Health Committee on March 4th, 2008

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much.

Is there anyone else from your group who is speaking? No? Okay.

We'll move on to the Canadian Association of Transplantation with Ms. Raylene Matlock.

[Raylene Matlock, President, Canadian Association of Transplantation]

Good afternoon, everyone. Thank you for inviting us to speak. My colleague Jan Emerton, president-elect of the Canadian Association of Transplantation, is here with me.

Thank you for asking us to speak in request to the exclusionary criteria of the Canadian general standards that are appended to the Health Canada regulations on the safety of cells, tissues, and organs. The Canadian Association of Transplantation, or CAT, as we're known, has represented health care professions in the donation and transplant field for 21 years. Over the years CAT members have participated on steering committees and subsequent advisory committees for the development of these standards.

The purpose of these regulations is to minimize the potential health risk to recipients of cells, tissues, and organs. The most important component of the organ donation process is that of the donor assessment. This provides the information required for decisions regarding acceptance or exclusion of organs for the purpose of transplant.

The following presentation will outline two of the main aspects of the assessment, which include organ function and risk assessment, both of which are required in order for a transplant physician to arrive at an acceptance or exclusion decision.

The organ function component involves a review of past and current laboratory investigations to determine organ-specific function as well as additional direct and indirect testing, which may include x-ray studies, electrocardiograms, echocardiograms, bronchoscopies, cardiac catheterizations, and diagnostic imaging procedures.

The potential donor's past medical history is also reviewed to identify if specific diseases exist that may directly or indirectly impair the organ function. Examples of this would include hypertension, high cholesterol, diabetes, chronic pulmonary lung diseases, or cancer.

The risk assessment utilizes two primary tools to identify any potential for disease transmission. First, serological or blood testing is conducted to determine the presence of infectious disease such as hepatitis B, hepatitis C, human T cell lymphotropic virus types I or II, Epstein Barr virus, cytomegalovirus, or human immunodeficiency virus--HIV--the virus that causes AIDS.

In addition to serological testing, a medical-social history interview is also conducted to identify risk factors. A number of questions are asked, ranging from past hospital visits to recent travel and social behaviours. For example, recent travel to warm climates may indicate a higher risk for West Nile virus. Some social activities have been identified to statistically increase the risk potential for hepatitis B and C and HIV, initially identified by the Centres for Disease Control in a 1994 document.

These activities have become standard screening tools for the American Association of Tissue Banks, the Eye Bank Association of America, and most recently, the Canadian Standards Association in 2003. However, we have been using a screening process since 1996.

The medical-social history is conducted only by trained coordinators in a private setting. The history is reviewed with the potential donor's next of kin, significant life partner, or other appropriate individuals, utilizing a standardized history questionnaire. A medical and social history interview is conducted with sensitivity, discretion, and respect. The purpose of the interview is explained with a brief description of the types of questions that will be asked of these folks. This process allows the presumed historian the opportunity to decide if he or she is the best historian for these types of questions or if another person should be included.

The interview may take place in person or over the phone. The interviewer should indicate that due to the personal nature of the questions, only those individuals who are providing information should be present. The family is welcome to request that others remain in the room. However, it is helpful for the interviewer to request extra individuals leave the room to save the historian potential discomfort.

The interviewer is familiar with the medical-social history questionnaire and always asks questions in a sensitive manner. When given an affirmative answer, the interviewer strives to obtain as much information as possible about the answer. This may include direct quotations from the historian. The interviewer is always aware of non-verbal cues such as looking away, coughing, and fidgeting, which may indicate that a historian is being less than forthcoming, or that another person present has additional information that he is uncomfortable sharing with the group at this time.

In some cases, it may be helpful to ask the historian to recommend another individual who might be able to provide more information to the coordinator. A typical example would be a young adult donor; parents would be providing the medical history, and friends or siblings would be providing the social component to the history.

In addition, the final question for any medical and social history asks the interviewee to consider the donor's behavioural risk factors, and if there is any reason why organ and tissue donation should not proceed. No explanation is necessary from the interviewee. The intent of this question is to allow the next of kin, the significant life partner, or others the opportunity to stop the donation process when they are hesitant to disclose sensitive information regarding the donor.

If the answer is yes and the interviewee does not wish to give more specific information, the donor will be deferred. But again, organs may be used and deemed acceptable by the transplanting physician, when the risk of not receiving an organ is greater than that of disease transmission, through the use of exceptional distribution that includes the informed and verified consent of the recipient.

In summary, I would like to say that the Canadian Association of Transplantation has supported the development of the Health Canada regulations over the past decade. Our primary concern is that of maximizing safety and minimizing risk to the transplant recipients. We feel that the regulations do not discriminate against any individual wishing to donate organs, but instead ensure full assessment of potential donors that better enable transplant physicians to make risk-benefit decisions.

Thank you for allowing CAT to participate in this meeting today.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much.

We'll move right into the questioning.

Dr. Bennett, you have five minutes. Each party will have one question of five minutes.

[Carolyn Bennett, Liberal, St. Paul's, ON]

Yes, and I have to say, Mr. Chair, that it's a bit frustrating. We've had so many witnesses and so many questions that this can't possibly be done this morning.

I'm very grateful, Dr. Levy and Dr. Shapiro, for your suggesting very clear recommendations on what you would like to see from this committee's report from this morning in terms of either a task force or certainly the call to have the regulations consistent with science and the practical, on-the-ground reality.

As much as I have sympathy for Ms. Gillham-Eisen's story of her son, I also think that most of the time, to be a clinician and to have to turn down an organ for what you know is a monogamous gay man, it seems ridiculous that we would actually have to go through.... You know, two of my best friends have been together as long as my husband and I have, for 29 years. They know perfectly well the sexual habits of one another. I just don't understand how we could end up, literally, with tough cases making bad law.

I have no idea where the science has come for most of the annex. What happens if the kids had been vaccinated against hepatitis? What if, in terms of people...know the behaviour of somebody in a prison? It just seems to be so wide, and then you are stuck having to go through all of this exception stuff to be able to turn down an organ. So I am a bit lost here.

I have been a minister where, when the department said they had consulted, I would spend my next two weeks finding out that the people who should have been consulted hadn't been consulted.

So I am not happy with this. I think it's almost impossible to do this today.

I would love recommendations, from any of you, on where you think we go from here in terms of putting the evidence back in instead of ideology, and in terms of real risk. The fact is that we are grown-ups. If my son needed an organ, I hope it would be done through consultations by Dr. Levy and Dr. Shapiro, not some list of things designed in some committee somewhere. So I expect that you would let us decide together whether or not we see this as an acceptable risk for the organ that's forthcoming.

Please let me know what you think we should do next.

[Dr. Lori West, Past President, Canadian Society of Transplantation]

Could I just say that although the consultation process may have been broad, the Canadian Society of Transplantation was not consulted in this process as an organization--

[Carolyn Bennett, Liberal, St. Paul's, ON]

I have a list about as long as my arm of people who say they weren't consulted.

[Dr. Lori West]

Individuals who are members of CST may have been consulted, but the organization was not. And I thank you for listening to our voice.

[Carolyn Bennett, Liberal, St. Paul's, ON]

I want to know if I have to put on my organ card when I last had sex. I mean, this is just nuts. This is craziness.

[Dr. Lori West]

This clearly will discourage organ donation, and we cannot afford it. I take care of children who have 100% risk of dying without a transplant. There is no alternative therapy for these children, and if we diminish our already not wonderful performance in organ donation, we will continue to not—

[Carolyn Bennett, Liberal, St. Paul's, ON]

One of my constituents suggested that there should be a tick-off on your income tax that says you'd be prepared to be an organ donor, and we should give a little tiny tax credit for it. What do you think of that?

[Dr. Lori West]

It sounds like a great idea.

[Dr. James Shapiro]

Can I make a comment?

[Dr. Gary Levy]

I would just comment that, first of all, I've had discussions with the Minister of Health, and I believe the intent was to improve safety. I don't believe anyone in this room did this to try to discriminate or to reduce organ donation. I just don't buy that.

My argument is that this will not take us where we want to go. The public has misinterpreted, or interpreted, this in the way they wish to. I don't think anyone in this room wants to be part of an exclusionary group. I just don't believe anyone feels that in order for them to move forward...that they are excluded, but we have the option of moving them into what we call the “good camp”.

I agree with you that it has to be based on science. I've consulted widely with the HIV expert community, coast to coast. I think that as a law, as Dr. West pointed out, and even the previous experts, it was drafted in 1994. HIV has changed since 1994. It is not the same disease.

What we don't want, I think, number one, is roadblocks put up that will limit our ability to help the most unfortunate of our society.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much, Dr. Levy.

Now we'll move on to Ms. Davidson.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

Thank you, Mr. Chairman. I have just a couple of questions.

I think everybody has been very clear in this panel and in the previous panel that patient safety is, first and foremost, the issue that we're all supporting, and also that we're trying to stop the transmission of disease and that we don't want to see that happen through a transplant process.

I think everybody has also talked about the science of the decision and that the decision needs to be based on good science. I want to come back to that a little bit, because I think, Dr. Levy, you cited some HIV statistics that were quite a bit different from what Ms. Gillham-Eisen talked about.

So I'd like to ask her if she could comment on this, please.

[Liz Anne Gillham-Eisen]

The statistics that we have come from our Public Health Agency of Canada. They bring them together and they report on them every six months. The information that we have, based on the Public Health Agency of Canada's surveillance reports, basically is quite different from Dr. Levy's. So I'm not quite sure where his statistics have come from, but again, we depend on our Public Health Agency for their statistics.

Up to June 2007, within the group identified as being MSM, it's actually 42.6% of the cases. The other highest incidence is intravenous drug users, at 22.8% of the cases. Heterosexuals who don't have sex with either sex trade workers or somebody who is known to be infected or is an IV drug user don't quite register on PHAC's particular statistics.

Again, they report to us under a basic criterion of men who have had sex with men, so it's not broken down. That's another reason we have to move forward. It's not broken down into men who have had sex with men but it's been protected sex. That's not information that we have available. The science is where it's at.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

Okay. I think Dr. Levy had indicated that everybody was in favour of moving forward and trying to make things better, but still maintaining the donor base that we so desperately need in this country. So if we don't go the exclusionary route, which we're hearing this morning has created difficulties and perhaps misunderstandings with the public, what do we do?

[Dr. Gary Levy]

First of all, before this regulation came into rule, we had a guideline that we used, and the community accepted the guideline. Incidentally, what has been brought into law or regulation, some people have argued, is not that different from what we have.

So what is the difference between a guideline and a regulation? A guideline is a notice to us. That's what the United States has. We are notified about a high-risk behaviour—very much like what we heard about this morning. We get the results of the serological tests, as we pointed out, for HBV, HCV, hepatitis B, hepatitis C, and so forth.

And you should be aware that we're not working in opposition here; we're also here to provide a safe system—and it is a safe system. So what we've done is use words like “exclusion” in a law, a word that was not used before. We've used very harsh language. I would argue, first of all, that we need to talk about high-risk behaviour. After all, when you've talked about MSM, that's a behaviour, perhaps. I would not get into defining a group, or whatever the case may be. I think we can leave people to decide. I don't think people necessarily want to be defined as groups.

The other thing you should know, in regard to the reference made to the case in Chicago—which is in the courts, and which I've been consulted about but am not allowed to give the details of—is that there was a lack of transmission of the data. That's what happened. There was a failure of the system. Nothing that we would have done would have protected.... This law will not prevent that; it was a breakdown in the system.

You asked what we wanted, Ms. Bennett. One, I think we need to amend this to reflect what we're trying to accomplish, and I would encourage you to mandate that we use the best test possible.

In regard to HCV, incidentally, which Mr. Fletcher alluded to, Canada did not embark on the high road. You didn't use the surrogate test. And I'm not talking about this government, so I apologize if you're assuming I'm a political animal; I am not. I'm an apolitical animal. I'm an advocate for patients. But the reality is that the Canadian government at the time did not take the best advice from the doctors. You should have used the surrogate tests. The United States did, and they didn't suffer the same costs.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thanks very much.

We'll move on to Monsieur Ménard.

[Réal Ménard, Bloc, Hochelaga, QC]

Thank you, Mr. Chair.

This is a clearly discriminatory regulation and it will certainly not withstand a charter challenge. At the same time, no one wants to compromise the supply of organs for donation and cause a scandal such as we had with tainted blood.

I would really have like to have Mr. Germain back at the table so that he could react to Mr. Levy's comments. I would like you to explain how third-generation HIV screening tests would allow us to maintain the safety criteria to which we all subscribe. It is too easy to say, as others, other witnesses have stated before you that it is “the” scientific community, as if it existed with a capital S and C, and everyone had the same opinion.

Between the time when Brian Mulroney's Conservatives tabled their first strategy in the fight against AIDS and the time when minister Pettigrew renewed it, the face of AIDS had changed. The two sets of statistics presented by Ms. Gillham-Eisen and by Mr. Levy are in agreement. People becoming infected in Canada are not, for the most part, men having sex with other men. That has not been the case for at least three years. So the statistics and the data that were presented to us by the witnesses before you cannot be entirely defended.

Tell us how these third-generation tests, particularly the PCR RNA test, would provide us with the quality standards you are upholding, and explain the difference between an organ donation when the person is alive and consents to it and a organ donation when a person is deceased. Explain to us how things would work in those two cases.

Mr. Chair, I would really like to have Mr. Germain's opinion. Can we get him back to the table?

[Dr. Gary Levy]

Do you want me to start?

[Réal Ménard, Bloc, Hochelaga, QC]

You and Dr. Germain.

[Dr. Gary Levy]

Okay, I'm happy to start. I know you have a time limit and I'm not going to give you a science lecture today.

The reality is that we can measure your immune response to the virus, which is an antibody, and we can do it with what we call an ELISA, and Dr. Germain alluded to that, but there are now new generations of ELISA, called Luminex or luminescence ELISAs, which have a higher degree of sensitivity. In other words, if I look on the floor there may be a tack there. I can't see it. If I have a microscope I'll find it. It's that kind of phenomenon.

The luminescence assays for serology will reduce the window from the time the person is exposed until they mount a response from 21 days back to 14, but that's not good enough. Now we know that when the person becomes infected there is an infectious virus and we can amplify that. We can use a technique whereby we can take blood out of the patient and we can do it in a four-hour period, in a timely period where it could become practical. It costs, so you'd have to talk to Dr. Sher about instituting this. He's your representative. We could do either the DNA, which means the part of the genome of the virus, or we could do the RNA, which is also part of the genome, and using those techniques we would eliminate almost to zero. Dr. Wainberg in Montreal and other people have said you wouldn't need a history anymore; you would just be able to detect the genome.

[Réal Ménard, Bloc, Hochelaga, QC]

Just to finish, is it possible to have Dr. Germain come to the table to give us his opinion specifically on that? Would he mind reacting very briefly to his colleague Mr. Levy's remarks?

Mr. Germain, would you mind? I do not want to make you uncomfortable.

[The Vice-Chair, Liberal, Lui Temelkovski]

We're going to wrap up anyway.