TACTILE INSULIN VIALS:

TACTILE INSULIN VIALS:

TACTILE INSULIN
VIALS: AN ONGOING SAGA
by Ed Bryant

In the last issue of VOICE OF THE DIABETIC, Vol. 12, No. 3,
I reported that, on June 3, 1997, the third meeting had been held at the Food
and Drug Administration (FDA), between insulin manufacturers, government regulators,
and interested consumer groups. We went to these meetings to push for change
in the current insulin vial labeling system, the one that only distinguishes
between vials of R, N, L, U, mixtures, or quick-acting Humalog, by print on
the label. Blind diabetics and those losing vision find the system dangerous
and discriminatory, requiring sighted aid or reliance on impermanent markers
such as rubber bands or tape. It was and is too dangerous to continue.

In our series of meetings, we reached a

consensus that all U.S. insulin vials should be marked with a

tactile code of one through four horizontal bars: a single bar

for the "rapid-acting" types like Humalog, two bars for

"Regular" insulins, three bars for mixed insulin

preparations (70/30 and 50/50 in the U.S.), and four bars for the

longer-acting insulins: NPH, Lente, and Ultralente.

The FDA agreed. Insulin manufacturer Eli Lilly

and Company agreed, and made it clear they were "ready to

go" with the four-bar system as soon as official permission

was given to do so. Vial label manufacturer CCL Label agreed, and

stated they had the technology to produce the labels, and that

label reliability ("robustness") could be 100%

guaranteed. All consumer groups present agreed, including the

watchdog ISMP (Institute for Safe Medication Practices), the

Juvenile Diabetes Foundation, the American Council of the Blind,

the American Diabetes Association, and the American Association

of Diabetes Educators. Of course we, the Diabetes Action Network

of the National Federation of the Blind, started the ball

rolling.

The only naysayer was Novo Nordisk

Pharmaceuticals Inc., the huge Danish insulin manufacturer. In

past VOICE articles, I reported how Novo has repeatedly sought

more time "to test alternatives," how they failed to

keep their commitments to complete research and deliver findings

to the FDA on time, and how they clung to an alternative system

("dots on the vial caps") long after all other meeting

participants had found that system inadequate.

As the June 3 meeting closed, we seemed to have

reached

a consensus. Novo could take its case to the

International Diabetes Federation meeting in Helsinki, Finland,

but if there was no major outpouring of resistance to the U.S.

plan, the four-bar system would become a requirement for insulins

sold in the United States.

The FDA agreed to let all participants know, by

fax on or about August 1, whether or not there was cause for

further delay. They did not do so. On August 13, I finally

reached Dr. William Berlin, chair of the June 3 meeting, who

stated he had been out of the country. He reported he "had

not caught up yet," had much more to read, but he thought

he'd seen a note from Novo Nordisk asking for yet another delay.

He promised again, to let all meeting partcipants know the

outcome. As of today (August 28) I have heard nothing further

from Dr. Berlin, and I have no idea what Novo may have said to

him.

Novo tried, as I've mentioned, to bring their

European "dot on the cap" system into the U.S. market,

but the coding couldn't carry enough different messages, and

wasn't pronounced enough to fill the needs of blind users. Novo

also pushed hard to have their Novolin System insulin pens and

prefilled syringes designated as "tactile-coded," but

again consumer groups found their markings inadequate (as did the

FDA, who require all insulin pens sold in the United States to be

packaged with the warning "Not for use by blind or

visually-impaired persons without sighted aid").

Some time ago, when a four-bar system of

tactile insulin vial codes was first proposed, CCL Label created

"mock-ups" of tactile labels, and sent them around for

comment (I got some too). Since that time, Eli Lilly has

perfected both the labels and the manufacturing technology

necessary to produce them, test them, and ensure their

reliability. At the June 3 meeting, both Lilly and CCL declared

their readiness to proceed.

But not Novo Nordisk. With arguments that left

me confused, Novo declared that they were not satisfied with

either the robustness or reliability of the tactile bars. They

claimed, there at the June 3 meeting, that approximately one

percent of their test labels failed. They then passed around a

sample, "proof of failure," that turned out to be part

of the mock-up sent them by CCL Label, over a year before, meant

to show conformation of the proposed system, not its durability!

When CCL Label set the record straight, and

declared they had developed the labels into a system they could

test and would guarantee, Novo seemed astonished. A Lilly

representative then stated his company had performed "rather

rigorous testing" of labels, that they had satisfied

themselves THE TACTILE BARS WERE MORE DURABLE THAN THE PRINTED

LABEL, that they had even soaked the vials in alcohol, destroying

the printed label, "without the bars falling off," and

could find no evidence of damage to any of the tactile codes. A

Novo Nordisk representative admitted his company had not

developed a single specific test protocol to determine label

reliability.

I couldn't believe it. How can one sit there

and proclaim statistics, or declare percentages, without a test

protocol to produce them? No findings are any more reliable than

the tests used to generate them. Not to slight Novo Nordisk's

perfectly valid questions about label reliability, but the

answers they offered were not straightforward, to say the least.

So where did that leave us? Novo agreed to

accept the four-bar system, if there was no outcry to the

contrary at Helsinki. They have not come back to us, or to the

FDA, claiming the weight of world opinion. In fact, they've been

rather scarce of late.

The FDA has not been much in evidence either.

Although they promised to let all participants know whether they

could proceed (as I discussed above), they have not done so.

Eli Lilly and Company indicated its acceptance

of the system, and its readiness to move forward, a long time

ago. Dr. Jerry Buehler, part of Lilly's delegation to the

meetings, told me:

We had no problems going in, and we...were

satisfied with the outcome. I think they [the FDA] were waiting

only for any potential objection from Novo. I'm assuming since we

haven't heard anything, that there are none. We [Lilly] are

proceeding ahead... on our own pace to go ahead and implement

this... We're going ahead with everything just as we would have

planned.

As I mentioned in earlier articles, the

"Code of Federal Regulations" (CFR), does not

specifically address the issue of tactile markings on vials of

injectable medication. Because of this, FDA regulators have

declared that the long process of regulatory change could be

greatly accelerated in this case. The FDA even agreed to allow

one company to proceed in advance of the other, once they issue

formal permission.

But while we wait, the misdosages continue. The

midnight ambulance rides continue. The threat of death remains

with any serious hypoglycemic episode. All credit to Lilly for

tiring of the wait, but we're still waiting for the FDA to issue

a definite opinion that they may proceed. And whatever Novo

Nordisk is doing, in my opinion it does not reflect concern or

respect for diabetics in the United States.

I hope to have more positive input soon.