DIF-HOME INDEX

Our thanks to GeneWatch, Megan Romano and Lynne Born for their diligent work on this issue that is of paramount concern to all diabetics world wide.

Dear GeneWatch and Megan Romano,

Thank you for your excellent and important article on genetically engineered insulin ("GE insulin"). I would like to offer a few additional comments, if I might. I have been researching this dangerous drug for over a year, and am a published author on pharmaceutical fraud. I have also been working with a large group of people both in the US and Canada who have tried every conceivable avenue for the past 15 years, to restore animal insulins back onto the market.

The title of the article is "Significant Minority" - in fact, we do not know how many diabetics are negatively affected by this drug. Dr. Arthur Teuscher, whom you reference in your footnotes and who is probably the world's foremost expert on this situation, did two independent studies on how many diabetics are affected. In his studies (which were independent of drug company influence), he found the numbers of diabetics who could not successfully switch from animal to GE insulin to be 36% and then 66% hardly insignificant and not a minority.

Further, Ms. Romano's article mentions the 90 deaths, 600 hospitalizations and 4,000 Adverse Event Reports (ADRs), which Ms. Romano got from FOIA information that was received by diabetic activists. To put this in perspective, the cholesterol lowering drug Baycol was pulled from the market after 50 deaths worldwide over a period of several years, while the 90 deaths Ms. Romano mention happened in only one year, and in the United States only. Additionally, one of the many people I have been working with, submitted a FOIA request on animal insulin that covered the same time period. While the ADRs from the FOIA on GE insulin that Ms. Romano references is several inches thick, the FOIA on animal insulin contained no deaths and was only 28 pages long.

Eli Lilly uses the poor ADR reporting system in the US, as approved and run by the FDA, to hide the negative effects of GE insulin. As you probably know, not only is the adverse reporting system entirely voluntary, but 90 to 99 percent of all adverse reactions are never reported. Forty percent of all doctors don’t know that an adverse reporting system even exists. And no program or oversight of any kind exists to ensure that reports made directly to the pharmaceutical companies are then reported to the FDA—the process is run entirely by the “honor system.” Another of the diabetic activists who has been working to get/keep animal insulin on the market was completely unable to handle GE insulin and found herself in the hospital within 12 hours both times she switched, only to restore her health and equilibrium virtually immediately upon switching back to animal insulin. When she tried to report her ADRs to Lilly, both times she was told "that didn't happen to you, that doesn't happen on this insulin," and Lilly refused to take her ADR report.

And as you may also know, in a profound conflict of interest, even as the marketing department attempts to bring sales of a new drug to “blockbuster” status for potential billions of dollars per year, it is this same marketing department that is responsible for tracking and reporting the ADRs that would take their multimillion-dollar investment off the market. Clearly, this is a system designed to fail with no incentive for change, since the end result produces massive profits for the pharmaceuticals.

And finally, not only was GE insulin the first genetically engineered drug which was approved by the FDA, it was also the first drug to be fast tracked through to approval. While most sources say that approval was given in 5 months, we obtained the original FDA and Lilly approval information from 1982, through another FOIA. In fact, the drug was actually approved in less than 2 1/2 months, and was tested on fewer than 400 patients. All of these tests were done on very small numbers of patients, such as 8 or 12 patients per study. Further, even in these very small trials of only 8-12 patients, the most prominent ADR - loss of warning signals - was apparent even in these tiny studies. This means that the problems were immediately apparent, even in such small numbers of participants, and that the FDA and drug companies knew that these types of high percentages of negative effects were present. These numbers should have been extrapolated upwards, to account for the larger numbers of people who were going to take GE insulin. And further, approval was predicated on Lilly specifically following several of the participants who had experienced negative effects. Lilly was supposed to provide additional information on the negative effects to maintain approval. We have not located any evidence that this was ever done.

Henry I. Miller was an early advocate of biotechnology and drugs. He began work for the FDA as the head of a special new department set up by the FDA to set up new procedures for approval of drugs created through biotechnology. He set up a special conference in 1980, two years before this first approval, in which several drug companies participated and papers were submitted setting out the various developmental and scientific problems that the companies were facing, especially in purifying the drugs for production. I have copies of these articles. I would be very interested in a scientist reviewing these articles, to see if the problems that were set out before approval are the very same problems that patients taking the drugs now, are facing. Additionally, this conference shows a lack of objectivity and a predisposition on the part of Miller, towards approval, even before the problems the conference set out were solved.

In his book To America's Health: A Model for Reform of the Food and Drug Administration (Hoover Institution Press, 2000), Miller states that he pushed for rapid approval of GE insulin from his boss, who was not comfortable approving it on such short notice and when it had been testing on so few people. Amazingly, Miller states in his book that he waited for his boss to go on vacation, and then took the approval to his boss' boss, who he pushed to approve it during his boss' absence, which he did!

The longer this situation continues, the fewer diabetics remain who can testify to their problem free use of animal insulin, often with decades of use with absolutely no hospital visits or diabetic emergencies. It has now become common place for young diabetics placed on GE insulin to experience the kinds of complications that diabetics used to experience only after many decades of insulin use (in their 50', 60's or 70's). Doctors now think these complications are simply part of the disease, and that the disease has "gotten worse", rather than GE insulin is not working. Dead in bed syndrome is up 350% after the introduction of GE insulin, an easily observable fact that seems to be lost amid the pharmaceutical's rush to profits.

Thank you again for this extremely important and timely article. If you should wish to delve into this situation any further and I can be of any assistance, please let me know. I have compiled a considerable collection of files, articles and records on this drug, which I would be happy to discuss with anyone.

Warm regards,

Lynne Born