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Alan Mackenzie wrote:
> Sbharris[atsign]ix.netcom.com <sbharris@xxxxxxxxxxxxx> wrote on 11 Sep
> 2005 16:14:52 -0700:
> >> Colleen Fuller:
>
> >> A 2002 Cochrane review of the evidence on recombinant human insulin
> >> (Richter B, Neises G. 'Human' insulin versus animal insulin in people
> >> with diabetes mellitus (Cochrane Review). In: The Cochrane Library,
> >> Issue 3, 2002. Oxford: Update Software) found that "At the time of
> >> introduction of human insulin, marketing strategies suggested that the
> >> lower immunogenicity of human insulin and the anticipated decline in
> >> antibody titres would offer a clinical advantage for insulin-treated
> >> patients". This appears to have been a "theoretical" advantage, not a
> >> real one.
>
> > COMMENT:
>
> > The Cochrane Review's point of view is that the human insulins were
> > introduced into the market without adequate long term safety and
> > efficacy testing. That's surely a matter of taste.
>
> No. It's a matter of clinical judgement. The difference being that in
> matters of taste, yours and mine are just as valid as anybody's.
COMMENT:
Not really in this case, since I'm a doctor and you're not. I saw a lot
of pateints changed from animal to human insulin in the 80's without
real problems. Some people did complain of shorter actions, but this
was usually fixable by adding more long-acting to the mix. And usually
wasn't as a bad as individual variations on different days, anyway.
> > But the review's suggestion that it was somehow mere "marketting
> > strategies"[!] that "suggested that the lower immunogenicity of human
> > insulin and the anticipated decline in antibody titres would offer a
> > clinical advantage for insulin-treated patients," is nonsense!
>
> I read that review once. Nowhere do I remember them mentioning
> market[t]ing stragies. As for "suggesting" them - Any such suggestion
> would have been in the minds of the readers.
COMMENT:
Well, I do remember it, and it's quoted by Colleen above. So unless you
can find a copy of the review on the web, we'll just have to leave it
at that.
> > At the time, no endocrinologist (involved in marketing or not) guessed
> > otherwise (if you want to argue that, find me the cite). Nor did the
> > Cochrane Review suggest (before the fact) that it might not be the
> > case. This result took EVERYBODY by surprise: industry, academia,
> > practising physicians and patients, alike.
>
> This is the sort of reason why most drugs have to undergo proper testing
> before being introduced. Why genetically engineered insulin was allowed
> to be an exception is the real mystery.
COMMENT:
It was testing in all kinds of ways. You can look at medline at the
many studies of human insulin in the mid 80's. You think it should
have been tested more. So? Diabetic complication and mortality studies
take a LOT of time and money. Those weren't done for most of the
various animal insulins until decades after introduction. Or quality of
life studies, either. You want a completely different standard here for
GE products. I don't think it's warrented.
> > It's simply the usual socialist boloney For Cochrane to blame this odd
> > outcome and failure to se the future, in retrospect, on some capitalist
> > mechanism. Where were the non capitalists of the time, in opposition?
>
> Cochrane restricted its discussion to purely medical and scientific
> matters. Nowhere did it mention political matters.
COMMENT:
We've been over that. If they said what they are quoted as saying, as I
believe they did, it's an overtly political statement.
> I was there too. And my insulin was casually switched over to GE insulin
> by my doctor (A GP, not a diabetes specialist of any sort). The new
> stuff wasn't as good as the old. Unlike the drugs you are referring to,
> the were no pressing reasons to stop using natural insulin.
COMMENT:
Well, you could have gone back. At that time, where was no reason not
to.
> Quite likely, the "human" insulin molecule is not identical to the human
> insulin molicule at all; .
What makes you say that? Evidence, please?
> > COMMENT:
> > Yup. In other words, it's still a big mystery, and weird one. The idea
> > that its future posiblity, 20 years ago, might have been rationally
> > used to uphold the development of a multi-billion dollar industry, is a
> > completely out-to-lunch idea. We'd still be waiting for human insulin.
>
> No, we wouldn't. There were people then who were allergic to pork and
> beef insulin, just as there are people now who are allergic to GE
> insulin. Other than for those few people, there was no need for GE
> insulin. It would have been developed (and nobody's suggesting it
> shouldn't have been) simply because it's much cheaper to get insulin out
> of a tampered-with tummy bug or yeast cell, than out of a slaughtered pig
> or cow. The real mystery is why the regulatory authorities were asleep
> at the wheel, and allowed it to be introduced withoug being properly
> tested.
COMMENT:
It was as well tested as any of the things it was competing against,
and far better than insulins were tested during the first half century
they were used.
Let's see you find me a quality of life study for beef vs. pork insulin
done prior to 1985.
> No. "Marketing strategy" here means forcing diabetics to convert to a
> drug more profitable for the manufacturers, regardless of how well it
> works. Willbill has pointed out on this newsgroup (misc.health.diabetes)
> that bovine products are used in the manufacture of Lantus, for example.
I can't find that cite. Cite please? I don't believe it.
> > On the basis of *what* BSE-centered studies of beef insulin
> > manufacture? How much looking at the issue has anybody really done?
> > Where is COCHRANE'S concern about safety issues when we really need
> > them?
>
> Do we really need them? Beef insulin has been used continuously for
> decades, all through the BSE scares of the last ten years. The
> manufacturers are careful in the extreme, where their bits of cow come
> from. If BSE in insulin were a problem, wouldn't we know about it by
> now? There'd already be a few hundred deaths from this cause, wouldn't
> there?
COMMENT:
Maybe. Maybe not. BSE in people (vCJD) took some time to show up in the
beef eating population, and they never did pin it all down. Where the
beef comes from to make insulin may not be the same places. How do you
know what the epidemic looked like in those years and how careful the
manufacturers were? Can you trace your bottle of beef insulin back to
the herd it came from, and when? And do they have tests on those cattle
on file? Are these German beef? It's all a bloody awful problem, and
far more difficult than the food problem.
> Anyhow, what about the same measures applied to Lantus, for example? It
> too uses beef products in its manufacture, and is used by far more people
> than beef insulin.
Again, I want to see evidence of that. If they just get the arginine
from beef, that's a chemical. In THAT case, the prion, as protein, is
surely destroyed. So it hardly counts with injecting one protein with
another, the way they used to do with human growth hormone. Which DID
give people CJD.
> Which raises the much bigger philosophical question, should we diabetics
> be expected to have to chose from amongst whatever drugs Novo, Lilly and
> Aventis find profitable to make? That is pretty much the way things are
> at the moment. The other extreme would be for regulatory bodies to
> specify rigidly what products are to be made. Doesn't seem much better.
> The real problem is, the supply of insulin is a monopoly, not a free
> market. If I had my way, there _would_ be a free market, one in which
> the existing monopolistic powers would be severely curtailed.
COMMENT:
I'm a libertarian. I think it should be entirely a free market, though
perhaps with some UL-like safety inspection or
kosher-certification-like inspection, which you demand in your products
if you like.
I do realize there are some orphan drugs and orphan diseases. That's
what charities are for. There are some odd allergies. But there are
many different human insulins from many sources.
Finally, I doubt that semi-synthetic pork insulin will ever disappear.
So you'll always have that.
> When I needed an insulin change a few years back, my last doctor told me
> "convert to Lantus, go onto the pump, or stay with GE NPH[*]. I refuse
> to even consider animal insulin.". I found a more suitable doctor.
>
> [*] For those not in the diabetic groups, NPH is a delayed action
> insulin, delayed by protamine extracted from fish testicles, and is
> notorious for causing symptom-less hypos (low blood sugar), and having an
> enormous action peak around 4-6 hours after injection. YUCK!!
COMMENT:
Curious: Where are you getting your long acting beef insulin without
protamine in it? I suppose it would be beef lente or ultralente? Not
PZI or isophane.
> There was, and is, however, massive and incontrovertible anecdotal
> evidence that GE insulin produces problems for many people. There is no
> convincing evidence and no reason whatsoever to believe that GE insulin
> is free of problems.
COMMENT:
"Massive and incontravertable anecdotal evidence." Sigh. Why can't we
get one of these people into a laboratory? Does the effect go away?
I'm not saying it can't be true. I'm just wondering why it's not better
documented.
> > Authors' conclusions
> > **A comparison of the effects of human and animal insulin as well as of
> > the adverse reaction profile did not show clinically relevant
> > differences.**
>
> Yes. As you mention, most of the testing was poor quality, and didn't
> take into account quality of life issues. Tell me, in treating a chronic
> disease, is there anything apart from quality of life which is worth
> testing for?
Nothing, but quality of life is highly susceptable to placebo issues.
Which means you need to do it in the hospital, blinded.
> > Meanwhile, you want the entire system to change because of a couple of
> > hundred diabetics, who say they don't get the same results with the new
> > stuff as the old.
>
> It's not a "couple of hundred". It's many, many thousands, probably
> millions, worldwide. You're dismissing their problems as something
> frivolous. Amongst them are a few who are allergic to GE insulin, who
> will die rapidly and nastily without natural insulin. One of them is
> called Sabine Hancl and posts here (misc.health.diabetes) from time to
> time. Her worst experience was being admitted to hospital in an
> emergency and being injected with GE insulin, despite her wearing a
> medical tag stating her allergy to it. Within hours she was on the brink
> of death, with kidney failure amongs other things. She spent a year in a
> psychiatric clinic as a result.
COMMENT:
A good story, but human insulins are made in at least three organisms.
Which one is she allergic to? Also, by the way, anybody who spends a
year in a psych clinic due to an allergy might have needed the psych
clinic to begin with--- did you ever consider that? It's not a usual
result. (Neither, by the way, is renal failure). Do you believe all
stories you hear on the web?
> In this particular case, natural insulin works better for many people,
> amongst them me. There has never been any convincing evidence that GE
> insulin works consistently well.
There is convincing evidence all over medline. Look it up.
> For many people, the difference between
> natural insulin and artificial is the difference between being a fully
> functional healty person and an invalid, barely able to hold down a job.
Sez you. Let's see this effect double-blind.
> The production of natural insulin is fully economic and profitable. I do
> not find it unreasonable to require it to be manufactured.
I do if it's not profitable. And if it is pofitable, you won't need to
require it.
SBH
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