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medical ethics?
Human growth hormone has successfully been cloned and it now commercially synthesized. early clinical trials showed that growth hormone deficient individuals have an allergic reaction to it. someone has achondroplasia, a type of genetic dwarfing condition, so his endocrinologist began him on growth hormone therapy. after two weeks he had severe allergic reaction called anaphylaxis. subsequently, growth hormone deficient treatments were discontinued because the hormone has no affect on intrinsic skeletal abnormalities (dwarfing conditions) 1.who is responsible for correct use of a new drug? the company the physician the parent or the individual 2. who is responsible for adverse reactions? 3. should parents/patients be required to sign consent forms that describe complications of treatment? should they be able to sue when a drug is used inappropriately and result in a severe side effect and possible long term complications? 4.do you think that financial reimbursement compensates for adverse side effects? does our society depend too heavily on monetary gain to heal all wounds? 5 what is the psychological effects of being told that a drug is available to help short statured individuals grow and then doesn't work in the clinical trial because it is ineffective for this specific disorder? do you think this has a serious long term psycological implication especially since short stature is so devalued in our society ?why is short stature devalued? can you list what we valuse in our society and why? decide what their true worth is by defining a number value system
Public Comments
- To have the FDA approve a new drug there have to be clinical trials run, which are paid for by the manufacturer of the drug being tested. To participate in these trials one has to meet strict guidelines, as well as sign alot of paperwork stating you can't and won't hold the drug company responsible for any side effects. For this they usually pay descent money for people to participate in these studies.
- in the example you offer--the problem is society's reaction to the 'affected' individual the physician who offered a treatment that would not 'solve the problem' ( hormone no affect abnormalities) could be negligent of course achondroplasia (a symptom) can be caused by a variety of mutations and without expensive genetic testing he would not know if the growth hormone would ameliorate the 'problem' all benefits have an associated risk--old saying is 'the infinitely safe bridge costs infinite money (resources) the 'hitch hiker's guide to the universe' offers some interesting scenarios involving telephone hand set sterilizers if you are approaching ethics from a legal perspective- note that the only ethics there is 'if u can get away with it' legal ethics are a myth FDA these days has few ethics-just the veneer-they adopt the principle in the paragraph above hope this makes you think sceptically read 'the selfish gene' by dawkins for a good perspective on the roots of human thoughts feelings strategies and tactics--the last chapter offers hope
- It isn't completely clear, but you seem to be asking about a clinical trial. Anaphylaxis is certain to occur in some individuals, and nobody would ever consider promising the drug would have the desired effect. If, on the other hand, the drug is known to be ineffective and is prescribed anyway, then liability would depend on whether the patient (or the parent of a child) knew that and gave informed consent. Drugs released to the market are somewhat complicated. The company, of course, has to produce a good product, and it's criminal, unethical and downright foolish of them to suppress negative information, since eventually the chickens will always come home to roost. They don't, however, have any control over the drug's use, and doctors are perfectly free to use them for off-label indications. Indeed, not to do so would breach standards of care and potentially be malpractice in many cases. All drugs have adverse reactions, too, and there's really no "responsibility" for them. If you choose to prescribe or take a drug, you have to do so knowing there's the potential for harm. Forms are signed for drugs in study, but it would be ridiculously burdonsome to require reams of disclaimers for each and every treatment. And it is a shame that money plays such an important role, but how else to keep count?
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