Should $2M Buy You A Personalized Clinical Drug Trial?

I came across an interesting piece on the The Conversation by Stephanie Swift, a researcher at the University of Ottawa. She writes about a proposal by Alexander Masters, recently published in Mosaic (a science magazine), in which he argues for a new system for matching sick rich people with emerging cures.

Notes Swift:

With Masters’ proposal…a rich benefactor essentially enables a clinical trial to go ahead that would otherwise have remained unfunded. The idea involves creating a not-for-profit “dating agency” that would match a sick benefactor with a researcher who has a promising new treatment for his or her disease.

One version of Alexander Masters’s proposal. The Wellcome Trust/Peta Bell/Jean Jullien

The dating agency would have an independent panel of scientists whose job it would be to validate the science behind the therapy. The rich benefactor donates, say, US$2m and both the benefactor and 19 other people suffering from that disease, who could not have afforded to pay a contribution towards such a trial, get a spot on the clinical trial. The framework of the clinical trial – including ethical and regulatory approval – remains unchanged. The only difference is where the funds are coming from.

Swift makes the case that the Masters model would address (a) critical shortfall in the funding of small, early-stage clinical trials and (b) the restrictive nature of large-scale efforts:

This funding situation is only expected to get worse. For instance, the Canadian Institutes for Health Research (CIHR), one of Canada’s largest funding bodies for health sciences, is debating whether clinical trials should be funded at all. They argue that funding a single clinical trial with a price tag of C$2m (US$1.8m) – the approximate cost for an academic researcher to run their own early-stage study – would mean that many other research labs who might otherwise expect to receive smaller grants to support their basic research would miss out.

The main alternative path for finding funds to take that first step into a clinical trial pairs a researcher with a pharmaceutical company. The industrial partner supplies the necessary funds needed to run the study, as long as they see good potential for a return on their investment. The downside is that researchers usually end up signing away their promising treatment as a condition of the partnership – and ultimately losing control of subsequent returns should the therapy prove to be successful.

Swift points out that the potential pool of funders is large:

There are 100,000 people in the world worth more than £20m (US$32m). According to the medical statistics, between three and five people in every 100,000 will get neuroendocrine cancer. So three to five supremely wealthy people will have the disease. For £1m, I was going to sell one or two of these wealthy individuals a place on the [biotherapy] trial. All the wealthy individuals had to do was pay for the entire trial.

This is a fascinating proposal, which would allow wealthy, risk-accepting individuals to fund trials at the cutting edge of clinical applications. I can imagine that there are people with specific social views who will decry the Masters plan as a way of giving plutocrats a voice over, literally, who lives and dies, since only persons with the disposable $2M will be able to fund these personalized trials. I disagree with that critique. The reality is that without those funds, these trials would probably not happen. The Masters plan allows rapid funding of disease-specific trials and, with the right oversight and ethical controls in place, should be implemented as a complement to the existing clinical trials mechanisms.

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