Wednesday, February 1, 2012

Supplements are untested Pharmaceuticals

Supplements like herbs are used by some instead (or in addition) of pharmaceuticals, but these supplements are in fact untested pharmaceuticals. In order to know that a pharmaceutical is safe, a proper clinical trial is needed with enough people in the treatment groups, enough people in the control group, proper blinding of the study and the recording of all adverse effects and the efficacy. If a supplement is not tested, it can either be a useless waste of money or it can be dangerous to your health. 
Since mandatory reporting requirements went into effect, the agency has seen a threefold increase in the number of all adverse events reported compared with the previous year. For example, from January through October 2008, FDA received 948 adverse event reports, compared with 298 received over the same time period in 2007. Of the 948 adverse event reports, 596 were mandatory reports of serious adverse events submitted by industry; the remaining 352 were voluntary reports, which include all moderate and mild adverse events reported and any serious adverse events reported by health care practitioners and consumers directly to FDA. However, FDA recently estimated that the actual number of total adverse events--including mild, moderate, and serious--related to dietary supplements per year is over 50,000, which suggests that underreporting of adverse events limits the amount of information FDA receives. To facilitate adverse event reporting for all FDA-regulated products, FDA is currently developing MedWatchPlus, an interactive Web-based portal intended to simplify the reporting process and reduce the time and cost associated with reviewing paper reports.
Experts have cited several possible reasons for underreporting related to dietary supplements, including reduced attribution of adverse effects to supplements due to the assumption that all dietary supplements are safe, the reluctance of consumers to report dietary supplement use to physicians, the failure to recognize chronic or cumulative toxic effects from their use, and a cumbersome reporting process
In other words, people assume supplements are safe, and therefore do not routinely associate adverse events that they might have with the supplements. The report also cites a number of problems that hamper the FDA, including limited information about supplements and their manufacturers (or even how many manufacturers there were ; the identity of ingredients in the various supplements; and the mild and moderate AERs made to companies. But the worst problem hampering the the FDA's ability to protect the public from dubious supplements is that it lacks mandatory recall authority. That's right. The FDA can recall drugs if it decides there is evidence that they are unsafe, but for supplements it has to prove they're unsafe before recalling them--yet another double standard favoring CAM.

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