On Mon, 30 Oct 2000, Valerie W. McClain, IBCLC wrote:
> How do you know that there is no cow's colostrum with human milk proteins
> being marketed? What proof can you offer me that it is not a done deed? FDA
> regulation? I am laughing. I see all these patents and companies forming to
> market lactoferrin and I am suppose to believe that it hasn't
> happened--particularly when the FDA refused to answer any more of my
> questions and referred me to FOIA (Freedom of Information Act).
Well, to be frank, I consider the burden of proof to be on you, but I will
explain my thoughts on the matter.
First off, the human milk proteins must have a source. It could be the
natural source, but I don't think that's what you're referring to, please
let me know if you are proposing that they are being obtained from milk
from human mothers.
As to being obtained from genetically recombinant organisms, it just
doesn't make sense. The research is expensive, and production costs are
substantial. Assuming that someone is trying to make a profit, if they
are going to add a relatively expensive product to one that is much less
expensive (remember, excess cow colostrum used to be a waste product that
was simply dumped), they have to tell people they are adding this
expensive product, so that they will pay more for it (and given the
expense of genetically engineered stuff, a *lot* more). Otherwise, they
will say, "Why should I pay $200/quart for your cow colostrum, when I
could pay $20/quart for this other guys?" Admittedly, cow colostrum sales
are incredibly hyped and marketed to support an outrageous price, but that
price is nothing compared to what it would be if you were producing
genetically engineered stuff to mix in. Again, why go to the expense of
adding it if you're not going to hype it?
Also there is the fact that there are substantially more profitable
avenues to pursue for any human milk proteins than adding it to cows
colostrum for people to drink. I do keep up with the research and news in
genetic research, so I'm sure I would hear about medical investigations
into such products long before I would hear about it being added to cows
colostrum.
If there is a genetically modified algae out there being used to produce
DHA, it will be patented somewhere, but the Martek patent isn't it. The
patent simply describes a method of culture and extraction, and says the
method could be used with any DHA producing microorganism, whether it be a
wild-type (naturally occuring), mutant, or recombinant microorganism.
This is not evidence that DHA from recombinant algae are being produced,
their specific production used a wild-type (naturally occuring) algae (see
the three examples at the bottom).
Typically, patents will try to "cover all the bases" in encompassing as
many variants of "the invention" as the inventor can think of, in addition
to what they actually did themselves (see the three examples at the bottom
of the patent). This is so that someone cannot change one aspect of the
process and claim the the patent doesn't cover it, or even file for a
patent themselves. Virtually all patents filed on microorganisms
(bacteria, yeast, algae, etc.) since recombinant organisms came into use
have included recombinant organisms as being covered by the patent, even
if those organisms don't (yet) exist, in order to prevent someone from
circumventing the patent with one. Reading this patent, one can see that
they similarly "spread their wings" to cover variations in culture medium,
food for the algae, solvents for extraction, etc.
> As for DHA--patent 5397591 which was filed in 1992 and approved in
1995--it > specifies that recombinant organisms are part of this patent.
Now since the > patent was filed in 1992, am I to believe that this has
not happened yet? > This is a patent from Martek Biotechnology Inc. and
as far as I know they are > still in business selling DHA to formula
companies in Europe and Asia and > supplements to everybody. > > you have
to go to the patent office on the web site >
http://www.uspto.gov/patft/index.html > > Any microorganisms capable of
producing a single-cell edible oil containing > DHA can be used in the
present invention. For example, photosynthetic diatoms > can be used.
Preferred microorganisms are marine dinoflagellates, including >
Crypthecodinium sp. Especially preferred is Crypthecodinium cohnii, an >
obligate heterotroph requiring a reduced carbon source for growth. C.
cohnii > is preferred because it contains a fatty acid profile in which
DHA is the > only PUFA present in sufficient quantities (greater than
about 1% of the > total amount of PUFAs). Samples of this organism,
designated MK8840, have > been deposited with the American Type Culture
Collection at Rockville, Md., > and assigned accession number 40750. As
used herein, microorganism, or any > specific type of microorganism,
includes wild strains, mutants or recombinant > types. Any microorganism
which produces enhanced levels of oil containing DHA > is considered to be
within the scope of this invention. One of the features > of the present
invention is its recognition of the edible oil-producing > capability of
microorganisms such as dinoflagellates and the attendant > solution to the
problem of maintaining a reliable, economic source of such > oils.
Accordingly, wild-type and recombinant microorganisms designed to >
produce single cell oil containing DHA are an aspect of this invention.
Such > recombinant organisms would include those designed to produce
greater > quantities of DHA in the single cell oil, greater quantities of
total oil, or > both, as compared to the quantities produced by the same
wild type > microorganism, when provided with the same substrates. Also
included would be > microorganisms designed to efficiently use more
cost-effective substrates > while producing the same amount of single cell
oil containing DHA as the > comparable wild-type microorganism." > >
--Valerie W. McClain, IBCLC > >
*********************************************** > The LACTNET mailing list
is powered by L-Soft's renowned > LISTSERV(R) list management software
together with L-Soft's LSMTP(TM) > mailer for lightning fast mail
delivery. For more information, go to: >
http://www.lsoft.com/LISTSERV-powered.html >
***********************************************
The LACTNET mailing list is powered by L-Soft's renowned
LISTSERV(R) list management software together with L-Soft's LSMTP(TM)
mailer for lightning fast mail delivery. For more information, go to:
http://www.lsoft.com/LISTSERV-powered.html
|
