21st Century Cures Act nears passage with little news media scrutiny

Veteran health care reporter and regular HealthNewsReview.org blogger Trudy Lieberman has been following the 21st Century Cures Act’s journey through Congress for nearly a year. As it edges closer to becoming law, she checks in with another report on how the news media have been covering the proposed legislation.

Dark Sky over the United States Capitol

21st Century Cures is winding its way through Congress.

With the exception of STAT News, a few other mainstream media outlets, and some boosterish op-eds appearing in local papers, the news media haven’t said much about the 21st Century Cures Act over the past 6 months. It’s fair to say most Americans are in the dark about that far-reaching bill passed by the House of Representatives last summer and now winding its way through the Senate.

A step backward for FDA Standards

Recall that the Cures Act lowers already weak standards for FDA approval of medical devices, and would allow companies marketing “breakthrough” devices to submit evidence of safety and efficacy based on sources other than clinical trials, including case histories which could mean the experiences of individual patients.

They would not have to conduct time-consuming and expensive clinical trials, randomized or not. As I wrote last August they “could submit documentation that Joe Blow Patient’s health had improved by having some device implanted in his chest.” At the time Dr. Rita Redberg, a prominent cardiologst at the University of California, San Francisco, told us, “This will result in a lot of dangerous drugs and devices on the market with no evidence.”

In recent months, three posts by STAT have probably given the public more clues about the legislation than any other news source except maybe the House Energy & Commerce Committee which has been pumping out news releases by the dozens over the past two years. They are trying — successfully it would appear — to build momentum for legislation that will benefit drug and device makers while potentially jeopardizing public safety.

Public not on board with speedier approvals

STAT’s contribution: A piece about the legislative wrangling over mandatory appropriations for the National Institutes of Health (NIH), which Democrats are trying to link to the bill’s other provisions; a discussion of a survey it conducted with the Harvard School of Public Health that found a majority of the public opposes regulatory changes that speed up the development and approval of new medical treatments; and a commentary by long-time pharma industry columnist Ed Silverman who concluded that coupling funds to speedier approvals “is a misguided notion that, unfortunately, is more likely to help companies than patients.” One Harvard expert he talked to called it the “19th Century Fraud Act.”

STAT’s stories are a good snapshot for its readers, who are probably savvier than most about the healthcare industry. But other news outlets also need to take a serious look at this legislation.  And I don’t mean stories like this one from the Detroit News, which used the word “landmark” to describe the Cures Act, was loaded with he said/she said quotes, and brushed off serious concerns about it with this sentence:

“Critics of the legislation have argued it puts too much pressure on the FDA to lower its standards for evaluating new drugs and treatments and could put vulnerable patients at risk.”

Nor do I mean a piece, all upbeat and positive, appearing on the Chattanoogan.com, a web-only daily, that might as well have been a news release from the Energy & Commerce Committee. It reported on a talk by the state’s senior senator Lamar Alexander at a Chamber of Commerce meeting. Alexander’s presentation highlighted a Nashville resident who was blind last August but who can see today. He had undergone a novel treatment using his own cells spun in a centrifuge and injected into his eye. “It’s a remarkable story,” the senator said. “But it’s just one story and there are millions of other Americans who could be helped if we complete the work that we set out to do.”  Readers would never know there were significant downsides to Alexander’s legislation.

Consumers and physicians are confused about “breakthroughs”

The Senate legislation is now 19 separate bills. A reporter, or Alexander’s constituents for that matter, wouldn’t learn much from his committee’s news release that summarizes those bills in the most glowing terms. It described the “Advancing Breakthrough Medical Devices for Patients Act” as a bill “to help anyone whose health could be improved by a truly breakthrough device—it will focus more of Food and Drug Administration’s (FDA) attention and resources and put more senior people at FDA in charge of the review of these breakthrough devices so that they will move more efficiently through the review process and get to patients more quickly.”

Dr. Sanket Dhruva, a Yale cardiologist, unraveled what this actually means in a blog post for The Hill. The bill defines breakthroughs as devices that offer “significant advantages over existing approved or cleared alternatives” or are in the “best interests of patients.” Dhruva argued that those requirements are vague and lack meaningful benchmarks and that “once a device is designated as a breakthrough, the legislation erodes that device’s standards.”

In an interview Dhruva questioned whether a breakthrough pathway is even necessary. “I say ‘no.’  Let the evidence speak for itself. This is more a marketing sales pitch than something that’s truly going to benefit patients.” The FDA already has a process for designating new drugs as “breakthroughs,” and grants more than one-third of requests for the designation. Evidence is also coming in that neither doctors nor patients understand what a breakthrough really means, but that labeling something a breakthrough is powerful stuff and sells a lot of drugs. A study of board certified internists and specialists found that they significantly overestimated what the FDA requires to be a breakthrough drug and believed the drugs were supported by stronger evidence than the law required. A second study found that 92 percent of Americans surveyed preferred a drug labeled as a breakthrough to one that was simply described as meeting the FDA breakthrough criteria. The takeaway from these studies: the term “breakthrough” can lead patients to be overly optimistic about a drug’s effectiveness. The same can be said for devices.

The National Center for Health Research, a non-profit think tank that analyzes and explains the latest research-based information for patients and policymakers, strongly opposes the Senate’s breakthroughs bill as well as other provisions such as one that deregulates electronic health records and other electronic health technology. That provision would also prevent the FDA from collecting data about harms caused by the technology or from recalling defective software even though it may have life-threatening flaws. The Center has studied FDA-reported recalls of medical software and what they found is disturbing: more than 600 software devices and 1.4 million units have been recalled for presenting moderate or high risks to patients. The Senate’s version of the House bill weakening the approval process and allowing anecdotal evidence to substitute for clinical trials is more moderate. Still, says Diana Zuckerman, the Center’s president, her group is concerned with the Senate’s bill.  “It’s not nearly as broad, but it does lower standards,” she told me. “I didn’t think it was humanly possible to lower the standards (for device approval), but they have found a way.”

Today’s lobbyist-led provisions are tomorrow’s “poor government regulation”

The nitty-gritty of crafting legislation is something the press usually doesn’t give a hoot about. It’s boring, too much inside baseball, the language will change a zillion times, and changes are hard to trace unless you have a reliable guru to help. It’s an old press dilemma. The deck is stacked against journalists who want to track the lobbyists’ handiwork. But unless a bill like the Cures Act and its Senate counterpart get more scrutiny, it will be easy for drug and device manufacturers and other interests that will gain financially to sneak in provisions that benefit them and not the public.

The end game is predictable. The next big story that comes along about a device that kills or injures a bunch of patients and was approved with swift clearance and little testing will lament the weak regulatory standards and blame poor government regulation for causing the harm. How those standards came to be will be forgotten. The story will include the manufacturer’s side— either a “no comment” or a denial of culpability. Any involvement the manufacturer or its industry had in weakening those standards will be forgotten, too.  There will be little discussion of how all this came to be.

In the meantime the Energy & Commerce Committee continues the drumbeat with the hope that the public hears its message that “cures” must come to market faster no matter what might happen to patients along the way. Dr. Phil just joined its crusade;  little Max, who has a rare disease, is back helping to market the legislation; and even The Avengers have re-united for an admiring teen battling cancer.

The Committee is taking no chances that its Cures Act will get tangled up in the Senate over the NIH funding dispute. It has attached various sections of the Act to the House Appropriations for the Agriculture Department and the FDA bill that will pass this year to fund the agencies.  Attaching controversial bills to must-have legislation is how things get done in Washington these days when no one—especially the public—is looking.

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