Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund, February 18, 2010
I am pleased to have the opportunity to testify as president of the National Research Center for Women & Families.
Our Center is dedicated to improving the health and safety of adults and children, and we do that by scrutinizing medical and scientific research to determine what is known and not known about specific treatments and prevention strategies. We do not accept contributions from companies that make medical products.
In addition, I am a fellow at the University of Pennsylvania Center for Bioethics, and a board member for two nonprofit organizations that work to improve resources for the FDA: the Alliance for a Stronger FDA, and the Reagan Udall Foundation.
I was on the faculty at Yale and Vassar, was trained in epidemiology at Yale Medical School; and I have worked on FDA oversight issues in the U.S. Congress. I have also worked on health policy issues at the Institute of Medicine and for nonprofit organizations.
I tell you this because my perspective is different from most of the speakers this morning – I am a scientist and public health expert who has not worked for industry.However, my perspective is not as an outsider.My Dad enjoyed working for a major medical device company for his entire career and as a result my family has substantial stock in that device company.I well understand the important advances made by device companies, but the 510(k) process has major problems and requires major improvements.
At today’s meeting, we’ve heard of the problems with the 510(k) process from the FDA itself, and some of these presentations describe the problems very clearly.
What are the results of these problems? We don’t know, because for many of the thousands of devices cleared through the 510(k) process, we don’t know how safe or how effective they are. No objective studies are published. No comparative effectiveness data are available to patients or physicians for most of these products.
Our Center is conducting a study of FDA’s Class I recalls. Class I recalls should not be confused with Class I devices. Class I recalls are those that the FDA states are needed because the product is likely to cause serious health problems or death. The data are clear: the vast majority of Class I recalls are 510(k) products – some are even 510(k) exempt devices. How could a low risk device result in a recall based on possible death or serious health risk? That’s a good question.
I will give a few examples of the Class I recalls of 510(k) devices:
COMPLETE® MoisturePLUS™ Contact Lens Solution was recalled after 57 million bottles were sold.It was recalled because of infections caused by parasites that are normally killed by contact lens solution, but were not killed by this 510(k) product.The infections caused permanent corneal damage; corneal replacements were required.
A more recent recall was of Baxter infusion pumps – pumps that deliver medication through IVs.Due to computer software errors and battery usage failures, these infusion pumps were not working properly, resulting in delays or interruptions in patients getting the medication, endangering their lives.
There are thousands of devices cleared every year, and most are not recalled.But there is tremendous human cost when these devices fail. I want to speak briefly about the human cost.
In addition to the above examples, there were many 510(k) defibrillators where the device malfunctioned and the patients died.
There are 510(k) bladder slings and surgical mesh that resulted in permanent pain and incontinence as well as vaginal atrophy for women across the country.
Some people today say that the process works well because thousands of devices are cleared, and most are not recalled. But are these devices safe? Are they effective? Many devices are sold that may not even work, and it is often difficult for doctors or patients to determine how well a device works, because some patients will get better and some will get worse, whatever their treatment.
Post-market studies and regulation is so important and yet is very limited. No “condition of approval” is allowed. The 510(k) devices should be the easiest to rescind, since clinical trials are usually not required before they are cleared, but the FDA points out that they don’t have that authority. This is a ridiculous situation.
Christy Foreman’s presentation spelled out all the fundamental problems with the 510(k) process very well. Clearly, the focus of the 510(k) process has been on letting companies change devices in the name of innovation, not based on public health standards or problems. As a result, devices are being sold that are so different from previous “substantially equivalent” devices that the FDA has no idea whether the product is safe or effective, and in many cases these innovative devices are either not as safe as other products on the market, or not as effective. This costs the medical system (and individuals) billions of dollars each year. Either they buy/use products that don’t work, or they spend a great deal of money on health problems that result from unsafe devices.