Nevermind that there is no “pressing need” for a drug that extends the dying process in one form of terminal cancer by 2 months and does not even extend that process in another …
You are then okay with the idea that if India decides that a genetically modified seed is “a pressing need” there is no need to buy it from the company that developed it?
IANAL but I do not think it works like that.
If they are going to steal from the other members, I’m guessing not.
[quote=“Der_Trihs, post:34, topic:680316”]
[ul]
[li]According to Indian law, if a pharmaceutical company abuses it’s exclusive rights to make and sell a drug by price gouging, it’s legal for those rights to be taken away. It’s also legal under international law.[/ul][/li][/QUOTE]
I am going to need a cite about international law. Perhaps you could make an exception and provide one.
Regards,
Shodan
The problem there is that if this becomes standard practice, then it gets priced into the market. I don’t mean higher prices for drugs to make it up, I mean simply investor money going elsewhere. Such as in entertainment.
Their was a commercial back in the 90s about an awesome new microchip that would revolutionize the medical industry, and they showed an old lady on a treadmill. Then they said, “But we’ll just use it to make video games” and the lady falls off the treadmill and they cut to first person shooters and sports games and platformers. It was a cute joke at the time, but if entertainment carries less risk of government appropriation and higher profit margins than needs, then entertainment will draw more investment and R&D dollars.
But they do consider costs. Britain’s NICE rejected the drug as too costly.
It’s always been the way of the world that new, cutting edge products are reserved for those who can afford them. The fact that we perceive that we “need” them doesn’t make them magically affordable, and theft creates a disincentive to continue such expensive research. Bayer might decide that maybe making gaming consoles is a better use of their money. They can charge as much as they want for that. Eventually, the price comes down. Would we have such awesome cheap electronics if the very first VCRs and computers were stolen and handed out to everyone back in 1982?
Besides, this drug has only a marginal benefit. I’d like to think that there is no way in hell I’d give up my life savings and leave nothing for my family just to live a few months longer. I’m waiting for a drug that really does something. And I’ll be waiting a long time if countries are willing to steal the marginal stuff. what happens when a $500,000 cure for cancer becomes available? What happens when anti-aging drugs become viable? The incentive to steal will be even stronger.
My seed question is a serious one. Right now the investments in developing drought tolerant crops, big investments with no assurance of any significant success are coming mostly from private industry. Right now the scientists with the expertise work there to no small degree.
Why should they bother in a world in which any and every country can, and some would, declare “eminent domain” over that intellectual property as soon as it is released as they having “a pressing need”, a real one this time, for the product at the cheapest possible price, make their own, and sell it to others as well?
Cite that they are “price gouging” please? That is, a cite that they are charging more than the cost of research, manufacture, testing, and so forth, plus a reasonable proportion of the costs of failed research over the period this drug was developed, plus a reasonable amount of profit, distributed over the likely number of doses of this drug to be distributed over the period Bayer hold the patent.
“Price gouging” doesn’t mean “charging more than someone can afford to pay”, or for that matter “charging more than some western liberal thinks is appropriate”. India could easily afford to pay for these drugs for anyone who needs them if it chose, but it chooses not to. The same choice, for that matter, that the UK and the US make, but those countries don’t assume the right to make the drug anyway. The UK considers it not cost effective, and the US considers health care an option, not a right.
I believe most national health authorities are reluctant to approve a drug unless they know what it is.
Actually, yes I am suggesting that the cost of clinical trials is a hell of a lot less than you might think. Unless you are suggesting that the phlebotomist that taps me is making more than the one that I understand is making not much more than minimum wage over at Backus Hospital… and the nursing staff is making more than the pitiful amount that she would make working at some other hospital? A study I was in doing ghu knows what with guaifenesen [absolutely distinctive taste, so I was definitely in the get the med group] had 10 000 subjects, paid $125 if you completed the study [there are always people who drop out for one reason or another.] took all of 1 week, and the only thing provided other than paperwork and the med was an inexpensive digital thermometer that cost $5.50US on Ebay. The most expensive program I have heard about with the lab is a 9 month, $1500 one for an injectible for some diabetic issue I don’t qualify for as I am on something else for a different condition that they don’t want to try in combination with whatever they are testing.
The drug company contracts with the testing facility to do the human testing and I can pretty much guarantee that the lab I test in is not making millions upon millions for doing the testing on anything in general. The drug development money is being spent internally on their processes. If you actually look at a lot of the cancer drug testing, they frequently test fewer than 10 000 test subjects - some of the odder ones might be numbered in the hundreds of human guinea pigs.
And trust me, there are enough idiots out there that will only take Tylenol brand X, or Robitussin brand Y or X brand Omeprazole [prilosec? No idea what the nongeneric is offhand.] They really do make that kind of money off the brand name OTC, and the brand name prescriptions of the nonrare meds.
No, actually it is not. I am familiar with the medical products industry. I know what is required for a clinical trial.
The expenses you mention are trivial. The phlebotomist and nurse may not be very well paid, but I can assure you that the people who design, conduct, monitor, and report the study are well paid, as they should be.
And I am one of those ‘idiots’ who frequently will not buy generic.
Would you like to know why? Because the packaging does not say where the drug is manufactured.
Why does that matter? Because I know what certain facilities have been caught at. Falsified data. Contaminated products that make the compounding pharmacies seem like Boy Scouts. A complete lack of understanding of basic principals of quality control, never mind quality assurance.
I am not saying the major manufacturers are faultless, just that I can usually find out where the drug is manufactured, and evaluate the risk.
And yet the costs of drug development in general and of this drug in specific have already been documented with cites in this thread. And the cost of development is obviously a lot more than you might think. Your blood draw is not the big cost driver.
Again, I am of the U.K. mindset: not enough benefit for that cost. But the standard in the U.S. has been to irration health care, rather than do anything that might be tarred as rationing it rationally. Paying for this only encourages more investment in research that futilely extends the death process at huge expense, and leaves less for research on avenues that might deliver more value in terms of quality adjusted life years saved (the term in the literature is QALY for short).
I figure this response and your response to my question are related. The reason generics are safe is because they are tested and found to be as reliable as the brand name. Plus we have the FDA to keep dangerous knockoffs out. As far as I know, there has never been a serious problem with bad generics coming to our shores and being sold in pharmacies. That’s why something like Tylenol poisoning, which didn’t even affect that many people, can cause a national panic. A messed up generic from a foreign country would affect a lot more people.
Why not use Indians for their clinical studies? The poor people get access to cheap/experimental cancer drugs, and once they are deemed safe, they can be rolled out to the rich Westerners for big $$$!
Win/Win!
There have been adulterated/false generics in the US, but they are very limited and frequently there are tip-offs like misspelled labels and other problems. Typically, these are found in places like flea markets.
In the US, purchasing the “house brand” generic at a place like Wal-Mart or one of the major chain drug stores (what the British call chemists) is safe.
Yeah, but isn’t it illegal to sell Rx drugs anywhere but a pharmacy? Obviously, when buying drugs from non-FDA approved sellers, it’s caveat emptor.
Over the counter drugs is what I was thinking of.
Rx drugs yes, you need to go to a pharmacy to get the legitimate stuff, but if you go to a reputable one you needn’t fear the generics there, either.
You occasionally get these trade secrets but they are rare for small molecules - as said it is usually easy for a generic company to design or copy a synthesis. There can be cases where there is an absolute bastard of a transformation that is impossible to replicate without in-house knowledge, but not often.
Some of the biggest selling pharmaceuticals atm are biologicals - large molecules like proteins rather than small molecules like the subject of this thread.
Part of the reason that pharma loves biologicals is that the composition of matter IP is naturally a lot more secure - at the moment it is far harder for generics to compete as they have to demonstrate equivalence of the biological material which is a complicated task relative to the small molecule case.
^^^ that is basically true.
Also if you have a blend of different ingredients (like Coca-Cola for example) all ingredients will stick together in the formulation, so its much harder to separate each individual ingredient and analyze what its exact chemical structure is through gas chromatography.
Thats why if you have a formulation of many ingredients its best to apply for a FDA trade secret, as opposed to a patent (although there are exceptions to that)
Well, that’s it’s entire stock in trade, so the incentive is to have something to sell. There’s also the fact that research costs can be written off against taxes, and frequently also allow money to be reclaimed from government subsidies and charitable grants.
Nothing has been “stolen” from the company. Intellectual property, so-called, is a government-backed monopoly and thereby an infringement on human liberty. It is only allowed to exist because of putative benefits to the common good which it is meant to incentivise. If Indian patent law is written so that patents that don’t serve the public good can be invalidated, that’s fine by me.
And don’t weep for Bayer. They’ve more than made their money back in the nine years they’ve been selling this drug, and will continue making more money than they can spend from it in developed countries. Just not from Indians. However, as they didn’t make it for Indians I expect their return on investment calculations didn’t include them anyway.
Glaxo has the right idea, also, so if Bayer lose a handful of sales to Indian oligarchs, their own incompetence is to blame.
Only if you call laws against theft or the possession of private property an infringement of liberty.
It is thus no different from all other laws.
Regards,
Shodan
Intellectual property is a gift from government that’s meant to advance the commonweal. If it doesn’t, the government can revoke it.
Patents are regularly seized in the west for reasons of national security. I’ve no doubt that if it was for a military jet Indian would do just that, and no-one would cause a fuss.
Who else would they have produce them?
It’s generally better to act within the law, as India is doing, that to allow unregulated and illegally manufactured drugs on the market.
This is nothing new and that hasn’t happened yet.