Discovery in the biomedical sciences is running at a pace that challenges our ability to keep up, financially, ethically, and legally. And thinkers in the field are calling on policy makers to reconsider our response.
We live in a time when it’s possible to imagine curing cancer. And the pace of research is there to back up that dream.
"It’s a breakneck speed, it’s absolutely phenomenal," said Dr Edison Liu. He heads up the Jackson Laboratory in Farmington, where the field of genomics is promising personalized responses to disease. “Just in the last ten years, I think we’ve accelerated our discovery in a manner that I haven’t seen in my academic lifetime."
For instance, sequencing the human genome, and developing advanced analytical capabilities have been foundational to advances in understanding cancer.
Yet Liu told WNPR’s Where We Live that the very speed of that discovery now exceeds our capacity to understand and manage it. “For example our ability to edit genes is phenomenal at this point," he said. "Which means that we can develop literally lifesaving cures for many diseases. And yet, how we manage these, to what extent can we actually implement these in human populations, is yet to be even discussed in any great degree.”
And it’s not just ethics, logistics, and a legal framework that are lacking. There’s the fundamental question of money.
“Even if we developed the potential cures, these cures are so expensive that the system itself is buckling under the cost considerations of distributing these cures,” Liu said.
Liu’s observations are backed up by Alec Ross. He was an adviser on innovation to Hillary Clinton when she headed up the state department, and he’s also the author of The Industries of the Future.
“The way that we finance healthcare in the United States, and the way that we commercialize drug discovery through the FDA process makes this much more difficult and costly than it ought to be,” said Ross.
Ross said the point at which discovery grinds to a near halt is in the costly and time-consuming clinical trial process. Ross predicts that unless there’s the political will to rethink the funding of health care, new cures could become available only to the wealthy in our society.
INTERVIEW HIGHLIGHTS WITH EDISON LIU
Jackson Laboratory: Medicine
It’s a breakneck speed -- it’s absolutely phenomenal. Just in the last ten years, I think we’ve accelerated our discovery in a manner that I haven’t seen in my academic lifetime. One of the challenges I think Alec really touched upon is the speed of discovery may exceed our capacity to understand and to manage it -- that this is becoming a greater and greater problem.
Many of our technologies are implementable now, and yet the ramifications of what they can do have not really caught on in terms of the legal, the ethical framework of how we can implement them.
For example, our ability to edit genes is phenomenal at this point, which means that we can develop literally lifesaving cures for many diseases; and yet, how we manage these, to what extent can we actually implement these in human populations is yet to be even discussed in any great degree.
Fingerprint for Disease
Cancer is a perfect example of the implication of the technologies. It’s a very, very complex disease that is genetic in nature because it involves the genes in the cells that become cancers. And it’s not just one gene. It’s actually thousands of gene mutations that occur that generate and sustain a cancer that will unfortunately kill patients.
How you decipher all these changes requires the analytics that has been mentioned in the previous speaker’s comments. And what we’ve been doing is using genome based technologies to, first of all, discover all the mutations that are there, using the analytics to prioritize as to which are important and not; using computational tools to look at how they’re related to each other; and then using very advanced cell and organism model systems to dissect out the meaning of all these changes.
Once we have that, then we can start thinking about how to intervene with the therapeutics that we have. The observation that we have made could never have been made without whole genome sequencing and the analytics that are available now that was not present even twelve years ago.
Health Care Finance
Much of this is in two phases. Number one, it’s actually the translation from the basic science into clinical impact. The limiting factor right now is the clinical verification that is the clinical trials. It is so costly and takes so long to get to that point. Many of the discoveries are just kind of waiting in the wings.
Now, in addition to that, we have a crisis in health care finance. So even if we develop the potential cures, these cures are so expensive that the system itself is buckling under the cost considerations of distributing these cures.
Looking Ahead
I think the regulators have heard the need to move more quickly, and I think that they’re trying very hard to streamline the process.
I do think that the attention of both government thinkers and deep thinkers like Alec Ross will drive solutions. One of the paradoxes we have right now is, our challenge is not the technologies that deliver the goods. It’s our ability to figure out how to manage these technologies and figure out how to finance the distribution of the wealth of knowledge that we have.
