No ‘green light’ for controversial biotech company’s plan to ‘bring dead back to life’
This article is more than 4 years old
“Scientists get green light to bring back dead to life with stem cells,” claims an article shared on Facebook in South Africa.
It says Bioquark, a US-based biotech company, has been “given permission to recruit 20 clinically dead patients and attempt to bring their central nervous systems back to life”.
The patients in the trial will have to be “declared certified dead and kept alive solely through life support machines”. The first part of the trial is to “determine whether or not they are capable of reversing clinical brain death through drug administration, nerve stimulation, and laser therapy”.
Bioquark has been granted ethical permission from review boards in the US and India to begin trials, the article says, and is looking to recruit patients for its ReAnima Project as soon as possible.
The article is on the website Science Page News, which mostly publishes rewritten scientific news from mainstream sources. It gives an article in Scientific American, a well-regarded science and technology magazine, as its source.
But the two articles have very different details about the Bioquark project. And while the Science Page News story is dated 15 October 2019, the Scientific American article was published more than two years earlier, in June 2017.
Has Bioquark been given the go-ahead to start this controversial medical trial?
Bioquark describes itself as a “life sciences company developing proprietary combinatorial biologic products for both the regeneration and repair of human organs and tissues, as well as the reversion of a range of chronic degenerative diseases”.
Ira Pastor, its CEO, told Africa Check that the ReAnima project was an exploratory programme “designed to target an area of biomedical research that has gotten very little attention or research dollars over the years, namely the severe disorders of consciousness”.
The project aims to research the state of brain death, or irreversible coma, in patients who have recently met the criteria of the US’s Uniform Determination of Death Act but are still on life support.
Pastor said brain-dead patients who remain on life support were known as “living cadavers”.
The initial goal of the project, Pastor said, was to regenerate consciousness and nerve impulses and get blood flowing again, essentially bringing people “back from brain death”.
The Bioquark website gives no details about the ReAnima project. Under the heading “CNS [Central Nervous System] / Disorders of Consciousness / Brain Death” on the page Bioquantine Clinical Plans, people are asked to email the company “to receive further confidential information about Bioquark’s plans in this space”.
The page has a link to the ReAnima website, but this is no longer live.
The Science Page News article claims that the Bioquark team “has been granted ethical permission from an Institutional Review Board at the National Institutes of Health in the US and India to begin trials on 20 subjects”.
An Institutional Review Board (IRB) is a group that “reviews and monitors biomedical research involving human subjects”.
There is no mention of this in the source article, and there is no “Institutional Review Board” at the NIH. The NIH is a large national agency that mostly funds medical research.
The NIH requires organisations it funds to have IRBs, and might set up IRBs for large-scale projects.
The Indian National Institute of Health and Family Welfare does have an institutional review board, but there is no evidence it would have made a decision about a clinical trial such as this.
Pastor confirmed to Africa Check that Bioquark had not been given permission by the NIH to recruit 20 clinically dead patients, as the Science Page News article claims. “No, this has been a misprint in the press,” he said.
Pastor did not comment on whether any official Indian agencies had greenlighted the project, but said it had “been given permission per the independent institutional review boards of a few small hospitals to conduct the research”.
Pastor referred us to the study description filed with the US National Library of Medicine’s list of clinical trials. Here only one hospital is listed: Anupam Hospital, in Rudrapur, India.
But according to the Scientific American article, and reported elsewhere, the clinical trial in Rudrapur was shut down in November 2016, after launching that April.
The trial was taken off India’s clinical trial registry by the Indian Council of Medical Research, says an article in Science magazine. This was partly because the Drug Controller General of India had not given it permission to proceed.
The trial was not listed on the registry in January 2020.
While the June 2017 Scientific American article quoted Pastor as saying “the company will announce a trial in Latin America in coming months”, he did not mention this when Africa Check spoke to him in December 2019.
We can find no documentation or evidence for any other ReAnima trials.
Ariane Lewis, associate professor of neurology and neurosurgery at New York University’s Langone Medical Center, co-authored a November 2016 response to Bioquark’s attempts at death reversal.
She said Pastor’s research “has no scientific foundation” and “biomedical science is based upon a quest for knowledge through observation and experimentation”.
Lewis told Africa Check that her comments from 2016 still held. “There is no data to support the feasibility of this work.”
She added that the phrase “living cadaver” was contradictory, “as one cannot be simultaneously living and dead”.
She said the project “creates room for the exploitation of grieving family and friends and falsely suggests science where none exists”.
Despite criticism of the company’s aims and methods, Pastor said he still anticipated that Bioquark would start attempting to bring patients back to consciousness within five years – and it “could be much sooner”.
Bioquark still claims to be proceeding with clinical trials that were halted in India in 2016.
And there is no evidence that its trials are going ahead or that its scientists have been given the “green light” to bring the dead “back to life”, as the Science Page News article claims. – Taryn Willows
It says Bioquark, a US-based biotech company, has been “given permission to recruit 20 clinically dead patients and attempt to bring their central nervous systems back to life”.
The patients in the trial will have to be “declared certified dead and kept alive solely through life support machines”. The first part of the trial is to “determine whether or not they are capable of reversing clinical brain death through drug administration, nerve stimulation, and laser therapy”.
Bioquark has been granted ethical permission from review boards in the US and India to begin trials, the article says, and is looking to recruit patients for its ReAnima Project as soon as possible.
The article is on the website Science Page News, which mostly publishes rewritten scientific news from mainstream sources. It gives an article in Scientific American, a well-regarded science and technology magazine, as its source.
But the two articles have very different details about the Bioquark project. And while the Science Page News story is dated 15 October 2019, the Scientific American article was published more than two years earlier, in June 2017.
Has Bioquark been given the go-ahead to start this controversial medical trial?
Bioquark and the ReAnima project
Bioquark describes itself as a “life sciences company developing proprietary combinatorial biologic products for both the regeneration and repair of human organs and tissues, as well as the reversion of a range of chronic degenerative diseases”.
Ira Pastor, its CEO, told Africa Check that the ReAnima project was an exploratory programme “designed to target an area of biomedical research that has gotten very little attention or research dollars over the years, namely the severe disorders of consciousness”.
The project aims to research the state of brain death, or irreversible coma, in patients who have recently met the criteria of the US’s Uniform Determination of Death Act but are still on life support.
Pastor said brain-dead patients who remain on life support were known as “living cadavers”.
The initial goal of the project, Pastor said, was to regenerate consciousness and nerve impulses and get blood flowing again, essentially bringing people “back from brain death”.
The Bioquark website gives no details about the ReAnima project. Under the heading “CNS [Central Nervous System] / Disorders of Consciousness / Brain Death” on the page Bioquantine Clinical Plans, people are asked to email the company “to receive further confidential information about Bioquark’s plans in this space”.
The page has a link to the ReAnima website, but this is no longer live.
No NIH permission to begin trials
The Science Page News article claims that the Bioquark team “has been granted ethical permission from an Institutional Review Board at the National Institutes of Health in the US and India to begin trials on 20 subjects”.
An Institutional Review Board (IRB) is a group that “reviews and monitors biomedical research involving human subjects”.
There is no mention of this in the source article, and there is no “Institutional Review Board” at the NIH. The NIH is a large national agency that mostly funds medical research.
The NIH requires organisations it funds to have IRBs, and might set up IRBs for large-scale projects.
The Indian National Institute of Health and Family Welfare does have an institutional review board, but there is no evidence it would have made a decision about a clinical trial such as this.
Pastor confirmed to Africa Check that Bioquark had not been given permission by the NIH to recruit 20 clinically dead patients, as the Science Page News article claims. “No, this has been a misprint in the press,” he said.
Pastor did not comment on whether any official Indian agencies had greenlighted the project, but said it had “been given permission per the independent institutional review boards of a few small hospitals to conduct the research”.
Pastor referred us to the study description filed with the US National Library of Medicine’s list of clinical trials. Here only one hospital is listed: Anupam Hospital, in Rudrapur, India.
ReAnima trial controversy
But according to the Scientific American article, and reported elsewhere, the clinical trial in Rudrapur was shut down in November 2016, after launching that April.
The trial was taken off India’s clinical trial registry by the Indian Council of Medical Research, says an article in Science magazine. This was partly because the Drug Controller General of India had not given it permission to proceed.
The trial was not listed on the registry in January 2020.
While the June 2017 Scientific American article quoted Pastor as saying “the company will announce a trial in Latin America in coming months”, he did not mention this when Africa Check spoke to him in December 2019.
We can find no documentation or evidence for any other ReAnima trials.
Criticism of study
Ariane Lewis, associate professor of neurology and neurosurgery at New York University’s Langone Medical Center, co-authored a November 2016 response to Bioquark’s attempts at death reversal.
She said Pastor’s research “has no scientific foundation” and “biomedical science is based upon a quest for knowledge through observation and experimentation”.
Lewis told Africa Check that her comments from 2016 still held. “There is no data to support the feasibility of this work.”
She added that the phrase “living cadaver” was contradictory, “as one cannot be simultaneously living and dead”.
She said the project “creates room for the exploitation of grieving family and friends and falsely suggests science where none exists”.
Despite criticism of the company’s aims and methods, Pastor said he still anticipated that Bioquark would start attempting to bring patients back to consciousness within five years – and it “could be much sooner”.
Article misrepresents clinical trial process
Bioquark still claims to be proceeding with clinical trials that were halted in India in 2016.
And there is no evidence that its trials are going ahead or that its scientists have been given the “green light” to bring the dead “back to life”, as the Science Page News article claims. – Taryn Willows
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