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Source: Medical Law  Oct 02, 2020  2 years, 11 months, 3 weeks, 4 days, 1 hour, 47 minutes ago

Medical Law: DIY Or Do-It-Yourself COVID-19 Vaccines Fraught With Legal, Ethical, and Public Health Issues Warns Law Professor At University Of Illinois

Medical Law: DIY Or Do-It-Yourself COVID-19 Vaccines Fraught With Legal, Ethical, and Public Health Issues Warns Law Professor At University Of Illinois
Source: Medical Law  Oct 02, 2020  2 years, 11 months, 3 weeks, 4 days, 1 hour, 47 minutes ago
Medical Law: According to a new research paper in the journal Science co-written by a University of Illinois, Urbana-Champaign legal expert who studies the policy implications of advanced biotechnologies. well-intentioned “citizen scientists” developing homemade COVID-19 vaccines may believe they are inoculating themselves against the ongoing pandemic, but the practice of self-experimentation with do-it-yourself medical innovations is fraught with important legal, ethical and public health issues not to mention the potential health dangers.

While the COVID-19 pandemic is surging and there are no therapeutics to date coupled with the fact that people are wary of the COVID-19 vaccines currently development due to meddling by politicians from the White House, several citizen science groups outside the auspices of the pharmaceutical industry have been working to develop and self-test unproven medical interventions to combat COVID-19.
Even though some of the interest in a DIY approach stems from the idea that self-experimentation cannot be regulated by the U.S. Food and Drug Administration and other public health authorities, that belief is legally and factually incorrect, said Jacob S. Sherkow, a Professor of law at Illinois.
Professor Sherkow told Thailand Medical News, “ The concept of ‘citizen science’ broadly describes activities having a scientific aim that invite public participation. While citizen science is important and has a strong tradition in the U.S., a homemade COVID-19 vaccine is perhaps more dangerous than individuals would like to believe.”
Professor Sherkow who is also an affiliate of the Carl R. Woese Institute for Genomic Biology added, “We are all sympathetic to the notion that people want to inoculate themselves against the virus,” he said. “But people need to understand that every home remedy is not necessarily going to help, and some may very well be fatal.”
The growing interest in a do-it-yourself approach stems from a mistaken belief that self-experimentation would not be subject to laborious ethics board review or federal regulation. But that misunderstanding has potentially dire public health implications said Professor Sherkow.
He added, “Individuals should be aware that just because they are experimenting on themselves doesn’t make it legal without approval. Some self-experimentation can qualify as human subjects research that is required to undergo ethics review, by law or institutional policy. Just because it is self-experimentation does not give you carte blanche.”
In the same light, simply publishing medical information on the internet is, generally speaking, not regulated by the U.S.FDA. But developing a possible therapeutic product using typical equipment, chemicals and reagents would likely be regulable by the U.S.FDA, Professor Sherkow said.
He added, “Taking information that you found in some dark corner of the internet but using it to develop your own materials and needing to ship materials or reagents across state lines that is interstate c ommerce and is what triggers FDA oversight. At that point, that is essentially where the FDA can stop you.”
It should be noted that homemade interventions exist in stark contrast to traditional paths to vaccine development, which require randomized controlled trials with well-defined endpoints, such as demonstrated immune responses, and protocols concerning the retention and use of data.
Furthermore, biohackers creating and self-administering unapproved and unproven medical interventions run the risk of not only endangering public health, but also undermining public trust in all vaccines, Professor Sherkow said.
He further added, “We are living in an age of vaccine disinformation. It is one of the reasons why we have phased clinical trials for the development of vaccines and medical treatments. It is not just a matter of figuring out whether something is effective or whether it works. It is also a matter of figuring out the gross toxicity of the treatment, and if it is been manufactured in such a way so that it’s not going to harm people.”
It must be warned that characterizing or positioning research as self-experimentation does not eliminate risks to bystanders or the collective good.
Professor Sherkow further added, “Citizen scientists, especially those professional scientists moonlighting as homemade vaccine makers, must take their heightened ethical responsibilities seriously when promoting DIY interventions or treatments, especially those with potentially serious public health and societal effects. Although many citizen scientists appear to take seriously the ethical responsibilities associated with their activities, it is important to recognize that those responsibilities expand when public health is at stake, such as with COVID-19 vaccine development. But just because there is a list of instructions on the internet created by a lot of well-respected and well-trained scientists does not mean that something cannot go wrong.”
It has been reported in numerous media that many Americans are now trying to develop their own vaccines and therapeutics at home simply based on what the learn from the internet and are using themselves or their loved ones as ‘guinea pig’s to test these vaccine or therapeutics without considering for a moment the possible repercussion including anaphylactic shock, sepsis etc.Most were inspired by a Netflix documentary series on Biohackers.
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