January 17, 2007
Dr. Rajiv Jain
Dr. Steven Graham
Dr. Frederick DeRubertis
VA Medical Center
University Drive C
Pittsburgh, PA 15240
Dear Drs. Jain, Graham and DeRubertis:
We are writing this letter to protest and express our outrage and sorrow over the destruction of valuable and irreplaceable research material that is critical to future research efforts. This includes developing new laboratory tests for atypical pathogens, new media for identification of Legionella, assessment of new antibiotics for Legionnaires' disease and correlation of virulent isolates with proposed models of pathogenesis. Before release to physicians and microbiology labs worldwide, all FDA-approved lab tests and antibiotics used for diagnoses and therapy for Legionnaires' disease were tested in the Special Pathogens Laboratory using these materials
Consequences of the Action
This treasure trove of research material includes the most comprehensive set of Legionella isolates worldwide, including rare species isolated from fewer than 10 patients. The pathogenesis of Legionella is now being elucidated using new molecular methods. Our collaboration with basic scientists has been predicated on the use of isolates from this collection that are known to be virulent to patients and from environmental isolates that are not linked to disease.
Moreover, the collection included environmental isolates from the Pittsburgh VAMC and other VAMCs nationwide. It included isolates collected from patient homes in ongoing studies supported by the American Legion, Environmental Protection Agency, and 5 US state departments of health. Retrieval of these isolates allowed assessment of the success
of disinfection measures over time. It also allowed identification of the environmental source using molecular methods if patients contracted Legionnaires' disease in the future. The greatest harm from this action will be to patients from our VAMC and other VAMC's as Legionella outbreaks continue to affect VA patients because they have the highest risk factors for the disease -smoking, alcohol use, and age.
How Could This Have Happened?
We have now been informed that the Pittsburgh VA Healthcare System Administration ordered the destruction of the entire collection of isolates.
It is important to note that repeated requests were made to the Administration to transfer these precious and irreplaceable research materials to a suitable laboratory at the University of Pittsburgh. The first of these requests for assistance in transferring the materials was made by Dr. Yu on August 12, 2006 to Dr. Steven Graham (cc: Dr. DeRubertis and Dr. Robert Muder). He expressed his deep concern over the safety of our frozen collection. We subsequently made arrangements with a qualified investigator at the University of Pittsburgh (Dr. Timothy Mietzner) to house the isolates and communicated with the Research Department regarding the necessary steps and proper procedure for accomplishing the transfer. After Dr. Graham stepped down as the ACOS for Research and Dr. Sonel took over, Dr. Stout pursued this with Dr. Sonel. Dr. Sonel replied on October 5, 2006 and cc'd Dr. Melhem, Dr. Jain and Nicholas Squeglia. He stated that "We will work with you to facilitate the transfer". Dr. Stout was then directed to work with Barbara Strelec to deidentify the material prior to transfer. Dr. Stout was scheduled to meet with her on December 4, 2006 when Ms. Strelec abruptly cancelled the meeting – citing direction from Dr. Sonel. It appears that Drs Melhelm and Sonel disregarded approved scientific practice and the direction of the Chief of Infectious Diseases by destroying the collection before the transfer could be arranged. This shameful behavior is unprofessional and barbaric. It will cause harm to VA patients at this facility. Janet Stout's research career has been severely damaged.
Under whose authority was the destruction of this scientifically and medically-important collection approved and when did this occur?
An investigation into this matter by the scientific community, congressional leaders monitoring the issue of Special Pathogens Lab closure, and the VA Inspector General should be conducted to prevent this from happening to another VA investigator.
Sincerely,
Victor L. Yu, M.D. and Janet E. Stout, Ph.D.
PS: Our collection included over 4,000 organisms, including Klebsiella, Staphylococcus aureus, Candida species, Streptococcus species, Enterococcus species, Cryptococcus neoformans, Stenotrophomonas maltophilia, and Pseudomonas aeruginosa. These microorganisms are also the property of numerous international scientists who entrusted us with the responsibility of keeping the collection intact in one laboratory with the proviso that we would provide unfettered access to these organisms. Was the entire treasure trove of these microorganisms also destroyed?
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February 2, 2007
Dr. Rajiv Jain
Dr. Steven Graham
Dr. Frederick DeRubertis
VA Medical Center
University Drive C
Pittsburgh, PA 15240
Dear Drs. Jain, Graham and DeRubertis:
We have received no reply to our email of January 17,
2007.
We still need to verify the status of the collection of non-Legionella
isolates. These isolates were accumulated from multiple observational
studies and were the property of over 40 international collaborators.
We need an immediate answer to whether you have destroyed the entire
collection for the following reason: A virulent Klebsiella has been seen in
Taiwan that causes an invasive syndrome of liver abscess and endopthalmitis
with high mortality rate. We were the first to demonstrate that it was a
Taiwan phemenonon not seen in Europe, North America, South America, or
Australia. At least 11 suspected cases have now been reported in the US,
but confirmation is lacking. Klebsiella isolates from California, New York,
and Barcelona from bacteremic patients with liver abscesses have been sent
to us for storage and safekeeping. We injected these isolates in a mouse
model of Klebsiella in a VA IRB-approved protocol, These 3 Klebsiella
isolates killed mice similar to the Taiwan isolates in storage, and, in
contrast, to Klebsiella from other continents which were avirulent in mice.
Our collaborators from Taiwan have recently developed new methods of
subtyping based on capsular serotype and presence of virulent factors. They
have requested our 3 isolates to confirm the fact that the virulent
Klebsiella has now reached Spain and the US. If we were able to confirm
that the Taiwan isolates have indeed made it to the US, it would have
immediate public health implications. Were over 400 Klebsiella isolates
from 6 continents and the 3 Klebsiella isolates from US and Spain destroyed
as were the legionella isolates?
If not, then it is imperative that the entire collection of microorganisms including the Klebsiella isolates should now be transferred to the University of Pittsburgh as planned months ago.
If Drs Sonel and Melhem indeed destroyed the entire collection, it becomes your responsibility to uncover the truth of why this despicable action could have occurred. On the other hand, if you stonewall or attempt to whitewash our inquiry, this irresponsible action would be consistent with your vindictive and unethical response to our attempts to save the Special Pathogens Lab. Eventually the truth would be revealed and besmirch all of you. As of now, your silence adds to the complicity of the entire Pittsburgh VA administration.
Victor L. Yu , MD and Janet E Stout, PhD