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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.
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.
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.
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"
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.
Its not flawed at all. Its often the case that people with the means will pay almost anything for healthcare. Its they canonical definition of inelastic. The Alzheimer's patient will pay anything for the drugs keeping him or her sane until they simply haven't got the resources to pay anymore. Nope healthcare (if its effective) *should* be wildly profitable. The problem is this funny idea we have allowed to creep in that everyone is entitled to be healthy even in God or nature did not end so.
Anyone should be free spend whatever they like on their health and any provider ought to be free to charge whatever they want or offer whatever services and products they like, what isn't good is for society to allow individuals to allocate the resources of others against their will. This is ESPECIALLY true of healthcare. Cold as this may sound its probably far more true of healthcare than other things because the economics say it can be near infinitely expensive and people are fundamentally irrational about the care they will choose to consume if there are no constraints. I also think there is no moral way to decide constraints other than to leave it to the individuals wherewithal.
Consider the case of my Great Uncle, (Keep in mind this is occuring in the 40s, situation can get much more crazy expensive today). This is a micro-economic example but I see know reason the tragic effects of over consumption of healthcare won't have the same effect on society as it did on our family.
My Great Uncle and his wife had third child with terrible birth defects. Without major surgical intervention the child would not have survived for more than a few days. The most hopeful prognosis was that if heaven and earth were moved maybe this child could eat on its own; but the brain damage was so severe even this was unlikely.
My Great Uncle could not see reasonable and humane thing to do was to let this baby pass quickly without minimal suffering. No they chose to do the surgery. He spent every dime he and his wife had, investing it all in this lost cause. The surgery was a "success". He and his family were now nearly destitute.
My Grandfather stepped in pay to keep this child in a nursing facility she could be cared for. She never spoke or sat up on her own in the three years she lived. Never indicated she could recognize her mother, nothing. My Grandfather could do that, for his brother and his child. What he could not afford to do was take on the crushing debts for the original surgery, or bear the cost of keeping my Great uncle and his family in their home. At least not without detriment to his own family, which he would not allow. They and the other children lost all the advantages that come from a comfortable middle class life. My Great uncle killed himself over what he had done to the rest of his family, which of course only made things worse for them.
Now I am not suggesting that the daughter did not have the right to live or should have been euthanized or something, merely that a decision not take for the mouths of his other children for her care would have been the wiser. My grandfather on the other hand did the right thing. He compassionately contributed what he could to his brothers plight and that of his child but was able to stop before it became destructive to him or his own; because he was not being forced.
Once we force people or companies to support the health of others there are no reasonable lines to draw, we all risk being sucked into a bottomless abyss. Force is never good and never moral.
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.
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 profits is disingenious. Everybody tries to protect their work and profits, that is the principle of self interest, that is the reason for competition, greed is good. The real problem is when greed can be backed up by the force of a government.
Your givernment is causing you this pain. The company is making a rational choice. I am with the people making rational choices, allowing governments to destroy free market capitalism and competition by regulating business and allowing government to be involved in money is irrational choice.
You can't handle the truth.
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.