Research Has Set National Safety Standards, Benefits All Americans
WASHINGTON – In a congressional hearing Secretary of Veterans Affairs James B. Peake, M.D., discussed the safety and importance of the research programs operated by the Department of Veterans Affairs (VA) as well as an absolute commitment to its patients, while expressing regret that even a single veteran would feel improperly treated or misused.
“VA has an outstanding research program, and has been innovative in its protection of human research subjects,” Peake said before the House Committee on Veterans Affairs. “I am determined that VA will remain a leader in the protection of human research subjects and in veteran-centric research.”
Peake pointed out VA researchers have played key roles in the development of breakthrough medical advancement such as the cardiac pacemaker, the CT scanner and improvements to artificial limbs. The first liver transplant was performed by a VA researcher. The Department’s researchers have also conducted important trials on medication for tuberculosis, schizophrenia, high blood pressure, shingles and many other diseases that affect not only veterans but all Americans.
The VA secretary’s remarks came in the wake of published reports in the Washington Times about a VA research program on smoking cessation involving veterans with post-traumatic stress disorder (PTSD). Peake emphasized the research project was not a drug study, but an examination of the most effective site of care to treat heavy smokers who have PTSD, using medications approved by the Food and Drug Administration (FDA).
“Veterans with PTSD are more likely to be heavy smokers and are only half as likely to quit as are smokers without PTSD in the general population and smoking kills,” Peake said.
None of the medications used in this study are investigational or experimental, all are FDA approved, and the drug that made headlines, Chantix, is in fact considered to be the most effective medication available for smoking cessation with six million prescriptions written.
Peake noted any veterans receiving Chantix in the study or anywhere in the VA had been put on the drug by their doctors as an individual doctor-patient decision, with continued monitoring the health status. As information within the VA and by the FDA suggested potential psychological side effects were being seen in some patients taking Chantix, Clinical providers were notified promptly. Not only were letters sent by researchers to members of the study, but, additionally, a letter has been sent to every veteran prescribed Chantix by the VA discussing possible side-effects, encouraging them to contact their provider immediately if they experience side effects and assuring them that the VA will help them find another way to quit smoking if they are concerned about Chantix or are having side effects.
More than 60 FDA approved drugs could have adverse effects that may include “suicidal ideation and suicidal behavior,” Peake said. “If VA were to withhold these medications from our patients with mental health issues, we would have great difficulty treating them. Weighing the risk -- and all drugs have risks -- against the benefit with the best information available is what the doctor and patient do as a drug is prescribed.”
The Secretary also addressed allegations implying VA research is somehow compromised by outside entities such as drug companies and universities calling it ridiculous. The smoking cessation study was solely funded by the VA, with no outside funding. VA research is approved by VA’s Office of Research and Development and does not require approval from the Secretary, including this smoking cessation study. The scientific review and human subjects protection processes ensure that VA research addresses specifically and only the purpose of the study.
Peake has also directed four internal investigations:
A comprehensive review of the smoking cessation study within 30 days;
A review of all PTSD drug protocols in the VA system within 45 days;
A full review of our adverse event reporting system for pharmaceuticals within 20 days;
A review of VA’s medication notification system to ensure the system’s policies support timely communications to our patients and providers within 20 days.
Peake said his intent is to ensure the best, the most ethical, and the safest scientific inquiries into the health care needs of our nation’s veterans.
