I should have a good run of columns on books I’ve read starting next week, but this week I’m thinking a lot about two separate articles in two separate issues of the New Yorker that collectively leave me feeling helpless because I’m informed.
We often portray it otherwise, that the acquisition of information is empowering, that it is necessary for constructive participation in a democratic society, that we need to know more always and to remember what we have learned. The older I get and the more I know, the more I think that knowing more means knowing that the hope of making reasonable and informed decisions collectively with a group of fellow citizens is a fool’s hope at the scales that modern states and institutions are forced to operate at.
What are the two articles in question? The first is by Gideon Lewis-Kraus, from the June 26th issue. It focuses specifically on people who have ALS (aka “Gehrig’s disease”) and the debate over access to untested but promising drug treatments. The second is by Ava Kofman (who works with ProPublica), in the July 3rd issue, on the medical and personal consequences of penis enlargement treatments, most particularly the insertion of implants.
They’re both carefully reported and detailed articles, further proof that the New Yorker is at the moment the absolute pinnacle of long-form journalism in the United States. I particularly appreciate that the editors do not seem to push reportage towards a kind of pre-ordained attitudinal or ideological position, unlike the Atlantic and the other surviving 21st Century magazines to survive the culling of American journalism and opinion writing. It’s probably because the magazine isn’t trying to coordinate some kind of advocacy that Lewis-Kraus and Kaufman’s reportage only one week apart ends up capturing two fundamentally different landscapes when it comes to regulation, patient rights, profit-seeking, and medical outcomes. I don’t think that’s the reporters or the editors: I think these are two real situations that are really different, and yet also profoundly entangled.
Lewis-Kraus explores the development of a drug aimed at slowing the progress of neurological diseases by a startup called Amylyx. The drug is the result of a speculative guess by a college student about the combinatorial effects of two different compounds, which then drew in several research collaborators and eventually some investors once the drug was reconsidered as a potential therapy for ALS as opposed to Alzheimer’s and Parkinson’s.
The article does a very good job of laying out how we’ve gotten to the deeply complex process involved in FDA approval of new drugs, and that’s the first point that moves me to a sensation of helplessness. Contrary to the impression that I think some people pick up in their high school history classes when they read—or at least hear about—Upton Sinclair’s The Jungle and the supposed origin of federal regulation, the FDA was for its early existence more or less without meaningful authority, acting largely as a kind of public relations stunt. As Lewis-Kraus observes, “drug regulation in America has been driven by public calamity”, and the FDA only acquired its much stronger power over medical treatments in fits and starts in the 1960s and 1970s. (Paralleled, I think, by the rising statutory influence of the AMA over medical licensing at the state level.) After 1980, fueled by the Reagan-inspired attack on regulation, some critics insisted that the FDA was now harming the public interest by excessive regulatory suppression of promising drugs and medical treatments. This criticism from libertarian and conservative observers combined with HIV-AIDS activists demanding more rapid approval of promising treatments for the disease in the 1990s.
The result is a bewildering landscape where on one hand Big Pharma is making huge amounts of money on treatments that are not really robustly tested or which have fairly marginal evidence of significant impacts on the conditions they’re meant to treat, while the companies are also allowed to pursue aggressive marketing campaigns and push our increasingly corporatized medical system into drug adoptions. On the other hand, the FDA process sometimes involves digging in fairly hard on a particular drug or therapy’s approval process despite passionate entreaties from patients who have absolutely no alternatives and are fully willing to take chances for even a short extension of their lives or a reduction of profoundly debilitating symptoms, where the FDA can’t help but end up seeming paternalistic or cold-hearted.
Lewis-Krause explores this dilemma expertly. A drug producer can end up making good money (as Amylyx has) on a treatment that may in fact not be more effective than a placebo, and the paradoxical problem that people facing death have to confront is that if a company with a marginally effective—or even actually ineffective—treatment is making that money, it might deter any other pharmaceutical company from researching drugs for the same condition, if the number of people suffering from it is fairly small. In some sense, it’s a very small-scale, highly individualized and rapid-fire version of the same problem all of us are facing with climate change. Holding off approval in order to push for a truly effective therapy is only abstractly meaningful to people with ALS right now: they will die before any therapy of that kind appears, and the only reason they might have to accept that prospect is a generalized kind of altruism towards future generations. And that doesn’t even come with any kind of promise: the FDA panels speak of the need to consider the welfare of future generations but they’re in no position to command the continuation of research into drug treatments for ALS or anything else. The regulators are helplessly supine in the face of profit-seeking: they could hold out for a better drug and find that people channeling massive flows of investment capital simply decide it’s not worth trying to make one. It also turns out that the process of retracting an approval is in fact more cumbersome than the process of gaining approval, which further complicates the possibility of approving an undertested drug for present use while reserving future judgment. The advocacy communities and the patients are certain they want a chance, because it’s better than no chance. But then they face a different challenge, which is trying to decide in their own experience of taking the drugs whether they see evidence of therapeutic effectiveness, a judgment that’s made harder because of the intensity of activist demands for access to the medicine.
There is so much evidence out there that doctors and medical authorities ignore patient testimony, especially from female, BIPOC or LGBQT patients. And there’s also evidence that wanting to feel better in many cases actually catalyzes forms of improvement and perhaps more important makes chronic or degenerative conditions more bearable, more integrated into a total experience of being human and alive for however long that might extend. But in every community of people dealing with profound sickness, terminal or chronic, there end up being people who feel marginalized simply because their experience of misery, fear and worsening health gets shouted down by the advocates, or their experience of a pharmaceutical or therapeutic solution being disappointed gets discounted or seen as an attempt to undercut the demand to be heard. The complicated history of SSRI drugs in the treatment of mental health is only one of a number of examples along these lines.
It’s when I move over to Kofman’s article that I end up feeling like we’re dealing with something so big, so vast, so urgent and so necessarily contradictory that there’s really no hope of an overall solution.
Kofman is investigating the runaway growth (yes, I know) of penis enlargement as a surgical procedure, primarily by plastic surgeons. The procedures she discusses in the article focus on one practitioner in particular who has invented and marketed a particular model of implant, essentially inspired by the earlier development of breast enhancement procedures, and on the debate over whether the procedure has caused harm to many of the men who have pursued it, but the article also touches on the general history of penis enlargement and on the cultural and biological histories of desires for bigger penises. Along the way, she continually revisits the complexity of those desires in terms of the secretiveness and shame felt by the male patients, both about their initial pursuit of enlargement and about whatever the outcome, positive or negative, might have been. (A fair number of the patients profiled in the article have undergone “explantation” of the implants since the initial procedure because of dissatisfaction with the outcomes in terms of pain, loss of sensation, or other dysfunctionality.)
The procedure is in any sense not necessary, any more than breast enlargement is, which is one of many issues that inform the debate between the two rival camps of medical practitioners featured in the article. Or is it? A lot of body positivity advocacy seeks to convince people who might undertake elective surgery or therapeutic intervention that they don’t need it, that they’re fine the way they are, that they’re trying to live up to some hegemonic view of what bodies should be like. You can talk to people and get them to see that, but a lot of the time, the feelings of shame and inadequacy remain and all you’re doing is getting that person to stop talking to you about it. And the uncomfortable reality remains that particular kinds of bodies return actual socioeconomic rewards—fat people have a much harder time getting hired and promoted, disabled people end up gated off literally and figuratively, women and men who don’t conform to stereotypes of sexual embodiment have a harder time finding partners and friends. (A perennial subject of men’s-rights outrage on Reddit, with some legitimacy, is how men shorter than 5’10” are often turned down on dating apps simply because of their height.) The felt need for the procedure is real, and prior to this current kind of implant, there are men who’ve died or become seriously ill seeking other ways to the same end, sometimes knowing that was a risk they faced.
The political economy that Kofman sketches out takes advantage of that desire, but it’s substantially different than the way Big Pharma operates. This is a world of individual entrepreneurs, some of them making money by performing procedures, others making money by performing procedures to correct the procedures. And the way the implant at the heart of the article passed FDA muster is completely different from how drugs undergo trials. The designer of the implant essentially used a loophole and got the device approved without any real scrutiny, despite the fact that he was proposing to put a fixed-size implant and plastic mesh inside an anatomical structure that changes shape when spongy tissues are filled with inrushing blood, precisely the sort of intervention that you think would demand intensive testing. What the ALS patients seeking experimental drugs want, men seeking bigger penises via an unevaluated therapy received, and without having to form an identifiable community of advocates.
I am sure there are reformers and technocrats out there who think there’s a way to handle all of these demands and needs that is reasonable, methodical and responsive. It’s plain in all these kinds of well-observed accounts of health care in the United States that a well-funded public health system would be at least one kind of slicing through the Gordian Knot, that some of the worst stressors on the whole system are coming from nearly unconstrained kinds of profit-seeking both from large corporations and entrepreneurs on the make. But I’m not sure there’s a regulatory apparatus that can square off against the desire for health and welfare in a democratic society where people rightly feel that they should be allowed to have what they want while also being protected from exploitation and harm. Where’s the hope of a bird’s eye view here? Where’s the thoroughly rigorous way to measure the effectiveness of a penis implant and an ALS drug? In both cases, there are all sorts of ways to work the statistics, but it’s not as simple as “the people with a money motive are lying manipulators and the scientists and experts are thoroughly rigorous in assessing significance”. There are wildly unlike kinds of needs and desires here—surviving longer versus feeling better about a private part of your body—but the distance between the two communities seeking medical intervention not only underscores how vast the excluded middle is, but also how unequipped a government institution is in answering to strong feelings. I am sure the men seeking bigger penises know that what they want is not remotely comparable to staving off or overcoming a terminal illness, but the patients in Kofman’s article have in some cases put much of their life savings into the procedure (and then in some cases to fix the procedure) as the ALS families have invested in pursuing experimental treatments. Economists speak of revealed preference, and here it seems relevant: the penis enlargers in this sense seem to think of what they’re buying as if it were life or death, whatever they might acknowledge if you put it all into perspective.
There’s penis enlargement in the EU: public health systems also answer to what populations want. There’s people dying who want drugs made more available, more quickly, in the EU, and some of them pursue the same workarounds as in the U.S. Money everywhere tries to put thumbs on the scales of measurement, but everywhere the determination of what counts as valid evidence of efficaciousness is as epistemologically and empirically difficult as it would be under any other system. And the scale of it all is beyond anybody’s ability to really grasp: all the people who feel in their bodies, suffer in their bodies, who testify to their experiences, all the systems we have for naming conditions and diseases but also all the material conditions of life that aren’t easily broken into conditions and diseases, all the institutions we have for medical therapy that break apart the whole people they treat and reduce them to a single vector of intervention on a body part, a disease, an injury. I can’t think of a way to build a system capable of grasping the scale of these decisions, these consequences, and yet it’s plain that the systems we do build not only fail in various ways because they are too local or parochial but that some imperatives—profit-seeking most of all—operate across the entirety of that scale, without direct human input or control much of the time.
Any single case, any single article, you can feel your way towards a reasonable judgment about how we could have better outcomes. A drug approval system that allowed experimental therapies without conferring almost irreversible approval on them; stronger incentives (even controls) for the development of therapies; some retention of the ability to consider long-term consequences even when patients themselves can’t and shouldn’t be expected to bear that weight themselves. Some greater oversight on elective surgery, some insistence that an entrepreneur designing, marketing and surgically implanting a device should have to keep and provide rigorously independent data about outcomes and complications both to potential patients and to regulators. But case by case, instance by instance, feels like whack-a-mole. It’s not a system pre-emptively securing the best outcomes, it’s a crudely reactive nervous system that only twitches when it’s on fire.
I know a great deal more than I did about the issues discussed in both articles. But the combination just makes me feel more hopeless and helpless rather than the other way around, which is not at all the fault of the authors or their magazine or anybody in particular. Technocracy fails in the end not because of specific design errors or the self-interest of technocrats short-circuiting their ability to live comfortably in the iron cage of modernity, but I think simply in the end because of irreducible complexity at the massive scales that characterize 21st Century global life. We can’t imagine our problems in their fullness and we can’t build responsive systems for managing them directly.