Do-It-Yourself Insulin?

For those of us with diabetes that is severe enough to require regular insulin injections, going without insulin is not a realistic option.  In the U. S., such people are at the mercy of the drug companies that make insulin, and they (or their insurance or governtment benefits, if they have any) have to pay whatever those companies charge.  A graph of insulin prices versus time gives a good imitation of an exponentially rising curve, increasing about 50% from 2014 to 2019.  A vial of insulin can cost today as much as $300, and as a result, many poorer diabetes patients are skipping doses and incurring complications from the disease such as infections and blindness.  For a drug whose inventor, Frederick Banting, refused to put his name on the patent because he thought it should belong to humanity, it looks like patients who need the drug to live are being gouged by Big Pharma.

An article in the May 25 issue of The New Yorker describes how some do-it-yourself-biology groups are trying to come up with an end run around this problem.  In "The Rogue Experimenters," Margaret Talbot interviews people at a meeting of the Open Insulin Project in Baltimore, where Ph. D's in biochemistry mingled with volunteers who set up DNA labs in their apartments.  Their goal is to engineer a bacterium to manufacture insulin, and make it available at a much lower cost than the big three U. S. manufacturers charge.  But even if the rather rag-tag group of professionals and volunteers succeed, they face huge hurdles in the form of the Food and Drug Administraion (FDA) approval process, which can cost millions of dollars.  The big drug companies like it that way, because it means that nobody much smaller than them can even hope to compete.

When asked about the high price of insulin, drug manufacturers point to patented improvements they have made over the years.  Each patent allows them to exclude competition, and while technically the U. S. market is not a monopoly, the only three significant insulin manufacturers operate what looks to this outside observer like a cartel, successfully defending their practices against attempts by government to break up the cartel.  But although one type of synthetic insulin introduced in 1996 has gone from $20 a unit to about $200 today, no one is claiming that it works ten times better than it used to.

A little historical perspective might help us see what is wrong here, and what might be done to fix it. 

Much if not most of modern medicine can be traced to two sources with Christian roots:  the tradition of charitable care, which gave birth to the modern hospital; and the tradition of scientific investigation, which led to the monumental achievements of medical science that makes medical care so effective today.  We sometimes forget how recently medicine has transformed itself from a sort of guesswork sideshow that only rich people could afford to a huge and largely effective enterprise that makes life better, or even just possible, for billions around the globe. 

As late as the 1950s, it was fair to say that while most doctors and drug companies were not hurting for cash, most of the people involved in medical care were in it primarily for reasons of love rather than money.  They wanted to help people, and a medical-related job or business did that.  This attitude explains Banting's willingness in the 1920s to forego what might have been a highly profitable patent in the interests of benefiting humanity.  But once medical science adopted the Big Science style made possible in other fields by government funding, enterprising business people found that if you made a drug that people had to have in order to live, they would pay almost whatever you charged for it.  And their patent lawyers found clever ways to prolong patents so as to exclude competition from this operation, which is a big part of how Big Pharma got where it is today.

Ah, but if all those profits hadn't been available to fund further research, would we have as many advanced drugs and medical technologies as we do today?  There is no way to tell for sure, but one thing that is certain is that the drug companies now look at medical needs mainly with an eye toward profit, rather than asking about who is suffering and what can be done about it?  This leads to situations such as "orphan drugs" that have small patient populations, have been around too long to patent, or are unprofitable for other reasons. 

This problem has been a long time in the making, and I'm not about to solve in it one column.  The biological do-it-yourself movement may lead to some changes, although if it gets to be a serious threat to Big Pharma, they can deploy herds of lawyers to manipulate the government regulatory system to put the DIY'ers out of business.  Government intervention of some kind may be helpful, but not simply by subsidizing whatever the drug companies charge, which is partly how we got here in the first place. 

Humanly speaking, any institution that gets too powerful and begins to exploit the public, needs to have an equally powerful force applied to it to make it quit.  That is why most of the solutions posed for this problem involve government intervention of one kind or another, because government (mainly meaning the federal government) is the only institution whose power and resources can compare with the multibillion-dollar multinational drug corporations.  There is some significance in the fact that although the U. S. insulin market is comparatively small compared to the rest of the world, the drug companies make about half of their insulin profits from that market alone.

And while it is perhaps a remote and forlorn hope, another thing that would help is if everyone involved in medicine—drug companies, hospitals, doctors, and yes, even patients—would recall the roots of the discipline in the motivation of the kind of love that wishes the best for the beloved, including healing.  Millions of ordinary health-care workers still have that self-sacrificial love, as the COVID-19 crisis has shown us in recent months.  But the marketplace is not a good place to look for love, so maybe we should start from a different place altogether in thinking about how to fix problems such as the high price of insulin.

Sources:  Margaret Talbot's article "The Rogue Experimenters" appeared on pp. 40-49 of the May 25, 2020 issue of The New Yorker.  I also referred to an article on the Vox website at https://www.vox.com/2019/4/3/18293950/why-is-insulin-so-expensive and a graph of diabetes care costs versus time at https://www.goodrx.com/blog/goodrx-list-price-index-rising-cost-of-diabetes-treatments/.

What Price Medicine?

Last week I had the privilege of attending the American Physical Society Texas Section's annual regional meeting, held this year at the campus of the University of Texas at Dallas.  Among several invited speakers was a professor of radiology who spoke about the latest medical imaging techniques being developed for observing biological activity on the molecular level. 

As interesting as that was, I want to focus on an offhand remark the speaker made.  He has many friends in the medical research community, among whom is one who has been doing cancer research with rodents.  His friend has found that if rodents who have cancer are fed ordinary bicarbonate of soda (the same kind you can get in the Arm & Hammer box at the grocery store), the alkalinity it adds to the animal's body chemistry is enough to stop the cancer from metastasizing. 

That's not what I want to focus on either.  What I want to highlight is what the professor of radiology said next about his friend's discovery:  "It's too bad in a way, because, you know, there's no money in it.  But I still think he's on to something." 

Why is there no money in a cure for cancer that would use a substance that is not patented and costs a couple of dollars a pound?  Asked that way, the question almost answers itself.  On the other hand, if some exotic and patentable chemical was found to do the same thing, it would probably be in clinical trials on humans by now.

The way the pharmaceutical industry in the U. S. and most other industrialized countries works is roughly this.  The firms spend millions of dollars on research directed at finding new drugs.  So far so good.  But not just any new drug:  a new drug that will be at least moderately effective against a malady that requires the drug to be taken indefinitely.  In this way, the company can recoup its investment over the lifetime of the patient as well as the lifetime of the drug's patent. 

Because it is potentially so profitable, this mode of operation has squeezed out other ways that drug companies could work.  If a drug is found that cures a disease with one dose, or if a drug's patent expires and the company can't find a way to extend it, or if a drug turns out to be something that can't be patented in the first place (such as bicarbonate of soda), then the drug companies aren't interested.  And because the companies have become such a dominant force in the research community, drugs and treatments that don't fit their profitability pattern are increasingly ignored and neglected. 

The companies defend their ways of doing things with the claim that modern pharmaceutical research is costly, and if their markets are controlled or supervised with governmental interference, it will be like killing the goose that laid the golden egg.  All drug innovations will cease and we'll be back to using leeches and bloodletting.  That's an exaggeration of their attitudes toward regulation, but only slightly.  And they do have a point:  the business model they have adopted is indeed costly, but when it works, it's extremely profitable and attracts investment capital, without which nothing much could be done, at least in the private sector. 

That is one model of healing.  Another model is that of Mother Teresa.  The famed founder of the Missionaries of Charity dedicated her life and the lives of her nuns to the service of the poorest of the poor in Calcutta, India, and ultimately hundreds of other places around the world.  Their financial system, if you can call it that, would give an accountant nightmares.  They will take donations from anyone—foundations, governments, individuals, even criminals—and spend it right away on the most urgently needed items for the people they serve.  Many of the people they help are dying anyway, but to the dying they bring companionship, hope, and love. 

The work of the Missionaries of Charity has not led directly to the invention of a cure for any disease.  It has not made anyone richer financially.  But it has added to the store of human capital in the form of good works and examples of how to live.

As long as sickness and the other consequences of the Fall of Adam and Eve are with us, there is going to be a tension between these two ways of healing.  In The Abolition of Man, C. S. Lewis portrays a contrast between two ways of approaching the world.  One way is to view nature as simply raw material to be fashioned according to our will or whim.  Another way is to learn from nature what the universe is about, and conform our actions and behavior to what Lewis calls the Tao, the set of perennial principles of right and wrong common to all times and peoples. 

Both the Missionaries of Charity and Big Pharma do good things.  Without the Missionaries, thousands of sufferers in desperate straits would live and die unloved and uncared for.  And without Big Pharma, many medical conditions ranging from the fatal to the trivial would go untreated, and many investors would have to find something else to do with their money.  In the debates about the U. S. Affordable Care Act, experts have proposed many kinds of large-scale plans and changes that would allegedly make things better somehow.  But they are all complicated, because the present way Americans deal with health care—itself a manifold topic of many facets—is complicated, and changing even one aspect of the current system is like pulling on one thread of a spiderweb—the whole thing is likely to be affected.

Historically, sick people have been cared for through a combination of love and money, Mother Teresa's nuns representing the love end of the spectrum and Big Pharma representing the money end.  When the main criterion of a potential cure for a fatal disease is the question of how much money it will earn for investors, we have gone too far toward the money end of the spectrum.  Medical care is a business, but it used to be more than a business—it was a calling.  And unless those involved at all levels of health care perceive the need for love as well as money, things won't get any better in that regard.