A Reuters noticia hoje (20/04/07) que os planos de saúde estão mais sensíveis e receosos em relação aos novos tratamentos, tudo depois do casos Vioxx. Cita também o trabalho fantástico da equipe de epidemiologia da Kaiser Permanent cujas análises argutas já mostraram risco sérios como o da nifedipina e dos Cox-2. A conclusão é óbvia, porque :
(1) os novos tratamentos são eficazes e seguros nos problemas que já se previa na fase de ensaio clínico;(2) o ensaio clínico por definição limita o tipo de participante, caso contrário, nada concluiria em tempo razoável;
(3) o medicamento ao ser lançado no mundo real passa ser objeto de observação de efeitos em pacientes que foram excluídos do ensaio clínico. Assim, uma série de efeitos não desejáveis que passam a ser notados. O oposto também ocorre, efeitos desejáveis não previstos mudam a indicação do fármaco, como no caso do minoxidil que foi lançado para hipertensão, mas como efeito não esperado, crescia cabelo. Assim, uma solução tópica foi criada com sucesso e, esqueceu-se o anti-hipertensivo;
(4) o ideal é que haja sempre um controle rigoroso de segurança nos primeiros anos, mas como é o momento da indústria recuperar o investimento, tal procedimento é quase sempre relegado.
Health plans back greater scrutiny of new drugs
CHICAGO (Reuters) - U.S. health insurers, whose patient records helped uncover heart risks of the withdrawn arthritis drug Vioxx, called on Thursday for a new body to compare the safety and effectiveness of new drugs versus older treatments. America's Health Insurance Plans, a trade group for big health insurers like Kaiser Permanente and WellPoint Inc., also backed greater authority for U.S. regulators to police the safety of drugs once they hit the market. The recall of Merck & Co.'s Vioxx in 2004 helped ignite a growing controversy over whether drugs are adequately monitored for safety after being approved. "We all tend to assume newest is best, which is not always the case," said Roberta Herman, chief medical officer at Harvard Pilgrim Health Care, a hospital system in Boston which recently won the top spot in a national quality ranking of U.S. hospitals. The health insurers group called for a new entity, funded with public and some private resources, that would be independent of the drug industry to conduct real-world studies of drugs. A representative of the Pharmaceutical Research and Manufacturers of America trade group was not available for comment. Kaiser Permanente, a big health maintenance organization in California with about 8.5 million, supplied some of the data used by the FDA finding Vioxx boosted the risk of stroke and heart attack. Several insurers have contracts with the FDA to supply the large swaths of data needed to detect side effects of drugs on the market. On Wednesday, a U.S. Senate panel approved a bill to bolster the FDA's oversight over prescription drugs, which includes a new power to fine companies for not completing studies and a ban on advertising for new drugs for two years. The Bush Administration has called the bill onerous and some Republicans tried to strike language on the advertising ban. Critics say aggressive consumer advertising boosts overuse of new drugs. Jack Hoadley, a professor at Georgetown University's health policy institute said health plans have vested interest in such reforms because they could trim drug costs, but their support adds clout to the idea. "It's the natural rivalry of the payers versus the manufacturers, but I think any time a major industry group comes out with a particular statement like this it does have some effect," Hoadley said
CHICAGO (Reuters) - U.S. health insurers, whose patient records helped uncover heart risks of the withdrawn arthritis drug Vioxx, called on Thursday for a new body to compare the safety and effectiveness of new drugs versus older treatments. America's Health Insurance Plans, a trade group for big health insurers like Kaiser Permanente and WellPoint Inc., also backed greater authority for U.S. regulators to police the safety of drugs once they hit the market. The recall of Merck & Co.'s Vioxx in 2004 helped ignite a growing controversy over whether drugs are adequately monitored for safety after being approved. "We all tend to assume newest is best, which is not always the case," said Roberta Herman, chief medical officer at Harvard Pilgrim Health Care, a hospital system in Boston which recently won the top spot in a national quality ranking of U.S. hospitals. The health insurers group called for a new entity, funded with public and some private resources, that would be independent of the drug industry to conduct real-world studies of drugs. A representative of the Pharmaceutical Research and Manufacturers of America trade group was not available for comment. Kaiser Permanente, a big health maintenance organization in California with about 8.5 million, supplied some of the data used by the FDA finding Vioxx boosted the risk of stroke and heart attack. Several insurers have contracts with the FDA to supply the large swaths of data needed to detect side effects of drugs on the market. On Wednesday, a U.S. Senate panel approved a bill to bolster the FDA's oversight over prescription drugs, which includes a new power to fine companies for not completing studies and a ban on advertising for new drugs for two years. The Bush Administration has called the bill onerous and some Republicans tried to strike language on the advertising ban. Critics say aggressive consumer advertising boosts overuse of new drugs. Jack Hoadley, a professor at Georgetown University's health policy institute said health plans have vested interest in such reforms because they could trim drug costs, but their support adds clout to the idea. "It's the natural rivalry of the payers versus the manufacturers, but I think any time a major industry group comes out with a particular statement like this it does have some effect," Hoadley said
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