Obama signs 21st Century Cures Act

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Today, at 2 p.m. Eastern, the President will sign the 21st Century Cures Act—approved by the Senate on Dec. 7 by a vote of 94-to-5, overwhelmingly passed by the House the week before, and seemingly supported by every pharma company, medical institution, healthcare advocate and their mothers. And why not? “21 st Century Cures” is the legislative equivalent of the Pee Wee League: In the end, there’s an award for everybody. (My colleague Sy Mukherjee has been all over the generous grab bag of provisions—here, here, and here—so I won’t go into the details now.)
But while this much-ballyhooed behemoth of a bill (nearly 1,000 pages) has been praised for being bipartisan, it’s also binomial: Technically speaking, "H.R. 34: the 21 st Century Cures Act" is a "re-texted" version of "H.R. 34: the Tsunami Warning, Education, and Research Act of 2015," which is intended to enhance and modernize the existing United States Tsunami Warning System. And the former isn’t exactly a “bill,” but rather an amendment to the latter—or, well, a House amendment to a Senate Amendment to the re-texted tsunami bill.
This procedural silliness, of course, is simply that: It’s just a little Congressional fun with words. But then, importantly, so is much of the 21 st Century Cures Act.

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In 1980, new investigators got their first major NIH grant, on average, at age 36; today, the average age is 42. Back then, more than 40% of research project grants went to principal investigators (PIs) under 40; the share in 2016 is less than 10%. We now have more PIs age 66 and older than we do 36 and younger—and with this aging of America’s biomedical research force, we have put "a generation of science at risk."
If all this sounds familiar, that’s because we’ve been singing this tune for a generation. In 1998, a distinguished committee led by Princeton University’s Shirley Tilghman warned that too many early-career life scientists faced diminishing and discouraging professional prospects. In 2005, another blue-ribbon committee—this one led by Nobel laureate Thomas Cech—said the situation was so dire for young American researchers that the U.S. was in danger of losing its "preeminent leadership position" in science. Three years later, another report, called ARISE, once again shouted the need to invest in early-career scientists.
All were substantive, well-researched reports that recommended substantive, well-researched fixes. So what does the 21 st Century Cures bill do to implement them? It establishes the "Next Generation of Researchers Initiative" within the office of NIH Director to "promote policies and programs" that help young scientists. Gotcha.Congrats, Congress—Collect your trophy after the game.

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Warren (D-MA)

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But there’s a complication: Instead of cracking down on the pharmaceutical companies that fueled the boom in opioid abuse, lawmakers rewarded the industry. No health care-related bill of this size could move through Congress without the support of Big Pharma. The authors of the 21st Century Cures Act earned the industry’s support by including regulatory rollbacks that drugmakers have long sought and creating cheaper and quicker paths for drug approval by reducing safeguards. It’s as if the fire department had to pay off the arsonist to get permission to put out a fire.

Lawmakers were left with a Hobson’s choice. The bill would make billions of dollars available for medical research. It would fund lofty goals, such as precision medicine, a White House initiative to map the human brain and Vice President Joe Biden’s “Cancer Moonshot.” It would save lives. But it would also undermine regulations that patient advocacy groups say are essential for making sure medical and drug research is conducted ethically and safely — meaning it could cost lives, too.

Some politicians thought the choice was clear. On Nov. 28, Sen. Elizabeth Warren (D-Mass.) denounced the measure in aggressive terms, calling it the result of “corruption” — fighting words on the Senate floor — and singling out Majority Leader Mitch McConnell (R-Ky.) for taking millions from a donor with an interest in the bill’s passage. Warren was hoping to make a battle around the Cures Act the moment that Democrats announced, in the wake of Donald Trump’s election, that they were standing up and fighting against a broken and corrupt system.

“The American people didn’t give Democrats majority support so we could come back to Washington and play dead,” she said on the floor. “They didn’t send us here to whimper, whine, or grovel. Now they are watching, waiting and hoping ? hoping we show some spine and start fighting back when Congress completely ignores the message of the American people and returns to all its same old ways.”

Others read the politics around the bill differently. Sen. Johnny Isakson (R-Ga.), one of the bill’s supporters, called Warren’s floor speech “the most irresponsible statement anybody can possibly make,” adding: “She pontificates as if she knows everything, when in fact she knows nothing.”

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