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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.
The brought a new level. It was somewhat less expensive. Maybe it
was $300. I’m guessing.
[Per Dr. Lebinger at http://www.kwd.org/dteam/1997-03/d_0d_1pb.htm
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.
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