I read an article in the Guardian titled Scientists find way to slash cost of drugs with some interest; one of the opening parts,
Improvements they devise to the molecular structure of an existing, expensive drug turn it technically into a new medicine which is no longer under a 20-year patent to a multinational drug company and can be made and sold cheaply.
sounds pretty much like the well-known and often cheeky practice of busting drug patents by trying to find a gap in what’s covered, or using a bioisosteric replacement to move outside the patented area, and then developing and patenting a compound of your own in that gap. Essentially you get to leapfrog over the work done by the first group, hopefully arriving at a working compound without having to go through the expense of a full research project. In the article’s case this doesn’t seem to be the method under discussion; a quick google around for the scientists involved turns up their company (I’m surprised that it wasn’t actually named in the article), which seems to be based on sticking PEG on proteins (which I would guess is done to improve their bioavailability). Fair play to them with their technology, but comments like this:
Professor Shaunak says it is time that the monopoly on drug invention and production by multinational corporations - which charge high prices because they need to make big profits for their shareholders - was broken.
Are just plain wrong. Developing drugs costs a lot of money because, frankly, we’re shit at it: we start with tens of thousands of chemicals and gradually narrow it down to one that enters clinical trials (i.e. actually makes it as far as being given to a person). Given that only one in five drugs makes it through this stage, the price of which can run into hundreds of millions of dollars, there are a lot of expensive failures along the way. (I got that one-in-five stat from this article, which is admittedly someone from the pharma industry saying that intellectual property is a good thing.) This failure rate has sometimes led to a rather risk-averse stance where companies only spend a money on a particular disease/target once someone else has shown that it is possible to produce a drug in the area; the follow-on drugs are often called “Me too” drugs. The final price of a drug incorporates the cost of research performed by the company, so using other people’s work to jump-start your own is an obvious way of saving money.
Putting this together with the article’s topic, I take the article to say that the company will be putting PEG on existing compounds, thus moving them outside the original compound’s patent and allowing them to produce the final compound at a lower price. But someone still has to come up with the original compound for them to use, and they’re going to be annoyed if they lose all their profits and so will come after infringers with rabid patent lawers, which will cost a lot to defend against. Plus I wonder how friendly the FDA will be to this approach; any significant change to a compound usually triggers a new clinical trial, so you still have to go through that huge expense. That’s alluded to in the article:
Once the drugs have passed through clinical trials and have been licensed in India, the same data could be used to obtain a European licence so that they could be sold to the NHS as well.
No mention of America, so I infer that they’re avoiding the FDA. I wonder if they’re saving money by doing the trials in India; out-sourcing is certainly a model that’s getting a lot of attention in the pharma industry.
To be honest, I think the main thing that rankles is their claim of being “ethical.” It’s no more ethical than any other industry where cloning and reverse-engineering exists; Behringer effects pedals are an example that spring to mind, and there was at least one law suit flying around when they came out. As ever, it’ll be in the hands of the patent lawers as to whether or not this idea will bear fruit.