Presumably this drug will be marketed (largely) to “westerners” who have a very different diet and lifestyle from those in China and Scandanavia. Does anyone worry that the results observed in those countries won’t necessarily translate to the US and Western Europe?”

“It seems to me that you and I can both agree that the BEST scenario is to run clinical trials in the intended market population.”

Ok - if people from the UK, Scandinavia, and China don’t fit your idea of the “market population” in the US then where does? I would think that European and Asian would hit a pretty broad range here in the US. Moreso than say, Peru or Micronesia.

“…the shift of clinical trials overseas has more to do with cost and regulation of clinical trials than it does with marketing. While China and India are viewed as a huge potential market, the more luctrative aspect is that it is cheaper to conduct clinical trials in China/India than in the US.”

You were bemoaning the fact that the results may not translate to - you(?) - the market population? I think, and my point was, in the near future you and I will slowly cease to be the target market. So, combining your point of cost and regulation with my point of a HUGE potential market - why do you still think Americans (which we still haven’t defined) are the target audience?

“In the past, most drug testing had been done on white men. This means that some groups, such as African Americans, Hispanics/Latinos, American Indians, Asians, Pacific Islanders and women,(not to mention children - my addition) had not always been included in the tests done on drugs. But sometimes drugs work differently in these people than on white men. So FDA wants people from many different groups included in these studies.” FDA website

Finally, am I wrong that you’re a white male? You didn’t exactly say. And if you think I’m not biased, you haven’t been reading my posts.

BTW, xenophobia is the fear of strangers.
Zenophobia is the fear of one hand clapping.

In essence I am “arguing that the marginal benefit of this drug isn’t likely to be worth the cost to patients”.

That’s not to say that I don’t think similar trials for other CV drugs in the future shouldn’t be done. My point is that even if the trial is done and efficacy is shown the marginal benefit in comparison to the adverse events and cost to so many people may not justify prescribing it.

One study has already failed. If it had been a positive study the equation at this point would look much different. Instead it didn’t work and so they have to racket up to study to have huge numbers of people to chase a statistical difference that is not likely a clinical improvement in treatment. Thus it looks like a therapy based on marketing and sales and not on a therapeutic or societal benefit.

To be fair, I also should say that Ed’s last sentence is a little ambiguous. It’s not clear whether the entire 25,000 person clinical trial is being conducted in China/Scandanavia/UK, or if the current recruiting is going on in those countries. For all I know, they could have already recruited 15,000 people in the US and now the last group of people needed are from these other places.

Second, I don’t where you get the notion that previous clinical trials have been primarily on “white males”. Do you have data to back this up? I have read that it is difficult to recruit minorities into clinical trials. But I’ve never heard of gender bias in clinical trials.

Finally, why do you assume that I am a white male? You seem to have some biases yourself…

And I think we were thinking along the same lines, JiM, except that I, as a woman of Scandinavian descent, was looking at it from the other side of the fence as I am already at a disadvantage as far as whether or not medications will “work” for me since the majority of research is aimed at white men. I think it was the ethnocentric and, seeming to me, callous nature of Nathan’s question that peeved me. China is the big bonanza for pharma now and I wouldn’t be surprised that more clinical testing and medications will focus on Asian types. I mean, ~360 million Americans vs. ~1 billion Chinese = tough luck whitey (not to mention that a lot of those Americans aren’t white or male either).

Although I did know where Scandinavia was, my own thought had to do with genetics as that may impact efficacy. Of course, everyone is talking about genetic ‘customizing’ of meds. So it seemed conceivable to me that gene pole ‘nodes’ might lead to different results for different drugs. Yes, ultimately one goes by one’s own experience. But if large claims are being made, it might become relevant; just as we know much of the statin claims do not apply to women.

Where do Americans come from? Ellis Island.