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The passage of the 21st Century Cures Act, which sailed through the House of Representatives last week on its way to a future White House signing ceremony, is due in no small measure to the activities of hundreds of patient advocacy groups and assorted other stakeholders that worked in overdrive the past two years pushing the bill to the finish line. Their lobbying and advocacy paid off with a 996-page bill that according to the Energy and Commerce Committee (whose slick lobbying campaign was also crucial) would “modernize” the FDA and its approval process while speeding the delivery of cutting-edge, lifesaving medicines to patients.
‘Progress’ touted by pharma is a huge step backward for patients
If the committee’s masterful sales job for the Cures Act is a textbook example of what constitutes effective PR and advocacy in Washington these days for legislation that may not be in the best interests of the public, press coverage offers a textbook example of media abdication of their watchdog role. As HealthNewsReview.org pointed out repeatedly over the past year and half, mainstream journalists, with some exceptions, did not look closely, ask hard questions, or explore the downsides until the last few weeks when the Cures Act was a done deal headed for victory.
As we reported in August 2015, the bill under consideration then would have been a huge step backward for FDA standards. Today’s version of the bill still is, according to many clinical researchers. “Ten years from now someone with a cancer diagnosis will be worse off with this bill,” says Dr. Vinay Prasad, an oncologist at Oregon Health Sciences University whose research has demonstrated that many new therapies ultimately fail to cure or are harmful because they are based on inadequate studies. “People will be exposed to more things that don’t work.”
Prasad and others believe loosening the FDA’s regulatory authority makes it easier for drug and device makers to market products based on lower standards, which eventually translates into more patient harm. Johns Hopkins physicians wrote in STAT that the term “FDA-approved will become a shadow of its former self.” Yale cardiologist Sanket Dhruva put it this way: “The patient advocacy groups think they are going to be getting cures from this, but that’s not likely.” The problem isn’t with the FDA, these critics say, noting that the agency is already approving more drugs more quickly than ever, but rather with drug companies that simply can’t provide evidence that their products work. Prasad has likened the Cures bill to a marathoner who wants to improve his time by buying a new stopwatch.
Provisions that will weaken consumer protections and enrich industry
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. The Cures Act furthers those objectives in the following ways:
Randomized trials may disappear if drug companies want to sell a drug for a different medical condition than the one it’s already approved for. If a drug is currently on the market for, say, migraines, a drug company can use “real world evidence” to show that it can also be used for neck pain. Real world evidence includes data “derived from sources other than randomized clinical trials,” which could mean insurance company claims data and observational studies — less costly and less time consuming but also less reliable.
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.”
A combination product that’s part drug and part device such as infusion pumps, could be approved based on the less stringent rules for device regulation than the tougher rules for drugs.
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? What is it that drug makers don’t want the FDA to see?
The FDA can use patient experience data to inform its regulatory decisions, which the FDA did in the precedent-setting approval of eteplirsen to treat Duchenne muscular dystrophy. The bill defines patient experience data as information about the impact for a disease or related therapy on patients’ lives and allows patients, family members, care givers, disease research foundations, drug manufacturers, and patient advocacy organizations to collect those data.
Even the billions that the bill calls for to shore up NIH research, seen as a trade-off for the more questionable provisions, are not guaranteed. Each year the money would be subject to Congressional appropriations battles.
Industry-funded advocates manipulated the media narrative
But while the benefits to government research budgets are contingent on future approval, the payoff for drug and device makers will be immediate and lasting. In fact, the drug industry, whose reputation is in the gutter thanks to price-gouging scandals and other exploitative practices, could never have gotten such a sweet deal without the help of patient advocacy groups, who fulfilled their roles as paid functionaries in the great network of PhRMA marketing.
A study published in November in the Mayo Clinic Proceedings shows just how pervasive that role has become. Three-quarters of 68 cancer patient advocacy groups studied in the first half of 2016 disclosed sponsorship from the biopharmaceutical industry. Some received funding from as many as 16 or 17 PhRMA companies while the Pancreatic Cancer Action Network got money from 19.
No wonder the Action Network and most other groups dependent on PhRMA largess signed letters of support to Congress urging passage of the Act. Take Mended Hearts, for example, which advocates for people with heart disease. It signed a letter in mid-November with some 200 other advocacy groups and research associations telling Congress, “Patients simply can’t afford to wait – time is running out.” Andrea Baer, director of patient advocacy for Mended Hearts, told me that members in 40 states responded to the group’s call for action with emails sent to Congress telling them how the Act would affect them personally. “We want to have access to treatments and devices when they become available so streamlining the FDA is important,” she added.
These patients were certainly well-meaning, but their efforts are also a pretty good quid pro quo for the members of their corporate advisory council – Amgen, AstraZeneca, BMS Pfizer, Daiichi-Sankyo/Lilly, Gilead, Metronic, Novartis, and Sanofi Regeneron, which are also listed as corporate sponsors in the group’s 2014 annual report. Meanwhile, groups that don’t accept industry funding were warning that the bill has the potential to hurt millions of patients and needed to be fixed before it became law. “The irony is calling this 21st Century Cures when they’re talking about standards that were left behind in the 20th century,” Diana Zuckerman, Ph.D., President of the National Center for Health Research has said.
‘Obfuscation’ rules the day and hard questions come too late
Last year, as the Energy and Commerce began the push to pass its bill, Ellen Sigal, who heads Friends of Cancer Research, argued in the Huffington Post that the Cures Act did not reduce safety standards. “Nothing could be further from the truth: the FDA’s authority for maintaining the gold standard for safety and effectiveness remains unchanged.” This year she was back with the same message, telling the Washington Post, “There’s nothing in this bill that suggests that standards are being lowered. There was substantial input from the FDA on this, as well as from the White House and patient groups. We would not support it there was a lowering of standards.”
To deny that that there’s nothing in the Act that says standards are being lowered is “a whole other level of obfuscation,” says Vinay Prasad. It’s especially hard not to consider that the organization’s supporters, listed in an annual report, reads like a who’s who of drug companies and cancer centers that will benefit from the Act – Amgen, Merck, Pfizer Genentech, Dana-Farber Cancer Institute, the Cleveland Clinic, and Duke Cancer Institute to name a few. Despite doing a nice job overall of exploring critics’ concerns about the legislation, the Post never disclosed the Friends group’s extensive ties to the drug industry.
In the last few weeks as passage neared, more journalists came forward and offered solid explanations of what the Act would do –Vox, for example and STAT News. And there was discussion of the role of patient advocacy groups and the money they get from PhRMA as in this excellent piece by ProPublica and this from The Intercept. But there were also a slew of stories with predictable headlines, such as these that were passed along in a news release from the Energy and Commerce Committee: “House Overwhelmingly Approves Sweeping Health Measure” from the New York Times; “House Passes Sweeping Health Innovation Bill with $1 Billion for Opioids,” from USA Today; and “House Overwhelmingly Passes ‘Cures’ Legislation to Streamline Drug Approval” from the Washington Post. Whatever specifics the body of these stories might convey, a casual reader of headlines would never know that the legislation includes an historic rollback of science-based consumer protections.
A potentially toxic legacy that has so far gone unexamined
The long, sad tale of journalists and the 21st Century Cures Act presents a much larger issue. In our truth-challenged world, how do we cover legislation shaped by a massive PR operation from a Congressional committee that takes a long time to gestate? Why weren’t more news organizations examining the bill long before October? Why didn’t members of Congress who are now raising questions, like Massachusetts Sen. Elizabeth Warren and Vermont Sen. Bernie Sanders, speak up sooner? Where was the dot connection between the 200 or so patient advocacy groups and their links to PhRMA? After all, much of that information is on the public record. And who was questioning the exploitation of young children with life-threatening diseases in order to sell looser regulation for drugs and devices?
Perhaps in today’s media environment, where fake news seemingly has more currency than facts, such questions don’t matter anymore. What most certainly does matter, though, are the consequences for all of us when we become patients long after Chairman Upton and members of the Energy and Commerce Committee have left Washington (or perhaps stayed in DC to become industry lobbyists). The bill has been described as Chairman Upton’s “legacy,” but if so it could well be a toxic one. There has been little discussion of what happens when some of these drugs and devices, which will be approved through “breakthrough” pathways or with evidence from families and caregivers instead of randomized trials, kill or injure patients. Will journalists even bother to write what has been the customary story when such events happen: Why wasn’t the FDA doing its job? The public will be paying the price for 21st Century Cures for a long time to come.
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