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OBOS Articles
and Position Papers:
Concerns about Lupron™ (leuprolide
acetate), used in the process of extracting eggs from women (for
IVF, research cloning, and potentially for inheritable human
modifications)
by Judy Norsigian, Executive Director,
OBOS
October 2002
There are substantial risks to women’s
health posed by Lupron™ (leuprolide acetate), the most common drug
used to hyper-stimulate the ovaries in the process of extracting
eggs, now commonly done as part of IVF (in vitro fertilization)
procedures. Such eggs are now only rarely used to produce clonal
embryos (either for human cloning experiments now being conducted by
a few irresponsible scientists or for human research cloning. In
both instances, somatic cell nuclear transfer (SCNT) takes place,
whereby the egg is enucleated and the nucleus of an adult cell is
inserted to take the place of the original nucleus).
At this point, lack of good quality data
makes true informed consent with Lupron impossible. However, there
are many women who feel comfortable taking what might be substantial
risks, because they are doing so in the interests of helping
themselves or another woman become a parent who is genetically
related to their offspring. In the case of research cloning, there
are no likely near-term benefits and a fairly distant promise of
therapies that may result from research with clonal
embryos.
As of the spring of 1999, the FDA had
received 4228 reports of adverse drug events from women using
Lupron™. (Interestingly, they also received 2943 such reports from
men, who used the drug in prostate cancer treatment, and despite the
differences in age, sex, and indication for use, the complaints were
remarkably similar.) 325 adverse events reported for women resulted
in hospitalization, and additionally, 25 deaths were reported.
Whether these deaths are directly attributable to Lupron remains to
be determined, and the FDA has indicated that it does not have
enough staff to follow up on this matter now. The BWHBC will be
filing an FOIA (Freedom of Information Act) request to obtain both
these reports and reports submitted since 1999 and hopes to work
with public health experts to review them.
Numerous women have reported serious
problems with persistent joint pain, headaches, fatigue and other
difficulties even years after their last Lupron™ shot. (See material
posted at the Lupron Victims Network website for many anecdotal
reports). There are also numerous reports in the medical
literature.
Given our current problems with
under-resourced and inadequate IRBs (Institutional Review Boards),
we cannot now expect most IRBs to adequately protect the women who
might provide eggs for research purposes.
Until such time when better and more
reassuring data might become available - or different drugs
developed with a better safety profile - it is unethical - on safety
grounds alone - to move forward with somatic cell nuclear transfer.
(There is a possibility that unused frozen eggs extracted initially
for the purpose of IVF could be used subsequently for producing
clonal embryos to be used in research - thus not requiring women to
be exposed to Lupron's risks solely for the purposes of research -
but there are still major problems with using frozen
eggs.)
Just at the practical level, it makes
little sense to pursue clone cures for the diseases most often
mentioned in media reports. Parkinson's and Alzheimer's diseases
alone affect 5 million Americans and would require minimally 250
million eggs to produce individualized therapies that would match
the patient's own genome. (This figure of 250 million assumes that
at least 50 eggs would be needed per patient.) And since about 10
viable eggs are likely to be collected, on average, from each
individual woman who is a donor, 25 million women would be needed as
donors - about half of all women of reproductive age. The specter of
such massive use of ovarian hyper-stimulation coupled with
laparascopic surgery makes no sense, especially when other fruitful
and less problematic approaches to developing therapies are already
underway.
Even Republican Senator Bill Frist had
strong cautionary words about proceeding forward with more
widespread use of Lupron. On the Senate floor he quoted from the
November 25, 2001 issue of the St. Louis Post-Dispatch, an article
entitled "Buying and Selling of Women's Eggs Raise Fears of Bidding
Wars'':
"In California, the increasing demand
[for eggs] has resulted in a flourishing egg-donation industry that
can reward donors with payments equivalent to a semester's tuition
at an Ivy League school. Greater demand also has increased prices on
the East Coast by several thousand dollars."
Frist goes on to comment: "I mention that
because clearly if there are individuals or companies out there with
what inevitably will be a financial incentive to obtaining these
eggs, the burden is very likely to fall upon women of low income.
The eggs will have to be obtained through a medical procedure. The
medical procedure has its own risks as well. There are no safeguards
today for women who would be used as sources of the needed eggs. I
believe that a failure to prohibit human cloning not only poses a
real risk to the health and safety of the women but will have the
effect of turning their bodies into commodities."
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