Adverse Event Reporting

February 1, 2007 by  
Filed under All, Opinion and Comment, Politics

Industry experts are proclaiming victory in getting a law passed that requires dietary supplement (and OTC drug) manufacturers to report all serious “adverse events” to their products to the FDA, which will, of course, make those reports public. The idea is that this will be seen as a “responsible” act by industry and help stem the tide of negative publicity about supplements. Oh really? With the obvious bias in the media against supplements, each reported (but not proven) “reaction” will likely be used to hammer dietary supplements. Does anyone think that reports of OTC “adverse events” will get the same exposure? Face it, another aspirin overdose or a liver destroyed by Tylenol is simply not news. Especially to media outlets heavily sponsored by drug companies.

Besides, a supplement manufacturer has no right to ask for a customer’s medical records, to see if she already had a health condition or risk factor that might explain the apparent reaction to a supplement. Marketers of supplements simply can’t fully investigate complaints, which may or may not be related in any way to the supplement. I’m reminded of the infamous case of a fatality attributed by the Texas Health Department to an ephedra supplement. Yes, the ephedra supplement user died, but the coroner blamed the knife wound. In another “ephedra fatality” it was probably the extreme blood alcohol coupled with the head on auto collision. Chaparral was said to be so dangerous it had caused a rash of liver failures. There have been none before or since. Same with kava. And scullcap, that turned out to be germander, itself probably innocent. Again, no problems before or since.

Maury Silverman, a literature researcher and staunch supporter of supplements argued unsuccessfully to have the language of the new law require the disclosure of simultaneous drug use, which may better explain the “adverse event”. For example, if someone takes an herbal supplement and a Tylenol, seriously, which one is more likely to have caused that liver toxicity?

Who Are These Guys?
The “Organic Consumer’s Association” comes on like a champion of ethics in organics, but really, aren’t these pretty extreme positions? According to their wiki entry (which no doubt they wrote),

It was formed in 1998 in the wake of the mass backlash by organic comsumers against the U.S Department of Agriculture’s (USDA)controvercial proposed regulations for organic food.

Last year, they launched boycotts against several of the larger organic dairies, protesting “factory farm” conditions instead of the “family farm” operations they support. They say:

While USDA bureaucrats drag their feet on closing key loopholes in national organic organic standards, retailers, wholesalers and major “organic” brands are continuing to sell milk and dairy products labeled as “USDA Organic, even though most or all of their milk is coming from factory farm feedlots where the animals have been brought in from conventional farms and are kept in intensive confinement, with little or no access to pasture.

Horizon Organics counters:

ALL of our products are certified organic. Organic is all we’ve ever done and all we’ll ever do.

  • We have been farming organically for 15 years.
  • Our founders worked with other industry leaders to develop the USDA Organic Seal.
  • We only operate farms and work with farmer partners who are certified organic and compliant with the standards.

Well, I’d like all the cows to have lots of pasture and the workers to have AC too, but seriously folks, if we want hundreds of millions of people to have organic milk and other organic products, things are going to get pretty large scale. And that’s a good thing, right? More organic feed means less agrochemicals in the environment and less pesticides in dairy products. I’ll admit it. I’m in it for the environment, and the people, not the cows. Sorry.

So why is this on Herb News? Because now OCA is taking on supplements too in their so-called Nutri-Con campaign. They claim some supplements contain partially hydrogenated oils, which they say is “one of the most toxic food ingredients known to mankind.” Oh please! Few supplements contain them, and the amount in an entire bottle would be less than a slice of pie. Oops, I mean a tablespoon of the crust of a slice of pie. Why the scare tactics, guys?

OCA has joined the shrill, pharma-sponsored attacks on dietary supplements. While they do highlight some companies they consider ethical and who do not use such ingredients, the net effect of attacks on supplements is an erosion of public and professional confidence in them.