Since direct-to-consumer drug advertising debuted in 1997, pharma's
credo has been When The Medication Is Ready, The Disease (and Patients)
Will Appear. Who knew so many people suffered from restless legs? Now
pharma is back to creating new diseases, patients, risks and "awareness
campaigns." Check out these eight new diseases they've invented.
1. SERM deficiency
A
pill to prevent postmenopausal osteoporosis packs the "magic three" of
drug sales-- fear, forever and faith--since you never know if it's
working or you need it but fear stopping. But 15 years after women began
swallowing bisphosphonates like Boniva and Fosamax because
pharma-planted bone density machines in medical offices revealed they
had "osteopenia,"* bisphosphonates are linked to jaw bone death,
esophageal cancer and causing the fractures they were supposed to
prevent. Sorry about that. Now pharma is hawking Selective Estrogen
Receptor Modulators (SERMs) like Evista and Tamoxifen to prevent
osteoporosis and even some cancers. Unfortunately they can cause others…
2. Statin Deficiency
If
it seems like the whole world is on statins, it's not your imagination.
Last year the FDA approved AstraZeneca's Crestor for children as young
as 10 and in March it approved Crestor for 6.5 million people who have
no cholesterol or heart problems at all! (See: fear, forever and faith.)
Many say, since lead investigator of the Justification for the Use of
Statins in Primary Prevention study Paul Ridker of Brigham and Women's
Hospital in Boston is co-patent holder/inventor of the C-reactive
protein (CRP) test which "proves" Crestor's effectiveness, there's a
conflict of interest. Others say, since CRP isn't necessarily even a
marker for heart disease and statins can cause Type 2 diabetes, it's bad
science along with a conflict of interest.)
3. Circadian Dysrhythmia
Insomnia
is a gold mine for pharma because everyone sleeps -- or watches TV when
they can't. But Ambien, Lunesta, Sonata and Rozerem have reached market
saturation, so pharma is rolling out subcategories like nocturnal,
middle-of-the-night (MOTN) and terminal insomnia and sleep eating, sleep
walking and sleep sweating (yes sweating) to boost the franchise.
Meanwhile another demo is swelling Circadian Dysrhythmia numbers: Thanks
to restless legs syndrome, sleep apnea, shift work sleep disorder,
people who skimp on sleep and of course insomnia meds themselves,
there's an epidemic of excessive sleepiness! Enter Provigil --"a
mood-brightening and memory-enhancing psychostimulant which enhances
wakefulness and vigilance," -- Adderall and Vyvanse, known in the days
of Lenny Bruce -- also an "excessive sleepiness" sufferer -- as speed.
4. Adult Autism, ADHD and Refusal to Play Nicely
Having
marketed adult diseases like depression, bipolar disorder and
schizophrenia in 4-year-olds to death, pharma is now finding childhood
diseases in adults. Adults with ADHD have hyperactivity, impulsivity,
"executive function deficits" and "difficulty with organization and time
management," says Harvard Medical School's Joseph Biederman, in a 2004
JAMA. The disease requires "lifelong" medication says Biederman, who was
accused of pushing Risperdal and hiding pharma income by Congress in
2008. Adults may suffer from autism too says a 2008 article in
Psychiatric News, if they're "unsociable, extremely rigid, given to
angry outbursts" and "acutely sensitive to light, heat, and pain."
Luckily, in two studies "SSRI antidepressants led to a decrease in
repetitive behaviors and to somewhat more socializing," in adults with
autism says Psychiatric News.
5. Asthma That Requires "Two Drugs"
Leave
it to pharma to develop an asthma drug--the long-acting beta2-agonists
(LABAs)-- that triples the rate of asthma deaths, especially in
African-Americans. And leave it to the FDA to approve LABA's on the
basis of a trial, the 2003 SMART trial (Salmeterol Multicenter Asthma
Research Trial), that was stopped early because of so many deaths. In
March, after more deaths, especially in children, a sheepish FDA recast
LABAs as a last resort medication with or without use of a concomitant
inhaled steroid. But AstraZeneca doesn't want to stop selling its LABA
with a steroid, Symbicort -- and GSK its LABA with a steroid, Advair --
just because they're correlated with death. So the LABA drugs are being
billed as safe and able to treat "both" causes of asthma (see: Vytorin)
and projected to earn billions this year.
6. "Treatment Resistant" Conditions
If
an engine additive or laundry product didn't work, who would chase it
with another product--or two-- because the manufacturer told them to?
Who would pay $300 to $900 a month out of their pocket for
antidepressants, antipsychotics, mood stabilizers and mood brighteners
some of which don't work? (see: fear, forever, faith.) Increasingly,
pharma is approving drugs as add on or "adjunctive therapy" like
AstraZeneca's antipsychotic Seroquel, approved last year "for patients
who had failed to respond adequately to an antidepressant alone." Also
last year, the FDA approved Eli Lilly's Symbyax, a combination of the
SSRI antidepressant Prozac and controversial antipsychotic Zyprexa -- do
patients gain 100 pounds but feel great? -- for "treatment resistant
depression." Why are diseases "treatment resistant" instead of the drugs
"ineffective" or diagnoses "wrong"?
7. Low T
Men
are you feeling run down and over the hill? Is your hair falling out,
skin wrinkling and abdomen developing its own zip code? Have you lost
interest in sex or worse, has your partner? (With you?) Do you need
reading glasses, dental implants and heel splints? You're not getting
old, you just have Low T and are ready for the
aging-is-really-just-low-hormones con that women have lived with for 60
years: hormone replacement therapy. Like 50 million women before you,
you can be Forever Masculine even though, to (quote hormone giant Wyeth)
you have outlived your testes if you start replacing your lost
testosterone. You'll get both kinds of zips back in your life, and it
won't change your prostate-specific antigens. Pharma promises.
8. "Spectrum" Disorders
Nothing
proves pharma's when-the-medication-is-ready credo better than the
legions of people who have fibromyaglia now that Cymbalta, Savella and
Lyrica are available to treat it. Still, a "grassroots" pharma front
group is conducting a Fibromyalgia Is Real awareness campaign like it
did for depression and bipolar disorder, just to make sure. Pharma has
also rolled out the term "depression spectrum disorder" for fibromyalgia
to make sure patients who have some but not all of the symptoms seek
treatment. And speaking of spectrums, "Epilepsy Spectrum Disorder" was
rolled out in January's JAMA -- a disorder which is not just about
seizures anymore but has "shared mechanisms" with "depression, autism..,
and other cognitive comorbidities." Spectrum disorders are Real--which
is pharma for Reimbursable.
* a pharma contrivance like "perimenopause" to widen the patient pool
