- The Washington Times - Wednesday, September 24, 2008

A key congressional leader says he has no confidence in the Department of Veterans Affairs and would have pulled his own children out of the VA’s human subject study that used a drug with dangerous side effects that is being prescribed to veterans with mental disorders.

“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.”

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