by Khaty Omar,
The treatment — deep brain stimulation — has long been used for movement disorders like Parkinson’s. Now, the first clinical trial of DBS for methamphetamine addiction is being conducted at Shanghai’s Ruijin Hospital, along with parallel trials for opioid addicts. And this troubled man is the very first patient.
As stated in AP NEWS, the surgery involves implanting a device that acts as a kind of pacemaker for the brain, electrically stimulating targeted areas. While Western attempts to push forward with human trials of DBS for addiction have foundered, China is emerging as a hub for this research.
Scientists in Europe have struggled to recruit patients for their DBS addiction studies, and complex ethical, social and scientific questions have made it hard to push forward with this kind of work in the United States, where the devices can cost $100,000 to implant.
China has a long, if troubled, history of brain surgery on drug addicts. Even today, China’s punitive anti-drug laws can force addicts into years of compulsory treatment, including “rehabilitation” through labor. It has a large patient population, government funding and ambitious medical device companies ready to pay for DBS research.
There are eight registered DBS clinical trials for drug addiction being conducted in the world, according to a U.S. National Institutes of Health database. Six are in China.
But the suffering wrought by the opioid epidemic may be changing the risk-reward calculus for doctors and regulators in the United States. Now, the experimental surgery Patient Number One is about to undergo is coming to America. In February, the U.S. Food and Drug Administration greenlighted a clinical trial in West Virginia of DBS for opioid addicts.
Before there were brain implants in China there was brain lesioning. Desperate families of heroin addicts paid thousands of dollars for unproven and risky surgeries in which doctors destroyed small clumps of brain tissue. Brain lesioning quickly became a profit center at some hospitals, but it also left a trail of patients with mood disorders, lost memories and altered sex drives.
In 2004, China’s Ministry of Health ordered a halt to brain lesioning for addiction at most hospitals. Nine years later, doctors at a military hospital in Xi’an reported that roughly half of the 1,167 addicts who had their brains lesioned stayed off drugs for at least five years.
DBS builds on that history. But unlike lesioning, which irreversibly kills brain cells, the devices allow brain interventions that are — in theory — reversible. The technology has opened a fresh field of human experimentation globally.
Sun said he has served as a consultant for two Chinese companies that make deep brain stimulators — SceneRay Corp. and Beijing PINS Medical Co. He has tried to turn Ruijin into a center of DBS research, not just for addiction, but also Tourette syndrome, depression and anorexia.
In China, DBS devices can cost less than $25,000. Many patients pay cash.
In fact, there are risks. There is a small chance Yan could die of a brain hemorrhage. He could emerge with changes to his personality, seizures, or an infection. And in the end, he may go right back on drugs.
Some critics believe this surgery should not be allowed.
They argue that such human experiments are premature, and will not address the complex biological, social and psychological factors that drive addiction. Scientists don’t fully understand how DBS works and there is still debate about where electrodes should be placed to treat addiction. There is also skepticism in the global scientific community about the general quality and ethical rigor — particularly around issues like informed consent — of clinical trials done in China.
The failure of two large-scale, U.S. clinical trials on DBS for depression around five years ago prompted soul-searching about what threshold of scientific understanding must be met in order to design effective, ethical experiments.
According to the U.S. Centers for Disease Control and Prevention, more than 500,000 Americans died of drug overdoses in the decade ending in 2017 — increasingly, from synthetic opioids that come mainly from China, U.S. officials say. That’s more than the number of U.S. soldiers who died in World War II and Vietnam combined.
The body count has added urgency to efforts to find new, more effective treatments for addiction. While doctors in the U.S. are interested in using DBS for addiction, work funded by the U.S. National Institutes of Health is still focused on experiments in animals, not people.
At least two U.S. laboratories dropped clinical trials of DBS for treating alcoholism over concerns about study design and preliminary results that didn’t seem to justify the risks, investigators who led the studies told The Associated Press.
China’s studies have offered mixed results. Sun and his colleagues have published one case study, describing a heroin addict who fatally overdosed three months after getting DBS. But a separate pilot study published in January by doctors at a military hospital in Xi’an showed that five of eight heroin addicts stayed off drugs for two years after DBS surgery.
Based on those results, SceneRay is seeking Chinese regulatory approval of its DBS device for addiction, and funding a multi-site clinical trial targeting 60 heroin addicts. SceneRay chairman Ning Yihua said his application for a clinical trial in the U.S. was blocked by the U.S. Food and Drug Administration.
But in February, the FDA greenlighted a separate, pilot trial of DBS for four opioid addicts, said Dr. Ali Rezai, who is leading the study at the West Virginia University Rockefeller Neuroscience Institute. They hope to launch the trial in June, with funding from the National Institute on Drug Abuse.
The FDA declined comment.