Pharma’s Stimulus Plan: Treatment Resistant Conditions

The recession has hit pharma too.

While it cites patent expirations of blockbusters like Lipitor, Effexor and Plavix for falling earnings — “patient” expirations from Vioxx, Bextra, Premarin/Prempro, Vytorin, Avandia, Chantix, Ketek, Baycol and fen phen have helped.

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.

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 — nor are people rushing to inoculate their 11-year-old daughters with Gardisil. And let’s face it: the depression-with-pain and pain-with-depression fibromyaglia financial eddy can only last so long.

What’s a pharmaceutical industry in the middle of a recession with nothing in the pipeline but me-too drugs 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 on their meds — including ones that fail as “monotherapy”–and insurers paying for them in the absence of any evidence they are working! (see: little light going out in the refrigerator.) They upsell patients who were on one med into increasingly common and perverse drug cocktails with several meds that require more drugs to treat the side effects. Best of all, they 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! In other words, they’re a stimulus plan.

Of course even before the recession, pharma’s favorite payup was pediatric conditions covered by state disability tax dollars — also known as Claim Approved. No wonder pharma’s got new drug applications before the FDA for pediatric use of antipsychotics Seroquel, Geodon and Zyprexa this June. (Though judging from childhood diabetes cases in the US, the drugs are already in wide, off label use.)

But thanks to the recession, the pediatric diseases that surfaced when pharma debuted pills for them like social anxiety, passive-aggressive, oppositional-defiance and personality disorders now have “treatment resistant” varieties. Think children can’t have “treatment resistant” depression, ADHD, aggression, mania, anxiety and bipolar, obsessive compulsive and mood disorders because they’re too young? You haven’t been to lately.

And speaking of clinical trials, drugs are also being tested on children with schizophrenia — a condition that was rare in childhood until recently and the recession.

“Awareness of childhood-onset schizophrenia is rapidly increasing, with a more precise definition now available of the clinical picture and early signs, the outcome and the treatment strategies,” writes Gabriele Masi, MD, a Lilly funded doctor, in the journal CNS Drugs, lamenting the “hesitancy on the part of clinicians to make a diagnosis,” of schizophrenia.

Symptoms of childhood schizophrenia — “social deficits” and “delusions . . . related to childhood themes” — might look like symptoms of childhood itself (hello) but Zyprexa in conjunction with “social, scholastic, and familial interventions,” writes Masi — once called “bringing a kid up” — can turn the child around.

Of course Zyprexa has had a checkered past–at least as “monotherapy” — with manufacturer Lilly agreeing in April to pay the state of Georgia $6 million for hiding its diabetes, high blood sugar and excessive weight gain side effects in the latest in a string of damaging settlements. But in March it was granted a new lease on life when the FDA approved it in Lilly’s Zyprexa/Prozac combination drug, Symbyax, as the first treatment for adults with treatment resistant depression.

The April suicide of 7-year-old Gabriel Myers of Margate, FL who the Florida Department of Children & Families says was also prescribed Symbyax drew less attention.

Martha Rosenberg is a columnist/cartoonist who writes about public health. Her first book, titled Born with a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp the Public Health, has just been released by Prometheus Books. She can be reached at: Read other articles by Martha.

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