With contributions from James Smith, a recent Oxford University graduate and current SENS Research Foundation Summer Scholar working at the Harvard Stem Cell Institute.
Consider this question: if I gave you the option to take a drug offering a 100 percent chance of survival to average life expectancy at which time you would certainly fall down dead, would you take it? Let’s say that age is 82. The other option is to take your chances and live to some undetermined point on a wider distribution around that age; you might only live to 60, you might live to 100, or you might fall somewhere in between.
Figure 1: Would you prefer to be uncertain about your age of death (A)? or know that you will certainly live to reach average life expectancy but no longer (B)? Image courtesy of Chris Hornsby, Risk Management Solutions.
Chris Hornsby from Risk Management Solutions posed this provocative question to the audience at the SENS Foundation’s Rejuvenation Biotechnology conference and the response was overwhelmingly in favour of the latter. We were included in this majority; however, we were not making the sensible choice – we chose to be risk prone.
Dying young is clearly undesirable. From a rational perspective, dying old, if you cannot predict exactly when, is also problematic as a majority of people are expected to outlive their savings, according to many sources. If this scenario had been framed in the context of a financial investment, those same people would likely have chosen the first, risk averse option.
The point of this example is to illustrate that people do not always think about their health rationally, an interesting consideration in the context of one of the key themes of the second day of the conference: regulation. Personal perception of payoff of a particular treatment, such as the hypothetical one above, influences the regulatory risk associated with the new treatment. In fact, rather than being a simple function of utility, regulation should take into account value of a treatment.
Value, according to Anant Jani, of Better Value Healthcare, can be divided into three subgroups: technical value, social value and personal value. It is only through consideration of all of these that effective and meaningful regulation will take place.
Regulators, it seems, are often considered to be an impediment to successful translation from the lab to the clinic, as is evidenced by the frequent discussion of difficulties with regulatory approval. However, as Wake Forest University’s Julie Allickson pointed out, regulators are ultimately motivated by the same overarching goals as many scientists and industry: providing safe and efficacious treatments to the public.
One of the salient messages of the day has been the need to bring regulators and innovators together, at an early stage, as collaborators towards this goal – not as perceived adversaries.
And this is not just rhetoric; my impression is that a fundamental change in how we approach the ‘regulatory barrier’ is occurring. Laura Esserman, of the University of California, San Francisco, spoke of the benefits that collaborating with the FDA, from the outset of the I-SPY TRIAL 2, is having on accelerating the approval of new treatments for breast cancer. Similar messages were echoed by other speakers. Howard Foyt, in reference to the commercialization of a new technology for treating diabetes, went so far as to say (albeit ‘hesitantly’) that the FDA was ‘enthusiastic’ and ‘supportive.’
There is certainly still room for improvement. In particular, an iterative model of regulation and innovation should be more widely pursued. The onus for initiating this would likely fall on the innovator; regulators need to dispose of the attitude of a one-time verdict on approval, towards encouraging a dynamic, adaptive licensing process.
Overall, the outlook seems positive; there were certainly more suggestions of strategies to improve and address regulatory issues than comments suggesting that approval is an insurmountable barrier. Seeing these strategies implemented requires fundamental change in the way regulation is often viewed. But doing so may ultimately allow a greater number of therapies to reach the clinic – accelerating the time to essential patient benefit.
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