The first ultra-personalized drug — made for one patient, the only one who will ever take it — is raising all kinds of new questions about how to handle a scenario that's likely to only become more common, the New York Times reports.

Driving the news: The drug, described yesterday in the New England Journal of Medicine, treats the neurological disorder of an 8-year-old girl.

  • The genetic presentation of her disease is unique, but one of her doctors had an idea about how to treat it, which was eventually successful.
  • It's unclear how much developing the drug cost, but the girl's mother and doctor raised $3 million through a foundation and on GoFundMe.

The big picture: This raises huge questions about how to regulate this kind of extreme precision medicine, who should get it and who should pay for it.

  • Researchers will have to decide which of the tens of thousands of patients with rare diseases to prioritize when creating custom drugs.
  • Families would likely end up on the hook to pay for such custom drugs, automatically limiting who has access to them.
  • It's also unclear how much evidence the FDA needs of such a drug's safety and how to evaluate its efficacy.

The bottom line: We now have no choice but to answer these kinds of questions as they play out in real life. Ultra-precision medicine is no longer only theoretical.

Go deeper: The struggle to evaluate drugs

Go deeper

Updated 9 mins ago - Politics & Policy

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Illustration: Aïda Amer/Axios

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  2. U.S.: Total confirmed cases as of 9 p.m. ET: 3,111,902 — Total deaths: 133,195 — Total recoveries: 969,111 — Total tested: 38,032,966Map.
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Tokyo in the time of coronavirus. Photo: Charly Triballeau/AFP via Getty

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Reality check: While some countries have thus far managed to keep cases under control after opening up, dozens of countries that had initially turned a corner are now seeing a worrying rebound. They have to decide if and how to return to lockdown — and whether their populations will stand for it.