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Indian Gov't Uses Special Powers To Slash Cancer Drug Price By 97%

suraj.sun sends this quote from the Times of India: "In a landmark decision that could set a precedent on how life-saving drugs under patents can be made affordable, the government has allowed a domestic company, Natco Pharma, to manufacture a copycat version of Bayer's patented anti-cancer drug, Nexavar, bringing down its price by 97%. In the first-ever case of compulsory licensing approval, the Indian Patent Office on Monday cleared the application of Hyderabad's Natco Pharma to sell generic drug Nexavar, used for renal and liver cancer, at Rs 8,880 (around $175) for a 120-capsule pack for a month's therapy. Bayer offers it for over Rs 2.8 lakh (roughly $5,500) per 120 capsules. The order provides hope for patients who cannot afford these drugs. The approval paves the way for the launch of Natco's drug in the market, a company official told TOI, adding that it will pay a 6% royalty on net sales every quarter to Bayer."

29 of 556 comments (clear)

  1. Just keep in mind the tradeoff by elrous0 · · Score: 5, Insightful

    I know I'm going to burn karma for saying this (wouldn't be the first time), but do keep in mind that the R&D costs for developing these drugs is paid from the profits these companies make. Now, maybe governments themselves should be doing the development instead of for-profit companies, maybe the drug company profits are too high, and maybe Bayer were dicks to charge that much for a drug in a poor country. But if you're going to keep the system as-is, you had think long and hard before you just start ripping patents left-and-right. It may be politically popular, but you can't have your cake and eat it too.

    If you're going to say "X company doesn't get to patent its drugs" you need to come up with a replacement for the money that X company put into its research and development. If the government wants to serve its people this way, that's fine, but they also have an obligation to pony up the money for their own R&D program (and not one that just does knockoffs of existing drugs). Because without that profit motive from those patents, the drug companies sure aren't going to be developing anything new.

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    1. Re:Just keep in mind the tradeoff by Anonymous Coward · · Score: 5, Insightful

      1. Most drug company expenditure is on marketing;
      2. Most drug research is academic;
      3. They can settle for less profit;
      4. If they won't settle for less profit, someone else will be prepared to take their position in the market.

      Problems solved.

    2. Re:Just keep in mind the tradeoff by elrous0 · · Score: 5, Insightful

      Well apparently the academic institutions, small biotechnology companies, and NIH are motivated by profit too, or they would be putting the drugs into the public domain, wouldn't they?

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    3. Re:Just keep in mind the tradeoff by CensorshipDonkey · · Score: 3, Insightful

      Somewhat wrong. Research and development (R&D) is a relatively small part of the budgets of the big drug companies.

      If this is actually true, I'd like to see some figures or at least a link.

    4. Re:Just keep in mind the tradeoff by cpu6502 · · Score: 4, Insightful

      1. Advertising actually save money because it encourages more sales.
      2. Academic research is funded by drug companies and other corporations.
      3. They don't make that much profit. I don't see Bayer in the top 100.
      4. Doubtful. No company sells at a loss. Bayer would just avoid India completely, and not release their patented drugs until 10-20 years later (after they recover their initial R&D investment).

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    5. Re:Just keep in mind the tradeoff by sjames · · Score: 3, Insightful

      If they choose not to market a drug in India at all, I guess the government will save a lot of deliberation when they approve a local company to make the generic. It's not like they can't figure out how it's being made.

    6. Re:Just keep in mind the tradeoff by Anonymous Coward · · Score: 5, Insightful

      1. Yes, because advertising for cancer drugs increases demand. In what universe?

      2. And at a pittance compared to government funding. Plus they demand tax cuts for doing it, so...net loss.

      3. Because that kind of comparison is valid, even if it were true.

      4. So let's see, Bayer is going to pursue profits from medicine by sitting on their hands instead of taking a lesser cut? At what price? The lives of human beings? You're not defending them, you're indicting them for gross indifference manslaughter. You've made them criminals.

    7. Re:Just keep in mind the tradeoff by Anubis+IV · · Score: 4, Insightful

      1. Most drug company expenditure is on marketing

      Simple fix: Ban drug advertisements. That's the way it used to be and the way it should've stayed, since there is no valid reason why consumers should be the target of drug marketing when they shouldn't even have any say over their prescriptions.

      Bonus: No more hastily spoken disclaimers regarding dry mouth and constipation at the end of every other commercial.

    8. Re:Just keep in mind the tradeoff by Hatta · · Score: 4, Insightful

      No amount of marketing can change the number of people who need a drug. That is fixed. If the number of sales is less than this number, that can be fixed by educating doctors. If the number of sales is greater than or equal to the number of people who need a drug, more marketing just leads to overprescription. Whatever savings you're imagining here are subsidized by encouraging people to take drugs they don't need. That's bad all around.

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    9. Re:Just keep in mind the tradeoff by Artraze · · Score: 3, Insightful

      > Most drug company expenditure is on marketing;

      On the other hand, advertising, by definition, increases profits or it's a waste of money. Thus, advertising actually _decreases_ individual costs because they sell more units and can thus amortize the overhead costs (which are the primary costs) across more units.
      For example, suppose your overhead is $1000, which cores things like labs, employees, trials, and other failed drugs and the cost to manufacture is $1. If you only sell 100 units, you must charge $11/each to break even. Suppose you then spend $200 on advertising and sell an additional 100. Now your break-even price becomes $7/each. The advertising money actually reduced the unit cost.

      Now, I suppose you could argue that they're greedy and will still charge $11/each, but that's blatantly ignoring the basic economics that set the price in the first place. After all, they could be charging $20/unit to start, but the idea is that the 'greed' is an overhead cost, not a unit cost, and therefore also amortized across the units.

      A viable argument is that on a macroeconomic scale, this increases the overall cost of healthcare because the drug price does factor in some advertising money. To this I have to say: whatever. That just get's too hard to trace. For advertising, if that ad money isn't in your drugs, it's in your Pepsi. Medically, the drug does some good (kinda part of the approval), maybe those people that missed it had much more costly problems because they didn't know the drug existed and had complications with their un/poorly treated condition.

      > 2. Most drug research is academic;

      Regardless of the truth in this (hint: it's rather limited), most cost is in bringing the drug to market. It's not as if these hypothetical academics make the compound, solve the engineering issues to produce it, and run all the trials. At best they find the drug compound, and usually it's more the mechanics, leaving the drug company to find the molecule that actually exploits that mechanism without killing people. Oh, and then develop the manufacturing process and run years of trials.

      > 3. They can settle for less profit;

      I guess. Given how much a crap shoot drug development can be, it's hard to define what exactly 'profit' is. Because often times it's just money to pay for the next year's research when income is down.

      > 4. If they won't settle for less profit, someone else will be prepared to take their position in the market.

      This is blatantly false. If this was the case then the Indian company would have done that, right? But no, they let Bayer do all the real work and are just spitting out chemicals. Hell, they probably are copying Bayer's manufacturing process as well, right off the friggin' patent. No wonder it's so cheap for them.

      Finally, regarding your point 3 in particular, let us not forget the elephant in the room:

      LIABILITY

      If/when this drug is discovered to be doing something bad, who's responsible? This mindless manufacturer? I'm betting not. The Indian governement? HAHAHA. Bayer is the one at the end of the barrel and they won't have any 'excessive profits' to pay damages with. Woohoo!

    10. Re:Just keep in mind the tradeoff by Wain13001 · · Score: 5, Insightful

      Popularity of a product doesn't lower the price...it results in a raised price or more production which lowers the cost for the company, but it doesn't necessarily lower the price.

      Viagra is currently $8-12 dollars per pill *with insurance* under most plans in the US...and you only get 8 or 9 pills (forget how many) for what is supposed to be a 3 month supply.

      Only when there is a legal generic in the US will that price drop (mass production/increased availability lowers price). Did the advertising impact the cost? yes it did, it made everyone on earth aware of the product's availability which greatly increased the potential market value, which in turn means the price the market is willing to bear in fact can often go *up*...not saying it did with V or not, just saying that it's not as simple as you're making it.

    11. Re:Just keep in mind the tradeoff by glop · · Score: 5, Insightful

      If you compare a country where advertisement for drugs is illegal, you can see that:
      - new drugs are used just as well (as long as the doctors and patients see the value proposition)
      - drugs are actually cheaper in countries where said advertisement is illegal (and we are talking expensive countries here, where most stuff is selling at prices similar to those of the US except for know ripoffs such as Verizon cell phone service or internet).

      In such countries the doctors are usually determining what your ailments are and offering what they think are the best corresponding drugs. So drug companies just have to convince these experts that you need the drugs and they will be used. That seems quite reasonable, efficient and reasonably respectful of individual freedom, although there is some abuse (drug companies sometimes offer free seminars in tropical islands for instance).

      In the US, advertising to end users also increases some risks that people will ask for drugs they don't really need. When you see the list of side effects, it's easy how to see how this could be quite dangerous and 'give cancer' as was said...

      Example: Lovaza is refined Omega3 with some testing done (basically filtered fish oil...). They have ads on TV all the time and the drug is very expensive. You can buy Omega3 for much less from all kinds of supplement manufacturers. That seems to contradict your theory.

    12. Re:Just keep in mind the tradeoff by Xtravar · · Score: 5, Insightful

      Yeah, his example only works on things like Viagra, which are completely optional.

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    13. Re:Just keep in mind the tradeoff by EvilBudMan · · Score: 3, Insightful

      Did you see the numbers? It's almost $50 a pill. Some drug company has now patented a propellant for asthma medicine. Since you can't use the old inhalers because of environmental concerns, if you want asthma medicine that used to be off patent is now back on. The patent office is screwed up entirely. Bayer may have lots of research tied up in this but many companies are mere patent trolls.

    14. Re:Just keep in mind the tradeoff by Anonymous Coward · · Score: 2, Insightful

      The cost of getting a drug approved is enormous. My wife participated in 3 cancer drug clinical trials. I can assure you that there are a staggering number of expensive procedures and tests. And not all drugs get approved, so the cost for all the failed attempts must be included in the price of the ones that do.

      Having seen the tremendous costs of getting a drug approved I don't fault the drug companies for making all they can on new drugs. That said, it seems to be dance between the drug companies and the insurance companies. Every drug seems to cost about $7000 / month. I suspect this is the maximum insurance companies will tolerate.

      The tragedy is for those uninsured or on drugs not approved for their disease. We were in that boat and ended up footing the bill ourselves, once for Nexavar (to their credit, Bayer helped us out and sold us the drug at a 90% discount), and again for Votrient (a plea for help to GSK was answered with "that drug isn't approved for that disease, and we think you really should pay more than your take home pay for drugs - fuckers.)

      All in all, I very grateful that companies are willing to attempt to make such drugs. They gave my wife years of quality life she wouldn't have had otherwise. Sure, things could be better, but they could be worse too. And I think India's actions here will tend to make things worse. In fact, if India is setting the price of the drug, it should be footing part of the bill for development and testing.

    15. Re:Just keep in mind the tradeoff by dkleinsc · · Score: 5, Insightful

      No amount of marketing can change the number of people who need a drug. That is fixed.

      Actually, it isn't. For instance, there are endless TV ads describing a list of symptoms and instructing the viewers to diagnose themselves with a disorder X and ask their doctor for a prescription for treatment Y. This may motivate somebody to seek out medical aid for a real problem, but what the drug companies are really hoping for is that a layperson will be convinced they have X (even if their regular doctor tells them they don't) and shop around until they get a prescription for Y. And since it's a treatment rather than a cure, this same person will get treated with Y for years regardless of whether they really need it, so long as the side effects aren't too bad.

      This is part of what's wrong with for-profit health care: It's profitable to create demand that's not only useless but actually counterproductive and sometimes dangerous.

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    16. Re:Just keep in mind the tradeoff by Hatta · · Score: 5, Insightful

      Guess what category 'educating doctors' falls under? That's right, marketing.

      Not a chance. Education and marketing are mutually exclusive.

      How do they educate doctors? By buying ads, and sending reps to talk to the doctors

      That's not education.

      How does a busy doctor have time to talk to a rep? The rep buys him lunch.

      Also not education.

      How does the rep convince the doctor that his meds are right for the doctor's patients? By giving him samples.

      Still not education.

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    17. Re:Just keep in mind the tradeoff by cfulmer · · Score: 3, Insightful

      When was the last time you saw advertising for an anti-cancer drug? The advertising is for things that many people didn't know was a problem -- toenail fungus, restless leg syndrome or problems that they were embarrassed to see their doctors about (Viagra.)

    18. Re:Just keep in mind the tradeoff by P-niiice · · Score: 5, Insightful

      Since when does less profit = loss? Less profit (even a little less) and putting the money to good use elsewhere would be the cure for so many of our problems today, it's uncanny.

    19. Re:Just keep in mind the tradeoff by lgw · · Score: 4, Insightful

      Bayer's profit margin is about 6%. Far less than Apple or Google or the like. Greedy? I hope so - far more people are motivated by greed than altruism, and I want whatever motivation cures cancer! I would you prefer eveyrone was nice to one another, and no cure for cancer?

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    20. Re:Just keep in mind the tradeoff by Hatta · · Score: 4, Insightful

      Getting white papers, case studies, etc to doctors is probably 70% of what drug reps do

      Still not education, because you can't actually trust an industry representative to give you accurate data. He's going to give you the results from private industry research which always err in favor of the industry. Any results they choose to share will play down risks, and play up efficacy over an academic study.

      What we need is real continuing education for doctors. With classes, and tests, and papers, oh my!

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    21. Re:Just keep in mind the tradeoff by batkiwi · · Score: 3, Insightful

      For instance, there are endless TV ads describing a list of symptoms and instructing the viewers to diagnose themselves with a disorder X and ask their doctor for a prescription for treatment Y

      Fortunately that's illegal in most countries apart from the USA.

  2. there's a reason they're overpricing this drug by ruebarb · · Score: 5, Insightful

    average life expectancy according to an article on the BBC is extended by only 3 months -

    http://news.bbc.co.uk/2/hi/health/8367614.stm

    with results like that, you have to overcharge like hell to get your money cause the patients will only be around three more months than usual if they weren't taking the drug -

    but if you're desperate and dying anyways, why not blow 2 months salary on a 120 day supply, right? And yet, I have no sympathy for the drug companies - I wonder why....could it be their way of using lawsuits to keep generics off the market for a few extra years while they re-release a "timed" version of their product?

    Drug companies are vultures - and I'd love to see more university/public funding of this research for the public interest and less for the profit motive - especially when lives are at stake

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  3. That argument is empirically false in this case. by langelgjm · · Score: 5, Insightful

    That argument does not work in this situation. Bayer had priced the drug so high in India that it was clear they had no interest in serving the Indian market. I'm on a listserv for this type of information, and someone close to the issue noted that "Last year Bayer sold 493 boxes of 120 tabs of Sorafenib in India. That was enough for about 49 people, in a country with a population of 1,210,193,422."

    Any money Bayer was making in India off this drug was a rounding error compared to the lucrative North American and European markets. Furthermore, Bayer argued to the Indian court that the Indian population did have access to the drug through an infringing version produced by Cipla, while at the same time Bayer was suing Cipla for patent infringement, trying to get their product off the market.

    Given the 6% royalty rate that NATCO has to pay to Bayer, I wouldn't be suprised if Bayer ends up making more money with the compulsory license than before.

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  4. Re:Companies will stop selling New drugs in India by Maximum+Prophet · · Score: 4, Insightful

    If a drug has been patented, and made it's way through FDA approval, it's chemistry is well known, and any decent lab will be able to make it. Not selling in a market is only cutting off the nose to spite the face. They will continue to sell in that market, because rich people will still pay for it rather than the generic.

    R&D are sunk costs. *Any* sales over your fixed production costs results in profit. If you want to maximize profit, you sell. (Of course, as others have pointed out, you have to make sure none of the low cost sales gets resold to someone in another country. YMMV)

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  5. Re:Protections by theArtificial · · Score: 3, Insightful

    Thanks for the quick reply. You make it sound very noble especially the foreign corporation bit. Your argument is: ignore everything everywhere when it benefits the citizens? Please, I'm not a defender of corporations, but surely you must see that this is a slippery slope?

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  6. Nonsense! Capital will flee by unassimilatible · · Score: 5, Insightful

    If they won't settle for less profit, someone else will be prepared to take their position in the market.

    Who is "they"? Spoken like a guy who doesn't own stocks. Scare investment capital from drug companies, and it won't go elsewhere in the market - it will go to Exxon and Apple! Buh-bye, private R&D!

    Government will never give out free gas and iPhones, so my investment dollars will go there.

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  7. Citation please by unassimilatible · · Score: 3, Insightful

    Only a handful of truly important drugs have been brought to market in recent years, and they were mostly based on taxpayer-funded research at academic institutions, small biotechnology companies, or the National Institutes of Health (NIH)

    Nice general talking points there, now how about some proof in the form of cites?

    Besides, it's utterly pointless to say one does more than the other. How about encouraging as much funding you can going toward lifesaving drug research, instead of private sector capital fleeing to oil companies and tech?

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  8. Re:Protections by betterunixthanunix · · Score: 4, Insightful

    Your argument is: ignore everything everywhere when it benefits the citizens? Please, I'm not a defender of corporations, but surely you must see that this is a slippery slope?

    Well, if governments are not supposed to work for the benefit of their citizens, then I have to wonder what you think the proper thing for a government to do might be. Where would you suggest that slippery slope leads?

    Keep in mind that the governments of the US and of western European nations work very hard to benefit their citizens at the expense of other nations, which is basically how India found itself in this situation. The west became wealthy through the exploitation of other countries; even our poorest citizens have better lives than the citizens of some of the countries we took advantage of. We pushed other countries to adopt certain industrial regulations that our corporations wanted, like copyrights and patents, rather than using our influence to affect changes that would benefit the working class (e.g. better education, better food and water, better living conditions, etc.). If we are willing to let another nation languish in poverty so that we can continue to exploit its labor force, we really cannot complain when other countries ignore corporate profits so that their citizens can get affordable medicines.

    At the end of the day, a government that is not doing what benefits its citizens is a government that fails the legitimacy test.

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