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!
--
"It is now safe to switch off your computer."
How do they insulate themselves from generic competition by stopping sales of their own brand name? If it's off-patent and there's demand then generic companies will offer it. If there's a sufficient advantage to the new one then doctors will order it in spite of the cost.
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!)
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.
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.
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 something for another time)
Always very expensive, but shortly before it was to turn generic, it was discontinued. They then combined Salmeterol with a steroid, re-released it, and continued to make a huge amount of money off of it. It has since lost patent protection, but no company is willing to make a generic, for fear of lawsuits I'm sure. Glaxo can afford a reasonable defense, but I'm sure the generic companies don't have the profit margins to be able to afford the risk of a suit.
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.
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.
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?
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?
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.
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 for a certain period after it expires. There are even drug companies that pay other companies not to produce their drug so they can continue to sell the brand name (at an inflated cost to ensure there's a profit even after these payments).
If I have been able to see further than others, it is because I bought a pair of binoculars.
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
(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/medicaid would have to cover it. Pretty much everyone with decent insurance would end up on your cure.
Costs: R&D costs ... hard to compare. But for marketing costs: A billion dollar marketing campaign for a new asthma treatment would capture a fraction of the market for a few years. For a cure, pediatricians would be beating down your door instead of you spending out the wazoo trying to get them to accept free samples. A cure would generate so much attention in the news, medical conferences, literature, etc. that the only marketing costs would be in explaining how to administer it.
Price: Treatment: set by the cost of competing treatments. Cure: list price, $30k a pop in the USA, easy. Actual average price would end up being more like $15k after various discounts.
Revenue stream: This is the biggest advantage of a cure. With a treatment, you have to wait for your profit from each patient: money comes in dribs and drabs from each patient over a decade, and you never know when they might switch to another drug or just stop taking asthma drugs. For a cure, you get all of your money from each patient up front on day one. A dollar earned by the cure is worth about two dollars earned by the treatment, because you get that dollar much sooner and with much less risk. Really. By the time a competitor comes out with a "me too" asthma cure, you've already cured most of the existing asthmatics ($15k x 15M patients = $225 billion dollars, spread over ~4 years), so you will only be competing for new cases.
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 is the replacement value of a human being? $100,000? $1 million? $10 million?
What that strongly suggests to me is that as a society we place more value on preserving human life regardless of cost, regardless of the fact that this cannot properly be handled in a free market environment.
And by definition in the edge cases where the free markets break down is where society should step up and socialize costs.
This isn't a matter of "privatizing the losses"; the breakdown has to do with the potentially unbounded cost of health care for an individual due to circumstances that cannot be properly predicted. For example, I know someone who needs nearly continuous care for the simple reason that she was unfortunately in a car accident that wasn't her fault. Allowing her to die because it's too expensive to let her live is not an option, and assuming that corporations are boundless fonts of endless money is absurd--and penalizing an insurance company because it is unable to cover an unexpected multi-million dollar loss (because as a society we don't want her to die) doesn't really fit the notion of insurance as covering a finite (and maximum) amount.
Thus, door 'C': socialize high-cost patients.
We already do something akin to this with Medicare; the whole point of Medicare was to cover the expenses of the elderly rather than having those expenses covered by private insurance. (And the structure of Medicare is pretty similar to what I'm proposing, with Medicare effectively serving as a back-stop against private supplemental insurance. We just think of Medicare as the base-line insurance and supplemental insurance as covering the 'gaps', when in some sense it's really the other way around.)
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.) compounds that have the same functional characteristics of existing drugs while encouraging the invention and publication of functional groups that can be interchanged and combined with other inventions.
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 summary anyway. They are moving production from a twice-a-day formulation to a once-a-day formulation, because the patent on the latter has a little more life on it. Nothing is stopping doctors from prescribing the older formulation. It's just that generic drug makers can't start making the extended release (XR) form yet, and so any prescription for the XR will be filled with the brand name rather than a generic.
The idea that healthcare isn't a business is crazy. Even purely socialized medicine like the VA or the NHS has to be a responsible steward of the public's money.
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.
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!
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.
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.
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 paid for by both states and the Federal government) IS the 'insurer of last resort' for complex, very ill patients.
There is nothing 'either / or' about this system. In fact, one of the biggest complaints about the system is in fact, that it is so "OR" - so friggin complex that nobody can figure it out. This leads to administrative waste, poor care and job security for those tens of thousands of people. Just about the worst system you could have come up with.
Faster! Faster! Faster would be better!
-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.
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.
John McAfee 'It was like that time I hired that Bangkok prostitute; to do my taxes, while I fucked my accountant'
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.
Look, what these snakes are doing is unethical and despicable.The whole pharamaceutical industry is full of rats who only care about their own interests. Any roadblock to their devious practices is welcome. In this case it's a really old trick they thought to implement.. changing one molecule on a chemical so that it's a "new" drug and then they have a brand new patent. The amount of research is negligible to nonexistent, as they already have a whole stockpile of isomers and other similar chemical formulations for almost every drug they supply. They probably have already done the testing as well and they just store the results. When a patent is about to expire they simply contact the FDA , supply the data and ask for approval. Similar drugs like this are also usualy fast tracked by the FDA to allow the company to market them quickly, as well. I mean, have you ever wondered why there's dozens of benzodiazepines (valium style drugs) on the market when the first ones worked so well? Patent expiry. Usually the ones with the best results are marketed first, and then they dig through their research, to find one to replace the one about to expire. Unfortunately, these often were passed over initially because of troublesome side effects, so often each new version is worse than the one it replaced. That's why it always seems that they get worse, or more addictive, or more serious side effects with each new drug. Yet they still get approval from their buddies at FDA. And if you need even more evidence of their complete moral corruptness, when I was more involved in the industry, my partner at the time (an RN) got offered the position of detail saleswoman, in large part because she was also an ex ramp model. She stormed out of the final interview, however, when it was clearly implied that she had to do *anything* to secure the sale (ie a guarantee that the MD would prescribe only their drugs) .. Basically she told me they expected her to prostitute herself for the deal. Although she refused, some other aquantances of ours did not. The money is, after all, extremely good...