AbbVie was spun off from North Chicago-based Abbott Laboratories in 2012 largely on the basis of Humira, a medication that treats autoimmune conditions like rheumatoid arthritis that's become the best-selling drug in the world.
Humira's success rests on two factors: Big Pharma's pursuit of costly biotech drugs (often earning $10,000 to $20,000 a year per patient) as blockbuster pills like Lipitor go off patent, and cagey marketing.
Though approved for the relatively rare conditions of rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn's disease, psoriatic arthritis and chronic plaque psoriasis, Humira became a best-seller with the help of the public relations giant Edelman and the health care advertising firm Harrison and Star, which gave it appeal beyond its limited indications.
Currently, AbbVie is raising "awareness" of the inflammatory bone and joint disease ankylosing spondylitis, which Humira happens to treat. Your back pain "may not be your fault" say AbbVie's ads; your pain may be caused not by muscle strain or a bad mattress but by a disease few had heard of -- until Humira's advertising blitz. The campaign even instructs listeners to tell their friends and family that their back pain may be from ankylosing spondylitis.
The AbbVie ad campaign raises ethical questions because the safety profiles of monoclonal antibody drugs, like Humira, that target the immune system are among the most concerning of all drugs, according to the FDA. While useful for autoimmune diseases, most experts agree that patients with less serious conditions should not be unnecessarily exposed to drugs with side effects like lymphoma, leukemia and super-infections.
And, speaking of ethics, questions about Shire, AbbVie's partner-to-be, have also been raised. Best known for its ADHD drugs Adderall, Vyvanse and Intuniv, in 2008 Shire launched a "Nationwide Adult ADHD Mobile Awareness Tour" called the RoADHD Trip. The caravan included tents with self-screening stations. A separate initiative included a "field-based team of experienced psychiatric nurses" who would "provide in-office education to physicians and their staff on ADHD in adults." ADHD is widely seen as overdiagnosed in the US.
In a conference call about its earnings, Shire bemoaned that it loses many of its college-age ADHD customers "as they kind of fall out of the system based on the fact that they no longer go to a pediatrician and they move on to a primary care physician." Soon ads with the slogan, "It's Your ADHD. Own It," telling young people they have not outgrown their ADHD, began appearing in college newspapers.
AbbVie's flight from US taxes to merge with Shire is especially hypocritical because in 2008 Abbott gave Humira free to elderly patients in order to churn demand while it successfully lobbied Congress to get Humira covered by Medicare. In addition to Medicare reimbursements, Humira costs state taxpayers as much as $50,000 per patient, according to a recent letter from pharmacies and insurers to Pennsylvania lawmakers.
AbbVie is also duking it out with drug maker Gilead over its à �ber-expensive hepatitis C treatment, Sovaldi. AbbVie claims it holds patents to the way the drug is administered.
Medtronic
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