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PHARMA: Why Stretch? by Maggie Mahar

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
.
Please return here to comment.

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8 replies »

  1. Your Doctor Is Not Your T.V.
    Often, usually on television, one viewing will often at times see an advertisement for some type of medication- usually one involved in a large market disease state and the commercial is sponsored usually by a big pharmaceutical company for a particular network. This is called direct to consumer advertising, and doctors would prefer they did not exist.
    Since 1997, when the FDA relaxed regulations regarding this form of advertising, the popularity of the creation of such commercials has greatly increased. The pharmaceutical industry spends around 5 billion annually on this media source now. Normally, the creation of such a commercial becomes visible to the consumer within a year of the drug’s approval, which raises safety concerns. And involves money spent that could be applied to greater uses, according t many, but we are dealing with a corporation here.
    The purpose of DTC ads is not education, in my opinion, as others have claimed. Any advertising of any type shares the same objective, which is to increase sales and grow their market and, in this case, for a particular perceived medical condition or disease state. The intent of DTC advertising is to generate an emotional response from the viewer, such as fear or concern, believing upon research that the viewer will then question as to whether they need to seek treatment for what may be an unconfirmed medical condition.
    DTC advertising is also a catalyst for and similar to disease mongering.
    Disease mongering is the creation of what some believe to be medical flaws, and illustrated by the creators through exaggeration and embellishments through media sources as an avenue for suc propaganda, as is often seen with DTC advertising. Yet the flaws may not be medical, but corporate creations of these questionable human ailments that do not require treatment, possibly, and may be an attempt to develop a particular medical condition to acquire profit. One of my favorite DTCs is the new indication for the use of an anti-depressant for a social disorder. This used to be called introversion, a term created by Dr. Carl Yung. And it is a personality trait, not a medical disease. There are other questionable medical conditions claimed in the contents of DTC commercials, as the creators wish to grow the market for a particular, and possibly fictional, disease state. Then there is baldness treatments advertised, as another example. Lifestyle meds are not treatment meds for illnesses, and should not be portrayed as such.
    Also, DTC ads discuss only one treatment option normally, so it seems, when likely several treatment options exist for authentic medical disorders. This should be left to the discretion of the doctor, as they assess your health, not your television or another media source. That’s why most of the world does not conduct DTC advertising, with the exception of our country and New Zealand.
    Finally, DTC advertising and its ability to influence viewers to make their own assessment instead of a medical professional remains largely unregulated, yet apparently effective for the DTC creators. People are prone to believe what they see and hear, regardless of whether or not it is actually true. Many, after viewing a DTC ad, seek out a doctor visit and request whatever product that was advertised, which makes things cumbersome for the doctor chosen for such a visit. So the doctor and patient relationship is altered in a negative way, because most DTC ads require a prescription.
    Medical information and claims of suggested health ailments should come from those in the medical field instead of the corporate world. Perhaps this will save some over-prescribing, which will benefit everyone in the long term. And the Health Care System can regain control of their purpose, which is far from financial prosperity.
    “Men of ill judgment oft ignore the good that lies within their hands till they have lost it”
    Sophocles
    “Do every act of your life as if it were your last.” —- Marcus Aurelius
    Dan Abshear

  2. I have a naive observation:
    If Pharm is going to market to consumers, then they will have to bear the brunt when the consumer is mad at them.
    If they go back to marketing to doctors, then consumers will be mad at the doctors.
    If I’m a Pharm CEO, which do I prefer on the liability side? Hmmm.
    Oh, and, yeah, who’s qualified to make those judgements? Um. A, what is it now…Doctor?
    Riight.
    Go back to the way it was. This is exactly why industrial-grade marketing doesn’t do anyone any good in the long run.

  3. I was directed here by a link from BlueMassGroup. Nice post by the way.
    I was particularly taken aback by the questions regarding “restless leg syndrome.” Particularly question 3. If discomfort in the legs can be ameliorated by moving around and stretching (which is what I do, and am doing now) why does anyone need a pill?
    As I mentioned at BlueMassGroup, pharmaceuticals can be highly addictive, and their use must be carefully monitored. As far as I can tell, they are not.

  4. Gregory, Spike, Bev M.D.–
    Greg, you are right–even cancer centers indulge in hard-sell advertising. In my book I talk about hospital advertising: it turns out that the most presigious academic medical centers all run ads. The only one that doesn’t is the Mayo Clinic. Mayo relies on word-of-mouth alone. . . (I don’t think this necessarily means Mayo is that much better than the other top medical centers, but it does suggest some old-fashioned internal standards about what it is appropriate for a hospital to be doing.
    Spike– thanks. You can comment on the blog by sending your comment to me–and then I will post comments on the blog. (The Century Foundation, where I am a fellow, and which is sponsoring the blog, wants me to look at the comments before putting them up in order to avoid extremely uncivil or inflammatory comments. We’re not set up to moderate in real time, so this is the best way to do it.
    In theory, to send me an e-mail you just click on the “contact” button (scroll down on the left), but we just launched, and it doesn’t seem to be working. As an alternative, e-mail me at maggiemahar@yahoo.com. )I”m sure we’ll fix the “contact” link on Tuesday.)
    Bev M.D.– I agree, the FDA decision to allow DTC was a sign the agency was losing its way. (And tell your teen-ager I said YUCK!!)

  5. Gregory, Spike, Bev M.D.–
    Greg, you are right–even cancer centers indulge in hard-sell advertising. In my book I talk about hospital advertising: it turns out that the most presigious academic medical centers all run ads. The only one that doesn’t is the Mayo Clinic. Mayo relies on word-of-mouth alone. . . (I don’t think this necessarily means Mayo is that much better than the other top medical centers, but it does suggest some old-fashioned internal standards about what it is appropriate for a hospital to be doing.
    Spike– thanks. You can comment on the blog by sending your comment to me–and then I will post comments on the blog. (The Century Foundation, where I am a fellow, and which is sponsoring the blog, wants me to look at the comments before putting them up in order to avoid extremely uncivil or inflammatory comments. We’re not set up to moderate in real time, so this is the best way to do it.
    In theory, to send me an e-mail you just click on the “contact” button (scroll down on the left), but we just launched, and it doesn’t seem to be working. As an alternative, e-mail me at maggiemahar@yahoo.com. )I”m sure we’ll fix the “contact” link on Tuesday.)
    Bev M.D.– I agree, the FDA decision to allow DTC was a sign the agency was losing its way. (And tell your teen-ager I said YUCK!!)

  6. I think one of the worst mistakes the FDA ever made was authorizing DTC drug advertising. Not only does it drive costs and magnify inaccuracies, but I have to listen to my teenager chortle every time they mention erection problems, which is ALL THE TIME when we watch football. Expletive deleted!!!!
    This should be rescinded – seriously.

  7. Congrats on starting a blog, Maggie! I look forward to reading it. When are you going to open it up to comments?

  8. On one hand, pharmaceuticals advertise extensively and the advertising is manipulative in the extreme. On the other hand, even NCI-designated cancer centers do this sort of direct to consumer, hard sell advertising (e.g. in LA, City of Hope National Medical Center, UCLA, USC, Cedars Sinai, et al). And in cancer medicine, the media advertising is no more misleading than the one-on-one communication which often goes on between a chemotherapy candidate and an oncologist.

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