Putting the life back in science fiction


Big pharma and printable drugs
August 3, 2012, 4:31 am
Filed under: Speculation, Uncategorized | Tags: , ,

This post was inspired by a couple of Charlie Stross’ recent postings, about expectations for 2030, and the future of computing. Also, my Mom’s friend subscribes Chemical and Engineering News, passes them to my Mom, who passes them to me about six months later. I’ve gotten a bit of education about Big Pharma through that, and through friends in the industry. I’m not a pharmacist, but I do like wild speculation, and that’s what I’m writing here.

As of last year (I’m only now seeing 2012 C&EM issues), Big Pharma was having troubles. It costs somewhat north of a billion dollars to bring a new drug to market in the US, mostly due to the costs of testing to meet regulatory requirements. As I understand it, most of that cost (I heard 75%) is salaries. Partly as a result, there’s a phenomenon known as the “Valley of Death” in the process of creating new drugs. That valley lies between discovery of an interesting new potential drug, and when that chemical enters human testing. Big Pharma has been increasingly scrapping their discovery divisions, and focusing on human testing (which is done in places like India, less in the US, to keep costs down. This is a global industry), and far less than 1% of interesting chemicals make it across the Valley of Death to be tested on people. Drug discovery is currently being paid for by government-funded research, and non-profit groups like the Gates Foundation. Weird but true–capitalism seems to require charity to make new drugs.

Now, let’s look at a disruptive technology, the chemputer that prints out chemicals, including potentially drugs. If this gizmo works out (and there’s no reason to think it can’t), then it bids to do to Big Pharma what the internet did to the music, film, and publishing industries. There’s no point in blowing a billion dollars on drug development, if any hacker can print out the drug on demand, using reverse-engineered recipes from another country.

What will Big Pharma do? In the short run, obviously they’re going to send out the lawyers to defend their patents, and I suspect those legal battles will be finally settling down around 2030. I shouldn’t be too flip about this, because there’s a terrible human cost to dismantling the industry: most of that billion plus dollars goes to highly trained drug industry professionals and the people who watch over them, and that’s a lot of people to put out of work. Of course they’re going to fight, just like the American insurance industry fights against government health care. Still, I think the industry is ultimately going to lose, and it will have to adapt or die.

Fortunately, there’s an alternative. The brighter companies will get into the printer business.

Here’s the way it might work. Absent some interesting catastrophe like Peak Oil or a random apocalypse, middle and upper-class people in 2030 will probably have their genomes read as a normal part of their health regimen. They’ll probably even have their epigenomes read, and they might even get a periodic microbiome workup done. They will also likely have all sorts of cute portable monitors for all sorts of conditions, just the way diabetics have their meters now, and they will have all sorts of information on how drugs interact with their particular -omes.

Big Pharma 2.0 could get into this market. They can, for example, offer new parents a free genome and epigenome workup on their new kids, so long as they get to keep a copy of the data for research purposes. Companies may similarly offer free monitoring of a person’s health, so long as they get to keep copies of all the data they get while performing those diagnoses. They can sell the family a printer, and offer to print out the drugs they need (so long as the company can legally produce them), or tell the family when to go to a doctor for more sophisticated care.

What Big Pharma 2.0 is trying to do here is to get people caught up in their technical ecosystem, much as Apple does with their computers. Big Pharma 1.0 already specializes in running human trials, and this is, effectively, a way to recruit human guinea pigs. It doesn’t even particularly matter if the clients of such companies do things like abuse drugs or experiment on themselves. It’s more data for the companies at the other end of the monitor, after all.

As for discovery of new drugs, I suspect the discovery process will come to resemble Amazon’s commercialization of the slush pile even more than it already does. Right now, most drug discovery is done using government funded research, and there’s no reason to think that won’t continue. Certainly, some private individuals will get into the drug discovery game, and their products might even get popular enough that Big Pharma 2.0 picks up their chemicals, and starts offering the experimental drugs through their chemputers.

Wherever they get their experimental drugs, Big Pharma 2.0 can certainly let their clients volunteer to test out new drugs, especially if the clients get paid for it. Since the companies have a lifetime’s medical history for their clients, it’s more defensible medically and statistically to use these well-known volunteers than to recruit random people out of a Mumbai slum for testing. Big Pharma will simply be trading randomly recruited test subjects and an unknown market, for a captive audience of volunteers and patients. They will trade in data and care, not drugs.

I’m not sure what role doctors will play in 2030, assuming people start depending on home diagnostic units and chemical printers to dose themselves. Doctors will certainly continue to treat injuries, deliver babies, treat novel infections, and handle more complex problems. Still, being able to print drugs is going to wildly affect the whole huge medical system, in both good and bad ways. I can imagine people getting harmed by cheaply printed drugs and other such problems, but I can also see people getting better and cheaper care.

What do you think?

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5 Comments so far
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Drug discovery for simple compounds (Lipinsky’s “rule of five” for easy, oral route and gut absoption) is done by screening vast compound libraries against simple tests to indicate potential efficacy. It is highly likely that at this point the chemical approach to therapy has pretty much run its course. Certainly there will be new uses for old drugs, and new diseases (tropical?) that could be treated with compounds, but most diseases that are tractable to drug therapy are probably already known.

Printing drugs is going to be interesting, but don’t forget you need to remove side products and, it is is a pill, also add a well formulated binder. This is not trivial.

OTOH, New Scientist just this week has an article on the “chemical internet” that was about a new database of chemical reactions that could be mined for new, simpler routes of production. I see illicit drug use as being more likely to lead the way in chemical printing. But Charlie Stross has already covered that in his last book (Halting State).

Comment by Alex Tolley

In the short run, Alex, I agree that recreational pharmacology will probably lead the new tech boom, just as pornography led in internet creativity.

In the slightly longer run, I’m not so sure that all drugs have been discovered. That billion dollar price tag means that it’s currently infeasible to test new antibiotics, for example, and we definitely need more of those. Similarly, diseases of the poor and uncommon diseases aren’t being treated much either. The problem in both cases is that there’s not enough money to be made from these drugs to justify the cost of getting them to market. That’s one reason why we’ve been deluged with lifestyle drugs that target chronic diseases.

Printing drugs may change that dynamic somewhat, because it might bring down the cost of getting human subjects. Obviously, this means there is going to be more poorly supervised human experimentation with drugs, but I won’t be surprised if that happens anyway. If your loved one is dying from a bacterial infection and you have access to a chemical internet, you’re probably going to try to synthesize something regardless. Why not?

Comment by heteromeles

Most of the development cost is in PIII clinical trials. The costs are due to:
1. High costs of testing, primarily in the US, bust also in EU countries. Moving to the developing world would reduce costs, albeit with the results being not quite so applicable to the US/EU genomes.
2. Much larger trials as the differences between new drug vs older treatment (not placebo) narrows. The statistics demand this.

Clearly a new antibiotic that works for drug resistant bugs will need a much smaller patient sample. Once tropical diseases enter the warming temperate world I think BigPharma will find the money to test as the ROI will hugely increase.

While I think you have a point about being able to print an experimental drug to save someone, the data will probably be useless for a trial and the result might be a crap shoot. How is the user going to determine dosage?

Here’s a thought – will printing result in more parenteral administration? This avoids the oral formulation issue, which is probably going to be moot with many new anti-cancer drugs anyway (although “printing” of large molecules might be a problem). Personally, experimentation with test drugs that will be hyped and full of disinformation sounds like a nightmare to me. But tastes and desperation will vary.

Comment by Alex Tolley

I think that this is way too technologically-minded. It’s already pretty easy to get cheap drugs shipped from other countries, as long as they don’t have recreational potential — but good luck telling whether they were properly manufactured or labelled. The same goes for getting your medications from the guy in the next town who runs a grow op next to his chemputer.

Home chemputers for prescription drugs with official endorsement by the FDA, professional associations, and large pharma companies? Remember that the USA still keeps Plan B behind the counter, under pharmacist control, for no better reason than “the medically sound recommendation is politically controversial.” We’re not going to see pharamcological Universal Constructors in every neighborhood 18 years from now. It’s akin to the crypto-anarchist fantasies of the 1990s that once everyone has PGP, private anonymous exchange will render banks obsolete and money untraceable, so the state will politely disappear from lack of funding.

But if it DID happen… note that methamphetamine is only about as chemically complex as ibuprofen. Barbital is simpler than omeprazole. Mescaline is simpler than fexofenadine. Pethidine is simpler than loperamide. GHB is simpler than Vitamin C. Every class of legally restricted CNS-active drugs has members that are simpler to synthesize than common antihistamines or blood pressure meds. If chemputers are everywhere, turning your chemputer into a polydrug party machine is probably about as difficult as jailbreaking your phone.

Comment by Matt

You may well be right, Matt. Still, there’s this yawning gap between the drugs Big Pharma is developing and the ones many people need, and it’s only going to get bigger. I figured that there might be a way to get small-scale drug production hooked up with data-mining in a way that would benefit everyone concerned.

Of course, if you are right, then chemputers will be much more tightly monitored than digital scales are today in labs. For those who don’t know, drug dealers often steal digital scales, so that they can quickly measure out their doses. Having the means of production would be an even bigger draw.

Comment by Heteromeles




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