In a radiation-proof room at the Erasmus Medical Center in Rotterdam, Emar Thoma...
AMSTERDAM - In a radiation-proof room at the Erasmus Medical Center in Rotterdam, Emar Thomasa sits behind shielded glass as he carefully measures and mixes lutetium octreotate, an intravenous treatment for certain types of cancer.
Three - Erasmus, Amsterdam’s University Medical Center and the Transvaal Pharmacy in The Hague - have vowed to bypass drug company products and make treatments for a handful of rare diseases themselves, exercising their right to “compound” medicines. Compounding is the ancient practice of preparing medicines for individual patients. Pharmacists are trained to compound, though nowadays most medicines are made by industrial producers.
A spokesman for Leadiant said when Dutch patients suffering from rare diseases were exposed to medicines that had not been subject to the stringent testing required of authorized drugs, it could have “significant repercussions” for their health. The Dutch pharmacies, whose production is on a small scale, acknowledge they may face legal challenges from the drug industry. However, such a case could set a precedent for other European countries.
Official scrutiny of the practice increased after the 2012 deaths in Massachusetts, which led to U.S. lawmakers requiring bulk compounding facilities to register with the Food and Drug Administration and meet quality and labeling standards - still not as stringent as full FDA drug approval. Dutch Medical Care Minister Bruno Bruins attended the opening of a new compounding laboratory at the Transvaal pharmacy in January. His government has vowed to curb drug price increases, a pledge welcomed by the public.
Novartis charges 92,000 euros for a one-off course of four Lutathera injections. But while the drug is innovative, its development costs were relatively small and cannot justify the price tag, said Erasmus MC Chief Executive Ernst Kuipers.
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