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An anonymous woman tries to disentangle a shopping cart from an interlocked row
of them, outside a suburban store. She is frustrated and angry. She becomes even
more exasperated when another shopper enters the frame, calmly unhooks a cart
and glides smoothly on her way. Watching this TV advertisement unfold, it might
look like the woman is experiencing little more than a normal bout of tension
or stress. But the folks at the drug company Lilly know better. This woman may
need a powerful antidepressant because she is suffering from a severe form of
mental illness known as PMDD. "Think it's PMS? It could be PMDD," intones
the voiceover.
Columbia University Professor Jean Endicott tells us premenstrual dysphoric
disorder (PMDD) is a psychiatric condition suffered by up to 7 percent of women.
Paula Caplan of Brown University claims that the condition has essentially been
invented and that there is no strong scientific evidence to distinguish it from
normal premenstrual difficulties. Even worse, argues Caplan, using a medical
label to explain away the severe distress some women experience in the lead-up
to their period runs the risk of masking the underlying causes of their suffering.
In the United States, the Food and Drug Administration has accepted
that the condition PMDD exists and has approved Lilly's Prozac and several similar
antidepressants for its treatment, yet in other parts of the world it is not
even a recognized disease. It is not listed as a separate disorder
in the World Health Organization's International Classification of Diseases.
And even in the United States, despite the hard work of Endicott, Lilly and
other pharmaceutical companies, PMDD still has only a partial listing in the
psychiatrists' manual of diseases, the DSM, and is therefore not seen as a fully
official category of illness.
Yet this scientific controversy is invisible in the avalanche of television
and magazine advertisements about PMDD in the United States--much of it targeting
young women. The $500 billion pharmaceutical industry has identified another
new mega-market--women of childbearing age--and the world of marketing demands
simple, clear messages. The emotional ups and downs preceding your period are
no longer a part of normal life--they are now a telltale sign you could have
a psychiatric condition. As Caplan puts it, by watching these ads "women
are learning to consider themselves mentally ill."
A friendly and hardworking academic, Endicott operates from a small office
buried in the basement of a psychiatric hospital in New York City. In stark
contrast to Caplan, she insists PMDD is a genuine disorder that can be "very
disabling" and is often not properly diagnosed or treated. She welcomes
drug company efforts to have the condition taken more seriously. It was Endicott
who led the key scientific meeting--funded by Lilly and attended by company
representatives--that paved the way for two of the most important developments
in the life of this young disorder: FDA acceptance of the condition and approval
of Lilly's antidepressant as the first drug to treat it. As to the appropriateness
of drug companies advertising disorders like this on television, Endicott is
a strong believer. "I think it educates people," she says.
The pharmaceutical industry in the United States now spends more than
$3 billion a year on direct-to-consumer advertising, promoting its most lucrative
brands. Increasingly, however, these commercials are not just selling drugs
but also the diseases that go with them. The shopping-cart ad for PMDD
is part of a new form of TV advertising designed to introduce millions of people
to previously unheard-of conditions. While the advertising claims made about
the benefits and risks of medicines are regulated by law--albeit very loosely--claims
about diseases remain a virtual free-for-all.
The story behind the "discovery" of PMDD illustrates how an unknown,
unofficial and, for some, unreal condition can be pushed from the back pages
of the psychiatrist's manual into glossy magazines and onto TV screens. In the
late 1990s Lilly's antidepressant Prozac--whose chemical name is fluoxetine--was
about to lose its patent, and the manufacturer stood to lose hundreds of millions
of dollars because of the emergence of cheaper generic competitors. Winning
approval of the drug for a new disease might re-energize sales of this blockbuster
chemical.
In late 1998 Lilly helped fund a small meeting, impressively titled a "Roundtable"
of researchers, which discussed PMDD. The meeting of just sixteen key experts
took place in Washington, and it was attended by a group of FDA staff and at
least four Lilly representatives. The chair was Columbia University's Endicott,
who had by then been pushing for the acceptance of this disorder for more than
a decade. This time, though, Endicott had a giant pharmaceutical company on
her side.
The meeting reached two important conclusions, both highly favorable to Lilly:
There was now an alleged consensus that the disorder existed, and most people
present thought there was sufficient evidence to support the use of antidepressants
like Prozac to treat it.
By Christmas of 1999 a meeting of advisers to the FDA had voted unanimously
to approve Lilly's fluoxetine for the treatment of PMDD. Soon after, the FDA
formally gave Lilly the green light to market its drug for PMDD, and Lilly organized
a launch to do just that. But in an extraordinary turn of events, the pill did
not debut under the name Prozac. After doing some market research with doctors
and potential patients, Lilly decided to repaint Prozac in attractive lavender
and pink and rename it Sarafem.
For specialists in pharmaceutical marketing like Vince Parry, the story of
PMDD and Sarafem is a great example of a company "fostering the creation
of a condition and aligning it with a product." He worked for Lilly on
the campaign, which he describes as helping to "build awareness for both
the condition and the drug." To kick it off, he says, the company sponsored
a "pre-launch initiative" to raise awareness of the condition. "By
changing the brand name from Prozac to Sarafem--packaged in a lavender-colored
pill and promoted with images of sunflowers and smart women--Lilly created a
brand that better aligned with the personality of the condition for a hand-in-glove
fit." Lilly's market research investigated how best to brand both the drug
and the condition to come up with language women felt most comfortable with.
Lilly's shopping-cart commercial duly followed and provoked a complaint from
the FDA alleging that the ad was "lacking in fair balance" because
it minimized information about the drug's side effects. In the end, the FDA
simply asked Lilly to withdraw the offending ad. This is typical. Despite repeated
violations across the industry, and tens of millions of Americans being regularly
exposed to misleading information about the risks and benefits of widely prescribed
drugs, companies are rarely fined and executives are not held accountable.
Another theme has recently emerged in pharmaceutical industry advertising.
Researchers are finding more and more ads helping to sell the idea that
everyday human experiences are symptoms of medical conditions requiring treatment
with drugs. Together with colleagues, two doctors from Dartmouth Medical
School, Steven Woloshin and Lisa Schwartz, recently analyzed some seventy drug
company ads in ten popular magazines. They found that almost half tried to encourage
consumers to consider medical causes for their common experiences, most often
urging them to consult a physician. The ads targeted aspects of ordinary
life including sneezing, hair loss and being overweight--things many people
could clearly manage without seeing a doctor--and portrayed them as though they
were part of a medical condition. The researchers speculated that advertising
was increasingly medicalizing ordinary experience, and pushing the boundaries
of medical influence far too wide.
Watching these trends closely is Canadian researcher Barbara Mintzes,
who included in her PhD thesis at the University of British Columbia in Vancouver
a rigorous examination of drug company advertising. She also discovered that
many ads now promote medical conditions, rather than just drugs, and are helping
to medicalize life, as she puts it. "To an unprecedented degree they portray
the educational message of a pill for every ill--and increasingly an ill for
every pill. It's a shift from a drug that's approved to treat people who are
actually suffering from an illness to the idea that you just take a pill to
deal with normal life situations."
Mintzes is particularly outraged by the promotion of PMDD, which has been aggressively
advertised in magazines read by teenagers, as well as in TV commercials. In
her view it seems designed to make younger women feel there is something wrong
with the normal emotional fluctuations they experience in the lead-up to their
monthly period. While accepting that for some people the problem can be severe,
Mintzes worries that the ads paint a shallow picture of what it means to be
a young woman. "There is pressure on people to be someone other than who
they are."
With all treatments there is a balance between benefits and harms. For someone
who is very sick, the chances of a great improvement may easily outweigh the
risks of side effects from a drug. The antidepressants like Prozac that are
being prescribed for PMDD carry many side effects, including serious sexual
difficulties, and for teenagers an apparent increase in the risk of suicidal
behavior. Such risks might be worth taking for someone severely debilitated
by chronic clinical depression, but for a woman arguing with a boyfriend or
frustrated by a shopping cart?
"When you're giving drugs to healthy people you're shifting the balance,"
says Mintzes. "If you're already healthy, the likelihood of benefit becomes
much, much smaller, and then there's a concern that what we are actually doing
at a population level is causing much more harm than benefit through drug treatment."
Professor Endicott bluntly rejects the concern that PMDD is an example of ordinary
life being medicalized. "It's an insult to suggest that women with less
severe symptoms would even be seeking treatment. Women are not running around
saying, Give me a pill for everything."
Finding hard scientific evidence to help settle this difference of opinion
is difficult. Mintzes's research has added to a body of studies suggesting that
these ads do drive many people into doctors' offices, and that some doctors
will prescribe the advertised drugs even when they may doubt their appropriateness
for the problem at hand. But there have been few, if any, large studies that
rigorously investigated whether direct-to-consumer advertising causes unnecessary
medical labeling or leads to inappropriate or harmful prescription of drugs.
What is crystal clear, however, is that the ads boost drug sales.
Industry executives argue that the most powerful case for direct-to-consumer
advertising is evidence of underdiagnosis and undertreatment among people with
serious health problems, including high cholesterol, high blood pressure, depression
and, presumably, PMDD. In a special issue of the British Medical Journal devoted
to the topic of medicalization titled "Too Much Medicine?" two senior
officials from the drug company Merck wrote that the rules governing drug advertising
should be loosened in Europe to help fix the urgent problem of undertreatment.
They claimed there was little good evidence to support the view of Mintzes and
others that advertising leads to inappropriate prescribing or harm: "Unfounded
fears" about advertising, they wrote, were restricting people's rights
"to have all the information they need to make informed choices about their
health."
One of the weaknesses in this argument is the failure to acknowledge the controversy
and uncertainty surrounding the definitions of the common conditions said to
be massively underdiagnosed. If estimates of the numbers of people suffering
from these conditions and requiring treatment are inflated to start with, as
some observers consider to be the case with high cholesterol and depression,
for example, then claims of widespread undertreatment deserve to be taken with
extra-large doses of scrutiny and skepticism. With PMDD, claims of underdiagnosis
and undertreatment make little sense if the condition itself doesn't even exist.
There is little doubt that many people in genuine need are not getting the
medical attention or medication they require, particularly among the poor of
wealthy nations and the wider developing world. Whether spending billions advertising
disorders like PMDD on television and in women's magazines is the best way to
correct that problem is highly questionable. Undertreatment may often have more
to do with lack of money or access than lack of information. And as to the claim
that advertising is the best way to inform, educate and encourage more choice,
the deputy editor at the Journal of the American Medical Association, Dr. Drummond
Rennie, disagrees. "Direct-to-consumer advertising," he says, "has
got nothing to do with the public's education and it has got absolutely everything
to do with...boosting product sales."
Postscript. In Europe Lilly's marketing of Sarafem/Prozac came to an
abrupt stop. In mid-2003 a panel from the European Agency for the Evaluation
of Medicinal Products noted that "PMDD is not a well-established disease
entity across Europe.... There was considerable concern that women with less
severe premenstrual symptoms might erroneously receive a diagnosis of PMDD resulting
in widespread inappropriate short- and long-term use of fluoxetine."