June 17, 2014
Good afternoon. My name is Dr. Laurén Doamekpor, and I am a senior fellow at the National Center for Health Research. Our non-profit research center scrutinizes scientific and medical data and provides objective health information to patients, providers and policy makers. Our organization does not accept funding from device companies, and therefore I have no conflicts of interest.
We all know that obesity is often debilitating. The VBLOC device is an innovative way of addressing this important health concern but the question is: how well does it work and does its benefits outweigh its risks?
We have carefully reviewed the data provided to you and have 2 major concerns:
1) The sponsor did not meet the objective for the 2 primary effectiveness endpoints at 12 months. There was no statistically significant difference in percent excess weight loss between patients with VBLOC and the sham controls. We cannot emphasize this enough.
2) It is unacceptable that there was so little diversity in the Recharge trial. 93% of patients were White: only 8 patients who received the device were Black, and only 2 were Hispanic. In fact, only 21 patients who received the device were men. You can’t draw any conclusions about the safety or effectiveness for any men or non-White women based on these data
Four out of five Black women in the U.S. are overweight or obese – almost twice the proportion of White women. Hispanic women are also more likely to be obese than White women. We obviously can’t draw any conclusions about the safety or efficacy of this device for either Black or Hispanic women – even though their health is at greatest risk because of obesity. In fact, we can’t really draw any conclusions about men either.
Even more disturbing is that the Recharge trial is a 5-year trial with plans to follow the same patients for this time period. As a result, the post-approval data would also completely lack the diversity needed to prove that the device is safe or effective for most obese Americans. The FDA has very clear guidelines that urge sponsors to include minorities in their clinical trials. However, the FDA often fails to enforce these guidelines. If the FDA were to approve this device, it would need to be approved for white women only. Is that an acceptable decision in 2014?
I think you will agree with our Center that it is not.
Millions of Americans try to lose weight every year – many of them morbidly obese. Some succeed only to gain weight later. Some never succeed. We all know that each failure to lose weight is very discouraging. People who have tried and failed to lose weight do not need another option that is not proven to work and that has risks as any surgery has, such as abdominal pain and difficulty swallowing.
The failure to prove effectiveness and the lack of people of color and men are the reasons that this device should not be approved until the studies conducted are more diverse and more long-term.
The FDA Advisory panel voted 6 to 2, with 1 abstention, that the benefits outweigh the risks