Why do we overmedicate babies for heartburn?

How to fix health policy.
June 17 2010 9:35 AM

The Reflex To Treat Reflux

Why do we overmedicate babies for heartburn?

Man with acid reflux. Click image to expand.
Are acid blockers over-prescribed?

In an attempt to slow down use of the drug that would become the second-highest-grossing pharmaceutical in the United States, the head of Medicaid and Medicare delivered a blunt admonition to a 2003 gathering of the American Medical Association: "You should be embarrassed if you prescribe Nexium, because it increases costs with no medical benefits."

At the time, the pricey heartburn drug—widely advertised as the "purple pill"—was the latest weapon in the war on stomach acid. AstraZeneca used a $500 million marketing campaign to propel $5 billion in annual sales of Nexium. So quickly did the drug sweep the country that the doctors with whom I worked began calling it "purple crack."

Nexium was the latest "proton pump inhibitor," or PPI, a massively profitable class of drugs that switches off the stomach's acid-producing cells. When AstraZeneca's prior PPI blockbuster, Prilosec, was on the verge of becoming available as a generic, the company hit upon a brilliant strategy. As with other medications—like albuterol for asthma—Prilosec's manufacturing process created a mixture of two molecules that were mirror images, of which only one had any effect on cells. To create Nexium, AstraZeneca tweaked Prilosec's production so only the active form was in the pill. The drugs are bio-identical but certainly not price-identical.

Critics like the former New England Journal of Medicine editor Marcia Angell often point to Nexium as an example of how unscrupulous pharma companies made health care costs skyrocket. Observe how AstraZeneca brilliantly intervened at Massachusetts General Hospital. As the Boston Globe Magazine reported, the company negotiated a "fantastic discount" on Nexium that saved the hospital hundreds of thousands of dollars each year. In exchange, the hospital administrators agreed to make it their preferred drug in its class. As journalist Neil Swidey wrote, AstraZeneca scored a coup: "[P]atients will be discharged on Nexium, residents will be trained on Nexium, and doctors across the country will be told that Nexium is the first choice of world-famous Mass General," even though an identical, cheaper generic exists.

However, shrewd marketing on the part of drug companies fails to explain the widespread use of heartburn drugs in adults and now in babies. When you examine that problem, it is clear that the crisis of prescription drug costs has little to do with the behavior of pharma companies—and everything to do with the unscientific prescribing habits of many doctors.

Last month, the Archives of Internal Medicine published five sobering articles on the overuse and risks of heartburn drugs like Nexium. Incredibly, doctors put half of all hospital inpatients on them, and 41 percent of all patients go home on them—regardless of the reason for hospitalization.

Keep in mind that, contrary to many people's beliefs, doctors don't get a cut of drugs they prescribe, and nobody is forcing or often even asking them to prescribe them. The over-prescription of acid blockers is a worldwide problem, occurring in single-payer systems like that of the United Kingdom and in largely privately insured countries like the United States. So why does everyone keep using drugs like Nexium so widely?

Let's take a step back to understand heartburn. Cells lining the stomach produce hydrochloric acid, which starts digestion and also appears to kill bacteria. Heartburn, goes the theory, is caused by the acid "refluxing" from the stomach upward into the esophagus, damaging the lining and also causing pain and discomfort. Based on studies involving more than 35,000 patients, acid blockers like Nexium can heal this damage and thus improve pain symptoms in those patients.

But there's a problem with the theory. In a study of 1,000 randomly selected healthy people who underwent endoscopy to look at the esophagus, 150 had damaged linings. Yet just 50 complained of any heartburn symptoms. The other 100 with damaged linings were doing just fine. Just as strangely, 100 of the patients without damaged linings had heartburn symptoms.

In many patients, heartburn has little to do with acid reflux. Most likely the symptoms come and go randomly, with no relation to reflux or any medication use. Further, while acid blockers are useless against nonspecific belly pain—because there's no hydrochloric acid in your intestines, liver, or other organs of the digestive tract—doctors frequently prescribe them for so-called "non-ulcer dyspepsia." The British Medical Journal in 2008 estimated that anywhere from one-quarter to three-quarters of all acid blockers like Nexium were prescribed for no good reason.

Because almost 20 percent of all adults complain of reflux-type symptoms, doctors tend to throw the drugs around at the first mention of mild heartburn. Ideally, physicians should endorse simple dietary changes (avoiding caffeine, high-fat meals, and eating just before bedtime), mention cheaper alternatives (like Tums), and explain the random ups and downs of the pain. But they don't. Across the globe, Nexium is over-prescribed for the most banal of reasons: It's less work to write a prescription and pretend the problem is solved.

The consequences of this worldwide clinical laziness are serious. Once you start the drugs, it's very, very hard to stop; even the stomachs of healthy people become "addicted" to the drugs. In 2009, studies showed that volunteers with no heartburn symptoms who took the anti-reflux drugs for two months actually experienced heartburn and reflux when they tried to stop. Further, the acid blockers increase the risk of fractures by one-quarter in women, are associated with more deaths after angioplasty, and increase the risk of major gut infections.

And now the war on stomach acid has a new front: babies with colic. Normal infants reflux all the time (the average preemie, for example, has 71 minor spit-ups daily), but fewer than one in 300 has any evidence of damage to the esophagus. Randomized studies regularly show that acid blockers do nothing to help baby reflux. Worse, drugs like Nexium or Zantac (which blocks acid in a slightly different manner) may increase brain bleeds and gut damage in preterm infants as well as the risk of food allergies in older infants.

Yet, in parallel with the jump in adults, the number of acid-blocker prescriptions for colicky infants recently quadrupled. Bemoaning this trend, Philip Putnam of Cincinnati Children's wryly observed that "gastric acid rivals mucus as the most maligned secretion from the body."

The overuse of drugs like Nexium isn't a new problem. For years, doctors prescribed COX-2 inhibitors like Vioxx and Celebrex, though they worked no better than Tylenol and ibuprofen. Pediatricians use antibiotics to treat almost half of all kids with colds, though the powerful drugs do no good and drive up the number of resistant microbes. Can we really blame the drug companies for these messes? Malcolm Gladwell, writing on the prescription drug crisis, notes, "For sellers to behave responsibly, buyers must first behave intelligently." For many adults with heartburn and for many babies with colic, doctors regularly write useless prescriptions and insurers happily pay to fill them.

That's the little-known secret of drug expenses. Our nation's drug bill has are risen not because the drugs cost more: Only one-third of the 9 percent annual jump comes from higher prices. The truth is that grown-ups and now babies are simply taking more pills. This situation will persist until health insurers, who inexplicably cough up billions of dollars for me-too drugs like Nexium, demand value for their outlays.

In the meantime, the next time your pediatrician suggests Nexium, Prilosec, or Zantac for your baby's mild spit-ups, ask her to explain their necessity better. Tell her you don't need any fancy pills. You would prefer a far more powerful therapy—words of explanation.

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