by Rick Mendosa
That was electrical powered, not battery operated? Right. The A.R.M. was battery operated. It was battery operated, originally with rechargeable batteries, but they had all kinds of problems. The history of the first meter, while the concept was fantastic, the first meter had all kinds of problems.
Is this written anyplace? No I don’t think so.
They brought a new level. It was somewhat less expensive. Maybe it was $300. I’m guessing.
[Per Dr. Lebinger, in 1978 the cost of the first commercially available meter, the Eyetone, was US$400.]
At this point, now we are at the very early 70s, people around the world were looking at this thing. They realized that this meter reading of Dextrostix was advantageous.
Did the Eyetone still read Dextrostix? Yes. Now the Dextrostix in and of themselves had some inherent problems. You had to wash it off, put a drop of blood on the strip, wait 50 seconds [Dr. Bernstein says 60 seconds], that was critical, then you washed it off with a stream of water, and then when you used it in the meter you had to blot it. So there were a number of steps you had to do.
These instruments all were being designed for the doctor’s office. The ability of a physician to screen patients for blood sugars was something physicians were interested in. it was a way of screening the patient base for high blood sugar and it made a lot of sense. So the developing concept was quite good, but as physicians started to buy and use them there was the strong suggestion that patients might be able to use things and do them on their own would improve their diabetes management.
Was it a prescription item? In the very beginning, not by law but by reason of the Miles legal department. They were quite conservative and when they started talking about selling them to patients the Miles legal department, and we were selling them direct, not through retail outlets, said that you are going to have to get a prescription signed by a doctor saying that they would be responsible for the training.
Were any A.R.M.’s ever sold to individuals? Yes.
When did the first individual buy one and who was that? I was wondering if you were going to ask me that because I happen to know.
I didn’t think you would. I do. It is an interesting story in itself and he is one person who I would strongly recommend that you talk to as well. Shortly after the introduction of the A.R.M. I got a phone call while I was working at Ames and it was a guy by the name of Dick Bernstein. He was an engineer and he had seen the meter at a doctor’s office or something and he had called me and said he wanted to buy one.
I told him that he would have to get a prescription and all that. He explained that he had had diabetes since he was a teenager and he was averaging one or two hospitalizations [Dr. Bernstein says it wasn’t hospitalizations. It was losses of consciousness.] a month, either in diabetic ketoacidosis or hypoglycemia, one or both, [Dr. Bernstein says it wasn’t due to diabetic ketoacidosis, it was due to hypoglycemia. One of the main reasons why I started all the blood sugar measurements was all the hypoglycemia. My family was mad at me. I made them miserable, terrified.] and that his diabetes was absolutely impossible for him to manage the way he had been managing it. So we talked a little bit. We had been discussing patient use around Ames in any case, and it turns out that his wife is a psychiatrist M.D., so she wrote the prescription for him. He got his own meter and began testing himself.
We are on the phone six times a month, I would say, he and I, just talking about his experiences. He actually laid the groundwork for much of what happened then in the United States.
But since he had started testing his own blood sugars he was no longer hospitalized, his acne cleared up, he felt better, he experienced a total change in his life. He became a zealot and went all around New York City trying to convince the diabetes guys there they ought to be doing this. He got so involved in it and went at age 47 [Dr. Bernstein says he was 45] to medical school, finished in 3 years and is now a licensed M.D. practicing in Mamaroneck, New York.
He is an old friend of mine and we talk frequently.
When was that that he was the first patient to get an A.R.M.? That was in the early 70s.
That was before the Eyetone came out in 1972? Then he got an Eyetone too. Well, he’s had one of every one that’s ever been made.
He knew the batteries were a problem with the first A.R.M. What would happen that if the batteries got weak and you didn’t realize it, you got bad numbers. So he as an engineer rewired his and made it a plug-in unit. Anyhow, he was one of the first, there was a doctor in Pittsburgh, Pennsylvania, named Ted Danowski, University of Pittsburgh, he was the first to publish a paper in a scientific journal on patient self-testing and what’s interesting was that the paper he published had less to do with the testing than they were using an insulin injector and there was some concern about whether they lost some of that insulin to spray when they made the injection. The only way they were going to know was by regularly testing the blood sugar, so they taught a group of 7 or 8 patients how to use the A.R.M.
Was that before Bernstein did? Yeah. No. It was after. What is important about Danowski is that this was the first time in the published medical literature that this idea of testing blood sugar came to the fore.
[Possibly: Danowski TS, et al.Diabetes-like glucose and insulin patterns in a control population. Bull Pol Med Sci Hist. 1971 Jan;14(1):7-12. No abstract available.]
So Dick Bernstein to our best record was the first individual to do this. Now there were dabblings here and there. For example, Dr. Priscella White at the Joslin Clinic, I think she has passed on now, she was 99 when I met her, in the 60s, right after Dextrostix came out, she was pediatric diabetologist as Joslin and she used to teach the parents of kids with diabetes how to read the Dextrostix visually and we had talked to her about publishing, and she said there was nothing to publish. It would be all anecdotal; there was no formal study, so we had gone to her for some help in establishing the concept of patient testing. Dick Bernstein gave us the first published paper on specifically home testing and then Danowski gave us the first paper published in the scientific press. Bernstein’s was sort of a memoir explaining what he did and how he did it. He later got published by Diabetes Care.
Interestingly, we are still at the midpoint of the 70s, Ames was a world-wide company and this idea sort of filtered into Europe, especially England. [Dr. Bernstein says, “It didn’t filter. I introduced it to the top endocrinologists in Europe at a meeting in Israel and demonstrated it and got them very excited. I also got the Ames sales manager for Europe and the Near East. That’s how penny-ante the whole world was in those days — one sales manager for Europe and the Near East. He was a smart guy, a nice guy, I don’t remember his name.] And surprisingly in the early years of blood glucose testing it was more advanced in England that it was here in the United States. Whether that had to do with socialized medicine over there paying for everything or whether it had to do with the way they practiced medicine, I don’t know. I have been over there many many times and I have never been able to come back with an answer.
And out of England came a new meter [Dr. Bernstein says this was the Glucochek]. And here again it was an engineer, the father of a diabetic child, saw the Eyetone and he said he could do better than that.
What’s his name? I don’t know, but somebody in the history of LifeScan would know. I would tell you why, because that was their first meter. Their first meter was developed in England by an electronics company and an electronics engineer and it had been designed to read Dextrostix, of course, and they were looking for a U.S. distribution so some folks out in California, saw this, formed LifeScan company, got the U.S. marketing rights for this meter, but the people at that time did not realize that the money in this business is not in meter. It’s in strips. But once they got their hands on them they contacted the Ames Company to private-label the Dextrostix and Ames turned them down.
In the meantime, Boehringer, the German company, Boehringer Mannheim developed a competing blood glucose strip and it was called Chemstrip bG.
Was that a small b, capital G? Yes.
People still write blood glucose that way. That was my name. I gave it that name. In the interim I left Ames and went to Boehringer just as they developed the strip. In my first couple of months on the job they showed it to me and my comment was that it was the strip that Dextrostix wanted to be, much more accurate, much easier. Now you didn’t have to wash it off. You put the drop of blood on it, you still had to time it, and then you wiped it off with a ball of cotton or Kleenex. [Dr. Bernstein says, “It was a ball of cotton, not Kleenex, because the Kleenex scratched off the coating and left too much oxygen in. Eventually they modified it so that you could use Kleenex. But with the first Boeringer strips you had to use cotton. You could not use Kleenex, it was too stratchy.] And then you read it visually. And that was an unbelievably easy strip to read visually, because you had two color reference blots, one blue and the other one was beige.
So it showed colors, rather than a number? Right. It was read visually like the Dextrostix.
Why did you make the b small and capitalize the G? That was part of my devious marketing. I wanted to worry the people at Ames Company. I left Ames on good terms, but I wanted to worry them and we started the rumor that the little b, big G indicated the first of a whole series of blood tests, bG for blood glucose, bC for cholesterol, bH for hemoglobin, and there was no such development planned.
People still very often write bG. And then do that not knowing it was just devious marketing.
Now you had two strips on the market. Right around the same time — the mid 70s — the people from LifeScan called Boehringer, they talked to me of course, and they wanted Boehringer to private-label their strip. Their instrument could be made to read either strip. They wanted to read the Boehringer strip and Boehringer turned them down.
So here you had a group of people with the rights to sell an instrument, realizing that the market was going to develop, so you have to give them credit for foresight, they then went to Japan looking for somebody to make strips for them and they found a company, and here you are going to have to get the history from LifeScan, because I don’t know it, I just know they went to Japan, found a company. The company not only made them strips but made them the instrument as well. So they never really marketed the instrument from England. Tried, very very spotty, places where they sold it for Dextrostix, but it never really caught on, and they of course to make money had to have their own strip, and that’s what they got from the Japanese. And that was the first LifeScan instrument.