A conservative news and views blog.

Location: St. Louis, Missouri, United States

Friday, January 06, 2012

Where has all the Animal Insulin Gone?

Timothy Birdnow

As regular readers of this website know, I am suffering from heart failure, and was hospitalized back in september and October. I am also a Type II diabetic and controlled my diabetes with pills - primarily Metformin. My doctors took me off that drug (and other pills) because they were no longer working and because they are all hard on the heart, and I began taking Lantis, a long-lasting form of insulin.

Because my health insurance has a thousand dollar deductible for drugs alone, I was begging Lantis from the doctors, hoping to get through until this year's deductible was met. (Not all that hard, given the vast cocktail of pills I am required to swallow every day.) Unfortunately I ran out and so did my doctor; the drug reps aren't coming around much with freebies. The price at the pharmacy for Lantis? $214, and that for a FIVE DAY SUPPLY!

I called the doc, who prescribed Humulan, an older synthetic insulin. I have to go to Walmart to get it (which I hate; the place is far, it's always a zoo, and customer service is terrible at the pharmacy) but I can pay for it out-of-pocket.

But I discovered something very odd. Prices are far higher than they have any right to be for insulin, and that makes no sense, as this drug has been around for 90 years. I looked into the matter, and the mystery deepend.

In 1922 the first human subject was given insulin, and it saved his life. In 1922 a Canadian boy named Leonard Thompson received shots of the new experimental insulin developed by two researchers - Frederick Banting and Charles Best - and miraculously recovered. Prior to 1922 Type I diabetics went into a coma and died; that was the inevitable progression of the disease. Shortly thereafter Banting and Best (who were truly in it for humanity; they sold the patent on insulin for $1 to get it on the market quickly and save lives) went to a Canadian sanitarium where diabetic children were stacked like cordwood, awaiting death while in comas. There were hundreds packed into the sanitarium, and the doctors began at one end and worked their way across the vast room. It was miraculous; by the time they were a third of the way through the first children were awakening! A miracle drug had been discovered!

Of course, Best and Banting developed insulin with the help of ground-laying work by others:

As with most major scientific discoveries, the groundwork for the discovery of insulin, had been laid by

several others before the Canadian researchers isolated it. In 1889, two European researchers, Minkowski

and von Mering, found that when the pancreas gland was removed from dogs, they developed all the symptoms

of diabetes and died soon afterwards. Minkowski and von Mering proposed that the pancreas was crucial for

sugar metabolism.

Later experimenters narrowed the search to the Islets of Langerhans-clusters of specialized cells within

the pancreas. In 1910, Sharpey-Shafer of Edinburgh suggested a single chemical was missing from the

pancreas in diabetic people. He proposed calling this chemical "insulin," and later the successful

Canadian researchers took him up on the suggestion.

Meanwhile, an American scientist E. L. Scott was partially successful in extracting insulin with alcohol.

R. C. Paulesco, a Romanian, made an extract from the pancreas that lowered the blood glucose of dogs. Some

claim Paulesco was the first to discover insulin.

The biggest breakthrough came in 1921 when Frederick Banting and Charles Best conducted a series of

experiments one summer in the laboratory of J.J. R. Macleod at the University of Toronto. Like Minkowski

and von Mering, they showed that removing the pancreas from dogs made them diabetic.

Then they went a step further and painstakingly took fluid from healthy dogs' Islets of Langerhans,

injected it into the diabetic dogs and restored them to normalcy - for as long as they had the

extract.With the help of a biochemist colleague named J. B. Collip, they were then able to extract a

reasonably pure formula of insulin from the pancreas of cattle from slaughterhouses"

End excerpt.

(The Islets of Langerhans are cells within the pancreas that produce insulin; they have to be extracted from the rest of the material of the gland and the fluid extracted.)

There were problems with animal insulin, although developments made insulin better and easier to use. Some had allergic reactions, although improvements in purification techniques largely fixed that. Methods were developed to make the insulin act more slowly in the body (such as putting an ingrediant from the sperm of whales, of all things into the mix). Animal insulin became better and better. And a great many different types of animals could be used. In Japan they often used sharks to produce it.

Animal insulin had been the norm until drug manufacturer Eli Lilly developed a synthetic insulin using bacteria and recombinant DNA techniques in 1980, and the FDA approved it's use in 1982. They stopped producing animal insulin in 2005.

And here we are in 2012, some thirty years after the advent of synthetic insulin, and there is no generic on the market! What is worse, there is no longer any animal insulin available anywhere in the United States.

The first part seems to be quite strange; generics generally appear as soon as the patent for a drug expires. But in the case of insulin the FDA refuses to even begin to entertain a pathway to cheap generics.

Consider this:


"Insulin guidelines would need to answer one basic question: whether generic insulin manufacturers can use

the usual generic shortcuts to approval. When generic manufacturers copy standard drugs, they aren’t

forced to repeat the exhaustive clinical testing that the drugs went through to get approved in the first

place. All they need to prove is that the generic version contains the same active ingredient as the name

brand, in the same purity, quality, and strength. The generic maker isn’t forced to start from scratch and

re-prove the drug’s safety and effectiveness. This shortcut is called “piggybacking” on the clinical

studies originally done by the drug company that invented the drug.

FDA Guidelines are a No-Show

Because the FDA has not supplied guidelines to the generic companies on how to achieve approval of generic

insulin, they don’t know what to do. Can they piggyback or not? The FDA said in 2001 that it was

developing guidelines for approving generic insulin, but it never did. Now the FDA says that it no longer

plans to issue guidelines for each biologic medicine, one by one. Instead, it’s announced that it will

develop global guidelines applicable to all biologic generics, from simple insulin to the latest super

proteins. This announcement has caused a lot of protest because such complex guidelines would take much

longer to produce than a single set of guidelines targeted to insulin alone.

No Piggybacking for Biologics, Says the BIO

Some say the FDA’s foot-dragging has been influenced by lobbyists from the Biotechnology Industry

Organization (BIO), which represents the biotech pharmaceutical companies. The BIO says that the shortcuts

awarded to conventional generic drugs don’t apply to biologics, even simple ones like insulin. According

to the BIO, the critical element in regular drugs is simply the active ingredient, but for biologics, it’s

different: it’s all about the little creatures in the manufacturing process, and that’s much more complex.

Just Give Us A Guideline

For safety reasons, Novo Nordisk and Lilly both oppose the FDA allowing generic insulin to piggyback

without repeating clinical studies. But generic drug makers note that biologic insulin has been around

since the eighties. It’s relatively simple, they say, and costly clinical trials would only raise the

price prohibitively high. They concede that the approval process for generic biologics should be more

stringent than for conventional generic drugs. They just want some guidance from
the FDA so they can get started."

End excerpt.

One can blame Big Pharma till the cows come home (or fail to in this case; bovine insulin is strangely missing) but it does not explain why there is no cheap animal insulin available.

I hunted high and low, and nowhere could I find a reason. Nowhere. Not that there isn't a demand for it; I've seen all sorts of web threads where former users of porcine insulin are desperately seeking it. A number of porcine users have bad reactions to the synthetics (despite the fact that the synthetics were said to be the cure for allergic reactions) and are desperate to obtain it. It can be mail-order purchased from overseas (where it is still produced in some minor quantities) but it's not made by anyone here in the States.

This violates the fundamental laws of economics in a free market system; someone who isn't legally allowed to produce a generic of the synthetic would make animal insulin as competition. It would be cheap, so many would buy it. I most certainly would.

Yet it is nowhere to be found. Why?

In some of the message threads I've read it has been speculated that this is "old technology" like the phonograph, and that we can't get it for that reason, but this doesn't address the fundamental point of price. Old tech is no longer available because it's too much trouble to make and new tech is as cheap to produce. This is not the case with insulin, which is an absolute necessity to Type I diabetics. You just need a slaughter house, some alcohol, and a centrifuge to make animal insulin. It's much easier to produce than the synthetic. People are desperate to purchase it, and it will definitely save lives, yet it is completely unavailable. I want to know why!

I smell a rat, and I suspect that rat resides inside the government of the United States.

Competition lowers prices, and if the FDA won't approve a generic insulin then they should not block the older animal version. I couldn't find any evidence that they ARE blocking the animal version, but then we would have it if they weren't. I suspect the animal rights crowd has a hoof in this.

If anyone has any information on this, please let me know. I think we may have a major untold story here - and perhaps even a major scandal?

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