Caution!

Today, I feel a responsibility to mention some things of which I am peculiarly aware.  It will require you to temper your optimism and beware those selling hope, because reality is usually less sanguine than advertised.  As stated, I have been suffering with Huntington's Disease (HD) for 15 years, which is a genetic disease where mutant protein production causes a host of deleterious metabolic effects and cellular death, especially in the brain (hippocampus and striatum).  Because of this fact, I have followed biotech research closely for many years with a very personal interest and stake in such research.  I have hoped and waited for real breakthroughs in this area, especially gene therapy, for years.  But, alas, here I am still ailing and not able to qualify for any clinical trials which may help (though I am currently applying for another one now).  Thus I have a good deal of knowledge on this subject (for a layman) which I will share with you now, as these techniques are now in the news relating to these new coronavirus vaccines which, as far as I can tell, make use of a type of synthetic MRNA coding often delivered within a (lipid) nanopolymer.

There are a variety of gene therapy types, targets, and methods being currently experimented with; and this has been ongoing for decades.  But, I'd like to mainly focus on the big picture, not the specifics.  Current gene therapy trials use small numbers of participants and run for long time periods, such as 5-10 years to monitor the effects, safety, and efficacy of such drugs.  There are also concerns about changing the germline, if mutations occur within the eggs or sperm, then those effects would be passed down to the child, and to the child's child, and so on.  Thus it is imperative to ensure that no deleterious off-target effects are seen, for that could endanger the entire species.  These grave risks have set a high bar for treatments to pass, and only a handful of gene therapies have ever been approved, and none have been widely distributed.  So, when I hear about pharmaceutical companies and government agencies rushing out coronavirus vaccines which make use of a type of gene therapy I am aghast; it is the height of arrogance and imprudence.

How can the FDA approve such a treatment with such a short study timeframe.  The long-term effects are unknown.  And the first rule of medicine is to do no harm, especially to those who are already healthy.  It makes no sense to put healthy individuals at risk by giving them a gene therapy when over 99% of healthy people recover from this coronavirus, many with few symptoms.  People need to be fired over this and lose their medical license.  Obviously, there are ulterior agendas at work here.  Drug companies are being paid big dollars for these vaccines and the companies have no liability (because of Congressional law) and offer no warranty -- what a good deal for them.  But why should we the people be bullied by government and corporations, and often blackmailed by employers, into taking something in which the risk outweighs the benefit?  As said, I am dying of a genetic illness, and even I am unsure if I want to take an experimental gene therapy (if given the chance).  I probably will cause I have little to lose, but if I were healthy I certainly would not.  

Don't forget money is still supreme, even within medicine.  Big dollars have been thrown at biotech and pharma for decades with very little to show for it.  Some of the only notable successes were made by Gilead the last decades relating to HIV and Hepatitis C treatments.  Other than that, little springs to mind.  Don't lose critical thinking and awareness, there are large private profits to be made from this pandemic from hospitalizations (grants), manufacturing (ventilators - which are harmful), treatments (Gilead's Remdesivir - which is worthless), and vaccines (Pfizer, Astrazeneca, Moderna).  These companies stand to make big dollars, and so will their shareholders.  There really are conflicts of interest here.  And big technology companies as well (such as Microsoft, owned by Bill Gates, whose foundation is now the biggest donor to the World Health Organization) benefit greatly from the new economy.  

So, count me skeptical when a company such as Pfizer develops a MRNA vaccine out of the blue.  As far as I know, they have no track record in this field.  They have no approved treatments or successes to point to for this class of drug.  There is no paper trail of clinical trials, results, and peer-reviewed studies for this technology.  I'm skeptical they are even technologically capable of creating such a treatment.  And I am skeptical it can be scaled to manufacture hundreds of millions of doses.  Who will know the difference?  Who will check the vaccine under a microscope to see what it truly contains?  

Furthermore, there is doubt that the premise even works.  Some studies suggest that extra antibodies circulating actually help and not hurt coronaviruses through Antibody-dependent Enhancement (ADE).  And, even if it helps, these type of treatments have an unknown useful lifespan (unknown because adequate studies have not yet been completed).  Injections may need to be given periodically, and it is unknown if it could actually cause a dependence which will be harmful for the remainder one's life (or even the child's life).  Moreover, these molecules are large enough where they are not easily moved throughout the body, so the delivery issue is unclear.  Will an injection in the muscle mass of the arm really get molecules to where they need to be?  For example, one leader in ASO's, or antisense oligonucleotides (which are synthetic MRNA), is Ionis Pharmaceuticals.  Their drug for Huntington's Disease (Httrx), which was licensed to Roche, is currently being evaluated clinically.  This drug is being injected into the base of the spinal column (intrathecally) every two months now (I think).  The point being, intravenous or oral administration was thought to be not effective at delivering this molecule to the brain.  Other ASO trials Ionis conducted had some success, such as in Spinal Muscular Atrophy (SMA), but not clear resounding success.  There were a bevy of serious side effects in some participants as well.  See this news story from 2017  that revealed a death and several serious problems relating to hemorrhage, platelet levels, and renal problems for a Transthyretin (TTR) amyloidosis ASO treatment. Another issue is the dosing; it is unclear what the proper dosing is for these treatments and how often it should be given. If too much is given there could be effects opposite of what's intended.

Of course I hope to see much progress in biotech and pharma, I am simply saying from experience, don't get too excited yet and believe all the hype.  I have heard of gene therapies coming for decades, but so far there is little tangible to show.  I hope for my own sake that changes quickly, and it might, there are even more exciting methods currently being tested such as Adeno-associated virus (AAV) vectors to administer gene therapies and CRISPR gene editing techniques.  I myself am considering participating in a study by Uniqure for HD if they'll have me.  It is a brain surgery where a benign virus is inserted in the brain which codes to stop the MRNA from producing the toxic protein.  It sounds good and works on mice, but that doesn't always translate to humans.  And the length of efficacy is unknown.  Also unknown is if there will be side effects to effectively turning off a gene.  Moreover, the treatment can't be undone or stopped once administered.  Also, autoimmune responses are always a risk from all of these types of drugs.  

CRISPR is of course most exciting, the idea that we can edit genetics as one would edit software code.  But, again the problem of unintended off-target effects is a concern.  Even if the transcription is 99% accurate, that 1% loss could cause major problems which will effect the germline and species.  So, this is all very serious.  The MRNA treatments should be much safer, but who really knows -- that is my point.  Go through the proper lengthy scrutinized exhaustive clinical trial process; don't fast track something for political and monetary expediency.  

Let me tell you the reality, as many simply seek to tickle your ears.  The reality is that you are mortal; you will die someday, no vaccine or drug can prevent that.  There is no magical elixir, or holy grail, which will remove all life's problems and grant immortality.  Viruses, infection, and illnesses are a part of life, and so is death.  Can we all just accept that.  No, a face mask will not save you from this uncomfortable truth.  The best thing to do is to not worry as stress can actually promote illness.  The best thing is to have a healthy immune system by eating well and resting enough so that your own body can defend itself, which it will.  Coronaviruses have been with man forever, and there has never been a vaccine for one before, as they probably will mutate and make the vaccine worthless anyways.

Vaccines have become like a religious sacrament to some; it's really quite bizarre.  If I choose to not subject myself to the toxic chemicals and additives in them that is my right, to do what I want with my own body, as the left says about abortion.  And if the vaccine works, then even if I get sick you should be ok, right?  To me vaccines are dubious science, mostly dogma of a fanatical few, which are likely at least partially responsible for many things such as the increase in autism.  Most of the benefit society has accrued the past two centuries is not from vaccines, it's from improved diet, sanitation, and treated water.  The reality now is that the world is global, and illnesses spread all over the world, and people will either succumb to it or recover with some degree of immunity (though you can have multiple colds in your life, thus no immunity from coronaviruses, making a vaccine worthless).  Viral pandemics are like wildfires, they eventually die out, having run out of fuel, or vulnerable persons to consume.  The viruses then die out and largely disappear.  Of course when new viruses appear, bad ones can kill 25-35% of the population.  For example, see the Black Plague, or when the Europeans came to the New World and gave their illnesses to the indigenous people.  

Again, count me skeptical of vaccines, as they claim to administer an attenuated virus, but how do you kill a virus, or weaken it, when it's not a living thing to begin with?  Viruses are not living creatures, they are more akin to software code, which if scrambled would then be unhelpful in building immunity.  But if unscrambled could then risk copying and multiplying thereby causing infection.  Most vaccines most likely simply give the virus they seek to stop.  And provoking an immune response as they say is simply becoming afflicted or sick with a bug, but of course healthy people quickly recover.  The idea of giving vaccines really is the idea of exposing the whole society to various bugs at various times so that you don't have that moment where a third of the population quickly perishes.  But as said, this coronavirus vaccine is more dubious than most.  I personally won't be taking it as I already have enough problems.  Remember the old adage, if it ain't broke, don't fix it.  There is wisdom there.

P.S.  There are bigger issues at play here which I didn't delve into here, but are in Chapter 20 of my book Hermetic Philosophy by Thomas Colquith relating to air pollution and aerially emitted particulate, which may be partially responsible for exacerbating this epidemic.  And of course, an article could be written on the economic effects of this pandemic and the pandemic response by governments and central banks which have largely favored large multinational corporations and further eroded civil liberties and destroyed the lower working classes for the benefit of the rich.