Welcome to Joe’s Blog. This is Number 1 and I sincerely hope that you will find my ramblings of interest and worthy of comment. I welcome your feedback.
Even before I started writing about drug-related issues 30 years ago, I was aware of the thalidomide scandal. In the 1950s thousands of babies were born with severely deformed limbs and other malformations. For years thalidomide represented the worst drug scandal in history. That the U.S. largely avoided the thalidomide tragedy was a point of pride for the FDA. The agency maintained that its rigorous testing and high standards protected the American public from this drug disaster.
Fifty years later the FDA is disgraced and in disarray. Over the intervening years we have watched as the agency was slow to recognize serious drug problems. Diet pills like Redux and phen-fen were allowed to linger on the market long after the handwriting was on the wall. The FDA dawdled over the herbal weight-loss and energy booster ephedra while gullible consumers experienced strokes or heart attacks. But all these misadventures pale in comparison to the FDA’s latest screw-up.
The greatest drug disaster in history has occurred while our federal watchdog was asleep at the switch. In fact it wasn’t the FDA that discovered the Vioxx disaster, but rather the manufacturer. When I asked one of the key FDA officials why the agency missed the iceberg that has nearly sunk his organization, he replied that the FDA is not very good at catching common things like heart attacks or strokes. They seem to be able to detect strange or rare complications like liver failure, but “common” problems frequently go undetected.
The FDA still to this day does not know how many people experienced heart attacks or strokes from Vioxx, Bextra or Celebrex and how many died. FDA safety officer, David Graham, MD, has estimated that it could be as many as 30,000 or 40,000 deaths, but that’s just an educated guess. That would make Vioxx the greatest drug disaster in history, dwarfing thalidomide and fen-phen and all the other drug scandals combined.
What is even scarier, though, is that virtually all NSAIDs (nonsteroidal anti-inflammatory drugs) can do the same thing. For decades doctors have been prescribing drugs like ibuprofen (Motrin), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), piroxicam (Feldene) and sulindac (Clinoril) to ease patients’ arthritis pain or strained muscles. No one knows how many heart attacks and strokes may have resulted from the hundreds of millions of prescriptions that have been filled over the last 40 years. The number could be in the hundreds of thousands. And even though naproxen (Aleve) has been reported to be neutral for cardiovascular complications, it is not entirely clear that it is perfectly safe either. At the very least, it and all the other NSAIDs can cause stomach ulcers that in some cases may lead to hospitalization or even death.
The bottom line is that the FDA has let us down for decades. It has allowed these pain relievers to be marketed without recognizing that millions of people would be put at risk for heart attacks and strokes. Only in the last few years have we seen strong warning labels on prescription-strength NSAIDs. But I doubt that most Americans still to this day realize how dangerous these drugs may be. Perhaps even scarier, we don’t know what other drug disasters the FDA continues to miss.
If there is a lesson to be learned from this sad chapter in American medicine, it is that the FDA is no longer capable of protecting you from dangers in the drugstore. Without adequate warning information, your doctor can’t protect you either.
You’re on your own. Good luck!