Remember the big pharmas sued the states that tried to copy life-saving drugs and are still doing so.
Also, aren't clinical tests indeed much more expensive for lifestyle drugs involving 5% better chance of this or that than life-saving drugs were you die if you don't take it anyway?
And I don't buy the aspirin argument, there was a somewhat recent large trial of people taking aspirin all day long, so obviously it would have been accepted today.
For Vioxx, it is established that the company deliberately withdrew critical data from the regulator, this is an horrible crime, nothing to do with the discussion here.
Last point, big pharmas will always prefer drugs you have to take until the end of your life rather than drugs that cure you. Economics 101, but often forgotten, another ill-effect of the current screwed-up IP system.
And I maintain that the FDA or EMEA criteria for safety are the same whether the drug is life saving or not. It is absolutely Kafkaian. For some "orphan" disease, they require proving the effect with double-blind trials involving more patients than you can enroll in a country the size of France, simply because there are too few people affected (they are now thinking about changing the workflow for those diseases...). And for drugs that only matter to the developing countries, they require proving that there are no interactions with prescription drugs for rich-world-only diseases.
The major preoccupation of the legislators and managers of approval agencies, is their own judicial security. So they build rules that nothing new can pass. They don't care for stuff that was approved before they took office: studies regarding aspirin are usually made by universities (big pharma doesn't pay to study public domain stuff) and since the universities have no hard cash, they make so-called meta-studies. By aggregating several other published studies primarily concerning other issues, but where patients were asked "do you regularly take aspirin", they can make findings by correlation which have a decent statistical meaning.
And if you look up most medical advisory text today, you really get a feeling that most physicians want to phase out aspirin because of oh-so-bad hemorraegic effects and stomach ulcers and-so-on... Pierre
