The brave new world of stem cell research
dangles the exciting potential for a host of leading-edge treatments that may
one day help cure debilitating diseases such as Alzheimer's, Parkinson's and
other maladies that today cannot be treated with modern medicine.
However,
not much thought has been given to how those products might be regulated and
how issues of legal liability may be addressed in a way that encourages
scientific innovation but also protects the patients for whom these treatments
might provide great relief.
Now, an
attorney and law professor from the UCLA School of Law and a member of the Eli
and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA
has developed a roadmap that could help guide researchers, stem-cell product
manufacturers, physicians and patients through the complex maze of imagining,
creating and developing stem cell products and using them to treat disease.
"Stem
cell research and its eventual applications hold enormous promise, but they
also carry some significant risks," said distinguished professor of law
Stephen R. Munzer, whose new article appears April 11 in the Boston University
Journal of Science and Technology Law. "Our understanding of the number
and gravity of those risks right now is incomplete and uncertain. Developing a
plan now that details how to deal with such issues as stem-cell product
liability is important because we need to think carefully and rationally about
how to address these issues before the market is flooded with products."
In the
article, Munzer offers suggestions on how stem cell products might be
classified in the future; examines how applying existing product liability
rules to stem cell products is inadequate; details the economic considerations
for a stem-cell liability regime; and offers his views of what the law should
be on liability for stem cells.
"One
thing I detect from the stem cell scientists I've spoken to is a certain amount
of judicious caution," he said. "What they don't want is to have
people rushing to get something approved by the FDA and then see it result in
unanticipated, unforeseeable problems."
One of
the byproducts of that judicious caution, both of the risk of liability and the
potential risk to patients, Munzer said, has been that scientists and
biotechnology companies are initially going after the so-called low-hanging
fruit of stem cell treatments -- those projects that appear to have the least
amount of risk and the maximum benefit, such as treatments for retinal disease
as opposed to organ regeneration.
In the
article, Munzer also emphasizes the "ethics of risk," or having all
those involved from the conception of an idea for a stem cell product to its
eventual development, manufacture and administration, accountable for the risks
they may be imposing on patients.
"The
scientists who come up with the ideas for these products, the people who design
them, the biotech companies that manufacture them and produce them in large
numbers, and the treating physicians who ultimately will be administering these
treatments all have to be accountable, as well as the FDA, which is charged
with regulating them," Munzer said.
Munzer
likened the anticipation for potential stem cell products to the excitement
created in the 1980s and 1990s over early gene therapies and what may have been
a rush to test the therapies without adequately considering the risks. That
potential for new gene therapy treatments was temporarily derailed after Jesse
Gelsinger, an 18-year-old, died in 1999 as a result of treatment in a gene
therapy trial.
"Existing
blood products, growth factors, vaccines -- we've got more understanding of how
those things work, and that is not true in the case of stem cells," Munzer
said. "We want to create a strict liability regime that encourages innovation
but on the other hand does not encourage it so much that products are put on
the market long before they should be."
Munzer
suggests creating a social-insurance arrangement that would pool resources from
everyone involved, from the scientists to the manufacturers to the treating
physician and the patients, contributing to a fund that could eventually be
used to compensate those harmed by stem cell products during their testing. His
proposal is similar to the National Vaccine Injury Compensation Program,
created in 1988 as a no-fault alternative to the traditional tort system
created to ensure an adequate supply of vaccines, stabilize vaccine costs, and
establish and maintain an accessible and efficient forum for individuals found
to be injured by certain vaccines.
Munzer
also recommends limiting punitive damages in stem cells cases, but only if the
product has been approved by the U.S. Food and Drug Administration, the FDA
regulatory requirements have been strictly followed, the risks of the products
have become more understood and predictable, and the FDA has gained sufficient
experience in regulating the products.
Munzer's
liability roadmap could be of value to courts, lawyers and regulatory bodies in
navigating what is to come in stem cell product development. It also should be
considered a dynamic document, he said, that responds to what is learned in the
coming decades about the creation and development of stem cell products.
"It
is important to address these issues this early with as much insight as we can
bring to it, recognizing that there will be, as the years go on, more
information and a better understanding of what we're doing," he said.
"Starting to address this now instead of waiting five to 10 years is
vital, as it will be much easier to prevent potential mishaps and messes from
occurring than it will be to try to clean them up later."
Munzer's
article attempts to tackle problems that are on or just beyond the horizon, and
looks to what has happened in the past for guidance.
"The
product liability claims regarding stem cell products will require the most
exacting attention to their safety and effectiveness that is possible without
imposing an undue burden on manufacturers," the study states. "No
existing category offers a perfect legal model for stem cell products. However,
we can tease out pertinent features of these categories for tort litigation to
show what might work well for stem cell products. Definitive recommendations
must wait for these products to appear on the market and for their risks and
rewards to become better understood over the coming decades."
ScienceDaily
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