As all who watched last week as Jon Stewart closed out his run as host of "The Daily Show" now know, he ended it all with a short speech about the ubiquity of a two-syllable word for baloney.
Stewart used the unabridged version of the word, but since this is a family paper, we will shorten it to BS.
Not all BS is bad, Stewart said. Low-grade BS keeps us nice. "It keeps people from making each other cry all day."
"But there's the more pernicious BS," he said. "Your premeditated, institutional BS designed to obscure and distract." One way it does this by "making bad things sound like good things," as he put it. "So whenever something has been titled 'Freedom Family Fairness Health America,'" he said, "take a good long sniff. … Chances are it was manufactured in a facility that may contain traces of BS."
Which is one way of looking at "The 21st Century Cures Act," a bill with a BS-detector-inviting name that just passed in the U.S. House with bipartisan support. The legislation combines a reauthorization of NIH funding and what can only be described as a lobbyist's wish list of patient safety- and consumer-weakening provisions in the name of "modernization."
At the outset, the bill seems like a win for the health of Americans, in that it contains the first hike in federal health research funding in a decade — $8.75 billion over five years.
Patient groups support the bill because among its many provisions it allows drug makers to get monopoly protection on new uses of dormant patents. The idea is to give researchers a reason to take a second look at a host of compounds that have gone generic.
After sitting down last week with Jennifer Hjelle, the executive director of ALS Minnesota, one of many patient groups that support the legislation — and a highly sympathetic cause if there ever was one — it's easy to see how any bill that incentivizes the study of new treatments, or new uses of old treatments, is a desirable cause for those fighting terrible illnesses. And the move is accompanied by a similar provision that would grant drug makers an extra six months of patent protection if they find a new use for a drug in the treatment of a rare disease.
This seems unnecessary, as doctors can already use drugs however they like, and drug companies are very close to being able to market drugs for any use at all. Plus, as a slate of $1,000-a-dose medicines have shown us in recent months, the drug industry won't be shy about charging whatever it takes to make it rain while selling pills that have few users.
The CBO estimates that extending patents will cost the taxpayers nearly a billion dollars over 10 years. You wonder if that money would be better used letting the NIH spend it on ALS research.
But the larger issue is this: The bill is ostensibly intended to support science, and yet it carves science out of the oversight of drugs and devices at every turn:
• It would create a less exacting review process for 'breakthrough" medical devices and drugs, even though compassionate use pathways are already in place, readily granted, and the word "breakthrough" is increasingly defined as loosely as it is in segments on the Dr. Oz show.
• It would remove the common-sense requirement that medical devices undergo a clinical trial before approval. Device-makers can soon say they used their product on a patient and that patient got better. Some years you'll find better science than that at the Folwell Science Fair.
• The bill imposes top-down policies for panels that oversee the safety of trials and even allows them to work for the drug maker. It also weakens the Sunshine Act, ending our ability to learn on Open Payments if a drug maker is paying your doctor for continuing medical education talks.
• It encourages alternative statistical methods to test drugs, surrogate outcomes and "adaptive" methods in a drug trial; all are ways to foster a preferred outcome. It seems highly unlikely the bill's sponsor, Rep. Fred Upton of Michigan — Kate Upton's uncle and an aspiring sportswriter in college — had anything to do with this request.
• It creates an outside (manufacturer-picked) board to review changes in medical devices.
"We are particularly pleased to see the draft's emphasis on reducing regulatory barriers that unnecessarily slow clinical trials," Mayo Clinic CEO Dr. John Noseworthy said of this bill back in April. I can understand Mayo's support of precision medicine language in the bill, but it's unfortunate that Mayo is supporting the bill for some of the very things it does wrong.
The 21st Century Cures Act is a Christmas tree. Should the hope it gives to patient groups and researchers seeking federal support require us to overlook all that's been lost in the bargain?