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.