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China is pushing for an overhaul of injectables based on traditional medicine, seeking to weed out unsafe products.
Sunday, 5 Nov 2017
ON a winter morning in January 2012, farmer Wu Xiaoliang stopped by his local doctor to remedy a headache. At a small clinic near his village he received two injections made from traditional herbs.
Hours later, villagers saw him struggling to prop himself up on his moped as he drove home. By noon, he was dead.
What killed Wu, 37, was later described in an autopsy report as a “drug allergy.” But doctors couldn’t pinpoint what he was allergic to because the shots he was given contained dozens, if not hundreds, of different compounds extracted from two herbs.
For centuries, Chinese have bought plant and animal parts from traditional clinics, and boiled them into bitter soups to treat colds, strokes and even cancer. But the Chinese medicine sector has modernised along with the rest of the country, with local manufacturers turning age-old recipes into fast-acting injectable drugs.
Chinese medicine injections generated sales of US$13bil (RM55bil) last year, according to the research firm Forward Industries Institute.
Yet, the industry’s ascent has also raised public health concerns. Over a hundred injections based on traditional recipes are sold in China these days, some without stringent human trials. Doctors often prescribe them in an array of untested combinations. Adverse reactions, from skin rashes to fatalities like Wu’s, doubled to about 133,000 last year from 2011, according to government data.
Having struggled for decades to rein in the sector, regulators have recently begun pushing for an overhaul of Chinese medicine injections, seeking to weed out unsafe and ineffective products. But the process could take up to a decade, given the complexity of these intravenous pharmaceuticals.
“For the majority of these chemicals, their properties and their safety to the human body are not properly evaluated and some of them are not even discovered yet,” said Justin Wu, associate dean at the department of medicine at the Chinese University of Hong Kong.
“If you just focus on this point, I don’t think traditional Chinese medicine injections can pass through any regulatory authority outside China.”
Manufacturers maintain their injections are safe and that the problems arise from incorrect use by doctors.
Still, due to the history of lax regulation, many injectables based on Chinese medicine haven’t been evaluated in strict scientific clinical trials.
Chinese medicine is based on centuries of practical experience. But it is traditionally taken orally, which gives the digestive system a chance to shield patients from harmful chemicals. Injecting the concoctions into the bloodstream can heighten side effects.
When China Shineway Pharmaceutical Group first registered its traditional medicine injections in the 1990s, no clinical studies were needed, said Chen Zhong, a vice president for R&D and quality at the company, which describes itself as the nation’s largest maker of these types of shots.
In recent years, Shineway has invested in post-market monitoring to track allergic reactions and has found its treatments highly safe, he said. But the drugs approved decades ago are still sold and haven’t had to undergo full-fledged testing in subsequent regulatory reforms, said Chen. Three stages of human trials were only required of therapies approved after 2008, he added.
Chen reckons less than 10% of the shots being sold by the traditional medicine industry have undergone this kind of stringent review. He compared the shortfall of scientific studies to skipped classes: “The lessons we missed before, we can make up from now on step by step.”
In developed countries like the United States, drugs must undergo several stages of review, often involving thousands of patients. China has instituted similar requirements for chemical medicines. But corrupt Chinese regulators in the early 2000s allowed thousands of therapies based on questionable data to be sold across the country, leaving a legacy of poorly tested treatments, the government has acknowledged.
“The safety problem of traditional Chinese medicine injections has always been rather serious,” Ke Sufang, an analyst at Shenzhen-based Forward Industries, said.
These are signs the sector is now drawing more scrutiny in Beijing. On Aug 29, the head of the China Food and Drug Administration, Bi Jingquan, declared that when traditional therapies are prepared with contemporary methods, the “results should be reported, reviewed and regulated as modern medicine.” They must show greater benefits than risks in clinical trials, he said.
In May, the agency pledged to reassess the quality of all marketed injections within the next decade, a push to advance a 2009 review of the Chinese industry that had made little headway.
Shineway’s ascent offers a window into the industry’s journey. The company, which started as a chemical drugmaker, developed 11 traditional injections between 1993 and 1995 to boost growth. They were seen as symbols of the modernisation of the ancient science.
“Clinical trials were needed for new drugs, but the requirements were very simple,” Chen said. And Shineway was copying existing products, so it didn’t have to do even the easier tests under the regulatory requirements of that time.
Drugmakers can charge more for injections because they require added production, according to Forward Industries.
Nowadays Shineway boasts US$160mil (RM678mil) in sales each year from injectables and a market value of about US$767mil (RM3.2bil). Its annual report states “evidence-based medical research is also being carried out.” Its top foreign investors as of mid-year included funds run by London-based Schroders and Norway’s Skagen. Skagen and Schroders didn’t comment.
Its competitor Livzon, which has a market value of US$5.1bil, (RM21bil) says injectable versions of traditional therapies act faster and help patients who can’t take drugs orally. The company said its main injectable, used by cancer patients, was registered in 1999 after three phases of clinical trials and was found safe with adverse reactions of less than 0.2% in a study.
Among other large players in the market are Wuzhou Zhongheng and Tianjin Chase Sun. Chinese medicine has inspired life-saving discoveries like artemisinin for malaria, which won a researcher from the country a Nobel Prize. The industry’s proponents argue Western drugs also have adverse effects, and traditional ones shouldn’t be discounted. The ancient formulas have been shown to be safe through their long history, said Wang Meng, a researcher at Tianjin University of Traditional Chinese Medicine.
Yet, the injectables business has introduced more complexity. Take a popular injection called Qingkailing, which Shineway and several other companies have approval to sell. Qingkailing logged the highest number of adverse reactions from 2011 to 2015, according to the China FDA, which didn’t list the manufacturers of the batches involved.
Shineway’s website says its version “relieves internal heat, reduces phlegm and promotes the restoration of consciousness.”
The product is safe and a monitoring programme found just 118 adverse events in 30,840 cases when it was used over five years, Chen said. The company says it’s the largest seller of the injection and borrowed the usage instructions directly from an ancient recipe. That, however, was intended for oral use.
Even though it wasn’t studied in late-stage trials, doctors prescribe Qingkailing for fevers, colds, comas and strokes “based on their own experiences,” Chen said. At the same time, he said that physicians who don’t follow the labelling are a major cause of adverse reactions.
Indeed, off-label use can be lethal. In February 2016, 24-year-old Yu Fu was given a mixture of Qingkailing and an anti-viral for a fever and died from an allergic reaction, according to a lawsuit filed by his family. A court ruled the clinic was “80% liable,” for mixing the drugs, blaming the rest on Yu’s own condition. Court documents didn’t list the manufacturer of either drug. The doctor at the clinic testified that he had followed standard practices.
In recent years, dozens of families have filed similar lawsuits in Chinese courts against hospitals and received compensation from them. Usually, the suits are against physicians and hospitals because it’s easier to sue a local entity instead of a faraway drug corporation, according to Huang Dongtao, a lawyer in northern China.
In February, the Chinese government restricted insurance reimbursements for 26 types of traditional medicine injections to larger hospitals, a bid to discourage use in clinics where emergency treatment for allergies isn’t available.
Shineway’s production of traditional Chinese medicine injections fell by about one third this year as those changes reduced usage, said Chen. Back in 2012, Wu Xiaoliang was given two kinds of herbal injections, neither of which required allergy tests or had warnings that they not be used in combination. Family members say that when he returned home after the injection he was nauseous and shivered although they piled blankets on him. By the time the ambulance arrived, his heart had stopped.
Wu’s family received 157,000 yuan (RM102,000) from the doctor who treated him after a medical review said the drugs weren’t used in violation of any rules but noted that the physician didn’t rinse the intravenous injection tube when switching medicines. The doctor “didn’t fully realise the risks of using Chinese medicine injections” the review said.
For his part, the physician maintained that he committed no error, and Wu’s death was an “unpredictable medical event.” — Bloomberg