Aug 3, 2017

The internal FDA discord over a controversial drug approval

Janet Woodcock, a top FDA director (Jose Luis Magana / AP)

The Food and Drug Administration's controversial decision last year to approve a drug for Duchenne muscular dystrophy sparked divisions within the agency — with one former-high ranking official alleging that another top official ignored the FDA's normal scientific review, according to emails obtained by journalist Charles Seife and published at Undark.

The big email: John Jenkins, who used to be the head of the FDA's Office of New Drugs, sent a memo to former FDA Commissioner Robert Califf this past September. Jenkins alleged Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, undercut the expert team that questioned the benefits of the drug — eteplirsen, branded as Exondys 51 by Sarepta Therapeutics.

Jenkins' memo also said Woodcock was in close contact with Sarepta and the patient advocacy groups who desperately wanted the drug to get the green light, and she approved the drug before vital outcomes data was published.

Why it matters: The approval process for Exondys 51 appears to have been just as controversial behind the scenes as it was in the public eye.

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South Korea and Italy step up measures as coronavirus cases spike

Data: The Center for Systems Science and Engineering at Johns Hopkins, the CDC, and China's Health Ministry. Note: China numbers are for the mainland only and U.S. numbers include repatriated citizens.

The novel coronavirus has spread to more nations as South Korea and Italy in particular scramble to deal with spikes in their countries.

The big picture: COVID-19 has killed at least 2,446 people and infected almost 79,000 others, mostly in mainland China. South Korean President Moon Jae-said country would increase its infectious disease alert to red, the highest level possible, the New York Times reports, as the number of cases in the country soared to 556 and the death toll to five. Italy's government announced emergency measures Sunday after infections rose to 79.

Go deeperArrowUpdated 2 mins ago - Health

Bernie Sanders wins Nevada caucus

Democratic presidential candidate Sen. Bernie Sanders waves to supporters at a campaign rally on Friday in Las Vegas. Photo: Mario Tama/Getty Images

Sen. Bernie Sanders is projected to handily win the Nevada Democratic primary caucus, becoming the clear frontrunner among 2020 Democratic presidential primary election candidates.

Why it matters: Nevada is the first state with a diverse population to hold a nominating contest, highlighting candidates' abilities to connect with voters of color — particularly Latino voters.

Go deeperArrowUpdated 28 mins ago - Politics & Policy

Heat wave melts 20% of snow cover from Antarctic island in days

The effects of February's record heat wave on Eagle Island in Antarctica. Photo: NASA

Antarctica's Eagle Island now has a side that's almost ice-free following this month's searing heat wave in the region, images released by NASA show.

Why it maters: "The warm spell caused widespread melting on nearby glaciers," NASA said in its report. It's the third major melt event of the 2019-2020 Southern Hemisphere summer, following warm spells in January and last November, according to the United Nation's World Meteorological Organization (WMO).