I have recently seen this article on a drug, which is as yet not approved by FDA due to lack of controlled study. However, the proponent doctor considers the drug a life saver for babies and the existing evidence sufficient to skip the trial phase and go ahead saving lives.
I am usually fond of evidence based medicine. However, in this case, I am shaken by the fact, that the drug is already in use in Europe for some time, with no scandals. Additionaly, it is basically a mixture of lipids from fish oil, which sounds like normal nutrition to me, not a novel chemical with unpredictable effects. (Although the application is intravenous, which is not “natural”).
I believe no finding will be found, which will, in retrospect, justify the current state of denying access to it to fataly ill children patients. No side effects of the kind of “Oh, I wish I let my baby die back then !” (Disability ? Chronic pain ? Mental retardation? - I do not expect any of that… After not seeing it in Europe so far.)
I want to transform this belief into a bet in prediction book. Can anybody give me advice, how to formulate the bet ? What should be a deadline for the bet evaluation ? It will be my first bet in prediction book...
Theoretically, that could make a difference.
In my country omegaven is available, but the pack insert gives warning about insufficient experience in children.
Anyway, I still want to bet. What is a fair time span ?
(BTW, do I understand it correctly, that in the USA, omegaven is approved neither for infants nor for adults ?)
I have recently seen this article on a drug, which is as yet not approved by FDA due to lack of controlled study. However, the proponent doctor considers the drug a life saver for babies and the existing evidence sufficient to skip the trial phase and go ahead saving lives.
I am usually fond of evidence based medicine. However, in this case, I am shaken by the fact, that the drug is already in use in Europe for some time, with no scandals. Additionaly, it is basically a mixture of lipids from fish oil, which sounds like normal nutrition to me, not a novel chemical with unpredictable effects. (Although the application is intravenous, which is not “natural”).
I believe no finding will be found, which will, in retrospect, justify the current state of denying access to it to fataly ill children patients. No side effects of the kind of “Oh, I wish I let my baby die back then !” (Disability ? Chronic pain ? Mental retardation? - I do not expect any of that… After not seeing it in Europe so far.)
I want to transform this belief into a bet in prediction book. Can anybody give me advice, how to formulate the bet ? What should be a deadline for the bet evaluation ? It will be my first bet in prediction book...
Not for infants.
Theoretically, that could make a difference. In my country omegaven is available, but the pack insert gives warning about insufficient experience in children.
Anyway, I still want to bet. What is a fair time span ?
(BTW, do I understand it correctly, that in the USA, omegaven is approved neither for infants nor for adults ?)