:
I call this meeting to order.
Welcome to meeting number 94 of the House of Commons Standing Committee on Health.
Today's meeting is taking place in a hybrid format, pursuant to the Standing Orders, although I don't think we have any virtual participants for the first panel, so we can dispense with that.
Pursuant to Standing Order 108(2) and the motion adopted on November 8, 2023, the committee is resuming its study of the government's advance purchase agreement for vaccines with Medicago.
I'd like to welcome the Honourable Mark Holland, Minister of Health, as well as the officials accompanying him this evening. From the Department of Health, we have Dr. Celia Lourenco, associate assistant deputy minister, health products and food branch. From the Public Health Agency of Canada, we have Heather Jeffrey, president; and Dr. Donald Sheppard, vice-president, infectious diseases and vaccination programs branch.
Thank you all for taking the time to appear this evening.
Before I call on Minister Holland to begin his opening statement, I want to remind colleagues that we have a convention here that the witness is allowed as much time to answer as the person used posing the question. You have discretion as to whether to let him go longer. I will make sure that he gets at least as much time, and it's up to you whether to give him more.
With that, Minister, welcome to the committee. You have the floor for the next five minutes.
It is a pleasure to be here with you today again, back at the health committee. I thank members for the opportunity to talk about the contract with Medicago, and more specifically, to talk about the government's action to ensure that all Canadians had access to a vaccine during the pandemic.
Maybe I'll start with global context, where we were when the darkness of COVID-19 first fell over this country. Folks will remember that there were open questions about whether or not a vaccine would be possible, perhaps for five or 10 years. It is an absolute miracle of science that vaccine solutions were found. I want to thank deeply and profoundly the officials with both PHAC and Health Canada for their incredible work during those incredibly difficult times.
In April of 2020, Canada established a COVID-19 vaccine task force. This was a multidisciplinary team of external experts and industry leaders in the fields of vaccines and immunology. They were tasked with looking at the viable options for a vaccine, and there were seven. Those seven options, based on science and technical ability to produce, were identified for Canada to move forward, to try to ensure that, if they did develop, we would have the opportunity for Canadians to have access.
Advance purchase agreements were entered into. The idea of entering into an advance purchase agreement was to mitigate the risk, to ensure timely delivery and, frankly, to make sure that every Canadian had a dose of the vaccine they needed to save their lives.
By their very nature, they were flexible, and it was also contemplated from day one that not all seven would be successful. Remember, we didn't know which one would be successful. We knew there were seven viable options, but there was no way of knowing which one would manifest as that which would be able to save lives, which was so essential to Canadians.
I think it's important to recognize that this strategy of using advance purchasing agreements.... I'm going to turn to it, because I think it's worth noting. An estimated 800,000 lives in Canada were saved. Some 1.9 million hospitalizations were averted, and 34 million COVID cases were averted. That was, again, all without knowing which solution would provide that answer.
When we take a look at Medicago, which is the one that's before us today and was one of those seven options.... This was Canadian-based, and it shared an exciting, innovative technology that used a plant base for the first time. As you will be aware, most were egg-based. This was the first in the world, an ability.... Of course, we don't know how that might be used in the future. It's a really important innovation that I hope will be able to make a huge difference.
With the Government of Canada's support, Medicago developed a safe and effective vaccine. In fact, on February 24, 2022, it was authorized for use in Canada. Now, if it hadn't been for the fact that there were other vaccines that were approved and in the market—and not, at that point, even on an ancestral strain but actually up to date with what the most current variants were—it could very well have been a world where we needed Medicago.
The reality is that Canada was well under way with an enormously successful vaccination campaign and many other products. As a result, there wasn't a need to proceed with the Medicago vaccine. That, of course, still meant that we had to honour that stab in the dark that we took to try to make sure that one of those seven options was there.
I would say, though—just around transparency, because I know there have been a number of questions in this committee on that—that the Public Health Agency of Canada and Public Services and Procurement Canada have shared all the relevant details of this contract, as with the other advance purchase agreements. They have shared it with the Standing Committee on Public Accounts and with the Auditor General, with appropriate confidentiality provisions in place.
I would also state that, as a final step, the Public Health Agency has publicly disclosed the amount paid as part of the public accounts.
Subsequent to the tabling of the public accounts, the company agreed to further public disclosure of additional details to identify the company and the amount of the non-refundable advance payment as well to confirm that the terms of the payment that had been met and that the contract was terminated by mutual consent.
I would also highlight that the Office of the Auditor General recently finished auditing the financial transactions of the Public Health Agency of Canada for the third fiscal year in a row and has confirmed the accuracy and the reliability of the financial information.
Further, committee members will recall that in December 2022 the Auditor General published an audit of COVID-19 vaccines covering the period of January 1, 2020, to May 31, 2022. This report found that the procurement, authorization, allocation and distribution of vaccines were efficient.
In conclusion, at a moment of great confusion, when we didn't know if any solution would be present, Canada took a bet on seven options, and thank goodness we did. We could never have known which one would work out and, from the beginning, the advance purchase agreements contemplated that not all of them would. Medicago is one that did pan out but it panned out in a time frame where it was rendered not necessary because of the success of the other options.
I want to close by thanking, once again, the incredible officials who have done unbelievable work to ensure that Canada had one of the best COVID-19 responses anywhere in the world, along with one of the lowest death rates that was seen anywhere in the world.
With that, Mr. Chair, it would be my pleasure to take questions.
:
Thank you very much, Mr. Chair.
Mr. Minister, Dr. Lourenco, Ms. Jeffrey, and Dr. Sheppard, thank you for being here.
The $150 million, which was recorded in the losses in the Public Accounts of Canada, is a payment made for the receipt of vaccines ordered by Canada. We agree on that. These are vaccines that would have been approved in the United States and were also approved in Canada. However, the World Health Organization decided not to include them in the possible solutions, because one of the minority shareholders was a tobacco company.
Canada signed on to the Framework Convention on Tobacco Control in 2005. Earlier, you told us that we could not guess what the World Health Organization would do. In fact, it was clear that the WHO would reject the vaccine if there were alternatives. However, if this vaccine had been the only one available, it can be argued that the WHO would have accepted it.
Before the WHO made its decision, did you look into the possibility of Mitsubishi Tanabe Pharma getting rid of the Philip Morris shareholder before the WHO approved the vaccine? Was that one of the requirements you would have asked Medicago for?
:
Thank you very much for the question. Allow me to answer in English, because it's easier for me when it comes to technical questions.
[English]
First of all, regarding the question of whether or not it was predictable who would reject it, there are two things I would say in response.
Number one, Canada had the sole ability to be able to approve this vaccine. When it was approved in February 2022, that would have allowed for its use in Canada. The decision made by WHO would not have affected that.
Number two, I reject in its entirety the idea that WHO took its position...or that it affected our position. Those are two separate things. With regard to the decision at WHO at that point in time, not only were the other vaccines available, those vaccines were actually for the current variants, as opposed to the ancestral strain. WHO was making its decision at a time when all of the other options were available in the world.
I would posit to you that WHO would have made a very different decision if Medicago had the only viable vaccines. It had to do with the competitiveness of the other options, as opposed to the fact that the minority position existed in Medicago from Philip Morris.
:
I think there are two important things.
Again, at the time the WHO made its decision, first of all, that was independent of the decision that would happen in Canada. The vaccine that was developed by Medicago, if it were first out of the gate, would have been the one that Canada was using.
Second, with respect to rejecting the shareholders, they were doing that because at that moment in time there was a bevy of other options that were not on the ancestral strain but in fact on the most current strain.
On the last point you made about divestment of Philip Morris, Philip Morris has completely divested itself. It had a minority position in Medicago and it no longer has a position in Medicago, so I suppose it's an academic exercise.
:
That seems fair from the Canadian government's point of view, but here's what actually happened.
In March 2022, the WTO decided not to accept Covifenz for emergency use because of Medicago's ties to the tobacco industry. They came to a different conclusion than the Government of Canada would have.
Here's the thing. The reason that Covifenz was not proceeded with was not because the Government of Canada decided not to.
A February 2023 Mitsubishi Chemical Group Corporation news release said, “after a comprehensive review of the current global demand and market environment for COVID-19 vaccines and Medicago’s challenges in transitioning to commercial-scale production, the Group has determined that it will not pursue the commercialization of COVIFENZ.”
Isn't it true, Minister, that the reason Medicago didn't proceed was because it was not commercially viable for them to produce this vaccine if they couldn't sell it to the world? They certainly wouldn't have proceeded with full commercialization if only Canada was going to proceed with it.
Isn't that right?
Good morning, Mr. Minister. Good morning, Dr. Sheppard, Dr. Lourenco and Ms. Jeffrey.
Mr. Minister, when the agreements were signed with the seven companies, you knew there was a problem. When the Medicago vaccine was authorized, and the WHO rejected it, we asked questions, but everyone was dodging, and no one wanted to answer.
We now know that the government was fully aware that there was a problem because it had signed the Framework Convention on Tobacco Control on February 27, 2005. Last week, officials from Public Works and Government Services Canada confirmed that. The director general and the deputy director general confirmed that the government knew there was a problem. Today, we learned that we are losing $323 million and that the government has taken a risk.
Are you prepared to admit today that this risk was known and that you went ahead anyway?
:
I call the meeting back to order.
Pursuant to Standing Order 108(2) and the motion adopted on May 16, 2022, the committee is now going to resume its study of women's health.
As we have some remote participants, I'd offer the following comments for their benefit.
You have at the bottom of your screen interpretation available to you. There are three channels: floor, English and French. Please don't take screenshots or photos of your screen.
I would like to welcome our panel of witnesses. Appearing today as an individual, we have Dr. Steven Narod, senior scientist.
[Translation]
We also have Jacques Simard, who is a full professor in the department of molecular medicine at Université Laval.
[English]
We also have with us Dr. Anna Wilkinson, doctor of medicine. Representing Dense Breasts Canada, we have Jennie Dale, co-founder and executive director, and Dr. Paula Gordon, both appearing by video conference.
Thanks to all of you for being here with us today. You each have five minutes for your opening statements.
We're going to begin with Dr. Narod.
You have the floor. Welcome.
I'm a professor at the Dalla Lana school of public health at the University of Toronto, and I'm grateful to the federal government. I hold the Canada research chair in breast cancer, which I've held for the past 21 years. I've been a professor at Women's College Hospital and, for 25 years, have focused almost entirely on breast cancer.
One of my topics of interest is early detection and screening. In 2014, I published what was considered kind of a landmark paper. I was the senior author responsible for the statistical analysis and the write-up of the Canadian national breast cancer screening study, which was a study of mammography.
In that study, which started in 1983, we took 90,000 women across Canada and randomized half of them—by chance, randomly—to a mammography every five years. The other 50% received a physical examination. We followed them for 25 years, and I published in 2014 with my mentor, Dr. Tony Miller. After the 25 years of follow-up, we saw almost exactly the same number of deaths from breast cancer in those women who received five mammograms—500—as in those who received no mammogram—505.
That led me to the conclusion that mammography was capable of early detection. The mammographically detected cancers were smaller. They were less likely to be node-positive cancers. Also, the survival of the women with the mammogram-detected cancer was much better, but unfortunately it didn't result in any reduction in the number of deaths.
In fact, there were 177 women who had their nonpalpable breast cancer detected by the mammogram—they found the breast cancer by the mammogram—who were alive at the 30-year mark. I believe that 177 of those women thought the mammogram had saved their lives and would testify to it and do a testimonial saying, “We really believe in mammograms. I had a mammogram and it caught my breast cancer before it was palpable, before you could feel it as a mass.” However, the number of deaths was the same.
The study has been criticized. To a large extent, people criticize that which they don't like. I've written hundreds and hundreds of papers—730 papers on breast cancer—and that was probably the one that had the most response to it, I think largely because we showed that we didn't believe mammography was capable of reducing mortality from breast cancer. A lot of allegations were made against the paper, generally in the lay press.
Anyway, I took the allegations seriously, went back to the data, reviewed all the data as to whether the allegations were consistent with the findings and came to the conclusion that they were not. I hold the paper to be the standard of scientific research. I think it remains the best breast cancer screening study done, and I think the results are valid.
I could go on, but is that my five minutes?
I would like to thank the committee for this opportunity to expose some of our work.
For 21 years I have been the holder of a Canada research chair in cancer genetics. I'm also a fellow of the Royal Society of Canada.
A screening program will be sustainable if it delivers more benefit than harm, demonstrates value for money, is feasible to implement, is accepted by both the users and the providers and ensures equitable accessibility.
Currently, breast screening programs determine eligibility based on age, primarily targeting women aged 50 to 74 years of age with mammograms every two years. However, the risk of developing breast cancer varies a lot among women. There are no national guidelines for screening individuals deemed high risk. Screening protocols vary across jurisdictions, and the definition of high risk of developing breast cancer also varies across Canada.
Typically, women are identified as high risk based on a family history of breast cancer followed by testing for BRCA1 and BRCA2 gene mutations. This identification process is often initiated ad hoc by the affected individual and their care provider rather than through systemic population-based identification strategies. This approach overlooks women without a known family history but with a significant genetic predisposition and women at high risk due to the combination of other risk factors like polygenic risk, lifestyle and hormonal factors and mammographic breast density.
Polygenic risk scores represent the combined effect of multiple genetic variants on cancer risk identified through genome-wide association studies—called the genomic approach—and provide a powerful risk prediction approach with the potential to identify many more individuals at high or low cancer risk than is possible by screening based on age alone. In this regard, comprehensive risk prediction tools, including both genetic and non-genetic risk factors, have shown promise in providing personalized risk prediction and informing cancer-screening strategies.
A risk-stratified program involves assessing the risk of breast cancer for each woman in the population, stratifying the population into several risk groups, assigning individuals to their respective risk groups and tailoring the screening strategy to each risk group. This approach may result in some women starting mammographic screening at a younger age, having different screening intervals or having supplemental screening with another imaging modality such as MRI. Additionally, women deemed to be at the highest risk of breast cancer could be offered prophylactic preventative treatment.
Evidence from simulation studies so far shows that risk-stratified screening allows for better trade-offs between benefits and harms. By focusing more intensive screening efforts on high-risk individuals, it is possible to detect cancers earlier in this group while reducing unnecessary screening of low-risk populations. This targeted approach would potentially lead to earlier detection and improved outcomes and reduce overdiagnosis and overtreatment. Also, these studies have shown that risk-stratified screening programs are more cost-effective than the current age-based screening, allowing more efficient use of resources within health care systems.
For 25 years I've been the principal investigator of an international interdisciplinary team. Our last large-scale project was called “Personalized Risk Assessment for Prevention and Early Detection of Breast Cancer: Integration and Implementation”, which is the first study that will provide real-world evidence on the optimal implementation of approaches within the Canadian health care system. The Perspective I and I study leverages resources available through the existing screening program, including infrastructure, data collection, methods and analytical tools. This will enable seamless integration into the existing health care infrastructure and facilitate adoption into clinical practice.
Our project will inform collection of saliva sample and questionnaire-based risk information at the population level, risk communication preferences, psychological and emotional outcomes following communication of breast cancer risk information, adherence to the risk-based recommendations of screening, outcomes of screening—cancer detection rates, false positive rates, stage of diagnosis—using multifactorial risk levels and also the relative contribution of self-reported risk factors, mammographic density and the polygenic risk score to breast cancer risk level estimates by the comprehensive CanRisk prediction tool.
This assessment is to strike a balance between the accuracy of risk assessment and the practicality of collecting this information at the population level.
Identifying screening protocols will optimize the cost-effectiveness and a benefit-harm balance of a risk-stratified screening program. We're also looking for a strategy to increase the health care organizational readiness to implement a risk-based breast screening program.
So far, we have learned that it's feasible to collect samples and data for risk estimation. More than 4,000 women participated in Ontario and Quebec in this real-world implementation study. Risk-based screening is acceptable to the woman and to the health care provider. Using multifactorial risk levels compared to age, family history or breast density alone may provide more appropriate recommendations by reducing over-screening in those at average risk and increasing screening for those at higher risk.
Thank you for your time.
Thank you to this committee for your important work, especially today, on the National Day of Remembrance and Action on Violence Against Women.
Very few people see the impact of breast cancer screening guidelines the way I do. I am a family doctor. I train future family doctors, and I am a GP oncologist, working on the cancer wards caring for patients who are too sick to be at home. I am also a researcher. I work with Statistics Canada to understand the impacts of Canadian guidelines on breast cancer outcomes. I became a researcher almost accidentally. I could not understand why, as a family doctor, I was told not to screen women in their forties, but as a GP oncologist I was seeing so many women in their forties and early fifties dying of cancer.
If you walk a day my shoes, you will see what it's like to have to tell a woman in her forties that she has incurable cancer. I talk with these women and their families. I sit with them. I walk them through the transition to palliative care. It's not something I forget. These women stay with me, as do their children and spouses who have journeyed alongside them.
The Canadian Task Force on Preventive Health Care determines the recommendations for screening in Canada. In 2011 the task force recommended against screening women in their forties. However, some provinces continued organizing screening programs and some did not, creating a natural experiment in our country. Together with Statistics Canada, Dr. Seely and I used these differences in provincial screening practices to perform an audit of the impact of the task force guidelines.
We reviewed more than 55,000 breast cancer cases over seven years. We found that the proportion of incurable or metastatic breast cancer increased by 10% in women in both their forties and fifties after the guidelines changed in 2011. When we compared jurisdictions that screened with those that did not, we found that women in their forties had significantly more advanced cancers and significantly lower survival than if there was no screening. We also saw a knock-on effect where women in their fifties had significantly more advanced cancers if they weren't screened in their forties. We saw an overall significant increase in the total number of breast cancer cases being diagnosed in women in their fifties if they weren't screened in their forties.
I've also investigated the cost of breast cancer treatment. The cost of treating just one case of metastatic breast cancer is half a million dollars. Compare that with $68 for a mammogram.
Working with Statistics Canada, we found that non-white women—Black, indigenous, Chinese, South Asian and Filipina—have a peak age of breast cancer diagnosis in their forties, while white women have a peak age in their sixties. This means that the majority of breast cancer cases in non-white women are diagnosed before screening even starts. Finally, we found that the incidence of breast cancer has increased rapidly in younger women over the last few years.
Currently, I am an expert for the evidence review team in the guideline update process. Our team creates the evidence base from which the task force makes their guidelines. We experts have recommended against using 40-year-old to 60-year-old trials, which were performed in primarily white populations with primitive and now obsolete technologies. This aligns with what the U.S. task force did for their new guidelines.
However, the Canadian task force dictated the inclusion of these outdated trials, thereby ensuring that the guidelines would not change. We wrote to to demand that the evidence base be established independently. I remain skeptical that the new guidelines will change, as I feel that this is a flawed process, with co-chairs who publicly state their bias against screening, place an overemphasis on harms and have limited openness to adjusting methodologies to embrace modern data.
The U.S. and many of our provinces have recommended that women 40 to 49 be screened. However, family doctors deeply respect the task force guidelines and follow their edicts, even if they are contrary to what the patient in front of them wants. Until the task force recommends screening women in their forties, most family doctors in Canada will not advise their patients to be screened, even if there is a provincial screening program.
My asks of the committee are as follows.
Ensure that the task force process is transparent and uses inclusive, modern evidence. We cannot be basing our 2023 recommendations on trials from 1963.
Ensure that experts can vote and that there is oversight so that individual biases cannot drive the outcome of the process.
As well, in the longer term, develop a guideline process that is responsive to new evidence, with scheduled frequent reviews and a mechanism to evaluate the effectiveness of guidelines once they are in place.
Thank you.
I am Dr. Paula Gordon, and I'll start.
Thank you for the opportunity to be here today.
I am a breast radiologist. I've been in practice for over 40 years, reading mammograms and ultrasounds, and doing needle biopsies and other breast procedures. I've volunteered with Jennie Dale and Dense Breasts Canada for seven years as their medical adviser, advocating for optimal breast cancer screening.
Breast cancer is common. One in eight Canadian women will be diagnosed with breast cancer during her lifetime. Mammograms are low-dose X-rays of the breasts that allow us to detect cancers earlier, before there are symptoms. Breast cancer treatments are less intensive and outcomes are better, when cancers are diagnosed at an early stage. The five-year survival rate for stage 1 breast cancer is 99%, but it's only 22% for stage 4.
Some breasts have more normal glandular tissue than fat, and we call these “dense breasts”. These people have a higher risk of getting cancer, and mammograms are less effective at finding their cancers. They benefit from supplemental imaging, typically with ultrasound or MRI, based on the patient's risk.
The current task force guidelines recommend against screening women younger than 50 and older than 74, against additional screening for people with dense breasts, and against doing breast self-exams. Experts disagree with these guidelines, which were created using a flawed process. The same process has impaired other guidelines on women's health. The Canadian task force is an arm's-length body with no accountability and no requirement to monitor the impact of their guidelines.
In the past, the task force has intentionally excluded subject matter experts from their guideline panels. Without expert input, the task force based recommendations on decades-old trials that included, almost exclusively, white women, so they discriminate against racialized women. The guidelines discriminate against women with dense breasts and against women older than 74, who have the highest mortality from breast cancer. The guidelines have led to inequity of access among provinces. A Canadian woman's access to early detection of breast cancer should not depend on where she lives.
The panel for the 2024 update includes family doctors, a nurse practitioner, a gastroenterologist and a kidney specialist. For the first time, four experts are included; however, the task force methods manual states, “Clinical and content experts do not provide input or vote on the direction or strength of recommendations”.
To ensure Canadian women have access to equitable and optimal breast screening, we ask that the guideline process be reformed to ensure appropriate oversight, use of current research and meaningful input from experts.
Jennie.
:
I am Jennie Dale. I am a breast cancer patient. In 2016, I co-founded Dense Breasts Canada, a non-profit that raises awareness and advocates for optimal breast cancer screening. I've spoken with hundreds of breast cancer patients across Canada, and it's an honour to be here tonight to represent them.
I could spend hours telling you about the damage the current breast screening guidelines are doing. I could tell you about Jennifer and Carolyn, who are in the committee room tonight. Both were diagnosed with later-stage breast cancer after not being given access to screening in their forties because of the current guidelines. Instead of lumpectomy and radiation, they were subjected to aggressive treatment—mastectomy, chemotherapy and lymph node dissection. I could tell you how they both missed critical years of work, how their families worried they would lose them and how they worry now about metastases. I could tell you they live with lingering pain and debilitating side effects, and I could tell you that the task force members who created these guidelines believe all of these are acceptable costs for Jennifer and Carolyn to pay in the name of not screening.
I could also tell you that, if Jennifer and Carolyn lived in B.C., Nova Scotia, P.E.I. or the Yukon, they could have self-referred for mammograms in their forties and been spared much of what they've gone through. I could tell you that, even though current research shows clear benefits to early detection, members of the task force don't believe that earlier screening results in better outcomes for enough women. Instead, they cling to the flawed findings of 40- to 60-year-old studies—like the CNBSS—that have now been discredited.
I could tell you more, but the one message I want to leave with you is that the current guidelines are harming Canadians and causing avoidable deaths. The very guidelines that everyone would expect to protect Canadians are doing the opposite. The task force is denying us the opportunity to access preventive health care that results in better outcomes. Their overstatement of harms and understatement of benefits are not based on modern science. Their paternalistic concern about anxiety caused by screening is not borne out by patients' lived experiences. Their insistence on shared decision-making perpetuates power imbalances between doctor and patient. Finally, their dismissal of the impact of the guidelines on patients' quality of life is reductive at best and callous at worst.
Please bring Canada into the modern era by using relevant, current and inclusive evidence. Don't allow a group of biased non-subject matter experts to continue to destroy Canadians' lives by denying us health care.
Thank you.
:
What you're referring to are the inequities that we are seeing. These inequities are driven by these guidelines. The inequities that are created by the task force guidelines happen on so many levels.
They happen on a provincial level because they create differences in provinces. Some provinces have the resources to create their own programs and some don't. They create inequities in patient levels, because when the task force says, “Don't screen”, family doctors really listen. The College of Family Physicians really pushes that mandate. Patients really have to know to advocate for themselves.
Having these national guidelines really drives inequity among individuals, particularly individuals who are marginalized; who are Black, who have worse outcomes with breast cancer; and who have lower socio-economic status—which we see with lung cancer, because these guidelines also refer to many different areas of preventative care, including lung cancer screening.
What would I like to see? Although health care is a provincial matter, these national guidelines really drive what the provinces do. Until we have a clear and transparent mechanism for creating guidelines that include modern, relevant evidence, we're going to continue, as a country, to be behind the eight ball, dragged back to really old data and not moving forward in an innovative fashion.
:
Thanks very much to everyone.
I just have to say that, in a study on women's health, I hope that we will be able to move more broadly in terms of the social determinants but also in terms of women's responsibility as the health care provider for their families and the fact that we actually do need, I think, to look at the big picture.
I'd like to ask a question of Dr. Narod from Women's College. One of the things, I think, in women's health research is listening to women about what's worrying them. At the beginning, I think it was women worrying that their sisters or their nieces or their daughters were going to get breast cancer, and I think that obviously the discovery of the BRCA gene has been very important.
I would like you to tell us what you think the future would be in terms of cancer genetics and prevention, testing versus screening and how that could eventually move to treatment with precision medicine.
:
Yes, that's a pretty good question.
I've been working on prevention. I've been working on screening. I've been working on treatment over the last 25 years. I was co-discoverer of BRCA1 and BRCA2. I've spent a lot of time thinking.
In 1991, when we did the first paper in The Lancet on BRCA1, I thought that, by the time we got to 2023, we'd have something better to offer than removing the breasts. So far, we don't. We just published a paper that using tamoxifen in several thousand women with BRCA1 mutations reduced the risk by about 20%. It's not really good enough.
I could talk all day about prevention. I'm not one who would think that we can tackle the breast cancer problem to a large extent in Canada by current preventive means. We recommend against alcohol. We recommend against obesity—weight loss, etc. Interestingly, for women under 40, being overweight is protective. No one ever talks about that, but it's very strongly protective.
Having worked in all three areas for 30 years, I would emphasize treatment. I think so. I mean, it's a matter of funding.
In terms of prevention, we have an idea of how we think we can do it, but it hasn't received funding yet.
I think a lot of the points made by the other speakers are valid. I do say though that, in our study, the end point was death. There were 500 deaths in one group and 505 deaths in the other group. I applaud Dr. Simard for his effort in trying to change it, but his study doesn't have death as the end point. None of the other studies have death as the end point.
You show me, Dr. Simard, that your program reduces the number of deaths, and I will be a convert to your program.
Interestingly though, Dr. Simard—I've been friends with him forever—is recommending a risk-based study rather than an age-based study. It's really interesting. Currently, the age base is 50 to 70. If we reduce the age base to 40 rather than 50, the genetic risk scores probably go out the window because, even for those people with a high risk score, the recommendation would be to start screening at 40 rather than 50.
Now, I heard all these things about outdated data for the national breast cancer.... Yes, it's outdated, but there are still 170 women who had breast cancer identified and are still alive. It doesn't mean.... You show me the current data. In my understanding, and having read every paper about it, I don't see any current data that supports using mammography to the extent to which the panel thinks it does.
One can talk anecdotally about this and that. The only other study that is always neglected to be mentioned is a U.K. age study done by Stephen Duffy and colleagues, published in 2022. It showed that, in randomized screening in the U.K., when women started at age 40 versus age 50—and we followed them until death or to age 60—it made no difference to the mortality rate, but you will never see that paper cited.
That paper was was written in 2020, and I've been communicating with Dr. Duffy. He actually gave me the information. You will never see the U.K. age study that actually showed that screening from age 40 was exactly the same outcome as screening from age 50.
It's very interesting to hear what our witnesses are telling us this evening as part of this study. I think many of us have known people who have had breast cancer. I would like to take a moment to remember Nathalie, a friend who was diagnosed with breast cancer several years ago. She was in her late forties, and she passed away a few years later, just in her early fifties.
This cancer affects far too many women and takes them away from us far too soon. This brings me to the whole issue of screening and treatment.
Dr. Narod, you mentioned a study in Great Britain. That's interesting. A lot of questions have been asked by my colleagues about age and national guidelines, but what's happening internationally?
Mr. Simard, you are part of an international research group, so I invite you to comment on that as well. What could we learn from the work being done internationally?
Dr. Gordon, in your brief, you talk about statistics and data from other countries. What can these studies that are done elsewhere bring us here?
:
I'm fortunate to be part of an international consortium that studies data from 400,000 women in more than 35 countries on six continents. Thanks to these participants, we have been able to develop new tools to evaluate something called polygenic risk, which has been validated in more than a dozen prospective studies.
It should be noted that approximately one woman in 200 or 300 carries a mutation of a rare predisposition gene. So it's quite rare. We also studied the frequency of mutations in the BRCA1 and BRCA2 genes, which I was involved in discovering, in certain ethnic groups.
What we're proposing is the use of about 300 markers that are very frequent. By combining this signature with other risk factors, such as breast density, certain lifestyle patterns, and hormone factors, we could assess personal risk and stratify it into three groups.
For example, we followed 4,000 women in our study. Of these, 80% were at or near the same risk as the general population, 15% were at intermediate risk, meaning that they would have to start doing an annual mammogram at age 40, and 5% were at high risk. In their case, they should start doing an annual mammogram immediately, in addition to using magnetic resonance imaging, because there is indeed more than just mammograms. You know the statistics better than I do, but we know that 17% of all breast cancer diagnoses are made before the age of 50, so it's very important to take action.
Internationally, we are also working on risk prediction models or tools, such as genomic signatures, that are specific to various ethnic groups, such as Asians and Hispanics. It's very important.
I'd like the committee to know how futuristic and wonderful Dr. Simard's work is, but it is futuristic. Certainly, Dr. Narod's discovery of the breast cancer gene was pivotal, but we're dealing with guidelines now that deal with average-risk women. Only 5% of women are high risk, and the vast majority of women who get breast cancer have no risk factors, not even a mother with breast cancer. In fact, having dense breasts is the most prevalent risk factor.
What the committee should understand—and I'm sorry to hear that Dr. Narod does not know this—is that the study with which Dr. Narod was associated, the Canadian national breast screening study, has been discredited. Although it was supposed to be a randomized trial, the randomization was flawed—corrupt you could say—and that explains why that study was the only randomized trial among eight others that did not show mortality reduction. We know why that study didn't show reduced deaths among women in the mammogram group.
For average-risk women, they should have a risk assessment. Right now, not all women can have the polygenic risk score that Dr. Simard spoke so well about, but women should be assessed for their risk. There are online risk tools that are free and easy to use, and average-risk women should start at age 40. If a women is shown to be at increased risk or at very high risk, she might start sooner, but otherwise, it should start at age 40 and, ideally, be annual because when women are premenopausal, the hormones made by their ovaries cause their breast cancers to grow faster.
That's why we must start screening women, especially Black, Asian and Hispanic women.... Indigenous women, in fact, have the same analogous inequities that we see for Black American women. They tend to get more aggressive cancers, and they're more likely to die from their cancers. Those inequities have to be addressed.
The other big inequity is for women with dense breasts. Now, that's something that no one can control. You can't control your breast density, yet women with dense breasts are more likely to get cancer, and we have a harder time seeing those cancers on their mammograms. We know that we can find them. We can find them with ultrasounds. If they're really high risk, we can find them with MRIs, but of course, MRIs are much more expensive and less accessible. It's not their fault that they have dense breasts. They deserve the same opportunity for early detection as women with non-dense breasts.
:
As you heard from Dr. Wilkinson, the Canadian task force procedures, to this point, have focused on rating the quality of evidence, if you will, and randomized control trials are always ranked the highest. The problem is that the randomized trials were all done between the 1960s and the 1980s, at a time when mammograms where done on X-ray film that you put on the light box. They are now done digitally, and we look at the images on a computer screen. They're much more accurate. We can use software, in fact, to help us decide whether a woman has dense breasts or not.
The old trials were done, as you heard, in white populations, so the guidelines discriminate against racialized women. Now, some people say, “Why don't you just do another randomized trial?” Because those old trials, even the flawed trials, prove that mammograms save lives, it would be unethical to repeat them and expect women to go in a control group that is not having any screening.
The newer observational studies.... The one this committee needs to hear about is one called the pan-Canadian study. It was published in 2014 and ignored by our task force. It looked at 2.8 million women having screening mammograms in our provincial screening programs, and it showed that, overall, women who have mammograms are 40% less likely to die than women who don't. It's even better for women in their forties; they're 44% less likely to die. However, the task force continues to use this old data, claiming that the randomized trials trump this new, modern observational data.
We have a natural experiment in the country, which you heard about from Dr. Wilkinson. Women who live in provinces that start screening at 40 are more likely to be diagnosed with early-stage breast cancer than women who live in provinces that start at age 50, and they have better survival. In provinces that don't screen until 50, the women in their forties are diagnosed more often with late-stage cancers than women in their fifties in the same province.
This is the outcome, and our task force has never audited the outcome of the current guidelines. The current guidelines are from 2018, but they are essentially unchanged since 2011. Dr. Wilkinson and colleagues, with Statistics Canada, were able to show the damage done by those guidelines. However, from what we can see, the current review under way is likely to come up with a recommendation for no change in those guidelines.
I want to state a quote I found at the Public Health Agency of Canada. The “breast cancer death rate peaked in 1986 and has [declined] since.” However, there has been a reduction in death rates due to “the impact of screening and improvements in treatment for breast cancer”. That's according to the Public Health Agency of Canada.
My question is going to be for you, Dr. Anna. I love your name.
You have been a supporter of organized screening for women under the age of 50. You have noted that, “There is a significant increase in survival for women if they live in a province with an organized screening program with self-referral and annual recall for women in their 40s”. You also mention that 16% of breast cancer occurs in women between 40 and 50 years of age.
Can you please help us understand the importance of screening? I know that you're an advocate of it. I really appreciate that as a woman, because I think we need to make sure that women deserve to live and deserve to have the screening. Without us, they wouldn't be here. Let's be honest.
I really love what you're saying and I love what Dr. Gordon is saying. I think you guys are on the same path. Could you please elaborate on why we can save more women if we implement more screening at an earlier age?
:
What screening does is it diagnoses cancers earlier. Screen-detected cancers are often only four millimetres wide. They're cancers that are detected before you can feel them. Smaller cancers, by definition, are at an earlier stage. Earlier-stage cancers, by definition, have better outcomes and less-intensive treatments.
In terms of why you should have an organized program, if that screening happens within an organized program, that means that a woman can self-refer. This is key in this day and age, where a lot of women do not have access to a family doctor or where a family doctor may be a barrier to screening. The family doctor is hearing that the task force says, “Don't screen.” The woman comes and says, “Can I be screened?” and the doctor says, “You don't need to be.”
Women in organized programs get recalls. We're all busy. Life gets a hold of you. The program sends you a letter and says to remember to come for your mammogram this year.
There are quality controls within organized screening programs as well. There are metrics that are followed in terms of the quality of mammograms, reading, follow-up and all of those issues. That's why organized programs are so key. With our current national guidelines, there are no organized programs for women in their forties across the country. It is completely dependent on the province you live in.
First of all, even the term “false positive” is pejorative. It's really fearmongering, because we're not telling women they have cancer when they don't. What they use the term “false positive” to mean is a false alarm, where something showed up on your mammogram and at the end of the day it's probably not going to be cancer, but it deserves another look. For women who have anything that's out of place or that needs more testing—sometimes it's just another couple of mammogram pictures—they are recalled.
That's what it should be: a recall or a false alarm. With the majority of women, we can sort it out with ultrasounds or mammograms. If you take the real numbers in this country, out of every thousand women who are screened, 70 will be recalled, and of those 70, 11 of them—so now we're talking about 11 out of the thousand—will be told that they should have a needle biopsy.
I must tell you that a needle biopsy is done with adequate local freezing, and most women say it's no more uncomfortable than a blood test from the arm. I know that no one believes me when I say that, but the best comment I ever heard from a patient was, “Dr. Gordon, I have shoes that are more uncomfortable than this test.”
In any case, out of the 11 who have a needle biopsy, four of them are told that they have cancer. For the 11 women going through this test, the task force calls them “unnecessary” tests. Well, it's not an unnecessary test until you find the answer. Most women would rather go through something relatively painless to be more sure that they don't have cancer.
That's the false alarm story.
Overdiagnosis is a little tougher to explain. Overdiagnosis is when we find a cancer and it's a real cancer, but that cancer would not have killed the patient had it been left untreated. The typical scenario is that, if we're dealing with an elderly woman and we find a small cancer, it may not be problematic for five or 10 years, but she's also got lung cancer because she's older and she's at higher risk for lung cancer. That lung cancer is going to kill her before her breast cancer would.
Here's another example. A woman gets diagnosed with cancer, she gets treated, she finishes all her treatment and two weeks later she gets hit by a car and dies. That's actually overdiagnosis, because that cancer wasn't going to kill her, but unless you have a crystal ball and you know that you're not going to have a fatal heart attack or be hit by a car, every woman with a new diagnosis of cancer is offered treatment.
It's estimating overdiagnosis that's tricky. The task force used an estimate of 48%. They said that almost half of cancers are overdiagnosed, meaning that they shouldn't have been found or treated. That's because they got that data from that flawed Canadian trial that we heard about from Dr. Narod, and that's why there was no difference in the death rate and all their stats are off. International experts believe that overdiagnosis occurs in about 1% to 10% of women, and probably at the lower end of that range. Now remember that these are real cancers. It's just a question of whether that cancer is going to kill the woman.
Most importantly, our task force is using overdiagnosis as a reason to not screen women in their forties. Women in their forties are much less likely to have a competing cause of death and overdiagnosis in that age group is negligible, so it's absolutely not a reason to not screen women. When it comes to false alarms, we should not only be telling women about overdiagnosis and false alarms but also letting them know there's a possibility that they'll be recalled and mostly it turns out to be nothing.
It's condescending for the task force to decide on behalf of women that they're too fragile to handle a little transient anxiety. Women should be able to decide for themselves. If they say, “No, it would ruin my life and I'd rather risk getting cancer”, that's a woman's choice. Most women, when they understand the principles of overdiagnosis and false alarms, would like to be screened.
:
I can only elaborate on what I've experienced. Certainly, I've not seen transparency to date.
Our recommendation was to not use old data as the expert. However, during the time that we were trying to establish the evidence base, it seems that the working group was already working on evidence—although I don't know where it came from, since we had not completed our review. When we went to finalize things and there was all of the old data included in the evidence, we were told this was because the task force had demanded that this evidence be included.
I asked where the overdiagnosis number was coming from, because this is a key number. If you say, as we said earlier, that the overdiagnosis rate is 50%, what that means is that, if you're using an old trial with the benefit of 15% and you say that 50% of those don't matter, then you're down to 7%. If you take the newer trials at 40% benefit and you say there's zero overdiagnosis, then you have a 40% benefit. The evidence review panel did not know where that number came from. That is not a number that they were supplying to the task force working group.
I want to thank all of you for being here, and the people in the audience as well. I commend them for being here.
Part of my discussion and my concern is that there are people watching. There are women watching this conversation, and they are concerned. They are very concerned about what's going on, about themselves and about the future for women in this country. It's great to hear many different aspects of this. I recognize the challenges we've had. I've been all over the map with questions I want to ask.
Ultimately, I recognize the challenges we have in doing RCTs in this subject area and the potential that could be there in someone designing that. Dr. Wilkinson, your comments about working with patients, I think, are tremendous, and dealing with women and understanding that.
In my years of practice.... I'm from a rural part of Canada, where I had many women come to me with signs and symptoms that were outside my scope of practice. They came to me because they realized that I would at least refer them to where I felt it was appropriate, to at least be assessed. My home is 14 miles from North Dakota. In North Dakota, they basically have 18-wheelers with mammography units, and they travel all over the state to do testing.
When I see recommendations from the U.S., where they recommend biannual testing for women between 40 and 74, I see that as a concern as to the research and the science they would have used to get that.
Dr. Wilkinson, what are your thoughts on that? If they had some research to support that, why don't we?
:
That is what we're saying. In fact, there were 28 former staff who came forward with evidence of protocol deviations. That's what they're called. That wasn't the only problem with the Canadian trial. In fact, they allowed women to be participants even if they had a known breast lump. Screening is for women with no lumps.
First of all, they allowed these women to participate. They were having trouble recruiting enough women for the study, and they actually approached breast surgeons to send patients to be in the study. The reason a woman goes to a breast surgeon is that she has a lump or a symptom.
First of all, they allowed these women to participate. What was supposed to happen was that every woman who came to participate—they were volunteers—got a clinical breast exam by a highly trained nurse, and then they would go to the coordinator, who would decide to put her in either the study group, where they got a mammogram, or the control group, where they didn't.
Nowadays, when we do these studies, the randomization is done by a central office, by a computer. In those days, the coordinators had a piece of paper in front of them with lines. The lines would say, “mammogram, control, mammogram, mammogram, mammogram, control, control”, and at the end of the sheet, you'd have an equal number of women in both arms.
What we know happened, because witnesses came forward and told us—and these are in three peer-reviewed published papers, by the way—is that the nurses would say, “This lady has to be in the mammogram group,” so the coordinator could write her name on the next available mammogram line, and then other women who came in later in the day could go in any blank lines that she had left. They didn't even have to make any erasures.
This was actually picked up in 1992, which was the first publication of the Canadian national breast screening study, because there was a significant imbalance of advanced cancers. In the very first year of the study, there were 25 advanced cancers, which they defined as a cancer with more positive lymph nodes in the armpit. There were 19 of them in the mammogram group and only five in the control group.
This was raised decades ago, and the principal investigators at the trial have denied it to this day. They claim that there was nothing wrong with the randomization. There was even a forensic—
:
This is my study. The data is on my computer.
Dr. Gordon and others made a claim of scientific misconduct at the University of Toronto last year, at which point I prepared a report on exactly what she's claiming. That report was submitted to the dean of public health sciences and was submitted to an international committee that reviewed the study and came out entirely on my side.
Let me tell you a couple facts. In the first round of screening, there were 270 palpable cancers on the mammography side, and 274 palpable cancers in the control group. If we had shunted women to the mammogram group who had a palpable cancer, that number would be different. There were 270 in the mammogram group, and 274 in the non-mammogram group.
Second, I removed all those women from the first round. I removed all the women with a palpable cancer from the analysis and reran it. The hazard ratio is 1.01.
Third, if what they are saying is true, then death from the cancer excessive in the mammogram group should have occurred in the first five years. This is a 30-year study. When I looked at the annual rates of mortality in the 30 years of follow-up, there was no difference in year one, year two, year three, year four and year five.
What Dr. Gordon is alleging is that I should see an excess of breast cancer deaths from the people who had prevalent breast cancer in the first round of screening, at which point we should see a high rate in the first group.
If I remove all the palpable cancers, which you can do, then I can get a hazard ratio of one. Second, the concept of a palpable cancer being excluded is ridiculous. Let's put it this way. In the studies that Dr. Gordon claims are the ones that provide evidence in favour of mammography was a Swedish two-county study. That was a study where the randomization was in 16 blocks of counties in Gothenburg and Östergötland, Sweden.
What did they do? The invited half the women to have a mammogram, and they didn't invite the others. They were just followed. Following the cancer rates—
In the Swedish trial, they invited women to come for a mammogram, and half the women were not invited.
How do you know that they didn't have a palpable cancer? The ones who came they could have excluded with a palpable cancer, but the controls were never examined. They don't know if they had a palpable cancer or no cancer. That trial, the Swedish trial, is considered the gold standard. I have reviewed it very closely and found many things that I consider to be inadequate.
Dr. Gordon claims that there are eight trials, of which only the Canadian trial is an outlier. I would love to see the other seven. The only two I know of are the Swedish trials. I would love to see the references to the other six trials that I'm not aware of. I'm only aware of the U.K. age trial, which showed no effect.
I'm aware of the HIP trial, which showed no effect after 15 years of follow-up, and the Edinburgh trial.
To come to this committee and say that there are eight trials that show an effect for randomized trials and one that doesn't is something that.... If I were on this committee, I wouldn't wish to have that evidence.
Trust me—it's not there. There are not eight trials that show a benefit. If there are, I'll be very willing to apologize to Dr. Gordon and the others.
:
Dr. Gordon, if you could table that with the committee, we'd be ever so grateful.
Dr. Simard, you haven't had a chance to weigh in.
If I might summarize, I think we've heard that Dr. Wilkinson and Dr. Gordon would suggest that moving the age for screening for asymptomatic women to age 40 would be appropriate and supported by the science. Dr. Narod, I would suggest, is not supportive of that change. Again, I'm not one to put words in people's mouths.
Dr. Simard, I know your focus is slightly different and is—if I could use a term—talking more about precision diagnostics. I think that's obviously the way of the future.
If you have an opinion, sir, could weigh in on what you think the Canadian task force should be doing? I think that would be beneficial.
:
What we proposed is to have a risk assessment, for example, at 40 years old. Based on their risk category—it's a risk stratification—those women who have a risk equivalent to the population can start later. However, the 20% of women having an intermediate or high risk should start at 40 years old. I think it's important to have a comprehensive risk assessment.
By the way, it's not so futuristic. We need the political will. We released the comprehensive risk prediction tool—by my colleague at the University of Cambridge in the U.K. Since 2020, already it has been used 1.7 million times in 120 countries.
This is the real world. Of course, if it's not currently available, the polygenic risk score, it will cost the same amount of money as a mammogram—around $100. It can be done once in a lifetime. It just needs political will to introduce this test. Any good genomic lab in Canada—because we have a very good platform and we have clinical labs—can perform maybe 5,000 to 10,000 tests per week. It's not so futuristic. We need political will to introduce innovation. The goal of our research is to provide innovation.
Two weeks ago, the Ministry of Health, during the annual meeting of the Quebec cancer program, gave us the award for our project for health promotion and prevention of cancer.
Welcome to all the witnesses.
Yesterday I had the opportunity to meet with the Cancer Action Now association. It was a very interesting meeting. It was quite informative.
They talked about a lack of Canada-wide standards around early detection programs that cover a spectrum of services on what we call the technology side. They talked about biomarkers or genetic testing. They talked about various tests that are available, such as CT scans, MRIs, ultrasounds and mammograms.
They also talked about the need to access support and the reduction of long wait times and access to oncologists. What became very clear is that they felt we don't have an early detection program that addresses a variety of considerations. They talked about some of the jurisdictions, and the fact that ethnicity, age and demographics—all of those—play a role in that early detection.
My question is for any of the witnesses who are comfortable responding to this. Is there any jurisdiction that we could look to around best practices for early detection programs that are supported by data and modelling and cover a spectrum of aspects of cancer detection?
Would anyone like to comment?
Dr. Wilkinson, you're here in the room.
:
Thank you. I have only two minutes left.
I'd love for you to submit that study and perhaps what you tried to submit as commentary as well but that was not accepted, from what you said.
Dr. Narod, I'm looking forward to your book as well as the JAMA article in 2024.
I want to shift a little bit and talk about access.
Dr. Wilkinson, I think you have a program about access to breast screening in women who do not have a primary care provider. Obviously, you've identified an area. I worry about women who, regardless of age, both in my territory but elsewhere, are not aware of screening guidelines at all, are often remote and are not accessing the available mammography programs. It's not just about geography. Sometimes it's about social access, fear, trauma or psychological access.
I wonder if you could comment on that and how we tackle that area.
:
We're going to try to wrap this up, please.
Dr. Hanley gave a very eloquent thanks to all of our witnesses. You can take that as coming from the full committee.
I can also say to you that you are welcome—and we encourage you—to provide any additional information to the committee, separate and apart from what's been specifically requested and what's been referred to. It will all be taken into consideration in the study.
Dr. Narod, we would love to see that embargoed report when it's no longer embargoed, for example.
By all means, what you submit to the committee will be taken as part of the evidence of the study. This has been a fascinating discussion and there have clearly been times when I've interrupted you when you've had something further to say. Feel free to say it in writing.
Thank you so much for being here. Your expertise and your patience are greatly appreciated.
Colleagues, our next meeting is on Monday. We had scheduled three hours, but we're only going to need two hours, because we haven't been able to secure the attendance of . We'll be meeting from 11 to one, with the first hour on the opioid study and the second hour on the Medicago issues.
Is it the will of the committee to adjourn the meeting?
Some hon. members: Agreed.
The Chair: The meeting is adjourned. Thank you.