VA ex­per­i­ment mishaps shake Congress’ con­fi­dence

The Washington Times Weekly - - National - BY AU­DREY HUD­SON

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 Sept. 19 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 reeval­u­a­tion 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 ment 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 Illi-

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

“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.”

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 ex­peri- nois, 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. 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.”

Bob Fil­ner

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