America has a kidney problem. The federal government has the power to help solve it.
Today, 37 million Americans have chronic kidney disease (CKD)—that’s one out of every seven U.S. adults. The majority have CKD as a result of diabetes or hypertension, but CKD isn’t a mere side effect of those conditions; it is its own dangerous disease. As it gets worse, people can experience high blood pressure, anemia, nerve damage, gout—and ultimately, kidney failure, heart attack, stroke and death.
A shocking 90% of the people in the early stages of CKD don’t know they have it. CKD does its damage silently, often over many years, so people do not experience symptoms until later stages.
Given the scale of the CKD epidemic, kidney health needs to become a routine part of the doctor-patient conversation. But we also need to encourage innovation in new treatments for kidney disease and kidney failure. That’s where the federal government must align and take a leadership role.
The Department of Health and Human Services (HHS) has taken some much-needed steps forward by launching the Kidney Innovation Accelerator, or KidneyX. This public-private partnership between HHS and the American Society of Nephrology (ASN) is meant to foster innovation in the prevention, diagnosis and treatment of kidney diseases. Thanks to this increased focus and collaboration among HHS, ASN, the pharma and biotech industries and investment capital, people with earlier stages of CKD have gained access to several new drugs that can help them delay or avoid kidney failure, known as end-stage renal disease.
As the largest kidney patient organization in the country, we have been gratified to witness this small but important growth in treatment innovation.
Even with these efforts, however, new treatments coming to market for people with kidney disease have been few and far between. The kidney community is troubled that while HHS is prioritizing access and innovation, the Food and Drug Administration (FDA) has a concerning pattern of rejecting much-needed therapies that would help America’s kidney patients, despite the fact that many of these new drugs have demonstrated more benefit than risk following extensive clinical trials.
While many of us have been optimistic about the promise represented by the billions of dollars invested in research and development over the years, the actual impact of these dollars has been disappointing. The FDA’s rejections of drugs for kidney patients is keeping new and innovative therapies out of reach. As a result, America’s kidney problem will only get worse—particularly for people of color, who are hardest hit by kidney failure. Kidney disease is complex. Not every drug works for every person, and it is imperative, especially for this patient group, that a variety of treatment options are available to meet their diverse needs.
Consider the latest and most disappointing example of how kidney patients are being left behind: The FDA’s recent rejections of several new drugs intended to treat renal anemia, which can be debilitating for many patients. To create more treatment options for patients, significant investment has been made in developing a brand new class of drugs called oral hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs). These drugs work by helping increase red blood cell production and balance the body’s response to reduced oxygen. As a result, they safely improve patients’ hemoglobin levels and promote greater iron utilization, relieving patients of severe exhaustion, mitigating anemia’s impact on cardiac health and empowering patients to live more independently. This new class is a significant advance because the medications can be administered orally; CKD patients and home dialysis patients could manage their anemia at home rather than travel to an infusion or dialysis center. Managing anemia in CKD patients can also help slow disease progression—delaying or preventing the need for dialysis or a kidney transplant.
Severe anemia is also a major concern for patients on dialysis, often requiring blood transfusions to treat their anemia. Transfusions can be risky because of the prevalence of transfusion-related antibodies that make it difficult for dialysis patients to subsequently be matched with a potential donor kidney for transplant—exacerbating the wait times patients must endure.
Yet, despite research showing the effectiveness of this new class of drugs and their uptake and approval in other countries, the FDA has issued arguably short-sighted rejections of the last few HIF-PHIs it reviewed. Fully 70% of nephrologists disapprove of these decisions.
Rejecting new therapies is also a step backward for the effort to improve health equity in kidney disease. Due to historic and systemic inequities, communities of color tend to be medically underserved and have the highest prevalence of diabetes, hypertension and other comorbidities that accelerate the progression of kidney disease to kidney failure. What’s more, historically marginalized populations tend to experience longer wait times for the limited number of kidneys available for transplant.
The FDA’s rejection of innovative drugs represents a step backward for our kidney patient community, frustrating patients and disheartening innovators in the renal community. Kidney patients need safe, effective treatments to be approved by the FDA, and they and their doctors deserve the opportunity to make an informed choice about the risks and benefits of therapies.
They also need better access to treatments that have already been approved. For example, ferric citrate, an oral medication effective at treating renal anemia, should be covered by Medicare (as it already is by virtually every other major payer). Solutions like the Renal Anemia Innovation Support and Expansion (RAISE) Act (HR 2934) would address this issue, if passed, further helping align the federal government’s approach to improving kidney care.
As we work diligently to improve outcomes and quality of life for patients with kidney disease, we urge patients, researchers and doctors to voice their support for new kidney disease treatments. We need real leadership from the federal government in addressing this relentless disease that results in 360 people starting dialysis every 24 hours. The FDA should work more collaboratively with researchers to create clear pathways to test and approve new drugs, and Medicare should cover those therapies once approved. When these two things happen, we can deliver more effective treatments for the millions of people in the U.S. with this life-altering disease.
LaVarne A. Burton is the president and CEO of the American Kidney Fund.