Relevant and even prescient commentary on news, politics and the economy.

8th District Congresswoman Elissa Slotkin Answering Candidate Paul Junge on Healthcare

In a face off with Republican candidate Paul Junge, Congresswoman Slotkin lets Paul Junge know Republicans must have a healthcare plan as they don’t. In this clip she gives her personal story about her mom having cancer and being unable to get insurance at a reasonable cost or not at all.

There are many more like Ms. Slotkin’s mom in the same category who are winging it so to speak. I for one was faced with the same dilemma from time to time of being denied healthcare insurance or was only able to get a limited catastrophic plan. I reside in 8th District Michigan and Ms. Slotkin is “all” of our representative. Prior to her taking office, Mike Bishop would not publically meet with his constituents and “yucked” it up with trump on healthcare. Ms. Slotkin holds frequent townhalls.

If you go to 19 minutes and 30 seconds of this clip (following link), you will see what set Congresswoman Elissa Slotkin off on Paul Junge. Paul specifically mentions Elissa Slotkin’s mother and why her premiums and deductible were so high instead of pre-existing conditions. Big mistake and Elissa answers back: Flashpoint 9/27/20: Candidates in race for Michigan’s 8th Congressional District debate. Big mistake on Paul Junge’s part. He made it personal.

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Dr. Anthony Fauci kicks some Dr. Rand Paul butt

The lies and politics in this are so deep, it defies explanation. How can someone defend Rand’s decision? I sit and listen to this and then I listen to McConnell say the Repubs will appoint a new SCOTUS Justice shortly disallowing a new president from doing so. There is no honor in these people. They would just as soon sell us into slavery if it allows them the status to maintain their position. How will history judge these liars?

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COVID-19, Moderna Therapeutics mRNA Vaccine, and Crichton

I understood how some combinations of drugs work in attacking Covid-19 with one drug acting as an ionophore allowing another drug to enter a cell and attach to Covid RNA stopping its replication. I found this nice chart on National Geographic offering up an educational semi -medical and microbiologist depiction of how Moderna’s new vaccine mRNA gives the human body the ability to attack Covid.  I duplicated the chart with the original wording on Power Point. Click on either chart to make them larger.

Where we are today, Some history, and Where this is going

Morderna’s mRNA has moved into a Phase III Clinical Trial stage testing in the treatment of Covid-19. It is considered to be more successful than the other drugs and it is being fast-tracked (Operation Warp-Speed [or “Tribble Infestation”]) by the administration. On May 18 of this year, Moderna Therapeutics announced preliminary findings that healthy subjects had responded to mRNA vaccine by producing “neutralizing antibodies” which is how the vaccine works in the treatment of Covid. The antibodies made by the immune system prevent infection by the coronavirus.

When a virus infects a body, the immune system scrambles to recognize and create a response. The more traditional results of vaccine development is the introduction of an inactivated or weakened form of a virus or introduce one of the virus’s viral proteins to the body. The immune system responds to the introduction by producing antibodies to counter the vaccine, recognizing particular proteins of the virus. Those antibodies can fight future infections as long as the virus does not evolve.

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Coronavirus dashboard for September 14: cases in the Midwest surge; the Northeast still lags Canada

Coronavirus dashboard for September 14: cases in the Midwest surge; the Northeast still lags Canada

 

Total US cases: 6,519,573
Average cases last 7 days: 34,744
Total US deaths: 194,071
Average deaths last 7 days: 733

 Source: COVID Tracking Project

I continue to expect the pandemic to wax and wane in relative terms at least until next January 20, as the public reaction in various States varies between panic and complacency.

Let’s start by comparing the rates of cases and deaths in the US with the North American standard – Canada:

In contrast with the US, Canada averaged 18 cases per day per million people in the last 7 days (vs. 105 for the US), and 0.1 deaths (vs. 2.2 for the US). That is what we could have as well if there were competent Federal leadership.

 

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Covid Vaccine Tracker

In a  recent conversation with one person who I would consider knowledgeable, I was led to this site. COVID-19 Live Vaccine Tracker. This is an initial rundown of various Covid vaccines being worked on by international companies and the phase they are in today. I will attempt to update this from time to time.

“A compilation of the active vaccine candidates being studied for coronavirus 2019 (COVID-19) cures. This tracker will update periodically and will have the latest news and information.” The COVID-19 Live Vaccine Tracker, ContagionLive

Phase 3

Vaccine Name: mRNA-1273
Company: Moderna
Moderna’s phase 1 trial, mRNA-1273 vaccine: Results of treating novel coronavirus (COVID-19) were published July 14, 2020 in The New England Journal of Medicine. The NEJM reported on the results of potential vaccine induced protective responses in 45 adult participants receiving doses of 25, 100, or 250 μg (micrograms) throughout March and April 2020.  Antibodies did occur and correlated with higher doses of the mRNA-1273 vaccine as by anti–S-2P antibody GMT (geometric mean titer) ; 40,227 in the 25-μg group, 109,209 in the 100-μg group, and 213,526 in the 250-μg group.

With the second vaccination on day 57, the titers  had again showed increased antibody GMT when tested; 299,751, 782,719, and 1,192,154 μg. Serum-neutralizing activity (antibody that defends a cell from a pathogen or infectious particle by neutralizing any effect it has biologically) was detected by two methods in all participants evaluated, with values generally similar to those in the upper half of the distribution of a panel of control convalescent serum (blood serum containing antibodies  from disease or inoculation) specimens.

Adverse effects, includes half of the participants were fatigued, exhibiting chills, headache, myalgia, with pain at the injection site. Systemic adverse effects occurred after the second vaccination  particularly with the highest dosage. Three participants (21%) in the 250-μg dose group reported one or more severe adverse events.

The mRNA-1273 vaccine had induced anti–SARS-CoV-2 impact with an immune response in all participants of varying intensity with no trial-limiting safety concerns were identified.

mRNA-1273 vaccine was given a  Fast Track designation enrollment for a phase 2 trial at the end of May with an enrollment of 600 in 2 cohorts of those aged 18-55 years and those over 55 years.

A phase 3 trial involving 30,000 volunteers is receiving funding from BARDA and Operation Warp Speed. Participants in the study will receive either an injection of 100 μg mRA-1273 on Days 1 and 29 or a placebo.


Vaccine Name: Inactivated Vaccine
Company: Wuhan Institute of Biological Products; China National Pharmaceutical Group (Sinopharm)

The project involving Sinopharm and the Wuhan Institute of Virology are funded by the China Ministry of Science and Technology to achieve a goal of developing a vaccine utilizing inactivated vaccine. Phase 1 and 2 clinical trials with individuals of ages 6 and up are underway. As of June 16th, 1,120 volunteers participated in the phase 1 and 2 trials. The volunteers have received two injections of the vaccine at low, middle, or high dosing strengths or a placebo scheduled 14 days, 21 days or 28 days apart as reported by China National Biotec Group (CNBG). The seroconversion rate (time period during which a specific antibody develops and becomes detectable in the blood) for the 14-day and 21-day schedule of the mid-dose was 97.6%. At 28 days, it was 100%.

The Inactivate Vaccine appears to be working best at the middle strength when given 28 days apart. All participants in middle strength dosing regime developed neutralizing antibodies.

Sinopharm has initiated a phase 3 trial to evaluate their vaccine candidate in the United Arab Emirates. The country has authorized up to 15,000 participants aged 18 to 60 years to enroll.

China’s Sinopharm touts 100% antibody response for COVID-19 vaccine with workers

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Off-Roading with the FDA

It appears the FDA is now willing to deviate from its “bedrock mission” of guiding the public with accurate science-based information to a different road emphasizing variable political interests.

“The deep state, or whoever, over at the FDA is making it very difficult  .  .  .   @SteveFDA“, addressing you directly with your Twitter handle (trump). 

FDA is endorsing twitter as a mechanism to broadcast actions with and by Commissioner Dr. Hahn. Tweeting:

I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.” SteveFDA.

It would appear the FDA is now under direction of trump who is taking it down roads not traveled by the FDA in the past with the medical profession in the back seat. Some are not so willing to go along for the ride.

“We cannot entrust the health of 330 million Americans to a person who is subservient to President Trump’s whims, unprecedented promotion of unproven therapies, outrageous lies, and political motivations.” Dr. Eric J. Topol, MD, the editor-in-chief of Medscape

Medscape has three interesting articles critiquing the FDA. The first article reviews the  expansion of remdesivir usage, the second covers FDA Commissioner Dr. Stephen Hahn actions, and the last is questioning the FDA’s Covid decisions.   The first two articles were published on August 31st and the last on September 2nd. Typically, I read the articles and then go on to the comments section to see what medical practitioners have to say. I would suggest you too read the articles and then read the comments which can reveal a different perspective.  The comments can be useful and insightful.

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“Be Ready to Distribute Vaccines on Nov. 1”

CDC tells states: Be ready to distribute vaccines on Nov. 1, Modern Healthcare, September 2, 2020

The federal government told states to prepare for a coronavirus vaccine to be ready to distribute by Nov. 1; from which the declaration of the early timeline raised concern among public health experts about the  “October surprise” of a vaccine approval and use being driven by political considerations ahead of a presidential election, rather than science.

The planning  documents here and here sent to governors Aug. 27 by CDC Director Robert Redfield advises states they will receive permit applications “in the near future” from the authorized distributor, McKesson Corporation, to distribute vaccines to places which include state and local health departments and hospitals. Dr Redfield wrote in an accompanying  letter,

“CDC urgently requests your assistance in expediting applications for these distribution facilities and, if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020,”

There is not even a hint or a suggestion of partial Phase 3 testing being given beforehand which causes me to wonder if the extent of this is allowed under the 21st Century Cures Act passed in 2018. The act allowed for the skirting of some testing and the use actual data outside of the normal testing protocol to show a drug works? I believe the Cures Act only allowed a partial go-live on new drugs during a phrase 3. We must be following Putin lead. He gave the vaccine to his daughter. Perhaps, Trump will have Ivanka inoculated ?

Any volunteers at AB?

C.D.C. Tells States How to Prepare for Covid-19 Vaccine by Early November, New York Times, September 2, 2020

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Coronavirus dashboard for August 26: detailed State breakdowns

Coronavirus dashboard for August 26: detailed State breakdowns

Total US infections: 5,777,710

Average last 7 days: 41,185/day
Total US deaths: 178,488
Average last 7 days: 952/day
Source: COVID Tracking Project
Today let’s look at both death infections and deaths. I’ve started to rate each State according to a system, so we’ll look at that after the overall picture.
When it comes to new infections, only the Northeast is doing well. The best that can be said for the other regions is that the rate of new infections, while awful, has at least come down in the South and West in the past several weeks:

A similar pattern is the case as to deaths. In the Midwest, the pace of deaths has not increased nearly so much as infections:

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