Roger Cochrane v. Her Majesty the Queen in Right of Ontario as represented by the Minister of Health and Long-Term Care, 2010 HRTO 1477

HUMAN RIGHTS TRIBUNAL OF ONTARIO

B E T W E E N:

Roger Cochrane

Applicant

-and-

Her Majesty the Queen in Right of Ontario as represented by the Minister of Health and Long-Term Care

Respondent

decision

Adjudicator: Janice Sandomirsky

Date: July 7, 2010

Citation: 2010 HRTO 1477

Indexed as: Cochrane v. Ontario (Health and Long-Term Care)

AppearanceS BY

Roger Cochrane, Applicant ) On his own behalf

Her Majesty the Queen in Right of Ontario ) Matthew Horner, as represented by the Minister of Health ) Counsel and Long-Term Care, Respondent )

1This Application was filed on February 2, 2009, under section 53(5) of Part VI of the Human Rights Code, R.S.O. 1990, c. H.19 as amended (the “Code”). The underlying human rights complaint was filed with the Ontario Human Rights Commission on November 16, 2006, and abandoned upon the filing of this Application with the Tribunal. The applicant alleges that the respondent’s policies governing the funding of prostate-specific antigen (“PSA”) testing in the province constitute discrimination in the area of goods, services and facilities on the basis of sex.

2The parties filed written submissions and a hearing was held on March 29, 2010. The respondent’s expert witness, Dr. Lawrence Paszat provided evidence by way of two affidavits and supporting documents. Dr. Paszat was also available by telephone at the hearing to answer questions in relation to his written evidence. The parties then made oral submissions.

The Background and the Parties’ Positions

3In August 2006, the applicant’s family physician issued a requisition for him to undergo a series of tests as part of his annual physical examination. The requisition included a PSA test. The applicant submitted his invoice and receipt for the PSA test to the Ontario Health Insurance Plan (“OHIP”) for reimbursement of the cost of the test. He received a reply advising that OHIP is prohibited by regulation from paying for the test.

4The applicant claims that he was discriminated against in the provision of services by the Ontario Ministry of Health because of his sex when it refused to cover the cost of his PSA screening test for prostate cancer. The applicant submits that the respondent applies a more stringent test for men than women when deciding which laboratory services will be paid for and spends far more money on a per capita basis on early detection of reproductive health problems for women than for men. The applicant takes the position that not covering the cost of PSA testing “exacerbates the imbalance unreasonably and unnecessarily” and is discriminatory.

5The respondent submits that the Application should be dismissed on the basis that the applicant failed to establish that the lack of funding for PSA screening tests denies him equal treatment on the basis of sex. The respondent noted that the applicant presented no scientific or medical evidence in support of his allegations that cancer screening tests provided to women are comparable to PSA screening tests for men. The respondent relies on expert evidence that mammography screening for breast cancer is supported by extensive medical and epidemiological evidence which does not exist in the case of PSA screening test.

6The respondent also submits that the Application should be dismissed on the basis that the applicant failed to demonstrate that its PSA funding policies are substantively discriminatory. The respondent argues that the policies for funding PSA screening tests are consistent with the medical evidence and do not perpetuate disadvantage through prejudice or stereotyping.

The Government of Ontario’s Policies for PSA Testing and Mammography

7The Schedule of Benefits under the Health Insurance Act, R.R.O. 1990, Regulation 552 provides that PSA testing is paid for in two circumstances:

1. when a man has been diagnosed with prostate cancer and is receiving treatment or is being monitored after treatment for the disease (“monitoring”); or,

2. where a doctor suspects prostate cancer because of a man’s history and/or the results of his physical examination (“diagnostic”).

There is no funding for PSA tests in men without symptoms or risk factors (“screening”).

8The Ontario Ministry of Health provides full funding for mammography to all women for breast cancer screening. It has developed a specific breast cancer screening program for women between the ages of 50 and 74, in association with Cancer Care Ontario. Mammograms for women who are not included in the breast cancer screening program age group are covered as an insured service with a physician’s referral.

The Respondent’s Expert Evidence

9The respondent presented expert evidence from Dr. Lawrence Paszat, a medical doctor and epidemiologist specializing in cancer prevention and cancer screening. Dr. Paszat is a senior scientist with the Institute for Clinical and Evaluative Sciences, and an Associate Professor with the Dalla Lana School of Public Health at the University of Toronto, as well as with the Departments of Health Policy Management and Evaluation and Radiation Oncology at the University of Toronto’s Faculty of Medicine.

10Dr. Paszat’s evidence is that the Ontario Ministry of Health’s policy not to fund PSA screening for asymptomatic men is consistent with the current medical and epidemiological evidence. The policy is also consistent with the World Health Organization (“WHO”) criteria for testing asymptomatic individuals in the entire population which requires that effective treatments to eliminate the screened condition must result in a reduction in mortality.

11Dr. Paszat contrasted the nature of prostate cancers and PSA tests with breast cancer and mammography. He identified four specific factors unique to the characteristics of prostate cancer that explain the lack of evidence supporting PSA screening for asymptomatic men:

i. PSA-detected prostate cancer has a low case fatality rate.

Prostate cancer has a relatively low fatality rate: 16% of symptomatic men die without treatment. Breast cancer has relatively high case fatality rates: left untreated, 80% of women with breast cancer will most likely die.

This low case fatality rate means that it is inherently more difficult (compared to other, more fatal cancers) to determine whether the long-term survival of the prostate cancer patient is attributable to screening or a given course of treatment, or whether they would have died from that cancer in any event.

ii. PSA-detected prostate cancers have a high prevalence of “lead time bias”.

Early detection of cancer does not always result in a decrease in death from the cancer for two reasons: lead time bias and length of bias.

Lead time bias occurs when a cancer screening test allows for earlier diagnosis, but does not allow for more effective treatment to be given, and thus the patient dies on the same day he or she would have died without the screening test. There is a serious risk of lead time bias with prostate cancer, as the potential benefit of early treatment is unknown. Even in symptomatic men, who would be expected to have a higher chance of mortality as compared with asymptomatic men, deaths from prostate cancer, have been shown to decrease by only 5% in absolute terms when treated by means of an immediate radical prostatectomy (removal of the prostate). There is no reliable or consistent evidence that detecting cancer earlier, through the use of PSA screening, would improve these mortality outcomes.

This differs from the circumstances of breast cancer, where screening has been shown to clearly reduce mortality from 80% to 30% (an absolute drop of 50%).

In the case of breast cancer, this drop in mortality was confirmed through dozens of high quality random control trials (“RCTs”) in which thousands of women were studied in order to demonstrate a mortality reduction for women age 50-69 years of age. Evidence of this magnitude has not been generated for PSA screening, for which there have only been two, very recent RCTs, which produced conflicting results.

iii. PSA-detected prostate cancers have a high prevalence of “length bias” which leads to over diagnosis.

Length bias and over diagnosis occur when a cancer screening test systematically detects some types of cancer with very low lethality, to the exclusion of cancers with higher lethality. This phenomenon is called “length bias” because the cancer would never have altered the health of the patient (or the length of his or her life) during the actual lifetime of the patient. Length bias is a serious issue for PSA testing because (a) the test is better at detecting low lethality cancers (because high lethality cancers have been found to not express PSA), and (b) because low lethality prostate cancer is so common: the vast majority of men have cancer in the prostate at the time of death even though very few of them had ever had symptoms of it or had any reason for it to be diagnosed.

Length bias for PSA detected asymptomatic cancers cause over diagnosis. This means that while many more cases of prostate cancer are diagnosed with PSA testing, than without PSA testing, most of these additional cases would never have caused any health problems during the man’s remaining life.

In the case of breast cancer, there is less length bias and over diagnosis because mammography is able to detect a wider range of breast cancers, including cancer that is highly lethal.

iv. The reduction of prostate cancer mortality by radical prostatectomy produces a small net benefit.

As discussed above, the mortality rate for prostate cancer is only reduced from 16% to 11-12% in symptomatic men when immediate treatment by radical prostatectomy was adopted. This means that to avoid one death from prostate cancer, 17 symptomatic men would have to undergo an immediate radical prostatectomy for which they would receive no benefit (and experience significantly increased risk of impotence and incontinence). The benefit is even less for asymptomatic men.

This net benefit (the number of men that would have to undergo treatment in order to save one life) is very small compared to the benefits attributable to the comparable treatments for breast cancer where the net benefit of treatment has been confirmed through metanalyses of dozens of high quality RCTs that show a real reduction in mortality.

In addition to decreasing mortality, breast screening also reduces harm to patients because mammographically detected breast cancers usually receive less aggressive treatment than clinically detected breast cancers. This is different from PSA screening asymptomatic men, where the treatment of a screened cancer can have significant potential harms for those men who were otherwise asymptomatic and leading normal, healthy lives. Radical prostatectomies have been shown to significantly increase rates of impotence and incontinence (increases of 79.3% and 16.0% respectively). Accordingly, asymptomatic men who are treated for prostate cancer risk suffering from such morbidities for a much longer period than for the men who are not tested. These chronic morbidities are much more frequent than the probability of preventing one prostate cancer death.

12Dr. Paszat stated that guidelines for applying preventative or therapeutic intervention to large numbers of a population generally depend on extensive RCT’s to determine effectiveness. To date there have been only two such trials involving PSA testing which, taken together, according to Dr. Paszat, failed to establish that PSA screening resulted in a reduction in mortality due to prostate cancer. In one trial, conducted in North America, researchers found that PSA screening had no effect on prostate cancer mortality rates. In a European trial, a small reduction in mortality was found. Dr. Paszat contrasted these outcomes with the case of breast cancer screening where there have been several trials with consistent results demonstrating a reduction of mortality as a result of screening through mammography.

13Dr. Paszat also provided a supplementary affidavit, attaching an article by Dr. Richard J. Ablin regarding the effectiveness and appropriateness of PSA testing. Dr. Ablin is a renowned cancer researcher who discovered prostate specific antigen in 1970. In his article, Dr. Ablin notes the statistics outlined by Dr. Paszat, that 16% of American men have a lifetime chance of receiving a diagnosis of prostate cancer, but only a 3% chance of dying from it because the majority of prostate cancers grow slowly. “In other words, men lucky enough to reach old age are much more likely to die with prostate cancer than to die of it.” Dr. Ablin goes on to note that,

Even then, the test is hardly more effective than a coin toss. As I’ve been trying to make clear for many years now, PSA testing can’t detect prostate cancer and, more important, it can’t distinguish between the two types of prostate cancer – the one that will kill you and the one that won’t.

“The Great Prostate Mistake” by Richard J. Ablin, New York Times, March 10, 2010.

14Dr. Ablin confirmed that the recent studies support the conclusion that PSA testing “should absolutely not be deployed to screen the entire population of men over the age of 50.”

The Legal Analysis

15Section 1 of the Code provides:

Every person has a right to equal treatment with respect to services, goods and facilities, without discrimination because of race, ancestry, place of origin, colour, ethnic origin, citizenship, creed, sex, sexual orientation, age, marital status, family status or disability.

16The respondent provided lengthy legal submissions on the appropriate framework for analysis in this case. It noted that the Divisional Court has held that the discrimination analysis developed under section 15(1) of the Canadian Charter of Rights and Freedoms applies to Code challenges to legislation and government policy and that the Supreme Court of Canada has recognized that the Code and the Charter share a common objective and should be interpreted in a congruent manner.

17The Tribunal has recently considered whether the analytical approach to discrimination under the Code is the same as that under s.15 (1) of the Charter. In Ball v. Ontario (Community and Social Services), 2010 HRTO 360 (CanLll) (“Ball”), the Tribunal reviewed the jurisprudence on this issue, and concluded that,

… whether the Code or the Charter jurisprudence applies, the important question in determining whether there is discrimination in a case such as this one is whether the complainants are denied benefits, on the basis of their disability, that fall within the purpose of the benefit scheme.

18Ball reviews the Supreme Court of Canada decisions and notes that this has been the approach of the Court in cases under human rights legislation involving allegations of discrimination on a prohibited ground and in Charter cases involving allegations that government benefits programs are under-inclusive on the basis of an enumerated or analogous ground in s.15 (see Ball at paragraphs 69-75 for the full analysis of this issue). Ball states:

The jurisprudence is clear that analyzing discrimination in circumstances like these requires a consideration of the purpose or underlying rationale of the special diet allowance [the issue in the Ball case], and whether individuals with different disabilities are given different benefits in a manner that is inconsistent with that purpose. The analysis must consider the differential treatment, as it relates to the purpose of the program, between the benefits received by others and the claims of the complainants.

19I agree with this approach. I find that analyzing the allegation of discrimination in this case requires a consideration of the purpose or underlying rationale of the government’s cancer screening programs, and a determination of whether men are denied access to screening tests that support the purpose of that program, when compared with screening tests provided to women, on the basis of their sex.

What is the Purpose of the Cancer Screening Program?

20According to the criteria set by the WHO, adopting a screening program that tests asymptomatic individuals in the entire population requires that effective treatments to eliminate the screened condition must result in a reduction in mortality. I accept the respondent’s submission that cancer screening program by the Ontario Ministry of Health has adopted this criterion and that the purpose of the program is to ensure public funding for tests that are shown to be effective in the amelioration of the hardship suffered by persons with cancer and reducing mortality rates.

Does the PSA Screening Test Fall within the Purpose of the Cancer Screening Program?

21Having considered the purpose of the cancer screening program in a general sense, the question is whether the PSA screening test for prostate cancer falls within the purpose of the program. That is, whether PSA testing used as a screening tool reduces mortality rates and the hardship suffered by individuals diagnosed with prostate cancer.

22Results from two large RCTs into the mortality outcomes after PSA screening of asymptomatic men were released only months prior to the hearing of this Application. According to Dr. Paszat, those results failed to establish that PSA screening resulted in a reduction in mortality due to prostate cancer. In light of these findings, and noting Dr. Paszat’s evidence on the serious health consequences related to treatment for prostate cancer, the high risk of over diagnosis and unnecessary radical prostatectomies, I find that the evidence does not support a finding that PSA testing, used as a screening tool, falls within the purpose of the government’s cancer screening program.

23It is trite to note that the reproductive systems of the sexes are different and, therefore, the cancers related to those systems are restricted to each sex and that each sex necessarily requires different screening tests. Based on the evidence presented, it is clear that there is a considerable difference in the effectiveness of screening, treatment and morbidity between prostate cancer, which is obviously a cancer only men experience, and breast cancer, which is a cancer primarily confined to women. The death rate in women diagnosed with breast cancer is significantly higher than the death rate from prostate cancer: 80% of women with breast cancer will most likely die if not treated, whereas 16% of symptomatic men die without treatment. Furthermore, early detection of prostate cancer does not always result in a decrease in death from the cancer because the potential benefit of early treatment is unknown. In addition, the treatment of prostate cancer detected through a screening test can cause significant potential harm for those men who were otherwise asymptomatic and leading normal, healthy lives. Breast cancer screening, on the other hand, not only has been shown to decrease mortality, it also reduces harm to patients because mammographically detected breast cancers usually receive less aggressive treatment than clinically detected breast cancers.

24Based on the available scientific evidence presented, it is apparent that it is the effectiveness of the screening test in allowing for successful early treatment and reducing mortality, not the sex of the individual subjected to the test, that is the basis of the decision to fund mammography for screening for breast cancer in women and to not fund PSA test screening for prostate cancer for men. The decision is not based on sex, but on the efficacy of the screening and its consequences.

25This was the conclusion reached by the B.C. Human Rights Tribunal in Armstrong v. British Columbia (Ministry of Health) [2008] B.C.H.R.T.D. No. 19; upheld on appeal 2010 BCCA 56. Having noted that the cancer screening tests being compared in that case (as in this one), were different tests for different cancers (because men and women have different reproductive organs), the B.C. Tribunal held that:

Given these biological facts, to say that men are discriminated against – because women are provided with cancer screening tests for parts of their reproductive system, and men are not – does not go far enough in the analysis. As noted in Weatherall v. Canada (Attorney General), 1993 CanLII 112 (SCC), [1993] 2 S.C.R. 872 (para. 6), equality does not necessarily connote identical treatment. In my view, the issue is whether the test in question, whatever it might be, and for cancer of whatever type of organ, has been determined to be medically necessary, based on sound epidemiological and public health considerations. The sex of the persons who might benefit from the test is, and must be, irrelevant.

26The B.C. Tribunal then concluded that:

Having reviewed the epidemiological evidence presented, it is my view that sex is not a factor in the Ministry’s decision not to pay for PSA screening tests. The tests have not been considered medically necessary because, to date, it has not been established that PSA testing, and its consequences, if publicly funded on a population-wide basis, would do more good than harm to the men taking the test. It is on this basis, and this basis alone, that the Ministry does not fund PSA screening tests. The fact that PSA screening tests would, if efficacious, only benefit men, is incidental to that decision.

27At the hearing, the applicant focused his allegation of discrimination in relation to the difference in the service provided by the respondent to asymptomatic men, whose doctor has ordered a PSA test for screening purposes, and asymptomatic women who, due to their age, are excluded from the government’s breast cancer screening program (women between the ages of 40-49). The applicant argued that by insuring the cost of mammography when ordered for screening purposes, regardless of the patient’s age, the respondent is providing a service to women not provided to men: that is, access to a publicly funded cancer screening test that is not justified based on medical evidence or the recommendation of medical experts.

28The applicant provided no scientific or medical evidence about breast cancer screening for women in the age group 40-49. The only reference regarding mammography and breast cancer screening in that age group was contained in a paper included in the respondent’s book of documents entitled “Screening Mammography for Women Aged 40-49 Years at Average Risk for Breast Cancer: An evidence-based analysis,” dated January 2007, from the Medical Advisory Secretariat, Ministry of Health and Long-Term Care. The applicant referred to the summary of findings in that report noting that there is evidence that mammography is not effective in reducing mortality in women between the ages of 40 and 49 years of age who are at average risk for breast cancer.

29In Armstrong, the B.C. Human Rights Tribunal also specifically commented on breast cancer screening for women in the 40 to 49 year old age group noting that:

….. the fact that there is some controversy about the efficacy of mammograms for women in the 40-49 age group does not detract from the fact that mammography is considered, from an epidemiological point of view, to be an efficacious screening test for a large segment of the population. This is not currently the consensus case for PSA screening, regardless of age group.

30On the evidence before me, I reach the same conclusion. Indeed, the evidence before this Tribunal on the ineffectiveness of PSA screening is even more compelling than that before the B.C. Tribunal in Armstrong, as the two (and only) RCTs on this subject were not yet completed at the time that case was heard.

31I find, therefore, that the applicant failed to show that men are denied access to funding for a cancer screening test that supports the purpose of the Ontario Ministry of Health’s cancer screening program. Further, in light of the scientific evidence on the relative effectiveness of PSA tests compared with mammography, I cannot conclude that the decision to fund mammography screening tests and not to fund PSA screening tests is based on the sex of the individual who is the subject of the test.

32Accordingly, the applicant’s allegation that the lack of funding for PSA testing is contrary to the Code is dismissed.

33The Application is dismissed.