Hyperventilation; Reaction to the Cures Act

December 9, 2016 – 9:37 AM | By Mark McCarty | No comments yet

 

Theatre_whiteThere may be someone on the dark side of the Moon that hasn’t heard about the Senate vote for the 21st Century Cures Act, but everyone else certainly has. One might have expected the reaction to the Cures bill to be split, but the degree to which the reaction on both sides has been hyperbolic is perhaps surprising even to the veterans of the Twitterverse.

What seems to be lacking is a level-headed examination of what this legislation will and will not accomplish. Dare anyone argue that H.R 34’s net effect will drop squarely into that plump, bourgeois, middle zone between a raging success and a crash landing to rival the Hindenburg disaster?

Hope springs … yet again

First, let’s ask ourselves what the money for the Cancer Moonshot will achieve. It’s $480 million a year over 10 years, and that might seem like real money to those who don’t deal with the U.S. federal budget. Let’s not forget, though, that NCI already gets more than $5 billion a year from the taxpayer, so this is an increase of less than 10 percent.

Does anyone remember the $10 billion NCI received via the American Recovery and Reinvestment Act of 2009? The NCI blew through that amount in two years, but whether that money was well spent is not a question anyone cares to answer. Just do a web search using “GAO National Cancer Institute,” and you’ll see that the last time GAO examined contract operations at NCI was in 1981. That’s 35 years ago.

The problem with this conversation is that the emphasis is decidedly on “Cures Now,” replete with a hashtag (#CuresAct, #CuresNow), and we also keep hearing about “eradicating cancer,” as if it were some pathogen that can be bullied out into the open and put to the torch. We all know that’s not how cancer works, though.

So another $480 million a year for cancer research might generate a good treatment or two, but the difficulty here will be in determining when a new treatment or diagnostic would have come into clinical practice even without the Cancer Moonshot. It’s the classic eye-of-the-beholder problem.

Panic button always nearby

On the opposite end of the spectrum, we have a variety of sources decrying the purportedly looser standards for drug and medical device reviews encoded in the Cures bill. It’s true that the legislation includes provisions for accelerated review, but as FDA likes to point out, “faster review” doesn’t necessarily mean “approval,” and it’s not as though these accelerated review programs aren’t already at work at the FDA.

But to hear some of the bill’s critics, the next generation of drugs and devices will be mowing down patients like a bush hog going through a field of orchardgrass. The problem with refuting these critics is that any recall or adverse event will automatically confirm their suspicions, and one supposes they won’t be bothered to find the narcolepsy-inducing denominator to go with their terrifying numerator. Thus the skeptic asks: Who can resist a self-fulfilling prophecy?

Unfortunately, my crystal ball is in for warranty maintenance, and the cat laid waste to my tarot deck the other day, so I won’t be offering any predictions as to the actual impact of the Cures Act. I will predict, however, that this is not the last we’ll hear of great expectations and of falling skies. What else is there to do on Twitter?

 

 

 

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