‘Pharmacy of the developing world’ under attack from the US, EU, Japan
handsoff.msf.org
handsoff.msf.org
TPP bill [0] which is being negotiated in secret will result in more sustained damage [1].
Since R&D will be the single most critical argument, this table [2] could highlight it's fallacies.
[0] https://www.eff.org/issues/tpp
[1] http://www.doctorswithoutborders.org/news-stories/briefing-d...
Just one more example of how drug companies are taking their customers for a ride. Knowing that a drug has a finite patent life, a drug company will stagger the release of two drugs that are pharmacologically similar by patent-wise different. The drug company will introduce an "improved" drug (which we'll refer to as "nu") just as the old drug's (which we'll refer to as "pro", as in before) patent is about to expire. This is accompanied by pricing tactics such as raising the price of the "pro" drug above the "nu" drug so as to incentivize patients to switch, paying generic-producing companies not to make it, and giving hospitals preferential pricing on the "nu" drug so that it is prescribed at hospitals but then patients pay the higher rate when they go home. One of the most insidious effects of this strategy is that, the drug company is either purposely pricing people out of medicine they need or knowingly selling an inferior product for a decade or more.
Highly recommend reading this book if interested on this subject: http://www.nybooks.com/articles/archives/2004/jul/15/the-tru...
"SWISS PHARMACEUTICAL COMPANY NOVARTIS first took the Indian government to court in 2006 over its patent law because Novartis wanted a more extensive granting of patent protection for its products than offered by Indian law. The company had been refused a patent in India on a cancer drug it produces. In a first case before the High Court in Chennai, Novartis claimed that the Act did not meet rules set down by the World Trade Organization and was in violation of the Indian constitution. Novartis lost this case in 2007, but launched a subsequent appeal before the Indian Supreme Court in a bid to weaken the interpretation of the law and empty it of substance. All of Novartis’s claims were rejected by the Supreme Court in a landmark decision announced on 1 April, 2013."
So much for world trade organization benefiting the world through more competition and a lowering of prices. Fuckers.
Doctors can import prescriptions drugs from other countries if they wish too, with a special import form to justify the exception.
edit @aikah: ok, point taken. You recall the issues Apple and Samsung had with the one phone looking like the other? Fighting on the streets and in court to prove that the edges were different or the home button is not the same? Patents are valid for phones, then why not for medicine? Because lives are involved? That seems a slippery argument - next animal life is endangered or quality of living is impacted: where does it stop?
It's not possible to start making exceptions, because there is always someone with a tear-jerking story who is impacted by not being excepted too...
That's not a good analogy. one could make an phone that has the exact same specs as the iphone or jeans that is the exact replica of a Levi's ,without the brand and the logo on it and it would not be an iPHone or a Levi's Jean.
it might not be legal but it wouldn't be shocking. The fact that you can't reproduce a formula ... TO SAVE LIVES ... is shocking.
US government prefers people dying because they can't afford meds rather than violating something that has nothing to do with the free market, ie , patents. We're not talking about phones or clothes here , we're talking about medication people's life depend on.
I'm not sure this is true. You'd likely fall afoul of one of Apple's design patents (like the famous "rounded corners" patent).
(See our other backwards drug laws for more confirmation of this)
I doubt they spend much marketing drugs to treat cancer or AIDS.
Knowledge that helps save lives should not be under copyright (nor should it be a for-profit enterprise, but that is a separate argument).
Its a lazy view that 'everything we need should be free' that ignores basic facts about invention and innovation.
>Its a lazy view that 'everything we need should be free' that ignores basic facts about invention and innovation
Nobody said that.
"Knowledge that helps save lives should not be under copyright (nor should it be a for-profit enterprise, but that is a separate argument). That's what I was getting at. Devices and processes are what patents are for, for a reason. Scientific research - ok, that's a different beast. I probably changed the subject there, sorry.
The scientists are normally working for hire, which means everything they discover belongs to the company or university that employs them, and universities do maintain and aggressively defend large patent portfolios. Very little of this is "given to the public domain for free".
Also, drug targets are a dime a dozen. That's the easy part. What's difficult and expensive is getting a drug through the regulatory process. If drug companies aren't going to see a profit that will all have to be publicly funded.
We have a globally broken system in that America subsidizes the world medicinally. American companies research and develop many (not all) drugs. Americans then pay out their asshole for those drugs. Other countries then get to make those drugs for "free". Not free free. But they get to ignore the R&D costs.
Eventually the camel's back will break. Research costs will become too high for 300m out of 7b to pay for. Then we can figure out a new system that works better. This is probably a good thing. I don't know what the system looks like though. No one does.
Americans then pay out their asshole for those drugs. Other countries
then get to make those drugs for "free". Not free free. But they get to
ignore the R&D costs.
Eventually the camel's back will break. Research costs will become too
high for 300m out of 7b to pay for.
But as the table below shows, drug companies spend far more on
marketing drugs - in some cases twice as much - than on developing
them. And besides, profit margins take into account R&D costs.
The fact that marketing is a higher spend is irrelevant. It's like free2play on mobile. You spend a bunch of money developing something. If you can spend $.90 in user acquisition to earn back $1.00 then you throw every single dollar you can muster so long as the benefit is higher than the cost. It's a diminishing returns equation so you do as long as you can. The highest grossing games have marketing campaigns on the order of $100,000,000. Basically the same thing here. Take out as many loans as you can so long as it works.
For the vast majority of drugs the cost of producing the tablet you take is just a few cents, which is dwarfed by the amortized cost of the R&D. Nobody is going to spend on R&D if competitors can skip that part and go right to production.
The main structural problem is the blanket protection from the market that the people/govt offer to the pharma companies. Many shills continue to argue that this is necessary for pharma to make progress.
The problem is that this a quantitative question -- how much protection in $$ should pharma companies receive that would still not get in the way of real progress? -- is given a blanket non-quantitative answer by fiat. The answer is neither known for certain nor a constant of nature, it changes with time and situation. Any mechanism addressing this problem should have a fast feedback loop and pretty much the only scalable mechanism that we have for such feedback on economic affairs is the market.
Rather than subverting the market, one should actively involve it to create an efficient market where the people/govt and the pharma companies negotiate the level of protection that they can both agree on.
Patents are a mechanism that largely nukes this negotiation completely in favor of the pharma companies.
A parting thought borrowed from Upton Sinclair : if the justification for patent protection is high dev costs, it only ensures that the dev costs will be kept high to enjoy the (dis-proportionate) protection.
The pharmaceutical industry pays for clinical trials, marketing, and bribing doctors and government officials all over the world.
Bribing goes both ways. Politicians and Doctors actively WANT to be bribed as well, let's not pretend they are victims.
I don't know about that. I think more people here have a career thanks to open source. It has proven that it's a lot more effective than the barriers to knowledge.
Drug trials are expensive and the ROI is not stellar at all. Without the prospect of copyrighting the result there would be way less efficient yet safe drugs for all of us. As a fact pharma companies - despite the conspiracy - are nowhere the biggest or richest companies of the world (Pfizer roughly #48). So why did you decide that actually pharma companies - and not for example YOU - should sponsor the treatment of the poor of this world? Do you equally expect Nestle to feed the hungry for free because it produces food?
TL;DR you can't pretend asking $1.000 to an American is the same as asking $1.000 from a Nigerian
In case people don't know - another way to start your last sentence is: In summary...
1. Research does not get funded unless there is a commercial market for the drug. This leads to overfunding of maintenance treatments of chronic diseases like diabetes, because they are widespread and never really go away. Meanwhile, the system does not incentivize investment in things like antibiotics (because the next wide-spectrum antibiotic that gets developed will likely be force-licensed for public health interests).
2. For the vast majority of life-threatening diseases that anyone is likely to catch, the most effective drugs are already off-patent. Unless you can significantly improve outcomes, how can you compete with a generic that works 95% as well as your new drug?
3. The only country currently willing to pay sticker price for pharmaceuticals is the US. Every other country negotiates prices down to a fraction of what the US pays. The idea of a month worth of pills costing $400 is unheard of outside the US. So US citizens are either directly subsidizing the cheap drugs for the rest of the world, or we're getting taken for a ride.
4. The majority of the cost of developing a drug comes in the clinical trial phases. This cost is the same for any drug -- and most of this is marketing budget. Studies are designed to have specific outcomes so they can be listed as bullet points on information sheets given to doctors -- doctors are smart, but they're busy, so if you can do a study saying that "outcomes in high-risk patients were improved by 30% over the leading treatment", the doctors will never look to see what high-risk patients means, whether the study was done correctly, or even what an improved outcome looks like for those patients. Never mind you may have done the study 8 times and this outcome was only observed once.
Pharma is broken. Our current pharma industry is geared towards "lifecycle" drugs that alleviate symptoms rather than fixing any underlying problems.
Drug research takes a long time. The drugs that cause this debate are drugs that the pharmaceutical companies decided to research decades ago, when they seriously expected people would respect intellectual property rights more than human lives.
Now that they know better, they will probably go invent a new Viagra or something instead of inventing something useful which can be prematurely generified for the common good.
Lots of people are already dying of antibiotic resistant bacteria, for example, and that's a problem likely to get worse over time.
EDIT: Not to mention having their own research and development. I bet it's cheaper to research stuff in India, but evil selfish pharma companies don't want to invest in research in countries with poor intellectual properties protection.
You can live a perfectly fine, if frugal, life in India on USD $2 a day, but not if you have to pay for USD $1 tablets.
I thought any lab could do that. Isn't the research part the most difficult and expensive part?
>if a pharma company takes an old drug and a new chemical to it to change its effects slightly, the patent is renewed, and that way it it never actually becomes 'old' enough
I've heard about this happening with 'me-too' drugs and bullshit antidepressants. Does it happen as well with essential life saving medicine?
"The Pharmaceutical industry in India is the world's third-largest in terms of volume and stands 14th in terms of value."
"Indian companies carved a niche in both the Indian and world markets with their expertise in reverse-engineering new processes for manufacturing drugs at low costs."[2]
There is skill involved in reverse-engineering new processes for manufacturing drugs.
Does it happen with essential life saving medicine?
Yes.
"...Glivec, a medicine for chronic myeloid leukemia"[1]
"The Supreme Court defended India’s right to deny patents to incremental improvements. It ruled that Glivec was merely a new form of an older drug and did not constitute a patentable invention. “This is a huge relief,” said Unni Karunakara, the president of Médecins Sans Frontières, which cares for patients in poor countries. Novartis is less pleased, declaring that the ruling “discourages future innovation in India."
Did you previously think pharmaceutical companies care about people's lives more than profit? I'm sorry to disappoint.
[1] http://webcache.googleusercontent.com/search?client=safari&r...
[2] https://en.wikipedia.org/wiki/Pharmaceutical_industry_in_Ind...
the only thing holding the system in place are the patents, not the knowledge.
This is money grab. There is no way to justify it. If they think the money isn't there, they are more than welcome to stop the research.
What's more appropriate to ask though is how do developing/under-developed countries compete with the money spending power of west. Are the poor people forever destined to look for aid from the west? If they ain't creating all the drugs, they ain't creating all the horrible diseases either. Many tribes were perfectly happy and healthy until the intruders affected their ecosystem.
No. That's just your american white guilt playing up.
When a company begins an expensive research project, they don't know beforehand if it will be profitable or not.
If little-to-medium pharma were compensated generously for the risks they take, they would make more research in new drugs, but because the risk is not compensated, only big pharma can afford the research.
It's not like if it weren't for the evil pharma companies, everyone would have access to advanced medicine. Quite the contrary, in fact.
We are not talking about software here. Developing medications requires huge investments in developed countries, and no one will develop in the other countries because there is no patent protection in those countries.
Ofcourse from the big pharmacy side, the generics represents lost opportunities, they want to make more money.
We need to incentivize research into important medicine (ie antibiotics, or something to actually cure AIDS and malaria for good), which is hard because as soon as they develop something actually useful, people refuse to honor their patents.
Well pharma companies tend to spend so much money because they are run very inefficiently in the first place. Plus there's the cost of lobbying...
That means research into important drugs like antibiotics, HIV and malaria medicine is underfunded.
/s
https://www.change.org/p/secretary-of-health-and-human-servi...
Prices have increased more than tenfold between 2000 (average price $5,000-$10,000 per year) and today (average price of new cancer drugs exceeds $120,000 per year).
http://www.nytimes.com/2015/01/15/opinion/why-drugs-cost-so-...
Novartis, the company that makes the leukemia drug Gleevec, keeps raising the drug’s price, even though the drug has already delivered billions in profit to the company. In 2001 Novartis charged $4,540, in 2014 dollars, for a month of treatment; now it charges $8,488. In its pricing, Novartis is just keeping up with other companies as they charge more and more for their drugs. They know we can’t say no.
http://www.nbcnews.com/health/cancer/utterly-broken-drug-mar...
Lauren Baumann is one of the lucky ones. Though she has cancer, chronic myeloid leukemia, it is manageable, as long as she takes a daily pill called Gleevec. Gleevec is considered a wonder drug, turning Lauren's leukemia from a death sentence to a disease she and thousands of others can live with. The problem is, even with health insurance and a full-time job, Lauren can't afford the monthly co-pay for Gleevec. It can be as high as $2,000 a month — twice the average mortgage payment in the U.S.
"I feel like you get punished," says Baumann. "I didn't ask to get cancer; I didn't ask to get sick. I was 26 and I was perfectly healthy."
This is essentially extortion due to price inelasticity of demand. $9,000-$12,500/month to survive, for the rest of your natural life! Patients+insurers have to pay whatever price the companies ask. For something as crucial as a life-saving drug, maybe the prices shouldn't be set only by market forces? Maybe generics should be allowed for import after patents expire the first time around?
(There are analyses of drug discovery costs around, and even after all those costs and reliance on basic research funded by taxpayer money, pharma companies make a very healthy profit. Much of the money goes into marketing, which we wouldn't need so much of in a system similar to the NHS which approves drugs for dispensing countrywide.)
Please sign the above Change.org petition (first link) and spread it! I normally don't make appeals, but this is one truly egregious case of unethical profiting.
An international panel of 115 doctors co-authored a paper decrying these ridiculous prices and offering 7 solutions, including allowing Medicare to negotiate drug prices once again (which they now aren't allowed to!):
http://www.forbes.com/sites/matthewherper/2015/07/23/155-ang...
It's (arguably) not the market here that's the problem, but the patent. The patent means that generic manufacturers can't get in on the market and create a commodity out of it with a race to the bottom on price. The problem isn't the market, but the absolute lack of a market created by the exclusivity of a patent.
We need to find a way as a society that these companies can profit off the research and development of these drugs while still allowing generic manufacturers to do what they do best: create a real, competitive market to produce the drug in bulk.
Unfortunately I don't think there's any clear answers here.
Wasnt that how NASA was supposed to work ? Oh wait, we know how it went...
It takes sometimes billions to find the next new drug. In order to keep showing quarter after quarter of sustained growth that investors demand, they have to continue raising prices.
Fixing patents, wouldn't necessarily fix this problem.
you don't raise prices on drugs that easily, Prices changes are heavily regulated as well.
It's far from being a market-forces driven market. Pharma pricing is a heavily regulated market involving parties which are not the end consumer (Pricing Authorities, FDA, Pharma Companies, Insurance Companies, and sometimes Patient Advocate Groups).
That has about NOTHING to do with Free Market ideals.
If pharmas set a certain pricing, the patients+insurers/Medicare feel the effect of that pricing, and respond accordingly. Patients have no choice but to take the price, and demand that insurers provide coverage for all cancer drugs. Insurers then spread the costs across their pool of insurees, resulting in skyrocketing premiums.
Did you know that Medicare isn't allowed to negotiate the prices of drugs, as part of regulatory concessions to pharma companies made in 2003?[1] What happens when Medicare (unlike other insurers) is forced to always pay what drug companies demand?
Further, in the case of Gleevec, the basic drug molecule was discovered by a university researcher, who went to Novartis to get it to invest in trials. So the costs aren't even fully borne by Novartis.
The system is broken and some possible solutions (proposed by researchers including those who discovered the drugs) should be evaluated. But strong lobbying from pharma is hard to get around.
[1] ...the 2003 Medicare Prescription Drug, Improvement, and Modernization Act contains legislation that forbids Medicare from negotiating drug prices. These policies have created an opportunity for drug companies, rendering them the sole decision makers on the price of cancer drugs. http://www.mayoclinicproceedings.org/article/S0025-6196%2815...
Make this a vote by the people instead of relying on your leaders to make such changes. Referendums can be used for important measures.
For Gleevec, almost surely yes. But what about other undiscovered drugs?
hello ? Prices are regulated by governments in most countries. You should start acting to make your government stop inflation on drug prices. Pharma companies can only abuse the system if you let them.
If the US system of insane drug prices leads to 10x the drugs of a system of capped drug prices, I could see an argument to be made that insane drug prices are saving lives.
US market because that's the largest pharma market in the world, and it's the most friendly to businesses as well (since you can do direct to consumer advertising for pharma drugs, which is forbidden is about every other country). It's kind of natural that this is the market with the most innovation, but also where prices go the craziest, because of the way the insurance system is structured,
Title typo: should be `generic`.
Back in 2010-2011, a few friends of mine showed me how an online pharmacy works, I couldn't believe it - vast majority of people ordering Indian generics are Americans. The reasons? - Costs. Theyve told me it sometimes takes multiple resends of medicines for them to get through the border. Don't know how well US clamped down on it in the past several years.
http://www.ft.com/cms/s/0/4ded8ca4-3b8a-11e5-bbd1-b37bc06f59...
That follows similar concerns in the US.
http://mobile.nytimes.com/2014/02/15/world/asia/medicines-ma...
http://mobile.reuters.com/article/idUSBREA2H06Y20140318
(I've given up guessing what a clean URL should be. Now I'm just going to post whatever stupid URL a site gives me.)
But most of the time, they ban some Indian generics, and let the same Indian company manufacture certain generics that USFDA/US needs. My friends say, generics are subjected to such stringent testing by USFDA that even the branded drugs are not.
1. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/uc...
Welcome to the global race to the bottom. I doubt that a little pressure from multinational pharma companies will do much to reverse the overall trend.
http://www.bloomberg.com/news/articles/2014-12-03/indian-lab...
Good. An imperfect (with the odd frog), but cheap, system that can save thousands of lives is perfectly acceptable to me.
The implications of dirty drug synthesis and medication compounding processes are dangerous and real.
Deleted testing results are a red flag; however, keep in mind that lack of evidence to the contrary is not evidence of the positive. I see this more as regulation being used to limit international competition than anything promoting general human welfare.