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paula_w · 11-09-2007, 07:32 PM

Pharma Live

This was a week of people speaking up and then running into the verbal equivalent of a sandblaster to the face. Former Intel executive Andy Grove managed to infuriate just about every single pharmaceutical researcher, and Eli Lilly executive Diedre Connelly managed to infuriate just about every single sales rep, especially those on Café Pharma. This week was also marked by Merck’s Vioxx settlement, as well as a settlement by Cephalon for off-label marketing practices.

When worlds collide
Yes, lots of folks had a lot of things to say about Mr. Grove’s interview with Newsweek, in which he complained that for all the advancements in medicine there still is not anything better to treat Parkinson’s disease than levodopa, and that the industry’s researchers can learn something from the semiconductor industry. Oh my. As expected, his words of wisdom were received with less-than-overwhelming enthusiasm. Dr. Derek Lowe of In the Pipeline had some interesting things to say in response, in which he picks apart some of Mr. Grove’s arguments.

“Mr. Grove, here's the short form: medical research is different than semiconductor research,” Dr. Lowe says. “It's harder. Ever seen one of those huge blow-ups of a chip's architecture? It's awe-inspiring, the amount of detail that's crammed into such a small space. And guess what — it's nothing, it's the instructions on the back of a shampoo bottle compared to the complexity of a living system.

“That's partly because we didn't build them. Making the things from the ground up is a real advantage when it comes to understanding them, but we started studying life after it had a few billion years head start. What's more, Intel chips are (presumably) actively designed to be comprehensible and efficient, whereas living systems — sorry, Intelligent Design people — have been glued together by relentless random tinkering. Mr. Grove, you can print out the technical specs for your chips. We don't have them for cells.”
Some might argue with Dr. Lowe that we do have some technical specs now, particularly the human genome. The industry’s defenders will point out that the actions of many living cells are still largely not understood.

Dr. Lowe’s readers largely agreed with his view. Compare these comments, however, with the comments to the Newsweek article, from people who for the most part are not pharmaceutical researchers.

Many of the people with Parkinson’s disease were mourning the abandonment of the synthetic GDNF liatermin by Amgen. You can find out more about how these patients feel about liatermin here. Amgen’s critics do bring up a good point in that the company has pretty much sat on liatermin and does not seem to be developing the drug. That smacks a bit of a dog-in-the-manger attitude. But it would not be quite fair to force Amgen to sell or give liatermin to another developer, especially if that new developer actually manages to bring the drug to market. Licensing the drug could be an option, though, and would give Amgen a share of the revenue if the drug makes it to market.

As a clear example of how science is messy and when it comes to drug development there is still a lot we do not know, we can point to TeGenero and the saga of TGN1412. Remember that? You can read the Institute of Clinical Research’s report here, which concludes that the adverse reactions were caused by “an unpredicted biological action of the drug in humans,” but that still does not tell us why the Phase I clinical trials went so drastically wrong. There are all sorts of theories about what happened. Was it this reason? Or this reason? Was it this reason? Whatever the ultimate cause was, the effect was even more caution from the United Kingdom ’s MHRA on letting complex monoclonal antibodies begin human clinical trials. That brings up the point so many researchers make, that the government regulatory bodies are part of the problem, demanding more clinical trials, more information, etc.

Ed Silverman at Pharmalot says despite executives’ complaints about regulatory foot-dragging, “Someone else thinks the slow rate of approvals is your fault.”. FDA Deputy Commissioner Janet Woodcock told Fortune that the slower rate of approvals is because FDA is receiving fewer new drug applications.

http://www.medadnews.com/magazines/medad/