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When giving thought of doing a clinical trial of a new drug on any child many questions first need to be asked. Will this drug truly help the patient enough were the damage done will be out weighed by the prospects of the new drug? Also what kind of harm will really happen to the patients put on this drug? And knowing that there maybe a potential for harm to these patients should you take them off of their current treatment, causing harm to them, to give them a placebo?
Many of these questions can be answered quite easily, while others we really need to put some thought into. First of all let me state that it is very unethical to give an epileptic a placebo when you know it will cause harm to that patient. Some may say well the harm being done isn t fatal, and therefore shouldn t really be considered when doing such a study on a new drug. But any time any harm is going to be done to the patients it will have an everlasting and very important part in their life from then on. The effects may not be apparent at the time of the harm being done, but when it is repeated and done again and again, it will become more apparent over time.
There are many ethical reasons why such harm should be avoided though. When a patient comes into a clinical trial of a new drug, they come in thinking that this new drug will help them, as well as those that have the same problem as them. In this they believe, or should believe, that the person over seeing such a trail would have the best interest of the patients in mind. Meaning that they shouldn t cause any unnecessary harm to any of the patients at any time. Doing so would violate the patients Autonomy. Meaning that the person s rights have been infringed upon.
When a patient enters a trail like this they give up some of their autonomy to the doctor, and it is then up to the doctor to protect their patient to the best of their ability. They also have to realize that the patient is freely giving this up and in turn be fully truthful and cause no unnecessary harm to their patients.
The drugs currently on the market control about 70-80% of the seizures, and help with the other 20-30% of them. This means that a hundred percent of these children are helped with the current drug, so now is necessary to cause harm to these children knowing that the current drug is so effective? Most would answer no, and I would agree with them on that. If a drug can control the seizures so well now there shouldn t be any reason why you would have to put any of those people in danger by offering them another drug that might cause any sort of harm to them.
No drug should be worth so much that anyone would be put in danger, these children that would be put through the test have their whole life ahead of them. If they were to be taken off their current drug and they had multiple seizures the damage from that could prevent them from doing or accomplishing other things in the future, to the point where they may not be able to do much of anything at all. Whenever faced with a question of doing harm or not doing harm many of us would think that the answer is easy. But then you have to consider that many of the people having to think about these questions that have jobs and lives that deal solely on them. True that no harm is suppose to come to these people, but some would argue what is harm? Put simply harm is anything that is going to have an indefinite impact on the person life for their entire life.
So in conclusion the right of these patients would be infringed upon, only leaving the possible solution of not going through with the trail. The cost of such a trail would be far to great on the patients and is more then expected. If we need a better drug, in this case we really don t, then we must take precautions that will allow us to cause no harm on those that which to go through the treatment.
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