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?
But pharma's recent plan to move from mass-market molecules into more lucrative vaccines and biologics did not see the anti-vaxer movement coming: millions of Americans saying You Want to Vaccinate Me -- and My Child -- with WHAT?? and condemning vials of H1N1, rotavirus and MMR vaccines to sit, well, way past their expiration dates. Nor were fears of an international vaccine conspiracy helped by former CDC Director Julie Gerberding resurfacing as President of Merck Vaccines in December. (Nice revolving door if you can catch it.)
Now pharma is back to creating new diseases, patients, risks and "awareness campaigns" faster than you can say thimerosal (the vaccine preservative that started the backlash.)
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 Nicey
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, found in most people's brother-in-laws, 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 antidepressant 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