The skeptical community is abuzz with the announcement by the FDA’s announcement that they are reviewing the “regulatory framework” of homeopathic products and are open to public input.
Never ever ever. Boiron... is the largest manufacturer of homeopathic products in the world. In 2004, it employed a workforce of 2,779 and had a turnover of € 313 million. Pfizer alone spent ten times that on advertising in 2013. Anything to say about Title 21? anything? Bueller? Bueller? Not even Cheerios is exempt from Title 21. Let's be straight about one thing: Homeopathy is groundless pseudoscience. But in the grand scheme of things, it's tiny, fringe, harmless corner of pseudoscience. Yeah, homeopathy is often implicated in deaths through neglect but death through neglect doesn't require homeopathy. If you're taking medicine and it doesn't make you better, sensible people try different medicine. Insensible people are insensible because they're insensible, not because they believe in magic water. Homeopathy is the "skeptic's" Benghazi. There's no there there. So long as the FDA permits Title 21 waivers there will be psuedoscientific health claims. Now riddle me this - how 'come nobody in the "skeptic" community gives a shit about Herbalife? 'cuz those mutherfuckers? $4b market cap. Or, you know, Vioxx? I'm gonna guess "ideology" but then, I'm just skeptical. I'm not a "skeptic."However, that does not mean that the FDA has to approve the homeopathic remedy. They have the authority to require evidence for safety and efficacy, just like they do with real drugs. They simply chose not to enforce this authority.
However, homeopathy has grown into a multi-billion dollar industry.
Require evidence for safety and efficacy for all homeopathic products. It that’s simple.
Probably because those cases are a bit more complex than "there is zero medicine per medicine in this bottle." Still, there are public critics of mainstream medicine, focused solely on the canonical drug approval pipeline: Bad Pharma, "Why Most Published Research Findings Are False". It's just their messages are generally a lot more detailed and specific than "this medicine fails all trials" or "half of what's on those shelves is mislabeled", so they tend to propagate less quickly. Neither of those two call themselves skeptics, but their work is referred to by those who take on that title: 1, 2 The "ideology" in this case though is that Vioxx and its competitors all go through clinical trials and if they fail at some point, you can point to that step along the way and lay blame at its owner's feet. Merck paid out almost $1b in fines for Vioxx. But if no trials are required in the first place, then the herbalist can throw up their hands and say they did all that was required of them by the law, maybe the customer should have been smarter and ignored the loose collection of studies that pointed them to our product in the first place.Homeopathy is the "skeptic's" Benghazi. There's no there there. So long as the FDA permits Title 21 waivers there will be psuedoscientific health claims. Now riddle me this - how 'come nobody in the "skeptic" community gives a shit about Herbalife? 'cuz those mutherfuckers? $4b market cap. Or, you know, Vioxx?
That's the thing that bugs the shit out of me - the whole point of the natural supplements act was that supplement manufacturers would be allowed to sell anything with the disclaimer "not evaluated by the FDA" and then the FDA would do all the testing so they could say "check it out! We've conclusively proven that Ginkgo is only marginally effective on depression!" But whenever anybody applies for FDA money to study Ginkgo Biloba, the "skeptics" start shouting about tax dollars and heresy and burn the witch burn the witch.
Well, FDA wouldn't be the one funding that study, but I think the disagreement lies in the fact that most supplements are labeled as "not approval for medical use" and then sold to people who take them for medical use because some small trial showed an effect. Nothing stops drug screens on some target from using the active compounds from ginkgo in the screen. Some might argue that if it's natural, it won't get a patent. The laws around that are somewhat unclear, but most drug companies only use the hits from their screens as a lead into further development of some final (and often different) molecule. In theory, you wouldn't care that someone is spending money testing gingko on cancer because it's only one of hundreds of thousands of compounds being screened. If someone is testing only compounds from gingko, they get dinged for having an abysmally small library in a world where n < 10k is laughable. And if they're skipping straight to testing those compounds in humans on an arbitrary or difficult-to-quantify condition, then the chances of it showing signal in a small trial are high, but in a large trial are low. And more often than not, that means wasted time, money, and undue exposure to something that may have side-effects or a better treatment. I'm going to shortcut this discussion though and poke at a topic that a friend of mine has taken interest in: Gingko is not its parts, but the sum of its parts, and there's a weird phenomenon in pharmacology / nutrition where none of the major components from a plant will show an effect, but grinding up the whole plant and putting that in a pill will. Why that is is an open question in many cases, and an interesting area of research. If it's just something effecting the uptake of a molecule in the GI tract, there are plenty of substitutes for that already. But if it's a synergistic effect from multiple compounds each having small effects, that presents a real alternative to the classic "find a drug that binds X tightly" pipeline.