NCHR Testimony at FDA at the Circulatory System Devices Panel Meeting

Varuna Srinivasan, MBBS, MPH, National Center for Heath Research; December 5, 2018

Thank you for the opportunity to speak today. My name is Dr. Varuna Srinivasan. I am a physician with a Master of Public Health from Johns Hopkins University. I am a Senior Fellow at the National Center for Health Research, which conducts research and scrutinizes 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.

I’m sure we all agree that it is important to set these standards.  I’d like to focus on what it means for patients and for public health.

  1. It is essential that devices intended for a specific high-risk population should be tested and indicated for the same group of people.  Indications should be based on the types of patients who benefited in the clinical trials that were conducted.  It is not appropriate to test a different group and then try to extrapolate to high-risk populations.  And, it is unethical if patients who are seeking and paying for treatment in the real world to be implanted with a device that was not proven to be safe and effective for patients like them.
  2. Too many devices are already on the market without ever being tested compared to other treatment options or an effective sham-control group.   Sham controlled studies should be used in devices that claim to be minimal invasive. In a situation where placebo or sham-controlled studies are deemed to be unethical, devices need to be compared to a control that patients believe will help, such as medication or a non-invasive placebo treatment.
  3. Safety endpoints need to be clinically and functionally relevant.  Patient-centered outcomes are essential because that’s what is important to patients.  These outcomes can be measures of safety, complications, or effectiveness.  They may include overall survival, hospitalizations, cardiac events, kidney function, vision changes, or fatigue.  They can include validated and reliable quality of life measures.
  4. In end-of-life patients with chronic cardiac illness, it is important to realize that while they may be willing to take on the risk of a device that isn’t proven to be safe or effective; the FDA already has programs in place to make that possible without approving the device.  For example, access is available through the expanded access program or Humanitarian device exemption pathway.  The standards must be higher for FDA approval or clearance because FDA owes it to patients and healthcare professionals to ensure that when patients pay for treatment the device is proven to have benefits that outweigh the risks for most patients.  Lower standards will add to the very negative media coverage that CDRH and medical devices have gotten this year, and that means patients will have no confidence in new medical devices.

At today’s meeting, as we consider how to clinically evaluate anti-hypertensive devices, it is important to remember who we are doing this for.  The FDA is a public health agency, and it is the patients and the American taxpayer who are FDA’s ultimate customer.  The standards must ensure that clinical trials are well-designed, clinically relevant, appropriately analyzed, and have adequate statistical power to determine safety and effectiveness.

We urge the committee today to consider these points in their discussion in an effort to set a better standard of care for our patients.