What seemed like a scary possible connection between the blockbuster heartburn drugs Nexium and Prilosec and heart attacks appears to be a false alarm, experts assure us.
The reappearance of these drugs in the news, however, is a reminder of one of the most highly questionable marketing practices in the pharmaceutical industry. The promotion of these pills may be legal, but it's still hazardous to our health care system, costing consumers billions of dollars a year.
Last week, the Food and Drug Administration announced that AstraZeneca, maker of both drugs, had found what might have been an increased risk for cardiac trouble in a 14-year study comparing the drugs to surgery. In reviewing the data, the agency said it agreed with the company that the result seemed to be a statistical fluke.
The FDA’s rather confusing report seemed to be an attempt at greater transparency following widespread criticism for its handling of alleged dangers of other drugs, including the arthritis medication Vioxx and the diabetes treatment Avandia. While most pharmaceutical experts agree there seems to be no heart danger from Nexium or Prilosec, their marketing has costly side effects.
Both drugs are approved mainly to treat ulcers and gastroesophageal reflux disease, or GERD, a chronic condition where the muscle that holds contents in the stomach weakens and the stomach’s acidic mixture moves back up into the esophagus where it can cause unpleasant burning. More serious problems, including scarring and even cancer, can result over months or years.
The FDA first approved Prilosec in 1989. AstraZeneca quickly earned huge profits from it. By 2000 it was the best-selling drug in the world with more than $6 billion a year in sales.
Biochemical chutzpah
But AstraZeneca had a big problem. The patent on Prilosec was expiring in 2001, meaning the company would have to compete with cheaper generic versions and could no longer charge whatever it wanted.
Often drug companies seek creative responses to patent expirations. Some sue on specious grounds, trying to prolong the patent. Sometimes they combine the drug with another existing drug to create a “new” product.
AstraZeneca attempted and got away with what I would call brilliant biochemical chutzpah.
Almost all drugs exist in an equal combination of two mirror images of the same molecule called isomers. Nexium is nothing more than one of the two mirror images that make up Prilosec. AstraZeneca carried out clinical trials comparing Prilosec and Nexium. The most charitable interpretation of the results is that at equal doses Nexium is 3 percent better at relieving symptoms.
The results were so weak that the FDA case officer assigned to review the data concluded that AstraZeneca’s contention that Nexium represented a “significant clinical advance” over Prilosec was “not supported by data.” The top management of the FDA approved Nexium anyway in 2001.
Blitz of the 'little purple pill'
With the approval in hand, AstraZeneca set in motion one of most expensive marketing campaigns ever with the goal of getting doctors and patients to switch from Prilosec to the almost identical Nexium. The company immediately quadrupled its sales force assigned to those products and according to Medical Marketing & Media, an advertising trade publication, spent $16 million in one month alone.
The blitz worked. At this point, who hasn't heard of the "little purple pill"? More than 7 million Americans now take Nexium, according to the drug company. And IMS Health, a company that tracks pharmaceutical sales, reports that Nexium earned more than $5 billion in sales in the U.S. last year, making it the second highest grossing drug after Lipitor, the cholesterol-lowering medication hawked by a celebrity doctor in TV and print ads.
Prilosec now costs about $30 a month. Nexium costs about $200.
If anyone doubts the influence of drug company ads on patients and physicians — consider all those wasted billions of dollars for a pill that sells for more than six times as much as another drug that does the same thing, made by the same company.