FDA wants to regulate homeopathy....Wooo peddlers wailing in anguish

[phands]

I love it...the FDA wants to subject homeopathy to the same regulation as pharmaceutical drugs, which is nuts because homeopathic "remedies" contain no active ingredient, but the Wooooooo peddling homeopath liars are wailing because there is an efficacy requirement...which they admit they will fail! Priceless...

BY ANH-USA ON AUGUST 23, 2018WAR ON NATURAL MEDICINE
The FDA is threatening homeopathy’s future. Here’s how we can save it. Action Alert!

The FDA has proposed a new policy for regulating homeopathy—a policy which is a direct threat to many, many homeopathic medicines. To fully protect consumer access to these treatments, we need Congress to pass a law.

Congress and the FDA have always exempted homeopathy from the same drug requirements as pharmaceutical drugs. Now the FDA, with pressure from big pharmaceutical companies who compete with homeopathic medicine, wants to create an unnecessary policy. As you’ll remember from our previous coverage, the FDA’s new policy states that no homeopathic medicines have been “generally recognized as safe and effective” (GRAS/E) by the FDA or gone through traditional FDA drug approval; therefore technically speaking all homeopathic medicines currently on the market are being sold illegally. However, the FDA said it would prioritize enforcement on products with safety concerns.

Homeopathy has grown into a $3 billion market with increasing demand from consumers looking for alternatives to prescription medicine. If we want continued consumer options for our health we need to send a message to Congress.

In response to the FDA’s new proposal, homeopathy advocates are arguing for a return to the Compliance Policy Guide (CPG) used since 1988. This document, which has provided regulatory guidance for homeopathic remedies, provides a definition for homeopathic drugs, current good manufacturing practices and labeling requirements. Going back to the CPG would help protect our present access but would still leave homeopathic medicine vulnerable to future agency action. Homeopathy should remain permanently exempted from traditional drug standards.
For example, over-the-counter homeopathic medicines are subject to the FDA’s drug review process, which began in 1972 and has since continued. The purpose of this process was to establish that every over-the-counter drug is both safe and effective. At that time, the FDA exempted homeopathic drugs, deciding to review them “as a separate category at a later time after the present over-the-counter drug review is complete” due to the “uniqueness of homeopathic medicine.”
This means that, at any time, the FDA has the power to review homeopathic drugs and is not required by federal statute to treat them differently than other over-the-counter medicines.

Subjecting homeopathy to new drug efficacy requirements would likely eliminate many medicines from the market. Homeopathy has been around since the early 19th century; many of the preparations in the Homeopathic Pharmacopeia—the official compendium of homeopathic monographs and standards—were included based on a history of successful use. This means they can’t be patented now, since they aren’t novel; patents also expire after twenty years, so even if they were patentable when they were first developed, that protection would have ended long ago. Without patent protection, it would be impossible for a company to recoup the astronomical costs of conducting drug trials to prove efficacy, which is required for traditional FDA approval. Forcing efficacy studies for homeopathy would also be duplicative, since the criteria for inclusion in the Homeopathic Pharmacopeia require that a product be safe and effective.

To truly save homeopathy, what is needed is federal legislation that acknowledges homeopathic medicine’s uniqueness and the inapplicability of conventional drug standards. It should provide a definition of homeopathic products, guidelines for manufacturing standards, and recognize the long history of homeopathy’s safe use. This legislation could provide a framework by “grandfathering” homeopathic medicines that have a history of safe use rather than requiring an unnecessary review process. For new homeopathic products, a notification system, recognizing homeopathy’s uniqueness, could be devised.

Why is homeopathy unique? While most medicine is based on drugs—that is, the use of pharmacological agents to treat or suppress the symptoms of a disease—homeopathy is an attempt to prompt the body to cure itself. It is based on the idea of “like treats like.” When you chop a red onion, for example, it causes watery eyes and a runny nose in most people. Allium cepa is a remedy created from red onion; in very small doses, Allium cepa is intended to activate the body’s own mechanism for stopping watery eyes and a runny nose. Homeopathic medicine is often so diluted that the original ingredient is virtually undetectable.

My bold.

Homeopathy doesn't need saving, it needs to be banned. While for most folk, it's harmless quackery, it kills people as well, when they try to treat deadly conditions with water or sugar pills.

Article at http://www.anh-usa.org/can-homeopathy-be-saved/

 

[scombrid]

Subjecting homeopathy to new drug efficacy requirements would likely eliminate many medicines from the market.

That's the funniest thing in the whole piece. What medicines?

To truly save homeopathy, what is needed is federal legislation that acknowledges homeopathic medicine’s uniqueness and the inapplicability of conventional drug standards.

Well these alt-reality people are always screaming for GMO labelling. Lets just have some truth in labelling for homeopathy. No ban needed. Just a big fucking sign saying that there is a 1000000000X chance that there is no detectible trace of any active ingredient in the water.

 

[whollygoats]

If it is a testable claim, test it.

Cochrane Collaboration is there.

The US Preventive Services Task Force Reports is there.

This is what 'Evidence-Based Medicine' is about.

While we're at it...let's eliminate the conflict of interest in testing in the FDA by eliminating the subsidies from the pharmaceutical industry.

 

[steve_bank]

Don[t call them medicines.

As I remember they are distilled so many times what you essentially get is water. Some are based on toxic substances, but what you get after distillation is the 'essence' of she substance.

 

[whollygoats]

Don[t call them medicines.

As I remember they are distilled so many times what you essentially get is water. Some are based on toxic substances, but what you get after distillation is the 'essence' of she substance.

Yeah...They'll still be able to market them as 'placebo'. And, make wild claims about the efficacy of their particular placebo.

 

[Keith&Co.]

Not sure how one would define homeopathy for the purpose of enforcement.


All the homeopathic vendors would just make up a new name. Glasswater cures, cold-fire treated water. Magik, elf-potions, solarized water, alchemy bases, magic wand cleaners....

Hell, i would like to open a brand of GUARANTEED NOT HOMEOPATHIC REMEDIES. Then spread word by mouth and internet that it was homeopathic, but BIG PHARMA forced us to hide the fact. Would be the most honest claim attached...


Or sell it as homeopathic remedies, but ONLY FOR PET ROCKS, not for use by humans, therefore not subject to FDA approval.

 

[Underseer]

Not just homeopathy. Regulate all of those "alternative medicine" quacks. We've had quite enough of their snake oil.

 

[phands]

Not just homeopathy. Regulate all of those "alternative medicine" quacks. We've had quite enough of their snake oil.

Agreed!!!!

The dangerous lunacy of Chiropractors needs to be regulated out of existence.
As does acupuncture - energy meridians indeed....garbage.
Hormesis...terrible non-science.
Faith-healers are liars and frauds.

 

[steve_bank]

Faith healers and sellers of holy water as a remedy should be regulated as well.

 

[Tom Sawyer]

Sounds like the FDA is doing a bit of a shakedown to generate some "campaign contributions" in advance of the midterms.

 

[whollygoats]

Not just homeopathy. Regulate all of those "alternative medicine" quacks. We've had quite enough of their snake oil.

Agreed!!!!

The dangerous lunacy of Chiropractors needs to be regulated out of existence.

I disagree with you on this, as do most health insurances in the US.

 

[phands]

Not just homeopathy. Regulate all of those "alternative medicine" quacks. We've had quite enough of their snake oil.

Agreed!!!!

The dangerous lunacy of Chiropractors needs to be regulated out of existence.

I disagree with you on this, as do most health insurances in the US.

That is of course, your prerogative.

But Chiro is quackery, and sometimes dangerously so. It features all too often on Quackwatch and similar places....
https://www.quackwatch.org/01QuackeryRelatedTopics/chirostroke.html


The evidence shows that chiropractors do more harm than good
https://health.spectator.co.uk/the-evidence-shows-that-chiropractors-do-more-harm-than-good/


Why chiropractic is patently ridiculous
http://scienceblogs.com/whitecoatunderground/2008/01/18/why-chiropractic-is-patently-r/



CHIROPRACTORS ARE BULLSHITCH
https://theoutline.com/post/1617/chiropractors-are-bullshit?zd=1&zi=2jmqk5lv

 

[whollygoats]

Sure.

Much of medicine is quackery and treating back pain is one of the major sources of quackery.

However, Richard A. Deyo, MD MPH, a researcher associated with Cochrane Collaboration, who teaches family medicine at Oregon Health Sciences University, in his book, Watch Your Back! How the Back Pain Industry is Costing Us More and Giving Us Less (ILR Press, Ithaca, 2014) has an enlightening chapter on spinal manipulation, and, on page 117, the doctor points out that the spinal adjustment by chiropractors is the same as provided by physical therapists and by osteopathic physicians and concludes that, "Some patients who fail conventional medical care do well with spinal adjustment and vice versa. My conclusion is that compared with conventional medical care, spinal adjustment may be no more and no less effective, but it is differently effective."

He also points out that, "An advantage of spinal manipulation is relative safety. In the low back, one credible estimate is that serious complications occur at about one per hundred million visits. If only the drugs I've prescribed were so safe! In the neck, serious complications are probably more common, but they're still rare."

This is included in a late chapter, after the good doctor has outlined the travesties perpetrated upon back pain sufferers by the medical profession and the medical device industry. I recommend the book.

Rather at odds with your claims.

 

[Elixir]

Sure.

Much of medicine is quackery and treating back pain is one of the major sources of quackery.

However, Richard A. Deyo, MD MPH, a researcher associated with Cochrane Collaboration, who teaches family medicine at Oregon Health Sciences University, in his book, Watch Your Back! How the Back Pain Industry is Costing Us More and Giving Us Less (ILR Press, Ithaca, 2014) has an enlightening chapter on spinal manipulation, and, on page 117, the doctor points out that the spinal adjustment by chiropractors is the same as provided by physical therapists and by osteopathic physicians and concludes that, "Some patients who fail conventional medical care do well with spinal adjustment and vice versa. My conclusion is that compared with conventional medical care, spinal adjustment may be no more and no less effective, but it is differently effective." He also points out that, "An advantage of spinal manipulation is relative safety. In the low back, one credible estimate is that serious complications occur at about one per hundred million visits. If only the drugs I've prescribed were so safe! In the neck, serious complications are probably more common, but they're still rare."

This is included in a late chapter, after the good doctor has outlined the travesties perpetrated upon back pain sufferers by the medical profession and the medical device industry. I recommend the book.

Rather at odds with your claims.

I think that the claim of quackery rightly applies to chiropractic as a whole, but like so many other lies, it does contain a kernel of truth.
I went to physical therapy after getting an MRI on my left shoulder (could barely lift my arm at all, or turn my head to the left). The surgeon gave me three choices when the MRI revealed a torn labrum - "I can go in, do some basic cleanup, and there would be a six week recovery time. Or I can go in and do the whole shebang - six month recovery time, OR you can go to physical therapy."
They can't repair the labrum, and I wasn't up for all that recovery time so I went to PT. That was two years ago, and I still devote 20-50 minutes every day to exercises specific to the probllem. I have recovered about 95% of my range of motion, and probably 80 percent of my strength in that arm. And zero neck pain. The therapist really knew his stuff, and the more I understood, the more I worked on the exercises. This has been a miracle... and also a life sentence; all it takes is a couple of days of not doing those exercises and it starts hurting again. But I moved hay this year for the first time in 4 years.

We did discuss manipulation as it related to my cervical spine. He's not a fan, but did say that chiropractic treatment could possibly help - temporarily, and IF the chiro (and I) got lucky. He's really not a fan.

Later I read about a very broad study on age and injury-related shoulder problems. One group got surgery, one got PT and the other got nothing. The only group with any statistically significant improvement a year later, was the PT group. I'm a religious believer in PT (at least for that kind of problem), but only a fraction of people who go to PT actually practice at home as much as they need to.

YMMV of course.

 

[steve_bank]

In the 80s I went to a chiropractor for a back problem. Insurance paid for it.

He had me extend my arms touching my outstretched fingers telling me I had a potassium deficiency.

At best they are physical therapists who are allowed to take x rays.

 

[Loren Pechtel]

In the 80s I went to a chiropractor for a back problem. Insurance paid for it.

He had me extend my arms touching my outstretched fingers telling me I had a potassium deficiency.

At best they are physical therapists who are allowed to take x rays.

Yeah. It's not total quackery--physical therapy is useful in many cases. Pretending it's anything more than physical therapy is quackery.

 

[whollygoats]

So...We're going with anecdotal?

In my youth, I was, for about five years, a refuse collection hauler, a job which, at that time, required a LOT of repetitive heavy lifting. Consequently, I did a fair amount of long-term damage to my back and shoulders.

Back then, taking such a complaint to a physician got you a script for 'muscle relaxants' and directions to take it easy for the next six weeks. The meds helped me toe the line, because they made me so loopy I couldn't work...for six weeks. Muscle spasms are not something one wishes to 'live with' for six weeks. So, I was referred to a chiropractor when a particularly nasty mid-back spasm practically prevented me from taking a deep breath without being in excruciating pain. In a ten minute therapy session, the chiropractor turned a searing band of pain around my chest in to a minimally sore spot about the size of a quarter, which was gone the next day. I could breathe, walk, bend, lift and all manner of other typical body movements I had been prevented from doing by pain. I went back to work that next work week. Needless to say, I found a practitioner I trusted and who seemed to have a 'touch' working with me and my chronic back pain. I ended up over the course of the next thirty years seeing my chiropractor two to three times a year to treat back strains and the occasional spasm. On almost every occasion, I could be assured that I would walk out of that chiropractor's office feeling significantly much more free of pain.

This is why so many health insurance companies in the US pay out for chiropractic treatment of back pain....It works. It reduces pain and makes the patient able to return to work much, much faster than six weeks of sitting on the couch at home popping muscle relaxants. I suspect that the 'medical' means of treating back spasms has been a significant factor in how the medical profession has been complicit in the spread of opioid addiction, something chiropractors have not been able to engage, because they cannot prescribe pharmaceuticals.

So, my experience is that chiropractic provides extremely fast and effective relief from a lot of back pain, a lot faster than medical treatment, and at a much lower cost.

I think that chiropractors should be expected to undergo at least the same rigorous education that a nurse or physical therapist might be expected to complete. Here, in my state, all practicing chiropractors need to be licensed as having completed such an education and demonstrated their proficiency to state regulators. In my state, that means any chiropractor treating conditions other than back pain is effectively engaged in malpractice, so we don't tend to get chiro obstetricians and the like....but those kinds of loose screws do move in from other locales, so locals need to seek out more 'conservative' practitioners who keep to treating back pain.

When it comes down to it, chiropractic effectively treated my back pain faster and more completely than any course of treatment ever recommended by any medical physician.

You can call chiropractic quackery if you like, but it is far more effective quackery than the quackery advanced by the medical profession to treat back pain in the US. Go ahead, refuse chiropractic....it'll keep their costs down while you sit and suffer in pain for six fucking weeks at home on your couch.

 

[Jimmy Higgins]

But the FDA is looking at maybe changing guidance on homeopathic drugs via a RISK BASED analysis. There are only two risks to homeopathic drugs:

1) to the wallet
2) potentially not taking a drug that is actually needed

 

[whollygoats]

If you want to talk about the FDA and quackery, let's talk about this. The saga of antidepressant medications and children is not even included.

What the fuck happened to RISK BASED analysis?

The FDA is complicit in the ongoing quackery perpetrated by the biopharmaceutical industry.

 

[steve_bank]

The stats on drugs prescribed to kids is staggering.

In the 90s I went for acupuncture, the insurance company was running a study. They'd pay amf you write a report. The things being said to patients was pseudoscience of the highest order.

I ended up with a licensed massage therapist with in depth knowledge of physiology who worked wonders on my back. One session lasted several weeks.

For a serious problem, I'd go to a degreed physical therapist.