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How Drug Companies Seek To Exploit Rare DNA Mutations

Posted by Soulskill on from the all-about-the-benjamins dept.

An anonymous reader writes: With so many people in the world, humanity can't help but generate a large amount of genetic outliers. Most random mutations are undetectable, and many of the rest lead to serious diseases. But there's another class of mutation that has drug companies salivating. For example: a few dozen people worldwide have a condition that prevents them from feeling any pain. Another condition called sclerosteosis affects less than 100 people, giving them incredibly dense bone structure. Both of these conditions have serious downsides, but drug companies are beginning to see the dollar signs behind isolating these mutations and making them safe.

"People with sclerosteosis lack a protein that acts as a brake on bone growth. Without that protein, bones grow abnormally thick. It stood to reason, researchers thought, that a drug that could block the protein in patients with osteoporosis would encourage bone regrowth. Amgen's scientists created hundreds of antibodies that they tested to determine which might be able to get in the way of the protein. It took them three and a half years of research before they were able to identify the best antibody to inhibit the protein. Then NASA came calling." It's an unfortunate situation for those with the rare conditions; there's a lot more potential profit in finding a way to genetically prevent pain for billions of people than it is to cure the handful with the condition.

64 of 93 comments (clear)

  1. "Drug Companies Seek to Exploit"!!! by mi · · Score: 4, Insightful

    The title suggested some che-guevarish rant against capitalism in general and profits in particular. Profits made on the backs of people with genetic diseases, no less!

    I sure am glad, TFA is not about that at all. And, yes, I exploited my computer to post this.

    --
    In Soviet Washington the swamp drains you.
    1. Re:"Drug Companies Seek to Exploit"!!! by captaindomon · · Score: 4, Insightful

      Yeah my thoughts exactly. "Drug company realizes that an extremely debilitating rare disease may have a cure with modern science, so they are researching how to cure that." Doesn't sound like exploitation to me.

      --
      Just because I can hook a shark from a boat, I do no offer to wrestle it in the water.
    2. Re:"Drug Companies Seek to Exploit"!!! by Anonymous Coward · · Score: 1

      They also neglect to mention that the more studied the pathway the more likely a cure will be found. Maybe the drug, used to reproduce the genetic effects of the drug, needs an antidote that will work as a cure for current sufferers. If I had one of these diseases I would welcome this news because before it really was hopeless for a cure to try to treat a dozen people.

    3. Re:"Drug Companies Seek to Exploit"!!! by bluefoxlucid · · Score: 1

      Of course there's more profit in providing cures to billions of people! 30,000 people with ALS and billions of wasted dollars successfullycuring them; or 2 million people with HIV, and the same billions of dollars spent curing HIV? Guess which one's more profitable? Hint: you spent $890 billion and cured 30,000 people in one scenario, and spent $890 billion and cured 2,000,000 people in the other.

      People think only in terms of money when considering economics; they don't think about non-monetary return.

      --
      Support my political activism on Patreon.
    4. Re:"Drug Companies Seek to Exploit"!!! by gstoddart · · Score: 2, Informative

      Except, that's not what is happening.

      They're using the rare and debilitating disease as a basis to develop treatment for other conditions ... the people with the rare and debilitating disease? Not profitable enough to cure.

      They're researching how to take someone's illness, leave them untreated, and then use that information to treat someone else.

      And, I'm sorry, but this is big pharma, which means they'll patent anything they discover and prevent people from actually working on cures for the people from whom they learned this in the first place.

      Never assume drug companies aren't complete bastards who care only for their own profits. They've make cures from ground up babies if they could get away with it.

      --
      Lost at C:>. Found at C.
    5. Re:"Drug Companies Seek to Exploit"!!! by Wycliffe · · Score: 4, Insightful

      They also neglect to mention that the more studied the pathway the more likely a cure will be found. Maybe the drug, used to reproduce the genetic effects of the drug, needs an antidote that will work as a cure for current sufferers. If I had one of these diseases I would welcome this news because before it really was hopeless for a cure to try to treat a dozen people.

      Exactly. While they are trying to block a particular protein, it's very possible that they also figure out how to synthesize it. Or in the reverse case, while they are trying to sythesize it, they might figure out how to block it or they might even need to figure out how to block it in a mouse first so that they have a way to test if their drug is working. Before, with only a few dozen people on earth, noone on earth was even looking at that area so the chance of a cure was nil. This way the chance of a cure goes up exponentially. Not to mention that if you get a relationship with a scientist who is studying your disease that they will likely take a personal interest in your case and you're much more likely to get access to experimental procedures.

    6. Re:"Drug Companies Seek to Exploit"!!! by burtosis · · Score: 4, Informative

      Quite likely true. However at least this gets them quite a bit of indirect exposure and may, yes may, eventually provide them with treatments (doubt we will have cures for genetic conditions anytime in our lifetimes). So I am going out on a limb and going to say it's not 100% bad for these people because without that interest they truly are 100% screwed instead of just 90%. If I was in that position I'd probably take those odds at a treatment.

    7. Re:"Drug Companies Seek to Exploit"!!! by mi · · Score: 1, Interesting

      Never assume drug companies aren't complete bastards who care only for their own profits.

      There! Thank you for restoring my faith in Slashdot.

      They've make cures from ground up babies

      Certainly! I even know, who the supplier would be.

      --
      In Soviet Washington the swamp drains you.
    8. Re:"Drug Companies Seek to Exploit"!!! by Anonymous Coward · · Score: 1

      It all started back with Penicillin... instead of curing the poor sandwich Big Pharma decided to use the discovery for evil!

    9. Re:"Drug Companies Seek to Exploit"!!! by Jason+Levine · · Score: 1

      Which is why the Vaccine Court was formed. Vaccines don't make drug companies a lot of money. In fact, they lose out on selling drugs to treat the diseases that vaccines prevent. Given our sue happy culture, the drug companies could wind up losing a lot of money in legal fees (even if the lawsuits are without merit) and could make the financial decision to stop offering the vaccines. Then, nobody would get vaccines, the diseases would make a comeback, and people would die.

      --
      My sci-fi novel, Ghost Thief, is now available from Amazon.com.
    10. Re:"Drug Companies Seek to Exploit"!!! by TsuruchiBrian · · Score: 1

      I don't see what is unethical about placing a higher priority on treating diseases that effect more people.

      choices:
      A. spend $1 billion researching a drug that helps a billion people.
      B. spend $1 billion researching a drug that helps 10 people.

      Here are some hypothetical facts that should not affect the answer:
      1. The entity spending the $1 billion is a pharmaceutical company.
      2. The pharmaceutical company is hoping to earn a profit.
      3. The drug is developed from learning about mutations of people in scenario B.

      I don't entertain nay fantasies that drug companies care about anything more than profits, but their profits are derived from creating products that actually help people. It's not a perfect system, but exploiting the profit motive of a capitalist society gets a lot of drugs made. Squandering billions of dollars helping a handful of people might make us feel good, but it's a pretty bad idea when you really analyze it rationally.

    11. Re:"Drug Companies Seek to Exploit"!!! by TsuruchiBrian · · Score: 3, Insightful

      This is a very common claim, but I don't think it's true for a couple reasons.

      1. Drug patents eventually run out, so it's not as if they can profit from a "treatment solution" indefinitely as opposed to a "cure solution". Both solutions have a limited time during which they can be exploited for profit.

      2. Why couldn't drug companies simply just charge more money for a cure, to where it is the same amount of profit as a treatment? Insurance companies are probably even more likely to pay for cures rather than treatments because it is probably cheaper for them in the long term, and drug companies can make more money while their patents are still valid. The only party losing out is that drug companies making generics don;t have as much of an opportunity for profit.

      3. If a drug company A already has a treatment for a disease, you are saying drug company B could make a cure for the disease and steal all of A's profits, but they'd rather just make another treatment and share the profits equally with A and deny society as a whole a cure for this disease?

      Here is what I think is probably more likely to be the reality. Cures for diseases are harder to find than treatments. The easy cures for diseases have already been found.

      In order to cure a disease, you either have to be really lucky, or have an incredibly deep understanding of the disease in order to intentionally engineer a solution.

      I have a good friend who is a doctor (just went to his wedding), and he had a very good analogy in regard to the current way we treat diseases with drugs.

      He said it's like opening the hood of a car and taking whatever fluid is lacking and just pouring out over all the components and hoping enough of it gets in the places it needs to go.

    12. Re:"Drug Companies Seek to Exploit"!!! by Software · · Score: 2

      Let me make the assumption that it's equally difficult to block or synthesize the protein which brakes bone growth. Let's pretend for a second that it would cost the same amount of money to do both, but there isn't enough money, so only one can be done. Blocking the protein would help millions with osteoporosis, while synthesizing it will help the thousands with sclerosteosis. It makes more sense to me to improve the lives of millions of osteoporosis sufferers first. This holds true regardless of whether or not the research is being done for profit.

    13. Re:"Drug Companies Seek to Exploit"!!! by Stem_Cell_Brad · · Score: 1

      Well said. One point to add is that people contributing to develop the therapies should all reap some sort of reward commensurate with their level of contribution. So, those folks harboring valuable mutations, who will not benefit from therapies, they should receive some compensation for giving up private information. I am not sure if this regularly happens or if they usually give away their information for free because they feel it is the right thing to do.

    14. Re:"Drug Companies Seek to Exploit"!!! by ArmoredDragon · · Score: 1

      Sometimes I wonder how short the attention span of the average Slashdotter is.

      http://m.slashdot.org/story/29...

    15. Re:"Drug Companies Seek to Exploit"!!! by ceoyoyo · · Score: 1

      You know that most of the established pharma companies make certain drugs for rare diseases and either give them away for free or charge completely nominal amounts for them, right?

      There is a new breed of startup company that buys up the rights to such treatments and raises their price by a hundred thousand percent (that's not hyperbole) though. Those guys are absolutely bastards.

      The pharma industry has engaged in some pretty questionable things at various times, but they're not demons.

    16. Re:"Drug Companies Seek to Exploit"!!! by msauve · · Score: 1

      No, it's not just "big pharma." This has been happening for a very long time, including with supposedly reputable research institutions, like Johns Hopkins. Ref: Henrietta Lacks.

      --
      "National Security is the chief cause of national insecurity." - Celine's First Law
    17. Re:"Drug Companies Seek to Exploit"!!! by ceoyoyo · · Score: 1

      The Henrietta Lacks story doesn't seem to have any real similarities with what the GP said at all.

      HL was treated with the standard of care for a tumour. Cells acquired during that treatment were then used for research, apparently without informed consent. That sample, which could have come from anyone, happened to be the first one that was successfully immortalized. The only reason that particular story is more than just an example of some of the shadiness that went on before we had international conventions on informed consent in human research is that the HL cells happened to be used to generate a research cell line that was then widely distributed. It's famous because of the PITA it would have been for everyone to destroy their HL cell cultures and start again with cells with a properly obtained progenitor.

    18. Re:"Drug Companies Seek to Exploit"!!! by ceoyoyo · · Score: 1

      Taxpayers have expressed their unwillingness to pay lots of money for research. So research, depending on the field, is funded to some extent by industry. Taxpayers are especially unwilling to pay for medical research on diseases that don't affect them.

    19. Re:"Drug Companies Seek to Exploit"!!! by GLMDesigns · · Score: 1

      Why are they bastards for looking for new ways to cure people? You say they're bastards for not investing billions for a market that won't be profitable? You're the one that's foolish.

      If you want to help those people start a foundation, raise money and team up with a company to make the drug.

      --
      If you're scared of your govt then you need to further restrict its powers
      Vote 3rd Party in 2016 and beyond
    20. Re:"Drug Companies Seek to Exploit"!!! by TsuruchiBrian · · Score: 1

      The people that are helping create the drugs by allowing their mutations to be investigated should absolutely be compensated just like the scientist who is doing the investigating should be compensated.

      And the recipient of that compensation is free to donate that money toward finding a cure for their own disease, or put it toward buying a new house, or whatever they feel is the best use of their own money.

      I'm assuming that at some point the march of progress will eventually get to tackling lower priority problems, like curing diseases that only affect a few people, maybe it will happen in a version of a post-scarcity economy, or maybe the advance of technology will allow for general cures to entire categories of diseases (e.g. all genetic diseases, or all autoimmune diseases, etc).

    21. Re:"Drug Companies Seek to Exploit"!!! by msauve · · Score: 1

      So, the ethics somehow change just because "international conventions," created by those who are advantaged by them, exist? You're confusing law and ethics.

      --
      "National Security is the chief cause of national insecurity." - Celine's First Law
    22. Re:"Drug Companies Seek to Exploit"!!! by gtall · · Score: 1

      This is the age old economics 101 thought problem: there it is usually phrased in terms of kidney dialysis. Do you sink all your kidney money into dialysis for the ones you know you can prolong their lives, or do you siphon it off for research. How much do you allocate? What are future generations worth?

      Nothing special here regardless of your disillusioned rants on big pharma.

    23. Re:"Drug Companies Seek to Exploit"!!! by clodney · · Score: 1

      Drug companies have no intrrest in researching cures.

      Drug companies are for-profit. While there is obviously immense profit in providing treatment for maladies, there is a very limited profit available in cures.

      Thus, drug companies do not have any intention of curing anything. It would be bad for business, you see.

      And yet, I was just reading that there are multiple new (and phenomenally expensive) drugs that cure Hepatitis C. Insurers don't want to pay for the cure, because the course of drugs necessary for the cure can run in excess of $100K. And the latest drug is better than the previous cure, but even more expensive.

      Presumably the companies bringing the cure to market are different than the ones selling the palliative care, so they have an incentive to sell the cure.

    24. Re:"Drug Companies Seek to Exploit"!!! by pepty · · Score: 1

      Horseshit. A cure for any major disease would be worth much more than the entire market of treatments it would displace. Want to make a few trillion dollars in less than a decade? Cure Type II Diabetes. The reason Pharmas aren't making cures is because it's a lot harder to create a cure than it is to create a treatment.

    25. Re:"Drug Companies Seek to Exploit"!!! by pepty · · Score: 1

      Would you rather earn $100k today or $833 a month for ten years? Pharmas would much rather sell cures, even if they couldn't price them for substantially more than the total price for a decade of treatments.

    26. Re:"Drug Companies Seek to Exploit"!!! by david_thornley · · Score: 1

      The ethics didn't change because of international conventions, the conventions just codified the ethical standard and gave them some teeth. I don't know enough to be sure, but I'm willing to believe that HL was unethically treated and the cells were used unethically. That doesn't mean the cell line is eternally tainted and shouldn't be used.

      --
      "When you have eliminated the unacceptable, whatever is left, however improbable, must be the truthiness" - Holmes
  2. Tit For Tat by Archwyrm · · Score: 1

    If I am one of twelve people with a rare genetic mutation, then perhaps I let them study my genes in return for researching a cure for my condition. The drug company stands to make a lot of money off of helping many people, so they can easily invest some into my problem of feeling no pain. Seems like a fair trade, right? Because it's a bit of a drag to think you've just sustained a flesh wound when actually your arm's off.

    --
    Fascism should more properly be called corporatism because it is the merger of state and corporate power. -- Mussolini
  3. Re:Drugs are for cows. by Anonymous Coward · · Score: 1

    Hi user:sexconker (1179573), we know it's you, you forgot to check the "Post Anonymously" box earlier:

    http://news.slashdot.org/comme...

  4. Profits are important to allocate resources by trout007 · · Score: 3, Informative

    I don't have a problem with the Pharmaceutical companies trying to maximize profits. Profits are necessary to help the market determine how to allocate resources. When a company makes "obscene" profits that is a signal to everyone else that resources should be taken from those enterprises incurring loses and invested in the more profitable ventures.

    But patents have nothing to do with a free market. They are a state granted monopoly that need to be eliminated. Get rid of patents and you will have quicker and smaller innovations as companies try to stay ahead in their market.

    --
    I love Jesus, except for his foreign policy.
    1. Re:Profits are important to allocate resources by mi · · Score: 2

      Get rid of patents and you will have quicker and smaller innovations as companies try to stay ahead in their market.

      You'll certainly see companies guarding their secrets themselves — and not publishing their discoveries — thus stalling science.

      Contrary to popular misconceptions, patents do not prevent you from using somebody else's discovery. You just have to pay the discoverer for the privilege...

      --
      In Soviet Washington the swamp drains you.
    2. Re:Profits are important to allocate resources by Anonymous Coward · · Score: 1

      Contrary to popular misconceptions, patents do not prevent you from using somebody else's discovery. You just have to pay the discoverer for the privilege...

      You're suffering from a common and utterly wrong misconception. A patent is the exclusive right to exploit an invention. The patent holder can and often does prevent others from using that invention. There is no requirement for them to accept payment in lieu of prevention, although it's common enough.

    3. Re:Profits are important to allocate resources by alvinrod · · Score: 2

      Which is why patents need clear duration limitations rather than outright removal so that even if someone does discover some new invention and prevents anyone else from using it, eventually it becomes completely fair game. I think that most people would agree that the original duration of patents is much too long in the modern world where the rate of advancement has accelerated greatly.

      Without patents at all, the market would quickly devolve into a small group of large players that can use economy of scale to stomp out all other competition. None will be particularly keen on spending large amounts of money on research into new drugs as those could be immediately copied by their competitors. Rather, research would be focused on reducing costs to manufacture current drugs, because those techniques, if kept secret, produce a competitive advantage. New businesses are a non-starter as no matter how good their new drug is, the established players will be able to duplicate it and stop any new entrant from gaining momentum.

    4. Re:Profits are important to allocate resources by mi · · Score: 2

      The patent holder can and often does prevent others from using that invention

      Sure. Which simply means, you have to offer more — money and/or access to your own inventions.

      There is no requirement for them to accept

      Of course, there is not! How could there be? I'm not obligated to sell my bike to you either. But I may consider doing so, if your offer is sufficiently compelling.

      --
      In Soviet Washington the swamp drains you.
    5. Re:Profits are important to allocate resources by king+neckbeard · · Score: 1

      Actually, patents usually lead to far greater consolidation of the industry. The generic market doesn't have the same kind of high margins as a patented drug.

      --
      This is my signature. There are many like it, but this one is mine.
    6. Re:Profits are important to allocate resources by businessnerd · · Score: 2

      Which is why patents need clear duration limitations...

      And they do. It's 20 years from the date of filing. But you must also keep in mind that the pharmaceutical industry is a highly regulated and that the clock is ticking on your patent before you receive FDA approval to actually sell it. It can take between 8-12 years from the time you file your patent to when you can market your drug. That means that you may only have an 8 year window to recoup all of your R&D costs on that one product (and all of the the ones that failed) and turn a profit. That is why proprietary drugs can be so expensive (supply/demand and many other factors of course also comes into play). Once you hit the "patent cliff", then the generics will pounce, and begin producing and selling your product for less than it costs you to make. You have some options, though. You could compete with the generics. This is a tough one. While most will for a while, their market share will quickly erode due to the cost disadvantage until they pull out of the market altogether. But even though you have pulled out, you still need to "support" the product including any legal liability, even if the patient took the generic version. Pfizer is one of the few with the manufacturing capability (and ability to absorb losses) to actually compete on price with generics, and it was pretty groundbreaking when they did for Lipitor. You could try to get over the counter approval, but this is only an option for products that meet certain criteria and the costs to get the approval might not make sense. You will need to revise your product labels (packaging + the instructions that come with it) and get them approved (more painful than you might think) and also prove that a patient can safely self-diagnose and self-administer the product. Then there is the more controversial option, which is to request an extension of your patent or exclusivity. There are a lot of ways to extend exclusivity (which is distinct from patent), but I won't get into all of that here. For patent extension, typically a company will re-formulate the product in some way. It could be a change in dosage, it could be a new delivery system (injection -> tablets) or an "extended release" version. There is a valid argument to be made that these are simply stall tactics to milk the patent system for longer patent protection (and more profits), but they do have to be a legitimate improvement/benefit for the patient, so it does encourage some level of innovation, even if some feel it is not much.

      So what I'm saying here is, patents are vital to pharmaceutical companies being able to actually make a profit on all of their hard work and there ARE limits on how long they can. Without the patent protection, I can see 2 scenarios: you could have "0 day generics", where the generic is available so quickly after a drug gets approval that the company that did all of the work of the work of identifying the compound, putting it through 3 phases of clinical trials and all of the other work necessary to gain FDA approval would be screwed. Or you would have companies treating the products as trade secrets, which would be difficult in the first place given the need for FDA approval, and likely mean no generics (and higher prices). Also, those discoveries would not be shared with the rest of the world, making it more difficult for competitors to improve upon or leverage the knowledge for something completely new.

      --
      "It's not whether you win or lose, it's how drunk you get." -- H. J. Simpson
    7. Re:Profits are important to allocate resources by GLMDesigns · · Score: 1

      Obscene profits?

      Then I suppose you are buying stocks in big pharma as then you would be getting a share of these obscene profits and would then be able to distribute your gains as you want.

      If you're not invested in big pharma then you're full of sh*t. You would grow rich, be able to influence the future direction of the companies you're invested in, and you would be able to help others.

      --
      If you're scared of your govt then you need to further restrict its powers
      Vote 3rd Party in 2016 and beyond
    8. Re:Profits are important to allocate resources by losfromla · · Score: 1

      Once you hit the "patent cliff", then the generics will pounce, and begin producing and selling your product for less than it costs you to make.

      So you are saying that generic manufacturers are better at manufacturing than the patent holders? Is that because patent holders don't care about setting up an efficient system like the generics do? Really, the generics can sell (presumably making some profit as they are a business) at less than it costs for the patent holders to manufacture? Or is it because they are seeking unreasonable profits and are unwilling to compete on quality of product alone once a generic comes along that can do things better and cheaper than they can?

      You also forgot to mention how in the US much of the early research is borne by the government (read taxpayers) and the pharmaceutical giants come in and take what we paid for, build on it and then sell it to us at extortionate prices.

      --
      Only I can judge you.
    9. Re:Profits are important to allocate resources by pepty · · Score: 1

      How would the market reward quicker smaller innovations in drug development? You don't know if it is a viable treatment or not until you finish phase III clinical trials. There's no revenue until after phase III clinical trials.

    10. Re:Profits are important to allocate resources by pepty · · Score: 2
      Year in, year out, about 25% of drugs are invented by academic labs (read taxpayers). The rest are invented by industry. Industry is also the source of the majority of funds spent on drug research. I think they are actually the source of the majority of life science funding in the US these days (Republican congresses haven't been too interested in increasing NIH funding for a while now).

      As to unreasonable profits: What rate of return would convince you to put your money in an investment if you knew it was going to be 10 years before you received the first dollar back - and there was a 90%+ chance of failure to boot?

    11. Re:Profits are important to allocate resources by trout007 · · Score: 1

      I was talking about a free market where drug developers and patients were free to deal with each other without regulation. In such a case if patients would normally try more established drugs first and if they did not get results they would work through newer and potentially more risky drugs as they determined by their own risk tolerance. No reason someone couldn't pay for drugs undergoing early development.

      Also the effect of drugs is very individual. If you tried to get peanut butter through clinical trials you would most likely not notice some people are deathly allergic until larger late trials.

      --
      I love Jesus, except for his foreign policy.
    12. Re:Profits are important to allocate resources by david_thornley · · Score: 1

      I'd assume the stock market had already adjusted pharma stocks for expected obscene profits. If you can buy into an operation that virtually prints money, it's going to cost you big-time. I can have a miniscule stake in a really profitable industry or a larger stake in a less profitable industry for the same price.

      --
      "When you have eliminated the unacceptable, whatever is left, however improbable, must be the truthiness" - Holmes
    13. Re:Profits are important to allocate resources by losfromla · · Score: 1

      It isn't that drugs are invented by academics/taxpayers, it is that they carry out the fundamental research that makes possible the "inventions" by the drug companies. The fundamental research is a huge part of the labor and cost and it is being borne by the taxpayer. As the AC below implies, a tremendous amount of the cost incurred by big pharma is in sales, marketing, lobbying and legal, and some with the trials to bring a drug to "market".
      So if you would be so kind, address that point as well as the other points regarding drugs being able to be sold by the generics companies for cheaper than the brand namers can even _manufacture_ them. What is wrong with the production process at the brand name companies that they cost so much more to make?

      --
      Only I can judge you.
    14. Re:Profits are important to allocate resources by jc42 · · Score: 1

      What rate of return would convince you to put your money in an investment if you knew it was going to be 10 years before you received the first dollar back - and there was a 90%+ chance of failure to boot?

      Funny thing; those numbers were used back in the 1980s, with interesting results. The topic wasn't drugs, though, but rather solid-state manufacturing, and very similar numbers were widely quoted in east Asia. At the time, it was generally estimated that to build a new solid-state facility would require several billion dollars, and would take around a decade to become profitable, due to the extreme difficulty of achieving the required low level of contaminants inside the equipment. Much of the decade would be spent making test runs, discovering that the output was useless because of some trace contaminant in one part of the process, and redesigning the setup to get past yet another failure. Success wasn't predictable; the 10-year estimate was just the minimum.

      But people in east Asia (mostly Japan and Korea) argued publicly that the American companies that controlled most of the production at the time wouldn't be able to get funding for new factories, because American investors would refuse to invest so much money in something with no payoff for a decade. If Asian investors would step in and support the effort, in 10 years they could own the world's solid-state industry. Enough people with money (including government agencies) listened, made the gamble, and a decade longer, they owned the industry.

      It's probably just a matter of time before the American drug industry goes the same way. Would you invest in something with no payoff for a decade or more, and wasn't even guaranteed to pay off then because nobody had yet created the drugs that might be created? If you guess that few US (or EU) investors will do this, you're likely right.

      In particular, the Republican US Congress is highly likely to continue its defunding of academic basic research, partly due to mistrust of investments that won't pay off during their current terms in office, and also due to a serious religion-based dislike of the biological sciences in general. Without the basic research, the only "new" drugs patented by industry will continue to be mostly small tweaks of existing drugs, which under US law qualify as new, patentable products.

      Of course, this is all a bunch of tenuous guesses, based on past behavior of the players. That's what investment is usually like. It's entirely possible that they'll wise up, and not abandon the drug industry the way they abandoned the electronics industry. The US does actually have a few solid-state production facilities, after all, though they're now a small part of the market.

      But, as the above poster said, would you be willing to gamble your investment money on the hope that US private drug makers will support the research that the US government is getting out of? Remember that, to corporate management, scientific research appears to have a record of 90% failure; i.e., 90% of funded research projects fail to produce a patentable and marketable product. This is the nature of research, which only discovers facts and theories, not products, and where the outcome of a study is unpredictable before the fact. (If it were predictable, it wouldn't be called "research", it'd be "development". ;-)

      --
      Those who do study history are doomed to stand helplessly by while everyone else repeats it.
    15. Re:Profits are important to allocate resources by pepty · · Score: 1

      About 18% I think, much higher than pretty much any other industry outside of semiconductors. "Big Innovators" like Apple spend about 2% on R%D.

    16. Re:Profits are important to allocate resources by pepty · · Score: 1
      I'm not quite sure what your point is. Most industries spend more on revenue on marketing and overhead as a percentage of revenue than Pharma.

      What is wrong with the production process at the brand name companies that they cost so much more to make?

      Could you give some specifics? The specifics I can think of are that offshore generic drug factories in 3rd world countries were historically not inspected very often or very thoroughly by the FDA. So they faked quality control and shipped a lot of garbage. Hence the $500M fine for selling adulterated statins that Ranbaxy caught.

    17. Re:Profits are important to allocate resources by pepty · · Score: 1

      Remember that, to corporate management, scientific research appears to have a record of 90% failure; i.e., 90% of funded research projects fail to produce a patentable and marketable product.

      Oh, they're pretty much 100% successful at creating patents. The patents get filed before the clinical trials even get started, for the most part. It's the "safe and effective" hurdles that trip everyone up.

    18. Re:Profits are important to allocate resources by pepty · · Score: 1

      No reason someone couldn't pay for drugs undergoing early development.

      Have to disagree with you there. Here are a couple:

      1. Which drugs are "newer and potentially more risky" and which are just straight up snake oil? Should both be allowed on the market, caveat emptor? How do you tell the two apart?

      2. If you own a new potential drug, why even bother finishing clinical trials? You're much better off doing small trials on random molecules until one looks "promising" and then putting it up for sale. So long as you don't do more research (which would just prove that your promising drug is actually crap), you can just keep on selling it.

      3. If you need a new drug, would you buy a "promising" drug or participate in a clinical trial where there's a 50% chance you will end up in the placebo wing? Would you maybe decide to do both and just not tell the folks running the trial about the other drug you are taking, thus messing up the trial? A lot of drug development efforts stall because they cannot enroll enough patients. This is especially true for cancer drugs.

      Basically it boils down to this: Imagine there are 10 new drug candidates for a particular cancer that have made it through Ph 1 clinical trials. 1 of them is actually a drug worth taking, the rest would prove to be failures if they are tested sufficiently. If you let people sell unproven drugs then 10 years from now all 10 will still be on the market. 10% of the people will be getting the best drug available, 90% will be getting prescribed the failures. The little dribs and drabs of data that come back about the prescriptions won't be statistically powerful enough to figure out which drug is the good one.

    19. Re:Profits are important to allocate resources by trout007 · · Score: 1

      The market is very good at sorting these things out. Plenty of people buy snake oil. Look at the vitamin/supplement market. Most of that is unproven but people take it anyway. If you have a new drug the reason you will still do trials is because of marketing. Companies send their stuff to UL for testing so they can get the UL Label. You can still have the FDA running trails but instead of banning sales of drugs they just give their seal of approval.

      If you are risk adverse you may just stay will older more well proven drugs. If you accept risk or are desperate enough you may try more unproven ones.

      --
      I love Jesus, except for his foreign policy.
    20. Re:Profits are important to allocate resources by pepty · · Score: 1
      No, the market is horrible at working things like this out. Even giant health insurance companies generally would not have access to the data they would need to separate the wheat from the chaff. And yes, look at the vitamin market. Lots of folks taking vitamins: most aren't receiving any benefit from them. But hey, if you market them, people will buy them. UL testing, in comparison to drug testing, is child's play, super cheap, and super fast. The equivalent would be sending a drug candidate to a lab that returns a result of "hey, we looked at this for a few weeks. It didn't kill any more mice than we expected it to. Go sell your new UL approved drug". Figuring out if a new chemical entity is a useful new drug, a drug that is inferior to other treatments on the market, or a drug that does more harm than good generally takes several years and several hundred million dollars. And since the end result is almost always "No, this is not a good drug", you would actually be better off spending the money on marketing it than on continued testing. Hence the supplement industry. Why bother to prove something works if you are already allowed to sell it?

      If you think pharma is asinine now, imagine what it would be like if they could just sell whatever they want.

  5. No cures? by Anonymous Coward · · Score: 3, Insightful

    Drug companies have no intrrest in researching cures.

    Drug companies are for-profit. While there is obviously immense profit in providing treatment for maladies, there is a very limited profit available in cures.

    Thus, drug companies do not have any intention of curing anything. It would be bad for business, you see.

    Care to explain the several recent drugs that cure Hepatitis C? http://www.webmd.com/hepatitis/features/cure

    Produced by for-profit drug companies. Kind of puts a hole in your "big pharma is da ebil" idea...

  6. Re:Foldit by methano · · Score: 2

    Man! I want some of what you're smoking.

    Foldit is a series of programs that work with human intervention and lots of distributed computing to try to help solve the problem of protein folding. That's going from a primary sequence (which you can get from the human genome project) to a tertiary structure, ie how it folds. If you figure out how to do that with great confidence, then you have a protein target to use to design drugs. But there are already tons of x-ray structures of proteins that are real available today to anyone who can hit this link (http://www.rcsb.org/). And they're more useful than a calculated structure and there are a lot of druggable targets in there to work on.

    So, Citizen Scientists, quit waiting around for Foldit and get to work.

  7. Cynical writers by gurps_npc · · Score: 1
    Look, the people 'exploiting' these rare mutations are learning about them.

    I absolutely guarantee you that no one will ever cure those medical conditions WITHOUT learning about them. Also, I guarantee you that if they come across a cure, they will make it.

    These are not evil companies/doctors heartlessly exploiting sick people. Instead, they are wise corporations and doctors investigating a medical condition, hoping to both make some money AND also cure the condition. If they can only do one, they will - regardless of which one it is.

    --
    excitingthingstodo.blogspot.com
  8. Suffering of a few vs. suffering of a billion by Koreantoast · · Score: 1

    It's an unfortunate situation for those with the rare conditions; there's a lot more potential profit in finding a way to genetically prevent pain for billions of people than it is to cure the handful with the condition.

    This one line in the opening comment rubbed me the wrong way, that some how, the pain and suffering of those billions of people is less important than the handful ill with a rare condition. It's not just crassly about profits, but it's a real ethical dilemma - maybe for the greater good, greatest bang for your research buck, focusing on those billions is a greater benefit to humanity than the small handful with an extremely rare condition. I hate making this statement because I don't want to downplay the severe suffering of those with rare genetic disorders, but I feel the issue is more nuanced than the hand waving the original post does on the trade off.

  9. Obvious, in hindsight... by rhazz · · Score: 1

    Seems rather obvious now that they point it out!

    Subject A: my bones grow too much!
    Subject B: my bones don't grow enough!
    Researchers: Hmm, I wonder if we can find out what causes A and apply it to B?

  10. At what cost by PeterM+from+Berkeley · · Score: 1

    Have you seen the PRICES for these medicines? They can dwarf the costs for MANAGING the disease for 10 years more or less, depending on the severity of the case. I.e., you break even on paying for the cure after saving 10 years of treatment cost.

    This price is so steep that states, for fear of going bankrupt, are refusing to pay for the cure from these "big pharma" companies.

    Pricing for these drugs were based by the companies figuring out not how much they should sell it for to recoup their costs and make a reasonable profit, but by how much they thought they could/should get.

    Personally, I think all drugs ought to be developed with public research dollars. There's less incentive to work on PROFITABLE drugs and work on IMPORTANT drugs. (Think cures for cancer instead of Viagra.) There's less incentive to falsify the result of drug trials so that you can get FDA approval and be able to sell the drugs, whether or not they are harmful and whether or not they actually work. And, when a really cool drug is developed, such as the cure for HepC, EVERYONE gets it immediately, and Hepatitis C is eradicated or nearly eradicated.

    --PeterM

    1. Re:At what cost by pepty · · Score: 1

      There's less incentive to work on PROFITABLE drugs and work on IMPORTANT drugs. (Think cures for cancer instead of Viagra.)

      And that's what Pharmas spend the most R&D money on: oncology drugs. After that it's CNS (neurodegenerative diseases like Alzheimers), and then cardiovascular. Which is what viagra was originally being developed for: cardiovascular problems like angina and hypertension.

    2. Re:At what cost by glwtta · · Score: 1

      not how much they should sell it for to recoup their costs and make a reasonable profit, but by how much they thought they could/should get

      That's literally the definition of capitalism. You know, that thing our entire way of life is based on.

      Personally, I think all drugs ought to be developed with public research dollars.

      Awesome! Please enclose your plan to increase NIH funding five-fold. Oh, and I guess also your plan to legally prevent private companies from investing in medical research... because apparently that's how our socialist planned economy works.

      There's less incentive to work on PROFITABLE drugs and work on IMPORTANT drugs.(Think cures for cancer instead of Viagra.)

      Can you name one other $1B+/year drug that you deem to be "unimportant"? Do you honestly think that a cure for any moderately common cancer wouldn't be stupendously profitable?

      There's less incentive to falsify the result of drug trials so that you can get FDA approval and be able to sell the drugs

      How many drugs can you name that were brought to market based on falsified results?

      And, when a really cool drug is developed, such as the cure for HepC, EVERYONE gets it immediately, and Hepatitis C is eradicated or nearly eradicated.

      As it stands, this will happen in the late 2020s when sofosbuvir goes off patent. Currently, it is licensed for generic manufacture in 90 developing countries, covering a patient population of 100 million.

      That's 100 million people that would be shit out of luck in your magical world of wishful thinking and unicorn farts.

      --
      sic transit gloria mundi
    3. Re:At what cost by PeterM+from+Berkeley · · Score: 1

      >>not how much they should sell it for to recoup their costs and make a reasonable profit, but by how much they thought they could/should get

      >That's literally the definition of capitalism. You know, that thing our entire way of life is based on.

      Maybe YOUR life, but not everyone's. Ever heard of "gouging"? That's where you have gained, through conniving, honest effort, or circumstance, control of something that other people need to live and you charge a very high price for it. Like water post-earthquake. A "good" capitalist would sell water for $100/bottle or more and make a very tidy profit off the desperately thirsty. Fortunately, many people are also guided by morality and would limit their mark-ups on vital commodities like this post-disaster, either taking a loss, selling the commodity at cost, or selling with a reasonable profit like 10%, EVEN THOUGH THEY HAVE PEOPLE OVER A BARREL. I'd much prefer capitalism tempered by some humanity and morality, thank you very much, than the pure psychotic ideal.

      I would not have any complaint at all with the drug company if they had set their prices based on "this is our development cost for the drug, these are our costs for developing failed drugs, +30% profit margin." Not "let's extract as much money as we can from the people we have over a barrel."

      >As it stands, this will happen in the late 2020s when sofosbuvir goes off patent. Currently, it is licensed for generic manufacture in 90 developing countries, covering a patient population of 100 million.

      In late 2020's instead of RIGHT NOW. D'you realize how much human misery that delay means? Is that really a good route to take, so that a company and their shareholders can make 1000% profit rather than 30%? If they truly did base their price based on recovery of costs and a reasonable profit, then I apologize to the company, however, they magically dropped their prices by huge fractions when the PR hit the fan, which I doubt they'd be willing to do if they were losing money off the new dramatically lowered (yet still very high) prices.

      >Currently, it is licensed for generic manufacture in 90 developing countries, covering a patient population of 100 million.

      How VERY KIND it is for that company to lower the price to affordability for foreigners while screwing over their own countrymen by charging rates here that challenge even the deepest US pockets. How truly admirable. I mean, wow, this might actually mean that someone in Africa gets the drug that people in America can't afford because their insurance won't cover it, because of the high cost here! I'm sure their decision to lower the prices for foreigners was driven by the realization that they wouldn't get paid their US asking price in most of the world because it couldn't possibly be afforded.

      As for raising the NIH budget from $30B to $150B, how about we don't indulge in pre-emptive wars of choice, and take the $2T or more saved and apply a small fraction of that to the NIH? Oh right, that money's already gone. How about the IRS collects more of the tax legitimately owed the Government but not paid? That's $400B right there. Done! NIH budged quintupled! (and $280B more available to say, pay down debt.)

      http://www.irs.gov/uac/The-Tax...

      --PM

    4. Re:At what cost by david_thornley · · Score: 1

      I assume the drug company is setting the prices for maximum profit. This puts a lid on them, because if the price is too high people won't pay it anyway. This suggests that a large number of people are getting the drug, particularly with generic licensing in developing nations.

      And, yes, the US health care system is really screwed up.

      --
      "When you have eliminated the unacceptable, whatever is left, however improbable, must be the truthiness" - Holmes
    5. Re:At what cost by glwtta · · Score: 1

      "this is our development cost for the drug, these are our costs for developing failed drugs, +30% profit margin."

      That's not how for-profit companies work. Literally not a single company in the world operates that way.

      Who is it, that you think will invest $2.5B into something that will take a decade and will almost certainly fail, on the promise of a 30% profit?

      How VERY KIND it is for that company to lower the price to affordability for foreigners while screwing over their own countrymen by charging rates here that challenge even the deepest US pockets.

      Yes, how truly awful for the US to contribute something positive to the rest of the world, for once.

      In late 2020's instead of RIGHT NOW. D'you realize how much human misery that delay means?

      Do you realize that that misery exists independently of Gilead, and they're the only ones to have done anything about it? They pulled together an insane amount of money and effort (and luck) and made a huge impact on that misery now and will likely help eradicate it in a few years. A single cured person is a positive change.

      You, on the other hand, have opinions about what they should be "allowed" to charge, because you can imagine some ideal society where all of this is magically taken care of by state money.

      In short: I know plenty of scientists who would be willing to work for nothing more than the betterment of society, but I don't know any investors who would contribute billions of dollars for the same goal.

      --
      sic transit gloria mundi
    6. Re:At what cost by PeterM+from+Berkeley · · Score: 1

      >Who is it, that you think will invest $2.5B into >something that will take a decade and will almost >certainly fail, on the promise of a 30% profit?

      I said, "this is our cost for developing THIS drug, these are our costs for developing FAILED drugs, add 30%". The failures are built into the price I proposed, actually. Let's be more specific about the 30% profit--how about a 30% profit per year capital was tied up? In most sectors of the economy 30% profit is pretty handsome. I don't mind them profiting reasonably from their labors, even if they are profiting from the suffering. What bothers me is them saying to, well, Americans specifically, "this drug is worth half your income potential for the rest of your life. Pay up or suffer."

      As for "you have opinions about what they should be allowed to charge", no, that's not what I think. They developed the drug, by law, it's theirs and they can charge what they want for it. I was arguing that the drug should have been the result of public investment and then made available at cost to everyone who needs it, not at the maximum that can be extracted from suffering people.

      I was also arguing that extracting money from suffering people according to the maximum that can be gouged rather than according to cost + reasonable profit is pretty awful and should not be done. Corporations are actually allowed to have some ethics instead of being profit maximizing predatory price gougers profiting on human suffering.

      I was also arguing that for a company to charge Americans lots of money for the drug so that it is practically out of reach for most, while being willing to cut deals for non-Americans is also pretty awful.

      Consider this scenario: there's a natural disaster, water infrastructure is broken, and I have big supply of bottled water that cost me $1.00 each. There are lots of thirsty-to-death people around for me to sell to.

      From an arbitrary set of people, namely, those who think it is OK for corporations to charge whatever they want of suffering people in need (I'll call these people "market religionists", I charge them 10% of the rest of their lifetime earnings, and consider myself generous, because I could have demanded more. From everyone else, I charge $1.30 each. And I'm totally indifferent to the suffering of the market religionists as they agonize in thirst.

      I mean, charging Americans a lot more than everyone else is actually more arbitrary than charging market religionists a lot more than everyone else--I'm actually treating market religionists according to their own system of ethics, right?

      Last, there ARE other drugs and treatments for hepatitis C. It's not like the rest of the world wasn't doing anything for these people until Gilead (actually it wasn't Gilead but a company that Gilead bought) came along.

      It's just that the other treatments are not as good--there's even another cure, it's just not as good.

      As such, I think Gilead's initial pricing strategy was pretty stupid. They should have charged a low enough price that EVERYONE who has HepC got on the drug, not just the few that the insurance companies and states have decided are so badly off that they are triaged into being given the drug.

      --PM

  11. Brakes are useful by manu0601 · · Score: 1

    Considering most tissues have limits on how much they can renew, removing the genetic brakes may be a bad idea: it could quickly exhaust the body part ability to regenerate, or lead to cancer. After all, programmed cellular death is the ultimate protection against cancer.

  12. I don't see it by tsotha · · Score: 1

    It's an unfortunate situation for those with the rare conditions; there's a lot more potential profit in finding a way to genetically prevent pain for billions of people than it is to cure the handful with the condition.

    Oh? How are these people harmed by the development of drugs for other people?