Goal of Barack’s Memo???
Recently our President, Barack Obama, issued a memo asking Dr. Amy Guttmann, chair, Presidential Commission for the Study of Bioethical Issues, for a review of human subjects protection.
This all stemmed from the recently discovered information regarding a study that the US Public Health Service conducted in Guatemala. While I don’t disagree that the matter deserves some attention, I feel the tasks requested require some review.
1. Convene a Panel – Sounds like a good start to any complicated issue
2. Thoroughly review Federal regulations and international standards to determine if they are adequate – When I think of all the time spent to develop and re-review Federal regulations and ICH; it’s hard to believe that a panel will find a gap in their given 9 month time period. I wonder how many people read ICH E6 on a daily basis. I have to admit; rarely a week goes by without me picking it up. I wonder if they will include the Declaration of Helsinki, as FDA doesn’t. Which reminds me, don’t we have at least two Federal bodies that do this as a day job?
3. Conduct a thorough fact-finding investigation into the specific Guatemalan study – What do we say here in Indiana about closing the barn door after the horses have left? Or is it cows? At any rate, I understand the intent, but so much time has passed, I’m not sure this will add value.
4. Seek insights and perspectives of international experts (include a Guatamalan) and have a meeting outside the US – Sounds like a good approach, but again, is this an ICH junior? Will individuals from FDA, OHRP and ICH be excluded to get a truly unique view?
This is a serious revelation that deserves serious attention. I fear it is duplicative at a time when we don’t have enough time and resources to do a job once. Anyone want to take a bet that not much is found in this mission?