December 5, 2016
The Honorable _______
United States Senate
Washington, DC 20510
Dear Senator _______,
The USA Patient Network respectfully and strongly urges you to vote against the 21st Century Cures Act this week, and instead insist that the bill be improved and more carefully vetted in 2017.
As patients and patient advocates, we support additional funding for medical research and to fight the opioid crisis. Unfortunately, this bill does not guarantee that funding. Without that guarantee, and because Congress is always confronted with other urgent priorities, we think it is unlikely that the promised funding will be available in future years, and it is essential to delay passage until research and opioid funds can be guaranteed.
Passing a 996-page, complicated health bill that was negotiated behind closed doors, finalized a few days ago, and has not been carefully reviewed in public hearings is unfair to patients. It adds to the cynicism that many patients feel about who is influencing the laws of our land, and who is standing up for the safety needs of patients.
Many sections in the bill would compromise patients’ health and safety because they lower the standards for drugs and medical devices at the Food and Drug Administration (FDA). For example, the bill pressures FDA to approve new medical products on the basis of “surrogate endpoints” instead of patient health and survival. A new cancer study shows how that harms patients: that study shows that most new cancer drugs that were approved on the basis of surrogate endpoints do not help patients live longer or feel better. The average Medicare cost of these ineffective cancer drugs was just under $100,000! An editorial in a prestigious medical journal points out how this harms patients and US healthcare in general. And yet the Cures Act would push FDA to use surrogate markers for many other serious diseases, on the basis of even less evidence.
The Breakthrough Devices sections of the bill would encourage shorter and smaller clinical trials for medical devices. These smaller studies make it impossible to include enough women, men, seniors, and racial and ethnic minorities to determine if the product is safe or effective for them.
The bill would also extend patent exclusivity for many drugs, which adds to the already unaffordable cost of prescription drugs and devices.
We do not know who will be in the leadership at the FDA next year or in future years, but we know that when Congress passes legislation pushing the FDA to approve medical products more quickly on the basis of smaller and shorter-term studies, including studies that rely on surrogate endpoints, patients have been harmed.
The USA Patient Network is a new nonprofit group that does not accept funding from pharmaceutical or Medtech companies, and we have been trained to understand the FDA approval process as well as the importance of well-designed clinical trials. Our members are from all over the country, and new members are added daily. Some of our members have been terribly harmed by unsafe medical products, and others are hoping that new safe and effective treatments will be developed soon.
Based on our own experiences and our solid understanding of the approval process, we strongly urge you to delay passing any legislation during the rush of a lame-duck session, and instead consider our perspectives when you take up these issues in 2017.
By lowering and even eliminating standards for FDA approval of drugs and devices, the current “Cures” Act would do the opposite of what it promises -- increase the cost of healthcare, result in millions of patients relying on treatments that aren’t proven to work and even endanger them with treatments that haven’t been proven safe.
Please stop this bill from passing. Patients deserve better! We’d welcome the opportunity to work with you to make revisions to the bill to ensure it will accomplish the goal of improving medical treatments for all patients.
Members of the USA Patient Network