Judge Rules Drug Maker Cannot Halt Sales of Alzheimer's Medicine 266
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.
It's called "evergreening" (Score:5, Informative)
The practice of tweaking drugs like that is called evergreening [wikipedia.org].
(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.)
The saddest part (Score:2)
The saddest part is that the system is designed to permit this. It takes less effort to bring a variant of an old drug to market than it does a new one. You don't have to prove that it's as efficacious as the old one, let alone moreso; you only need to prove that it doesn't kill statistically significantly more people than the old one.
Scummy (Score:2)
It is a terrible thing for the drug company to force this switch.
But doesn't this imply that the first drug can be created generically now? Can't we take Actavis out of the equation entirely by having Alzheimer's patients switch away from the company? Why must they take Actavis' new drug?
Because patent still applies (Score:2)
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Re:Scummy (Score:5, Informative)
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.
Re:Scummy (Score:4, Informative)
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.
Explanation? (Score:2)
Can somebody please explain why BigPharma creates a medication X (consisting of components A B and C) and patents it, then halfway through its life creates X+ (consisting of A B and D) and patents it again, this affects the patent for medication X? I should be able to create a generic for X using the old formula (A B and C) when the patent for X expires, regardless of any patents for X+, or Y.
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Then all that would happen is more lobbying to outlaw the old drug for some threadbare reason ("side effects" is usually cited. That the new drug has the same or worse side effects doesn't matter, oddly).
If you need proof, just look up and down some of the latter drug laws and watch closely what has been outlawed and when, and whether you find some correlation with the date some drugs are approved. You might be in for a surprise.
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Then all that would happen is more lobbying to outlaw the old drug for some threadbare reason ("side effects" is usually cited.
Sound dangerous, like a pre-admission of guilt in a lawsuit.
1968? (Score:2)
Memantine (AKA Axura, Akatinol, Namenda, Ebixa, Abixa and Memox) has been around since 1968, why in the world is it still under patent? I fully understand why individuals/companies should be GRANTED LIMITED patents, and even why those patents should be longer for medical applications, but 46 years? From what I can understand the patent on this drug has been sold so many times its nowhere near the original developers, the constitution seems pretty clear that patents apply "to AUTHORS AND INVENTORS the exclu
Confusing summary - there are no generics (Score:5, Informative)
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.
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AFAIC the market has to remain free, the company in question must be able to do this of-course. The actual problem is government issuing patents in tge first place. Patents and copyrights protected by governments are the actual problem. Beyond that the government rules that doctors must prescribe the brand name and can only prescribe generics if they are exactly the same is a problem. FDA is the problem, it should not even exist. Blaming a company for HACKING the government laws to extend its own profi
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A tire company is no different than a pharma company, are you telling me that quality of tires does not have any effect on human lives? Hmmm, have you driven a car?
A food company, a tire company, a construction company, a transportation company, energy company, you can make your tired anti-competitive anti-freedom argument about most real businesses, it does not change the facts.
The facts are everybody tries to protect their business model and if they are given a choice of using government rules (hacking l
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Not so, the exact opposite is the case, government shouldn't be allowed to hand out monopoly power and curb competition with business regulations. A blown tire can cause you to die, by the way. It's the FDA that should be illegal, so that people would have many more options in the market than they do now.
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Yes, market remaining free is the not just 'some moral good', it is THE ONLY moral good we actually have. Free market is not based on violent coercion, it is based on voluntary exchange, that's the only moral compass a society has at all if any. Starting wars for profit, printing money to write off government debts (inflating the money supply), regulating businesses, so that businesses will have a way to destroy competition while lining up pockets of politicians, creating a welfare state and thus buying v
Re:This really should... (Score:5, Informative)
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.
Murder for profit (Score:5, Insightful)
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 [wikipedia.org] 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 can't they use eminent domain? (Score:2)
So instead of making general law changes asking for broad restrictions to patented drug
Do what India does (Score:2)
Fuck your patents. We're making it anyway, you just lost your privileges to do business under normal business rules. The drug and any derivatives of it become public domain, and any knowledge you have relating to that particular drug becomes public domain. ALL OF IT, regardless as to how it relates to other work you have.
Then, as stage two, take all the execs and every employee who didn't openly, publicly, actively work against this move out back and shoot them, preferably in a way that makes their death
it's not illegal (Score:2)
" Drug companies cannot illegally prioritize profits over patients"
actually, it's not illegal, and in fact what the judge is doing is directly against the Articles of Incorporation of the Company. if this is something you're not familiar with, watch the first few minutes of the Documentary called "The Corporation" or read professor Yunus's book "Creating a World Without Poverty". basically it is a LEGAL REQUIREMENT that the Directors of Corporations enact - pathologically and absolutely - the Articles of
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For some perspective... (Score:2)
....I invite you to compare the cost of health care in the US with that in just about any other developed country in the world.
Absolutely mystified (Score:3)
I freely admit to being absolutely mystified how the social compact of a supposedly enlightened civilization does not include basic nutrition, shelter, schooling and health care for all without direct charge. I am serious. I don't get it. With regard to the topic, this should include medical research including development of drugs, absent repulsive features such as some getting rich off the misfortunes of others.
If you don't think society, with today's robotics, can afford to provide basic nutrition, shelter, schooling and health care for all without crass commercialism and people falling through the cracks, IMO you are an idiot; an ass. I say this as a believer in TRUE free enterprise (not necessarily corporatism with all the sickening corruption that goes with it). I just think these three necessities trump everything else, and a society is not worth having if it spurns providing them.
Please note, when I say basic, I mean basic. The nutrition would be in the form of cost free provision of healthy but plain foods PICKED FOR the user and SERVED TO him. Shelter would be in the form of shared communal or semi-communal barracks. The health care would be limited to necessities for health. There would be no limit for what is truly needed, including dental and vision, but no pampering. If you want contact lenses instead of glasses, cosmetic surgery, sex change BULLSHIT, go ahead and pay for that shit yourself, but fuck you if you expect the pampering. If you want TV, cell phone, car and other pure luxuries, you pay. For free you would get lending libraries and communal computers.
If you raise specific objections, for example the living spaces would not be respected because they are free, and people would let them become decrepit, there are ways to deal with this. I won't belabor the details here; I think it is fairly obvious given any serious thought given to the matter.
You can be goddam sure there would still be a sizable worth ethic for those who desire more than the basics. Probably as much as, or more than, there is in the USA today. As it is, with provision of raw money to the "needy", some get to enjoy luxuries without working for them, while others fall through the cracks completely.
I don't really think this makes me a "communist". "From each according to his ability" is pretty obsolete given the state of robotics today. And if you want o cede "to each according to his needs" to the communists, tell me why. I certainly don't see why the rest of us should cede the high moral ground.
PRELIMINARY injunction (Score:3)
The summary above is highly misleading, possibly because of the bad headline the NYT editor put on the story. The judge didn't rule on the merits at all. All he did is issue a preliminary injunctiion, which forces the drug company to maintain the status quo for the duration of the trial. The judge didn't "block an attempt by the drug company" he just deferred the attempt until the case is over. If New York wins its case, the judge will actually block the attempt by entering a permanent injunction.
In other words: this ruling only reflects a judgement that, until we know who wins, it's better to force the company to keep the drug on the market, which is obvious to everyone. It doesn't reflect a judgement on whether the drug company may legally withdraw the drug.
Simple Solution (Score:4, Insightful)
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.
Re:Can you say... (Score:5, Insightful)
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!
Re:Can you say... (Score:4, Insightful)
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.
Re: (Score:3, Informative)
The term for the old drug has not run out yet, it is still patented, so there is no competition yet.
Re:Can you say... (Score:5, Interesting)
Then make it so if a company abandons the product the patent becomes invalid.
Re:Can you say... (Score:5, Interesting)
Comment removed (Score:5, Insightful)
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Patents have traditionally had an exploitation requirement: you can't just patent something and then sit on it, any more than you can stake a mining claim without 'proving it out.' This seems to have changed in recent years, now that we have so many examples of 'submarine' patents that suddenly come to life after sitting unused for years.
Legal question - was there a law change that enabled this, or is everyone just filing their patent suits in East Texas today?
Re:Can you say... (Score:4, Informative)
Re:Can you say... (Score:5, Informative)
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.
Re: (Score:2, Interesting)
That objection is solved by carefully delineating the drug itself into (non-)patentable components as with other inventions. Obvious candidates for the parts would be: the functional groups that generate therapeutic action, the functional groups that constitute the delivery system, and the functional groups that enable desired interaction with other drugs or diagnostic compounds. That would kill the practice of patenting redecorated (e.g., through methylation, hydroxylation, isomerization, salting, etc.) co
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Re:Can you say... (Score:5, Interesting)
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.
Re: (Score:3, Interesting)
This is why I would like to see the FDA stripped of its powers to keep products off the market. Testing of medical devices and drugs is a vital function, but let the FDA be a pure provider of information. The customer, his doctors and insurance companies would be free to look at the FDA data and decide for themselves what to medicate with.
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That's effectively what they are. They don't do the testing. They simply tell you how much testing you have to do before you don't get charged with a federal crime by selling your poison. If you left it to the courts (which is what all Libertarian types like to do), you'd be decrying judges finding against doctors who prescribed under-tested products because that's not "free market" either. So to fight it, you go about bandying "facts" like implying that the FDA does the testing. They don't they just set th
It's about who's doing the coercion (Score:2)
If you left it to the courts (which is what all Libertarian types like to do), you'd be decrying judges finding against doctors who prescribed under-tested products because that's not "free market" either.
Libertarian philosophy as I understand it is about coercion. A doctor knowingly or recklessly prescribing a health product that isn't right for a patient is coercing the patient. But if a doctor prescribes a product after weighing the risks and benefits, and a judge punishes the doctor for doing that because the FDA pulled the product from the market, the judge is doing the coercing, as was the product's maker who defrauded the FDA into pulling it in favor of the maker's new product.
They don't they just set the standards. Or should theree be no standards?
Let's just say that ther
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The colonels secret recipe: Take 7 seas italian dressing mix, put in blender and powder. Add to flour used in breading chicken. Flour, egg wash, flour. Let sit for 10-15 minutes for breading to set. Fry chicken.
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This is a slippery slope to slavery, requiring people to do something against their collective will.
You know where this leads, don't you? "We've decided to exit the health care business because the requirements to manufacture drugs that are no longer profitable has left us an unprofitable company.
Well, you can't exit the healthcare business anymore.
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Not to mention that the concept of private healthcare is logically flawed in a free market. The typical person creates much more value than the amount they are paid. A person dying will cost the economy a lot more than the loss of their wage.
Re:Can you say... (Score:5, Interesting)
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.
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You cannot use 'slippery slope' argument and then complain about other people making 'either/or' arguments! They are *the same* concept! You saying that this is a slippery slope is exactly an either/or proposition: That we should not do this thing because it *will* lead to this other thing.
Re:Can you say... (Score:4, Insightful)
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.
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But think of it: fundamentally insurance is a finite pool that insures against finite losses. Home owners insurance, for example, only pays out at most what the replacement value of your home is, and car insurance only pays out at most what is the replacement value of your car.
This model clearly breaks down--even in government-run "single payer" systems (such as the example I gave about British health care) when you come up against the potentially unbounded cost of a major medical emergency.
After all, what
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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?
It may be "a very small percentage of the overall costs to the health care system," but it's a large cost to many hospitals.
The best (and cheapest) solution is not to have the government pick up the ER tab, it's to get those frequent fliers into a place where they can (1) regularly see a doctor or specialists, (2) consistently manage their chronic condition(s), and (3) not have to use the ER for basic medical care.
Some hospitals have proactively set up programs to do exactly this.
They were eating the ER cos
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Your view of the American system is hopelessly naive. It is already a complicated mix of public / private - so complex that there are literally tens of thousands of people involved in figuring out the minute details of how to actually deliver care. CMMS (Centers for Medicare / Medicaid Security) is a government entity that both pays money - directly to providers and to other companies and, simultaneously, regulates payments AND sets standards for 'private' companies to pay.
Medicaid (a government entity pa
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-by using taxpayer dollars to implicitly insure the uninsured who use an ER, while leaving the rest of the system alone?
It's cheaper to treat the issue before to go to the ER. The ER is about 10x more expensive than just letting them see the doctor in the first place. Since they can't afford a normal doctor, then tax payers still foot the bill, but now it's 10x higher.
Cold War-era stigma against socialism (Score:3)
Why the fuck are profits the motivating factor!?
Because there are powerful people still alive who see socialism as the enemy because they remember World War III (also called the Cold War) against the Union of Soviet Socialist Republics.
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Despite the legal analogy, companies aren't really people. If you also made it illegal for people to quit the company, that would be akin to slavery. But requiring a company to do something is not slavery.
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Like soylent green, companies are made of people.
And a "company" is just a legal fiction by which a group of people can hold property and IP rights without those property rights being held by any single individual, so that the company can continue to operate when there are changes in personnel.
So if you insist on making a company continue to operate even when it is no longer profitable--as was in my example--then at some level that company still must contain people: a company without any people cannot funct
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There is no mechanism to force owners to become active in a company's daily affairs. That's one of the key benefits of incorporation: if shit hits the fan, you just declare bankruptcy and walk away unscathed. Owners have no responsibility to the company, and legal judgments cannot touch them as individuals. So no, it would not be forcing anyone to work for the company against their will. If everyone just quit the company, it would fold and it'd be up to a bankruptcy court to try to find a buyer or otherwise
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Because currently no mechanism exists to force a corporation to take action.
My hypothetical above was premised on the idea that if we were to listen to our emotions and demand that a corporation not leave the health care business simply because it was unprofitable--and after all there are lives to save--that we would create a mechanism which would effectively exempt corporations from folding.
And note if the only way I can exit a business is to zero out millions in assets I own, that's a pretty hefty burden
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So all the drug companies will do is spin off small sub-companies that own the rights to the drugs in question then defund and de-personnel them.
And make sure to "campaign contribute" to the right politicians to ensure this remains legal.
The correct response is to pass laws that removes patent protection on these drugs and allow generics to enter the market. Probably at a tiny fraction of the price of the original drug also. If the new drug really is that much better than the old one, it will succeed in any
Re:Can you say... (Score:4, Insightful)
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.
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you are effectively requiring someone to act against his will and work for the company without being able to quit--which is akin to slavery.
Isn't that the whole idea behind capitalism in the first place? Make people act against their will and work for a company without being able to quit? Sure, you can quit working for a specific company, but it's a bit harder to quit working for any company.
There's some delicious irony in forcing the company owners into the same shoes as their employees - I approve of your idea :)
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You know where this leads, don't you? "We've decided to exit the health care business because the requirements to manufacture drugs that are no longer profitable has left us an unprofitable company.
Well, you can't exit the healthcare business anymore.
Perhaps the solution is to make generic drugs illegal. Allow a drug company perpetual patents so they won't ever become unprofitible.
Then they can avoid competition, because competition is bad. Umm ..... right?
Because this is the other side of the coin. Generic drugs are widely hated by the drug companies because they are competition. Making a minor change, say adding caffiene to an antidepressant, then re-patenting what is essentially the same drug, is more a loophole exploitation that a response to c
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I would think the solution would be quite the opposite: subsidize the ramp-up costs for generic drug manufacturers so that when drugs fall out of patent they can be easily manufactured by other drug makers.
My understanding is that there are essentially two classes of drug manufacturers--those which make patented compounds, and those which make generics. Patented compounds tend to be very expensive because it can cost billions to bring a new compound to market, largely because of the cost to get FDA approval
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The fix for that one is to allow patients to fill their prescriptions on the worldwide market, rather than being legally restricted to domestic suppliers. If the drug is any good, Ranbaxy or some other offshore manufacturer will be glad to produce it.
Ripe for contraction (Score:2)
We've decided to exit the health care business because the requirements to manufacture drugs that are no longer profitable has left us an unprofitable company.
Then the market might be ripe for contraction. Sell your assets to another drug company that will benefit from economies of scale or synergy or whatever the marketroids are calling it today. Then start a video game company or something.
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So it is ok to keep forcing them to make the product if it was not making them money?
I am sorry but the law you propose would lead to less people helping people. there has to be a balance.
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So it is ok to keep forcing them to make the product if it was not making them money?
If a sudden stop would lead to a drug shortage and huge price spike, sure. Generic companies manipulate the price of drugs (think 1000% price hikes, if you can get the drug at all) this way. It works because it would take a drug manufacturing plant months and millions of dollars to become approved to make a given drug, and that assumes the plant wouldn't need several months and millions of dollars of retooling to even make the drug at scale.
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doctors have to swear this
No, we don't. Most medical schools do feature some form of the Hippocratic Oath as part of either their induction or graduation ceremonies, but it's purely symbolic. Hospitals have certain legal requirements to treat patients who show up, and members of the medical staff of that hospital may be required to treat those patients as long as they want to retain privileges to treat patients at that hospital, but there is no general obligation to treat anyone who shows up at your clinic door.
This is a terrible
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It makes sense to write the laws based on that intent and to interpret the laws based on how they are written.
This is a horrible thing being done by the drug company but the correct action is to fix the laws, not allow judges to create new ones out of thin air.
makes no sense (Score:3)
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How do they insulate themselves from generic competition by stopping sales of their own brand name?
Step 1. Make a slightly new formulation (tweaked molecule, prodrug, extended release)
Step 2. Blanket the information channels with advertising for the NEW BETTER product
Step 3. Drop the price of your original drug to screw with the generic manufacturers ---They preempted this step by ending production entirely
Step 4. Profit because everyone has moved to your NEW BETTER product, which has no competition.
I personally take a XR medication, even though there are cheap generics for the older two-a-day formulatio
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I personally take a XR medication, even though there are cheap generics for the older two-a-day formulation. If my insurance situation changed for the worse, I'd switch in a heartbeat...
The people in your insurance pool should see to it that you are removed from it, one way or another. Seriously. You are a selfish bastard. Fuck you.
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...overturned on Appeal?
I'm sorry, that's just an insane ruling. REQUIRING a company to manufacture a specific product???
Yeah, you're right. That's insane.
Almost as insane as a the practice of changing a product ever so slightly and re-branding it under a different name in order to avoid further lawsuits and bad publicity they would receive from the previous formula riddled with side effects or fatalities.
Perhaps we should learn to look through the forest being planted in front of our eyes, or at least ask why it exists, because it would certainly appear this type of activity is not always about simple greed like patents.
"Stop making" should equal "patent expired" (Score:5, Interesting)
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).
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That does seem like the better solution, but probably not within the court's power. In an antitrust case a court can issue injunctions relating to a company's business practices or changes in business practices, but can't invalidate a patent. Congress could certainly pass such a law though, and probably should.
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So, how long should they have to "stop" to lose the patent?
Short enough time that a fire at the factory would be sufficient to void the patent? Hmm, I can see a lot of factory fires at my more innovative competitors in the near future....
So, how about they have to produce some of it annually or lose the patent? Hmm, well, I can mix up a couple doses in the lab every year and keep the patent forever, and it hardly costs me a thing.
Note that you won't be able to phrase a law that does what you want witho
Re:Can you say... (Score:5, Informative)
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.
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Kudos to the judge on this one, because the company is pursuing a bald-faced scam in forcing patients to switch to the new version in this manner.
Yes, it's weird to in effect require a company to manufacture a given product. Actavis could easily start having "manufacturing problems" that mysteriously cramp its ability to keep producing the old substance. How I would like to see this shake out is for the old patent to be automatically voided in cases of product hopping. The old drug would become a generic th
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"Drug companies cannot illegally prioritize profits over patients"
what's the problem?
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I'm sorry, that's just an insane ruling. REQUIRING a company to manufacture a specific product???
I agree that it's insane to require a company to manfacture a specific product against their will but in the case of a life saving
medicine, they should probably be required to open source/release the patent of the product if they cease manufacturing it.
That would allow someone else to manufacture it if there is a demand.
A company shouldn't be required to produce an unprofitable product but it shouldn't be able to prevent a competitor or
non-profit from doing so.
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Being able to parrot advertising slogans is not the same as being educated.
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I understood it perfectly, thanks.
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It obtained Namenda when it bought Forest Laboratories.
The drug, known generically as memantine, is one of Actavis’s most important products.
There's already a generic. So, what's the problem?
Drug company pays Doctor to prescribe it's products.
Doctor prescribes new not really improved, yet patented product.
Profit.
The rest of us pick up the tab..
In the continuum of medicines, the idea that a company can hold on to a specific recipe in perpetuity would rewuire us to go to the doctor for asprin, or simple antihistamines, as they simply add another ingredient as the patent expires.
What a lot of people do not understand is that this is a strong anticompetitive movement. If all the drug manu
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Is there a drug to help people understand that it's means it is?
Yes, I believe the trade name name is pedanticassholeitol.
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There's already a generic
There's already a generic name. The government, in all its benevolence, has been permitting drug holders to "lock in" their expiring drugs and prevent generics from being marketed [google.com] for a certain period after it expires. There are even drug companies that pay other companies not to produce their drug [google.com] so they can continue to sell the brand name (at an inflated cost to ensure there's a profit even after these payments).
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I'd be fine with refusing the company the patent protection on an obvious follow-up product.
What if the new formulation is clearly better for some or most patients? Even when several drugs all have the same active ingredient, different formulations can change side effects drastically. Ditto for when the "me too" drug contains an active ingredient that is slightly different from the original.
Re:I don't get it... (Score:5, Informative)
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.
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as I can tell, manufacturers are free to manufacture the generic, doctors are free to prescribe it and patients are free to take it.
According to the lawsuit, in some areas, doctors are not free to prescribe generics, but a generic may be substituted at the pharmacy. If the name-brand version of the drug does not exist, then that drug may not be prescribed, meaning the generic versions may not be substituted.
While I've never thought of this before, now that I look at it, I've never had my doctor prescribe a generic drug for me before. Always a name brand, and then the doctor would tell me I could also ask for a generic at the pharmacy
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in some areas, doctors are not free to prescribe generics ... If the name-brand version of the drug does not exist, then that drug may not be prescribed
What the actual flying ****! Were the lawmakers in bed with big pharma or something? That's ridiculous. What needs fixing there, though, is not anti trust actions against drug companies but stupid, stupid laws.
You'd think health insurers would have kicked up a fuss about this because the bulk of the increased cost must fall on them.
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Were the lawmakers in bed with big pharma or something?
Not just 'were', and not just 'in bed', but wild kinky shit. This is pretty much how the US legal system's relationship with big business has operated for years.
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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?
Always so negative. In a more positive look, that good doctor perhaps got a free cruise or otherwise positive incentive for knowing that the patented version was infinitely better than the generic crap. "After all, you do want to be sure that dad is getting the best possible treatment for his Alzheimer's don't you? The caffiene in the new patented formula might just have some synergy with the real drug in it, and he might be the first person to go into remission. Now do you want to trust your father's ment
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When the generics become available, the insurance companies will say they will only pay for the generic drug, after all they are thte ones paying.
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Well, if you accompany discontinuing the product with publicity about how dangerous it was (but then take the medicine, tweak the formula slightly, and re-release), nobody will be able to make the generic in a profitable way. This happened with Glaxo and Salmeterol inhalers (sold as Serevent). Like any other drug, it is dangerous when not used properly. I found it was the only drug that relieved my asthma symptoms (the discussion about how it is far more profitable to treat as opposed to cure asthma is some
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(the discussion about how it is far more profitable to treat as opposed to cure asthma is something for another time)
I think a cure for asthma would be a goldmine, especially compared to a new treatment. Imagine a best case scenario "take a pill, your asthma is cured, works for pretty much all patients" drug, then look at the numbers:
Market: 25 million+ asthmatics in the USA. A new treatment would have to compete against all of the existing treatments. A cure would own the market, full stop. It would displace pretty much all of the brand and generic treatments. Insurance companies would have to cover it. Medicare/medicai
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Really, you don't think that is reaching pretty far? I hardly think an Alzheimer patient can be trusted to properly medicate himself, whether it is once a day or 2-3 times a day. Big deal. Either way, he needs a care giver, the absence of which is simple neglect. The difference in resources between taking 10 seconds once a day, or 2-3 times a day to medicate the patient is very slight.