NCHR Testimony at FDA Advisory Panel on TissuGlu

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 can all agree that a safe and complication-free recovery from any type of surgery are major concerns for patients and their physicians. We believe in the innovative potential of this product to aid in the healing process for patients after abdominoplasty. Unfortunately, the larger study does not support this, and both studies raise questions that need to be answered before this product meets the standards of FDA approval.

The sponsor’s data from the 1st pivotal trial did not meet the key primary or secondary effectiveness end-points. Using TissuGlu with drains did not effectively decrease the number of days patients needed drains or the amount of total wound drainage output.  One can only conclude that it did not work.

The sponsor tried a different design for their 2nd pivotal trial, comparing TissuGlu to drains.  The TissueGlu group had significantly fewer post-operative invasive treatments compared to the control group.

The problem with the 2nd pivotal trial is that it is too small and too short-term.  That makes it impossible to just ignore the results from the 1st trial, which the company has asked you to do.  Almost 100 patients received the product in trial 1 and only 64 in the 2nd trial.  The FDA should not approve a product for millions of patients on the basis of such a small study.

The size of the study is of particular concern because there are no men in the 2nd trial (and only 2 in the first), and only 7 Hispanics and 12 Blacks using TissuGlu.  At the very least, the sponsor should show subgroup analyses of the various measures of effectiveness and separately for Blacks and Whites, to see if the results are favorable for each group separately, not just when combined. The FDA doesn’t need to use tests of statistical significance, they just need to see those two racial groups separately to be able to draw conclusions about whether TissueGlu is likely to be safe and effective for women. Given the lack of men, it should not be approved for men.

FDA guidelines urge sponsors to include people of color in their clinical trials and analyze them separately. The sponsor included a reasonable percentage of people of color, but since the total number of patients was too small, the number of Blacks and Hispanics was also too small.  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.

The product was NOT studied on cancer patients and definitely should not be approved for them.  In fact, the label should specify that it has not been studied on cancer patients.