Ethical issues in stem cell research and application

Ethical issues in stem cell research and application

Dr. Jeff Blackmer MD MHSc FRCPC Vice President

Medical Professionalism

Canadian Medical Association Ottawa, ON

May 2016

Outline

§  Ethics and stem cells

§  Umbilical cord blood banking

Ethics

§  What is “ethics”?

§  Dictionary.com:

§  1. a system of moral principles

§  2. the rules of conduct recognized in respect to a particular group or culture: e.g. medical ethics

§  3. that branch of philosophy dealing with values relating to human conduct, with respect to the rightness and wrongness of certain actions

Medical Ethics

§  A system of applying ethical concepts and principles to the practice of medicine

§  Every doctor agrees to abide by a Code of Ethics that sets forth the ethical norms and expectations of the profession

§  Canada

§  CMA Code of Ethics

§  First adopted in 1868

§  Undergoes regular revisions to ensure it remains up to date

§  Referenced by physician licensing bodies and Canadian courts

§  All Canadian physicians are expected to abide by its contents

Importance of ethics in science

§  Without considering the ethical implications of

medicine, science and research we are missing a critical piece of the whole picture

§  With rapid technological advances, taking the time to perform a critical ethical analysis is more

important than ever

§  History is full of examples where significant harm occurred to research subjects as a result of

unethical research trials (WWII, Tuskegee and dozens of others)

§  Just because we can do something does not mean we should do it

Ethical issues in stem cell therapy

§  The overarching ethical concern involves the destruction of an embryo to obtain stem cells

§  While legally the debate (in most countries) has been settled as to when life actually begins,

morally the issue is far from clear

§  If life begins at delivery, then there are no

significant moral qualms because the developing embryo is not a human being and has no true

moral status beyond its potentiality

§  If life begins at conception, the issue becomes much more complicated

§  Pro-life groups feel that embryonic stem cell

research and treatment represent destruction of one human being (or at the very least a potential human being) to help another and are therefore morally unacceptable

§  “The ends do not justify the means”

Summary of ethical issues in stem cell research (Lo B End Rev 2009)

Phase of research Ethical issues

Donation of biological materials Informed and voluntary consent Research with hESCs Destruction of embryos

Creation of embryos specifically for research purposes

1. Payment to oocyte donors

2. Medical risks of oocyte retrieval 3. Protecting reproductive interests of women in infertility treatment Use of stem cell lines derived at

another institution

Conflicting legal and ethical standards

Stem cell clinical trials Risks and benefits of experimental intervention

Informed consent

§  The Canadian Institute for Health Research (CIHR) has created guidelines for human stem cell

research to help address these ethical issues

§  Available online at http://www.cihr-irsc.gc.ca

Umbilical cord blood banking: Public versus private

§  There has been a lot of recent attention paid to umbilical cord blood (UCB) banking

§  UCB is a rich source of stem cells that most

consider to be relatively ethically uncontroversial

§  Prior to the baby’s birth, parents can opt to donate the blood to a public UCB bank, or store it, for a cost, in a private UCB bank

Public UCB banks

§  Advantages:

§  Potentially, all patients who need the blood and are a match could benefit

§  No individual costs

§  Encourages altruism and societal engagement

§  Increases the number and diversity of cord blood units available for all patients

§  Widespread donations by minorities will expand the available pool of minority cord blood units in the public system and make it easier for these groups to find matches

§  Disadvantages:

§  Very costly, which limits the number of public banking options

§  Does not “reward” individual donors, they cannot usually access their own UCB later on

Private UBC banks

§  Advantages:

§  Individual donors can always access their own blood later on, optimizing the chance of

successful treatment (especially for a sibling)

§  Generally indicated if an infant has a full sibling with a malignant or genetic condition treatable with cord blood transplantation or if there is a family history of malignant or genetic conditions that might benefit from cord blood stem cells

§  Theoretical possibility of future use for

conditions such as Parkinson’s, Alzheimer’s, etc…

§  Disadvantages:

§  Expensive: initial costs and yearly storage fees

§  Not accessible by all those in need

§  Arguably not in keeping with the spirit of the Canadian health care system

§  Largely unregulated

§  No universal guidelines, so there may be concerns regarding quality control (US experience)

§  Only 1/2700 chance of actually needing the blood

§  Stem cell transplant using an individual’s own cord blood (autologous transplant) cannot be used for genetic disorders such as sickle cell disease and thalassemia, because the genetic mutations which cause these disorders are also present in the baby's cord blood

§  Other diseases that are treated with stem cell transplant, such as leukemia, may also already be present in a baby’s cord blood

§  The SOGC, AAP and the AMA recommend

against privately storing cord blood as a form of

"biological insurance“, because the potential benefits are too remote to justify the costs

Informed consent

§  Three components:

§  Patient capacity

§  Disclosure of all information required

§  Voluntariness

§  Challenges to informed consent in UCB banking:

§  Vulnerability of new parents

§  “If you really love your baby, you’ll do this.”

§  The way information is disclosed and statistics are presented

§  What happens when parents disagree with each other

Summary

§  Basic ethical principles can be used in medical and research ethics to help guide physicians and

researchers to “do the right thing”

§  Science without ethics has a great potential to do harm to individuals and to society

§  There are important ethical issues inherent in stem cell research and stem cell therapy that need to be considered

§  This includes informed consent and the advantages and disadvantages of public and private UCB

banking options