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Month: May 2021

U.S. Transhumanist Party Second Letter in Opposition to Nevada Senate Bill 292 – Sent to the Senate Committee on Finance – May 4, 2021

U.S. Transhumanist Party Second Letter in Opposition to Nevada Senate Bill 292 – Sent to the Senate Committee on Finance – May 4, 2021

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Gennady Stolyarov II


Note: Senate Bill 292 (SB292), which would make it essentially impossible for minor political parties to compete at the ballot box or even attempt ballot access, continues to be rapidly advanced in Nevada. It was authored by a former Democratic Party Chair who would like to require the number of signatures to be impossibly “equally apportioned” by petitioning district, move the deadline for submitting petitions to an earlier June 1 date, and institute straight-line party-ticket voting that shuts out other options and discourages individualized decision-making.

After SB292 passed on a party-line vote (3 Democrats in favor, 2 Republicans opposed) out of the Senate Committee on Legislative Operations and Elections, I drafted a letter to the Senate Committee on Finance, where the bill is headed next, in opposition to SB292. The text of this letter appears below. 

I urge all Nevadans and Transhumanist Party members, as well as those who are sympathetic to other minor political parties, to submit their opinions in opposition to SB292 here: https://www.leg.state.nv.us/App/Opinions/81st2021/Be sure to reference the amended, “April 16, 2021” version as the bill you are opposing – so as to signal that even the recently amended bill continues to pose serious problems. If you would like your comments to be published, you can also submit them via e-mail to SenFIN@sen.state.nv.us

The Senate Committee on Finance will meet this Wednesday, May 5, at 6:30 p.m. Pacific Time to hold a public hearing on this bill. Meeting information will be updated on this page: https://www.leg.state.nv.us/App/NELIS/REL/81st2021/Bill/7895/Meetings. If you can dial in during the time period for public testimony and lend your voice in opposition, that would be greatly appreciated. Focus your testimony on the adverse fiscal impacts of this bill, as that is what the Committee will be primarily considering. Please feel free to reference any of my arguments below for inspiration. Remember to be civil and respectful but firm in your opposition!

~ Gennady Stolyarov II, Chairman, United States Transhumanist Party, May 4, 2021


May 4, 2021

Re: Opposition to Amended Senate Bill 292 (First Reprint)

Dear Chairman Brooks and honorable members of the Senate Committee on Finance:

As Chairman of the United States Transhumanist Party and Chief Executive of the Nevada Transhumanist Party, I strongly urge you to oppose Senate Bill 292, which would deprive all minor political parties in Nevada of the opportunity to fairly compete at the ballot box or to even viably attempt such competition.

My comments today will focus on the adverse impacts of Section 2 of the amended (First Reprint) Senate Bill 292, especially the adverse financial impacts to the State of Nevada which are germane to the purview of this Committee.

At a time of great fiscal strain to the State of Nevada, which is just beginning to recover from the devastation of the COVID-19 pandemic, and immense economic hardship for the people of this State, it is highly imprudent to impose additional costs upon the State or any of its agencies for the doubly imprudent and entirely deleterious purpose of raising the barriers to ballot access for minor political parties.

While the amended bill no longer raises the petition-signature threshold from 1% to 2% of the Nevada voters who voted in the last election, it does still, via Section 2, Subsection 2, Paragraph (c), seek to impose an impossible “equal apportionment” requirement for the petition signatures and would also move the deadline for submitting petition signatures from the current third Friday in June to June 1.

The “equal apportionment” requirement renders it essentially impossible for a minor political party to qualify via the petition process and also unnecessarily burdens the Nevada Secretary of State’s Office.

Currently, to verify the validity of a petition signature, the Nevada Secretary of State’s Office simply needs to consider an individual petition signature and whether it belongs to a registered voter in the State of Nevada. With Section 2 of SB292, the Secretary of State’s Office would have the additional burden of verifying that the signatures are “equally apportioned” among the four petition districts in Nevada. This could lead to a significant expenditure of time and resources beyond what can be formally budgeted for – because the added workload would be sporadic, punctuated, and inherently unpredictable given the difficulty in anticipating when (i.e., during what election season) a minor party would seek to qualify for ballot access, as well as how many minor parties would seek to qualify. The potential for significant additional costs to the State of Nevada will be illustrated below via a discussion of how the bill would burden the State by encouraging a multitude of major-party challenges to any minor-party petitions that are submitted.

Nevada has four petition districts, corresponding to the U.S. Congressional Districts. The 3rd Congressional District is the most populous, with a population of 857,197 as of 2019. All three of the other Congressional Districts have populations below 800,000. Suppose that a minor political party were spectacularly successful in gathering petition signatures and managed to collect them from the entire population of registered voters in the 3rd Congressional District. (For this example, I assume that the proportion of registered voters to the general population is the same in each Congressional District.) The very fact that this minor political party could accomplish such a feat would ironically render it impossible for that party to qualify for ballot access, because the other petition districts simply do not have enough registered voters to match the number of signatures gathered from the 3rd Congressional District in that case.

Moreover, the “equal apportionment” requirement renders it almost effortless for a major party to initiate challenges to petitions submitted by minor parties, simply by counting the signatures from each district and noting any difference whatsoever in the numbers of signatures, even if the difference is literally one signature! Even if the total number of signatures is well above 1 percent of the registered voters statewide, if the number of signatures gathered in one petition district were 10,000, and the number of signatures gathered in another petition district were 10,001, that also, by itself, would be sufficient to technically fall out of compliance with the requirement of “equal apportionment”. Note that the text of the amended NRS 293.1715(2)(c) would not allow any room for deviation from a strictly “equal” apportionment. There is no mention of a possibility for the apportionment to be made “approximately equal” or “reasonably equal” or “equal within a tolerance of X%”; the text would mandate strict equality of petition signatures by district, and it appears to enable major parties to seek to disqualify any minor party’s petition on a technicality. Given that different circulators of petitions are likely to operate in different petition districts, it is virtually certain that different numbers of signatures will be gathered by each team of circulators. This is so because the precise coordination at the level that would be needed to achieve exactly equal numbers of signatures among all four districts and to stop gathering signatures in a perfectly choreographed fashion once such equal numbers were attained, would be essentially impossible to achieve.

While it would be easy for major political parties to challenge a minor party’s petition under these circumstances, the experience would be made more difficult for the Secretary of State’s Office and the judicial system of the State of Nevada, because more challenges could be expected to be initiated than otherwise. Responding to a contested matter always involves an added, indeterminate, potentially immense expenditure which, I reiterate, has no compelling public benefit behind it.

Moving the deadline for petitions to June 1 would both unduly burden minor political parties and expose the State of Nevada to additional costs from potential legal challenges.

Because of the additional coordination required to even attempt to gather petition signatures “equally” by petition district, as contrasted with simply trying to gather as many signatures as possible, one would expect that the petitioning effort would be more time-consuming than previously. However, Section 2 of SB292 reduces the available time for a minor party to comply with the added burdens, thereby further lowering the probability of successfully meeting all of the requirements. This disenfranchises the citizens of Nevada who would like to see more options at the ballot box.

Moreover, the United States District Court for the District of Nevada already struck down an even somewhat less burdensome deadline of June 10; this occurred when the Judge in the case of Lenora B. Fulani et al. v. Cheryl A. Lau, Secretary of State (“Fulani v. Lau” – Case CV-N-92-535-ECR) issued a preliminary injunction on October 1, 1992, to require the State of Nevada to include Lenora Fulani and other independent and minor-party candidates on the ballot despite those candidates not having been able to gather the required number of signatures by June 10 of that year. In issuing the preliminary injunction (which effectively decided the case, since the election took place in November of the same year), the Judge wrote “that plaintiffs have shown likely success on the merits, that the balance of hardships tips in their favor and that they will suffer irreparable injury if their names are not put on the 1992 ballot” (Fulani v. Lau, p. 14). The Judge explained that

The character and magnitude of plaintiffs[‘] injury caused by the June 10 filing deadline shows a burden on their First and Fourteenth Amendment rights. The deadline burdens the rights of nonmajor parties[‘] candidates by excluding late[-]forming parties and forcing candidates to circulate petitions before most of the voting population has thought about the elections. Although this date is not as early as others which have been struck down as unconstitutional, most other states require the petitions be submitted several months later. Also, no evidence suggests that candidates who lack an established national affiliation are easily able to access the ballot. (Fulani v. Lau, p. 11)

If the United States District Court found that a June 10 petition-filing deadline is burdensome to non-major parties’ First and Fourteenth Amendment rights, then, logically, a June 1 deadline would be even more burdensome. Such a deadline would indeed serve to thwart any but the most amply funded minor political parties, if those parties choose to begin gathering the signatures extremely early in the year, whereas new minor parties, as well as minor parties that rely largely or exclusively on volunteer efforts and grass-roots organizing, would find themselves hobbled by lack of time. SB292 is seeking to institute in Nevada law a deadline more stringent than the one which the District Court has already overturned. SB292 would also entrench the role of money in politics and cost money to the State in doing so.

If SB292 is enacted with the June 1 deadline, then any number of parties adversely affected by that deadline could file a legal challenge with Fulani v. Lau as a precedent. The State of Nevada could be exposed to the costs of a legal proceeding, along with associated attorneys’ fees. The costs of responding to such a legal challenge are again indeterminate but potentially immense. Comments submitted separately to this Committee by Mr. Richard Winger discuss situations in other States where such early petition deadlines were struck down and those States were left with the expenses of the associated proceedings. To emphasize, this is not an outcome that I would wish for the State to experience in any manner; as a citizen of this State, I, too, would be adversely affected by continued needless expenditures on legal contests at a time when the State needs to devote all available resources to the economic recovery and to the genuine well-being of its residents.  This is why I urge this Committee and the Legislature more generally to refrain from proceeding with SB292 and to avert such an outcome.

Senate Bill 292 is bad policy, counterproductive in all respects, and the fiscal burdens and risks it imposes upon the State have no offsetting benefits. Indeed, Senate Bill 292 exacerbates a highly polarized political situation to the detriment even of major-party officeholders.

Senate Bill 292 would achieve the opposite of establishing a fair, level playing field for political candidates and parties.  Unfortunately, Senate Bill 292, if enacted, will only serve to exacerbate today’s political trench warfare by solidifying the bifurcation of the contemporary American body politic into two blocs that have each become increasingly monolithic and radicalized internally, and increasingly hostile toward the other, with no room between them to pursue unconventional and innovative solutions that can bridge partisan divides. This anticipated effect of SB292 is likely not anyone’s intention; however, the two-party system in the United States has a built-in downward spiral of incivility, hostility, and division which has, over the past year, crossed the line from mere acrimony into deadly riots and insurrections from extreme exponents of both sides of the partisan gulf. Any Legislator interested in stable and sensible governance should seek to avert an intensification of this scenario, and there is a vital role for a vibrant minor-party ecosystem in helping to prevent it.

How does Senate Bill 292 exacerbate political polarization? It does so by making it effectively impossible for minor political parties to even attain ballot access – in the ways described above. This bill would make it clear to voters that minor parties are not just long-shot participants but are effectively shut out of the process altogether. Thus, many people who would have otherwise given a minor party a chance would be shunted into one of the major political parties that is barely more aligned with their views than the other major political party. This would reinforce the bifurcation of America into two distinct blocs which are engaged in an ever-intensifying struggle with one another, to the detriment of any actual progress on policy and any actual solutions to the many pressing problems (including fiscal problems) facing our State, country, and world. Bifurcation of the American body politic creates an “us-versus-them” dynamic, where anyone who is not part of one’s own bloc is automatically considered to be “the enemy” and whose ideas are automatically disregarded. The record increase in independent and nonpartisan voters already shows many Americans to be disillusioned by the toxicity and acrimony that characterize the electoral tactics of the major parties and their most vocal adherents. Without minor parties for them to seek alternatives in, these Americans will either be reluctantly dragged into the deleterious fray they have always wished to avoid, or try to refrain from political participation altogether – in which case the fray will still find them, as extremists from the major parties have increasingly been demonizing conscientiously apolitical Americans as well.

The antidote to polarization is hyper-pluralism, which is precisely what a vibrant minor-party scene would facilitate. In a hyper-pluralistic body politic, there is no clear “enemy” for any constituent, because different smaller parties will align with one another on different issues; one’s adversary on one issue could be an ally on another, and so it is worthwhile to remain on at least respectful terms with everyone. It is for this reason that parliamentary democracies, which allow for proportional representation and numerous political parties competing on each ballot, are generally far less roiled by partisan strife than America’s uniquely contentious two-party system. But Nevada does not even need to adopt a parliamentary system to achieve a similar outcome; it just needs to allow minor political parties to compete on the ballots. Note that we are not even asking for the minor parties to win (which would still be difficult enough on its own), but merely to be allowed to compete!

Allowing quick, easy ballot access for minor political parties is the low-cost ­option to the State of Nevada as well. The less time and effort need to be spent validating petition signatures or enforcing restrictions, the more savings result for the State of Nevada.

Even the possibility of competition motivates both incumbent officeholders and major-party candidates to be more responsive to the needs of their constituents. Furthermore, minor parties can be fruitful repositories of ideas for major-party politicians to draw upon; the Transhumanist Party would be delighted to have any of its platform reflected in legislation advanced by major-party lawmakers. Ideas from minor parties tend to sufficiently depart from the prevailing major-party packages that they avoid triggering contentious and mutually intransigent debates about “wedge” issues and so may actually lead to solutions that most major-party policymakers are willing to entertain. Incumbents and major-party candidates can even derive much valuable campaign intelligence from election results involving minor political parties. A strong showing for a minor party indicates a set of issues that voters are interested in and that the incumbent or major-party candidate would do well to address while in office or on the campaign trail. Having a wealth of ideas from minor parties to draw upon will also improve the State of Nevada’s fiscal situation, since minor parties – which, out of necessity, have significant experience running low-budget or no-budget operations – will often develop creative ways to reduce expenditures without compromising the quality of service and benefits that the State provides to its residents.

By shutting minor parties out of viable political participation, Senate Bill 292 would only accomplish the illusion of stability for leading figures of a major political party. In reality, one cannot have a stable or tranquil political experience in a general environment marred by ideological polarization and all of its attendant ills. Depriving people of legitimate alternatives will only alienate them further and feed into the undercurrents of frustration and perceived disenfranchisement that permeate American politics today. Minor political parties are a major safety valve of American politics and can act to effectively channel dissent and discontentment into constructive avenues of mutual improvement and enhanced justice.  In the Federalist No. 10, James Madison, at the onset of the American Republic, noted that the advantage of a large representative republic is precisely in “the greater security afforded by a greater variety of parties, against the event of any one party being able to outnumber and oppress the rest”. The American Founders, who feared precisely the scenario of two dominant factions vying for power at the citizens’ and the Republic’s expense, saw the “greater variety of parties” as an important safeguard against such an outcome. The Transhumanist Party echoes the Founders’ wisdom and would urge the Legislature to consider reforms in the opposite direction from those proposed in SB292 – namely, the elimination of all ballot-access requirements and the ability of any candidate or political party to compete fairly for office on the same terms as any other. After all, if a minor-party candidate is unpersuasive to the voters and the major-party candidates remain more popular, what is there truly for a major party to fear from allowing participation for all? But in the absence of such truly progressive reforms, we urge that the Legislature at least refrain from taking steps that would further limit electoral competition.

Removing ballot-access restrictions, rather than maximizing them, is the fiscally prudent, the consequentially best, and the morally just option. Please reject Senate Bill 292.

Sincerely,

Mr. Gennady Stolyarov II

Chairman, United States Transhumanist Party

Chief Executive, Nevada Transhumanist Party

https://transhumanist-party.org

My Path to Transhumanism and Becoming the First Transhumanist Party Member to Hold Political Office in North America – Article by Gerald Shields

My Path to Transhumanism and Becoming the First Transhumanist Party Member to Hold Political Office in North America – Article by Gerald Shields

Gerald Shields


In 2016 I changed my political party membership to Transumanist on my voter registration card. Then, I became a town councilmember of the Town of Berwyn Heights in Maryland. I served in that role from October 2016 to May 2018. I believe I am the first Transhumanist Party member to hold a political office in North America (during the time period of the U.S. Transhumanist Party’s existence).

Gerald Shields at the Library of Congress in 2013. Photograph from Gerald Shields

My path to Transhumanism has been varied and interesting. I changed my voter registration for a variety of reasons. During the 2016 election cycle, I was disappointed in the various election platforms of the major parties. I thought that pushing the goal of making humanity a two-planet species was a more important goal than what was listed in those parties’ platforms. After some research for alternative parties, I discovered Mr. Zoltan Istvan’s campaign for the U.S. Transhumanist Party. Mr. Istvan called for a medical Moonshot program. Even though it was not a direct step to a two-planet species, it was a step in the correct direction to long-term colonization of other stars. I contacted the campaign, and I saw that there were no campaign posters for an internet-based campaign. I realized that without visual legitimacy, the transhumanist ideas will not get much traction. A visual will look good on television, blogs, and YouTube. A visual aids in the message. I helped create campaign posters with Ms. Chelsea Gilbert. It was my idea to use vector graphics in orange and black with classic Americana political phrases to illustrate some transhumanist ideas. The idea is to tap into the Americana meme under the banner of the Transhumanist Party without causing future shock. The goal is to stir the passion of our members as discussed during the various transhumanist conversations on YouTube.

The phrases I proposed were:

“The Future is here. The Transhumanist Party.”

“We can do it….With the Transhumanist Party.”

“The Transhumanist Party builds the Future.”

“Wake up America with the Transhumanist Party.”

“Reclaim America. Join the fight for the future and the Transhumanist Party.”

During the campaign, I attended several Washington, DC, and Seattle, Washington, transhumanist meetings, during which I met Zoltan in person.

 On October 3 2016 at Berwyn Heights Town Office, Gerald Shields (left) was sworn by Mayor Jewitt (right) in an a member of the town council. Photograph from Gerald Shields

Then, as part of my political path, I was on the Town Council of Berwyn Heights, Maryland, from October 2016 to May 2018. The competition was nonpartisan between a total of three people. I filled an empty position on the Town Council, and this was done via a special appointment, not a general election. However, in normal times, this is a nonpartisan, general-election position. I believe I am the first Transhumanist  Party member to hold a political office in North America (during the time of the U.S. Transhumanist Party’s existence). During the special appointment, I campaigned on a very local and non-glamorous issue of improved storm drains. Storm drains are important because, in Berwyn Heights, there was a 100-year storm that flooded the basements of several houses.  On a town or even county level, there really is no way to have a longevity Moonshot in my view.  I am a very practical and nuts-and-bolts (no transhumanist pun intended) type of person, who wants this Party to be a success.  However, when I was on the Town Council, my political portfolio was Parks & Recreation, Education, and Civic Affairs; not Public Works. I laid the foundation for the town’s policy on non-governmental organizations. During my term, Berwyn Heights achieved the title of Banner City for the first time and attained other objectives due to my efforts. At the end of my term, I achieved my Parks and Recreation goals, so I decided not to run in the election.

Right now, the public view of transhumanism is characterized by cyborgs and other scary things. We must adapt and put forth the benefits of increased medical knowledge and increased energy resources in a beneficial way while addressing the general public’s concerns. That is why I suggested to Zoltan to emphasize the Good Neighbor Next Door policy.  The Good Neighbor Next Door policy would focus on volunteering on local committees, such as Neighborhood Watch, the State Government’s official State Defense Force, Green Team, or other local small-town groups, as well as just saying “Hi” to one’s neighbors, to show that one is a normal person who cares about local matters. Also, I suggested that Zoltan post photos of himself and his kids because this would make him more relatable to other fathers. Then, as time progresses, Transhumanists who follow this approach would show that they are ready, willing, and, most importantly, able to lead in political positions.

That is my varied path to Transhumanism and becoming the first U.S. Transhumanist Party member to hold a Town Council political office.

Gerald Shields is a member of the U.S. Transhumanist Party and was a Town Council Member in Berwyn Heights, Maryland, between October 2016 and May 2018. 

To the FDA: Approve Leronlimab Now for Critically Ill COVID-19 Patients – Article by Dan Elton

To the FDA: Approve Leronlimab Now for Critically Ill COVID-19 Patients – Article by Dan Elton

Daniel C. Elton, Ph.D.


Author’s Note: This article is cross-posted from my Substack.

How does Leronlimab work?

Leronlimab is a humanized monoclonal antibody that antagonistically binds to the CCR5 receptor to block activation of immune cells and lower the release of cytokines. The development of Leronlimab started with mouse antibodies that bind to CCR5. Unfortunately, mouse antibodies can’t be directly imported into humans since they are attacked by the immune system as foreign invaders. That’s where next-level genetic engineering comes in. Researchers looked at the genes for human antibodies, identifying ones that were closest to the genes for the antibody that the mice produce. They then took the segment of DNA from the mouse antibody that coded for the antigen binding site and stitched that into the human antibody gene. (The antigen binding site is the key part of the antibody allows it bind to the CCR5 receptor). The result is a chimeric or humanized antibody which can be mass-produced in bacteria.

As alluded to, the specific place where these antibodies bind is the CCR5 (Chemokine Receptor Type 5) receptor, a “G Protein coupled” receptor that resides on the surface of cells, in particular immune cells such as macrophages. When the receptor is stimulated, calcium channels open up and Ca++ ions move into the cell, causing activation (movement) of the macrophages.

Leronlimab was originally developed to treat HIV, because the HIV virus uses the CCR5 receptor to get into cells. (By blocking the receptors, the HIV virus could be blocked.) Despite being under study since 2007, Leronlimab is still not FDA-approved for HIV, although it appears to be getting close. To treat HIV, it is given as a once-weekly at-home injection. Researchers have found many other uses, however. For instance, when Leronlimab blocks the CCR5 receptors on breast-cancer cells, it prevents them from moving around so that the cancer can’t move to other parts of the body, which makes the cancer easier to treat. Note that Leronlimab is not yet FDA-approved for any of these possible applications, so off-label use for COVID-19 is impossible.

In the case of COVID-19, infection by the SARS-CoV-2 virus induces stressed endothelial cells to produce CCL5. When CCL5 reaches T-cell and macrophage cells in lymph nodes and binds to their CCR5 receptors, it induces those cells to become activated and then move towards the source of the infection along the CCL5 gradient. Unfortunately, in severe COVID-19, the immune response can be so strong that it leads to tissue damage. CCL5 also induces the production of inflammatory cytokines including TNF and IL-6.

What do we know about the efficacy of Leronlimab?

CytoDyn Inc. published a press release on January 28th, 2020, announcing that it was beginning to evaluate Leronlimab’s use for COVID-19. In that press release, CytoDyn clearly explained the mechanism of action described above, noting that clinical experience in China found that many patients who died from COVID-19 did not die from the virus but from an overactive immune response causing inflammation and the infamous “cytokine storm”.

A study published in preprint form on May 5th, 2020, looked at 10 terminally ill COVID-19 patients on ventilators at the Montefiore Medical Center in Manhattan. The experimenters administered 700 mg of Leronlimab to each patient. Within three days they found that found that IL-6 had decreased in all of the patients, reaching healthy levels in two weeks. After two weeks six patients had recovered while four died (a 40% mortality rate). At that time the mortality rate for ventilated patients was said to be “as high as 88%” in New York City. So, while there was no control group in this study, one can argue there was an observed reduction in mortality here. While the results on reduced mortality are weak due to a lack of a suitable control, the biomarkers studied all showed a reduction of immune response. The researchers found a reduction of new immune cells manufactured in the bone marrow and a return of platelet cell counts towards normal levels. The researchers also found that the concentration of virus in the blood (viremia) decreased. In a TEDx talk, one of the authors, Dr. Bruce Patterson, claims that Leronlimab was responsible for the drop in blood virus concentration. He said this:

“Leronlimab restored CD8 T-cells and increased Granzyme A to better clear virally infected cells. It also inhibits Treg cells and repolarizes macrophages which both enhance the immune response against infected cells.”

I honestly do not understand these details or know how well they are empirically supported by this or other studies.

CytoDyn initiated two Phase IIb/Phase III clinical trials in mid-April 2020 to study mild-to-moderate COVID-19 and severe or critical COVID-19. To their credit in 2020 the FDA did provide about 60 emergency IND (eIND) authorizations that allowed patients to receive Leronlimab. However the company had to defer seeking eIND authorizations to accelerate the pace of enrollment in their clinical trials.

The mild-to-moderate trial did not meet its primary efficacy endpoint, but in a post hoc analysis in the subset of subjects with more severe disease, a higher proportion of Leronlimab-treated subjects (50%; 24/48) versus placebo-treated subjects (21%; 5/24) showed improvement in National Early Warning Score 2 – a risk score for “rapid clinical deterioration requiring critical care intervention” (p ​= ​0.0223).

The severe-to-critical trial also did not meet its primary endpoint — considering all patients, the difference in Day 28 mortality between Leronlimab and placebo was not statistically significant (N=384, 2:1 split, p > 0.05). (Update: a commentor pointed out that the placebo group ended up being younger and was small, so unfortunately they missed statistical significance. You can see all the details here.).

However, the researchers then analyzed patients on invasive mechanical ventilation or ECMO. They found that if Leronlimab was added to the standard of care, then on the 14th day there was a reduction in mortality of 82% (p=0.0233, N=62) and an average reduction in the length of stay of 5.5 days (p=0.005, N=62). They also found a 400% improvement on a 7-point ordinal scale for COVID-19 severity when compared with standard of care.

There have been several clinical reports and anecdotes about patients on ventilators or ECMO who rapidly recovered after receiving a single dose of Leronlimab (see here (N=1), here (N=4), here (N=1), and here (N=1)). A somewhat larger observational study with N=23 patients reported that after 30 days, 74% no longer required hospitalization. Six out of the seven patients that required ventilation survived. The biomarker results were somewhat mixed – while the researchers found evidence of reduced immune activation in the patients who received Leronlimab, they also found that the inflammatory marker CRP didn’t decrease until after two doses were given. Another small study on N=3 lung transplant patients with COVID-19 found a decrease in CRP after one week.

On March 29th, 2021, the Phillippines’ FDA began issuing compassionate use authorizations on a per-patient basis and for up to one year. Incidentally, one of first two patients was a former President of the Phillippines. In April compassionate use authorizations were given to 28 critically ill patients.

Why hasn’t the FDA acted?

CytoDyn’s failure to reach either their primary or secondary endpoints in their Phase II/III trial on critically ill patients is undoubtedly a major blow. The company has not yet applied for an Emergency Use Authorization (EUA), and it seems this failure is the reason why. (News reports from August 2020 saying that company had applied for an EUA turned out to be incorrect.) CytoDyn is moving forward, however, and has filed a new protocol with the FDA that will study four doses given over four weeks to critically ill COVID-19 patients.

The use of any immunomodulator like Leronlimab is clearly a double-edged sword. It makes sense that it would only be helpful in the most severe cases. This is what the two clinical trials showed – they showed a significant effect on mortality for patients on ventilators and no statistically significant effect on other patients. Unfortunately the analysis of the patients on ventilators was a post-hoc analysis, which is frowned upon in science due to the possibility of data dredging. So clearly the science is not settled here.

Let’s consider this from an ethical point of view. Patients who are in ICUs and on ventilators have a high chance of dying. Inflammation macrophage activity, and excess cytokines are implicated in many COVID-19 deaths. There is strong evidence, going back over a decade, showing that Leronlimab decreases inflammation, macrophages, and cytokines. Leronlimab is known to be a very safe drug (prior to 2020 no serious side effects have been found in nine clinical trials with more than 800 patients). Even if Leronlimab only saves 20% of those to whom it is given, then one can argue we have an ethical obligation to do so. It is a somewhat expensive drug (for HIV patients getting weekly therapy, it costs about $2000 per dose; another source suggests it would cost about $1100). However, keeping someone in the ICU costs around $3,000-$10,000 per day. So in addition to saving lives, Leronlimab could also save money as well by reducing the amount of time patients need to spend in the ICU. This could lead to second-order life-saving effects in places where ICU beds are in short supply.

Medical educator Dr. Mobeen Syed has said this:

“I believe that if there is a drug that can help someone who is on a ventilator or ECMO and it can save them, then whatever small population that is, it is useful — that is my opinion. I have no financial interest or commercial interest or any other interest of any sort with them (CytoDyn).”

I agree. While the evidence is not conclusive, we have good reason to believe Leronlimab can help very critically ill COVID-19 patients such as those on ventilators or ECMO. There are likely gains from receiving Leronlimab for such patients and very little downside, especially if the patient is considered terminally ill. So not allowing doctors access to Leronlimab risks many unnecessary deaths. The drug should be an especially impactful tool in places like Brazil and India, where there are currently shortages of ICU beds and ventilators.

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. If you like his content, check out his website and subscribe to his newsletter on Substack.

For an overview of the possibilities of Leronlimab to save the lives of critically ill COVID-19 patients, watch this brief video by Random Ryman. 

The U.S. Transhumanist Party Endorses Jennifer A. Huse for Mayor of Camden, New Jersey

The U.S. Transhumanist Party Endorses Jennifer A. Huse for Mayor of Camden, New Jersey

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The U.S. Transhumanist Party is pleased to announce the endorsement of our first candidate during the 2021 election season – Jennifer A. Huse – who is running for Mayor of Camden, New Jersey. See the website for Ms. Huse’s campaign.

Our electronic vote of the members, which took place on April 23-30, 2021, led to an overwhelming endorsement of Ms. Huse’s candidacy by 91.9% of the members who cast their votes.

The vote totals are as follows:

Question: Shall the U.S. Transhumanist Party endorse the candidacy of Jennifer A. Huse for Mayor of Camden, New Jersey?

 

Watch the U.S. Transhumanist Party Officers’ interview of Jennifer A. Huse, conducted on February 15, 2021, by U.S. Transhumanist Party Chairman Gennady Stolyarov II, Director of Applied Innovation David Shumaker, and Director of Energy Issues John Kerecz.

On April 29, 2021, Jennifer Huse was interviewed by U.S. Transhumanist Party Regeneration Advisor Ira Pastor on the Progress, Potential, and Possibilities program. Watch this interview on YouTube here.

On Sunday, May 2, 2021, at 1 p.m. U.S. Pacific Time, the U.S. Transhumanist Party is holding a Virtual Enlightenment Salon with Jennifer Huse to give our members the opportunity to ask her further questions and discuss key transhumanist political issues with her. Follow the link above to watch the livestream of the Virtual Enlightenment Salon or the subsequent recording.

We hope to be able to endorse other candidates during the 2021 election season as well.  If you would like to be considered as a candidate for endorsement by the U.S. Transhumanist Party, please e-mail Chairman Gennady Stolyarov II with an expression of interest. Describe the office for which you plan to run, your background and qualifications, your platform, how it relates to the U.S. Transhumanist Party Platform, and what motivated your interest in running with the endorsement of the U.S. Transhumanist Party. Please check our Candidate Eligibility Criteria in Article VII of the U.S. Transhumanist Party Constitution.