The general health of the population today must be considered one of the greatest marvels of human civilization and ingenuity. Pregnant women no longer have to dread the 10 percent risk of death at childbirth that used to be usual; a newborn in Canada today can expect to live 80 years; death related to childhood infections is now rare; the long-term outcome of childhood leukemia has changed from 85 percent mortality to 85 percent survival; patients with cataracts, osteoarthritis and heart disease benefit from surgery that was unimaginable 40 years ago; many cancer patients can now be offered substantial relief and some even long-term survival. The focus now in well-developed countries such as Canada is on personal healthcare services, but we still must keep in proper perspective the indirect societal factors that are mainly responsible for making and keeping people healthy.
I learned a salutary lesson as a young and enthusiastic surgeon, a member of the team sent from Glasgow University in 1966 to help establish the new medical school in Nairobi. At a meeting with the Kenyan minister of health, we were complaining about the lack of drugs and equipment at the hospital when he interrupted, thanked us warmly for our service and politely explained that his major priorities as health minister were schools, safe water, houses, sewers and nutrition. We did not find this very endearing at the time, but he was displaying an excellent understanding of the determinants of human health.
Living in Canada, we have high expectations for relief of ailments that in past generations were accepted as normal accompaniments of daily living and aging. The scope of these services has expanded to an extent that Justice Emmett Hall in 1964 could never have contemplated as he drafted the recommendations for Canada’s national medicare system. The federal legislation enacted two years later established a publicly funded insurance plan to cover all “necessary medical services” provided by physicians and hospitals. The system has continued to live up to that mandate to a remarkable degree while multiple new drugs and health services have become available and eagerly accepted by the public. But now we come to the sticking point. The fact that continuous limitless growth of health services cannot possibly be sustained—in any system—is a fairly recent realization that still seems to escape many providers and politicians alike.
There are two major interrelated issues in dealing with the fact that without major policy changes our healthcare system is unsustainable: the limits of funding and the appropriateness of services. The first has been under continuous discussion, but remarkably little attention has been paid to the second. For both issues there is compelling information about the problems and credible research on potential solutions, but the serious need for change seems to face an even more serious lack of political enthusiasm. Some of the solutions would be well within governments’ powers to adopt and implement.
It is fascinating that almost all the attention in the national debate about how to solve the supply/demand equation recently has focused on the supply side—more doctors, more nurses, more hospital beds, more drugs, more operating rooms, more, more, more. The committees chaired by Don Mazankowski and Michael Kirby both concentrated on finding new and more funding for health services, whether by looking at all possible sources as suggested by Mazankowski or by staying only within the public domain as in Kirby’s report.
The Romanow Commission took a broader view, with the clear message that new funding alone will not help in the long run unless the expectations of the public can somehow be curbed. It is absurd to imagine that any healthcare system can continue to provide all possible health benefits to all people at all times no matter how small the benefit and how great the cost. This would be as absurd as planning for infinite growth of the economy or the population. A degree in economics is not necessary to understand what happens when growth in anything outstrips the availability of the resources necessary for its existence.
We know from evidence in the literature that a paradoxical situation often develops where more resources thrown at a healthcare problem bring only very temporary relief. This has been shown, for example, in relation to surgical waiting lists. For the elective surgical procedures with significant waiting lists, whether to operate involves a lot of judgement both by the patient and the surgeon. The result is that the rate of elective surgery in the population varies widely from place to place with little correlation to disease prevalence. This discussion does not apply to essential operations where less judgement is involved—operations for broken bones, appendicitis or cancer of the bowel—but rather for surgery for the degenerative diseases of the joints, the eyes, the prostate or the heart and blood vessels, to name a few examples. The net result of simply providing more resources is that the decision swings more toward surgery and away from other alternatives. The rate of heart surgery in Canada, although less than in the United States, is twice that in the United Kingdom; yet all three countries have the same death rate from heart disease. And the paradox is not confined to surgery. No matter what healthcare intervention is examined, large variations in the rates are found, whether for diagnostic tests, prescriptions, hospitalization, operations or follow-up visits. These wide variations are usually not explicable on the basis of any difference in medical need.
In dealing with the public appetite for ever more health services, it is necessary to examine the effectiveness of those services in relation to cost. How great or little is the benefit, is it worth the extra cost and can I afford it? Everyone is used to making decisions every day based on the “is it worth it” question, whether grocery shopping, choosing a coat or buying insurance. This process is called cost-effective analysis by health economists who insert actual numbers into the equation to calculate the cost per unit of benefit expressed as Quality Adjusted Life Years (QALYs) gained. For example, a total hip replacement costs around $10,000, but this translates to only $3,000 per QALY because of the positive effect on the patient’s quality of life.
When the decisions concern what should or should not be covered in our publicly funded system, we sometimes lose our ability to weigh the potential benefit and cost sensibly in the balance. And there is another serious consideration with health care that does not apply to groceries or coats—the risk of harm. With the current clamour for provincial governments to pay for the new anti-cancer drugs, for example, this is a good time for a reality check. Time and again when the media deal with the problem of funding for these hyper-expensive drugs, the report emphasizes the potential benefits, lamenting the fact that they are not freely accessible and criticizing the government for not providing adequate funding. Two essential issues are usually ignored entirely, namely the cost effectiveness of the drug stated in simple language and the consequences of allocating the necessary funds. A good example is Avastin (bevacizumab), now being vigorously marketed for patients with colorectal cancer and currently accepted reluctantly onto the provincial lists in most provinces after strong lobbying by cancer-interest groups. The research shows that this drug can prolong life—but how much more life, at what cost and causing how much harm? The answers are an average of four months, $50,000 per patient and a stunningly wide range of adverse effects from high blood pressure to gastrointestinal problems to severe hemorrhage. Half of the patients receiving the drug get no benefit whatsoever.
When this kind of “benefit” is accepted for funding under the public insurance system, the options for paying for it are obvious and limited: take the resources from other programs or raise taxes. It is noteworthy that interest groups demanding funding for innovations like this usually do not rush to suggest where they would cut existing funding or which tax they would prefer to be raised. The only suggestion usually offered is greater efficiency—do more with the same resources. Yes, there are inefficiencies in the healthcare system, but the most efficient management conceivable could never yield sufficient funds for the public system to survive the onslaught of these drugs that offer questionable benefit at enormous cost. If the use of Avastin were extended to all patients with early colorectal cancer, which is currently being promoted by the manufacturer, the cost in Canada would be around $4 billion annually. And a multitude of similar drugs is on the way.
There is no doubt that continuing to pour money into services that offer so little benefit could ultimately devastate the system. How many people would opt for this treatment if they were fully aware of the extent of the benefit, the probability of suffering complications and the consequences of diverting healthcare funding in this way? The most reasonable option, although unpalatable to many, is to accept that the public system should not and cannot fund such ineffective services and formally deinsure them, as the UK government has recently done. Public funds for terminal patients are so much more badly needed for appropriate palliative care.
Modern technology has led us to the point where all but the most mathematically challenged supporters of universal health care recognize that there is a limit and that we have reached it. Our governments and ministries of health must find the intestinal fortitude to inform the public that for drugs like Avastin the potential benefits are just too little and the costs too enormous to justify public funding. This decision does not even need to get into the tired doctrinaire debate about one- or two-tier systems since it can be made simply on the grounds of affordability or value, like many of the items in the 30 percent of health services already uninsured in the Canadian system, such as out-of-hospital prescription drugs, regular dental care and chiropractic.
More serious than the problem of adequate funding is the relentless, inappropriate medicalization of society to the extent that, in many areas, the border between net benefit and net harm is crossed. There are many examples to choose from in making the point. Medical care related to childbirth has saved countless lives, but over a quarter of women seem now to be either unable or unwilling to give birth without the surgeon’s knife. For some serious infections, there are few if any effective antibiotics left because they have been (and still are) widely prescribed for trivial indications such as the common cold and other minor self-limiting respiratory ailments. Menopause is, thankfully, now emerging from decades of routine mistreatment with estrogen. The marketing aimed mainly at male physicians asked “how would you like to be castrated in middle age?” Nobody—at least of the male variety—is likely to decry the benefit of some erectile help in time of need, but aggressive marketing has turned another natural process of aging into a disease that must be treated. Men are also urged to see their doctor for baldness, a process in the same category. Health risks that in many cases are insignificant, such as raised cholesterol or lowered bone density, are now categorized as diseases and the relevant drugs are marketed vigorously, even though they at best cause only very marginal benefits, again at huge cost to the public purse.
The diagnosis and treatment of non-disease is also popular in some areas of psychiatric practice. Among the hundreds of diagnoses listed in the Diagnostic and Statistical Manual of Mental Disorders (known as the psychiatric bible) published by the American Psychiatric Association, dozens would be considered by most people as normal variants of the human condition but for the relentless attempts by the pharmaceutical industry to have them known as common diseases treatable by drugs. “Attention deficit disorder” condemns a significant portion of our children to a decade or more of drugs. The normal and inevitably painful grieving process following the death of a loved one is no longer permitted by many physicians without the help of tranquillizers, and general unhappiness and shyness are no longer tolerable without mood stimulants. Mental illness is a serious health issue, but by labelling and treating many of these “disorders” all we have really done is narrow the acceptable bandwidth of normal human behaviour.
The belief that early diagnosis of cancer can save your life is deeply ingrained in the North American population. As a result, screening programs, especially for cancer of the breast and prostate, are widely supported by the health professions and demanded by disease-specific advocacy groups. After dozens of studies and careful analysis over the last two decades, an uncomfortable fact has emerged that is not yet getting much media and public attention—the potential benefit is very small in relation to the large amount of harm caused.
A successful screening program urging healthy people to undergo a test for cancer must satisfy three requirements: the test must be capable of diagnosing the disease before it would otherwise be found, the early diagnosis must be shown to cause a significant reduction in the number of cancer deaths, and the screening test and its consequences must not cause serious harm. Unfortunately, mammography for breast cancer and prostate-specific antigen (PSA) testing for prostate cancer get a pass only on the first point. These tests can and do make the cancer diagnosis before any symptoms appear, but unless the eventual cancer death rate is convincingly lowered in screened people, the only result is an increase in the length of time that the patient knows that they have the disease, thus allowing the medical industry to crow that the five- or ten-year survival rate has been raised, while no benefit at all has been given to the patient.
The pressure on women has been intense: many will remember the television and magazine advertisements from cancer agencies suggesting that “if you are over 35 and haven’t had a mammogram, you need more than your breasts examined.” The current pamphlets in Canada have toned down the rhetoric a bit, but they all begin with variations on the “mammography saves lives” theme. The same mantra supports the PSA screening for prostate cancer that is widely recommended by urologists and prostate cancer patient support groups.
How do the facts shape up in relation to this kind of public information? The recent analysis of all the available evidence from multiple studies published in the British Medical Journal shows that if 2,000 women are screened with mammograms regularly for ten years, only one single woman’s life will be prolonged, but 500 will have at least one false positive and ten will be diagnosed with a “cancer” that would never have become a real disease if it had been left alone. In view of the slim evidence on the benefit side, the question of the harm caused is crucial. Mammography hurts, although that may be considered trivial by some, and the severity of the anxiety caused by the screening process has been well documented. The false positive mammograms inevitably lead to repeat X-rays, and often other more invasive procedures. False negative results, although less common, also occur where the mammogram is reported as normal but a cancer is actually present. Nothing in this discussion detracts from the value of mammography as a diagnostic test when a breast lump or other symptoms appear. Screening tests are aimed at healthy people with no symptoms.
For prostate cancer the story is remarkably similar. In two large long-awaited studies recently published in the New England Journal of Medicine, one found no benefit from PSA screening, while in the other, 1,410 men had to be screened and 48 treated to prevent a single cancer death. A positive PSA test is usually followed by a biopsy of the prostate gland, which often leads to a cancer diagnosis that may or may not represent a real disease for the patient. This is, in turn, frequently followed by a recommendation for radical prostatectomy, carrying a significant risk of impotence and incontinence.
The most pernicious adverse effect of breast and prostate screening is the resulting over-diagnosis of cancer because of the difficulty that even experienced pathologists have in predicting the future behaviour of some kinds of abnormal-looking cells in a biopsy. It has been known for decades that prostate “cancer” can be found in up to 80 percent of elderly men who never knew about it and died of unrelated causes. The more recent finding that the same problem occurs with in situ breast cancer is even more disturbing. Long-term studies have now shown that many more of these so-called cancers are detected by mammography—and given full cancer treatment—than would ever have developed subsequently. The point has been made nicely in editorials in prestigious medical journals: “The Mammography Dilemma: A Crisis for Evidence-Based Medicine?” in the Annals of Internal Medicine in September 2002 and “Overdiagnosis and Mammography Screening: The Question Is No Longer Whether, But How Often, It Occurs” in the British Medical Journal in July 2009. It is bad enough for someone to be wrongly labelled as having a malignant disease, but the consequences of further tests, biopsies, operations and drugs can certainly bring serious harm and no benefit to a person who had no medical problem in the first place. It will be difficult for cancer and screening agencies to continue to ignore these confirmed research findings.
There will likely be dismay among healthcare professionals and the public alike when these recent revelations begin to attract the media attention they deserve. This kind of information is extremely unwelcome after the hope and hype with which the screening programs were launched in the fight against cancer and the large industry we have built to support them, involving physicians, nurses, technologists and equipment manufacturers. The necessary review of public health policy with consequent resizing and redistribution of resources will take time and careful planning, but at the very least, screening organizations should, as soon as possible, revise their processes for recruitment and obtaining informed consent. A personal decision to undergo screening or not, as with any other medical procedure, should be made only after hearing a clear and accurate explanation of the potential benefit and harm.
In our society, the dangers of over-treatment intensify with advancing age. The pharmaceutical potpourri currently being swallowed by many seniors is an alarming indictment both of the power of pharmaceutical advertising and of the prescribing habits of the medical profession. It is not unusual for seniors to be taking a dozen drugs or more (most of them prescription); in 5 percent of hospital admissions, drug reactions or interactions are the main cause of the patient’s problem. Hospital pharmacologists often begin by cancelling all medications and then reintroducing only those few that are really necessary.
Finally, even death is no longer always recognized as a normal phenomenon. In Canada today, two thirds of deaths occur in hospitals, where it is very difficult for health professionals to manage the dying process appropriately instead of fighting to keep the patient alive. One of the most egregious examples of inappropriate and harmful intervention is cardiopulmonary resuscitation, a combination of chest compressions, artificial ventilation and electric shocks in response to cardiac arrest. When applied to patients after an acute heart attack (the situation for which it was designed in the first place), there is a modest success rate of around 15 percent, but for obscure reasons CPR became standard practice for all patients dying in hospital without specific written instructions to the contrary from the physician—even when the cause of death is a terminal incurable disease. This macabre practice continues in spite of a success rate varying from vanishingly small to zero and the research showing repeatedly that what people overwhelmingly want in quality end-of-life care is pain control, a strong relationship with loved ones, a sense of self-control and avoidance of inappropriate prolongation of the dying process.
In the very large sector of health care now devoted to elective surgery where surgeons’ judgements vary so much, the factors justifying operations need to be better standardized. Follow-up should include patient-reported quality-of-life measurements that are disseminated to surgeons, referring doctors and the public. The proven methods for doing this are not used regularly at present except in some areas of orthopedics. Electronic health information and pharmacy systems have hit the news with the recent eHealth Ontario debacle, but a sustainable public health system needs them urgently to help prevent the huge amount of resource wastage from duplicate tests and unmonitored prescribing. Many of the more expensive and marginally effective drugs should be put on reserve programs, available only under specific circumstances. The evidence that direct-to-public drug advertising increases the number of inappropriate prescriptions is conclusive, but the pharmaceutical industry, unsurprisingly, maintains its relentless attack on the controlling legislation that is already too weak in permitting the sneaky “ask your doctor” campaigns that are so successful at stimulating inappropriate demand.
As recently suggested by the world’s major medical journals, the cosy back-scratching link between drug firms and doctors must be broken. Tight guidelines for the acceptance of drug firm money are essential to minimize the bias and selective publication of research results that have recently been exposed. It has been recognized for decades that fee for service is not the most appropriate method for paying doctors in modern healthcare systems, and yet it remains dominant in Canada. Alternative remuneration with appropriate contracts and incentives would facilitate doctors’ willingness to deal with the problem of inappropriate tests and services and to put in place ongoing evaluation. Kickbacks and self-referral among physicians, pharmacies and diagnostic centres are already prohibited by fiduciary law, but these abuses continue and regulators need to ban them outright. The rush to implement new technologies must be tempered by balanced assessment of real need and value. Nurses’ and pharmacists’ scope of practice needs to be extended to improve access to services well within their capability that do not require a physician.
In summary, elimination of inappropriate current services and control of expenditure on ineffective new services or technologies are two of the most crucial measures to ensure sustainability of our healthcare system. Unfortunately, most of these options are not greeted with wild enthusiasm by politicians for two powerful reasons: the public’s reaction to the perception that services, whether appropriate or not, are being restricted and the predictable organized resistance to change by many vested interests within this huge industry. Unlike in the U.S., we at least do not have to deal with the hysterical behaviour of a private health insurance industry terrified at the prospect of losing the 4 percent of the GDP it currently enjoys.
There is certainly much that can and should be done to limit inappropriate medical care. Canada’s population is generally literate and well educated. There is a crying need for massive, eye-catching, sustained public education programs to disseminate accurate and balanced information based on evidence, rather than on the marketing biases of big pharma. This communications initiative should be designed and presented by advertising professionals who can match the medical industry’s techniques, but with the close collaboration of independent experts who understand the evidence. Don’t ask your doctor if you need [the latest miracle drug being pushed on television]; ask your doctor to explain why you really need each of your prescriptions and what the side effects are. The same approach would help the public to understand the sound reasons for not insuring every new technology and drug that comes along. The “informed consent” currently given by many patients for medical procedures is perfunctory. People need to be fully informed about the balance of potential benefit and harm that is inherent in any medical intervention. Is the 55-year-old man getting a PSA test aware that it carries a much higher risk of leading to incontinence and impotence than offering any benefit? Is the woman about to have her breasts compressed onto an X-ray plate aware that she has a much greater chance of harm than benefit resulting from the test?
All of these measures stay within the principle of equitable access to medically necessary care regardless of financial means that is the most defining characteristic of Canadian health care. We have to recognize the paradox that increasing healthcare interventions can cause more harm than benefit, and take an intelligent, evidence-based approach to setting limits not only to funding but also to what is in the best interests of people’s health.