Chicago, April 11–The Secretary of the U.S. Department of Health and Human Services, Michael Leavitt, did something quite unusual for a political speech–he inspired. As a veteran listener to DC political oration, I expected Leavitt to tell the biotechies during his breakfast speech at the Biotechnology Industry Organization's annual convention (BIO 2006) how much George Bush has done for them, how much money his Department dispenses to them and how much more taxpayer dollars he hoped to give them in the future if they would just get behind his programs and so forth.
Instead, Leavitt outlined a vision of the next decade of biomedical progress that even I, as an inveterate techno-optimist, might hestitate to promote. In Leavitt's crystal ball he sees the advent of what he calls patient-centered medicine by 2016. First, he offered the experience of a young woman (let's call her Joy) whose mother and grandmother died young of strokes. In 2006, her doctor would have focused on prevention by means of exercise, diet, and if she is unfortunate, medications to limit damage from a stroke.
By 2016, Joy will have voluntarily enrolled with other North Americans in a genetic profile registry. Her doctor will run her profile against the whole database and find that researchers had discovered that other people who share her family's medical history have a variant gene which produces an abnormal protein. Joy will be alerted via email by her doctor that researchers are developing a new medicine that specifically targets that particular abnormal protein. Joy will sign up with the researcher/physicians who will monitor how the medicine effects her with biosensors that automatically send wireless updates to the researchers. The medicine will directly target the molecular processes that make her vulnerable to stroke.
Leavitt noted that it now takes $1 billion investment and up to 12 years before a new medicine makes it to patients. This means that drug companies are forced to seek out blockbuster drugs that treat millions of patients and cast aside many drugs that could produce miracles for people suffering from rarer diseases.
Leavitt believes that this situation will change by 2016 for Tom the bioentrepreneur. Tom combed through health databases that collect privacy protected real time health and genetic histories of 35 million volunteers in North America. Tom noted a correlation in a subpopulation of 120,000 Alzheimer's patients that have a specific antibody to a common cold virus. This exposure initiated the process that eventually led to Alzheimer's. Tom identifies a specific biomarker that created this reaction. He downloads a list of 3000 compounds that he thinks might block this antibody reaction. Using computer assisted criterion, the list is winnowed to just 20 compounds. He finances his company's research by selling shares of a pre-competitive compound.
By 2016, the FDA's requirement for a slow painstaking trial and error testing procedure has been transformed into a 6 month sprint. This is possible because the bioinformatics and diagnostics revolution enable qiuck testing compounds against gene expression, metabolic assays, and othe adverse effects. Safety testing of a compound is now just a matter of months, not years.
Leavitt then turned to the role of a pharmacist in 2016, let's call him Bill, in the new era of patient-centered medicine. Today most medicines are not tailored for specific patients and they generally treat symptoms, not the causes of diseases. By 2016, pharmacists like Bill will dispense drugs that target specific biological processes and correct them. For example, Leavitt imagined that Bill might dispesene nanobiospheres that have the ability to deliver ten medicines at the same time. Bill might also implant computer chips to restore sight to people suffering from macular degeneration. (He left unexplored how ophthalomologists and optometrists would react to this development.)
However, there is dark cloud over this future–Leavitt warned that "it is sociology that will block this" because health care providers, payers, and regulators are not ready for the fast disruptive changes that biomedical research is about to unleash. In a more political vein, Leavitt went on to describe some of his efforts to help the era of patient centered medicine to dawn. He said that he is working to speed up the FDA drug approval process, and launched the NIH Roadmap for Medical Research which identifies gaps in research tools, and the NIH Genes and Environment Initiative to measure individual reactions to environmental exposures. I don't know if Leavitt will have an impact, but it was pleasant to hear someone who thinks that the future is going to be amazing and soon. (For something really amazing, my next dispatch will be on some fantastic progress being made in biomedical imaging.)