Let's say you're going to test a new ACE inhibitor drug for lowering high blood pressure. You would think that one of the obvious questions you want answered in this trial is whether the new medication is better than the existing drugs on the market. If the new drug isn't any better, then the only purpose it serves is to pad a drug company's profits, by giving that company a new exclusive drug to market. If your clinical trial doesn't compare the new drug to older drugs, if instead you just compare your new drug to a placebo, then you have no idea which one is better. Even worse, you put half the subjects in your blood pressure study at risk by using a placebo - if a good treatment already exists, it's unethical to deny patients that treatment and give them a placebo instead. A new proposed regulation by the US FDA gives drug companies an incentive to perform these substandard clinical trials, by allowing them test their drugs in foreign clinical trials without following the international ethical standards for those trials, laid out in what's called The Declaration of Helsinki. Specifically, this regulation would allow drug companies, when applying for drug approval in the US, to use data from poorly designed studies performed in developing countries, where you can get away with substandard clinical trials - such as putting study subjects on a placebo, instead of giving them the current best standard of care. For minor medical issues, a placebo is not a big deal, but for more serious conditions, using a placebo is dangerous. But companies have a strong incentive to do these placebo studies: they don't have to show that their new drug is better than what's already out there, and they don't have to provide the best standard of care to all of their study subjects. Do we really want more drugs sold in the US that have no new benefits, and that are approved based on substandard studies that take advantage of patients in less affluent countries?