Os bastidores de um ótimo artigo científico: a segurança das estatinas e o mercado americano OTC

Quinta-feira à noite é publicado no The Lancet uma revisão excelente mostrando que as estatinas são muito seguras, mas como pouco destaque para a efetividade desse grupo de medicamento. Confesso que não entendi o desbalanço dessa revisão, mas fui convencido que o medicamento deve ser amplamente comercializado no Brasil. Tanto que no domingo, eu recomendei nesse blogue que as estatinas façam parte do rol do programa Farmácia Popular. Além disso, já há genéricos da lovastatina, pravastatina e lovastatina no mercado brasileiro. Segunda-feira, à noite, compreendi a preocupação com a segurança das estatinas expressa no referido artigo. Publicou-se a notícia que a Glaxo Smith Kline (britânica como The Lancet) comprou os direitos da lovastatina nos Estados Unidos para venda livre de receita. O FDA não aprovou o uso sem receita (OTC, over the counter) por causa dos riscos do uso indevido do medicamento, principalmente lesões musculares e hepáticas. A recusa ocorreu em duas oportunidades, mas no Reino Unido há permissão para venda sem receita. Ou seja, há uma possibilidade maior de aprovação para venda OTC.

Como se pode deduzir, as decisões editorias do The Lancet são bem independentes e, desligadas de qualquer interesse empresarial.

Glaxo Gets Rights to Sell ProposedOver-the-Counter Cholesterol Drug By JEANNE WHALENNovember 26, 2007 3:28 p.m.GlaxoSmithKline PLC acquired the rights to sell a cholesterol-lowering drug without a prescription in the U.S. but could face a tough time winning Food and Drug Administration approval to actually sell the product. Glaxo said Monday that it has bought the marketing rights to the drug Mevacor from Merck & Co. for an undisclosed sum. Despite two past attempts, Merck has so far been unable to get the FDA to approve Mevacor for sale without a prescription. Selling a cholesterol-lowering drug without a prescription could potentially be big business for Glaxo. The drugs, known as statins, are available only by prescription in the U.S. today and are among the industry's top sellers. The drugs racked up U.S. sales of $21.6 billion last year, according to IMS Health, a healthcare research firm. An FDA advisory panel is scheduled to meet Dec. 13 to consider Merck's most recent application to sell Mevacor without a prescription. A Merck spokesman said the company plans to present new data addressing earlier concerns that consumers wouldn't take the drug correctly. Merck will handle that FDA meeting, but Glaxo will take over marketing of the drug should the FDA grant approval, the Merck spokesman said. Merck will receive royalty payments on any sales, he said. The company's decision to sell the rights does not reflect any concern that OTC Mevacor won't be approved. "We're optimistic," he said.The FDA's rejection of Mevacor goes back to 2000, when it rejected an application by Merck to sell a weaker version of the drug without a prescription. In 2005, the FDA again rejected an application for over-the-counter Mevacor, this time filed by Merck and former partner Johnson & Johnson, after advisers to the FDA expressed concern that consumers would use the drug incorrectly. In 2004, the U.K. approved for sale a non-prescription version of the statin Zocor, which is sold by a joint venture between Merck and Johnson & Johnson—and is similar to Mevacor. When they started selling the drug, the companies estimated that the market for an OTC statin was about £600 million ($1.25 billion) in the U.K. alone. Merck began selling prescription Mevacor in 1987. The U.S. patent for the drug expired in 2001