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Patents Choking Off Medical Research
pq writes "The New Republic has an insightful article talking about the
"absence of truly innovative drugs in current drug company pipelines. And the explanation for that might well come from the supposed fount of American innovation: our patent system." Apparently they are trapped in a situation where "it's much easier to argue that `patents support innovation' than to try to explain that some patents are good for innovation while others are bad." A long read, but unlike the latest copy-protected mp3 player, this is definitely stuff that matters!"
1. Pharmaceutical companies have big ties into our government, controlling legislation.
50% of every dollar spent on medicine in the US comes from the Federal Government. No big suprise it is politicized. With prescription drug coverage for Medicare coming, the percentage will rise.
3. The FDA has limited manpower, which means less drugs tested.
This is wrong. Every drug is tested by its maker, on its maker's dime. The FDA only requires testing and examines results. The average cost of testing is near $100 million, and the drug may then not work (most don't make it through testing). Backups due to the FDA do not lead to untested drugs being released, it leads to fewer drugs being released.
I work in an industry that supports the very early stages of drug discovery at all the large pharmaceutical companies, so I can give you a different perspective than the author, who is apparently not a chemist.
First of all, the complaint that "Nexium... is essentially AstraZeneca's old heartburn drug Prilosec with a minor chemical twist that allowed the company to extend its patent." is shallow. Prilosec was a racemic mixture - a mixture of two mirror-image molecules with the same atomic connections. This is the old way that bioactive molecules with one or more chiral centers were patented and sold, because it was too expensive or impossible to separate the mixture into its chirally-pure components. Unfortunately, the mechanisms of the body are chiral, and often it is only one of the mirror-images which is the active ingredient. The other enantiomer is at best inactive and at worst toxic, mutagenic, teratogenic, etc. It is only with the chiral preparative and analytical methods and tools available in the last 15 or so years that it has become economically feasible to either prepare only the active enantiomer or to purify away the undesired enantiomer from the mixture. This is what AstraZeneca has done. From Prilosec to Nexium is not a minor chemical twist - it is a profound biochemical change. In the meantime, anyone else could have separated Prilosec into its components and patented only the active enantiomer, which is what a company called Sepracor has been doing. Sepracor is a company specializing in chiral separations. They have been taking patented compounds and isolating and patenting the active ingredient. Sometimes they license the compound back to the original manufacturer, but if the holder of the patent on the racemic mixture doesn't want to pay, Sepracor sells it themselves or in partnership with another firm.
Second, my customers are under constant pressure to shorten the discovery pipeline so that successful drugs can be sold under patent protection for as many years as possible. That means more work for me, luckily. To argue that the patent process is wrong or flawed is to ignore the full shelves in the pharmacy. If it weren't for the patent process, those bottles would be full of roots and bark. (Not that there is anything wrong with roots and bark, just that they may also contain toxic compounds.)
Which reminds me of: third, the author confuses small-molecule patents with biochemical patents. The old school (classical small-molecule therapies) patent system works pretty well. You get some years to make money to fund R&D on new drugs. It is the silly biochemistry and genomic patents which are insane, and the patent office has let them get away with it. From PCR to broad gene therapy claims based only on sequence - that process is as flawed as the software/business model patent crap that is every fifth story on slashdot. This is the area the author should have concentrated on.
Last, the author gives the impression that there are no new areas for drug therapies out there. This is just a lack of effort on his part. Most drugs initiate change in the body by interacting with receptor proteins on the outside of cells. And each type of receptor - the calcium channel, for example - comes in subtypes which may be expressed in different amounts dependint on tissue type or even on different areas of the same organ. Many of the drugs currently in use do not differentiate very well between the receptor subtypes to which it binds or interacts. There is a huge opportunity for development of drugs which are more and more specific to a specific receptor and so demonstrates fewer and fewer side effects - which are manifestations of interactions with other receptors than the family targeted. The combination of high-throughput screening and combinatorial synthesis, both of which are still in their early stages, promise to supply us with many times more drug candidates than classical one-pot organic preparations and one-rat-at-a-time testing of those compounds.
If Slashdot were chemistry it would look like this:Cadaverine