Tuesday, March 28, 2006

Of Insulin and Freedom

I have been a Type I diabetic – what used to be called insulin-dependent or juvenile-onset diabetes – for 26 years. (Type I is an autoimmune disorder in which the body destroys its own insulin-producing cells, leaving the body with no capacity to make insulin. It is distinct from the far more common Type II diabetes, in which the body makes insulin but metabolizes it poorly.) When I first became ill in 1980 I was told not to lose hope, because a cure was five to ten years down the road. Several research dead ends and a quarter-century later, new diabetics are apparently still told that (it is a joke we tell among ourselves), but there is no denying that the treatment of the disease is far better now than then. In particular, several new generations of insulin have been introduced over the years that make the disease easier to manage. How those insulins got there, and what I have to go through to use them, is surprisingly informative about how our society has changed during that time.

In 1980 the only types of insulin were made from cows and pigs. They were imperfect substitutes for human insulin. But they had been around since the 1920s, in an age when Americans were still assumed to be grownups capable of running their own affairs, and so no one needed anyone’s permission to buy it. In the mid-1980s these insulins were pushed out by a superior product, human insulin made from genetically engineered bacteria (Humulin). If, as seems reasonable, human insulin is better for humans than insulin made from animals with hooves, this is a significant step forward. While it was correspondingly more expensive (something indispensable in giving companies an incentive to learn how to produce it in the first place, and unsurprising in any event given its greater value to patients), it was still available without having to seek anyone’s permission.

But a key weakness of all injected insulin was that it took a long time to be absorbed through the muscles and to start acting on sugar in the blood. And so if you took it when you ate, your blood sugar would soar far more than that of a healthy person for the first few hours after eating, and all that time the extra sugar would be coursing through the circulatory system, damaging blood vessels everywhere it went. A healthy person, in contrast, begins to produce insulin as soon as his insulin-producing cells detect elevated blood sugar. And so this was a significant problem, a major contributor to the terrible complications many diabetics suffer later in life from elevated blood sugar. The greatest breakthrough to address this problem in my lifetime occurred in 1996, when Lilly received approval for Humalog, an insulin that begins to take effect almost immediately, while also wearing off faster. A few years later Aventis created Lantus, an insulin whose effects are more uniform over 8-12 hours than the spiky pattern of the older longer-term insulins it is designed to replace. This enables better control of blood-sugar level during the overnight period, when it is nearly impossible to test.

Unfortunately, the America of the late 1990s was fundamentally different from that of 1980. In particular, it is impossible to purchase these newer insulins without the explicit permission of a doctor – a prescription, in other words. This has an immediate practical cost, in that if I take a trip and forget a bottle, or drop my last one from the refrigerator on the floor and shatter it, I am unable to replace it until I can consult my doctor and have him forward his permission to a pharmacist. In the meantime, if I have had enough foresight to store Humulin (which expires within 18 months and so must be replaced even if I've hardly used any and is in any event an inferior product) in the refrigerator I can use that instead. If not, I am without insulin until I can get some more. Either way, my diabetes is more poorly managed.

The whole history of insulin is emblematic of how a society ought to be structured but, increasingly, isn’t. First, note that its creation is a story of synergy between pure science and pure commerce. According to Wikipedia, the animal version of the hormone was synthesized and first tested by scientists at the U. of Toronto. But ultimately the reason diabetics could actually use it was because of its commercialization and distribution by Lilly. And so this reveals the indispensability of commerce and those dreaded drug multinationals in making sure that medical breakthroughs are actually available to those in a position to benefit from them. Even if drug companies conducted no research themselves (and of course they conduct a lot), breakthroughs like insulin would satisfy nothing other than scientific curiosity without their ability to marry buyers with the owners of the resources needed to produce what the buyers want. Note also that while Lantus was approved in 2000 in the U.S., it was not approved by the NHS in the U.K. until 2002, with corresponding deleterious effects on U.K. diabetics in the meantime. This is because, as the overlord of all U.K. public health care, consumer (i.e. patient) welfare is considerably far down the list of British government incentives. This is an example of how single-payer health care divorces the tradeoffs patients want to make (and would be willing to make if new medical innovations were introduced) from the providers of health care, a problem I have discussed elsewhere. Remember all this next time someone agitates for a single-payer system or against the scary monster known as “Big Pharma.”

But the most compelling lesson about insulin is what it says about our freedom to be responsible for ourselves, which Leviathan increasingly holds in contempt. There is simply no reason why I should have to get someone else’s permission (other than the seller’s) to acquire it, or most medicines. Humalog and Lantus generate medical problems (especially involving control and low blood sugar episodes) that are different only in kind rather than degree from those associated with their predecessors. But the presumption now is that medicine is something that only an Officially Licensed Medical Person is qualified to dispense. That Humalog and Lantus require prescriptions where older types of insulin do not is a function not of any intrinsic differences they possess but of the way our society has changed – in particular, its evolution toward one in which the presumption is now against freedom. I am a grownup, capable of deciding for myself whether I need to buy this insulin at this moment. The only reason older insulin is dispensed this way is because of its grandfathering in. Aspirin, which is now used (like, say, prescription statins) to prevent heart attacks but which is associated with Reye’s syndrome in children and excessive bleeding in adults, would never be available without a prescription if it were introduced today. In the story of the new insulins we see the transformation from a society of free people to a society of pleaders at the throne of the nanny state.

And this is a sign that the whole prescription system is probably out of control. There are some medicines, mostly those that can generate resistance by the microbes they combat and hence a much greater ultimate disease burden, that can clearly be restricted by prescription on grounds that misuse harms others. I am thinking here of such things as antibiotics and anti-HIV drugs. But any medicine that might harm only me should be available to me as I see fit. To be sure, many medicines that I misuse (or even use properly) could harm me. But I know that they could harm me, and I know my limitations – that I don’t know enough just from reading the popular press to know whether I should use them. I know, in other words, that I should consult a doctor over such matters, and will gladly do so before I begin gulping down pills left and right. In the meantime, the epidemic of prescription requirements serves as an entry barrier and an extra transaction cost, both of which drive up drug costs and hence less access to drugs, even as (more importantly) they confirm what we have become, a society where Bureaucrat Knows Best and citizens are simply children.


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