Biobanking: How the Lack of a Coherent Policy Allowed the Veterans Administration to Destroy an Irreplaceable Collection of Legionella Samples

Opening Statement By Chairman Brad Miller

The subcommittee staff for Investigation and Oversight conducted an extensive investigation into the handling of an irreplaceable collection of Legionella samples at the Veterans Affairs Pittsburgh Healthcare System.  The purpose of this hearing is to make public the findings of the Subcommittee investigation of this case and to highlight the need for a uniform national policy on biospecimen management.

On December 4, 2006 – late in the afternoon – two employees of the clinical microbiology laboratory at the Veterans Affairs Pittsburgh Healthcare System (VAPHS) were ordered by Dr. Mona Melhem, the associate chief of staff for clinical services, to go to the Special Pathogens Laboratory and destroy the research collection of Dr. Victor Yu and Dr. Janet Stout.  Dr. Melhem said her orders came from Michael Moreland, then the system’s director.

The two employees commandeered the help of three other employees and, within three hours, a collection that represented almost three decades of research by Drs. Yu and Stout was gone.  Drs. Yu and Stout are international experts in the detection, treatment and control of Legionella, a bacterium which causes a type of severe pneumonia called Legionnaires’ Disease, and their laboratory was internationally acclaimed.  Dr. Yu was also known for his work on other infectious pneumonias and antimicrobial resistance.  According to Dr. David Snydman of Tufts Medical Center and one of our witnesses today, this collection was used to develop new diagnostic tests and therapies and to study resistance and mechanisms of disease transmission.

The destruction of the research collection was the culmination of an acrimonious series of events that included the closing of the nationally acclaimed laboratory, the firing of Dr. Yu, the system’s long-time chief of infectious disease, and the attempted firing of Dr. Stout.

As an impartial audience, the most troubling part of this story is that the destruction of this one-of-a-kind collection occurred less than an hour after Dr. Melhem learned that formal steps were being taken, on the following day, to transfer the collection to the University of Pittsburgh, where Drs. Yu and Stout were affiliated.  And the destruction of this collection occurred after Dr. Melhem made a false statement to the system’s chief of staff and the head of the research office, telling them that the collection could not be transferred because it had already been destroyed on the orders of the medical center’s director.  That false statement kept the head of the research office from effectively intervening to try to save the collection.

Months of investigation by the Subcommittee have not revealed any credible reason for the destruction of the collection.  Dr. Melhem said that a former research official had approved the destruction months before.  That official has denied giving such approval.  She also claimed the decision was made in July without ever informing Dr. Stout or Dr. Yu, both of whom were still on staff.  Mr. Moreland can’t remember giving her such an order on December 4 and seems unclear about his understanding of the difference between the research specimens and the clinical specimens being processed in the laboratory on the day it was closed.  Both Dr. Melhem and Mr. Moreland are now taking the position that the collection wasn’t really a "research" collection and did not need to be preserved.  This is despite the fact that dozens of peer-reviewed papers have come out of the laboratory in its 25 years of existence, and statements made to Dr. Yu in July that he would be able to continue his research even if the lab closed.

What the Subcommittee did determine is that the Pittsburgh VA – and perhaps the entire VA system – had no clear policy on what to do with research collections after the researcher left.  In the past, it appears those decisions were made in a deliberative process by the research office and the Research Compliance Committee.  The decisions were not made by a single person ordering her staff to grab up biohazard bags and to empty freezers of a research collection to prevent it from being transferred to another institution for continued use.  In a similar prior instance, it took more than five years to determine what to do with a retired researcher’s collection.  Also, according to the head of the research office, an official from the compliance committee should have been present to verify the destruction of any collection.  That did not happen here.

We also found that there were years of neglect by the board of the Veterans Research Foundation of Pittsburgh, which was handling the Special Pathogens Laboratory’s funds, but paid little attention to it until a few months before its abrupt decision to close the lab.  The Research and Development Committee didn’t seem to know what research it had approved, and its records were incomplete.  This institutional failure to establish and follow clear procedures spilled over into the decision to close the lab, and the various investigations into its finances.  For example, one of two members on the supposedly independent board of investigation was the head of the research office and a member of the Foundation board – a clear violation of VA guidelines.  It appeared that the most important thing to the Pittsburgh VA hierarchy in the summer of 2006 was to close the lab and rid itself of Dr. Yu and Dr. Stout by whatever means necessary.

Scientists from several other agencies and institutions have been contacted by the committee staff and, while their own policies may be based more on habit and common sense than actual guidance, all of them indicated that such an act would not have occurred in their agency.  A much more common practice is to determine if any other researchers at the institution are interested in the collection and, if not, ask the departing researcher if he or she wants to take the collection.  If no one wants the collection and its long-term value to the originating institution is deemed minimal, it may be offered to outside researchers who have worked in the field.  If there is absolutely no interest, the collection is destroyed.  The Pittsburgh VA’s actions were so out of the norm that more than 200 infectious disease researchers have called for an independent investigation.

Mr. Moreland’s testimony came in late yesterday.  The Subcommittee has made two very comprehensive document requests concerning the closure of the Special Pathogen Laboratory and the destruction of its research collection, and we have received many documents.  Yet in his testimony, Mr. Moreland refers to a "technical" review regarding biohazards at the lab; disposal acts done in July of 2006; and a December 2006 "determination" that not a single one of the samples in question were collected as part of any previously approved research efforts.  The Subcommittee has never received any documentation of any of these claims.  Either they do not exist or they have not been provided, but either way, this testimony is very troubling.

Mr. Moreland and other witnesses from the Pittsburgh VA should remember that their testimony is under oath.  It is simply not credible that important, technical decisions were made entirely based on conversations with no documentation.

I cannot imagine the circumstances under which a federal health agency official would unilaterally order the destruction of a human tissue collection without receiving the approval of the agency’s research office and the Research Compliance Committee.  I cannot imagine why that official would, apparently, make false statements during the destruction to keep the associate director for research at the Center in the dark until the destruction was complete.  It disappoints me that in the time since those actions, neither Pittsburgh nor national VA officials have taken formal action to discipline the managers involved in this case or establish clear policy on the disposition of biomedical collections to make sure that this could never occur again.

All of us may pay a price for this conduct, veterans most of all, because the nation lost one of its’ leading research labs on hospital infectious diseases.  While the researchers can relocate and restart their work, the research samples can never be wholly reconstituted.  Those who are in hospitals, the elderly, severely sick children, or anyone else with compromised immune systems, are those most at risk.

The work of Dr. Yu and Dr. Stout cannot be recovered.  However, we can protect the work of thousands of other professionals at the VA and other federal agencies or institutions that result in the collection of biological collections funded by taxpayer money.  These collections should not be subject to similar mishandling simply at the caprice of a powerful administrator.  It is time for the Office of Science and Technology Policy to start an inter-agency effort to create a core set of policies for the handling, maintenance and disposition of such specimens.  I intend to introduce that legislation shortly.

Witnesses

Panel 1

1 - Dr. Victor Yu
Professor of Medicine University of Pittsburgh University of Pittsburgh
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2 - Dr. Janet Stout
Director Special Pathogens Laboratory Special Pathogens Laboratory
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3 - Dr. David Snydman
Chief of Division of Geographic Medicine and Infectious Diseases Attending Physician in Infectious Diseases, Department of Medicine Tufts Medical Center Attendi
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Panel 2

1 - Dr. Jim Vaught
Deputy Director, Office of Biorepositories and Biospecimen Research National Cancer Institute National Institutes of Health National Cancer Institute National I
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2 - Dr. Janet K.A. Nicholson
Senior Advisor for Laboratory Science Coordinating Center for Infectious Diseases Centers for Disease Control and Prevention Coordinating Center for Infectious
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Panel 3

3 - Mr. Michael Moreland
Director Veterans Integrated Services Network 4 Department of Veterans Affairs Veterans Integrated Services Network 4 Department of Veterans Affairs
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2 - Dr. Mona Melhem
Associate Chief of Staff and Vice President, Clinical Support Service Line Pittsburgh Healthcare System Department of Veterans Affairs Pittsburgh Healthcare Sys
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1 - Dr. Ali Sonel
Associate Chief of Staff (Research) Pittsburgh Healthcare System Department of Veterans Affairs Pittsburgh Healthcare System Department of Veterans Affairs
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4 - Dr. Steven Graham
Director, Geriatric Research Education and Clinical Centers, Pittsburgh Healthcare System Department of Veterans Affairs Education and Clinical Centers, Pittsbu
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5 - Ms. Cheryl Wanzie
Chief Technologist Pittsburgh Healthcare System Department of Veterans Affairs Pittsburgh Healthcare System Department of Veterans Affairs
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