Pebble Beach, CA FDA Approvals For New Medical Devices Are Taking Too Long.by Richard Kuehn on 06/22/12
The Wall Street Journal recently ran a sad story about a device called the Sapien Transcatheter Heart Valve which treats severe aortic valve stenosis. Although clinical trials found that 70% of patients who received the heart valves were alive one year after treatment versus only 50% of those receiving an alternate treatment, it took more than five years for the Food & Drug Administration (FDA) to approve it. The device has been available in Europe since 2007 saving many lives abroad, but not here. Sadly, this type of delay is typical. Currently, Americans wait as much as 60% longer than they did in 2005 to get new lifesaving and live-enhancing medical devices, according to a recent report by the Government Accountability Office (GAO). During the long wait, many Americans remain sick, disabled and pass away because they aren't getting the treatment they need. I hope the FDA can find a way to move things through the approval process more quickly. I recently wrote on my blog about research being conducted by Banner Research on Genentech's drug Crenezumab. It attacks amyloid plaques in the brain and may be a viable candidate for a vaccine for Alzheimer's disease. I spoke with Eric Reiman, MD, the CEO of Banner Research and the Executive Director of Banner Alzheimer's Institute (BAI) and the Alzheimer's Prevention Initiative. He explained that many drug companies have been frustrated by the long time it takes to conduct clinical trials and get drugs through the FDA approval process. It's even more difficult for drugs for Alzheimer's disease given the fact that it can be decades before symptoms come on. However, by tapping a pool of public and private funds, Reiman is hoping to get a number of research projects going simultaneously. And by testing the drug on a small group of people in Columbia which have a rare gene giving them 100% odds of getting early onset Alzheimer's disease, the results of the testing will come in sooner than they would have if the general population were tested. This could lead to quick FDA approval of Crenezumab or another contender. Regular readers of my blog know that both my father and my grandmother had Alzheimer's disease when they passed away. I am a big supporter of the Alzheimer's Association, which has a 24-hour help line at 800-272-3900. They are also the largest private supporter of Alzheimer's research in the United States. Please help them with their important mission if you can by clicking on this link for Family inHome Caregiving fundraising site for Alzheimer's Association. To find out more about the great work that the Banner Alzheimer's Institute is doing, click here.