The House passed legislation intended to accelerate the “discovery, development and delivery” of treatments for patients with unmet medical needs on Wednesday evening after spending more than two years in political limbo.
Next it heads to the Senate for a vote. If passed, the 21st Century Cures Act would allocate more funding to the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) that will help them move new drugs and devices through the approvals process more efficiently, says Paul Melmeyer, associate director of Public Policy at National Organization for Rare Disorders. […]
Dr. Diana Zuckerman of the National Center For Health Research described the Cures Act as a “misnomer to start with.” She cited two issues with the bill: it lowers the standards for medical products, drugs and devices — and the money outlined in the bill is promised, not guaranteed.
Both concerns could have severe implications, she explained, by saturating the market with ineffective FDA-approved drugs and increasing overall medical costs.
“We’re doing the research showing there are a lot of drugs already on the market that don’t work,” Zuckerman said, “And it’s contributing billions of dollars to the cost of Medicare, billions of dollars to the cost of health insurance, and thousands of dollars per patient.”
She continued: “When insurance companies pay money for drugs that don’t work, all of us have more expensive premiums and more expensive co-pays.”
Those concerns haven’t escaped prominent politicians like Vermont Sen. Bernie Sanders and Massachusetts Sen. Elizabeth Warren. Prior to the vote Wednesday morning, Sanders spoke about the “greed of the pharmaceutical industry,” urging Congress to stand up to corporations instead of giving them “handouts” and “giveaways.”
On Monday, Warren blasted the bill, saying she knows the difference between “compromise and extortion.” And one of her chief complaints echoed the concerns of Zuckerman: Warren described the $4.8 billion allocated to the NIH as a “fig leaf” compared to what was initially requested, $8.75 billion.
“And most of that fig leaf isn’t even real,” Warren said. “Most of the money won’t really be there unless future Congresses pass future bills in future years to spend those dollars.” […]
Zuckerman described the Cures Act as an “effective lobbying campaign,” referring to the idea of exploiting patients’ vulnerability and appealing to people’s empathetic tendencies.
“It’s really unfortunate how desperate patients, and desperate parents of patients with rare diseases, have been used to lobby for a bill thinking that it’s actually going to benefit them when it isn’t,” she said.
“Anybody who knows anything about NIH research will tell you that the vast majority of research that NIH does is what’s called ‘basic research.’ It takes many, many years to go from basic research at NIH to a product that can be tested on a human being, and even more years before it’s proven to be safe and effective for patients.” […]
Zuckerman, who spent a number of years on Capitol Hill pushing for heath reform and advocating for safe treatments, said that her opposition to the bill doesn’t equate to an apathy for patients and their illnesses.
“We need to speak not just for the patients who are desperate for treatments, we need to speak on behalf of the patients who have tried treatments that harmed them, and in some cases made their final weeks and months painful and miserable,” she said.
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