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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

Senate retirements could attract GOP troublemakers

Sen. Roy Blunt (R-Mo.). Photo: Jim Lo Scalzo/EPA/Bloomberg via Getty Images

Sen. Roy Blunt's retirement highlights the twin challenge facing Senate Republicans: finding good replacement candidates and avoiding a pathway for potential troublemakers to join their ranks.

Why it matters: While the midterm elections are supposed to be a boon to the party out of power, the recent run of retirements — which may not be over — is upending that assumption for the GOP in 2022.

Congressional diversity growing - slowly

Data: Brookings Institution and Pew Research Center; Note: No data on Native Americans in Congress before the 107th Congress; Chart: Danielle Alberti/Axios

The number of non-white senators and House members in the 535-seat Congress has been growing steadily in the past several decades — but representation largely lags behind the overall U.S. population.

Why it matters: Non-whites find it harder to break into the power system because of structural barriers such as the need to quit a job to campaign full time for office, as Axios reported in its latest Hard Truths Deep Dive.

Staff for retiring Senate Republicans a K Street prize

Illustration: Eniola Odetunde/Axios

The retirements of high-profile Senate Republicans mean a lot of experienced staffers will soon be seeking new jobs, and Washington lobbying and public affairs firms are eyeing a potential glut of top-notch talent.

Why it matters: Roy Blunt is the fifth Republican dealmaker in the Senate to announce his retirement next year. Staffers left behind who can navigate the upper chamber of Congress will be gold for the city’s influence industry.

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