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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

« Where Credit's Due | Main | Silver Tongues, Golden Hands? »

October 1, 2002

Overpatenting?

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Posted by Derek

There's an article in the latest New Republic on innovation in the drug industry. As far as I'm concerned, it draws good conclusions from faulty premises (which, admittedly, is a lot better than drawing bad ones from a good starting point!)

The author, Nicholas Thompson, says that

shares in the pharmaceuticals index, meanwhile, are down 25 percent. And the industry deserves it. For years it has squeezed consumers the world over, endlessly arguing that it needs its huge profits in order to invest in new, lifesaving innovations. But while that might once have been true, lately the industry hasn't been innovating at its past rate--and that's probably the main reason investors have started to back off.

Well, that last part rather goes without saying. But, talk of "deserving it" aside, his reasons why this has happened are a little too glib:

The cliché of the moment is that pharmaceuticalcompanies have picked the low-hanging fruit, developing drugs that interact with the limited number of enzymes and molecules that we already understand and have thoroughly modeled.

Sounds like he's been reading this site. Some things get to be truisms because they're true.

But people have always mourned the loss of the low-hanging fruit--and then smart and innovative folks built taller ladders. The tools and computational abilities available to drug companies today dwarf those that companies employed to develop the blockbusters that fueled the 1990s boom. Scientists now have access to the human genome and a vastly increased understanding of everything from gene expression to organ physiology as well as extraordinarily powerful computing and modeling capabilities. In many ways, discovery should be easier and cheaper now than ever before.

You'd think so, wouldn't you? Problem is, all that knowledge has also bred more complications. Look at gene expression: we can now look at thousands and thousands of genes going up and down when we administer our drug candidates. What percentage of that do we actually understand? You'd be hard pressed to get a knowledgable answer that gets out of the single digits. As for computational ability, the big news the other day was that we finally (after decades of trying) predicted a protein's structure from knowing its amino acid sequence. Another few hundred thousand of those and we'll be in business. Then we can start figuring out how they interact with each other, and then we can start figuring out how to make drugs that do the same. It'll be a great day when we do - but that day isn't here.

And the very successes of the industry over the last 25 years have led to the bar being raised. Some things that were huge blockbusters back then wouldn't stand a chance today - too many side effects, for example. Racemic compounds (Prozac, to pick an example from the article) don't stand much of a regulatory chance today; the FDA wants single enantiomers. (Ironically, the active enantiomer of Prozac actually has a worse window for tox effects - the same compound might not have made it at all today.)

Thompson goes on to decry the amount of money put into marketing, and I can't argue with him much there (tomorrow I'll try to talk about the new government guidelines issued today.) But I think he's fallen into a post hoc, ergo propter hoc fallacy: in many cases, the marketing has been cranked up because the drug pipeline is thin. The money spent on marketing isn't necessarily what thinned it out.

Where he strikes gold is when he starts talking about the patenting of "upstream" products: assays, research tools, biological pathways, and methods of treatment. He goes over some examples familiar to readers of this blog (Ariad!) and correctly points out that this sort of thing is fast becoming a crippling influence. Actually, I think it's been a lesser contributor to the productivity decline so far, but it's set to pile on top of what's already a tough situation. Then we really be up the creek.

His solution? Right on target, to my thinking:

The best thing for the pharmaceutical industry would probably be to maintain its strong protection over downstream products while opening access for upstream products.

Preach it, and speed the day! I've been working on some pieces addressing this issue (guess I won't be selling them to TNR, dang it all.) We haven't heard the last about this issue - at least, not if I have anything to do about it.

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