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To Maryland Governor Larry Hogan: Liberate Vaccine Doses from the FDA! – Article by Dan Elton and Edward Hudgins

To Maryland Governor Larry Hogan: Liberate Vaccine Doses from the FDA! – Article by Dan Elton and Edward Hudgins

Daniel C. Elton, Ph.D.
Edward Hudgins, Ph.D.


Note from the Authors: This was an op-ed we wrote in the first week of February 2021. Unfortunately, no newspaper wanted to publish it. We first submitted it to the Baltimore Sun, which promptly turned it down. We then submitted it to the Capitol Gazette, The Washington Times, and The Washington Examiner but never heard back from any of them. Sadly, this op-ed is just as relevant today as when we first wrote it almost two months ago. Since it was written, the evidence for the safety and efficacy of the AstraZeneca vaccine has only gotten stronger. An observational study of millions of people in Scotland published in early March found that a single dose of the AstraZeneca vaccine offers ~94% protection against hospitalization, outperforming Pfizer’s vaccine, which offered ~85% protection. Last week AstraZeneca reached an endpoint in the Phase III trial in the United States that the FDA requested, finding an efficacy of 76%, very similar to the previous Phase III trial result (70%). Despite all this, there has been no action from the FDA,and millions of AstraZeneca doses remain languishing in factories in Baltimore, Maryland and West Chester, Ohio as thousands of American taxpayers that are desperate for them die every day.

~ Daniel C. Elton and Edward Hudgins, March 31, 2021


If Maryland Governor Larry Hogan acts immediately and decisively, he can save thousands of Marylanders from suffering and death from COVID-19. A facility in Baltimore produces the very effective AstraZeneca vaccine and has stockpiled millions of doses. But the U.S. Food and Drug Administration, headquartered in suburban Maryland, which must certify all vaccines and medical treatments before patients can reap their benefits, is holding those doses hostage to its antiquated, bureaucratic red tape. Hogan should act now to liberate the vaccine to save the lives of Marylanders.

Over a year into the pandemic, over 8,200 Marylanders have died, and some 410,000 have suffered from COVID-19. Marylanders have suffered from a chronic shortage of the FDA-approved Pfizer and Moderna vaccines. AstraZeneca is approved in the E.U. and 19 other countries. So as our morgues fill up, what’s the FDA’s excuse for delay?

The AstraZeneca vaccine has passed Phase I and Phase II efficacy trials, which were published in the medical journal The Lancet in July and November 2020. A Phase III peer-reviewed study that was conducted in three other countries indicates the vaccine has an efficacy of 70 percent, ranging from 62 percent to 90 percent with different dosages. Most importantly, the vaccine showed a 100-percent efficacy at preventing COVID-19 hospitalizations and deaths. The AstraZeneca vaccine was also the first shown in a scientific study to reduce transmission. And unlike the two already-approved vaccines, it requires only regular rather than ultra-cold refrigeration. It has been given to over one million people in the U.K. without safety issues detected, yet FDA has requested that AstraZeneca redo most of their Phase III trials using patients from the U.S.

Some media outlets have reported that AstraZeneca’s vaccine “may not work” in the elderly. Unfortunately, AstraZeneca’s Phase III data published so far does not allow for efficacy to be determined for those older than 65. However, Phase I & II trials showed a similar immune response after the second dose across all age groups, including those over 65, so there are good reasons to believe the efficacy should be similar for the elderly. Even if the efficacy is much lower, because the elderly are at such high risk it still makes sense to give them the vaccine in order to save lives. This was shown clearly by Oxford bioethicists Jonathan Pugh and Julian Savulescu, who ran some numbers to show the grave consequences of denying the vaccine to the elderly. It is also true that recent results show the AstraZeneca vaccine is not very effective against the South African variant at preventing mild forms of COVID-19. However, the current study only addressed mild illness and AstraZeneca’s vaccine gives a similar immune response to Pfizer’s vaccine, which has been shown to protect strongly against hospitalization from the South African variant. The World Health Organization recently released guidance recommending the rollout of the vaccine not be halted due to this finding and that the vaccine be given to all age groups. 

The U.S. government has already contracted for 300 million doses of the vaccine, costing taxpayers over $1 billion. Yet with thousands dying daily and many more suffering from COVID-19 across the county, the FDA projects they won’t approve the vaccine until late April.  

Since FDA won’t certify the AstraZeneca vaccine immediately, Governor Hogan should act. He might invoke emergency authority to simply take possession of enough of the AstraZeneca vaccine supply in the Baltimore factory producing it to meet Maryland’s needs. But this would likely be unnecessary. He should request that the facility release the vaccine and inform them that the state will likely be able to guarantee no adverse repercussions from the FDA. After all, during the past decade over 40 states passed “Right To Try” laws that allowed terminally ill patients to access safe treatments not certified by FDA for efficacy. The only “repercussion”: in 2018 Congress passed bipartisan legislation, signed by President Trump, recognizing the state’s authority to do so. 

But in parallel, Hogan should call on President Biden to issue an executive order suspending the need for final FDA certification in this exceptional case.

Or Biden, backed strongly by the Maryland Congressional delegation, could request Congress pass emergency legislation creating a Free To Choose Medicine track parallel to FDA’s normal, slow certification process, on which COVID vaccines, tested safe and promising in Phase II or III trials, could be accessed by individuals, with informed consent. Such a track was created in 1992 for AIDS treatments, saving the lives of thousands of sufferers.

Or Biden could request Congress pass a reciprocity law certifying for the use of Americans any COVID treatment approved  in other advanced countries. Rep. Chip Roy (TX-21) and Sen. Ted Cruz, (R-TX) have introduced legislation allowing for reciprocal approval of drugs approved in other trusted countries. This proposal could be focused to allow access to COVID vaccines.

Since AstraZeneca is produced in Maryland and the FDA headquarters is also in Maryland, Hogan is in an ideal position to be the hero, shake things up, and break the bureaucratic walls separating citizens from a lifesaving medication.

If you agree that Hogan should act now, please sign this petition on Change.org:
Larry Hogan : Liberate the AstraZeneca vaccine from the FDA!

Ed Hudgins is founder of the Human Achievement Alliance and a science policy researcher.  He can be reached at ehudgins@humanachievementalliance.org. Dan Elton is  Director of Scholarship at the US Transhumanist Party.  You can reach him via direct message on Twitter (@moreisdifferent).

How We Can Judge the Safety and Efficacy of New Vaccines Prior to Phase III Data and Why We Must – Article by Dan Elton

How We Can Judge the Safety and Efficacy of New Vaccines Prior to Phase III Data and Why We Must – Article by Dan Elton

Daniel C. Elton, Ph.D.


A common refrain we hear from public intellectuals about vaccines prior to Phase III data is “we don’t know anything about the safety or efficacy of vaccine X”. This attitude is both false and misleading to the public, instilling uncertainty and fear about vaccines. To see why it is false, consider if a normal vaccine safety study was done, but by coincidence all of the vaccines were given in hospital rooms that were painted blue. Could we conclude on the basis of such a study whether the vaccine would be safe if administered in rooms painted red? Yes, we can, and we should. We can utilize two forms of reasoning to conclude that the vaccine is safe if given in red rooms, even though we have no data on the matter.

The first form of reasoning roughly approximates the way an ideal Bayesian statistical reasoner would function to compute what is called a “prior probability distribution”. Under this form of reasoning, we consider the millions of doses of similar vaccines (called the “reference class”) that have been administered. For instance, we might consider the vaccines developed for very similar coronaviruses like SARS and MERS.  We note that if the color of paint did affect the safety of those vaccines, this would have likely been detected over the course of prior studies and over the course of millions of doses given previously. Of course, there is a chance the correlation might have been missed. To figure out how big that is, we can go a level deeper and consider a reference class of “things people might notice or fail to notice in medical studies”. We can conclude that for prior vaccines, if such correlations existed they would generally be picked up. On the basis of this and the fact that no such correlation was ever discovered in the reference class of prior vaccines we can conclude that the probability of vaccines like the COVID-19 vaccine being dependent on the color of paint is very small. 

The second type of reasoning, which happens to be much more straightforward in this situation, is what the physicist David Deutsch calls “reasoning from our best explanation of the world”. According to the philosopher of science Karl Popper, we should reason using our explanatory theories of the world which have survived the most rounds of attempted falsification, and which have the highest degree of falsifiability (this rules out non-testable explanations like “vaccines work via invisible ghosts”). In more prosaic terms, this simply means reasoning using the best scientific theories which make predictions in the domain under consideration. We note that our best theories of vaccine function do not anywhere depend on the color of paint in the room. Instead they depend on things like T-cells, binding affinities of molecules, the concentrations of certain molecules in the body, etc. So, we decide that the vaccine is safe regardless of the color of paint in the room where it is administered. 

Both of these forms of reasoning are valid and both are foundational to science, rationality, and human progress. Both of these types of reasoning can be used to say that vaccines under development are likely to be safe and effective before any data comes in. It’s why a reporter who interviewed numerous top scientists reported that they all told him that “they expected the vaccines were safe and effective all along.” Yet instead of proudly sharing this important knowledge with the public, we rarely hear scientists say publicly that they expect the vaccines are safe and efficacious. Instead, they hedge, saying “we have to wait until the data comes in”. This is unethical both on Kantian grounds (they are lying) and on consequentialist grounds, because it leads to undue caution and the public being afraid of vaccines. 

Unfortunately, there is little incentive for scientists to tell the truth about what the likely risks and benefits are with new vaccines before full Phase III data is published. If, for instance, one or two people suffer severe side effects in a Phase III trial (which is rare, but has happened) a scientist who said they suspected it was “very safe” might receive harsh criticism for making a premature assessment. On the other hand, the same scientist will get no pushback for saying “we need to wait for data to make a judgement”. Indeed, they are likely to even be praised for exhibiting the virtues of “caution, prudence, and scientific skepticism”. Moreover, under no scenario should someone be allowed to get a vaccine until the full data comes in, even though it’s fine to allow people to sign up for studies where they have a 50-50 chance of getting the vaccine. Not very consistent, eh?

As US Transhumanist Party Chairman Gennady Stolyarov II has described in detail in an an earlier publication on this site, all of this is the result of a deeply flawed and deadly ethical principle called the precautionary principle, which unfortunately many people have fallen under the sway of. The principle originates in the environmentalist movement but is widely applied in medicine, and was instrumental in decisions such as the Bush administration’s ban on stem-cell research and decisions to ban life-saving GMO technologies such as golden rice. It has been formulated to varying degrees in several different ways. The United Nations World Charter for Nature (1982) issued one version of the principle, stating: 

Activities which are likely to pose a significant risk to nature shall be preceded by an exhaustive examination; their proponents shall demonstrate that expected benefits outweigh potential damage to nature, and where potential adverse effects are not fully understood, the activities should not proceed. 

The principle starts off OK but dives into serious error in the last line. The issue is that the precautionary principle only focuses on the potential adverse effects of proceeding and ignores the potential adverse effects of not proceeding, i.e., the effects of delay. As should now be clear in the case of the COVID-19 vaccines, not proceeding can sometimes be much more deadly than proceeding! There is often a high but unclear risk to not proceeding, and a low but unclear risk to not proceeding. (Picture two probability distributions, both wide (unclear) but one with a mean that is distinctly higher than the other). That’s where the precautionary principle throws expected utility theory (cost-benefit analysis) out and says we cannot proceed. The Nobel Prize-winning physicist Freeman Dyson stated the issue as follows: 

The Precautionary Principle says that if some course of action carries even a remote chance of irreparable damage to the ecology, then you shouldn’t do it, no matter how great the possible advantages of the action may be. You are not allowed to balance costs against benefits when deciding what to do.” — Freeman Dyson, Report from the 2001 World Economic Forum

Imagine an alternative world in which our society and government was not under the sway of the precautionary principle. In this alternative world, scientists would give their truthful assessment of new vaccines to the public, stating that they are likely safe and effective, using one or both of the reasoning methods mentioned above. In such a world, given the clear potential harms of inaction, the public would be allowed to purchase new vaccines if they wanted, if the companies manufacturing them were comfortable doing so, and if they were fully informed prior to their decision that they were taking an unapproved product that carries potential risks but also potential benefits. Initially, only a few people would purchase the vaccines, perhaps on the basis of Phase I results. These would be folks like those who injected themselves with a DIY vaccine over the summer, and the tens of thousands who were willing to participate in clinical trials as early as last spring. Companies would be incentivized to survey those who took the vaccine and collect self-reported data on their outcomes, which is very cheap and easy to do. After a few months going by without any of those people keeling over and dying, and with very few (likely none) of those people getting hospitalized for COVID-19, more people would feel comfortable getting the vaccine. Things would quickly snowball, with more and more people becoming willing to get the vaccine. During this time the distribution system would have been stood up and become operational, with on-site stockpiles building up ahead of the FDA’s Emergency Use Authorization (currently, the FDA does not allow hospitals to stockpile unapproved vaccines ahead of their EUA). To present this case in its strongest form, in a future post I plan to estimate how many lives would have been saved, assuming many vaccines had become available to those who wanted them last March or August. However, I hope it’s easy to see that thousands of lives would have been saved in this alternative world.  

For more on the transhumanist alternative to the precautionary principle, the proactionary principle, see Max More’s excellent book chapter as well as the Wikipedia article and references therein.

Dan Elton, Ph. D., is Director of Scholarship for the U.S. Transhumanist Party.  You can find him on Twitter at @moreisdifferent, where he accepts direct messages. 

Near-Term Improvements to Cities to Combat COVID-19 – Article by Pavel Ilin

Near-Term Improvements to Cities to Combat COVID-19 – Article by Pavel Ilin

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Pavel Ilin


While we are still on lockdown and there is no certainty about when we can safely reopen everything, it is worth reflecting on how we organize our living spaces. COVID-19 is not the first and not the last virus-caused pandemic humanity will have to encounter, and we should be prepared.

Especially we should focus on what improvements can be implemented right away. But first, let’s analyze how the novel coronavirus is spreading.

Virus transmission

It appears that viruses travel inside of droplets. Virus particles can’t travel far just in the air. If that were the case, and the virus could be distributed by the ventilation system within the buildings or in public transportation, then the infection rate would be much higher. We don’t see that yet, and therefore we can conclude it is not happening, and we are very fortunate in that case.

It seems that the virus can be transmitted through close contact (3-4 feet, 1-2 meters away) from person to person. (Source: Centers for Disease Control and Prevention. Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions. Spread.) Also it can be transmitted through surfaces. It has been observed that the virus can live on surfaces in some cases between a few hours and few days. (Source: CDC updates COVID-19 transmission webpage to clarify information about types of spread.)

The challenge is that in a lot of cases, people carry the virus asymptomatically, and they have no idea that they carry a potential threat to the lives of others.

How can we reduce spread?

I can identify 4 levels of control where we can intervene and stop or reduce spread of the virus:

1. Eliminating the source of infection

Efforts could be devoted toward implementing automated virus checks while people come into buildings. We can do automated temperature screens, measure oxygen level in the blood, and implement more potential technologies powered with artificial intelligence (AI) systems to come, which can help with automated and non-invasive testing.

Of course this raises big questions about surveillance, collecting data without people’s consent, and potential discriminatory practices. This is another big conversation we should have.

2. Administrative control

Social distancing – it’s what we are doing right now. And it’s not only a stay-at-home solution. We can also make public spaces less dense. We can put fewer chairs from conference rooms, fewer desks in the offices. Most of the office jobs do not require physical presence. And many manual-labor jobs can be automated.

Of course if we ask people to stay at home, they have to be able to stay at home. First, people should have a home to stay in. To ensure that everyone has a place to stay, we can use rapid 3D printing of the houses and give them to the people who cannot afford to take out a house loan or make a rent payment. 

We can see how job markets have shrunk during recent the pandemic, and many people simply cannot afford to stay at home. Pandemic or not, you have basic needs such as food, hygiene, communication, and healthcare. And these needs must be met in order to keep people in a good physical and mental state. I believe that introduction of some form of basic income would be a good solution.

3. Engineering controls

Through engineering tools we can upgrade our spaces without fundamental rebuilding of the infrastructure.

Increasing ventilation rates in the rooms allows one to bring in more outdoor air,  and the implementation of personalized ventilation and a personalized exhaust system for airborne infection control can reduce the risk of airborne infection significantly. (Source: Ventilation control for airborne transmission of human exhaled bio-aerosols in buildings. Hua Qian, Xiaohong Zheng. J Thorac Dis. 2018 Jul; 10(Suppl 19): S2295–S2304. doi: 10.21037/jtd.2018.01.24)

Installation of the UV-C light within the ventilation system can clear the airflow from any germs and viruses. (Source: Aerosol Susceptibility of Influenza Virus to UV-C Light. James J. McDevitt, Stephen N. Rudnick, Lewis J. Radonovich, Appl Environ Microbiol. 2012 Mar; 78(6): 1666–1669. doi: 10.1128/AEM.06960-11)

As was mentioned before, viruses can survive on the surfaces for some time and can be transmitted while people touch the surface. Through remote-control technologies we reduce interaction with surfaces to minimum. Light switches, elevator buttons, doors, and other aspects of a building can be controlled through the phone or other devices without direct interaction.

4. Personal protective equipment

This level is especially important during an active pandemic situation. Masks, gloves, and face-protection shields, should be produced in advance, stockpiled so they can be available for the people, especially for essential workers when they need this equipment.

Conclusion

To implement all these preventive measures, we don’t have to invent anything and completely rebuild cities’ infrastructure. All technologies are there; we just need to use them rationally and be willing to invest some time and effort into implementation. In the next article we will look into the future and talk about more radical city planning approaches,  such as 3D cities and Arcologies.

Pavel Ilin is Secretary of the United States Transhumanist Party.

Bait and Switch on Nevada AB226 – Article by R. Nicholas Starr

Bait and Switch on Nevada AB226 – Article by R. Nicholas Starr

R. Nicholas Starr


TL;DR – Nevada Assembly Bill 226 is an attack on bodily autonomy hidden in a good idea.

On February 22nd, 2019, Assemblyman Skip Daly (D-Sparks) presented AB226 for review and debate. The act, in its original form, is a good thing. It prevents against forced implantation of a “microchip or other identifying marker”, punishable as a class C felony (up to 5 years in prison and/or $10,000 fine). Fantastic! No one should be forced to do anything to their bodies they don’t want to do! But on March 4th Daly proposed an amendment  to his own bill that also bans VOLUNTARY implantation. This is a staggering attack on bodily autonomy and self determination. To be clear, the exact language of the bill and amendment is below.

1. An officer or employee of this State or any political- subdivision thereof or any other person shall not~

(a- original language) Require another person to undergo the implantation of a microchip or other permanent identification marker of any kind or nature. 

(b- amendment) Establish or participate in a voluntary program for the implantation of a microchip or other permanent identification marker of any kind or nature.

2. A person who violates the provisions of this section is guilty of a category C felony and shall be punished as provided in NRS 193.130.

3. Each day or part of a day during which a violation of this section is continued or repeated constitutes a separate offense.

First of all, I find this amendment suspicious. Why would the original author amend his own bill that he said was inspired by a company’s voluntary program? It appears to me that the amendment’s ban on voluntary implantation was always the intent, but Daly knew that it would never pass on its own. And he’s right! Such a blatant attack on a person’s bodily autonomy, even under the pretense of privacy concerns, would certainly create resistance. And let’s be clear, today’s implants pose no privacy threat. They actually help maintain an individual’s privacy and data security. We also aren’t talking about dangerous devices or chemicals. These implants are extensively tested and biosafe. Any attempt to say otherwise is either deliberate, or ignorant, fear mongering.

The consequences of violating this act, in its amended form, are also extreme. I certainly support felony charges against a person forcing implantation on another. But voluntary implantation carrying the same punishment? That is beyond extreme. Let’s examine Sections 2 and 3 in a realistic scenario. DEF CON, an annual conference held in Las Vegas, has hosted biohacking and implantation during the event since 2015. Indeed, many have traveled to the conference to get their implants. If each implant is a separate offense, and each offense carries a maximum prison sentence of 5 years’ imprisonment, the person performing the implantations could effectively earn a life sentence by lunch! All for agreeing to implant a biosafe tag in a person who volunteered and given their informed consent. 

Bodily autonomy and free determination: these are human rights that guarantee control over your own body. Getting “chipped”, or not, has always been a choice left to the individual with zero known incidents of forced implantation. Mr. Daly’s concern, while appearing noble on the surface, has no basis in reality, but rather arises out of fear and fiction. Sadly, those are two things easily sold these days. Let’s make sure we set the record straight and prevent a crisis where it doesn’t exist.

Ryan Starr (R. Nicholas Starr) is a member of the U.S. Transhumanist Party / Transhuman Party and the founder of the Transhumanist Party of Colorado