1. The last animal-sourced insulin sold in the U.S. was Lilly's Iletin (porcine insulin), which was discontinued by the company at the end of 2005.

The FDA permits patients who have allergies to rDNA human insulin (some patients get hives from it), but patients must now seek FDA permission to import animal insulins from the UK and elsewhere in the world. The UK is perhaps the most reliable source, but others have also obtained it from Argentina or even India. Its possible to import porcine [and bovine] insulins on a personal importation basis from Wockhardt UK, but the process requires a letter from a doctor in the US stating that pork insulin is essential teatment. Canada has approved the sale of imported, animal-sourced insulin, therefore some Canadian pharmacies can sell it to Americans without much difficulty.

The Insulin Dependent Diabetes Trust (IDDT), a UK-based organization has identified a Canadian pharmacy that will provide Americans with Hypurin Regular Pork and Hypurin NPH Pork insulins by ordering online without a doctor's letter and without all the other form-filling! It has been used successfully by a number of American consumers.

If you need porcine insulins, here are the details:

Order online at:
http://www.getcanadiandrugs.com

Pharmawest Pharmacy
101 20560 56 Ave
Langley, BC Canada, V3A 3YB
USA Toll-Free: 1-877-530-0799
USA Toll-Free Fax: 1-877-530-0700

The pork insulins are:

- Hypurin Regular Insulin PORK
- Hypurin NPH PORK
- Manufactured by Wockhardt UK Ltd.

Posted at 8:19AM on Apr 16th 2007 by Scott

2. BTW, I forgot to mention that since I was diagnosed in 1976, the only insulin available at that time was animal-sourced insulin and I used it successfully for about 18 years. When I switched to rDNA human insulin, I found that the symptoms of hypoglycemia were nowhere close to as noticable, and apparently IDDT cites several UK-based studies confirming this.

Posted at 8:32AM on Apr 16th 2007 by Scott

3. Hi Scott,

http://www.thediabetesblog.com/2007/04/17/is-human-synthetic-insulin-a-cock-block/#comments

post#9; 3rd paragraph...

Warm thanks; Nick

Posted at 3:31PM on Apr 21st 2007 by Nicholas Dynes Gracey

4. Allie,
I appreciated reading your blog. It sounds like we're on a similar path. I've been doing a lot of research on the same topic, having been on GE Human Ultralente (UL) insulin for about 10 years and now needing to switch to something else since UL's been discontinued.

On the question of diabetes control you raise between animal and GE human insulin, there is an excellent Cochrane Review dated January 25, 2005, entitled "Human insulin versus animal insulin in people with diabetes mellitus (Review)". The IDDT site mentioned in one of the responses does an OK summary of it, though I found it very helpful to read in its entirety. If you're not familiar with the Cochrane Database, this is THE research to watch for evidence-based care. I obtained a copy of this particular review from our local university's health library for the cost of the print-out. The focus behind Cochrane reviews is that they look at all of the research that's been done on a particular topic and qualify it for the quality of evidence and summarize the best evidence-based care. Their review on animal vs human GE insulin clearly shows that the push to put people on genetically engineered human insulin was not based on safety or efficacy. All of the reasons for switching people have proven to be false (e.g. an expected worldwide shortage of animal insulins, that genetically identical insulin will create no antibodies, etc.) The vast majority of the research that's been done on the topic is of 'C' quality (poor methodological quality) and a full 70% of the research that was done and used to support the switch to GE human insulin was done by the manufacturers themselves. The research as a whole says that A1Cs drop an insignificant 0.1% on GE human insulin; but, as pointed out by the Cochrane review, if you look at the quality 'B' work only (which was largely not done by the manufacturers), the A1C results are the same between animal and GE human insulin. The short answer: there's no difference in control between animal and GE human insulin.

On the study you mention (which I don't have, but will obtain), here were my thoughts. The length of the trial was good. Most trials are too short, and as the antibody levels seem to peak and then fall after 6 months or so, the trials need to be longer to pick that up. But, even so, the results you cite were not fully consistent with the research I've read. What I've read is that with bovine insulin, the antibody levels are significantly higher, with porcine, they're the same or somewhat lower. The Cochrane Review states that beef insulin was associated with higher insulin antibody levels than pork or human. And in one study comparing bovine, porcine and GE human, porcine produced a 60% lower antibody response than did GE human and a 900% lower response than with bovine. Despite the numbers, I'm not sure yet how to read them. (Is the 900% really "bad" or is the actual antibody level still so small as to be clinically irrelevant?) (Reference: Immonogenicity of bovine, porcine and semisynthetic human insulin, Neth J Med 28 (1985).)

In your blog, you also mentioned that the antibodies are responsible for "killing your islets". I'm not sure if this is true, although it might be akin to splitting hairs. I don't think it's the antibodies, per se. If it were, Faustman's work wouldn't make sense. (She's thinking the presentation of diabetes is caused by a virus. (By the way, her office through Massachusetts General Hospital sends out a newsletter on their progress which is helpful to obtain. You can also get on their waiting list to participate in their human trials, which are expected to begin soon in Boston.) Have you found a paper that really nails that concept down, i.e. that antibodies kill your islets? From what I've read, the clinical significance of the presence of antibodies seems to be speculative. I've seen research on both sides. While it seems logical to me that the antibodies are a bad thing, I can't find any proof that what you wrote is actually true, and to avoid bovine insulin for that reason.

On your comment that it would cost big pharmaceutical companies more to manufacture highly purified porcine insulin, I couldn't agree with you more. It's clear that their move to GE human insulin was strictly a profit move. In the UK, upon public outcry, the government stopped the manufacturers from discontinuing the manufacture of the non-GE insulin products (on grounds that pregnant women can't use Lantus and Detemir, that Lantus and Detemir can't be diluted for children, that Lantus has increased mitogenicity problems (read: it could cause cancer), that there are no longer term studies on their safety, and on and on.) But, here in the U.S., companies are for-profit, period. Who cares if people could get cancer (simply put: that's not their problem unless it negatively hits their bottom line).

For me, the more research I do, the more I can say, there's no way I'll put Lantus in my body. Same with Detemir since it's only been on the market since 2005. No history, no way. (Can you say Vioxx?) For basals, that leaves porcine isophane or GE human NPH, which I'm still considering, if I consider a 3x or 4x a day shot regime to get a better profile. I hate using NPH, but might be willing to try it again.

The IDDT (IDDT.org) is excellent and I've contacted Wockhardt directly to learn how to do the personal importation of porcine insulin. On their website, they outline how to go about doing personal importation. (I'd love to hear from others out there who have actually done it to see how long it took from start to end.)

I also wanted to mention one other uuuugggllly stat: the diabetic death rate has increased 244% since GE insulin was introduced. Since hypo unawareness has been reported to occur more often with GE insulins and death by hypo is often mistaken for heart failure, it is plausible that death by hypo is primarily responsible for the increase. From 1980 thru 2002, the number of hospital discharges for heart failure as the 1st listed diagnosis and diabetes as the 2nd diagnosis increased dramatically from 97,000 to 334,000, or 237,000, an increase of 244%, while deaths from heart failure declined for the rest of the population. Here are the stats from the CDC.
a. 1982 Death Rate: 14.9/100,000 (only animal insulin available)
b. 1983 GE insulins introduced. Death Rate: 15.5/100,000.
c. 1995 Beef insulin discontinued. Death Rate: 22.6/100,000.
d. 1996 Diabetes Definition lowered (% diabetics increased, diluting death rate) Death Rate: 23.3/100,000.
e. 1998 Beef/Pork discontinued. Death Rate: 24/100,000
f. 2002 Death Rate: 25.4/100,000 (increase of 244%)

The citation given for these stats is http://www.cdc.gov/diabetes/statistics/cvdhosp/hf/table1link.htm. While I haven't pulled the stats myself yet, I know the source well, and I think it's valid.

Posted at 1:52PM on May 2nd 2007 by Kelly