OIT may not produce lasting effects?

[CMdeux]

Yeah-- it's not really about alt med.  More like the scientific process.  I know a lot of people on the traditional, research side of things that have zero beef with herbals as effective pharmacotherapuetics.  Only with snake oil and woo.

The fact, is, though, that NCCAM funds this kind of research because traditionally, NIH won't... but equally unfortunately, NCCAM seems to be unable (or unwilling?) to sort the wheat from the chaff there, which winds up meaning that preliminary data... has almost no bearing on funding.  They also fund a lot of pure snake oil (which, to be clear, wouldn't happen if they relied heavily on higher quality preliminary data) which contributes to the problem.

There's also a barrier (VERY difficult to overcome) of such therapeutic approaches absolutely mandating (either traditional botanicals or allopathic modern pharmaceuticals, I mean) sham treatment and/or placebo comparisons.  Apples to apples, yk?

Few researchers do those, particularly not on the CAM side of things.  I can't quite decide if this is deliberate omission because they suspect that the efficacy is mostly placebo, or if they sincerely don't understand why comparison with other therapeutic interventions-- or with no treatment at all-- isn't a true comparison.  Ace researchers do use good experimental design, however.


Just don't be too surprised that there are hard-core scientists interested in TCM and other traditional herbal/apothecary practice.  We all know that some of that stuff is real.  And some of the real stuff probably isn't placebo-- which then makes the question more interesting.  Who wouldn't be interested in that??       Some of those people seem to have a personal background which supports (explains?) the source of that interest, at least superficially.  Here's what I know from working in biological sciences, though-- it's ALWAYS personal.    Every single passionate person at a national meeting has an interesting (and sometimes heartbreaking) personal story of why they do what they do.

So I wouldn't put too much on family background/ethnicity.  At least not in an obvious way; the truth is probably a lot more complicated.

[twinturbo]

OK, I guess you use the word background to mean ethnicity? I don't. Background to me is full context including profession.

When I say background I mean specifically the following:

Medicinal training in both Chinese medicine and Western MD who have worked at the large metropolitan hospitals in mainland China that incorporate BOTH in treatment. We've had family members we've sent to them for treatment we couldn't get in the US. Shanghai, specifically. We also have friends stateside who have worked the bigger hospitals in Beijing and obviously Shanghai which is how we got a connection in.

Those connections, the doctors in the large metropolitan mainland hospitals are a specific echelon. I know you all Dr. Li so I use her as an example.

That's a rare background statistically to find strictly housed within research and/or the FDA focused on herbal medications. That would require the FDA taking herbs seriously and the wholly qualified person seeking such a position. However that came about it's a net positive.

The family friend MD who worked at the Shanghai hospital practices only as an MD in the US. The TCM facility I use locally have a similar professional profile from a Beijing hospital. They choose not to practice as MDs but as instructors for alt med practitioners here. I'm not sure if traditionally it has been difficult bureaucratically to try to practice both as an MD. Most of my circle of Asian American (DH and I are Asian for readers needing context) friends who became MDs or Pharm Ds, do not go anywhere near TCM even though everyone grew up with it or use it themselves.

You know in the old movie Ghostbusters where they say the streams can't cross? Usually they don't in USA, or it was discouraged by the structure of the system to cleave it.

[CMdeux]

OK, I guess you use the word background to mean ethnicity? I don't. Background to me is full context including profession.

I don't either-- I meant exactly what you did about that.    I specified 'ethnicity' because there is probably a temptation to refer to a first generation American with extended family in New Delhi, who, for example, takes an interest in Ayurvedic medicinal compounding... as... well, someone who is interested BECAUSE of ethnicity, and that simply isn't the whole story a lot of the time-- in my experience.

I'm just glad that we're finally getting to a point (in N. America) where people feel that they can come out of the closet, so to speak.

It's been difficult until fairly recently-- allopathic, North American medical training taught doctors that all Ayurvedic/TCM practices were bunkum, and far too many TCM practitioners were afraid of (? not exactly what it is, I realize, but there IS a barrier) toward scientific validation of those practices, and toward the pill-pushing western side of things.  Not all Ayurvedic/TCM/ethnobotanical treatment is empirically valid.  But some of it sure is.  Then again, not all western medicine is about pill-popping, either-- but some of IT is. 


All medical practice is an unfortunate tangle of placebo effect and mind-body interactions alongside of clinically meaningful interventions that work regardless of the patient's beliefs.   The allopathic side of things isn't always as critical as IT needs to be, either.  It's a structural problem, but what is ironic (in my own experience as a researcher looking at both fields) is that TCM sneers at allopathic medicine for its wholesale dismissal of placebo as a valid practice (and they are probably right), but at the same time, allopathic practice does quite often use what amounts to placebo effect.  It's all in how the effect is examined, and in what sort of control groups you select.  How to define "effective" basically, since it is by definition a relative term.

We all run into that re: challenges and outgrowing-- what exactly constitutes "tolerance" anyway??  Is is "ad libitum?"  Or a single serving?  Something less than that?  Only in some forms (fully heat-denatured)?  Compared with WHAT?    That's always the most important (and vexing) question.  It's very seldom black and white.

[twinturbo]

Sort of. I'm used to having to verify my sources within my 'community' where we have a vetting process based on our intercontinental social network. Sometimes this leads to a store front with no English running on cash only. Sounds shady, right? But I go through a different vetting process where the certifications that have meaning to me, to us, ironically have no paper equivalent by the national system we have in place here in USA. On paper the type of person who looks qualified here takes some NP or is a chiropractor with some a couple community college courses in acupressure.

It has to be someone that was well established within the medical system elsewhere, not someone whose entry into medicine was US med school and then pursued something tied to ancestral cultural medicines. In a very narrow category I would describe it to a select few who are international researches having an equally maintained career researching in collaboration where TCM isn't TCM but part of an openly integrated approach without the hipster granola co-option. They still have a hand in the game so to speak because they never left the system, only expanded upon it with additional resources, new collaborators.

Found him. This FDA guy. He was one of the moderators for the 2010 East-West Symposium organized by Mt. Sinai for the US-Asia-Europe group of botanicals in asthma and allergy.

Jinhui Dou, Ph.D.
Pharmacognosy and Pharmacology Reviewer
jinhui.dou@fda.hhs.gov
Phone: (301) 796-1062
Dr. Jin-Hui Dou joined the Botanical Review Team as the pharmacognosy reviewer in July 2002.  Dr. Dou is uniquely qualified for this position having earned his B.Pharm, and M.S. at the Bejing University of Chinese Medicine and his Ph.D. at the University of Mississippi.  In addition to his formal training, Dr. Dou has extensive practical experience in the areas of medicinal plant biology, pharmacology of herbal preparations, and clinical uses of botanical products.

[CMdeux]

I do think, though, that there is a real risk of wholesale legitimizing happening as this process transpires, though-- because while someone who has a long history of practical TCM experience may be legitimately an expert...

someone who just happens to take a couple of accupressure classes and set themselves up... does not.

And really, no matter how much anecdotal evidence you collect as an individual practitioner, it simply isn't the same thing as data that rigorously validates your hypothesis.  Unfortunately, too few clinicians genuinely understand the distinction.

I'm okay with anecdote and speculative ideas in medical treatment out on the edge.  But I'm mightily uncomfortable with practice standards written from them.

This is the problem that I've witnessed:  when NCCAM was built as a funding agency, it was intended to fund things that were "known" anecdotally but were not scientifically validated, or well-understood mechanistically.  Things like pain management with accupuncture, herbal TCM, etc.    Then, though, the mission expanded exponentially when "practitioners" started figuring out that they could "study" things like NAET and BioSET using that same pool of funding.  {sigh}  Now all of it gets lumped together as "alternative but probably something to it, since so many people seem to think so..."  which of course is no kind of validation at all.


Basically, it begs the question-- how does anyone know that FAHF-2 is worthwhile and NAET isn't?  Well, experience suggests that this is so, I get that part... TCM has a few thousand years of practice behind it.  But so did bloodletting.   Bottom line is that it boils down to a litmus test of "does this fit within the known natural laws governing the natural world and what we understand of it?"  In the case of FAHF-2, it's an obvious "Sure-- completely possible."  NAET?  That would be a big old NO, thank-you-very-much.  COULD it be a placebo effect at work?  Yes-- in both instances.

Bu the answer to that first question means that FAHF-2 deserves funding for research and NAET probably does not.  The problem is that the agency doing most of this funding isn't asking that question very well.  IMO.

[CMdeux]

It is also a serious shame-- IMO, again-- that the west has more or less lost its traditional herbal knowledge.  We chose (culturally) about 400 years ago to regard those people with that knowledge as "uneducated" relative to a newly defined set of emerging standards of education via a university experience.    It also didn't help that a lot of practitioners were.... female.  (Midwives, specifically.)

The trouble is that pharmacognosy/ethnopharmacology was a genuinely sophisticated specialty field with real local experts (apothecaries and herb-women or midwives) much the way TCM continues to be. 

So most of the west has no real idea how to utilize its native plants which have pharmacological activity-- though such knowledge DID exist once.  A lot of it was oral, and has been lost.  On purpose-- because it wasn't something that "fit" well with the emerging ideals of a male-dominated educated "professional" class.

A look at the histories of digoxin and valium is ample demonstration of the kind of nuanced, very sophisticated understanding that I'm talking about.  Now imagine that there are THOUSANDS of other drugs that some Parisian apothecary or Irish midwife in 1500 would have known about... but we don't because those things were proprietary information at the time.

Anyway.  There ARE people in pharmacognosy in North America and in Europe who seek out primary sources from theses regions in order to harvest information from them.  But the process is different than it is with Ayurvedic or TCM practices and remedies, because in the latter two instances, there are living, traditional practitioners to ASK.

[twinturbo]

This was 2013. I'll keep cyberstalking him to see if his Guidelines for Botanical Drug Development is published somewhere. Most likely for the rest of us since you're likely to know anyhow. I'm going through .edu backchannels to see if I can get the official USFDA Guidelines (etc.) in print from Jinhui Dou/FDA if one were to approach as a university botanical researcher.

Track C

C4 Botanical Drugs: Navigating an Emerging BioPharma Pipeline

Track:   IP Best Practices
Target Audience:   Intermediate
Moderator:   Andrew K. Gonsalves, Esq., Heslin Rothenberg Farley & Mesiti PC
Speakers:   Allyson M. Best, M.B.A., University of Mississippi
   Jinhui Dou, Ph.D. , U.S. Food and Drug Administration

The botanical prescription drug industry is in its infancy, but there are signs that it is trending upward. In 2006, the U.S. Food and Drug Administration (FDA) approved the first new botanical drug under the FDA's industry guidelines for botanical drug products. This approval has helped to stimulate more interest in the development of botanical products for therapeutic uses. Early-stage university research will be critical in advancing this technology. As this market matures, we can expect a greater interest in the procurement, management and licensing of patents covering botanical products derived from university-based research. However, commercialization of botanical products includes unique challenges. Unlike small molecule drugs, botanical drugs are typically plant extracts containing a mixture of components. At times, the active compounds in these plant extracts have not been identified or fully characterized. Panelists will discuss the intellectual property, regulatory, and licensing hurdles that university technology transfer offices may face in partnering with industry to commercialize botanical prescription drug innovations. Panelists will also discuss lessons learned from the licensing and launching of actual botanical dietary supplement products derived from university research.

A video overview

http://www.integrativeonc.org/index.php/past-conferences-sec/shanghai-international-symposium/108-regulations-panel

And the panel on Sinai's 2010 East-West Symposium http://www.mountsinai.org/vgn_lnk/Regular%20Content/File/Faculty%20Profile%20Pdfs/EastWestSymposia_agenda.pdf. I never looked much at the Italian or Austrian contribution because the FDA trials concentrate on FAHF-2.

[LinksEtc]

TT,

This link is for you 

http://www.asthmaallergieschildren.com/2013/10/01/chinese-medicine-minus-the-enigma/

[twinturbo]

Any idea of which Henry Ehrlich this would be? If it's the Professor Emeritus in hard science my confidence is more moderate. The philosopher's NY Times piece, however, is exactly the sort of perspective I want to be phased out and replaced in the entire discussion. He's so off it irritates me reading it. Jeez, it's not like we don't use Panadol or vaccinations. But I guess that plays out better for readership than an FDA bureaucrat discussing real barriers to regulating formulations.

Not you links, it's not you.

[LinksEtc]

Not you links, it's not you.

That subject ... I automatically think of you ... whether you like/agree with the content - I don't take offense 

[twinturbo]

Good.

Maybe I should detail what a visit with Dr. Li is like to illustrate what happens even inside a private TCM clinic outside the FDA purview.

It gets routed through Mt. Sinai. In order to be seen you must get a full standard blood work up including (if I remember correctly) complete blood count, IgE levels total and food specific. She reviews the blood work, and in my case she was the first to diagnose my single-line neutrophil deficiency correctly which was later confirmed at a second opinion appointment at Harvard Med.

We didn't talk about feng shui, other supplements, chi, nothing of that sort. In TCM herbs it's common for the doc to want you to stay away from certain foods or drink often times because of its diuretic effects. She didn't even bring that up - I did, and even then she had no concerns.

Now, she did sneak some acupuncture on me but that was unrelated. She heard how hectic life circumstances were so she wanted me to chill the heck out. For the record none of our family use acupuncture we don't like having the skin punctured. Moral of the story is we walked a firm medical line even with an herbal formula. There was nothing mystical about it and THAT is how it usually rolls.

[booandbrimom]

Any idea of which Henry Ehrlich this would be?

He's the brother of the doctor who writes for that site. He did interview me for the book. Of course, he didn't TELL me he was writing a book (I assumed it was for his web site or I wouldn't have done it) and he was horribly condescending in his emails to me (making fun of me because i use a pseudonym)...but I guess I'll be in it. In some twisted form.

Can't wait. 

[CMdeux]

{cringe}

Yeah, hey-- who WOULDN'T use their real name, location, and post their child(ren)'s medical information publicly?

[twinturbo]

Alright, that sounds more like the garbage I'm used to in this area. I think I may slide her an email to see if she's even aware of it.

[GoingNuts]

Recently someone posted on our local support group board (someone I've never met, which is not unusual since we haven't met in person in years) that her DD who had been successfully going through OIT anaphylaxed from a trace amount.  She had been up to 3 peanut M&M's a day, and got some cross-contam baked goods by mistake.

Quite disheartening.