Background: Pain in the World Today

Prevalence of Pain

Chronic moderate and severe pain is a common symptom of cancer and HIV/AIDS, as well as of various other health conditions.[5] A recent review of pain studies in cancer patients found that more than fifty percent of cancer patients experience pain symptoms[6] and research consistently finds that 60 to 90 percent of patients with advanced cancer experience moderate to severe pain.[7] The intensity of the pain and its effect vary depending on to the type of cancer, treatment, and personal characteristics. Prevalence and severity of pain usually increase with disease progression.

Although no population-based studies of AIDS-related pain have been published, multiple studies report that 60 to 80 percent of patients in the last phases of illness experience significant pain.[8]  Even though the increasing availability of antiretroviral drugs in middle and low income countries is prolonging the lives of many people with HIV, pain symptoms continue to be a problem for a significant proportion of these patients.[9] Several studies have found that between 29 and 74 percent of people who receive antiretroviral treatment experience pain symptoms.[10]

Experts believe that worldwide there are 24.6 million people who suffer from cancer annually, and that more than 7 million people die of it every year. Overall, 12 percent of all deaths worldwide are due to cancer.[11],[12] WHO warns that these numbers will continue to grow over the coming years, with 30 million people projected to be living with cancer by 2020.[13]  UNAIDS estimates that about 32 million people live with HIV worldwide, that some 4.1 million people are newly infected each year, and that almost 3 million die of the disease.[14],[15]

The Impact of Pain

Moderate to severe pain has a profound impact on quality of life. Scientific research has demonstrated that persistent pain has a series of physical, psychological and social consequences. It can lead to reduced mobility and consequent loss of strength; compromise the immune system; interfere with a person's ability to eat, concentrate, sleep, or interact with others.[16] The psychological consequences are also profound. A WHO study found that people who live with chronic pain are four time more likely to suffer from depression or anxiety.[17] The physical effect of chronic pain and the psychological strain it causes can even influence the course of disease. According to WHO, "[p]ain can kill..."[18]

Pain has social consequences for people experiencing it and often also for their care givers, who may face sleep deprivation and other problems as a result. These social consequences include inability to work, care for children or other family members, and participate in social activities.[19] Pain can also interfere with a dying person's ability to bid farewell to loved ones and make final arrangements.

While the physical, psychological and social consequences of pain are measurable, the suffering caused by the pain is not. Yet, there can be little dispute about enormity of the misery it inflicts. People who experience severe but untreated pain often live in agony for much of the day and often for extended periods of time. Many  people interviewed by Human Rights Watch who had experienced severe pain in India, expressed the exact same sentiment as torture survivors:  all they wanted was for the pain to stop. Unable to sign a confession to make that happen, several people told us that they had wanted to commit suicide to end the pain, prayed to  be taken away, or told doctors or relatives that they wanted to die.[20]

Pain Management: Elements, Effectiveness, Cost

According to WHO, "Most, if not all, pain due to cancer could be relieved if we implemented existing medical knowledge and treatments."[21] The mainstay medication for the treatment of moderate to severe pain is morphine, an opioid that is made of an extract of the poppy plant. Morphine can both be injected and taken orally. It is mostly injected to treat acute pain, generally in hospital settings. Oral morphine is the drug of choice for chronic pain, and can be taken both institutional settings and at home. Due to the potential for its abuse, morphine is a controlled medication, meaning that its manufacture, distribution and dispensing is strictly controlled both at the international and national levels.

The WHO Pain Relief Ladder is the basis for modern pain management. Originally developed for treating cancer pain, it has since been applied successfully to HIV/AIDS-related pain.[22] The ladder recommends the administration of different types of pain medications, or analgesics, according to the severity of the pain. For mild pain, it calls for basic pain relievers like acetaminophen (Tylenol), aspirin, or nonsteroidal anti-inflammatory drugs that are usually widely available and without prescription. For mild to moderate pain, it recommends a combination of basic pain relievers and a weak opioid, like codeine. For moderate to severe pain, it calls for strong opioids, like morphine. Indeed, WHO has held that for managing cancer pain, opioids are "absolutely necessary" and, when pain is moderate to severe, "there is no substitute for opioids" such as morphine."[23] The Pain Relief Ladder also recommends various other medications, known as adjuvant drugs, that serve to increase the effectiveness of analgesics or counter their side effects, including laxatives, anti-convulsants and anti-depressants.

Pain medications vary greatly in terms of cost. Basic oral morphine in powder or tablet form is not protected by any patent and can be produced for as little as US$0.01 per milligram.[24] (A typical daily dose in low and middle-income countries ranges, according to one estimate, from 60 to 75 milligrams per day).[25] Other pain medications, such as Fentanyl skin patches that gradually release the active substance, are very costly, and some protect by patent. Because oral morphine can be produced cheaply, providing pain management should be possible at the community level even in developing countries. However, a 2004 study by De Lima and others found that, for a variety of reasons (see below, under Cost),  opioid analgesics, including basic oral morphine, tend to be considerably more expensive in both relative and absolute terms in low and middle income countries than in industrialized nations.[26]

Chronic pain management often comes as a part of broader palliative care services. Palliative care aims to improve the quality of life of patients and their families facing problems associated with life-threatening illnesses, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual.[27] The World Health Organization recognizes palliative care as an essential component of a national response to HIV/AIDS, cancer and other diseases.[28] The organization estimates that,

despite an overall 5-year survival rate of nearly 50% in developed countries, the majority of cancer patients will need palliative care sooner or later. In developing countries, the proportion requiring palliative care is at least 80%. Worldwide, most cancers are diagnosed when already advanced and incurable.[29]

For those with incurable cancers, the only realistic treatment options are pain relief and palliative care.[30] Palliative care is often provided alongside curative care services.[31] While palliative care providers may offer inpatient services at hospices or hospitals, their focus is frequently on home-based care for people who are terminally ill or have life-limiting conditions, thus reaching people who otherwise might not have any access to healthcare services, including pain management.

Widespread Consensus: Pain Relief Medications Must Be Available

For decades, there has been a consensus among health experts that opioid pain relievers like morphine and codeine must be available for the treatment of moderate and severe pain. Almost fifty years ago, UN member states articulated that consensus as follows when they adopted the 1961 Single Convention on Narcotic Drugs:

The medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering and adequate provision must be made to ensure the availability of narcotic drugs for such purposes.[32]

The International Narcotic Control Board, the body charged with overseeing the implementation of the UN drug conventions, clarified in 1995 that the Convention "establishes a dual drug control obligation: to ensure adequate availability of narcotic drugs, including opiates, for medical and scientific purposes, while at the same time preventing illicit production of, trafficking in and use of such drugs."[33]

The World Health Organization has included both morphine and codeine in its Model List of Essential Medicines, a list of the minimum essential medications that should be available to all persons who need them. WHO has also repeatedly stated that palliative care and pain treatment are an essential-not optional-component of care for cancer and HIV/AIDS. For example, in its guide on the development of national cancer control programs it observes that "a national disease control plan for AIDS, cancer and noncommunicable disorders cannot claim to exist unless it has an identifiable palliative care component."[34]

Over the last twenty years, the INCB, WHO and other international bodies have repeatedly reminded countries of their obligation to ensure adequate availability of opioids for the treatment of pain.

·In 1986, the WHO recommended the use of oral morphine for treatment of long term pain.

·In 1989, INCB made a series of recommendations to states on the need to improve availability of opioid analgesics.[35]

·In 1994/5, it conducted a survey to identify obstacles to improving such availability and assess the response of member states to its 1989 recommendations.[36]

·In 1987 and 1996, the WHO issued guides to cancer pain relief with recommendations for countries on improving opioid analgesic availability.[37]

·In 1999, INCB devoted a chapter in its annual report to the issue.[38]

·In 2000, WHO developed a tool for governments and providers to use in evaluating national opioid control policies and recommendations on improving availability.[39]

·In 2007, in consultation with INCB, WHO established the Access to Controlled Medications Programme, which aims to address all identified impediments to accessibility of controlled medicines, with a focus on regulatory, attitude and knowledge impediments.[40]

In its annual reports, INCB routinely expresses concern about the poor availability of pain treatment medications in many countries and calls on member states to take further steps. Various other international bodies, such as the UN Economic and Social Council and the World Health Assembly, have also called on countries to ensure adequate availability of opioid analgesics.[41]

The Pain Treatment Gap

"Most, if not all, pain due to cancer could be relieved if we implemented existing medical knowledge and treatments…There is a treatment gap: it is the difference between what can be done, and what is done about cancer pain." – World Health Organization[42]

Despite the clear consensus that pain treatment medications should be available, approximately 80 percent of the world population has either no or insufficient access to treatment for moderate to severe pain and tens of millions of people around the world, including around four million cancer patients and 0.8 million end-stage HIV/AIDS patients, suffer from moderate to severe pain each year without treatment, according to the World Health Organization.[43] Approximately 89 percent of the total world consumption of morphine occurs in countries in North America and Europe.[44] Low and middle income countries consume only 6 percent of the morphine used worldwide[45]-while having about half of all cancer patients[46] and 95 percent of new HIV infections.[47] Thirty-two countries in Africa have almost no morphine distribution at all,[48] and only fourteen have oral morphine.[49]

However, inadequate pain management is also prevalent in developed countries. In the United States, an estimated 25 million people experience acute pain as a result of injury or surgery, and between 70 and 90 percent of advanced cancer patients experience pain. Surveys of subjects ranging from children to elderly patients have shown that over one third are not adequately treated for pain.[50] Lack of access to pain medication in pharmacies and fear of addiction on the part of both patients and providers are significant limiting factors in the United States.[51]  Studies in Western Europe also document under-treatment of pain. A study of people living with HIV in France found that doctors underestimated pain severity in over half of their patients and under-prescribed both opioids and antidepressants.[52]

Up to 85 percent of people living with HIV have untreated pain, twice the proportion of people with cancer whose pain is untreated.[53]  A study in the U.S. found that less than 8 percent of AIDS patients who reported severe pain were treated according to official treatment guidelines, and women, less-educated patients, and patients with histories of injection drug use were most likely to report inadequate treatment for pain.[54]