Parasites for certain IBDs

[Gayle]

...another aproach in using living organisms to oppose a disease condition, similar to using maggots to assist with debrieding and infection.

http://www.npr.org/2010/12/02/131753267 ... mmentBlock


Gayle

[Gloria]

Fascinating description of why this treatment seems to work. Thank you for posting it.

Gloria

[Gayle]

Hi Gloria,

I posted that as a matter of general interest to GI patients. (I viewed it more or less a “news of the weird” type thing).

And then today I attended a CCFA conference here in the Phoenix area where --- lo-and-behold ---, the main speaker, a GI Doc of considerable repute from UNLV, had a singular slide included in his presentation regarding a similar type parasite treatment that had been investigated -- and had shown some promise -- in the treatment of IBD. When the FDA became involved in this circumstance, they closed (permanently terminated) any possible further research into (or the use of) such an avenue of treatment in the United States.

This was the sum-total of this presenter’s comment on this topic. This had been something of an aside in his presentation, and something he was obviously not going to get into any further discussion on. It was just kind of a point of interest.

One would have to factor in the presence drug reps in the audience at this meeting (they do sponsor these meetings after all) as a controlling influence against any further discussion on the merits of further investigation of such an approach. The use of parasites to influence and/or control certain disease conditions is certainly not of any interest to the Pharmaceutical companies with no potential patents possible on using such a treatment approach.

This slide and his terse commentary was particularly interesting as the group at our table had been talking about this article before the program started --- and thinking ???? Hummmm!


Gayle

[Gloria]

I never thought about the influence big pharma might have on the lack of promotion for parasite therapy. Wouldn't they be able to market parasite pills containing eggs? It does sound pretty disgusting, though. Maybe they don't want to be in the parasite business for that reason. From what I understand, there would be repeat business from it because the parasites need to be continually replenished.

Gloria

[tex]

I suspect that one of the problems with this type of therapy is that it may fall under the jurisdictions of both the FDA and USDA, (since pig whipworms showed the most promise in early research. I've posted about the research of Dr. Joel Weinstock before, (he is mentioned in that article), when he was at the University of Iowa, which I'm pretty sure is a land grand university, (IOW, an ag university), and that's probably why he moved on. The odds of the FDA and USDA agreeing on the use of a parasite as medical therapy would probably be a pretty sizable stretch.

I believe that somewhere I have a bookmark for the website of a laboratory in the Philippines, or somewhere in that part of the world, where it's possible to order the ova of pig whipworms, (or other species of helminths), if anyone is interested in trying it on their own.

Yes, I'm sure that Big Pharma is not interested in selling worm eggs - that's probably beneath their dignity. Selling blood-sucking leeches would be right up their alley, though.

Tex

[MBombardier]

[starfire]

Big pharma can't get a patent on a "natural" product. Of course they could always alter it or add something that supposedly makes it work "better" which would probably be found to be detrimental in the next 20 years or so.

Love, Shirley

[Gayle]

Gloria said -- I never thought about the influence big pharma might have on the lack of promotion for parasite therapy. Wouldn't they be able to market parasite pills containing eggs?

Oh my goodness, the cost of getting such a “product” to market would be prohibitive. A product such as parasites is not “patentable” --- simply because parasites already exist in nature. Then too, the cost of trials etc. to show safety, efficacy … etc. would be prohibitive in relationship to what could be expected to recoup in sales volume. Pharma analysts are all experts in the science of estimating cost/benefit, and such an endeavor with worms would engender huge costs --- without sufficient potential for any monetary benefit. NOT!!

Sooooo ... since there would be no interest on the part of Pharma in such a product, this area might then be left open to be positioned somewhere in the “supplement, health food market”, where according to current law, there is no FDA regulation. I would kinda bet that would be the reason that FDA got involved and lowered the hammer so quickly on such an approach. They simply did not want to see a door opened for a market for worms to be developed in that industry -- which would/could not be subjected to regulation!!! (Then too, try to imagine how creative the marketing for such a product would be!)

Gloria said -- It does sound pretty disgusting

I certainly do agree that this approach does sound disgusting. However, putting myself in the place of a person with UC that is facing the necessity of a total colectomy. If such a thing were available, I believe I would think it might be worth a try -- before such radical surgery. Plus -- this kind of approach really isn’t much different in a way than the practice of using leaches to clean out serious tissue infections when antibiotics alone are not getting the job done. I haven't the faintest idea where these (medically approved) leaches are obtained from tho??? There must be some company that supplies them?

Gloria said -- From what I understand, there would be repeat business from it because the parasites need to be continually replenished.

Sounds that way to me also, but then … don’t we have to use medications on a more or less continual basis. This approach doesn’t seem to claim to cure the disease process itself, only to control the effects of the disease within the organ. So I suppose, any intestinal worm “business” generated in this manner would be on a “repeating” basis.


Oh well, enough on GI treatments with worms here --- but interesting concept.



Gayle

[tex]

Actually, the FDA does have the power to regulate helminth ova sold for therapeutic purposes, (or at least they think they do), and as I mentioned, the USDA may have that authority also, as part of their department of Animal Health Inspection Service, (APHIS). Anything claimed to have therapeutic powers, in it's labeling, meets the definition of a drug, (according to the FDA), regardless of the actual shape or form of the product.

Remember the trouble that General Mills got into with the wording of their advertising for Cheerios last year?

The Food and Drug Administration slapped General Mills Inc. with a warning over its Cheerios cereal, saying the box's claims about heart benefits contain "serious violations" of federal law.

In a May 5 warning letter sent to the company and posted on the FDA's Web site Tuesday, the agency said statements that the product is "clinically proven to help lower cholesterol" make the product a drug under federal law.

http://online.wsj.com/article/SB124216077825612187.html

General Mills isn't the first company to find themselves in such a position, and certainly, anyone selling worms, or worm eggs, to treat inflammatory bowel diseases, or autoimmune diseases, would also run afoul of the FDA's interpretation of the labeling laws. This would be a substantial roadblock for anyone trying to sell such a product, because unless the label contains some sort of claims as to it's efficacy in treating Crohn's disease or UC, very few people would be likely to buy it as a "vitamin supplement", or "herb" with unnamed benefits.

Tex

[Gayle]

As I recall this action, the FDA’s beef with General Mills was over the marketing/advertising campaign in which there was verbiage used which made a strong claim to the effect that Cheerios was a “Heart Healthy” product.

FDA’s position essentially was that General Mills could not make such a claim with out having evidence to back up such a claim, which of course --- they did not.

Therefore, that Marketing/Advertising campaign had to be terminated. Don’t know if there was a fine assessed on the company attached to this action, or not. But if so, it was probably of no significance to this huge (Fortune 500) company, beyond having to ditch an expensive ad campaign.

Since I am not, never have been, a Cheerios fan, haven’t paid any attention to the status of Cheerios in the marketplace today -- but I'm pretty sure that it is still on the shelves … sans any “Heart Healthy” claim. (Do people really pay attention to all these claims anyway?)

So anyway, the action had nothing to do with the product itself, but was about the words and the manner in which the manufacturer choose to describe and advertise their product -or- In a nutshell, it was about what the FDA considered misleading product promotion (i.e. a health benefit was being claimed - without benefit of evidence to substantiate the claim).

From my point of view --- Lesson here is that it was strictly the manner of promotion that mattered. The product is unchanged and on the market. So one really can't be sure exactly what was accomplished other than that some really silly advertising was discontinued.

Now ------ if there was only a way to get rid of some of those tedious, disgusting, obnoxious, (explitive deleted) Drug advertisments that pollute the airways!!! ,


Gayle

[tex]

From my point of view --- Lesson here is that it was strictly the manner of promotion that mattered. The product is unchanged and on the market. So one really can't be sure exactly what was accomplished other than that some really silly advertising was discontinued.

Exactly. That was my point. General Mills' label description for Cheerios met the definition of a "drug", and it's illegal to sell "unapproved drugs", so the label had to be changed.

In the trade, that's known as a labeling violation, which is a minimal offense, and it usually results in a "cease and desist" order from the FDA. Normally, no penalties are imposed, unless corrective measures are not implemented within the allotted time specified in the letter, and the only corrective measures required are typically changes in the wording of the label, along with an assurance that the company will "never do it again".

Advertising is an essential part of drug sales, since a lot of prescriptions are written after the patient asks her or his doctor about the drug. Therefore, the drug companies can justify spending huge sums of money on advertising, and the ads obviously must pay off, (or they wouldn't be wasting their money). Therefore, the best way to get rid of some of those tedious, disgusting, obnoxious, drug advertisements that pollute the airways, would be for everyone to simply stop responding to them. It takes a while for the market to work, but if no one buys the drugs, the advertisements will eventually stop. I'm not aware of any other options that work as reliably. Unfortunately, though, the world is full of people who are conditioned to be eager to respond to those ads, (they want relief, and by golly, they want it now), so it's pretty clear that this option is doomed to failure.

The option that seems to bring the fastest and surest success, as far as I can determine, (at least on a practical basis), is to simply avoid the "airways", or at least, avoid the parts of them that are infiltrated with not only those ads, but any other ads that are generally considered to be obnoxious. They're only a problem if we choose to view them. It works for me, anyway.

Tex

[Joefnh]

While this subject makes my skin crawl... It does seem to be practiced and provide some good results. I ran across this article today and its quite interesting

http://www.cnn.com/2010/HEALTH/12/09/wo ... l?hpt=Sbin


--Joe