Zosia Chustecka

October 10, 2012

October 10, 2012 (Vienna, Austria) — Legal and bureaucratic restrictions on opioid drugs — introduced to stop abuse and drug trafficking — are hampering the legitimate medical use of these medicines and are preventing millions of cancer patients around the world from obtaining treatment for often unbearable pain.

The scale of this problem is revealed in a landmark global survey, presented here at the 2012 European Society for Medical Oncology (ESMO) Congress.

"In many places across Africa, Asia, the Middle East, and Latin and Central America, governments are failing cancer patients in the delivery of adequate pain relief," the report concludes. A priority action identified by the report is the need to examine drug-control policies and to repeal excessive restrictions that "impede this most fundamental aspect of cancer care."

Dr. Nathan Cherny

"Unrelieved cancer pain is a cause of major worldwide suffering, not because we don't have the tools necessary to relieve pain, but because most patients don't have access to the essential pain-relieving medications," said Nathan Cherny, MD, head of the oncology and palliative medicine unit at the Shaare Zedek Medical Center in Jerusalem, Israel. Dr. Cherny is lead author of the report and has been head of the ESMO Palliative Care Working Group since 2008.

"This pandemic affects literally billions of people," he said. "Not only are patients suffering terrible unrelieved pain, but their family members are often permanently scarred by the memories of witnessing such suffering in their loved one," he explained.

Global Survey

The report was initiated by the ESMO, working in collaboration with the European Association of Palliative Care, the Pain and Policies Study Group at the University of Wisconsin Carbone Cancer Center, the Union for International Cancer Control, and the World Health Organization. In addition, many local oncology and palliative care organizations helped collect the data.

Data were collected between December 2010 and July 2012 from 76 countries (56% of the countries in Africa, Asia, the Caribbean, Central America, Latin America, and the Middle East). The authors estimate that the report covers about 83% of the 5.7 billion people living in these regions.

The International Association for Hospice and Palliative Care has a list of 7 opioid medications that it considers to be essential for the relief of cancer pain: codeine, immediate- and slow-release oral morphine, oral oxycodone, transdermal fentanyl, methadone, and tramadol.

The global survey found that very few of the countries investigated provided all 7 products on the list. Often, fewer than 3 products were available, availability was limited, and the products were not subsidized or were only weakly subsidized by the government.

In many countries, a big issue is the drug-control policies that restrict the prescribing of these opioid drugs by imposing restrictive limits on dose and/or duration of treatment.

"We now know which countries have suboptimal formularies of medication to relieve pain, we know how much patients must pay out of pocket for the medications, and we know which countries have excessive regulatory barriers that can make it nearly impossible for a patient to get a prescription, get it to a nearby pharmacy, and have the medicine dispensed," Dr. Cherny explained.

"In many, if not most, of the countries and states we looked at, patients are stymied by regulatory barriers at multiple steps in the process," he said.

First-Hand Experience

Dr. Jim Cleary

Jim Cleary MD, FRCAP, FAChPM, director of the Pain and Policies Study Group and associate professor of medicine at the University of Wisconsin Carbone Cancer Center in Madison, has traveled around the developing world to investigate the problem of cancer patients not having access to opioid medications. He spoke movingly about his first-hand experience in some of these countries.

"Morphine is nearly impossible to get in India," he told meeting attendees.

Dr. Cleary showed a video that starts in a school courtyard that was transformed for an afternoon into a makeshift clinic on the outskirts of Kolkata, India. It then follows a traveling doctor as he visits a woman dying of breast cancer in a remote village. She has a massive breast tumor that is clearly infected, and she is crying from the pain and says she cannot sleep at night. Her daughter says that her mother screams in agony day and night.

"With adequate medication, she would not be screaming in pain." Dr. Cleary said.

Policies introduced to control and regulate opioid use are now forming a barrier to the legitimate use of morphine for pain relief, he explained.

Most of the morphine used in the world (about 80% to 95%) is used in high-income countries, Dr. Cleary noted. In the United States and Canada, morphine use is around 75 mg per person per year. The global mean is 6 mg per person per year. In India, it is only 0.095 mg per person per year, even though India is the largest producer of morphine in the world.

Unfortunately, these data on morphine use do not distinguish between morphine used for pain relief and that used for substitution in addiction therapy. Austria is a big user, but that is because it uses morphine as a substitution in the treatment of drug addiction, he noted.

There is also a huge discrepancy between Western and Eastern Europe in the availability of opioid medications, Dr. Cleary said. For example, in the Ukraine, a strict bureaucratic system means that morphine is available only as an injectable, and only in a limited dose, he explained.

Dr. Cleary showed another video. It featured a highly decorated former army general with stage IV prostate cancer slowly dying in unrelenting pain. He had moved away from his family in Kiev to live alone in a remote village miles away because, he said, he did not want his loved ones to watch him cry with agony day after day. To dull the pain, he drinks a bottle of homemade alcohol each day. He sleeps with a loaded revolver under his pillow — for when the pain gets too much.

"The impact of the severe pain is so great that he is preparing to take his own life," Dr. Cleary said.

"We as medical oncologists are obligated to help these people," he concluded.

Substantial Worldwide Public Health Concern

Carla Ripamonti, MD, head of the supportive care in cancer unit, IRCCS Foundation, National Cancer Institute of Milan, in Italy, who was asked to comment on this study, agrees that "unrelieved pain continues to be a substantial worldwide public health concern in patients with solid cancers and hematologic malignancies."

She emphasized how frequent pain is in cancer patients. It is reported by up to "64% of patients with metastatic advanced or terminal-phase disease, 59% of patients on anticancer treatment, and 33% of patients after curative treatment," Dr. Ripamonti noted.

"These statistics suggest that cancer-related pain may be a major issue in healthcare systems worldwide," she concluded.

2012 European Society for Medical Oncology (ESMO) Congress: Abstract 1707_PR. presented September 29, 2012.