NCHR’s Testimony at FDA’s November 3, 2021 Circulatory Systems Devices Advisory Committee Meeting

Thank you for the opportunity to speak today on behalf of the National Center for Health Research. I am Dr. Meg Seymour, a senior fellow at the center. We analyze scientific data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug or medical device companies, so I have no conflicts of interest.

We are concerned about the conflicting data on EVAR devices, and the reliance on 5-year studies that include different iterations of a device. These are high-risk devices, and FDA should require clinical trial data for the approval of revised versions of the device. The FDA’s executive summary discusses some long-term clinical trial data, following patients up to 5 years post-EVAR procedure. However, the FDA clearly noted that many devices have undergone modifications, so that the clinical trials include data on products that are no longer on the market, with more recent iterations including fewer years of follow-up data.  Real world data can be useful, but not when it includes numerous devices but doesn’t specify the data for each different device.

Let’s simplify what is happening. The newer version of the device is assumed to be better, but with no clinical trials required by the FDA, it can take years before any problems with the modified device are clearly documented. That revised device may be revised again – once again without clinical trials — and that new version of the device is also assumed to be better. This creates a cycle in which a lack of clinical trials for each modification makes informed consent impossible for patients, and informed decisions by surgeons is also impossible. How many patients are harmed before new data on new versions of these devices have enough follow-up information to be useful? The death rates for EVAR patients is high – they are high-risk patients and this is therefore a high-risk device. Clinical trials should be required each time a high-risk device is revised because of problems, ensuring that the new device isn’t as bad or worse than the previous version that was recalled or withdrawn. Moreover, FDA should not allow devices to be approved for all patients with a particular medical need if the device is only effective for a very small subsample of patients.

As you consider conflicting data, we want to raise the question about how conflicts of interest may affect those findings. As Dr. Menard stated at yesterday’s meeting, many of yesterday’s public speakers did not mention if they had financial conflicts of interest. We know that the FDA does not require such disclosures, but when physicians discuss their clinical experiences or provide data to the FDA’s Advisory panel, it is important that conflicts of interest are disclosed, just as they are at medical conferences.