Costs, ethics, and malpractice litigation

C H A P T E R

20 Costs, ethics, and malpractice litigation O U T L I N E 20.1 General 474 20.1.1 Rising costs of cancer 474 20.1.2 Classification of costs by activity 475 20.1.3 Classification of costs by phase of illness 476 20.1.4 Costs arising from side effects and complications of therapies 476 20.1.5 Cost-effectiveness versus coste benefit analyses 477 20.1.6 Attempts at cost containment 478 20.1.7 The hospice movement, the Liverpool Care Pathway, current hospice care 480 20.1.8 Statement of principles on cost containment by the American Cancer Society 480 20.1.9 The global perspective 481 20.2 Paying for the costs 482 20.2.1 Government-funded health care and private medical insurance 482 20.2.2 Sources of “financial toxicity” 483 20.3 Ethical issues in medical treatment 20.3.1 At diagnosis of cancer: who should be told? 20.3.2 Deciding no treatmenteany treatment and nature of primary treatment

Principles of Tumors https://doi.org/10.1016/B978-0-12-816920-9.00020-1

483 483

484

(a) No treatment versus any treatment (b) Suitable for primary treatment: which?

484

484 20.3.3 Ethical issues in the monitoring and terminal phases: hope and abuse of hope 484 20.3.4 Ethical issues in withdrawal of supportive care: physician-assisted suicidedeuthanasia 485 20.3.5 Role and rights of relatives 485 20.3.6 Ethics of reducing the patient’s estate 485

20.4 Ethical issues in oncological research 20.4.1 Research “participation” 20.4.2 Likelihood that the research will produce an outcome 20.4.3 Risk that the research will produce harm to the participants

486 486 486 487

20.5 Ethical issues in resource allocations at national and international levels 487 20.5.1 Allocation of resources nationally 487 20.5.2 Allocation of resources internationally 487 20.5.3 Ethical considerations in relation to health care availability according to international standards 487

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Copyright © 2020 Elsevier Inc. All rights reserved.

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20.5.4 Ethics and research 20.6 Litigation, malpractice, and avoidance errors 20.6.1 Scope and natures of complaints 20.6.2 Avoidance of errors: second opinions

487 of 488 488

20.6.3 Arising from advance care directives 20.6.4 Importance of multidisciplinary meetings References

490 491 491

489

This chapter gives an overview of issues surrounding the costs of cancer caredincluding the cost burden to patients and societydethical issues arising within the cancer care continuum and areas of potential clinical malpractice leading to litigation. These topics have attracted relatively limited attention in the mainstream medical literature, but nevertheless are important, not only to patients but also to health care workers and the community at large [1,2]. For at least a decade, leading national bodies in the developed world have described the efficacy of cancer treatment in terms other than that of cost [3,4]. There is a discordance between these bodies’ positions and the rising cost of cancer care which poses a significant issue for clinicians’ quality of practice (Table 20.1).

20.1 General 20.1.1 Rising costs of cancer Numerous articles over the years have pointed to the rising costs of cancer care. In 1995, Schuette et al. pointed to total costs in the United States as being $US 95 billion per annum [5]. In 2008, Warren et al. noted the statistically significant rise in the cost of cancer treatments, which they predicted would only increase in the near future [6]. In 2015, Glover reported that oncologists were worried about increasing costs of drugs used to treat cancer [7], and in 2018 the National Cancer Institute’s President’s Cancer Panel described the need to address the

cost of cancer drugs as “imperative” [8]. (See Fig. 20.1 for a comparison of total health care expenditure as a percentage of the GDP of selected countries.) Overall costs of cancer care are rising due to (i) the increasing incidence of tumors as the population ages (see Section 7.2.2), (ii) greater prevalence of tumors associated with longer survival times of patients, and (iii) developments of further complexities in treatments (Chapters 12e18). In 2011, it was estimated, assuming constant incidence rates and survival periods, that cancer care costs would increase by 39% between 2011 and 2020 (Fig. 20.2). Assuming constant incidence, survival, and cost, we projected 13.8 and 18.1 million cancer survivors in 2010 and 2020, respectively, with associated costs of cancer care of 124.57 and 157.77 billion 2010 US dollars. This 27% increase in medical costs reflects US population changes only. The largest increases were in the continuing phase of care for prostate cancer (42%) and female breast cancer (32%). Projections of current trends in incidence (declining) and survival (increasing) had small effects on 2020 estimates. However, if costs of care increase annually by 2% in the initial and last year of life phases of care, the total cost in 2020 is projected to be $US 173 billion, which represents a 39% increase from 2010 [9].

In 2014, a Milliman report on rising overall costs identified that (i) While the per-patient cost from 2004 to 2014 for cancer patients showed much the same

20.1 General

TABLE 20.1

475

Domains and metrics for defining and assessing value in cancer care delivery.

Domains for defining value Duration/quality of life Cost Quality of care Compassion Health status Equity Adverse effects Opportunity Metrics for assessing value Utilities Cost per quality-adjusted life year (QALY) Efficiency Necessity/reasonableness QALY Cost/quality Effectiveness Affordability Source: Adapted from Institute of Medicine. Assessing and improving value in cancer care. Workshop Summary. Washington, DC. The National Academics Press, 2009, p. 5.

increase for noncancer patients, the perpatient cost of chemotherapy drugs increased at a much higher rate than other cost components and (ii) The site of chemotherapy infusion had shifted from lower-cost physician office to higher-cost hospital settings [10].

20.1.2 Classification of costs by activity The activities are mainly incurred through (i) fees-for-service of medical and ancillary professionals, (ii) salaries of all professional health care workers not charging fees-for-services,

(iii) investigations (pathology and imaging), (iv) drugs (chemotherapeutic and others for side effects), (v) radiation- and other therapies, (vi) in-hospital care, home nursing, and hospice care, (viii) miscellaneous expenses such as travel and accommodation for patients and relatives for treatment and tests [11], (ix) where therapies are associated with hospitalizations or serious side effects, cancer care may cause some economic loss to the patient through inability to work [12]. Of these, most publicity has been directed at the prices of some anticancer drugs, which can

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20. Costs, ethics, and malpractice litigation

Health Care Cost (1970-2016) 20

Percent of GDP

15

Austria Canada Germany Switzerland United Kingdom United States

10

5

0 1970

1975

1980

1985

1990

1995

2000

2005

2010

2015

Year

FIGURE 20.1 Health care cost comparison between countries (1970e2016). Health care cost as percent of GDP (total economy of a nation). Source: Wikipedia. List of countries by total health expenditure per capita. https://en.wikipedia.org/wiki/List_of_ countries_by_total_health_expenditure_per_capita.

be of the order of $US 10,000 per month for “targeted” or personalized treatments [13], while basic long-used (out of patent) cytotoxics are only a few dollars. The cost of some immunotherapies and gene therapies can be up to $US 1,000,000 overall [14] (Table 20.2).

20.1.3 Classification of costs by phase of illness In 2007, it was reported that among studies that reported costs of cancer care in multiple phases of care and for multiple tumor sites, costs were generally highest in the initial year, following diagnosis and the last year of life, and lower in the continuing phase (i.e., the period between the initial and last year of life phases), following a “u-shaped” curve [15]. However, in 2011, it was evident that almost all the total costs of cancer care are incurred equally between (i) Initial diagnostic and treatment costs, (ii) Continuing (maintenance) costs, and (iii) End-of-life (terminal) costs (Fig. 20.3).

The quantity of care provided to terminal cancer patients is apparently little different to health care spending generally in the United States. 25% of all medicare spending is allocated for the 5% of patients who will die within a year [16,17].

20.1.4 Costs arising from side effects and complications of therapies The costs of treating the complications of the primary cancer therapies may be increasing, but data on this point are difficult to establish. A 2018 study showed that, in the United States, the adverse effects experienced by patients during cancer treatment were frequent and associated with a substantial economic burden [18]. The opportunity costs (due to loss of employment years) are also difficult to assess because of the increasing longevity of populations and resulting higher incidences of cancer, together with the retirement age remaining the same [19].

477

20.1 General

Female Breast Colorectal Prostate Lymphoma Lung Leukemia Ovary Brain Kidney Bladder Head and Neck Melanoma Uterus Pancreas Stomach Esophagus Cervix All Other Sites 0

5,000

10,000 15,000 Expenditures (million) 2010

2014

20,000

25,000

2018

FIGURE 20.2 Expenditure for cancer care by type and year (United States). Cost estimates expressed in 2010 dollars using CMS cost adjusters and adjusted for out-of-pocket expenditures, including copayments and deductibles. Estimates for the population younger than 65 were developed using ratios of cost in the younger than 65 and older 65 populations from studies conducted in managed care populations. Source: Mariotto AB, Yabroff KR, Shao Y et al. Projections of the Cost of Cancer Care in the United States: 2010e20. J Natl Cancer Inst. 2011 Jan 19; 103(2): 117e128.

20.1.5 Cost-effectiveness versus coste benefit analyses The prospect of continuing rises in the costs of health care has been met by a small literature on assessing what is “value for money.” “Value” is often measured in terms of extension of life (effectiveness) or extension of quality life (patient benefit) [20]. The distinction has become much more significant in the last three decades, because the number and complexities of investigations and treatments of cancer patients has increased discomforts as well as the significant side effects which patients

may experience. This applies particularly to intensive care for terminal treatment. Although it may extend life for a few days, the patient has no life out of bed and is maximally inconvenienced at the greatest rate of expenditure. Another consideration is the “risk/benefit ratio,” being whether the possible benefit which can be expected justifies the additional suffering and inconvenience which the patient may have to undergo [21]. In some counties, the “costebenefit ratio” may be considered. This is whether a doubtful degree of benefit justifies the investment of scarce and

478 TABLE 20.2

20. Costs, ethics, and malpractice litigation

Spending by specific advanced cancer service category.

Service category

Description

Mean 6-month spending, 2011 $US

Acute hospital care

Acute hospital and inpatient physician services

$16,953.00

Chemotherapy

Intravenous and oral-equivalent chemotherapies

$5705.00

Outpatient procedures

Outpatient surgery and other outpatient procedures

$2281.00

Imaging

X-ray, ultrasound, CT, MRI, and nuclear medicine

$1837.00

Radiation therapy

Radiation therapy

$1832.00

Hospice

All hospice services

$1743.00

Home health

Home care services, excluding hospice

$870.00

Outpatient physician services

Outpatient physician evaluation and management

$865.00

Diagnostics

Laboratory and pathology testing and evaluation

$864.00

Part B medications

Part B medications, excluding chemotherapy

$804.00

Postacute facility

Skilled nursing facilities and rehabilitation hospitals

$611.00

Other part B

Ambulance, vision, and hearing services, etc.

$406.00

Durable medical equipment

Durable medical equipment for home use

$351.00

Total

All service categories

$35,257.00

expensive resources which might be used more effectively for some other patient more likely to benefit [22]. This author notes that in countries with a market approach to health care, coste benefit hardly enters into the calculation. Quality of life considerations are difficult to apply a clinical level. Pressure from relatives, peers, and sometimes fear of litigation (particularly in the United States) may lead the physician to overinvestigate and overtreat the late cancer patient without considering the quality of the patient’s life [23].

20.1.6 Attempts at cost containment The major example of government-sponsored cost control is NICE (National Institute for Health Care excellence) in the United Kingdom [24]. Its responsibility is to provide guidance to the NHS on whether new treatments and services are a cost-effective use of NHS budgets. It takes

into consideration the quality of the patients’ lives by using the QALY (quality-adjusted life year), where one QALY is equal to a year of healthy life. To be accepted, a new therapy should give additional QALYs (over existing therapies) at a cost of no more than £20,000e£30,000. There is still little by way of direct management protocols to reduce expenditure per patient on cancer care. The following areas of treatment have been identified as unnecessary: (i) repeated searches for occult symptomless metastases after a primary attempt at curative treatment (ii) intensive treatment of apparently solitary metastases (iii) use of two treatments in combination when one would be adequate (iv) prolonged palliative treatment (not defined) relative to patient’s life expectation

479

20.1 General

Cost () per Year (in millions)

National Costs of Cancer Care by Phase of Care, All Sites, All Ages, Male and Female, in 2010 Dollars 80,000 60,000 40,000 20,000 0 Initial

Continuing Phase of Care 2010

Last

Currently, a significant proportion of terminal cancer patients die in intensive care wards. A further initiative has been to deliver chemotherapy in the home by nursing practitioners, rather than in hospital or office by medical practitioners [27]. A recent systematic review of home hospitalization found that it might be suitable as an alternative to hospital-based care for cancer patients and could be considered as a possible way of reducing the burden of cancer care [28].

2020

Assumptions: Incidence - Constant (2003 - 05 average rate) Survival - Constant (2005 rate) Cost Increase - 0% per year Source: https://costprojections.cancer.gov

FIGURE 20.3

OVER THE ODDS Linking a drug’s price to the clinical benefit that the medication provides — a practice known as value-based pricing — has the potential to reduce spending on cancer drugs. The DrugAbacus tool provides reasonable estimates of value-based prices* and can be used to indicate whether cancer drugs are priced appropriately.

National costs of cancer care by phases: all sites, all ages, male and female (United States). Source: NIH Cancer prevalence and cost of projections. https://costprojections. cancer.gov/.

More than 50% DrugAbacus price of cancer drugs in the UK cost UNITED less than the STATES value-based price

(v) side effects which are severe relative to the degree of palliation which could be achieved (vi) administration of chemotherapy for psychological support [25].

UNITED KINGDOM 80 60 40 20 Drugs priced below (%)

0

20 40 60 80 Drugs priced above (%)

100

The total estimated spend on cancer drugs in the United States in 2015 was US$32 billion — almost $5 billion more than if the drugs had been purchased at the prices suggested by DrugAbacus. The same drugs would have cost only $14.5 billion at UK prices. 40 The US would save more than $17 billion 35 $32 billion a year if it could buy 30 $27 billion cancer drugs at UK prices 25

Estimated cost of cancer drugs in the United States in 2015 (US$ billion)

One idea described by Rendell [2] which uses a value-based approach for drug prices is to tie them to the level of clinical benefit provided. DrugAbacus, developed at Memorial Sloan Kettering Cancer Center in New York City, is one such calculator of value-based prices. This online tool calculates drug prices on the basis of the relative importance of factors such as tolerability, new mechanisms of action, research and development costs, and disease raritydas well as the monetary value placed on a year of life. Under reasonable economic assumptions, Rendell found that DrugAbacus showed 80%e85% of cancer drugs were overpriced in the United States. Doglin [26] used DrugAbacus to compare drug pricing in the United States with the United Kingdom (see Fig. 20.4). Hospice care is another way of reducing expenditure on cancer care (see below).

100

Almost 80% of cancer drugs in the US cost more than the value-based price

20 $14.5 billion

15 10 5 0

DrugAbacus UK prices prices *The value-based pricing (DrugAbacus price’) used in the analysis assumes that an extra year of life is worth $132,000 and that a 15% discount should be applied to drugs with severe side effects. Increasing the value of an extra year of life increases the percentage of drugs that are available at or below the DrugAbacus price. The data cover the prices of 52 cancer drugs in the US Medicare system and the UK National Health Service. US prices

FIGURE 20.4 Over the oddsdlinking drug pricing to clinical benefit. Source: DrugAbacus https://drugpricinglab.org/ tools/drug-abacus/. Doglin E. Bringing down the cost of cancer treatment. Nature March 2018; 555: S26. https://www.nature. com/articles/d41586-018-02483-3.

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20.1.7 The hospice movement, the Liverpool Care Pathway, current hospice care Traditionally, severe illnesses were treated in hospitals, destitute asylums and prisons, or at home. Terminal phases of illness were short, and death occurred in any of those places. In the United Kingdom, “work houses” (begun in 1834) for the indigent had wards for those who could no longer work. “Homes for Incurables” were first created in 1861, for persons whose family could pay for the care. The “Hospice” movement began in 1948 on similar bases, as places for “palliative/ supportive” care only (see in Chapter 19). The hospices generally exclude medical activity and cost less per day than full-service hospitals [29]. In the United Kingdom, the Liverpool Care Pathway for the Dying Patient (LCP) was developed in the 1990s, as a collaboration between the Royal Liverpool University Hospital and Marie Curie Palliative Care Institute in Liverpool [30]. It was intended to offer the services of a hospice, but within teaching hospitals. In the 2000s, the Pathway was criticized for not delivering hospice care, but rather oversedating and underhydrating patients so that the appearance became that of euthanasia. In 2013, the Pathway was discontinued [31]. Hospice care for cancer patients is now part of the accepted care available in the palliative care paradigm (see Chapter 19). With appropriate care delivery, there is mounting evidence to show that palliative care delivered outside the hospital setting provides benefits in both the quality of care and cost [32e36].

20.1.8 Statement of principles on cost containment by the American Cancer Society It is a fundamental principle of the American Cancer Society that the goal of the nation’s health care system should be to ensure well-

being. The Society supports the following principles in addressing costs in the health care system: [37] • The high rate of health care cost growth needs to be controlled, but only in conjunction with increasing the value of what the nation gets for its health care dollar. A focus on costs alone is not sufficient or acceptable; the health care system needs to be reoriented toward achieving better health outcomes. • Substantial changes need to be made to the financing and delivery of health care from the funding of medical education to reimbursement rates to incentives for both providers and individuals. Incentives in the health care system should be structured to promote the well-being of the patient by placing greater emphasis on prevention, early detection, as well as greater utilization of evidence-based guidelines in the treatment of cancer and other serious medical conditions. Changes should be designed to • Reduce overutilization and underutilization of health care services. • Encourage coordination across the continuum of quality care. • Promote prevention by including incentives for healthier behaviors by individuals. • The health care system needs to develop and provide access to information for patients and providers (e.g., electronic medical records). • Patients and providers should be aware of the costs and benefits of services and products used. Evidence-based guidelines should be promoted and further developed to improve quality and reduce the unexplained variation of health care, but this should be done without unduly constraining the basic science and clinical research needed to discover better, more efficient treatments. Comparative-effectiveness of medical procedures, technologies, and pharmaceuticals and

20.1 General

biologics should be promoted as a means of improving the treatment of critical health conditions. • Providers and patients should have knowledge of the relative value of services and products available. • Health plans, payers, and providers should promote the availability of comparativeeffectiveness information to assist patients and providers in making more informed decisions about treatment and care. Because there is no clear path to containing costs and increasing health care value, a research program should be funded to develop and evaluate promising approaches to containing cost growth while improving the value the nation receives from its health care dollars. Topics that should be explored include the following: • Analysis of existing incentives and experimentation with alternative approaches for providers and consumers should be undertaken by governments, employers, and other major purchasers of health care to better understand the role incentives can play in altering medical practice and personal behavior toward achieving better medical outcomes and improving patient well-being. The costs and benefits of incentives should be explicitly measured. • Defining and developing medical home models and other approaches to ensuring the coordinated care, and the full array of appropriate services are provided in the treatment of chronic condition patients. • Examine the range of effects from the simple (e.g., can cash payments induce patients to lose weight and maintain the weight loss) to the more complex (e.g., how to enhance coordinated care for a cancer patient with comorbidities). • Government, academic institutions, and other entities with an interest in health should conduct or support research on ways to

481

improve analytical and methodological techniques for synthesizing research results and bringing that information to providers and consumers rapidly in easily understandable terms as well as promoting greater utilization of the guidelines. • We should ensure better databases and new research to fill voids in the knowledge of effects on subpopulations.

20.1.9 The global perspective Cancer is the second leading cause of death worldwide behind cardiovascular disease [38]. According to the Global Burden of Disease 2015 Study, which was conducted as part of a comprehensive regional and global research program assessing the mortality and disability caused by major diseases, injuries, and risk factors and involving over 500 researchers representing over 300 institutions and 50 countries, cancer mortality decreased between 2005 and 2015 despite the global incidence rates of cancer increasing during this period Ref. [38]. However, improvements in cancer survival rates due the use of precision medicine or immunotherapy have mainly occurred in high-income countries, whereas in low-income countries cancer prevention, education, and access to cancer screening tests as well as cancer treatment are inadequate [39,40]. The potential of cancer prevention techniques, including vaccinations and smoking cessation programs, to reduce the incidence and mortality rates of cancer has not been sufficiently realized worldwide, and efforts are especially lagging in socioeconomically disadvantaged populations [41]. This has led to worse cancer outcomes and higher incidence rates of cancer in certain lowincome countries [42]. As the global burden of cancer grows, cancer control measures must be tailored to regional and national priorities, underscoring the need for high-quality cancer registries [43]. According to the 2018 GLOBOCAN database, the global cancer

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20. Costs, ethics, and malpractice litigation

burden is predicted to rise to 18.1 million new cases, 9.6 million cancer deaths, and 43.8 million people living with cancer in 2018 [44]. When stratified by Human Development Index [45], highquality registries are still very much skewed to the wealthier nations, but the International Agency for Research on Cancer and other global partners in the Global Initiative for Cancer Registry Development have been working toward improving the quality and coverage of cancer registries. As a result, population-based cancer registries are becoming more widespread [46].

20.2 Paying for the costs The costs of cancer care also can be divided into those borne by the individual and those by the community. Their relative proportions vary from country to country according to the extent of government-sponsored health care [47].

In the United States, because the proportion of the elderly in the population is rising, and cancer is most common in this age group, the costs of cancer care are falling increasingly on government programs, such as Medicare (Fig. 20.5).

20.2.1 Government-funded health care and private medical insurance In the United Kingdom, 93% of the population rely on the government service (the NHS) for health services. In other countries, such as France, Sweden, Australia, and New Zealand, various proportions of the population buy medical insurance. Policies in these countries may be variable as to expenses for particular treatments. In Germany, there is a multicomponent system of compulsory health insurance and some private insurance. In the Netherlands, there is government coverage for long-term nursing care, but all others must pay compulsory insurance.

Cost-Related Access Problems in the Past Year, Among Adults Age 65 or Older Percent * 30

19

20

10 3

4

4

FR

SWE

NOR

5

6

6

8

9

10

7

GER

AUS

CAN

NZ

0 UK

NETH SWIZ

US

* Had a medical problem but did not visit doctor, skipped medical test or treatment recommended by doctor, and/or did not fill prescription or skipped doses because of the cost. Source: 2014 Commonwealth Fund International Health Policy Survey of Older Adults in Eleven Countries.

FIGURE 20.5

Cost-related access problems in the past year among adults 65 and older. Source: Munro D. U.S. Healthcare For Seniors Ranked Poorly Compared To 10 Other Countries. Forbes, Nov 30, 2014. https://www.forbes.com/sites/danmunro/2014/11/30/u-shealthcare-for-seniors-ranked-poorly-compared-to-10-other-countries/#479e5be9339e.

20.3 Ethical issues in medical treatment

In the United States, the percentage of people with health insurance coverage for all or part of 2016 was 91.2%, higher than the rate in 2015 (90.9%) [48]. Government sources of cover include Federal employees’ health benefit plan (FEHBP), Veterans Administration (military), and Medicare (age >65 years). Private health insurance is complex and divided into employer and nonemployer. The nature of the insurance includes traditional reimbursements of fees-forservice and various forms of prepaid contracts for treatment of specified or unspecified future illnesses. Insurance for additional expenses, such as loss of income, disability, long-term care, medicare gap, etc., are available.

20.2.2 Sources of “financial toxicity” This term was introduced in 2013 [49] to highlight the burden of the high costs of cancer treatment, the increasing “out-of-pocket expenses” associated with the treatments, and the increasing underinsurance against those costs. A review covering 10 years from 2004 to 2014 revealed that even insured patients receiving anticancer therapy are vulnerable to financial distress, which can impel patients to borrow money, deplete their savings, or engage in costcoping strategies including nonadherence to prescribed treatment (Refs. [8], [50]). The continuing literature on the topic indicates that between 15% and 80% of patients, according to survey, reported financial hardship due to cancer treatment costs. The highest frequency of hardship is associated with the lower-income levels [51]. The National Cancer Institute publication on financial toxicity and cancer treatment describes the growing evidence that cancer patients are at higher risk of financial difficulty than individuals without cancer and the impact it is having on patients and patient care [52]. The 2017 Milliman Research Report looked at out-of-pocket expenditure for patients and found that high costs of some treatments put these

483

treatments beyond the reach of lower-income groups, thus effecting their treatment success and overall health outcomes. The Report found that the average monthly spending per patient spiked immediately following diagnosis to as high as $US 25,000 from less than $US 2,000 in previous months. Spending declined but did not return to prediagnosis level in subsequent months [53]. The American Society of Clinical Oncology noted that high drug prices can have a severe impact on the financial well-being as well as the physical well-being of cancer patients. It found that 25% of people worried about paying for cancer treatment reported postponing prescriptions, cutting pills in half, or doing something else against doctors’ orders to cut costs. Such behaviors could lead to underdosing or inadequate side effect management and worse health outcomes, including earlier death [54].

20.3 Ethical issues in medical treatment Almost all aspects of oncology involve ethical issues [55]. Issues of privacy can be identified in the administration of screening programs and collection of genomic data on individuals, including children and infants [56e58]. The most significant ethical issues for the practicing clinician arise from the moment of diagnosis of a poor-prognosis cancerdi.e., stages 3 or 4, when the primary tumor is unresectable and metastases are present.

20.3.1 At diagnosis of cancer: who should be told? Historically, medical practitioners often withheld diagnoses of malignancy from patients. Theodor Billroth (1821e94), the great surgeon in the 19th century, wrote I consider it the duty of a surgeon, under certain circumstances, to deceive his patients as to the incurability of their disease whenever he considers an operation unadvisable, or when he declines to undertake it. The

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20. Costs, ethics, and malpractice litigation

surgeon, when he cannot remove, ought to relieve the sufferings of his patient, both psychically and physically. Few persons possess that peace of mind, resignation, or strength of character, call it what you will, necessary to enjoy life quietly with the knowledge that they are subjects of a fatal disease. Patients, although outwardly calm, seldom really thank you for too plain a confirmation of what they secretly suspect [59].

Billroth assumed confidentiality of medical matters to the patient and presumably thought the patient’s relatives could be told if the family situation was appropriate. In addition, prognosis for all cancers at late stage was certain death, so in withholding diagnosis from the patient, prognosis was also withheld. Since the 1960s, confidentiality has been preserved, but there has been a change to greater frankness about diagnosis. This has been associated with maintaining limited frankness about prognosis. With the availability of improved treatments, patients may be told the diagnosis, but not the actual prognosis. Optimism can be maintained in this way. It has been reported that at the present time, most patients are told their prognosis only in the obviously terminal phase of their illness (usually 1 or 2 months before death) [60].

found to have a breast lump tethered to the skindhence very likely to be carcinomadbe given any treatment other than the support care she is already receiving? Less certain are the cases in later stage of a tumor type for which no treatment is accepted as effective. These cases may be attracted to trials of experimental regimens as described in Chapters 16 and 17 or to unproven treatments described in Chapter 18. (b) Suitable for primary treatment: which? For some tumor types, there are few ethical issues. Thus, whether or not a resectable carcinoma of the colon in a patient with no comorbidities should be removed is rarely contentious. For other tumor types, the choices for primary treatment in these cases is usually between surgery, radiotherapy, and chemotherapy (see in Chapters 12e15). The matter is particularly relevant to carcinoma of the breast. In this disease, the outcomes achieved by surgery and radiotherapy seem to be similar (see in Chapters 12 and 14). In addition, in carcinoma of the prostate, radiotherapy and prostatectomy achieve similar results.

20.3.2 Deciding no treatmenteany treatment and nature of primary treatment

20.3.3 Ethical issues in the monitoring and terminal phases: hope and abuse of hope

There are several options to be considered. According to the guidelines for informed consent (see in Chapter 12), all of them are discussed with the patient, usually initiated by the clinician [61].

Every time a person seeks the advice of a medical practitioner, hope is felt that the symptom or illness will not be significant or, if serious, is treatable. Even faced with a diagnosis of a severe and probably incurable disease, hope persists for many reasons [62]. These include that the patient may be “one of the lucky few” who survive the disease or that some new treatment will become available before the patient dies. Most patients accept treatment and remain hopeful of a long life ahead, even when all accepted therapies have been given and the

(a) No treatment versus any treatment No treatment is probably indicated in cases of significant comorbidity. For example, should a 95-year-old bed-ridden woman with advanced dementia, who has already suffered bouts of pneumonia due to poor cough reflex, and is

20.3 Ethical issues in medical treatment

patient is nearing their “lifetime limit” of radiation- and chemotherapy (see Section 13.1.10). When the last/“terminal” phase occurs, some low-dose therapy may be continued to preserve essentially false-hope, and also for the patient to be spared any sense of being “abandoned” by his/her oncologist. In the same stage, patients may be offered experimental therapies on a “just in case it does good” basis, when there is no proof that such untested therapies will offer any real benefit [63].

20.3.4 Ethical issues in withdrawal of supportive care: physician-assisted suicidedeuthanasia The commonest situation in which this issue arises is when a comorbidity supervenes in a terminal cancer patient. Thus, a patient with Stage 4 lung cancer with metastases to the brain may have severe neurological deficit. If pneumonia develops due to poor cough reflex, should the pneumonia be treated or should “nature take its course”? Physician-assisted suicide is an extension of these situations. For example, a patient with disseminated prostate cancer may have multiple bone fractures due to the metastases. Any movement, active or passive, such as associated with eating causes pain, and the only effective pain medications are analgesics to the point of loss of consciousness. Is the physician justified in ending the patient’s life at the express wish of the patient? Assisted suicide is legal in only a few states in the United States, and in approximately 20 other countries, including the United Kingdom, Canada, Germany, France, The Netherlands, Switzerland, the Scandinavian countries, and Japan. It is highly controversial because of the issues clinicians may have with taking rather than prolonging life (including religious convictions as with the Commandment “Thou shall not kill”) juxtaposed against the durations of

485

terminal pain which the cancer patient may have to enduredunknown before the present times. Certainly, effective analgesia is available, but some would argue this leaves the patient in a state of little more than “cardiorespiratory life.” Perhaps one of the key issues is the “wanting to die.” A person at any time of life, or state of health, may wish to diedor at least state the wishdbut it is a wish which is uncommonly translated into action, and thus is almost always not fully sincere, or merely a manifestation of mental depression. If the only way to achieve symptom control is terminal sedation, is that a reasonable approach or can that in any way be equated with euthanasia? [64]. Discussion on the topics of assisted death and euthanasia is difficult.

20.3.5 Role and rights of relatives In many countries, the patient’s relatives may be included in decision-making about treatments. The degree of involvement varies from case to case, and, usually, the relatives accept the advice of the health staff. Ethical issues arise when the relatives request that the patient’s previously expressed wishes (as in an Advance Care Plan, see in Chapter 19) be ignored (see previous subsection). Alternatively, the relatives may disagree with staff advice, and according to circumstances, want the health staff to continue or to stop treatment. Disputes can lead to litigation (see Section 20.6 below) [65e67].

20.3.6 Ethics of reducing the patient’s estate The high costs of some cancer treatment are well recognized, and more and more agents and combinations (of modalities or agents within one modality) are being trialed (see in Appendix A9). For a patient with Stage 4 cancer and full knowledge of the prognosis, costs of cancer

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care may become relevant through family circumstances. For example, a patient has terminal Stage 4 malignancy and has relapsed after all conventional therapy. The patient also has moderate personal assets and a young family member is showing high academic ability. Many high cost unapproved/experimental unreimbursable therapies are offered, which at best might extend the patient’s life by a month or so. Ethically, should the patient spend his/her assets on a month of his/her own life or alter her will to make the young family member a beneficiary? Ethical issues and value in oncology largely relate to the cost of treatments and the efficacy of those treatments. A good introductory discussion is given by the summary of the Institute of Medicine workshop: Assessing and improving value in cancer care [68].

20.4 Ethical issues in oncological research 20.4.1 Research “participation” Few patients of their own accord seek out clinical trials in which to participate. Thus, usually, patients not long after diagnosis are often invited to participate in a clinical trial (see in Appendix A9). Without clinical trials, however, there would be no way of assessing new therapies [69,70]. This situation is ethically difficult. The reported benefits will be only an average of a whole group. Some patients in the group may have severe side effects of the treatment than patients not receiving the treatment. It is also possible that some patients will die of the treatment, and hence sooner than if no treatment had been given. Another ethical issue is whether or not the attending clinician should attempt to persuade a reluctant patient into a trial. A further ethical issue arises if the trial budget cannot assist with all the “out-of-pocket” expenses (see Section 20.2.2). The ethical issue of allocation

of resources then arises. In some countries, there are charitable “compassionate funds” available for some patients in this situation.

20.4.2 Likelihood that the research will produce an outcome At present, “research” still can accept compilations of cases (see in Appendix A9). Thus, although not encouraged, some clinicians may conduct their own informal studies by offering nonstandard therapeutic regimens. These are usually “off-label” uses of existing agents. If good effects are noted, they may be able to publish this work. If a patient enrolls in a trial, it is ethically desirable that (i) credible evidence exists from preclinical testing. This refers to clinical circumstance for which a “standard therapy” is accepted, a new clinical trial should be based on laboratory or clinical evidence of the possible superiority of the new agent or regimen in comparison with “standard” therapy. If one or more previous trials have shown the agent to be ineffective, any proposed new trial should be based on reasons why the new trial may yield better data than the previous trial(s). (ii) enough cases being recruited to the trial. (iii) the design and conduct of the trial should minimize biases, to ensure that the results will be valid in the sense of answering the original question. (iv) the trial should not be of a treatment compared with no treatment, unless no other treatment is known to be beneficial. Other ethical issues relate to Phase 0 and Phase 1 clinical trials. In these, normal individuals consent, usually for monetary payment, to being exposed to a potentially harmful agent [71,72]. The subjects should be fully informed, and the payments should reflect the risks.

20.5 Ethical issues in resource allocations at national and international levels

Phase II and III clinical trials raise additional ethical issues insofar as patients in one or other group in a particular trial may not be treated optimally. However, which group in any particular trial suffers cannot be foreseen (if it were foreseeable, the trial would be redundant and should not be undertaken). Apart from human studies, the main aspects of oncology research relate to use of animals for detecting potential carcinogens and testing potential drugs. Most of the issues relate to welfare of the animals (Ref. [72]).

20.4.3 Risk that the research will produce harm to the participants As mentioned in Section 20.4 above, there is a risk that patients my suffer harm in the course of a trial undertaken as part of medical research projects. (The Research Ethics Review Committee (ERC) is a 27-member committee established and appointed by the Director General. Its mandate is to ensure WHO only supports research of the highest ethical standards. The ERC reviews all research projects, involving human participants supported either financially or technically by WHO.)

20.5 Ethical issues in resource allocations at national and international levels 20.5.1 Allocation of resources nationally In communities with limited financial capacities, questions arise as to how best to allocate this resource. This aspect of “Health Economics” is becoming more and more pressing. This is because the costs of delivering all possible medical care to all individuals who may benefit from the many kinds of care continue to rise and exceed many other costs to community. Even the wealthiest communities are beginning to consider this issue.

487

The decisions required can be allocations between • Health and nonhealth expenditure • Direct patient care and prevention • Direct patient care and research (if these can be separated, because in many disciplines of medicine, these activities are interlinked) • Live-saving and nonelife-saving treatments • The young and the old • Infrastructure, equipment, and salaries of staff [73e76].

20.5.2 Allocation of resources internationally Ever since the end of the Second World War, there has been commitment to the idea that all humans, wherever they live, have the right to health. The Constitution of the World Health Organization (45th Edition, Supplement, October 2006), expresses it as follows: The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.

20.5.3 Ethical considerations in relation to health care availability according to international standards The WHO World Cancer Report provides a detailed analysis of cancer from an international perspective [77].

20.5.4 Ethics and research Certain groups such as refugees are considered vulnerable when being targeted for research [78]. Research in third-world countries runs the risk of being underpowered for several reasons: target populations, numbers needed to have statistical significance, comorbidities, etc.

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Setting aside the validity of these pieces of work, there are ethical issues surrounding the patients recruited to such studies [79]. In the absence of absolute certainty, rarely if ever reached in biology, it is essential to adopt an attitude of responsible caution, in line with the principles of primary prevention, the only one that may prevent unlimited experimentation on the entire human species L. Tomatis, 2002 (former director of the International Agency for Research on Cancer (IARC [80].

20.6 Litigation, malpractice, and avoidance of errors 20.6.1 Scope and natures of complaints Medical malpractice litigation varies according to specialty. In general, surgeons are sued more commonly than others, but whether or not cancer operations result in more or less than the general rate of litigation is unclear (Fig. 20.6). Medical oncologists are less sued than general physicians. Main complaints are errors in dosing, either under- or overdoses arising through prescription errors. Other complaints are related to delay in diagnosis, inadequate pain control, informed consent, maintenance of privacy, genetic counseling, and communication breakdown [81,82]. However, other specialists may be involved when the complaint is delayed or during incorrect diagnosis. Legant (Ref. [81]): Alleged errors in cases of delay in cancer diagnosis typically involve misreading of pathology slides; breakdown of communication between the diagnostic physician (pathologist or radiologist) and the ordering physician, or between the physician and the patient; or failure to follow a symptom or biopsy a mass after initially negative tests. These claims mostly affect primary care and diagnosing physicians such as radiologists and pathologists, rather than oncologists. Nevertheless, oncologists often become entangled in the cases too, either as part of the usual litigation sweep to involve all physicians providing care, or as expert witnesses.

Imaging specialists are sued relatively frequently for failure to identify lesions, so that diagnosis and treatment is delayed. Pathologists are sued for wrong diagnosis. These diagnostic errors can be from a screening test (e.g., cervix) or a surgical specimen. In these cases, the following questions could be raised: (1) The appropriateness of the specimendWhat kind of specimen was taken in relation to the clinical question and how was it handled (none or appropriate fixation)? Could the specimen be sufficiently identified (prevention of specimen mix-up)? Explicit criteria for the suitability of the specimen in relation to the clinical question should be available, and the pathologist should report if the diagnostic material is ill-suited for the question. (2) The suitability of the clinical informationdLack of adequate information may be a source of latent causes of error. What clinical information was available? What is the complete clinical question? This information is essential for guiding the pathologist in both morphological interpretation and the use of ancillary techniques. (3) Analytical factorsdThis involves the review of all the logistic and technical processes in the laboratory involved in sampling, tissue processing, slide preparation, and the appropriate use of ancillary techniques, especially immunohistochemistry. Are protocols routinely being used for defined types of diagnostic procedures? What standard operating procedures are in action for proper laboratory work-up and also to prevent labeling errors and consequent slide mix-up? (4) Postanalytical factorsdAfter slide examination, the conclusion is formulated and then the final report is made, clerically processed, and delivered to the attending physician. How is the report in terms of correctness and completeness? Computerized information

489

20.6 Litigation, malpractice, and avoidance of errors

Claim with payment to a plaintiff

Any claim

Neurosurgery Thoracic–cardiovascular surgery General surgery Orthopedic surgery Plastic surgery Gastroenterology Obstetrics and gynecology Urology Pulmonary medicine Oncology Cardiology Gynecology Neurology Internal medicine Emergency medicine All Physicians Anesthesiology Diagnostic radiology Ophthalmology Nephrology Pathology Dermatology Family general practice Other specialties Pediatrics Psychiatry 0

5 10 15 Physicians with a Malpractice Claim Annually (%)

20

FIGURE 20.6 Annual malpractice claims against physicians (United States). Source: Jena AB, Seabury S, Lakdawalla D et al. Malpractice risk according to physician specialty. N Engl J Med 2011; 365:629e636. https://www.nejm.org/doi/full/10.1056/ NEJMsa1012370.

systems require a check on processes of verification and authorization, report format, and proper delivery [83].

20.6.2 Avoidance of errors: second opinions Second opinion in pathology is intended to expose clinically significant errors that have a

direct impact on patient care [84]. In surgical pathology, many reviews discuss alleged error rates in cancer diagnoses overall [85]. When to obtain opinions in anatomic pathology is a complex issue. The authors discuss the cognitive process of morphologic interpretation, the influence of expertise on the need for a second opinion, the role of ego, and the impact of economic factors on the patterns of consultation.

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20. Costs, ethics, and malpractice litigation

However, there is much less consensus on diagnostic criteria for cancers of some organsd especially in small biopsiesdthan in others. The reasons for discordant opinions are often based on subjective weightings of histologic features (see in Chapter 10). Reviews of discordance should be done by practitioners from an entirely separate institution, because those in the same institution are likely to recognize, and favor, the reports of their own colleagues. The “not quite certain” reports are not black and white, and where written as such have to be considered carefully [86,87]. There has been little change in uniformity of definition, attitudes, and perception of interpretive error in anatomic pathology in the last 10 years [88]. Achieving quality communication in surgical pathology is essential. Finally, the pathologists’ availability to answer questions and discuss cases is an important factor in effective communication, including their willingness to verbally report urgent and significant unexpected diagnoses to ensure that important diagnoses are not overlooked [89] (Table 20.3). In radiology, there are apparently higher rates of discordant opinions. Some literature suggests

TABLE 20.3

that second opinions by subspecialist radiologists may improve accuracy of reports [90].

20.6.3 Arising from advance care directives In the United States, there is a growing incidence of lawsuits brought against physicians and medical institutions that ignore or override advance directives, resuscitating patients against their written instructions, and providing unwanted life-preserving care. Oncologists face liability for not explicitly warning patients about the limited benefits of care, and health care providers face legal action for failing to let a patient die. Advance Care Directives or “Living Wills” are becoming more common and in some countries have legal status [91]. In oncology, there is a lot of unwanted treatment at the end of life. Treatments may be given against a patient’s wishes for several reasons: (i) The patient had never expressed any wishes or documentation was not available to treating clinicians

Different methods of peer review.

Review of a randomly selected percentage of cases Focused internal review of specific organ system or malignancy type (for example, breast cancer) Interdepartmental conferences (for example, tumor board) Intradepartmental quality assurance conference Frozen section/permanent section correlation Cytology/surgical pathology correlation Review of previous pathology material Intradepartmental review of material before release to other institutions Review of outside diagnosis of in-house cases Source: Nakhleh RE. What is quality in surgical pathology? J Clin Pathol. 2006; 59(7): 669e672.

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[5]

20.6.4 Importance of multidisciplinary meetings

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In recent decades, multidisciplinary meetings have become widespread in specialized/ “tertiary” hospitals. Each body area in which tumors occur, for example, lung, upper gastrointestinal tract, gynecology, etc., is managed in a Unit which holds meetings to discuss unusual or problematic cases. In these, the imaging, pathology, and other investigations are shown. This includes reviews of images and pathology on patients referred after initial diagnosis and assessment outside the hospital. A wide range of discrepancy rates between original imaging and pathology reports and opinions of staff at the specialist institution have been reported [93,94]. The significance of the differences in opinion may be similar to those observed in studies of second opinions (see above). Changes in therapeutic plan made in multidisciplinary meetings may be influenced by revelations of comorbidities as well as changes in imaging and/or pathology assessments [95].

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