Dear Sir,
I would like to
congratulate Jeff Swiatek on his article,
Oct. 31 1999, about the issues relating to
biosynthetic so-called 'human' insulin and
natural beef and pork insulins and also to
express deep concern from the UK for all the
people in the US that are being denied the
beef/pork insulin they need. Although Novo
Nordisk are systematically withdrawing their
natural animal insulins from the UK, we are
fortunate to have an alternative supplier,
CP Pharmaceuticals, as mentioned in the
article.
But we are also
fortunate in that our Committee on the
Safety of Medicines, the equivalent to the
FDA, does recognise that some people are
unable to use biosynthetic insulins and
issued a statement to that effect, August
19, 1999. In the UK we do have easy access
to the number and type of reported adverse
reactions so the truth is much more obvious
here and perhaps this explains why two
leading regulatory bodies can come to such
different conclusions.
In addition to this,
there is a further admittance of the
problems from Novo Nordisk in their press
release, Sept. 9 1999 which says
'Historically improving glycaemic control
with soluble human insulin has been
associated with an increased risk of hypoglycaemia
( hypoglycemia , insulin shock, insulin
reaction ).' Yet again
interesting that the two leading insulin
manufacturers can have such different views.
For Holcomb, the Lilly physician, to suggest
that people who cannot get on with human
insulin haven't tried, is insulting to
patients and even more insulting to their
physicians. For Zimmerman, President of the
ADA, to suggest that patients who need
animal insulin are simply 'emotional' shows
his total disregard and somewhat outdated
view of patient participation in healthcare
issues.
It is worth pointing
out that the initial research into this
first ever, biosyntheically produced drug
was carried out in only 300 people before
marketing approval. No large scale,
long-term double blind studies comparing
natural and synthetic insulins have ever
been carried out. Most of the research
referred to in the article were small
studies carried out in a laboratory setting
- not in a real life environment. This is
why the problems have not been shown.
Furthermore, the Diabetes Group of the
Cochrane Collaboration presented a Review of
the research into this issue at the British
Diabetic Association Professional Conference
earlier this year. Professor Rhys Williams
pointed out that studies of the type carried
out, do not exclude the possibility that
there is a difference and that 7 out of 38
studies do show differences and these need
an explanation. He also said that 'in some
cases the increase in frequency of hypos and
the lower awareness of an impending attack
appeared to be linked to a number of deaths
associated with 'human' insulin.
Finally I cannot help
but comment that Holcomb's statement that
animal insulin is antiquated. I would
suggest that it was perhaps their animal
insulin plant that was antiquated and
bringing it up to required modern standards
was more costly than converting it into a
car park. Having visited CP Pharmaceuticals'
new production plant I certainly do not get
the impression that there is anything
antiquated about natural animal insulins.
Jenny Hirst
Co-Chairman
Insulin Dependent
Diabetes Trust - International