quarta-feira, 13 de junho de 2007

O Yin e o Yang da regulação de medicamentos.

O The New York Times publicou um artigo com questionamento já abordado nesse blogue e, defendido por muitos pesquisadores e diretores clínicos da Big Pharma: não é possível liberar um medicamento novo com a velocidade exigida e que seja, ao mesmo tempo, seguro. Ponto final. Defendo também a Big Pharma na questão tempo de patente: o ideal é a contagem de tempo após a publicação de estudos de segurança e , não do registro do medicamento.
Outro problema decorrente dessa pressa é que medicamento com grande utilidade - mas, com prescrição mais restrita - foram "queimados" pelo risco apresentado em indicações de certa forma indevida.
O texto do NYT começa dessa forma:
Potentially Incompatible Goals at F.D.A. By GARDINER HARRISPublished: June 11, 2007 Safety and speed are the yin and yang of drug regulation. Patients want immediate access to breakthrough medicines but also want to believe the drugs are safe. These goals can be incompatible. Race a drug to market and much is likely to remain unknown when patients take it. Test a drug thoroughly to assess all possible risks and its release may be delayed by years.A series of drug-safety scandals has led many on Capitol Hill to question whether the Food and Drug Administration has failed to strike the right balance between speed and safety. A clear sign of this imbalance, these critics say, is the increasing number of F.D.A. drug-safety officers who say they have been punished or ignored after uncovering dangers of popular medicines.
Aqui se apresenta as origens da crise atual:
In the 1980s, the F.D.A. took nearly three years to approve most drugs. The AIDS crisis demonstrated that such long delays could condemn to death patients who might have been helped by recent scientific breakthroughs. F.D.A. managers said they did not have enough people to assess reviews more quickly. So in 1992, Congress helped the F.D.A. and the drug industry reach a deal. Companies agreed to pay millions of dollars in fees, and the F.D.A. guaranteed that drug reviews would be completed within a year or as little as six months for a life-saving medicine. At the time, it seemed a good solution. But the deal’s fine print soon came to haunt the agency. Drug makers refused to let their money pay for the routine monitoring of drugs’ safety once they were on the market. As the agency began to depend more and more on industry fees, those parts of the agency slowly withered.

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