Andrew and I are still wrestling with what I call the "only-possible-intent" problem. A funny thing about the law is that it defines drugs based on manufacturer *intent*, rather than claims. The specific language is:
"articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease"
A regulator might try to argue that the only conceivable intent for adding a vaccine antigen to yeast is the prevention and treatment of disease caused by the virus from which the antigen was derived. It's essentially the argument my scientific colleagues are making - everybody knows what I'm doing when I add a viral antigen to yeast. My intent - whether spoken or not - is obviously to prevent or treat disease.
Fortunately, a judge would laugh this argument out of court for BK polyomavirus (BKV), because the manufacturer has no idea which diseases might or might not be prevented (see footnote [1]). The BKV yeast are truly just pursuing a possible general health effect - which is allowed for foods. Unfortunately, the only-possible-intent argument starts to become more plausible for something like influenza - where there's obviously one specific disease in the crosshairs.
My sense is that legal precedents would make an only-possible-intent argument a nonstarter in court. Historically, marketing claims are the only thing regulatory agencies have ever used as evidence of manufacturer intent. In the case of Activia yogurt, a court ruled that the manufacturer couldn't have a label claim saying that eating the added Bifidobacterium animalis DN-173 010 ingredient is clinically proven to relieve temporary irregularity (i.e., constipation). Activia complied with the court ruling by changing the label to the general health claim "helps regulate your digestive system."
In the Activia case, the manufacturer essentially announced on its original label that the only-possible-intent for adding Bifidobacterium animalis DN-173 010 is relieving constipation. The point is that the court didn't attempt to psychoanalyze the manufacturer to infer an only-possible-intent - the ruling only used the text of the label claims to infer disease-treatment intent. We all know what Activia is trying to do when they add Bifidobacterium animalis DN-173 010 to the yogurt - but it doesn't matter, so long as it's not in the sales pitch.
With the Activia case in mind, it seems to me that yeast with influenza antigens would be just fine, so long as the label doesn't state an intent to foil the flu. The label could, on the other hand, lawfully have a general health claim along the lines of "promotes healthy immune function."
Another example to consider is golden rice, which is engineered to produce beta carotene. The only-possible-intent of adding beta carotene is to treat diseases associated with vitamin A deficiency (beta carotene is a harmless dimer of vitamin A). Golden rice is marketed as a food, not a drug.
Although the only only-possible-intent argument is something I can imagine a power-mad regulator trying to read into the law, the fact that there is no legal precedent for that interpretation makes it very unlikely to hold up in court. Trying to use the interpretation only against vaccines would be an obvious case of selective enforcement, which is illegal.
"Unfortunately, the only-possible-intent argument starts to become more plausible for something like influenza - where there's obviously one specific disease in the crosshairs."
I suppose it could be used for entertainment purposes like to wind up a doctor by asking for a titre test.
"According to Prof. Heininger:”For none of the generally recommended so-called basic vaccinations is a routine control of the vaccination success planned or even advisable". (Heininger 2017) [7] or the blanket statement regarding the measles vaccination,
"that a positive laboratory result does not certify protection" (Heininger 2016) [8] - If the latter were the case, the vaccination could not have been certified as effective and therefore approved...
However, in medicine we have known for decades that circulating antibodies are not synonymous with protection against a disease, a fact that can be understood even by laypeople using short examples."
A great many covid studies have shown that people with a neutralizing antibody titer >1000 don't get infected. There are similar antibody-based correlates of disease resistance for the polyomaviruses I study. At my most recent physical, I asked for my measles titer - and while the report didn't have a golden asterisk certifying an absolute guarantee of protection, my titer number is high enough that I'm not gonna bother with an MMR boost. Antibodies are just a proxy for disease, but in most or all cases they're a pretty good proxy.
To the point at hand, I think we can all agree that antibody titers aren't a disease. If a product label said "intended to raise your influenza-specific antibody levels" I think it would be hard to argue that's a disease treatment claim. The power-mad control freaks at the FDA would probably try to argue the case, but I doubt a judge would buy it.
In terms of market economics, it would be great if somebody could offer lateral flow rapid tests for antibody serology. Then everybody could easily tell which vac yeast products are or are not likely to work.
One study is better than none. None is better than 'a great many'.
"antibody titers aren't a disease"
'Antibodies' were used to 'test' for 'HIV'. If globulins are increased it might suggest the GMO yeast causes inflammation and is unsafe for consumption.
"If a product label said "intended to raise your influenza-specific antibody levels" I think it would be hard to argue that's a disease treatment claim. "
Cold and flu like symptoms are detox symptoms, not "a disease".
What's so exciting about this project is that we'll soon be able to experimentally test your hypotheses. If people who choose to try food-based vaccines against common cold viruses stop getting common colds then the question will be settled once and for all. The dream scenario is that herd immunity effects might even cut down on colds for people who don't want to try food-based vaccines themselves.
I'm with you - it makes it really hard that there's so much snake oil out there. It's hard not to want to just throw up my hands and declare all supplements worthless.
The basic problem is that we've allowed the bioethicists to make scientists afraid of testing and sharing opinions about medical products - and we're totally dependent on government approval instead of the ordinary market forces that help me pick the best dishwashers and automobiles. I can easily imagine how we could do a lot better at sifting through the snake oil:
Andrew and I are still wrestling with what I call the "only-possible-intent" problem. A funny thing about the law is that it defines drugs based on manufacturer *intent*, rather than claims. The specific language is:
"articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease"
A regulator might try to argue that the only conceivable intent for adding a vaccine antigen to yeast is the prevention and treatment of disease caused by the virus from which the antigen was derived. It's essentially the argument my scientific colleagues are making - everybody knows what I'm doing when I add a viral antigen to yeast. My intent - whether spoken or not - is obviously to prevent or treat disease.
Fortunately, a judge would laugh this argument out of court for BK polyomavirus (BKV), because the manufacturer has no idea which diseases might or might not be prevented (see footnote [1]). The BKV yeast are truly just pursuing a possible general health effect - which is allowed for foods. Unfortunately, the only-possible-intent argument starts to become more plausible for something like influenza - where there's obviously one specific disease in the crosshairs.
My sense is that legal precedents would make an only-possible-intent argument a nonstarter in court. Historically, marketing claims are the only thing regulatory agencies have ever used as evidence of manufacturer intent. In the case of Activia yogurt, a court ruled that the manufacturer couldn't have a label claim saying that eating the added Bifidobacterium animalis DN-173 010 ingredient is clinically proven to relieve temporary irregularity (i.e., constipation). Activia complied with the court ruling by changing the label to the general health claim "helps regulate your digestive system."
In the Activia case, the manufacturer essentially announced on its original label that the only-possible-intent for adding Bifidobacterium animalis DN-173 010 is relieving constipation. The point is that the court didn't attempt to psychoanalyze the manufacturer to infer an only-possible-intent - the ruling only used the text of the label claims to infer disease-treatment intent. We all know what Activia is trying to do when they add Bifidobacterium animalis DN-173 010 to the yogurt - but it doesn't matter, so long as it's not in the sales pitch.
With the Activia case in mind, it seems to me that yeast with influenza antigens would be just fine, so long as the label doesn't state an intent to foil the flu. The label could, on the other hand, lawfully have a general health claim along the lines of "promotes healthy immune function."
Another example to consider is golden rice, which is engineered to produce beta carotene. The only-possible-intent of adding beta carotene is to treat diseases associated with vitamin A deficiency (beta carotene is a harmless dimer of vitamin A). Golden rice is marketed as a food, not a drug.
Although the only only-possible-intent argument is something I can imagine a power-mad regulator trying to read into the law, the fact that there is no legal precedent for that interpretation makes it very unlikely to hold up in court. Trying to use the interpretation only against vaccines would be an obvious case of selective enforcement, which is illegal.
"Unfortunately, the only-possible-intent argument starts to become more plausible for something like influenza - where there's obviously one specific disease in the crosshairs."
I suppose it could be used for entertainment purposes like to wind up a doctor by asking for a titre test.
"According to Prof. Heininger:”For none of the generally recommended so-called basic vaccinations is a routine control of the vaccination success planned or even advisable". (Heininger 2017) [7] or the blanket statement regarding the measles vaccination,
"that a positive laboratory result does not certify protection" (Heininger 2016) [8] - If the latter were the case, the vaccination could not have been certified as effective and therefore approved...
However, in medicine we have known for decades that circulating antibodies are not synonymous with protection against a disease, a fact that can be understood even by laypeople using short examples."
https://truthseeker.se/wp-content/uploads/Stefan-Lanka-The-Misinterpretation-of-the-Antibodies-English-Translation.pdf
A great many covid studies have shown that people with a neutralizing antibody titer >1000 don't get infected. There are similar antibody-based correlates of disease resistance for the polyomaviruses I study. At my most recent physical, I asked for my measles titer - and while the report didn't have a golden asterisk certifying an absolute guarantee of protection, my titer number is high enough that I'm not gonna bother with an MMR boost. Antibodies are just a proxy for disease, but in most or all cases they're a pretty good proxy.
To the point at hand, I think we can all agree that antibody titers aren't a disease. If a product label said "intended to raise your influenza-specific antibody levels" I think it would be hard to argue that's a disease treatment claim. The power-mad control freaks at the FDA would probably try to argue the case, but I doubt a judge would buy it.
In terms of market economics, it would be great if somebody could offer lateral flow rapid tests for antibody serology. Then everybody could easily tell which vac yeast products are or are not likely to work.
"A great many covid studies "
One study is better than none. None is better than 'a great many'.
"antibody titers aren't a disease"
'Antibodies' were used to 'test' for 'HIV'. If globulins are increased it might suggest the GMO yeast causes inflammation and is unsafe for consumption.
https://gmwatch.org/en/106-news/latest-news/20593-another-long-term-feeding-study-raises-questions-about-the-safety-of-gm-maize
"If a product label said "intended to raise your influenza-specific antibody levels" I think it would be hard to argue that's a disease treatment claim. "
Cold and flu like symptoms are detox symptoms, not "a disease".
https://www.youtube.com/watch?v=s1GYK2Coc84
What's so exciting about this project is that we'll soon be able to experimentally test your hypotheses. If people who choose to try food-based vaccines against common cold viruses stop getting common colds then the question will be settled once and for all. The dream scenario is that herd immunity effects might even cut down on colds for people who don't want to try food-based vaccines themselves.
I'm with you - it makes it really hard that there's so much snake oil out there. It's hard not to want to just throw up my hands and declare all supplements worthless.
The basic problem is that we've allowed the bioethicists to make scientists afraid of testing and sharing opinions about medical products - and we're totally dependent on government approval instead of the ordinary market forces that help me pick the best dishwashers and automobiles. I can easily imagine how we could do a lot better at sifting through the snake oil:
https://cbuck.substack.com/p/consumer-reports-for-medicines
P.S. the original snake oil probably had actual health benefits
https://pharmaceutical-journal.com/article/opinion/the-history-of-snake-oil