The 21st Century Cures Act overwhelmingly passed the Senate on Wednesday, and will almost certainly be signed into law by President Barack Obama within the next few days.
Minnesota’s two senators, Amy Klobuchar and Al Franken, joined 92 of their colleagues to support the sweeping, 996-page bill. Only five senators — Elizabeth Warren of Massachusetts, Bernie Sanders of Vermont, Ron Wyden and Jeff Merkley of Oregon, and Mike Lee of Utah (the sole Republican) — voted against it.
With such a positive name (who can be against a law aimed at curing people of disease?) and with so many superlatives being used to describe it (“a truly once-in-a-generation opportunity to bring our health care system light-years ahead of where it is today,” according to its chief sponsor in the House, Rep. Fred Upton, R-Michigan), what’s there not to like in this bill?
After all, doesn’t it offer almost $5 billion in National Institutes of Health funding, mainly for the Precision Medicine Initiative, the BRAIN Initiative, and the “cancer moonshot”? And won’t it make it easier for people with serious illnesses to get speedy access to state-of-the-art, lifesaving treatments?
‘A deregulatory giveaway’
Well, as Pulitzer-Prize-winning Los Angeles Times financial columnist Michael Hiltzik notes in a recent column, “If universal praise for a measure makes your B.S. detectors twitch, you’re on the right track.”
Yes, the bill has some highly laudable elements, but it is not the “win-win” that its most ardent proponents have claimed. Far from it.
“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,” writes Hiltzik. “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.”
Moreover, as Hiltzik also explains, “despite the universal praise for provisions for state grants to battle opioid abuse and for mental health research and treatment, [the bill] 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.”
The public health efforts that will be receiving funding cuts also include immunization and tobacco-use-prevention programs.
‘Huge step backward’
Veteran health-care journalist Trudy Lieberman has equally harsh words to say about the Cures Act, which she describes as “a huge step backward for FDA standards.”
“The bill’s imminent passage is the culmination of a 20-year drive by conservative think tanks and the drug industry that began during the Clinton Administration to ‘modernize’ the FDA, loosen regulation over drug and device makers, reduce the number of clinical trials needed to approve a drug, and permit advertising for off-label drug uses, all of which would help drug and device makers expand their markets,” she writes in a column for the Minnesota-based Health News Review.
Some medical devices would get an easier pathway to market, one that is already relatively easy. Overall devices are held to a lower standard than drugs, but the bill gives device makers even more wiggle room by calling for the FDA to ensure that the design of clinical trials for devices designated as “breakthroughs” is as “efficient and flexible as practicable when scientifically appropriate.”
New drugs could be approved on the basis of data summaries rather than requiring the FDA to independently analyze study results for a new drug indication. Companies would have to submit all their data, but the agency would not have to review it.
“What happens if the data are incomplete or only partially accurate?” Lieberman asks. “What is it that drug makers don’t want the FDA to see?”
Another long-time health reporter, Larry Husten, calls this last detail about data summaries “really quite frightening.”
“Companies could submit their own reviews for new indication approvals,” he writes in his Cardiobrief column for MedPage Today. “Currently FDA reviewers have full access to raw data and they perform their own rigorous analysis of that data. Anyone who has observed the FDA approval process knows that these independent reviews often turn up important issues that might otherwise go unnoticed but that could later spell disaster.”
A weaker FDA
The Cures Act also allows the FDA to make decisions based on “real world evidence” — information derived from sources other than randomized clinical trials.
“A homeopath would love this provision, and, I’m sure, so would drug companies,” writes Dr. David Gorski, a surgical oncologist at the Barbara Ann Karmanos Cancer Institute in Detroit, in a column for the Science-Based Medicine website. “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 based on therapeutic use, uncontrolled observational studies, or registries instead? If I were the CEO of a pharmaceutical company, I’d love it. Indeed, the one thing this provision most definitely does not do is to speed effective treatments to patients. Rather, it smacks of being a payoff to pharmaceutical companies.”
Dr. Vinay Prasad, an oncologist at Oregon Health Sciences University whose research has shown that many new therapies are ineffective and/or harmful because they are based on inadequate studies, was equally blunt. “Ten years from now someone with a cancer diagnosis will be worse off with this bill,” he told Trudy Lieberman. “People will be exposed to more things that don’t work.”
Other physicians agree, including Dr. Reshma Ramachandran, an assistant scientist in the Johns Hopkins Bloomberg School of Public Health and co-chair of the National Physicians Alliance FDA Task Force, and Dr. Zackary Berger, an assistant professor of medicine at the Johns Hopkins School of Medicine and a faculty member in the Johns Hopkins Berman Institute of Bioethics.
“Despite all of their clinical and scientific knowledge, health professionals need a way to convey to patients that treatments are safe and effective,” the two doctors write in a commentary for the Boston Globe’s StatNews website. “The imprimatur of the FDA is currently a kind of Good Housekeeping Seal of approval. Weakening the FDA’s standards would undermine our trust and leave patients at a loss. Without a strong FDA, who else will let providers and patients know if a treatment will work or is even safe? Pharmaceutical companies? Medical device manufacturers?”
“We don’t need #CuresNow,” they add. “Instead, we need legislation that will let us all continue to trust the term “FDA approved” into the 21st century.”
FMI: You can access the full text of the 21st Century Cures Act through the Congress.gov website.