All opinions are my own and do not necessarily reflect those of Novo Nordisk
The Long Tail is Everywhere There’s Information
Several years ago I happened upon Chris Anderson’s great book The Long Tail. He wrote about the amazing changes that were taking place in commerce because of the digitization and electronic dissemination of information. Mix incredibly cheap (essentially free) data storage with the Internet and reasonable bandwidth, throw in the power of search and individual customization algorithms, and suddenly business models no longer had to rely on bulk consumption and the generation of popular hits.
The first industries to feel the change were in entertainment: music, movies, books, where having a physical copy was once necessary to enjoy Madonna, Star Wars, or Carl Hiaasen’s latest thriller. Digitization turned that upside down. It became clear that what we’re really paying for is information, and it’s a lot harder for the entertainment industry (or any industry) to keep control over the dissemination of information than when they sold that information packaged in shiny plastic discs.
Anderson also described how in this digital world, and aided by the powers of personalized search, niche markets could not only survive but thrive. Once, something like Tuvan Throat Singing was a niche musical form that you might have heard of on a trip to Siberia, but you’d have had no luck finding a CD at your local Tower Records (remember them?). Now, you can not only find several tracks from iTunes or Amazon, you’ll also get suggestions for what else you might like based on your fondness for overtone singing. Since it costs Amazon basically nothing to store the music and associated information, they can afford to have it available for the 20 people who might want to buy it. Tally that up across all the niches in the world and it’s a hefty sum.
This is pretty neat. But it’s still uncertain how the business of entertainment will shake out financially and logistically among the producers, distributors and promoters. I’m not real fond of chaos like that in my professional life, and for a long time felt secure that my job–drug development scientist–was not in danger of becoming part of a long tail phenomenon. Only now I’m not so sure.
Information is a Drug, but Drugs are Also Information
I’ve come to realize that what we sell when we sell drugs is also really, ultimately, information. Drug companies discover new compounds, whether they’re small molecules or antibodies or other formats, and it’s the information about those compounds, the biological change they cause for the patient, and the know-how that goes into manufacturing those drugs that is what’s really being sold. There’s a reason we call it Intellectual Property, after all. The contents in the syringe or the pill bottle are just the ultimate expression of that information.
Given that drugs are information, I’ve been wondering if there will be ways in which that information will eventually find expression outside of the normal drug development/delivery paradigm. After all, some people believe information wants to be free. Two kinds of recent cultural/technological developments in particular are making me wonder: Do-it-yourself (DIY) Bio, and 3D printing.
DIY Bio and 3D Printing as Democratizing Drug Making
DIY Bio, sometimes colloquially described as garage science, is doing biology experiments without the structure of an organized institution. The Scientist devoted several articles in a recent issue to the DIY phenomenon. It’s no news to anyone reading Xconomy how many Biology PhDs we’ve trained over the past several decades and a lot of them are both quite good and also looking for work. Given a few thousand dollars, one can buy a microfuge, some gel boxes, a used thermocycler and even some incubation and tissue culture equipment. If a bunch of like-minded scientists decided to set up a small scale shop to manufacture drugs, they might have a real chance of succeeding. And especially as 3D printing takes off.
Printing in three dimensions has been around for several years, but this past year has seen an amazing explosion in platforms and an equally intriguing drop in price. A desktop printer, capable of creating a 3-dimensional object as big as a nerf football out of plastic, can be bought for $2,000 or less. More expensive models can print in more kinds of plastics, rubber, or even metal. If we assume these devices will decrease in price while increasing in capabilities (which is how almost every other technology has developed in the past), people in DIY Bio labs wouldn’t be restricted to off-the-shelf equipment. In time, they could create any specialized piece of equipment they needed to replicate, at a small scale, the manufacturing processes used to make drugs. This recent article on 3D printing from Chemistry World points out how processes like organic synthesis can be replicated and scaled down using 3D printers, printing both the containers and the substrates at strategic locations through the apparatus.
At first a DIY Bio/3D printing approach would almost certainly take the form of replicating existing, generic drugs. Whether through chemistry or protein production, the first replicate drugs would be done by hobbyists in a proof of concept way, just to see what could be made and at what purity. And also to help peoples’ pets. I can tell you, in Seattle there are a lot of people who would go to great lengths to give their dogs some relief. Here I think the biologics market is particularly open, as it’s likely that generic versions of biologics (biosimilars) will not sell at much below original drug prices, leading to greater incentive to replicate.
Patents supply the basic information: the amino acid sequence of an antibody, for example. Nucleic acid manufacturers like Blue Heron will make any DNA sequence you want if, for example, you want to create a plasmid that would let you try to produce a protein at a small scale.. Someone with a background in contract manufacturing and quality control can figure out the proper tests to analyze purity and activity. And what then? Well, the FDA regulates the sale of drugs so this would seem to put this all in the realm of the fun, if geeky, hobby.
But. What if people didn’t sell these drugs? What if they gave them away?
DIY Drug Making Collectives
I’ve already taken several pretty outrageous leaps, so what are several more? The Internet has created the ability to build communities in a bottom-up way. If a consortium of patients decided to, could they organize with a bunch of DIY biologists to manufacture drugs as a nonprofit collective? The collective would accept donations, and like KUOW-FM, the local NPR affiliate in Seattle, it could offer supporter benefits. Like a duffle bag. Or a cheap copy of the rheumatoid arthritis drug etanercept (Enbrel).
What does the government do? Well, if it’s off-patent drugs we’re talking about, maybe the government does nothing. It depends on whether the perception is that a commercial line has been crossed, and if human health is being endangered via a commercial enterprise. But again, if we’re talking autonomous non-profit collectives, the lines get fuzzy. We’re already starting to see elements of grass-roots drug development funding by patients’ groups.
It gets interesting if you imagine thousands of these kinds of organizations springing up across the U.S. Because at some point, someone looks speculatively at the on-patent drugs and thinks Hmmm… If enough of these DIY labs start creating on-patent drugs, at what point does enforcement become unrealistic? Like our current debate about legalized marijuana in Washington and Colorado, at some point the government may well decide not to do anything because it’s too much money and the government has higher priorities. Health costs are the fastest growing expense for the U.S.economy. If the cost of drugs could be reduced, that creates competing incentives for government.
But what happens to the drug companies and the arguments that are so often put forward about innovation and the connection to intellectual property? That’s where the French Bistros come in.
A Drug Production Model for Every Taste
I like food writing, and one of my favorite authors is Jeffrey Steingarten. He writes the food column for Vogue, and in his first collection, “The Man Who Ate Everything,” he has a piece on the rise of neighborhood French Bistros. He describes how a number of young French chefs, trained in the classical skills of Haute Cuisine, chose to break away from the established process of waiting their turn to head one of the great kitchens of the French culinary establishment. They instead created local bistros. These bistros make affordable, delicious, impeccable food, using the techniques they learned from the Masters, but adapting them to humbler ingredients and largely affordable presentations. Oxtails and beef cheeks instead of Filet Mignons.
Has that led to the demise of the Haute Cuisine, the three-star restaurant? Not at all. What it has led to is a diversification of the market. You want a three-star meal, you want the assurance of a large scale manufacturing facility? You go to the name places, the Guy Savoy, the Pfizer. You want something more intimate, more local, possibly more experimental but where you have a personal relationship with the drug maker? Maybe you go to a Bistro or a local drug production collective. And so, the market space becomes diversified, fragmented, with potentially enough demand for what the big pharma are selling so that they can continue to exist, but also with a raft of other choices.
Moving From Making to Creating Across the Collectives: Real Participatory Medicine
Looping back to concepts surrounding the long tail, remember again that what we’re talking about is information. If a bunch of collectives did spring up, they would be flinging ideas around like meatloaf in a high school cafeteria food fight. Plans for 3D printing a more efficient culture chamber. Recipes for growth media and conditions that would increase cell culture production by 3 percent. Tips on how to minimize risks of contamination. Bottom up rules and agreements on what constitutes a safe product, such as are being recommended for other technologies like transcranial direct current stimulation of the brain. All that information doesn’t go away, it just accumulates, and consolidator software and web portals can ensure that it doesn’t take too much effort to keep up with the latest trends in DIY drug production. This could well provide the collectives with an edge.
Will they ever move into trying to create new drugs rather than replicating existing ones? Maybe. The long tail might manifest in DIY researchers taking on very specific niches of disease–sub-populations of sub-populations, taking advantage of electronic medical records, personal genome profiles, patient groups like PatientsLikeMe, the quantified self movement, and search algorithms to identify these groups and coordinate hypothesis generation and testing. Perhaps drug development companies move into the area of talent scouting, management and consulting, rather than discovery. This would be an even more extreme version of what Gary Pisano described in Science Business.
Of course, in the immortal words of Ebenezer Scrooge, “Are these the shadows of the things that will be, or are they shadows of things that may be?” Obviously it’s pretty unlikely that any of these changes will come to pass. There are a huge number of legal, scientific and ethical hurdles that would need to be overcome. But while this essay is no more than a fun thought experiment, I do think, like many others, that the way we develop drugs is going to change, if for no other reason than because the current blockbuster-reliant model is showing real, fundamental cracks and can’t be sustained. I’ll be quite interested to see how drug development companies adjust to a world where the power of making is distributed and information, not drugs, is the product.