The Food and Drug Administration’s move to tighten the regulatory screws on personal genomics company 23andMe has ignited a fierce debate between those who believe government oversight of medical data should be increased and techno-libertarians who worry government intervention could squelch innovation.
It’s no surprise where Reason magazine falls in this debate. Editor-in-chief Nick Gillespie interviews Peter Huber, a senior fellow at the Manhattan Institute and author of the recently published The Cure in the Code: How 20th Century Law is Undermining 21st Century Medicine, to discuss whether the
FDA’s aggressive actions will inhibit the next era of medical intervention and drug development, limiting pharmaceutical companies from bringing the advantages of personal genomics to patients quickly and efficiently.
“The search for one-dimensional, very simple correlations—one drug, one clinical effect in all patients—is horrendously obsolete,” says Huber. Scientists today have the technology to tailor treatments to an individual’s unique genetic code, but the FDA’s outdated “one-size-fits-all” drug approval model is blocking innovation.
Until recent advances in personal genomics and molecular chemistry allowed researchers to see the human body at a molecular level, developing drugs was akin to “one hand clapping”—scientists could control the drug’s chemistry to affect clinical symptoms in patients, but they could not see what the drugs were doing on a molecular level. Every person’s body chemistry is unique, even if two people with a disease have identical clinical symptoms. An understanding of personal genomics can lead to narrowly targeted treatments for individuals.
Regulatory processes within the FDA are choking pharmaceutical efforts to bring the benefits of personal genomics directly to patients, Huber contends. Pharmaceutical companies are very good at designing targeted drugs. The technology—and talent—exists to tease out complex patterns from the enormous amount of molecular and clinical data needed to develop those drugs. However, the FDA does not have the expertise nor the resources that are found among companies like Google or Microsoft, which regularly work with big data. The FDA is still locked into the traditional model of ‘one drug, one clinical effect for all patients.’ Diseases are not ‘one cause, one effect,’ says Huber, and “if you demand that drugs perform that way, we will not cure many of the serious diseases we’re now facing.”
Read the full, original story here: How The FDA is Killing Molecular Medicine: Q/A w Peter Huber
- FDA action against 23andMe reveals importance of communication in regulatory process, Genetic Literacy Project
- Drug trial, dubbed ‘Master Protocol,’ uses tumor genomics to customize treatments, MIT Technology Review