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Rogue Biologics Production (And Bonus Ignorance)

You don’t expect to find unlicensed biologic drug-packaging operations in an English warehouse, but that’s just what the government’s MHRA uncovered recently. There has been a boom in unlicensed sales of the the blood factor gcMAF, which is being touted as a cancer cure, HIV cure, pretty much good for what ails you. And these folks were supplying that market:

Investigators from MHRA carried out an unannounced inspection of a production site in Milton, Cambridgeshire, after the medicines regulator in Guernsey raised concerns in relation to the product. The blood plasma starting material being used to make this drug stated “Not to be administered to humans or used in any drug products”. It was concluded that the production site does not meet Good Manufacturing Practice (GMP) standards and there are concerns over the sterility of the medicine being produced and the equipment being used. There are concerns that the product may be contaminated.
More than 10,000 vials were seized at this site and production of this unlicensed medicine has now ceased. . .

No doubt. What amazes me here is that they were actually going to the trouble of producing gcMAF at all. These folks believed in their product to what is an unusual degree in the black-market-medicine business. I hadn’t heard of this particular craze, but I have noted (here in the US) another boomlet in another naturally-occurring hormone, HCG. This was suggested decades ago as a diet aid, and has had cycles of popularity over the years, despite no actual evidence that it does any good. It’s picked up again, and now you not only have people selling actual repurposed HCG (and fake HCG that looks like the actual stuff), you also have other entrepreneurs who have jumped into the market with “homeopathic” and “herbal” HCG, whatever the hell those are supposed to be.
This actually bears on the blog post I put up earlier today, on general scientific ignorance. Not only do people not know all that much real science, they don’t even tend to get the fake stuff right. For many customers, putting “homeopathic” or “herbal” in front of a drug name is just fine – they treat these as alternate forms of the same thing, just, you know, more natural and safer and all that. There’s a homeopathic everything, just like there’s an herbal everything; that’s just how it works, right? What’s more, the great majority of people in this country who buy homeopathic whatever don’t actually realize what homeopathy is, that these “medicines” are supposed to be these amazingly dilute, amazingly potent substances produced by a sort of “like cures like” principle. It’s hooey, but people don’t even grasp the hooey. “Homeopathic” just sort of means “natural” in a fuzzy way, and there are plenty of marketers willing to slap the word on a label if it helps to move some product.
So as I say, I’m surprised that the gcMAF people were conscientious enough to actually be working with plasma (although perhaps not conscientious enough to be working with plasma that was fit to produce a human drug). They should have just filled the vials with distilled water. That’s how they’d do it over here. One production line, with the same water, but three different labels – one says gcMAF, for the people who want that, one says homeopathic gcMAF, for the ones who’ll spring for that variety instead, and finally one that says herbal gcMAF, because there will surely be people who will bite for that one, and you don’t want to miss getting their money, either, now do you?
It occurs to me, and not for the first time, that if I could arrange for some sort of consciencectomy operation, I could be a wealthy man.

29 comments on “Rogue Biologics Production (And Bonus Ignorance)”

  1. Dr Manhattan says:

    With the arrival of Jublia (efinaconozole) on the market, a topical treatment for nail fungus is now available, albeit at a ridiculous price point. I came across a web site (Toenail Fungus Rankings…no kidding) while looking at Jublia and this site said that the best product was something called “ZetaClear” was the best product. Ok, followed the link, as it said that ZetaClear had an oral and topical component, and I was curious (could this be terbinafine?).
    No, ZetaClear was the top recommendation of homeopathic doctors, and the oral part contains such items as tea tree oil, jojoba oil, lemongrass oil, almond oil etc. The topical has “Arsenicum Album, Mancinella, Nitricum acidum, sulfur ” and other wondrous ingredients. But hey, it’s natural! (Nitricum acidum wouldn’t be nitric acid in Latin, would it?)

  2. Derek Lowe says:

    Looks like “nitricum acidum” is produced, if you’re a dedicated homeopath, from sulfuric acid and sodium nitrate. Then of course you dilute it down to one part in about a million Avogadro’s numbers, so no worries! Feel free to pour it all over your most sensitive parts, or try it as a mixer with your favorite single-malt Scotch.

  3. dearieme says:

    “It occurs to me, and not for the first time, that if I could arrange for some sort of consciencectomy operation, I could be a wealthy man.” Or a lawyer.

  4. exGlaxoid says:

    This post goes well with the one about expensive placebos being more effective. I have seen many people who were cured within minutes of taking a drug that should take days to work. So if people truly believe that an expensive homeopathic medicine works, there is a good chance that it might at least make them feel better or even cure some psychological diseases, since many of those are of the mind anyway. I don’t think that will hold as true for cancer, bacterial infections (although even many of those will go away in due time if untreated, due to the immune system), or other serious illnesses.
    The key is shopping around for the best priced homeopathic treatments. Maybe the insurance companies need to negotiate with pharmacists to create a whole line of them which are GMP, dispensed only by pharmacies, reasonably priced, and safe. That might get rid of some of the overuse of antibiotics, anti-depressents, overused narcotics, and other overprescibed drugs that might not be any better than a placebo. While I am all for pharmaceuticals where needed, I do see a lot of overuse of some of them.

  5. I am equally mystified as to why anyone bothers with real rhino horn, or real tiger testicles, or whatever. And yet, they do. People actually go to an immense amount of trouble to go kill an actual rhinoceros, cut off it’s horn, and so on.
    I’m sure there’s a great deal of fake horn on sale in the right markets as well, but why on earth is there any of the real stuff at all?

  6. anonymous says:

    I feel horrible mocking somebody who tried to commit suicide, but I remember reading in the paper ten or twenty years ago about a person who tried to commit suicide by drinking an entire vial of a homeopathic medicine.

  7. entropyGain says:

    And the herbal remedies aren’t even what they say they are. Oddly ironic.
    http://www.bloomberg.com/news/articles/2015-02-03/gnc-wal-mart-found-by-new-york-to-sell-fake-herbal-supplements

  8. opsomath says:

    This stuff is one of the alt-med items-of-the-moment.
    http://www.betterhealthguy.com/gcmaf
    When I got my first academic job, a family acquaintance messaged me out of the blue asking if (esssentially) I could produce it under the table in my lab. I declined.

  9. UndergradMinion says:

    Because you mentioned going through trouble because of actually beliving: Recently in Austria a guy named Vasyl Novytskyi was arrested for selling the (not approved) “drug” Ukrain. It is supposed to be some kind of semi-synthetic Chelidonium ingredient (although the structure is debated) and it heals cancer. In general. No distinction which kind.
    This guy claimed that he collected TONS of this plant in a public park over the years all by himself, and somehow managed to produce tens of thousands of ampules of that final stuff. Again, all by himself… And because he sold it at less than what it cost him in production (because he is a philantropist, also) he sold a dozen Faberge eggs out of his heritage. To the british Queen, among others. At least he told that to the judge.
    They eventually arrested him for fraud because after the police confiscated his stockpile (presumably 200,000 ampules, if you can believe it) he rubbed off the labels of some older ampules and relabeled them with extended expiration date. Because it’s an alkaloid salt. Those don’t expire, or do they?
    I can’t judge if Ukrain works or not, although the whole story smells awfully of snake oil. I also don’t think that the arrest or any kind of sentence to come will stop anyone. But reading all those stories and explanations in the newspaper was really hilarious…

  10. StartupPharma says:

    I always enjoy the “like cures like” type remedies.
    If you break a bone, you can easily heal that by eating bone. Or if you’d like to get smarter, try eating brains.

  11. metaphysician says:

    #10-
    I can understand the appeal of “like cures like”. Sympathetic magic may not actually work, but at least its logically coherent. What always confuses me is the “homeopathic potency” bit. In what way does ‘dilute it to make it stronger’ even begin to make sense?

  12. Secondaire says:

    #6 – did you hear the one about the homeopath who forgot to take his medicine and died of an overdose?

  13. Scarodactyl says:

    @11: iirc it was inspired by quinine. A low dose helps with malaria, but a large dose causes nasty, somewhat malaria-like symptoms.

  14. Rob Usiskin says:

    On the subject of snake oil in general:
    In situations where scientific understanding can eliminate the placebo effect but can’t yet provide an effective replacement, I wonder if the most practical option for most people is actually to ignore the science in order to get the placebo effect from the snake oil.

  15. tangent says:

    Huh, in that news story about fake herbal ‘remedies’, it says they looked for DNA from the source plant. Does that make sense to even expect to find?
    I’d think that a production process could easily start with, say, a steam distillation off of the plant material, which is pretty good at leaving behind macromolecules. Any fractionation step will tend to cleanse the active drug of crud like stray DNA. And don’t you need to do some degree of fractionation in order to assay to standardize the dosage of the product? Some manufacturer might do a real job here, instead of just crushing up some plant matter with catnip filler, right?
    Not that I’m defending the general value of this snake oil, but I question whether this criticism is good science either.

  16. EdM says:

    Slightly off topic, but ” the ‘walking suggestible'” is a highly appropriate description: http://www.newsbiscuit.com/2010/04/21/new-age-terrorists-develop-homeopathic-bomb/

  17. Frank says:

    @15 I think most herbal remedies are supposed to be made from the herb as a whole rather than a specific active substance in it.
    If someone had isolated which compound in the plant was active, they must have have done tests and amongst other things found out that something in it did actually work. Then if you’re extracting and purifying it you’d have to stop calling it st john’s wort or echinacea and start describing it as the actual substance. And at some point you’d stop having a herbal supplement and end up with a drug that happens to come from a plant.

  18. Anon says:

    Derek, consciencectomy is available – it’s called a law degree

  19. db says:

    What a perfectly…organic…post.

  20. okemist says:

    hey the other day my daughter asked me to go to the drug store; I thought oh great I have to get something embarrassing like tampons. No, “daddy would would you pick me up a package of henna and placenta oil, please.” for split ends??? what the heck.
    Another hemeopathetic for lice…natrium cloridium, $10.00 for 50 grams.

  21. Urboe says:

    Not that it has any “snake oil” profit potential, but I might have stumbled onto a low-cost remedy for at least one kind of toe fungus. When I retired this past year I resolved to much increase my daily walk, and average about 5 miles a day. Over the past nine months, the fungus under my right big toenail has cleared up. I attribute this mostly to better blood circulation, admittedly an unscientific conclusion. But I can’t bottle and sell that, unfortunately.

  22. Dr Manhattan says:

    ” …When I retired this past year I resolved to much increase my daily walk, and average about 5 miles a day. Over the past nine months, the fungus under my right big toenail has cleared up.”
    Maybe you outran it?

  23. Mike says:

    Not quite snake oil, but this reminded me of one time I walked through Whole Foods to find “Organic Water”, which of course was more expensive than the other (inorganic?) water. How does one even make “Organic Water”? I personally find the idea of large amounts of organic material in my water a bit unnerving…

  24. AndrewD says:

    Mike@24
    Organic water is called Beer or coffee

  25. dave w says:

    I once saw a product intended as a “mud pack” to improve one’s skin – now some folks may be into that as far as it goes, but on the jar it said “organic bentonite” – now there is no way in any sense of the word that bentonite can be “organic” – it’s not derived from living matter, doesn’t contain any carbon compounds (except maybe carbonate?) and isn’t even an agricultural product in the first place. (Maybe that’s the trick – they can say, perfectly honestly, that “No Pesticides or Fertilizers” were used in its production!)
    Aside from that, if you -want- bentonite, a 50 lb. sack from a well-drilling supply place is probably about the same price as the quart-jar sized package of cosmetic product at issue here…

  26. Mike says:

    @14: more to the point, why hasnt someone worked out a cognitive/behavioral therapy to replicate placebo effects in general? Dopaminergic pathways. How complicated can they be? (Famous last words)

    1. Mfernflower says:

      Last time we messed with the dopaminergic pathway look what happened…. *Stares at the structure of ropinirole*

  27. Mfernflower says:

    Speaking of rouge biologics production – I have been following “Prevagen” – Supposedly recombinant Jellyfish aequorin without the cofactor (Something like PDB: 1EJ3) that is then freeze dried and put into capsules and sold for insane amounts of money as a nootropic. Needless to say the protein does not survive treatment with pepsin and is ineffective orally. There is a lawsuit in the works to get this junk off the market – https://www.truthinadvertising.org/wp-content/uploads/2015/02/Prevagen-class-action-lawsuit.pdf – But it’s very new – I guess the quacks decided that with the fall in prices of custom RNA, DNA and protein synthesis that they could move from small molecule natural products to proteins!!!! Now only if there cures really worked!

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