Personalized Medicine

Patient X was rushed to the hospital for emergency surgery. As she entered the hospital she said to the anesthesiologist, “You may not want to use suxamethonium on me.”

“Have you had a previous reaction?” inquired the anesthesiologist.

“No.”

“Ah, a family member must have had a reaction.”

“No.”

“Why then are you concerned about this drug?”

“I’ve had a good portion of my genome sequenced,” the patient replied, “and I found that I have a genetic variation in the enzyme that breaks down suxamethonium and am part of the 5% of patients who respond unusually to this drug. I thought you should be aware of this information.”

The flabbergasted anesthesiologist wondered how long it would be before more of her patients came prepared with their own genetic code.

I made up the details of the conversation above, but otherwise the story is true. The patient was a customer of 23andme, a service that for around $200 will give you information on about half a million sites on your genome, how you differ from other people at those sites, and which of your variations are associated with various diseases, behaviors and capabilities.

The costs of sequencing are falling so rapidly it will soon make sense for everyone to carry their entire genetic code with them on a USB drive (23andme only identifies part of the code). In 2001 it cost Craig Venter $100,000,000 to sequence the first human genome (his own.) Today, it costs just $16,000; in a few years, it will cost less than $1,000–a 100,000-factor decrease in costs in less than two decades!

That’s me from a piece called The FDA and Personalized Medicine written to help launch a new blog from the Manhattan Institute, Medical Progress Today. I go on to argue that if we are to take advantage of the new possibilities for personalization “we must move the FDA away from pre-market gatekeeping and towards post-market surveillance and information provision.”

David Henderson, Rita Numerof and Paul Howard all comment.

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