China’s instant ban on unapproved stem cell treatment will affect some US patients, and a handful of specialist medical tourism agencies who have been accessing China for treatment that is not available in the US or most European countries.
In recent years, China has attracted foreign citizens to experimental hospitals and doctors willing to treat seriously ill patients with unproven stem-cell therapies.
The Ministry of Health announced that the country has stopped all unproven and experimental stem-cell treatment programmes and refuses to accept any new applications for approval of stem-cell treatments. The ban will initially last until the end of June 2012, but the chances of the ban being lifted quickly after then seem very slim.
China’s experimental stem-cell treatments have been used on patients with severe neurological diseases, other chronic illnesses and injuries. While some patients have said that these unproven stem cell therapy programs in China have done them good, critics argue that the benefit is purely in the mind.
The government seeks to bring under control its growing but loosely regulated industry. It realizes that an official ban will not work unless it can be enforced. A ban on organ transplants is still blatantly ignored by some hospitals. The ministry is implementing a year long campaign to halt unauthorized stem cell therapy trials.
Regulations on stem cell treatments were relatively relaxed in China compared to other nations and the country is often seen as a last hope for people suffering from serious medical problems ranging from cancer to spinal cord injuries. But there are many horror stories where unapproved untested stem cell treatment has led to death, disease and infection.
Stem cell therapies introduce new cells into damaged tissue in order to treat disease or injury. Patients, both local and from overseas, can pay tens of thousands of dollars in a last ditch attempt to restore back functions or sight. The lucrative nature of the treatment for hospitals and agencies, as many patients will pay anything asked, means that an official ban will reduce it, but may just drive it underground.
China has no specific policy for clinical trials or applications of stem cell technology. Such trials are subject to the same general regulations governing all medical practices, such as the importance of volunteers’ rights and health. Stem cell treatment and trials already approved by the State Food and Drug Administration will continue. Those that are not approved must be stopped immediately-even in mid trial.
The Ministry of Health and State Food and Drug Administration are working together to seek to control the expanding stem cell industry. Stem cells have the ability to become any type of cell in the human body, and researchers around the world are studying them to see whether they can cure disease. The potential of Chinese stem-cell research is high and the long-term aim of the government is to get stringent regulation working and seen to be working, so that it can sell research results, treatment and drugs to overseas countries.
A growing number of hospitals and clinics in large cities in China have been offering stem cell therapies for treatment of diseases ranging from cancer and Alzheimer’s to spinal cord injuries, treatments that are backed by little or no scientific evidence and which are considered at best experimental. Some of these involve large general hospitals where patients pay thousands — or even tens of thousands — of dollars for treatments that are advertised online, which attract both Chinese patients and those from overseas. According to patients, doctors and relatives of patients, patients have come away with little or no improvement and a number have died. The ministry has made it clear that health providers can no longer charge money for experimental stem cell applications under the new order.
Whether the government can enforce the ban is questionable, as many hospitals making money from stem cell treatment are affiliated with government organisations such as the army, the PLA, and the domestic police forces, each more politically powerful than either of the enforcing government departments. They were unable to enforce a 2009 order that hospitals and clinics offering advanced and experimental medical technology had to obtain approval or face closure.
Days before the Chinese ban, the United States’ Food and Drug Administration (FDA) issued a warning about unproven stem cell claims, where patients are vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful. The FDA warned consumers that any stem cell treatment they are considering must be approved by FDA or studied under a clinical investigation that has been submitted to and allowed to proceed by FDA. The FDA has recently participated in activity to fight illegal activity involving stem cells. In December 2011, three men were arrested and charged with 15 counts of criminal activity related to manufacturing, selling and using stem cells without FDA sanction or approval. One of these was a consultant at a university in South Carolina who used university facilities to manufacture stem cell products, then sold them to a man posing as a doctor who travelled to Mexico to perform unapproved stem cell procedures on people suffering from cancer, multiple sclerosis and other autoimmune diseases. The three defendants received more than $1.5 million from patients seeking treatment for incurable diseases.
Medical tourists may turn to clinics and hospitals in Mexico, India, Turkey, Russia and elsewhere for stem cell therapies that have not undergone clinical trials, are not recognised as standard treatment, and where governments have a more relaxed view of a practice that brings in income from overseas patients.