[QUOTE=MassageLady;4946897]
This is funny…how many times do we hear warnings of ‘tested safe drugs’ being pulled off the market because of deaths? How many infants were needlessly deformed because of a ‘tested’ drug (thalidimide-sp?), so PLEASE spare me the ‘tested, safe’ jargon that you love to throw out there. The herbs and supplements have not ever caused these serious effects on their own.[/QUOTE]
Massage Lady,
The reason for this has to do with basic statistics, as follows:
As a general statement, severe reactions to drugs/herbals/nutriceuticals are rare events. Also, as a general statement, most if not all drugs/herbal/nutriceuticals have the potential to cause a severe reaction in the rare individual.
A standard pharmaceutical agent (i.e. drug) is tested and demonstrated to be safe on approximately a maximum of 2000 human volunteers for typically less than a year before it is submitted for Food and Drug Administration (FDA) approval to be available to the general population. To test it on more people and for a longer period of time prior to release to the general population is simply prohibitively expensive and would severely limit useful drugs from becoming available. Once a drug is released on the market, all licensed health care providers are required to report to the FDA any adverse reactions. If the adverse reactions reported to the FDA are severe enough/ frequent enough, the drug will be pulled from the market. A drug will get pulled from the market if the reported rate of severe reaction is as low as 1 in 200,000 (even as low as 1:500,000). So while the testing the drug on the limited number of individuals (i.e. 2000) prior to FDA approval demonstrated that the drug appeared to be safe, when the drug is released for use to the general population (i.e. on 100,000’s of individuals), the rare individual that will have a severe reaction to will become apparent. Basic statistics.
An important component of this is the FDA requirement that any adverse reaction be reported. It is only through the central gathering of this adverse reaction data that the overall safety of a drug when used on large numbers of people (i.e. millions) can be determined. Specifically, it is only through this kind of thorough and complete data collection that the rare individual with an adverse reaction can be detected.
At this time, the herbal / nutraceutical industry is not required to report their adverse reactions. Accordingly, it is not possible to hold herbal / nutraceutical agents to the same degree of statistical analysis when it comes to any possible adverse reactions. So when I am told that a herbal / nutraceutical is considered safe because “it has been used for hundreds of years on millions of people”, I always ask to see the mechanism for reporting rare adverse events analogous to that required of pharmaceutical agents. So until such data is gathered an analyzed, a fact-based statement regarding the safety (one way or the other) of these agenst when applied over large populations cannot be made.
It is only through statistical analysis on thorough and complete adverse event reported data on large populations that any fact-based statement can be made on any agent - whether it be a pharmaceutical drug, herbal product, or nutriceutical - regarding that agent’s safety.
None of the above is pro-pharmaceutical, anti-herbal or vis versa. It is simple data collection and statistics.
As for my frame of reference, I am an M.D. and my area is liver disease including severe liver disease resulting in liver transplantation. I have seen patients with fulminant hepatic failure due to a pharmaceutical agents and others with fulminant hepatic failure due to herbal agents. The difference is the ones due to the pharmaceutical agent by law have to be reported to the FDA, likely resulting in the drug being pulled from the market. With the fulminant hepatic failure due to the herbal agent, no such reporting (with the possibility of the product being pulled from the market) is required.
Crikey, digoxin is an “herbal” remedy and getting the dose wrong will kill you dead in a day. And that’s with the kind that’s KNOWN!