Though some might not agree, it cannot be a coincidence that less than a year after the death of Orioles pitcher Steve Bechler, the Food and Drug Administration finally succeeded in doing what it had been trying to do for ten years - getting the herbal supplement ephedra off the market. Bechler’s death from heatstroke in 2003 was linked to his use of the diet pills containing ephedra. Though doctors had known for years that the active ingredient in ephedra supplements could cause dangerous increases in both heart rate and blood pressure, putting users at increased risk of heart attack, stroke, and related ailments, Bechler’s death gave the media a high profile casualty to link with the drug.
Some might say that it is too cynical to presume that without a martyr, the FDA ’s case against ephedra might never have made it this far, but history tells a different story. In fact, due to the double standard in how supplements and drugs are regulated, it might actually be surprising that the ban has happened at all.
The first thing to understand is that, legally speaking, there’s an inequality in your medicine cabinet. Supplements, vitamins, minerals, and medicinal herbs are not subject to the same standards of efficacy and safety as manufactured prescription and over-the counter-drugs. Thanks to 1994’s Dietary Supplement and Health Education Act, supplement manufacturers do not have to prove that a product is effective or even safe before putting it on the market. In order to take a product off the market, the product must be shown to pose “imminent harm.” The burden of proof of this harm lies with the FDA. In contrast, the FDA subjects drugs to safety and efficacy trials before they can ever be put on the market. The manufacturers must prove that the product is safe when it first comes on the market and must report all complaints and adverse affects to the FDA. If the FDA has safety concern about any drug on the market, it has the power to remove it from the market immediately.
With supplements like ephedra, the FDA has to wait for adverse action reports to come to them about the product, collect the data, weigh the number and severity of cases against the number of people known to use the product, and decide if a ban is justified. It’s a daunting task considering that adverse action reports are rarely filed, rarely detailed, and nearly impossible to track. The FDA has to rely on hospitals, individual physicians and individual consumers to link problems with the product at hand and get the information to the proper channels. You can guess how often that happens. Now cut that guess down to 1% because that’s the percentage of problems that the FDA estimates actually get reported. If you’re thinking that a lot of bad things can happen to people in the meantime, you’d be right.
Even with these obstacles, the FDA amassed a collection of 16,000 adverse action reports and a mountain of scientific evidence about the effect of ephedrine (the active ingredient in all ephedra supplements) on the circulatory system in order to move forward on the ban. Officials at the Administration expect court challenges from the supplement industry but say they are ready for the fight because they believe there’s more at stake than getting this particular weight loss drug off the market.
Even before the FDA announced the ban, supplement companies were touting new “ephedra-free” formulations of their weight-loss products. These products use ingredients that, once in the body, act just like ephredine, meaning they carry the same dangerous effects. But, since they too are supplements, the FDA would need to start from square one to remove them from the market as well. It’s the pharmaceutical equivalent of herding cats.
So is this really a big deal? How many people really take supplements, particularly weight loss supplements hawked mostly by radio-dee-jays? (I swear, I have heard enough Metabolife ads while waiting in traffic to last a lifetime.)
According to the Washington Post, sales of supplements in the United States have nearly doubled in the last half-dozen years, from $8.8 billion in 1994 to an estimated $15.7 billion in 2002. Thanks to effective marketing techniques, the increasing popularity of alternative medicine, and the fact consumers are getting more of their health information from magazines, the Internet, and other sources, instead of their physicians, supplements are all the rage. Since supplement claims are not evaluated by the FDA, consumers are deluged with products claiming to help them do everything from lowering their cholesterol to … well, you’ve gotten the emails.
A study published in the Archives of Internal Medicine estimated that 48% of American adults take supplements regularly. Generally, the only information that consumers have about these products is provided by the manufacturer. The consumer has no authority to turn to in order to verify the validity of the claims, dosage limits, or even ingredient lists. Consumers may not even know how or if the supplements they take may interact with their prescription medication. It’s a big deal - a big deal that Congress needs to fix by allowing the FDA to regulate supplements at least as stringently as it does medication.
This however, will be an uphill battle. When Congress was debating the DSHEA in the early 90’s, the supplement industry launched a campaign against stricter regulation. Arguing that the government was “trying to take their vitamins,” they urged consumers to write to Congress opposing parity between drug and supplement regulation. The tactic worked. Consumers were incensed that the meddling FDA would try to deny them their St. Johns Wort and ginkgo. The problem was, most of these consumers were misinformed about the law. Then, as today, 47% of supplement users believed that the FDA or some government agency is watching supplement manufacturers to make sure the products they buy are at least safe. Nobody could sell something that was dangerous, right? Wrong. Under current laws, a supplement isn’t considered dangerous until after many, many people are dead. It doesn’t make sense.
If the supplement industry does challenge the ephedra ban, expect a lengthy court battle. Recent reports suggest that the industry will argue that FDA doesn’t have the authority to ban a supplement, even with the “imminent harm” argument. Some at the Administration say that a court loss may be a mixed blessing. They feel that if the supplement industry is successful in overturning the ban, the public outcry will be enough to stir Congress into amending the DSHEA. Perhaps, but let’s hope that happens before there are more casualties, high-profile or not.