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"Sbharris[atsign]ix.netcom.com" <sbharris@xxxxxxxxxxxxx> wrote in message
news:1126693927.998574.215720@xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
> 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.
And I'm a diabetic who's lived through it. Giving up the less expensive,
easier to notice hypoglycemia, animal version of NPH to wind up switching to
the hideously more expensive Lantus with its standard usage of not mixing in
the syringes is a pain in the ass, costs money, and gained me absolutely
*NOTHING*.
The Humalog is useful for its speed of action at mealtime.
> 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.
And I remember the patent expiration issues. Patents on the refining
techniques for animal insulins were expiring, and it would have been easy
for other companies to enter the market place making less expensive insulin,
since they would not have to support Lilly's research departments, extensive
advertising, long-established relationships with doctors and hospitals, and
bureaucracies. But by getting people switched over to the newly patented
"human" insulins, and encouraging exclusive use of them through what seem
not to be well-founded concerns about the animal sources, they've helped
lock in another 20 years of profitability.
>> > 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.
Agreed. Also, the genetic engineering is of the E. Coli used to produce the
insulin, not of the insulin itself. The insulin produced, and extremely
highly purified because hey, they learned how to to do that almost perfectly
with the animal insulins and none of us want surprises with weird
by-products, is the standard human insulin molecule.
It just happens to be inferior to the bovine or pork in terms of
hypoglycemic awareness and cost easily twice as much.
>> 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.
The hand-writing was already on the wall for animal insulins, and has been
for a while.
>> Quite likely, the "human" insulin molecule is not identical to the human
>> insulin molicule at all; .
>
>
> What makes you say that? Evidence, please?
Agreed. The insulin molecule is a very small protein, and one of the first
synthesized. It's well understood.
> 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.
Agreed. Curse Lilly and their peers for what they did do wrong, not for
this. The hypoglycemic unawareness was a serious booby trap, and the expense
is a nastier one without any noticeable benefit of the human insulin
overall. (The short-acting nature of Humalog is useful, I admint.)
> 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.
True, but as I remember in the papers at the time, the purification
processes for insulin would easily have blocked problems like mad cow. Lilly
and their peers had gotten *very good* at refinement, since immune reactions
to animal insulins were a big concern.
> 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.
Wait 10 years. Lilly does *not* like having competitor insulins out there.
>> 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.
Partly funding: who's going to pay for the study, and who's going to peer
review it? Also, what exactly can you do with the knowledge in the face of
already completed switchover to human insulins? The animal insulin
production capacity is mostly gone now, and disappearing even as we type.
>> 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.
Just not as well as animal insulins, except for the speed of Humalog.
>> 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.
Yeah, it's usually not *THAT* bad.
>> 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.
Profitable for whom? For Lilly, it's certainly not as profitable as their
newly patented GE-produced insulins. For small companies that might try to
enter the market, the startup costs are *ENORMOUS* especially as Lilly will
try to put them out of business ASAP. A very few companies own the entire
insulin production of the world, and can easily engage in cartel or
monopolistic practices to shut down new factories.
The idea that "if it's profitable, someone will do it" is often bandied
about when its first cousin, "if it's apparently profitable *enough*,
someone will do it" is much more true.
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