DRUG ON TRIAL

Sun’s older sister told NewsChina that her mother, who was first admitted on December 4, had been prescribed nutritional supplements and Xingnaojing, a traditional Chinese medicine (TCM) herbal injection mainly for treating brain injuries caused by strokes, hemorrhages or other brain trauma.　

Despite the treatment, the patient’s condition worsened and her relatives alleged that Yang had administered the wrong medication. Sun asked to transfer his 95-year-old mother from the emergency ward to an inpatient ward so they could cover part of the cost on the government health insurance system, but allegedly, Yang refused. 　

Hospital staff had explained that it would take a long time for such an elderly patient with complicated health conditions to improve, according to media reports. The family allegedly quarreled repeatedly with hospital staff, who was warned to watch out for their safety. Yand died the following day after the attack. 　

The tragic case led some to look again at Xingnaojing, a commonly prescribed medication, and whether it has any medical validity in treating patients with serious brain conditions. 　

Zhang said that before he uses Xingnaojing, he obtains consent from a patient’s relative because it is not cheap. One or two boxes of Xingnaojing are usually used for hospitalized patients each day at a cost of 200 to 300 yuan (US$29-43). The patient often has to use the drug for 15 days. Zhang said that he is still unconvinced of the medication’s efficacy. If he uses it, it is mostly because he is out of other options. 　

“To be frank, I don’t think it would make any difference if a patient is in a coma. What’s more, there are no authoritative institutions or data to explain how many patients actually wake up [after using Xingnaojing],” Zhang said. He added that now he tries to not use medications that do not have clear and definite effects. “When patients come to hospital, doctors have to do something and maybe it [Xingnaojing] will be effective,” he said.　

Xingnaojing hit the Chinese market in 1978. According to a specialist consensus on the clinical application of Xingnaojing for terminally-ill patients, published by the Chinese Research Hospital Association, Xingnaojing is applicable to diseases including coma, high fever and acute poisoning caused by stroke, epilepsy and brain trauma.　

According to the diagnosis and treatment guidelines on acute ischemic stroke released by the Chinese Medical Association in 2018, herbal injections are widely used in China for the treatment of strokes, but their medical efficacy needs more high-quality randomized controlled trials.　

In 2008, Wu Bo and Liu Ming, two professors of neurology at the West China Hospital of Sichuan University conducted research on the effectiveness and safety of Xingnaojing on cerebral hemorrhages, finding that from 1997 to 2007, only 13 randomized controlled trials were up to standard, but 12 of them did not specify which randomized methods had been adopted.　

Qin Weixing (pseudonym), a doctor in the neurology department of the Peking Union Medical College Hospital (PUMCH) in Beijing, told NewsChina that his hospital has not used Xingnaojing for a decade. 　

“Xingnaojing has not proved its medical effects in line with internationally recognized methods. PUMCH has extensive contacts with hospitals overseas and if we continue to use Xingnaojing, we may have problems in international communication,” he said. “We abandoned Xingnaojing, however, mainly because of its lack of randomized controlled clinical experiments to prove its efficacy.”　

A Chinese-American doctor working at a specialist neurology hospital in the US told NewsChina that no patented Chinese drugs are used in the US. When treating patients who have suffered a stroke, for example, the standard treatment is rehabilitation to prevent further strokes and complications.　

Zou Zhenlei, a technician at the drug evaluation center of the China Food and Drug Administration, analyzed 30 cases of patients suffering from adverse reactions after using Xingnaojing. Zou found that 70 percent of patients had an adverse reaction within 30 minutes after it was administered, and 60 percent of adverse reactions are systemic body damage caused by allergy and allergic shock. The findings were published in the Chinese Journal of Pharmacovigilance in 2014.　

In March 2015, the China Food and Drug Administration required all pharmaceutical enterprises producing Xingnaojing to add warnings about possible side effects. The new instructions said Xingnaojing’s adverse reactions include allergic shock and should only be used at medical institutions that have ICU facilities. In addition, adverse reactions can affect the cardiovascular and respiratory systems and cause skin problems.　

Listed in 2017, Dali Pharmaceutical Company in Yunnan has spent more and more money on marketing. According to its website, the company spent 1.43 million yuan (US$207,000) on R&D for the first half of 2019, but its sales expenses hit 100 million yuan (US$14.5m) during the same period. The company likes to describe itself as a modern pharmaceutical enterprise “specializing in R&D, production and sales,” but it had only nine people in the R&D department in 2017 and seven people in 2018.　

Over the years, Jemincare has organized and financed a number of academic conferences nationwide. In September 2016, Jemincare supported the 19th National Mental Disorder Studies Conference of the Chinese Medical Association in Guangzhou, Guangdong Province. During the conference, the company presented its Xingnaojing injections and organized a VIP dinner. In 2018, the company promoted the reputation of Xingnaojing at the annual neurology conference of the Chinese Medical Association through similar methods.　

Starting in late 2017, a series of policies were introduced nationwide to monitor the abuse of some medicines including Xingnaojing, aiming to control the use and the amount of medical insurance payouts. At the end of 2017, health authorities tightened control of the medicare reimbursement of 39 TCM injections and 26 types of medication, including Xingnaojing, which can only be prescribed in major hospitals.　

Against this backdrop, Xingnaojing sales dropped significantly. According to statistics from the China National Pharmaceutical Industry Information Center, the sales volume of Xingnaojing hit 512 million yuan (US$74m) in major cities in 2018, a drop of 20 percent year-on-year. As a result, Dali Pharmaceutical Company generated revenue of 161 million yuan (US$23m) in the first half of 2019, a decline of 21 percent year-on-year.　

In 2019, the National Health Commission stipulated that doctors of Western medicine who have not trained in TCM cannot prescribe any TCM, which appears likely to further cool the TCM injection market. Qin Weixing told our reporter that overuse of TCM prescriptions is worse in diseases related to neurology and the heart. In the past, treatment in China for neurological and cerebrovascular diseases was lacking in China, leaving room for medicines whose effectiveness is not clearly defined.　

Official data showed that in the past two years, most medicines approved by Chinese health authorities are oral medications. In 2018, all four new TCM products are oral medicines and granules. Qing said the abuse of TCM injections has largely decreased across the country.　

“There should be the same standards to judge the efficacy of drugs. Patented TCM products are no exception,” he said.