If you listen to the mainstream media, you'd be scared to death to take a supplement. According to a steady drumbeat of articles in print and electronic media, supplements are both “unregulated” and “dangerous”, and you never know what you are getting. But before we accept these charges as correct, let's have a look at the facts.
In the United States, herbs are largely regulated as supplements-- a category that also includes vitamins, most weight loss products, body-building products, natural remedies, and a variety of other kinds of health care products. Since 2008, supplement manufacturers have been required to submit an Adverse Event Report (AER) to the FDA for every serious adverse reaction requiring hospitalization or medical intervention, or causing serious injury or death. This reporting system is similar to that required of prescription and over-the-counter (OTC) drugs. And similar numbers of people take prescription and OTC drugs and supplements. In fact, according to the CDC, the number of Americans who have used at least one prescription drug in the last month is about 48%, versus 77% for nonprescription (OTC) drugs and 53% for supplements. But that is where the similarity ends.
In September 2008, USA Today reported that the first six months of supplement AER reporting resulted in 604 AERs and included 5 possible deaths, and projected about 900 AERs and 10 deaths for the full year. It went on to quote several industry “experts” to say how supplements were unsafe and that there was no assurance that they actually contained what was on the label. However, the last paragraph of the article ends with an interesting fact: “Adverse-event reporting has been required for prescription and some non-prescription drugs for years. The FDA took in 482,154 adverse-event reports for prescription drugs last year.”
So if you actually do the math, there are slightly MORE Americans using supplements than prescription drugs (53% vs 48%), and yet they produce about 537 TIMES fewer AERs submitted to the FDA (900 vs 482,154). Clearly, the AER reports provide no evidence that the supplements are unsafe, at least compared to prescription drugs.
But some people would (and do) argue that AERs for supplements are a relatively new system, and are probably under-reported. So as an additional data point, let's compare the alleged death rates, shall we? It seems safe to assume that anyone thinking a death in the family was caused by supplements is more likely to report that fact, than a mere temporary illness. Again, recall that more Americans take supplements, and 10 deaths per year are predicted in the article.
To put those predicted supplement deaths in context, a 1998 article in the Journal of the American Medical Association (JAMA) reported that adverse reactions to prescription drugs, in hospitals alone, kill over 100,000 patients a year, the rough equivalent of crashing four fully-loaded 747s every WEEK, killing everyone on board. This does not include any deaths outside of hospitals. These prescription drugs are the most highly regulated of all the classes of goods that FDA oversees (drugs, foods, medical devices, and supplements), and with good reason.
Now, don't get me wrong. I take adverse events VERY seriously, and deaths even more so. We make products that people take into their bodies, and since every body is different, we can never be completely sure that they won't have an adverse event. But we can do things to keep those adverse events to a minimum, and to reduce their severity. The irony is that we in the supplement industry (as a rule) do much more on those lines than our counterparts in the more-regulated drug industry. But more on that another day.
I tried to find updates for some of these statistics, but was unable to find any. Still, several things are immediately apparent from these numbers.
First, prescription drugs are clearly MUCH more dangerous than supplements, no matter how you look at it. Those congressional leaders who demand investigations of supposedly “unsafe” supplements, while allowing prescription drug companies to conduct business as usual, certainly seem to be in the same league with those blind guides whom Jesus described as “straining at gnats, while swallowing camels”.
Second, supplement AERs clearly seem to be over-reported, at least when compared to deaths. This could be because of the media hype surrounding supposedly “unsafe supplements”, or it could simply be that given an existing adverse event, prescription drugs are more likely to kill the victim. I don't see any evidence that supplement AERs are suppressed or under-reported.
Third, more extensive regulation clearly does NOT necessarily mean greater safety. Supplements are used by more people, yet the more highly-regulated prescription drugs kill more than 10,000 times as many people, and result in 537 times as many AERs.
Furthermore, supplements ARE in fact regulated very strongly-- though not (thank goodness) in exactly the same way as prescription or OTC drugs. They are more tightly regulated than foods in many respects, and only slightly less than medical devices. But that is a topic for another day.
So why does the conventional media continue reporting, quite wrongly, that supplements are “unregulated” and “unsafe”? I look forward to your thoughts.
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