-page transcript; Donahue makes a quick introduction and Clarke interjects unsubstantiated claims about fluoxetine regularly throughout the rest of the show. Only at the end of the program is Clarke's tie with Scientology made, when Donahue and Clarke defend Scientology's campaign to have fluoxetine taken off the market.
D: "I should remind this audience that Eli Lilly, the one taking the heat because they are the prescribed—they have the patent on Prozac, alleges, perhaps not frontally but out loud, that much of the criticism coming against Prozac is originated by the Church of Scientology. We should say that Mr. Clarke, I believe you are a member of the Church of Scientology."
C: "That's correct."
D: "And when last I looked, that was legal to be a member of the Church of Scientology."
C: "That's correct. Phil, I thank God every day that there's an organization big enough and strong enough to take on Eli Lilly."
According to Thompson, a member of the APA's council on education, the program "probably undercut five years of work" by the council. "This kind of journalism kills people," he said. "There are probably 10,000 depressed people who can't go to work who are shuffling around the house in their pajamas watching 'Donahue.' " The illness makes it difficult for patients to keep a clear perspective, and they likely will believe whatever is said on the program, he said. "Tens of thousands of depressed people may not go to a physician or take a medication because of this kind of garbage on TV."
"A mini-panic" is how Robbie Campbell, M.D., chief of psychiatry at Oakville Trafalgar Memorial Hospital in Ontario, describes reactions from patients in the hospital's 30-bed psychiatry ward when they saw the "Donahue" show. "I was on my rounds, and patients called to me from the day room where they were watching the show," he said. "One patient taking Prozac said: 'My God, it's going to make me kill somebody or myself!' They questioned my integrity for putting them on the drug." Campbell said he immediately met with the patients but that was not enough. He said the nurses talked with the patients, he brought in a pharmacist, and still two of the seven patients on fluoxetine were so upset he was forced to change their medication. Campbell had Eli Lilly send him its most recent information so he was sure he was on top of the subject. "It was dreadful," he said.
Dime-Meenan said Eli Lilly called her the day before the Donahue show and said that the show's producers had agreed to carry patients who could speak about fluoxetine's effectiveness. She arranged for association president Gary Goldsmith and another member, Evie Barkin of Boston, to fly to New York for the show. Goldsmith flew to New York from Washington, D.C., where he was attending the National Mental Health Leadership Forum chaired by former NIMH director Lewis Judd, M.D. He said that when he and Barkin arrived in New York he called the studio and found out they would not be on the show. Goldsmith said he was furious: "The people on the 'Donahue' show told me they had changed the format and I was no longer scheduled to be on the program. Only people who had negative effects were on the program, and there were no medical professionals at all. It reminded me of 'Geraldo'!"
Goldsmith called Judd and told him what had happened. Jim Broatch, executive director of the Obsessive Compulsive Foundation, one of about 25 to 30 mental health groups represented at the meeting, said: "We stopped what we were doing and drafted a protest and faxed it to the show." It said in part: "Describing anecdotal incidents with no balance can frighten people who are ill and could cause them to stop using their medications. This could have serious repercussions, for which you could be held legally as well as morally responsible." Judd said the 36 organizations in the forum represent 1.5 million professional, scientific,, and consumer members; nevertheless, the fax was ignored.
Now in her 40s, Barkin began psychiatric treatment in her mid-20s when she lost her job and was diagnosed with chronic neurotic depression that was incapacitating. She was hospitalized about six times for a month or two each time, and has attended the day program at McLean Hospital in Belmont, Mass., for several years, and participated in psychotherapy. "She was on every antidepressant drug available showing only marginal responses, and developed tardive dyskinesia on an antipsychotic drug. She started Prozac about five years ago when it was a research drug and has done beautifully," according to Jonathan O. Cole, M.D., who has been following the patient's case for 10 years. Cole is director of the affective disorders program at McLean. Barkin and her therapist agree that she has made a lot of progress in therapy, Cole said, and she currently is an active full-time member of the manic depressive association at McLean where she started a drop-in center for depressed patients and single-handedly runs a hotline. "She is energetic, well-organized, functioning well, and creative," he said. "She's better than she was when she got sick and has shown none of the more usual side effects. She's one of a group of patients I've seen around here with an outstanding response to Prozac.
"Ten to 20 percent of treatment-resistant patients who get Prozac have a wonderful response," Cole said. "Other patients get better, but they aren't wonderful."
Cole is a coauthor of the much-quoted Teicher study of six patients who developed suicidal ideation while taking fluoxetine, published in the February 1990 issue of the American Journal of Psychiatry.
"I probably should have known that no good would come of it," he said of the study, "but all we wanted to point out was that this strange reaction occurs at times. The main point was that people who weren't suicidal, were after taking the drug. I had one patient in the study who had had some suicidal thoughts in the past, but nothing like what she experienced when she started Prozac. A couple of Teicher's patients cut themselves. These were primarily treatment-resistant patients, so it may be more frequent in people with a long, complicated history and who have been resistant to treatment for several years, people like Evie Barkin."
Cole said the journal pushed Teicher to estimate the frequency of suicidal ideation as a side effect of fluoxetine, and Teicher estimated about 4 percent. "I personally think it's one percent or less," Cole said. "About twice a month I see someone who says when they were on Prozac they got suicidal. It really may be happening, but I think it's partly because they read something about it.
"It's a good antidepressant, and I have used it as the first drug in people who come to me who do not have sleeping problems rather than a sedative tricyclic," he said.
Peter Stokes, M.D., chief of the division of psychobiology and associate professor of psychiatry at Paine Whitney Psychiatric Center in New York City, was one of the first psychiatrists to study fluoxetine with inpatients. "I prescribe Prozac for a very significant percentage of patients, and it has been increasing over the years since the drug was made available," he said. "I would say probably it's one of the two or three antidepressants most commonly used, probably prescribed for 30 percent or more of patients with major depression."
One advantage of fluoxetine is that it has a more benign side effect profile, Stokes said. "This is important because in acute illness you are always worried about suicidal activity, in particular overdose. If you look at emergency room records you find that many patients overdose with antidepressants. With Prozac the data to date show that overdose is more benign."
Stokes said fluoxetine side effects occur in 10 to 15 percent of patients, but they tend to show up in the first two weeks "and then lessen with time. This is unlike the older antidepressants where the side effects become more serious as you increase dosage. This is a problem since full dosage should be reached within two weeks."
A forensic study of 3,800 patients reported in the September/October issue of the Journal of Analytical Toxicology, by RL Kincaid and colleagues supports Stokes' belief. It reports one suicide caused by an overdose of fluoxetine. But Kincaid told The Psychiatric Times that "This was definitely an aberration. I think it's a very safe drug."
The woman who used fluoxetine to overdose had "evidently been saving up the Prozac medication," according to Kincaid. "Several prescription vials were inappropriately empty of fluoxetine, but propranolol dosages remaining were appropriate and intact." The report said that "the decedent had available to her as much as 6,000 mg of Prozac (300 single dosage units, 75 maximum daily doses).
In a 1990 talk paper, the FDA stated that "there appears to be no basis to conclude that the use of Prozac is associated with any unreasonable or unexpected risk." But the FDA has received 12,372 complaints about side effects of fluoxetine between the time it was approved in 1987 and February 1991. The spokesperson said of the number of complaints: "It's certainly high," but did not have a breakdown of how many complaints referred to suicidal or homicidal ideation.
The Psychiatric Times has obtained a copy of a letter sent to "Prozac Survivors" by CCHR in December, however, that might account for the high number of complaints. The FDA's adverse reaction report is attached and the letter states: "If you haven't filled this out and sent it in to the FDA, please do that today."
Suicidal thinking is common in patients treated with antidepressants. Stokes estimated that 60 percent of patients he sees have suicidal thinking, and one in five report suicidal plans or attempts. "One can see increased suicidal thinking and even attempts during treatment with any antidepressant, including Prozac," he said. "There doesn't seem to be any evidence that there is a specific drug-initiated suicidality. I think the consensus among physicians is that there is little evidence to support that Prozac is inducing suicidal thoughts."