Eli Lilly Correspondence

Eli Lilly Correspondence

CORRESPONDENCE BETWEEN
THE DIABETES ACTION NETWORK OF THE NATIONAL FEDERATION OF THE BLIND AND ELI
LILLY AND COMPANY

by Ed Bryant

Long-term VOICE readers have no doubt been

following the progress of our campaign to convince insulin manufacturers to incorporate

tactile markings on insulin vials, so that blind diabetics, and those losing vision, could

reliably distinguish between their slower and faster-acting insulin types. We have been

pursuing this worthwhile goal for years.

Eli Lilly and Company is the biggest manufacturer

of insulin for the U.S. market. Until late 1998, they seemed interested and cooperative,

and put in a great deal of time and effort toward this goal. Then their progress seemed to

fizzle.

On October 16, 1998, I wrote to Eli Lilly, asking

them why there had been no more movement toward our goal. I invited them to respond, and

told them I would publish my letter and their response in the VOICE.

Eli Lilly's response reached my office
on March 5, 1999, too late to appear in the VOICE April edition, Vol. 14, No
2--but I keep my promises, so here it is, followed by my response of April 12:

Thane Wettig
Eli Lilly and Company
Director - U.S. Diabetes Care
Indianapolis, Indiana

March 1, 1999

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

Dear Mr. Bryant:

As stated in your letter, Eli Lilly and Company

and Roche Diagnostics have just introduced a combination device called Accu-Chek(TM)

VoiceMate(TM), primarily designed for insulin-taking patients. Thanks to the input of many

individuals, including yourself, the VoiceMate System meets an important patient need,

namely the dual capability of identifying insulin type and monitoring blood glucose in the

same device. This advancement fulfills a promise Eli Lilly and Company made in 1992 to

make it easier for the visually impaired patient on insulin therapy to identify the type

of insulin in a vial.

Since January 1999, all seven human insulin vial

formulations manufactured for sale in the United States by Lilly have a unique bar code

designed to activate a voice synthesizer in the VoiceMate System when placed into the

device. This allows patients who use Lilly insulin to identify the type of insulin they

are about to administer, providing patients peace of mind in knowing that they have the

correct insulin for their injection. This effort was strongly supported by everyone who

offered input during the early stages of our commitment to help resolve the needs of our

visually impaired customers. Thank you, Mr. Bryant, for your input and support of this

significant milestone. Comments we have received from patients have been positive.

I also want to address your comments regarding

tactile markings. Lilly has discontinued the project due to a number of significant

manufacturing and quality concerns.

To protect patient safety, Lilly has a corporate

goal of "0% defect" in our manufacturing processes. In addition, as required by

the FDA, Lilly may not knowingly produce, manufacture, and/or market a pharmaceutical

product that may be identified incorrectly or mistaken for another formulation or product

type. Despite significant effort and investment, we can not consistently produce a

tactile-coded label which meets the required specifications. As a result, Eli Lilly and

Company cannot guarantee that a visually-impaired, insulin-using patient could read the

label with 100% accuracy which could result in potentially serious medical consequences,

an outcome I am sure you would agree is not desirable. The technological advances required

to institute a reliable tactile coding system would necessitate years of additional

research to overcome such issues.

In addition, tactile markings have not been

delayed "because someone thinks the new machine (VoiceMate) will make them

redundant." In a parallel development process Lilly and Roche/Boehringer Mannheim

have co-developed the VoiceMate System with bar-coded Lilly insulin vial labels. This

device has been reviewed and cleared by the FDA and qualifies for reimbursement by

Medicare (as you know, persons who are legally blind qualify for Medicare reimbursement).

Because of the fail-safe mechanisms built into the VoiceMate System, this option will

afford visually-impaired people with diabetes a reliable method of identifying their

insulin product, thereby allowing greater autonomy and flexibility in their diabetes care.

Also, the vials with a bar code offer an advantage over vials with tactile markings. The

bar code will accurately identify each formulation by name whereas the tactile method only

identifies four time-action profile categories (i.e. rapid, fast, intermediate and

mixture).

I apologize for the delay in responding to your

letter and I hope we have answered your questions. I sincerely thank you for your input.

Please feel free to contact me with any other questions you may have.

Thane Wettig

* * * * * * *

Ed Bryant, President
DIABETES ACTION NETWORK
NATIONAL FEDERATION OF THE BLIND
Columbia, MO

April 12, 1999

Thane Wettig, Director
U.S. Diabetes Care
Eli Lilly and Company
Indianapolis, IN

Dear Mr. Wettig:

Thank you for your letter of March 1, 1999, in

which you attempt to address my concerns about your company's abandonment of the promised

tactile markings on insulin vials. It is an understatement to say that I am disappointed

in Eli Lilly and Company.

As you may know, I started the push for tactile

markings on insulin vials in 1992. I have written, conversed with, and had meetings with

officers of your corporation, your insulin-manufacturing competitor Novo Nordisk

Pharmaceuticals Inc., and officials from the U.S. Food and Drug Administration. I have

consulted senior members of the American Association of Diabetes Educators, and senior

officers of CCL Label Corporation, a well-known pharmaceutical labeling firm. I have

surveyed blind diabetics. I am fully aware of all aspects and viewpoints.

You speak of the Accu-Chek Voicemate. It is

indeed a fine instrument, the most advanced blood glucose monitor for the blind or those

losing vision available today. I use it, and I often recommend it to health professionals

and other blind diabetics. However, its existence is almost irrelevant to the issues I

have been raising for the last seven years. Without in any way disparaging the Voicemate,

or your company's initiative in developing an electronic voice-synthesized barcode reader

to identify insulin types, allow me to respond to your "facts."

My "input," until the Voicemate was

almost ready for market, consisted of trying to push all parties toward placement of

tactile cues on the insulin vial label, so that any blind or visually-impaired insulin

user could differentiate between insulin types, without purchase of any new equipment. I

was not a party to the planning of the Voicemate (though I heard rumors), and in fact, in

1995, I was offered the chance to see the project (then known as "Code Blue") if

I would sign an agreement to write nothing about it until November 1 of 2001. I judged the

agreement ambiguous and restrictive, and refused to sign it--so your company did not show

me anything! Between October 1995 and April 1998 I contributed nothing to the Voicemate,

though I have always made myself available to Eli Lilly and other diabetes-related

manufacturers. In my October 31, 1995 letter to James A. Harper, President, Endocrine

Business Unit, Eli Lilly and Company, I stated: "I believe we, blind consumers of

adaptive medical equipment, have a lot to offer you, the firms who design and manufacture

such equipment. By freely interacting with us, by enlisting our experience in the design

process, we can help you create truly useful products."

I wish you had seen fit to accept that advice.

What is wrong with the electronic bar code

reader? It is expensive, it is limited to Lilly insulins only, and it is not the

"worldwide, universal system" we have been discussing for the past seven years.

When we, the National Federation of the Blind,

Eli Lilly, Novo Nordisk, CCL Label, the FDA, and others sat down to talk in Washington,

June 3, 1997, Lilly Representative Dr. Jerry Buehler made it clear to all that Lilly was

tired of the delays, and was going ahead with the plan. My response was to offer Lilly

free publicity for their new tactile labeling system (an offer I extended to Novo Nordisk

if they would do the same). No one took my offer.

Then came the Voicemate. Yes, it is a fine

product. Yes, I applaud your (and Roche Diagnostics') efforts in producing it--but however

excellent a meter it is, it does not address the questions we have been asking. They still

need answering.

As to your assertion that a tactile labeling

system acceptable to the FDA was not possible, CCL Label Representative Mr. Jack Gilroy, a

label-making professional just as you are a pharmaceutical professional, Mr. Wettig, stood

up in front of Lilly, Novo Nordisk, the FDA, and the rest of us, and asserted that such

was possible, and that his company could guarantee it. No one contradicted his statement.

Is it not a bit late to do so now? He even flew to Lilly headquarters in Indianapolis, but

found your firm disinterested (you were perhaps already committed to the Voicemate?).

Another point: The FDA told all of us that as

modifications to a vial's label were not directly covered by Federal Regulation, and as

the proposed modifications would in no way interfere with labeling protocols already

established, they, the FDA, would be lenient in the matter of error rates. There was no

push for "zero defects."

As to where I got the idea that Lilly had put the

tactile-markings project on hold, in favor of the Voicemate, look to your own

representatives! I quote again in part from a letter I received from a Registered

Dietitian, a member of the American Association of Diabetes Educators (AADE), who visited

the Lilly booth at her organization's national convention in Minneapolis, in August of

last year, and there inquired of the tactile vials. In her words: "The gentleman I

spoke with (and I can't remember his name) says they are going to be holding off until

they see how the marketing of the new Voicemate meter goes..." (And I had included

this information in my letter to Eli Lilly of October 16, 1998.)

In that same letter I asked why, if you were

indeed having so much difficulty, you did not ask for another meeting, to explore

alternatives such as slightly lower or shorter tactile bars? Again, why did those

"difficulties" not emerge until the Voicemate was ready to go on line?

Your people were so cooperative, and so

forthcoming, up to the point the Voicemate was ready for market. Then you "blew us

all off." I think you understand now why I am disappointed with Eli Lilly and

Company.

Most sincerely,

Ed Bryant