Health Committee on May 14th, 2007

[The Chair, Conservative, Rob Merrifield]

We'd like to call the meeting to order. It's pursuant to Standing Order 108(2), a study on prescription drugs, the common drug review. This is our seventh meeting, and we look forward to the presenters we have before us today. We also look forward to being able to quickly get to our report soon after we hear all of the testimony, which is coming up very quickly now.

With that, I want to introduce those we have with us.

From the Canadian Medical Association, we have John Haggie. It's good to have you here. I believe you have Briane Scharfstein with you.

It's good to have you here as well.

From St. Michael's hospital, we have Andreas Laupacis, who is on his way from the airport, I believe, so he'll be joining us very soon.

Then from Mood Disorders Society of Canada, we have Phil Upshall. It's good to have you here.

From Hit the slope for hope, we have Michelle Calvert and Sarah Calvert. It's good to have both of you here.

So with that, we will yield the floor to you in order.

From the Canadian Medical Association, John Haggie, you can start. The floor is yours. You have 10 minutes.

[Dr. John Haggie, Chair, Board Working Group on Pharmaceutical Issues, Canadian Medical Association]

Thank you, Mr. Chair.

The Canadian Medical Association represents more than 65,000 physicians in Canada, and pharmaceutical issues play a critical part in the everyday practices of these physicians. To help Canada's doctors better serve and treat patients, the CMA is developing a growing body of policy on pharmaceutical issues. In November 2003, we presented its study of prescription drug issues to the House of Commons Standing Committee on Health. Last July, the CMA partnered with four other national organizations representing patients, health professionals, health system managers, and trustees to form the Coalition for a Canadian Pharmaceutical Strategy. That coalition released a framework and principles that we believed should govern the development of pharmaceutical strategy in this country.

The CMA believes that any pharmaceutical strategy must be built on the foundation of two critical principles: all Canadians should have access to safe and effective prescription drugs, and secondly, no Canadian should be deprived of medically necessary drugs because of inability to pay.

Whether the common drug review, or CDR, furthers these goals has been a matter of vigorous debate. Federal and provincial representatives told the committee that the CDR is meeting their needs, and they even said that in some cases it provided them with a higher-quality review than they could have achieved on their own. On the other hand, patient groups have charged that the CDR is an unnecessary layer of bureaucracy and a barrier between them and potentially life-saving new therapies.

We understand the frustration of patients and their advocates when the CDR recommends against public reimbursement, and it can be even more frustrating when the CDR approves a drug but provinces refuse to include that drug on their formularies. In each of these cases, sustainability of the health care system is an important and valid consideration. It would be unfortunate if our limited health care dollars that could have been spent on treating patients and preventing illness were wasted funding expensive drugs, ultimately found to be no more beneficial to patients than other cheaper versions.

There must always be a drug review process. To dismantle it entirely would be unacceptable, both economically and politically.

The primary purpose of a drug review process should be to help ensure access to prescription drugs for which evidence indicates safety and effectiveness in the treatment, management, and prevention of disease and/or significant benefits in quality of life.To help ensure that it achieves this purpose, drug review in Canada should follow these principles.

The review process should be impartial and founded on the best available scientific evidence.

The primary criterion for inclusion in a formulary should be whether the drug improves health outcomes and is an improvement over products currently on the market.

Evaluation of cost-effectiveness should be part of the review process.

Drugs cannot be and should not be evaluated in isolation, but as an integral part of the health care continuum. For example, the review should consider a drug's impact on overall health care use. If a drug reduces a patient's hospital stay or replaces other costlier or more invasive therapies, this should be considered in evaluating its overall cost-effectiveness. It should also consider alternatives to the drug under review. The review should compare a drug's performance to other drugs in the same class and to available non-drug therapies, such as surgery, for instance.

The review process should be flexible, taking into account the unique needs of individual patients and the expertise of physicians in determining which drugs are best for which patients.

The review process should be open and transparent. We support the CDR's intent to publish the rationales for its decisions, including lay-language versions.

The CDR results should be communicated to caregivers and patients as part of an ongoing strategy to encourage best practices in prescribing.

Meaningful participation by patients and health professionals should be part of the review process. Here we would recognize and applaud the expansion of the Canadian Expert Drug Advisory Committee to include members of the public. We also suggest that the CDR experiment with other means of obtaining public input, open forums, for example.

A process for appealing the review's decisions should also be established.

Ongoing evaluation of the review process should be required. The CDR has already undergone an evaluation and is planning to implement some of the key recommendations. Impartial evaluations should continue to take place to assess whether the CDR is having a positive impact on the health of Canadians and their health care system.

The common drug review does not and cannot exist in isolation. It is linked to other issues in prescription drug policy, and there are three specific issues that merit the committee's consideration.

The first is drugs for rare disorders. It has been alleged that the Canadian Expert Drug Advisory Committee's current review standards, which place a high value on large-sample clinical trials, cannot capture the value of these drugs. This issue merits much closer consideration.

The CMA recommends that Canada develop a policy on drugs for rare disorders, that it encourage their development, evaluate their effectiveness, and that these policies ensure that all patients who might benefit have reasonable access to them.

Second is a common formulary.

The CMA recommends that Canada's governments consider the possibility of a establishing a pan-Canadian formulary. Canadian patients need a national standard; having 18 different levels of coverage is simply not acceptable.

Should the CDR form the basis of this formulary? Well, the answer to that question would depend on whether evaluation proves that the CDR is the most effective vehicle.

Third is catastrophic drug coverage. It's now generally accepted that Canada must institute a pan-Canadian catastrophic drug program.

The CMA recommends that governments and private insurers work together to assess the drug needs of Canadians, particularly those who are uninsured or under-insured, and agree on an option for meeting these needs. The underlying principles of this effort must be to ensure that Canadians can get the drugs they need, regardless of where they live or how much they earn.

As a starting point, the CMA recommends that governments give priority to a national pharmacare program to provide necessary drugs for all Canadian children and all Canadian youth.

In conclusion, the CMA believes that a process for reviewing the clinical and the cost-effectiveness of prescription drugs can contribute to improving the health of Canada's patients and our health care system. The value of the CDR in this process will be determined by how well it performs its function on evaluation.

We understand that the CDR study is part of a larger and more comprehensive study of prescription drugs being contemplated by the committee, and we look forward to assisting you with this study.

Thank you.

[The Chair, Conservative, Rob Merrifield]

Thank you very much for your presentation to the committee. It's very valuable as we look for solutions to what we see as potential problems. So thank you.

We'll now move on to St. Michael's Hospital. Dr. Laupacis.

[Dr. Andreas Laupacis, Director, Li Ka Shing Knowledge Institute and former Chair of the Canadian Expert Drug Advisory Committee, St. Michael's Hospital]

Thank you very much. I've managed to spill my water here.

[The Chair, Conservative, Rob Merrifield]

That's not a problem. We'll give you a quick minute.

We could go on to another presenter first. What's your preference?

[Dr. Andreas Laupacis]

It's up to you.

[The Chair, Conservative, Rob Merrifield]

Let's go on to the Mood Disorders Society of Canada.

Phil Upshall.

[Phil Upshall, National Executive Director, Mood Disorders Society of Canada]

Thank you for the opportunity to present today. I know it has been difficult squeezing everyone in. I appreciate the effort that you and the staff made, and I appreciate the opportunity to be here today.

Members of the committee, Mr. Parliamentary Secretary, and others, first I want to give you a quick overview of where we stand on the CDR and the questions you've asked.

Quite frankly, there is no evidence that I have seen that the current CDR is effectively achieving its mandate. Health Canada continues to review drugs, other countries that have as rigorous standards as ours review drugs, so in my view, the CDR single process of review starts in third place. Then, after much duplication of testing and after consulting with so-called experts whose knowledge of mental illness issues in particular is very unclear, recommendations, usually “no”, are followed by the decision-making processes in the provinces, which, of course, unfortunately are frequently “no”. So we have a four-stage process, in my view, and I believe we were intending to have a one-stage process.

Quite frequently now in Canada, as I mentioned, most applications receive a “no”. Again, from our perspective, straight cost-per-pill comparisons used for provincial drug plans and CDR perhaps save money in the health care budgets—and I assume that's how they establish costs—but my argument is that in order for the process to be cost-effective as it relates to people with mental illnesses, it must include the cost to the economy and the cost to the patient consumer. Costs don't just mean cost per pill; they mean recovery, they mean avoiding costs--$33 billion to the economy, costs to the patients and consumers and their families when they lose their jobs because they don't have adequate or the right medications, or any medications.

Currently the CDR is not patient-centred and it does not engage those who we believe are real experts in the mental health field. Particularly, they don't engage patients and consumers, who quite frankly have the experiential expertise that I think is essential to be at the table at the beginning, the middle, and the end of the process.

As I'm sure is obvious, there's a significant lack of transparency, and quite frankly, while the physicians, scientists, and health care providers at CEDAC are wonderful people, I'm sure, I don't think any of them have significant or adequate expertise in the mental health field to be providing advice as to “no” or “yes” on medications for mental illnesses.

So there you have our answers to the questions. If I can just be a little broader now in my responses, I have filed a reasonably detailed brief with you, which I believe you all have and I hope you and your researchers—your highly esteemed researchers, by the way—have an opportunity to read completely. It's a little broader than what was originally requested, but there is such a need for positioning the issue of mental illnesses as opposed to other chronic diseases that I felt it was necessary to be reasonably broad.

The Mood Disorders Society of Canada is a non-governmental charity incorporated under the laws of Canada. We are not an advocacy group, and I do not consider myself an advocate; I consider myself a manager of an NGO. Our activities include research, communications, and working with provincial and other national organizations in collaborative efforts.

One of the things we're proudest of is the document called A Report on Mental Illnesses, which is from 1962. I believe all of you received copies of this. This is the first document ever produced by Health Canada on mental illnesses, one of the most significant aspects of illnesses in Canada. This document was produced in partnership with Mood Disorders Canada and Health Canada. It was one of the original documents that helped the Kirby-Keon committee start its work.

The interesting thing was that Health Canada didn't have the money to produce it, so we had to work as a partnership to get this out, because they didn't want it to be an official government publication. It fell upon me to develop not only the editorial board and the other contributors, but to find the money to print it, because Health Canada didn't have the money to print it.

You'll see on the back of the document advertising that we had to sell. Two of the advertisers were Wyeth and Pfizer, and I'll get to the reason for that in a minute. The other advertiser was the Institute of Neurosciences, Mental Health and Addiction. They provided the $90,000 that allowed us to get these 10,000 copies out and around.

Subsequently, I'm sure you've all received our new edition for 2006-07. The interesting thing about this is that there's no advertising. Health Canada has accepted the fact that we need an official publication on mental illnesses. It's a significantly broadened document from the one you have. If you don't have copies of it, please let me know. We made sure that every MP and senator got a copy. It's a very important document that we think will stand the test of time. The only NGO that was involved in the development of this project was the Mood Disorders Society of Canada.

Our operating funds are secured by working on contracts with Health Canada and other departments of the Government of Canada. We also obtain funds from many corporate sources, including pharma. I notice there were a couple of comments in previous testimony about pharma, and quite frankly, our relationship with pharma is quite good. We started on the basis that we have an awareness to raise. We asked for support to help us raise awareness. We worked with four very good pharma companies. We've thrown several out the door because they asked us to manipulate our messages.

That's sort of the standard process, unfortunately, that you run across, whether it's a pharma or any other support you seek. Everyone is looking for a bang for their buck when they invest, even when they invest in charities.

As you may notice in my c.v., I have a reasonable understanding of the scientific community, particularly the neuroscience, mental health, and addictions community. I sat on CIHR's Institute of Neurosciences, Mental Health and Addictions advisory board for five years. I must tell you that I've made a lot of friends in our scientific community, and I'm surprised by one or two of the expert witnesses who suggested that our scientific community is capable of somewhat altering its findings in clinical trials when those trials may be funded by pharma. I've never known a scientist in Canada, clinician or otherwise, who was prepared to do that.

Our concern with the definition of “expert” that CEDAC uses is that it's too narrow. It uses people who don't have any experience in the mental health field, as far as we can see. This makes a difference to us because the stigma of mental illness is so great. I'm sure my physician friends would agree that mental illnesses are not adequately taught in medical schools. Psychiatrists are considered to be at the bottom level of the pecking order when it comes to specialties.

The reality is that very few people really take the time to understand what mental illness is all about and what recovery is all about. I'm asking this committee to take note of the fact that a huge population is affected by mental illnesses. In Canada it's about one and a half million to two million people, plus the caregivers who are required to help people. It's a huge issue--as big as cancer and cardiovascular issues--and quite frankly, the experts don't exist to pay enough attention to what our issues are.

One of our issues is the fact that recovery is a process, and access to medication is one of the most important first steps on the road to recovery. With mental illnesses, unlike some other illnesses, trial and error frequently occurs between a patient and the physician as they try to find the right medication that will work for that patient. Restricting the opportunity, because of an incomprehensible cost formula, for people to recover and become contributing citizens again in Canada is an unfathomable rationale for me to understand.

We know there are medications that could be made available to people with mental illness with significant depression, schizophrenia, and bipolar illness. They're not exceptionally costly. If they were made available to those people, we would have the opportunity to try those medications, see what works and what doesn't, and allow the patient who has the experience to enter into the recovery process a lot faster and not sink as deeply into mental illnesses as they could.

I'll remind you, finally--because I'm sure I'm out of time--that one of the principal factors of homelessness is mental illness. One of the principal reasons we have homelessness is that hospitals closed a significant number of psychiatric beds--more than 60,000. Community supports were supposed to be made available by the provinces and they weren't. So many people fell through the cracks during that time that a lot of them ended up on the streets, homeless. They lost access to appropriate medications that would have helped them recover, to the point where they lost faith in the medical community and in the supports that would have been available if they had been willing to access them.

When we were able to get some people who were homeless off the streets to try medications, provincial formularies said to try the cheapest ones with the most side effects first. Of course that just reinforced the lack of trust on the part of the recipient. Our argument is that if there's a good drug available anywhere in the world, it should be available to everyone in Canada who suffers from a mental illness. Either experts at places such as CEDAC need to have that guidance and direction, or the process needs to be replaced.

Thank you, Mr. Chair.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

We'll now move on to St. Michael's Hospital.

Dr. Andreas Laupacis, it's good to have you here with us. The floor is yours.

[Dr. Andreas Laupacis]

Thank you, Mr. Chair.

I'm the previous chair of the Canadian Expert Drug Advisory Committee, which I'll refer to as CEDAC. This committee recommends to the drug plans participating in the common drug review which drugs should be funded and which should not.

I'm also a practising physician and a researcher, and like all of you, my family and I use the services of the health care system.

In previous hearings, you've heard from many others about the common drug review. Therefore, I'll proceed directly to answer the specific questions you posed to me and will not review the CDR. I'll conclude with a couple of remarks that I personally feel are important.

You first asked about the effectiveness of the CDR. As you know, the CDR performs a thorough independent review of all relevant available information on the benefits, the harms, and the cost-effectiveness of the new drugs it considers. A summary of the reviews are publicly posted on the CDR website. While I was chairing the CEDAC for three years, the accuracy of those reviews was almost never challenged; and the importance of the independence of those reviews, I believe, can't be overstated.

Your second question was about duplication. The CDR provides one national review of the available evidence about a new drug. However, in our federal system, the final decision about drug reimbursement does lie with each jurisdiction. To my knowledge, the vast majority of jurisdictions, except the CDR, do not conduct their own independent evaluations, and over 90% of the time, CEDAC's recommendations are accepted. Thus, I don't think duplication is a bigger issue than it was before the institution of the CDR.

However, in some provinces there are delays of many months between CEDAC making a recommendation about funding and the province's final decision. In my opinion, that's an unacceptable delay, and the time between the CEDAC recommendation and a jurisdictional funding decision should not be more than a couple of months.

The third issue you asked me to address is transparency. To my knowledge, the CDR is the only drug reimbursement committee in Canada to make the reasons for its recommendations publicly available on its website. For this degree of transparency, the CDR deserves credit. While I fully support calls for greater transparency in the CDR process, the fact is that greater transparency is needed in the whole drug evaluation system. In general, the entire drug evaluation process in Canada is, in my opinion, a transparency free zone.

So let's have transparency and make the protocols of all studies of a drug publicly available, so that anyone can compare the protocol with the study results reported later.

Let's make the pharmaceutical companies' submissions to Health Canada, which contain detailed information about their drugs' benefits and harms, publicly available. Aren't Canadians who will consume and pay for those drugs entitled to this information?

Let's make Health Canada's review of the pharmaceutical companies' submissions publicly available. Aren't Canadians entitled to know what their publicly funded regulator thinks about companies' submissions?

Let's have transparency, as we just heard, about the relationship between the pharmaceutical companies and disease-oriented groups and those who develop clinical practice guidelines.

Let's have transparency about the agreements that various jurisdictions and pharmaceutical companies negotiate on the price paid for a drug, and on any rebates or arrangements negotiated.

And yes, let's make the CDR process much more transparent. Let's make public the drug companies' submissions to the CDR, and the CDR reviews and the minutes of the CDR meetings.

The next thing you asked me about was public input. It's absolutely true that the public has had little direct input into the CDR process—although two public members have recently been added to CEDAC, which I think is an important step. Increasing the transparency of the whole drug review process, which I've just called for, will in and of itself increase public involvement. However, I also believe there needs to be greater public input into the CDR. This can be done in many ways, including public submissions, the opportunity for the public to appeal a CEDAC recommendation, and forums for CEDAC and the public to discuss CEDAC recommendations. I think it's important to engage the public in the whole drug evaluation process, rather than only obtaining its input on decisions about individual drugs.

I've been asked to comment on the joint oncology drug review. This has been established since I left my position as chair of CEDAC; therefore, I can't make an informed comment. However, whatever reimbursement process is established for cancer should use the same principles used for other diseases and other drugs. Patients with heart failure, a condition with a high risk of death, should not be treated differently from patients with cancer.

Let me now turn to two other issues that I think are very important.

The first relates to the fragmentation of the whole drug evaluation process in Canada. There is virtually no integration between those who make decisions about whether a drug can be sold in Canada, which is Health Canada; those who establish the maximum price of a drug, which is the Patented Medicine Prices Review Board, or the PMPRB; and those who decide whether a drug will be publicly funded, and that's CEDAC or the CDR, and eventually the federal-provincial-territorial drug plans.

Let me give you one example. Both the PMPRB and CEDAC are interested in the price charged for a drug. The PMPRB sets the maximum price that can be charged for a drug in Canada, based upon the price charged in seven other countries, which often has nothing to do with the benefits of the drug. CEDAC makes its recommendations based upon a drug's cost-effectiveness, but has absolutely no input into the maximum price established by the PMPRB and has no authority to negotiate price. The CDR is a relatively small component of the whole drug evaluation system in Canada, and I would respectfully urge you as a committee to look at the whole system.

The final issue I wish to discuss is the price of drugs. As you know, cost-effectiveness, or value for money, is the main criterion that CEDAC uses to guide its recommendations, and here I'd make the very strong point that CEDAC does not just look at which drug is the cheapest; it looks at benefits and costs, and benefits include non-drug benefits such as avoidance of heart attacks and the future avoidance of hospitalization, etc.

Cost-effectiveness is affected by two factors. The first is how beneficial a new drug is compared with existing therapies. Even a very expensive drug is cost-effective if it is safe and provides a very large benefit.

The other factor that markedly affects a drug's cost-effectiveness is its price. In the last ten years there has been a massive increase in the price of drugs without, generally speaking, a massive increase in their benefits. Only a few years ago, I thought that a drug that cost $1,000 a year was expensive. Now the average drug submitted to CEDAC costs about $5,000 a year--that's the average drug--with a number costing more than $20,000 a year. These drugs in general don't cure disease, and in many instances their benefits are actually quite modest.

In my opinion, the single most important factor limiting access to drugs is skyrocketing drug prices, with no apparent end in sight. Skyrocketing prices are making some drugs unaffordable, and I would point out that the common drug review does not have the authority to negotiate price; CEDAC is simply provided a price by the pharmaceutical company and essentially told to take it or leave it.

We all know that access to quality of care is an important issue in our health care system. In many parts of Canada, patients with arthritis of the knee are waiting in severe pain and immobility for many months before they are able to benefit from a knee joint replacement. Joint replacements are among the most dramatically effective interventions in medicine. One joint replacement costs about $11,000 to $13,000, and its benefits last for decades; contrast that with the greater costs and less impressive benefits of some of the drugs considered by CEDAC.

My point is not that joint replacements are always better than drugs--that's clearly not the case--but as parliamentarians, you are aware that the resources available for health care are limited, and difficult choices about what we can afford and what we cannot afford are being made every day. I would suggest that the CDR and the drug plans are not in the business of purchasing drugs; as one component of the health care system, they are in the business of purchasing health outcomes. It is incumbent upon the pharmaceutical industry to ensure that the outcomes provided by drugs are at least competitive with the outcomes that can be purchased by similar investments in other parts of health care.

Thanks very much for the opportunity to address you today.

[The Chair, Conservative, Rob Merrifield]

Thank you very much for your presentation. I'm sure it has stimulated a significant number of questions.

Now we'll move on to Ms. Michelle Calvert. I believe you're the spokesperson. The floor is yours.

[Michelle Calvert, Chair, Hit the slope for hope]

My name is Michelle Calvert. This is my sister, Sarah.

Thank you very much for the opportunity to share our experiences, and for considering our ideas. We both feel privileged and honoured to be here as a voice of the public sector with regard to the current study on the CDR.

[Sarah Calvert, Spokesperson, Hit the slope for hope]

Sunday, May 13, 2007, yesterday, marked the first Mother's Day we've spent without the presence of our mother, Gloria Calvert.

Mom died last summer on July 25, 2006. Several months later, I received a letter, dated October 26, from our member of Parliament, Patrick Brown, informing me that Tony Clement wanted Patrick to pass on to me information about Mom's next step in the drug process and about cancer. It began with an apology about the delay in responding.

In the next paragraph, he began by stating that cancer is a serious disease, which seemed a little redundant, as if we didn't already know this. At that time, this very delayed response seemed insensitive, inappropriate, and inept in every way. We therefore felt sad, frustrated, and then, obviously, angry. However, those powerful, yet not really positive or purposeful emotions eventually transformed themselves into something else, something that whispered to us to do something and take action. It was most certainly Mom's voice. She was always interested and active in local politics and believed in the benefits of living in a democratic society. It was then that Hit the Slope came to fruition.

This now annual fundraiser, held at Horseshoe Resort outside Barrie, Ontario, is to honour our mother and to help build the Simcoe-Muskoka Regional Cancer Centre at Barrie's Royal Victoria Hospital. It's a great hospital where, unfortunately, we spent a lot of our time.

Mom's voice also defused our anger and confusion when we received those letters and we heard her voice echo, “What's done is done.” Although her life here is done, we'd like to offer just a few suggestions, based on our concrete experience, as to how we can avoid such situations in the future, particularly you honourable people who actually have tangible power and opportunity to make change.

We would like to address the effectiveness of the current CDR and give some of our insights on what we think about the addition of a new layer of bureaucracy, the lack of transparency, the lack of public input, and the lack of timely access to new drugs.

We'll begin with the last issue: lack of timely access to new drugs.

Mom was diagnosed with lung cancer in April 2005. I wrote numerous letters and had a visit with our MP, Patrick, and wrote two letters to the health minister, from whom I received no reply at all until Patrick became our liaison. Mom's prognosis was not great, and it was inferred that she had about six months to live. It took about six months to hear any sort of reply. In addition, the reply we got offered no real solution, and I was advised that my concern was a provincial issue and that I should contact the Minister of Health, which I had already attempted to do twice, six months prior to this. This is what I would call defer, defer, defer, and it seemed to me to be a little bit of passing the buck, as they say.

When you're dealing with a life and death situation, time is of the essence, and there's no time for bureaucratic back and forth. We never know how long we have, but when it's something like cancer, we know it's not long. So I'm sure you can see why we would have been frustrated.

[Michelle Calvert]

Mom finally received the drug we had been searching and striving to obtain, based on the suggestions of Bryn Pressnail, Mom's amazing acting oncologist in Barrie. She began taking this drug in July 2006, 15 months after her diagnosis, and three weeks before her death. The drug, called Tarceva, did not have time to work. We believe that had she had access to the drug, her quality of life would have improved immensely, and she could still be alive. We do not say this with false optimism, as a family friend, a doctor who was also diagnosed with lung cancer, had the opportunity to participate in a study using Tarceva. He continued to live for almost a decade, and during this time he continued to hike and enjoy his life at his cottage with his friends and family.

You can surely see why the lack of timely access to the drugs is our main concern. ln addition, we believe that drugs like Tarceva should be covered under OHIP if the patients meet the criteria and their lives are depending on it.

This drug we refer to is specifically for the treatment of non-small-cell lung cancer and advanced pancreatic cancer patients. This is used for those patients who aren't able to take chemotherapy or receive radiation or surgery, meaning the cancer is at a very progressive stage. Tarceva has the power to prolong a cancer patient's lifeline and quality of life. It is sometimes their only hope, and unfortunately that hope has a big price tag attached to it. The average person could never afford the drug.

According to Tarceva's website, Tarceva is the first and only oral treatment and inhibitor proven to significantly prolong survival rate in second-line lung cancer patients. However, the Canadian study shows that in Ontario the drug is only getting to the third-line cancer patients, according to Bryn Pressnail. This doesn't make much sense, to distribute this to a patient whose cancer has metastasized so much so that the drug won't work to its full potential.

According to the Cancer Advocacy Coalition, statistics from their 2007 report on current incidence and mortality show that the number of lung cancer cases, both men and women, is greater than the number of either prostate or breast cancer. Additionally, lung cancer remains the leading cause of cancer death for both men and women. On the whole, there is a staggering estimated 159,000 new cases of cancer, where 73,000 deaths from cancer will occur in Canada in 2007. With those statistics, we can be sure that if hasn't already affected all of us, it will. This could be your wife, this could be your brother, it could be your daughter.

[Sarah Calvert]

We will next address the issue of bureaucracy and lack of transparency.

Although my sister and I are both university educated, as a teacher and a business professional, we found the present amount of bureaucracy and the jargon and vernacular of forms and applications often really difficult to discern and pretty daunting. So imagine the numerous people—and as we know the number is pretty staggering—battling cancer who are less educated, have less money, and have limited access to information, due to not having Internet access or just having the misfortune of having a doctor who is not very good. And unfortunately, during our journey throughout cancer, we had to deal with a couple of those doctors. The majority of them were great, but there are always the few who aren't. These people are thus ostracized and are not even aware of the CDR.

ln our hospital there were no pamphlets, and it was only because our oncologist recommended we look specifically into Tarceva personally by writing to the health minister and our MP that we pursued obtaining the drug for Mom. A major concern for most doctors, specifically overworked oncologists like Bryn Pressnail in Barrie, is that there is already too much bureaucracy. Dr. Pressnail is currently the head of oncology in Barrie, where there will soon be a regional cancer centre implemented. He is consumed and involved with the cancer centre and, furthermore, is inundated with patients from all over, with numbers rapidly rising on a daily basis.

According to him, he is also responsible for the requesting of certain drugs for his patients that are extremely effective yet are not covered, such as Tarceva and the like. When these requests are denied, which they often are, he must then write letters and appeals. There are simply not enough hours in a day for one man to perform all of these tasks. He's concerned that the amount of time wrapped up in bureaucratic matters is hindering his ability to care for all of his patients effectively. So basically, as his job scope is broadening, his cancer patients are suffering.

Based on the points that we've just made, l'm sure you'll be able to guess that we think there are some serious inherent flaws with the CDR and its effectiveness. As caregivers to our mother, we've already gone through the heartbreaking. yet common, would-haves, should-haves, and could-haves. Why didn't we just go to Ottawa? We should have done this and could have done that. But no good is going to come of the would-haves and should-haves, so instead, we are here before you now with hopes of not only honouring our mother's memory and her struggles, but also benefiting the future generation that will inevitably have the same struggles.

Thank you for hearing us.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

Now we'll move on to the question and answer part of the meeting.

We'll start with Ms. Brown. The floor is yours; you have 10 minutes.

[Bonnie Brown, Liberal, Oakville, ON]

Thanks very much.

I'm a little mixed up by the story of the Calvert sisters. There seem to be many factors at play, as there are in every medical history.

Do you know the reason for the delay in your mother's having access to Tarceva? Was it a new drug that was being reviewed by Health Canada for approval? Was it approved by Health Canada but not yet approved by the CDR?

[Sarah Calvert]

I think it was the latter. Dr. Pressnail was saying it looked as though it might get passed. It looked as though he was just crossing his fingers, waiting.

[Bonnie Brown, Liberal, Oakville, ON]

Do you have any evidence that the CDR was slow with it? It comes to the CDR after Health Canada approval; that's usually for a drug that is pretty new and where the manufacturer has applied. In other words, I don't know whether the length of time that Tarceva took to go through the process was normal for a new drug, or whether there was some undue delay and it was just your mother's bad luck to need it exactly when she did, before it was really approved.

[Michelle Calvert]

As far as I know, it's still not covered. That's as far as I know; I'll find out.

[Bonnie Brown, Liberal, Oakville, ON]

Well, that's a different issue.

[Michelle Calvert]

I'll find that out.

[Bonnie Brown, Liberal, Oakville, ON]

That's a different issue, coverage. Approval comes first. There are the three steps, the third of which is the provincial agreement to cover it.

Would your mother have been in a position to have it covered out of hospital?

[Sarah Calvert]

I'll answer that.

We're luckily in a situation where we could have afforded to.... We were going to pay for it, but It hadn't been approved yet, so it was a holdup—

[Bonnie Brown, Liberal, Oakville, ON]

So it wasn't to do with listing for coverage; it was to do with the length of time—