VA Orders Nationwide Review of Research_BNA

Wed, 12 Mar 2003

Following several research-related deaths at the Albany VA, it was revealed that the researcher under whose care several patients died in clinical trials, was not even a licensed physician. The Bureau of National Affairs (BNA) Health Care Report states that among the eggregious violations found at the Albany VA: “falsification of individual patient data that contributed to the death of one or more patients; the inadvertent overdosing with a study medication of a research participant; [and] an experimental procedure that was conducted without” prior VA approval.”

Dr. Nelda P. Wray, a newly appointed VA Chief of Research and Development issued a memo ordering a “stand down” of all human subjects research at 130 VA Medical Centers across the country, beginning Monday, March 10.

However, the order doesn’t really require shutting down all human subjects research. Instead, the memo ordered a nationwide review of human studies at VA medical centers and a background check of the credentials of VA doctors and staff involved in research. The memo also ordered research staff to undergo training, and the VA will verify compliance with federal and VA regulations.

The research faculty of VA medical centers is drawn from neighboring academic centers. The Albany VA is affiliated with the Albany Medical Center (AMC), which claims it “has developed state-of-the-art core facilities to strengthen the research environment.” One wonders whether the researchers apply those same standards to research conducted at VA medical facilities.

In January, the VA abolished its independent research safety watchdog office, the Office for Research Compliance and Assessment (ORCA). BNA reports that “the move has puzzled Capitol Hill observers, some of whom have suggested an act of Congress to restore an independently functioning office.”

BNA further reports that “In addition to study safety, Wray oversees the VA’s research fund-raising efforts.”

Doesn’t that dual responsibility present an intolerable conflict of interest?

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BNA’s Health Care Daily

March 11, 2001

By M. Alexander Otto

VA Orders Nationwide Review of Research, Stronger Safety Rules After Deaths, Mishaps

The Department of Veterans Affairs has ordered a nationwide safety review of human studies at VA medical centers in the wake of patient deaths and other mishaps, according to a March 6 VA memo obtained by BNA.

VA centers were also ordered to check the credentials and privileges of doctors doing research to make sure they are qualified.

Background and licensing checks on all other research staff were ordered as well, along with the creation of an electronic data base to track research staff.

VA Chief of Research and Development Dr. Nelda P. Wray, author of the memo, also required VA researchers to take study safety courses.

Wray gave the nation’s 115 VA medical centers until June 6 to get the job done.

Thousands of studies involving thousands of veterans will be affected by the orders. The VA spends $1.3 billion annually on research, making it one of the country’s leading research institutions. Much of that money comes from the pharmaceutical industry.

The move comes only weeks after news broke about the death of at least one study subject at the Stratton VA Medical Center in Albany, N.Y. Critics charge that the Albany center did not do enough to check the history of a research assistant linked to the case, Paul Kornak. Kornak’s medical license had been revoked in two states before coming to the Stratton center.

The memo also comes as a major television network contemplates an expose of VA research mishaps.

Not a Shut-Down In her two months on the job, Wray said she’s learned of “falsification of individual patient data that contributed to the death of one or more patients; the inadvertent overdosing with a study medication of a research participant; [and] an experimental procedure that was conducted without” prior VA approval.

Wray also learned of a “drug study that was conducted without a principal investigator … with clinical privileges to prescribe and monitor the study medication and the failure [of the center’s study oversight committee] to meet even the minimal” federal safety requirements.

Though she termed the plan a “stand-down,” Wray opted not to shut down VA human research completely, because mishaps “are rare, and the chance that we would prevent others from…occurring is small,” she said. Plus, patients rely on studies for experimental treatments and other medical services, she said.

Critics have charged that study safety could be eroding at the VA. A program to accredit VA medical centers for research safety has been on hold for months, after early inspections turned up significant safety problems at several centers.

In January, the VA abolished its independent research safety watchdog office, the Office for Research Compliance and Assessment. The move has puzzled Capitol Hill observers, some of whom have suggested an act of Congress to restore an independently functioning office.

Wray was put in charge of study safety following ORCA’s demise. In addition to study safety, Wray oversees the VA’s research fund-raising efforts. Because safety enforcement can delay or even derail studies, observers have told BNA that the arrangement is “unworkable.”

Background Checks Ordered Wray ordered medical center directors, chiefs of staff, and associate chiefs of staff for research to review how their centers review studies for safety and to ensure that studies meet minimum federal safety requirements. VA administrators are also charged with ensuring study safety boards are properly composed and meet frequently enough to “provide timely review and oversight” of studies.

Investigators must also be told their “standing in the VA” will be compromised if they conduct studies without proper review and that they will be held responsible for ethical breaches, which “may affect the [investigator’s] ability to do research with the VA in the future,” the memo stated.

Kornak was hired by the Albany VA research foundation, not the Albany VA directly. In a provision that seems to speak directly to the Albany situation, Wray ordered that researchers hired by foundations must have “credentials confirmed, a scope of work established, and a record of such maintained and available for review.”

“I am confident that these activities will enable us to identify and correct any problems in our human subjects research programs, help us to properly educate and train our researchers, and ensure the protection of our most valuable assets,” she said.

Wray did not say in the memo what will happen if safety reviews turn up problems. She was not available for comment at press time.

By M. Alexander Otto

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