March 18, 2000Legal MurderIn the late sixties I graduated from high school while America was at war in Southeast Asia. I joined the military and went to Vietnam, honorably discharged I graduated from college. I went to work, paid my taxes, raised a family- essentially falling into the “Average American” category. In 1976 I became diabetic, a genetic disorder with no cure. Shortly after WWI Doctor Banting and his colleagues perfected an Insulin derived from the pancreas of slaughtered beef and swine. Though not a cure, treatment with Insulin allowed many diabetics to live relatively normal lives. With the advent of new genetic engineering technology in about 1980, it was discovered that “human insulin” could be produced synthetically in the laboratory. With the incidence of diabetes rapidly on the rise, this new synthetic human insulin would prevent a supposed and eventually possible insulin shortage. Because Humulin Insulin is closer in its biochemically identical to human insulin, according to Eli Lilly, the resistance and allergy factor in diabetic treatment would become considerably less. There are no studies to prove this position, in fact this hope has been disproved. Eli Lilly and Company, a pioneer and the leading US producer of beef, pork and beef-pork Insulin, immediately began producing the new Humulin Insulin. Most diabetics believe treatment with Humulin Insulin works as well as the original natural animal products. Since fewer and fewer diabetics are using the natural insulins, Lilly and Novo feel that the price of production versus revenues does not warrant further production of natural insulins. In order to stop production of natural insulins Eli Lilly was required to get FDA approval for their new synthetic insulin. In this effort Eli Lilly courted the medical community and the American Diabetes Association (ADA), but not those who would be most effected--the diabetics using natural insulins. With each of these three groups (Eli Lilly, FDA and the ADA) intertwined and each having their own political and economic agendas, Eli Lilly was given de facto approval to cease production of natural insulins after a record five month approval for the new genetically engineered insulin. Doctors and scientists in these three groups working hand in glove made their decision, in effect passing a death sentence on any diabetic unable to use Humulin Insulin. CP Industries tried to purchase US Beef-Pork Production rights from Eli Lilly. Eli Lilly refused their offer. Instead Eli Lilly, poised with bulldozers began demolition as soon as they had FDA approval to stop production of natural insulins, destroying the only facility in the United States capable of producing natural insulins replacing it with a parking lot. Desperate diabetics began trying to import Beef-Insulin from Great Britain, only to have the FDA stop this vital import until the insulin from CP Industries met lengthy and expensive FDA testing requirements. In spite of thousands of complaints, Eli Lilly contends that there are no problems with this new insulin that diabetics simply do not “want” to change. With their blunt disregard for human health and safety Eli Lilly has fabricated and is actively engaged in a campaign of lies to cover their unethical and greedy practices. I don’t believe any headway for diabetics can be made by way of Eli Lilly. Our hope lies in CP Pharmaceuticals, a company in Great Britain that continues to produce natural insulins, or any drug company willing to produce natural insulins. The FDA has received thousands of adverse reaction complaints and hundreds have complained their loved ones died because they were using synthetic insulin. FDA arguments about BSE are completely invalid as well as their small number effected argument. The FDA must be made to understand through our elected representatives that natural insulins will be available for diabetics in the United State of America. At the present time, Eli Lilly maintains that they continue to produce purified pork insulin. Once again this Insulin has benefits and drawbacks for the control and treatment of diabetes. Kept on the market for veterinary purposes, this Insulin is a very poor substitute for the original Beef-Pork I have taken for twenty-five years. The negative side effects are dizziness, nausea, headaches and extremely erratic glucose control. Without proper control I will be doomed to endure diabetic complications such as blindness, kidney failure, neuropathy and ultimately an early death. As soon as Humulin became available I found a specialist in internal medicine and made an optimistic attempt to use this new product. I tried several different approaches from mixed doses to straight shots of Humulin, not only didn’t Humulin work it acted as a poison; my system was in complete rejection. It was obvious to me as the years passed I had to try again. I felt that because most diabetics were now using Humulin, my supply of Beef-Pork would one-day stop. Five years after my original attempt I sought out a doctor who was himself a diabetic and made my second attempt to use Humulin, sadly another failure. I am once again under a doctor’s direct supervision attempting to somehow use this “wondrous” new drug. As of today the results are worse than ever. Not only does Humulin not work at all; it works against my natural insulins. Humulin creates a variety of negative side effects--simply stated it makes me deathly ill. After conferring with doctors, pharmacists and lawyers I have found that the government has a policy called the “Orphan Drug Program”. This program allows people with life threatening illness to acquire a necessary medication even though their illness is either unique or the number of persons needing this medication is very small. The government decides which medications fall into this category and then supplements the loss of profit for the providing Drug Company. Eli Lilly as a major drug company in the United States is aware of this program. They would not have lost any profit by placing natural insulins in this category. Instead they lied and sold the medical community a bill of goods allowing all diabetics to become guinea pigs on a poorly tested new drug, Humulin. This insulin is synthetically produced from e-coli bacteria. The potentials for side effects and long-term damage were never properly assessed because this drug was never suppose to be in general use unless there was an insulin shortage. I contacted Eli Lilly. After a lengthy discussion with a phone operator who had no medical expertise, I was given their official position, “the medication you are taking will cease to be produced (best of luck)!” I have asked for help from politicians and the news media to date it appears that no one cares. I am not certain exactly how many other diabetics are trapped in this nightmare, but I am certain my circumstances are not unique. An estimated 300,000 diabetics may share my dilemma. Every human life is valuable. We are desperately in need of the Orphan Drug Program. We are desperately in need of anyone who can help us achieve this end result before we result in an end! “Personal Importation” is a very poor solution to the natural insulins problem. It leaves diabetics with great expense and uncertainty, their lives in constant danger. If for any reasons this import is damaged or lost in route or at home (through fires, flood, etc.) there is no supply available anywhere in the United States. Insulin must be kept within proper temperature control or it is ruined. Shipments from Great Britain take only 2 days but FDA intervention moves that to four to fourteen or more days to arrive without refrigeration potentially producing an unusable denatured medication of great risk to anyone trying to use it to control diabetes. Within 24 hours I will die without natural insulins. The only viable short-term solution is open-importation, this would put the responsibility for a pristine product back on producers and suppliers. This insulin must be available in every pharmacy for both economic and safety reasons. Most sincerely yours,
Errol Dennis Hohrein |