It was because I had published what appears to have been one of the earliest meta-analyses in medicine (Stjernswärd 1974) that Iain Chalmers invited me to provide an account for the James Lind Library explaining how I came to do it (Stjernswärd 2009). My analysis of five trials of adjuvant radiotherapy for breast cancer identified a previously unrecognized hazard of the treatment – increased mortality. My findings prompted more detailed systematic reviews and meta-analyses, which confirmed the effect and elucidated its causes. As a result, radiotherapy regimens to control local recurrence of breast cancer were improved, and the women most likely to be helped by radiotherapy were selected more carefully (Cuzick 2006). Iain Chalmers has now invited me to provide a brief account of how my findings influenced what I have done subsequently to help people with cancer.
Promoting international collaboration to address treatment uncertainties
The meta-analysis convinced me of the need to recognize that accepted treatments do not necessarily do more good than harm. It also made clear that cancer treatment trials had to be much larger if they were to be expected to yield statistically reliable results – and this meant that there should be greater multicenter and international collaboration in doing these studies.
I had done the meta-analysis after being appointed clinical head of the Ludwig Institute of Cancer Research in Lausanne, Switzerland. This post, and my later appointment as director of the Ludwig Institute in Bern, provided me with the opportunity to initiate, with Marvin Zelen of Harvard, two international multi-institutional cooperative study groups to assess adjuvant therapies in patients with breast or lung cancer. These initiatives led to the creation of the Ludwig Breast Cancer Study Group in 1977, later renamed the International Breast Cancer Study Group (IBCSG 2002). The Group has continued to produce important information on the impact of adjuvant therapies on the quality of life of people being treated for cancer.
WHO and global cancer control programmes: prevention, treatment, and palliative care
When I left the Ludwig Institute in 1980 to become Chief of Cancer at the World Health Organisation (WHO) I applied the principle of finding out what is already known, organising services to reflect this knowledge, and research to address continuing uncertainties. My philosophy was that nothing would have greater impact in global cancer control than being able to deliver the knowledge that already existed in the developed world. Out of the eight most common cancers globally (Parkin et al. 1984), five were more common in developing than in developed countries. Three of these were preventable; early diagnosis increased survival in three; therapy is curative in three, but only if the diagnosis is made at an early stage; and pain relief and palliative care are needed for most (WHO 1990a).
In my interview for the job at WHO I had presented Halfdan Mahler, the director general of WHO, with a 3½ page document outlining how I wished to reorient WHO’s Cancer Program to achieve global coverage. At that time, even in WHO, the prevailing dogma was that cancer was not a major health problem in developing countries. I told my director general that “there cannot be one future for the developed world and another for the developing. Either it is one common future or none”.
I explained what I thought we could achieve with the programme I had outlined. I suggested that it would be like high jumping, from 3 cm to 164 cm, while developed countries were spending all their resources on jumping from 164 to 166 cm. I pointed out that the great majority of cancer patients were incurable in developing countries, even those with cancers that could be cured with standard therapies if they had been found earlier. Almost all cancer patients in the developing world suffered severe pain, so pain relief and symptom control would have to be one of the priorities (WHO 1981).
Global resources for cancer control were limited and horrifyingly unequally distributed, and it was not realistic to expect them to increase appreciably any time soon. A public health approach for delivering cancer control worldwide was worked out, using systematically collected evidence to identify rational priorities and strategies, and working whenever possible through establishing national cancer control programmes.This entailed prevention of preventable cancers; earlier diagnosis of curable cancers presenting too late for effective treatment; making curative therapies more widely available; and organizing pain relief and palliative care for incurable patients.
We launched this reoriented WHO global cancer control programme in collaboration with the WHO Division of Information and Health Education (WHO 1984), and it was picked up in daily national and international newspapers, international technical journals, and radio broadcasts (WHO 1986a). The Lancet drew attention to our programme in notes on preventing primary liver cell cancer (Lancet 1983), cancer in the third world (Lancet Note 1984a), and the objective of freeing cancer patients from pain”(Lancet Note 1984b).
The Cancer Unit was severely under-staffed and dependent on extra-budgetary resources I was able to raise from the German Ministry of Health, the Canadian Government, and the Australian Cancer Society. Our programme was also helped greatly by many expert volunteers, for example, David Eddy (USA) for quantitative data and modeling strategies; Anthony Miller (Canada), for epidemiology and screening; and Robert Twycross (UK), Neil MacDonald (Canada), Eduardo Bruera (USA), and Neil Donaldson (Canada), for aspects of palliative medicine, Jerry Martin (Canada), for management and Gillly Burn (UK) advocacy India.
Primary and secondary prevention
As tobaccohad been confirmed asa major cause of ill health, we organised a consensus meeting in 1981 on lung cancer, which had overtaken gastric cancer as the most important cause of cancer deaths. The recommendations stressed the need and cost-effectiveness of changing priorities to primary prevention of lung cancer rather than committing extensive resources to treatments of uncertain benefit (WHO 1982).
Liver cell cancer was the eighth most common cancer in the world and the majority of cases occur in developing countries. Patients were always beyond cure at the time of diagnosis. In 1982, WHO convened a meeting to review the evidence suggesting that the hepatitis B virus causes liver cancer and concluded that it was strong enough to justify use of a vaccine against it as a strategy for preventing this cancer. Effective brand name vaccines were available, but only in limited quantities, and WHO recommended that other types of HBV vaccines be developed and that field trials be done to test their effectiveness in reducing the incidence of liver cancer (WHO 1983a; 1983b). Within a few years, affordable, effective vaccines had been produced in Australia and China and routine vaccination of newborn in populations with an HBV carrier rate higher than 12% began. As cancer control is too important to leave to oncologists, WHO’s Expanded Program of Immunization became responsible for this vaccination programme. Establishing a National Cancer Control Program in Mongolia revealed that 40% of cancers were primary liver cell cancers (NCCP 2007). thanks to Mongolia’s Minister of Health at that time, there is now since 1996, 96% coverage with neonatal HBV vaccinations.
A WHO study group was set up in 1989 to assess the role of “Diet, Nutrition, and the Prevention of Chronic Diseases” (WHO 1990b). It addressed the diversity and complexity of diets in different countries, of local food supplies and the social economic and political contexts in which changes of national diets are to be sought. A general approach, a population-oriented primary prevention strategy based on national nutritional goals was proposed. Population nutritional goals were outlined and recommendations were made to national governments. Existing dietary recommendations in industrial and developing countries, were summarised as well as those done to reduce coronary heart disease risk and cancer risk (WHO 1990b). Among the conclusions done was that free sugars should account for between 0 and 10% of total energy needs. This caused uproar from the sugar industry and one big USA sweet company led the attack on WHO. But that will be another story, together with examples on how the big international companies try to manipulate essential drug policies for cancer therapy and pain relief.
Our efforts in secondary prevention concentrated ways of diagnosing some cancers earlier. In developing countries, cancers often present late, at a stage beyond any hope of cure. The term ‘down-staging’ (Stjernswärd et al. 1987; Stjernswärd and Hanson 1997) was used to describe efforts to identify cancers at an earlier stage. For example, in Sri Lanka and India primary healthcare workers were trained to diagnose oral leukoplakias and refer people for diagnosis and possible early treatment (Warnakulasuria et al. 1984). We suggested that the same ought to be possible by visual inspection of the cervix uteri to identify pre-malignant changes. WHO’s International Agency for Research on Cancer in Lyon went on to demonstrate the positive effect of these initiatives to find cancer early enough by acid staining and visual inspection in well conducted clinical trials, for therapy to be helpful (Sankaranarayanan et al.2007).
Radiotherapy was not generally available in developing countries. Although it had very limited curative effect, it was important for palliation. In collaboration with our counterparts in the International Atomic Energy Agency (IAEA), WHO wrote some position papers suggesting how this situation could be improved (Hanson et al. 1990; Nofal et al. 1990; Stjernswärd 1990; Stjernswärd and Hanson 1997), complementing the published NCCP Guidelines (WHO 1990a; WHO 1995; WHO 2002). The Deputy Director of the IAEA invited the Chief of Cancer and the Chief of Radiation, both of whom had recently ‘retired’ from WHO, to discuss this issue. This ultimately resulted in the IAEA creating a Program of Action for Cancer Therapy (PACT), through which they provided radiotherapy machines to low and middle income countries in the context of a NCCP and if not existing established a NCCP too, according to WHO outlines and often with the help of WHO. The IAEA PACT program is already starting to have an impact in global cancer control.
The incidence of cancers in children is higher than it is in developed countries, thus emphasizing the importance of making available effective forms of chemotherapy, so the WHO Cancer Unit established a list of essential drugs for cancer chemotherapy (WHO 1985; WHO 1994). Drugs were selected if there had been at least two randomized clinical trials showing statistically significant effects on important outcomes. All the drugs selected were available in generic forms. This was important as drug expenditure usually is a major economic post in cancer control, in the high income countries. All the palliative care drugs, including opioids listed in ‘Cancer pain relief’ (WHO 1986b) were listed under anti-neoplastic essential drugs in WHO’s ’The use of essential drugs’ (WHO 1992a), thus reflecting the duty of oncologists to address the pain and suffering of their patients (WHO 1990a).
Pain relief and palliative care
Soon after arriving at WHO in 1980, I did a situation analysis to estimate the prevalence of cancer pain. Globally, two thirds of cancer patients end up needing pain relief. As more than half of the world’s cancer patients are in developing countries, and at least 80% of them are, at the time of diagnosis, incurable, pain relief is the only realistic, pragmatic and humane thing we can do for them (Stjernswärd 1985;1988a;1988b;1993). Yet the resources for adequate pain relief were at that time completely inadequate. In India in 1985, for example, there was not a single tablet of oral morphine available in the health services. In sub-Saharan Africa (excluding South Africa) there were only 75 specialists to serve the needs of 290 million people. Pain relief should have been one of the first feasible approaches to helping patients with cancer, yet 90% of the scarce cancer resources were being spent on therapy delivered by specialists – surgeons, medical oncologists, epidemiologists, cancer nurses, and cytologists – who had no or inadequate training in pain relief. WHO estimated that 3.5 million cancer patients globally were suffering moderate to severe pain, and that only a very small fraction of them received adequate pain relief. With Indian colleagues, we estimated that there were 350,000 patients experiencing severe pain who needed relief, and that only 16,000 were receiving it.
The WHO Cancer Unit was responsible for convening the first international consensus on a simple pain relief protocol – the ‘WHO pain ladder’ (WHO 1986b), and the meeting at which the first official definition of palliative care was developed, mainly by Robert Twycross (WHO 1990a). The WHO pain ladder became widely accepted, partly because it can be applied at community level and in homes (Stjernswärd 2004). A second edition of the ladder, with the addition of a guide to opioid availability, was published in 1996 (WHO 1996); and a follow-up for pain relief and palliative care in children with cancer was published in 1998 (WHO 1998a). Although there have been some sensible suggestions for flexibility in applying the pain ladder (Vargas-Schaffer 2010), it continues to be considered an essential principle in pain management (Watson et al.2009).
Once a valid method for pain control had been established (WHO1986b), strategies, priorities, guidelines and recommendations for implementation of pain relief and palliative care were worked out (WHO 1990a; 1992b; 1995; 1997). Nine concrete recommendations on establishing palliative care and ensuring opioid availability were made to the then 167 member states of WHO, which, if implemented, would have a major impact on the quality of life of cancer patients. Their implementation would require strong political motivation and leadership, but could be achieved without high expenditure. A global network of leading individuals and organizations was established for implementation (WHO 1990a;Stjernswärd 2007). We needed to make people aware that freedom from cancer pain is their right (Stjernswärd 1988a;1988b;1993; Stjernswärd and Clark 2004). Civil society was also addressed and urged to ensure that freedom from pain should come to be seen as the right of every cancer patient (Stjernswärd and Backman 2009; Backman and Stjernswärd 2012). India became the first country in Asia to declare palliative care a human right (HRW 2012).
These initiatives were important in establishing successful national palliative care programmes, combining drug availability with education and training. Pain relief and palliative care were declared responses to a neglected humanitarian problem solvable by a public health strategy (Stjernswärd 1993; 2007) and primary health care approach. Cancer pain was used as spearhead. It was made a mandatory part in every National Cancer Control Program (NCCP)/National Palliative Care Program (NPCP). From the outset, we involved relevant governmental and international organizations.
WHO Demonstration projects were initiated (Stjernswärd et al.1996) – one in Catalonia, Spain, now with over 20 years follow up (Gomez-Batiste et al.1996;2002;2007;2012; Stjernswärd and Gomez-Batiste 2008), the other in Kerala, India, (Ajitakumari et al.1997;Kumar 2004;Nair MK 1989;NPCP 2008;Stjernswärd 2005)which has demonstrated that it is possible to cover the majority of those in need of pain relief and palliative care in large populations, independent of the cause and with affordable generic morphine tablets. Uganda was the first country in Africa to make palliative care and morphine availability elements in its National Health Policy Strategy based on the WHO strategy (Jagwe and Barnard 2002; Merriman 2010; Stjernswärd 2002). In 1988, Zimbabwe included generic morphine tablets in its National Essential Drug List in addition to injectable morphine, which had been included in the list since 1985. Zimbabwe had already included generic morphine tablets in its National Essential Drug List in1988 (EDLIZ 1988).
I have worked in over 50 countries, most recently in Oman ,Kuwait, Jordan (Stjernswärd et al.2007), Lebanon, Georgia, (NPCP 2011; Stjernswärd 2006), Mongolia (Davaasuren et al 2007; NCCP 2007), Albania (joint WHO/IAEA) (NCCP 2009), Bulgaria (NCCP), Latvia (NCCP), Moldova (joint IAEA/WHO NCCP), Turkey (NCCP 2011) and Sri Lanka NPCP.
In 1998, WHO reported that more than 60 countries now had national policies on cancer pain management (WHO 1998b). In 2012, WHO listed 103 countries as having policies for cancer control (WHO 2012). Hopefully, the WHO Pain Relief and Palliative Care Initiative may be starting to have a positive impact on mankind by curbing unnecessary suffering and improving the quality of life of incurable patients globally.
Although I retired from WHO in 1996, I remain very active continuing helping countries to establish national palliative care and cancer control programmes based on the strategies and official recommendations we established in WHO in the 1980s. I run workshops, identify and support champions, follow up on recommendations to establish national cancer control programs, and for pain relief, and/or national palliative care programmes. I am an advisor to ministries of health, to WHO and the European Union, the International Atomic Energy Authority, the Open Society Institute, and the Diana Princess of Wales Memorial Fund’s palliative care initiative. Since ‘retirement’, I have been medical director of Global Cancer Concern; international director of the WHO Collaborating Centre for Palliative Care in Oxford; and a board member of the International Society for Hospice and Palliative Care; and the WHO Collaborating Centre for Public Health Palliative Care Program, Barcelona.
In brief, I am happy to have played a part in efforts to curb unnecessary pain and suffering globally, and to have seen pain relief becoming seen as a human right.
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