Flop Flop Fizzle Fizzle

Oh, what a rippoff it is. When the safe and effective turn out to be unsafe and ineffective with lethal consequences we've got problems. When it comes to over the counter and prescription medications for gastroesophageal reflux disease (GERD) what you get isn't always what's good for you. US News & World Report reports that: "In 2008, proton pump inhibitors were the third largest-selling therapeutic class in the United States, ringing up $13.9 billion in U.S. sales, according to IMS Health, a Norwalk, Conn.-based health-care data company. With 113.4 million prescriptions, they were the 6th most widely dispensed retail prescription medications, IMS reported."

The recently released research in this month's American Academy of Otolaryngology -- Head and Neck Surgery was presented at the Annual Meeting of the American Academy of Otolaryngology–Head and Neck Surgery, San Diego, CA, October 4-7, 2009. The research precedes the release of Dr. Jonathan Wright's book: "YOUR STOMACH: WHAT IS REALLY MAKING YOU MISERABLE AND WHAT TO DO ABOUT IT" which finds that: "Shockingly, the problem may not be too much stomach acid, but too little! Stomach and other maladies—heartburn, bloating, constipation, and indigestion—may all be the result of too little acid. Antacids and acid blockers may be making the problem worse."

Consumer Reports reported Proton pump inhibitors or: "(PPIs) have been heavily promoted, which has led to overuse in people with garden-variety heartburn. Nexium, one of the most widely-prescribed PPIs is also the most expensive at $240 per month (the cash price you would pay if your insurance did not cover it). Not surprisingly, Nexium was also a top-selling drug in 2008 at a whooping $4.8 billion."

When things are considered safe and effective you don't expect anything else. The question we posed to the FDA is how the heck can that happen especially in a billion dollar industry whose product is not safe or effective. MEDIndia reported this about the study: "PPIs are not effective at treating all cases of gastroesophageal reflux(GERD) and laryngopharyngeal reflux (LPR). In addition to the evidence that acid isn't the only contributing agent in reflux disease, the new study has revealed that there are many unexpected consequences and side effects from this class of drugs."

Until release of the research all news focus has been on the cost to consumers and relative ineffectiveness of the available consumer products both over the counter and prescription. We replaced the loud commercial ridden news report by NBC 9 News Colorado and replaced it with a Consumer Reports video. This another of the studies that demonstrates harm caused by use. While U.S. Food and Drug Administration (FDA) has begun its "Safe Use Initiative" the concern for drugs considered safe and effective that are neither creates a category not likely considered in a cooperative public and private interest environment. With this much money at stake in this financial environment decisions are not likely to fall in favor of the consumer. Be warned. Be forewarned.