Pharma Companies Try 'DRM' For Drugs As A Ploy To Stymie Generics

from the just-can't-give-it-up dept

Wed, Jan 16th 2013 1:19pm — Glyn Moody

One of the striking features of the drug world is how pharma companies become noticeably more inventive immediately before their patents are due to run out and their drugs are about to enter the public domain. That's because they need to find a way to differentiate themselves from the generic manufacturers that are then able to offer the same medicines for often vastly lower prices.

Usually this takes the form of modifying the formula of a drug slightly, patenting it, and then seeking to convince the medical profession that the new formulation is better in some way. But sometimes it involves more novel approaches, as here:

In coming months, generic drug producers are expected to introduce cheaper versions of OxyContin and Opana, two long-acting narcotic painkillers, or opioids, that are widely abused.

But in hopes of delaying the move to generics, the makers of the brand name drugs, Purdue Pharma and Endo Pharmaceuticals, have introduced versions that are more resistant to crushing or melting, techniques abusers use to release the pills' narcotic payloads.

As the New York Times article quoted above reports, having introduced these "tamper-resistant" designs, the pharma companies are now pushing to get a ban on generic versions that lack this feature. If you think of "tamper-resistant" techniques as a kind of DRM for drugs, the pharma companies are effectively asking for their own version of the DMCA, which forbids the circumvention of DRM.

The drug companies have dressed this up as a service to society, but some aren't buying it:

While companies like Purdue Pharma insist the public's health is their main concern, others note that producers introduced tamper-resistant versions of their products just as the drugs were about to lose patent protection. In court papers filed in response to Endo’s lawsuit, the F.D.A. described the company's action as a "thinly veiled attempt to maintain its market share and block generic competition."

There's no doubt that the abuse of painkillers is a significant problem, but according to another recent story, in The Washington Post, alarming levels of addiction to OxyContin and similar painkillers may be partly the drug companies' fault. For instead of warning doctors about this issue, the latter were assured that there were "minimal risks of addiction and dependence" if they prescribed these kinds of drugs for their patients: according to a Washington Post examination of key scientific papers, a court document and FDA records, many of those claims [about minimal risks] were developed in studies supported by Purdue Pharma, the maker of OxyContin, or other drug manufacturers. In addition, the conclusions they reached were sometimes unsupported by the data, and when the FDA was struggling to come up with an opioid policy, it turned to a panel populated by doctors who had financial relationships with Purdue and other drugmakers.
So it would seem that rather than mandating the use of tamper-resistant packaging for these kinds of painkillers, a better long-term solution would be to avoid the use of these drugs altogether, where possible.

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Filed Under: drm, drugs, generics, pharmaceuticals
Companies: endo pharmaceuticals, purdue pharma

52 Comments

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Shadow Dragon (profile), 16 Jan 2013 @ 1:27pm

But of Course
The big only cares about $$$
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kenichi tanaka, 16 Jan 2013 @ 1:33pm

How do they put digital rights management on a drug? I'd really like to see this one? What happens? If you try to crush the pill, it says "you cannot crush me, I am a pill"?
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ShellMG, 16 Jan 2013 @ 2:07pm

Re:
When you try to crush it, it turns to powder.

I'm on a long-term pain management plan and narcs are part of it. I *hate* taking them and try to cut the pill in half so I don't have to take the whole thing. I've had a couple of different tablets that, when placed in the pill cutter, get pulverized. The last thing anyone wants it a mouth full of bitter powder.
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Anonymous Coward, 16 Jan 2013 @ 2:16pm

A glowing example of abuse of patents coupled to abuse of the regulatory system to protect a companies monopoly. I expect that the new formulation is obvious, as in general the mechanical properties of the pill have little to do with the active content, and much to do with the inert fillers and binders. If they get away with this, expect them to repeat the trick on the next drug to fall out of patent.
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Anonymous Coward, 16 Jan 2013 @ 2:23pm

Next step: drigs that only work as long as you're connected to the internet...
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weneedhelp (profile), 16 Jan 2013 @ 2:24pm

Re: Re:
Snort it. Im not kidding. If that's not for you then dilute it in about a shots glass worth of water. Sprinkle half of it on to a small amount of ice cream.

My brother-in-law has really bad back pain and the cost to manage it is a burden. He started cutting them to offset cost and to not feel the narcotic effect as much.

My wife uses the ice cream trick to get her elderly patients to take medicine they dont like.

Sucks to be in constant pain.
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Anonymous Coward, 16 Jan 2013 @ 2:24pm

Next step: drugs that only work as long as you're connected to the internet...
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weneedhelp (profile), 16 Jan 2013 @ 2:25pm

Re:
Nah, I would rather have the drigs.
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Anonymous Coward, 16 Jan 2013 @ 2:47pm

Re:
I think you can brace for a period of patenting relating to mechanical properties. The capsules only breaking in the stomach is just the beginning. Next thing will be sugar-coating to cross the blood brain barrier and after that, well, let us just say that timed releases in the body is a way to improve the effect of the active content significantly. That we are dealing with mechanics instead of compounds would seem insignificant.

Now, the abuse is smarter than that: You make a discovery get a patent on only the core properties. When it runs out you "improve" the patented technology by adding just enough of the properties you already know to make the improvements significant. You might get a free patent or two by being selective with the papers you put out. But the competitors? Well, unless it was a directly competitive invention process you can easily do this since no competitors would be stupid enough to invent from a knowledge disadvantage. Ironically 5 years is far too short a period for inventing from behind to be a realistic business model and it takes some seriously effective shortcuts in the processes to even think of such a praxis in a 20 year regime.

What they abuse is a hole in the way economics work: Patents are said to improve scientific output, which is true when everybody knows everything. The problem is that nobody read 10000 patents each year to keep up with the development just as well as reproducing results from patents is a significant cost for competitors. Therefore niche science and improvement on your own patents are the ways to go in this field. Niche science will often get shot down by the economic steps in the process if they are too far from the big markets. The only true way to abuse this part of the system is by stepwise patenting. It is cheap and disgusting, but it works!
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Anonymous Coward, 16 Jan 2013 @ 2:49pm

There's a bunch of drugs coming up that the patents are coming to and end on. Among the ideas big pharma has come up with is asking doctors to only subscribe their products with a return on sales...read that as kick back. Then there is the wanting of striking a deal with the generic companies to increase their charges on drugs. And the request to pharmacies that they will match the price of the generics if the pharmacies will recommend theirs over the generic.

If you get to watching, in the last years before the patent runs out these drug companies will increase the cost of the drug to the patients, running the price up as much as they dare.
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Anonymous Coward, 16 Jan 2013 @ 2:52pm

Re: But of Course
How simplistic of you...you deep thinker you.

The company requires the big Govt to pass a DMCA for drugs, thus Big Govt is the problem.

The big Govt installed the current fucked up "protection" systems (copy write, patents, etc). Competition (Capitalism) is the key to getting these drug makers to be more innovative and less protectionists.

�If you think of "tamper-resistant" techniques as a kind of DRM for drugs, the pharma companies are effectively asking for their own version of the DMCA, which forbids the circumvention of DRM.�
Govt initiates the protection and asks for bribes (contributions) for a quid pro quo all day long, every day.
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DannyB (profile), 16 Jan 2013 @ 2:55pm

Patents increase innovation
> pharma companies become noticeably more inventive
> immediately before their patents are due to run out

Ah ha! So TechDirt admits that patents increase innovation!
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Overcast (profile), 16 Jan 2013 @ 3:00pm

With sufficient force - I suspect a hammer will still do the trick.
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SilverBlade, 16 Jan 2013 @ 3:28pm

Wouldn't this make the drug harder for the body to digest and process?
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The dude, 16 Jan 2013 @ 3:40pm

Re:
Who cares? DRM, Hurray!
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monkyyy, 16 Jan 2013 @ 4:07pm

Re: Re: Re:
"My wife uses the ice cream trick to get her elderly patients to take medicine they dont like."

revenge for being drugged as a child?
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Anonymous Coward, 16 Jan 2013 @ 4:09pm

Re: Re:
???

That can't be right, if it turns to powder that make it easy to bind to other chemicals and extract the opiates.

Still, if it turns to powder that is great you can mix it with anything :)

or you can make your own pills.

http://www.amazon.com/Empty-Gelatin-Capsules-Size-1000/dp/B000ACUJRW

https://greenanthr opology.wordpress.com/2011/08/12/diy-pill-pockets-for-your-pet/ (works for humans too)

Youtube:DIY PILL PRESS 8mm Hexagon (Herbal)
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Anonymous Coward, 16 Jan 2013 @ 4:12pm

Re:
Are you trying to protect criminals now?!!! Hmmm...hmmm...!
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Anonymous Coward, 16 Jan 2013 @ 4:13pm

Re: Patents increase innovation
Now that it's proven (since Techdirt admitted it) that patents increase innovation just before they run out, I've got the solution to make them really effective:

Reduce the patent validity to one year, or three months. So big pharma will become very inventive on a much bigger pace :D
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Anonymous Coward, 16 Jan 2013 @ 4:13pm

Re: Re:
Monsanto probably patented the "i" in "drigs" and "idrugs".
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Manabi (profile), 16 Jan 2013 @ 5:00pm

Re:
OxyContin's supposed to be an extended time release formula, over 12 hours. What has happened is that addicts crush the drug up and take it all at once to get one major dose of the drug, instead of a dribble of medicine over 12 hours. So done properly (the body still dissolves it gradually) it wouldn't have any effect on people taking it properly, but would make it harder for addicts to get their fix.
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Thomas (profile), 16 Jan 2013 @ 5:41pm

Pharma companies...
are all about making the most money possible, NOT about curing disease or improving people's lives. If they could make $ 10 million saving 100,000 lives OR 8 million saving 1,000,000 lives, they would definitely choose to make $ 10 million since that is what their their stockholders demand. Profit rules.
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gorehound (profile), 16 Jan 2013 @ 5:41pm

Re: But of Course
Fucking Corporations Are Evil !!!
Over and over we keep on seeing the abuses.
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Anonymous Coward, 16 Jan 2013 @ 6:26pm

Re: Re: Patents increase innovation
Capitalism would agree with you...Govt has driven the protectionist agenda with a fury-
Giving patents that should have NEVER been given in the first place while pushing protectionism with specialized courts and extending copy write to a ridiculously long time.

Maybe if the companies seeking protectionism didn't seek to cover the good with the bad, there could be an innovation boom. OxyContin and Opana have helped people and now they want to apply �protectionism� to artificially extend the patents.
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Anonymous Coward, 16 Jan 2013 @ 6:36pm

Re: Re: But of Course
Not as evil as big Govt.
Only stupid Govt pukes issue bogus Patents: Here We Go Again: Apple's Pinch-To-Zoom Patent Rejected On Re-Exam
http://www.techdirt.com/articles/20121219/17584521445/here-we-go-again-apples-pinch-to-zoom -patent-rejected-re-exam.shtml

List of the "supposed" Good Guys that are "easier" to control than Corporations:
UN
EU
UK
USA
Oz
CA
The list is endless, filled with moronic GOVT pukes that FU things that don't need to any interference.

�UN: The Problem With The Internet Today Is It's Just Too Open & Terrorists Might Use It�
http://www.techdirt.com/articles/20121022/17162220792/un-problem-with-internet-today-is-its-jus t-too-open-terrorists-might-use-it.shtml
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Anonymous Coward, 16 Jan 2013 @ 6:47pm

Shit if they still want to make top dollar just start selling it on the streets.
/s
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Anonymous Coward, 16 Jan 2013 @ 6:52pm

Re: Pharma companies...
Well, I would like to point out that they have done more to save people's lives than you have...you leach off their discoveries.

Invent some of your own life savers, then actually do something to help some people.
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Travis, 16 Jan 2013 @ 7:04pm

What should be done.
The gov should ban non tamper-resistant versions, then seize the patents "For the Public Good" and give manufacturers (generics and primary) free licenses. (This is all dependent on the patent actually does make it difficult to abuse the drug.)
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Anonymous Coward, 16 Jan 2013 @ 7:27pm

Re: Patents increase innovation
By the same logic, reducing the protection periods for pharma-patents would increase their innovation too, as they would more often face the imminent loss of them.
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monkyyy, 16 Jan 2013 @ 7:27pm

Re: Re: Re: But of Course
protip: corps ARE already directly government related
they exist, and the evil they do is solely based on the legal fiction that save shareholders from the actions of the ceo and save the ceo from his actions that the shareholders "forced" him to do

dont go on any unnecessary rants
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G Thompson (profile), 16 Jan 2013 @ 8:51pm

Re:
It seems the new and informed Spelling drigs worked ;)
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G Thompson (profile), 16 Jan 2013 @ 8:58pm

Re: Patents increase innovation
No your comprehension is completely wrong.

This shows that the concept of patents makes pharma companies more inventive in their endeavour to gouge as much money from the public using the same product no matter the ethics.

In no way did this sentence create the idea that the ability of patents themselves allows increases in innovations.
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G Thompson (profile), 16 Jan 2013 @ 9:00pm

Re: Re: Patents increase innovation
Dammit.. my sarcasm meter must be broken..

Though my statement still stands.. it just has a wooshing sound over the top of it now

*goes and hides in the corner*
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anoncow, 17 Jan 2013 @ 1:32am

Crocodile Tears
FWIW, Purdue Pharma _refused_ to add such a blocker when sued/supplicated by the Commonwealth of Kentucky, often the nation's leading per capita abuser of Oxycontin...now that they might have a dollar impact, losing the legions of addicts they've created, they want to bar the door on others making that money.

Insidious.

Further, the mental health professionals I know that serve in the opiate trenches have little faith that addicts cannot learn adequate chemistry skills to defeat such blockers, as they already have with similar addictive medications. While still worth doing, but don't be surprised that pharmacological DRM is no more effective than software DRM.
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Anonymous Coward, 17 Jan 2013 @ 1:44am

Re: Re: Pharma companies...
What an amazing insight, may I ask what have YOU done in order to feel in such a position to order people around like that?

And that secondly, if we were to talk about doing what is right, the people who would earn the highest salaries would be the doctors and researchers rather than some stock holder who sits in his chair 8 hours a day looking at a graph and making money out of thin air.

The financial sector reaps the profits of every other sector to themselves, and while doing that, demands that this must be the case or else there wont be any money invested in the first place.

Finaly, when was the last time a banker(or investor) actualy helped salved a life again?

The point is the profit motive is the most important motive for a large corporation, and one of the places this is very obvious is in Big Pharma.
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Anonymous Coward, 17 Jan 2013 @ 3:02am

Re: Re: Re:
Apple will be upset if they have idrugs.
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Ninja (profile), 17 Jan 2013 @ 3:03am

So it would seem that rather than mandating the use of tamper-resistant packaging for these kinds of painkillers, a better long-term solution would be to avoid the use of these drugs altogether, where possible.

Mike, Mike, Mike. (!!!) Showing our Communist colors, are we?

ahem, trolling apart that's not in the best interests of the big pharma pockets, is it? In the end they couldn't care less if people are addicted or if millions are dying because they can't afford the cheer expensive medicine they sell, it's all about profit. They will, however, try to keep that incredible greed under a disguise that will suffice for people not to be outraged and backlash at their abusive practices.
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relghuar, 17 Jan 2013 @ 3:27am

...better long-term solution would be to avoid the use of these drugs altogether...
What, like, have pharma companies make even LESS money?
Are you crazy???
Think of all the sick children, please!

(Sorry, I really couldn't find a plausible way to get hackers and terrorists into this, too :-( )
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Niall (profile), 17 Jan 2013 @ 4:59am

Re: Re: Re: But of Course
'Big government' is just a paid shill for 'Big corps'. You'd have a half a point if you allowed for your corporate Randian overlords being less than perfect, but no, selfish self-interest MUST win over any form of altruism or enlightened self-interest.

Aynbots are soooo transparent!
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btrussell (profile), 17 Jan 2013 @ 6:13am

Re:
The way it was, they could crush it, dissolve it and inject with needle.

The "new" pill gels when you try to do this. It has been here in Canada for a bit.

Supposedly, I heard from an old high school friend, another old high school acquaintance of ours, had a way around this in one week. He supposedly sells this method for a percentage of your prescription.

Isn't it odd that the drug was safe for 12 years, then we have so many addicts this drug is no longer safe IN ITS CURRENT FORM, but safe in another form?

How did we get so many addicts? Where are the news reports of these facilities being broken into and millions upon millions of these pills being stolen?

Doctors are the source.
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Anonymous Coward, 17 Jan 2013 @ 6:40am

Re: Re: But of Course
Corporations are proxies the people behind those corporations are really evil though.
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Anonymous Coward, 17 Jan 2013 @ 7:09am

Re: Re: Pharma companies...
LoL

Did you read the news about how superbugs are becoming unstoppable and big pharma companies only care about anti-baldness and erection sustaining pills?

If I am not mistaken even one of the big international bodies came out and outright said it, that drug patents failed to improve vital life saving drug research and they were calling others to invest in open source initiatives, now that is desperate.

The New York Post: The right way to stop superbugs

Not even making monopolies stronger makes pharma companies care.

Quote:
Congress recognized the problem earlier this year, inserting a provision in an FDA authorization bill to grant an additional five years of market exclusivity � meaning no competition from generics � for companies inventing new antibiotics.

�It�s a great first step,� said Spellberg, but he added that the provision �is not strong enough to turn things around.�

Washington Post: NIH superbug outbreak highlights lack of new antibiotics

Economist:Resistance to antibiotics
The spread of superbugs (2011)

Medicine is not the only thing affected by patents, your food may get increasingly toxic over the years thanks to making plants resistent but not humans, so the plants absorb more toxins and become more and more toxic to humans.
huffingtonpost: Pesticide Use Proliferating With GMO Crops, Study Warns
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Anonymous Coward, 17 Jan 2013 @ 10:16am

Re: Re: Re: Re: But of Course
You can't prove anything you posted about paid shills...you're bitter and wrong mainly because you can't effectively compete with others due to your flawed ideology.

Steve Jobs was the most self-interested person on the plant (when he was alive). He's done more to advance the human race than all the Govts in history. You lose.
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Anonymous Coward, 17 Jan 2013 @ 10:44am

Re: Re: Re: Re: But of Course
So you're saying that evil Govt laws (legal fiction) saved the shareholders? I would agree that Govt passes evil laws and instead should let corp fail - GM is prime example. No rants, just truth.
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Anonymous Coward, 17 Jan 2013 @ 11:55am

Re: Re: Re: Pharma companies...
What?? The following statement was in question.
�Pharma companies...are all about making the most money possible, NOT about curing disease or improving people's lives.�
Nothing demonstrated to back that opinion.

Your financial sector "argument"/sarc is about capital that backs everything we do. Without capital, we limit our discoveries and our life styles.

Where do you think Your pension/retirement fund is invested? Yes, companies like big pharma. YOU and your ilk are funding these companies by investing in them through your retirement account.

I just suggested that the poster use something like Kickstarter to fund his own "life saving" drug. Or would that be too hard? Oh yea, the poster doesn't have someone sending money via a retirement acct so they can do research.

Big Pharma's gain is your retirement�
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Anonymous Coward, 17 Jan 2013 @ 12:08pm

Re: Re: Re: Pharma companies...
So if big pharma is out, where do we get the cure? Are you going to do it? I'm not, how about one someone in your family? Use Kickstarter to fund research for the �bugs� you talk about. Solution anyone?
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Anonymous Coward, 17 Jan 2013 @ 12:49pm

Re: Re: Re: Re: Re: But of Course
No, we're saying that the corporations are the government for all real purposes. Laws aren't passed for the public, they're passed for the corporate good. All your railing about 'Big Government' is still railing against corporate greed.
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Anonymous Coward, 17 Jan 2013 @ 12:50pm

Re: Re: Re: Re: Re: But of Course
Really? You're going to go with Steve Jobs?
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Anonymous Coward, 17 Jan 2013 @ 12:56pm

Re: Re: Re: Re: Pharma companies...
Ooooh! So close, then you had to make your own invalid and unsupported assumptions. It's long been acknowledged that we do not look for cures, we look for treatments. Treatments pay the bills while cures would quickly put them out of business. Don't bother asking what I've done to save people. That is just a distraction, and irrelevant to the discussion.
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Anonymous Coward, 17 Jan 2013 @ 12:58pm

Re: Re: Re: Re: Pharma companies...
Still asking the wrong questions, which is just a thinly veiled attempt to derail the conversation. You have nothing of substance to offer, apparently.
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weneedhelp - not signed in, 18 Jan 2013 @ 6:56pm

Re: Re: Re: Re:
"revenge for being drugged as a child?"

No, just to, ya know, keep them alive, or have some kind of quality of life.
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Anonymous Coward, 28 Jan 2013 @ 12:41pm

Re: Re: Re: Re: Re: Re: But of Course
No, the people in Govt can and should say no more. Thus, Big Govt is the problem.
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