Focusing on the root causes, that there is insufficient funds to do the job correctly, and that the US is using IP to cover over a shortage of production is to be able to solve the problem, to wave your hands at the weeds and vent, is to do nothing effective. It is a great deal easier to fix than you are implying.
>You raise a good point. How do we sort through techno-babble and hand-waving by experts?
Ask yourself the simple question: would you want something injected into your nervous system directly that had been left out over night with an open container?
Your post is pervasively dishonest. First, you clearly don't even know what the formulation loophole is. It isn't, as you falsely assert, about creating particular dosages for particular patients with particular prescriptions. That is a matter for state regulation of the practice of medicine, and while some harm can be done, it is a one off question of standard of care.
But as anyone with a modicum of honesty can tell, which is not you – you, not I, are shilling for an industry – this isn't what was going on here. Instead a group of investors where manufacturing thousands of doses and introducing them into interstate commerce. There was no prescription in hand when the formulation was done, which in most states is a requirement for formulation.
After decades of incidents of patient adverse drug reactions, and even deaths, finally prompted the FDA to put pressure on the industry the result was a 1992 set of guidelines set out by the USP and co-ordinated with the other pharmacological organizations, primarily American Society of Health-System Pharmacists (ASHP) and National Association of Boards of Pharmacy(NABP). The guidelines and risks of such manufacture were codified in 2004 by the inclusion of Chapter 797 "Pharmaceutical Compounding—Sterile Preparations" included in The United States Pharmacopeia and The National Formulary issue by the USP. It specifically sets standards for sterile preparation and formulation, and was deemed enforceable as regulation.
From the forgoing, you are advocating illegal behavior that kills people, some I am just going ignore your baldly defamatory accusation that any of this in any way touches on specific dosage formulation for pediatric or geriatric patience. The issue is, and has been for decades, that formulation is an intrastate issue of the practice of medicine, but that unscrupulous and unsafe actors have used it to get into the unregulated intra-state commerce in pharmaceuticals. As noted, companies that have complied with labeling and regulation should have a private qui tam right of action, including the use of the False Claims Act as amended, to sue companies illegally and fraudulently manufacturing compounds, and introducing them into interstate commerce, and claiming that is formulation. This would allow the to file civil suits in Federal Court to collect damages and get injunctions.
For example in this case, the company in question had been repeatedly warned it was not in compliance with sterile manufacture, and its practiced prior to the regulatory enforcement of the guidelines in what would become chapter 797 was well known.
Finally your claim on risks is entirely fraudulent. There were 14000 affected doses, 236 infected individuals, which is a 1% infection rate, and 23 deaths so far, which is a CFR of 10%. On net, that is more deaths in the same time in that population cancer or heart disease. 300 million people didn't get steroid shots the the last three months, so the are not part of the risk pool. That's Public Health Stats 101. In addition there is another fact which you conveniently attempted to cover up, and that those infected have an uncertain prognosis, and many have suffered non-fatal strokes. They haven't recovered. In fact, no one who has been infected has recovered yet, so the CFR is likely to be worse. This for a treatment to a non-life threatening condition.
In summary, the risk number you put forward is a deliberate lie, you mis-state what the loophole is, you accuse me of attempt to restrict actual formulation, and then have the gall to say I'm a shill? On the contrary, the evidence indicates, that if anyone is shilling, it is you, for a company that willfully ignored the standard of care, and has with gross negligence exposed thousands, sickened hundreds, and killed or disable hundreds in the space of a few months.
I dunno, you don't seem to know the first thing about what you are talking about. Perhaps you know the different risk rates between specific formulation adverse drug events and general formulation adverse drug events?
Meningitis is a description, namely, inflammation of the coverings of nerves or the brain. There are several causes. Bacterial meningitis, which is serious but generally treatable, and viral meningitis, often caused by cocksackie viruses, the same family as the common cold, which is not generally serious, but also not easily treatable, because the body generally prevents movement into the nerve bundle itself large compounds, which most anti-virals are.
Fungal meningitis is rare, largely unstudied, because rare, and of varying severity. One reason for the danger of this outbreak, is that there is no generally accepted course of treatment. As such, we are about to learn things we did not want to know, and under pressure of several thousand potentially exposed patients.
According to Peter Hutt, accorded the status of "The Dean of Health Law" and the author of the medical devices rules for the FDA, the Agency has lost its way. The criticism that he leveled then is only more appropriate now. Formulation slips into the area between Federal law, which regulates what can be introduced in to interstate commerce, and state law, which regulates the practice of medicine. Because of the narrowness of testing, the FDA approves uses of drugs for specific illnesses and populations, but once approved for what is called "an indication" doctors are free to prescribe it for any use, including those not encompassed by the FDA Label.
Such "offlabel" use is necessary, because many drugs are approved for narrow populations, but are useful in wider areas. Some 70% of adult oncology prescriptions are off-label, and virtual all childhood prescriptions in cancer treatment. The same is true of formulation, which is supposed the mixture of pharmacological compounds by standard means.
However, because of cuts to regulation, focus on easier approval soaking up the remaining budget, and fee based payment introduced through the most recent FDA reform, basic enforcement of the mandate of the FDA has decayed drammatical, raising risks as we have seen. Similar problems at the USDA, which has an overlapping mandate in food safety, have seen outbreaks of tainted food.
In this case there were two violations, one of state medical practice, and one of the Food, Drug and Cosmetics Act as amended. The first is that a formulation should be for a particular patient, with a particular script. The second is that introduction of the formulation into interstate commerce is a violation of the FD&C. Both of these practices have been widely winked at, because of the prevalence of off-label formulation, and because there was too much money being made. Formulators would often corner the market on a particular compound, more or less requiring that it be bought through them, at a mark up.
The solution here is for Congress to close the formulation loophole, and for the Agency and the states to work together to create a unified standard of rules. My co-author and I have proposed also a private right of action by indication holders which would allow the to bring qui tam suits against off-label marketers in overlapping indications, thus giving companies an incentive, namely triple damages, to police companies that use their compounds, or who offer off-label competition.
The people who brought the slaves over spent enormous sums on doing so as well. Clearly abolition was a naked attempt to deprive people of their property.
It is this kind of statement that makes people run into the arms of the copyright industry, because the can say "It is for the artists!" The copyright industry is, of course, lying, because what they do has nothing to do with the artists, except as unfortunate inputs into the hit making process, but that is beside the point. Paying creative people for their work is, indeed, a moral issue, because if they cannot protect and profit from their work, they die. And then their out declines, for some odd reason.
Copyright is an intensely moral issue for two reasons, first it is immoral to profit from some one else's work while allowing them to starve to death, but second, copyrights can only work to the extent that people see them as moral.
In our current situation, we have the worst of both worlds. Spotify pays me.01 for ever 10 listens. That is, even to live in poverty I would have to generate 20 million listens a year. The artists are not being paid by and large. Conversely imposing a economic death sentence, which is what 100,000 dollars of damages are to an ordinary person, is clearly immoral.
Copyright is, and always was, a moral issue, and the present system is breaking down precisely because it is immoral.
People who like copyright as it is today, would have liked slavery as it was in 1859. Every argument about the legality of IP law today, was made by apologists for slavery then.
The present bit slavery system is the cost we have for wanting a 21st century standard of living while dependent on 19th century invention for our transportation. When you are willing to kick the carbon habit, and leave the 20th century sprawlconomy behind, we can kick the paper mill, and its creation of perpetual property rights on people, to the curb.
"To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries."
If a law is not within the confines of that grant of power, it is unconstitutional.
Slashdot Mirror
I am going with experience over youth in the conflict between law and evolution, as is most of the smart money.
Focusing on the root causes, that there is insufficient funds to do the job correctly, and that the US is using IP to cover over a shortage of production is to be able to solve the problem, to wave your hands at the weeds and vent, is to do nothing effective. It is a great deal easier to fix than you are implying.
Because the USPO is paid for by fees.
That the offices full of three year olds that run most companies will love it.
Ask yourself the simple question: would you want something injected into your nervous system directly that had been left out over night with an open container?
But as anyone with a modicum of honesty can tell, which is not you – you, not I, are shilling for an industry – this isn't what was going on here. Instead a group of investors where manufacturing thousands of doses and introducing them into interstate commerce. There was no prescription in hand when the formulation was done, which in most states is a requirement for formulation.
After decades of incidents of patient adverse drug reactions, and even deaths, finally prompted the FDA to put pressure on the industry the result was a 1992 set of guidelines set out by the USP and co-ordinated with the other pharmacological organizations, primarily American Society of Health-System Pharmacists (ASHP) and National Association of Boards of Pharmacy(NABP). The guidelines and risks of such manufacture were codified in 2004 by the inclusion of Chapter 797 "Pharmaceutical Compounding—Sterile Preparations" included in The United States Pharmacopeia and The National Formulary issue by the USP. It specifically sets standards for sterile preparation and formulation, and was deemed enforceable as regulation.
From the forgoing, you are advocating illegal behavior that kills people, some I am just going ignore your baldly defamatory accusation that any of this in any way touches on specific dosage formulation for pediatric or geriatric patience. The issue is, and has been for decades, that formulation is an intrastate issue of the practice of medicine, but that unscrupulous and unsafe actors have used it to get into the unregulated intra-state commerce in pharmaceuticals. As noted, companies that have complied with labeling and regulation should have a private qui tam right of action, including the use of the False Claims Act as amended, to sue companies illegally and fraudulently manufacturing compounds, and introducing them into interstate commerce, and claiming that is formulation. This would allow the to file civil suits in Federal Court to collect damages and get injunctions.
For example in this case, the company in question had been repeatedly warned it was not in compliance with sterile manufacture, and its practiced prior to the regulatory enforcement of the guidelines in what would become chapter 797 was well known.
Finally your claim on risks is entirely fraudulent. There were 14000 affected doses, 236 infected individuals, which is a 1% infection rate, and 23 deaths so far, which is a CFR of 10%. On net, that is more deaths in the same time in that population cancer or heart disease. 300 million people didn't get steroid shots the the last three months, so the are not part of the risk pool. That's Public Health Stats 101. In addition there is another fact which you conveniently attempted to cover up, and that those infected have an uncertain prognosis, and many have suffered non-fatal strokes. They haven't recovered. In fact, no one who has been infected has recovered yet, so the CFR is likely to be worse. This for a treatment to a non-life threatening condition.
In summary, the risk number you put forward is a deliberate lie, you mis-state what the loophole is, you accuse me of attempt to restrict actual formulation, and then have the gall to say I'm a shill? On the contrary, the evidence indicates, that if anyone is shilling, it is you, for a company that willfully ignored the standard of care, and has with gross negligence exposed thousands, sickened hundreds, and killed or disable hundreds in the space of a few months.
I dunno, you don't seem to know the first thing about what you are talking about. Perhaps you know the different risk rates between specific formulation adverse drug events and general formulation adverse drug events?
Fungal meningitis is rare, largely unstudied, because rare, and of varying severity. One reason for the danger of this outbreak, is that there is no generally accepted course of treatment. As such, we are about to learn things we did not want to know, and under pressure of several thousand potentially exposed patients.
Such "offlabel" use is necessary, because many drugs are approved for narrow populations, but are useful in wider areas. Some 70% of adult oncology prescriptions are off-label, and virtual all childhood prescriptions in cancer treatment. The same is true of formulation, which is supposed the mixture of pharmacological compounds by standard means.
However, because of cuts to regulation, focus on easier approval soaking up the remaining budget, and fee based payment introduced through the most recent FDA reform, basic enforcement of the mandate of the FDA has decayed drammatical, raising risks as we have seen. Similar problems at the USDA, which has an overlapping mandate in food safety, have seen outbreaks of tainted food.
In this case there were two violations, one of state medical practice, and one of the Food, Drug and Cosmetics Act as amended. The first is that a formulation should be for a particular patient, with a particular script. The second is that introduction of the formulation into interstate commerce is a violation of the FD&C. Both of these practices have been widely winked at, because of the prevalence of off-label formulation, and because there was too much money being made. Formulators would often corner the market on a particular compound, more or less requiring that it be bought through them, at a mark up.
The solution here is for Congress to close the formulation loophole, and for the Agency and the states to work together to create a unified standard of rules. My co-author and I have proposed also a private right of action by indication holders which would allow the to bring qui tam suits against off-label marketers in overlapping indications, thus giving companies an incentive, namely triple damages, to police companies that use their compounds, or who offer off-label competition.
I have already explained, but I know that you will not understand, because your paycheck depends on your not understanding it.
The people who brought the slaves over spent enormous sums on doing so as well. Clearly abolition was a naked attempt to deprive people of their property.
I'm fully aware of where the quote comes from, you seem not to understand what it means.
"It's Marshall's ruling, let him enforce it."
It works for someone.
You obvious haven't been paying attention to the attempts to make US law apply to every one everywhere in the world
Caught is not the same as giving attribution.
But they did not get credit for their work. The correct term here is plagiarize. And Nikolai Ivanovich Lobachevsky is his name.
Wait until the DCMA take down from netflix comes...
I'm saying when a corporation does it, it's not illegal.
Copyright is an intensely moral issue for two reasons, first it is immoral to profit from some one else's work while allowing them to starve to death, but second, copyrights can only work to the extent that people see them as moral.
In our current situation, we have the worst of both worlds. Spotify pays me .01 for ever 10 listens. That is, even to live in poverty I would have to generate 20 million listens a year. The artists are not being paid by and large. Conversely imposing a economic death sentence, which is what 100,000 dollars of damages are to an ordinary person, is clearly immoral.
Copyright is, and always was, a moral issue, and the present system is breaking down precisely because it is immoral.
Guilty until proven convicted.
And you should return all runaway slaves to their owners, and report black people sitting in the front of the bus.
People who like copyright as it is today, would have liked slavery as it was in 1859. Every argument about the legality of IP law today, was made by apologists for slavery then.
The present bit slavery system is the cost we have for wanting a 21st century standard of living while dependent on 19th century invention for our transportation. When you are willing to kick the carbon habit, and leave the 20th century sprawlconomy behind, we can kick the paper mill, and its creation of perpetual property rights on people, to the curb.
"To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries." If a law is not within the confines of that grant of power, it is unconstitutional.