The following is a guest blog post from one of our contributors, veteran health care journalist Trudy Lieberman. Trudy keeps an eye out for the way in which health care topics are promoted to the public, and this is one of the latest to catch her eye.
Imagine a world where no one would suffer from acid reflux disease. You might think such a thing just might be possible after reading “Heartburn hell: Woman finds relief with magnetic bead implant,” published a few weeks ago on the website for the NBC Today Show..
It was a story about 28-year-old Jennifer Aronson who’s had digestive problems since childhood. We’re told that she could barely swallow a sip of water without it coming back up. Recently, she traveled to Froedtert & the Medical College of Wisconsin to have a magnetic string of beds surgically implanted in her esophagus.
The story explains that “The beads, called the LINX system, are made by Torax Medical and help the sphincter resist acid flowing upward. Food pressure pushes the magnets open to allow swallowing.”
Ever since her surgery, Aronson said she’s leading a normal life.
“I have my energy back and am doing all the things I love.” By New Year’s Eve she was even guzzling champagne. Before the operation anything with carbonation would have been a “no-no.”
TODAY’s piece read almost like a press release from Torax Medical, the firm that makes the device.
It had all the earmarks of a marketing pitch for the LINX, the implantable device the FDA approved in 2012, and it’s a classic example of how marketers of drugs and devices use journalists to help them diffuse their products into widespread clinical practice. The story glowed with the positives and downplayed the negatives. Readers learn that acid reflux disease, which it said affects at least 10 percent of Americans, “is more prevalent than ever” with an expanding market for drugs to treat it. Are more people getting acid reflux disease, or has industry simply figured out a way to expand this market like they have with so many other drugs and devices?
The reporter didn’t go there, but noted more than one-third of people on medications are not getting significant relief, according to Dr. Jon C. Gould, chief of surgery at Froedtert & the Medical College of Wisconsin. Coincidentally, he was the surgeon who implanted the device in Aronson’s esophagus. A company press release in October noted the procedure is now offered in more than 200 medical centers, and the number is expanding monthly. Its website may be helping fuel that expansion. Many people go online to learn about their conditions. The story says that the young woman patient, Jennifer Aronson, flew to Milwaukee for the surgery “after researching the treatment online.”
The Torax website is carefully designed to facilitate the proliferation of the device. It provides a list of hospitals performing the procedure, and there are more testimonials touting its benefits. A sub-theme from some of the testimonials seems to be that medicines like proton pump inhibitors don’t work very well. Alie, a 24-year-old from Boston, said she had been on high doses of proton pump inhibitors that caused a hospitalization. Her doctor said there was nothing more she could do for her. She had to have surgery. “I feel really, really strongly this procedure actually saved my life, she says. And even though there’s a recovery period, it’s worth it, Alie explains, knowing that “for the rest of your life” you’ll feel so much better. Then there’s Tricia, a California outdoor enthusiast and surgery nurse who says, “the biggest misconception is that pills are going to help. Pills don’t help a mechanical problem. They mask a symptom, adding “what a simple mechanical fix for a mechanical problem.” Like Alie she says LINX gave me “back my life,” and she no longer has to take medicines or antacids.
TODAY did acknowledge that first line treatment should be lifestyle changes and mentioned one significant drawback. “Five or ten years down the road we don’t know it will work,” says Dr. Karthik Ravi an assistant professor at the Mayo Clinic. There are no long-term experiences with LINX in a large population. Larry Sasich, co-founder of Patient Drug News who once worked for Public Citizen’s Health Research Group, told me the recommendation his group has been using is to avoid new drugs for seven years until there is a clear track record for safety. Should the same apply to medical devices given that the FDA quickly approves drugs and devices these days and that problems have arisen with some of them? Cleaning problems with duodenoscopes and the cancer risk from using morcellators to break up fibroid uterine tumors come to mind.
There are other drawbacks TODAY didn’t get into, but the FAQ on the Torax website hinted there might be some. One revealed that MRIs are only considered safe in scanning machines with a magnetic field strength up to 0.7-Tesla (0.7T) and patients should discuss the procedure with their doctors. I asked Harold Demonaco, an expert member of the HealthNewsReview.org contributor team, what that meant. “The vast majority of MRIs in the U.S. are either 1.5 or 3T. The LINX is NOT safe for anything over a 0.7T which essentially means the device precludes use of the majority of clinically available MRI,” Demonaco said. Another FAQ said LINX uses “permanent magnets that are designed never to wear out.” Hmm. The “Indications for Use” section of the website states that one of the potential risks associated with LINX is “device erosion.” Did that mean it might wear out? GERD sufferers might want to know that. And they might want to know that studies have shown that the removal rate for the device has been between three and six percent.
Besides device erosion, the manufacturer lists these potential risks: dysphagia, stomach bloating, nausea, odynophagia, increased belching, decreased appetite, inability to belch or vomit, flatulence, early satiety, device migration, infection, pain, and worsening of preoperative symptoms. The TODAY story didn’t mention any of these.
This all means that prospective patients need to ask a lot more questions and so should have the TODAY reporter. News release journalism might help boost web traffic but does little to help patients navigate the complexities of medical treatments.
Follow us on Twitter: