April 16

Death & Other Problems at Fargo VA Research Detroit_BNA

Death & Other Problems at Fargo VA Research Detroit_BNA

Mon, 21 Apr 2003

Medical research at the Department of Veterans Affairs appears to be in disarray–veterans’ lives are at serious risk in an environment that does not take seriously federal safety requirements. It is apparent that during its tenure as the VA’s oversight arm, investigations by the Office of Research Compliance and Assurance (ORCA) proved especially embarrassing to the VA research establishment.

ORCA found numerous serious violations at several VA medical centers. For example, failure to track medication doses, in some cases led to massive overdoses; serious adverse effects were not reported or reviewed; institutional review boards (IRB) failed to meet their responsibilities– as required under federal regulations. At Fargo, ND, the IRB didn’t meet in 5 months while serious adverse effects went unreported and unreviewed.

Indeed, Dr. Nelda P. Wray, the VA’s chief research and development officer, acknowledged in a VA memo: The Fargo IRB “failed to meet even the minimal standards required by the Common Rule.” While she told a Congressional hearing that increased funding was needed because “our facilities are crumbling,” Dr. Wray claimed that she is confident veterans are safe in the department’s projects.

The VA administrators’ decision to disband the Office of Research Compliance is difficult to explain. Do these administrators think that by eliminating the oversight body VA research safety problems will disappear?

Study Death, Other Problems Discovered At Detroit, Fargo VA Research
By M. Alexander Otto
BNA’s Medical Research Law & Policy Report

April 16, 2003
As a murder investigation into medical study deaths at the Stratton Veterans Affairs Medical Center in Albany, N.Y., continues, additional cases of VA research mishaps have surfaced at two Midwest centers.

Veteran Cyril Krcmarik died during a prostate cancer study at the Dingell VA Medical Center in Detroit April 2, 2002, allegedly after receiving a massive overdose of the steroid dexamethasone. The VA’s Office of Research Compliance and Assurance concluded in January that researchers did not properly track the medications Krcmarik took or heed his complaints of growing sicker while on the drug, according an ORCA inspection report obtained by BNA.

In February, the VA shut down all human research at the Fargo, N.D., VA Medical Center after ORCA discovered that Fargo’s institutional review board, which is responsible for reviewing protocols to ensure patient safety, had not met in five months and that an ongoing study had no principal investigator in charge. The more than 20 adverse events that occurred during the five months went unreviewed by the IRB, according to a separate ORCA inspection report obtained by BNA.

Fargo is the first VA center ever to have its federalwide assurance suspended, a source close to the case said. VA centers must have valid FWAs, a promise by institutions to follow federal research safety regulations, to conduct research. Until now, the VA only had restricted FWAs in response to safety concerns.

“The investigations completed by this office have documented serious problems with the integrity of the research,” ORCA Chief Officer Dr. John Mather said.

The Fargo IRB “failed to meet even the minimal standards required by the Common Rule,” Dr. Nelda P. Wray, the VA’s chief research and development officer, said in a VA memo.

Additional Problems.
VA research has been plagued with other safety problems recently as well.

Last spring, ORCA temporarily banned the Martinez, Calif., VA center from enrolling patients in studies after Martinez failed National Committee for Quality Assurance safety inspections. The Providence, R.I., and Pittsburgh (Highland Drive), Pa., centers also did not pass inspection (1 MRLR 194, 6/19/02 ).

News broke in February 2002 that a research assistant at the Albany center could soon face murder charges after enrolling patients in studies for which they were ineligible, possibly contributing to at least one patient death (2 MRLR 85, 2/5/03 ).

In March, Wray ordered the nation’s VA centers to review how they conduct studies and improve research safeguards (2 MRLR 205, 3/19/03 ).

During a break at an April 10 hearing of the House VA Subcommittee on Health, Wray told BNA that VA medical centers “were not as compliant as they need to be with the Common Rule.”

In addition to the review, Wray said she has commissioned a report due in August on ways the VA could improve research safety. She also has taken steps to centralize VA IRB review so that one IRB can be in charge of multisite projects.

She noted that research mishaps are extremely rare in VA studies and that she is confident veterans are safe in the department’s projects. The Martinez, Providence, and Pittsburgh centers have fixed the problems found by NCQA, she noted.

Research subject advocates are concerned that the moves may not go far enough to address what they see as a pattern of research misconduct, especially since the VA plans to disband ORCA, its independent research watchdog office. Rep. Steve Buyer (R-Ind.) has introduced a bill to reverse the controversial move (see related item in the News section ).

Despite “years of effort by a few veterans and a few whistle-blowing staff within” the department, “the VA has done an abysmal job of monitoring” study safety, said Vera Sharav, president of the Alliance for Human Research Protection. With the demise of ORCA, she added, “it is not clear who is charged with conducting” the nationwide safety review.

Funding Pitch.

The VA conducts roughly $1.4 billion of worth of medical research annually, some of it new drug testing for the pharmaceutical industry and other sponsors. The arrangement is a steady source of income for the department.

Wray told the subcommittee that the department needs a major funding increase to renovate laboratories and clinics, some of which are approaching 100 years old. “Our facilities are crumbling,” she said.

Wray did not link the funding request to safety issues, but noted that funds are desperately needed to provide VA centers with a “first-class research environment.”

Wray said the VA’s roughly 2 percent annual budget increases in recent years do not keep up with inflation, proposing instead a 15 percent annual increase that would double the VA’s budget in a few years. Rep. Vic Snyder (D-Ark.) seemed particularly supportive of the idea.

Fargo, Detroit Center Details. Only two studies are affected by the Fargo shutdown, a cardiac trial and a vitamin study, said center spokeswoman Peggy Wheelden.

Fargo blamed the five-month IRB lapse on staff shortages and the absence of the IRB chairman, who was out of the country, according to Wheelden. Three expired protocols and more than 20 adverse events, some serious, went uninvestigated by the IRB as a result. The VA is unsure at this time if one death was related to a lapsed protocol.

Fargo did not comply with the Common Rule or the terms of its FWA, ORCA concluded. The center currently is working on an overhaul of its research oversight procedures. Wheelden said she expects the center will make the changes necessary to restart trials by the end of the summer.

Researchers at the Detroit VA missed several chances to catch Krcmarik’s dexamethasone overdose, which was due originally to a mistranslation of the prescription by his urologist and his VA pharmacist, according to the ORCA report. The principal investigator in the trial delegated prescribing and dispensing duties to them, although neither was involved in the study.

Among many problems found by ORCA, Detroit staff did not fully understand and adhere to federal research regulations or adequately track and review research. An August 2002 Food and Drug Administration review concluded that the center had failed to maintain drug accountability. The VA currently is overseeing a plan to fix the problems.

Copyright©2003 by The Bureau of National Affairs, Inc., Washington D.C.

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