Safety and Effectiveness of Herbs and Pharmaceuticals

Steven Novella of The Skeptics Guide to the Universe also maintains a blog called NeuroLogica Blog that combines his interest in science and skepticism with his background in medicine (he's a practicing neurologist on the faculty at Yale).His January 2nd entry is titled The Plant vs Pharmaceutical False Dichotomy, and it touches on an issue we debated a couple months ago about the error of stressing "natural" over safety and effectiveness.Novella defines a drug as any "any chemical or combination of chemicals that has biological activity within the body above and beyond their purely nutritional value." By this definition an herb is a drug, and it is my position that the only measures that matter regarding drugs like herbs and pharmaceuticals are demonstrated safety and effectiveness. [forum=-11] is probably the best destination.--Percy

Well, there isn't going to be much discussion if no one from the other side of the issue joins this thread. LindaLou and PurpleDawn are both advocates of natural products and naturopaths, and they participated in a couple threads on closely related issues a while back, but no sign of them here yet.Steven Novella just posted a followup to his The Plant vs Pharmaceutical False Dichotomy entry, here's the link: More On Herbs and Drugs. This is an even more excellent read than the first one, because he goes into detail about what constitutes valid evidence for safety and effectiveness.--Percy

Maybe I didn't summarize enough of Novella's comments. His basic point is that herbs are, in many cases, untested drugs of unknown safety and effectiveness that should be placed under the jurisdiction of the FDA. At one point he says, "Herbs...are typically marketed based upon tradition and anecdote with insufficient scientific evidence for safety or efficacy."--Percy

Probably a semantic issue, since I'm sure he didn't intend to imply that all chemicals have nutritional value. Would it read differently to you had he said, "any chemical or combination of chemicals that has biological activity within the body above and beyond *any* purely nutritional value." Actually, Novella *is* making the point that an FDA stamp of approval is superior to tradition and anecdotal evidence, because it means the drug has gone through clinical trials that can ferret out a host of effects and relationships. There's complete agreement that many herbs have been in use for a long, long time. And perhaps you're already aware that many pharmaceuticals developed from studying plants. But while many herbs have a long history of use, what they don't have is any history of systematic data gathering in clinical settings. Anecdotal data gathering is almost always absent even the basics of such measures as blood pressure, temperature, blood analysis and weight tracking, just to mention a few. And since there's no data gathering, there's also no data analysis.The negative effects of a drug like Vioxx, which only became evident when the number of users went from hundreds in the clinical trials to millions after release, would be impossible for tradition and anecdote to ever detect. That the negative effects of smoking took so long to demonstrate scientifically also demonstrates the difficulty of detecting long-term effects, and if not for the contributions of science we still wouldn't be aware of the dangers of cigarette smoking. And of course the dangers of ephedra, in use for 5000 years in China, only became evident after use skyrocketed in the United States. A 2005 study (The severity of toxic reactions to ephedra: comparisons to other botanical products and national trends from 1993-2002) reported: But 5000 years of use in China didn't reveal these problems.--Percy

Because you believe clinical studies of pharmaceuticals are tainted by sources of funding and that anecdotal data is not only every bit their equal but even superior because of the absence of bias. Further, we know you have little confidence in clinical studies or in traditional medicine in general because you've frequently made statements like this from Message 24 in thread Misunderstanding Empiricism: Given this position that you've advocated in past discussions, it seems reasonable to conclude that you would be unlikely to agree that the safety and effectiveness of herbs hasn't already been established.--Percy

Should you decide to participate, please keep in mind that any dissembling will not be ignored.--Percy

You've already posted four times to the topic and have yet to actually say anything about it. You asked why I thought you might have a different opinion from mine, and I explained why, including a quote from you.If you'd like to actually participate in the thread, then please begin participating.If you're instead only interested in making content-free "no you're wrong" assertions, then please just go away.--Percy

Purpledawn doesn't seem to be advocating those positions. Let's have peace in the house.--Percy

If the government decides that herbal medicines should be regulated by the FDA, including not only clinical studies of safety and effectiveness but also quality standards for delivery mechanisms, the broader question would be how best to structure and manage the interim period for each herb until FDA requirements are satisfied. Certainly an outright ban during the interim period would be extreme.--Percy

You're closer to Canada then we are down here in southern NH, so I would expect this to be more common up by you, but I have a couple friends who pick up ephedra, or have friends do it for them, if they happen to visit Canada. They don't make special trips, and it isn't a black market but just for personal use. Supposedly ephedra is a prescription drug up there, but Health Canada seems to be weak at enforcement, so ephedra is widely available.But a ban on herbs pending FDA approval seems extremely unlikely. Even a change allowing FDA regulation of herbs seems extremely unlikely. The US is very libertarian regarding many aspects of health care. Did you know homeopaths in Arizona can perform surgery?--Percy

Yeah, Primatene is one, it also contains guaifenesin, don't know if that matters. Anyone know how the amount of ephedrine in asthma pills like Primatene compares to the amount in the diet pills they used to sell?--Percy

Naturally I disagree that anything resembling modern approaches to scientific investigation were performed by the ancient Chinese, but there's no need to debate this particularly point. Given a scientific question, just ask yourself what is the difference between a scientific study never performed versus a scientific study that was meticulously performed and then all the results lost?The answer becomes even more obvious when you consider the issue at a more detailed level. Even the most basic tools of medical inquiry, such as blood pressure, temperature and blood analysis, were not in the possession of the ancient Chinese. Systematic tracking of results using basic data like this could not possibly have been performed. Any results would have had to have been based upon self-reporting, i.e., asking people how they felt. Certainly they never performed the double-blind trials that would eliminate the placebo effect, and control of dosage levels would have been impossible.But let's get real here. While it would be unfair to claim that no systematic investigations were ever performed by the ancient Chinese, the reality is that Chinese herbal folk knowledge for the most part accumulated the way all such knowledge accumulates, gathered anecdotally and spread by word of mouth. This paragraph asks the wrong question, which you acknowledge later, but let me emphasize anyway that no one questions that drugs, which includes herbs and pharmaceuticals, can have serious side effects. The issue is one of whether the requisite studies have been performed to reveal what the side-effects might be. You appear to agree with this at least somewhat when you say: But you go on to repeat your initial premise: There's no documentation. There are no records of studies by the ancient Chinese. There's only folk knowledge, and the only thing resembling documentation is what people have recorded concerning this folk knowledge. Until you can point to the journals documenting the peer-reviewed double-blind placebo-based studies you have no assurance about things like safety, effectiveness, dosage level, potential side-effects, drug interactions, etc.--Percy

Besides that scientific studies have found no link, thimerosal was removed from vaccines in the US beginning around 2000 and autism rates have continued to climb. The increasing incidence rate might be real or it might be due to increased diagnosis, but it is definitely not due to thimerosal.--Percy

Other than their use of the word "holistic" on a few of their webpages, Scripps Health (not Scripts Clinic) seems like a standard network of physicians, hospitals and clinics promoting traditional medicine. I wouldn't have any problem using Scripps, though their Center for Integrative Medicine seems a bit flaky with their promotion of treatments like acupuncture.--Percy

Of course hospitals would implement treatment centers with no scientific foundation. All it takes is demand. Hospitals add homeopathic treatments and naturalistic treatments and holistic treatments for the same reason that pharmaceutical companies got into the supplement business: it brings in money. And the big bonus with bogus treatments and supplements is that they're usually simple and cheap, and I'd even add safe as long as a responsible doctor is involved.--Percy