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Patient requests an untested medical operation

  1. Mar 7, 2016 #1
    (I know this is a little farfetched but please just explains the logistics of how he'd go about doing this)
    .
    Imagine a key medical researcher discovers he has a terminal lung cancer.
    He knows the operation and treatments necessary to save himself because he's a genius and an expert in the field of lung cancer. (I know it's far fetched - please just ignore that and imagine it was true).

    However the treatments haven't been legally approved (will take at least 5 years and by this time he'll probably be dead or have other cancers) and he'd need a team of physicians/doctors to perform it.
    SIDE NOTE: the treatment doesn't involve anyone but him (the only illegal thing is that he's doing an officially untested medical procedure).

    How would he go about getting this operation done (either legally or illegally)?
    Are there other countries that would perform it (such as countries were euthanasia is legal anyway)?
    Could he volunteer himself to test out the operation or would this be illegal?
     
  2. jcsd
  3. Mar 7, 2016 #2

    Ryan_m_b

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    I believe what you are getting at is referred to as expanded access by the US FDA (other nations have equivalents)
    http://www.fda.gov/ForPatients/Other/ExpandedAccess/ucm20041768.htm

    Under epanded access a patient may be given experimental or non-FDA approved treatments as a last resort. It's not a free for all though. It's regulated and still requires other doctors/agencies to consent to it.
     
  4. Mar 7, 2016 #3
    Very interesting, thank you!
    If other agencies said no (due to lack of knowledge on the effects of the treatment) could the patient and doctor collectively overrule this?

    Also for the purposes of the question, assume the patient was willing to fund the treatment himself.
     
  5. Mar 7, 2016 #4

    berkeman

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    Can you say a bit about why you are asking this question?
     
  6. Mar 8, 2016 #5

    Choppy

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    In my experience, procedures that are not approved by the regulatory agency (FDA in the US) can be performed, but are done so as a clinical trial.

    Generally speaking, in order to conduct a clinical trial, you need ethical approval. This is granted by a health ethics board. The details vary by location, but generally the procedure needs to be described in detail and reviewed by experts and a protocol is established by which the trial will be conducted. This process can take months or in some cases even years. In addition, the people accrued to the trial need to grant informed consent to the procedure - meaning that they have to be of sound enough mind that they are capable of understanding the implications of their decision, they have to be given an adequate amount of information to make an informed decision, and they cannot be coerced into the decision to proceed.

    EDIT: I think Ryan_m_b's post probably gives a better response.
     
  7. Mar 8, 2016 #6

    berkeman

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    But if it were a clinical trial, the patient could get the placebo version...? That would be ironic.
     
  8. Mar 8, 2016 #7

    Choppy

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    :biggrin:

    Depends on the way the trial is set up, I suppose.
     
  9. Mar 9, 2016 #8
    Would you happen to know if something such as an "Ebola Drug" fall under such a criteria?
    Clinical trials in the field so to speak, for its effectiveness as a cure.
    "Proper" clinical trails would probably be only able to determine such things as toxicity vs dosage for example in Ebola free patients.
    Interesting thread.
     
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