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U.S. Big Pharma Sues European Medicines Agency to Hide Adverse Drug Safety Data on Humira and Esbriet

Drug companies maximize the sales of new drugs by hyping their benefits while downplaying significant risks. In 2010 the European Medicines Agency began releasing patient-level data from the clinical trials used to approve new medicines in Europe – a development hailed by American, and European researchers and researchers around the world as a major step towards drug safety. This process has been shut down by a lawsuit taken by two American corporations – AbbVie, makers of Humira, the number one selling medication in the world with projected sales of $10 billion in 2013; and InterMune, whose pulmonary-fibrosis drug Esbriet has recently been approved in Europe at a cost of over $40,000 per year. AbbVie and InterMune have filed suit to deny access to the data from their trials on the benefits and harms of these drugs, claiming these vital facts are “trade secrets” whose release would harm their profits. Their action has led to the shutdown of the entire public-access program, leaving millions of patients worldwide, and their doctors, in the dark.

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How Can a Drug that Causes Leukemia, TB, and Listeria Remain on the Market?

In 1998, the FDA approved a new class of anti-inflammatory drugs called TNF-alpha blockers. The best-known drugs in this class are Enbrel and Humira, which are used to treat juvenile rheumatoid arthritis, Crohn’s disease, and other inflammatory diseases. But these drugs have dangerous side effects. In 2008, 2009, and 2011, the FDA determined that these drugs increase the risk of different—but all potentially fatal—infections and cancers, including tuberculosis and childhood leukemia. Despite all their well-documented dangers, as of 2013, TNF blockers remain on the market. The FDA has simply asked manufacturers of TNF blockers to let them know when someone got cancer—essentially taking a “wait and see” approach to a drug that has caused at least thirty-five deaths from cancer, at least fourteen deaths from Legionnaire’s Disease, and at least seven deaths from listeria infections. Over fifty people have died, and the FDA is still at the “information-gathering” stage.

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