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Misleading Medicine
By Kelly Patricia
O’Meara
komeara@InsightMag.com
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
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