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In article <5d86gd.76.ln@xxxxxxx>, Alan Mackenzie <acm@xxxxxx> 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.
>> 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.
The suggestion has strong biological reasoning behind it.
The insulin produced by the insertion of human insulin
genes in microorganisms is identical with that made by
the persons whose genes were do introduced. It is far
easier to remove the possible contaminants. From what
I have seen, humans produce the same insulin molecule,
which is slightly different from that produce by animals
which are normally processed in slaughterhouses.
>> 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.
Humulin and Novolin are not "genetically engineered" molecules.
They are, apart from the few impurities and the additives
deliberately put in for preservatives and stabilizers.
Humalog and Novalog are genetically engineered, and I believe
had to go through a testing processes, and are still available
by prescription only. The same is true for Lantus.
>> 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.
....................
>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.
>>> "Human" insulin is not less likely to produce antibodies than pork
>>> insulin. We know why those who use pork or beef insulin produce
>>> antibodies, but it's not clear to me why antibodies result from the
>>> use of an insulin whose molecular structure is identical to the human
>>> insulin molecule. Some (Lewontin, eg.) have suggested that the folding
>>> and unfolding action that is used to produce the human insulin molecule
>>> is responsible for some of allergies and other problems associated with
>>> the resulting insulin.
>Quite likely, the "human" insulin molecule is not identical to the human
>insulin molicule at all; .
If it was not identical to the human insulin molecule, this
would be known. Biochemistry can tell us exactly where in
the amino acid chain beef and pork insulin differ from human
insulin. They could tell whether the insulin in Humulin or
Novolin is different from the insulin found in the blood of
healthy people.
>> 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.
>> And probably criticized by all the people who complain we still produce
>> flu vaccine in chicken eggs.
>>> Colleen Fuller:
>>> Novo Nordisk withdrew all of its animal insulins from the Canadian
>>> market, and most from the US market, in 1995. Novo distributed a broad
>>> range of beef, beef/pork and pork insulins (Toronto, NPH, Ultralente,
>>> Semilente and Lente, among others and in all three formulations)
>>> through Connaught. Eli Lilly withdrew all of its beef insulin from the
>>> North American market in 1998. On July 6, it announced it was pulling
>>> the remaining two types of Iletin II pork insulin.
>>> Steve Harris:
>>> Beef insulin is no longer available due to mad
>>> cow disease.
>>> Colleen Fuller:
>>> Without discounting concerns about BSE, most physicians incorrectly
>>> believe that beef insulin was withdrawn because of BSE (or antibodies).
>>> The fact is that beef insulin was withdrawn by manufacturers purely as
>>> a marketing strategy.
>> COMMENT:
>> "Marketing strategy" meaning anticipation of much stricter regulation
>> on injectables made from cow innards (the BSE prion is MUCH tougher
>> than the insulin molecule--- you tell ME how they're going to make sure
>> you get the insulin and not the prion.)
>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.
>> But you've got me. I didn't think anybody could still be that stupid as
>> to continue to produce beef insulin in this day and age, but
>> apparently, there are some people who still are.
>It's not stupid at all, and it's surprisingly simple. Beef insulin is a
>natural product of the highest quality, known from many decades of
>experience to be effective and safe (not taking into account things like
>BSE), and there is, as yet, no artificial product available to match it.
>Much the same way, I suppose, that there is no artificial product to
>match the qualities of "beef" leather. The quality of life of people who
>use beef insulin would diminish markedly, were they forced to convert to
>substitute drugs.
Beef insulin is not free of other bovine molecules. Anyone can
manufacture beef insulin, or pork insulin, or chicken insulin,
and market it, providing evidence is given of safety and effectiveness.
>> But let me put it on record here and now, WHY and think it's stupid,
>> and predict that more trouble is to come from it. And that you
>> disagreed with me.
>>> Regulators did not require its withdrawal, and it continues to be
>>> marketed in the United Kingdom (where 20% of diabetics use
>>> animal-sourced insulin), Australia, India and many, many other
>>> countries, along with pork insulin. It is safe, effective and
>>> affordable.
>> COMMENT:
>> Ahem. "Safe" you say?
>It's safe in the sense that it is known (from around 80 years of use) to
>have no long term side effects. It does not cause cancer, for example.
>The same is not yet known for recently introduced drugs such as Lantus.
>Beef insulin is also robust (it's not sensitive to hot weather), and easy
>to use (for example, it can be mixed in a syringe with other insulin).
>Put it in a fridge, and it will last the best part of a century.
You mean the same is not true of human insulin?
>> 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?
>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.
>> By the way, regulators did not require withdrawal of beef insulin in
>> the US, because they didn't need to. Companies withdrew voluntarily.
>> But the FDA does indeed have concerns about BSE in beef insulin
>> imported from other countries, and is on record about it.
>Entirely properly.
>>> Steve Harris:
>>> Pork insulin is available just about everywhere,
>>> including Canada (where about 200 Canadian still us it).
>It's supply is being relentlessly restricted. Here in Germany, Novo has
>announced it will withdraw Semilente from the German market. This is a
>mere two years after building a new manufacturing line for Semilente,
>the old one having broken down due to massive overuse, due to the
>increase in popularity of Semilente.
>>> Colleen Fuller:
>>> IMS data suggest there are roughly 700 people using Iletin II NPH and
>>> Regular insulin in Canada. Eli Lilly estimates about 400 people. On
>>> July 6, Eli Lilly announced it is pulling the remaining pork insulin
>>> from the North American market. Wockhardt, based in India, has applied
>>> for a license to market its own brand of pork insulin in Canada, but
>>> not in the United States. They have been assisted by Eli Lilly, whose
>>> own Canadian supplies will be exhausted by April '06.
>> COMMENT:
>> Well, good for them. If you can find a little niche market, like people
>> who think that vacuum radio tubes give better amplifier sound, have at
>> it. I'm sure that being Canadian, you'll want the government to pay for
>> it, though.
>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.
No, the supply of animal insulin IS a free market. Even the
supply of most vaccines is essentially a free market. Try to
find enough manufacturers; nobody seems willing to enter the
market without government safeguards agains legitimate or
illegitimate suits.
>>> Colleen Fuller:
>>> The biggest impediment to those who try to manage their blood sugars
>>> effectively is doctors who are ignorant of the issues and evidence
>>> regarding animal-sourced insulin.
>Largely because the insulin manufacturers have great influence over what
>doctors learn.
<>> In 1995, Humulin was among the top 10 drugs with reported serious
<>> adverse side effects in the United States. Humalog has racked up an
<>> astonishing number of reported serious ADRs in Canada. Although these
<>> are suspected links only, there has been no attempt in Canada to
<>> determine causality. (I recognize that this would be difficult;
<>> however it's impossible to say how difficult since the national
<>> regulator hasn't ventured to find out.). The point is that the
<>> experiences patients have had are very real, and the attitude of many
<>> physicians is appalling. These patients are accused of being nothing
<>> more than some kind of modern-day Luddites, when in fact what's
<>> happened to them is that they were using the wrong species of insulin.
<>> There are too many irresponsible doctors to whom these often desperate
<>> patients turn - and this hard-hearted and ignorant attitude is what
<>> they have to deal with. It's really unbelievable.
>Been there, done that, got quite a few teeshirts. I tried Humalog once,
>as a correcting drug, not (thankfully) my main insulin. The stuff died
>after two days of at least two summer holidays. It died within a few
>weeks of my carrying it back and forth with my normal insulin. ~80% of
>the total I was ever prescribed ended up being chucked out.
Did you keep it cold enough? It is more fragile than
Humalin, as it is a different molecule. I have used
one vial for more than three months without it losing
effectiveness, but I keep it refrigerated, or using an
ice-pack carrier, for that period. There were some
hot periods for one of the vials, and I was worried
about the effectiveness of the ice packs.
>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!!
I have a problem with a peak around 10-12 hours after
NPH. But I do not find the hypos any more symptomless.
.......................
--
This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
hrubin@xxxxxxxxxxxxxxx Phone: (765)494-6054 FAX: (765)494-0558
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