- The photos mentioned are included in the transcript below.
- Kaplan’s National Inventors Hall of Fame induction.
I’d like to tell you the story of a man who wasn’t satisfied with mere success. He took Uncommon Sense to a new level in order to help others.
Welcome to Uncommon Sense. I’m Randy Cassingham.
Sheldon Kaplan got his degree in mechanical engineering from Northwestern University in 1962 and, like many engineers during that era, got a job with NASA. Hired by the Goddard Space Flight Center in Maryland to design hardware for satellites, he moved to a contractor company in 1965, where he still worked on NASA projects. One of his first tasks was to design an emergency medical kit for the Apollo program.
The company had other government contracts too: he also designed something called the PneumoPak, a pressure dressing for high-altitude reconnaissance pilots. Starting to see the pattern here? Medical technology: Kaplan liked to be a part of saving lives by coming up with solutions that helped solve problems.
The company had another device that just wasn’t working out. It was called the AtroPen, designed to administer drugs in the field. To keep it rugged, the drug to be dispensed was held in a stainless steel capsule: that meant only drugs that could be kept stable in steel could be used, and there were other mechanical issues. Kaplan set upon completely redesigning the device from scratch — and figuring out how to use glass to hold the drugs: glass is the gold standard in injectable drug storage, which also enabled users to see the drug to ensure the right amount was there, or to see if it was discolored or cloudy.
Why was the device needed? In the 1950s, a new chemical weapon was starting to be developed: organophosphate nerve agents. There are a couple of antidotes for it, but obviously they must be administered pretty quickly to save the victim. That meant, for instance, that soldiers needed to carry the antidotes with them, and be able to inject themselves quickly should the antidote be needed, rather than wait for a medic to arrive to help. So the entire package had to be self-contained, stable over time, stay sterile until use, be relatively fool-proof, and be injectable through clothing. That’s a tall order, especially in battlefield conditions.
But when Kaplan was done, he met all of the objectives. It was called the ComboPen, because there were two auto-injectors, one for each of the drugs. The U.S. military called the package the Mark I NAAK, or Nerve Agent Antidote Kit, which is pictured on the Show Page. It works against nerve agents like Sarin and VX. Survival Technology received a patent on the device in mid-1977, with Kaplan shown as the lead inventor. The diagram of the thing is a study in complexity: I have that on the Show Page too.
But once that process was done and the contract satisfied, Kaplan had already realized there was another application for the auto-injector he invented: one that could have much wider application and save the lives of a much larger number of people. It may have already dawned on you what other drug needs to be delivered quickly from a package that is self-contained, stable over time, sterile until use, relatively fool-proof, and be injectable through clothing. That’s another tall order, especially for, say, kids, in playground conditions.
Epinephrine, otherwise known as adrenaline, is the emergency antidote for anaphylaxis, or the out-of-control allergic reaction that develops in at least two percent of the population. Anaphylaxis sets in quickly, leads to shock, and rapidly becomes life-threatening when airways start to swell and cut off breathing. Even the 5-10 minutes it takes for an ambulance too arrive could well be too long.
So Kaplan re-purposed that same device that he developed to save soldiers from nerve gas to something much more civilian in nature: the EpiPen — the Epi being short for epinephrine. In about a third of cases where the EpiPen is used, the reaction is bad enough that a second dose is needed. By the time it’s needed, it’s pretty likely an ambulance can be there with more epinephrine to give a second dose. Some who know they have particularly severe reactions will often carry two doses themselves.
Kaplan, who liked to invent medical devices to help save lives, looked beyond his assignment for the military. Rather than just find a solution to one specific problem, he applied Uncommon Sense to his job to extend the solution he came up with to another pressing problem — one that certainly has a lot more victims to save on a day-to-day basis. Kaplan’s EpiPen was approved by the FDA in 1987, and has since saved countless lives: millions and millions have been sold. And when you look at the EpiPen that was used through the rest of the 20th century and beyond next to a Mark I nerve agent kit, you can see the two devices are essentially identical, other than the drug inside.
“Shel was proud to know that his invention had affected tens of millions of people, had kept them alive,” said Kaplan’s wife, Sheila, after his death in 2009 from liver cancer, at age 70. She says that on their third or fourth date, when she was 24 and he was 30, she and Sheldon talked about their life goals. “I want to do something that’s going to leave the world a better place than when I got here,” he had told her. “Being an engineer working in medical products, I think I can do that.”
And, Sheila said, “He really did accomplish what he wanted to do.”
Once Kaplan finished that work, he left Survival Technology to work at other companies that let him continue to develop medical devices. He eventually retired to Florida and, the Tampa Bay Times noted, he “died in obscurity.”
“He was very analytical but also very creative,” said his son, Michael. “He could deconstruct and fix any problem if he understood the mechanics. ‘Give me a shot at it,’ he’d say. ‘I’m an engineer.’”
So what is someone like Kaplan like? “He was not ego driven,” Michael says. “He didn’t spend time trying to figure out how to do things that were flashy or that would make him famous. Every day he was committed to solving important problems that no one else could.”
And indeed Kaplan wasn’t famous, though in 2016, well after he died, Kaplan was inducted into the National Inventors Hall of Fame. He didn’t get rich, either: Survival Technology owned the patent, and the EpiPen has bought out by company after company over time. “He was not wealthy,” confirmed his son Michael, who ought to know. “And,” he continues, “I don’t think he would’ve liked to be. I don’t think he expected that.”
Yet the device Kaplan invented for the government is now being used to make money for someone else. A drug company called Mylan bought the rights to the EpiPen in 2007, and they have been relentlessly boosting the price to squeeze money out of insurance companies who are pretty much obligated to pay for this lifesaving device. What was well under $100 for a two-pack in 2007 now costs as much as $700, and Mylan has been clever in marketing, even lobbying Congress to pass a law requiring schools to have them on hand. By 2015 their sales reached $1.5 billion per year, accounting for 40 percent of the company’s profits. All for a device that delivers a drug that costs about a dollar, and was funded by taxpayers.
Ironically, the cost is now so high that ambulances are more and more carrying plain syringes and vials of epi to administer the drug, just as was used in the old days before the EpiPen. It’s not all that difficult to train someone to use a plain syringe, just like insulin-dependent diabetics do several times per day. It’s how I, as a medic in my rural community, carry it: I’ll put a photo of that on the Show Page too. It’s slower to use than an EpiPen, but in addition to the massive cost savings, the vial and syringe system allows for multiple doses to be given if needed: a tiny vial holds about three adult doses.
And no doubt, Sheldon Kaplan would have just shaken his head in amazement.
Meanwhile, military personnel going into areas where nerve agents are considered a hazard are still issued autoinjectors, though Kaplan’s original design has since been updated to deliver both antidotes in one shot, one right after another. But even with that improvement, you can bet the government doesn’t pay several hundred dollars apiece for them! Because after all, American taxpayers paid for it all up front.
Just a quick note that I’ll be on travel again next week for a class, and there won’t be a new episode next week.
For links and photos related to this episode, the Show Page is thisistrue.com/podcast32, where you can also comment.
I’m Randy Cassingham … and I’ll talk at you later.