Department of Veterans Affairs watchdogs have concluded that the department failed to alert veterans suffering from post-traumatic stress disorder in a timely manner to the dangers posed by a drug it was prescribing, VA officials acknowledged Wednesday under sharp questioning from lawmakers.
The legislators also were told that the department’s inspector general has begun investigating a report that research personnel falsified certain study records at the VA Medical Center in the District.
“That is something we need to make sure never happens again,” VA Secretary James B. Peake said of the delayed warnings to veterans using the smoking-cessation drug Chantix, which has been linked to psychotic and suicidal behavior in its users.
He said that veterans participating in a smoking-cessation study can continue to take the drug, but that an internal review conducted by agency doctors will have the final say in a report to Congress on July 18.
“I have dictated a detailed review not only on this study, but of all studies involving our veterans with PTSD,” Mr. Peake told the House Veterans’ Affairs Committee oversight hearing.
“Where we find inadequacies, I will demand institutional and personal accountability,” Mr. Peake said.
A review by the VA Office of Inspector General found that researchers in the study “did not ensure that patients involved in the smoking cessation study were notified of the risk of suicidal thoughts or behavior in a timely manner.”
The Food and Drug Administration issued its first alert in November that side effects of Chantix could include suicidal thoughts and behavior, and the drug company Pfizer followed with a warning label change in January. The FDA issued another alert on Feb. 5, but warning letters trickled out to study participants from March to June.
The IG said it could not confirm whether warning letters reached the intended study participants, and more than half have not signed and returned amended consent forms advising that the drug may cause hallucinations or psychotic or suicidal behavior.
“This lack of action is concerning because it is evident that the pharmacy service considered the Nov. 20, 2007, communication important information requiring dissemination to providers and the creation of lists of patients on this medication,” the IG report said.
“This was particularly important in the smoking-cessation study, as it by definition enrolled only those veterans who had PTSD,” the IG report said.
During the course of its review, the IG also began investigating a report that research personnel had falsified certain study records at the VA Medical Center in the District.
“These kinds of documentation irregularities may affect the credibility of study results,” the IG said.
The congressional hearing stemmed from an investigation by The Washington Times and ABC News that found that the VA took at least three months before it began to alert 245 veterans taking the drug about the possible dangerous side effects.
In the meantime, decorated Iraq war veteran James Elliott suffered a mental breakdown that resulted in a showdown with police in which he was nearly shot. Nearly 38 suicides in the U.S. have been reported in conjunction with Chantix prescriptions, and Mr. Elliott blames the drug for his mental relapse.
Mr. Elliott told the panel that he began taking the drug in November. In January, he said, he sought emergency psychological counseling but was denied.
Until the internal review is completed, Mr. Peake said, no reason exists to alter the study or withdraw the medication.
Once the internal review is completed, “We will make specific recommendations and changes so that this does not happen again,” said Dr. J. Thomas Puglisi, chief officer of the Office of Research and Oversight.
Mr. Peake said the agency’s Institutional Review Board will analyze how drugs are distributed to soldiers with PTSD “to ensure that there is appropriate sensitivity to the study population in the context of FDA alerts and warnings.”
But Rep. Bob Filner, California Democrat and committee chairman, questioned the validity of the research and said the program should be terminated immediately.
“Your faith in the bureaucracy is overwhelming to me,” Mr. Filner told Mr. Peake. “A bureaucracy studying itself does not give confidence to the public.”
“Stop it, is what I advise you,” Mr. Filner said.
Mr. Peake said one of the reasons for the delay in the warnings was that different branches sent the letter to patients at different times.
“This is a major problem,” said Rep. Steve Buyer, Indiana Republican and ranking member of the committee.
Added Rep. Tim Walz, Minnesota Democrat: “If corners were cut or protocol skipped, it’s tragic.”
Mr. Filner summed up the thoughts of most on the panel: “The loss of any veterans to suicide would be a tragedy. That’s why I fail to understand why the VA didn’t act.”
Amy Fagan contributed to this report.