“Biobanking:
How the Lack of a Coherent Policy Allowed the Veterans Administration to Destroy an
Irreplacable Collection of Legionella Samples.”
Staff Report
Subcommittee on Investigations and Oversight
Committee on Science and Technology
U.S. House of Representatives
September 2008
Summary
Late in the afternoon of December 4, 2006, laboratory staff from the Veterans Administration Pittsburgh Health Service (VAPHS) – based on an order from Dr. Mona Melhem, the associate chief of staff for clinical services, a few minutes earlier – in less than three hours destroying a unique collection of legionella and other isolates that had been collected by two prominent infectious disease researchers over their almost three decades of research.
The destruction was the culmination of an acrimonious process that resulted in the closing of the nationally acclaimed Special Pathogens Laboratory by the VAPHS, the firing of Dr. Victor Yu, its long-time chief of infectious disease, and the involuntary resignation of Dr. Janet Stout, the other researcher and director of the laboratory. But it occurred only after a number of false statements about the existence of the collection were made by Dr. Melhem to the VAPHS officials just hours before final steps were to be taken to facilitate transfer to a laboratory at the University of Pittsburgh for continued use by the researchers.
Such a collection of many disease strains that has been built over the years can never be replaced. It was particularly valuable because it was not a simple collection of disease strains, but correlated microbiologic factors to clinical outcomes. Researchers around the country and the world were outraged at this action by the VA. Hundreds signed a petition asking for an independent investigation. The Subcommittee decided to examine this event, not just for what it would tell us about how such a unique collection could be destroyed, but for what we could learn about the Federal policies for management of bio-materials collections across the government.
It is very common for researchers who have left one laboratory for another to take their collections with them if there are no other researchers in the first laboratory who are interested in continuing that work. This was certainly true of this collection. But while the research side of the VAPHS was attempting in good faith to transfer the collection, Dr. Melhem appeared determined to destroy it before such a transfer could take place, even to the point of making false statements to her supervisors.
What Committee staff uncovered in its investigation was that the VAPHS had no clear, written policies in place to determine what to do with such collections and to protect biospecimens collected with federal funds. The processes the VAPHS appeared to have used in the past which involved the Research Compliance Committee in these situations appear to have been ad hoc and were not used in this instance. But the person who ordered the destruction of this collection did so without any consultation with the head of the research office or the Research Compliance Committee.
After the destruction was completed, Dr. Melhem tried to justify her action by claiming that a research official had approved it months before. That official denied ever having done that. Michael Moreland, the medical center director at the time, doesn’t remember having given her such an order on December 4 and didn’t appear to have a clear idea about what was contained in the collection. Both of them are now taking the position that it wasn’t really a “research” collection, despite the fact that dozens of peer-reviewed papers had come out of the laboratory over its 25 years of existence.
Additionally, we found years of management neglect by the board of directors at the Veterans Research Foundation of Pittsburgh – which included top officials at VAPHS -- that resulted in minimal knowledge of its funded projects and extremely sloppy financial practices. The Research and Development Committee at VAPHS also did not appear to have adequate control over and knowledge of its approved research projects. This failure to institute and follow clear procedures spilled over into the process for closing the SPL and the various investigations into its finances and Dr. Yu. VA procedures and conflicts-of-interest guidance were violated; conclusions were drawn without adequate documentation; and Dr. Yu was not allowed to respond to serious allegations about non-compliance with research protocols. It appeared that the most important thing to the VAPHS hierarchy was to close the lab and rid itself of Dr. Yu and Dr. Stout quickly by whatever manner necessary.
It is breathtaking that a federal health agency official would order the destruction of a human tissue specimen collection without discussing it with and receiving approval of the agency’s research officials. It is even more breathtaking that the top officials at the VAPHS and the Veterans Affairs Department have taken no formal action since to make sure that such an action never occurs again.
These events point to a broader problem. Although scientists at other federal agencies assured the staff that such an action would never occur at their laboratories, we found that there are no clear policies across federal agencies for the control and disposition of biomedical collections. In the case of the Veterans Affairs Department, Committee staff found some policies at the agency level requiring the banking of all human tissues collected for research, but no one in Pittsburgh seems to be aware of them, and they produced no written policies of their own in response to a document request.
To date, the National Institutes of Health (NIH) and more specifically the National Cancer Institute (NCI) are the furthest along in developing a biobanking policy, which was hastened after a scandal uncovered the sale of specimens by one of their researchers. NCI’s guidelines recommend open and transparent policies for biospecimen retention, establishing points during the study to review the collection, and that biospecimens be advertised for transfer to other institutions if they can no longer be maintained by the original host institution or if there is no further interest in using the materials there. For biospecimens used in research, the guidelines state "…permanent storage generally is preferred…."[1]
Based on its work, the staff recommends that the Committee consider legislation directing the Office of Science and Technology Policy be directed to establish an interagency effort to create a core set of policies for the handling, maintenance and disposition of biomedical collections. Taxpayers spend millions of dollars supporting research that creates valuable and unique research resources. It is incomprehensible that there are no policies in place to ban arbitrary and capricious management decisions by administrators without any assessment of the value of the collection and its potential use in other research.
The work of Dr. Yu and Dr. Stout cannot be recovered. However, the work of the thousands of other professionals working at the VA or other Federal agencies or building collections with Federal money should not be subject to similar mishandling simply because they run afoul of a powerful administrator in their management chain.
[1] NCI Best Practices; p. 16 (Sections C.1.2 and C.1.3).
Read the full staff report >>
