Bipartisan consensus is rare these days. But one thing that Republicans and Democrats have agreed on in recent years is federal support for biomedical research at the National Institutes of Health. Congress has approved significant increases in federal funding for disease research in each of the last four years.
Since Congress funds the research, Congress also has responsibility to get results. Unfortunately, there is a significant gap in funding for translational research. Because of this gap, federally funded research is sitting on the shelf, ignored and unused.
Translational biomedical research advances taxpayer-funded NIH research into viable cures and treatments that can be developed by private companies. Without funding for translational research, much of the basic research done at NIH cannot be put into clinical trials to determine its effectiveness. This issue is so common — and so detrimental to applied research — that this gap is often referred to as the “Valley of Death.”
Rather than spend additional federal money on translational research, we have proposed a unique public-private partnership as a solution. H.R. 2620, the Faster Treatments and Cures for Eye Diseases Act, creates a pilot program focused on a single medical issue – blindness. The bill creates unique financial instruments called “Eye Bonds” that would allow private investors to fund translational research for a variety of eye-related diseases and conditions. H.R. 2620 uses a public-private partnership to bridge the “Valley of Death.”
In the United States, there are more than 4 million adults and almost half-a-million children who are blind or have severely impaired vision. Their vision is impaired by a variety of medical conditions, such as age-related macular degeneration, diabetic retinopathy, retinitis pigmentosa and sickle-cell retinopathy.
Furthermore, blindness is a significant issue for our veterans of the armed forces. According to the Vision Research Program of the Department of Defense, traumatic eye injuries account for upwards of 16 percent of all injuries in Operation Enduring Freedom and Operation Iraqi Freedom. Close to one-third of service members that experience an ocular trauma become legally blind.
H.R. 2620 implements numerous safeguards to ensure taxpayers’ interests are protected, and to quickly reimburse taxpayers for the small initial outlays to start the project. The pilot program stipulates that the National Eye Institute (NEI), part of NIH, will select eligible projects so that only legitimate, viable projects receive funding. Packages of loans to scientific projects deemed viable for investment by NIH would be sold in Eye Bond issuances of no more than $250 million per year for four years, backed by a limited federal guarantee to encourage private investors to invest in a complex field.
Eye Bonds would NOT replace existing federal funding to the NEI or the NIH. Furthermore, taxpayers are repaid first – not last – as researchers advance treatments and repay their obligations. We have built in many other controls at each stage of this pilot program, which would also proceed only following rules from the Departments of Health and Human Services and Treasury to maximize taxpayer protections, speed cures, and prevent conflicts of interest.
Less than two years ago Luxturna became the first FDA-approved gene therapy for patients with an inherited retinal disease. Since then the treatment has worked for several patients with Leber congenital amaurosis (LCA), a rare genetic disease that primarily affects the retina and causes severe visual impairment starting in infancy and deteriorates slowly over time.
For example, 6-year-old Monroe Le, who was diagnosed with LCA when she was three, was able to see in the dark for the first time and enjoy a trip to Disneyworld after receiving the treatment. And Heather Hodlin, at 25-years old, was finally able to see her first star through a telescope. But Luxturna is an exception. With new funding mechanisms to push research ahead, there is no doubt the science and technology capabilities exist to deliver more breakthroughs for eye diseases and beyond.
Once proven to work for blindness, this funding model can be expanded to cross translational research boundaries in other disease groups such as cancer and neurological disorders. Because of the proximity of the optic nerve to the brain, some medical researchers say that, “The eye is the window to the brain.” Treatments for blindness have been shown to have related benefits for neurological conditions such as Alzheimer’s and Parkinson’s Disease.
If the Eye Bonds pilot program is successful, it could have ancillary benefits for millions more Americans.
Bishop represents Georgia’s 2nd District. McMorris Rodgers represents Washington’s 5th District and is a member of the Energy and Commerce Committee.