by John Shaw
Tagamet, an anti-ulcer drug, was developed and marketed by the pharmaceutical giant SmithKline Beecham in the late seventies. Hailed as a medical breakthrough, this blockbuster drug gave relief to millions of people suffering from peptic ulcers. In 1977, the Food and Drug Administration approved Tagamet for sale in the United States.
Tagamet works by reducing the amount of acid released into the digestive tract, which reduces the pain associated with ulcers. Since the drug only masks the symptoms and does not cure ulcers, patients had no choice but to continue to take this maintenance drug on a regular basis for as long as the ulcer persisted (1, 2).
But patients who experienced significant pain relief from peptic ulcers didn't seem to mind, and insurance companies were more than happy to cover the drug cost, with higher premiums of course. Over the seventeen years following its introduction, sales of Tagamet exceeded $14 billion (3). In the early nineties, the anti-ulcer drug market was estimated to be over $8 billion dollars a year (1, 4). By any account, Tagamet was a true pharmaceutical success story—for both SmithKline Beecham and the millions suffering from peptic ulcers.
However, there is more to the story.
Soon after Tagamet (and other anti-ulcer drugs like Zantac) hit the market, two Australian physicians, Dr. Barry Marshall and Dr. Robbin Warren, were conducting research to determine the true cause of peptic ulcers, in hopes of finding a cure. In 1983, they announced that they had discovered the cause of almost all peptic ulcers, a tiny bacterium known as Helicobacter pylori (H. pylori). They determined that this bacterium is immune to the harsh acidic conditions of the stomach and is attracted to the stomach's lining. They found H. pylori in over 90 percent of the ulcer patients they examined.
Having discovered the cause of the ulcers, these physicians demonstrated that peptic ulcers could be cured by eradicating the bacteria with a combination of antibiotics over a two-week period. The scientific community reacted with extreme skepticism. But Dr. Marshall convinced them of the link between peptic ulcers and H. pylori with an unorthodox experiment. He intentionally ingested H. pylori cultured in his lab and developed peptic ulcers in his own body, which he was able to cure with antibiotics in a short period of time (1).
Although their research was published in 1983 in a prestigious medical journal, The Lancet, the pharmaceutical industry was in no rush to embrace the study's conclusions. If it became an acceptable practice to use low-cost antibiotics to cure peptic ulcers, the industry would lose billions of dollars a year in sales of anti-ulcer drugs. They were not about to let that happen without a fight. With pharmaceutical reps as the main information source for most physicians, word of this discovery did not spread throughout the medical community, and sales of Tagamet and other anti-ulcer drugs continued to climb for years after the H. pylori discovery.
Throughout the eighties and early nineties (a time when Tagamet had U.S. patent protection), antibiotic treatment of peptic ulcers was never accepted as standard medical practice. But that all changed in May 1994 when the patent protecting Tagamet in the United States expired. Without patent protection, Tagamet sales were doomed to collapse under competition from lower-priced generic drugs. With the impending decline of Tagamet sales, the use of antibiotic treatments on ulcers was no longer the great threat that it once had been. It was time for a new strategy, and the Big Pharma machine went to work.
Over ten years after the discovery of H. pylori, and three months before the Tagamet patent expiration, the linkage between the bacteria and peptic ulcers was finally acknowledged by the U.S. government. In February 1993, the U.S. National Institutes of Health issued a recommendation to all U.S. physicians to discontinue the use of anti-ulcer drugs to their patients, and instead endorsed a regimen of antibiotics to kill the H. pylori bacterium and thereby cure peptic ulcers (4). To maintain sales of Tagamet, however, SmithKline Beecham convinced the FDA to approve a watered-down version of Tagamet for a different application. One month after the patent expiration, Tagamet was approved as an over-the-counter treatment for routine heartburn.
The storm had been weathered. Big Pharma had kept a blockbuster maintenance drug for the treatment of ulcers on the market throughout the seventeen-year life of its patent, while a known cure for ulcers was silenced for over ten years. And as for those two physicians who discovered H. pylori back in 1983 and were squelched for over a decade, they were awarded the Nobel Prize in Medicine and Physiology in 2005 for their discovery that peptic ulcers are caused by H. pylori and can be cured by antibiotics (5).
REFERENCES
1. Alper, Joseph. "Ulcers as an infectious disease." Science, Vol. 260, April 9, 1993, pp. 159-60.
2. Conwell, Carl F., et al. "Prevalence of Heli-cobacter pylori in family practice patients with refractory dyspepsia; a comparison of tests available in the office." The Journal of Family Practice, Vol. 41, No. 3, September 1995, pp. 245-49.
3. Freudenheim, Milt. "New Drug Era Begins as Tagamet Patent Ends." New York Times, May 17, 1994.
4. Vines, Gail. "The enemy within." New Scientist, October 15, 1994, pp. 12-14.
5. Helicobacter pylori, Office for Science and Society, Department of Chemistry, McGill University, 2003.
ACKNOWLEDGMENTS
My heartfelt thanks to my good friend and collaborator, Dr. Johnny Powers. It was his inspiration, insights, and technical advice, that helped bring my story together. Dr. Powers was the president of TriPath Imaging, a biotech company located in Burlington, North Carolina, before the company was sold to a major multinational competitor. In his career, Dr. Powers has dealt extensively with the Food & Drug Administration (FDA), has published numerous scientific research papers, and holds medical patents in both the U.S. and Canada.
Thanks also to my wife, Mary Ellen, for the countless hours she spent reading variations of the manuscript and offering invaluable insight, all the while remaining supportive of my efforts and devoted to the cause.
While I do not have the opportunity to name all of the others who participated in the editing process that was critical in producing the final manuscript, I want to offer a special thank you to Janelle Powers; my mom, Betty Shaw; my sister, Stefanie Longbrake; and my two brothers, Jim Shaw and Dr. Terry Shaw for their support and feedback throughout the process.
Finally, I wish to thank Dr. Nicholas Smedira and Dr. Harry Lever of the Cleveland Clinic for saving my life. I was diagnosed with hypertrophic obstructive cardiomyopathy (HOCM), a form of heart disease, prior to completing my manuscript. If not for the expertise in diagnosis of Dr. Lever and the surgical skills of Dr. Smedira, you would not be reading this now.