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
As one of Garrison Keillor's characters says (in WLT), "I always knew the end would come. And here it is, the end". Lipitor (atorvastatin) goes off patent today, and I can recommend this overview by Matthew Herper at Forbes. Will there ever be another drug like it? The people developing the CETP inhibitors hope so. . .
I think the most interesting thing about the arrival of generic Lipitor is Pfizer's strategy so far. I can't even think of a time when a pharma company put this much effort into holding onto branded sales post LOE.
So far:
- discounts to PBMs to get preference to the generics (which seems to have caused a number of them to refuse to reimburse for the generic)
- co-pay assistance to make the out-of-pocket expenses for patients equal to the generics
- setting up a mail-order system so patients can get Lipitor directly from Pfizer
I think the next 6 months are going to be VERY interesting. Obviously Pfizer is pulling out the big guns on this one.
3. NoDrugsNoJobs on November 30, 2011 1:55 PM writes...
Gonna go out on a limb and say the CETP inhibitors will never come close to the statins and for no other reason than we already have the statins - the baseline is moved so high with statin treatment that even if we see an additional benefit from CETP-inhibition, it is not going to be so dramatic and there will be additional side effects, and there is the cost, etc. I hope they really are as good as the lipid profiles they yield but would be very surprised if they are....but here's to hoping!
From what I've read, CETP inhibitors aren't just going after the "improved lipid profile" but rather reversal of atherosclerosis similar to the apo A-1 milano therapy.
If they get that indication, then it wouldn't surprise me if they get bigger than the statins.
@3 NoDrugs
True. But with statin "resistance" running at roughly 20%, there's a sizable chunk of humanity that needs other therapeutic options. If shown to be effective & safe, newer CETPi could nonetheless add a lot of $imoleon$ to PharmaCo's bottom line.
7. Anonymous on November 30, 2011 5:50 PM writes...
Well, we all know that Pfizer has been preparing for this day. They laid off so many scientists that I'm surprised anyone would even consider going there now or in the future.
Until the FDA is reformed and we get smart people in Pharma boardrooms, the drug industry isn't coming back. Read: never; it's cheaper to repackage existing products. If Vioxx isn't safe enough for the FDA, what hope do any of us have?
10. Ricardo Rodriges on December 1, 2011 2:25 AM writes...
Unfortunately, I got some friend at the blue monster, really sorry for them. It seems like is worst there than at many other industries.
I was reading how Pfizer behave towards its employees over the 1929 depression, for a decade it made the concious decision to not lay off any employees, some companies should learn from their past.
13. Anonymous on December 2, 2011 7:26 AM writes...
Vioxx was save enough for the FDA, Merck decided it was not save enough for the public and pulled it. Hence the mess the industry is in now; the public doesn't trust the FDA and the FDA has raised the bar so high it's almost impossible to get new drugs approved, especially novel ones.
CETP inhibitors: I didn't go through this for length reasons, but my basic argument would be that in order to be used for primary prevention, CETP inhibitors would have to work in quite a giant trial versus statins. In clinical trials, the event rate is already pretty low in those people. So even if they work very well, it's going to be hard to reach the market Lipitor reached with a CETP inhibitor.
More likely, with current market forces, they will be priced much higher than statins were and used mostly for secondary prevention.
15. john calhoun on September 18, 2012 7:29 PM writes...
Derek, you're PRICELESS! Having read about hexanitrohexaazaisowurtzitane (CL-20), I annotated my copy with "a molecule just itching to become an explosion," and, noting its 3-D shape, "birdhouse-cum-boom." Like those? The worst TIWWW I ever handled was pyruvic acid, which, after I synthesized it, turned dark and suddenly ignited out the twin necks of my distilling flask to coat my lab partner with thousands of little curlicue carbon strings, which of course greatly endeared me to him. I also looked up chlorine trifluroride (ClF3) on Wiki and decided that I'd give anything that sets solid concrete on fire at least 100 megaparsecs of room to do its thing. I just finished John D. Clark's book 'Ignition! An informal history of liquid rocket propellants' and found out even more about all those hypergolic horrors that he researched for NASA, Thiokol, and other creators of deadly witches' brews. I highly recommend it, but I'll bet my last gram of Pu-239 you already have read it. Say, as a writer myself, I'll give you some free advice: Why not compile all those TIWWWs (and more) into a book? A hilarious tome like that might just make you enough money to pay for all those burn-ward stays you've no doubt accumulated--just reserve me an autographed copy and I'll call the whole thing even. Oh yes, I note that hexayaddayaddayadda even made it into Wiki on its own, so the people willing to fool with it are probably dwindling asymptotically to zero. I dropped out of that group as soon as I read your blurb.
Keep 'em coming, brother--you're one of the planet's true originals.
College chemistry, 1983
The 2002 Model
After 10 years of blogging. . .
), "I always knew the end would come. And here it is, the end". Lipitor (atorvastatin) goes off patent today, and I can recommend 
1. startup on November 30, 2011 1:44 PM writes...
I figured as much when on the way to work I heard Pfizer ad promising it for as low as $4/month.
Permalink to Comment2. Biotechtranslated on November 30, 2011 1:55 PM writes...
I think the most interesting thing about the arrival of generic Lipitor is Pfizer's strategy so far. I can't even think of a time when a pharma company put this much effort into holding onto branded sales post LOE.
So far:
- discounts to PBMs to get preference to the generics (which seems to have caused a number of them to refuse to reimburse for the generic)
- co-pay assistance to make the out-of-pocket expenses for patients equal to the generics
- setting up a mail-order system so patients can get Lipitor directly from Pfizer
I think the next 6 months are going to be VERY interesting. Obviously Pfizer is pulling out the big guns on this one.
Mike
Permalink to Comment3. NoDrugsNoJobs on November 30, 2011 1:55 PM writes...
Gonna go out on a limb and say the CETP inhibitors will never come close to the statins and for no other reason than we already have the statins - the baseline is moved so high with statin treatment that even if we see an additional benefit from CETP-inhibition, it is not going to be so dramatic and there will be additional side effects, and there is the cost, etc. I hope they really are as good as the lipid profiles they yield but would be very surprised if they are....but here's to hoping!
Permalink to Comment4. Biotechtranslated on November 30, 2011 2:06 PM writes...
@#3,
From what I've read, CETP inhibitors aren't just going after the "improved lipid profile" but rather reversal of atherosclerosis similar to the apo A-1 milano therapy.
If they get that indication, then it wouldn't surprise me if they get bigger than the statins.
Mike
Permalink to Comment5. pete on November 30, 2011 2:14 PM writes...
@3 NoDrugs
Permalink to CommentTrue. But with statin "resistance" running at roughly 20%, there's a sizable chunk of humanity that needs other therapeutic options. If shown to be effective & safe, newer CETPi could nonetheless add a lot of $imoleon$ to PharmaCo's bottom line.
6. Curious Wavefunction on November 30, 2011 4:42 PM writes...
Another good quote for the company marketing Lipitor would have been "We have met the enemy and he is us".
Permalink to Comment7. Anonymous on November 30, 2011 5:50 PM writes...
Well, we all know that Pfizer has been preparing for this day. They laid off so many scientists that I'm surprised anyone would even consider going there now or in the future.
Permalink to Comment8. Chemjobber on November 30, 2011 7:19 PM writes...
I stood in a room in 2007 when outgoing PGRD chief John LaMattina said that Pfizer was right-sized for this day.
I wonder if JLM ever rues making that statement.
Permalink to Comment9. Fred on November 30, 2011 7:31 PM writes...
Until the FDA is reformed and we get smart people in Pharma boardrooms, the drug industry isn't coming back. Read: never; it's cheaper to repackage existing products. If Vioxx isn't safe enough for the FDA, what hope do any of us have?
Permalink to Comment10. Ricardo Rodriges on December 1, 2011 2:25 AM writes...
Unfortunately, I got some friend at the blue monster, really sorry for them. It seems like is worst there than at many other industries.
I was reading how Pfizer behave towards its employees over the 1929 depression, for a decade it made the concious decision to not lay off any employees, some companies should learn from their past.
Permalink to Comment11. Morten G on December 1, 2011 9:54 AM writes...
I think maybe I'm confused about how atherosclerosis works.
LDL-particles oxidised -> taken up by macrophages -> foamy cells -> plaque, right?
How would messing with CETP improves this? Won't LDL particles simply become less stable if there's less cholesterol in them than nature intended?
Permalink to Comment12. Vader on December 1, 2011 1:02 PM writes...
"If Vioxx isn't safe enough for the FDA, what hope do any of us have?"
Bears repeating. And repeating.
Permalink to Comment13. Anonymous on December 2, 2011 7:26 AM writes...
Vioxx was save enough for the FDA, Merck decided it was not save enough for the public and pulled it. Hence the mess the industry is in now; the public doesn't trust the FDA and the FDA has raised the bar so high it's almost impossible to get new drugs approved, especially novel ones.
Permalink to Comment14. Matthew Herper on December 2, 2011 7:42 AM writes...
CETP inhibitors: I didn't go through this for length reasons, but my basic argument would be that in order to be used for primary prevention, CETP inhibitors would have to work in quite a giant trial versus statins. In clinical trials, the event rate is already pretty low in those people. So even if they work very well, it's going to be hard to reach the market Lipitor reached with a CETP inhibitor.
More likely, with current market forces, they will be priced much higher than statins were and used mostly for secondary prevention.
Permalink to Comment15. john calhoun on September 18, 2012 7:29 PM writes...
Derek, you're PRICELESS! Having read about hexanitrohexaazaisowurtzitane (CL-20), I annotated my copy with "a molecule just itching to become an explosion," and, noting its 3-D shape, "birdhouse-cum-boom." Like those? The worst TIWWW I ever handled was pyruvic acid, which, after I synthesized it, turned dark and suddenly ignited out the twin necks of my distilling flask to coat my lab partner with thousands of little curlicue carbon strings, which of course greatly endeared me to him. I also looked up chlorine trifluroride (ClF3) on Wiki and decided that I'd give anything that sets solid concrete on fire at least 100 megaparsecs of room to do its thing. I just finished John D. Clark's book 'Ignition! An informal history of liquid rocket propellants' and found out even more about all those hypergolic horrors that he researched for NASA, Thiokol, and other creators of deadly witches' brews. I highly recommend it, but I'll bet my last gram of Pu-239 you already have read it. Say, as a writer myself, I'll give you some free advice: Why not compile all those TIWWWs (and more) into a book? A hilarious tome like that might just make you enough money to pay for all those burn-ward stays you've no doubt accumulated--just reserve me an autographed copy and I'll call the whole thing even. Oh yes, I note that hexayaddayaddayadda even made it into Wiki on its own, so the people willing to fool with it are probably dwindling asymptotically to zero. I dropped out of that group as soon as I read your blurb.
Keep 'em coming, brother--you're one of the planet's true originals.
John Calhoun,
Permalink to CommentFort Collins, CO