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Articles by Patrick Foong
Stem cell companies and co-founders lose multi-million dollar lawsuit
Following a lengthy litigation, the co-founders of the Stem Cell Institute of America and related companies have been prohibited from promoting and selling stem cell therapies under a federal district court order. The court, in the case of Federal Trade Commission and State of Georgia v Steven D Peyroux and others, also issued a separate order requiring the defendants to pay $1,845,0000 in civil penalties and $3,310,146 in refunds to 479 consumers, totalling $5,155,146 million.
FDA victory offers hope for better stem cell regulation
After almost two years, the US Food and Drug Administration (FDA) has won its appeal in a stem cell lawsuit in California brought by the FDA against the California Stem Cell Treatment Center (CSCTC), which was brought to the Court of Appeals for the Ninth Circuit.
Florida stem cell clinic to pay out class action | PET
Recently, a Florida jury found the Tampa-based Lung Institute guilty of engaging in deceptive and unfair practices when it provided patients with ineffective stem cell therapies to treat incurable lung diseases. This nearly decade-long class action led the defendant to pay US$9 million (£7,062,570) to its former patients. This is probably one of the costliest sums awarded against a stem cell clinic in US history. Stem cell research is regarded as a holy grail for treating a number of diseases.
Category: research ethics
When COVID began to spread rapidly in 2020, sending the UK and other countries into lockdowns, many people asked what they could do to help....
Utah's new stem cell law undermines FDA's authority
The state of Utah has just enacted a law permitting patients to receive medical treatments using placental stem cells without formal approval by the United States’ federal regulatory body, the Food and Drug Administration (FDA). Some experts are worried that this will undermine the FDA’s authority to regulate drugs and other medical treatments. Furthermore, what is also concerning is that other states may follow suit.
Australia’s first human challenge trials centre opens
Australia’s first clinical trial unit specifically commissioned to conduct human challenge trials, or controlled human infection model (CHIM), Doherty Clinical Trials (DCT) Ltd, was recently opened in Melbourne. This type of research involves purposely infecting participants with a pathogen to study the effects of the infection. At the moment, the comfortable 25-bed facility is located in a repurposed building in East Melbourne. In 2027 it will move to a larger site.
Day: April 4, 2024
This story comes from the intersection of China’s one-child policy, voluntary childlessness, surrogacy, and traditional norms of filial piety. As reported in the South China Morning...
Day: February 15, 2024
They may have been the most publicised deaths in the history of euthanasia in the Netherlands. A former prime minister of the country and his...
FDA approves first gene-editing therapy
The Food and Drug Administration (FDA) recently approved Casgevy (exagamglogene autotemcel), the first cell-based gene-editing therapy to utilise the CRISPR/Cas9 system (CRISPR) in history, to treat transfusion-dependent beta thalassemia. In December last year, the FDA also approved Casgevy for the treatment of life-threatening forms of sickle cell disease.
Consumers should beware of stem cell treatments for Covid-19
A recent analysis has identified 38 companies offering so-called stem cell treatments and exosome treatments for preventing as well as treating COVID. These interventions are not supported by convincing safety and efficacy data; they have not been authorised by regulatory bodies such as the Food and Drug Administration (FDA). The study, led by Professor Leigh Turner, from University of California, Irvine, also found that some of these dubious businesses are claiming to treat long Covid.
Day: January 4, 2024
A recent analysis has identified 38 companies offering so-called stem cell treatments and exosome treatments for preventing as well as treating COVID. These interventions are...
Moving on after the CRISPR baby scandal – is China's updated regulation enough? • PET
Image by Bill Sanderson via the Wellcome Collection, © Wellcome Trust Ltd 1990. Depicts Laocoön and his family (from Greek and Roman mythology) entwined in coils of DNA. China recently updated its regulation on human genome editing, a positive outcome after Dr He Jiankui created the world's first genome-edited babies. However, do these regulations go far enough?... Recently, China updated its regulation on human genome editing.
China's revised regulation on human genome editing: the good news and the bad news
Remember the scandalous revelation of the world’s first births of genome-modified twins (Lulu and Nana) by Dr He Jiankui in 2018? Recently, China revised its regulation on human genome editing. While this is undoubtedly a positive development, there are ambiguities and various concerns. In Dr He’s experiment, the girls had their genomes modified by CRISPR-Cas/9 to confer resistance to HIV, the virus that causes AIDS.
Day: April 25, 2023
Lobbying to do away with the dead donor rule and even to make possible organ donor euthanasia has begun in the state of Victoria, in...
Third global summit on human genome editing: Moving on after the He experiment
The much anticipated Third International Summit on Human Genome Editing was held in London earlier this month to explore the advances of the science, challenges and opportunities in research, regulation and equitable access to human genome editing technologies and treatments. It was organised by the World Academy of Sciences, Royal Society (UK), Academy of Medical Sciences (UK) and the National Academies of Sciences and Medicine (US).
Medical advances and ethical dilemmas in human genome editing
Image by Matthew Daniels via the Wellcome Collection. Depicts human cells, showing the stages of cell division. The latest genome editing approaches and treatments, as well as ethical issues and equitable access, were discussed at the Third International Summit on Human Genome Editing...
Regulating dodgy stem cell clinics: FDA is appealing against ruling
The US Food and Drug Administration (FDA) has decided to appeal a surprising decision after it lost a case it was fighting against a California stem cell clinic. The appeal was made against a decision by a California District Court that the California Stem Cell Treatment Center (CSCTC)’s medical procedure that utilises patients’ personal stem cells does not fall under the FDA’s authority. Conflicting rulings about stem cell treatments could raise questions about the FDA’s authority.
California court creates regulatory uncertainty over the FDA regulation of stem cell therapies
In a recent lawsuit brought by the Food and Drug Administration (FDA), a California judge entered a judgment in favour of the California Stem Cell Treatment Center (CSCTC). The decision was that the use of patients’ own stem cells to treat various diseases and conditions does not fall under the purview of the FDA’s authority. This is a massive win for private stem cell clinics. Critics say that the ruling by Judge Jesus Bernal of the Central District of California is regarded as flawed.
Regulation of Clinical Trials and Pandemic Research: Upholding Ethical Standards During a COVID-19 Crisis
Biotechnology Law ReportVol. 41, No. 3 Original ArticlesFree Access 1. Introduction The COVID-19/SARS-CoV-2 pandemic presents an unprecedented and extraordinary challenge to global health. Cases, as well as mortality, continue to increase globally. To prevent the spread of disease and control the pandemic, numerous studies involving human participants are performed and many COVID-19 vaccine candidates, including multivalent ones, are currently in development.
Class action over unproven stem cell treatment settled for US$3.65 million
San Diego-based StemGenex, a now-bankrupt stem cell clinic, has to pay out US$3.65 million to its former patients for ineffective stem cell treatments. The complaint, filed in a California federal Court, alleged that the clinic offered stem-cell therapies and claimed that they could cure many diseases and disabilities. The plaintiffs alleged that the company deceived them with its claims and that the treatments were ineffective.
Are human challenge studies for Covid ethical?
BIGSTOCK by Patrick Foong and Grace Borsellino Researchers at Oxford University, in the UK, are seeking volunteers to participate in human challenge studies. These are carefully controlled experiments which involve deliberately infecting volunteers with a pathogen to analyse the effects of the infection. It could be important for future vaccine development.
Human blastoids give insight into implantation
Human blastoids give insight into implantation 6 December 2021 Appeared in BioNews 1124 Scientists have created a 'blastoid' model of the human embryo at early-stages that can successfully attach to uterine cells in vitro, mimicking the implantation of an embryo in the mother's uterus. In the first week of fertilisation human embryos form a ball of cells called a blastocyst, which must implant into the uterine wall for a pregnancy to continue.
The CRISPR babies: the story unfolds
Remember the shocking announcement of the first births of genome modified twins (Lulu and Nana) globally? In an article in Nature Biotechnology, we learn a little more about these girls, now toddlers. But, it says, “… their fate remains shrouded in secrecy amid swirls of rumors. Many people contacted for this story refused to speak about the babies … Some would speak to Nature Biotechnology only on condition of anonymity”.
Shonky stem cell products explode in US
Disturbingly, there are now more than four times as many businesses in the United States offering untested stem cell treatments than there were five years ago. This is the finding of a recent study led by Leigh Turner, professor of health, society and behaviour at the University of California, Irvine (UCI) published in Cell Stem Cell. Such so-called therapies lack solid evidence of safety and efficacy.
Category: stem cells
Disturbingly, there are now more than four times as many businesses in the United States offering untested stem cell treatments than there were five years... University vehemently denies allegations that organs were removed from living foetuses The use of foetal tissue at the University of Pittsburgh is becoming a hot... This week Professor Jose Polo and an international team have reprogrammed human adult cells to create an “iBlastoid” at Monash University. This breakthrough has opened a...
Unproven stem cell treatment industry in the USA: a concerning boom
Unproven stem cell treatment industry in the USA: a concerning boom 22 November 2021 Appeared in BioNews 1122 In the USA, clinics offering stem cell therapies not approved by the US Food and Drug Administration (FDA) expanded four-fold in just five years. These putative medical treatments lack concrete evidence of safety and efficacy, a study published in the journal Cell Stem Cell earlier this year has shown.
CRISPR genome editing may select for cells with cancer-associated mutations
CRISPR genome editing may select for cells with cancer-associated mutations 22 November 2021 Appeared in BioNews 1122 Cells with mutations linked to cancer can outcompete normal cells after CRISPR/Cas9 genome editing. The study, published in Nature, reports that cells with pre-existing mutations known to drive cancer can be positively selected during CRISPR/Cas9 editing.
Early stage of human embryo development seen for the first time
Early stage of human embryo development seen for the first time 22 November 2021 Appeared in BioNews 1122 High-resolution single-cell gene expression analysis has been performed on a gastrulating human embryo, providing landmark insights. Because human embryos cannot legally be cultured longer than 14 days in the UK (see BioNews 1083 and 1086), if scientists wish to study them the embryos must be conceived naturally and donated following a termination.
mRNA HIV vaccine trial to start
mRNA HIV vaccine trial to start 23 August 2021 Appeared in BioNews 1109 Moderna has started a trial for its HIV vaccine, based on mRNA technology. After its successful development of the COVID-19 vaccine last year, the US pharmaceutical and biotech company will use mRNA technology in two new HIV vaccines. A series of these will be used alongside some HIV vaccines already developed using more traditional vaccine technology.
Fertilisation, the fourteen day rule, and beyond
Fertilisation, the fourteen day rule, and beyond 7 June 2021 By Dr Sigal Klipstein Dr Klipstein practices reproductive endocrinology and infertility at InVia fertility specialists in Chicago, Illinois. She is an assistant clinical professor at the University of Chicago and is the chair of the Ethics Committee of the American Society for Reproductive Medicine.
Book Review: CRISPR People - The science and ethics of editing humans
Book Review: CRISPR People – The science and ethics of editing humans 1 June 2021 Appeared in BioNews 1097 In November 2018, the Chinese scientist Dr He Jiankui announced to attendees of the second International Summit on Human Genome Editing that he had used CRISPR-based genome editing to alter the DNA of embryos before transferring them into their mother's uterus.
New embryo and stem cell research guidelines allow for possibility of extending the 14-day rule
New embryo and stem cell research guidelines allow for possibility of extending the 14-day rule 26 May 2021 The International Society for Stem Cell Research (ISSCR) has published wide-ranging new guidelines, covering areas of research and clinical practice that range from the routine to the novel and contentious.
Human/monkey chimeric embryos: context and questions
Human/monkey chimeric embryos: context and questions 10 May 2021 Appeared in BioNews 1094 'What is the moral status of these novel creatures?' Scientists raise ethical concerns after lab creates a human-monkey HYBRID for cancer research' – Headline from the Daily Mail On 15 April 2021, the journal Cell published a paper reporting the creation of part monkey, part human embryos (see BioNews 1091).
The question of embryohood
The question of embryohood 4 May 2021 Appeared in BioNews 1093 Students of bioethics sometimes imagine that the philosophical, moral and legal status of the human embryo is reducible to the single question: 'Is the human embryo a person?' In English law, a human being is regarded as a 'natural person' from the moment he or she is born alive. Yet, this is hard to justify philosophically.
Biden scraps human fetal tissue research limits while New York stops stem cell research funding
Biden scraps human fetal tissue research limits while New York stops stem cell research funding 26 April 2021 Appeared in BioNews 1092 President Joe Biden's administration has reversed the Trump-era decision which restricted federal funding for medical research using human fetal tissue from abortions.
The emergence of iBlastoids: Time to update the law?
The emergence of iBlastoids: Time to update the law? 26 April 2021 Appeared in BioNews 1092 Adult human skin cells have been reprogrammed to form three-dimensional structures similar to early human embryos by a team led by Professor Jose Polo at Monash University, Australia (see BioNews 1088). Called 'iBlastoids', they could potentially enable us to learn how early human embryos develop and implant in the uterus.
Sorry mate, you're a monkey…
Sorry mate, you're a monkey… 26 April 2021 By Dr Anna Smajdor Associate Professor of Philosophy at the University of Oslo, Norway Appeared in BioNews 1092 Many of our legal and moral frameworks are based on natural distinctions. There's an obvious biological difference between humans and animals, embryo and adults, men and women, parents and non-parents, black and white... isn't there?
Researchers generate human-monkey chimeric embryos
Researchers generate human-monkey chimeric embryos 19 April 2021 Appeared in BioNews 1091 Monkey embryos containing human stem cells have been grown successfully for the first time. Scientists at the Kunming University of Science and Technology in Yunnan, China, injected human stems cells into fertilised macaque monkey embryos which were then cultured for up to 19 days.
FILM: Researchers create monkey/human chimeric embryos
FILM: Researchers create monkey/human chimeric embryos 19 April 2021 Appeared in BioNews 1091 In the news item below – which was originally broadcast by 5 News – Sarah Norcross, director of the Progress Educational Trust (which publishes BioNews), discusses the creation of chimeric embryos which contain material from both monkeys and humans (as reported elsewhere on BioNews this week).
What is the law on iBlastoids?
What is the law on iBlastoids? by Patrick Foong | 21 Mar 2021 | Link This week Professor Jose Polo and an international team have reprogrammed human adult cells to create an “iBlastoid” at Monash University. This breakthrough has opened a legal and ethical can of worms. Are the current laws ambiguous or superannuated? The importance of these iBlastoids is that they enable us to learn how early-stage human embryos develop and implant in the uterus.
Lawmaker indicted for stem cell fraud
Lawmaker indicted for stem cell fraud 8 February 2021 Appeared in BioNews 1082 A Missouri state representative has been indicted by a federal grand jury for her part in a fraudulent scheme where patients were allegedly administered with COVID-19 treatments that were falsely claimed as containing stem cells.
A class action suit against an Australian IVF provider is a reminder that IVF is a huge industry
A class action suit against an Australian IVF provider is a reminder that IVF is a huge industry Remember Erin Brockovich, an inspiring consumer advocate and environmental activist in winning a US$333 million class-action lawsuit, the biggest of its kind in US history? She brought a small town to its feet and a huge corporation to its knees, as the tagline goes. A class action was just lodged against Monash IVF Pty Ltd, the owner of IVF clinics in Australia.
Class action lawsuit: has Monash IVF breached its legal duty of care?
Class action lawsuit: has Monash IVF breached its legal duty of care? 1 February 2021 Appeared in BioNews 1081 A law firm has filed a class action against Monash IVF, one of Australia's largest IVF clinics, following allegations that the fertility clinic may have destroyed healthy embryos through a defective non-invasive genetic screening test (PGT-A test).
California's Proposition 14: short in the arm for stem cell research
California's Proposition 14: short in the arm for stem cell research 14 December 2020 Appeared in BioNews 1076 The recent close-call US presidential election grabbed headlines, but no less closely-fought was California's Proposition 14, also on the ballot in October, which will have a huge impact on the future of stem cell research in the state.
The California Institute for Regenerative Medicine gets a second lease on life
The California Institute for Regenerative Medicine gets a second lease on life by Patrick Foong | 13 Dec 2020 | Link California, the state of sun, sand, surf, Botox, tech and stem cells. Like the tense national election, the stem cell field also saw deep divisions among Californians. Proposition 14, the Stem Cell Research Institute Bond Initiative (Prop 14), was on the ballot in an initiated state statute.
Panacea of 21st century for ovarian rejuvenation
Panacea of 21st century for ovarian rejuvenation 7 December 2020 By Dr Dusko Ilic Assisted Conception Unit, Guy's Hospital, London Appeared in BioNews 1075 In ancient times, theriac, a medical concoction made by Greeks that was thought to cure all illnesses, had spread all over the then known world. It took months to prepare a proper theriac and that, of course, made it expensive. Only rich people could afford it.
Why we should use mild stimulation in egg donation
Why we should use mild stimulation in egg donation 30 November 2020 Appeared in BioNews 1074 There are two strong ethical reasons to avoid harm to egg donors: a duty to minimise harm and the proportionality rule. The general duty to minimise harm applies to all medical interventions but it is even more relevant for donors because they are submitting to the intervention for the benefit of others. Most forms of body material donation will carry with them some harm.
New study on CRISPR: the stake of unintended consequences in embryos
New study on CRISPR: the stake of unintended consequences in embryos 23 November 2020 Appeared in BioNews 1073 A recent paper published in the journal Cell revealed the cautionary finding that unwanted changes are introduced after modifying genes in human embryos with CRISPR/Cas9.
Patients with neurological diseases seeking stem cell treatments
Patients with neurological diseases seeking stem cell treatments 24 August 2020 Appeared in BioNews 1061 A recent study in the USA suggests that some patients with neurological disorders, such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) and Parkinson's disease, are increasingly seeking information on stem cell treatments as a therapeutic option from their doctors. This group sent out a survey to neurologists in the USA to assess their experiences.
should we deliberately infect volunteers?
Covid-19: should we deliberately infect volunteers? by Patrick Foong | 2 Aug 2020 | Link In a desperate race to develop a Covid-19 vaccine, it is tempting for scientists to compromise quality control and rigour. But crises are not an excuse for lowering the bar of stringent ethical and scientific standards. Ethicists have warned scientists not to cave into bad science. Can permitting volunteers to be purposely infected with COVID-19 to develop a vaccine be done ethically? Yes, according to Adair D.
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