The problem with bills in Congress that roar toward passage like juggernauts is that they’re especially worthy of close examination, and especially unlikely to get it. That’s the story with the 21st Century Cures Act, which reaches the Senate this week after achieving overwhelming bipartisan support in the House. Almost certain approval by President Obama lies on the horizon.
To judge from the huzzahs, the Cures Act represents a landmark in funding for biomedical research — a $5-billion bounty for the Obama administration’s “cancer moonshot” as well as its initiatives on brain research and genomics-based “precision medicine.”
“Simply put: 21st Century Cures is an innovative game-changer and a truly once-in-a-generation opportunity to bring our healthcare system light years ahead of where it is today,” proclaimed Rep. Fred Upton (R-Mich.), the measure’s chief sponsor in the House. The measure is due for a vote in the Senate on Monday closing debate, with a vote for enactment likely later in the week. [UPDATE: The Senate passed the bill Wednesday afternoon and sent it to the White House.]
This continues a trend of eroding standards at the Food and Drug Administration since the 1990s.
If universal praise for a measure makes your B.S. detectors twitch, you’re on the right track. The 21st Century Cures Act is a huge deregulatory giveaway to the pharmaceutical and medical device industry, papered over by new funding for those research initiatives. The punchline is that the regulatory rollback is real, but the funding may not be — it’s subject over the next decade to annual appropriations by Congress that might never come.
“This continues a trend of eroding standards at the Food and Drug Administration since the 1990s,” says Michael Carome, director of the Health Research Group at the advocacy organization Public Citizen, which issued a broadside against the bill last month. “We don’t think there should be any further erosion.”
Moreover, while there’s widespread support for provisions in the bill offering states money to battle opioid abuse and for mental health research and treatment, what’s overlooked is that the measure also cuts $3.5 billion, or about 30%, from Obamacare’s Prevention and Public Health Fund, which fosters work to prevent Alzheimer’s disease, hospital-acquired infections and other conditions.
One would expect Congress to ask the drug industry for something in return for regulatory rollbacks like those in the Cures Act. Remarkably, nothing in the measure would address the main problem the public sees with the drug industry — excessive prices.
The 21st Century Cures Act has been meandering through Congress since 2015. But it was only this year that its promoters hatched the idea of combining the rollback of FDA standards with funding for the National Institutes of Health, which long has been starved of resources. That prospect brought many Democrats on board.
It may also have clouded their vision, leaving unnoticed the extent to which the bill reduces regulations on drug- and medical-device makers.
The bill opens a path for the FDA to approve new uses, or indications, for existing drugs without demanding thorough clinical tests conducted along customary lines. These include randomized samples, to prove they’re safe and effective for the new indications. Instead, the FDA could rely on “real world evidence,” which includes observations, safety and side-effect claims, and other data not subject to rigorous analysis. “That’s a much lower level of evidence,” Carome says.
“A homeopath would love this provision, and, I’m sure, so would drug companies,” writes David Gorski, an oncologist and prominent debunker of pseudoscience and medical nostrums. “Why bother with the time, bother and expense of those pesky clinical trials to get your drug approved for additional indications, when you can rely on clinical experiences?”
The bill also permits drug makers to promote off-label uses of their drugs to insurance companies. This is a green light for them to vastly expand the markets for these drugs while bypassing FDA scrutiny. And it creates what Public Citizen calls an “overly broad” category of “breakthrough devices” that the FDA will be pressured to approve hastily.
These rollbacks are premised on the notion that the FDA has been a bottleneck in drug and device approval. As we reported earlier, the libertarian right loves to attack the agency for its careful approach to drug approval, even blaming it for killing people denied ostensibly lifesaving drugs.
The possibility of harm from overly indulgent regulatory approval is conveniently overlooked by industry mouthpieces demanding lessened scrutiny. Consider Merck’s Vioxx, a painkiller and arthritis drug the FDA approved in 1999. Vioxx was pulled off the market in 2004 after it was shown to raise the risk of heart attacks. By then, according to research in the British medical journal Lancet, 88,000 Americans had heart attacks from taking Vioxx, 38,000 of them fatally.
Carome further points to the case of Essure, a device implanted in women’s fallopian tubes as an alternative to permanent surgical sterilization. Currently marketed by Bayer, Essure was given expedited approval by the FDA in 2002 based on “two nonrandomized, nonblinded, prospective studies that lacked a [control] group and enrolled a total of 926 women,” according to a report last year in the New England Journal of Medicine. Experience since then has pointed to serious potential side effects and a lack of firm evidence that the device is safer than tubal ligations, amid signs it also may be less effective at preventing pregnancy. The FDA hasn’t taken Essure off the market, but it has convened a new study panel and requires a stringent warning of health risks on the label.
Once the 21st Century Cures Act was dressed up with a handout to the NIH, the voices advising caution were drowned out. In the rush to enactment, they need to be heard more than ever.
12:20 p.m., Dec. 7: This post has been updated to report that the Senate gave the act final legislative approval Wednesday afternoon.