Questions and Answers Regarding Washington University vs. Catalona |
| WU’s Question 1. What was the dispute between Washington University and Dr. Catalona? |
WU’s Answer 1: Washington University
developed, paid for, and maintained
a substantial repository of tissue and
serum samples for prostate cancer research.
The University’s researchers used
these samples, and made them available
to researchers at other institutions, including
Dr. Catalona, to better understand
the cause of prostate cancer and
possibly find a cure. Washington University
asked a federal court to determine
whether Washington University
owns the repository and has the authority
to continue to use it and share it. Dr.
Catalona claimed we do not. We are
pleased the judge ruled in the University’s
favor. |
Dr. Catalona’s Answer 1: In 1983, Dr. Catalona conceived and spearheaded
the establishment of a “biorepository” for the collection and storage
of tissue and blood samples for future prostate cancer research. Dr. Catalona
arranged for the training of his technicians to take the samples from cancerous
prostates he removed surgically in such a way that he could freeze them
for later research and, at the same time, not interfere with the samples
needed for pathology reports. Dr. Catalona also collected tissue and blood
samples from relatives of patients who were affected with prostate cancer as
well as those who were not.
Because of Dr. Catalona’s foresight, these samples and this repository are
the oldest and one of the world’s largest of their kind and, in many instances,
represent three generations of family history and research.
Virtually all of the individuals who contributed their tissues and blood
samples to the biorepository were either Dr. Catalona’s patients or participants
in studies directed or overseen by him.
As the driving force behind the studies, Dr. Catalona conceived and established
research protocols for the cancer research studies and appointed
other members of the urology division to specific research projects.
In addition, Dr. Catalona raised virtually all of the money - millions of
dollars - to support the activities of this “biorepository” through grants from
the federal government (NIH), private foundations (Urological Research
Foundation, CaP Cure), industry, and patient gifts.
When Dr. Catalona left Washington University to continue his surgical
practice and life-saving research activities at Northwestern University, he expected
to take the samples with him, samples that his patients had directed
for his research in prostate cancer. It is not unprecedented that a researcher
would take samples he had been instrumental in collecting. |
| WU’s Question 2. Why does the University believe it owns the tissue and did it take the tissue away from
Dr. Catalona? |
WU’s Answer 2: The donors gave their
tissue to Washington University. They
provided it for the University to use in
research. Many of the donor consent
forms had Dr. Catalona’s name on them
as the person who had the lead position
on a team of research collaborators, but
that didn’t mean the donations were
made personally to Dr. Catalona. Dr. Catalona’s employment agreement with
Washington University clearly specified
this. The University could not “take” the
repository from Dr. Catalona because he
never owned it, though for a time he
managed it. |
Dr. Catalona’s Answer 2: Dr. Catalona’s position is that neither he nor
WU own the samples in the repository. He believes that he was the custodian
of the sample collection, but the research participants and patients own
their own genetic material, and they should decide who should coordinate
access to their tissue samples, how and for what the samples should be used,
and where they should be stored on their behalf.
He believes that the men who provided samples for his collection did so
because they wanted him to direct how those samples would be used in
prostate cancer research. Dr. Catalona believes that, under federal regula-tions and the University's own consent forms and brochures, the patients remain
the owners of the samples, and, as the continuing owners, they have
the right to decide who directs the use of their samples.
The patients who joined the suit along with Dr. Catalona clearly believe
the same.
In fact, to say that Dr. Catalona “managed” the tissue samples shows a
lack of respect for the results of his years of research from these samples
which have changed world-wide practices for treatment, detection, and research
of prostate cancer, such as use of the PSA test, testing of PSA velocity
to determine timing for biopsy and cancer aggressiveness, and discovery of
several new genetic regions statistically associated with prostate cancer and
its aggressiveness. |
| WU’s Question 3. If patients want the samples given to Catalona, why not give them to him? |
WU’s Answer 3: We would like all tissue
donors to know that if Dr. Catalona
has a research proposal and wants access
to the tissue samples in the Washington
University repository, he can
submit a proposal to the repository’s
peer-review panel and get access to the
tissue. Our goal is to ensure that the tissue
is used to do important research on
prostate cancer, and we have always
been open to requests from Dr. Catalona
or any other researcher to use the tissue
samples for their intended purposes. In
fact, Dr. Catalona’s previous requests
were granted by the peer-review panel.
We fear some of his former patients believe
that Dr. Catalona no longer has access
to the donated tissue samples, but
in fact he does. |
Dr. Catalona’s Answer 3: Dr. Catalona has been stymied in his efforts to
get tissue samples from past requests and sees no evidence that the situation
has changed. As Dr. Catalona’s research was posted on WU’s website as
“landmark” research, WU concedes that his research is important. Yet, WU
would not honor the requests of the patients who wished to transfer their
samples to him.
In fact, the repository’s peer-review panel was put into place only after WU
took away Dr. Catalona’s directed use of the samples and discretion on sharing
them with fellow researchers. The peer-review panel was, in one way, evidence
of WU’s intent to limit Dr. Catalona’s previous access to the samples.
From court evidence, the University’s Vice Chancellor for Research admitted
that he “stalled” approval of research requested by Dr. Catalona in the
past. And also from court evidence, in 2001 the University’s Business Development
Director wrote to the Vice Chancellor: “Bill Catalona wants to send
nearly 2,000 documented samples to Hybertech for free. Just from a cost recovery
scenario, this should be worth nearly $100,000 to the University.
The only consideration Hybertech is offering is the potential for Catalona to
get a publication. It is my opinion this is an unacceptable proposal.”
Dr. Catalona and Hybertech had collaborated on important studies related
to PSA testing. Dr. Catalona’s publications are his way to share his
findings with the medical world. That goal is laudable and the highest and
most valuable contribution a scientist can make.
These tissue samples are non-renewable resources. Once they are used
up, they are forever lost to additional research.
Dr. Catalona envisioned and coordinated the research endeavors for
these samples for almost twenty years and his expertise and experience resulted
in world changing practices for treatment, detection and research in
prostate cancer.
Allowing far less experienced researchers than Dr. Catalona to decide
who should use these non-renewable resources and for what studies could
be at odds with the desires of the patients and set back prostate cancer research
by years. |
| WU’s Question 4. Why not split the samples between WU and Catalona? |
WU’s Answer 4: The University attempted
to negotiate a split of the samples
with Dr. Catalona, but as we neared
a settlement, he backed away from it
and asserted that all the samples should
be under his sole control. Later, Dr. Catalona changed his position again and asserted
that the donors retained control
over their samples and could redirect
them to him. We believe the research
consent forms the donors signed give
the samples to Washington University. |
Dr. Catalona’s Answer 4: The University of Virginia had offered Dr. Catalona
the position as Director of their Mellon Prostate Cancer Institute. The
Dean of the University of Virginia attempted to negotiate a split of the samples
with WU on behalf of Dr. Catalona. Dr. Catalona requested a usable
portion of the samples from all patients and research participants enrolled in
his studies and the ability to continue to obtain critical follow-up information on them. Dr. Catalona offered to support research assistants and partial
secretarial and salary support to one of his close collaborators at WU to continue
his follow-up studies on these patients.
Samples are far more valuable when the researcher knows the patient’s
treatment, whether or not there was a recurrence of the cancer, how the recurrence
was treated, how the recurrence responded to subsequent treatment
and what the ultimate outcome was. Without the follow-up
information, samples are far less valuable for research. WU would not agree
to this arrangement and broke off negotiations for sharing the samples. |
| WU’s Question 5. Since the federal judge ruled that Washington University has ownership of the samples,
will you still let Dr. Catalona use any of them? |
WU’s Answer 5: Any researcher will be
able to make a request to use some of
the tissue for research related to prostate
cancer. Dr. Catalona’s previous requests
have been granted. We’re open to further
requests from Washington University
scientists and from researchers
elsewhere, including Dr. Catalona. |
Dr. Catalona’s Answer 5: Based on WU’s past actions, Dr. Catalona has
no reason to expect that he would be granted meaningful access to the samples.
As mentioned above, from court evidence , WU’s Vice Chancellor for
Research admitted that he “stalled” approval of research requested by Dr.
Catalona in the past.
And also from court evidence, in 2001 the University’s Business Development
Director wrote to the Vice Chancellor: “Bill Catalona wants to send
nearly 2,000 documented samples to Hybertech for free. Just from a cost recovery
scenario, this should be worth nearly $100,000 to the University.
The only consideration Hybertech is offering is the potential for Catalona to
get a publication. It is my opinion this is an unacceptable proposal.”
WU released a statement following the Eighth Circuit Court of Appeals ruling:
“Based on this decision, Washington University will resume sharing the
tissues in the repository with its own scientists and those at other institutions
who want to conduct promising research using the
samples, including Catalona. Proposals will be evaluated on a peer-review
basis by a panel of Washington University Researchers.” It is important that
under the Court’s ruling the “promising “ research does not have to be
prostate cancer research to which the patients consented, which in many instances
was only for PSA testing.
Most relevant, as one of Dr. Catalona’s patients, Richard Ward, who has
joined the suit on behalf of the patients said: “Thousands of men afflicted
with prostate cancer are not able to have their cancerous tissues directed to
the specific research projects for which they were donated.” |
| WU’s Question 6. What will Washington University use the tissue for in light of the judge's ruling? |
WU’s Answer 6: We will use the repository
for its intended purpose, which is
to pursue new information about the
development of, and potentially a cure
for, prostate cancer. |
Dr. Catalona’s Answer 6: If WU is sincere in its desire to have the repository
used for its intended purpose to pursue new information about the development
of, and potential cure, for prostate cancer, one would think WU
would want the material to be with the best and most experienced person to
pursue that goal. Where it is should be less important than how the best
life-saving research can be accomplished in the fastest time frame.
However, under the Court’s ruling, WU could sell or use the tissue samples
for research not of the patients’ preferences. |
| WU’s Question 7. How has this dispute affected research using the repository? |
WU’s Answer 7: Unfortunately, research
with these samples was halted while the
court decided on the case, preventing
any research with the tissue bank, which
includes tens of thousands of samples donated by thousands of men who were
enrolled in the research by other surgeons
on the Washington University faculty.
Donations from all the surgeons’
volunteers went into this University
repository.
Research was halted because the
courts ordered an injunction against the
use and/or distribution of the samples
until the case was decided. This injunction
was granted because the tissue and
blood samples are non-renewable resources.
Once used up by whoever has
discretion of their distribution, they are
lost forever to other research that might
have been more productive. |
Dr. Catalona’s Answer 7: Needless to say, Dr. Catalona’s research has been
substantially affected and is still affected by not having the use of these samples.
Instead of being able to use information from a 20+-year biorepository
that he created, his research is limited to information from surgical patients
and research volunteers of the last four and a half years.
Dr. Catalona’s research program at Northwestern University has been
highly productive, as documented in his publication record (See
www.pubmed.com and search under "catalona w"). He was a principal author
in a paper in 2006 that announced the discovery of prostate cancer genetic
risk factors that has been heralded as “…perhaps the most significant
discovery in prostate cancer genetics to date.” Moreover, he is a participating
member of the National Cancer Institute (NCI)-funded International Consortium
of Prostate Cancer Genetics and a co-chair of the NCI-funded
Prostate Cancer Specialized Program of Research Excellence Genetics Working
Group.
But one can only wonder how many potential new discoveries and new research
directions have been postponed because of Dr. Catalona’s inability to
continue his studies with his over 20-year tissue and blood sample collection.
Also, as stated previously, all of the individuals who contributed their
tissues and blood samples to the biorepository were either Dr. Catalona’s personal
patients, patients he referred to other members of his staff for treatment,
or participants in studies directed or overseen by him.
Dr. Catalona conceived the studies and established the protocols for the
cancer research studies and appointed other members of the urology division
to specific research projects. |
| WU’s Question 8. How would it affect tissue/blood banks nationwide if patients could change their mind
about a tissue donation and redirect the tissue to another institution? |
WU’s Answer 8: It would become difficult
if not impossible to manage tissue
banks. Researchers would be concerned
about starting large, long-term research
projects because of the prospect that
thousands of samples could be pulled
from the experiment at the instigation of
another researcher. If donors always retain
control over their tissue, even after
they donate it, as Dr. Catalona claims, it
could have horrible implications for
blood donation and organ transplantation.
Each research volunteer who testified
in court on Dr. Catalona’s behalf was
asked during cross-examination whether
at the time they read and signed the consent
form they thought they had the right
to reclaim their donated tissue, and they
all said they did not. |
Dr. Catalona’s Answer 8: In the aftermath of terrible abuses of research
participants in the past, federal regulations have been promulgated to protect
patients and research participants. These regulations provide for the participant
to be able to change his mind about participating at any time, for any reason,
and without penalty. In fact, the Eighth Circuit Court of Appeals decided
that donors of tissue and blood samples have the right to compel the University
to stop using their tissues and to direct WU to destroy the samples. Just as
in clinical practice, patients have a right to direct the donation of a kidney or
blood to a specific individual, they have the right to choose the type of research
they will participate in.
Federal regulations also forbid the use of language in research consent forms
that appears to have the patients waive any of their rights, such as the right of
ownership of their tissue. Each research volunteer testified in court that his or
her intention was to provide a sample for Dr. Catalona to use in his research and
not to give it to Washington University to own and use as it wishes.
Acknowledging that donors own their genetic material and have the
right to decide where and how it is used would be a boon to research and to
researchers. Patients could be assured that a sample provided for a specific
kind of research and to a specific researcher would be used for that and no
other purpose without their permission. And researcher would have more
security, not less, in making long-term commitments to their research. They
would know that an institution could not take away years of their work because
of a change in policy or personnel. The scenario of patients ordering
their samples destroyed or completely withdrawn from research is far worse
than the one WU proposed and would make management and use of
biorepositories for research projects more precarious.
As a patient and donor, Richard Ward, said: “Because we have established
the right to compel the University to stop using our tissues, we can only hope
they will honor our wishes and transfer the tissues to Dr. Catalona to continue his
research. “Otherwise, our only recourse is the unfathomable and repugnant
choice of ordering the University to destroy our samples or put them permanently
on the shelf. Either choice imperils vital past, current and future research.” |
| WU’s Question 9. Has the tissue been used for research since the dispute began? |
WU’s Answer 9: The tissue has not
been used for research since this dispute
began. Washington University sent some
of the samples to the National Cancer
Institute for important research on the
mechanisms of prostate cancer. Washington
University researchers’ ability to
contribute to that important project was
taken away as a result of Dr. Catalona’s
claims about who had control over the
samples. |
Dr. Catalona’s Answer 9: As stated above, research was halted because
the courts ordered an injunction against the use and/or distribution of the
samples until the case was decided.
This injunction was granted because the tissue and blood samples are
non-renewable resources. Once used up by whoever has discretion of their
distribution, they are lost forever to other research that might have been
more productive.
WU sent hundreds of serum samples to the National Cancer Institute for
a type of research to which the patients had not consented and without
telling the researchers there that there was a dispute over the control and
custody of some or all of the samples.
The head of Pathology at the National Cancer Institute told Dr. Catalona
that, in his opinion, the patients should decide who uses their samples and
for what purpose, and he returned them to WU unused. |
| WU’s Question 10. Historically, who has been granted ownership in such disputes, researchers, donors or
universities? |
WU’s Answer 10: Faculty researchers
are representing the university when
they do the research. The samples may
be under a researcher’s management as
the principal investigator of the study,
but the courts have upheld that the tissue
in a repository like this belongs to
the university once the volunteer has
donated it. |
Dr. Catalona’s Answer 10: There is little or no historical precedent for
this case dealing with unaltered blood and tissue samples, which is why it
has garnered so much national attention.
In prior cases, in which the issue was derivatives or altered products of
the samples, courts have ruled that the universities own the intellectual
property derived from the samples.
Tissue repositories are a relatively new advance that developed along with
advances in genetic research. Whereas medical researchers
and the public now know how valuable genetic samples can be, such knowledge
was not common when Dr. Catalona began his repository. He was very
much “ahead of his time” in this regard. His patients and research volunteers
trusted his intuition and provided their samples for his research.
Dr. Catalona’s position is that the genetic material in the repository belongs
to the donors and they maintain their ownership forever. Under federal regulations
and WU's own consent forms and brochures, he believes that neither he
nor the University can say it belongs to them with no strings attached.
This issue, and similar ones regarding use and sharing of genetic information,
is of more and more concern as genetic research is in the forefront of scientific
research and “personalized medicine.” In the emerging era of personalized
medicine, these samples could benefit the patients and their family members in
their personal health care, such as determining their susceptibility to diseases
and selecting treatments that may be best for their individual case.
The corollary is that careless use or misuse of the samples could render
them unavailable for personalized health care when they are most needed and
could result in their genetic blueprint being published on the Internet, which
could affect their and their family members’ ability to get insurance or employment.
These exact risks are specified in WU’s consent forms and brochures. |
| WU’s Question 11. What did patients agree to when they signed Washington University’s research consent form? |
WU’s Answer 11: They volunteered
to donate specimens for research related
to prostate cancer. Any research volunteer
has the right to withdraw from research,
and Washington University
supports that right. We are not aware of any basis for the claim that withdrawing
from research means that the donor gets
the tissue back or gets to redirect it to a
third party. (This would be like donating
money to the Red Cross and then calling
them two years later and saying you
want them to send your money to the
American Cancer Society.) With research
tissue repositories, withdrawal is accomplished
by wiping out all information
that connects donors to the tissue sample
they donated, or by destroying the
sample. These are the standard approaches
used by all universities, as far
as we know. |
Dr. Catalona’s Answer 11: WU acknowledges that research volunteers
have the right to withdraw from research and that “withdrawal is accomplished
by wiping out all information that connects donors to the tissue
sample they donated, or by destroying the sample.” WU stated in court that
it would have the right to de-identify the samples and use them for other
types of research. However, with today’s advances in genetic technology, it is not possible to completely de-identify a sample, and it is possible to trace a
DNA sample to an individual person.
Six thousand research participants said in a formal document that they
wanted their tissue samples to follow Dr. Catalona and to be part of his research
studies.
Rather than respect their wishes, WU would see the possibility of samples
being destroyed or de-identified and the research thereby stopped or
limited.
Richard Ward, a patient litigant, said that if WU does not respect our requests:
“Our only recourse is the unfathomable and repugnant choice of ordering
the University to destroy our samples or put them permanently on
the shelf. Either choice imperils vital past, current and future research.”
WU’s analogy of requesting transfer of a donation of money from the
Red Cross to the American Cancer Society is inapt. Tissue samples contain
a patient’s personal genes, and federal regulations allow a research participant
to change his mind about allowing his samples to be used in research
at any time. Money has no specifically personal ownership characteristics,
and there are no federal regulations stipulating a donor’s right to change his
mind at any time. |
| WU’s Question 12. Why does Washington University think the second consent forms, requesting that the
tissue be given to Dr. Catalona, are invalid? |
WU’s Answer 12: We believe those consent
forms are invalid because they do
not comply with the federal law that requires
any research related consent form
to be reviewed by an ethics panel called
an Institutional Review Board, whose
highest priority is to protect research participants.
These consent forms had no
IRB review at Washington University or
at Northwestern University. In addition to
being illegal, we believe they were unethical,
because the forms and accompanying
letters led donors to believe that Dr.
Catalona no longer had access to the tissue
for his research, and that these tissues,
retained solely for research
purposes, were somehow connected to
the donors’ future medical care. |
Dr. Catalona’s Answer 12: Dr. Catalona never asserted that the transfer
forms signed by the patients constituted formal informed consent documents.
The request forms from Dr. Catalona’s patients simply show their desires
to have their samples transferred to Dr. Catalona for his use in research.
The patients' cancer tissues of course are connected to their future medical
care. Indeed, the University's Head of Urology testified under oath that
he "absolutely" and "wholeheartedly" agered agreed that the tissue samples at
issue here were "very important" to the Patients' future health care. And he
testified that the potential to notify patients' families of prostate cancer risks
was "the benefit" of keeping tissues traceable to their source.
Ignoring its own official's testimony, WU now seems to suggest that Dr.
Catalona was merely "blowing smoke" to coerce his patients into transferring
their samples. He resents such an implication and finds it insulting to him
and to the patients who have also joined the suit on their behalf to have the
samples transferred. |
| WU’s Question 13. Is it legal for the University to discard this tissue or send it to other researchers? |
WU’s Answer 13: Yes, in fact as manager
of the repository Dr. Catalona on
frequent occasions both discarded samples
he felt he no longer wanted to
keep, and sent samples to collaborators
at other institutions. He didn’t ask patients’
permission to do these
things, presumably because he felt the
research consent form covered it. Sharing
tissue and discarding unneeded
samples are routine among researchers who deal with tissue repositories. Collaboration
through sharing specimens is
vital to research and the University
wants to resume using the collection as
soon as possible to conduct research
and provide samples to other researchers
with good proposals. |
Dr. Catalona’s Answer 13: Dr. Catalona was more than the “manager” of
the repository. He created, maintained, and sustained it over decades. And
much of his career’s work in finding better means of treatment, detection
and clues into the genetic causes of prostate cancer involved the use of that
repository.
Responsibly, Dr. Catalona only discarded portions of patient samples
where duplicate material was available to conserve freezer space and allow
room for samples from other patients.
The patients’ signed consent forms allowing Dr. Catalona to share their
samples with his collaborators around the country, which he did in a responsible
and highly productive manner.
It is Dr. Catalona’s position that, based on his research track record and
experience with the biorespository, if the patients’ feel that he would make
the best use their limited and non-renewable resources in the biorespository,
he should be able to use them. |
| WU’s Question 14. It has been suggested that Washington University has financial motivations for keeping
the repository. Is this true? |
WU’s Answer 14: The prospects for
any licensing income from the repository
are slim to none. The University
has never profited a nickel from the
repository, although it has spent hundreds
of thousands of university dollars
and federal research dollars to create
and maintain the repository and conduct
research using it. Our motivation is
to contribute to the understanding of
what causes cancer and perhaps learn
how to cure it. We share the tissue—but
not the donors’ personal information--
with other university researchers for the
cost of shipping. If a for-profit company
has researchers who want to use the tissue,
and their proposal is acceptable to
the peer-review panel, the transfer of
specimens is documented through
something called a Material Transfer
Agreement. All research universities use
Material Transfer Agreements. If one
wants to believe that the repository hasgreat
financial value, then it would have
that value for Dr. Catalona, too, should
he have succeeded in wresting it from
Washington University. |
Dr. Catalona’s Answer 14: That large research universities, including
WU, derive very substantial income from their respective research “enterprises”
can be a matter of no dispute.
As stated above, from court evidence, in 2001 the University’s Business
Development Director wrote to the Vice Chancellor: “Bill Catalona wants to
send nearly 2,000 documented samples to Hybertech for free. Just from a
cost recovery scenario, this should be worth nearly $100,000 to the University.
The only consideration Hybertech is offering is the potential for Catalona
to get a publication. It is my opinion this is an unacceptable
proposal.” The proposed payment of $100,000 to the WU would be
through a Material Transfer Agreement. Dr. Catalona is aware that WU has
received substantial moneys from Material Transfer Agreements.
WU claims “It has spent hundreds of thousands of university dollars …
to create and maintain the repository and conduct research using it.”
In truth, Dr. Catalona raised virtually all of the money for the direct support
of the biorepository. He raised millions of dollars through grants from the
National Institutes of health, private prostate cancer foundations, industry
and gifts from patients to maintain the repository and associated databases
and to conduct research using it.
In addition, the prestige and worldwide recognition given to WU because
of Dr. Catalona had no price tag.
And neither did the invaluable research and resulting world-wide practices
in early detection of prostate cancer that have saved so many men’s
lives.
Dr. Catalona is continuing his career’s work at Northwestern, and many
of his patients and research volunteers want him to assist him in attaining
his goals. |
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