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by Patrick Cox
December 9, 2016
Having passed the House with overwhelming support, the $6 billion 21st Century Cures Act is on track to become law. Its original purpose (before lobbyists spent more than $100 million to influence the legislation) was to accelerate the development and approval of new drugs and medical devices.
Faster regulatory approval would clearly aid patients who are denied access to unapproved treatments and cures. It would also heal the economy by addressing the rising cost of healthcare for the aged, which drives government spending and debt.
The CBO has explained the issue here, so I’ll just summarize. An increasingly older population means growing medical costs. This takes resources away from saving and investment, which create economic growth.
Former Fed Chair Alan Greenspan agrees with this assessment. He states that our employment and debt problems are not driven by bad economic policies. Rather, they’re the result of “age and health and the like.”
Research alone isn’t the answer
The problems of “age and health and the like” are solvable. But the Cure Act won’t be enough to do it. Why? Because it doesn’t clear the logjam holding back innovation. Rather, most of the money ($4.8 billion) would fund research into key areas. This includes stem cell or regenerative medicine. I’m generally in favor of increased research spending, but that’s not where our current focus should be.
We already have cures. The last two decades have seen more biological discovery than all those in previous history. In fact, many world-changing biotechnologies are already licensed to startups, but most of them are limping toward commercialization in a process that can take more than a decade.
Due to high regulatory barriers, drug development typically costs tens of millions of dollars in the early stages. Phase 3 trials cost even more. I’ll give you a good example.
Perhaps the most dramatic medical news in recent years came from Asterias Biotherapeutics. For the first time ever, quadriplegics with catastrophic spinal cord injury have had significant control and sensation restored. Moreover, these results occurred in the first three months of a 12-month trial using partial doses of genetically modified stem cells.
You might be surprised to learn that this isn’t even a 21st century technology. Michael West PhD created this therapy 20 years ago at Geron, the company he founded. But Geron was so ground down by the effort to move this cure to market, the board gave up. Later, West reacquired the rights to his breakthrough for BioTime. He then created a subsidiary, Asterias Biotherapeutics, to take the technology into trials.
Reforming the drug development process
Over the past 20 years, West has pushed the science of regenerative medicine much further. In fact, the embryonic stem cells used in West’s revolutionary spinal cord therapy are, according to him, now obsolete. But regulators won’t allow the use of non-embryonic pluripotent stem cells without a lengthy and costly approval process. West also seems to have applied for a patent on a biotechnology that would repair older spinal cord injuries as well as damaged organs and limbs. These are important breakthroughs that exist right now.
So why would we spend billions of dollars on pure research, including stem cell medicine, when a private company is decades ahead of academic researchers? It makes no sense.
The government of Japan knows this. Japanese law permits regenerative medicine procedures in patients after proving safety. That process might take only a few million dollars and six months. This allows companies to skip phase 2 and 3 trials, which account for most of the cost and delay associated with drug development. Instead, they can move from phase 1 to phase 4 (tracking and publishing results in real patients).
This is the real model for regulatory reform. If we truly want to speed up the development and approval of new drugs and medical devices, that’s how we should do it.
So where did the Japanese get the idea? They got it from Andrew von Eschenbach, former commissioner of the FDA. You can read more about his ideas here.
We live in very exciting times, and there’s a good chance we might see a shift to more de-regulation here in the US too.
— Patrick Cox is the editor of Transformational Technology Alert. This article originally appeared at Mauldin Economics.
Rod is one of our nation’s leading minds. He’s smart, original, and very committed—a combination that one rarely finds.
Rod Martin and [former Howard Dean campaign manager] Joe Trippi are America’s two foremost experts on online politics.
Rod Martin is a Reaganite-Thatcherite conservative…[and] a man who has spent much of his life ministering to and working for the benefit of others. I know Rod as an advocate for freedom, a leader who understands the real changes we need in Washington, and who has the drive and ability to make those changes happen.
Rod Martin is the kind of dynamic leader who has the knowledge, ability and experience to lead us successfully into the 21st Century. His vision for America is compelling.
Rod Martin literally wrote the book on excellence. Humble yet brilliant, a man of love and compassion, with penetrating clarity he illuminates the world around us, and we are both stirred and enlightened.
Rod Martin is a born leader and an outstanding political mind. Anyone who takes him on is going to have a serious fight on their hands.
Rod Martin is a man of uncommon vision and character. Ever since I first worked alongside Rod in the early days of PayPal, I’ve been struck by his powerful vision for the future. Rod understands the intersection of technology, politics and culture in a way that few others do.
Rod Martin wears with uncommon grace an uncanny ability to link his vigorous faith to the practical challenges of both the business world and the political arena. Yet the respect he shows for others carries a warmth and modesty that are both too rare among those who are strong advocates of feisty positions.
America badly needs more leaders who really get the future. We need more Rod Martins.
Rod Martin is a modern day philosopher-statesman. He is a capitalist intellectual, a conservative iconoclast, a gentle adversary and a kind prophet. He inspires us towards a fresh national vision built upon the original founding principles.
Rod Martin is not only effective and efficient, but he is also perceptive, wise and gracious. He gets things done. He is a great friend and a great ally.
Rod is one of the sharpest, most gracious men I know, and one of the most gifted political thinkers today. His ability to analyze issues and communicate thoughtful insights on them have earned him the respect of people across the political spectrum.
I am proud to have been Rod Martin’s friend for a quarter century, and I can tell you that he is one of the finest men and most outstanding leaders in our church and in our country today. He has a knack for turning everything he touches to success.
Rod Martin is a cornucopian entrepreneur and eutropic thinker whose influence radiates through an array of companies, institutions, movements and churches. A renaissance American, he is also a prolific friend of freedom and faith around the globe.
If Rod Martin represents the next generation of leaders, America has nothing to worry about.
A leader and a servant, in public life and in private, Rod Martin strides at the top of his profession, and has nowhere to go but up. He is in the truest sense of the word ‘outstanding’.
Rod Martin is undoubtedly one of the most accomplished thought leaders today. He is a wonderful mentor, a humble role model, and a deep inspiration for the next generation of scientific innovators and entrepreneurs.
Rod’s achievements pale beside his character and his brilliance. He sees what others can’t. He leads when others won’t.
Rod Martin is one of America’s finest young minds.
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