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A Polite List of Requests to the FDA – Article by Dan Elton

A Polite List of Requests to the FDA – Article by Dan Elton

Daniel C. Elton, Ph.D.


A List of Requests to President Joseph R. Biden, Jr.,
HHS, FDA, and Congress: 

Approve the following vaccines for emergency use immediately: 


Give people the right to try the following vaccines: 

Seriously study and consider these actions: 

  • Allow hospitals and pharmacies to start stockpiling unapproved vaccines so they can be rapidly disseminated upon approval. 
  • Allow Moderna to give fractional doses. Data from Moderna’s clinical trials have illustrated that people between ages of 18 and 55 who received two 50-microgram doses showed an identical immune response to the standard of two 100-microgram doses.
  • Allow all age groups to get the vaccine. Research published in the journal Science indicates that as of October 2020, “individuals aged 20-49 are the only age groups sustaining resurgent SARS-CoV-2 transmission with reproduction numbers well above one”. Thus, targeting vaccines at these groups may accelerate the end of the pandemic and save more lives than continuing to restrict the vaccines to the elderly and vulnerable.
  • Consider making “First Doses First” national policy.


The FDA has not moved fast enough given the gravity of the situation we face. Consider the following: 

  • Pfizer sent its paperwork to the FDA on November 22, 2020, but rather than immediately convening its panel of experts, the FDA scheduled a review meeting for December 10. During that three-week wait, 27,000 Americans died of COVID-19. According to Dr. Marty Makary, a professor of public health policy at the Johns Hopkins Bloomberg School of Public Health who has conducted over a hundred clinical studies during his career, the FDA “could have done the approval in 24-48 hours without cutting any corners”.  The slow rollout that followed after the FDA approved the vaccine on December 11 was not due to delays in production – Pfizer had millions of doses produced and sitting in cold storage at the time of the approval. 
  • While Americans were waiting for the Pfizer vaccine that millions of their taxpayer dollars had been invested in, the FDA went dark for 4 days during the Thanksgiving holiday, with almost all of its 17,000 employees taking that time off, including those working on critical COVID-19-related work. 
  • Moderna sent its paperwork to the FDA on November 30, 2020. As with the Pfizer vaccine, the FDA needlessly delayed the approval by scheduling the review meeting for December 17. 
  • The FDA’s equivalents in the EU, Canada, Switzerland, UK, Israel, and Singapore all use rolling reviews, evaluating data as it becomes available for the sake of efficiency. The FDA does not. 
  • The Sputnik V vaccine was approved September 4, 2020, over 150 days ago. In a paper in The Lancet, phase III results indicate it has an effectiveness of 91.6% and excellent safety profile. 
  • China began administering the CanSino Biologica vaccine to its military in June after Phase I and Phase II clinical trials established safety and immune response. (The phase II results were published in The Lancet on July 20th, 2020). China approved the vaccine for their public on December 24, 2020. 


Here’s what public-health experts are saying:
 


“The F.D.A. needs to catch up to the science… They are inadvertently killing people by not following the science.” – Michael Mina, Epidemiologist, Immunologist, Physician, Harvard Medical School.

“We’ve gone from ‘Operation Warp Speed’ to develop a vaccine to ‘Operation Turtle Speed’ to review it… The FDA needs to stop playing games and authorize the Oxford-AstraZeneca vaccine.  It’s safe, cheap ($2-$3 a dose), and is the easiest vaccine to distribute.”Marty Makary, M.D., a professor of health policy at the Johns Hopkins University School of Medicine. 

I do think we’ve been too conservative… companies that potentially make public health diagnostic tests did not feel that there was, for example, a pathway to get those approved at the F.D.A.”Vivek Murphy, President Biden’s nominee for Surgeon General.

“We’ve already bought 300 million doses of the AstraZeneca-Oxford vaccine. We’ve paid for it — over a billion dollars — so let’s use it… I know we have some of that vaccine stockpiled.”Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and the lead developer of a COVID-19 vaccine being produced in India.


More quotes from notable public figures: 

“For years the FDA was focused on, don’t repeat thalidomide. Drugs must be safe. AIDS forced a hard reckoning. The people who are dying while you wait matter. But this is a third, even harder conceptual change. Stopping the spread of the disease matters. And the FDA does not have the years it took to make the AIDS change of mindset.”John Cochrane, Senior Fellow at the Hoover Institution. 

The new strains spread quickly. The speed of our countermeasures will decide our fate. What feels like reasonable delays in our normal experience of time — a few weeks here for Congress to debate a bill, a few weeks there for the F.D.A. to hold meetings — could lead to the kind of explosive infections that overwhelm our hospitals and fill our morgues.”Ezra Klein, co-founder of Vox.

“The US failure to authorize the AstraZeneca vaccine in the midst of a pandemic when thousands are dying daily and a factory in Baltimore is warmed up and ready to run is a tragedy and dereliction of duty of epic proportions. The AZ vaccine should be given an EUA immediately and made available in pharmacies for anyone who wants it while continuing to prioritize Moderna and Pfizer for the elderly and essential workers.”Alex Tabarrok, Bartley J. Madden Chair in Economics, George Mason University. 

“It’s amazing that not only is this vaccine (AstraZeneca) not approved, there’s no political pressure to approve it.”Matthew Yglesias, author of One Billion Americans: The Case for Thinking Bigger.

“The UK has authorized #AstraZeneca vaccine for #CV19 but #FDA won’t “because of questions about its efficacy among older people.”
Then authorize its use for younger people!
Dear FDA: Get out of the way!
Over 7,000 Americans died of CV19 in the past two days!
You are murdering us!”
– @Robert Zubrin on Twitter, author of The Case for Mars and The Case for Space.

Further reading: 

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. 

Reject the Deadly Precautionary Principle: Approve All COVID-19 Vaccines Immediately! – Article by Gennady Stolyarov II

Reject the Deadly Precautionary Principle: Approve All COVID-19 Vaccines Immediately! – Article by Gennady Stolyarov II

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Gennady Stolyarov II


It should be a mild relief that vaccination efforts against COVID-19 are finally beginning in the United States, but they are beginning eleven months too late, while the pandemic surrounds us and most of us must wait months longer to receive vaccinations. Over 300,000 Americans have already died needlessly and preventably from COVID-19; hundreds of thousands more are likely to die in the coming months, even though the exact same vaccine from Moderna that is even today still undergoing Food and Drug Administration (FDA) review already existed in its current form by January 13, 2020. As David Wallace-Wells writes in New York Magzine, in an article entitled “We Had the Vaccine the Whole Time” (dated December 7, 2020):

You may be surprised to learn that of the trio of long-awaited coronavirus vaccines, the most promising, Moderna’s mRNA-1273, which reported a 94.5 percent efficacy rate on November 16, had been designed by January 13. This was just two days after the genetic sequence had been made public in an act of scientific and humanitarian generosity that resulted in China’s Yong-Zhen Zhang’s being temporarily forced out of his lab. In Massachusetts, the Moderna vaccine design took all of one weekend. It was completed before China had even acknowledged that the disease could be transmitted from human to human, more than a week before the first confirmed coronavirus case in the United States. By the time the first American death was announced a month later, the vaccine had already been manufactured and shipped to the National Institutes of Health for the beginning of its Phase I clinical trial. This is — as the country and the world are rightly celebrating — the fastest timeline of development in the history of vaccines. It also means that for the entire span of the pandemic in this country, which has already killed more than 250,000 Americans, we had the tools we needed to prevent it.

As has been demonstrated time and again during this pandemic, scientists and doctors have been the true heroes in their rapid and immensely creative responses, whereas institutions and their processes have failed massively, and our egregiously broken society and culture have precipitated abysmal mass-scale reactions and behaviors as well. But the major reason why now almost 300,000 Americans died who did not need to die at all, is the Precautionary Principle – a cornerstone of contemporary “bioethics” which is, in fact, deeply unethical. The Precautionary Principle is the fundamental reason why new medical treatments, including vaccines, are required in the United States to undergo extensive safety and efficacy testing before they are allowed to be provided to patients, even willing patients who may knowingly accept the risks of experimental medicines. Essentially, unless safety and efficacy can be rigorously demonstrated first, along with a sufficient lack of adverse consequences, adherents of the Precautionary Principle believe that no action should be taken to implement an innovation. Those who espouse the Precautionary Principle completely ignore, of course, the costs and risks of inaction – which, in the case of a global pandemic, can be measured in more than 1.62 million lives worldwide, but which have also resulted in far greater numbers of deaths from more “routine” otherwise terminal illnesses, whose victims might have been saved by new treatments whose approval the FDA delayed, sometimes for a decade or more while billions of dollars were spent on hyper-expensive efficacy testing.

While laudable efforts were made in the United States to greatly accelerate the review timeframe for COVID-19 vaccines – hence the now well-known “Operation Warp Speed” – those efforts did not come in time for the hundreds of thousands who died and the hundreds of millions who now live in fear of death every day as the pandemic’s spread has become all-encompassing. Cutting the approval timeline from the typical unconscionable 4-5 years to 9 months is an improvement, but not nearly enough. Much more should have been done right away. Approval for the vaccines should have been granted as soon as they were developed, and instead of putting review roadblocks in the way, governments should have actively aided in vaccine production and distribution of all serious candidate vaccines from day one.

While New York Magazine’s David Wallace-Wells made the seemingly obligatory (during this tragically precautionary era) disclaimer that “To be clear, I don’t want to suggest that Moderna should have been allowed to roll out its vaccine in February or even in May, when interim results from its Phase I trial demonstrated its basic safety” (and Wallace-Wells still faced considerable vitriol for the quite modest observations he sought to make) – I do want to suggest exactly that. Indeed, I would go further and insist that it was a moral imperative to approve and facilitate the mass production and distribution of vaccines such as Moderna’s mRNA-1273 to willing members of the general population as soon as those vaccines were available.

Transhumanists reject the Precautionary Principle and instead follow the Proactionary Principle, which, per the description of Max More (Extropy Institute, 2004), “urges all parties to actively take into account all the consequences of an activity – good as well as bad – while apportioning precautionary measures to the real threats we face, in the context of an appreciation of the crucial role played by technological innovation and humanity’s evolving ability to adapt to and remedy any undesirable side-effects.” The Proactionary Principle does not ignore the potential for adverse consequences of an activity, but recognizes that there are situations when the benefits can greatly outweigh any potential adverse effects.

Imagine how, in an alternate history, a Transhumanist administration would have dealt with the COVID-19 crisis. Suppose, for instance, that Zoltan Istvan had been elected President in 2016 and thus was the President who faced the COVID-19 pandemic in 2020. Or suppose that Charlie Kam, the U.S. Transhumanist Party (USTP) Presidential nominee in 2020, had held the country’s highest executive office. The U.S. Transhumanist Party Platform contains 21 sections specifically addressing COVID-19 responses – proposals that were adopted by USTP members in late March 2020, and would have saved most of the lives of the COVID-19 victims had they been expeditiously implemented by governments. These proposals, indeed, are applications of the Proactionary Principle to the COVID-19 pandemic. Section CIII of the USTP Platform specifically states that “The United States Transhumanist Party supports the rapid research into effective cures and vaccines for COVID-19 and the harnessing of synergies from this research to also develop a cure for the common cold and more effective vaccination against influenza. Such research should proceed with no barriers, subject to the researchers’ expression of ethical intentions, and any regulations or processes that would delay the progress of such research should be immediately waived or repealed. In the effort to accelerate progress in this field, the United States Transhumanist Party advocates for an immediate $100 billion funding package for the rapid development of a COVID-19 vaccine, with all volunteers being accepted into human trials as soon as practicable.”

This is exactly what would have been done by a Transhumanist administration with the Moderna, Pfizer, AstraZeneca, and any other vaccines, including do-it-yourself experiments such as that undertaken by Josiah Zayner. The Transhumanist administration would have asked the vaccine developer one question: “Do you intend to apply this candidate vaccine in an ethical manner when offering it to the general public?” After giving an affirmative answer to that question, the vaccine developer would have the full legal right to test, give away, or sell its product to any volunteers capable of giving informed consent – provided that the recipients understood that the vaccine was experimental and had not passed the typical safety and/or efficacy tests. Receiving any vaccine would always remain entirely voluntary. Individuals who were uncertain or concerned about side effects – or even motivated by pseudoscientific, anti-scientific, or religious objections – would maintain the right not to get vaccinated. However, those who chose to get vaccinated would be shown clearly and quickly to have far lower incidence of COVID-19, and the statistical disparity in infection rates between the vaccinated and the un-vaccinated would grow too large in just a few months for reasonable people to ignore. Those who become vaccinated would be free to lead their everyday lives and participate in economic activities as usual, and massive disruptions to the economy and to people’s livelihoods would have been completely avoidable. The multifaceted advantages of vaccination under this approach would become abundantly clear in a relatively short time.

Testing would not be eliminated by the Transhumanist administration. Indeed, it would be accelerated and fully funded via the $100 billion emergency package (and likely via other resources as well), so that vaccine developers would need to pay absolutely nothing out of pocket for any compliance with testing protocols. However, testing would occur in parallel with mass distribution of the vaccines, and as much data as possible would be collected from vaccine recipients in the general population, to greatly augment the samples of tested patients. If any specific side effects manifested themselves in a statistically significant portion of the population, protocols for administering the vaccine would be adjusted in real time. For example, if a specific group of people were found to be particularly vulnerable to certain side effects, members of that group would quickly receive additional disclosures and warnings and would be able to make informed decisions in light of this information.

Could there conceivably be adverse side effects or even deaths of certain patients under this approach of mass distribution in parallel with testing? Of course, that is a possibility. However, the scale of such side effects and deaths would surely be orders of magnitude less than the all-encompassing devastation that the current sequential review-and-approval process has allowed to happen. So far nobody has died specifically from any COVID-19 vaccine. At least 1.62 million people in the world have died from COVID-19. Numerous others have died because of the fallout of the restrictive measures taken to contain the spread of COVID-19. Even if the vaccines had been far more dangerous than they actually are, it is absolutely impossible for them to have caused anywhere near the death toll inflicted by the disease itself and the societal havoc that it and responses to it have wreaked. This basic insight, whose evidence is all around us, is precisely what the Precautionary Principle misses. By placing all of the burden of proof on the innovation, the Precautionary Principle gives a free pass to the wantonly murderous status quo. Inaction is not safety. Inaction is quite frequently the greatest danger – and at no time is that truer than during a global pandemic. If we do nothing, any of a vast array of perils will befall us rather quickly.

The United States has already lost more people to COVID-19 than it had to all but one of its historical wars. The novel coronavirus is the enemy here to be sure, but the Precautionary Principle is an even more pernicious and insidious foe. The Precautionary Principle is responsible for the hundreds of thousands of American dead just as much as the novel coronavirus itself, since it prevented an implementation of an existing off-the-shelf solution that could have saved the vast majority of their lives. Every war in history has resulted in unacceptable death tolls because of fundamentally flawed premises – ideas and practices that brought about the war because people accepted them as commonplace and justified. Slavery, religious intolerance, jingoistic nationalism, and totalitarianism have all stemmed from deep moral errors that caused colossal loss of life – and fortunately most of humanity has recognized the great evil that these notions entail and has resoundingly rejected them. The Precautionary Principle, when implemented in institutions that have the power to make life-or-death decisions, is in that same league of moral errors; it will be remembered decades and centuries hence as the greatest destroyer of lives in our epoch.

How much senseless loss of life needs to occur before we recognize that our institutions, based on the Precautionary Principle, are wantonly negligent in allowing our fellow humans to die and are still withholding life-saving solutions from them? It is time to reject the Precautionary Principle once and for all and to institute the truly humane policy of allowing all rationally capable individuals to assess the risks and benefits of emerging medical treatments for themselves. This would not only save colossal numbers of lives in the immediate term, but also greatly accelerate medical discovery and technological progress – since innovators would be able to obtain data rapidly and iterate upon their approaches. The arrival of cures for cancer, dementia, diabetes, and biological aging itself will depend on how free medical innovators are to offer their treatments and how free patients are to accept them. Extensive and expensive pre-distribution review processes kill many more people than they save. End them now!

Gennady Stolyarov II is the Chairman of the United States Transhumanist Party.