The pharmaceutical industry has a dream: at least one disease (and
more than one prescription drug) for every American.
You see a TV show or a commercial featuring medical problems, and you start
feeling the symptoms yourself: a twinge in the leg or maybe a moment of doubt
about your emotional stability.
If so, you, like millions of Americans, could be suffering from a serious condition
known as telechondria. But help is here, with new Advertil(R) in the green-and-yellow
caplet. Ask your doctor …
No, wait, don't really ask. Telechondriacs have not yet been recognized by
science. Pharmacists are not dispensing drugs like "Advertil," and
they probably never will. The last chemical that pharmaceutical executives would
want to sell you is one that makes it harder for them to convince you that you're
sick and need their products.
Drug corporations and their "awareness" groups, as we're all painfully
aware, have defined and redefined a host of medical conditions -- including
female sexual dysfunction, erectile dysfunction, restless legs, sleeplessness,
bipolar disorder, attention deficit disorder, social anxiety disorder and irritable
bowel syndrome -- to include larger and larger segments of the population in
the United States and other Western nations.
Accepting for a moment the industry's claims about the numbers of people suffering
from the eight diseases listed above, we could do some simple calculations
showing that up to 93 percent of adult women and men in the United States suffer
from at least one of them. Throw in a few more conditions like depression, bone
density loss and premenstrual dysphoric disorder, and industry figures make
it appear that virtually every American has a disease in need of a treatment.
Last year, Ray Moynihan and Alan Cassels called attention to the epidemic of
disease marketing in their book "Selling
Sickness." Last month, health professionals, academics, journalists
and consumers gathered in Newcastle, Australia, for the Inaugural Conference
on Disease Mongering. A set
of papers from that meeting was published free by the online journal PLoS
Medicine. Also last month, the Prescription Access Litigation Project (PALP)
in Boston announced its "2006
Bitter Pill Awards," recognizing drug companies that engaged in the
year's worst "overzealous and questionable marketing practices."
These and other recent activities make it all too clear that the profitable
practices exposed in Lynn Payer's 1992 book "Disease Mongers: How Doctors,
Drug Companies, and Insurers Are Making You Feel Sick" have been refined
and amplified in recent years, with the apparent goal of medicating an entire
Unruly body parts
The evolution of "restless legs syndrome," documented by Steven Woloshin
and Lisa Schwartz in a paper from the Disease Mongering Conference, is a case
study in how a pharmaceutical company, with help from the media, can turn what
is a serious problem for some people into a contrived medical condition for
Woloshin and Schwartz analyzed media coverage in the interval between 2003,
when GlaxoSmithKline Inc. first issued press releases about trials of its drug
Requip for relief of restless legs syndrome, and 2005, when the U.S. Food and
Drug Administration (FDA) approved that use.
Of 187 major newspaper articles published during those two years, 64 percent
relayed without comment the industry's claims that millions of Americans --
as many as "1 in 10 adults" -- suffer restless leg. Forty-five percent
of the articles stressed that many people may be unaware they're sick, even
though, according to 73 percent of the articles, the syndrome can have extreme
physical, social and emotional consequences. Reports of the relief provided
by drug treatment used "miracle language" 34 percent of the time,
while 93 percent of articles failed to quantify Requip's side effects.
Yet the relief people get from Requip appears to be anything but miraculous.
In one trial, 73 percent of subjects saw improvement -- compared with 57 percent
whose symptoms improved with a placebo! Side effects that occurred in clinical
trials at least twice as often with Requip as with a placebo included nausea
(40 percent of subjects), vomiting (11 percent), somnolence (12 percent), dizziness
(11 percent) and fatigue (8 percent).
My attempts to obtain responses from several drug companies to charges of mongering
restless leg and other conditions went unanswered. Quoted last month by the
Guardian (U.K.) as he defended
his company against bad publicity generated by the conference, David Stout of
GlaxoSmithKline said, "You need to talk to the patients. Things like restless
leg syndrome can ruin people's lives. It is easy to trivialize things when you
don't have them. If people did not want the treatments, they would not seek
Restless leg syndrome in its most serious form is indeed no joke. My father
was tormented for years by near-constant symptoms, until, without ever having
seen an advertisement, he sought treatment.
But, says Dr. David Henry, who is a physician, professor at the University
of Newcastle and co-organizer of the Disease Mongering conference, "When
you extend a drug beyond the [most severely afflicted] group on which claims
of its effectiveness are based, you see a falling ratio of good to harm. The
benefits of the drug diminish, while the side effects tend to stay the same."
Henry told me, "The companies know quite consciously that they're going
into areas where they're doing net harm."
In their conference paper, Woloshin and Schwartz note that restless legs syndrome
is one of those "disease promotion stories" that the press loves to
cover: "The stories are full of drama: a huge but unrecognized public health
crisis, compelling personal anecdotes, uncaring or ignorant doctors, and miracle
Irritable everything syndrome
The story of another disease, irritable bowel syndrome, has all of those dramatic
elements, plus dead patients.
In "Selling Sickness," Moynihan and Cassels describe public-relations
offensives by Novartis Pharmaceuticals and GlaxoSmithKline to popularize a condition
called irritable bowel syndrome (symptoms of which are described as "abdominal
pain or discomfort associated with changes in bowel habits in the absence of
any apparent structural abnormality").
The companies stood to gain billions in sales if, as they claimed, as many
as 20 percent of Americans had the syndrome. GlaxoSmithKline's drug Lotronex
received FDA approval for treatment of irritable bowel in 2000, and Novartis'
Zelnorm was approved in 2002. In statements to the FDA and the public, the companies
tended to characterize irritable bowel syndrome as it is experienced by the
worst-afflicted patients -- a tiny percentage of the total -- while emphasizing
claims that the syndrome hits vast numbers of Americans.
TV star Kelsey Grammer and his wife Camille Grammer, who suffers from the disease,
made the rounds of talk shows in a publicity effort quietly funded by GlaxoSmithKline,
while Novartis deployed former Wonder Woman Lynda Carter to stress that common
stomach problems might be irritable bowel, a "real medical condition."
The FDA wrote to Novartis in 2003, demanding that the company discontinue other
advertising that it considered misleading because it exaggerated the drug's
benefits and the numbers of people who need it while minimizing its side effects.
Lotronex can now be prescribed only by doctors who have enrolled in a GlaxoSmithKline
"Prescribing Program." According to Moynihan and Cassels, the drug
came under fire in late 2000 when three FDA scientists wrote to their superiors
expressing alarm over a rising toll of deaths and hospitalizations of irritable-bowel
patients during the nine months that Lotronex had been on the market. (The concern
was spurred by the remarkably increased rates; the deaths had not been shown
in a clinical trial to have been caused by Lotronex.)
"Selling Sickness" contains this frightening description of one side
effect: "For some of those who experienced severe constipation after taking
the drug, their feces would become so impacted within their bowel that the bowel
wall perforated, leading to potentially fatal infections inside the body."
A conference paper by David Healy traced the expanding definition of bipolar
disorder over the past quarter century. The disease officially entered the manual
of mental disorders in 1980, and based on its original diagnostic criteria --
which included an episode of hospitalization -- bipolar disorder is a devastating
disease for 0.1 percent of the U.S. population. Over time, it has been broadened
with additional criteria based on community surveys, so that the disease once
known as "manic depression" is now said to affect 5 percent or more
According to Healy, there is "almost no evidence" that drug treatment
works for that much broader group of "community-based" disorders.
Yet manufacturers like Eli Lilly and Co. and Janssen L.P. have heavily promoted
pharmaceutical treatment of bipolar, as broadly defined, through websites, patient
literature and new scientific journals devoted to the disease.
Evidence is accumulating that one drug prescribed for bipolar disorder (Lilly's
Zyprexa) causes withdrawal symptoms, that patients on drugs for bipolar tend
to be hospitalized more often than those who are not, that the drugs are associated
with a heightened risk of suicide and that antipsychotic drugs in general are
associated with increased death rates.
Despite such problems, says Healy, there is a recent "surge of diagnoses
of bipolar disorder in American children." He cites one book that actually
appears to accept the possibility that bipolar disorder may first show up in
The drug industry has thoroughly penetrated the juvenile market for another
well-known disease, attention deficit disorder (ADD, also called attention deficit
hyperactivity disorder, ADHD). The numbers of prescriptions to be written are
huge; the National Institutes of Mental Health estimates that there's an average
of at least one afflicted child per typical-size classroom. But people spend
many more years as adults than as children, and stiff competition among the
major ADD drugmakers -- among them Shire PLC, Novartis and Lilly -- guaranteed
that the larger pool of potential adult patients would be targeted.
All three companies contribute or have contributed funds to the organization
Children and Adults with Attention Deficit/Hyperactivity Disorder (CHADD), which
calls ADD "a lifespan disorder, affecting children, adolescents and adults."
In "Selling Sickness," Moynihan and Cassels describe a talk by a Shire
executive at a CHADD charity golf event, in which he estimated that 8 million
U.S. adults could benefit from treatment. CHADD gets about 20 percent of its
funding from drug firms, and its website provides detailed advice on medication
for ADD. One example:
Although there is little research on utilizing short-acting and long-acting
medications together, many individuals, especially teenagers and adults, find
that they may need to supplement a longer-acting medication taken in the morning
with a shorter-acting dose taken in mid- to late afternoon. The "booster"
dose may provide better coverage for doing homework or other late afternoon
or evening activities and may also reduce problems of "rebound"
when the earlier dose wears off.
The marketing of ADD can venture into bewildering territory. One of PALP's
2006 Bitter Pill Awards went to Lilly for a TV commercial plugging its drug
Strattera. In the ad, information on approved uses and risks is accompanied
by wildly distracting sights and sounds of a video game. The FDA issued Lilly
a mild rebuke over the ad: "The overall effect of the distracting visuals
and graphics is to undermine the consumer's ability to pay attention and comprehend
the risk information …"
The Bitter Pill Awards stressed the obvious irony of an attention-confounding
ad targeted at a clientele who have difficulty paying attention. It could also
be that the well-known practice of drawing notice away from side-effects information
had to be cranked up a couple of notches in this ad to help persuade people
who don't really have a serious ADD problem that they might just need Strattera.
"Selling Sickness" traces another history of market expansion: the
memorable publicity blitz that started with the FDA's 1999 approval of GlaxoSmithKline's
antidepressant Paxil for a condition called "social anxiety disorder."
An early press release insisted that social anxiety disorder is "not just
shyness" but something far worse.
Enough people were convinced that they had that "something worse"
to make Paxil the country's biggest-selling antidepressant for a time in 2000.
Moynihan and Cassels write that GlaxoSmithKline avoided the term "social
phobia," which was preferred by psychiatry for what can be a seriously
debilitating condition, probably because "a lot more people can be categorized
as being ill if you apply the definition of an anxiety disorder rather than
It also couldn't have hurt that the initial letters of GlaxoSmithKline's name
for the disease spelled "SAD."
The pinking of Viagra
Seeing the continuing deluge of advertising for impotence remedies in the American
media, a visitor from the planet Zefitor could be forgiven for wondering how
Earth, with such seemingly dysfunctional male humans, ever came to be inhabited
by 6.5 billion of the species.
At the Disease Mongering Conference, Joel Lexchin traced the history of the
Pfizer Inc. campaign that transformed the father of all impotence drugs, Viagra,
"from an effective product for erectile dysfunction due to medical problems,
such as diabetes and spinal-cord damage, into a drug that 'normal' men can use."
Pfizer spent $303 million in direct-to-consumer advertising for Viagra in 1999-2001,
often featuring younger-looking men and sports stars. That effort paid off handsomely,
by extending the market well beyond men with well-defined medical conditions
and attaining its greatest sales growth in the 18 to 45 age group. Pfizer's
salesmanship broke the age barrier for Viagra, but the company failed to extend
the drug's market to that half of the human population that is completely immune
to erectile dysfunction: women.
A paper by conference speaker Leonore Tiefer traced the term "female sexual
dysfunction" (FSD) back to 1997. In the years that followed, demand for
a "pink Viagra" was boosted by sisters Jennifer and Laura Berman,
who, says Tiefer, "became the female face of FSD, opening a clinic at UCLA
in 2001, and continuing to popularize FSD and off-label drug treatments on their
television program, website and books; in appearances on the television show
Oprah; and in innumerable women's magazines."
Pfizer aggressively promoted FSD, which it labeled "female sexual arousal
disorder." But its plans for a women's Viagra eventually fizzled because
of "consistently poor clinical-trial results."
Tiefer is coordinator of the Campaign for a New View of Women's Sexual Problems,
which runs the media-watchdog website fsd-alert.org.
The Campaign and other groups have been fighting back against the medicalization
of sex with some success.
What latest malady is the pharamaceutical industry selling? It's turning out
to be a hard-to-escape one-two punch: sleeplessness and sleepiness.
In the past year, any TV viewer who's managed to stay awake through commercials
knows that the drugmakers' latest target is sleeplessness. The media blitzes
of two companies, the sanofi-aventis Group (that's their lower-case), which
makes Ambien, and Sepracor Inc., which makes Lunesta, earned them a 2006 Bitter
Pill Award "for overmarketing insomnia medications to anyone who's ever
had a bad night's sleep."
Last month, at the request of government- and industry-funded groups, the National
Institute of Medicine issued a report
concluding that 50 million to 70 million Americans suffer from sleep problems
and that U.S. businesses lose as much as $100 billion a year because of sleepy
In a Baltimore Sun op-ed column, Ira R. Allen, vice president of the
Center for the Advancement of Health, blasted the Institute for having been
"co-opted." He stressed to me that he was not criticizing the report's
methods or results, that "sleep is an important issue" and that "there
were some legitimate partners in sponsoring the report." But, he said,
"The report was issued right on the heels of National Sleep Awareness Week
(March 27-April 2), and just as advertising for sleep aids was reaching a peak."
That, he said, is just too much of a coincidence: "I doubt that the United
States has suddenly been invaded by tsetse
flies! I'm not naive; I know the country's economy is built on advertising.
But our organization's message is 'Transparency, transparency, transparency.'
Don't hide your motive."
Even if we accept the Institute's and the drug industry's claims of a sleep-loss
epidemic, other research has shown that the benefits of drug treatment are far
from overwhelming. The class of drugs to which Ambien and Lunesta belong provide
an extra half-hour of sleep per night, on average. (And Ambien made headlines
earlier this year when reports revealed that some patients who took the drug
were eating and even
cooking in their sleep.)
The lack of a clearly superior pharmaceutical solution to sleeplessness may
partly explain the recent orgy of advertising for sleep problems and sleep aids
in general. Drug companies spent $345 million on ads for sleep drugs in 2005
alone, and that's expected to increase this year.
Wake up and smell the coffee
But, you say, you're already getting enough sleep? Well, maybe it's too much!
The latest, and perhaps most disturbing, wave of sleep-controlling drugs are
designed to let you stay awake for up to 48 hours with no ill effects.
According to the Feb. 18, 2006, print edition of the British magazine New Scientist,
Cephalon Inc., the maker of one such product called Provigil, insists that the
drug is meant only for treating serious diseases like narcolepsy and sleep apnea.
But Provigil is also becoming a "lifestyle drug" for people who can't
fit everything they want to do into 16 hours a day. And it can't help but beckon
employers with the promise of an always-alert work force.
New Scientist reports that the Pentagon's Defense Advanced Research Projects
Agency (the notorious DARPA)
"is one of the most active players in the drive to conquer sleep."
Sometime this year, DARPA will test an experimental wakefulness drug, CX717,
on combat soldiers engaged in hard work for four straight nights with only four
hours of "recovery sleep" in between. Tests have shown that monkeys
awake on CX717 for 36 straight hours had better memory and alertness than undrugged
monkeys after normal sleep.
Yet another generation of drugs that skew sleep toward the most restorative,
so-called "slow wave" phase are on the horizon. Due for release as
early as next year, Merck & Co. Inc.'s gaboxadol, says New Scientist, holds
out "the promise of a power nap par excellence." The temptation to
seek approval for the broadest possible labeling (and profit base) for drugs
like Provigil, CX717 and gaboxadol will likely be overwhelming.
What kinds of medical conditions will expand to embrace millions of newly diagnosed
"patients" in the coming months and years? I put that question to
Dr. Richard Lippin, an occupational-health physician, health forecaster, and
co-founder of a health-care reform blog, Critical
Condition. His response:
"My guess is anything to do with pain, fatigue or feeling stressed. The
first two are related to medicalizing the avoidance of aging and death among
baby boomers and the third -- stress -- is due to very real anxiety people should
feel about a host of worldwide and U.S. megatrends that legitimately create
anxiety and depression -- trends like global warming, wars, economic collapse,
political corruption, etc. But the answers are not pills. The answer is to elect
sane political leaders. There is no pill for the 'white water' that's ahead
for all of us."
David Henry says that the disease-mongering documented at his conference "can't
be stopped. It's a consequence of our political economy, the domination of marketing
in all areas of life. So we need to build counterforces. People are becoming
more skeptical, and that needs to be encouraged. We should exercise the same
healthy skepticism when being sold a drug as we do when being sold a secondhand
He says greater use of the attention-getting term "disease mongering"
will prove useful in changing the behavior of medical professionals, the media
and even pharmaceutical public-relations departments. "We want it to be
an idea that pops up in their heads, so PR people will say, 'Hey, we don't want
to run this ad and be accused of disease mongering!'"
Where would be a good place for average Americans to start exercising the healthy
skepticism that's needed to fight disease mongering by the pharmaceutical industry?
Ask your doctor.
Stan Cox is a plant
breeder and writer in Salina, Kan.
Read From Looking Glass News
Tylenol Toxicity Terror
Big Pharma Uses Scare Tactics to Keep Americans Buying Prescription
Drug firms accused of turning healthy people into patients
Statistics prove prescription drugs are 16,400% more deadly than terrorists