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Sunday, Nov 8, 2009
The key concept here is "a patient" -- i.e. you or you but not her. This is the world of personalized medicine, made possible by gene-scan-powered molecular diagnostics. In a perfect future, these gene scans will tell us which seven women can decline chemotherapy. But in the immediate future, these scans will only tell us the probability that a woman can safely decline treatment. This probability will get better every year, but when will molecular diagnostics be reliable enough to base life-and-death decisions on?
This work on breast cancer is, literally, just the tip of the iceberg. Long before single-molecule DNA sequencing (or $1,000 genomes) hits the marketplace, thousands of labs around the world will be using standard biotechnology instrumentation such as DNA microarrays to create molecular profiles of people and populations. These profiles will be used to develop diagnostics for every major disease and disorder. Like reproductive cloning, this technology takes us to the very essence of what it means to be an individual. Unlike cloning, the field of molecular diagnostics is receiving almost universal acclaim as a worthy goal for the future of medicine.
"A little knowledge is a dangerous thing. So is a lot." Once again, Einstein provides the appropriate homily. Like the manifestation of Moore's law in computing, improvements in molecular diagnostics and nanomedicine are astonishing but still leave us far short of where we need to be. Unlike for the next generation of semiconductor chips, the time to market for each new product in targeted medicine will be measured in human lives. Before we have the set of genetic profiles or the tools to treat all breast cancers, we will know enough to modify the treatment regimes of a few breast cancers, then enough to help some breast cancers, then enough to help many. At what point will this knowledge be allowed to enter the healthcare system? Will everyone have access to it? Who will pay for it? And who will make all these decisions?
Theoretical microbivores notwithstanding, no one seriously questions the transformative power of nanotechnology for human health. But it is equally true that no one understands how this revolution in personal medicine will impact a healthcare delivery system that, for many, is already hopelessly complex and frustrating.
New pharmaceuticals now reach the marketplace by showing efficacy in clinical trials based on the average response of a patient population. But nanotech-based diagnostics will open the option of personalized medicine, which, by definition, means that there is no longer an "average" response to therapy. Each patient's treatment regime should be unique. But there's no way we can do that with our existing healthcare system.
The reality is that we will have a world of molecular diagnostics long before we have a world of molecular cures. In the immediate future, gene scans will guide the use of conventional or biopharmaceutical therapies. In this world, women diagnosed with breast cancer will be advised that postoperative chemotherapy will not extend their survival. But this advice will come with a statistical caveat. More correctly, each patient will get her own prognosis with her own statistical caveat. The woman, her doctor, her insurance company and the government will all receive a statistically weighted prediction about her future. How are society, the government, private industry and the individual going to deal with this situation? The first act of the drama called personalized medicine will still be written by nature, the second by biotechnology, the third by nanotechnology. But who or what will be the author of the finale?
Within a generation, nanotechnology will completely invert our concept of medication. Today vaccines come with literature warning of a low probability that "some people" are subject to side effects or complications. In the age of nanotechnology-driven personalized medicine there will be no such thing as "some people." Theoretically, you should be able to know if you are that one in 10,000. But will you want to know? Will you be allowed to know? What will it cost to know, and who will pay? What if you could have known but didn't ask ... or weren't told? And perhaps most disturbing of all: What if it turns out to be too expensive for society to pay for universal diagnosis, let alone treatment? Could we enter a world in which the rich live on and on, while the poor are denied even the knowledge of the disease that is inexorably killing them and whose prevention is at hand?
Our already faltering system was never designed for, nor can it handle, the flood of molecular diagnostic data that will reach biblical proportions within a decade. Just when we thought the web of healthcare delivery couldn't get any more tangled, patients, doctors and HMOs are about to meet the world of personal genome sequencing. Then will come gold nanoshells and, perhaps a bit later, microbivores.
And by the way, the proliferation of unique molecular identifiers will make medical privacy an impossibility because, ultimately, these types of data cannot be encrypted. The medium is the message. Millions of people have your fasting-blood-sugar value, but no one else on earth has your gene sequence. Get the idea? Any single-molecule-based nanomedical procedure could identify you beyond a shadow of a doubt. Yet a fundamental principle of nanomedicine is that billions of single-molecule fingerprints from DNA, RNA and proteins will be routinely available for diagnostic and therapeutic strategies. Which is the same as saying farewell forever to anonymity for your health records.
O brave new world, that has such genes in it!
