Good spot, and that is great to know.
Nevertheless, it can still be argued that significant cross-cultural differences exist between US and UK and that the data does not generalize from one population to the other. Implausible, but arguable.
We need the data. Think how powerful this would be in the public arena, too. Just witness what's happened since the UK study in the (worldwide) press.
Nevertheless, it can still be argued that significant cross-cultural differences exist between US and UK and that the data does not generalize from one population to the other. Implausible, but arguable.
We need the data. Think how powerful this would be in the public arena, too. Just witness what's happened since the UK study in the (worldwide) press.
As a followup to the other thread, which I can not find right now. All these studies can be used by the American FDA without change, and without needing to do them again. The exact language from the FDA follows:
B. Studies Conducted Outside of the United States
You may submit studies of new tobacco products conducted outside the United States as part of your PMTA. All studies conducted outside the U.S. should be conducted to ensure that the rights, safety, and welfare of human subjects have been protected in accordance with ethical principles acceptable to the world community and that the data are scientifically valid and applicable to the U.S. population. The investigator should conduct these studies in conformance with international standards for good clinical practices or obey the laws and regulations
of the country in which the research is conducted, whichever affords the greater protection of human subjects. These patient protection and data integrity measures help ensure that data from studies conducted outside the United States constitute “well-controlled investigations” (see section 910(c)(5)(A) of the FD&C Act) that provide reliable data to FDA.
I had always thought that those heavily armed guys raiding the milk farmers were the police force
Talk about using undue force....