I’d be very interested in seeing a post — heck, a book — solely on this topic from you, I think it would be challenging and useful reading (and probably challenging and useful writing as well). I’d like to see the medical argument, but also how you would then relate that same principle outside the medical arena. If anxiety about privacy shouldn’t be put above the lives of others in medicine, what about counter-terrorism? Community policing? Motoring? Spousal and child abuse?

A key aspect of such a system would be anonymizing the data without losing valuable information. For instance, if I’m diabetic and am enrolled in data collection about a diabetes drug, and it turns out I’m also alcoholic but my doctor doesn’t pick up on that (because like any addict I’m lying to him about my units) and it’s not until I see another doctor much, much later that it’s revealed, how do we ensure that the data is updated to flag patient X as an alcoholic? (What with alcohol having a fairly significant effect on blood sugar stability.)

Capturing that data without compromising anonymity, or more to the point, without creating a massive database subject to failures and abuse, would be extraordinarily difficult in at least four areas I can think of: Procedurally, technically, politically, and socially.

I’m not saying it can’t be done, and I’m certainly not saying that it wouldn’t be fantastic if possible to track effects of health inputs (including drugs) on outcomes; such a thing could be a huge boon to all of us. I’d just really like to see a well-thought-out discussion of how it can be done, touching on at least those four areas, and of how it can and can’t, should and shouldn’t, be generalized beyond medical outcomes.

@Ben: Despite the above, this is your best post in months. The devil as ever would be in the detail, but as a vision it’s first class.

However, not sure about the idea of randomising patients whenever there is any uncertainty. You’d end up with a whole bunch of very heterogeneous randomised trials. It’s a nice idea in principle, but I don’t see how it could work in practice. Who would pay for it? How would you decide when to analyse the data? Would the trials be blinded, and if so, how long would patients be on a treatment before they could be unblinded? What if patients are not responding and need to switch to a different drug?

I think there are too many practical problems for it to work.

Once again your bias against bogus alternative therapies is showing.

Hang on…

This case does make one wonder if the FDA applies the right standard in deciding whether a drug should stay on the market. In the case of rosiglitazone, it is not clear there are any patients in which the benefits of the drug clearly exceed the harms. Even in patients with difficult to control blood sugars, is it really reasonable to believe the benefits of better blood sugar control outweigh the potential cardiovascular harms? Especially when insulin is a reasonable alternative?

Given what we know now, would rosiglitazone be approved? My guess is no.

Must remember to link to this next time some homeopath or nutritionista starts banging on about their critics being in the pocket of Big Pharma.

‘Associated with’ means the study found a high risk in insulin dependant people who also took rosiglitazone. But no more than that, the study design being insufficient to prove causation. Proving causation would require a double blind case controlled study at the very least.

‘Unfavourable risk ratio’ means they calculated that the risk of heart attacks outweighed the benefits of taking rosiglitazone. These things are a balancing act, all drugs have risk and all have a risk-benefit analysis. For eg the maximum daily dose of paracetamol is just below the level where it becomes toxic to the liver. But paracetamol taken below this level is a very useful drug. Ibuprofen like most NSAIDs should not be taken on an empty stomach, but it is much less harsh on the stomach than aspirin.

Also this blast from the past, particularly the comments section:

unspeak.net/evidence-based-medicine/

I thought you might be interested in this blog post, which is critical of you d-squareddigest.blogspot.com/2010/07/one-for-philosophers-me-from-couple-of.html . I generally like the output from this blogger, but I think he is quite wrong in this instance and that you might like to engage him in a dialogue/debate. Comments can be left here www.blogger.com/comment.g?blogID=3699020&postID=2358563306751101775 .

I was disappointed that you didn’t make it to this year TAM! in Las Vegas. It was a lot of fun and I would have loved it if you could have autographed my copy of Bad Science. Maybe next year.

Cheers!

Nissen, et al: “*** the totality of randomized clinical trials continue to demonstrate increased risk for MI although not for CV or all-cause mortality *** current findings suggest an unfavorable benefit to risk ratio for rosiglitazone.”

As the public, I need to know more about what “associated with” and “unfavorable benefit to risk ratio” might mean. Were I Big Pharma, I’d already know: just shut up and don’t get in road between me and my bank.

I thought relative risk ratios were just about the worst way of providing information on risks (whilst providing the largest numbers).

How do we ensure that GPs and judges don’t – wilfully or inadvertently – show bias in what patients/criminals they assign to the trial? I mean, it’s all fine and dandy that there are two equally valid treatments/sentences, but what’s to stop them from systematically assigning a third treatment/sentence to a non-random section of the population?