Lady Princess M. Galang 4-NRS1 Prof. Herman F. Zoleta: Aborted Fetuses Are Not The Only Source of Stem Cells
Lady Princess M. Galang 4-NRS1 Prof. Herman F. Zoleta: Aborted Fetuses Are Not The Only Source of Stem Cells
Lady Princess M. Galang 4-NRS1 Prof. Herman F. Zoleta: Aborted Fetuses Are Not The Only Source of Stem Cells
GALANG
4-NRS1
PROF. HERMAN F. ZOLETA
Stem cells are in all of our body and lives, but are far more potent in a fetus (also spelled foetus,
fœtus, faetus, or fætus) than in an adult body.
Some types of stem cells may be able to create all other cells in the body. Others have the potential
to repair or replace damaged tissue or cells.
Embryonic Stem Cells are developed from a female egg after it is fertilized by sperm. The process
takes 4-5 days.
There are stem cells in the both placenta and blood contained in the placenta.
Also the primary source of stem cells is from blastocysts. These are fertilized
human eggs that were not implanted into a woman.
The controversy surrounding stem cell research led to an intense debate about ethics. Up until the
recent years, the research method mainly focused on Embryonic Stem Cells, which involves taking
tissue from an aborted embryo to get proper material to study. This is typically done just days after
conception or between the 5th and 9th week.
Since then, researchers have moved on to more ethical study methods, such as Induced Pluripotent
Stem Cells (iPS). iPS are artificially derived from a non-pluripotent cell, such as adult somatic cells.
This is probably an important advancement in stem cell research, since it allows researchers to
obtain pluripotent stem cells, which are important in research, without the controversial use of
embryos.
There were two main issues concerning stem cell research with both pros and cons:
The first issue is really not just about stem cell research, as it may be applied to most research about
human health.
Since 2007, the second point, concerns about the methods involved, has been less debated,
because of scientific developments such as iPS.
As you will most probably notice, the following arguments are not exclusively in use when talking
about stem cell research.
Pros
Stem cell research can potentially help treat a range of medical problems. It could lead humanity
closer to better treatment and possibly cure a number of diseases:
Parkinson’s Disease
Alzheimer’s Disease
Birth Defects
Reduced Risk of Transplantation (You could possibly get a copy of your own heart in a heart-
transplantation in the future
Better treatment of these diseases could also give significant social benefits for individuals and
economic gains for society
Cons
Some argue that stem cell research in the far future can lead to knowledge on how to clone
humans. It is hard to say whether this is true, but we have seen devastating consequences of
other research-programs, even with good intentions, such as nuclear research.
2) Stem Cell Research - Pros and Cons About the Methods Involved
The controversy regarding the method involved was much tenser when researchers used Embryonic
Stem Cells as their main method for stem cell research.
DISCLAIMER:
These points are based on the old debate about the methods of stem cells research, from before
2007. Since then, scientists have moved on to use more ethical methods for stem cell research,
such as iPS. This section serves as an illustration of the difficult evaluations researchers may have
to analyze.
"The benefits of stem cell research have such a great outcome that they outweigh the ethical
issues." (Cost-benefit-analysis)
"If someone is going to have an abortion, isn’t it better that we use it for something useful?"
Adult stem cells would not be that interesting because they do not have the same properties as
stem cells from a fetus.
The research would give great insights about the basics of the body.
Cons Before 2007
Critics against stem cell research argued that the ethical issues of scientific work on aborted
fetuses did not justify the possible benefits.
"A life is a life and that should never be compromised. A fertilized egg should be valued as a
human life even if it is in its very first weeks. Destroying human life in the hopes of saving human
life is not ethical."
We should (and will) develop more ethical methods (such as using adult stem cells) which will
enable us to research ethically. We should wait until those methods are available.
The scientific value has been overstated or has flaws. E.g. we do not know for sure that we can
use stem cells to clone transplantable organs.
Conclusion
The stem cell-research is an example of the, sometimes difficult, cost-benefit analysis in ethics
which scientists need to do. Even though many issues regarding the ethics of stem cell research
have now been solved, it serves as a valuable example of ethical cost-benefit analysis.
The previously heated debate seems to have lead to new solutions which makes both sides happier.
Stem Cell pros and cons had to be valued carefully, for a number of reasons.
When you are planning a research project, ethics must always be considered. If you cannot defend a
study ethically, you should not and will not be allowed to conduct it. You cannot defend a study
ethically unless the presumed cost is lower than expected benefits. The analysis needs to include
human/animal discomfort/risks, environmental issues, material costs/benefits, economy etc.
Why was the debate regarding the stem cell research so intense?
First, it was a matter of life - something impossible to measure. And in this case, researchers had to
do exactly that: measure life against life.
Both an abortion and someone dying, suffering from a possible curable disease, is a tragedy. Which
have the highest value? Does a big breakthrough in the research justify the use of the method in the
present?
Would the benefits of studying abortions outweigh the costs? The choice was subjective: Nobody
knows all the risks or all the possible outcomes, so we had to value it with our perception of the
outcome. Perception is influenced by our individual feelings, morals and knowledge about the issue.
Second, at the time we did not know whether the research was necessary and sufficient to give us
the mentioned health benefits.
Third, other consequences of the research are uncertain. Could the research be misused in the
future or not? We simply do not know. All knowledge acquired, within research or other arenas, may
be used for evil causes in the future - it is impossible to know.
The Stem cell research-debate is an example on how people value various aspects differently. It is
also an example of how critics and debate can lead to significant improvements for both sides.
ANYAYAHAN, ALDRINE A.
PROF. HERMAN F. ZOLETA
4-NRS1
Bone marrow contains adult stem cells that have been used for decades to
treat leukaemia and lymphoma and certain blood diseases. While the potential
for embryonic stem cells to develop and multiply and ultimately replace faulty
cells has been long recognised, ethical concerns – and legal restrictions in
some countries – have to some extent constrained the development of
treatments using embryonic stem cells.
But more recent developments in stem cell science – whereby already
specialised cells, such as fat, blood or skin cells, can be induced to behave
like embryonic stem cells – have opened up the field and its role in the future
of regenerative medicine.
It's these so-called induced pluripotent stem cells that are used in many of
the stem cell therapies offered directly to consumers.
Regardless of the type of stem cells used, stem cell-based therapies can be
broadly considered as autologous, where the patient's own cells are used,
or allogeneic, where the cells are from a donor. Induced pluripotent stem
cells obtained from the patient's own body are likely to be well-accepted by
the patient's immune system, as opposed to cells from other people which
may be rejected.
While treatment using allogeneic cells are highly regulated in Australia,
autologous therapies, and those in development, are not subjected to the
same degree of scrutiny and regulatory oversight.
Safety concerns
Apart from lack of evidence, the safety of these marketed stem cell treatments
is also questionable. Some of the adverse events arising from stem cell
therapy include the development of tumours and abnormal bone growth, blood
clots, paralysis, infection, allergic reactions, and even death.
Meanwhile, patients who opt to try stem cell therapies may discontinue
conventional proven treatments or palliative care, and may find themselves
ineligible to take part in properly administered clinical trials in the future.
Stem cell tourists face additional challenges, in that people who conduct stem
cell therapy in other countries may not be suitably qualified, and there may be
lower standards of hygiene and infection control. And if something goes
wrong, options for legal or medical recourse may be limited or unavailable.
There are also concerns about the medical practitioners in Australia carrying
out stem cell therapy. It may be the case that the doctor administering stem
cell therapy has no formal training in that area of medicine. For example, a
cosmetic surgeon attempted to treat a patient for dementia using stem cells
from fat; the patient died due to complications.
Then there's the inherent conflict of interest: due to the lucrative nature of the
industry, stem cell providers may not make treatment decisions in the best
interests of the patient.
Ultimately, consumers are forking out thousands of dollars – typical costs
range from $10,000 to $60,000 – with very uncertain outcomes, and with little
or no follow-up or aftercare. They may even be encouraged to come back and
try again if their treatment hasn't worked the first time.
Proponents of the status quo argue that increased regulation will stifle
innovation and delay potentially life-saving therapies, and some have argued
for self-regulation and oversight. However, Dr Munsie argues that improved
regulation won't inhibit the implementation of properly conducted clinical trials.
Independent monitoring and oversight is essential to ensure patients are not
placed at risk, but also that progress in the field isn't compromised by those
offering unfounded treatments in the name of stem cell science.
As the result of a review into stem cell treatments and advertising, the TGA
announced some changes to regulations to take place in 2018. We don't know
the details yet, but indications are that procedures that take place outside of
hospitals will be more tightly regulated, and advertising will be restricted.
Some commercial clinics may suggest that you're part of clinical research, or
even call it a clinical trial, but unless the experimental intervention on offer is
listed on a reputable clinical trial registry, it is unlikely to have been
appropriately reviewed and approved. Even then, some clinics have started
the controversial practice of registering treatments on the clinical trials register
as case series, and they're charging people to take part. So-called pay-to-
participate trials don't have the same oversight as genuine clinical trials, and
it's on the increase overseas as well.
Being asked to pay for the treatment should sound warning bells. If fees aren't
mentioned outright, look for 'unfunded' or 'self-funded' trials. Another red flag
is a reluctance of the clinic to share data about the safety and effectiveness of
the proposed treatment – and patient testimonials, blogs or 'as seen on TV'
are not evidence a therapy is safe and effective.
Unlike commercial clinics, properly conducted clinical trials will declare their
experimental nature upfront, as well as possible positive and negative
outcomes. Patients are under the highest standards of medical care and are
monitored throughout, given all necessary aftercare and long term follow-up.
And patients aren't charged for the treatment. Importantly, real clinical trials
will have been cleared by an ethics committee, will have a consent form with a
clearance number from the ethics committee and contact details. The
absence of an ethics committee review is a major red flag.
If it's already too late, and you've paid your money with no results – or bad
results – it's important to lodge a complaint. Perhaps understandably, people
who've suffered at the hands of stem cell shonks often want to put the
experience behind them rather than become embroiled in a long-winded
complaints process. However, Dr Munsie believes that a lack of formal
complaints is giving a false impression of consumers' experiences with stem
cell treatments, and is an excuse for the regulatory inactivity in Australia.
Complaints about the professional conduct of a medical practitioner can be
made to the relevant board (doctors, dentists and various allied health
professionals) via the Australian Health Practitioner Regulation Agency
(AHPRA). Patients and/or their family members, as well as their concerned
doctor, can lodge a complaint.
You can also complain to the health care complaints commission in your state
about a practice, clinic or hospital, as well as registered and unregistered
health practitioners.
Consumers misled or deceived by claims suggesting a treatment was safe or
effective may also have recourse under Australian Consumer Law, and are
encouraged to lodge a complaint with their state's fair trading department, or
the Australian Competition and Consumer Commission (ACCC).
CARMONA, MA. GERALDINE S. 4-NRS1
PROF. HERMAN F. ZOLETA
“Stem cell miracle” headlines are easy to find: the self-renewing, cell-replenishing machines hiding
in our tissues are touted as fixing any condition you can name: arthritis, multiple sclerosis, cancer,
ageing, blindness, even autism.
But while stem cells have lifesaving potential in a narrow set of diseases, and researchers are busy
testing them for a huge number more, many therapies on offer have yet to pass the rigorous process
of trials to ensure their safety and efficacy.
Around the world, and increasingly in Australia, private clinics have sprung up to offer unproven
treatments to patients who haven’t time to wait or who can’t get into a trial. Researchers, doctors and
ethicists say this not only fleeces patients and exposes them to unacceptable risk of infections,
tumours, bleeding, strokes and other adverse events, even death, it also obstructs legitimate clinical
research and erodes trust in the field.
“Scientists have discovered all these great attributes of stem cells and want to harness them, and the
public’s quite enthused — but we’re nowhere near delivering on the promise,” says Megan Munsie,
head of engagement, ethics and policy at Stem Cells Australia and deputy director of Melbourne
University’s Centre for Stem Cell Systems.
“There’s this expectations gap between what we’re doing in the lab and what the community might
want us to do or think we can do already. And into that gap have stepped all these commercial
clinics.
“We started off with a handful of clinics in far-flung nations around the world, in areas where there
was no or limited jurisdiction. But recently we’ve seen a lot of doctors, particularly those with access
to liposuction machines, opening clinics in Australia and America because they can use the patients’
own cells at their discretion. They market it as stem cells, they believe they’re putting stem cells back
in the patient, but it’s often very disconnected from the science of stem cell biology.”
There are two main modes of stem cell therapy. Haematopoietic stem cell transplantation, which uses
stem cells to reconstitute bone marrow after high-dose chemotherapy, is well established for cancer
and is being investigated for other immunological diseases.
Ian Kerridge is a haematologist and bone marrow transplant physician at Royal North Shore Hospital
in Sydney, chairman of the Australian Bone Marrow Donor Registry and a professor of bioethics and
medicine at the University of Sydney.
“The stuff that’s clear and straightforward is using autologous (your own) and allogeneic (donor)
cells for bone marrow transplant,” Kerridge says. “Rheumatoid arthritis, scleroderma, multiple
sclerosis — they’re all on the edges of investigation, becoming more or less proven as the data
accumulates. So there are clinical trials, but not everyone gets in. People don’t want to wait so they
find someone who’ll offer them the same treatment outside the context of a clinical trial. Some
people are just saying, ‘Fine, I’m paying my $100,000 and going to Moscow or Mexico City. ”
Another kind of treatment, so-called mesenchymal stem cell therapy, takes cells from fat or
connective tissue to treat a wide range of conditions, most commonly osteoarthritis. It is this kind of
intervention that is offered by private clinics, with cells harvested through liposuction and reinfused
intravenously.
But while stem cells can be identified and counted, and can be relied on to find their way back to
where they came from, in haematopoietic transplantation, there is no reason to expect fat cells -
injected into the bloodstream will magically home in on a sore joint or the brain and fix arthritis or -
dementia. There is also little information about how private clinics process the cells they extract.
“When these people extract the fat, we don’t know what they do with that material and what they put
back in,” Sydney University associate professor of bioethics Wendy Lipworth says. “We have no
idea what this sort of ‘Nutribullet’ preparation ends up containing. It’s one thing to put it into a joint,
but for a lot of these other conditions they put it into the bloodstream, hoping the cells will somehow
find their way to the right part of the body and do this magic once they get there.”
Gerhard Bauer and his team counted the reports in scientific literature and the media of bad outcomes
from unproven stem cell interventions before publishing a long and stomach-turning list this year
in Stem Cells Translational Medicine.
A 13-year-old boy from Israel with a neurodegenerative disease went to Russia to have neural cells
injected into his brain and cerebrospinal fluid, and grew a tumour from the donor cells. American Jim
Gass travelled to Mexico, China and Argentina for stem cell treatments after a stroke and developed
an enormous mass on his spine, causing paraplegia, again from the donor’s cells. Three women with
macular degeneration had their own fat cells injected into their eyes at a US clinic (Bioheart, now
trading as US Stemcell) and lost their sight.
In Australia, Sheila Drysdale, 75, of Sydney, who had dementia, died after liposuction in 2013. A
coroner found her doctor, Ralph Bright of Macquarie Stem Cells, had not ensured that she had
stopped taking her blood thinners, and when she suffered blood loss leading to hypovolemic shock
— a known risk of liposuction — failed to send her straight to hospital.
The most egregious aspect of her death, Kerridge says, is that injecting adipose cells intravenously to
treat dementia is an intervention for which there is “not even a shred of evidence”.
At the inquest in 2016, deputy state coroner Hugh Dillon recommended an investigation, saying:
“The reasonableness or appropriateness of applying this experimental procedure to Sheila Drysdale is
highly questionable … Dr Bright appears to have no idea whether the procedure has any genuine
therapeutic value.”
The regulation of stem cell treatments is shared by the Therapeutic Goods Administration and the
Australian Health Practitioner Regulation Agency. The TGA regulates products, including
“biologicals”, with an exemption for tissues taken from a patient to be used on the same patient, by a
registered medical practitioner, or in a hospital for a patient in that hospital.
Since July, private clinics have been banned from advertising services direct to consumers, and -
clinics are on notice that from July next year the kind of procedure Bright performed on Drysdale
will be subject in some cases to TGA regulation. The AHPRA oversees practice, in co-regulation
with the Medical Council of NSW in that state and with the health ombudsman in Queensland. This
oversight, Lipworth says, does not prevent doctors from “innovating” with unproven interventions.
The Medical Council of NSW imposed some restrictions on Bright’s licence in 2016 but he is still
allowed to treat patients from whom he has already harvested cells and to take on new patients for
osteoarthritis treatment.
“It’s quite problematic,” says Lipworth, “because it left the impression that there was this clear
distinction between osteoarthritis and the other types of intervention — it was in a way validating
osteoarthritis interventions.” This is despite a statement from the Australasian College of Sport and
Exercise Physicians that there was insufficient scientific support for this treatment.
The council tells The Australian it “considered it appropriate to impose restrictions on Dr Ralph
Bright in the public interest and to protect the health and safety of the public. Proceedings under s150
(of the Health Practitioner Regulation National Law [NSW]) are not public, nor may the reasons for
decision be published.”
Because of the lack of high-quality evidence, the council considers stem cell treatments for
osteoarthritis “a ‘complementary’ therapy”, meaning not scientifically validated.
Kerridge says dissatisfied patients theoretically have several avenues of recourse: AHPRA, the TGA,
the Health Care Complaints Commission and consumer legislation. But complaints are rare.
“Patients are very vulnerable. They’d have to say, ‘I was an idiot, I was coerced into this, I was
crowdfunded $100,000 by my friends and family, and this has been of no benefit at all — and I’m
happy for all that to be on the public record.’ People aren’t going to do that.”
Lipworth adds: “And what happened with Ralph Bright was an exception — most patients are not
hurt, they’re just spending $80,000 on something that doesn’t work.”
Munsie says it is often hard for patients to complain after a failed treatment that may have diverted
them from a more standard therapy.
“I’ve met people who feel outraged about it but are now too ill to make a complaint — they can’t -
invest in it, they want to move on. In one example I asked them to speak out to the media but they
didn’t want to — they felt they had to divert their energies into care rather than complaint.
“When the TGA was undertaking a review (into stem cell therapy), there were a lot of questions as to
why there weren’t more complaints to the HCCC, to AHPRA, and I was trying to point out that those
processes aren’t simple and the people who’ve been through this feel like it’s a failure of theirs that
the treatment hasn’t worked.”
Another stem cell “service” that elicits outrage is private cord blood storage, marketed using emotive
imagery to mothers-to-be. Cord blood is an easily accessible source of donor stem cells for
haematopoietic transplants; AusCord is the Australian public bank for storing cord blood stem cells.
But undermining this public resource, Kerridge says, are the businesses convincing mothers to store
their own baby’s cord blood for thousands of dollars a year. It’s a terrible investment, and not only
because the likelihood of acquiring a disease treatable with stem cells is somewhere between one in
25,000 and one in 250,000.
“If you develop something nasty, often you don’t need your stem cells, you need someone else’s. If
you need autologous stem cells, we just get them from you at that time,” he says.
“And by the way, that’s all covered by Medicare. You don’t need to pay for 50 years of storage for
something that will come out with a storage injury as well. It’s a total scam.”
Lipworth says further or tougher regulation is not the answer. “I’d like to see the current processes
we have used in more effective ways,” she says. “We don’t want to stifle innovation but we need to
have systems in place to, if not prevent, then at least stop people in their tracks when they take
advantage of people.”
Kerridge would like to see “a genuine conversation about the co-opting of science and research and
medicine for nefarious commercial ends. We need a genuine discussion about medicine at the
margins.”
-Avoid treatments that don’t have a Medicare number and are not recognised by your insurer
-A cosmetic surgeon offering treatments for dementia, autism or osteoarthritis is a red flag
-Beware a clinic offering the same kind of intervention for multiple conditions
-Seek a second opinion from someone who is not selling you the product
-Patient support groups for your condition, e.g. MND Australia and MS Australia, can help you
navigate and connect you
-Stem cells are undifferentiated cells that have the capacity to self-renew and, given the appropriate
cues, to differentiate into more than one cell type.
-Embryonic stem cells are derived from the inner cell mass of blastocyst-stage embryos; they can
self-renew indefinitely in culture and can develop into any cell type
-Adult (or somatic) stem cells can be derived from most organs and typically differentiate into cells
types specific to that organ
-Differentiated adult cells can be reprogrammed into ‘induced pluripotent stem’ cells, with self-
renewal capacity and pluripotentiality similar to ES cells