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
Hmmm. As a colleague just pointed out to me, I've spent some time here defending "me-too" drugs. And just this morning (see the previous post) I take off after what can only be described as "me-too reactions", saying that I don't see the use for so many of them.
Well! The only defense I can offer (until I think of a better one) is that there is no drug category so populated as the aldoxime-to-nitrile conversion is in synthetic chemistry (or acetal formation/deprotection, desilylation, or the other categories I spoke of in that other post). I suppose I might have a tougher time standing up for me-too drugs if there were (say) twenty-nine statins on the market. But still. . ."I'd better put up a post on that", I said. "Better you than someone with a funny pseudonym in your comments section", came the reply.
I remember ~ 20 years ago when Searle deveolped Daypro as about the 21st NSAID as a 1200 mg horse pill thinking are they crazy. But then it went on and sold ~ 300 to 400 M/year at peak. Guess they had good marketing / sales or something
The situations aren't that parallel. (Of course, I've just heard an egregious ad hominem on Al Gore, so I may be primed for worse cases of implied hypocrisy.)
I think there are about 20 beta blockers on the market, so I think that market has gone through the diminishing marginal returns phase and is well into the why bother phase, but maybe some market analyst has a different opinion.
4. piratechem on October 9, 2009 12:03 AM writes...
Definitely not analogous in terms of multiplicity--way more me-too reactions. However the much larger financial scale of developing a drug vs developing a reaction should get some consideration.
5. RB Woodweird on October 9, 2009 6:39 AM writes...
What do ya mean, funny? Let me understand this cause, I don't know. Maybe it's me, but I'm funny how? I mean, funny like I'm a clown; I amuse you? I make you laugh... I'm here to amuse you? What do you mean funny, funny how? How am I funny?
Anyway, I don't see the parallel at all. So-called me-too drugs have some utility. There are going to be people who tolerate one such drug better than another and people for who one such drug works better than another. Plus, the enormous effort necessary to bring a drug to market means that there are not going to be dozens of very similar drugs.
Reactions, however, have a very different genesis. I'm willing to bet dollars to disposable pipets that each of these little me-too dehydration reactions wasn't dreamed up by someone thinking that the world really really needed another one. They were cooked up by graduate students who just needed a publication or two to get the hell out of graduate school.
6. Analytical Scientist on October 9, 2009 7:33 AM writes...
It's a mater of degree: a couple of me-too's provide depth to the bench, but a new me-too with undistinguished safety/efficacy after the lead is already generic is just excessive. I get annoyed everytime I learn about a new proton pump inhibitor that I was unaware of. To your statin example, new statins are fine...but they better be more potent (and safe!) than Lipitor!
Regulatory authorities have no right to reject safe effective therapies on the basis of non-superiority to existing therapies in a free society. The arguement has been rightfully made many times on this blog that there are always differences which may benifit one patient population over another and equivalent therapies drive down cost as well. The USDA can't keep pork chops off the market because they do not taste as good as a good ribeye, nor can government keep a Ford off the market because it is not as good as a BMW. We have drifted into the sureal when we allow government this level of control. Payers are becoming more agresive in setting the price/benefit bar they will pay for high, and rightfully so, but price/benefit should not be the authority of a free government. We need to be careful in asuming we know who will benefit from certain drugs, and remember that choice is the only true form of wealth. If today's standards were used there would be no Lipitor (It was 4th with no apparent differentiation at the time of approval). The 5th PPI to market still sells >1B/yr, someone is getting some benefit. I just know as a taxpayer I don't want to fund the 200th oxime dehydration, I could care less if it gets published.
1. John Freskos on October 8, 2009 2:32 PM writes...
I remember ~ 20 years ago when Searle deveolped Daypro as about the 21st NSAID as a 1200 mg horse pill thinking are they crazy. But then it went on and sold ~ 300 to 400 M/year at peak. Guess they had good marketing / sales or something
Permalink to Comment2. Sili on October 8, 2009 3:10 PM writes...
Awwww.
The situations aren't that parallel. (Of course, I've just heard an egregious ad hominem on Al Gore, so I may be primed for worse cases of implied hypocrisy.)
I think your argument holds water.
Permalink to Comment3. John Johnson on October 8, 2009 10:07 PM writes...
I think there are about 20 beta blockers on the market, so I think that market has gone through the diminishing marginal returns phase and is well into the why bother phase, but maybe some market analyst has a different opinion.
Permalink to Comment4. piratechem on October 9, 2009 12:03 AM writes...
Definitely not analogous in terms of multiplicity--way more me-too reactions. However the much larger financial scale of developing a drug vs developing a reaction should get some consideration.
Permalink to Comment5. RB Woodweird on October 9, 2009 6:39 AM writes...
What do ya mean, funny? Let me understand this cause, I don't know. Maybe it's me, but I'm funny how? I mean, funny like I'm a clown; I amuse you? I make you laugh... I'm here to amuse you? What do you mean funny, funny how? How am I funny?
Anyway, I don't see the parallel at all. So-called me-too drugs have some utility. There are going to be people who tolerate one such drug better than another and people for who one such drug works better than another. Plus, the enormous effort necessary to bring a drug to market means that there are not going to be dozens of very similar drugs.
Reactions, however, have a very different genesis. I'm willing to bet dollars to disposable pipets that each of these little me-too dehydration reactions wasn't dreamed up by someone thinking that the world really really needed another one. They were cooked up by graduate students who just needed a publication or two to get the hell out of graduate school.
Permalink to Comment6. Analytical Scientist on October 9, 2009 7:33 AM writes...
It's a mater of degree: a couple of me-too's provide depth to the bench, but a new me-too with undistinguished safety/efficacy after the lead is already generic is just excessive. I get annoyed everytime I learn about a new proton pump inhibitor that I was unaware of. To your statin example, new statins are fine...but they better be more potent (and safe!) than Lipitor!
Permalink to Comment7. JGault on October 10, 2009 7:51 PM writes...
Regulatory authorities have no right to reject safe effective therapies on the basis of non-superiority to existing therapies in a free society. The arguement has been rightfully made many times on this blog that there are always differences which may benifit one patient population over another and equivalent therapies drive down cost as well. The USDA can't keep pork chops off the market because they do not taste as good as a good ribeye, nor can government keep a Ford off the market because it is not as good as a BMW. We have drifted into the sureal when we allow government this level of control. Payers are becoming more agresive in setting the price/benefit bar they will pay for high, and rightfully so, but price/benefit should not be the authority of a free government. We need to be careful in asuming we know who will benefit from certain drugs, and remember that choice is the only true form of wealth. If today's standards were used there would be no Lipitor (It was 4th with no apparent differentiation at the time of approval). The 5th PPI to market still sells >1B/yr, someone is getting some benefit. I just know as a taxpayer I don't want to fund the 200th oxime dehydration, I could care less if it gets published.
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