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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).

World Health Organization Puts the Elderly Back in the Picture – Article by Elena Milova

World Health Organization Puts the Elderly Back in the Picture – Article by Elena Milova

Elena Milova


Editor’s Note: In this article, Miss Elena Milova explains the success the anti-aging community has had in influencing policy makers at the WHO in including several provisions related to aging, in their global strategy and action plans of the next decade. This article was originally published by the Life Extension Advocacy Foundation (LEAF).

                   ~ Kenneth Alum, Director of  Publication, U.S. Transhumanist Party, January 27, 2018

Not long ago, we wrote about some complications involving the WHO 13th programme of work. In the initial version of this document, developed by the WHO working group in November 2017, the problems of the elderly were nearly completely overlooked. The joint effort of our community helped to bring this critical flaw to public attention.

During the meeting of the working group, it was announced that 90% of the comments received by WHO (out of 400) pointed out the need to set healthy aging as one of the priorities of the new programme of work. However, we didn’t know if our demand to focus on the implementation of the global strategy and action plan on aging and health would be fulfilled.

The good news is that the new draft programme published on the WHO site on November 5th includes several provisions related to aging. Our community managed to persuade these global policymakers to implement all activities listed in the global strategy to help society prepare for the Decade of Healthy Aging (2020-2030). Let’s have a closer look at these provisions.

15. The foundation of WHO’s work is SDG 3: ensuring healthy lives and promoting well-being for all at all ages. WHO is an organization focused principally on promoting health rather than merely fighting disease, and especially on improving health among vulnerable populations and reducing inequities. Leaving no-one behind, the Organization aims to give women and men, girls and boys, in all social groups, the opportunity to live not just long but also healthy lives. WHO will explore measuring this foundation of its work using healthy life expectancy, which could serve as one overarching measure aligned with SDG 3, complemented by the triple billion goal, which leads to three more specific priorities, each with overlapping one-billion people goals.

Healthy life expectancy (HALE) is an assessment of the period of time a person can live in full health. HALE is usually lower than total life expectancy, and the difference between HALE and total life expectancy is regarded as years of life lost to disease.

As the goal of our community is to prolong the healthy period of life by addressing the root mechanisms of aging and postponing age-related disease, the introduction of HALE as a way to measure WHO activities is a very good outcome. It is very hard to preserve health in older ages without addressing the underlying mechanisms of aging and implementing an extensive program that involves educating the public about healthy lifestyles. This choice of indicator means that WHO will strengthen its efforts to keep people healthy for as long as possible, which will ease the introduction of rejuvenation interventions once they are available, as it will likely be a cost-effective way to achieve a more favorable HALE.

16. Life expectancy at birth has consistently increased since the 19th century, largely due to socioeconomic developments and public health measures such as vaccination, nutrition and
sanitation. Today, socioeconomic, political, cultural, environmental and economic forces continue to drive changes in the burden of disease. However, efforts are needed to ensure that their impact is positive. Poor health literacy coupled with weak health-promoting policies make it difficult for people to make healthy choices for themselves and their families. Investment in health promotion and disease prevention allows countries to address economic concerns about the rising costs of the health system and enables potential savings if disease can be avoided.

The WHO draft programme of work refers here to the increasing burden of chronic, non-communicable diseases due to the increasing proportion of people age 60 and over. Indeed, it would be really hard to double or even triple healthcare and pension expenditures for many countries, especially taking into account the ongoing economic crisis. However, this is what aging societies will have to do, if HALE does not grow faster.

This is why WHO is only promoting evidence-based interventions that represent the “best buy” scenarios: the most realistic and cost-effective. When it comes to age-related diseases, which can last 20-30 years or longer, prevention could be much cheaper, and it is more humane, as this scenario would reduce unnecessary human suffering. Therefore, we could consider this provision of the new draft programme as supporting our efforts to introduce longevity lifestyles and even “soft” (careful and evidence-based) biohacking.

17. Healthy life expectancy has not increased at the same pace as life expectancy, and increasing age often brings increasing morbidity and reduced functioning, making healthy ageing an important focus. Most disability-adjusted life years in older age are attributable to chronic conditions and the accumulated impact of such conditions can lead to significant loss in function and care dependence in older age. At the same time, there is emerging evidence that healthy ageing depends on early childhood development and is epigenetically determined. Ensuring healthy ageing is an urgent challenge in all countries.

This provision once again underlines how important it is to focus on prevention. I would like to point out that if childhood is perceived as the foundation of healthy lifestyles, longevity advocates receive carte blanche for working with the younger generation. Activists could think of developing corresponding education programs for schools and universities, and this very provision can be a strong argument when offering such a program to educational authorities.

37. Ensuring healthy ageing is central to universal health coverage, just as it is to the other priorities of GPW 13. The number of people over the age of 60 is expected to double by 2050 and this unprecedented demographic transition will require a radical societal response. The Secretariat will support Member States to promote healthy ageing through the actions defined by the Global strategy and action plan on ageing and health (2016), as well as through the Decade of Healthy Ageing that is planned for the period 2020−2030. These actions include aligning health systems to the needs of older populations, with a special focus on enhancing the functioning of older persons and the management of chronic disease; improving access to medicines; developing systems of longterm care including community-based services; promoting palliative care, creating age-friendly environments; and improving measurement, monitoring and understanding of healthy ageing.

This provision is exactly what we were aiming for when calling the members of our community to take part in the Open Consultation or the Draft. As you remember, all mentions of the WHO documents related to aging were absent; this provision clearly shows that we achieved our goal! Even though the global strategy and action plan on aging and health may not be ideal in terms of rejuvenation research promotion, it helps member states navigate the field with more confidence. This global strategy, which we wanted so much to be the foundation of the draft programme provisions related to aging, contains a very important paragraph that every activist should know about:

105. Finally, better clinical research is urgently needed on the etiology of, and treatments for, the key health conditions of older age, including musculoskeletal and sensory impairments, cardiovascular disease and risk factors such as hypertension and diabetes, mental disorders, dementia and cognitive declines, cancer, and geriatric syndromes such as frailty. This must include much better consideration of the specific physiological differences of older men and women and the high likelihood that they will be experiencing mutimorbidities. This could also be extended to include possible interventions to modify the underlying physiological and psychological changes associated with ageing.

Conclusion

Dear friends, this is a victory! Our community managed to influence policymakers of the highest level: the World Health Organization. We managed to ensure that the new programme of work considers aging and age-related diseases to be an important issue, and the resulting global strategy and action plan on aging and health is an effective guide to helping our society adapt to population aging.

In terms of advocacy, this is a complete victory, which shows two important things. First, when we join forces, we can influence global health policy at the highest level. Our community became stronger, and our voice is being heard! Second, this victory shows that dialogue with the UN and its institutions, including decision-makers in these agencies, is possible, and it goes in the directions that we need: more focus on prevention and more focus on public health education related to aging.

I offer special thanks to Dr. Ilia Stambler for initially turning the attention of the community to this issue. I want to thank and congratulate all participants of the Open Consultation with this achievement. Of course, we are still at the beginning of our path to rejuvenation as a public health priority, but outcomes like this one make me believe that there are more victories to come. Let’s keep working, as the main reward is worth it: health, youth, and freedom from age-related diseases for all!

About Elena Milova

As a devoted advocate of rejuvenation technologies since 2013, Elena is providing the community with a systemic vision how aging is affecting our society. Her research interests include global and local policies on aging, demographic changes, public perception of the application of rejuvenation technologies to prevent age-related diseases and extend life, and related public concerns. Elena is a co-author of the book Aging Prevention for All (in Russian, 2015) and the organizer of multiple educational events helping the general public adopt the idea of eventually bringing aging under medical control.

About LIFE EXTENSION ADVOCACY FOUNDATION (LEAF)

In 2014, the Life Extension Advocacy Foundation was established as a 501(c)(3) non-profit organization dedicated to promoting increased healthy human lifespan through fiscally sponsoring longevity research projects and raising awareness regarding the societal benefits of life extension. In 2015 they launched Lifespan.io, the first nonprofit crowdfunding platform focused on the biomedical research of aging.

They believe that this will enable the general public to influence the pace of research directly. To date they have successfully supported four research projects aimed at investigating different processes of aging and developing therapies to treat age-related diseases.

The LEAF team organizes educational events, takes part in different public and scientific conferences, and actively engages with the public on social media in order to help disseminate this crucial information. They initiate public dialogue aimed at regulatory improvement in the fields related to rejuvenation biotechnology.

We are the Lifespan – Video and Commentary by the Life Extension Advocacy Foundation

We are the Lifespan – Video and Commentary by the Life Extension Advocacy Foundation

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Life Extension Advocacy Foundation


The U.S. Transhumanist Party is pleased to share this message and video from our allies at LEAF – the Life Extension Advocacy Foundation. The video includes a short clip of remarks from U.S. Transhumanist Party Chairman Gennady Stolyarov II, taken from his video for the “I am the Lifespan” campaign.


As you might remember, during the month of October (often called Longevity Month) we at LEAF were accepting videos to hear your reasons why defeating the diseases of aging is so important — and hear from you we did!

Dozens of videos poured in, and this #GivingTuesday we at LEAF are so proud to share with you all a video that shows how strong we can be when we join forces for longer, healthier lives — how together #WeAreTheLifespan.

Thank you so much for raising your voice with us in support of longevity research, and if you wish to continue to help us please feel free to join our Hero campaign or to participate in Facebook’s #GivingTuesday donation match by clicking any of the donate buttons on our Facebook page or posts. If you want to get creative, you can even make your own fundraisers easily on Facebook on posts or with a live video.

Finally, to illustrate the importance of speaking freely on what you care about, we are pleased to let you know of the developments related to the recent Open Consultation on the 13th draft programme of work of the WHO. As we wrote not long ago, the problems related to population aging and corresponding health and social issues were left out of the draft, and we invited the members of the community to step in and recommend an improvement.

90% of responses during the Open Consultation (out of around 400 responses) underlined the need to make healthy longevity one of the priorities for the 13th programme of work, and the WHO have recognized this. A joint effort of many pro-longevity organizations made that happen.

Each voice matters. Your voice matters. So please, keep being active and vocal, and let’s become the generation who can say: “I helped set all people free from age-related diseases. I helped defeat aging.”

Thank you, and happy #GivingTuesday!