I wrote last week about the harrowing near-death experience my wife Gena endured, triggered by a contrast dye called gadolinium, commonly used during Magnetic Resonance Imaging procedures. An estimated 30 million MRI scans are performed each year in this country. A third of these patients are injected with gadolinium, a heavy metal used by radiologists to generate a better image. Doctors and drug makers have long insisted that gadolinium, a Food and Drug Administration-approved drug, is quickly expelled from the body following this procedure. While this may be generally true, it is not the case with all patients. For them, “approved” doesn’t mean safe.
Before a drug can come on the market, clinical evidence that the drug has the therapeutic effect it’s supposed to have and is safe must be provided. Once the basic questions of safety and effectiveness are settled, the agency will approve the drug if it deems that its benefits outweigh its risks. Meaning, there are always risks. We are all different and drugs work differently on different people. It’s an accepted fact by the Food and Drug Administration that not everything is known about a drug’s side effects until after it enters the marketplace and more people start using it. It’s also true that all drugs come with side effects. Many are minor, some are seen as inconvenient, while others can be serious.
The Food and Drug Administration’s stamp of approval is considered the last word on safety, yet we’ve recently learned that nearly a third of the drugs the agency approved between 2001 and 2010 were involved in some kind of safety event after reaching the market. According to the report, which appeared in the Journal of the American Medical Association, 222 new drug therapies were approved during that period. Of these, 123 post-market safety events were reported involving 71 products requiring Food and Drug Administration action. Three were withdrawn from the market.
Manufacturers were required to add 61 “black box” warning to their products, a safety communication issued by the Food and Drug Administration to let physicians and patients know that new safety information has been determined and to call attention to serious or life-threatening risks.
This is above and beyond package inserts with their long list of possible side effects dispensed with prescription drugs. We commonly get a reading of these lists during TV commercials for new pharmaceuticals. These little narrator comments at the end of the commercial tend to come off as comical until you stop to think about what they imply.
Two things are painfully true about this side effect problem. Clinical trials for new drugs often don’t include enough patients to accurately determine drug safety and effectiveness. Many believe studies are far too short to identify long-term drug safety risks that could cause chronic health conditions or even death. Also, once new drugs are used under real-world circumstances, with a much wider patient population, we – the general population – becomes the litmus test for a product’s true health risk.
In fairness, researchers involved in the previously mentioned study also point out that, although the percentage of safety events may sound high, they believe it is also reassuring that the system works well enough to catch these problems. Yet it took more than four years for serious problems with these drugs to become apparent enough to warrant their being reviewed once again by regulators, in the meantime leaving possibly millions of patients at risk.
The Food and Drug Administration’s current fast-track approval process is also considered problematic, leaving too much room for things to be overlooked. Studies have shown that some drugs approved using this quicker process had a large number of adverse events requiring additional warning labels. If Food and Drug Administration approval is to be the standard for safety, then testing drugs to make sure they work within the widest range of variables possible should be essential.
Given the common long lists of possible bad side effects accompanying pharmaceuticals, it seems almost essential we have a good relationship with our local pharmacist; an expert who will take the time to talk to you and answer your questions, even give an expert opinion free of charge. It’s an approach not always followed by doctors who get paid for providing treatments, not for spending time talking to patients.
The chemical agent with which Gena was injected was an approved rare earth heavy metal that has no place in the human body. Little did we know?
A movement is now afoot to at least ensure a patient is tested before being injected with this agent. Experts and patients are also calling for an investigation of the brands of gadoliniums used at hospitals, and for an analysis of the hospitals and treatment centers with the highest number of gadolinium reactions.
The truth is the long-term harm of gadolinium accumulation is not yet scientifically known. In current practice, it’s used far too liberally, and is not necessary in many cases. Not only is testing for patient susceptibility to gadolinium accumulation essential, but so is the development of effective treatments to remove toxic gadolinium from patients affected by it. At present, traditional medicine is failing us in both instances.
You should know the Food and Drug Administration does perform post-market monitoring to identify new needed safety information for approved drugs.
Within the packaging provided with over-the-counter medications must be a label with a toll-free number for the purpose of reporting side effects with drugs, what you would call “adverse events.”
Drug companies are also required to report adverse events to the Food and Drug Administration. Failure to do so can lead to prosecution.
Write to Chuck Norris with your questions about health and fitness. Follow Chuck Norris through his official social media sites, on Twitter @chucknorris and Facebook’s “Official Chuck Norris Page.” He blogs at ChuckNorrisNews.blogspot.com.