-Caveat Lector- http://www.insightmag.com/archive/200104301.shtml Misleading Medicine ---------------------------------------------------------------------------- ---- By Kelly Patricia O’Meara [EMAIL PROTECTED] ---------------------------------------------------------------------------- ---- Pharmaceutical giant Eli Lilly is promoting Sarafem as a miracle pill for women suffering from PMDD, a ‘mental disorder’ not yet proved to exist. What ’s more, Eli Lilly admits that Sarafem has the same active ingredient as Prozac, complete with the same dangerous side effects. Australian-born singer Helen Reddy’s 1972 hit song “I Am Woman” has been called a feminist battle hymn. Many a male disc jockey at the time refused to air it until the song became part of the soundtrack to a movie and catapulted to the top of the Billboard charts. Taking a look at the song today, it’s hard to imagine the furor generated by the lyrics from the lady down under: “Oh, yes, I am wise, but it’s wisdom born of pain. “Yes, I’ve paid the price, but look how much I gained. “If I have to I can do anything. “I am strong. I am invincible. I am woman.” Nearly three decades since the release of this feminist anthem the lyrics neither threaten nor offend — if they ever did — but seem to acknowledge pride in feminine strength. As if it needed to be said, historians agree on the significance of women in the building of this nation. The Jamestown settlement, for instance, was a disaster and on the brink of failure until women were added to the new colony. The West was won by men and women working side by side, and the United States triumphed over its enemies in World War II with the help of nearly 500,000 women in the ranks and millions more in the factories. Not surprisingly, women achieved these feats completely unaware that a few days out of each month they were suffering from a mental disorder. That’s right. The Food and Drug Administration (FDA) recently approved the use of Sarafem (fluoxetine) for women suffering from a mental disorder just three or four days a month — in the “luteal phase” or just before the onset of menses. This “mental disorder” — which the American Psychiatric Association (APA) has not yet accepted, but which is listed in the appendix of the APA’s Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) — is called premenstrual dysphoric disorder, or PMDD. It’s a new-and-improved version of premenstrual syndrome (PMS), which also has not made it to the hit parade of the official APA list of mental illnesses. The fact that PMDD is listed only in the diagnostic manual’s appendix reflects the APA’s desire for further research before accepting it as a full-fledged mental disorder. According to the DSM-IV and the FDA, a woman must experience five or more symptoms before the diagnosis can be made. The unofficial mental disorder is said to be characterized by the following symptoms: Markedly depressed mood Marked anxiety Marked affectivity Decreased interest in activities Feeling sad, hopeless or self-deprecating Feeling tense, anxious or “on edge” Persistent irritability, anger and increased interpersonal conflicts Feeling fatigued, lethargic or lacking in energy Marked changes in appetite A subjective feeling of being overwhelmed or out of control Physical symptoms such as breast tenderness, swelling or bloating. Eli Lilly and Co., the Indianapolis-based pharmaceutical company that makes Sarafem, has been marketing the “new” treatment with such gusto that there are jokes about the company exhibiting obsessive-compulsive disorder. It seems there isn’t a magazine to be picked up or a channel to be surfed that isn’t running a Sarafem advertisement. These ads show women expressing many things. One TV spot depicts a woman trying to button her slacks and looking angry and agitated. Another scene shows a woman snapping at her husband, “Just leave me alone,” while still another involves a woman slumped on the couch sobbing. Then there is the slogan: “Sarafem — More like the woman you are.” Lilly reports in its ads that now, “Doctors can treat PMDD with Sarafem — the first and only prescription medication for PMDD.” The ad further states that, “Sarafem contains fluoxetine hydrochloride, the same active ingredient found in Prozac.” But both Sarafem and Prozac are fluoxetine hydrochloride. According to Laura Miller, marketing associate for Eli Lilly, “Fluoxetine hydrochloride is the same active ingredient in Sarafem as in Prozac.” Again and again Insight asked, “Then is it the same thing?” Again and again Miller only repeated that the two identical doses of fluoxetine hydrochloride have the same active ingredient. Miller refused to acknowledge that Sarafem is just Prozac repackaged, or that the pill color was changed from green to feminine pink and lavender to market it for a not-yet-approved “mental disorder” that never before existed. The Lilly representative did say the difference in the treatments is in “how women react to the drug.” Never mind that all this dramatic hype, supported by millions of dollars in marketing, has occurred just before Lilly loses its exclusivity on Prozac in August. “We asked women and physicians,” says Miller, “about the treatment of PMDD, and they told us they wanted a treatment option with its own identity that would differentiate PMDD from depression. [Prozac is the most common treatment for depression and has been available since 1987.] PMDD is not depression. As you know, Prozac is one of the best-known trademarks in the pharmaceutical industry and is closely associated with depression. They wanted a treatment option with its own identity.” But what is the difference, Insight asked Miller, if a woman takes 20 milligrams (mg) of Prozac (fluoxetine hydrochloride) for depression or 20 mg of Sarafem (fluoxetine hydrochloride) for PMDD? “The difference,” explains Miller, “is that PMDD is a distinct clinical condition different than depression. PMDD is not depression.” What’s the difference if it’s the same drug? “PMDD,” continues Miller, “is cyclical — women suffer from PMDD up to two weeks before their menses, and the other two weeks of the month they don’t have the symptoms of PMDD.” Hmm, so they are crazy “up to” half the time! In any case, if the Lilly representative is correct, ask critics, why is Sarafem/Prozac prescribed for every day of the month for as long as it takes to eliminate the PMDD symptoms — which could be years. Pressed to explain the difference in the two drugs, not the disorders, Miller suggests Insight speak with women who have PMDD. She flatly refuses to clarify any pharmacological difference between Sarafem and Prozac. More importantly, how can one offer a treatment for a mental disorder (PMDD) before it is determined that it exists? According to Lilly’s own literature there is no science to support the diagnosis. “While it is unknown what causes PMDD, many doctors believe it may be related to an imbalance in a natural chemical in the body called serotonin. The actions of Sarafem on serotonin may explain its effects in improving the symptoms of this condition.” The “science” that Lilly forwarded to Insight included a position paper from the American College of Gynecologists (ACOG) citing several clinical studies and an article published last year in Lancet, a prestigious British medical journal. The ACOG paper, “Premenstrual Syndrome,” and the Lancet article, “Efficacy of Selective Serotonin-Reuptake Inhibitors (SSRIs) in Premenstrual Syndrome: A Systematic Review,” suggest the efficacy of treating PMDD in women with SSRIs (Sarafem/Prozac). The point is that when asked if Lilly has the science to prove that PMDD exists and that Sarafem is anything but a mind-altering drug, Lilly responded instead by pointing to controlled clinical trials involving SSRIs and placebos. While there are many trials supporting the efficacy of SSRIs in making women said to have PMS/PMDD “feel better” in the two weeks before menstruation, no indication is provided that this effect is anything but a psychotropical masking of discomfort. According to Renay Tanner, a respected researcher in the field who holds a bachelor’s degree in biological sciences, a master’s in sociomedical sciences and is finishing her doctorate in sociomedical sciences at Columbia University, “PMDD is a socially constructed disease. There is no MRI [magnetic resonance imaging], X-ray, blood test, etc. [to confirm that it even exists]. There is nothing scientific about this.” Women feel differently when on SSRIs, Tanner explains, “because of what are commonly known as the side effects of these drugs. This does not indicate that the patient is ‘better’ by any scientific standard. How can a drug that is used to treat separation anxiety in dogs also be used to treat PMDD? This is an insult to women. It’s almost mind-boggling that all these physicians are playing along.” Tanner tells Insight that promotion of fluoxetine hydrochloride to treat PMDD as a mental disease “is an example of a health-care system driven by the maximization of profits, not by what works. The patient has be-come a commodity. The bigger picture is that such greed-centered medicine is leading to human- and civil-rights abuses at a phenomenal rate, ranging from disability discrimination in the workplace and educational institutions to coerced drugging of individuals by the legal system. Prozac is being prescribed for everything: It’s like snake oil. They have a drug, they come up with a disease and then they come up with the science to justify using the drug as treatment. There is something very wrong with this.” Robert Whitaker is an award-winning author of a series written for the Boston Globe about research, pharmaceutical companies and the mentally ill, as well as author of the soon-to-be-released book Back to Bedlam — a look at the failure of modern medical treatments of schizophrenia. He tells Insight, “This sort of thing is becoming very common. With PMDD you’re talking about the extreme end of something normal in life — regular ups and downs. But you see it time and again.” Sarafem, explains Whitaker, “is a mind-altering drug, and it has all kinds of adverse side effects — the most immediate being sexual dysfunction, but the primary effect is altering emotion. No one knows how the brain reshapes itself in response to the drug, and let’s remember we’re talking about symptoms of a type that are very common.” The drug, Whitaker further explains, “cannot differentiate the diagnosis in the brain. Whether you have depression, PMDD or no mental disorder, this drug will make you feel different. The reduction in symptoms is a subjective measurement in the sense that there is no easy way to measure irritability. Calling it Sarafem rather than Prozac is misleading and unethical. It hides what is known about the side effects of Prozac. It is profound intervention. This is at least in part about selling drugs — making sure you have a flow of patients who have been taught that they should have a miracle pill. Today we believe in mind pills —it’s a kind of worship of the day. But people know about Prozac, and they know it has serious consequences.” Just how serious are the adverse effects of Prozac? Houston attorney Andy Vickery of Vickery & Waldner (www.justiceseekers.com) has spent a great deal of time researching what he believes is a deadly serious question. Vickery has represented numerous clients in lawsuits where Prozac was alleged to be the cause of violent deaths, including Forsyth v. Eli Lilly. “Lilly” says Vickery, “has avoided all but two trials out of hundreds of lawsuits by settling out of court or having the suits dismissed.” Bill Forsyth spent two days on Prozac and was taken to the hospital by his son, who testified that his father reported having weird thoughts about knives and had mentioned this while being admitted to the hospital. Forsyth remained in the hospital for seven days, where the Prozac was continued, and then was released. He returned home, stabbed his wife of 37 years 15 times, then impaled himself on a butcher knife and died. In April 1999, Lilly won in the Forsyth case. However, the Forsyth family has filed a new lawsuit to set aside the judgment on the grounds that it was obtained by defrauding the court. According to a press release put out by Vickery & Waldner, “The suit alleges that critical information was withheld from the judge and jury.” Specifically, the new lawsuit notes that Lilly agreed to pay $90 million for a patented new Prozac molecule to reduce certain side effects of the original Prozac, including “nervousness, anxiety, insomnia, inner restlessness, suicidal thoughts, self-mutilation and manic behavior.” But, contends the lawsuit, a Lilly in-house patent lawyer sat mutely in the courtroom while Lilly’s trial counsel told the judge and jury that suicide is not a side effect of Prozac. In other words, Lilly consistently has denied that Prozac causes suicidal thoughts, but has a new Prozac patent to improve the original by eliminating its potential to cause suicidal thoughts. According to Vickery, who also has filed suit against Lilly for fraud, the pharmaceutical company now has dropped interest in the new patent. It also was during the Forsyth trial’s closing arguments that Vickery first made public a time line of Lilly’s internal documents, obtained in discovery, that he says confirms Lilly has been aware of Prozac-induced suicidal thoughts and violence. The time line begins in 1978 and continues until 1998 — a year before the judgment in the Forsyth case. Perhaps the most revealing internal document is one dated Jan. 30, 1999, that Vickery explains is a letter giving sales representatives a heads-up on a forthcoming article regarding Prozac and suicide. It instructs 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.” Asked if this information was made available to the FDA during the approval process for Prozac, FDA Public Affairs Specialist Susan Cruzan tells Insight, “The issue was thoroughly investigated by the FDA, and the safety and effectiveness is taken into consideration. All side effects and safety information are taken into consideration.” The internal documents presented in the Forsyth case are not the only indication that there may be a strong association between Prozac and suicidal behavior. Psychologist Blake Tracy, a Ph.D. who is author of Prozac: Panacea or Pandora (www.drug awareness.com), reports that, “according to FDA spokespersons, there have been more adverse-reaction reports on Prozac than any other medical product. As of October 1993, a total of 28,623 complaints of adverse side effects had been filed with the FDA, including 1,885 suicide attempts and 1,349 deaths.” Tracy further reported that the “FDA’s general rule of thumb for estimating the true figures is that these reports represent only 1 to 10 percent of the actual figures.” Insight requested updated information from the FDA on the number of adverse reactions reported on Prozac but was told it would not make that information available until requested in writing under the Freedom of Information Act. Paula Caplan is an affiliated scholar at Brown University’s Pembroke Center for Research and Teaching on Women, and the author of nine books including, They Say You’re Crazy: How the World’s Most Powerful Psychiatrists Decide Who’s Normal. She tells Insight that, “I’ve written and said it many times: There is no such thing as premenstrual mental illness.” Caplan says, “No one has ever found any evidence that PMDD exists, let alone PMS. Why do we focus on women’s cycles even though there is no data to support that women get more angry or aggressive than men at a certain time of the month? And why are they blaming it on serotonin instead of hormones?” According to Caplan, “Prozac has been prescribed for everything — anorexia, depression, obesity, obsessive-compulsive disorder. Apparently it’ s good for whatever ails you. But to say that a large number of women are crazy once a month is demonizing and demoralizing to women.” It also is highly profitable for Eli Lilly, which is spending millions to hype that idea in a way that will sell Sarafem. And the fact is, according to the Wall Street Journal last year, 84 percent of women who ask their physician for a drug by name leave the office with a prescription for it. ---------------------------------------------------------------------------- ---- Internal Lilly Documents Introduced at Forsyth Trial Reveal Knowledge of Violent and Suicidal Tendencies 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 (p. 3, sixth paragraph) 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 do 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 (pp. 18 and 22) June 1986: Draft of proposed “Precaution and Adverse Reactions” sections of the Prozac package insert — “Mania and psychosis may be precipitated in susceptible patients by antidepressant therapy.“ Exhibit 5 (first page) (never included in actual inserts) August 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. Aug. 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 first page and top of second page) Oct. 2, 1990: Memo of 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 (second page) Nov. 13, 1990: Memo from Claude Bouchy [Lily 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 Nov. 14, 1990: Second memo from Bouchy to 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 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 Copyright © 2000 News World Communications, Inc. 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