Sunday, October 23, 2016

Recall of Pyridostigmine Leaves MG Patients Scrambling in China

by Yin Yijun
Chinese people living with the autoimmune disease myasthenia gravis (MG) are running out of medicines they consider life-saving after drugs made by the sole domestic supplier were recalled.

State-owned Shanghai Zhongxi Sunve Pharmaceutical Co. Ltd. is the only supplier of the medicine pyridostigmine bromide, which MG patients take daily to keep their symptoms — such as muscle
weakness in the eyes, limbs, and respiratory system — from becoming severe or even life-threatening.

In early September, the company reported to the local Shanghai Food and Drug Administration (SFDA) that it had found problems in its production process. This led to a nationwide recall of the medicines produced between October 2015 and April 2016. An employee of SFDA’s publicity department declined to comment on the record.

Now, patients like 27-year-old Tan Yongli are running out of the medicine. “Around Sept. 10, I found out that I couldn’t get ‘xiaoming,’” he told Sixth Tone, using a nickname for pyridostigmine bromide. “I only had a few boxes left.” Other patients have voiced similar concerns on social media.

Zhang Xiaohui, 43 and an MG patient, is in charge of the service department at Aili Myasthenia Gravis Care Center, a nonprofit social organization based in Beijing that aims to promote patient well-being. She told Sixth Tone that a patient living in Beijing first told them about the supply shortage on Sept. 4, and that they have received calls for help from various places in China ever since.

The center estimates that there are about 650,000 people with MG in China.

In a meeting with Zhongxi Sunve on Sept. 21, the company told the care center that the recalled drugs, if taken, generally won’t put people’s health at risk. Zhang said that based on individual accounts, patients had differing opinions about the efficacy of the disqualified drugs. According to Zhang, the company expects to resume regular supply of the drug in late October, as its production line undergoes annual maintenance from July to September.

A spokesman for Zhongxi Sunve told Sixth Tone on Friday that while its version of the MG drug took longer to be absorbed than normal, the medicine was still safe for patients to take. Quality-maintenance considerations drove the recall decision, he said, adding that it would not affect the future price of the drug.

Tan, who was diagnosed with the disease over a decade ago, experienced a similar medicine shortage in 2006. Back then, he solved the problem by asking someone to bring him the drugs he needed from Beijing. This time around, the shortage hit when Tan’s symptoms were already acting up more than usual. “I could be in critical condition without one day’s dose of pills,” said Tan.

The obstacles to research, production, and circulation of drugs for rare diseases such as myasthenia gravis are an issue worldwide. As a result, the medicines for treating such diseases are called “orphan drugs” globally because the pharmaceutical industry has little interest in “adopting” them, as the market is relatively small. In other countries, legislation such as the U.S.’s Orphan Drug Act of 1983 has provided incentives and support for the development of orphan drugs.

Dr. Zheng Weiyi, the founder of an innovation alliance for research on China’s orphan drugs, thinks the lack of government support and regulation is the main reason why the shortage happened. “China has no laws on orphan drugs for now,” said Zheng. “Some companies just find that the production of these drugs doesn’t earn profits or even makes them lose money.”

(Header image: A boy with myasthenia gravis is carried downstairs on his parent’s back in Fuzhou, Fujian province, Jan. 14, 2013. Strait Metropolis Daily/VCG)


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