A Night At The Opera - The Debate Over Mandatory Adverse Event Reporting - National Health Federation

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A Solution Without a Problem

The problem, we are told, is that the natural-products industry looks bad. It looks bad because there are people out there claiming that our products are dangerous and harmful and that we are unregulated. Of course these people are so incredibly wrong that they make rocks look brilliant. The real truth is that not only is the industry regulated to a much higher degree than the mass media and politicians would have us believe (just consider how slickly the FDA took ephedrine alkaloids off the market with no evidence of harm), but dietary supplements are also exceptionally safe. As I have been writing and saying for years, statistically, a person is more likely to die from a bee sting or a lightning strike than he or she is from taking dietary supplements.

Dr. Andrew Saul confirmed this viewpoint when he cogently wrote, “The 2003 Annual Report of the American Association of Poison Control Centers Toxic Exposures Surveillance System states that there have been only two deaths allegedly caused by vitamins. [See American Journal of Emergency Medicine, Vol. 22, No. 5, September 2004; http://www.aapcc.org/Annual%20Reports/03report/Annual%20Report%202003.pdf.] Almost half of all Americans take nutritional supplements every day, some 145,000,000 individual doses daily, for a total of over 53 billion doses annually. And from that, two alleged deaths? That is a product safety record without equal.”

Compare this to pharmaceutical drugs, Dr. Saul continued, which even when properly prescribed and taken as directed, kill some 106,000 Americans each and every year. At over 2,000 deaths each week (and some doctors estimate the toll to be much higher), that is quite a death rate. (See Leape LL, “Error in Medicine,” Journal of the American Medical Association, 1994, 272:23 at 1851; Leape LL, “Institute of Medicine Medical Error Figures are not Exaggerated,” JAMA, 2000 Jul, 5;284(1):95-7.) Clearly, supplements and drugs are not even in the same class. And they should not be treated in the same way either.

So why are they treated as if they are dangerous and deadly drugs? The easiest answer is to say that it is simply out of ignorance, that those who would saddle supplements with drug-like regulatory burdens are just unaware of the existing statistics long proving that supplements are safer than drugs, food, horseback riding, lawn mowing, thunderstorms, and even bees.

Others, less sanguine, see AER bills as yet another effort to force dietary supplements into the ill-fitting, expensive regulatory straightjacket intended for drugs. The more that you create a drug-like regimen for supplements – such as is already being done with the drug-like good manufacturing practices regulations issued by FDA – then the less available and attractive supplements will become as costs increase and availability declines. The drug industry and its allies, then, will win on two fronts: (1) there will be less direct competition from low-cost supplements; and (2) there will be more need for drugs since the disease-prevention effects of supplements will be diminished or even eliminated from the marketplace.

In short, the only real problem with supplements is that they are low-cost competition to drugs and are increasingly showing drugs up as useless and unnecessarily dangerous. Seen in that light, then, AERs are part of a drug-industry solution for a competition problem, not a safety problem. So, why should we buy into that?

The Arguments for Compromise

Various natural-products companies, trade associations, and nonprofit organizations are enthusiastic backers of S.3546. This includes the Natural Products Association (formerly the National Nutritional Foods Association), the Council for Responsible Nutrition (CRN), the United Natural Products Alliance, and others. To be fair, they have seen Senator Durbin in action and have feared that a less-industry-friendly AER bill would pass the Senate in the absence of S.3546.

And they have a valid point. According to National Health Federation lobbyist Lee Bechtel, two years ago Senator Durbin sought to add mandatory AER for dietary supplements to the 2005 USDA/FDA spending bill. This attempt was voted down in committee, mirroring his earlier defeat with a similar bill (S.722) that he had sponsored.

Then, Durbin tried twice to amend the Department of Defense (DOD) 2005 spending bill to establish mandatory AER for dietary supplements sold on all military bases. These amendments were withdrawn, but only after he reached an agreement with Senators Hatch and Harkin to draw up a separate bill.

Last Fall, Durbin again offered a similar DOD amendment that was withdrawn after the timely intervention of Senators Hatch and Harkin. As Bechtel observed, it was clear that Durbin had enough votes to pass his version of AER legislation in the Senate even though there was no corresponding legislation in the House of Representatives. Alarmingly, the Durbin AER legislation was very broad in its scope and definition of what would constitute an adverse medical outcome for supplements. Durbin was clearly getting closer to driving a hard stake into the side of the industry.

Remember, Durbin was in the House of Representatives during our health-freedom campaign of 1992-1994, which culminated in the passage of the Dietary Supplement Health and Education Act (DSHEA). At the time, he was chairman of the Agriculture subcommittee with jurisdiction over the FDA and was quite hostile to the passage of DSHEA. Ever since, he has been aching to rein in DSHEA freedoms.

Even worse, Bechtel said to me recently, is the prospect of the 2006 elections. If the Democrats regain control of the House, then our old nemesis Henry Waxman would almost certainly become chairman of the committee that would take up consideration of any AER bill coming across from the Senate. That’s a sobering thought, and one that gives weight to the argument to do something sooner rather than later.

It was within this atmosphere, then, that some dietary-supplement backers fled into the arms of a compromise bill that, however distasteful, would be far preferable to the more-draconian Durbin legislation. The drafters’ underlying legislative strategy has been to craft a compromise bill that will placate Durbin while inflicting the least harm, cost, and burden upon supplement manufacturers.

S.3546 supporters point out that this bill’s provisions: (1) limit AERs to serious adverse events only, such as death or long-term injury; (2) include OTC drugs within their ambit; (3) allow third parties to report or evaluate claims; (4) exclude retailers from any mandatory reporting requirement; and (4) will enable the industry to prove that its products are safe.

The Natural Products Association thinks that few AERs would need to be filed by its member companies. Testimony recently given by Dr. Robert Brackett, the director of the Center for Food Safety and Applied Nutrition (CFSAN), before the Committee on Government Reform might confirm this belief. Since becoming operational in June 2003, he testified, the CFSAN Adverse Event Reporting System has received 1,145 voluntary adverse event reports. Over some 32 months, then, the FDA has received an average of 35 AERs per month or 420 AERs per year. Some think that the numbers would be similar for mandatory AERs.

Perhaps the most important argument in favor of compromise, though, might be the one Alan Richman pointed out in his well-titled editorial “Sleeping With the Enemy?” in the August 2006 issue of Whole Foods Magazine, when he wrote “stubborn stonewalling of this bill would make this industry appear to not give a damn about public safety.”

The Arguments Against Compromise

The dilemma that we have put ourselves in is that, now, after years of ceding the high ground on supplement safety to the likes of the Durbins, Kennedys, and Waxmans of the world, we are faced with the choice of supporting a bad bill or else looking “bad.” That stinks.

And it is a bad bill. Forget for the moment that the Durbin alternative might be worse. S.3546 completely and totally cedes the argument to the other side that dietary supplements are closer to drugs than they are to foods. Our strongest argument against throwing supplements into the common bin with drugs has always been that supplements are safer than drugs, safer than food even. Once we concede that mandatory, drug-like AERs (not required for food mind you) are even acceptable for supplements, then we acknowledge that supplements are not food. From there, as they say, it will be smooth sailing to hell.

How on Earth will anyone in the industry be able to resist future and more intrusive regulations in this area? Will we argue that supplements are different than drugs? No, we will have already conceded that point. There will be no real argument against more regulations other than those lesser arguments just based on the utility of the regulation. And the utility argument is an argument that all industries have been losing for a 100 years each and every time some politician decides to garner votes by crying “safety.”

Thus, the argument that we better get the best deal we can now while we can may be appealing, but history guarantees that S.3546 will not be the final say on AERs. Durbin and future Durbins will revisit the well for more and tougher regulations; and when they do, the framework will already be in place, the moral ground lost, and the general principle accepted so that it will be so very easy to twist the ropes even tighter on the torture bed. The line must be drawn here and now, otherwise we lose.

Many health-freedom groups already know this. The National Health Federation (NHF), the nation’s oldest health-freedom group for consumers, strongly opposes S.3546 for this and many other reasons. Similarly, the American Association for Health Freedom (AAHF), the International Advocates for Health Freedom (IAHF), the Nutritional Health Alliance (NHA), the Freedom of Health Foundation, the National Health Freedom Coalition, and the Health Freedom Foundation, among others, all oppose S.3546 as the mistake that it is.

Very importantly, too, S.3546 repeats the trap found in Durbin’s earlier proposed legislation by retaining the “guilt by association” definition of adverse event. S.3546 defines “adverse event” as “any health-related event associated with the use of a dietary supplement that is considered adverse.” (emphasis added) By using the words “associated with” rather than the words “caused by,” any serious adverse event experienced by any one of the majority of Americans who consume dietary supplements could be attributed to their supplements rather than to their cigarette use, alcohol intake, prescription or non-prescription drug use, illicit drug use, poor dietary habits, or other factors.

As I have argued before, all it will take is for some intern or other medical professional who is treating an emergency-room case with serious problems stemming from years of prescription- or OTC-drug abuse and poor diet to learn that the patient (who, for example, perhaps just recently got the message that l-arginine might help lower his blood pressure) had also been taking that amino acid. So, even though only “serious” adverse events are to be reported to the FDA, the underlying experience has been defined so broadly that it could cover an amino acid or other supplement that has been taken at the same time as the pharmaceutical drug that actually induced the serious adverse event. As such, this bill could potentially destroy the availability of effective dietary supplements by associating their usage with serious health events.

But that’s the funny thing about S.3546, it does not really tell us what all of the penalties will be in the event that an AER is submitted on a dietary supplement. Yes, the product will be considered misbranded if the label does not contain the toll-free reporting telephone number on a most-likely already-crowded label, And, yes, if a false report is filed, then there can be civil and criminal penalties. But, otherwise, what is to happen? That is a very troubling blank space yet to be filled in.

So, should we be excited that S.3546 is better than the Durbin alternative? Probably not, because the blank spaces – and more – will be filled in during later legislative sessions anyway. At most, S.3546 is simply a delay in the first step towards the Brave New World of full drug-like regulation of dietary supplements. To my mind, that removes any appeal whatsoever for S.3546. Yes, it’s a compromise; but for what? A little time? That’s a bad bargain.

It is an especially bad bargain for small companies, too. The small companies will have a harder time bearing the regulatory burden of adverse event reporting and compliance should there be a problem. The larger companies will have the staff and the legal expertise to handle such matters, so it is far easier for them to support a bill such as S.3546. And since the larger companies call the shots at the trade associations, such as the Natural Products Association, it is no surprise to me that those associations have come out in support of more regulation.

Actually, the only argument for S.3546 that makes any moderate sense to me is the state-preemption one, that is, that with this national bill the several states that have thought to enact their own AER legislation will be prevented from doing so. That makes some sense. But is it truly worth a bill like S.3546 just to prevent a hodge-podge of different AER state laws in a few states? Why make the AER mistake nationwide when lobbying hard at the state level with the same arguments as are made nationally will most likely defeat or limit the effect of bad AER state laws?

Any AER bill - whether a compromise to placate one lonely Senator or not - is a mistake. Passing a bad bill just to make one Senator happy is not only bad law, it’s bad politics, especially where that compromise bill would just be the camel’s nose in the tent – leading to later versions of mandatory AER legislation that would tighten the noose around the necks of supplements and supplement users. You can be sure that Durbin has great plans to take S.3546 to the next, harsher step after its passage. And after witnessing too many compromises between the proponents of freedom and those of big government that have simply led to fewer freedoms for private citizens, I am tired of this losing process. If you keep slicing the salami, eventually you reach the end. We are getting far too close to the end.

Fight Back, Not Sing Opera

The solution is not to fight yet another rear-guard action in the face of the ninja turtles. Let us stand firm and persistently point out the obvious to our legislators, the media, and the public:

Supplements are safer than food and statistics already prove this.
Supplements are just another form of food. They are not drugs and should not be treated like the toxic chemicals that drugs are.
A system of voluntary adverse event reporting already exists, which is extremely user-friendly and cost-free. Why fix something that is not broken?
Mandatory AERs are not cost-effective given the incredibly safe track record of supplements. Why add unnecessary costs to and regulatory controls upon products that are already greatly benefiting consumers? It makes no economic sense.
We already have a safety record second to none and have no need to “prove” it through AERs. It does not look bad to reject AERs when presently even OTC drugs have no AER system of their own and where not a word has been breathed – ever – about requiring an AER system for far-more deadly consumable food products.
All that S.3546 will achieve is having supplements bear the blame for ill health effects caused by other factors, such as prescription, OTC and illicit drugs. Far from confirming the safety of supplements, S.3546 actually risks contaminating the sterling safety record of supplements through “guilt by association.”

Frankly, we should be laughing at Durbin and his ilk, pointing to already existing statistics demonstrating that supplements are incredibly safe. Make fun of Durbin and show that he is just another mindless big spender wanting to waste taxpayers’ money on more red tape and silly laws that will be counterproductive. Nothing can kill bad law as quickly as ridicule, in this case so justly deserved.

Mandatory AERs are the hallmark of dangerous and not-so-dangerous drugs, not foods. Would we regulate pigs the same way we would regulate 18-wheel trucks just because they both move? Of course not. On the safety issue, we have absolutely nothing that has to be proved; so why should we jump through Durbin’s silly hoops like some circus animal? Fortunately, the House of Representatives opposes S.3546. We need to take a similar principled stand, born of conviction, and say no to drug-like regulation of what is just a food industry. Let them pound sand, we have better things to do with our lives.