February 20, 2014
My name is Laurén Doamekpor, and I am a senior fellow at the National Research Center for Women & Families. Our non-profit research center assesses scientific and medical data and provides objective health information to patients, providers and policy makers. Our organization does not accept funding from medical device companies, and therefore I have no conflicts of interest.
We carefully reviewed the data provided to you by the FDA. We believe that the device under review today may represent a novel way to improve the lives of patients who are not effectively treated by CPAP.
However, we have 2 concerns.
- Sleep apnea is a serious condition that affects people of all races and ethnicities, but is more common among African Americans than whites or other groups. For that reason, it is unacceptable that the sponsor’s STAR pivotal study includes ZERO African Americans. None. In fact, the sample was 97% White, and no subgroup analyses were conducted to see if the device was safe and effective for the small number of non-white patients. Based on this study, it is not possible to know if this product is safe or effective, even in the short-term, for African Americans or other races or ethnicities.
The FDA has pointed out the need to include minorities in future studies. However, we believe it is not appropriate to approve this device until it has been tested on a sample of African American patients. It would also be appropriate to do a subgroup analysis of the other minority patients in the STAR pivotal trial.
In addition, we know that sponsors whose products are approved on the basis of White samples lack the incentive to achieve diversity in post-market studies. Although many companies have promised to do better in post-market studies, they often do not do so. And they are never penalized for that short-coming.
2. We are also concerned about the long-term safety of this device.
For the non-randomized STAR pivotal trial, the sponsor provided data for the primary end-point measures at baseline and at the 12‐month follow‐up. We urge you to require that the sponsor conduct studies that assess the long-term effects of the safety and efficacy of this device BEFORE this device is approved.
We agree that a 5-year study is needed. We believe that prior to approval, the company should be required to submit data for at least a subgroup of patients who have had the device for at least 2 or 3 years. The remainder of the data could be collected post-market.
During the time needed to collect longer-term data, the sponsor should also be required to enroll African Americans in the STAR pivotal trial. Although the longer-term data would initially be on White patients and Hispanics only, there is no reason to believe that the long-term safety of the product would differ for different groups. In contrast, there is reason to be concerned about the short-term safety and effectiveness of an implanted device for diverse populations.
Obstructive sleep apnea can be devastating, and we applaud the sponsor’s innovative device. Nevertheless, we strongly urge you to ensure that the FDA requires the sponsor to complete trials that collect long-term data and include a more diverse sample BEFORE approving this device.