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Pharma Bucks Recession with "Treatment Resistant" Conditions

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Pharma is citing "patent expirations" for flat and falling earnings as its Lipitor, Effexor and Plavix blockbusters go generic.

But "patient expirations" explain the demise of other blockbusters like Vioxx, Bextra, Premarin/Prempro, Vytorin, Avandia, Paxil, Chantix, Seroquel, Ketek, Baycol and fen phen.

Forty years of marketing the "diseases" of menopause and aging-Over 35? You Might Be At Risk for Menopause! - ended when hormone replacement therapy was found to cause not prevent the symptoms women feared.

bipolar
Cartoon by Martha Rosenberg
A decade and a half of osteoporosis profits collapsed when bone drugs Fosamax, Boniva and Actonel were found to cause not prevent fractures and jaw bone death in some cases. Nor did it help that Boniva czar Sally Field allegedly broke a bone. Oops.

And speaking of causing not preventing, SSRI/SSNI antidepressants are linked to so many suicides - 660 in newspaper reports alone - the pharma founded and operated American Foundation for Suicide Prevention (AFSP) is staging massive anti-suicide walks in June against an epidemic it largely created.

Even asthma inhalers are causing deaths they were supposed to prevent.

What's a pharmaceutical industry in the middle of a recession with nothing in the pipeline to do?

Say hello to monotherapy and treatment resistant conditions.

Expensive and dangerous drugs that don't work are now said to not work as monotherapy. You need to add a second or third drug.

Conditions that don't respond to expensive and dangerous drugs that don't work are now said to be treatment resistant - not conditions treated with the wrong drugs or assigned the wrong diagnoses.

Monotherapy and "treatment resistance" keep patients taking their meds - including ones that fail as "monotherapy" - in the absence of any evidence they are working. (see: little light going out in the refrigerator.)

The concepts upsell a patient who was on one med into taking two or three meds, doubling or tripling pharma's revenues, especially if more meds are required for side effects in increasingly common, perverse drug cocktails.

But most importantly monotherapy and "treatment resistance" shift the emphasis from pharma's failures to a patient's "failures": It's not our drug that's not working, it's your treatment resistant condition.

Monotherapy has often been the hallmark of drugs that don't work in pediatric conditions like bipolar disorder, ADHD, major depression, generalized anxiety, social anxiety, passive-aggressive, oppositional-defiance and obsessive-compulsive disorders and other personality/conduct disorders which surfaced when pharma had medications to treat them. (And states had disability tax dollars to pay for them.)

But children with "treatment resistant" depression aggression, mania, anxiety, mood and psychotic disorders, bipolar disorder, and ADHD are also now being seen - and enrolled in clinical trials.

While some say a developing child is by definition too young to have treatment resistant anything, that was also said about schizophrenia which is also suddenly "recognized" in children like four to six-year-olds in clinical trials at Massachusetts General Hospital.

The FDA is considering pediatric schizophrenia drugs next month for childhood-onset schizophrenia which Lilly funded Gabriele Masi, MD says suffers from "hesitancy on the part of clinicians to make a diagnosis," in the journal CNS Drugs.

Meanwhile in March the FDA approved the first drug for "Treatment Resistant Depression" (TRD) in adults, Lilly's Symbyax which is a combination of Zyprexa and Prozac.

Zyprexa and Prozac are so checkered with adverse effects and law suits - Lilly agreed this week to pay Georgia $6 million for hiding Zyprexa's diabetes, high blood sugar and excessive weight gain side effects - it's astonishing they're still on the market much less approved as new drugs.

In fact when 7-year-old Gabriel Myers of Margate, FL killed himself in April after being prescribed Symbyax according to the Florida Department of Children & Families it barely made the papers.

Martha Rosenberg is a columnist and cartoonist, who writes about public health

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