How did it become a blockbuster even though such drugs (which include Remicade, Enbrel and Cimzia and are called TNF blockers) are linked to TB, rare cancers and lethal infections like histoplasmosis?
How did it become a blockbuster even though Humira is only approved for the rare conditions of rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis adults, Crohn's disease, psoriatic arthritis and chronic plaque psoriasis?
The same way all expensive, dangerous drugs become blockbusters: an easy touch FDA, bought doctors and doctor groups, PR firms to establish diseases as "public health threats" and massive direct-to-consumer advertising!
The FDA approved Humira, the first TNF blocker to use human, not mice and hamster cells, three months early, in 2002, and its Arthritis Advisory Committee announced the following year, that TNF blockers do not, repeat not, increase the risk of lymphoma.
Abbott enlisted the public relations giant Edelman to "educate" doctors about the exciting new drug and to team with the Arthritis Foundation. It also enlisted the PR giant Young & Rubicam, and the healthcare advertising heavy, Harrison and Star to let the world know about their Humira deficiencies.
And Abbott gave out free samples of Humira to seniors in 2003 while it lobbied Congress to get the drug's $15,000 to $20,000-a-year costs on the Medicare dole. It wasn't even Halloween. (PS--it worked!)
In fact, Abbott advertised Humira so widely, pharmaceutical reporters asked why since the general public can neither afford the drug nor does it need it. "Rheumatoid arthritis is a market where people often don't know what they have for a while," and it is often "misdiagnosed," said Abbott Vice President of Specialty Operations, Heather Mason in classic disease-selling Pharma language.
When Pharma sells a disease to justify a drug, the disease is always "under-recognized," with "barriers" and "stigmas" preventing treatment and with under-recognized social costs and "burdens."