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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. 

Breaking the Bottleneck: A Synergy of Technology and Medicine – Article by Zach Richardson

Breaking the Bottleneck: A Synergy of Technology and Medicine – Article by Zach Richardson

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Zach Richardson


In March of 2019, I began to have a very strange problem. I was breathing normally, but felt like I was suffocating. The problem became much worse when lying down, but seemed to come and go arbitrarily. Some days it would be really bad, and on others I didn’t even notice it. This happened twice in a week, and I checked with a doctor. He assured me I had anxiety and gave me a prescription for some anxiolytic medicine. I couldn’t breathe, and his solution was Xanax. I stupidly trusted him.

In May 2019, I ended up in the hospital. My body was turning yellow, and my liver, kidneys, and heart were failing. The cause was idiopathic; none of the 7 specialists knew why I was having congestive heart failure. A couple of drugs were tried, but in the end the only solution they said would save my life was the implantation of a mechanical device that would help my heart pump: a Ventricular Assist Device, or VAD.

I was lucky enough to be selected as a perfect candidate for a clinical trial, partially due to being particularly young for having Congestive Heart Failure (CHF). A new version of an already cutting-edge technology would be tested on my body, and the results would be recorded for their study. The machine they implanted was called the Heartmate 3, and it saved my life.

The VAD is currently used either as “bridge” or “destination” therapy, with “bridge” meaning that it is used only temporarily until one can get a heart transplant, and “destination” meaning that one is ineligible for transplant at all, and will have the VAD for the rest of one’s life. Some of the contraindications for VAD implantation being bridge therapy include being obese or over 65 years of age. Luckily, I am not either of those two, and therefore am eligible for a transplant. However, there are two factors that are going to lead to it likely being an extremely long time before a donor heart is available. One is that I am a larger man, standing at 6 feet tall, meaning I require a larger-than-average heart. The other is that I have Type O blood, which is the hardest from the standpoint of receiving an organ donation.

This puts me in a very interesting situation, where I am a young man who may have many years still ahead of him with an implanted device. It may be 7 years from now when I get the call for transplant, or it may be tomorrow. If it happens 7 years from now, there may be therapies that will have been developed that would allow me to regrow my heart, or clone one from my stem cells, and thereby avoid having to be on a cocktail of immunosuppressants indefinitely. Unfortunately, even Athersys only has CHF treatments in the preclinical stage, which means I may have to wait a while. I intensely wish those trials weren’t being constrained like they are.

Having set significant life extension towards the very top of my hierarchy of values, I am extremely grateful that I live in a society where these technologies are available to me. I have a highly personal interest in seeing a society of scientists and biomedical engineers emerge to help develop these technologies! However, part of my situation was just me getting lucky: I had the treatment I needed approved just months before receiving it, and happened to have top-notch insurance.

One unfortunate side effect of having a centralized regulatory system is that the Food and Drug Administration (FDA) is only held responsible for what are known as “Type I Errors”. A Type I error is where the FDA passes an unsafe drug or treatment, leading to harm to an individual or group. Unfortunately, this means that FDA officials do not seem to care at all about “Type II Errors”, where they do not pass a life-saving treatment or drug in time to save someone’s life. The FDA is so terrified of having another Vioxx incident, that FDA officials are overly cautious in approving the use of radically innovative and breakthrough technologies. The fact that these technologies carry some risk is something of no worry to someone who is going to die if they don’t get the treatment. It is much harder to blame the FDA for being too safe than it is to blame them for being reckless.

This is why I am proud to be a member of the U.S. Transhumanist Party (USTP), where science and technology are put at the forefront of American politics. The current bottleneck those like me with CHF face is regulatory hurdles. Article VI, Section VI, of the USTP Constitution states: “The United States Transhumanist Party upholds morphological freedom—the right to do with one’s physical attributes or intelligence whatever one wants so long as it does not directly harm others.” Right now what I and others with CHF would like to do is to get a stem-cell heart. We are being hindered not by direct legislation restricting morphological freedom, but by the far more pernicious hindrance of excessive regulatory burden. The treatments we want are being developed exponentially slower than they could be, because each step of the way has to adhere to draconian testing standards. This means a lot of Type II errors are being committed. We are not being told, “You cannot get this treatment.” Providers are being told, “You cannot provide this treatment.”

In my ideal world, regulatory agencies would work more like Underwriters Laboratories or Quality Assurance International. Leaving regulatory activity to the market, far from the fearmongering of producing dangerous and shoddy drugs and treatments, would instead invigorate the institutions as they would compete to certify the best products and treatments for consumers, since their names and reputations would be on the line.

I believe there needs to be a much stronger focus in regulatory institutions toward the elimination of Type II Errors, because there are a lot of sick people going untreated.

Zach Richardson is a Certified Supply Chain Professional and small-business co-owner producing respirator-style masks to help stem the tide of COVID-19’s spread. His website is isgmanufacturing.com. He is a member of the U.S. Transhumanist Party.