November 7, 2023
I’m Dr. Diana Zuckerman, president of the National Center for Health Research. We scrutinize the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products. So I have no conflicts of interest.
In addition to my current work, my perspective reflects my post-doctoral training in epidemiology and public health, my training in bioethics, previous policy positions at HHS and a Congressional Committee with oversight over FDA, and as a faculty member and researcher at Yale and Harvard. I am also a founding board member of the Alliance for a Stronger FDA, which is a coalition of industry and nonprofit organizations that work to ensure that the FDA has sufficient appropriations to fulfill its important mission.
Thanks for the opportunity to speak today. Since you have such impressive medical expertise on this panel, I will focus on policy issues that have important implications for patients – a goal that we all share.
The FDA has spelled out their concerns about these devices in their written summary and will talk about them today, so I will focus on the big picture.
- These devices have been treated as 510k devices since 1976 and that has resulted in limited scientific data — in fact, FDA found very few studies of either safety or effectiveness, none of which were randomized controlled trials and none that evaluated a specific device used to prevent cancer metastasis.
- Most importantly, no studies indicate that the use of blood irradiators improves patient outcomes.
So given the lack of evidence of benefits, what are the risks?
- There are few adverse event (AE) reports to FDA’s Medical Device Reporting (MDR) system. But that may be because the devices aren’t used frequently and MDR reports are voluntary and everyone agrees that AEs are under-reported. We all know that surgeons are very busy and do not have strong incentives to report AEs, especially when it isn’t clear if a problem was caused by the device vs. human error.
- Even so, the FDA has identified numerous potential serious risks, including incorrect or improper dose of radiation, damage to blood components caused by the radiation, and radiation causing an immune response that is harmful to cancer patients. Device malfunction or poor design could result in unintended radiation exposure of the operator or the public, or electrical shock or burn.
- Several papers reported that blood irradiation took additional time, 15-20 minutes, and that can sometimes be harmful.
- Perhaps most important, most patients and surgeons assume that these products are proven safe and effective. Would they choose to use them if they knew how little scientific evidence there is regarding safety or effectiveness?
THE BOTTOM LINE: These devices fit FDA’s definition of Class III
- “Insufficient information exists to determine that general and special controls are sufficient to provide reasonable assurance of its safety and effectiveness.”
- “The device is for a use which is of substantial importance in preventing impairment of human health.”
The FDA is asking if special controls would be sufficient instead of a PMA. They don’t specify which special controls, but the problem here is we don’t know if the products have any benefits regardless of how they are used.
Would FDA impose special controls requiring evidence of effectiveness, and if so, why not require a PMA instead? We don’t know if either of the current products are safe and effective, and we don’t know if one is better than the other. That is why I encourage you to urge the FDA to categorize these as Class III and require a PMA, so that we will finally have well designed clinical trials to determine safety and effectiveness.
Would registries be as good as clinical trials to study blood irradiators that are already on the market? Registries can collect important information. But registries do not provide a control group, and this is especially problematic for a device that is not widely used, since those who use blood irradiation to prevent metastasis may differ in important ways from those who do not.