Law in the Internet Society

Free Medicine

Second Draft -- Ready for Review

Prescription drug spending in the U.S. is projected to nearly double by 2020. At the same time, drug development is becoming even more expensive and less productive. Today's drug R&D methodology is based on the development of chemicals that target short-term, acute symptoms and infection. But, most of these problems have already solved by generics, and even where needed, profitability of infectious disease treatment is limited by the ability of Third World patients or governments to pay. Medicine in the future is being defined now through a comprehensive revolution based on three big shifts.

First, the underlying science, biology, has transformed. The most outwardly visible manifestation of this is the Human Genome Project, and the re-orientation of biology towards the primacy of DNA sequence and understanding the cell as a complex system of molecular interaction. But, the changes are broader than that. The techniques of molecular biology have changed to become more modular, kit-based, and reliant on instrumentation and software applications than it was before. There is now even the possibility of both computational and wetlab tinkering available outside the traditional laboratories, leading to the emergence of "DIY biology" and "biohacking." To be sure, kit-based biology is sloppy and requires substantial tuning, and computational methods are still limited. But, the trend is clear. An already substantial and growing part of molecular biology is no longer trial-and-error, basic discovery-oriented science.

Second, the broader information and communications revolution is fundamentally reshaping medicine. Twenty years ago, the molecular understanding of human health was limited to a few metabolites and protein levels, like glucose concentration and insulin levels. Now we are aware of the billions of bases in the human DNA sequence, and of the importance of the dynamic expression levels of 30,000 genes, hundreds of thousands of proteins, thousands of small molecule -- and even beyond that, the identities and dynamic function of the bacteria that live within us. And, the technologies to actually measure all of this information are becoming more precise, more comprehensive, more portable, less expensive, and faster at an exponential rate. In addition to providing the means for storing and analyzing massive data sets for individuals, the global information revolution means that all of these data can be recorded and compared with data from other people in other conditions.

Third, the basic nature of the diseases that are important in medicine is changing. Medicine's future is dealing with chronic diseases that are a function of heredity, lifestyle, and environment: diabetes, asthma, cardiovascular disease, COPD, long-term infections like HIV/AIDS and hepatitis, and cancer. These are not really "diseases" in the way we understand an infectious disease like flu. Chronic diseases have no discrete causative moment, particular group of symptoms, specific range of outcomes, and most importantly of all, definable "cure." Chronic diseases involve a complex of molecular pathways, and disease etiology and progression vary highly between individuals. So, all that information about genetics and complex molecular dynamics of cells matters for prognostication, prevention, and treatment.

Big Pharma has responded by considering and applying these transformations separately in the context of conventional drug development. The problem is that there is simply too much information for a drug to interface with -- the nature of the molecular structures and complex chemical reactions that are reprogrammed by the drug to change the function of cells and organs to affect the course of disease. Moreover, this information varies between individuals. The result is that the state-of-the-art includes drugs like statins, like Lipitor, which have at best an uncertain impact, despite their ubiquity and cost. Alternatively, there have been unequivocal failures like Vioxx -- which was designed to be more specific than its predecessor, but which through that specificity somehow causes more serious side effects. Overall, drug pipelines are running dry, as most projects fail despite the use of expensive new technologies in the development process.

The future of medicine requires absorbing the revolution as a whole: rethinking the integration of information and health. One vision, favored by incumbent interests, is "personalized medicine." The idea is to match drug choice and dosage to an individual's DNA sequence and information from real-time measurement of biochemical processes. Personalized medicine will be based on the current legal regime of data exclusivity and patents on both drugs and sequence information. Pharmaceutical companies would retain exclusive rights over how to diagnose and treat patients based on their own DNA sequence and sensor data. To get there, drug patents or exclusive rights to market drugs will be extended, by allowing the extension of monopoly rights on both chemical isoforms and new applications of drugs, as well as patents on diagnostic methods based on restricting the use of otherwise freely available genetic information. In this context, open source drug discovery can exist on the margins of strictly "humanitarian" -- i.e. unprofitable -- projects, like tuberculosis.

The alternative is Free Medicine. This is exemplified by the emerging use of social networks for conducting genome-wide association studies at one end of a new pipeline, and clinical trials at the other end. These developments will facilitate distributed innovation in networks of the doctors and patients. Indeed, innovation once emerged from case studies rather than mass trials. In an era when we can measure individual variability, it makes sense to return to a more distributed and flexible form of medical development.

The power of free medicine is that it works on health as a process, rather than just focusing on products, like drugs. So, it will lead not to just better health care, but to better health. Unlike personalized medicine, free medicine won't just be about products that can be tied to exclusive rights, whether through patents or patent-like legal schemes. The IP regime puts such an emphasis on research that can lead to the award of exclusive rights, which neglects a wide range of ways of treating patients, including natural products, changes to diet, and modifying the built environment --a world that would open up with the renaissance of free medicine.

-- BahradSokhansanj - 5 Mar 2012



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r18 - 06 Mar 2012 - 02:48:16 - BahradSokhansanj
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