# Bootleg RX: Are there private pharmas worldwide that will manufacture a drug without government approval? **URL:** \ **Category:** Factual Questions\ **Created:** [February 2, 2023, 4:28pm UTC](https://boards.straightdope.com/t/bootleg-rx-are-there-private-pharmas-worldwide-that-will-manufacture-a-drug-without-government-approval/979214 "2023-02-02T16:28:43Z")\ **Posts on this page:** 13\ **Page:** 2
**Author:** ![KarlGauss](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/karlgauss/32/3713_2.png) [@KarlGauss](https://boards.straightdope.com/u/KarlGauss)\ **Post date:** [February 8, 2023, 6:15pm UTC](https://boards.straightdope.com/t/bootleg-rx-are-there-private-pharmas-worldwide-that-will-manufacture-a-drug-without-government-approval/979214/21 "2023-02-08T18:15:56Z")
> [@md-2000](#): > > There was the famous case of the people in California who were taking a bad batch of some drug and ended up with the symptoms of severe Parkinson’s. News reports said that the problem was, many illicit concoctions are doing by reaction and refining and if the refining is not done often enough and repeatedly (and correctly) you end up with similar but less friendly molecules in the mix. It was actually due to the presence of a neurotoxin (MPTP) that was produced during the attempt to synthesize a potent Demerol (meperidine)-like molecule. For anyone interested, [this link to the Lancet](https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(18)30072-3/fulltext) (not paywalled) shows the tragic effect of ingestion. One positive from this tragedy was that it made the creation of animal models of Parkinson’s Disease more feasible, i.e by injecting them with MPTP. ---
**Author:** ![Caribbean\_cruiser](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/caribbean_cruiser/32/9349_2.png) [@Caribbean\_cruiser](https://boards.straightdope.com/u/Caribbean_cruiser)\ **Post date:** [February 25, 2023, 3:28am UTC](https://boards.straightdope.com/t/bootleg-rx-are-there-private-pharmas-worldwide-that-will-manufacture-a-drug-without-government-approval/979214/22 "2023-02-25T03:28:00Z")
Thank you, one and all, for your insightful answers. ---
**Author:** ![kaylasdad99](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/kaylasdad99/32/3398_2.png) [@kaylasdad99](https://boards.straightdope.com/u/kaylasdad99)\ **Post date:** [March 12, 2023, 12:09pm UTC](https://boards.straightdope.com/t/bootleg-rx-are-there-private-pharmas-worldwide-that-will-manufacture-a-drug-without-government-approval/979214/23 "2023-03-12T12:09:30Z")
> [@Sage\_Rat](#): > > the problem where you have different sized jugs and you need to measure out a specific amount of water. If you want to make exactly 6 gallons and you have a 4 gallon bucket and a 2 gallon bucket then Bob’s your uncle; if you want to make exactly 6 gallons and you have a 3/7ths gallon bucket and a 19/11ths gallon bucket, then you might have a long journey ahead of you. Completely beside the point, but not that long a journey. Just fill the 3/7ths gallon bucket fourteen times and pour it into whatever container you’re collecting water in. You can leave the 19/11ths gallon bucket in the closet. ---
**Author:** ![pjd](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/pjd/32/3009_2.png) [@pjd](https://boards.straightdope.com/u/pjd)\ **Post date:** [March 12, 2023, 12:33pm UTC](https://boards.straightdope.com/t/bootleg-rx-are-there-private-pharmas-worldwide-that-will-manufacture-a-drug-without-government-approval/979214/24 "2023-03-12T12:33:29Z")
Nobody likes a smartass !! 😃 ---
**Author:** ![DrDeth](https://avatars.discourse-cdn.com/v4/letter/d/b487fb/32.png) [@DrDeth](https://boards.straightdope.com/u/DrDeth)\ **Post date:** [March 12, 2023, 6:29pm UTC](https://boards.straightdope.com/t/bootleg-rx-are-there-private-pharmas-worldwide-that-will-manufacture-a-drug-without-government-approval/979214/25 "2023-03-12T18:29:22Z")
There are many, many small indy drug companies. My Buddy is the CFO of one of them. It would be simple as pie- the “armchair biochemist” just provides the formula and the funding, and the small indy company will make the drug, which , after preliminary tests to make sure it isn’t insta death etc, can then “test” it on a number of willing participants. The devil is in the side effects… _death_ being a rather bad one. “Yay, my disease is cured!! But I am dead…”… “the operation was successful but the patient died”… There is no reason to make this “bootleg”. It would not be “illegal” just not “approved”, and there is no reason- and in fact the drug company would insist- to not go ahead and submit the drug to approval. Every drug company has dozens if not hundreds of drugs that are in the testing process that are not yet approved- but they are not illegal, just illegal to sell. Some of them work quite well, but the side effects are such that they can’t be approved. However there is no such thing as an “armchair biochemist” , you need a pretty good lab to come up with anything new. Note that most of the illegal drugs talked about here- the recreational pharmaceuticals, so to speak- were not _developed_ in a garage, even tho they now can be _made_ in one. ---
**Author:** ![Knighted\_Vorpal\_Sword](https://avatars.discourse-cdn.com/v4/letter/k/ac91a4/32.png) [@Knighted\_Vorpal\_Sword](https://boards.straightdope.com/u/Knighted_Vorpal_Sword)\ **Post date:** [March 12, 2023, 8:43pm UTC](https://boards.straightdope.com/t/bootleg-rx-are-there-private-pharmas-worldwide-that-will-manufacture-a-drug-without-government-approval/979214/26 "2023-03-12T20:43:23Z")
I’ll bet Heisenberg could do all this pretty well, and it would be a pretty blue color too. ---
**Author:** ![Sage\_Rat](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/sage_rat/32/399_2.png) [@Sage\_Rat](https://boards.straightdope.com/u/Sage_Rat)\ **Post date:** [March 12, 2023, 9:02pm UTC](https://boards.straightdope.com/t/bootleg-rx-are-there-private-pharmas-worldwide-that-will-manufacture-a-drug-without-government-approval/979214/27 "2023-03-12T21:02:30Z")
> [@kaylasdad99](#): > > Completely beside the point, but not that long a journey. Just fill the 3/7ths gallon bucket fourteen times and pour it into whatever container you’re collecting water in. A fourteen step process is seven times more complicated than a two step. It also took five weeks to find someone who could do the math. ---
**Author:** ![Treppenwitz](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/treppenwitz/32/3445_2.png) [@Treppenwitz](https://boards.straightdope.com/u/Treppenwitz)\ **Post date:** [March 13, 2023, 4:40pm UTC](https://boards.straightdope.com/t/bootleg-rx-are-there-private-pharmas-worldwide-that-will-manufacture-a-drug-without-government-approval/979214/28 "2023-03-13T16:40:22Z")
I guess this is tangentially related to the OP (as it addresses production of “regular” illicit drugs), but it might be interesting, just to give a feel for what’s out there. I was googling something - don’t remember what - and stumbled across the United Nations Office on Drugs and Crime World Drug Report 2022. Here are the Annexes to the report **BUT BE WARNED that clicking on an Annex will download the file to your computer. Site (not annexes) spoilered for double click.** [World Drug Report 2022\_Annex](https://www.unodc.org/unodc/en/data-and-analysis/wdr2022_annex.html) The period covered appears to be 2015 to 2020. Clicking on Annex 9.1 **Clandestine Laboratories Detected And Dismantled** will download an Excel file that you can play with. It gives numbers for labs ranging from “Kitchen laboratories” to “Industrial-scale laboratories”. The annex doesn’t name them, it just gives figures; but you can, for example, sum the column for “Industrial-scale laboratories” - which I did. An even 250. And those are only the ones detected and dismantled. Interesting, eh? j ETA - I realized that there is possibly/probably some double counting going on in that file. For example M134-M139 sums to 48; M156 = 48; both are listed under Australia. Possible double counting - so view with caution, I guess. ---
**Author:** ![Caribbean\_cruiser](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/caribbean_cruiser/32/9349_2.png) [@Caribbean\_cruiser](https://boards.straightdope.com/u/Caribbean_cruiser)\ **Post date:** [March 13, 2023, 6:40pm UTC](https://boards.straightdope.com/t/bootleg-rx-are-there-private-pharmas-worldwide-that-will-manufacture-a-drug-without-government-approval/979214/29 "2023-03-13T18:40:49Z")
Thank you, Treppenwitz, but surely the “Clandestine Laboratories Detected And Dismantled” heading in the linked report refers to labs that produce crystal meth, cocaine, heroin, ketamine, LSD, designer hybrids, and other illicit drugs. I cannot imagine hundreds of biochemists worldwide currently producing homebrew treatments for cancer or depression or such – or that there’s a strong market for them. I can see a black market for PEDs, but for serious medical conditions? It’s equally hard to imagine a handful of for-hire biochemists who operate in the dark alleys of medicine outthinking large teams of world-class medical researchers, in any endeavor. The sophistication just isn’t there. Perhaps you are suggesting teams of private, for-hire biochemists producing copycat meds of drugs currently awaiting FDA approval, yes. But their making cutting-edge medical breakthroughs? Hard to believe. ---
**Author:** ![Treppenwitz](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/treppenwitz/32/3445_2.png) [@Treppenwitz](https://boards.straightdope.com/u/Treppenwitz)\ **Post date:** [March 13, 2023, 7:09pm UTC](https://boards.straightdope.com/t/bootleg-rx-are-there-private-pharmas-worldwide-that-will-manufacture-a-drug-without-government-approval/979214/30 "2023-03-13T19:09:02Z")
As I said > [@Treppenwitz](#): > > I guess this is tangentially related to the OP (as it addresses production of “regular” illicit drugs) - I just find it interesting that there were hundreds of “industrial scale” factories that were able to operate clandestinely. You posed a question about clandestine manufacture. I’m not for a second suggesting that the factories enumerated here would be up for contract manufacturing an unofficial medicine (or whatever we might call it) but at least a few of these factories have some competencies. The manufactured drugs listed include steroids, alprozalam (an anxiolytic in legitimate use), ketamine, psilocybin, fentanyl, “New psychoactive substances” - as well as the sorts of things you would expect to see on the list. You were asking about a grey area in drug manufacturing; I thought you might be interested to hear about what grey areas have been shown to exist. j ETA - “grey area” isn’t the right word - but you know what I mean. ---
**Author:** ![scudsucker](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/scudsucker/32/14101_2.png) [@scudsucker](https://boards.straightdope.com/u/scudsucker)\ **Post date:** [March 13, 2023, 7:28pm UTC](https://boards.straightdope.com/t/bootleg-rx-are-there-private-pharmas-worldwide-that-will-manufacture-a-drug-without-government-approval/979214/31 "2023-03-13T19:28:42Z")
3,4-methylenedioxymethamphetamine, and lysergic acid diethylamide (MMDA, aka “ecstacy”, and LSD) respectively are not trivial to produce, and the less known members of the family group MDMA comes from (MDA, MBDB, 2ci, 2ct, 2cb etc) are not either. The fact that people are even bothering to create obscure psychoactive chemicals like 2ct shows the “hidden hand of the market” \* Yet illicit chemists do. The profit margin drives the industry. If I was diabetic and my local dealer had insulin cheaper than the pharmacy I would be on it in a flash. \* As far as I know, all of these chemicals are illegal in most countries. Don’t try this at home. ---
**Author:** ![Caribbean\_cruiser](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/caribbean_cruiser/32/9349_2.png) [@Caribbean\_cruiser](https://boards.straightdope.com/u/Caribbean_cruiser)\ **Post date:** [March 17, 2023, 3:34am UTC](https://boards.straightdope.com/t/bootleg-rx-are-there-private-pharmas-worldwide-that-will-manufacture-a-drug-without-government-approval/979214/32 "2023-03-17T03:34:20Z")
Thank you for that information, Treppenwitz. Eye opening. ---
**Author:** ![md-2000](https://avatars.discourse-cdn.com/v4/letter/m/9d8465/32.png) [@md-2000](https://boards.straightdope.com/u/md-2000)\ **Post date:** [March 17, 2023, 12:39pm UTC](https://boards.straightdope.com/t/bootleg-rx-are-there-private-pharmas-worldwide-that-will-manufacture-a-drug-without-government-approval/979214/33 "2023-03-17T12:39:07Z")
I would imagine a more interesting approach than illegal drugs - I read an article about Ozempic for weight loss that mentioned it was $13,000/year for treatment. I don’t know how the drug is made, but I’m guessing a lot of that cost is not related to ongoing manufacturing costs. I would think a “bootleg” lab could make a generic knock-off much cheaper if they were not worried about licenses or royalties. It appears to be much in demand, especially in LA. As one comedian said, “who knew so much of Hollywood has diabetes?” [Previous page](https://boards.straightdope.com/t/bootleg-rx-are-there-private-pharmas-worldwide-that-will-manufacture-a-drug-without-government-approval/979214.md?page=1)