By Christoph Westphal
Jonathan Swift’s masterful satirical essays addressed serious issues of his day, proposing humorous solutions. In this vein, I propose applying the rules slowing biopharmaceutical innovation to the highly productive information technology sector.
It is a melancholy object to contemplate the divergent paths of innovation for biotechnology and information technology over the past two decades. One industry has ever longer timelines and greater expenses to provide innovation; while the other requires ever shorter timeframes and less capital to provide products to consumers.
Let us pretend that a genius, Steve Jobs, is seeking to develop and market the iPad. Within a couple of years of having the idea, tens of millions of consumers will have adopted his highly effective device. But we can do better if we allowed the parameters governing drug development to guide Jobs’ path from idea to market, in a thought experiment, comparing the iPad to a drug for Alzheimer’s.
Jobs has a great idea and builds a prototype of the iPad. In the biotech industry this would be called a drug candidate. Jobs should then take his iPad prototype and expose hundreds of mice to the device. No matter that mice are very different than humans, and that effectiveness with mice does not predict positive effects in humans for an Alzheimer’s drug – it is the prescribed path. Jobs should spend about three to four years working on his initial iPad prototype, and on testing in mice.
Once the iPad prototype has been tweaked so that it works well for mice, we would go into human testing. We should do this in separate phases, lest the product advance too rapidly to prematurely satisfy the consumer demand. First for about two years in perhaps 100-200 human volunteers, but looking only for safety, and costing perhaps $10 million. Then, if the iPad is shown to be safe, we should progress to perhaps 300 humans over three years of studying and reviewing the results, to see if we can discern whether the iPad has the wanted activity – this step costing on the order of $50 million. Then, we should test thousands of humans in long term studies, costing many hundreds of millions of dollars and lasting perhaps four to five years.
Even if the iPad is shown to be effective, and if consumers would like to buy the iPad, we should make sure that only a minority of these types of products with proven efficacy and hundreds of millions of dollars invested reach the market. This could be achieved by establishing a regulatory agency governing approval of iPads. Furthermore, we should make sure that consumers do not directly pay Jobs for iPads if they would like to have them. Instead, we should separate the consumer from the purchasing decision by having them buy an insurance for electronic devices, which would seek to ration access to such devices in order to keep overall costs under control.
Once the iPad has cleared the regulatory hurdle for approval to market, and a price has been negotiated between Jobs and the insurance agencies, it is time to begin marketing the product. However, we need to make sure that Jobs is liable for billions of dollars of damages if any single iPad is ever defective. In addition, if Jobs discovered a new, innovative use for the iPad (in the case of drugs, if he discovered another patient population that might benefit), he should go back to retesting the device through the entire process, and should risk his iPad being taken off the market were something to go awry in these studies. Finally, if Jobs ever marketed his iPad for something that was not approved by the regulatory agency, Jobs should risk additional fines of billions of dollars.
In summary, then, I think we have taken Steve Jobs’ lackluster performance with the iPad to a much better place. We have lengthened his timeline to market by perhaps tenfold, reduced his revenues by a similar amount, and made sure that he is liable for any iPad malfunction, or any store ever selling an iPad for a non-approved use.
Invoking Jonathan Swift’s “Modest Proposal”, I profess that I have no personal interest in endeavoring to promote this necessary work of improving the information technology industry by applying the principles governing drug development.
Christoph Westphal, an occasional contributor to the Boston Globe, is a biomedical entrepreneur based in Boston. He can be reached at www.twitter.com/drcwestphal