Androlog Mail:
During the last few days, we have been following a resurgent discussion of
the continued use of Percoll versus new alternatives on the market for the
separation and purification of human sperm. This resurgent discussion seems
to have been initiated by Dr. Patrick Quinn's letter to Androlog-Mail on
March 25, 1998. He mentions that a problem may be arising since most labs
have used up their reserve supplies of Percoll.
Dr. Quinn also mentions that the FDA has taken no action to remove Percoll
from the market, although Percoll has never been registered by the FDA for
this purpose and the manufacturer of Percoll, Pharmacia Biotech, has been
desperately trying to show responsibility by restricting it's use to
research only, for which it is intended.
We refer readers to the FDA memo of December 1997 proposing full regulation
of the ART industry. During our last contact with the FDA we were informed
that the regulations would be coming during the summer of 1998 and, as far
as we can see, Percoll would not stand a chance of being 510(k) registered,
whereas the alternatives have at least been submitted for 510 K
registrations.
We also refer readers to the newsletter "The Embryologist" published by the
Association of Clinical Embryologists" (ACE). In the No. 12 issue of July
1997, David Morroll on the executive committee presents a complete and sound
discussion of the problem in two short but detailed articles entitled "Use
of Products which are not ART-specific" and "Results of Survey of Current
Practices in Clinical Embryology". The first article deals with the
litigation consequences for clinicians using non ART specific products such
as Percoll. The second article deals with a survey of Percoll usage
compared with ART specific products and techniques. Perhaps David Morroll
or another A.C.E executive would like to comment further if they are
subscribers, as they have obviously taken legal advice on this issue.
Further to this, readers should also check the Embryo-Mail news item no.
683 from January 31, 1998, wherein Dr. David Mortimer, one of our most
knowledgeable andrologists, comments on Percoll and alternatives, and
provides the reference to his abstract at the Edinburgh ESHRE-97 meeting.
This abstract can be down-loaded from the FertiNet Library and exhibits
clinical results.
Readers are now referred to Dr. Quinn's comments on the pricing of the new
alternatives, which are approx. $2.50 -$3.00 per sperm preparation (1mL of
upper layer and 1mL of lower layer). To bring this cost of one sperm
preparation into proportion, readers, ask yourself what a cup of coffee
costs today, and then compare that to the cost of the hormones for an IVF-
stimulation. $2.50 - $3.00 is a negligible price for ART specific products
which, after all, are aimed at improving efficacy and safety for the
patient. What price should one put on this??
Paul V. Holmes MSc, PhD, DrMedSc.
CEO. NidaCon International AB. Sweden.
nidacon@swipnet.se
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