Buen artículo en Forbes de David Henderson y Charles Hooper sobre la nueva ley Waxman que permitirá que ciertos medicamentos no tengan que pasar los tests clínicos de la FDA en Estados Unidos. Henderon y Hooper sostienen que el mercado es capaz de determinar la eficacia de un medicamento sin necesidad de controles estatales, y que la obligación de que sea supervisado por la FDA debería suprimirse para todos los medicamentos.
Doctors, hospitals and patients see what works for them. Even when not forced to do so by the FDA, pharmaceutical companies often find it advantageous to run well-designed, expensive and lengthy clinical trials to show efficacy. Government agencies and universities also run clinical trials. Medical groups, managed-care organizations and insurance companies codify and use treatment guidelines. Individual physicians make names for themselves by analyzing medicines and writing scientific papers.
What is the harm in giving the FDA the power to exclude new drugs until they have proved effective? Plenty. Approximately 35% of drug development costs are for safety testing, while 65% are for efficacy testing. Because of this, good drugs are being delayed or not developed at all. One of us (Hooper) has helped kill drugs for brain cancer, ovarian cancer, melanoma, hemophilia and other important conditions--not because they weren't good drugs, but because the anticipated clinical development costs were greater than the anticipated financial returns.
Si alguno de vosotros es escéptico y quiere profundizar en el tema que visite esta página: FDA Review.org, una iniciativa del Independent Institute. Alex Tabarrok y Dan Klein, economistas de la George Mason University, presentan el proyecto con esta introducción:
Medical drugs and devices cannot be marketed in the United States unless the U. S. Food and Drug Administration (FDA) grants specific approval. We argue that FDA control over drugs and devices has large and often overlooked costs that almost certainly exceed the benefits. We believe that FDA regulation of the medical industry has suppressed and delayed new drugs and devices, and has increased costs, with a net result of more morbidity and mortality. A large body of academic research has investigated the FDA and with unusual consensus has reached the same conclusion.También hay que tener en cuenta que ya existe un mercado de nuevos medicamentos que no está sujeto a los controles de la FDA: aquellos que luego de haberse aprobado se prescriben para otros usos. Tabarrok tiene un interesante ensayo sobre este tema: Assessing the FDA via the Anomaly of Off-Label Drug Prescribing (pdf). Aquí un breve resumen:
Drawing on this body of research, we evaluate the costs and benefits of FDA policy. We also present a detailed history of the FDA, a review of the major plans for FDA reform, a glossary of terms, a collection of quotes from economists who have studied the FDA, and a reference section with many webbed links. A more detailed table of contents follows. We are happy to receive comments and criticisms.
Once a drug has been approved for some use it can be prescribed for any use, even one quite different than the one for which it was approved. Since new uses for old drugs are discovered all the time what this means is that we already have a voluntary system of drug review and approval that exists outside and apart from the apparatus of the FDA. A safety-only system does not mean an absence of regulation it means greater reliance on a voluntary regulatory system that better takes into account the hetereogeneity of patient diseases and preferences - what I have called the Consumer Reports model of regulation rather than our current paternalistic model.
