[liber8]

I've heard this from countless other people as well (including many doctors). Apparently, it was a fantastic pain drug for many people.

Should Merck have disclosed the increased risk of heart attack and stroke? Absolutely.

But, part of the problem is the incentives fostered by a bureaucracy like the FDA. If you know that your new wonderfully effective pain medication increases the risk of heart attacks from 4% to 6% (or whatever the numbers were), are you going to disclose that to the FDA, knowing it essentially spells doom for the billion dollars plus you spent on development?

[jeremyarussell]

Wouldn't it be nice if pharmacies could just publish all these finding and let people decide what to put in our own bodies. I know they argue that we aren't doctors and therefore shouldn't be forced to make those decisions, but with the aid of a doctor and true transparent facts I'm pretty sure I would have no problem going, okay this drug is twice as good at helping with my terrible pain, and the side effect is that I'm more likely to die of a heart attack. I'd go, well maybe I don't want to take that risk since I'm at risk already for a heart attack, or I could go oh I'm young and have no family history of heart failure, I should be alright the risk is worth the gain.

I can't for the life of me figure out why we can't just do that. Anyone around care to enlighten me?

[refurb]

The majority of patients have ZERO ability to evaluate the risks and benefits with pharmaceutical intervention. The best example I can provide is patient compliance (do they take their drug as prescribed?). You'd be hard pressed to find a rate higher than 50% for any disease (other than the immediately life-threatening ones).

[jeremyarussell]

I don't see how the example you list is relevant to my argument that with proper disclosure and warning of risks people won't be able to decide if the risks out-way the gains.

Example I listed: That with full disclosure I can make an educated choice as to what goes into my body.

Example you listed: That over 50% of people that get prescribed something decide to take that something the wrong way as opposed to as directed.

They don't seem to be the same. (for one, using a drug in a matter different then what you've been told to is just gross negligence.)

[refurb]

Sorry, I should have been clearer.

My argument is this: If you can't count on people to take a drug that will drastically reduce their likelihood of dying, how can you trust them to accurately determine the trade-off between efficacy and safety?

Most patients don't display the ability to figure out risks and trade-offs now (and relatively simple trade-offs at that). Do you think they'll be able to figure out what "45% increase in the risk of heart-attacks (41.2 - 48.8%, 95% confidence interval) in populations who have had a transient ischemic attack in the last 180 days, excluding those who have diagnosed atherosclerosis" means to them?

[yew]

I think the real problem is that many doctors also lack the capacity to translate statistical data into a rational evaluation of risk.

Consider the infamous 'mammogram statistics problem' as an example. So what do you do then, when nobody in the decision-making chain can be trusted to understand the data?

[liber8]

Yes, yes I do.

Especially if the alternative is denying other people loads of relief (not only in the form of proven effective drugs that are taken off market, like Vioxx, but all the drugs that aren't even investigated because they fit in a class of drugs with known negative side effects).

Edit: misread your post. Yes, I do trust people to make decisions on efficacy v. risk. This would be even easier if we had a system that promoted the discussion of this information rather than one that effectively prohibited it. Merck should be able to openly say, "Hey guys, we have this great drug that is really effective at managing pain, plus it's non-narcotic. The only downside is, it increases your risk of heart attack by 50%. Talk to your doctor about it."

[jeremyarussell]

"Do you think they'll be able to figure out what "45% increase in the risk of heart-attacks (41.2 - 48.8%, 95% confidence interval) in populations who have had a transient ischemic attack in the last 180 days, excluding those who have diagnosed atherosclerosis" means to them?"

That's why I stated earlier that your doctor is and should explain to you what those words and statistics mean in laymen. Your example is full of the exact opposite of what I was saying.

[tedunangst]

People are typically very poor judges of risk, even while they think they're good at it. If I take this pill I'll lose ten pounds for my class reunion, but I'll probably need a new liver? Sounds good, sign me up!

People are more than sufficiently educated about the risks of drunk driving, but it's still a problem, because bad outcomes only happen to other people.

[jeffdavis]

"If you know that your new wonderfully effective pain medication increases the risk of heart attacks from 4% to 6% (or whatever the numbers were), are you going to disclose that to the FDA, knowing it essentially spells doom for the billion dollars plus you spent on development?"

Did Merck not disclose something? http://en.wikipedia.org/wiki/Vioxx seems to indicate they did disclose the increased risk over naproxen, but tried to explain it away without further investigation.