Is Big Pharma bad or just misunderstood?

I saw this article last week, and quite enjoyed it at the time. But then after a great deal more thinking I realised that it wasn’t such a great piece of journalism after all.

Basically it’s a fairly disparaging piece about Big Pharma, and their common practice of filing as many European patents for one drug as possible. It seems a pretty cynical ploy, designed to wring as much cash out of a single molecular entity as possible, and let’s face it Big Pharma is actually a very easy target to get stuck into when you think about it. I know, I’ve thought about it for fourteen years.

When I thought deeper about it though I must confess I actually feel some sympathy for the companies – never in my darkest days did I think that would be possible, but another recent Grauniad article brought this home. Paul McCartney still has to pay royalties to the Michael Jackson Estate if he wants to play any of the Beatles back catalogue, apparently. If one looks at it as a question of ownership and copyright then things seem a little clearer.

A drug I worked on many years ago had been developed by Bristol Myers Squibb; it had been disclosed in the literature and so they owned that little piece of metabolic pie, so to speak. But then they sold it to another company because they could not or would not pay for a phase III trial. As a consequence they lost ownership of a rather nifty drug but in return for stacks of cash, and the contract they signed basically gave away the patents for that drug. I can’t remember who picked up the tab, but on a personal note I know they’ve got a winner there, whoever they are.

Let us use a different analogy: JK Rowling writes a book, has a few characters in there who all appear rather distinctive: a boy wizard with glasses and a scar, a big hairy man, someone who cannot be named, that sort of thing. If I were to write a book with the same (or at least startlingly similar characters) and somehow it got into print I would then have to pay Ms Rowling a substantial percentage of my earnings from that book, simply because I have breached her copyright.

The European patents that drug companies are filing are essentially a way of reinforcing that copyright – it is actually all too easy for a chemist with a decent knowledge of how patents work to find a way around the filing and create a “novel” molecule. The eighties and nineties were full of “me-too” drugs, so I don’t really need to go into details. Therefore Big Pharma takes great care to detail as many synthesis steps, as many analogues and as many disease targets as is relevant and possible. They are all too afraid of someone doing a “patent-bust” and creating another me-too.

There is a humanitarian edge to this as well. The European patents are there to try and (futilely, some might say) block the production of generic drugs. Let’s say a company by the name of Astra Zeneca makes an Antimalarial drug, runs the trials and sells it to 3rd world governments. All well and good. Now supposing a factory in another country starts churning out generic copies of this drug which the governments buy at a quarter of the price? Not only would AZ be cross about the cut in income (it will have cost a lot to develop and trial the damn thing as well!) but there would be an additional worry.

Many of these generics are poor quality or low dose, which can all too frequently lead to drug resistance and the rise of “superbugs”; malaria is but one example. Big Pharma at least is required to undergo bioequivalence and quality control testing. Plus, as evil as Big Pharma is, it doesn’t want to lose patients.

Hence my sympathy with Big Pharma this time around. Unfortunately the Grauniad is guilty of shoddy journalism this time.