Alex Tabarrok alerts readers to a piece in Science by Intel’s Andy Grove about reforming the FDA. Grove notes:
The biomedical industry spends over $50 billion per year on research and development and produces some 20 new drugs … A breakthrough in regulation is needed to create a system that does more with fewer patients.
While safety-focused Phase I trials would continue under their [FDA] jurisdiction, establishing efficacy would no longer be under their purview. Once safety is proven, patients could access the medicine in question through qualified physicians. Patients’ responses to a drug would be stored in a database, along with their medical histories. Patient identity would be protected by biometric identifiers, and the database would be open to qualified medical researchers as a “commons.” The response of any patient or group of patients to a drug or treatment would be tracked and compared to those of others in the database who were treated in a different manner or not at all. These comparisons would provide insights into the factors that determine real-life efficacy: how individuals or subgroups respond to the drug. This would liberate drugs from the tyranny of the averages that characterize trial information today. The technology would facilitate such comparisons at incredible speeds and could quickly highlight negative results. As the patient population in the database grows and time passes, analysis of the data would also provide the information needed to conduct postmarketing studies and comparative effectiveness research.
Grove cites the important work of Bart Madden, who spoke to us about these ideas in his book Free to Choose Medicine.
Meanwhile, Scott Gottlieb highlights some of the high costs of the FDA impeding useful innovations.
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