Eli Lilly Plans Withdrawal of Insulin in Canada; Diabetics Not Happy

Animal-based insulin is becoming increasingly difficult to find in the West, and Eli Lilly recently announced plans to stop selling animal-insulin in Canada. That decision has brought on the anger of a number of diabetes charities who accuse the drug company of putting people ahead of profits in withdrawing the animal-insulin.

Until the early 1980s, all insulin was either beef or pork-based. But in the early 1980s, synthetic insulin began to get approval in Western countries and has gradually displaced animal-based insulin. Synthetic insulin has a number of advantages, including that it is cheaper to produce, has fewer impurities, and its is more-or-less identical to human insulin.

But some users of animal-based insulin claim that the synthetic insulin causes any number of side effects, and that it gives them better awareness of impending low blood sugar.

Comparative studies between the two, however, have tended to show that synthetic insulin is just as safe and effect as animal-based insulin, and avoids the potential of an immune response that is a risk with animal-based insulin.

Source:

Diabetics fear loss of animal insulin. Don Harrison, The Province, July 22, 2005.

PCRM Develops Animal-Free Insulin Assay

Physicians Committee for Responsible Medicine reported in February that it had worked with BiosPacific and Linco Research to develop an insulin assay that measures insulin levels in individuals without relying on animal products.

PCRM president Neal Barnard said in a press release that PCRM needed to conduct insulin assays as part of a study of the effects of vegan diets on type 2 diabetes. Barnard said,

We only had two options available to us when we began our diabetes trials. One, we could use test kits with insulin antibodies grown in vivo — literally from cells injected into the abdomens of live mice — or we could use kits containing antibodies from cells cultured with fetal calf serum. Neither was acceptable to us.

So PCRM’s Megha Even worked with California lab BiosPacific to create an animal-free replacement for the fetal calf serum, and then with Linco Research created a test that uses antibodies cultured in the non-animal serum.

According to Barnard, details of PCRM’s non-animal assay will soon be published in a peer-reviewed journal, and the non-animal test will be made available commercially,

We hope that by making the test readily available and competitively priced, researchers and medical labs will use it. We have proven that if researchers are willing to make the effort, there are effective, humane alternatives to animal-based assay, and other testing procedures — alternatives that could help save the lives of millions of people and animals.

Source:

PCRM develops world’s first cruelty-free insulin assay. Press Release, Physicians Committee for Responsible Medicine, February 9, 2005.

First Successful Live-Donor Islet Cell Transplantation Procedure

In February, the BBC reported that a team at Japan’s Kyoto University Hospital had succeeded in transplanting islet cells from a healthy woman into her 27-year-old diabetic daughter.

Islet cell transplantations have been performed before, but always from dead organ donors, which created a number of problems since the islet cells were frequently damaged after the death of the donor. And in countries as Japan, dead organ donors are extremely rare.

As the BBC notes, this could be an effective treatment for Type 1 diabetes, and we have animal research to thank for this advance.

That islet transplantation might be used to treat diabetes was first established by Dr. Paul Lacy who used a rat model in which he made the experimental rats suffer from diabetes and then transplanted islet cells from healthy rats. The rats were effectively cured of their diabetes.

How important was this animal research? Dr. James Shapiro was the lead surgeon on the team that transplanted the islet cells. In an interview, he said that a key at DiabetesStation.Com, Shapiro noted that animal research was instrumental in helping researchers understand where the islet cells should be transplanted to for maximum effectiveness,

The idea to use the liver was not mine. Experiments in rats, in large animals, and eventually in people all suggested that the liver was about the only site where islets could take well and work in people.

Sort of odd how that could happen if animals are too different from human beings for animal research to be applicable to human health problems.

Sources:

Living donor diabetes transplant. The BBC, February 4, 2005.

Islet Cell Transplant. Dr. James Shapiro, April 13, 2003.

World-first living donor islet cell transplant a success. Press release, University of Alberta, February 3, 2005.

Mouse and Rat Research Leads to Compound that Might Treat Human Diabetes

Scientists at pharmaceutical company Hoffman-La Roche recently published the results of their research into a compound that boosts production of insulin while simultaneously reducing the release of glucose.

The compound, referred to as RO-28-1675, binds to the glucokinase enzyme. In rats, it boosted glucokinase activity thereby resulting in an increase in insulin production. The compound also increased glucose usage by the liver in both mice and rats, causing glucose levels in the animals to fall.

Hoffman-LaRoche researcher Joseph Grimsby was quoted by Scientific American as saying,

By turning on glucokinase, this novel compound improves insulin secretion by the pancreas and stimulates glucose usage by the liver, both of which are abnormal in diabetes.

If this RO-28-1675 has the same abilities in human beings, an oral version of it could someday replace insulin shots. Human clinical trials of the drug are, however, likely years away.

Source:

Drug shows promise as diabetes pill. Scientific American, July 21, 2003.

Researchers Keep Diabetic Monkeys Alive for 70 Days Using Pancreatic Cells from Pigs

A University of Minnesota researcher presented the results of his successful xenotransplant of islet cells from pigs into monkeys at the American Transplant Congress in June.

In research sponsored by Immerge BioTherapeutics, Dr. Bernhard Hering transplanted pancreatic tissue from pigs into monkeys who were not capable of producing their own insulin. Drugs were used to prevent the monkeys’ immune systems from rejecting the pig cells.

That is not news — cross-species transplanting of islet cells has been performed before. What was new was that as of June the monkeys in Dr. Hering’s experiment had kept producing insulin from the pig islet cells for more than 70 days,

We have been able to reverse diabetes in past islet studies, but we had only seen two or three-week survival times before the graft was lost due to the overwhelming rejection response. The survival times we are reporting on today should only increase as we further optimize the immunosuppressive regimes.

Which, of course, gets us one step closer to the possibility of one day transplanting non-human islet cells into human beings to treat diabetes.

Source:

Pig-to-monkey transplants may herald cure for diabetes. Steve Connor, The Independent (London), June 4, 2003.

Does Milk Cause Diabetes?

In a recent e-mail dispatch, Robert Cohen went on at length about the evils of Abbott Laboratories for Pediasure, a nutritional supplement marketed for children ages 1-10.

Cohen writes in his inimitably bizarre style,

Child abuse comes in many forms. Pediaphiles [sic] are child abusers. Pediatrics is the field of medicine dedicated to childhood diseases. The most respected pediatrician to have ever lived, Dr. Benjamin Spock, advised that no child should ever drink cow’s milk, Pediatricians who advise mothers to feed their children bovine secretions can be classified as ignorant child abusers.

. . .

A visit to Abbot Lab’s website reveals a company that is big on diabetes medicines. How ironic. One of the major components of Pediasure is whey protein. The most abundant protein in concentrated whey powder is bovine serum albumin.

On July 30, 1992, the New England Journal of Medicine reported:

“Studies have suggested that bovine serum albumin is the milk protein responsible for the onset of diabetes.”

The claim that bovine serum albumin is a major cause of Type 1 diabetes is one that is repeated incessantly on animal rights web sites, but the reality is a lot less dramatic.

The 1992 NEJM study that Cohen refers to involved Finnish and Canadian researchers who discovered that children with Type 1 diabetes that they examined turned out to have elevated levels of anti-BSA antibodies. In the Finnish case, 100 percent of the children with Type 1 diabetes had high levels of anti-BSA antibodies.

Most animal rights sites tend to cite only this study. They never cite Jill Norris’ 1996 study published in the Journal of the American Medical Association which, unlike the 1992 report, had a control group.

Norris and others examined 253 children from families that were genetically prone to Type 1 diabetes, and tested them for beta-cell autoimmunity, which is a common precursor to diabetes. Eighteen children had beta-cell autoimmunity. She then added a control group of 163 children who were BCA-negative as a control group. The results?

There were no differences in the proportion of cases and
controls who were exposed to cow’s milk or foods containing cow’s milk or to cereal, fruit and vegetable or meat protein by 3 months or by 6 months of age. These data suggest that early exposure to cow’s milk or other dietary protein is not associated with BCA. This calls into question the
importance of cow’s milk avoidance as a preventive measure for
IDDM.

Part of the problem with the few studies that have found a connection between early exposure to milk and diabetes is that they may not have included accurate information about when infants first consumed milk. Norris specifically constructed her study to minimize this problem,

Our study was designed to overcome what we perceived as limitations in the collection of infant diet information of the previous research. Specifically, we shortened the amount of time that parents had to remember their child’s infant diet, which would likely improve the accuracy of the information. Also, we collected the diet information from the parents before they knew whether their child had beta-cell autoimmunity. Previous studies had collected this from parents of children who already had diabetes, and it has been suggested that parents of sick children respond differently to questions such as these than parents of healthy children.

These improvements in the collection of the infant diet may explain, in part, why our findings are contrary to those of previous studies, which have suggested a 60% increased risk of diabetes if the child had been exposed to cow’s milk by 3 months of age.

In some of the studies that found a link between milk consumption and diabetes, for example, parent were asked to recall their children’s eating habits as infants more than 10 to 15 years after the fact.

Other studies that have looked at infants have come to largely the same conclusion as Norris. University of Florida researchers Mark Atkinson and Noel Maclaren, for example, found that only 10 percent of newly diagnosed diabetics had anti-BSA antibodies. Atkinson wrote a 1996 article for The Lancet outlining the methodological problems with studies that found a link between early milk consumption and diabetes.

Not surprisingly, Robert Cohen has on occasion cited articles by Atkinson suggesting that Type 1 diabetes is an autoimmune disease, but Cohen conveniently leaves out any citations to Atkinson and Maclaren’s debunking of the milk hypothesis.

One of the major outcomes of research into whether milk or a virus or other environmental factors cause Type 1 diabetes has lead many researchers to the conclusion that the disease does not have a simple, one-factor cause. Instead, Type 1 diabetes is likely a combination of genetic and environmental factors of which milk may or may not play a part.

As Atkinson pointed out in his Lancet article, however, there is clear epidemiological evidence that milk does not play the sort of key role that animal rights activists like to pretend. Finland, Atkinson pointed out, consumes about twice as much milk as Sardinia does, and yet the two countries have similar rates of Type 1 diabetes.

Sources:

Not so sure about Pediasure. Robert Cohen, Notmilk Newsletter Digest, May 29, 2002.

Florida Researchers: Formula-Fed Babies Are Not At Greater Risk For Diabetes. Melanie Fridl Ross, University of Florida, May 29, 1996.

Cow’s Milk Not Linked to Type 1 Diabetes. ChildrenWithDiabetes.Com, August 28, 1996.

Follow-Up to Cow’s Milk Not Linked to Type 1 Diabetes Report. ChildrenWithDiabetes.Com, September 14, 1996.

Electronic Food Rap. Bill Evers, PhD, RD and April Mason, PhD, VOL. 6 NO. 43, 1996.

NOTMILK – – – SHARE THIS WITH A DIABETIC FRIEND. Robert Cohen, August 24, 2000.

The Diabetes Research Pipeline. Robert S. Dinsmoor, Juvenile Diabetes Foundation, Summer 2001.

Common Class of Viruses Implicated as Cause of Type 1 Diabetes. Thomas H. Maugh II, Los Angeles Times, 1994.

Milk & diabetes. Judy Ismach, Physicians Weekly, Septebmer 15, 1997, Vol.XIV, No.35.