‘Pharmacy of the developing world’ under attack from the US, EU, Japan

http://handsoff.msf.org/generics-under-attack

by shekhar101 • 11 years ago

166 120 11 years ago

handsoff.msf.org

petecooper• 11 years ago

India under pressure from Pharma lobby to stop gneric medicines

Title typo: should be `generic`.

PhantomGremlin• 11 years ago

Maybe the Indian generic companies should worry a little more about the frogs and flies in their manufacturing facilities. And maybe they shouldn't delete test results.

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...

forgetsusername• 11 years ago

I doubt that a little pressure from multinational pharma companies will do much to reverse the overall trend.

Good. An imperfect (with the odd frog), but cheap, system that can save thousands of lives is perfectly acceptable to me.

StavrosK5• 11 years ago

Really? I'd rather die than eat some fly poop that found its way to my life-saving medication!

rickdale• 11 years ago

This is funny because I am literally on the phone with my bank to get them to lift the block on the charge for indian provigil. I didn't realize this was a big thing, but I am excited to try the provigil. I did ask my doctor for it for what its worth, but he said its too expensive to prescribe to me. I don't have insurance...

MagicWishMonkey• 11 years ago

I don't think it's legal to import prescription drugs from overseas, FYI. So it might not be a good idea to discuss the transaction with your CC provider.

ekianjo12• 11 years ago

I don't think it's legal to import prescription drugs from overseas, FYI. So it might not be a good idea to discuss the transaction with your CC provider.

Doctors can import prescriptions drugs from other countries if they wish too, with a special import form to justify the exception.

oneJob2• 11 years ago

You definitely can't import scheduled drugs, of which provigil (modafinil) is one.

gwern• 11 years ago

This is one reason why it's worth it to take the time to use Bitcoin to buy from the clearnet sellers: it is less risky both for you and them, and leaves less obvious traces. (Managing CC payments is the single biggest risk & difficulty for them. They hate it and all want to move to Bitcoin as fast as possible.)

qwerty85344324i5• 11 years ago

Serious question for anyone opposes this. What incentive would pharma companies have to publish their secret formulas if Indian generics simply take the IP and drastically undercut prices, preventing the pharma companies from making any profit on the billions they invested in their research? What would compel these pharma companies to invest in any further research?

joesmo4• 11 years ago

I think billions of dollars in profit should be enough, don't you?

qwerty85344324i5• 11 years ago

I don't understand what you're implying. A drug requires billions in investment. Why would a company invest billions into a new drug if they can't make that money back?

saint_fiasco9• 11 years ago

I think you are focusing on the successful pharma products.

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.

drabiega• 11 years ago

I'm not sure why you need to get hypothetical here. Clearly, they currently have sufficient incentive since they're currently investing in research. They are trying to get a likely small amount of additional money (the people in India who could actually afford their prices) in return for an immense cost human cost.(The people who would lose access because of their prices) Why would anyone not oppose this?

meric5• 11 years ago

They don't even need the information published - many of the patented medicines are simply reverse engineered in India.

Thriptic• 11 years ago

What happens when more countries decide that they're only willing to pay generic prices. The financial incentive to do the R&D will disappear.

qwerty85344324i5• 11 years ago

They're investing in research on the expectation that their patents will be honored. If patents are ignored, what do you think this will do to any future research that requires tons in capital expenditures?

nnain• 11 years ago

qwerty's question isn't hypothetical. Pharma research indeed is a high stakes game.

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.

fla• 11 years ago

But up to what point ? What happens when investing into research becomes too risky ? This is a tough problem.

saint_fiasco9• 11 years ago

Clearly, they currently have sufficient incentive since they're currently investing in research

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.

exelius• 11 years ago

Very little; which is why pharma research is such a problematic industry. We need to seriously rethink the way we develop drugs:

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.

myth_buster2• 11 years ago

The ominous quote "This is just the beginning" seems apt here.

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...

[2] http://i.imgur.com/3kmBKcS.png

carstimon• 11 years ago

In case anyone else is looking, here's the story source for the last picture: http://www.bbc.com/news/business-28212223

oneJob2• 11 years ago

Timely. I'm reading "The Truth About the Drug Companies" by Marcia Angell. Per Wikipedia, Dr. Angell is "the first woman to serve as editor-in-chief of the New England Journal of Medicine. She is currently a Senior Lecturer in the Department of Global Health and Social Medicine at Harvard Medical School in Boston, Massachusetts". So, a good person to write a book on the issue.

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...

delinquentme• 11 years ago

"How is the pharmaceutical industry responding to its difficulties? One could hope drug companies would decide to make some changes—trim their prices ..." It seems this, extrapolation, or "logical next step" well encapsulates what the writer knows on the topic of pharma. On what planet would one derive this conclusion from the precursor of lessening profits?

Alex39172• 11 years ago

This is hardly new. The Clintons threatened to impose trade sanctions on South Africa if they distributed HIV treatments to the poor, and that was twenty years ago.

rev_bird• 11 years ago

"The Clintons"? We're going to lump Hillary in with the policies of an administration that she married into?

JustSomeNobody2• 11 years ago

Whatever. We all know Hillary was running the show back then.

Alex39172• 11 years ago

It's a healthcare issue and she was head of healthcare reform.

forrestthewoods3• 11 years ago

Of course they are. In the United States you also can't import cheap generic from Canada. Most intellectual property law is recognized and enforced internationally. Everyone on this board has a career because of IP law.

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.

jacobolus• 11 years ago

American taxpayers fund most of the basic research through public grants to universities.

The pharmaceutical industry pays for clinical trials, marketing, and bribing doctors and government officials all over the world.

ekianjo12• 11 years ago

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.

myth_buster2• 11 years ago

  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.

This "Drug industry scare card" is easily refuted [0] (check the table).

  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.

[0] http://www.bbc.com/news/business-28212223

forrestthewoods3• 11 years ago

Few people dispute that it costs a billion dollars or so to bring a new drug to market. That's a heavy cost foreign manufacturers don't have to pay.

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.

srean• 11 years ago

Absolutely.

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.

pavanky• 11 years ago

Can you name some drugs whose IP has been immediately broken by other countries? From what I have read India is breaking IP laws for life saving medicines and / or trivial modifications to existing products.

emodendroket• 11 years ago

Lots of programmings jobs could easily exist without any IP protection at all (if you're writing the server-side code for a Web-based product, nobody ever gets the opportunity to pirate the code) so you're going a little bit too far.

PietdeVries2• 11 years ago

Then again, as long as the big pharmaceuticals still have a profit margin of 25% or so I don't think they are the victims here... Point is that there are two sides to this coin: the pharmaceuticals charging way too much for their medicine and the Indian companies copy-catting/piggy backing on the US R&D

presty• 11 years ago

Everyone on this board has a career because of IP law.

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.

J_Darnley• 11 years ago

I think the stranger thing is that he thinks everyone here has a career or even works.

creamyhorror2• 11 years ago

Look how Novartis and other drug companies are pricing their cancer drugs:

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...

ultramancool• 11 years ago

maybe the prices shouldn't be set only by market forces??

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.

brianwawok2• 11 years ago

Government funding the research + selling the drugs at cost would benefit mankind overall... but then politicians would decide how many $ to spend researching which drug per year, which has it's own downsides..

JustSomeNobody2• 11 years ago

The problem, yet again, is quarterly earnings reports.

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.

ekianjo12• 11 years ago

Patients have to pay whatever price the companies ask.

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.

brianwawok2• 11 years ago

But where do most new drugs come from? (Not a rhetorical question, but serious).

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.

yummyfajitas• 11 years ago

I'm a bit nervous about doing this. At the moment, I've got the possibility of paying $2k/month or dying. If we mess with a system that's clearly working, will I continue to have the choice of paying $2k/month?

For Gleevec, almost surely yes. But what about other undiscovered drugs?

ekianjo12• 11 years ago

maybe the prices shouldn't be set only by market forces??

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.

creamyhorror2• 11 years ago

In the end, patients either get the drugs or they don't.

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...

qwerty85344324i5• 11 years ago

Big pharma compoanies like Pfizer and Novartis generate lower net profit margins than Google and Apple. They're making less than 20 cents for every $1 in revenue. These are all public companies and you can look for their financial statements online.

dandare2• 11 years ago

I call your hypocrisy.

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?

ivanca• 11 years ago

This is about IP. Not about a limited resource like food. And is very easy to understand economically: is the same reason why in Finland and other countries traffic tickets amounts are based on the income of the driver, following the same logic costs of drugs should be tied to the ability of a country to pay them.

TL;DR you can't pretend asking $1.000 to an American is the same as asking $1.000 from a Nigerian

dandare2• 11 years ago

Read my post again. I am not saying the needy should pay the same as the rich - I am saying there is no reason why only the pharma companies should pay the bill for the needy.

WorldWideWayne• 11 years ago

I'm mildly annoyed at the absurdity of people writing TL;DR after typing out three whole sentences.

In case people don't know - another way to start your last sentence is: In summary...

saosebastiao• 11 years ago

Drug companies do a great job at developing drugs, but then turn around and spend twice as much marketing them. Doesn't it seem like it would be a better system if government(s) set up drug development bounties, and pay the bounty in exchange for the patents? Drugs immediately gain generic availability, and the drug companies no longer need to sell their shit with Super Bowl commercials in order to make a profit.

tsotha5• 11 years ago

Drug companies do spend a lot of money on marketing, but not every drug is the same. The ones you see on Superbowl commercials are usually drugs you don't need, like mild pain killers and allergy medications. My suspicion is the only reason these kinds of drugs aren't OTC is this way the drug company can get your insurance to pay.

I doubt they spend much marketing drugs to treat cancer or AIDS.

effie• 11 years ago

This sounds like a great idea! It could potentially remove the massive conflict of interest drug companies are soaked in.

ksk2• 11 years ago

The science that these drugs are based on was given to the public domain for free by scientists all around the world throughout history. Lets see if these greedy companies are willing to pay those scientists whose results they freely use.

Knowledge that helps save lives should not be under copyright (nor should it be a for-profit enterprise, but that is a separate argument).

JoeAltmaier2• 11 years ago

The free market has been pretty efficient at inventing lifesaving gadgets and processes. They are protected by patent and copyright. Its arguable they wouldn't exist otherwise.

Its a lazy view that 'everything we need should be free' that ignores basic facts about invention and innovation.

ksk2• 11 years ago

If we're being generous - your argument is weak. Most governments heavily subsidize core scientific research through public funds. It is decidedly NOT a free market. The free market has always been horrible at anything to do with public good.

Its a lazy view that 'everything we need should be free' that ignores basic facts about invention and innovation

Nobody said that.

tsotha5• 11 years ago

The science that these drugs are based on was given to the public domain for free by scientists all around the world throughout history. Lets see if these greedy companies are willing to pay those scientists whose results they freely use.

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.

theworstshill2• 11 years ago

US Pharmaceutical companies don't give a damn about their own compatriots, so why wouldn't they try to monopolize the world?

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.

theworstshill2• 11 years ago

The piece at the very end is enlightening:

"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.

werber• 11 years ago

There should be a global consortium for socialized medicine. It's insanely problematic to have for profit companies demanding the right to kill the poor.

raphinou• 11 years ago

I heard a country in europe stopped drugs import from india on quality concerns. Is that true? Is that the real reason or is there more behind that decision?

DanBC• 11 years ago

There's a recent trade deal where concerns about data led to ban on 700 meds.

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.)

girishso• 11 years ago

I have many friends working in Indian pharma companies, working mostly on generics. There have been some instances where USFDA has forced shutdown of the entire plants, due to non-compliance of the USFDA norms (1).

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...

‘Pharmacy of the developing world’ under attack from the US, EU, Japan

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