That we have recently had serious trouble dealing with something as familiar as the flu should horrify us. A new vaccine has to be developed at least once a year to keep pace with the fast-mutating virus, but that process is now technically routine. In 2004, just three companies controlled most of the skill, and one of them got unlucky. The United States was left unable to provide even the seasonal flu shots needed by the elderly and health care workers — and would have been helpless against a pandemic had one materialized.
HIV and the flu virus exploit the simplest kind of biochemical complexity that can thwart magic-bullet antidotes. Washington, paralyzed by the fear that error is politically lethal, is rigid and slow; the new germs are flexible and fast. The whole edifice leans sharply toward the past. Germs are always future, always reinventing themselves in their ingeniously stupid way. They dont have to be smarter than our scientists anymore, just faster than our lawyers.
Unable to afford the future, Washingtons paymasters are systematically biased in favor of the drug licensed decades ago. Their principal concern is who should pay how much for the new, patented drug, or whether the old, cheaper generic might do as well. To continue to advance and spread its benefits more widely and equitably, however, molecular medicine must mimic life in all its nimble, diverse, discriminatory, and changeable complexity.
In knowledge-based industries, as in life, constant change is the key to survival. Margins always collapse when yesterdays technology matures, key patents expire, manufacturing processes get standardized, and the next-generation technology emerges. The digital economy discovered the Darwinian economic law years ago: innovate or die. The law applies to drugs, too: tomorrows profits always depend on taming the next shard of endlessly variable human chemistry, or beating natures next new pathogen.
In a welcoming environment, Wall Street, venture capitalists, monster drug companies, small biotechs, research hospitals, and many others would be pouring intellect and money into this process. While drug companies have made fortunes selling one-size-fits-all cures for very common problems, over the long term there is far more money to be made in tracking unhealthy differences down to their fragmented molecular roots. Drugs that target the flaws in our own chemistry must often become an integral part of daily life, and thus can end up extremely profitable even when they address problems that arent very common at all.
If we let them, drug markets will strive endlessly to do exactly what markets do best, and what drug markets most need. Propelled as they are by dispersed initiative and private choice, free markets are uniquely good at extracting and synthesizing information thats widely dispersed among innovators, investors, workers, and customers. In no other market are the sellers so dependent on information that is in the sole possession of the buyers. Nowhere could the free markets information-extracting genius be more important and valuable than in a market for products whose value depends on their ability to mirror biochemical information inside the people who use them.
The reactionary fear that market forces will be brutally Darwinian in deciding whom to cure overlooks the inherently social forces that rule down at the molecular level of life where drugs operate. The targeted drugs that will emerge from the free-market pursuit of life will be fiercely discriminatory in their chemistry, but economically indiscriminate, because copying know-how is so cheap. New knowledge, the most valuable ingredient of every drug, ends up shared for free with everyone when intellectual property rights expire. The cures in the code are the ones that make health care equitable, affordable, and accessible to all.
Public policy should be framed accordingly.
Viewed from the perspective of Washingtons paymasters, the three most insidious diseases in todays America are diversity, freedom, and privacy. For the rest of us, the insidious peril is the conviction that health rooted in the diversity and freedom of three hundred million Americans should be managed by small committees convened by federal authorities.
Researchers, drug companies, doctors, and patients should have the right to communicate and collaborate more freely. Academics should be permitted to patent drugs developed under federal grants (as a Reagan-era law allows). Drug-related intellectual property rights in general should be strengthened. More drugs should be declared orphans under the Orphan Drug Act. Adaptive trials are better. More drugs should receive accelerated approval. Doctors and patients should have more discretion and control instead of less. We should welcome biochemical sniffers and digital networks that help doctors and patients decide for themselves what they might need and then mobilize to fight for it.
We now know how to replicate and distribute at least some snippets of lifesaving biochemical code fast enough to overtake the most hostile code on the planet. We proved it when we beat smallpox by spreading the vaccine for it faster than the virus could spread from person to person. Since then, we have learned to read biochemical code, distribute it worldwide at the speed of light, and enlist more capital and human intellect in its design and manufacture.
When the wealthy spend lavishly trying to beat the unbeatable, we should thank them. We should not only permit but encourage affluent people to spend more, on a much broader range of drugs, including leading-edge experimental treatments, than government paymasters could ever afford or include in any one-size-fits-all health care scheme. We need the very rich here — and, happily, they need the rest of us even more. They are built out of the same molecules as we are. They cant lock away the know-how that their bodies and their money help develop, and they cant develop it on their own, either. They need the rest of us to help build the databases that reveal how all the molecular pieces fit together.
Anchored in the sharing of biochemical knowledge, the new socialized medicine offers far more power and is far more egalitarian than anything imagined during the days when much of the developed world was socializing hospital beds. Because knowledge is inherently, unstoppably socialist: it spreads wealth faster than autocrats can spread poverty, and it can spread life faster than germs can spread death. The orderly socialization of potent know-how is also the one form of socialism that can be harmonized with free markets and vigorous competition.
The sharing of knowledge doesnt centralize power; it disperses it. With this unique form of wealth, the hard part isnt the sharing; its finding ways to limit the sharing long enough to give markets the incentive to develop the know-how in the first place. With germ-killing know-how, theres the further problem that indiscriminate sharing quickly breeds drug-resistant germs. These problems are solvable, but not by people who reflexively assume that more free sharing sooner is always better.
By democratizing the power to read biochemical text, the sniffers are rapidly exposing the limits and frailties of the old medical media, beginning with the government licenses, labels, mandates, and proscriptions that attempt to dictate who may sell and who may use what kind of molecular medicine for what purposes. By pooling and distributing what the sniffers detect, the digital cloud will democratize our understanding of health and disease. The cloud will end up linking the great repository of the old code, patients themselves, with the developers of the new, the biochemists and doctors who design clever fixes and patches and find new ways to use them well.
If Washington persists in forbidding or strictly controlling such connections, the information will move through intermediaries, based in the United States or abroad. As biochemical knowledge accumulates and its implications become clear, free people will come to understand what they are missing, and insist on taking far more personal control of the sniffers and drugs that will let them control the arc of their biological lives.
It cant be denied that this agenda has an ideological slant. It favors dispersion of information, authority, and economic interest. It relies less on electing drugs in large biochemical referenda overseen by Washington, and more on town meetings convened by biochemists and doctors. It benefits those who add their own intelligence to the drugs when they use it, and it may endanger those who dont. It requires parents to pay more for new pills today in order to get cheap generics to their grown children and new and better drugs to their grandchildren. It accepts that even while still under patent, medicine brewed by the vat with Wall Streets money provides far more health care, far more cheaply, than any alternative.
In support of this agenda we can, however, invoke the biochemical logic of drugs and patients. The patients chemistry matters as much as the drugs. Americans are biochemically diverse. The intractable diseases that we now confront are biochemically complex. Trying to work out all the science up front in a handful of conventional FDA-approved clinical trials leads to quagmire and stifles the most important part of the learning before it begins. We will need a broad range of different drugs to deal with the bio-chemical diversity that underlies many of our diseases. We wont get them if we let the paymasters stage further rounds of FDA-like trials that aspire to lead us all to the cheapest, one-size-fits-all cures.
That said, the best that free markets can do is to keep stocking the pharmacy with an ever-expanding array of drugs as diverse as the human and microbial chemistry that shapes our health. Freedom gives people the freedom to choose, even if it doesnt always give them the wisdom to choose well.
Original Source: http://www.wired.com/opinion/2013/11/how-20th-century-law-code-messes-with-21st-century-bio-code/