Mr. Chairman, thank you and Ranking Member Buyer for holding this important hearing on the VA smoking cessation program for patients with Post-Traumatic Stress Disorder (PTSD) and the alleged failure of the VA to promptly notify program participants of FDA health advisories, as well as documentation that informed consent procedures were properly followed.

It is important that we examine the process of how veterans in this study were informed of the side effects of prescribed drugs and whether they gave proper consent. More importantly, while we will hear testimony about drug safety, consent procedures, and bureaucratic oversight, we must remember that today’s hearing is about the patients – the veterans who bravely served our country and now rely on the VA for proper healthcare.  

Many of our veterans are suffering from PTSD as a result of their service to our nation, including thousands returning from the conflicts in Iraq and Afghanistan. We must honor their service by ensuring they receive proper treatment, and we must make certain they are not taken advantage of for the purpose of clinical study.

I find it alarming when I read claims that veterans were not given adequate and prompt notification of the FDA advisories, as required by human research subject protections on informed consent. Furthermore, I am disturbed by the lack of informed consent documents in cases involving the Cooperative Study Program No. 519.

Veterans should be allowed to have a face to face conversation with their doctor about the treatment they are receiving, along with potential side effects, and the drugs they are taking so they can make informed decisions about their care. Discussing possible side effects and obtaining proper consent are vital to the doctor-patient relationship and the cornerstone of the human subject research. If veterans in this study did not receive adequate information about their treatment and did not consent, this threatens the validity and integrity of all VA research.

Mr. Chairman, I hope that our witnesses will address the notification and consent procedures involved in this study. And I hope that we gain a greater understanding of the procedures required to conduct medical research studies and what steps will be taken to hold anyone accountable if they did not follow the procedures.