# National Ethics Teleconference

# *Notification of Patients Potentially Exposed to Mad Cow Disease Through Prior Blood Transfusion: Testing the Limits of Full Disclosure*

# April 24, 2001

**INTRODUCTION**

**Dr. Berkowitz:**

I am pleased to welcome you all to this call. By sponsoring this series
of Ethics Hotline Calls, the VHA National Center for Ethics tries to
provide an opportunity for regular education and open discussion of
important VHA ethics issues. Each call features a presentation of an
interesting ethics topic followed by an open moderated discussion of
that topic. Today, for the first time, we're even going to try to give
you all an opportunity to let us know your opinion on the issue in
question through an informal electronic survey. I will give you more
details on this later, but please do try to formulate your own opinion
by the end of the call. Also, we always reserve the last few minutes for
the from the field section, which is your opportunity to speak up, let
us know what is on your mind regarding ethics-related topics other than
the main focus of today's call.

Before we get going, two quick announcements. Generally soon after each
ethics hotline call we post a detailed summary of the call on the
Center's web site. Unfortunately during last month's call we experienced
technical difficulties and, as many of you have brought to our
attention, the detailed summary is not available. We are posting a
general outline of the call and hopefully things will be back to normal
starting with a detailed summary of this call which we will post in
several days.

For a second announcement, I would like to thank Barbara Chanko. After
more than a decade with the VA, Barbara has recently joined our staff as
a program specialist at the National Center for Ethics and Barbara is
going to tell us about this year's annual intensive ethics training.
Barbara.

**Barbara Chanko:**

Thank you. The National Center for Ethics and EES are pleased to
announce that the National Center for Ethics' annual intensive ethics
training, titled "Building an Integrated Ethics Program," will be
conducted in Washington, DC from July 23 through the 26. This four-day
intensive course will provide up to 90 selected participants with
specialized knowledge, skills, and strategies to improve VHA's
effectiveness and promoting ethical practices. The intensive training
will cover practical topics such as establishing an integrated ethics
program, applying a results oriented approach to ethical problems,
overcoming common barriers to success for ethics programs, and creating
an action plan to improve ethics quality. This course is designed for
clinicians, administrators, and others whose work influences ethical
health care practices across VHA. Special consideration will be given to
teams of 2-3 persons who are designated by their facility to attend this
conference, although individual participants are also encouraged to
apply. Applications can be submitted on VA Outlook to ethics
chairpersons today and are due by Friday, May 25. For additional
information, please contact Dr. William Delfyett at EES in Northport.
His number is 631-754-7914, ext. 7456. Thank you.

**Dr. Berkowitz:**

Thank you Barbara. Before we begin, I would like to review the overall
ground rules for the ethics hotline call. We do start on time. We ask
that when you talk, you tell us your name, location and title so that we
can all keep getting to know each other better. Please try to use your
Mute button to minimize background noise when you are not speaking. Due
to the interactive nature of the ethics call and the fact that at times
we deal with sensitive issues, we think it is important to make two
final points. First it is not the specific role of the National Center
for Ethics to report policy violations. However, please remember that
there are many participants on the line. You are speaking in an open
forum and ultimately you are responsible for your own words. And
finally, please remember that these hotline calls are not an appropriate
place to discuss specific cases or confidential information, and if
during the discussion we hear people providing such information, we
unfortunately will have to interrupt and ask them to make their comments
more general.

**PRESENTATION**

**Dr. Berkowitz**:

Now we will proceed with today's discussion, which will focus on the
notification of patients potentially exposed to the New Variant of
Creutzfeldt-Jakobs disease (nvCJD) through a prior blood transfusion:
testing the limits of full disclosure. The topic was chosen for an
ethics hotline call after the interest it generated as we worked on a
consultation request brought to the center. We were asked to comment on
the ethics of notifying transfusion recipients of the theoretical
possibility that they had been exposed to the agent responsible for Mad
Cow Disease through prior blood transfusions. I would like to stress
that an actual case of such transmission has never been reported. The
concerns were that such a notification might unnecessarily alarm those
notified, that it might affect patients trust in the blood supply, and
that it would require a disproportionate resource expenditure for only
theoretical benefit. These concerns prompted some people to wonder
whether this was a circumstance beyond the limits of our general ethics
based policy of full disclosure to patients. To discuss her thoughts
when she contacted the Center as Chairperson of the Transfusion
Functional Group in VISN I, we have Dr. Nora Ratcliffe and Dr. Ratcliffe
is also the Chief of Laboratory Services in White River Junction, VT.
Dr. Ratcliffe, are you there?

**Dr. Ratcliffe:**

Yes I am. Thank you. I think you summarized our concerns very well, Dr.
Berkowitz. I received notification from my Network Director of the
Consolidated Laboratory, Lionel Wells, asking me my opinion on what was
recently a note that he received from the American Red Cross. They were
now sending out withdrawal notices to transfusion services for CJD based
on a 1999 FDA guidance regarding donors who had resided six months or
more in the United Kingdom between 1980 and 1996. I guess what caught my
attention in the guidance is that it further stated that the FDA did not
recommend consigning notification for the purpose of tracing and
notifying prior recipients. We often receive withdrawal letters from the
Red Cross for various donor irregularities, where a donor forgets to
disclose a piece of information or they remember something after they go
home and they call back the Red Cross or the blood donor center and say,
gee, I remember now and maybe I shouldn\'t have donated that unit. The
Red Cross , or any blood agency, will then send out a withdrawal letter
that comes to the transfusing service and the transfusing service will
then either issue a letter, usually to the recipient if it has been
transfused or withdraw the unit from the supply and send it back to the
collection agency.

In our VISN we are trying to do things in a uniform fashion and in Dr.
Wells inquiry I found out that one of our transfusions services at VA
Connecticut actually had received some withdrawal letters on this issue
and had gone and drafted a letter that they were sending out to
providers, and I think Dr. Stack is on this call and will speak to that.
I also contacted the two collection agencies in our VISN. The other is
not Red Cross. It\'s the Rhode Island Blood Center in Rhode Island, and
they actually issue a withdrawal letter and in the context of their
letter they say that you should notify the physician that is responsible
for caring for the patient that was transfused if the unit was
transfused. In Rhode Island, their service handles this by sending the
information to an infectious disease nurse. I wasn\'t able to speak with
her, but then she either notifies the patient, I\'m not sure what she
does with the information after she gets it. But that those were my
issues and that\'s why I asked for some guidance.

**Dr. Berkowitz:**

Thank you Dr. Ratcliffe. Dr. Ratcliffe mentioned Dr. Gary Stack. Dr.
Stack is Chief of Pathology for VA Connecticut in West Haven. His group
has also struggled with this issue locally and in fact decided to
implement the notification program there. Dr. Stack, could you please
tell us what issues your group considered and describe the process that
you used to think through this question.

**Dr. Stack:**

Yes, thank you. We received a letter from the American Red Cross called
an \"Urgent CJD Market Withdrawal\" last May and it informed us that a
unit of FFP that had been distributed to us from them had come from a
donor who had lived in the United Kingdom for two years from 1990 to
1992. And according to that FDA guidance document that Dr. Ratcliffe
referred to, the donor actually should have been ineligible for donating
that unit of blood that was made into FFP. So in other words, that was
an ineligible unit and the Red Cross in their letter to me asked me to
immediately quarantine and withdraw that unit from distribution from any
recipient. As it turned out at the time that we received the letter,
that unit of FFP from that ineligible donor had already been transfused
to one of our patients. The question was \"What do we do next? Do we
notify the patient? Or in my case, do we notify the physician and/or the
patient regarding this theoretical risk?\"

And just to emphasize again, with nvCJD, there have been no cases
documented of transmission through blood transfusion. However, there is
evidence from animal studies that transmission can occur by transfusion
or injection of blood. So there is a theoretical risk based on animal
studies. And we don\'t know for sure that the donor involved here was
actually infected with the infectious agent of variant CJD. The donor
had an increased risk for it based on having lived in the United Kingdom
at a time when cases of variant CJD were appearing in humans and
thousands of them in cows under the name of BSE, bovine spongiform
encephalopathy.

So in order to get guidance on what to do in this case, should I notify
anyone. It\'s a theoretical risk. The donor was theoretically exposed
and even if the donor was known to carry the agent of infection, it\'s a
theoretical risk that it could be transmitted by transfusion. So I
wasn\'t really quite sure how firm my notification should be, if any, to
either the physician or the patient. So I went to our local clinical
operations board, which is composed of the Medical Service Chiefs of all
the clinical services and asked for an opinion from them. On that board
sits the chairperson of our local ethics committee. After discussion of
the theoretical nature of the risk, but with some discussion of the
animal studies, it was the consensus opinion of our clinical operations
board that I, as Blood Bank Director, notify the physician caring for
the patient of the theoretical risk involved and recommend that
notification of the patient be made. So on the basis of that
recommendation I did write a letter, that Dr. Ratcliffe referred to, to
the physician caring for the patient, so that my notification
responsibilities were discharged. And that is the extent of our case.
We\'ve only had one case in the past year.

**Dr. Berkowitz:**

Thank you Dr. Stack. Dr. Ted Beals is the Chief Consultant of Diagnostic
Services at the Strategic Health Care Group in VA Headquarters. Dr.
Beals is involved in this question at the national level and has agreed
to discuss some of the scientific facts of nvCJD, the possibility of its
transmission via transfusion, what hasn\'t already been covered if there
are any points, as well as the policy issues involved in this and other
notification programs. Dr. Beals.

**Dr. Beals:**

Let me give you some background. A lot of the science has already been
talked about, but a couple of things need to be brought in so that we
can have a perspective. Maintaining the quality of the blood product has
always been an extraordinarily high standard and there are a number of
ways in which the product is being controlled. One of them is that you
screen the donor because that donor may have an increased chance of
having acquired an infection because of either background experience,
personal behavior, visiting certain places in the country, things like
that. Anybody who has ever donated blood realizes that before you are
allowed to donate, you have to fill out this little form that asks a
whole bunch of pointed questions and if you answer any of them in
certain ways, then they politely tell you, well we are very sorry, but
you can\'t donate. Then if you pass the screening test then in fact the
blood product is put through a rigorous chemical analysis, immunological
analysis to determine whether or not there are any infectious agents of
the kinds which are described and known and for which we have tests. All
that testing occurs before the unit and various products from that unit
are given out to hospitals for transfusion.

What has happened in the past is that in situations where after the unit
has been delivered to the hospital, some information, either the test
turns out to be positive or the screening if found to be incomplete and
now they know something different, or in fact as in this case, the
screening criteria changed or in the case of HIV that some of you may
remember and certainly in the case of HCV where the tests that were
being performed on the blood product after they had been donated were
perfected and so were more sensitive and so detected infections that
hadn\'t been able to be detected in the past. All of these things are
then by law required to have look backs. And a look back merely means a
notification and a notification carries with it the expectation that
somebody is going to talk to the patient.

In the VA it has generally been considered that we do notify patients in
all of these cases with the physician who is primarily assigned to that
patient to be involved in that discussion. In this particular case the
important things to understand are that there is no way at the present
time to test blood products for the protein which is the agent involved
in these diseases that we are talking about. And the screening exclusion
criteria were only added quite recently. And of all of the things
concerned, the screening is intended to reduce general risk whereas the
testing is generally expected to remove real risk. Another thing to put
into perspective is that we transfuse about 100,000 units of blood
product in the VA every year and so this sort of thing is real and the
numbers are big and when the American Red Cross decided that they were
going to send out these notification letters, it impacted on us probably
faster than it did on anybody else as a system.

So the issues in here have already been well described. The important
things to remember are that CJD disease which has been around for
generations and generations and occurs almost exclusively sporadically
in the United States at the rate of about 200 cases per year, has been
going on for a very long time and there is no way of testing blood for
that product, although there have been mechanisms now evolved for
examining brain tissue to look for the disease to confirm the clinical
diagnosis. The variant of CJD, which is the agent that is suspect in
this particular case, is new on the scene, and came about as the result
of the proliferation of what is now being called Mad Cow Disease in
cattle in certain parts of the United Kingdom, that disease, that
variant, has not been reported to the CDC in this country to date. So
there are no examples. The agent, the protein partly responsible for
CJD, can also be detected in brain tissue with sophisticated testing but
at the present time there is no way to test blood that could be used as
a screening test. That is the background and it has already been
indicated that there have not been any reported cases of this disease
transmitted in humans by blood.

**Dr. Berkowitz:**

Thank you Dr. Beals. For an analysis of the ethical principles involved
in this issue, I will call on two of my colleagues from the National
Center for Ethics, Dr. Michael Cantor and Ryan Walther.

**Dr. Cantor:**

Good afternoon everybody. In this brief conversation we are going to
talk about the ethical considerations in involved in answering two
important questions. First, should patients who receive blood products
from donors at risk of nvCJD be informed that they have received
potentially contaminated blood products? The second question is if
recipients are to be notified, what can be done to minimize the
ethically problematic aspects of informing those patients? Before
answering these questions, I want to echo several scientific assumptions
about the nvCJD because I think in getting to the ethics you have to
have the facts down. First there is no test or treatment for either CJD
or nvCJD at the current time. Secondly, there has never been a case of
nvCJD reported in the United States. In fact, my understanding is that
there have been 80 cases reported total in the United Kingdom. Is that
correct, Dr. Beals? I just want to check with you on that.

**Dr. Beals**:

That is right. You have to remember these are reportable cases, so there
is always the possibility that they were not reported, but yes, that is
correct.

**Dr. Cantor:**

So if we compared that to CJD, we have about 200 cases per year in the
United States alone. We are talking about 78 or 80 cases in the United
Kingdom total of this new disease that we are aware of ever. So the
relative risk is something we should think about from an ethical
perspective as well. And finally, as has been mentioned several times,
there is no confirmed case of transmission of either CJD or nvCJD
through blood products. I do want to mention previous VHA policy before
we get to the ethics as well. VHA directive 10-95-076 \"Management of
Patients Identified in the CJD Lookback Notification\" was dated August
8, 1995 and actually expired last August. This directive stated
\"Notwithstanding the theoretical nature of the transmission risk, VA
believes we have an ethical obligation to inform patients of the
exposure of potentially contaminated products. VA voluntarily elected to
notify all patients who may have received these blood components or
plasma derivative products while under VA\'s care.\" So the history of
the policy here is that VA in the past did notify people if they
received blood products from donors who had identified cases of CJD. Now
contrast this with the recent FDA recommendation made in November, 1999
guidance for industry that if a patient received blood products from a
donor who is thought to be at risk for the nvCJD, the FDA \"does not
recommend notifying such patients of their exposure.\" So we see a
difference even in the way the FDA would recommend handling CJD and
nvCJD and even the Red Cross has a different opinion than the FDA in
terms of whether or not they would recommend notification as we heard
earlier from our colleagues in Connecticut. So we have a very
complicated scientific background, policy background, and conflicting
recommendations from the experts in the blood transfusion community.
Let\'s get to the ethics of this. Ryan, should patients be informed that
they have received blood products from persons at risk from CJD?

**Mr. Walther:**

Thanks Michael. I would just like to present five ethical arguments in
favor of notification. First of all, patients have a right to know all
the information about their health that is materially relevant to making
their treatment choices and other health care decisions. Withholding
that kind of information violates the trust the patients put in
clinicians and VHA as a whole. Secondly, in order to make responsible
health care decisions, patients need to have full information about
their medical condition. With the proper assistance from health
professionals, most patients are capable of interpreting and
understanding information about their health and using this information
to make decisions that they think are best. Withholding information
limits their ability to choose. Thirdly, if a reliable test or effective
treatment becomes available in the future, the best ethical result is to
identify and test or treat those people thought to have been exposed to
risk of nvCJD. Even if there is no test or treatment developed, the
patients at risk need to know this so they can integrate that
information into their own care planning. In either case, failure to
notify now means that patients can be lost to follow-up that\'s
important to both individual patients and the public health. Fourthly,
notification of all patients thought to be potentially at risk would
make lookback studies easier to conduct. So it would be possible to
learn what happens to recipients of potentially contaminated blood
products\--thus benefiting future patients. And finally, failure to
disclose known potential risk is paternalistic, and in the shadow of the
HIV/HCV epidemics, when sins were made not to disclose, this failure
could potentially lead to further loss of confidence in the safety of
the blood supply and the ethical practice of medicine in general. That
covers pretty much the arguments in support of notification. Michael,
what do you have to say about the arguments against notification?

**Dr. Cantor:**

Actually, I think notification could harm some patients. The Hippocratic
oath, first, do no harm (*primum non nocere*), is fundamental in medical
ethics. Notification would definitely cause some patients unnecessary
anxiety and worry. There is no reliable test or effective treatment.
There is no evidence that anyone has ever gotten CJD agents, either CJD
or nvCJD, through blood transfusions, let alone from someone at risk
from the disease because they spent time in a foreign country during a
16 year period that ended five years ago. Worse is a case where parents
are notified, not so much applicable to VHA, but there are many cases
where children receive blood products and their parents would be given
this information, and the implications of that I think are ethically
troubling as well. Also, I worry about stigmatization. This certainly
happened with HIV. We don\'t know how nvCJD is transmitted. We don\'t
know how it spreads. We do know that it is debilitating. And the
combination of a lot of publicity about this with a lack of scientific
knowledge could lead to problems in terms of public perception of people
who are at risk for this disease. Thirdly, I would say that notification
is very costly. To do it well, and we will talk about this later, we
would have to have skilled counseling, adequate medical evaluation. The
previous directive I mentioned, Directive 10-95-076 covered cost of
physical examination for CJD regardless of service connection. In this
case we are talking about an extremely small risk of finding cases.
Potentially we have more important uses for limited VHA resources.
However, even with these arguments, I think it\'s possible that VHA will
continue its policy of recommending notification. Ryan, what can you say
about the second question. How should patients be notified? Are there
ways of doing this to minimize the risks of harm to the patient?

**Mr. Walther:**

There are several different notification models we could look at. Each
has its own potential advantages and disadvantages. First of all, a
letter could be sent to the patient notifying them. The advantage of
this is that it is easy and is relatively inexpensive. The disadvantage
is that this is a rather impersonal way of notification and can further
increase rather than minimize a patient\'s anxiety. Simply notifying
someone that they have been exposed to a life threatening illness for
which there is no treatment can make people somewhat anxious. Secondly,
you could send a letter to the physicians and notify them that their
patients have received potentially contaminated blood products. It would
then be at the physician\'s discretion to determine whether or not to
notify their patients. The particular advantage of this is that the
physician will personally know the patient and can decide how best to
inform them so as to minimize patient anxiety. The disadvantages are
that if the physician chooses not to notify, this could result in the
ethical problems previously mentioned. Secondly, you may not be able to
find the primary care MD for every patient who needs counseling and
notification. This would be a difficulty if this were the avenue chosen.
Also, it\'s possible that VHA may not be meeting its obligation to
patients by shifting the decision entirely to individual clinicians. And
this creates the possibility of different levels of counseling depending
on the values or choices of different providers.

Another method of notification would be the counseling approach. The
facility could ask all blood recipients to come in for counseling about
transfusion risks. The real disadvantage of this is one Michael has
already noted, is that the cost is very high both in terms of time and
training of counselors or MD\'s and of doing the counseling itself.
Additionally, as a form of notification you could let the patient choose
how much they are informed and whether they are informed. You could send
them a letter stating that they may have been exposed to a health
problem and they are free to choose whether or not to receive further
information and/or counseling. Again, a disadvantage of this is that
it\'s hard to find the right wording, and any such letter might provoke
just as much anxiety as a letter of straightforward notification.

And lastly, another notification model could be kind of a public
information campaign. I talked to the Head of Communications for VHA and
was told that we could potentially reach about 5 million veterans by
putting stories into the five top Veterans Service Organization
journals. So we could reach a broad spectrum of the audience. However,
the significant disadvantage is that we will be notifying many people
who do not need to know this information and potentially missing those
that do. And it could certainly increase fear rather than decrease it.
So what does that leave us now, Michael?

**Dr. Cantor:**

I think there are strong ethical arguments both for and against
notifying recipients of blood products from donors who are at risk of
nvCJD. Either course of action has some negative ethical consequences.
No matter what is done, there is risk of causing harm and/or losing a
potential benefit. I think VHA policy decision should minimize negative
consequences. If notification occurs, it should be done in ways of
minimizing anxiety and reinforce the idea that notification is the best
way to serve veterans. Emphasis should be on VHA desire to have a
well-informed veteran population and adequately prepared clinical staff.
I also think that this policy decision needs to be made in the context
of a great deal of scientific uncertainty and with the recognition that
the American Red Cross is pushing for further restrictions and deferrals
of donors. Now they are talking about deferring from Western Europe
including France and Portugal where other cases of nvCJD have been
reported. So the potential future implications of a notification policy
in terms of the expense, the cost, the numbers of people affected will
certainly be greater.

**MODERATED DISCUSSION**

**Dr. Berkowitz:**

Thanks Mike and Ryan. I still think we have some time left for
discussion of this topic. Remember, feel free to speak up. I will try
and keep the dialogue moving and focus on the ethical issues related to
this topic. Anyone have any ideas?

**Dr. Beals**:

Can I add some little things that are important?

**Dr. Berkowitz:**

Sure.

**Dr. Beals:**

One of them is at least in the number of lookbacks that we have done in
the past under this circumstance, there are two principle purposes for
the notifications. One of them we have to remember the patient and the
clinical principle purpose for notification is to bring that patient
back into the health care system to test for infection at that time and
to monitor for any evidence of future infection at a later time. That\'s
what we do for HIV, HCV and others. And that\'s the primary purpose for
doing it. There is a legal principle for notification which has to do
with minimizing the legal risk, which essentially shifts the burden to
someone down stream by sending a letter out that says okay, we told you
and it\'s now up to you to take the responsibility and then if that
person sends the letter to somebody else, then it\'s up to them to take
care of the responsibility. Another thing that everybody should know,
and maybe they do, but if I could briefly remind you is that not only is
this disease not detectable very readily, but in fact the latency before
clinical manifestations can be several decades long. All we can do is
monitor them for any evidence of clinical expression and there is no
testing that you can perform to identify those infected. Thank you.

**Dr. Gary Stack:**

I have a couple of comments. One is, I think it is interesting to just
play a little bit with the analogy between HIV and AIDS and nvCJD and
just to emphasize the point that Dr. Beals just made that according to
FDA data, the incubation period of NVCJD is felt to be at least five
years and perhaps as long as 20 or more years. And the cost of this long
latency there is a feeling that in the United Kingdom and perhaps
elsewhere, that there may be as many as hundreds of thousands of
potentially infected individuals out there that don\'t know that they
have been infected and are a potential pool of blood donors that could
affect many more patients through transfusions. I do have some updated
information with regarding to actual numbers of cases worldwide.
According to some data from the FDA from February of this year, it
doesn\'t change the numbers very much, but there have been 92 cases
worldwide and 88 of those have been in the United Kingdom. The last
point I want to make is that I was a little bit confused about some of
the comments the speakers have made about the FDA\'s recommendation of
notifying recipients. Just looking over right now the guidance for
industry on this from the FDA and at the end of the document there is a
recommendation. They say that the recipient tracing and medically
appropriate notification and counseling may be performed at the
discretion of the care providers. They don\'t specifically say it should
be done but that it may be done at the discretion of the care provider.

**Dr. Berkowitz:**

Right, and the purpose of that notification was for the quarantine and
disposition of the blood. And again, the notification was left to the
discretion of the provider.

**Dr. Beals:**

Right.

**Dr. Berkowitz:**

Thank you. Any comments.

**Dr. Ellen Fox**:

I have a question. What is the scope of this problem? Are we talking
about going out and trying to find people that may have visited the
United Kingdom who have already donated blood? I understand the people
that are coming forward now will not be accepted for blood transfusions.
Are we talking about just a few cases that are going to come up in the
next year or are we talking about a larger number?

**Dr. Beals:**

Maybe I can answer that. There are a couple risks. There are only three
donor centers within the VA. So we are really not talking about that in
the VA. But if you talk about the actual numbers in the American blood
donor, the total population of the United States, it\'s a huge number.
And as I mentioned before in the VA we are talking about 100,000
transfused products a year. So again, that is a fairly high number of
our veterans that are getting products. But just to understand that we
are not going to be going out looking for them. These are ones that are
not found by going out and looking. These are ones that are repetitive
donors in almost all cases that come back to donate at some subsequent
time and either answer the question differently or the question is
different from what it was before. That\'s what precipitated the
transmittal letters from the American Red Cross.

**Dr. Berkowitz:**

Dr. Beals, how many notifications were there in the prior CJD look back,
if you have that information, and were there actual problems when people
were notified? In other words, are our concerns regarding the harms
valid concerns?

**Dr. Beals:**

Those numbers are relatively small. We do not collect that data. By the
way, just for everybody\'s understanding, one of the things that I have
put into play nationally is that I have asked the IT folks to modify
Vista so that it would be possible to have a field in the patient file
that would be a place where you can log in the fact that the patient was
involved in a lookback so that years later there will be some way of
knowing that that has occurred. At the present time we do the
notification with HCV, we did collect a national database that\'s
individual person specific, but in HIV there was no attempt to do that.
But there has never been an attempt in the past to keep a record of
these nationally, but the difficulty is as Dr. Stack says, is that
nobody knows what the risk is now. Nobody knows what the pool is at the
present time, but there is every evidence to believe that the pool has
changed significantly in the last decade, and it\'s this risk and the
mounting risk that we are worried about. So my guess is that there
probably are several hundred notification letters out there right now
and there will be orders of magnitude more in the VA system by the time
the new standards for exclusion of donors are expanded.

**Dr. Berkowitz:**

What I think I am going to do right now is to unfortunately conclude the
discussion in this format. Again, it can be continued in the electronic
format on our web board, which you can get to through the VA National
Center for Ethics web site
([vaww.va.gov/vhaethics](http://vaww.va.gov/vhaethics)). But as
promised, what we wanted to try and do is to give you all an opportunity
to let us know your opinions on today\'s topic. From the discussion, I
think it\'s safe to say that both notification and non-notification are
arguably ethically justifiable courses of action. Having heard today\'s
discussion, hopefully all of the callers have formed at least a
tentative opinion on whether or not we as a system should as a matter of
policy notify all prior transfusion recipients who have potentially been
exposed to nvCJD. Since most people who listen to these calls don\'t
have a chance to participate verbally and since time constraints really
severely limited discussion today, we thought it would be fun to
informally poll our callers on the question. What I would really like
every caller to do is immediately after the call, if you could send us
an e-mail on the Outlook system. The address is
[VHAethics@med.va.gov](../VHAethics@med.va.gov%20) or just VHAethics if
you are on the Outlook system, with either the word \"Yes\" or \"No\" in
the subject line. \"Yes\" would indicate your opinion that we as a
system should commit to notification of all involved patients. \"No\"
would indicate that you feel that based on the information as we
understand it today, that we as a system should not notify involved
patients at this time. Now we recognize that the question does not
address the method of notification, we know this is not a scientific
study, we know that it is just a fun, informal poll of the callers and
we promise not to associate anyone\'s name with their response. In fact,
if there are several people listening in from a single location or
phone, you can aggregate your responses and just tell us in the subject
line in the e-mail how many yes votes and how many no votes from your
group. Again \"Yes\" for a policy to notify potentially exposed
patients. \"No\" would indicate non-notification at this time. The
e-mail address again is [VHAethics@med.va.gov](../VHAethics@med.va.gov).
If you could all participate, that would be great. I will be sending up
a follow-up e-mail to this call that will include the links to all of
the appropriate web sites to the call summary, to the web board
discussion, and the poll results.

**FROM THE FIELD**

**Dr. Berkowitz:**

We do try to save the last few minutes of the call for our \"From the
Field\" section and it\'s your opportunity to speak up and let us know
what\'s on your mind about topics that are other than the main call
topic. If you have anything, please let us know now. And again, we
can\'t handle specific consult requests. Anything on anyone\'s mind?

**Fred Moolten:**

I am HUS at the Bedford, MA. I\'d like to stir the waters up a little
bit by raising a contentious issue that pits some U.S. investigators,
some drug companies, and to some extent the FDA, basically against the
rest of the world, at least as embodied in recent World Health
Organization (WHO) declarations, and that\'s the question of the use of
placebo controls in clinical research involving conditions for which an
active known treatment exists. The arguments have gone on fast and
furious, but most objective observers that I am familiar with believe
that to use placebos under these circumstances violates a fundamental
obligation to serve the best interest of the patient as a priority over
other concerns. Most of the justifications for placebo tend to be made
in terms of public health although they certainly advance the interest
of some investigators and some drug companies. And I guess my question
is will the VA be willing to confront this issue possibly taking a stand
that will invite criticism and attack from those who disagree, or is
that too daring. The VA has enormous leverage and it could make a huge
difference.

**Dr. Berkowitz:**

I think Dr. Moolten, as you know, this is a very controversial topic
that has a very large literature on the topic. It is incumbent upon
people who design research projects to assure that the risks are
minimized to anyone participating. I think it\'s safe to say, and
someone correct me if I am wrong, that in general you are not allowed to
put people in a research project and withhold treatment that is
available in an arm of the treatment for the sake of the research
project. But again, this is very complicated. There is a question of
identifying intermediate effects which requires a placebo arm and there
is a question of the integrity of the scientific design of the study and
assuring the results of the study are valid as you conduct the study. So
again, a very complex issue and in many ways different for each specific
study that is in question by the local IRB\'s who have the authority to
make those decisions. Anyone have comments on that?

**Dr. Cantor:**

I think at the risk of sounding cowardly, I\'d say very few people like
to take stands for which they know they are going to be attacked, and
the VA, of course, is not alone in trying to steer a cautious course
between two very difficult choices. On the one hand we have our
priority, which is protecting the veteran, and making certain that our
research is safe and to minimize risk in all ways possible. On the other
hand, we have the need for the best scientific outcomes to maximize the
best achievements we can devise for our patients and for non-veterans as
well. I think that it is complicated in this area because VHA rules and
regulations, which by the way are overseen by the Office of Research and
Development and not by the National Center for Ethics, and they would
probably be in a better position to answer your question. They establish
the ground rules for how research is conducted in VHA facilities.
However, other regulatory agencies which over see certain types of
research, their regulations directly apply to the way research is
conducted as well. In this particular case, the question of FDA rules
and regulations regarding the use of placebos becomes very important.
Again, it\'s a highly technical area I have to admit that I am not
familiar with the exact sections of the FDA regulations, that\'s where I
think a lot of the language and policy concerning placebos is currently
found. And so in terms of whether or not the VA would take a stand,
it\'s really more complicated even than that. You are talking about
interactions between VA, FDA, probably the office of Human Research
Protection, and the Dept of Health and Human Services, so at a minimum
three federal agencies, plus there are state rules and regulations. In
some cases you have university affiliates working with VHA investigators
or vice versa, which means that the university policies are also coming
into play. So it\'s a very difficult area in terms of the policy and
regulations and rules that currently exist. I don\'t think it would be
as simple as saying the VA would be able to take a stand on its own
without working with its fellow federal agencies at a minimum to
minimize the risk to patients in changing and examining current
regulations from FDA and other agencies that affect this area. I can
also say that the IRB plays the final and most important role in
protecting their community and the patients who may be participants in
research at their facility. Therefore, if any IRB determines that the
risks outweigh the benefits, they can always determine that the study
should not be done at their site. There is always that one last final
place where risk can be minimized.

**Dr. Berkowitz:**

Dr. Moolten, if you have a specific question you can take it up with
your local IRB, your local ethics committee, or send it to us at
VHAethics. Again please mail your poll results. "Yes" for notification,
"No" for non-notification based on today\'s discussion to
[VHAethics@med.va.gov](../VHAethics@med.va.gov). I need to thank
everyone who has worked hard to make this call happen. It\'s not a
trivial task. I appreciate everyone\'s efforts and thanks to all the
speakers. The next call will be on Wednesday, May 30 at 1:00 p.m.
Eastern Time. Look to our web site and to your Outlook e-mail for
details and the announcement of the topic. Again, you should be getting
a follow-up e-mail to this call with all the links and addresses that
you need. Let us know at VHAethics if you or someone you know should be
receiving the announcements or if you have suggestions for the topic of
future calls. And the last time, our e-mail address is
[VHAethics@med.va.gov](../VHAethics@med.va.gov). Thank you everybody and
have a great day.