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Hullabaloo


Wednesday, November 30, 2016

 

Sausage-making 101

by Tom Sullivan

It's a big country. Everybody wants a piece of it. Big pieces of legislation are like that. Everybody wants something. A lot of money rides on who gets what and who pays for it. Sam Stein, Ryan Grim, and Matt Fuller at Huffington Post offer an exhaustive (exhausting?) stroll through the machinations behind the 21st Century Cures Act. As with the Affordable Care Act, lawmakers have to buy off Big Pharma if they want to pass the parts that may actually help people. They write:

... It’s as if the fire department had to pay off the arsonist to get permission to put out a fire.

Lawmakers have been 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.
Sausage-making at its finest. Funding VP Joe Biden's cancer moonshot is perhaps the biggest carrot, Stein et al. explain, but not the only one. There is the EUREKA Initiative [Exceptional Unconventional Research Enabling Knowledge Acceleration]. (Please shoot me now.) EUREKA "directs the NIH to establish a competition for innovative work to combat serious biomedical diseases." And there are other promising-sounding projects. Of course, there is a "but" coming:
But assembling a broad, bipartisan coalition often requires including ethically suspect giveaways. And this bill has those, too. The REGROW [Reliable and Effective Growth for Regenerative Health Options that Improve Wellness] Act, introduced by Sen. Mark Kirk (R-Ill.) and co-sponsored by Sens. Susan Collins (R-Maine) and Joe Manchin (D-W.Va.), is one of many stray pieces of legislation sewn into the 21st Century Cures Act to help it gain support.

The bill would speed up the delivery of adult stem cell therapies to patients. But it would do that by allowing those therapies to go to market before they’re definitively proved to be safe and effective.
No worries. However, Zoë Carpenter writing about the Cures Act at The Nation recalls a fast-tracked contraceptive device released in 2002 called Essure. Another of those troublesome buts:
But it turned out that the device was neither as safe nor as effective as expected: as many as one in 10 women who used Essure got pregnant, thousands reported injuries or other serious complications, and a few died.
So what if stem cell patients grow an ear on their foreheads before the recalls? Just so long as the stock goes up.

Including "lobbyist and donor-backed measures" like REGROW is how business gets done on Capitol Hill, HuffPost continues:
The bill’s supporters are making concessions to Republicans, too. Late Tuesday night, Republicans pulled a bipartisan provision ― authored by Sens. Orrin Hatch (R-Utah) and Ron Wyden (D-Ore.) and Rep. Vern Buchanan (R-Fla.) ― promoting evidence-based prevention services to help keep more children out of foster care after Sen. Richard Burr (R-N.C.) demanded it be stripped out.

The bill had passed the House unanimously in June when it came up for a standalone vote, and it’s backed by more than 500 child welfare groups. But Republican leaders backed down Tuesday after Burr, along with Republican Sens. Thom Tillis (N.C.), Mike Enzi (Wyo.), Pat Toomey (Pa.) and Dan Coats (Ind.), pressed McConnell and Ryan to remove it from the larger Cures Act.
Your guess is as good as mine why they object to keeping children out of foster care. But follow the money.