I watched Bigger, Stronger, Faster* a couple weeks ago, and one of the things the movie touched on that I wasn’t aware of, was that Orrin Hatch lobbied for the free pass the FDA gives to “supplements” because of his and Utah’s ties to the industry.
This is a HUGE industry, seemingly almost completely unregulated, full of some stuff that is probably harmful to humans (chromium picolinate), some stuff that is definitely harmful to ecosystems (shark cartilage), and a whole lot of stuff that is completely ineffective.
How long can this party last, and should it? How long should placebo “cures” for the common cold like Coldeze and echinacea be allowed to generate billions of dollars based on false, misleading, or unevaluated claims?
Normally, I don’t think it’s a problem if some idiot wants to take some herb claiming to prevent their cold. It’s their money, they are free to spend it as they wish. However, problems start to arise when people with serious medical conditions use herbal and “alternative” treatments instead of legitimate medical care, and end up making things worse.
At the very least, as Chronos suggested, safety needs to be proven, and some sort of “dose” should be agreed upon. Just because zinc or St. John’s wort is safe in X amount that manufacturer A uses, doesn’t mean that Y amount manufacturer B uses will be safe. Not to mention that many, MANY herbal “treatments” not only have filler that aren’t on the label, but some contain such a small amount of what they claim to have, you have to wonder if it could even have any effect, even if it WAS proven to have efficacy.
And let it be said that while I do think most herbal remedies are BS, I do have an open mind. If they can prove through controlled, clinical trials that they can do what they claim, then I’m all for them. St.John’s wort is actually an example. Several studies have shown that it does have an effect greater than a placebo for treating depression. I think it’s worth looking into what active compound(s) might be responsible, and establish some sort of dosing guidelines. it’s hard to treat a disease with a remedy that isn’t standardized.
The problem is that a lot of proponents will point to existing studies that do just that, but when you look into them, you see that the methodology is bad (like too small of a sample size,) or their results are barely better than a placebo (if they even used one.) When a decent study IS performed, and (as predicted,) shows no results, they will scream bloody murder that that study was bad, either for the same reasons we say their studies are bad (even if they don’t apply,) or, more frequently, they will say they are completely fabricated because they are funded by “Big Pharma” and therefore can’t be trusted. But to me, that makes very little sense. If “Big Pharma” is only out to make money, then wouldn’t it be in their best interest to cash in on these herbal treatments and sell them, too? I mean, surely it would be a lot cheaper and easier to just sell a lot of echanacea pills than to put millions of dollars of research into some “scary chemical” that will prevent the common cold.
Suppose I manufacture a car, and advertise it as getting 80 miles per gallon of gas. But you drive it around and only get 25 MPG. Who is the idiot here?
If you mean prove that they are not contaminated, and are accurately dosed sure, I’d love that!
But we allow the sale of some substances - alcohol and tobacco for instance - that are not so safe. How do you all feel about banning them? How do you all feel about keeping recreational drugs illegal?
This is how I feel about all proscribed substances (in addition to food, medicine and “herbal remedies”). I’d like to retool the FDA from a sanctioning body to an educating one. The government shouldn’t simply ban everything dangerous, but should investigate products, ensuring that citizens are informed and well prepared to make wise decisions. Then if someone goes ahead and kills themselves by taking herbs instead of antibiotics… well, the fault is entirely their own.
Chronos and bouv said they should have to prove their safety - which means that those products whose safety is not proven (by what standard?) would not be allowed to be sold.
Safety is proven in a similar manner as current drugs. You evaluate what therapeutic effect it has, and what danger it presents. If it’s deemed that the beneficial effects outweigh the harmful effects, then a reasonable dose is determined and it can be packaged with the information about what it does, both for good and for ill, as well as the recommended dose.
Nobody selling alcohol is allowed to claim it is an effective seizure medication. Nobody selling tobacco tries to claim it can fix astigmatism. But people selling dietary suppliments and herbal treatments are allowed to print labels that imply their products do things they do not do.
A good sound voice in scientific rational thought about medicinal herbs in the modern age is Dr. Jim Duke Really, he’s a well respected scientist who has done well over his duty in government work, and has done a great service by meticulously cataloguing the components of medicinal herbs after a long career here. An incredible life’s work of botanical medicinal chemistry to peruse, for all. And, so, after a good lifetime of 76 years of scientific knowledge, here is his statement on the potential of herbal medicinals:
And how, precisely, are we supposed to even know what the appropriate “farmaceutical” is to compare to? I mean, if I’m developing a new blood pressure medication, then I want to compare that to a supplement that’s good for blood pressure, right? How do I know which one that is? Do I have to compare it to every old thing that anyone, anywhere, claims is good for blood pressure? Or would the drug companies be required to do the tests to figure that out, too? And if so, why should the drug companies be forced to do the studies on the snake-oil, instead of the snake-oil companies?
Chronos, I understand what you’re saying, and, I’m very sure Dr.Duke has too. Again, Jim Duke is no New Age feelgood doctor, but, the best honed botanical expert in medicinal herb chemistry, as my second link shows.
He is the expert that medical studies go to for advice, but, he has had a good experience of getting frustrated with the system Not taking his advice to study an herbal remedy, because you cannot patent it. This is the Catch 22 with herbal medicinals. I have seen this as well in the Natural Products Center at the University of Mississippi. You can study the effects of herbal medicinals, but cannot patent a natural product, so, the research is on the herb, but the thrust is towards a patentable extract. That means that pure research on the herb in it’s own right is not done because it’s not profitable.
So, you won’t see good research accepted in the US (it is done in other countries—The Commission E German Herbal Monographswere done a decade ago) because of that Catch 22 factor.
I don’t buy it. There are TONS of generic and un-patentable drugs out there that companies make money off of. Do they make as much? No, but they still make them. If drug companies ONLY cared about patentable medicine, then no one would be making aspirin, ibuprofen, etc…
Herbal remedies are a HUGE business, billions of dollars a year, and if drug companies had proof that they did anything, you can bet your ass they’d be all over that market. But since they are under more scrutiny, and have to actually prove their claims, they are in a pickle. But I know lots of companies are researching herbal remedies, but in a more scientific way. They aren’t just going to throw a bunch of St.John’s wort in a pill and sell it, they are going to find out the active compound(s) in it first.
This is a classic argument used by alt med advocates, and it is dead wrong.
First off, lots of research is done in the U.S. on plant-based medicinal substances, including herbs. One example is the hundreds of millions of dollars spent every year on government-sponsored research through the National Center for Complementary and Alternative Medicine ((NCCAM) under the auspices of the National Institutes of Health (more on that later). There is also lots of university and drug-company based research involved. Just do a Pub Med search on various herbs and other plants and you’ll be startled at the volume of U.S.-based research.
There is a tremendous capacity to patent and profit from plant-derived and other “natural” medicines through purification and tweaking of active principles in such drugs, and many have come down the pipeline to be accepted prescription meds (Taxol is one major recent example, but just one of many).
The problem with this is the gross lack of evidence that “culinary” products can compete with pharmaceuticals. I love the implication that herbal drugs are 1) not actually drugs at all, but “foods”, implying they’re just ever so safe and natural, while at the same time 2) they are as powerful as or more powerful than prescription drugs. Sorry Dr. Jim, you can’t have it both ways. That there is known as magical thinking.
Supplement dealers (and increasingly “Big Pharma”, which is finding the “nutritional supplement” market to be quite profitable) are getting away with murder (sometimes pretty much literally) in slyly and often quite openly promoting their unproven products as effective and safe for various medical conditions, while tossing in the disclaimer that well, they’re not actually claiming that their potions are intended to treat or cure any disease. The line, such as it is, gets crossed with relative impunity (the FDA doesn’t have the policing manpower it needs or the authority to crack down on offenders).
And while the OP is correct that Sen. Orrin Hatch is one of the major forces behind the creation and maintenance of DSHEA (the legislation making these abuses possible), another equally guilty party is Senator Tom Harkin, who recently made his foolish biases public when he lambasted NCCAM (the governmental body that sponsors alt med research, as noted above) for not doing its duty (as he sees it) to legitimize alternative treatments (as opposed to being a facilitator of rigorous, unprejudiced research). Tom, you see, is pissed that NCCAM isn’t rubber stamping the woo that Tom Harkin likes. More on Harkin’s incredible views here.
So yes, I think herbs and other supplements that make health claims should back them up with solid research, maybe spending a tiny fraction of their 23 billion dollars a year in sales on such research. But with big-time lobbyists and powerful allies in Congress, reform will be a tough go.
I would be fine with that, as long as the ingredients are confirmed by the FDA to be safe. If they are not safe, they should have clear warning labels stating so. Right now, we just have the weak “this product is not meant for the treatment of any medical condition” fine print, right under the list of all the miracle things the snake oil will do for you. There should be absolutely nothing even remotely implying a health benefit on any edible product that has not been demonstrated to the FDA to actually provide that exact benefit.