The primary problems with drug development are self-evident from the data. Firstly the process of drug development has become enormously more expensive over the past seventy years, a period in in which rapid technological progress has diminished the cost and effort required for any task in pharmacology and biotechnology by orders of magnitude. Secondly, the pace at which useful new medicines emerge in the clinic has diminished considerably, over the same period of technological progress in which the bounds of the possible have opened up enormously. The article I'll point out today is well worth reading, a lengthy treatment of these problems and the various viewpoints on what has caused the present dismal state of drug development. I am not sympathetic to the argument that drug development has become inherently harder for technical reasons. I am sympathetic to the viewpoint that regulation and the inherent waste and misaligned incentives present in governments and other large organizations are to blame.
Given that the pace of drug development in the longevity industry is an existential question for all of us, determining how long and in what state of health we will live, it becomes ever more important to ask how the present dismal state of drug development can be changed for the better. How can it be made faster and cheaper to produce new medical technologies? Or to put it another way, how can we get rid of the ball and chain that has been applied to the process of producing new medical technologies? Working within the system has failed dramatically. Some well-funded groups in the US have tried over the past twenty years, a period of time in which the regulatory cost imposed on medical development by the FDA has doubled. Consider the past efforts of FasterCures for example. Given this, and the many other examples of failure to change bad institutions from the inside, I believe that the only viable way forward to create meaningful change in medical regulation in the wealthier regions of the world is to produce competition through medical tourism.
This means more than just a larger medical tourism industry as it presently exists, because while that industry managed to accelerate the acceptance and regulatory approval of first generation stem cell therapies, that change was still too little and too slow. Forms of organization are lacking in the medical tourism industry, which remains small and disorganized. For example, there is a lack of hybrid organizations that combine aspects of venture capital, clinical business, preclinical development, and respected reviewer of data. The Longevitytech.fund (venture capital and clinical business) and the biotech side of the Próspera project (real estate investment, clinical business, clinical trial infrastructure) are examples of steps in this direction. The part that remains missing is a robust way for the medical tourism industry to produce reputable human data, via the existence of organizations that provide reputation, trust, and value for the industry without turning into just another mini-FDA, beholden to its own interests above those of the field.
In 1953, aged 27, Paul Janssen set up the research laboratory on the third floor of his parents' Belgian drug import firm from where he would grow his eponymous pharmaceutical company. In the years between the 50s and 90s when he was most active, Janssen and his team developed over 70 new medicines, many of which are still in use today. Such prolificacy is unlikely to be repeated any time soon; if current trends hold, a drug discovery scientist starting their career today is likely to retire without ever having worked on a single drug that makes it to market.
The cost to discover and develop a drug today is orders of magnitude higher than in the 1950s. Despite this, the probability that a drug entering clinical trials will eventually reach the market has hardly improved in the intervening years. If Janssen were born today, there's little chance he would be able to repeat his success. He would probably not even get the chance to start.
What changed? Some lay the blame for these deteriorating conditions on regulators like the FDA, claiming that if we were to abolish regulators we would release the stranglehold on industry and unleash a deluge of stalled medicines. Others blame 'big pharma', claiming the industry is suppressing cures - more interested in price gouging on old drugs than investing in R&D. These explanations lack nuance. In reality, the productivity crisis in the pharmaceutical industry is the culmination of decades of just about every aspect of drug discovery and development getting gradually harder and more expensive.
So how did one man and his start-up manage to achieve a level of output that would be the envy of today's pharmaceutical giants?
The article starts out with the premise that it is an increased expense of discovery and development, resulting from structural shifts in the way these processes are conducted, that is the major factor in the problems facing the drug development industry. The author still includes a good, long view of issues on regulatory side of the house. I would argue that those issues are the major factor, both in direct and indirect ways: not just by directly imposing costs, but also by indirectly steering researchers and industry into poor, inefficient strategies. I encourage you to read the whole article.
View the full article at FightAging
