From Science
No questions, but I welcome your comments.
Thank you for the interesting but disheartening read... It really just makes me question the Ethics chapter we study in EPM103... When we read about the unethical horrors that happened decades ago, we sort of have the hope that something like that would never happen in this day and age considering all the regulations that came into place due to those events... turns out it's just hope and not reality...
The authors here argue that the Vit-D-kids trial was ethical because the estimation of vitamin D was not routine and they are not worse off than if they were not in the trial. But the point is that even if the estimation is not routine, if at all any child is tested and found to be deficient, they would be offered supplements in the real world and not placebo, not for asthma but for the multiple other problems that arise due to the deficiency. The trial involves testing all the children, so it's not appropriate to raise the justification of no routine testing. It s actually quite shocking that such a study in children (already an at-risk vulnerable population) was approved based on this justification. The study compared placebo with high dose vit D- both of which would not happen in the real world- just doesn't make sense. Just goes to show that any regulatory agency in the world can be manipulated with the help of strategic loopholes.
It would be really interesting to see if anybody thought the Vit-D-trial was justified. They were aiming to look at the effect of vitamin D in reducing asthma attacks- the trial should have been done in children with normal vitamin D levels (maybe on the lower side) because I understand that the majority, in the population of children with asthma, have normal vit d levels (if vitamin d deficiency was a serious problem in these children- then testing would be by default routine and supplementation routine as well- since that's not the case we have to assume that Vit D deficiency is not a major problem with these children). In children with normal levels, using placebo would be justified, and a low dose vit d supplementation for the intervention arm would be justified as well. The basic problem was the population they selected for the study.
The line that stood out for me was " “It’s just common sense. Why study two things inside of a trial that nobody does outside of the trial?” and makes perfect sense... an extension of that would be- why leave out the standard treatment that is done outside the trial as a comparison arm when trying to study a potentially better treatment inside the trial?.. the problem arises in the definition of what is standard care- and this is where investigators can find loopholes to justify not having a standard care arm or using placebo.
Would love to hear your thoughts...
Fathima
The authors here argue that the Vit-D-kids trial was ethical because the estimation of vitamin D was not routine and they are not worse off than if they were not in the trial. But the point is that even if the estimation is not routine, if at all any child is tested and found to be deficient, they would be offered supplements in the real world and not placebo, not for asthma but for the multiple other problems that arise due to the deficiency. The trial involves testing all the children, so it's not appropriate to raise the justification of no routine testing. It s actually quite shocking that such a study in children (already an at-risk vulnerable population) was approved based on this justification. The study compared placebo with high dose vit D- both of which would not happen in the real world- just doesn't make sense. Just goes to show that any regulatory agency in the world can be manipulated with the help of strategic loopholes.
It would be really interesting to see if anybody thought the Vit-D-trial was justified. They were aiming to look at the effect of vitamin D in reducing asthma attacks- the trial should have been done in children with normal vitamin D levels (maybe on the lower side) because I understand that the majority, in the population of children with asthma, have normal vit d levels (if vitamin d deficiency was a serious problem in these children- then testing would be by default routine and supplementation routine as well- since that's not the case we have to assume that Vit D deficiency is not a major problem with these children). In children with normal levels, using placebo would be justified, and a low dose vit d supplementation for the intervention arm would be justified as well. The basic problem was the population they selected for the study.
The line that stood out for me was " “It’s just common sense. Why study two things inside of a trial that nobody does outside of the trial?” and makes perfect sense... an extension of that would be- why leave out the standard treatment that is done outside the trial as a comparison arm when trying to study a potentially better treatment inside the trial?.. the problem arises in the definition of what is standard care- and this is where investigators can find loopholes to justify not having a standard care arm or using placebo.
Would love to hear your thoughts...
Fathima
Thank you Sujit.
That a plainly unethical study should be supported by mainstream organisations and not change when its errors are brought to their attention is shocking.
Well done to Charles Piller, the journalist who publicised this.
That a plainly unethical study should be supported by mainstream organisations and not change when its errors are brought to their attention is shocking.
Well done to Charles Piller, the journalist who publicised this.