Two nonfiction reviews

[rivkat]

Marcia Angell, The Truth About the Drug Companies: How They Deceive Us and What to Do About It: Well, that pretty much sums it up. Drug companies aren’t responsible for most innovative new drugs, most new drugs aren’t innovative, they don’t spend most of their money on research but on marketing new uses and new diseases to us, they make profits that would shame Rockefeller, they own Congress and have an option on the Presidency (as a result of which, a potential FDA head was rejected because of a concern, in the words of Bill Frist, that he was “too concerned about safety”), et cetera. The new prescription drug benefit includes a provision barring the government from negotiating price discounts, a provision both mind-boggling and totally natural under the corrupt circumstances Angell recounts. This is a screed, and a pretty well-backed screed at that. 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 unknown for a while. Of course, neither change is likely to happen any time soon, as long as drug companies can afford to buy themselves a nice Congress and a compliant, demoralized FDA.

Bernard Taper, Gomillion versus Lightfoot: Apartheid in Alabama: I got a bunch of books from my dad, who’s cleaning out his study, so expect some strange reviews of books from the 1960s/early 1970s here, including Goffman, Kuhn, and some other classics I’ve never actually read. This is a short book made out of two New Yorker pieces and a bit of followup, about the events surrounding Gomillion v. Lightfoot, the Supreme Court case declaring that Alabama couldn’t gerrymander the boundaries of Tuskegee to exclude basically every black in order to ensure that, even if blacks did manage to register to vote, they wouldn’t be able to participate in governance. What’s striking about this account is how simple, how blunt the tactics of discrimination were. Although they were defended violently and I’d never say they were easy to overcome, it was easy to figure out what was wrong.

Tuskegee had long had “good” race relations, in part because of Booker T. Washington’s insistence that political rights were unnecessary and would be granted in good time if black citizens proved themselves worthy. The gerrymander, designed to turn Tuskegee from a black-majority to a white-majority city in anticipation of the state’s being forced to register more black voters, was pretty decisive proof of the contrary. The Tuskegee Institute had fostered a well-educated, middle-class black citizenry, somewhat disconnected from the poorer rural blacks around them – one brief but compelling moment in Taper’s account comes when he suggests that the black laborers/farmers experienced some gentle schadenfreude when the black professors finally realized that, as far as whites were concerned, they weren’t ever going to be anything but “Negroes,” and that on a good day.

But the most telling moment in the narrative comes from a white businessman who’s just been talking about how good white Tuskegee’s relations with blacks have always been. Taper asks why he’s afraid of blacks voting: “I asked if he didn’t think it possible that his fears were exaggerated – that if Negroes got into office they might treat white citizens with justice. ‘Well, they wouldn’t,’ he said. ‘They couldn’t!’ But how could he be so sure, I asked. He burst out, ‘Listen, if there’s such a thing as hate, there’s gotta be hate in [blacks’] heart for the white man in the South!’” That’s a statement from a man who knows he’s done wrong. These days, with formal segregation gone and the worst excesses of racism routinely decried by top leaders, it’s a lot harder to find a clear enemy.

Comments

[wearemany.livejournal.com]

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.

however, my biggest gripe continues to be the lack of phase IV (post-marketing) trials, which companies agree to in principle in order to get accelerated approval, and yet almost never execute. this would allow the really important factors mentioned here in comments (side effects, dosing differences) to be made a part of a rigorous trial rather than catch as catch can. it would mean using real-world dosing levels (not the maximums that they can sell w/ safety) and real-world drug competition.

thanks for this review, rivka -- i have yet to actually READ angell's book, just a lot of noise around it. (I also find it interesting you didn't mention her former job, as that seemed to be what got her so much of the press when this came out.)

[boniblithe.livejournal.com]

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.livejournal.com]

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.