Commercial determinants of cancer control policy (Eurohealth)
https://eurohealthobservatory.who.int/publications/i/commercial-determinants-of-cancer-control-policy-(eurohealth)
European Observatory on Health Systems and Policies (downloadable)
27 April 2022, Journal article
Summary by Dr. Cécile Bour - 30 April 2022
In this Eurohealth report, the authors focus on the negative influence of private interests on prevention, screening, and healthcare policies.
Cancer control, as defined by WHO and also often referred to as "cancer prevention and care," consists of a continuum from prevention, early detection (i.e., screening and early/rapid diagnosis of symptomatic patients), diagnosis, and treatment, to palliative/supportive care and survivorship
A definition of "the commercial determinants of health" was presented to the United Nations (UN) General Assembly 2017: "The commercial determinants of health are those conditions, actions, and omissions that affect health. Commercial determinants arise in the context of the provision of goods or services for payment and include commercial activities, as well as the environment in which commerce takes place.
Generally, private sector activities that impact population health."
This issue of the commercial determinants of cancer, referred to as the "dark side of health," has not yet been thoroughly explored.
According to the World Health Organization (WHO), 30-50% of all cancer cases are preventable, with tobacco use being the leading preventable cause of cancer in Europe. Other important risk factors are alcohol consumption, overweight and obesity, poor diet, and insufficient physical activity.
Added to this are sources of radiation and other chemical carcinogens, including from the cosmetics industry. These sources also increase the risk of developing various forms of cancer.
Europe is one of the largest markets for alcohol sales and is also the region with the highest proportion of alcohol-related diseases and premature mortality.
Europe has the highest average current tobacco use among adolescents. The evidence for a causal link to cancer is indisputable.
Of course, various behavioral and environmental factors account for the increased incidence of cancer. Many are preventable, but corporate interests and actions undermine public health efforts to combat them.
The response to industry criticism takes many forms. It ranges from threats of legal action for infringement of the industry's commercial rights, including intellectual property and economic freedom, to concerns that constraints on the industry will have a disproportionate impact on the economy and employment.
Other examples of industry tactics include enhancing corporate reputation (the concept of corporate social responsibility (CSR)*), denying the impact of their products or diverting attention from the harms caused by their products, and attempts to build an "evidence" base and then divide the public health community.
The bottom line is that the impact of tobacco and alcohol industry players on the cancer continuum includes a range of effective tactics that undermine public health, including recent direct marketing** to consumers.
* Companies consider environmental, social, economic, and ethical issues in their activities.
** Direct marketing is a communication and sales technique that consists in broadcasting a personalized and inciting message to directly reach a target of individuals to obtain an immediate and tangible reaction.
Deceptive drifts
A-Innovation as a panacea
It is striking that most of the articles reviewed in this report raise a particular concern, namely a blind and deceptive faith in "innovation."
Innovation has great appeal to policymakers, clinicians, the public, and donors, but all authors caution against launching new preventive, diagnostic, or therapeutic innovations without a rigorous evaluation of their basic safety and benefit to the population and call for an adequate evidence base to demonstrate their effectiveness and cost-effectiveness.
They also remind us of the rapid growth in pharmaceutical revenues generated by the sale of cancer drugs, despite a lack of return in terms of survival or cure during the same growth period.
B- Screening
The Council of the European Union still recommends screening for cervical, breast, and colorectal cancers, but with more nuanced information, and has published a guide to the proper use of systematic screening.
Since then, research continues to evaluate the advantages and disadvantages of screening, particularly for other types of cancers (lung is under study).
Despite an evidence base that does not support such practices, much "opportunistic" (i.e., off-recommendation, requested by a public demanding more medical care) screening occurs across Europe.
Managers and sales representatives play an essential role in promoting systematic testing practices that can do more harm than good (see the massive sponsorship at Pink October).
Commercial drivers can work through financial incentives, creating a "culture" that promotes rapid adoption of new technologies, lobbying, and marketing to clinicians and consumers.
The report says that many people may be included in irrelevant screenings, and resources may be diverted from those most in need of medical attention and treatment.
Overdiagnosis, in particular, is currently a specific problem. Since, at the individual level, it is not possible to determine whether cancer will progress or not, healthy people may be subjected to potentially unnecessary diagnostic procedures and treatment, with a consequent risk of adverse effects.
For example, thyroid screening has no benefit for the population but provides considerable evidence of massive overdiagnosis and unnecessary therapeutic procedures.
The first wave of cancer screening tests was developed mainly in the public sector and promoted by charities and professional bodies. There is a new wave of innovation in cancer screening, and much of this innovation comes from the private sector, often supported by professionals.
Diagnostic companies have become essential players in promoting new screening technologies, private laboratories and clinics may seek to expand the market for screening services by offering new technologies (such as 3D mammography) or expanding into disease areas not covered by national programs, which could increase public demand and intensify political pressure for their adoption within public health systems.
There has been a lot of commercial enthusiasm for cancer screening (such as predictive software, see for example here and here), industry analysts predicting the potential for "drug-like blockbuster revenues."
Companies developing new cancer screening technologies based on liquid biopsy have attracted huge billions of dollars in private investment. The technology has been very disappointing in screening, clinical studies that lack the rigor to assess the harms and benefits of this technology fully and accurately have been published to great media hype, and a phenomenon of "capture" of key opinion leaders has been added, through research collaboration with industry.
There is evidence, according to the report, that the new generation of molecular testing is being marketed using strategies that come directly from the pharmaceutical industry: recruitment of key opinion leaders, direct-to-consumer advertising, direct-to-physician advertising, and funding of NGOs, including patient organizations, to engage in ostensibly independent lobbying for government adoption of new technologies.
The commercial drive to generate revenue leads to distorted messages that present a partial view of the scientific evidence, biased towards claimed health benefits but obscuring potential harms, resulting in unnecessary public expenditure.
Carefully crafted public relations strategies can ensure media coverage that reinforces this unbalanced image, such as liquid biopsy molecular tests, 3D mammography, and artificial intelligence-based detection, which are heavily geared toward declaring tremendous benefits to populations and generally fail to report conflicts of interest.
C-Hyper-technology
Da Vinci Robot: this device is put forward in the report as the archetype of NPT (non-pharmaceutical technology).
Few technologies better represent the commercialization of the so-called NPT than the Da Vinci Robotic Surgical System.
This device, which allows surgeons to perform surgery remotely, sitting at a console to operate remote-controlled arms for micro-invasive surgery, was first approved by the U.S. Food and Drug Administration (FDA) in 2000.
Despite the lack of clear evidence of its superiority over open and laparoscopic techniques and its enormous costs, the method has been widely adopted throughout Europe, even in countries with lower living standards. Its inherent benefits, including improved visualization of the surgical field, greater range of motion of the robotic arms, and improved ergonomics for the surgeon, were expected to translate into improved patient outcomes. However, in the case of prostate and rectal cancer, no improvement in functional or oncologic outcomes was observed.
This is even though guidelines have been created to improve the rigor of evidence collection, particularly for medical devices.
Regulatory approval of a new medical device or technology requires clinical data and a demonstration of its safety before bringing the device to market.
In comparison, systemic therapies must go through a more complex process of demonstrating efficacy beyond current standards of care. This partly explains the lack of randomized controlled trials for medical devices.
However, the recent Cumberledge review highlighted the devastating impact of integrating drugs and devices without rigorous and thorough evaluation of the implications for patients, especially in terms of safety and health benefits. Unfortunately, the design of studies used to evaluate new technologies often lacks rigor. However, it can form the basis for clinical implementation, with less reliable single-center retrospective series still dominating the literature.
D-Lack of balanced media coverage
This drift can influence public perceptions and those who make decisions about funding biomedical research and clinical care, exacerbating general support.
We refer here to the enormous enthusiasm for innovation and, in particular, the idea of personalized or precision medicine, rooted in the long-standing belief that genomics will revolutionize the practice of medicine, a view now reinforced by faith in the transformative potential of digital technologies, including artificial intelligence
Public policymakers are prone to this form of buy-in, which can have two potential adverse effects on public health, including:
- a willingness to adopt new technologies because they are believed to represent the future of health care, without solid evidence that they improve clinical outcomes;
- misallocation of research resources, as funding goes to the discovery and development of new technologies, at the expense of simpler incremental improvements in care delivery, such as improved rapid clinical diagnosis for patients with actual potential symptoms of cancer
This can be a waste of resources, but in countries that lack qualified technicians in areas such as imaging or endoscopy, it exacerbates these shortages and delays in diagnosis for symptomatic individuals. It also exacerbates growing inequalities in access to medical care.
The landscape of commercial screening offerings is being transformed by innovation in diagnostic technologies and the broader development of the Internet as a new mechanism for consuming health care. In recent years, various consumer biological testing services sold over the Internet have been the subject of regulatory action.
In conclusion, and as Ioannides noted, medicine and health care waste society's resources because "we" as clinicians have allowed evidence-based medicine in cancer to be diverted by using technologies with marginal effectiveness but maximum cost.
The commercial determinants of cancer remind us that both governmental and whole-of-government approaches (combining vertical and horizontal management while partnering with organizations outside of government) are essential to meeting the challenge facing our society and that health decisions remain a political choice.
Range of ways in which private interests influence public health
1. Financial incentives affect all areas of health
- Economic incentives are misaligned with the promotion of overall quality of life.
- There is a misrepresentation of clinical information and public health data. (For example, in breast cancer, read here and here)
Economic incentives drive the development of new drugs with increasing applications, leading to trials over weak comparators (e.g., non-inferiority studies) and approvals based on modest effects in new settings.
In discussing the development of new screening technologies, diagnostic tools using molecular biomarkers, new precision therapies, or targeted drugs, all authors of the WHO report raised concerns about whether a drug or device efficacy measures were validated correctly.
Measures of benefits may or may not track in parallel outcomes that matter to patients, such as data on reduction in overall (all-cause) mortality or parameters such as quality of life; several of the report's authors expressed concern about how social factors and economic incentives have shaped clinical care, advertising, and investments in ways that do not promote the health and well-being of patients overall.
2° Lobbying
On behalf of the industry, and with the complicity of physicians and opinion leaders, the promotion of cancer screening research and technology development has led to an overemphasis on the benefits of these tools and technologies. It underestimates the harms of false positives or overdiagnosis.
3. Advertising
Many authors have drawn attention to the misleading nature of advertising and media communication about cancer risks and treatments.
They have raised concerns about the overselling of cancer drugs and new and unproven technologies.
4° Economic factors
Economic factors influence the rising costs of care, which disproportionately affect the most disadvantaged. For example, the uncritical press for new drugs and "technomania" has contributed to the increasing costs of new drugs and screening technologies, making access to care even more difficult for many patients, particularly those in developing countries.
Regulatory tools could encourage investment in actual prevention measures (alcohol, tobacco, obesity, physical inactivity), better palliative care, and more integrative care.
There is also a need for improved medical education on the roles of commercial interests in shaping cancer care, which may already mitigate tendencies toward "technomania" among physicians so that medical students have a better appreciation of the costs and benefits of new treatments and technologies, as well as the importance of palliative and end-of-life care with better patient integration.
How can we do better?
In summary, there are ethical and justice issues everywhere, and these issues have to do with respect for patient autonomy, equity, and beneficence.
Autonomy, with strong patient support and transparent communication about the benefit-risk balances of health devices.
Equity and justice about risk identification and prevention, early detection, alternative solutions, therapeutic solutions, and palliative care appropriate to the patient's real need.
Regulatory tools need to be developed to improve medical education, emphasizing transparency. Public administrations, national governments, and international agencies can do, and civil society can demand to mitigate the harms associated with conflicts of interest.
The authors also note a clear need for high standards, both at the level of the European Medicines Agency and through more robust health technology assessment mechanisms, with more sophisticated pricing and reimbursement systems at the national level.
The inadequate quality of research and regulatory standards and the critical lack of correlation between economic incentives and what is sought in terms of overall patient quality of life is a critical issue.