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A Drug As Scary as Halloween; Blockbuster Drug Causes Cancer, TB and Lethal Infection

How did Abbott Laboratories' Humira become an $8 billion a year drug, capable of anchoring an entirely new drug company as Abbott splits into two? 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 whysince 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." Sure, Humira is expensive, Joel M. Kremer, MD, an Abbott consultant, told the New York Times in 2008 but there are unrecognized social burdens. "Inadequately treated rheumatoid arthritis typically leads to multiple joint replacements, lost productivity, lost tax revenue and a greatly diminished quality of life, as well as an increased risk of life-threatening infections and cardiovascular disease," he said. "You have to consider what it costs to fix a bridge against what it will cost when the bridge collapses." In Reviews in Gastroenterological Disorders in 2007, Abbott consultant Stephen Hanauer, MD echoed the cheaper-to-treat argument. Humira treatment reduces "overall costs" and enhances "patients' quality of life," he says. But is it really cheaper to give patients Humira when they could use less expensive and dangerous drugs that don't suppress the immune system? The Cochrane Collaboration, an international, not-for-profit drug review organization says, "Overall, in the short term biologics were associated with significantly higher rates of total adverse events, withdrawals due to adverse events and TB reactivation," and stresses that, "There is an urgent need for more research regarding the long-term safety of biologics and the comparative safety of different biologics." In 2008, the FDA announced that 45 people died from fungal diseases from taking Humira, Enbrel, Remicade and Cimzia--20 percent of those who got sick! People who lived near the Ohio and Mississippi river valleys were especially at risk. The same year, the FDA investigated Humira for thirty reports of childhood cancer and its links to lymphoma, leukemia and melanoma in children. Yes, lymphoma. This year, the FDA warned that Humira can cause, "a rare cancer of white blood cells," in young people and five patients died during Humira trials in Italy. In the October 5 JAMA, an article warns that "potentially fatal Legionella and Listeria infections are the latest opportunistic infections to be added to the boxed warning for medications that block tumor necrosis factor (TNF)," such as Humira. The FDA's Adverse Events Reporting System discloses 80 cases of Legionella and 14 deaths and 26 cases of Listeria and 7 deaths in people on TNF blockers. Other articles, this year, link drugs like Humira to heart problems. Still, the Humira's spin machine is humming as Abbott prepares to found an entire company on the blockbuster drug. An investigator with the Italian trials called the deaths "bad luck" and not necessarily Humira-related. (Trials were not stopped.) An avalanche of Pharma planted articles dispute the heart findings. And Abbott is seeking approvals to market Humira for ulcerative colitis and pediatric Crohn's disease. Maybe there will be free samples. Martha Rosenberg's first book, Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health, will be published by Prometheus Books next year.