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Big Pharma Presses US To Quash Cheap Drug Production In India

An anonymous reader writes "Pharmaceutical Research and Manufacturers of America (PhRMA), are leaning on the United States government to discourage India from allowing the production and sale of affordable generic drugs to treat diseases such as cancer, diabetes, HIV/AIDS and hepatitis. India is currently on the U.S. government's Priority Watch List — countries whose practices on protecting intellectual property Washington believes should be monitored closely. Last year Novartis lost a six-year legal battle after the Indian Supreme court ruled that small changes and improvements to the drug Glivec did not amount to innovation deserving of a patent. Western drugmakers Pfizer, GlaxoSmithKline, Novartis, Roche Holding, Sanofi, and others have a bigger share of the fast-growing drug market in India. But they have been frustrated by a series of decisions on patents and pricing, as part of New Delhi's push to increase access to life-saving treatments in a place where only 15 percent of 1.2 billion people are covered by health insurance. One would certainly understand and probably agree with the need for for cheaper drugs. But don't forget that big pharma, for all its problems still is the number one creator of new drugs. In 2012 alone, the U.S. government and private companies spent a combined $130 billion (PDF) on medical research."

19 of 255 comments (clear)

  1. We need Indian drug companies by PCM2 · · Score: 5, Funny

    I think it's terrible that the US would try to keep more people from getting access to effective, affordable remedies, such as beta blockers.

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    1. Re:We need Indian drug companies by icebike · · Score: 5, Insightful

      The drug is Gleevec, not Glivec. I take it, and it's a miracle drug for those it helps. And it's expensive as HECK!

      Novartis had its 17 years of patent protection. Invented prior 1996, the first patent expired in 2013, and so Novartis decided to seek a patent on a slightly altered version, to gain 20 year protection. The Indian court saw through this and said No way. Good on them.
      The drug has paid back its development costs many multiple times already.

      This is a common tactic of drug manufacturers as their patents run our they suddenly find a way to color it pink or something equally trivially unimportant change and try to start the patent clock all over. This is a total subversion of the purpose behind patents.

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  2. Jai Hind! by Applehu+Akbar · · Score: 5, Interesting
    This is real News for Nerds. We need to support this effort by India to bust the pharma monopoly if we are ever going to afford medical care in this country. It doesn't matter whether that care is public or private; either style of payment encounters the same tsunami of uncontrolled cost.

    But of course, reams of whiny butthurt over the proposed new appearance of Slashdot trumps all real issues this week. Will you crybabies please boycott the site as you have promised and let the rest of us get back to discussing real issues? You're like those Hollywood cokebrains who promise to leave the US whenever some Republican gets elected, but who let us down every time.

    1. Re:Jai Hind! by s.petry · · Score: 4, Interesting

      I agree with the meat of your statement. At the same time, what gets neglected in these debates is that the Government "should" have a small role in the industry. Primarily, making sure that the drugs being sold are safe.

      That "safe" has a few meanings, such as ensuring there are no materials in the drugs that should not be there. Ensuring that the drugs contain what they are supposed to contain, and that the levels are correct. Legally today, our supposedly "controlled" environment can get away with giving you 80% of what they are supposed to give you. They can put trace levels of mercury into vaccines too, so our "controlled" environment is not doing so well.

      Point being, yes there should not be this nasty monopoly. Further, there should be more law suits for false advertising against drug agencies, and many people should be in jail for releasing dangerous drugs without advising the public to the dangers (Guardasil).

      Our "Government" is failing on all accounts. Not the agents fault mind you, but the agencies fault.

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      -The wise argue that there are few absolutes, the fool argues that there are no probabilities.

    2. Re:Jai Hind! by Applehu+Akbar · · Score: 4, Informative
      There is no necessary connection between assuring drug safety and using the legal system to prop up a monopoly, although the FDA long ago mission-crept beyond its safety mandate to become a willing enabler of Bigger And Bigger Pharma. The FDA keeps compounds that have been selling in Europe and Canada off the US market for years, just to delay competition with one of the big domestic moneymakers. You're not going to convince me that European safety agencies are more lax than the FDA.

      Guys, were you aware that in April, 2012, the patent on Viagra expired? But this was not a great day in the history of masculinity because Pfizer was able to get a federal judge to extend its reign to 2019 on the usual mysterious technical grounds.

    3. Re:Jai Hind! by Uberbah · · Score: 4, Insightful

      At the same time, what gets neglected in these debates is that the Government "should" have a small role in the industry. Primarily, making sure that the drugs being sold are safe.

      Why not a large role. As in, publicly finance 100% of drug research, since the worst university could piss away 50% of it's funding and still have a better return than Pharma, who spend more than that on stock options and advertizing.

    4. Re:Jai Hind! by wierd_w · · Score: 4, Informative

      Thalidomide is an interesting case.

      It is a photo enantiomer, meaning that it has a left handed, and right handed isomer that will bend light one way, or another, when in solution.

      The right handed isomer is an effective sedative, while the left handed one is a tetragenic compound.

      The problem is that even if highly refined so that only R isomer is administered, the pH of the patient's blood will racemize the isomers again.

      It could be entirely possible for thalidomide to be safe, if administered with a chaparone to prevent racemization.

      At the time, the preparations of thalidomide were a heterogenous mix of both isomers, as there was no research into possible side effects from the mixed sample, and the prospect of birth defects wasnt considered, as the intended use was not for treating morning sickness. As an anti-cancer treatment for non-pregnant people, it is still a useful compound.

      Thalidomide was originally developed as a sedative/hypnotic compound, and not as a treatment for nausea. (This would be similar to say, scopolamine, which is used to treat motion sickness. This is not meant to imply that the comounds are related. They arent. However, scopolamine is ALSO useful for treating some forms of nausea. Fancy that.) The use as treatment for nausea is what heralded the use of the product to treat morning sickness, and the subsequent epidemic of infant mortality and deformity that swept the world. It isn't that thalidomide is a bad drug: it was, and is still being shown to be a VERY useful drug. The problem is that thalidomide was not used properly, and was provided OTC, which strongly exacerbated the problem. To pick on poor scopolamine again, it too had a stint as an OTC motion sickness medicine and sleep aid, which ended up causing all manner of problems when certain... shall we say, "Degenerate" people discovered that it made an excellent date rape drug when dissolved in alcoholic beverages.

      It isn't that either drug is "bad". It is that the lust for profits from the sale of the drugs can lead to very bad decisions in marketing and distribution of those drugs. Drugs developed for a certain purpose should be extensively and thuroughtly tested for efficacy before being used in alternative manners; such as for instance, Minoxadil. It is the primary ingredient in Rogaine, a male hairloss treatment with FDA approval. It was originally a prescription heart medicine for treating hypertension. It took quite some time for minoxadil to recieve FDA approval for treating alopecia. That is a good thing, as the testing helped establish what the ideal dosages are, and that the concentration must be different for treating women than for treating men. If minoxadil had been rushed to market as a treatment for alopecia, there could have been very dangerous results, since it *IS* a blood pressure medication! This is one of the reasons why rogaine is a topically applied preparation, and not a preparation for internal consumption. (The regrowth of hair was a common side effect of orally administered minoxadil for treating hypertension. Oral administration of the compound would be effective for regrowing hair, but the concentrations needed would make taking the drug dangerous to a patient's cardiac health. Topically applied minoxadil allows high concentrations at the site of interest, with a slow overall rate of absorption, making it ineffective at lowering blood pressure. If rushed to market, it is quite concievable that minoxadil tablets would have been seen for treating alopecia, and that there would have been class action suits as bald people all over started dieing.)

      The FDA's insistence on efficacy studies is to prevent dangerous drug use, and to ensure that a drug actually does what it says it does. The long term drug study requirements are intended to catch things like thalidomide birth defects, as it would have shown up with thalidomide being used as a sedative/hypnotic as a

  3. It is far, far better ... by Alain+Williams · · Score: 4, Insightful

    that poor people die because they cannot buy the cheap drugs that may save their lives than a few rich western pharma lose any profit. :-(

    Let them produce cheap drugs for local consumption. OK don't allow them to be imported to the west where (most) people can afford them. But condemning people to die just to protect your profits is, frankly, sick. Maybe not much different from tobacco companies, but still sick.

  4. Friend of mine just got cheap drugs from India ... by timothy · · Score: 5, Informative

    It sounds odd, or the start of a joke, but I'm serious.

    She ordered some variety of medicine from an online pharmacy (which one, I don't know) and had some heavy cognitive dissonance. 'Did I just give money to scammers?' She waited slightly longer than she expected to, and had the thought that she really had been taken for a ride ... but then they arrived, and (to her surprise) were postmarked India.

    "They were cheap, and worked."

    She'll be displeased to hear about just how far regulatory capture can go, in this arena ...

    timothy

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  5. Re:Friend of mine just got cheap drugs from India by ebno-10db · · Score: 4, Informative

    Yup. A friend of mine needed some medications, taken on a regular basis. IIRC he had some limited insurance, but it didn't cover squat in medication. He ordered them online from a pharmacy in Canada. A legitimate outfit - had to show he had the prescriptions and whatnot. The meds were drop shipped from Switzerland and India, complete with funny foreign return addresses and stamps. He saved a bundle. There were the real McCoy too, not some brand X knockoff. Switzerland and India was where they were made.

    Even better is doggy Prozac. Apparently they have Prozac for dogs - and it's the exact same stuff, from the same factory, but at a fraction of the price. This one is 2nd hand, from my neighbor the veterinarian, but she's not a BS artist. A coworker's wife had a Prozac Rx, so hubby writes an Rx for their dog, and she takes it.

  6. No, they weren't.... by trims · · Score: 5, Insightful

    The current crop (and the future crops, too) of drugs were NEVER intended to have to recoup costs out of non-developed-world countries.

    In fact, pretty much ALL drug research is based solely on the American market. That is, everything else outside the American market is gravy (or, in this case, pure profit). The metrics are driven by how long it takes to recoup money from the USA's market.

    The reason why is that the US drug market (due to a combination of large population, and completely unregulated pricing) is so much more lucrative than anywhere else, by an order of magnitude even more than Western Europe. That's right - the USA alone brings in more profit THAN THE ENTIRE REST OF THE WORLD for a drug.

    Letting India manufacture these domestically (and, heck, the entire rest of the developed world) wouldn't affect drug research and investment strategies one little bit. The big fear from drug companies is reimportation, where drugs manufactured in India are imported back into the USA for sale, without the major patent premium being paid. This is fairly trivially avoidable.

    So, yeah, in the end, it's about squeezing that last dime in profits out of people, and not fundamentally giving a damned about anything else.

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  7. Re:Wouldn't it be something by icebike · · Score: 4, Informative

    Get rid of FDA, get rid of government and basically costs drop dramatically that prices could truly be taken down

    The FDA doesn't keep drug prices high, they keep people alive. Returning to the days of snake oil is not the solution.

    The problem is that patents can be extended by silly little changes that have no real effect, and the world is deprived of the invention or charged unconscionable amounts of money. Glivec (Imatinib) the first of the exceptionally expensive cancer drugs, costing $92,000 a year. Yet its development costs were not that great, and production costs have fallen dramatically.(especially in India).

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  8. Re:BETA NEEDS TO BE RAPED BY HORSES by dmbasso · · Score: 5, Insightful

    The reason is pretty clear, it is about Imaginary Property (IP). The same pixie dust that makes copyright, trademarks, and patents.

    And they're bullying a poor country like "hey, all these medicines that we were not going to sell because you can't afford, you are not allowed to make them yourselves; tell your population to just die." Yeah, pretty nice.

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  9. No magic bullet. by westlake · · Score: 4, Informative
    There is no quick, cheap, safe path to the development of a new drug.

    Someone has to pay the bill.

    Glaxo spent more than $350 million over 25 years to develop [a malaria] vaccine for military personnel and travelers and expects to invest an additional $260 million to complete development. But Glaxo was reluctant to pay for pediatric trials in impoverished nations on its own, so the Bill and Melinda Gates Foundation provided $200 million through the nonprofit PATH Malaria Vaccine Initiative to drive development and testing over the finish line.

    Hope for a Malaria Vaccine [Oct 1013]

  10. Re:BETA NEEDS TO BE RAPED BY HORSES by Uberbah · · Score: 4, Insightful

    Wow. I hate to be the guy asking "why is this on Slashdot", but WTF? This is a purely political click-trolling story. This is not what Slashdot is for.

    I don't hate to be the guy to ask you, but did you really just fall off the turnip truck? This is a story on drug patents. Slashdot runs stories on patents and greedy companies extracting money from them allllll the fucking time, and twice on Thursdays.

  11. Re: BETA NEEDS TO BE RAPED BY HORSES by maynard · · Score: 5, Informative

    (Of course, a true communist would reply: it will be free, because taxes will pay for it.)

    Taxes have nothing to do with communism. In a communism all productive assets is owned by the state. That means farmland, power plants, factories, and all deeded property. Personal property is excluded; the state doesn't care about your model train collection.

    Intellectual property would fall under state deeded property just as housing does. That's because only the state manages property deeds and assigns ownership. That the ownership is automatically assigned to the state merely simplifies bureaucratic administrative overhead. The state might be inefficient in aggregate, but not so in the Registration of Deeds office.

    I know it's nit picky, but your statement conflates that communist system with every other government system imagined. Every government that has existed taxed its citizens to provide for a common good. Governments tax to build roads, bridges, schools, military and police departments. New research and development is funded through education grants. For example: the internet. Also: medical research. In fact, a lot of tax money is spent on drug development.

    Perhaps you think government shouldn't do these things. Some even think government should be abolished. But to argue the abolishment of government on the pretense that taxes equals communism mixes terms and beliefs such that the rationale is nothing more than nonsense. It's no argument. It's not anticommunist or pro-USA or holds any ideological consistency.

  12. Re: BETA NEEDS TO BE RAPED BY HORSES by Anonymous Coward · · Score: 5, Insightful

    Much of the expense, and focus, of drug research of the US is on new patents, not on new treatments.

    Let me take you a visit to the world of patent history: Welcome to insulin, which was released *with a free patent* because of its discoverer's desire to help humanity, immediately. The *refinement* and processing of insulin has, fortunately for profits, been filled with many patentable processes. Business has benefited, and there have actually been useful improvements in its purity, which helps prevent allergic reactions, and its price. The original refinement from slaughterhouse fetuses, to avoid contamination by pancreatic juices, was effective but unsustainable as we diabetics survived longer and became a larger market. Refinement from pancreases from adult slaughterhouse animals filled the supply, and was very profitable for decades.

    But the last round of significant patents was running out. Factories worldwide were geared up to operate, outside the control of the Eli Lilly company, and to halve the price of insulin. What to do, what to do? Wait! We can patent *human* insulin! By first modifying animal insulin with new ly patented enzyme treatments, and by eventually using genetically modified e.coli to produce it without animals, we now have "pure human" insulin, to the benefit of diabetics worldwide! It's human insulin, what could be better?

    The answer is that almost all other sources of insulin better. Human insulin is faster acting, but that's pointless when you're wearing an insulin pump and the updake is much faster *anyway*. The claims about animal insulin leading to insulin resistance or allergy were due to the *impurities*, which are almost nonexistent in modern processing of animal insulins. And human insulin actually contributes to hypoglycemic unawareness which gave me one heck of a time when I couldn't get animal insulin anymore. (I tried!) Human insulin does not provide a single benefit over animal insulin to its users, and the deficits are very real. Other fast acting insulin mixtures, have been available for *decades, and long acting versions for different shot based insulin treatments. They're now all now replaced by "human" insulins that are roughly twice the price, even with inflation

    So as a diabetic who's faced this sort of thing, the "Big Pharma" companies can go play "Rites of Spring" on my !@#$. They've demonstrated that they prefer profits on new and actively inferior patent-ptoected products over the health and safety of millions of medication who absolutely require this medication. I cut companies like Lilly *no* slack in legislation or in the courts or in global treaties. They've abused us for decades, and I hope their leadership rots.

  13. Re: BETA NEEDS TO BE RAPED BY HORSES by tragedy · · Score: 4, Interesting

    ...someone has to pay for drug research...

    Well, that $130 Billion works out to about $415 per person in the US. Government and charaties and the like paid about half of that and "industry" paid the other half. Total healthcare spending from that same PDF was $2,939 Billion (although those numbers are a bit confusing because it seems to include the money industry spent on the research added to the amount industry was paid by patients). In any case, that's about $9390 per person in the US, or around 45 times the amount industry spent on research. So, if a few percent of total healthcare spending goes towards the pharm/biotech/medical devices industry, they're doing just fine. Also the answer to who is paying for medical research is that the taxpayers and patients are. Frankly, if you look at the math, it's pretty ridiculous. If half of the research costs aren't going to be paid by industry anyway, and it's such a small fraction of the total healthcare costs, why not just double or triple what the government is paying for research and stop giving a cent of it to for profit industries. Then, do all the research through public research institutions and relegate industry to a manufacturing role. Let them all be 'generic' manufacturers competing on production of the same drugs. In the meantime the few extra percent that would raise total healthcare expenditure by would be offset by the much larger drop in healthcare spending due to the fact that a bunch of artificial monopolies just vanished.
    Now, I know it's tragic that people who didn't pay might also benefit from this research. Even worse than the people in other countries are the untold future generations of humans who will also benefit with better health and happier lives without paying for it. Bunch of filthy freeloading descendants.

  14. Re:XR Drugs by sirlark · · Score: 5, Interesting

    I don't know if AC's get notified about reponses to their comments, but either way, this question goes out in response.

    We tried making an "extra strength" version of our biggest seller, Patanol, a few years ago and lost. We had to come up with a lot of changes to get the once-a-day version approved.

    The phrase "come up with" implies some measure of deliberate but spurious inventiveness, as if you made the changes exclusively to get a new patent, rather than to improve the drug itself. While the grandparent's post mentioned adding pink dye, and that surely is a trival change, if you are "coming up" with changes, it sound like your are fixing something that isn't broken, and the only reason your tinkering beyond adding a dye is precisely because that is not enough to get a patent. In other words, you are ding precisely enough to get more money (as a company), rather than making the best possible drug.

    So, genuine questions here:

    Why do you think such behaviour should be rewarded?

    Why should limited tinkering that was done to change the drug without the eventual aim of improvement extend a patent?