Licensed to Ill

Increasingly, drug companies aren't just selling cures. They're also
marketing disease.

Bradford Plumer
July 25 , 2005

One of the biggest concerns in the United States today is that health
care costs keep accelerating upwards, growing faster than inflation,
faster than our paychecks. But no one seems to be able to agree on why,
exactly, costs are climbing so rapidly. About a decade ago Paul Krugman
argued, quite convincingly, that health care keeps getting more
expensive simply because Americans keep demanding the latest and most
expensive treatments, and are prepared to pay good money to get
it‹well, some of them, at least. As such, rising health care costs per
se are nothing to fret over: modern medicine keeps getting better and
we should expect to pay more for it.

Fair enough, but here's an alternate theory: health costs are zooming
upwards in part because millions of more-or-less healthy Americans are
being misled into thinking that they actually have diseases and
disorders that require expensive medical treatment. No? Too outlandish?
Consider this story. In 1998, Lilly, one of the world's largest
pharmaceutical companies, was on the verge of losing its patent on
fluoxetine (more commonly known as Prozac) worth over $2 billion
annually. However, if Lilly could find a new use for the drug, the
patent could be extended. That year, Lilly helped fund a "roundtable"
of researchers to gather in Washington D.C., along with staff from the
Food and Drug Administration to discuss a scientifically controversial
condition called "premenstrual dysphoric disorder" (PMDD), which had
only recently, and after much controversy, been included in the
appendix of the Diagnostic and Statistical Manual‹the bible of
psychiatric disorders‹as a disorder "under evaluation." But the
Lilly-funded researchers soon published an article in a small medical
journal suggesting, falsely, that the debate was over and that PMDD
could now be considered a "distinct clinical entity," distinct from the
stress and tension that can accompany ordinary PMS.

Lilly has not said what role it played in turning the "roundtable" into
a journal article, but by 1999, the article helped convince the FDA to
approve the use of fluoxetine to treat PMDD‹and extended the patent
until 2007. Lilly simply repackaged the drug in lavender pill-form,
renamed it Serafem, and began marketing it to women. Never mind that
independent researchers questioned whether PMDD even existed as a
condition. Never mind that Europe's drug regulators raised serious
questions about PMDD and criticized Lilly's clinical trials that
purported to show the benefits of Serafem. Never mind that even the
industry-friendly FDA was appalled at Lilly's television ads, with
their too-vague tagline: "Think it's PMS? It could be PMDD." Undaunted,
Lilly continued its advertising barrage, trying to convince women who
thought they were experiencing regular PMS-related distress that,
actually, they might well have a serious disorder that required heavy
medication. Soon thereafter, both Pfizer and GSK got their own
anti-depressants approved for treating PMDD. For all intents and
purposes, the "debate" over whether PMDD was a disorder‹let alone
requiring medication with serious side-effects‹was over. Industry money
had carried the day.

From a pharmaceutical company's perspective, the big money can be made
not only by selling drugs to the sick, but by selling drugs to the
healthy, the people who don't even know that they need drugs yet. A
recent Reuters Business Insight report, designed for drug company
executives, suggested that the drug companies can reap billions by
"creat[ing] new disease markets." That involves convincing people that
"problems they may previously have accepted as, perhaps, an
inconvenience"‹such as, for instance, the distress that can accompany
PMS‹are in fact "worthy of medical intervention." In other words,
nothing short of the medicalization of everyday troubles. Cheerfully,
the report believes that drug companies are up to the task: "The coming
years will bear greater witness to the corporate sponsored creation of
disease."

If it sounds ominous, it is. As Ray Moynihan and Alan Cassels document
in their new book, Selling Sickness, the "corporate sponsored creation
of disease" is rapidly gaining ground, often with appalling results. To
be sure, many diseases are obviously very real and the latest
treatments can often do a world of good. But some health problems are
so mild or temporary‹high-blood pressure, for instance, or
menopause‹that powerful treatments can often do more harm than simply
leaving it alone. Yet that hasn't stopped drug industry from tapping
its multi-billion dollar marketing budget to "raise awareness" for new
illnesses or ginning up scare stories over light medical conditions.
The gap between "marketing messages and scientific truthsŠ is often as
wide as it is frightening," say the authors, and this book is an
attempt to bridge that gap.

Here are some strategies for marketing illnesses. The first thing to do
is to hire a PR firm to "brand" a certain condition. When GSK, an
American drug company, wanted to repackage its best-selling
anti-depressent, Paxil, to treat "social anxiety disorder"‹a
questionable variation of "social phobia" that requires medication
rather than therapy‹it hired PR firm Cohn & Wolfe to help raise
awareness about the condition. Slogans were developed: "Imagine being
allergic to people." Posters depicting sad men and women brought to
light the symptoms, which only seem like normal nervousness to the
untrained eye: "You blush, you sweat, shake‹even find it hard to
breath. That's what social anxiety disorder feels like." Journalists
were faxed press releases so that they could write up
attention-grabbing stories about the new disorder in the New York Times
and Wall Street Journal. (Does the deadline-pressed journalist need a
bit of color for her story? No problem! Patient-advocacy groups,
usually funded by drug companies, can provide patients to interview.)
GSK even got university of California psychiatrist Murray Stein to
vouch for the drug. Stein, it turns out, was a paid consultant to
seventeen drug companies, including GSK, and had run company-funded
trials of Paxil to treat social anxiety disorder.

Celebrities, too, can help bring new diseases to the public eye‹as
football star Ricky Williams did in 2002 after revealing that he had
social anxiety disorder. His appearances on Oprah and other talk shows
generated a wave of publicity for GSK, and Paxil, although few of the
shows disclosed that Williams was being paid by the company to raise
awareness for the disease, and rarely was it mentioned that doctors had
long known about severe withdrawal effects associated with Paxil.
Oftentimes celebrities can be paid to say things that drug companies
could never get away with: In 2002, supermodel Lauren Hutton appeared
in a Parade magazine cover story‹a newspaper insert seen by over 70
Americans‹telling her audience that her "No. 1 secret" for dealing with
menopause was hormone therapy. Perhaps lost on most readers was the
fact that Hutton had signed a contract with Wyeth, a drug company
offering hormone therapy for menopause, and that under FDA regulations
the company itself could never have made such one-sided claims. (Many
doctors dispute that menopause should even be considered a medical
condition, and the most comprehensive trials on hormone therapy, run in
1998, found that drugs did no better than placebos at treating symptoms
of menopause, and might even increase a woman's chance of having a
heart attack. Wyeth, resilient as ever, responded to the trial results
with a new marketing campaign to remind women and doctors of the
dangers of estrogen loss at menopause.)

Everywhere one looks, drug money is sloshing about. During the 1990s,
the U.S. National Institute of Health's cholesterol guidelines
estimated that 13 million Americans could benefit from treatment with
statins‹new cholesterol-lowering drugs. In 2001, a new panel of experts
revised that number upwards, to 36 million. In 2004, another panel
updated the guidelines again, to 40 million, a number that included
many Americans with relatively low risk of a future heart attack. Why
was this? Was it actually true that statins could now benefit not only
the sick, but the healthy as well? It's possible. But it's hard to
ignore the fact that eight of the nine experts who wrote the 2004
guidelines also serve as paid speakers, consultants, or researchers to
drug companies‹companies that stood to reap billions from overnight
changes that relabeled healthy people as sick and created a new market
for statins.

This doesn't mean the experts deliberately fudged the results, although
many researchers who aren't on the take, such as Dr. John Abramson of
Harvard, believe that statins, while useful for those who have suffered
heart attacks, offer very little benefit to healthy individuals, and
may even cause harmful side-effects. Rather, the problem is that it's
impossible to trust industry-funded numbers. A 2002 study estimated
that almost 90 percent of those who write guidelines for their peers
have financial conflicts of interests with drug companies. Combine that
with the knowledge that, as Moynihan and Cassels write: "The industry's
sponsorship is strategic, systematic, and systemic." That sponsorship
is designed to portray conditions that often are not very well
understood as severe, widespread, and, above all, treatable with drug
therapy. That's not to say that doctors are being paid to go against
their better judgment and shill for drug companies. But it does put the
objectivity of medical science into severe doubt.

Where is the Food and Drug Administration in all of this? Disturbingly,
on the take. Over 50 percent of the agency's budget for reviewing drugs
comes from the pharmaceutical industry, and not surprisingly, officials
are loath to offend their paymasters. In 2000, FDA researchers
recommended that the agency consider pulling a controversial medication
from the market. Lotronex, a new drug manufactured by GSK, had been
used to treat irritable bowel syndrome, a condition that can be
extremely debilitating for some, but relatively minor for others. The
condition, of course, had been played up by a GSK marketing campaign
suggesting that some 45 million Americans were affected by the
condition, although that was very far from the scientific consensus.
The trouble was that FDA researchers had discovered two horrific side
effects of Lotronex: Some users would experience constipation so severe
that impacted feces could perforate the inner bowel wall and lead to
fatal infections; other users were contracting isachaemic cholitis, a
potentially fatal condition in which the blood can stop flowing to the
bowels. Many drugs, of course, can have severe side effects; what was
shocking here is that many patients were, potentially, being
unnecessarily exposed to such gruesome risks.

Initially, Lotronex was pulled, but after much lobbying, GSK convinced
the FDA to reapprove the drug 18 months later, over the objections of
the agency's staff. Here the picture gets murky: "The real reasons why
the FDA was so keen to bring this drug back, are not clear." Indeed,
Lotronex does provide undeniable benefits for people suffering from
severe symptoms of irritable bowel syndrome. But striking a balance
between ensuing that those who need the drug get it, without exposing
the relatively healthy from potential side-effects, requires an
objective agency with the public interest first and foremost in mind.
Moynihan and Cassels write: "Whether the established regulators like
the FDA, with its recent history of close communication with drug
companies, are the appropriate bodies to be forging this new role, is
highly questionable." Highly questionable is one way to put it. Or, as
Fran Hawthorne wrote in her book, Inside the FDA: "Yes, the pressure
behind the scenes can be that heavy-handed. Yes, the drug companies
carry that much clout." So much for public oversight.

The problems with overselling illnesses are legion, and go well beyond
the fact that powerful drugs‹often with equally powerful
side-effects‹can be pushed on patients who simply don't need them.
Oftentimes, the marketing campaign focuses heavily on the
neurobiological basis for disease, without so much as glancing at the
social, cultural, or environmental factors that can contribute to some
medical conditions. Female sexual dysfunction, for instance, has been
reduced to a blood-flow problem that needs to be treated with pills,
rather than understood as the complex event it quite obviously is.
Oftentimes the emphasis on biology can preclude alternative treatments.
In 2003, Americans spent $1.7 billion on Fosomax, a drug to treat "low
bone density," although both the seriousness of low bone density and
the effectiveness of the drug are hotly disputed. While it's true that
drugs to treat bone density can sometimes prevent painful and costly
hip fractures, often a change in diet and lifestyle is just as
effective, at a fraction of the cost. Likewise, a public anti-smoking
campaign could, potentially, do as much to reduce heart attacks in the
United States as all those expensive drugs to lower high blood
pressure.
Note also that drug companies often push the latest and most expensive
medications, even if they are no more effective than cheaper
variations. (One study by publicly-funded researchers showed that the
world was wasting billions of dollars a year on expensive drugs to
treat high-blood pressure when cheaper substitutes would work just as
well or better.) Taken all together, it soon becomes clear that the
medicalization of daily life‹the "corporate sponsored creation of
disease"‹is bankrupting the health care system with a flood of
potentially unnecessary treatments. Drug companies often push to get
conditions classified as disorders so that treatments can be covered by
medical insurers, which in turn can push up premiums, along with the
cost of taxpayer-funded programs like Medicare. Not only that, but
health resources are being directed to healthy people in developed
nations rather than to severe diseases among the poor‹such as the AIDS
epidemic that is devastating Africa. And perhaps most damaging of all,
the overselling of illness may begin to undermine the credibility of
scientists genuinely trying to understand disease and mentally
disorders.

Can the "corporate sponsored creation of disease" be controlled?
Selling Sickness is rather short on solutions, but in fairness,
solutions are genuinely hard to come by. One thing Moynihan and Cassels
do neglect to discuss, however, are the economic and legal forces
driving the push to sell sickness. The patent system, as currently
structured, offers a strong incentive to find and promote new
diseases‹Lilly was going to lose its patent on Prozac, so it discovered
PMDD, repackaged the drug as Serafem, and extend its patent another
seven years. Indeed, as Marcia Angell has pointed out in The Truth
About Drug Companies, the pharmaceutical industry has brought to market
only a handful of truly innovative drugs in recent years. Most of the
money is to be made through gaming the patent system: either by
creating slight variations on existing drugs‹changing a few molecules
to turn, say, daily Prozac into weekly Prozac can extend a patent
another 20 years‹or by finding new diseases for existing drugs to cure.
Perhaps the time has come for Congress to reform the patent system.
Moynihan and Cassels also suggest the creation of publicly funded
institutions to "rigorously review all of the available scientific
studies about a particular treatment, and come up with an unbiased
summary of how it works." Indeed, more unbiased information about
illnesses and their treatments would benefit consumers‹although it
would actually have to reach them to be effective. Yet so long as
industry-funded patient advocacy groups are raising "awareness" about
the latest disease sweeping the nation, so long as young bleary-eyed
hospital interns are offered late-night pizza and coffee by friendly
drug reps, so long as credulous journalists writing for glossy
magazines will write up breathless reports like "Living with Adult
ADD," unbiased information will be hard to come by.

What really needs to happen is that public gatekeepers‹especially
journalists and doctors‹need to be more aware of what is going on.
Moynihan and Cassels give some signs that this is happening: Carla
Johnson, a medical reporter for the Spokane Spokesman-Review recently
wrote an attention-grabbing expose on the medicalization of female
sexual dysfunction after she grew suspicious of a faxed press release
claiming that 43 percent of women suffer from the condition. Meanwhile,
the American Medical Student Association, "literally the face of
tomorrow's physician," has been engaging a "PharmFree" campaign to
convince its members not to accept handouts from drug companies trying
to ingratiate themselves to the next generation of doctors. But in
addition to all that, a wider cultural change may need to take
place‹perhaps a new understanding that not every condition of daily
life reduces down to neurobiology, and that there's not necessarily a
pill for every problem.

Bradford Plumer is the assistant online editor of Mother Jones.

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