"I don't have confidence in the leadership that allowed this to happen," said Rep. Bob Filner, California Democrat and chairman of the House Veterans' Affairs Committee, which oversees the VA.
A review released Friday of a smoking-cessation study on veterans suffering post-traumatic stress disorder (PTSD) found that the VA was responsible for numerous "unacceptable failures" in ensuring safeguards for soldiers in the experiment.
The smoking-cessation study at one time included more than 200 veterans who took the drug Chantix, which was later found to have psychosis and suicidal behavior among its possible side effects.
The internal review was prompted by an investigation by The Washington Times and ABC News published in June, which found that the veterans were not notified in a timely manner about new warnings from the Food and Drug Administration (FDA) about the drug's side effects.
Dr. Tom Puglisi, chief officer of the VA's Office of Research Oversight (ORO) and author of the report, confirmed that the study "did not adequately fulfill VA's singular responsibility to maximize safeguards for veterans who volunteer to participate in research."
"I'm just disappointed," Mr. Filner said. "If my children were involved here, I would be scared to death. They don't have any right putting my kids, or any veterans, in serious jeopardy."
The review of the study points out that Chantix was "newly approved by the FDA for smoking cessation when it became available for use by [the study's] participants, and it had not been formally evaluated in a comparable study population."
"ORO was unable to locate any documentation that the [study] considered the possibility that the use of varenicline [Chantix] by participants might warrant a re-evaluation of the study's safety monitoring plan."
The review also found that no system was in place to warn veterans when the FDA issues new warnings that drugs they are taking might cause serious side effects. The Times report prompted concern from Democratic and Republican lawmakers on Capitol Hill, many of whom asked the VA to cease the experiment.
VA officials later briefed congressional staff that every veteran taking Chantix in the study had been notified by telephone and e-mail about the possible side effects.
"In other words, this has forced the VA to be more forthcoming and take real steps to address the problems The Washington Times previously identified," said Brian Walsh, spokesman for Sen. John Cornyn, Texas Republican and a critic of the study.
"Clearly, the consent procedures the VA had in place for the study were neither adequate nor timely," Mr. Walsh said.
VA officials promised Mr. Filner that they would provide concerned lawmakers with a review of the study in early August. But delaying the report until late September - just days before Congress is set to recess - provides no way to dismantle or defund the study, he said.
"Unfortunately, we should have stopped it then, but now it's impossible to get any legislative remedy," Mr. Filner said.
The review found that researchers responsible for the study first failed to notify internal review boards that oversaw the experiment when the FDA first publicized its concerns in November.
When a second warning was issued in February, it took 16 to 134 days to alert veterans.
As of Feb. 1, when the FDA issued its warning, 120 participants were still taking Chantix. All except 27 have signed an addendum referencing the newest warnings and nine have dropped out of the study, the VA said.
Democratic presidential nominee Sen. Barack Obama of Illinois, a member of the Senate Veterans' Affairs Committee, called the lapses in the experiment "outrageous" and "unacceptable."
"Senator Obama has serious concerns about the results of this investigation
and expects the VA to take immediate steps to strengthen its safeguards to
ensure veterans are not put in danger," said his spokesman Michael Ortiz.
Republican presidential nominee Sen. John McCain of Arizona has declined several
requests for comment about the issue.
Dr. Arthur Caplan, a medical ethicist and director of the Center for Bioethics
at the University of Pennsylvania, said the ORO report identifies the key
ethical problems with the study to date.
The review found monitoring of the studies at 10 different sites to be an
"unacceptable failure" and that review boards did not investigate some 26
"serious adverse events" that some participants experienced.
"If the study is going to proceed, then it must be given very close and
continuous review by local [review boards]. Consent forms must adequately
reflect information about risk factors and adverse events which may occur," Dr.
Caplan said.
Hundreds of experiments are conducted every year using veterans as subjects for
a variety of clinical studies. Some studies are behavioral in nature; however,
most test the use of drugs on ailments suffered by veterans, including PTSD.
Almost all of the studies are conducted at veterans hospitals.
Joe Davis, a spokesman for the Veterans of Foreign Wars, said the review of the
study described a thorough procedural breakdown within the VA human research
system and expressed concern that similar breakdowns are occurring in other
studies.
"It appeared they were more concerned about their research than about their
people," Mr. Davis said.
"This report verified what we suspected and also calls for accountability in the
chain of command. That is the only way to make the system better, is to hold
people accountable," Mr. Davis said.
VA spokeswoman Alison Aikele said the agency is following the report's
recommendations and has convened an administrative investigation board of 13
members that will review the actions of personnel involved in the study.
The ethics of human subject research experiments at several VA hospitals has
come under scrutiny in several states.
A recent investigation of human studies conducted at an Arkansas veterans
hospital uncovered rampant violations, including missing consent forms, secret
HIV testing and failure to report more than 100 deaths of subjects participating
in studies.
When Mr. Filner's committee held an oversight hearing in July in response to The
Times' reports, Iraq war veteran James Elliott told the panel that he sought
treatment from the VA for PTSD and instead was persuaded to join the
smoking-cessation study.
While taking Chantix, he suffered a psychotic episode that led to a nearly fatal
confrontation with police.
A research study at the Philadelphia VA Medical Center was suspended in August
after blood was drawn from a half-dozen veterans as part of an undisclosed study
without the veterans' consent.
And the widow of a veteran who died of Creutzfeldt-Jakob disease less than a
month after being dismissed without diagnosis or treatment at the James J.
Peters VA Medical Center in New York was denied an investigation into whether
his dismissal was a result of his refusal to participate in an Alzheimer's
study.
Mr. Elliott said he is "disgusted" that the study will continue.
"VA Secretary James Peake had an opportunity to fix a wrong. This was not his
fiasco, but he could have fixed it," Mr. Elliott said. "The VA doesn't seem to
truly care about our health."
Retired Marine Lt. Col. Roger Charles, editor of Defense Watch, the Internet
newsmagazine of Soldiers for the Truth, said human research testing performed by
the VA should be suspended and revamped.
"What is it going to take for them to admit they have a problem?" he said.
Mr. Filner's response: "A new administration."