Designer Drugs in 3-D: An Innovation Lesson

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  • 08/11/2015

The announcement that Aprecia Pharmaceuticals has produced the first 3-D printed drug approved by the Food and Drug Administration  prompted a slew of articles about the technology that produced it.   There as no coverage about what it took to move 3-D printing from being a science fair project to a tool for mass production of customized medicines. Nor has their been any discussion about the implications of such commercialization on medicine. In particular,  the marketing of 3-D printed drugs underscores Sir Harold Evans observation that “innovation is not simply invention; it is inventiveness put to use. Invention without innovation is a pastime.”

The emphasis  on ‘pragmatic’ is what distinguishes invention from innovation.  Michael Shrage,  a research fellow at MIT Sloan School's Center for Digital Business says that innovation is not what innovators do but what customers adopt.    Semi-conductors were an amazing invention but no one really saw any use for them beyond industrial applications:  then someone came up with idea of using one programmable chip to make personal electronic calculators.   It wasn’t long after that the PC revolution was launched.  

While Human Genome Project was a worthwhile investment, it was only made so by the efforts and investment undertaken to make it’s tools accessible and to product medicines and devices that millions could use.  Otherwise it would have been a very expensive science fair experiment as well.

The sale of 3-D printed medicines demonstrates that it is possible to make targeted medicines or treatment combinations widely and quickly available.   Often overlooked in the discussion about Aprecia is the fact that it applied it's manufacturing process to medicines that are in short supply because generic companies have found them too expensive to make using existing technologies or because they are products -- such as those for neurological conditions -- require absorption and availability within very narrow therapeutic indexes.   Finally,  the Aprecia approval is notable because it takes an injectable drug and turned it into a pill (Spritam).   Levetiracetam is used to control pediatric (and adult) epileptic seizures.   A stable, oral medication that works more quickly and can be produced in real time meets an important clinical need and solves a growing problem of drug shortages.  Can we say disruptive? 

Finally,  it should be noted that Tom Arrington, who invested in Aprecia many years ago, placed a huge bet on 3-D printing of drugs.  He didn't need the money.  In fact, Mr. Arrington has a successful authorized generic company Prasco Laboratories. .  Like many other entrepreneurs, Arrington's goal was not making more money. There a less risky ways to make a return.  Rather, profit is a means to an end that other incentives cannot easily achieve.  As Sir Harold noted: "Iinnovators are committed to making their developments as widely available to the populace as possible. This mass market democratization has been a hallmark of American success in the world."

Commercialization is part of the virtuous cycle that has made progress against disease and in enriching and extending life possible.  Aprecia has opened the door to the commercialization of medicines that can serve unique populations and it creates unprecendented opportunity to repurpose injectable medicines so that they are easier to administer, ship and store.  But the effect of commercialization cannot be divorced from the character of the person making it possible.

The Talmud observes:  Which is the best path for someone to choose for themselves?  Whatever is harmonious for the one who does it, and harmonious for mankind.

That sums up the path Tom Arrington took when he invested a small fortune in Aprecia. 

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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