Biolectronics tries to shock patients out of drug habits

Can researchers shock Americans out of our drug habit? A growing number of them want to try.

Their field is called bioelectronics, and it employs electrical stimulation of the central nervous system to regulate the body’s natural response to ailments. Bioelectronic implants have been used for years to treat seizures and depression. Now, researchers are stepping up efforts to ease or cure myriad conditions — everything from asthma to Crohn’s disease – with bioelectronics. They believe they can do it more cheaply and with fewer side effects than drug treatments.

At a time when prescription drug use is spiraling, that’s welcome news. According to a study published late last year in the Journal of the American Medical Association, 59% of U.S. adults in 2012 were taking one or more prescription drugs, compared to 51% in 2000. And the percentage of people taking at least five drugs shot up to 15% from 8%.

Even drug companies understand the gravity of the issue and are getting in the act. This summer, for example, GlaxoSmithKline and Google’s parent company Alphabet launched a bioelectronics joint venture called Galvani Bioelectronics. The two companies put up 540 million British pounds – or more than $700 million – to support Galvani, which they hope will yield bioelectronic treatments over the next seven years.

Also this summer, researchers published the results of a clinical trial showing significant improvement in patients with rheumatoid arthritis from bioelectronic treatment. The study was conducted by the University of Amsterdam, the Feinstein Institute for Medical Research in Manhasset, NY, and Setpoint Medical of Valencia, CA.

The target of these and many other bioelectronics activities is the vagus nerve, which is chartered with maintaining calm in the body. The far-reaching nerve touches almost every organ in the body, and plays a leading role in the so-called “rest-and-digest,” or parasympathetic, nervous system. It sends signals to the brain that it’s time to take it down a notch by quieting “fight-or-flight” responses like elevated heartrate, high blood pressure and inflammation. It is the yin to the body’s yang, the sympathetic nervous system.

By stimulating the vagus nerve as it makes its way up to the brain, researchers find they can coax the brain to control many of the things that drugs are prescribed to do: relieve pain and swelling, control acid production in the stomach – even improve mood.

Vagus nerve stimulation, or VNS, devices have been prescribed for nearly 20 years to treat medication-resistant seizures in epileptics. Early on, doctors noticed that those patients seemed much happier. That led to research into the effectiveness of VNS to treat depression. The results were compelling enough to convince the FDA to approve VNS for depression as well.

The big drawback of VNS treatment today is that it requires a serious commitment, because thus far only implantable stimulators are approved for use in the U.S. The devices, which look and act a lot like pacemakers, are surgically implanted into the chest cavity and attached to the vagus nerve. Complications reported are typically associated with surgery – like pain, irritation and swelling at the surgical sight – along with hoarseness and some voice alteration.

To lower the commitment, a few companies have developed transcutaneous VNS devices, noninvasive stimulators that direct electrical signals through the skin at spots where the vagus nerve runs close to the surface. As of yet, none have been approved by the FDA for use in the USA.

One such company is Cerbomed. The German supplier developed a device that delivers signals via electrodes attached to the outer ear canal. That device is approved to treat epilepsy by the European Union, and the company is expanding sales into new countries there. Another company, New Jersey-based ElectroCore, built a handheld device that sends signals into the neck. It’s approved for use in a few countries to combat migraines and cluster headaches.

The process for getting medical devices through FDA approval is no less rigorous than it is for new drug therapies, so it will take years before your doctor will be able to prescribe VNS for something other than seizures or depression. It took Cyberonics, which developed the first implantable VNS devices, 10 years from the time the company began trials in humans until the FDA approved them as epilepsy treatment. (Cyberonics merged with Sorin a year ago, and is now called LivaNova.)

The good news is that you don’t need a prescription to stimulate your vagus nerve. Earlier this year, a Florida-based startup called Nervana began selling a VNS device as a wellness product. The company claims their device, which uses conductive earbuds to deliver the signals into the left outer ear canal, helps promote calm and enhance focus. (Full disclosure: earlier this year, Nervana contracted me to write a pair of briefs explaining VNS technology and their device.)

In fact, you don’t even need electrical signals to stimulate the vagus nerve. Activities like yoga, meditation and massage all stimulate nerve activity. And members of the growing do-it-yourself wellness movement called biohacking have identified many more ways to promote a vagal response. To name a few: deep breathing exercises, singing forcefully – even a splash of ice-cold water to the face.

Shocking, you might say.

Mike Feibus is principal analyst at FeibusTech, a Scottsdale, Ariz., market strategy and analysis firm focusing on mobile ecosystems and client technologies. Reach him at mikef@feibustech.com. Follow him on Twitter @MikeFeibus.