Two nonfiction reviews

[rivkat]

Comments

[skipthedemon]

I've grown up here in Birmingham, and the race issue is clearly still not dead. There's a whole lot of what I call "structural segregation". The vast majority of blacks live in the heart of the city with poor schools, a dying downtown, and unreliable public transportation. The middle and upperclasses (and the commerce that follows them) continue to flee further and further south of downtown. They don't care about transportation, because they have big SUVs. They tax themselves to have the best schools in the state, but it only works because each suburb has it's own school system. I'm not sure how to break the cycle, but it makes me very sad.

[boniblithe]

Angell does make the excellent point that right now most new drugs are only required to show they work better than placebo, but where a treatment exists, it would make a lot of sense to change the standard. She advocates that the standard should require superiority to the existing drug, but parity or superiority in a particular subgroup would probably be worthwhile too, especially since long-term effects can stay unknown for a while.Just peeking in to say that in Oncology, that is exactly how it is: you must show therapeutic equivalence with a better safety profile, or increased therapeutic benefit over existing treatment. There are no placebo controlled studies in oncology - it's too unethical to not treat terminal disease with at the very least, the best currently approved therapy as a comparator. All of pharma gets painted with the same brush, which is sad. Although when I see our marketing people coming, I can't get away fast enough. *shudder

[wearemany]

I'm not a treatment expert, but in my experience in AIDS advocacy, the bigger problem is less about therapy-vs-placebo (because, yes, double-blind studies are generally considered a no-no) and more about therapy from company A-vs-second therapy from company A. pharma companies are starting to do some trials to prove their drug is better than someone else's (though of course this requires that they BUY that competitor's drug for the trial, because they're certainly not getting it for free), but almost never will they admit that their own me-too drug isn't much of an improvement

[boniblithe]

In fact it was patients in HIV trials who made placebo-controlled trials a thing of the past, because they would enroll in the trial, take their drug to a pharmacy and break the blind and if they were on placebo they'd drop out and go enroll in another trial. Health authorities finally twigged to it and realized that placebo in terminal disease was really a horrible thing, so now they allow head to head comparator studies to carry the same weight that they used to mandate thru placebo control.

We do a lot of phase IV post-marketing trials where I am, but maybe in HIV research it's different. I think the patient population and privacy issues are probably vastly different in HIV vs cancer - people don't get socially ostracized for having cancer and for reporting back about their drug experiences.

I'm hoping to get around to reading Angell's book myself, soon!

[rivkat]

Great discussion! I think Jerry Avorn's book is better overall, but that's probably an overreaction to Angell's fairly strident tone. It's not as if she doesn't have reasons to be mad.

[londonkds]

I think Angell condemns “me-too” drugs with too broad a brush, though. Very few drugs approved each year are new molecular entities or otherwise major advances in treatment; often they’re similar to drugs already available for the same condition. This can be wasteful, but sometimes there is an improvement. I’m especially thinking of drugs that can be taken once a day instead of three or more times - the difference between the one-a-day and the 3-a-day is the difference between a drug that people will actually use according to instructions and one that, despite their best intentions, they’ll often neglect to take on time. Angell does make the excellent point that right now most new drugs are only required to show they work better than placebo, but where a treatment exists, it would make a lot of sense to change the standard. She advocates that the standard should require superiority to the existing drug, but parity or superiority in a particular subgroup would probably be worthwhile too, especially since long-term effects can stay

[rivkat]

Possible, but I'm not aware of how often that happens. From what I've seen, the side effect profile of me-too drugs is often quite similar to that of the benchmark drug. But you're right that a difference in safety ought to matter.

[londonkds]

Even if the general side-effect profile is the same, individual patients may find that they don't get the side effects from one drug that they do from a very similar one. Even the actual effectiveness of two similar drugs can be completely different for two different people due to personal idiosyncracies. I've personally been put on a drug for hay fever which was the official "ideal" one and found that it simply didn't work. The one which works best for me is usually a second-line drug because it causes unpleasant side effects in some people, but I have no problems tolerating it at all. Just ask one of the many depressed people on LJ about how different the effects of two allegedly all-but-identical antidepressants can be

[therck]

It's actually fairly common. Over the course of my lifetime, I've taken a lot of different medications for different conditions, and it's always a juggling act. Not only do my doctor and I have to look at how effective a particular med is for me personally, but we also have to look at whether or not it has a potential interaction with the other things I'm taking. Then we consider side effects. Very often, we've tried several different medications before settling on one that works