THE GE Insulin Coverup
Letter From a Reader on Biosynthetic Human Insulin
by Lynne Born

Thank you for your excellent and important article on genetically engineered (GE) insulin [“A Significant Minority,” GeneWatch Volume 16 Number 6]. I would like to offer a few additional comments. I have been researching this dangerous drug for almost two years, and am a published author on pharmaceutical fraud. I have also been working with a large group of people, both in the United States and Canada, who have tried every conceivable avenue for the past fifteen years to restore animal insulins to the market.

The title of your article is "A Significant Minority." In fact, we do not know how many diabetics are negatively affected by GE insulin. Dr. Tauscher, 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 people with diabetes are affected. In his studies (which were independent of drug company influence) he found the numbers of diabetics who could not switch from animal to GE insulin to be 36% and then 66% — hardly insignificant and not a minority. And Dr. John Hunt, who works in Canada, was a participating doctor in one of the drug company-sponsored studies comparing animal and GE insulin; he found that users of the latter became unstable in the morning, and had to increase the number of injections they take each day — results which were suppressed and never published.

Ms. Romano's article mentions the ninety deaths, six hundred hospitalizations, and four thousand 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 fifty deaths worldwide over a period of several years, while the ninety deaths Ms. Romano mention happened in only twenty-two months in the United States alone.

Eli Lilly uses the poor ADR reporting system in the U.S., as approved and run by the FDA, to hide the negative effects of GE insulin. Not only is the reporting system for adverse effects entirely voluntary, but ninety to ninety-nine percent of all adverse reactions are never reported. Forty percent of all doctors don’t even know that an adverse reporting system 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 on the “honor system.”

In a profound conflict of interest, even as marketing departments attempt to bring sales of a new drug to “blockbuster” status, these same marketing departments are 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.

Finally, not only was GE insulin the first genetically engineered drug approved by the FDA, it was also the first drug to be fast-tracked through to approval. As far as we can ascertain, all pre-approval tests were done on very small numbers of patients, as few as eight or twelve per study. Further, even in these very small trials, the most prominent ADR — loss of warning signals — was apparent. The FDA and drug companies knew that 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. Furthermore, approval was predicated on Eli 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 head of a special department created to establish new procedures for approving drugs created through biotechnology. 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, especially when it had been tested on so few people. Amazingly, Miller states that he waited for his boss to go on vacation, and then took the approval to his boss' boss, who then approved the drug.

The longer this situation continues, the fewer diabetics remain who can testify to their decades of problem-free use of animal insulin, without any hospital visits or diabetic emergencies. It has now become commonplace 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. Doctors and patients now believe these complications are simply part of the disease, and that the disease has become worse, rather than understanding that GE insulin is not stabilizing the patient. ‘Dead in bed’ syndrome (the unexplained deaths of young people with Type 1 diabetes) is up 350% since the introduction of GE insulin — yet another easily observable fact that seems to be lost amid the pharmaceutical companies' rush to profits.

Lynne Born has been an independent medical researcher, writer and alternative health care activist for over 20 years. She has compiled a considerable collection of files, articles and records on genetically engineered insulin. If anyone wishes to delve further into this situation, and she can be of assistance, please contact her at thegrail@pacbell.net.