ELI LILLY FAILS TO RESPOND TO EDITOR'S LETTER

by Ed Bryant

Blind and visually-impaired insulin-using diabetics have an urgent need for tactile-marked insulin vials. We at the Diabetes Action Network have been working toward this goal for a number of years. Although insulin manufacturer Eli Lilly and Company initially appeared cooperative, things have changed.

On October 16, 1998, I sent the following letter. There was no reply. On November 2, just to be sure, I sent another copy, certified. It was received. I asked Lilly to respond by December 3. As of December 16, there has been no reply.

Here is the letter:

Diabetes Action Network
National Federation of the Blind
Columbia, MO

October 16, 1998

Tom Brodie
Marketing Plans Associate
Eli Lilly & Co.
Indianapolis, IN

Dear Mr. Brodie:

I am coming to you because I am confused. Over a year ago, in June of 1997, we concluded a series of meetings in which Eli Lilly and Company promised to expedite work on a system of tactile markings on insulin vials. Nothing has happened since.

The system in question has been discussed in detail. Representatives from associations concerned with blindness and diabetes, regulators from the Food and Drug Administration, and even your competitor, Novo Nordisk Pharmaceuticals Inc., participated in the (sometimes contentious) design process. And it appeared, back in June of 1997, we had a consensus, about what kind of system we would see, and approximately when we would see it. One of Lilly's representatives at that meeting, Dr. Jerry Buehler, seemed to make it clear that Lilly was ready to proceed with the FDA-sanctioned plan. Fellow meeting participants applauded his resolve. We all waited.

On October 27, 1997, I even offered Lilly, and Novo Nordisk, free publicity for your new tactile marking systems, in the pages of VOICE OF THE DIABETIC. You responded with a phone call to my office; Novo Nordisk sent me a letter. You said: "We're working on it;" but there has been no follow up. Why the delay? Why, after publicly declaring its support for tactile insulin vial markings, does Lilly appear to be backpedaling?

I am aware that Lilly and Roche Diagnostics have developed a machine that will scan and read an insulin vial's barcode, to identify contents, and attached it to the new Accu-Check Voicemate talking glucose monitor. The meter is a fine piece of equipment—a high-tech solution to a lot of problems; but I would not like to think that tactile markings on insulin vials are being delayed because someone thinks the new machine will make them redundant!

A Registered Dietitian, attending the annual convention of the American Association of Diabetes Educators, in Minneapolis, last August, reported to me:

"We were talking with some of the representatives from Lilly. We were around that area talking to them, and I had mentioned, to my nurse friend, our concerns about what had been happening with the tactile insulin vials, and she encouraged me to ask them what was going on and where we were... The gentleman I spoke with (and I can't remember his name) says that they are going to be holding off until they see how the marketing of the new Voicemate meter goes. I asked him why that was, and that we thought the tactile insulin vials were working and were moving forward, and they indicated that there were so many problems with making sure they were going to work effectively, and he told me that there had to be a 0% room for error, when they make these tactile insulin vials. They were having some difficulty not only producing the vials, but they were concerned that so many blind people couldn't use them effectively, we would make mistakes, and then they would be in trouble.

I don't know how much of this is true. I don't know how the whole process works. It seems ridiculous that there should be a "zero percent error rate" on these vials, since there aren't 0% error rates on other medications..."

Mr. Brodie, a company representative, present at an official function, should be scrupulously careful to avoid disbursing erroneous information. The above issues were covered in depth at three FDA Tactile Label Project meetings, and Lilly was present at all of them. Recognizing that pharmaceutical label configuration is not part of the Code of Federal Regulations, the FDA is on record as "prepared to be more lenient" in the matter of error rates (which would surely be lower than the error rates for blind, visually-impaired, and sighted diabetics misdosing themselves with insulin under the current system). And, casting aspersions on "the abilities of the blind" is neither valid nor appropriate—that is a misconception—we ask merely for the tools with which to care for ourselves. Blindness is not synonymous with "inability."

I like the Voicemate. I think it is an excellent machine. But its "bar code reader" (which reads only Lilly insulins) is not a reasonable substitute for the tactile marking of all insulin vials. That is not what we discussed in our meetings with the Food and Drug Administration. That is not what we have been campaigning for. That is not what I meant, when I started this process, back in 1992. It is not the "universal access" blind diabetics need, and it is not what we agreed.

What is wrong with the idea of using a bar-code reader on the new glucose monitor? First, what of the diabetics who are NOT insulin users? Surely they have enough to purchase without paying for gear they don't need? Diabetes is not a disease of the wealthy, and as much as one would like to market to the well-heeled, all diabetics need access to safe and reliable vial identification, not just those who can pony up the approximately $500 for the Voicemate.

Eli Lilly representatives were present at every one of the Tactile Label Project meetings, and conducted research on feasibility of tactile bar codes on insulin vials. You were "ready to move," and then you stopped. Why?

If it was, as you now suggest, that you were "experiencing difficulties" with the tactile bars, why did you not get back to CCL Label, the pharmaceutical label company who assured the meeting participants it could guarantee the success of the system as presented? Why did you not ask for another meeting, to explore alternatives (such as slightly lower tactile bars)? Worse, why did those difficulties not emerge until the Voicemate was ready to go on line? I see a tremendous confusion of public safety with market share, and I wish it were not so.

I am often contacted by blind or visually impaired diabetics, who ask me about the state of tactile insulin vial markings. Doctors, nurses, and diabetes educators call to inquire as well. There is real need here—I am not the only one wanting to see this happen. I intend to write about this in VOICE OF THE DIABETIC. I will publish this letter, for our 236,000+ readers—and I will, of course, publish your response, if you would care to make one.

Mr. Brodie, we need a resolution of this issue. I hope to hear from you soon.

Most sincerely,

Ed Bryant
President, Diabetes Action Network
National Federation of the Blind