Why does the
pharmaceutical industry pour billions into direct-to-consumer (DTC)
ads? One explanation is that drugmakers need a way to market new
products that they are having a hard time selling to doctors—at
least this is what one medical ethicist suggests in the May 2007
issue of The Oncologist.

Noting that more and more
pharmaceutical companies are peddling their products directly to
cancer patients, he writes:

"I have a
hypothesis about which types of oncology drugs are most likely to be
advertised directly to the consumer. I think they are less likely to
be those drugs that have been proven to have benefits, have no
competitors, or are known to be cost-effective. There would be no
reason to promote them, as they are going to be used anyway. In
contrast, it’s those drugs in competitive markets, at the margins of
evidence-based medicine, where pressure from patients resulting from
direct-to-consumer advertising might lead to more prescribing. I
suspect that these marginal drugs will be the very ones that are
advertised most, which is worrisome."

A recent report in The
New England Journal of Medicine confirms that drugmakers tend
to promote their newest drugs DTC: “Notably, nearly all
(17 of 20) advertising campaigns for the most heavily advertised
drugs began within a year after FDA approval of the drug. . .
.which raises questions about the extent to which
advertising increases the use of drugs with unknown safety
profiles.”

In other words drugmakers are going directly to the consumer at a
time when their products are, indeed “at the margins of
evidence-based medicine.” Experience with drugs like Vioxx has
taught many doctors to take a wait-and-see attitude toward remedies
that have not yet been widely used by the general population. .
Unless the “new, new thing” is likely to save lives, many
prefer to wait until more evidence has come in about risks versus
benefits before turning their patients into guinea pigs.

Meanwhile, the NEJM
reports, drugmakers have stepped up their campaign to market their
wares to laymen. From 1996 to 2005 spending on DTC promotions has
grown more than three-fold, spiraling from $985 million
to $4.237 billion.

Who picks up the tab?
As always, when it comes to healthcare spending, the answer is: “you
and I.”  Which leads me to wonder—how much value are we
getting for these ad dollars? Do DTC ads actually perform an
educational service, as the industry claims,, alerting us to diseases
that we don’t know we have while apprising us of cures that our
doctors may not be aware of?

Pondering these
questions, I can’t help but think of Mirapex, a drug originally
developed as a treatment for Parkinson’s until its manufacturer
decided to market it to a second, potentially much larger audience:
folks with twitchy legs, a.k.a. Restless Leg Syndrome (RLS) .
Probably you’ve seen the animated spot on television featuring
a very cute pair of curvy legs painted in the Mirapex logo colors,
orange and green, tossing and turning in bed. The music is catchy. At
the end of the ad, after touting the benefits of Mirapex, a
voice-over warns about possible side effects: “dizziness,
nausea and sweating.”

Okay, this sounds like the risks involved
in taking many medications.  But then the voice  mentions something
about consulting your doctor if you experience “gambling,
sexual or other intense urges . . .”

A little Googling
turns up an explanation. It seems that a 2005 Mayo Clinic study
revealed that some patients taking Mirapex or similar drugs have
become compulsive gamblers.  No surprise, you can find full details
on websites like www.lawyers.com
Patients who have lost tens of thousands playing slot machines have
begun suing the drug’s manufacturer, Connecticut-based
Boehringer-Ingelheim Pharmaceuticals. (The company says there is no
evidence that Mirapex causes the problem.)
)http://72.14.205.104/search?q=cache:ckAiigp3V2MJ:health.dailynewscentral.com/content/view/0001262/62/+Mirapex+and+lawsuit+and+gambling+and+2007&hl=en&ct=clnk&cd=10&gl=us.

Finally, the voice-over issues one more warning: “Mirapex may cause you to
fall asleep without any warning, even while doing normal daily
activities such as driving. When taking MIRAPEX
hallucinations may occur  . . . You should talk with your
doctor if you experience these problems.”

Assuming you survive
the car accident.

At this point, the
risks do seem to be piling up. One can see how it might be hard to
pitch this drug to doctors—especially doctors who are shy about
meeting lawyers.

On the other hand, the
ad is both entertaining and memorable. The production values are
high—it’s  likely to catch the eye of many consumers.
Moreover, if you go to the Mirapex website and click on “Identify
Symptoms”  you’ll begin to realize just how many of us
may be suffering from RLS—without even knowing it.

“You may have
restless leg syndrome, the site explains, if you answer yes to these
four questions:

1. Do you feel a
strong desire to move your legs from time to time, often when they
make you uncomfortable?
 

2. Do these
sensations in your legs occur or get stronger when you are inactive?

3. Does moving around
or stretching help ease these uncomfortable sensations in your legs?
 

4. Do these
uncomfortable sensations feel their worst at night?

I answered “yes”
to all four questions—which suggests that Mirapex may be just
what I have been looking for. After all, I spend hours, every day
chained to  my computer. I read. I write. My knees lock.

Why should I give in to
that “strong desire to move my legs from time to time” if
I can sit still and take a pill? Why “stretch to ease those
uncomfortable sensations in my legs?” if Mirapex can relieve my
symptoms, and solve my problems. As the ad says: “When your
legs feel better, you feel better.”

Little wonder the FDA
approved Mirapex for RLS in 2006. That year, world-wide sales jumped
by 23.4 % to 536 million Euros.

And
that was before Boehringer Ingelheim’s broke out its print,
online and broadcast campaign in July of 2007. (The company isn’t
telling how much it’s spending.)

If you are interested
in hearing more about the hazards of direct-to-consumer advertising,
government policy on DTC ads, and why Merck’s ad campaign for
its cervical cancer vaccine is making health officials in other
countries uneasy— I’ve written about these issues on my new
blog.
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