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Thread: Why does it take them so long?

  1. #1 Why does it take them so long? 
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    When scientists create something new (like finding out how to grow limbs, or a new medicine that will help a huge disease) and they test it on rats or frogs or rabbits and it works, why cant they then use it on humans straight away? If it works then why do they have to take 20 years before they use it on people?


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  3. #2  
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    Hi Z3,

    The short answer is that rabbits, rats and frogs aren't humans. Whilst, for example, mus musculus is arguably the best model that we have available in terms of mammalian biology - short of experimenting on humans - still, there are sometimes glaring differences in physiology between such model organisms and humans. This is why so much time and effort is invested in confirming in vitro findings in vivo and subsequently conducting clinical trials. Arguably, the efficiency with which basic biological findings are translated into clinically useful bedside therapeutic agents needs to be improved. It's a balance between getting novel therapies onto the market pronto and ensuring that the product is not detrimental to human health. It's no good rushing a product onto the market if it injures, harms or kills those whom use it. That's why the whole process takes so long.

    Best wishes,

    Tri


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  4. #3  
    Universal Mind John Galt's Avatar
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    It tends not to get reported that even well researched and tested drugs, once they are used widely, will show up side-effects on particular persons in particular situations. And some of those people die. Thousands of people each year likely die as a consequence of the medication they are taking. The medical profession prefers not to talk much about this for the very solid reason that the layperson would tend to ignore the millions who remain alive because of those same drugs. Taking time to anticipate and identify problems is the best compromise we can currently make.
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  5. #4  
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    Don't forget the legal reasons. Introduce a drug, even a life saving drug, too soon so that unforeseen side effects arise, and the drug company will get sued for hundreds of millions of dollars.
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  6. #5  
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    Quote Originally Posted by tridimity View Post
    The short answer is that rabbits, rats and frogs aren't humans. Whilst, for example, mus musculus is arguably the best model that we have available in terms of mammalian biology - short of experimenting on humans - still, there are sometimes glaring differences in physiology between such model organisms and humans.
    remember the case in 2006 of TGN1412, where the tentative opinion of the enquiry was that "the problems resulted from unforeseen biological action in humans"
    "Reality is that which, when you stop believing in it, doesn't go away." (Philip K. Dick)
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  7. #6  
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    No, I don't recall hearing about this at the time. This is a truly tragic and horrific case. It seems that there is no way of going from animal model to human scenario that is 100% safe. There will always be a margin of doubt - if there wan't, there would be no need for clinical trials. Thinking about the types of people whom participate in such trials is worrying. In the case of those with degenerative or life-threatening illness, they may have more to gain than to lose from the trial, so the risk is worth it. However it is worrying if vulnerable people participate whom are healthy and have not or are unable to properly weigh up the associated risks. E.g. those motivated by financial desperation.

    Tri
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  8. #7  
    Forum Junior TheDr.Spo's Avatar
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    Tridimity,

    I am not well versed on the ways of drug trails, but I am thrown off by your scenario of a healthy person entering a drug trial for a specific disease. This would make sense if the drug is preventative but only to the extent that the healthy person is at risk toward developing the disease in question. Would the drug be tested on healthy individuals to account for effects in the event of misdiagnosis? This question comes from the logic that a drug target toward an existing disease in the patient would only be used on afflicted individuals and not those deemed healthy at the time.
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  9. #8  
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    Quote Originally Posted by TheDr.Spo View Post
    Tridimity,

    I am not well versed on the ways of drug trails, but I am thrown off by your scenario of a healthy person entering a drug trial for a specific disease. This would make sense if the drug is preventative but only to the extent that the healthy person is at risk toward developing the disease in question. Would the drug be tested on healthy individuals to account for effects in the event of misdiagnosis? This question comes from the logic that a drug target toward an existing disease in the patient would only be used on afflicted individuals and not those deemed healthy at the time.
    Hi Spo,

    I don't know the scope of risk that healthy volunteers would typically be exposed to in terms of testing for disease-specific therapies, but there are certainly ample recruitment advertisements out there offering lucrative monetary incentives, e.g:

    http://www.quintilesclinicaltrials.co.uk/upcoming-trials/students-unemployed-or-part-time-workers-needed/

    T
    he only assurances we have are that the medicines have undergone 'extensive lab testing'

    Best wishes,

    Tri~
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  10. #9  
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    Quote Originally Posted by tridimity View Post
    The only assurances we have are that the medicines have undergone 'extensive lab testing'

    Best wishes,

    Tri~
    oh, that would make me, the guinea pig feel MUCh safer
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  11. #10  
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    And the good news is MeteorWayne, you will be the next n number!
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  12. #11  
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    Quote Originally Posted by TheDr.Spo View Post
    I am not well versed on the ways of drug trails, but I am thrown off by your scenario of a healthy person entering a drug trial for a specific disease. This would make sense if the drug is preventative but only to the extent that the healthy person is at risk toward developing the disease in question. Would the drug be tested on healthy individuals to account for effects in the event of misdiagnosis? This question comes from the logic that a drug target toward an existing disease in the patient would only be used on afflicted individuals and not those deemed healthy at the time.
    After animal trials, these trials involving healthy humans comes next. They are to test for toxicity and sides effects. Healthy subjects are used to ensure that they can endure any foreseeable adverse reaction from the medication, and to prevent any adverse interaction with a disease or condition humans might have (for example, if it increases blood pressure, you don't want to use someone already with high blood pressure).

    The healthy human subjects are extensively screened to ensure that they have no pre-existing condition that might prove ruinous to them or the test results.

    Then the medication is administered at ridiculously low concentrations (based on animal testing) to ensure that human subjects don't suffer adverse effects, death, etc. Then the dosage is carefully ramped up toward what they think would be the therapeutic range. The human subjects are monitored very carefully.

    Then the data is crunched and analyzed and reported to the FDA who must be satisfied as to the drug's safety at therapeutic levels before the drug maker can move onto the next phase of testing on a small, select group of people with the disease/condition in question.

    Why would healthy people subject themselves to such testing? Aside from purely humanitarian reasons (the same as why healthy people donate blood), they might have a friend or relative suffering from the disease/condition, or they might have an interest in the advancement of medicine.
    Grief is the price we pay for love. (CM Parkes) Our postillion has been struck by lightning. (Unknown) War is always the choice of the chosen who will not have to fight. (Bono) The years tell much what the days never knew. (RW Emerson) Reality is not always probable, or likely. (JL Borges)
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  13. #12  
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    The current system with all the checks and balences and animal and human trials taking years of time still lets some medications go to general distribution that turn out not to be safe. In my 40 year career in healthcare I can recall two medications that had to be pulled from the market after a year or so because they had a side effect of sudden death! The incidence was very low so it did not show up in the testing stages. But when a product is on the market and millions of people are taking it, things show up that are not evident with a smaller sample. Both the meds in question were non narcotic oral pain relievers. I remember using one to control post operative pain in patients under my care and the other I actually took myself. They were wonderfully effective, if they did not kill you.
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