1. A letter signed by a US licensed Physician or Practitioner with their name, address, & phone #, who takes responsibility for your diabetic treatment with beef insulin. Stating that the insulin sold in the US doesn't effectively control your diabetes and that he will notify Wockhardt if there are any unusual bad effects caused by the insulin. Note, all insulin causes hypoglycemia sometime.
2. An Import Permit from the U.S. Department of Agriculture (USDA) to assure compliance with their requirements.
Fax 1-301-734-4952 x 1001 & 1005.
Phone 1-301-734-3277
3. An order form from Wockhardt. Go to www.wockhardt.co.uk/export/usa.asp
4. Your signed letter stating that the bovine insulin is for your use only.
Go to the Wockhardt web site for more specifics.
Copies of the above documents are required to be attached to every shipment. Keep the originals. Fax all the completed forms to Wockhardt's export department.. You can import up to a 6 mo supply. You aren't allowed to sell it. It is only allowed for your personal use. Wockherdt will check your papers & charge card & usually ship in 1 to 1.5 weeks. It takes about 2 to 3 days to clear customs & another 2-3 days to arrive on your door step. Wockhardt will give you a tracking # if you ask.
Q1 How can I obtain beef insulin for my personal use?
A. You may be able to import beef insulin for your personal use from a foreign country, if you follow the FDA and USDA requirements in items 1-4 above. After your shipment of beef insulin arrives in this country, the United States Customs Service will notify FDA. FDA then will decide whether or not to allow the shipment to enter the country. No orders have been blocked by the FDA when accompanied by the required paperwork.
Q2 Why can't I obtain beef insulin manufactured in the US?
A. Eli Lilly stopped making Iletin-1 (a combination beef-pork insulin product) in November 1998 & pure beef Iletin II in 1995. Although other types of insulin are available in the US, including human insulin and pork insulin, no FDA-approved insulin derived from beef is available in this country. If you need or want it, It must be imported as per items 1-4 above. [Pork cost $45 in 2003. It was $18 in 2000]
Q3 What is the FDA hypothesis blocking the approval of market availability causing the requirement for one to import beef insulin for personal use only?
A. They claim there is a possibility that it can cause bse. However,there is no threat of bovine spongiform encephalopathy (BSE) Mad Cow Disease transmission found through the use of beef insulin even if derived from a cow contaminated with the BSE agent. No one in the world has ever caught bse from injecting beef insulin.
Wockhardt makes their beef insulin from US Cattle. Also, manufacturers producing beef insulin for sale in foreign countries do not have to comply with FDA requirements. Wockhardt has passed all the FDA test with hi marks. It appears that the FDA is trying to scare you. This sad situation is costing many insulin dependent diabetics to have ill health and a shorter life. www.diabetictypeone.org/Charts,%20Stats%20&%20Policy1.html
Q4 What's the problem?
A. FDA claims that beef insulin is an unapproved new drug in the US. However, it was sold in the US for 78 years, until Lilly tore their plant down thus discontinuing Iletin I Insulin production,,,,, for ECONOMIC REASONS.
1. The FDA refuses to approve foreign made beef insulin, using the Mad Cow Disease hypothesis to block trade of this life giving non prescription 83 year old drug.
2. The FDA staff can use discretion and allow importing of unapproved drugs with certain conditions such as personal importation of recently unapproved beef insulin, that is medically necessary and not sold in the US.
3. The USDA and FDA have made up a hypothetical MadCow beef insulin scare for your protection? And it is this hypothetical MadCow (BSE), CJD and vCJD scare tactic working to block access to the life giving drug.
4. Many are sick or have died because of the USDA/FDA's hypothetical interference.
5. The disease is not transmitable via beef insulin. If your diabetes can not be treated with human or pork insulin (2006 not available in the US), FDA can allow you to import beef insulin for your own use only.
6. At the present time neither Beef or pork (not as effective but it works for the t1's) insulin is available at your local pharmacy.
7. Cloned Human insulin is available at your local pharmacy but it is injurious to a large minority and has never been proven to be better than Beef Insulin.
8. Pork is only a little better than Human cloned insulins. At this time 2005 the only animal insulin product available in the United States is Iletin 2 pork, NPH or Regular via special order from some pharmacies. 2006 Pork insulin is no longer available in the US.
9. Insulin dependent diabetics must have insulin to stay alive. Synthetics are better than nothing but results of the existing insulin treatment today in the US is my complaint.
Q5 What is required before I can import beef/bovine insulin?
A. Must have the paperwork required by the FDA and USDA. The hardest part is the Dr. letter, few doctors will sign the necessary letter. The doctors believe the lie that everyone can successfully take human insulin and many blame the patient's lack of self control rather than finding fault with the synthetic insulins. So you have to find a doctor that will, understand the need and sign the necessary letter. {Please read the CLONED HUMAN INSULIN page.}
Wockhardt's Hypruin Bovine Insulin is the only source of Beef/Bovine Insulin approved by the FDA for import. It is all nonsense but required if you need beef insulin. I am struggling to change this horrid scenario. {Please read the Cloned Human Insulin page}. Will you help support my efforts
Please, please, please pay no attention to the FDA's mad cow scare or accept the scary negatives included in their web sight and don't miss the word 'possible' in front of mad cow disease (there is no evidence of said possibility). If you care to be coerced at the FDA/CDER beef insulin web site. Go to www.fda.gov then search for beef insulin
Be aware that there is more risk of BSE 'prions' in human insulin (made with cattle brain) than than there is in natural beef insulin made with insulin from the pancreas of cattle. Beef insulin can't cause BSE.!
If you are not sure about the import proceedure
http://www.fda.gov/cder/drug/beefandporkinsulin/default.htm
EMail - floridacracker@ij.net
Margie Baker, manager
Diabetic Type One Org.
