Double trouble

Early in my career, I worked in the editorial department of a newspaper syndicate in New York, editing a variety of columnists, one of whom was the renegade medical columnist Dr Robert Mendelsohn.

Bob introduced me to the dangers of modern medicine. In particular, I remember his stark warnings about what he maintained were the most dangerous and unproven new drugs on the market. Top of Bob’s list were a new class of new painkiller, the non-steroidal anti-inflammatory drugs (NSAIDs), such as Motrin. These, their manufacturers claimed, would take down inflammation without the use of steroids.

Bob was almost alone in his criticism of these so-called miracle drugs, warning that they also happened to cause serious, life-threatening stomach ulcers and bleeding. 

That clarion call burned in my consciousness. So, it was particularly shocking for me to learn, a few decades later, that US and UK regulatory agencies had approved Motrin and other me-too drugs like it—albeit in slightly diluted form—as over-the-counter (OTC) drugs.

The drug in question was ibuprofen—a drug now considered so tame that we’re routinely advised to give it to children. Bob’s nemesis had been watered down, repackaged and sanitized: same drug, virtually the same side-effects, but with most of the warnings taken away.  

In our cover story this month, publisher Bryan Hubbard has shone a bright light on the dark side of medicine: the burgeoning OTC business.  

After the success of Motrin and other drugs with OTC status, many other drug companies have followed suit. Tired of years of regulatory red tape, many companies are creating a ‘lite’ version of their best-seller drugs to sell directly to consumers. The advantages are legion: the OTC version of the drug manages to remain completely under the radar, with little regulation, no post-marketing follow-up, no consumer awareness of potential dangers and no accountability. A pharmaceutical company is obliged to disclose far less about the potential dangers of an OTC drug than a drug that requires a prescription.

Yet, as many OTC drugs have the same deadly side-effects as their big brothers, the likelihood is that untold millions of people are being harmed, and even killed, by OTC drugs. 

Nevertheless, because no one writes out a prescription for these products, there’s no one to monitor where the bodies are buried.

What is most worrying about the exodus of ‘Rx to OTC’, as it’s termed, is the complete abdication of responsibility by regulatory agencies such as the US Food and Drug Adminstration (FDA).  

Back in Motrin’s early days, the FDA had an entire agency committed to rooting out fraud in drug-testing. These days, any semblance of that watchdog activity has all but disappeared, as the FDA and its counterpart in the UK become increasingly chummy with Big Pharma and increasingly lax about drugs being sold directly to consumers. 

The entire balance of the evidence has shifted. A drug—and the testers themselves—used to be considered dangerous until proven safe. Now, the only regulatory requirement is the market share. 

Published 04 May 2010 09:51 by Joanna Evans