civil disobedience and diybio

[Reason]

http://www.fightaging.org/archives/2013/05/civil-disobedience-and-diybio.php

From a point of view of materials and time it is not costly to set up a home
laboratory for the purposes of synthesizing chemical compounds or even
perform simple procedures in biotechnology - raising bacteria, assaying
genes in lower animals, and so on. It is, however, illegal to just forge
ahead and do this in most US states or in much of Europe due to the many
prosaic, stupid laws that encrust the body politic. Such laws hang around
for long after they stop serving whichever special interest wrote them and
bribed politicians to pass them. Then there are the cases of mass hysteria
that become written into law and continue onward for decades no matter how
much harm they cause, such as the drug war.

It is in fact the drug war, and not the normal background level
protectionism of licenses and zoning, that turns DIYbio, amateur chemistry
and other similar citizen science activities into an expensive and risky
endeavor. It should be cheap, but the cost is now all in the risk. The state
has shown great willingness to smash first and ask questions later, if at
all, and this leads to things like reagent providers only selling to
registered labs, requirements to register all glassware, and raids conducted
on people who followed all the rules - because the left hand doesn't care
what the right hand said, and local police departments make out like bandits
from confiscation and auction of assets belonging to those merely accused of
breaking laws. Where there are incentives, there will be those who follow
the incentives, and the incentives today are very much aligned with less
citizen science and more police accusation.

The present state of medical regulation is every bit as bad as the drug war,
and indeed very much influenced by it when it comes to thing like
painkillers. The massive body of law concerning medicine and life science
research accomplishes numerous iniquities beyond ensuring that people suffer
more pain at times when drugs could prevent that suffering: it slows
development; it makes therapies much more expensive; it eliminates whole
regions of development by making it too costly to attempt; it prohibits some
classes of therapy by fiat, such as those that aim to treat degenerative
aging; it makes it illegal for a dying person to make an educated decision
about trying an experimental therapy. And so forth.

At some point the massive wall of laws, all of the forbiddances telling
people that they cannot try to make their lives better, will run headlong
into the fact that it is becoming ever cheaper to synthesize drugs and the
basis for therapies in a home laboratory. All it takes is knowledge and the
willingness to undertake civil disobedience: to disregard a law because it
is evil and unjust. It has to be said that near every law that touches on
medicine in this day and age is evil and unjust, and the costs they impose
in their aggregate cause great pain, suffering, and death. What might have
been accomplished without the ball and chain of regulation is invisible,
however, and therefore easily waved away by those who claim that regulation
is necessary. Everyone takes the present state of affairs as the way things
are and looks little past it.

Unlike recreational drugs, it is clear that the costs and the benefits for
manufacturing your own medicine are not yet at the point of spurring people
to action at the level of small chemistry or biotech laboratories. The
knowledge is still too specialized, the complexity of the work too great,
and the benefits too narrow. This will change, however, and think it will
largely change on the benefit side of the equation. For example, consider
mitochondrially targeted antioxidants like SS-31 and SkQ compounds:
synthesizing them is an exercise in organic chemistry that is many steps in
sophistication above the bucket chemistry of a recreational drug laboratory,
but I have to imagine that there will be a market for these things once the
public starts to appreciate that they seem to have significant effects on
aging tissue. SS-31 produces endurance benefits in older mice when tested,
and that's probably a draw if it does the same for people. The athletics
community certainly includes an underground of experimental biochemistry,
one of the consequences of all the money floating around there.

Targeted antioxidants shown to reverse some aspects of aging and extend life
in mice are a trivial exercise in comparison to what is coming down the
line, however. It won't be too many years from now before researchers can
describe exactly how to repair and replace damaged mitochondria, construct
infused enzyme solutions that destroy specific metabolic waste products that
contribute to aging, and so forth. The future of medicine to treat aging and
extend life will consist of a whole range of precisely designed proteins
like the waste-product-chewing enzymes that can be manufactured in an
appropriately equipped biotech lab. The cost of materials will continue to
fall, the knowledge needed to perform the work will continue to disseminate,
and when the upside of civil disobedience is rejuvenation and more years of
healthy life then there will be a whole lot more civil disobedience.

In actual fact, think that the scenario of scofflaw medical manufacture will
happen along the way, long before SENS-like rejuvenation biotechnology is at
a point where portions of it could - in theory - be performed in a
sufficiently well equipped home laboratory. Something better than SS-31 will
emerge, or at least something better equipped to catch the public
imagination, and grey and black markets will bloom. I'm looking forward to
it: the present system of medical regulation is ugly, repressive, and costs
lives: the sooner it collapses in the face of ubiquitous disregard the
better.

Reason

[Bryan Bishop]

On Mon, May 27, 2013 at 5:45 PM, Reason <rea...@fightaging.org> wrote:

Unlike recreational drugs, it is clear that the costs and the benefits for
manufacturing your own medicine are not yet at the point of spurring people
to action at the level of small chemistry or biotech laboratories. The
knowledge is still too specialized, the complexity of the work too great,
and the benefits too narrow. This will change, however, and think it will
largely change on the benefit side of the equation. For example, consider

I am not so sure it will change. Individuals with rare blood diseases spend a fortune to get their medication, and yet I haven't heard of them popping their head around these parts (ever). By comparison, replicating an antibody production setup is pretty easy compared to the other projects that are sometimes discussed. So how expensive does it have to be before people wonder if they can just solve their own problems without spending $10,000/mo on a drug?

Is it supposed to happen at $20,000/mo for a drug? Because those already exist too, and they aren't here either... even though it would be relatively simple (and much cheaper) to snatch up some cheapo postdocs or diybio enthusiasts to implement those projects.

- Bryan
http://heybryan.org/
1 512 203 0507

[Alex]

I have seen this issue with a lot of things. It's hard to get a hold of good stump remover because KNO3 can be used in explosives (It is also useful for simple harmless chem experiments like making smoke bombs).  Can't get a hold of syringes with needles easily because druggies will use them. The list goes on. The worst part is, those with nefarious plans will still find a way while we with legitimate interests are inconvenienced and harassed. It's sad and doesn't seem like something that will ever change because there are people who see us as dangerous wackos because they don't understand what we're doing.

Alex

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[Nathan McCorkle]

On Mon, May 27, 2013 at 3:57 PM, Bryan Bishop <kan...@gmail.com> wrote:
> I am not so sure it will change. Individuals with rare blood diseases spend
> a fortune to get their medication, and yet I haven't heard of them popping
> their head around these parts (ever). By comparison, replicating an antibody
> production setup is pretty easy compared to the other projects that are
> sometimes discussed. So how expensive does it have to be before people
> wonder if they can just solve their own problems without spending $10,000/mo
> on a drug?
>
> Is it supposed to happen at $20,000/mo for a drug? Because those already
> exist too, and they aren't here either... even though it would be relatively
> simple (and much cheaper) to snatch up some cheapo postdocs or diybio
> enthusiasts to implement those projects.
>

From what I've been hearing, it's all about liability in the medical
industry. Doing medicine on the grey/black market will add cost simply
because it's illegal and that increases the risk for the operator.
Licensed/Insured doctors mess up and they get sued, when some
underground treatment screws up, how do you sue?

[Mega]

I guess we wouldn't be doing it, if it wasn't worth it.
I'm just doing what I'm loving, and I believe everyone (maybe with an official diy bio licence to show he knows what he does) should be allowed to do what he loves -  if he (and science) is sure that it won't harm the environment nor other people.


That doesn't mean I endorese civil disobediance, infact there are other ways to do your experiments. In a university lab, or a private/public S1-certified lab. Doing it at home would be too unsafe for me, because there probably are hard punishments.


As for your question, just found this... http://en.wikipedia.org/wiki/Right_of_revolution (In German it's called law of resistance) and the phrase of Berthold Brecht: "where rights become injustice, resistance is moral duty"




>  $10,000/mo on a drug ?

Wow! with that amount of money it would surely be possible to produce one's own medicine. However, then you're not guaranteed that it will work as good.

[Cathal Garvey]

Not a direct comparison though; drugs that cost XX,000 per month are
paid for by medical insurance, or not at all. So the individual
receiving the overpriced treatment is paying a lot of money, but
probably nowhere near enough to pay postdocs to make their own drugs
more cheaply.

The drugs wouldn't even *be* that expensive if it weren't for the
expectation that patients all have insurance, and privatised insurance
that can't legislate for fair pricing, besides. There is talk over
here, for example, that we should be forcing drug companies who take
advantage of our tax haven to provide drugs to Ireland at a fair price;
at the moment, they charge us *extra*, and it's dragging down our
healthcare system.

Will there be basement biotech labs providing stuff people want/need
at a price they can afford? Certainly; there are basement organic
chemistry labs all over the world providing people with fairly pure (if
still frequently dangerous) recreational drugs. The question is what
those biotech labs will provide that the market demands.

I'm not convinced it'll be anti-ageing drugs for a long time yet,
because for now most people who worry about ageing are simply unaware
of the technology, and have no trigger to google around for anti-ageing
treatments as it is seen as inevitable.

By contrast, patients of cancers and other progressive diseases
increasingly join patient peer groups and forums where they discuss
speculative treatments, providing a way to inform one another of
options that may be illegal or (more likely) unaffordable in their
area. They're the likely candidates for early dark-lab therapies, if
you ask me.

[matt harbowy]

In poking around to support my response to this, I came across an excellent example of why this is not just a political or regulatory problem.

 

In my head, I started to go through a "use case analysis" of a hypothetical research project. I wanted to come up with something practical, that might even be a project someone here is willing to take on. So I chose diabetes as the problem, and settled on galegine, a natural anti-diabetic found in galega officianalis. or French lilac. http://en.wikipedia.org/wiki/Galega_officinalis. Not surprisingly, after a little searching on publicly accessible journals, I found a link to "Furman and Coxon et al"- http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2438274/ and, according to the article, pure galegine is hard to get but is "easily synthesized" from "benzyl amine" and 2-methylpseudourea sulphate, both available from Sigma.

 

But wait- I thought galegine was also known as N-dimethylallyl guanidine: I woundered how they could have gotten an allyl from a benzene, which if you have synthetic chemistry experience is a huge red flag. So I managed to find a non-free publication, "Coxon and Furman et al"- http://www.ncbi.nlm.nih.gov/pubmed/19422230 which correctly shows the rather complicated synthesis of galegine. I quote:

1-(3-Methylbut-2-enyl)guanidine Hemisulfate 1 (Galegine) and General Procedure for Synthesis of Guanidine Hemisulfates. 

 

 

A mixture of 4-bromo-2-methyl-2-butene (19.4 g, 1.0 equiv, 130 mmol) and potassium phthalimide (29.8 g, 1.2 equiv, 161 mmol) were suspended in DMF (200 mL) and stirred at 120 C for 1 h before heating to 160 C and stirring for a further 18 h. The mixture was poured over ice and washed with dichloroethane (5 × 50 mL), and the organic phases were separated and combined before washing with sodium hydroxide solution (0.1 N) (2 × 100 mL) and water (2 × 50 mL). The organic extracts were separated, dried over anhydrous magnesium sulfate, filtered, and concentrated to leave a crude solid that was crystallized from cold ethanol to give the intermediate 2-(3-methylbut-2-enyl)isoindoline-1,3-dione (25.6 g, 93%) as a white solid; mp 100-101C

 

A mixture of 2-(3-methylbut-2-enyl)isoindoline-1,3-dione (10 g, 1.0 equiv, 46.6 mmol), ethanol (100 mL), and hydrazine hydrate (85%) (2.9 mL, 1.2 equiv, 51.1 mmol) were stirred under reflux for 1 h, cooled, hydrochloric acid (1M) (5.2 mL, 1.2 equiv, 51.1 mmol) added, and then refluxed for a further 1 h. The mixture was allowed to cool, filtered, and the residue washed with cold water (100 mL) before reducing the filtrate under vacuum to give the intermediate 3-methylbut-2-en-1-amine hydrochloride (4.4 g, 78%) as a white solid; mp 95-97C

 

2-Methylthiopseudourea sulfate (6.95 g, 1.0 equiv, 150 mmol) and 3-methylbut-2-en-1-amine (9.1 g, 2.0 equiv, 100 mmol) were dissolved in water (100 mL) and ethanol (100 mL). The mixture was stirred at reflux for 18 h, connected to a series of bleach traps, before cooling and reducing under vacuum to give a white crude solid. The compound was suspended in water (30 mL) and heated until it barely dissolved before allowing to slowly cool upon which a white solid began to form. After allowing the formation of the solid to continue overnight, it was collected by filtration and dried in the oven to give the title compound (5.4 g, 62%) as a white solid; mp 216-218C 

 

 

It turns out that you get a related compound, N-benzylguanidine. The class of all the compounds has been patented http://www.google.com/patents/US5373008 but this patent is now expired and the entire class of compounds should be free of patent, including the leading indication and first line therapy, metformin http://en.wikipedia.org/wiki/Metformin.

 

So why do I mention this? Let's start off thinking about some of the research plans someone might take toward finding "open source" diabetes drugs. They might just be tempted to hack the minimal procedure from "F&Cetal" instead of following the correct procedure of "C&Fetal". The lingering doubt I have about this work is, what if the paper principally authored by Furman actually studied benzylguanidine instead of galegine? What is the differences of approach between Furman's lab and Coxon's lab that results in the difference in reported experimental procedure? Who edited and checked these papers? By simply following published research, it would be so easy to fool yourself when synthesizing drugs.

 

At least with synthetic chemistry, I can fall back on the methods of chemistry to give myself at least some confidence that what I think I have, I can be sure I have, because proton and carbon NMR and mass spec and melting point and FTIR, while they all have flaws, eventually suss out the truth.

 

Now move on to bioengineering: let's say you engineer a recombinant cell line to produce galegine. As with the chemical synthesis, actually recovering the free base is not easy, and when you add up all the possible side reactions that might make various contaminants, it could be really difficult to isolate the multigram quantities of any compound you would need to do a study n=1. You might just get a mixture. You might get poison. You don't know- and even if you are successful, the next person you give the drug to might die of lactic acidosis because you "happen" to have a gene that prevents that side effect. Who knows? Although we know metformin inhibits a particular enzyme(s?) involved in gluconeogenesis, we don't really know what giving somebody metformin does to the body, or why some people react so badly to it. As much as we don't know about metformin, we know even less about galegine, except that every animal reacts slightly differently to it.

 

So, even in a pure libertarian utopia, drug research is fraught with difficulties on where to start and tons of conflicting theories on what we know. That's not to say doing some basic investigation in a DIY lab couldn't do some of the groundbreaking early stage research that might gain us some critical insights into the why and how of diabetes. There are GREAT projects to be had. But DIY medicine is more than just bad politics: hacking ceases to be science when you stop following scientific best practices. N=1 experiments are interesting and all, but they're not science. The politics and regulation is, in large part, a way to shut down random people from poisoning each other, as happened all the time at the turn of the 20th century. For the chemical example, google "elixir sulfanilamide". For the biohack example, google "a horse named Jim", the ultimate in N=1 biohacked medicine and a case study on where biohacking could go very, very wrong.

 

Do you really want to get your medical care from "a horse named Jim?"

 

-matt

 

 

On Monday, May 27, 2013 3:45:05 PM UTC-7, Reason wrote:

http://www.fightaging.org/archives/2013/05/civil-disobedience-and-diybio.php

From a point of view of materials and time it is not costly to set up a home
laboratory for the purposes of synthesizing chemical compounds or even
perform simple procedures in biotechnology - raising bacteria, assaying
genes in lower animals, and so on. It is, however, illegal to just forge
ahead and do this in most US states or in much of Europe due to the many

prosaic, stupid laws that encrust the body politic....

[Nathan McCorkle]

I think synthetic organelles could help increase the specificity of
the chemistry. Synthetic organelles and a shuttling system.

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[Cathal Garvey (Android)]

Guys, *enzymes* increase specificity. Problems that are nigh intractable in organic chemistry can be trivial for enzymes that select naturally for desired isomers.

Sent from my Android phone with K-9 Mail. Please excuse my brevity.

[matt harbowy]

While you are technically correct, I am not talking about intractable problems in organic chemistry. Synthesis of tons of a compound is dead easy if you have a synthetic route. If you have to isolate 10g of (in the example, galegine) to do a study, you could be talking about kilos of lilac. You would need to find where in the plant it is made. And while you could isolate and clone the specific genes that produce the specific enzymes and put them into a model organism, you might still not get a very significant yield, and that's $$$ down the drain when you could have done it for $ with organic chemistry.

 

If you want to talk theoretical and hypothetical, fine, enzymes are obviously the way to go. But between enzymes -> ??? -> profit, you've got nothing to convince me that the DIY bio community has any handle on the ??? part. That's speaking as a natural products chemist who has used enzymes extensively for years, and as a DIY biohacker, not just an off-the-street enthusiast. Don't wave your hand and pretend it is all solvable with mol bio.

 

I'm not trying to be discouraging- I am trying to encourage people to be realistic, and talk in terms of what they want to accomplish. Once we know that, then we can work on removing the real barriers to making that happen. The legal boundaries are all solved once you form a (shell) corporation- there's not a single qualification you need other than the proper paperwork to do anything if you happen to be a corporation. Yes, individuals have trouble ordering drug precursors and nitric acid and the like, but how many corporations face the same barriers, except for the really hot items like iodine (!).

 

In all things, the right tool for the job is always going to win. DIY craftsmanship making furniture, metalwork, art cars, and the like have known this for years. You don't DIY a hammer by using the backside of a wrench, you use a hammer, you find someone with a hammer, you borrow a hammer. Not just any hammer, the right hammer.

 

The real barrier is that the tools for mol bio are way overpriced, are one offs that have little utility beyond a dedicated application. A PCR machine is a peltier with a little programming- why is it that the feedback I get on DIY solutions is that they're not so reliable? We need to infuse the DIY Bio community with a sense of craftsmanship, idea-to-finish bespoke quality. The idea of DIY, as I understand it, is that you replace money with time.

 

Reason sez:

It is in fact the drug war, and not the normal background level

protectionism of licenses and zoning, that turns DIYbio, amateur chemistry

and other similar citizen science activities into an expensive and risky

endeavor.

 This is simply not true for the most part. Yes, if you want to use crystalline iodine, or distill ethanol, and advertise the fact, you're going to attract unwanted attention, but you have just as much to be worried from criminal elements raiding your lab for supplies as getting shut down by the feds, and the more money you pour into your hobby, the more risk you incur in terms of theft. Now, you might argue, no drug war->no gangs. But the unwanted attention is by far the smallest part of the challenge- the biggest is getting the knowledge into people's hands to actually accomplish things, instead of talking. Unwanted attention could also mean curious teens who want to see what happens when you build a bomb. Unwanted attention could be hangers-on that have no money and no skills but want to be up in your grill all the time and wonder why a cure for cancer isn't free as in beer free.

 

I think a new model where everybody shares their toys and works toward making the tech very, very cheap will transform the playing field, and that's why I'm in the game. I think the "I could be successful if x and y law weren't keeping me down" attitude, and the rebellious, lawbreaking "nuh uh" in response, are two sides of the same coin. I'm not interested in that filthy money.

 

-matt

[Bryan Bishop]

On Wed, May 29, 2013 at 1:40 PM, matt harbowy <hberg...@gmail.com> wrote:

I'm not trying to be discouraging- I am trying to encourage people to be realistic, and talk in terms of what they want to accomplish. Once we know that, then we can work on removing the real barriers to making that happen.

Your approach was bizarre, though. You picked a topic where you weren't sure about success, instead of playing to your strengths. Given the entire range of easy solutions to problems that are current costing people a great deal, there are much easier projects to engage in (like I said before, even antibodies), especially if you are wiling to be underground/maybe-illegal-who-knows/anonymous/whatever.

[matt harbowy]

Bryan:

The OP was not discussing any project in specific, just saying that any project that involves chemical synthesis would be illegal to perform at home. I picked an example synthesis to show how a practical reaction which is fairly easy to do and is legal to do can have unintended consequences. I am certain of the outcome: but if you're not careful, the average DIY person reading and repeating published methods in reputable journals might be misled if they take what is written at face value. It requires two chemicals which can be obtained easily, and refluxing in a mix of ethanol and water. It's not the legality of any hypothetical non-dea-regulated synthesis that is the barrier to the home or DIY lab that's the problem, it's what to do next- if you try any follow on work based on what you made, that research would be worthless, whether illegal then to take as a drug or not. The regs exist not to prevent you from doing good work, but to prevent the haphazard use of dangerous materials. It's like a "beware of dog" sign. The dog may or may not be a killer, most likely not. But, you're warned that the relationship might turn sour quickly if you're not careful, and play nice.

In schools, organic chem lab is typically e.g. "make methyl salicylate" but once you've made it,you just throw it in the waste bin. This mode of teaching is absurd and wasteful, and probably why so many people treat chem techniques as a dark art practiced by evil people. Making things glow green is fun and a learning experience, but if all you learn is how to do that one trick, you're just a circus animal. The real fun begins when you put lots of steps together, and do something not in a recipe book.

Matt

[matt harbowy]

As for projects with antibodies, the classic problem in manufacture of antibodies is, did I create an antibody against the target, or some excipient co-present, or something else? Anyone can do it, but few people understand it. We need to put understanding in the hands of people, not "stuff". Just because some chemical says it is an antibody and it clouds up in the presence of the target, doesn't mean you understand why or how.

Matt

[Reason]

> -----Original Message-----
> From: diy...@googlegroups.com [mailto:diy...@googlegroups.com] On
> Behalf Of matt harbowy
>
> The OP was not discussing any project in specific, just saying that any
> project that involves chemical synthesis would be illegal to perform at
> home.

Can be illegal. I believe it is illegal to do the chemistry you described in
your longer post without appropriate licenses and red tape in much of the
US, though it's hard to quantify what the attendant risk actually is in any
given case, and what can be done to mitigate it. The scenarios I'm more
concerned with are those that fall under FDA purview and are therefore
definitely illegal.

The rest of your comments appear to be arguing the cost side of the
cost-benefit equation, in that you think it's high enough to be an issue for
any work of significance, particularly around knowledge transfer.

A concrete example of the procedure that I was thinking of would be this
sort of thing: the SENS Research Foundation establishes a bacterial enzyme
derived small molecule that breaks down A2E usefully (or some other
lipofuscin constituent) and shows it's effective and non-toxic in vivo in
mice and in vitro for human cells. The protocols are all laid out in the
relevant papers, with the usual amount of domain knowledge required. The
enzyme-derived molecules are something that could be created with the right
toolkit, but certainly not something that's ever going to see the other side
of the FDA for anything other than treatment of advanced AMD, despite
general utility for all older people.

With collaboration, you could reliably reduce something like this down to an
established procedure, something that can be taught, videos made, ebooks
written, meetup classes held, etc, etc. But it's certainly illegal - or
retroactively illegal as soon as it is noticed - to sell a compound that the
FDA will class as a drug, and quite possibly illegal to even manufacture it
in small amounts for the sake of curiosity. Publishing on the topic may or
may not be legally risky, but given that the FDA isn't all that restrained
it may get you attacked and greatly inconvenienced by agents of the state.
And so on, with the risk rising the greater the attention you gather to your
operations: anything that looks like medical manufacture, becomes popular,
and winds up in the news will result in some form of attack, even the FDA
has to first declare what you are doing illegal. This sort of threat matrix
puts a big damper on generating the grassroots ecosystem you need to
recreate research results effectively in a diybio environment.

> I picked an example synthesis to show how a practical reaction
> which is fairly easy to do and is legal to do can have unintended
> consequences. I am certain of the outcome: but if you're not careful,
> the average DIY person reading and repeating published methods in
> reputable journals might be misled if they take what is written at face
> value.

So where you argue for the hardness of the work as a barrier, I'd argue for
the personal risk attendant to the regulatory threat as something that makes
it hard to build the necessary structures to make the work accessible.

Reason

[matt harbowy]

The argument that you are not allowed to perform a synthesis without a license because you cannot sell what you synthesize is a straw man.

For example, in Texas, you cannot sell or manufacture for sale drugs without a license, just like you cannot sell food without a license. http://www.dshs.state.tx.us/fdlicense/links.shtm But you don't need a license to cook food for yourself and anyone else in your home, you just can't open a business and sell it. Likewise, you don't need a permit to buy most chemicals. It is not illegal to buy either bleach or ammonia, for example- you can do so at any corner store. It's not even illegal for you to mix them without a permit. It is however illegal to mix them in significant quantities and spew the fumes out into the air- it's called attempted murder and pollution of the environment with a deadly poison.

Matt