- The law came into effect on December 1 and forbids pharmaceutical firms giving patients drugs from unapproved clinical trials
- But cancer sufferers benefiting from the drug courses want their treatment to continue
After Wu Xianfa was diagnosed with lung cancer last year, he had surgery to remove part of his lower left lung.
When his doctor recommended chemotherapy to wipe out any remaining cancer cells, Wu refused as colleagues who had also had lung cancer had died after getting chemotherapy straight after surgery.
Following a friend's recommendation, the 50-year-old instead started taking an experimental drug. He signed an agreement with a Shanghai pharmaceutical company in April last year to join its trial " and says it has been a boon to his health.
"I get no other treatments besides the drug," Wu says. "I get regular checks at hospitals and send the reports about my cancer index and other medical data to the company for research. Without the drug, my condition would have been a lot worse."
Wu's continuation in the trial, however, has been thrown into doubt after a new law targeting the use of experimental drugs in China came into effect on December 1. Passed in August, the law forbids pharmaceutical firms from giving patients experimental treatment not approved for clinical trials. It also forbids firms from starting clinical trials without government approval.
Companies that do not comply could incur a maximum 5 million yuan (US$710,000) fine, see their drugmaking and operation licences revoked, and face a lifelong ban from engaging in pharmaceutical production and operation.
The new law follows an explosive scandal last year involving Chinese scientist He Jiankui, a former academic at Southern University of Science and Technology in Shenzhen. He launched an unapproved clinical trial that shocked the world last year when he edited the genes of twin Chinese girls to prevent them from inheriting HIV from their father.
It made the girls the world's first gene-edited babies and unleashed a storm of criticism from the international scientific community and Chinese authorities for unethical use of the technology.
In China, clinical trials for new medical treatments must be approved by the State Food and Drug Administration, and the trials must be conducted only in organisations the administration approves. According to the latest 2019 National Cancer Centre report, there were more than 3.9 million new cases of cancer and 2.3 million cancer deaths in China in 2015, with 7.5 new cancer cases reported every minute.
Taking experimental treatments outside sanctioned clinical trials is hardly a rare occurrence in China.
Earlier this year, it was reported that a man in the US state of Oklahoma suffering from late-stage small-cell lung cancer claimed all the cancer had disappeared from his scans after he heeded a veterinarian's suggestion to take the dog deworming drug fenbendazole, which had shown cancer-fighting properties in cell studies.
Although there have been no clinical trials of fenbendazole for treating cancer, mainland media reported that thousands of patients in China were flocking to try the drug. Wily veterinary surgeon drug sellers even marketed the drug as a cancer treatment.
After taking the drug, the chest pain was gone and my swallowing was easier. I am very worried about the new law. If I have to stop taking the drugs, my health will get worseEsophageal cancer sufferer, Tan Defu
Shanghai Spark Pharmaceutical is currently producing two experimental drugs " one for cancer and the other for removing plaque in arteries " which the government has yet to approve for clinical trials. A company spokeswoman said since 2012, more than 100 patients with cancer and cardiovascular diseases had taken these drugs.
The research and development cycle for the two drugs takes over a decade, and the drugs are then given free of charge for the patients to try.
"The new law will not affect our research and development which will proceed as usual," the company's spokeswoman says. "But it will affect patients' treatment. A majority of the cancer patients who take our drugs are terminally ill, and will be required to leave hospital now.
"With no treatments whatsoever available to them, they will go home and wait to die. Our drugs have brought some therapeutic breakthroughs for patients and given them hope. Suddenly suspending their drug use is like giving them a second death sentence."
The spokeswoman added the company still hopes to be given exemptions under the new law so patients can continue their treatment. But there may be another stumbling block to get over before they do, as the company's drugs are made using an approach that mixes Western and traditional Chinese medicine.
"This means we are not considered (under the law) a chemical, biopharmaceutical or Chinese medicine drug maker, so there's no channel for us to make an application (for clinical trials)."
Tan Defu, aged 75, has been taking the same drug as Wu since March, following his esophageal cancer diagnosis.
"The doctor said my condition was urgent and I had only one month left to live. Before I took the drug, I had pain in my chest and it was difficult to swallow food. After taking the drug, the chest pain was gone and my swallowing was easier. I am very worried about the new law. If I have to stop taking the drugs, my health will get worse," he says.
His son Tan Jun said he is not getting any other treatments besides the drug.
"The average survival time for esophageal cancer patients is six months. Eight months after taking the drug, his condition is still very good," Tan Jun said.
Many experts have reservations about the use of such experimental drugs however, including Holly Fernandez Lynch, an assistant professor in medical ethics and health policy at the University of Pennsylvania School of Medicine in the United States.
"The argument that patients are 'dying anyway' can be problematic," she says. "Patients who are dying still have interests to protect. They can be exploited by false claims about investigational products, and they can have their deaths hastened or made more painful by unsafe products.
"It is also important to recognise that there are implications for all patients if some patients are permitted to access unapproved products without making sure that there are adequate protections for the clinical trial process."
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