In recent weeks concerns have been raised about the safety of some anti-reflux medications. A generic formulation of a common H2 antagonist, has been found to contain higher-than-safe amounts of N-Nitrosodimethylamine (NDMA), a known carcinogen. Consequently, global production and distribution has halted and Novartis has begun recalling its generic Zantac drugs.
Other antireflux medications, such as certain PPIs, are correlated with conditions as diverse as poor iron uptake and dementia, yet are still on the market and are some of the most prescribed medications globally.
Anti-reflux meds have been a blessing for many suffering from reflux. But as Dr. Tom DeMeester asks “At what cost?” Back in 2013, Dr. DeMeester foresaw this cascade of challenges with PPIs and shared in an editorial in the Huffington Post:
“PPI-treated GERD patients who have mild or absent symptoms while on the medication, were 60 percent more likely to have Barrett’s esophagus, a precancerous condition, than those with more severe symptoms while on the medication. Disappointedly, a good response to the medication does not eliminate the risk of cancer.
In another ongoing long-term study conducted in Europe, researchers determined that today’s treatment model, which is predominantly focused on drug therapy, does not stop the progression of the disease. More importantly, of all the risk factors studied, which included diet, obesity, smoking, alcohol use and family history, the one factor with the highest odds ratio associated with progression from mild to severe disease and leading to Barrett’s Esophagus was daily PPI use. So why are reflux disease patients treated with today’s routine clinical care standard most at risk for pre-cancerous conditions or esophageal cancer?”
If patients under a doctor’s care fare so poorly, what about those who self treat without the benefit of any oversight or surveillance? For reflux sufferers using over-the-counter medications, the FDA has compiled a useful treatment guide to help you self-treat more safely and effectively.
For many patients under a physician’s care, the big question will be why they were subjected to potentially harmful drugs, sometimes for years at a time, without an objective test confirming a diagnosis of reflux and the necessity of medicative treatment. Some insurers require a round of PPI therapy before approving a pH test for a patient. Using a therapy to confirm a diagnosis is marginalized, in that 30% of patients thought to have reflux actually have normal levels of pH when given an objective test. Placing these patients on a medication they don’t need carries the possibility of actually creating rebound acid hypersecretion (RAHS) when the medication is discontinued. Aside from confusing the diagnosis, this sometimes leads to the chronic use of a PPI which was never necessary.
If you have questions about your medication regimen, its efficacy, or necessity, contact your physician today and ask for an objective test – such as Restech’s Dx-pH test. It is a simple, painless test that lasts only 24 hours, and helps your physician accurately diagnose or rule out reflux – so you know exactly where you stand.
If you have questions about your reflux, visit our website or give us a call at 800.352.1512. To find a doctor who performs Restech pH testing, please check out our physician finder.
Bree has been an integral part of Restech from the very beginning. She holds a Masters in Public Health from George Washington University, a BFA from The University of Kansas in Visual Communications, and is a National Board Certified Health & Wellness Coach. Her command of marketing, public health/health delivery systems, and human health behavior change gives her a unique perspective in developing effective marketing strategies for the company.
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Thomas previously worked as a polysomnographic technologist in the Virginia Mason system, before moving into sales with Restech in 2007. After spending 9 years working with distributors across Europe, he was moved into an organizational role at the head office in Houston. In this capacity he works closely with sales and marketing to provide clinical support, manages clinical studies, and provides clinical perspectives on business development. In his spare time Thomas plays rugby for Houston Athletic Rugby Club.
Jeff has over 30 years of experience in the medical device industry and previously worked in sales at companies such as Encision Inc., Interventional Therapies, LLC, Boston Scientific, and United States Surgical Corporation. He has been working as the VP of Sales for Mederi Therapeutics since 2009 and now brings his extensive expertise to Restech. Jeff was part of the team that bridged the Mederi asset sale to Restech. His clinical knowledge of the Stretta and Secca technologies is invaluable. Jeff has three decades of physician relations experience that he brings to Restech as part of the leadership team.
Ray joined Restech in May 2018 as the Vice President for Sales. He has been in the medical device, and specifically in the GERD space for more than 18 years. Starting in sales at Sandhill Scientific pH diagnostics, he moved on to Curon Medical when Stretta and Secca were first introduced to the market. He then worked for Given Imaging when Curon closed operations. When Stretta was relaunced he joined Mederi as VP of Sales. Ray was instrumental in keeping Stretta alive and the customer based informed when Mederi ceased operation and assets were purchased by Restech. He is part of the leadership team directing all product sales for Restech. Ray graduated from Old Dominion University in Norfolk with a BS in Marketing and Business Administration.
Mark is a seasoned professional and Certified Public Accountant in Texas who brings a unique blend of creative vision and financial expertise to any leadership team. He worked as a Senior Executive for 15 years on a leadership team which grew a private equity backed cash logistics company performing at negative EBITDA on $100 million revenue into an international industry leader with superior profitability on revenue exceeding $1.5 billion. In addition, he spent 10 years as a Senior Manager at Price Waterhouse delivering results-oriented merger & acquisition, audit and strategic consulting services to middle market clientele including over 40 manufacturing, distribution, service, nonprofit and technology clients. Mark currently serves as a Chief Financial Officer and consulting CFO (seven years) providing in-house and outsourced CFO and transactional services to the middle market.
Larry is the CTO for Restech and holds a B.S. in Computer Science. He is a software architect specializing in remote patient monitoring, medical sensors, and clinical trial software. Larry holds a patent on massively distributed computing and has worked for a number of major software startup companies including Sybase, Oracle, and Teradata. Larry was also the co-founder of a startup to deliver advanced clinical pathways to patients using mobile devices and medical sensors. Larry is truly a pioneer and now a veteran in the deployment.
Jeff has a breadth of experience with over 25 years in engineering and executive positions within major fortune 100 healthcare companies. He also has proven success in startup medical technology companies. Jeff provides leadership in securing and managing Restech’s patent portfolio. He also built Restech’s compliance platform that established regulatory acceptance in 25+ countries worldwide. Jeff’s scientific support and in-depth understanding of the device industry set the foundation for current and future commercial innovations at Restech.
With nearly 30 years of working with physician thought leaders developing novel and emerging technologies, Leo has played a key role in the development and evolution of balloon angioplasty and stent technologies that revolutionized the therapy of cardiac disease. His experience was instrumental in the development of the patented platform technology which drives the Restech sensor. Leo provides a vision and passion for effecting change in the diagnosis and management of atypical reflux.
With over 20 years of executive experience in both the private and public sector, Debra brings a broad understanding of healthcare delivery system. With experience managing products aimed at wide scale disease and population management for 20 million subscribers, Debra has extensive experience in effectively and efficiently developing models of delivery that address specific health issues. Debra has also been involved in the legislative process and served as the elected President of the Independent Physician Association of California. Debra is dedicated to bringing tools to the healthcare market that improve and support the clinical process.