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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.

15 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 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.
    3. 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.

    4. 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.

    5. 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.

    6. 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.

  2. 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 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.

    3. 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.
    4. 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
    5. 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?

  3. 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...

  4. 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.