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

Louisville police declare state of emergency as Breonna Taylor decision looms

A demonstrator holds up a sign of Breonna Taylor during a protest in Louisville, Kentucky. Photo: Brandon Bell/Getty Images

The Louisville police chief declared in a memo obtained by news outlets a "state of emergency" for the department on Monday to prepare for Kentucky Attorney General Daniel Cameron's expected announcement on the Breonna Taylor case.

Of note: Louisville has witnessed more than 115 days of protests over the police killing of Taylor, an unarmed Black woman, with calls for all the officers involved to be charged.

Updated 1 hour ago - Politics & Policy

Coronavirus dashboard

Illustration: Sarah Grillo/Axios

  1. Global: Total confirmed cases as of 9 p.m. ET: 31,1833,800 — Total deaths: 962,793— Total recoveries: 21,348,410Map.
  2. U.S.: Total confirmed cases as of 9 p.m. ET: 6,833,800 — Total deaths: 199,818 — Total recoveries: 2,615,949 — Total tests: 95,841,281Map.
  3. Health: CDC says it mistakenly published guidance about COVID-19 spreading through air.
  4. Media: Conservative blogger who spread COVID-19 misinformation worked for Fauci's agency.
  5. Politics: House Democrats file legislation to fund government through Dec. 11.
  6. World: U.K. upgrades COVID alert level as Europe sees worrying rise in infections — "The Wake-Up Call" warns the West about the consequences of mishandling a pandemic.

Sen. Cory Gardner on vacant Supreme Court seat: "I will vote to confirm"

Photo: Alex Wong/Getty Images

Sen. Cory Gardner (R-Colo.) will vote to confirm President Trump's nominee to replace the late Ruth Bader Ginsburg, he announced in a statement Monday.

Why it matters: The development is a win for President Trump and Senate Majority Leader Mitch McConnell (R-Ky.). It should mean Republicans are all but assured to have enough support to hold hearings for Trump's potential nominee.

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