Mary Chris Jaklevic is a reporter-editor at HealthNewsReview.org. She tweets as @mcjaklevic.
Tiffany Mielcarek was aghast when she saw NBC’s Today Show hype an experimental weight loss procedure that freezes a branch of the vagus nerve that sends hunger signals to the brain and regulates digestion.
“They were talking about it as if this were a miracle. No risks were brought up at all,” said the 48-year-old Ohio resident, who has a digestive disorder called gastroparesis, which can be caused by damage to the vagus nerve. “It just struck me as very irresponsible.”
She wasn’t alone in her concern. Nearly 100 comments about the segment were posted on the Today Show’s Facebook page, most expressing shock that the program didn’t broach any potential risks of a procedure that has only been studied for a few months in a handful of patients.
Similar imbalanced coverage about the procedure — undergoing a clinical trial at Emory Healthcare — ran in other news outlets including ABC and Fox affiliates. We previously wrote about the Today Show coverage.
Many commenters said they have gastroparesis, a rare and sometimes debilitating condition in which the stomach doesn’t properly digest food. Gastroparesis can be caused by damage to the vagus nerve from surgery or, it’s hypothesized, from hyperglycemia induced by diabetes. In some cases, the trigger isn’t known.
Some people in the Today Show audience chuckled when Melissa Donovan, the first woman to get the nerve-freezing procedure, exuberantly proclaimed: “I forgot to eat!” Donovan said she lost 25 pounds as a result.
But losing your appetite is a grave matter for people with gastroparesis, who commonly experience nausea and vomiting, problems with blood sugar levels, and weight loss. They can be prone to depression, partly because they can’t share normal meals with family and friends. Some resort to liquid diets and feeding tubes.
The Today Show segment struck fear in some gastroparesis patients that people desperate to lose a few pounds would join a clinical trial for the vagus nerve freezing procedure without understanding the potential harms.
“This is a life sentence for us,” said advocate Melissa Adams VanHouten, who administers a 19,000-member Facebook page called the Gastroparesis Support Group, where the Today Show segment was shared. “We can’t believe that anybody could know this disease and still participate in a trial, with even a small chance of something going wrong.”
Emory doesn’t mention any potential harms in promotional material for the nerve-freezing procedure, which it said was proven safe in a pilot study of 10 patients observed for 90 days. Those results were presented at a scientific meeting of the Society of Interventional Radiology and have not been published in a peer-reviewed journal.
The study is being funded by HealthTronics, a medical technology company that makes the ablation probes used for the treatment.
The lead researcher, interventional radiologist David Prologo, MD, of the Emory University School of Medicine, holds himself out as a weight loss expert, although his published papers don’t relate to that field.
Emory said the frozen nerve will grow back after eight to 12 months, at which point Prologo “hopes that the newly regenerated nerve will be less hyperactive, providing a new set point for patients.” A “set point” refers to a theory that the body uses hormones, hunger signals, and other mechanisms to maintain a certain weight.
On the Today Show, Prologo said researchers had in fact followed 20 patients who had had the procedure an average of four months, and “we haven’t seen any complications related to the procedure or adverse effects yet.”
At least 20 gastroparesis patients tried to open a dialogue about the safety of the nerve-freezing procedure on the doctor’s Facebook page, but their comments were removed, VanHouten said.
In a post on the Today Show page, Prologo said he was deleting comments from his own page only “if they aren’t nice.”
But VanHouten said most of the comments asking about gastroparesis risk were respectful. “His goal, in my opinion, was to snuff out any remarks which might cause people to second-guess the procedure or which did not blatantly praise his (Today Show) interview,” she said.
When we checked, Prologo’s Facebook page contained only laudatory comments, like these:
Prologo did respond to the concerns of gastroparesis patients on the Today Show Facebook page. In a post punctuated with hearts and smile emojis, he said: “We are definitely reading all of your comments, it is my passion in life to help people.”
He wrote that “all of the potential risks and side effects (including gastroparesis, among many, many others that these groups may not know about)” were considered by the research team, and patients were being monitored.
He also said researchers “reviewed hundreds of research papers around surgical, chemical, and electrical vagotomies before starting this trial.”
But there doesn’t appear to be published research on the safety of freezing the vagus nerve. Asked what evidence exists that the vagus nerve will indeed grow back, an Emory spokeswoman said via email: “Many previous studies have been done in animals and in humans describing the regeneration of nerves following cryoablation,” or nerve freezing.
She provided a list of 13 published journal articles, most about freezing nerves to block pain. Only one described a human clinical trial, which involved freezing a leg nerve to reduce knee pain. None of the articles appeared to deal with the vagus nerve.
Mayo Clinic gastroenterologist Michael Camilleri, MD., who studies gastrointestinal disorders as well as the role of appetite in obesity, watched the Today Show segment and did his own search of the medical literature. He also looked at information submitted about the trial on clinicaltrials.gov.
“There are a lot statements that this process is reversed in up to 12 months. Typically you’d want to have some proof of that — for example, from studies that are conducted in animals, and I can’t find such proof,” Camilleri said. “I certainly did not find enough information on the effects of treatment applied to the vagus nerve to be assured that this cryoablation procedure is safe, in contrast to effects on (motor and sensory) nerves. The procedure involves three cycles of freezing and thawing of the vagus nerve. Specifically, it is unclear whether another important function of the vagus nerve — which is the emptying of food from the stomach — is compromised, or if the stomach is paralyzed temporarily or permanently — if the freezing effect is, in fact, irreversible.”
The Emory spokeswoman said “this ‘first in man’ procedure is being done in the context of a clinical trial – a highly regulated environment in which a small number of patients are being enrolled and the safety and feasibility of a new procedure tested.”
But history shows that harms often don’t become fully evident in small, highly controlled, clinical trials. As we’ve written, many devices have been declared safe in a clinical trial and put on the market, only to have serious harms emerge once they’re in widespread use.
We’ve documented other weight loss devices that were heavily promoted after early studies showed they were benign but were later found to create serious complications, such as the lap band.
In his own take on the vagus nerve freezing trial, Bruce Lee, executive director of the Global Obesity Prevention Center at Johns Hopkins University, cautioned: “It’s not clear yet what other functions may be disrupted by freezing even just a portion of the nerve. Did the research team do enough to monitor these other functions of the vagus nerve? What side effects may the procedure have immediately and eventually? It may take longer than 90 days for potential side effects to manifest.”
Mielcarek, who says her life was forever altered by gastroparesis, said she’s concerned the hope of permanent weight loss might blind people the severity of the potential harms, even if they are listed on a consent form.
Potential trial participants are “going to read ‘gastroparesis,’ but they are not going to know what it means,” Mielcarek said. “It’s not worth 25 pounds, let me just say that.”
VanHouten agreed that while Emory may follow proper guidelines to inform patients of potential harms, “I also know that many, many people who have participated in clinical trials later say that they were officially told the risks but did not fully understand them — and I do not see why the gastroparesis community further emphasizing them would be an issue for anyone.”
“I’m not sure why this is being pushed so soon and so aggressively. I think they need to slow down and think about the bad things that might result,” she said.
Fueling the outrage of people with gastroparesis is a lack of awareness about their condition, even in the medical community. At the same time, they’ve seen too many news reports that exaggerate the benefits and downplay the potential harms of medical treatments, creating unrealistic expectations.
In some cases, those skewed expectations led to bad outcomes, which is the focus of HealthNewsReview.org’s ongoing series on how misleading media messages can cause harm.
For Tennessee resident Riah Daniels 48, whose post appears above, the Today Show segment harkened back to a television story she saw a decade ago, featuring a child whose epileptic seizures were controlled with a vagus nerve stimulator.
Seeing that child on TV contributed to her decision to get the device implanted in her chest and neck to treat her own epileptic seizures, in the hope of being able to drive her middle school children to their activities, she said.
“I watched it and I thought, ‘Yeah, I could do that. I could get my life back,'” she said.
About half of patients with VNS devices see at least a 50% long-term reduction in seizures, but a quarter don’t benefit, according to a published analysis.
For Daniels, the implant didn’t work, and now she has to avoid magnetic resonance imaging scans, which could heat the device and cause injury.
While she had stomach problems before getting the device, Daniels said her doctor believes having it clamped to her vagus nerve led to her developing gastroparesis.
“I live with this every day now,” she said. “Had I known that putting an implant in my chest so I could be with my children would start me down this path and cause me to get worse, I would never had done it.”