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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?
__________________________________________________________________________________________
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 |
