Dr. T. Raymond Foley is a partner in an established private practice in Lancaster, Pennsylvania. In addition to having his own practice, Dr. Foley has served on innumerable committees and advisory boards throughout the medical industry, from hospital advisory boards to insurance company committees to the Lancaster Board of the American Cancer Society. He has also participated in and published research on clinical trials of new medical treatments for several years.
Reflux1: Tell us a little bit about how you got started in gastroenterology.
Dr. Foley: After my residency, at the Medical University of South Carolina, I did three years of public health service, and after that I did my GI fellowship, and I went into private practice. My partners and I provide the entire range of gastroenterology services to our patients 24 hours a day, seven days a week. The professional accomplishment that I’d highlight is our recent participation in clinical trials utilizing Enteryx® for patients with gastroesophageal reflux disease.
Reflux1: Can you please provide our users with a brief overview of heartburn and gastroesophageal reflux disease, or GERD, and explain the distinction between the two?
Dr. Foley: Heartburn is a symptom of GERD. It’s said that up to 25% of the population will experience heartburn on a weekly basis, so it’s very common. A lot of people use over-the-counter preparations, which are effective in the majority of patients. The people we see have failed traditional treatments, such as lifestyle modifications, and over-the-counter medications such as H2-blockers; or they’ve seen their family doctors and been put on proton pump inhibitors and continue to be symptomatic. Or, they have an atypical manifestation of GERD: something like a cough, or adult-onset asthma.
Reflux1: If there were one thing you could tell our readers about heartburn and heartburn treatments, what would it be?
Dr. Foley: People have become increasingly aware of more medical therapies, but I think that most people should be able to expect complete relief of their symptoms. I think that’s true of at least 95% of people.
Reflux1: What are some of the upcoming trends in heartburn therapy that our readers should know about?
Dr. Foley: Traditionally the treatment has been medical therapy, including PPIs, for people with more difficult-to-treat reflux. If their treatment was less than optimal, or they didn’t want to take medications, we might send some of those patients for surgery. The trial that we were involved with recently was an endoscopic procedure, during which we injected Enteryx®, an inert bipolymer, into the region of the lower esophageal sphincter, or LES, to treat patients with GERD who previously had been well-controlled.
Reflux1: Where does the Enteryx® study stand right now?
Dr. Foley: The initial trial, a multicenter study, has been completed, and that trial resulted in FDA approval of Enteryx®. They’re now enrolling a second trial, and there’s another one being enrolled in Europe with a sham control. The procedure is available to the public now: Boston Scientific is just bringing it out.
Reflux1: The polymer used in the procedure has been used in a variety of other operations for a while, hasn’t it?
Dr. Foley: Most of the information on this polymer came from Japan, where it was used in over 2500 patients: primarily injected into aneurysms (blood vessels) in the brain. It seemed to be effective, and it seemed to be safe. And there’s also a lot of animal data on the safety of the polymer.
Reflux1: What other procedures are currently available for the treatment of GERD? How do they compare with Enteryx®?
Dr. Foley: One is the Stretta® procedure, where radiofrequency ablation is delivered to the lower esophageal sphincter.
There’s also endoscopic suturing. My understanding is that it’s difficult and time-consuming, and I don’t know that we know the long-term results.
It seems to me that Enteryx® is probably going to be easier to use for most gastroenterologists; it takes a treatment which we’re used to doing (the injection of Botox and endoscopic sclerocins), so a lot of endoscopists will have relevant experience.
Reflux1: Can you give our readers a little more information on the workings of the procedure and its effectiveness?
Dr. Foley: I don’t think we know exactly how it works, but it's postulated that it may interfere with transient LES relaxation. But approximately 70% of patients, twelve months after the procedure, were off all medications, and another 10% of patients had reduced their medications by at least half, so overall it appeared to be successful. Before the trial, the patients had to come off medications for ten days, and they had testing done before and after the procedure, and there was significant improvement. There was also significant improvement in how they felt, according to a quality-of-life questionnaire.
What we don’t know about Enteryx® is its long-term effectiveness. But then, there was a study published just about a year ago in the New England Journal of Medicine on a ten year follow-up of open fundoplication (a conventional invasive surgical procedure for GERD), and in ten years about two-thirds of patients had resumed taking medication. Twelve months after Enteryx®, the plastic was stable, so you’d think the relief would persist; but we we don’t have long-term data.
Reflux1: If I’m a patient with reflux, where should I look for more information?
Dr. Foley: The first place to start is with your primary physician, and then if you’re treated and you’re happy with the results, or you’ve quit smoking and you gave up drinking, then that might be all you need. I should also say that there are certain alarm symptoms associated with reflux: difficulty swallowing, weight loss, or anemia. All of the people with those symptoms should see a gastroenterologist. If you’re happy taking a pill a day, then you may not need anything further. Otherwise, or if you’re having trouble affording your medication or would like to try and get off your medication, you might want to see a gastroenterologist to discuss possible treatment.