The “innovation” in this approach is not scientific, but economic.
Improvements they devise to the molecular structure of an existing, expensive drug turn it technically into a new medicine that is no longer under a 20-year patent to a multinational drug company and can be made and sold cheaply. The process has the potential to undermine the monopoly of the big drug companies and bring cheaper drugs not only to poor countries but back to the UK.
Okay, I may be missing something here, but this is not a scientifically innovative strategy. They are called Me-Too drugs. Pharma has been doing this for years. Read this article in the Stanford Medicine Magazine about exactly how this is done.
Nexium illustrates the drug makers’ strategy. Many chemicals come in two versions, each a mirror image of the other: an L-isomer and an R-isomer. (The “L” is for left, the “R” is for right.) Nexium’s predecessor Prilosec is a mixture of both isomers. When Prilosec’s patent expired in 2001, the drug maker was ready with Nexium, which contains only the L-isomer.
Is Nexium better? So far,
there’s no convincing evidence that it is, says Stanford drug industry watcher Randall Stafford, MD, PhD.
This is a well known and well used strategy. The Government Accounting Office (GAO) recently released a study which concluded that 68% of all drugs developed in the US between 1993 and 2004 were Me-Toos.
So, what is “innovative” and “revolutionary” about this approach is that non-profits are driving the drug development. By outsourcing the entire clinical trial to India, substantial savings are to be had. By not having to fund the US shareholders’ need for huge profits, enormous company overhead, high salaries, multi million dollar executive bonuses and marketing expenses that US/European pharma require, cost savings are potentially huge.
The downside? Well, unless the studies are run according to US/EU GLP/GMP guidelines, data quality, and therefore, drug safety can be suspect. The pedigree of the people involved in this effort makes it unlikely that the data is going to be suspect. If their ultimate aim is to sell these drugs in England, then they will have to meet the most stringent standards available.
Of course, these drugs will never hit the US of A. I can already hear the fear mongering, the safety doubts being raised, the “terrorists may get their hands on your pill” bogey, etc. But, Americans can afford to pay for their drugs more than your average Indian suffering from Hepatitis C can. Once the already teetering (by first world standards, of course!) healthcare system in the US gets closer to collapse (by first world standards, of course!), some of these “innovations” will become more viable in this most reactionary of countries.
I hope this model is proven to be viable.