We see the same tragic situation several times a year: a patient, often a young person in their twenties or thirties, goes to their primary care physician with the signs and symptoms of "GERD," or gastroesophageal reflux disease. They have persistent heartburn that seems to resist antacids, giving them pain in their throat and chest, maybe even a dry cough or trouble swallowing. Their doctor prescribes a proton-pump inhibitor - maybe Nexium, or Prevacid, or Prilosec - and then sends them on their way with instructions for them to follow-up in a couple weeks.
The heartburn drug works a little bit, but doesn't resolve the problem entirely. The patient goes back to the doctor two or three months later, and the doctor tells them to keep taking the pill, and reminds them to quit smoking, quit drinking alcohol, or get more sleep, or improve their diet. The patient starts just living with the pain and discomfort, and adding a couple antacids before and after their meals, too, and asking their family physician what to do. The doctor tells them they should avoid overeating, shouldn't go to bed with a full stomach, shouldn't eat onions or drink caffeine, and should raise their pillow. All the usual stuff.
After many more months, maybe more than a year, much more worrying symptoms appear - nausea, severe fatigue, blood in the stool, or throwing up blood. That's when the patient starts to get worried, and then either gets their doctor to finally order some follow-up diagnostic tests (often just blood work, or maybe a colonoscopy) or ends up in the Emergency Room wondering what's going on. Those other doctors, the ones at the imaging facility or in the emergency department at the hospital, tell the patient what's happening: cancer. The next day the patient gets a CT Scan or an MRI, and one of two things are confirmed: stomach cancer or esophageal cancer. And it's often inoperable by that point.
There's a little secret buried deep in the "prescribing information" given to physicians with those proton-pump inhibitors, information they're supposed to know but often don't: those drugs aren't meant to be used if you have signs of a serious condition, and they aren't supposed to be used for more than a couple weeks at a time.
Here's the approved usage on Nexium's FDA label:
Healing of Erosive Esophagitis
NEXIUM is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of NEXIUM may be considered. …
Symptomatic Gastroesophageal Reflux Disease
NEXIUM is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.
And here's the approved usage on Prilosec's warning label:
1.3 Treatment of Gastroesophageal Reflux Disease (GERD) (adults and pediatric patients) …
The efficacy of PRILOSEC used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of erosive esophagitis or GERD symptoms (eg, heartburn), additional 4-8 week courses of omeprazole may be considered.
And Prevacid's label:
1.7 Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
PREVACID is indicated for the treatment of heartburn and other symptoms associated with GERD.
Short-Term Treatment of Erosive Esophagitis
PREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis.
For patients who do not heal with PREVACID for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis an additional 8-week course of PREVACID may be considered.
Notice the key term there: "short-term treatment." Doctors are supposed to prescribe the medications for 4-8 weeks, evaluate how well they're working, and then prescribe them for at most another 8 weeks. Nobody is supposed to be on any of these proton pump inhibitors for more than four months at the very most, and then only while a doctor is evaluating them. (H2 receptor antagonists like Zantac are even shorter: the warning label for Zantac says to see a doctor if "you need to take this product for more than 14 days.")
Why? For the same reasons the medications tell you not to use them "if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor." It could be sign of gastric or esophageal cancer, or of Barrett's esophagus, which is tied closely with esophageal adenocarcinoma, a particular lethal cancer. Like with all cancers and precancerous tumors, the sooner a patient can be diagnosed and treated, the better, but that diagnosis requires an endoscopy be done of the throat and stomach.
For years, there has been frustratingly been debate in the medical community over when a doctor should tell a patient with signs of GERD to undergo upper endoscopy. Three different physician associations had completely different guidelines, all of which were bad and which shockingly discouraged doctors from recommending an endoscopy to patients:
The American Society of Gastrointestinal Endoscopy recommends that screening upper endoscopy be considered "in selected patients with chronic, longstanding GERD." GERD several times a week, or GERD for more than five years, or nocturnal reflux symptoms were risk factors.
The American Gastroenterological Association guidelines recommend against screening the general population with GERD for Barrett esophagus and esophageal adenocarcinoma but say that it should be considered in patients with GERD who have several risk factors associated with esophageal adenocarcinoma, like age, hiatal hernia, elevated body mass index, and intra-abdominal distribution of fat.
The American College of Gastroenterology guidelines note that "screening for Barrett’s esophagus in the general population cannot be recommended at this time. The use of screening in selective populations at higher risk remains to be established, and therefore should be individualized."
This advice was awful, and it cost lives. Frankly, it's hard not to think that the guidelines were written that way to excuse negligent physicians who failed to properly order tests. Thankfully, back in December 2012, the Clinical Guidelines Committee of the American College of Physicians published in the Annals of Internal Medicine new proposed guidelines that are far, far better than the guidelines from the other organization:
Best Practice Advice 1: Upper endoscopy is indicated in men and women with heartburn and alarm symptoms (dysphagia, bleeding, anemia, weight loss, and recurrent vomiting).
Best Practice Advice 2: Upper endoscopy is indicated in men and women with:
- Typical GERD symptoms that persist despite a therapeutic trial of 4 to 8 weeks of twice-daily proton-pump inhibitor therapy.
- Severe erosive esophagitis after a 2-month course of proton-pump inhibitor therapy to assess healing and rule out Barrett esophagus. Recurrent endoscopy after this follow-up examination is not indicated in the absence of Barrett esophagus.
- History of esophageal stricture who have recurrent symptoms of dysphagia.
Best Practice Advice 3: Upper endoscopy may be indicated:
- In men older than 60 years with chronic GERD symptoms (symptoms for more than 5 years) and additional risk factors (nocturnal reflux symptoms, hiatal hernia, elevated body mass index, tobacco use, and intra-abdominal distribution of fat) to detect esophageal adenocarcinoma and Barrett esophagus.
- For surveillance evaluation in men and women with a history of Barrett esophagus. In men and women with Barrett esophagus and no dysplasia, surveillance examinations should occur at intervals no more frequently than 3 to 5 years. More frequent intervals are indicated in patients with Barrett esophagus and dysplasia.
(If you don't want to read the journal article, Medscape has a summary here.) The first two examples of "best practice advice" are the most common issues we see in our work on behalf of malpractice victims. Either a doctor ignored an "alarm symptom" like blood in the vomit or stool or weight loss, or the doctor kept a patient on prescribed heartburn medication for too long even while GERD symptoms persisted.
It's our hope that these new guidelines, published in as widely-read journal as the Annals of Internal Medicine, will help educate family physicians, primary care physicians, and other about the warning signs of cancer that can be masked by GERD treatments. The unfortunate truth, however, is that negligent treatment persists among doctors long after the standard of care moves forward, and so we expect to continue to see these tragic cases for years to come.