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/.

Questions Remain About Visakhapatnam Gas Leak

Here's what we know so far.  In the early morning hours of Thursday, May 7, workers at a petrochemical plant in the southeastern India coastal city of Visakhapatnam were trying to restart the plant, which had been shut down earlier due to lockdown restrictions imposed in connection with the COVID-19 pandemic.  Around 3:30 AM, a gas leak occurred and spread rapidly throughout the densely-populated area surrounding the plant.  At least 200 people wound up hospitalized, and as of May 8, 13 had died from the effects of the leak. 

The plant is presently owned by the South Korean firm LG Chem, but was founded in 1961 and has passed through several changes of ownership since then.  Its main output is polystyrene plastic, and to make polystyrene requires styrene, a benzene-like molecule that is liquid at room temperature.  About 2,000 metric tons of the monomer were stored onsite in tanks.

A Chevron safety sheet on the styrene "monomer" (what the molecule is called before it is polymerized into a chain) emphasizes the main danger from storing it:  runaway polymerization.  Most polymers have to be forced into polymerizing, but evidently styrene is an exception:  it will polymerize if given half a chance, and especially at temperatures above about 68 F (20 C).  When it polymerizes, it gives off heat, which makes it polymerize faster, and the resultant heat and pressure buildup can cause an explosion.

This is why storage tanks of styrene are normally refrigerated to keep them cooler than 20 C, so that spontaneous polymerization doesn't happen.  While the exact sequence of events is not yet clear, it appears that a computer glitch or other problem interfered with the refrigeration of the styrene tanks.  Once the temperature rose much above 20 C, polymerization in the tanks would have raised the temperature and pressure, and eventually a safety valve somewhere must have opened, or else a rupture in the tank or piping occurred.

At any rate, a large amount of styrene monomer escaped the limits of the plant and must have traveled hundreds of meters, affecting several villages that have sprung up around the plant in the sixty or so years since its founding.  Styrene, being heavier than air, sticks to the ground, and in sufficient density it will suffocate you.  But lower concentrations than that will still cause intense respiratory problems and death, as it did for 13 people that night.  Eventually, authorities evacuated a 3-km-radius area around the plant, but by that time most of the damage had been done.

While this accident pales in comparison to the well-known Bhopal tragedy of 1984 in which about half a million people were exposed to a toxic chemical and thousands died, even one death of a resident near a chemical plant is unnecessary.  What lessons can be learned so far from the LG Chem plant accident?

A common thread that shows up in many chemical-plant accidents is that they tend to occur when a plant is being started up after a shutdown.  There are several reasons why starting up is a dangerous time.  Conditions in the system have to be brought from a low-pressure, low-temperature state to operating pressures and temperatures without straying into combinations that can be dangerous to equipment or personnel.  This requires more than typical vigilance from operating personnel, who may not have experienced that many shutdowns and restarts in their careers.  The procedures for starting up a plant can be much more complex than those required to keep it running, and more mistakes can be made in a complicated, time-sensitive process than simply one in which your job is to make sure everything stays the way it is and runs smoothly.  Last but not necessarily least, it seems that a favorite time for doing a startup is after the beginning of the midnight shift.  Whether the implied secrecy of early morning is appealing in case anything goes wrong, or whether it is simply a more convenient time with regard to plant schedules, I don't know.  But from the viewpoint of sounding an alarm to the general public if anything goes wrong, the period from late evening to early morning is the worst possible time to do something that might cause problems to people outside the plant, who will all be asleep and hard to evacuate in an emergency.

Another factor in this accident is the presence of densely-populated villages just outside the plant boundaries.  According to one news report, in 1961 the region where the plant was erected was rural, but with the subsequent population growth of cities such as Visakhapatnam, that changed.  The permit status of the plant is reportedly in a legal gray area, which might result from the fact that if the plant were to be built from scratch today in the same location, it might not be allowed at all, or at a minimum a large buffer zone would be required between the active plant and the surrounding populated areas.  As is true in most parts of the world, the land surrounding chemical plants is where you find some of the lowest-priced housing, and the kind of people who live in low-priced housing are generally poor people.  While they are not happy to be taking an unknown risk of sudden death or long-term illness by living within the sights, sounds, and smells of a chemical plant, they may not have much of a choice.

At last report, an investigative team from LG Chem's South Korean headquarters was onsite trying to determine the accident's cause.  But that is little comfort for those who lost loved ones or the hundreds who were injured in this accident. 

Absolute safety in industrial processes is virtually impossible without exiling plants to an uninhabited island operated entirely by robots.  And in any case, such an operation would be undercut in cost by operations such as LG Chem that runs with human beings and in proximity to people who may not know they are taking a chance every day of their lives just by living close by.  In a sovereign nation, the only force that can generally make sure powerful manufacturing interests don't hurt or kill too many people is the various branches of government, with perhaps private insurance companies coming in a distant second.  I hope that this accident teaches all concerned—corporations operating in India, the government officials responsible for regulation, and the Indian people—how to do things better next time, and to make it a long time before the next such accident occurs.

Sources:  I relied on the Wikipedia article " Visakhapatnam gas leak," as well as reports on the website thehindu.com at https://www.thehindu.com/news/national/andhra-pradesh/visakhapatnam-gas-leak-lg-chem-dispatches-technical-team-from-seoul-for-investigation-rehabilitation-works/article31573936.ece and https://www.thehindu.com/news/cities/Visakhapatnam/visakhapatnam-lg-polimers-chemical-plant-gas-leak-updates-may-7-2020/article31523178.ece?homepage=true.  I also referred to a Chevron safety sheet on styrene at http://www.cpchem.com/bl/aromatics/en-us/Documents/Safe_Handling_and_Storage_of_Styrene_Monomer.pdf.

In Defense of Ham Radio

A nasty letter from the California Department of Forestry and Fire Protection (CAL-FIRE) to an unnamed amateur radio operator ("ham") has been making the rounds of the Internet.  To understand it, you need to know a little context.

Amateur radio is just that:  people who like operating two-way radios not for profit, but for fun, and also for community-service purposes such as emergency communications.  In disasters such as Hurricane Katrina in 2005 that decimated New Orleans and its communications infrastructure, amateur radio operators using their portable "rigs" and privately-owned VHF repeater systems managed to help rescuers locate survivors, relayed health and welfare information, and generally made themselves useful during a time when many mobile-phone base stations were knocked out and phone service was nonexistent in many areas. 

Because they have proven so helpful in emergencies, many public-safety government organizations such as police and fire operations have allowed amateurs to install repeaters on towers and in equipment vaults across the country.  While normally, a private entity such as a telecomm company would have to pay good money for such a privilege, amateurs have on occasion worked out agreements whereby they can install their equipment without being charged the usual fees, and in turn the community gets the benefit of their potential for emergency services.

Obviously, such agreements can be changed, and apparently it was one bureaucrat's heavy-handed attempt to clear space in a repeater vault that got the attention of amateur radio operators nationwide, to the extent that their umbrella organization, the quaintly-named American Radio Relay League (ARRL) had to issue a clarification. 

Some time last year, it appears that a group of amateurs who operated a repeater installed in a CAL-FIRE communications facility received a letter demanding payment of several thousand dollars plus an annual rental fee, or else they would have to come and take down their equipment.  With the addressee and date redacted, a copy of this letter gained the attention of several groups, and the ARRL contacted CAL-FIRE for further information. 

It turns out that internal management changes at CAL-FIRE introduced some property management personnel to the unfamiliar world of amateur radio repeaters, which they apparently viewed as simply some people having fun at the taxpayers' expense.  Accordingly, one ill-informed manager named Lorina Pisi drafted and sent the letter, which was not representative of CAL-FIRE's overall attitude toward ham radio in general.  Such situations are negotiated at the local level and other such controversies have come up in the past.  But this letter was egregious enough that it inspired someone to leak it publicly, and it got a lot of attention.

Being an amateur radio licensee myself, I am not exactly a neutral observer.  Admittedly, the exotic aura attached to ham radio has lost some of its luster in the last few decades.  Back when the only people who could communicate with others while in a moving vehicle were policemen, firemen, cab drivers, and the odd millionaire who could afford to pay nearly an infinite amount for the five or ten mobile-phone channels available in a city like New York, having a rig in your car, let alone being able to talk over a wide area with a handheld radio operating through a repeater, was a thrill worth studying for, because getting a license was a substantial ordeal involving learning Morse code and knowing a minimum of technical information about radio science. 

But with the advent of commercial cellular mobile-phone networks, anybody who could afford a phone could talk from their car, and so it's understandable that people whose only experience with ham radio is possibly the crochety old uncle with a pile of electronics under his dashboard would think that with everybody having mobile phones, ham radio is just a hobby and no longer potentially useful for public service in emergencies.

And it is just a hobby for some people.  But there is a small but dedicated group of amateurs who practice emergency communications with drills, procedures, and other means of being ready to spring into action if a natural disaster strikes such as Katrina.  The disaster most relevant to the California situation is the self-imposed blackouts that PG&E has imposed in areas where their lines on poorly-maintained right-of-way can cause wildfires during windy weather.  In defense of PG&E, the reason they haven't trimmed more trees away from their lines is a combination of financial straits and environmental laws that perversely make such fires more likely. 

Even if PG&E didn't impose blackouts, California has plenty of other potential disasters—earthquakes, landslides—in which amateur radio could come in quite handy.  The point here is that while most of the time, amateur radio folks seem to be just playing, their hobby can become a vital necessity in certain rare and critical situations.  So I for one would like to see them defended against any movement on the part of goverments to abrogate agreements regarding repeater space on towers and in vaults, or other government-mandated conditions with wider implications.

For example, the lifeblood of amateur radio is the portions of the frequency spectrum allocated to their operations.  No allocations, no amateur radio.  In the last few decades, the spectrum has increasingly been viewed in economic terms, with auctions and sales of bandwidth becoming routine. Amateur radio operators, who not only don't have profits to spend on bandwidth but are legally enjoined from making any money with their hobby, can't pay for their frequencies, so they must rely on other justifications for their existence, and one of the main ones is their role as a backup communications means in emergencies. 

I hope the CAL-FIRE letter doesn't represent a wider trend in government against amateur radio in general, and the ARRL, at least, doesn't seem to think it does.  Nevertheless, the price of liberty is eternal vigilance, and it seems to me that we should do what we can to encourage hams to continue in their role as providers of a backup communications means when all others fail.

Sources:  My wife directed my attention to a rather colorful writeup of the original CAL-FIRE letter carried by the website Offgridsurvival.com at https://offgridsurvival.com/california-officials-declare-ham-radio-no-longer-a-benefit/?fbclid=IwAR0DkHc4fJAKnbP82tyyqTLaVAfItdh35YeT43hP7IxJaHJz7uZ6Myam32A.  A more even-handed view was taken in this report:  https://californiaglobe.com/section-2/cal-fire-severing-ties-with-ham-radio-operators-jeopardizing-millions-of-californians-during-an-emergency/.  And the ARRL's response to the controversy can be viewed at http://www.arrl.org/news/report-causes-concern-and-confusion-in-california-s-amateur-radio-ranks.  For an article about how ham operators helped out during Hurricane Katrina, see

http://www.nbcnews.com/id/9228945/ns/technology_and_science-wireless/t/ham-radio-operators-rescue-after-katrina/#.XrfR2xNKhXg

The Grand 5G TV Frequency Reshuffle

From now until July, TV broadcasters in the U. S. are in the final phases of a grand reshuffle of broadcast frequencies that has been going on for several years.  Unless you happen to watch TV the old-fashioned way—by getting a signal from a rooftop or indoor VHF/UHF antenna directly from the terrestrial broadcast transmitter—you probably haven't even noticed.  But this is the tail end of a process that began back in 2012, when the U. S. Federal Communications Commission (FCC) auctioned off a slather of frequencies in the 600-700 MHz range to be used as a part of the new 5G mobile-phone plan.

You may not think of the radio spectrum this way (if at all), but it is a limited natural resource, like fresh water or land.  As humanity has learned how to exploit it in increasingly effective ways, the value of various parts of it has fluctuated, mostly upward, but not always.  For the first seventy years or so of the FCC's existence, the agency treated the spectrum like the federal government treated federal land:  if you qualified, you could just get some of it for free, and then it was yours to use or sell just like any other private property. 

This wasn't always the best or the fairest way to do things.  Back in the 1920s, when it wasn't clear that radio would amount to much more than some hobbyists annoying their neighbors with loud spark-gap transmitters, it seemed like a reasonable approach.  But by the 1950s, when radio and then television frequencies were valued on the private market in the millions of dollars, politicians began to pull strings and the whole thing got very complicated.  For example, how much of a coincidence was it that the application for a new TV station that then-Senator Lyndon B. Johnson wanted to build in Austin in the early 1950s was the only application filed in that city?  None at all, because everybody else knew that LBJ was so connected in Washington that filing a competing application would be a waste of time.  So LBJ's family became the proud owners of  the first TV station in Austin in 1952, and the next TV station there didn't open until 1965.

Eventually, laws were passed so that the FCC could actually hold auctions to allocate new spectrum frequencies.  This change acknowledged that the radio spectrum had value, and probably a better way to allocate it than political influence was to sell it to the highest bidder. 

And of course, technology wasn't standing still during this time, either.  When the first UHF TV band was opened in 1952, it was viewed as the most wasted part of the "vast wasteland" of TV, in the words of a cynical FCC commissioner.  Originally it covered the entire frequency range from 470 MHz to 890 MHz, with channel numbers designated 14 through 83. Because a TV channel then occupied about 6 MHz, in principle there was room for almost 70 channels in the UHF band.  But for many years, that promise went largely unfulfilled for technical reasons.

It was a considerable challenge to early consumer-TV makers to build a UHF tuner, which is the "front-end" part of the TV that takes the signal from the antenna and converts it down to a reasonably low frequency to be demodulated and used.  Those old UHF tuners were fussy, handmade devices that you tuned with a continuously-rotating knob, like a radio dial.  And they were very subject to interference from other UHF stations.  Because of these problems, the FCC handed out a whole lot fewer UHF frequencies than it looked like at first glance you could fit in that huge range, because if the spectrum got anywhere close to crowded, all the UHF tuners would start picking up the wrong signals and everything would go to pot.  Also, UHF signals didn't carry as far as the lower VHF frequencies (channels 2-13), so a lot of early UHF stations were local low-budget affairs that couldn't afford anything better.

Technical times changed, as they always do, and around 2000 the TV industry made its move to digital broadcasting.  This change, plus advances in tuner design, rendered the old super-cautious FCC allocations pointless.  And with the advent of cable TV, the importance of over-the-air broadcasting began to wane, and once tuning your TV became a job for a computer, the channel numbers no longer had to be irrevocably fixed to particular frequencies, as they had to be with electromechanical tuners. 

Fast-forward to 2012.  The new 5G mobile phone service plan includes the use of a 600-700 MHz band that will allow base-quality service over a much wider area than the current higher-frequency mobile phone cells permit.  The problem was, there were still a lot of TV stations in that frequency range, hanging on to their old UHF TV allocations.  The FCC made them a deal:  if you let us auction off your frequency for 5G, we'll either share some of the profits with you and you can take the money and go off the air, or move to another frequency.  Either way, we've got to clear this band for 5G.  Kind of a spectrum-allocation eminent-domain action, as it were.  Some stations took the money and quit.  Others have been shifting up and down the frequency spectrum in a ten-phase process that will be completed by July of 2020.  While this can be a big deal for the broadcasters, involving costly new transmitters and transmitting antennas, the most that even off-the-air consumers will notice is that a station may go blank, but all you have to do is "rescan" your digital TV, and it will automatically hunt for the new frequency and find it for you.

To a geezer like me, who grew up having to get up off the chair and twiddle with the fine-tune control on the TV tuner every so often, it all seems too easy.  And there's something odd about the fluid shifting going on behind the scenes.  Back when a channel allocation was something to be proud of, stations often incorporated their channel number in their logo.  For example, in Fort Worth, the local independent station was Channel 11, and their logo featured the two numeral 1's as two nattily-dressed guys in little white suits, complete with handkerchiefs in their breast pockets (I may be imagining the handkerchief part, but you get the idea). 

No longer.  It's all as invisible as sewer pipes now, and about as interesting to the average consumer.  But in case you were wondering where your off-the-air station went, this may be part of the explanation.

Sources:  Not being a watcher of TV any longer myself, I learned about this process from an article in the San Jose Mercury-News at https://www.mercurynews.com/2020/04/30/heres-why-you-might-need-to-rescan-your-tv-right-now/.  I also referred to articles from Gizmodo at https://gizmodo.com/5g-is-forcing-hundreds-of-tv-channels-to-change-how-the-1837111135 and Venturebeat at https://venturebeat.com/2019/12/10/the-definitive-guide-to-5g-low-mid-and-high-band-speeds/

and the Wikipedia article on UHF TV broadcasting.  The FCC has a handy map on which you can look up your local TV stations and see what's going on with their channel moves, if any, at https://www.fcc.gov/media/engineering/dtvmaps.  And I got the short version of the KLBJ story from Slate, which summarizes LBJ biographer Robert Caro's extensive research on the matter at https://slate.com/news-and-politics/2007/07/how-lady-bird-and-lyndon-baines-johnson-came-by-their-millions.html.