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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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May 9, 2013

Merck's Liptruzet: A Cause For Shame?

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Posted by Derek

Vytorin's been discussed several times around here. The combination of Zetia (ezetimibe), the cholesterol absorption inhibitor discovered at Schering-Plough, with Merck's simvastatin looked as if it should be a very effective cholesterol-lowering medication, but the real-world data have been consistentlypuzzling. There's a big trial going on that people are hoping will clarify things, but so far it's had the opposite effect. It's no exaggeration to say that the entire absorption inhibitor/statin combination idea is in doubt, and we may well learn a lot about human lipidology as we figure out what's happened. It will have been an expensive lesson.

So in the midst of all this, what does Merck do but trot out anotherezetimibe/statin combination? Liptruzet has atorvastatin (generic Lipitor) in it, instead of simavastatin (generic Zocor), and what that is supposed to accomplish is a mystery to me. It's a mystery to Josh Bloom over at the American Council for Science and Health, too, and he's out with an op-ed saying that Merck should be ashamed of itself.

I can't see how he's wrong. What I'm seeing is an attempt by Merck to position itself should the ongoing Vytorin trial actually exonerate the combination idea. Vytorin, you see, doesn't have all that much patent lifetime left; its problems since 2008 have eaten the most profitable years right out of its cycle. So if Vytorin turns out to actually work out, after all the exciting plot twists, Merck will be there to tell people that they shouldn't take it. No, they should take exciting new Liptruzet instead. It's newer.

If anyone can think of a reason why this doesn't make Merck look like shady marketeers, I'd like to hear it. And (as Bloom points out) it doesn't make the FDA look all that great, either, since I'm sure that Liptruzet will count towards the end-of-the-year press release about all the innovative new drugs that the agency has approved. Not this time.

Update: John LaMattina's concerned about that last part, too.

Comments (38) + TrackBacks (0) | Category: Cardiovascular Disease | Why Everyone Loves Us


COMMENTS

1. anon2 on May 9, 2013 8:40 AM writes...

It might have different, even possibly improved, results with different, even possibly improved, side effects.....just like the different statins themselves.

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2. Marilyn Mann on May 9, 2013 8:58 AM writes...

I would be surprised if IMPROVE-IT is positive.

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3. darwin on May 9, 2013 9:09 AM writes...

Ashamed? Right. From the same beast that tried to pawn Arcoxia off using a favorably controlled study design amist the shadow of Vioxx

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4. nonexistant on May 9, 2013 9:16 AM writes...

As an ex-Merck employee, I am surprised that they came out with this combination. The management never missed an opportunity to constantly remind us, how great we are and so on! Scientifically, this was true given the fact that historically Merck pioneered many innovative therapeutic programs. Seen against that background, the combination of Zocor + Lipitor makes a nice marketing story (for a few thousand dollars more in its coffers) but not a scientific one. So from that stand point it, personally, it was let down for me as well. With market flooded with so many statin analogs, there was no sense of urgency to come out with a tandem pill. It is ideal for generic or other start ups, but not for the company of Merck caliber!

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5. Anonymous on May 9, 2013 9:35 AM writes...

This is an interesting development when juxtaposed with the earlier article on Ken Frazier, and questions around how strong a hand he has on the tiller. This would seem like a Schechter/Kim driven decision that is at odds with Frazier's apparant desire to restore Merck's reputation, but lack of a clearly articulated plan. It would suggest that he, in fact, does NOT have a plan.

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6. former merck on May 9, 2013 9:39 AM writes...

I think Merck jumped the shark when the cult of lean six sigma came in. Also as a former Merck employee, I'm ashamed, but not terribly surprised by this. What I'm flabbergasted by is that the FDA approved it!

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7. Hap on May 9, 2013 9:51 AM writes...

I don't know if I'd be ashamed if I worked for Merck - the new combo might work better than the corresponding combo with Zocor, since Lipitor does have effects that other statins don't.

It doesn't make Merck look so good, though, since it looks like they're trying to chisel some more time out of an unoriginal idea. It also will probably give India yet another opportunity to show how it can give the finger to foreign pharma, and unless there's good evidence that it works better than Vytorin, I don't know why people would buy it or insurance companies would pay for it.

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8. anon on May 9, 2013 10:03 AM writes...

as a scientist, i agree this is shady. thou s a business, i see no issue at all in them trying to make more profits, for without this, the discovery/development engine is pursued even less.

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9. PPedroso on May 9, 2013 10:29 AM writes...

Wasn't there a interim analysis of IMPROVE-IT in March?
When are we supposed to the know the outcomes of that?

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10. josh bloom on May 9, 2013 10:29 AM writes...

@8- Yes, profit is great, and I certainly know its role in funding future R&D. But there is profit and there is profit. Unless it involves marketing something that will at the very least be of *some* help to humanity, it just makes the whole industry look bad.

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11. D-Not on May 9, 2013 10:56 AM writes...

If you have a well oiled marketing machine like Merck does then you can pretty much make and sell anything. Real benefits to patients was never the issue, only profits.

Singulair is a classic case of Merck ripping off the public. Singulair was a sugar pill for the most part. The key was its stellar safety. Singulair was marketed as first line therapy with Corticosteroids as an add-on. Merck made billions !!

Why not perpetuate the Singulair model yet again, this time with a Lipitor-Azetemibe combo. a safe bet for profits.

@7 HAP: FYI the Lipitor-Azetimibe combo has been selling in India for over 5-7 years now !!

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12. Bernard Munos on May 9, 2013 10:56 AM writes...

Liptruzet is what happens when marketers demand that scientists produce successor drugs to replace those losing patent protection, instead of letting scientists come up with real innovation. If Ken Frazier wants to be seen as a champion of innovation, he should put an end to that nonsense.

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13. darwinsdog on May 9, 2013 11:13 AM writes...

FDA advisory review and approval documents is made public and should address the WHY of it for anybody that wants to be a reporter. I don't know if it is the case with this switcharoo of statin components (sounds like not) but for the sake of argument anyway I wonder, in this day of so supply issues with so many drugs, if cost of goods or shelf life or other such non-pharmcological consideration should become a consideration in seeking approval for an equivalent drug for an indication. I really don;t know enough about this part of the regulatory sausage making though.

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14. BioBritSD on May 9, 2013 12:01 PM writes...

OK, I admit it feels a little shady. But, the devils advocate in me is wondering if this is inconsistent with your opinions on "me too" drugs Derek.

You normally are supportive of "me too's" and push back against popular opinion (aka it's essentially the same compound, why do we need so many statins...) with the argument that physiology is complex and we need lots of shots at goal in the clinic to succeed, and that patients benefit from choice in approved drugs as different patients react differently. So - why is this different?

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15. Lyle Langley on May 9, 2013 12:01 PM writes...

@10, Josh Bloom and Dr. Lowe...

I'm not a Pharma apologist by any means, but I don't fully understand the outrage here. Everyone recognizes that profits aren't bad and they fund R&D, blah, blah... But shouldn't the market dictate the reaction to Merck doing this rather than us? If the Vytorin story comes out positive (and I have no idea whether that is the case or not), and Merck has an alternative to Vytorin that will make them money, why shouldn't they be able to sell it? As long as they are not hiding any data or forcing people to buy this (*cough* Gardisil *cough*), it's up to them (once approved by the FDA) to decide if it's worth it for their business model. It would then be up to the funding agencies (insurance companies/people) to decide whether or not they want to actually pay for it, and if they don't, then Merck will be left with an expensive failure. But if you really do believe in the free market - which your comments seem to defend - they should be able to sell any "new" drug they want. Seems to me this argument goes against any and all capitalism or free market arguments that you try and make.

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16. josh bloom on May 9, 2013 12:22 PM writes...

@Lyle-
I'm all in favor of free market, etc. Merck *can* do whatever they want. But the price they are paying is their reputation, and this will spill over into the rest of the industry. They look really bad here.

Also, the "free market" can be not-so-free if it is influenced by direct to consumer ads that push products that are no better than older alternatives. See: Nexium-Prilosec. AstraZeneca made a fortune by changing the color of the pill and using a single enantiomer (not sure which of these was less useful) and marketing it like crazy. And doctors obviously fell for it, since they wrote a bazillion scripts for the stuff.

I'm thinking that Merck is going to try something like this.


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17. Derek Lowe on May 9, 2013 12:27 PM writes...

#15 Lyle:

My problem here is that the entire absorption inhibitor/statin combination idea is currently in doubt as a useful therapy; the jury won't come in until IMPROVE-IT reports, whenever that is.

And while the ezetimibe/atorvastatin combination might be different in some people than the ezetimibe/simvastatin combo, I think the odds of this are much lower than usual. The biggest differences in the statins among different patients, from what I know about it, are in side effects. And the statin dose in the combination is lower, which tends to bring all these differences back down into the noise. It's not like Merck tested this new combo against the old one, either, of course.

So while I don't mind "me-too" drugs in general, it's possible to push things too far for me. And I think that this is one of those times. For another, see Claritin/Clarinex, if you're wondering.

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18. darwinsdog on May 9, 2013 12:39 PM writes...

Reputation vs. sales: Wasn't that behind spin-off Merckmedco to serve to get the stink of sales/marketing away from the storied reputation of Merck pharma (I'm paraphrasing of course).

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19. Lyle Langley on May 9, 2013 12:47 PM writes...

Again, the company should be able to sell the drug as long as the FDA says it's okay. Let people/payers determine whether it's worth it.

@16, Josh Bloom:
That's laying the entire "blame" on AZ for that story. Where is the outrage for the doctors? The payers? Why is it that doctors never get pulled into this argument? It's always the big bad Pharma industry; but there is a gatekeeper in all of this and that is the person writing the prescriptions. Why aren't we outraged and bring to the public the doctors that write all of the scripts? If doctors are really that stupid, then we really should cut all of their reimbursement by more than Congress has already.

And, the free market is in fact, free when companies are allowed to advertise - an act I am 100% against, by the way - but if they aren't allowed to let everyone know about their products, then it's not free.

@17...

I agree we don't know that advantages of this drug combo over anything else and that is up to the FDA. If they decide the risk/benefit is sufficient to be approved, then it should be approved, and if it's beneficial to even a small population that would be good. Doesn't mean anyone has to use it or pay for it. Insurers can still say "no thank you".

Sorry, it's pretty clear the outrage here is displaced - especially since the drug is not on the market yet. Me-toos and drugs like (apparently) this should help the free market with pricing, and if that doesn't happen then the payers need to be looked at.

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20. Marilyn Mann on May 9, 2013 12:54 PM writes...

The result of the interim analysis in March was to continue the study. The study will be completed in late 2014.

One thing seems fairly certain: if there is a benefit, it cannot be very large or the study would have been stopped for benefit by now. The same with respect to harm.

In the trials in the prestatin era, cholesterol-lowering interventions took a long time to show a benefit. For example, seven years for cholestyramine. In contrast, statins show a benefit much earlier. There really does seem to be something special about statins.

Besides the ezetimibe data, such as the ENHANCE and ARBITER 6-HALTS trials, raising doubts about ezetimibe, no nonstatin has shown benefit when added to a statin (e.g., niacin, fenofibrate).

Maybe the PCSK9 inhibitors will be different. I hope so.

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21. darwinsdog on May 9, 2013 1:01 PM writes...

Co-hinky-dinky-ly, Merck has a press release today about pricedropping on HPV vaccines to poorer countries but they are getting beat-up unfairly IMO on this if you read the blog here:
http://www.nytimes.com/2013/05/10/health/prices-cut-for-hpv-cervical-cancer-vaccines-for-neediest.html?partner=rss&emc=rss&src=igw&_r=0

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22. NoDrugsNoJobs on May 9, 2013 2:00 PM writes...

Lets give the fda some credit. Perhaps they feel that the additional risk of the combination is minimal or likely nothing. Then they look at the potential benefit. While an improvement in better outcomes has not been shown, it is nevertheless possible. The question is that in a very high lipid population who cannot control by a statin alone, what is the choice? They can wait for the data on out comes to come in or jumpstart the treatment based on the general cholesterol guidelines. Doctors are instructed to get their patients lipids within guidelines and if a statin alone does not work, they are to look to other possibilities. Is the guideline wrong? Perhaps, I don't know. But for the record, many advocate exercise as a cure all for CHD but it, like the Merck drug combos, have not been yet shown to procvide benefit in a double blind placebo controlled study. All of the data connectiong exercise with better CHD outcomes is correlational or based on open study designs just as the lipid correlations are. While we know statins provide benefit in a proven double blind fashion, we do not know if it is simply due to lowering lipids or not - correlation is not causation but that does not mean correlation without proof of causation is bunk, like with exercise, we rely on that type of evidence all the time.

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23. josh bloom on May 9, 2013 2:47 PM writes...

@Lyle-
Re: Nexium. There is plenty of blame to go around. But in this case, it starts with AZ. They made the decision to develop a drug that is virtually identical to Prilosec (I don't know how there even got a patent) and then market the hell out of it on TV (I also oppose TV ads for Rx drugs), knowing full well that most people wouldn't know it was "Purple Prilosec".

The "purple pill" campaign made it sound like it was something new and different, so naturally, people went to their docs and demanded it. How many docs have the time, knowledge and interest to know that Nexium was simply a single enantiomer? Probably very few. And you better believe that the sales reps didn't mention this.

So, I guess you can also blame the doctors for not knowing, insurance companies for allowing it, maybe the patent office....

I'm all in favor of pharma companies making money. They need it badly (having come from that world, I am painfully aware of what happens when they don't get enough). But I don't think it's too much to ask that they provide a new drug with at least some advantage instead of a new color.

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24. flem on May 9, 2013 3:08 PM writes...

why all the fuss??
- until a crestor-ez combo, this atorva-ez will enable the greatest LDL reduction of any product
- high risk pateints need to reach goal - this is another way for Merck to expand usage of EZ - presumable price of this combo will be similar to ez price
- i doubt this has anything to do with patents, when ez patent expires there will be generic combos - just like generic combo is otehr classes (eg hypertensive combo)

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25. fenichel on May 9, 2013 4:21 PM writes...

I don't know the extent (if any) to which this consideration contributed to Merck's thinking, but simvastatin (and lovastatin) have distinguishing bad features among their sibling statins. Their metabolism is _entirely_ CYP3A4-dependent, so serum levels in the presence of CYP3A4 inhibition can be _20-fold_ increased; that's where most of the AEs seem to come from. The other statins are CYP3A4 substrates too, but they have alternative eliminative pathways, so the effects of 3A4 inhitors are much less marked.

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26. anon1 on May 9, 2013 5:06 PM writes...

another thing Merck must be ashamed of is exemplified by the recent sexual bias case--->

Merck sued for $100 million in sexual bias case

a "race bias " case might not be far behind... Looks like this pharma company's reputation is at stake from all angles.

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27. Gambler on May 9, 2013 5:18 PM writes...

Can't say I share the outrage. Payers currently hold the cards, not consumers. The value of this product will ultimately be determined by them and they will require some evidence of benefit. One can question whether the anticipated income is worth the development cost, but IF the LDL hypothesis holds true, there may be value in having multiple LDL lowering options.

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28. Whatever on May 10, 2013 2:58 AM writes...

Nexium: Please google "Chiral Switch". There are a couple of known drugs where one should be really happy to get the right enantionmer and not the racemate. A statement like: "is virtually identical to Prilosec" is wrong. An enantiomer is actually not "the" racemate and talking about racemates not every ee ratio in a racemate has to be the same or has to stay the same in the body with the consequence of severe side effects. What was discussed (and criticized) is the nonobviousness of enantiomers in light of its disclosed racemate but this is up to the national patent law. Obviously AZ fullfilled the criteria.
Another point of the critic could be towards direct consumer marketing and the role of the prescribers in the context of the pharma sales model.
The definition of me-too drugs is a bit loose, but for me it contains at least one structural change in the main active component of (and there ambiguity starts) a first-in class or close to the market drug or first patented/published drug. What Merck is doing is applying for a new formulation/combination product. Is it usefull? Is is necessary? Up to the regulation authorities and the market.

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29. emjeff on May 10, 2013 7:25 AM writes...

Just because a company markets a drug does not mean it needs to be prescribed. Physicians can vote with their pens and not write for it, if it has no value. However, I think it is incorrect to state that this is a "me-too" Atorvastatin has significant advantages over simvastatin, so the new combo might well work better. That's why we do the trials.

As far as the FDA's role in this, it is not in their purview to decide if a drug is "needed" or not. Thier role is to determine safety and efficacy. And honestly, do we really want the FDA to decide what should be marketed? Frankly, the FDA should get out of the efficacy business altogeter - MDs and payers are more than capable of determining whether a given compound is worth paying for, in fact it is being done already in health care systems and hospitals.

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30. David Borhani on May 10, 2013 9:17 AM writes...

Silverman and Lee, in their classic text “Pills, Profits, and Politics” (Univ. of California Press, Berkeley, CA, 1974), reviewed the arguments against fixed-dose drug combinations. Their conclusions, based in large part on the enormously popular use of antibiotic combinations of dubious utility, are durable and generally applicable.

Combinations:
1. Reduce flexibility in individualized dosing, for both components — the best doses for the patient may not be achievable.
2. Make it difficult to stop (temporarily) dosing of one component, if needed.
3. Bring added safety risks, especially if a patient truly needs only one of the components, or if the patient develops an adverse reaction to one of the components.
4. Complicate the administration and dosing of additional drugs when needed (drug-drug interactions).
5. Bring only minor added convenience to the patient (if the dose is truly correct).

Combinations do, however, bring significant marketing advantages to pharmaceutical companies — which is why they promote them so eagerly.

Sometimes it seems like the same battles are destined to be waged over and over again, never to be settled.

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31. Josh Bloom on May 10, 2013 9:39 AM writes...

@28, 29
You both have valid points.
With regard to the FDA, yes- they are not responsible for determining whether a drug is innovative, or has any real advantage over other drugs. Yet that is exactly what they were trying to do in the 90s when they applied this to new antibiotics, which is pretty much why we are in the mess we are now. It would seem that they have pulled a 180.

Re: chiral switching, I am well aware of the (obvious) theoretical advantage of using a single enantiomer drug, however, my perception is that this hasn't worked out so well in the real world. You might want to ask the former Sepracor guys how well that worked out.
If there is something I'm missing I'd like to know. But no matter how hard I dug, I couldn't find any real advantage to Nex over Pril (except the double dose- duh). Presuming that I'm right, this is a clear example of the market system (docs, payers etc) failing completely.
I'm also a big fan of me-too drugs. Nowhere is their utility more obvious than with HIV. Virtually all of the preferred meds are me-toos, and the differences can be huge.
But I don't even consider Liptruzet to be a me-too. More like "you-too?". And Nex is more like "you-too must be kidding."

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32. Hap on May 10, 2013 9:59 AM writes...

The problem with the FDA not looking at efficacy is that we seem to expect patients, doctors, etc., to understand that all drugs have risks, and that therefore, people should not look for drugs to not have risk (because they don't exist) but instead look for drugs to have appropriate risks for what benefits they provide. In that case, however, the interpretation of safety would then have to incorporate efficacy - if a drug provides little additional benefit compared to current drugs but does provide higher risks, it is effectively less safe. Without a judgment of efficacy, safety can't be judged.

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33. emjeff on May 10, 2013 12:56 PM writes...

#32 - I think that physicians are perfectly able to develop risk/benefit scenarios for their patients. It's a little arrogant to suggest that only FDA (whose physicians are mostly unlicensed in the US, by the way) can somehow make the choice for patients.

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34. Hap on May 10, 2013 1:42 PM writes...

Except doctors are holding an awful lot of balls in the air - lots of things for lots of patients, while people at the FDA are likely to have far more complete data on the risks and benefits of a drug and nothing else on their plates. Doctors and patients know (if anyone can) how certain risks and rewards might be more important to them, so they can weight the risks and rewards more accurately, but the FDA is likely far better at assessing the magnitudes of risks and rewards than general doctors.

I don't really see what the FDA's job is or should be under your scenario - if they can't assess efficacy, they can't do safety. Do they only step in when risks exceed a certain threshhold (in a subset of the population, or in total overall risk)?

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35. fenichel on May 10, 2013 9:44 PM writes...

@#33
"I think that physicians are perfectly able to develop risk/benefit scenarios for their patients."
Physicians are not trained to interpret randomized trials, they have no time to look at raw data, the raw data are not available to them, they are biased by their (usually scant) recent experience, and they know no statistics. They thought they knew the risk/benefit of gastric freezing for ulcers, bone-marrow transplant for metastatic breast CA, mammary-artery ligation for coronary disease, and so on. People like FDA, the Cochrane group, and others, do what physicians can't do.

That's not the last word. There is a public-policy issue here: Just because the Cochrane collaboration (or FDA) is better at deciding what is safe & effective, it's not obvious that physicians should be prohibited from making decisions that are known to be probably (but not necessarily) wrong.

". . . FDA physicians are mostly unlicensed in the US. . ."
This may be true, but only if one counts people at FDA who are foreign-licensed and working at FDA as non-physicians. To be an FDA medical officer, one must hold a current US medical license.

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36. Chris D on May 13, 2013 1:48 PM writes...

What is neglected in the analysis of this issue is the opportunity cost of this trial. How many hundreds of millions is Merck spending on this trial that is likely to have incremental value at best? What other innovative programs are neglected (and scientists laid off) to pay for this trial? This certainly doesn't seem like something the old (successful) Merck would commit resources to.

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37. Wage Slave on May 14, 2013 11:49 AM writes...

Looks like a great marketing vision to me. It's win/win whenever the Vytorin data come in. If Vytorin fails - well then take this new drug, it has 'the right' statin in it. If Vytorin succeeds - then take this drug, it has 'the best' statin in it.

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38. Barry on June 28, 2013 7:55 AM writes...

@D-NOT

You can hardly say that Singulair (montelukast) is a sugar pill. It reverses inflammatory changes in the bronchial tree, there's good data on that. I found it worked damn well. And now it's generic.

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