Merck 'Evergreens' Off-Patent Lipitor By Creating Combination Drug With No Additional Benefit

from the and-this-is-medical-innovation? dept

Big pharma often gets a rather rough ride here on Techdirt, what with its attempts to stop governments granting licenses for life-saving and low-cost generics in emerging countries, engaging in legal action to prevent drug safety information being released, and paying kickbacks to doctors. But sometimes you get the impression that drug companies really go out of their way to be disliked, as this great post by Josh Bloom on the Medical Progress Today site, pointed out to us by John Wilbanks, demonstrates:

[Merck] just received approval for the cholesterol-lowering combination drug Liptruzet — a functionally similar (identical?) version of their own Vytorin, which is a combination of their statin Zocor and Schering’s (now part of Merck) cholesterol absorption blocker Zetia (ezetimibe).

Liptruzet, ironically happens to be a combination of Zetia and atorvastatin (generic Lipitor). Yes — Merck is substituting a former Pfizer drug for their own Zocor with combining it with Zetia to make a “new” medication with additional patent protection.

If it were just another case of trivial “innovation”, the story wouldn’t hold much interest. But there’s something more here:

[Liptruzet] reduced LDL cholesterol more for patients who took Lipitor alone, but it did not reduce patients’ chances of developing heart disease. Not surprisingly, this left some doctors to wonder why it was approved at all.

Bloom quotes an interesting comment on this from Philip Gelber, Chief Cardiologist at Cardiovascular Consultants of Long Island:

“The modern movement requires that drugs not just be safe and effective in their immediate goal, but to also show efficacy in improving outcomes. Cardiac medications should not just reduce the cholesterol count, but reduce the risk of heart attack and stroke as well.” He continues, “There was, I’m sure, pressure by big pharma to get this approved, which by pairing it with another drug, would in effect restore blockbuster Lipitor back to branded status.”

That is, this is a slightly unusual kind of “evergreening“, applied this time to Lipitor, from Merck’s rival Pfizer, but now off patent. Before that happened, Lipitor was the world’s top-selling drug:

Over 14.5 years, the cholesterol-lowering medicine has made over $125 billion in sales, and has provided up to a quarter of Pfizer Inc.’s annual revenue for years.

Bloom goes on to explore the FDA’s role in this surprising approval of a drug that offers no additional benefit over Lipitor, and notes that the agency doesn’t come too well out of this business either. As he concludes:

This episode just plain smells bad on many levels. I get the feeling that just about everything except science is driving this, and this will be a black eye that Merck will be inflicting on itself and the rest of the industry.

In other words, it doesn’t look as if the pharmaceutical industry’s image is going to improve any time soon….

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Comments on “Merck 'Evergreens' Off-Patent Lipitor By Creating Combination Drug With No Additional Benefit”

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art guerrilla (profile) says:

Re: Re: Re:

…except the FDA is like nearly ALL gummint agencies who are supposed to OVERSEE and REGULATE the industries they have been captured by…

the revolving/revolting door has blurred the distinction between serving merck/monsanto/citicorps in their boardroom as an employee, and serving them on the FDA/FCC/SEC/etc as a gummint employee…

its called ‘regulatory capture’, and it essentially describes THE ENTIRE gummint and representatives, who have basically legalized bribery…

art guerrilla
aka ann archy

jupiterkansas (profile) says:

Re: Re: Re: Re:

True, but that’s still the government’s problem, not the corporations. Complaining about Merck won’t fix the problem. Our focus should squarely be on what’s wrong with the government. We need to hold our government accountable to hold the corporations accountable, because only the government can hold any authority over the corporations.

Anonymous Coward says:

What I think isn’t clear — the patent would cover the new (ineffective) combination medicine, and not its sub-parts. So Lipitor would still be patent free, when taken alone. If Doctors don’t have faith in this new patented combination, they won’t prescribe it (ha~!) and it will get the quick demise it deserves.

Anonymous Coward says:

Re: Re:

AC at 6:23 AM:

You hit the nail on the head. Lipitor was not “evergreened” at all. Lipitor still has generic counterparts that works just as well as Lipitor always has. Indeed, I take generic Lipitor, and will continue to do so.

What is puzzling is the grasping as straws attitude that Merck is taking on Lipitor given that the “new” drug combination is apparently ineffective. Of course, a patent does not require that an invention be useful, only that an applicant claims that the invention is useful. If someone were to challenge the claim of usefulness in court, the patent might overturned.

Chris Rhodes (profile) says:

Re: Re:

If Doctors don’t have faith in this new patented combination, they won’t prescribe it (ha~!) and it will get the quick demise it deserves.

That depends entirely on what doctors believe. IIRC, Lipitor has been shown to reduce cholesterol, but not overall mortality.

It’s one of those instances where we get so wrapped up in correlation we can’t see the forest for the trees.

1. People who die of heart disease tend to have high cholesterol.
2. Cholesterol must cause heart disease.
3. Drug XYZ reduces cholesterol.
4. Drug XYZ must stop people from dying from heart disease.

Much like:

1. Places where hurricanes have hit tend to have a lot of construction crews working.
2. Construction crews must cause hurricanes.
3. Burning down construction firms reduces the number of construction crews.
4. Burning down construction firms must prevent hurricanes.

Iron-clad logic.

Christopher (profile) says:

This was obviously in 2009.

Zetia was tested in combination with Lipitor several years ago and it was the most efficacious combination possible then, as it likely is now. We at SP knew it was only a matter of time before we swapped out Zocor for Lipitor and combined them for a single-dose solution. Merck just took an SP play and ran with it — not surprising since Merck’s last good idea was buying SP.

This is not an ineffective drug. It might not be *novel* and I wouldn’t dispute it, but if you read up on Zetia testing you’ll find, publicly, that the Lipitor+Zetia combo was identified very early as the best pairing, and going off-patent was clearly going to result in this.


Anonymoose Custard (profile) says:

This tells me we need to change the drug approval process.

Clearly, the FDA is at fault for a lot of this, and the Patent Office is clearly at fault for allowing the patent to be extended in this way.

What needs to happen, in my mind, is that the structure of the approval process needs to be inverted a little: When a pharma comes to the FDA with a new drug, making claims that it improves over another drug, then the FDA should have the resources from its own budget to perform the study and evaluation for efficacy, safety, etc., and then if the drug doesn’t meet expectations, then the pharma should pay a fine for wasting the FDA’s time, in addition to getting the approval denied.

In this way, the impetus is less on producing more drugs to extend patents and massive earnings and more on making more efficacious and safer drugs.

Getting rid of the shareholders’ opinions in this matter would also be of great benefit.

Pharma Worker says:

Patient Compliance

Disclaimer: my mortgage is paid by Big Pharma.

I will grant the 30,000 foot view of this looks sketchy, but the #1 problem facing the efficacy of medications is patient compliance. If we can take a regimen of pills a patient must take and combine them into 1 tablet, that in the end has tremendous positive outcomes.

Yes, it may not look good in research – yep, taking X and taking Y gets the same result as taking XY. However, in the real world, a patient will NOT take X 3 times a day and Y 2 times a day, every day. If they can take a single pill once (or twice) daily, compliance goes through the roof and you have statistically better outcomes.

You may not agree, and you may be compliant with your meds, but think of the 70 or 80 year old patient with that pillbox with dozens to take daily. Combining them makes a lot of sense. I hope this helps it make a little sense. Some people will always detest this practice, I get that, but it does have merit. You’re very welcome to use the generic versions and take more pills daily. That’s always an option.

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