From the Wall Street Journal:
http://online.wsj.com/article/SB1000....html?mod=e2tw
Quote:
While many chronic disabling conditions play only a limited role in premature death, they are major drivers of health-care costs, Dr. Murray said. "We are not very good at preventing them or curing them and only mildly good at treating them."
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The US healthy life expectancy has declined from 13th (1990) among OECD nations to 26th (2010). The biggest contributing factor is the morbidity of chronic diseases. All of the treatments are palliative not curative - allowing patients to live longer with disease. This may be good for PhRMA markets and the bottom line, but not so good for patients. Moreover, chronic disease management is the major driver of escalating health care costs in the US. And as we all know, health care costs are a major contributor to our national debt. This situation is economically unsustainable!
IMO, there are two major problems that need to be corrected: (1) Innovation in pharmaceutical drug discovery/development and (2) the business model for drug development to market.
PhRMA would have us believe that the problem lies in the long regulatory approval process (FDA) and that is why it costs $0.8 B - $1.2 B to bring a new drug to market. Not true! Most of the cost is the infrastructure and overhead cost of PhRMA that stems in a large part from the failure rate of new drug candidates. Only 1:1,000 new molecular entities makes it market! Moreover, the ones that do are not curative of the diseases target and only allow the patient to live with the disease. What PhRMA company wants to erode its market by curing the disease? As long as this is the focus then the trend of living longer less healthy lives will continue and the cost of health care will continue to spiral upwards.
So as to Innovation, well don't look to PhRMA on that one for reasons I just mentioned. What about Universities? Traditionally, university research laboratories were the caldron of innovation. Not so much today. The problem is funding research. In order to survive an university investigator must get grants (primarily NIH for medical research). In order to get a grant the application must be scored favorably for funding. In order to get scored favorably the researcher must propose something that his peers can readily comprehend and believe that can be accomplished. In other words the NIH is in the business of picking winners and losers. The smart researcher will therefore propose something that is simple, comprehensible extension of that which is already known. I liken this to proposing to extend the known value of Pi by one decimal place. Not exactly transformative research. Unfortunately that is exactly what is needed in medical research. A good read of the trials and tribulations of pioneers in cancer research is
Catching Cancer by Claudia Cornwall.
But even if the researcher overcomes the research funding hurdle the worst is yet to come - the discovery must now cross the "Valley of Death". Aptly named because no one wants to take the risk of developing a discovery through the maze of transforming the discovery into a drug candidate. Yep, even if the discovery negotiates the Valley of Death it still is only a drug candidate and has yet to go through human testing in clinical trials (Phases I, IIa/IIb, and III) and await final FDA approval.
The whole process kinda reminds me of SF selection. Fortunately some of us are willing to follow this path. Not for personal glory, but because the mission is just that damned important!