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    Shortage of Critical Leukemia Drug Threatens Ill Children

    Chinese manufacturers have stopped producing the low-profit 6-MP chemotherapy medication.

    SHANGHAI — When their 5-year-old son was diagnosed with acute lymphoblastic leukemia (ALL), Druk Gyal Tsering and his wife felt helpless. Back then, in December 2015, doctors in their hometown in northwestern China’s Qinghai province advised them to seek treatment at a better hospital, so the family turned to the Shanghai Children’s Medical Center (SCMC) — one of the nation’s best children’s hospitals. But just half a year into treatment for their son, Luo Zhang, the supply of a drug that was critical to his chemotherapy dried up.

    “I was anxious,” Druk Gyal Tsering told Sixth Tone, adding that he was also stunned when he heard that the top-tier hospital had run out of their son’s cancer medicine. “I had no clue why this was happening.”

    A look at the drug’s price history and interviews with experts, however, reveal that producing the drug might not be in pharmaceutical companies’ financial interest.

    The drug, mercaptopurine — often referred to as 6-MP — is used in the treatment of various autoimmune diseases and certain types of cancer, including ALL. But three prominent leukemia treatment centers in the Shanghai area — SCMC, the Children’s Hospital of Shanghai, and the Children’s Hospital of Fudan University — confirmed to Sixth Tone that the drug has been out of stock for more than six months.

    The medication shortage in Shanghai can be traced to a sudden halt in production at Shaanxi Xingbang Pharmaceutical Co. Ltd., the Shanghai hospitals’ only supplier of 6-MP.

    According to a staff member at the Children’s Hospital of Shanghai, the same supply issue occurred once before in early 2012, but the drug was back in stock within a month or two. Yet the current shortage persists, and all that the hospitals can do is advise families to seek the drug elsewhere.

    ALL is the most common form of leukemia in children. It mostly affects kids aged 5 to 10 and accounts for around 70 percent of the 20,000 children’s leukemia cases diagnosed in China every year. With proper treatment, the chances of survival are high. Out of all cases, about 80 percent of children survive — and 6-MP, medical experts say, plays a vital role. The medication kills cells and is currently the only chemotherapy drug that can be used on the mainland at a critical stage of ALL treatment to ensure the disease doesn’t reoccur.

    With the hospital unable to provide the medication, Druk Gyal Tsering began his own search for 6-MP. The ethnic Tibetan man traveled to Beijing to buy imported 6-MP for almost 20,000 yuan (around $3,000). He thought he had saved his son, who began taking the imported drugs at the family’s home in Xining City.

    But when Luo’s condition worsened, Druk Gyal Tsering flew back to Shanghai to consult doctors at SCMC. He was given a clear explanation: The expensive imported drugs were fake. The news was devastating. Druk Gyal Tsering works as a civil servant and said that his family’s income is average for the city. (Annual disposable income per capita in Xining was 21,696 yuan last year.) Yet their son’s treatment had already cost the family more than 500,000 yuan, and they were deep in debt to friends and family.

    Based on advice from other parents of sick children, Druk Gyal Tsering traveled in February to Hefei, in eastern China’s Anhui province; Anhui and Guangdong are the only two Chinese provinces that still have a limited supply of 6-MP. At a local pharmacy, 250 domestically manufactured tablets cost him 500 yuan.

    Druk Gyal Tsering still considers his family lucky: The small amounts of the drug still on the market were most recently produced in July 2015 and will expire in June 2018 — exactly when his son is expected to conclude his two-year course of treatment.

    Shanghai lawyer Luo Yanjie has a 3-year-old son with ALL. “It’s not just any common disease,” he told Sixth Tone. “It could take away a child’s life anytime.”

    Although he has managed to amass a stockpile of 6-MP imported from Hong Kong pharmacies to ensure a few more months of treatment for his son, Luo Yanjie said he worries about the thousands of other families who will suffer without the medication. “Any parent of a child with leukemia knows how important this drug is — it means the chance that our children get to live,” Luo Yanjie said.

    Because this type of drug can have severe side effects — for example, it can damage a child’s liver function or cause bone marrow suppression — Luo Yanjie said parents feel more at ease if they can get the medicine directly from a doctor at a hospital rather than from a pharmacy.

    According to the China Food and Drug Administration, six Chinese companies are licensed to manufacture 6-MP. However, when contacted by Sixth Tone, four of the companies said they ceased production years ago, leaving only two Chinese manufacturers of the drug: Zhejiang Zhebei Pharmaceutical Co. Ltd., based in eastern China, and Shaanxi Xingbang Pharmaceutical Co. Ltd., the supplier for hospitals in Shanghai.

    An employee in the sales department of Zhejiang Zhebei told Sixth Tone that it ceased production of the drug when there was sufficient supply in the market. “We didn’t expect the drugs to be consumed so quickly,” said the staff member, who refused to reveal his name. He added that production would resume in September, and that the drugs would reach the market around the end of October. Sixth Tone could not locate a point of contact for personnel in charge of the company’s external communications.

    The other 6-MP manufacturer, Shaanxi Xingbang, hasn’t determined when it will resume production. “We’ve received inquiry calls from parents almost every day over the past few months,” said a factory employee surnamed Liu. “We feel very anxious, too.”

    According to Liu, a complication involving one of the drug’s ingredients has interfered with the production of 6-MP. “We’re waiting for approval from the provincial food and drug administration so that we can produce this ingredient on our own,” she said, adding that production won’t resume for at least two months.

    Shaanxi Xingbang used to sell its medications through hospitals, with a bottle of 100 6-MP tablets costing less than 100 yuan with reimbursement from public health insurance. Zhejiang Zhebei continues to sell the drug at pharmacies for 100 yuan per 50 tablets.

    When contacted by Sixth Tone, the press office of the Shanghai Municipal Food and Drug Administration declined to comment on whether the administration was aware of the drug shortage or whether it has intervened to resolve the issue.

    Staff at both 6-MP manufacturers refused to comment on whether low drug prices influenced their companies’ decisions to cease production, or on whether they’ve been in touch with government departments regarding the matter.

    To address drug shortages, China piloted initiatives to designate pharmaceutical companies as producers of certain drugs as early as 2007. However, the appointed companies have been reluctant to cooperate, since profit margins for most of the drugs are low.

    In 2015, the National Development and Reform Commission (NDRC) — the country’s top economic planning agency — removed the price ceiling on all drugs except narcotic and Type 1 psychotropic drugs.

    Helen Chen, head of the China Biopharmaceuticals & Life Sciences practice at L.E.K., a global management consulting firm, told Sixth Tone that even though the NDRC removed drug price caps, it left the door open for local governments to control pricing via their own tendering practices — bidding among prospective hospital drug suppliers. “The NDRC also allowed the hospitals to conduct secondary negotiations, which further reduced the prices,” she said.

    The tender price for 6-MP in Shanghai was 50.15 yuan for a bottle of 100 tablets in 2016 — 8 percent lower than the price in 2014. In the most recent bidding process, in eastern China’s Fujian province, the price dropped further to 48.50 yuan. “The manufacturer may not wish to continue to supply the product at such price levels,” Chen said.

    In the U.S., for example, a shortage of diphtheria and tetanus vaccines occurred in 2000 when one of the main manufacturers halted production because revenues were too low.

    In February, the State Council — China’s cabinet — issued a guideline aiming to improve drug production and distribution in the nation. The document recommended that a mechanism be set up to monitor drug supply and track factory production for more efficient coordination.

    At the end of June, nine national government departments jointly released another guideline aiming to address shortages of certain medications. Zeng Yixin, deputy head of the National Health and Family Planning Commission, said at a press conference on the day the guideline was released that China has around 3,000 drugs approved for clinical use, but that 130 of them are in short supply from time to time.

    Most of these drugs are used in gynecology and pediatrics departments or in emergency rooms, according to the guideline. “It’s not logical to rely on the market itself to solve the existing problems,” the document states. “Government departments should intervene to guarantee the supply of life-saving drugs.”

    The June guideline also said that drug supply monitoring efforts would be expanded to ensure more thorough coverage, with no fewer than 15 monitoring stations in every province.

    While change may be on the horizon, parents of children with leukemia are, for the time being, left anxious. Druk Gyal Tsering and his son are now back in Shanghai for hospital checkups. The father hopes that 6-MP will be available in the hospital pharmacy soon for patients who will still need treatment in the latter half of 2018 and beyond.

    “Families of children with leukemia are already suffering a lot,” he said. “This issue is undoubtedly making things even harder.”

    Editor: Colum Murphy.

    (Header image: A boy with leukemia waits for a checkup at the Shanghai Children’s Medical Center, Aug. 3, 2016. Wu Yue/Sixth Tone)