Quintin Loden Whitaker - Comment

I agree with this proposed rule. Unfortunately, I feel as though there are omissions when it comes to investigations on finding out the background of the initial trails of many medications and if those consent documentations exist. In 1996, Pfizer presided over a coercive, botched 1996 experiment on Nigerian children with the Kano Trovafloxacin test which allegedly led to the untimely death of about 200 children. In a class-action suit, families say the company violated the Nuremberg Code by forcing an unapproved, risky experiment on unwitting subjects who suffered brain damage, loss of hearing, paralysis and death as a result. Had that drug made it to the US market what traces would there had been of that experiment? The FDA references that the consent regulations are based on ethics codes such as the Nuremberg Code and the Declaration of Helsinki. This should also include the Pfizer experiments that took place in Nigeria as well. Clinical trials offer no guarantee. Kevin Weinfurt, Ph.D., a medical research psychologist at the Duke Clinical Research Institute and lead investigator of the study stated, "Our study suggests that you cannot always interpret patients' high expectations of benefit as clear signs of poor understanding," That is why is it so important to ensure these patients have clear a understanding of the consent process. Other revamping pressures probaly came from Sen. Sam Brownback (R-Kan.), who introduce legislation (bill S.1956) that would create a new three-tiered approval system for drugs. In a similar yet unrelated case, CropLife America is pleased that the U.S. Court of Appeals for the DC Circuit has granted a petition for review and vacated EPA's moratorium on using human clinical test data in pesticide risk assessments. When this proposal rule comes into effect, I believe it will hold pharmaceutical companies to a higher testing standard. I propose the Nigerian case be referenced as well.