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Judge Rules Drug Maker Cannot Halt Sales of Alzheimer's Medicine
HughPickens.com writes Andrew Pollack reports at the NYT that a federal judge has blocked an attempt by the drug company Actavis to halt sales of an older form of its Alzheimer's disease drug Namenda in favor of a newer version with a longer patent life after New York's attorney general filed an antitrust lawsuit accusing the drug company of forcing patients to switch to the newer version of the widely used medicine to hinder competition from generic manufacturers. "Today's decision prevents Actavis from pursuing its scheme to block competition and maintain its high drug prices," says Eric Schneiderman, the New York attorney general. "Our lawsuit against Actavis sends a clear message: Drug companies cannot illegally prioritize profits over patients."
The case involves a practice called product hopping where brand name manufacturers make a slight alteration to their prescription drug (PDF) and engage in marketing efforts to shift consumers from the old version to the new to insulate the drug company from generic competition for several years. For its part Actavis argued that an injunction would be "unprecedented and extraordinary" and would cause the company "great financial harm, including unnecessary manufacturing and marketing costs." Namenda has been a big seller. In the last fiscal year, the drug generated $1.5 billion in sales. The drug costs about $300 a month.
The case involves a practice called product hopping where brand name manufacturers make a slight alteration to their prescription drug (PDF) and engage in marketing efforts to shift consumers from the old version to the new to insulate the drug company from generic competition for several years. For its part Actavis argued that an injunction would be "unprecedented and extraordinary" and would cause the company "great financial harm, including unnecessary manufacturing and marketing costs." Namenda has been a big seller. In the last fiscal year, the drug generated $1.5 billion in sales. The drug costs about $300 a month.
The practice of tweaking drugs like that is called evergreening.
(I'd only heard about that term being used for the pharmaceutical industry practice, but the linked Wikipedia article implies it is a general term for all patents.)
yes, requiring a company WHO IS IN THE HEALTH-CARE BUSINESS to continue saving lives and not taking profits as the first thing.
yes, makes sense to me. but then again, I'm a human being, not a pycho CEO or politician.
there should be a law: if you are in the healthcare business (which is your choice) then you MUST put patients first above all else.
doctors have to swear this. why not the makers of drugs and such? it would fix a LOT of what is broken with the western world, if we did that. think of how much GOOD would be done to humanity, as a whole!
--
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yes, requiring a company WHO IS IN THE HEALTH-CARE BUSINESS to continue saving lives and not taking profits as the first thing.
But the whole reason why they are required to do so is because there are other companies producing the same drug. If this wasn't the case nobody would have cared which of the two versions they produced.
It's fixing a stupid situation with even more stupidity rather than attacking the root causes: patents and excessive effect of advertising on doctors' decisions.
There's a hidden treasure in Python 3.x: __prepare__()
an antitrust lawsuit accusing the drug company of forcing patients to switch to the newer version of the widely used medicine to hinder competition from generic manufacturers.
Were the drug company sending hit squads round to take out the doctors that were prescribing generics? Did they launch a tactical air strike on the generics factories? Hijack the lorries carrying the generics?
I'm sorry but, so far as I can tell, manufacturers are free to manufacture the generic, doctors are free to prescribe it and patients are free to take it. I don't see why Actavis should be forced to produce a drug they no longer want to produce and I don't see what this can possibly achieve because once the drug leaves patent protection the generics manufactures will be able to manufacture it regardless and, before then, patients will have to buy the pricier brand-name drug anyway.
I don't think the patent had actually expired yet on the older medicine. It was just getting close to expiring. Drug companies have figured out the 'new' way to keep you off of generics is to 'improve' the formula so that your doctor wants to keep you on the new one. I'm on Tribenzor, which is literally just a mix of three regular and cheap blood pressure medicines, but it's 'not generic' so I have to pay a much more expensive rate.
So yeah, this is just scum sucker scam way of maximizing profits at the cost of the patient and his insurance.
No! It's a *SIG*. Keep the Special Interest Groups away! (Con joke!)
The term for the old drug has not run out yet, it is still patented, so there is no competition yet.
Stopping to make the original drug should cause immediate expiration of its patent. A patent is a government-created monopoly to encourage people to make the stuff. Clearly, if the company won't make it, there's no need for the patent. Requiring a company to make something they don't want to make is absurd; instead, just let others make it. And if they raise the prices substantially, perhaps require patent licensing in those cases (just as we did for music).
- David A. Wheeler (see my Secure Programming HOWTO)
Then make it so if a company abandons the product the patent becomes invalid.
When you cant win, ad hominem.
read the fucking article. they plan to continue making it but only for certain 'special needs' patients.. so the judge is just telling them they can't restrict distribution but must make it available to all. makes sense...
further, the company is by far the largest producer of the drug worldwide, generic or namebrand, and its market share likely triggers antitrust provisions for it.
the new version, btw, is only the same fucking drug, just in an 'extended release capsule' instead of a 2x daily tab. one of the easiest and most common ways a drug company pulls this shit.
Any law made like that could almost certainly be used to ensure that any Patent YOU might ever have could be voided if you weren't making the product the day the patent was issued, and every day thereafter.
"I do not agree with what you say, but I will defend to the death your right to say it"
The summary doesn't make clear whats going on. I've been dealing with this personally for several months and what Actavis has been doing is terrible, the judge made the right decision.
They have been making the drug in question, Namenda, for many years and it has become a critical component of treating Alzheimers and several other related conditions. It is an instant release form.
There are no generics, it is still under patent until later next year. What Actavis did was create a new version of the drug which is extended release, and patent that. Its the exact same thing but with some coating that makes part of it release more slowly.Earlier this year they announced that they were discontinuing the instant release version, and they stopped manufacturing it.
Again, there are no generics yet, and no alternatives. The point was to force everyone to switch over to the extended release (which they have the patent on until 2025) BEFORE any other company could start making a generic version of the drug. This would make it extremely unlikely that any generic company would start making it at all since sales would be low and margins on generic medications aren't high. Most generic manufacturers don't have much in the way of a marketing budget, so once Actavis has gotten everyone prescribing the extended release version it would be too difficult for the generics to get doctors to switch back to the instant release version just because there was a cheaper option. Additionally, you don't want to change an Alzheimers patients medication any more than you have to, and since Actavis is forcing them to switch from the instant release to extended now you wouldn't want to switch them back to the instant just a year later, unless you had to.
To be clear Actavis stated all of this in their shareholder report. They were confident this plan would prevent generic manufacturers from taking any significant amount of the sales.
To make this much worse, Actavis stopped making the instant release without making nearly enough of the extended release. Google Namenda shortage to see the affects this has caused. Nursing homes have been forced to give patients their medication every other day, or instant some days and extended other days, because there isn't nearly enough to go around. I had to fill a 30 day Rx for it in September and had to contact 44 pharmacies to find one that had any (I was lucky and it had just arrived). People have been flying to other cities, even other states to fill the medication for their loved ones. Its been terrible for anyone suffering from Alzheimer's or any of the other conditions that it treats, as well as their families and the people providing care for them.
Any law made like that could almost certainly be used to ensure that any Patent YOU might ever have could be voided if you weren't making the product the day the patent was issued, and every day thereafter.
Bingo...
I wish I had a good sig, but all the good ones are copyrighted
According to the article, the issue is that doctors in many areas are not allowed to prescribe generics directly. They must prescribe the name brand, and a generic may be substituted if it is identical to the name brand. In this case, the name brand would no longer be offered, meaning the generics may no longer be offered.
Sounds like big drug makers lobbied to have these stupid rules made, and because of the rules, we have technical issues that could harm patients if a name-brand suddenly pulled a drug from the market. It's much easier to force a company to keep producing drugs than it is to change decades of medical rules.
This goes to a major complaint I have about the way we seem to be approaching health care in the United States: it's always an "either/or" proposition. Either the entirety of 1/6th of the economy in the United States can be handled by free markets, or the entirety cannot. There is never any consideration that perhaps one part isn't profitable under the current rules and needs a rule tweak, or that a small part doesn't work under free market rules and should be socialized but the rest should use free market rules.
Take, for example, discussions about the unprofitability of Emergency Room operations. I've seen the fact that hospitals who run an ER are required to treat anyone--and thus wind up treating the uninsured for minor ailments as a suggestion that the entire health care system is broken and so we need single payer.
But does anyone in the debate consider the possibility that ER visits only represent a very small percentage of the overall costs to the health care system? Does anyone consider the possibility of perhaps just socializing the costs for ER visits--by using taxpayer dollars to implicitly insure the uninsured who use an ER, while leaving the rest of the system alone?
Or take the fact that it is profitable for insurance companies to dump high-expense patients who run up large insurance-paid health care bills due to things like cancer. "Oh, we must switch to single payer, otherwise insurance companies will dump expensive patients and leave them to die." (Never mind that in Great Britain, they are implicitly dumping expensive older patients by pushing them onto the Liverpool Care Pathway without their consent. Bean counters are bean counters regardless of if they work for the government or for private corporations.)
But did anyone consider the possibility of the government backstopping insurance companies for high-expense patients, by (for example) putting a cap on the amount of money an insurance company must pay out in the lifetime of an individual (call it $1 million)--then when you hit that cap, the money beyond that cap comes from the government, filtered through the insurance company? That is, we socialize costs for expensive patients, while privatizing costs below the cap.
Ohhhhh, no. It's "either/or." Because we're too stupid to think of anything more subtle than reshaping the entire industry to fit either in the mould of Ayn Rand or in the mould of Karl Marx.
This reminds me of a situation my wife dealt with a few years back. She was on a pain medication that was really the only one she had found that provided the relief she needed to get through the day. But it suddenly stopped being sold or prescribed one day.
That day, the FDA banned the drug. It cited a study that found that the drug was linked with something bad, I think maybe suicidal thoughts.
But then she found that the study was produced by the company that made the brand name version of the drug, which had competition by generics by that point.
Hmm.
Also, the brand name company had just created a new similar pain medication that had new patent protections. The FDA ruling effectively killed the competition of this new drug.
Hmm.
Mind you, that new drug is ineffective for my wife's pain. Also, the study was done over a very short period of time, had a weak sample size, and when you look at its bias, there's no way that study would have made it into a real medical journal. But would the FDA accept it (presumably along with a check with lots of pretty zeroes)? Absolutely.
All my liberal friends think I'm a conservative, all my conservative friends think I'm a liberal.
I couldn't agree with you more. It's not illegal currently but should be. Alternatively as others have suggested, if you stop making a medication other companies should be able to make a generic version.
Others have called this "ever-greening" but that's not completely right. The Namenda XR is evergreening but what Actavis/Forest (it was Forest when this started, now they are part of Actavis), what they have been doing is known as a "forced-switch" and has only been tried a few times. Its been extremely effective. Companies normally lose 90% market share when a generic comes out, but if they've done a forced-switch a year or more in advance it is usually only around a 25% loss.
Forest (now Actavis) has been desperate since the patent expired on their other blockbuster drug, Lexapro, in 2012. This was an attempt to retain the marketshare of their other blockbuster, and would have worked if they hadn't screwed up the implementation so badly. Forest cut over $500 million from their RnD and manufacturing budget in the last 2 years which I'm guessing is part of why they couldn't ramp up manufacturing of the new extended release quickly enough. Drug makers have to report on shortages and potential shortages to the FDA, and Forest/Actavis was fully aware that they could not make enough of the extended release to cover all the people they were forcing off of the instant release. However they decided to stop the manufacturing lines making their instant release anyway, since they knew the longer they kept making the instant release the more market share they would lose to the generic manufacturers when the patent expired. They really are scum.
This is not an environment were the consumer can just automatically go to another vendor. The myth of a free market does not apply because there is no parity between the user and the producer. Although generics exist, they cannot always be substituted, and sometimes they don't even exist.
Medical companies are profit driven to the extent that they cannot be trusted. They routinely lie about both the safety and the efficacy of their products. This puts the health and even the lives of patients at risk all the time.
For example, De Puy/Johnson and Johnson produced metal on metal hip implants, and their own internal data showed that they were failing at a high rate and requiring additional surgery. Additionally, metal fragments were released into the bodies of recipients and causing metal poisoning. They decided to phase out the product because of "declining sales" and did not do a recall or inform doctors or the FDA.
Regulation is a necessity because the history of drug and medical equipment is filled with business practices leading to horrible outcomes, including needless death.
In addition, drug companies get huge direct and indirect subsidies from the government. A lot of the basic research is government funded and handed over the the drug companies at no cost. When a drug is going off patent, it is legal for the patent holder to pay other drug companies to not produce generic versions. This is the polar opposite of free enterprise. It's legalize collusion to maintain state sanctioned monopolies.
I'm routinely baffled and angered by self-styled "defenders of capitalism" who excuse dangerous and grossly anti-competitive business behavior. If the government did things like this they would be screaming like stuck pigs, but when the same or worse is done under the flag of capitalism it somehow is transformed into a sacred act, and negative consequences are left out of the picture. It seems obvious to me that the same kind of scrutiny should be applied to any big organization. Only being critical of one side is just stupid. Stop doing it.
Why is Snark Required?
But did anyone consider the possibility of the government backstopping insurance companies for high-expense patients, by (for example) putting a cap on the amount of money an insurance company must pay out in the lifetime of an individual (call it $1 million)--then when you hit that cap, the money beyond that cap comes from the government, filtered through the insurance company? That is, we socialize costs for expensive patients, while privatizing costs below the cap.
My god no!
That's socialising the losses and privaising the losses. That's using tax money to let the insurance companies cream off only he most profitable bits while making the taxes pay for the unprofitable bits.
SJW n. One who posts facts.
I wouldn't use Soylent Green as an analogy if I were you. Companies are made up of people, but they shouldn't be eating people. In too many cases, this is exactly what they end up doing.
If Actavis were to lose the patent on the old Alzheimer's drug when it started selling the new one, it would still be totally free to profit on the new drug if it were a significant improvement over the old one. The very fact that they object to having to keep manufacturing the old one tells us they're lying. If they were not, the new drug would automatically take over the market and demand for the old one would fall.
2) I can cease production all I want and not have the patent voided, as long as I do not switch production to a different drug designed to do the same thing.
So, you were saying?
You really can't see the loophole in that? The new drug isn't designed to do the same thing. It would do something slightly different. Sure, you could try to reword that, but that's the difficulty with creating laws...you either get too broad and have unintended consequences, or you get too specific and someone finds a way around it on a technicality you didn't anticipate.
In the U.S. there hasn't ever been an exploitation requirement per se. The only kind of IP that explicitly requires action by the holder is a trademark, which they're required to aggressively defend at the risk of losing it otherwise. However, it used to be that you could file an application and tie up the approval process for years without it actually being issued, which effectively let you secretly hold a patent as long as you wanted and have it formally issued only when it was to your advantage to do so. About 20 years ago the U.S. changed patent terms from "date of issuance" to "date of filing", so the clock now starts ticking when you first send in the application.
Please stand clear of the doors, por favor mantenganse alejado de las puertas
According to the article, the issue is that doctors in many areas are not allowed to prescribe generics directly. They must prescribe the name brand, and a generic may be substituted if it is identical to the name brand. In this case, the name brand would no longer be offered, meaning the generics may no longer be offered.
You might want to re-read TFA.
Most generic drugs are dispensed because state laws allow or require pharmacists to substitute a cheaper generic when a doctor prescribes the brand-name drug. But if the brand-name version is different from the generic, then the substitution cannot be made.
Nothing about not-prescribing generics directly.
That would be ridiculous and insane.
[Fuck Beta]
o0t!
Use it or lose it.
As soon as they stop making it they should lose the patent.
It's a simple solution.
Even limiting supply should trigger this clause.
This also works against the patent trolls who never did use it.