Stephanie Fox-Rawlings, PhD, National Center for Health Research, June 20, 2019
Thank you for the opportunity to speak today on behalf of the National Center for Health Research. I am Dr. Stephanie Fox-Rawlings. Our Center analyzes scientific and medical data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug and medical device companies, so I have no conflicts of interest.
We’ve been very impressed with the discussion yesterday and today. We agree with the FDA and the Panel that the increased risk for death for patients treated with paclitaxel-coated balloons or –eluting stents, as shown in the meta-analysis of randomized pivotal trials, is very concerning. Any potential increase risk for death is important for health care professionals and patients to know about, so that they can make appropriate decisions about whether to use a product.
We greatly appreciate the efforts that FDA is undertaking to evaluate this safety signal.
We also agree that there are unanswered questions about the clinical trial data and the cause of the increased risk. More research is clearly needed. While many kinds of studies can contribute to our understanding of the risks of these devices, the best source of information will be additional high-quality long-term clinical trials.
Meanwhile, information about the signal for the increased risk of death should be included in the labeling for these products. This information is important to help patients and their physicians make informed health-care decisions, even though we still have questions about the meaning of the data. A 50% increase in deaths from a meta-analysis of numerous studies is information that patients and physicians deserve to have. However, it may be more informative and possibly less frightening if it were provided in terms of the absolute risk and not just relative risk. For example, if the absolute risk for death is only 2%, then a 50% increase may not be of great concern for many patients. However, for an absolute risk is much higher, then a 50% increase may have a greater impact on their decision.
In conclusion, while there are still many questions, the fact that this signal was seen in a solid meta-analysis is important. It is a reminder of the value of long-term studies conducted after products are on the market. It also shows the importance of FDA’s continued role in post-market surveillance and communicating their findings to physicians and patients. This information is absolutely vital for health care providers and patients to make informed decisions about their care.