Streamlining Clinical Trials: Enhancing Efficiency and Affordability for Medical Innovation

• Randomized controlled trials (RCTs) have become more expensive, with median costs estimated at $41,413 per patient for trials conducted between 2015 and 2017.
  
  
• Per-patient costs can reach up to $500,000 in some trials, compared to the typical $10,000 per patient in the past.
  
  
• Structural reasons for increased costs include longer trial durations, a larger number of subjects, and a focus on chronic diseases and existing drugs.
  
  
• Pharmaceutical companies have sought alternatives such as outsourcing trials or pursuing less burdensome forms of approval.
  
  
• Cheaper yet rigorous trials have been demonstrated by examples such as the U.K. Recovery Trial and decentralized Covid-19 trials.
  
  
• Proposed changes for addressing RCT costs include:
  
  
• Deregulating clinical trial advertising.
  
  
• Fixing tax disincentives for research participants.
  
  
• Extending tax advantages for trial participation to increase socioeconomic diversity.
  
  
• Requiring more Institutional Review Board (IRB) transparency.
  
  
• Walking back FDA and congressional diversity mandates to avoid slowing trials and raising costs.
  
  
• Affirming the FDA's commitment to modern trial monitoring methods, such as risk-based monitoring.

These changes aim to remove unnecessary barriers, make trials more affordable, and benefit patients, healthcare resources, and pharmaceutical companies.

 Clear the Way for Clinical Trials

Find the Joy

Lyrics

I don’t know why it happened.

Where it’s going, a mystery.

Somewhere there’s an answer,

But the hurt is still inside.

And time just keeps on passing,

I can’t escape it, I want to take you.

Together we will always be.

The love we have, it makes us both so

Free.

Just wait and see, love will 

Keep us together so

Happy.

Find the joy. It’s still there.

Why do bad things happen?

No reason or rhyme, it’s bigger than us, but

Together we will find our way

To the light, we’ll smile and both be so

Free.

Just wait and see,

We’re together, laughing and

Happy, we're

Full of joy. It’s out there.

Our story is still unraveling.

The ups and downs, the turnarounds.

Transcending and overcoming, 

Nothing can stop the love we share.

I don’t know why it happened, 

But you and me, it’s no mystery, we're

Together forever,

We’ll wander & find our joy, it’s still inside making us

Free.

We’re full of smiles,

We’re laughing together and

Happy.

We found the joy. It’s still there.

I’m so glad that you happened.

You’ve filled my life, it’s overflowing.

I’ll stay by your side forever.

Whatever comes next we’ll see.

Essay

Quantum entanglement describes how two particles can be linked together in spite of a separation of billions of light-years of space (1). Although this phenomenon is an observable scientific finding, does its also explain our deep connections with other people, with nature, with everything we love? Quantum theory may just possibly explain how we experience these connections that persist beyond time. 

When I was an intern at Cape Fear Valley Hospital in North Carolina, one of my patients passed away. While the death was not unexpected, nevertheless, it profoundly affected me. When discussing this with the unit clerk of the hospital wing, she simply told me that my patient had gone to a better place. Not dead. Not the end. Just to a better place. Although my religious faith believed in life after death, her great, unshakable certainty surprised me. She taught me a lifelong lesson. The love entanglements we have supercede life and death. 

Find the Joy reflects on a lifetime of experiences where as a physician I’ve had to intimately face and share with others great tragedy, pain, and suffering. How can we find the strength and the peace to go on? How can we get past grief and keep our spirits strong and intact? It’s challenging.

I believe that love is the most powerful force in the universe, that it  overcomes everything, and that it has both a spiritual and scientific basis. Quantum field theory  seems to explain just how waves of love can transcend space and time.  And our spirits can sense this. We can feel these timeless connections of love, these inescapable entanglements. 

As the French Jesuit priest Pierre Teilhard de Chardin said, we are not human beings having a spiritual experience, we are spiritual beings having a human experience. So as we realize that our spirit is our core essence, we find meaning in spite of sadness. From the ashes of tragedy sparks an eternal flame. 

Find the joy. It’s still there.

- TFH 11/5/2022

1. Emspak J. Quantum entanglement: A simple explanation. Space. 2022. 

Sheet Music

https://www.sheetmusicplus.com/title/find-the-joy-digital-sheet-music/22430004

Piano

YouTube 

Health-care workers recovered from natural SARS-CoV-2 infection should be exempt from mandatory vaccination edicts

The Lancet has just published an editorial arguing that health care workers who have recovered from natural SARS-Cov-2 infection should be except from COVID-19 vaccination mandates. I agree.

The goal of public health is just that- to protect and improve the health of the public. Too often during the Covid-19 pandemic politicians have resorted to blatant power grabs in the name of public health. A prime example is vaccine mandates without recognizing natural immunity. Those with natural immunity do not require vaccination, and actually appear at this point in time to be less of a danger to public health than fully vaccinated individuals who do not have natural immunity. Fear is not a substitute for a rational analysis of the data. Mandating vaccinations for those who have natural immunity is either a blatant power grab by politicians, or a complete subjugation to fear over rational thinking. 

The editorial makes three major points:

1. Natural immunity to single stranded RNA viruses such as SARS-CoV-2 provides better protection than vaccination. ADVANTAGE: NATURAL IMMUNITY

2. Those with natural immunity appear to be less likely to transmit the virus to others. Vaccinated individuals without natural immunity appear to be more likely to transmit the virus to others. ADVANTAGE: NATURAL IMMUNITY

3. Those with both natural immunity and vaccination, appear to have a "super-immunity" to SARS-CoV-2. However, there appears to be minimal, if any benefit of super-immunity over natural immunity. Natural infection appears to be superior to vaccination because it may lead to innate cytokine response preventing a SARS-CoV-2 viral breach of the mucosal barrier in our respiratory tracts. While vaccines help the body respond to the virus once it is in the blood, natural immunity appears to also help prevent the virus from crossing the mucosal barrier, and thus prevent the virus from getting into the blood. ADVANTAGE: NATURAL IMMUNITY

This is an excellent read, short and right to the point. Take a look: 

Health-care workers recovered from natural SARS-CoV-2 infection should be exempt from mandatory vaccination edicts - The Lancet Rheumatology

The Beholder NFT Collection

 The Beholder was written in 1985.

Vitamin C as a Possible Therapy for COVID-19.

In this letter to the Editor, the authors argue that Vitamin C has been shown to decrease the severity of at least one coronavirus infection, the common cold. Thus, it is possible, even likely that vitamin C would also have a positive effect against infections by other coronaviruses, including Sars-CoV-2 infections leading to COVID-19. In addition, since Vitamin C has been shown to improve outcomes in patients admitted to the ICU, there may be additional benefits.

Comment: at this point in time, it appears that SARS-CoV-2 is highly infectious, and that large segments of the population will get infected regardless of social distancing policies or mask policies. While social distancing and masking slows down transmission, right now it seems that these measures will not stop the spread of the virus. Since there are no known good treatments for COVID-19 right now a great strategy is to build up your immune system, now.

Building up the immune system is simultaneously complex and simple. The biochemical reactions underlying the immune system are complex, but for you and I, the way to build up our immune systems as simple as diet and exercise. Eat right. Exercise regularly. And possibly, take Vitamin C.

Too much emphasis has been placed on social distancing, which is a controversial policy that may or may not turn out to be the best policy in fighting the global pandemic of COVID-19. While most countries have followed strict social distancing policies, others have not. Most notably, Sweden has not been as stringent as other European countries, yet their disease rate is about average.


Vitamin C as a Possible Therapy for COVID-19.:

Infect Chemother. 2020 May 15;

Authors: Hemilä H, Chalker E

PMID: 32410417 

#covid19: Primary Prevention is Not Enough

In quarantine for another 24 hours due to a cough with fever, now thankfully getting better. So here are my quarantine thoughts on how *you* can get through this stronger than ever.

First, I'll discuss some basic preventive medicine principles, then I'll give the specific measures I am taking and recommend you take as well. Finally, there's a personal note.

Preventive medicine involves primary, secondary, and tertiary measures. Primary prevention is the prevention of catching the disease. Secondary prevention is the early detection of disease. And tertiary prevention is the prevention of side-effects of disease, or in the case of covid19, steps to maximize your chance of survival if you get infected.

Primary prevention of covid19 involves measures to prevent ever getting the virus. Wash your hands. Engage in physical distancing. Quarantine affected individuals. Clean surfaces and the air.

Secondary prevention involves the early detection of of covid19. Get tested early if you have symptoms. Help make tests easily and widely available; make the tests free of charge so there are no financial barriers to being tested; and finally we need to make the tests available without a doctor's order.

Tertiary prevention involves taking measures to decrease the impact of covid19 infection if you get the disease, mainly by decreasing adverse side-effects. For example, a person with a coronovirus infection may be treated with hydroxychloroquine, but they may take another medicine such as ondansetron to prevent the side-effect of nausea.

For covid19 our public health officials so far are taking correct, but incomplete measures. They are doing great at addressing primary prevention by stressing we all take common sense measures to prevent catching the disease.

They are behind the curve, but rapidly catching up in terms of secondary prevention. Test kits for covid19 have been in short supply but availability is ramping up quickly now.

However, our public health officials need to work much more aggressively on tertiary prevention. This involves getting people to take measures right now to increase their chances of surviving if they get infected by covid19. All of us should stay active, eat right, and not smoke or vape. These measures are hard to implement widely, but even small improvements will significantly decrease the chances of dying if you get infected. So let's look more closely at tertiary prevention, since it has been largely ignored to date.

First, stay active. The most serious complication of covid19 infection is acute respiratory distress syndrome. The virus attacks the lungs, and this is generally how it kills people. So right now, make your lungs as healthy as possible. This means staying active and not smoking or vaping. We know from surgical studies that people who stop smoking even for a week prior to surgery have significantly fewer side-effects. We don't know how long this coronovirus pandemic is going to last, so right now is a good time to optimize your exercise program. Get your lungs and entire cardiovascular system as healthy as possible. Walking is a great exercise for your lungs, so is laughing, so is singing, so is weight lifting. Find an exercise you enjoy, do it in moderation but with a plan to gradually improve your health and strengthen your lungs.

Second, eat right. If you get infected by covid19 you want your entire body ready to respond quickly and aggressively. Many people who get infected don't even know it, because their body fights off the infection so fast. Others, however, get sick, some to the point of requiring hospitalization, and some to the point of death. The healthier you are prior to getting infected, the more likely you won't even know you got it and the less likely you are to die from it. Have the attitude that if you get infected, you'll be okay because you are maximizing your fitness right now.

Finally, strengthen your thoughts and your spirit. The will to live is a powerful force. It is real. But when you get sick, often it can be greatly challenging from a spiritual standpoint. Feelings of depression and hopelessness can weaken your ability to fight off the infection. The best strategy is to prepare yourself mentally for the possibility of getting covid19 or for that matter any other illness. Have the attitude that you will stay strong spiritually no matter what. Your thoughts will remain hopeful. You will continue to love life, love your family, love your friends no matter what. You will help strengthen other people's spirits by your generosity, kindness, laughter, compassion, and love. Love will overcome the fear and hopelessness, but it can be very challenging when you're sick. It is best to take measures right now to keep your spirit strong and healthy.

So your plan should be to take all 3 steps of prevention:

a) do everything you can to never catch the disease. Clean your hands, your air, your environment. Support the rapid development of a vaccine.

b) if you get exposed or start getting symptoms such as fever with a cough, get tested early because there are treatments available right now and new treatments will be identified. These always will work better early in the course of the infection. Early detection of infection will help you, and help you take measures to not infect others. Push the system to make tests widely available.

c) get as healthy as possible right now. Stay active and exercise regularly. Eat right. Don't smoke or vape. And keep your spirit strong, enthusiastic, and optimistic. Keep the love flowing in your life.

I share these thoughts with you not as a professor, or a doctor, but as a friend. We are all physically isolated now, but socially we remain strong and together.

As someone who has suffered from acute respiratory distress syndrome, who was placed in a medical coma and put on a ventilator; someone whose lungs were almost destroyed by an overwhelming infection; and someone who faced death very intimately but survived, I implore you to not just wash your hands and get tested if needed. Take major action right now to improve your overall health, and to strengthen your spirit.

I went into my medical misadventure pretty well prepared, yet it nearly got me. It was razor close. But the disease lost. Due to the measures I took ahead of time to stay as healthy as possible, due to my incredible doctors and nurses at Deaconess, due to the love from my family & friends, due to my crazy optimism, and by the grace of God I survived. Maybe just so I could pass along this message to you.

Stay safe, eat well, laugh often, and tell people you love them.

Let it Rain

Let it Rain

So your past is turned upside down

you're the last one in line, the last one around.

And the time, it doesn't change a thing

Because you are the one who is always missing.

 

So let it rain on the outside.

Leave your pain- won't you leave it behind.

Then maybe someday

All your love inside will be found.

 

Collect your thoughts, Set yourself to rights.

Try to undo your wrongs, try to retell your lies.

Make a change, don't let it pass you by.

Stand up tall, don't let yourself down.

 

Just let it rain on the outside.

Leave your pain- won't you leave it behind.

Then maybe someday

All your love inside will be found.

 

Turn your eyes, you've been there all along

searching, waiting, around.

So let it hold you tight, and feel the warmest glow

Surround you, hear the light.

 

Just let it rain. Just rain.

 

Love can hide but it's never that hard to find.

oh, don't let it go.

Love can hide but it's never that hard to find,

no, just hold tight and don't let go.

Just let it rain.

c1979