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Would you volunteer for a COVID-19 vaccine trial? 1,500 people just did.
Human-challenge trials are not without risk, but they could speed up the process.
- 1Day Sooner recruited nearly 1,500 volunteers for a potential human-challenge trial to test for COVID-19 vaccines.
- Human-challenge trials could help expedite the process that clinical trials must endure.
- At least six COVID-19 vaccination trials are currently underway, with over 70 planned around the world.
Americans are being asked to sacrifice a lot right now. Shelter at home orders are in place to help limit the number of elderly and high-risk citizens flooding into hospitals, which overwhelms the health care system. It's not that we aren't feeling the pain. Over 26 million Americans have filed for unemployment in a mere five weeks. There are reasons for our sacrifices, yet that doesn't make them any easier to bear.
Which leads to another question of sacrifice: Would you be willing to be infected with COVID-19 as part of an early-stage vaccination trial? For nearly 1,500 healthy, young citizens, that answer is yes.
Nature reports that roughly that number of Americans signed up for 1Day Sooner, early-stage research that could potentially speed up the vaccination process, which typically takes 12-18 months. Known as a human-challenge trial, volunteers would be infected so that researchers could test vaccines and treatments—basically, a rushed clinical trial, with everyone well-informed of the stakes.
Germany approves trials of COVID-19 vaccine candidate
1Day Sooner co-founder, Josh Morrison (whose organization is not funded by companies working on a coronavirus vaccine), is pre-qualifying volunteers now in case human-challenge trials are coming down the pipeline. He's hoping that this enthusiasm will help inspire politicians and public policy experts to expedite the testing process. Being a high-risk endeavor, Morrison believes the payoff could be even bigger.
"Many note that they recognize the risk but believe the benefits of vaccine acceleration are so tremendous that it is worth it to them."
1Day Sooner isn't the only organization looking for a vaccine. Two volunteers were just injected with COVID-19 as part of a study at Oxford—the first of over 800 people that have signed off on being tested.
Meanwhile, volunteers at Kaiser Permanente's Vaccine Treatment and Evaluation Unit in Seattle are undergoing their second round of vaccination trials. That study began on March 16.
Hong Kong's CanSino Biologies, in partnership with the Beijing Institute of Biotechnology, has also just entered phase 2 of their clinical trials.
Clinical trials at Beth Israel are planned to launch in September, with companies such as Johnson and Johnson dedicating $1 billion to this research.
The World Health Organization announced its Solidarity Trial, with over 100 countries participating in an effort to identify effective treatments as soon as possible. All told, the WHO announced six coronavirus trials that are currently underway, with over 70 planned around the world.
A red cross nurse applies a vaccine during a drive thru influenza vaccination operation at Riocentro on March 26, 2020 in Rio de Janeiro, Brazil. This vaccination does not prevent against the coronavirus (COVID-19), but helps the most vulnerable from other diseases.
Photo by Bruna Prado/Getty Images
A human-challenge trial, such as the one being proposed by 1Day Sooner, is not without potentially deadly consequences. Nir Eyal, director at the Center for Population-Level Bioethics at Rutgers University, recently said that human-challenges are not uncommon. They've been conducted on cholera and malaria. COVID-19 is a bit different, given its novelty. While we don't know the extent of damage of this virus, overall he thinks such trials are worth the risk.
"The main attraction is that they could greatly accelerate the time to approval and potential use. The thing that takes the longest time in testing vaccines is phase III efficacy testing. That's done on many, many people, some of whom get the vaccine and some of whom get placebos or competing vaccine candidates. Researchers then look for differences between these two groups in infection rates."
Making a sacrifice is always a gamble, yet it points to the importance of a collectivist mindset: It's not just about you, but everyone. These volunteers deserve a lot of respect for their service.
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Scientists are using bioelectronic medicine to treat inflammatory diseases, an approach that capitalizes on the ancient "hardwiring" of the nervous system.
- Bioelectronic medicine is an emerging field that focuses on manipulating the nervous system to treat diseases.
- Clinical studies show that using electronic devices to stimulate the vagus nerve is effective at treating inflammatory diseases like rheumatoid arthritis.
- Although it's not yet approved by the US Food and Drug Administration, vagus nerve stimulation may also prove effective at treating other diseases like cancer, diabetes and depression.
The nervous system’s ancient reflexes<p>You accidentally place your hand on a hot stove. Almost instantaneously, your hand withdraws.</p><p>What triggered your hand to move? The answer is <em>not</em> that you consciously decided the stove was hot and you should move your hand. Rather, it was a reflex: Skin receptors on your hand sent nerve impulses to the spinal cord, which ultimately sent back motor neurons that caused your hand to move away. This all occurred before your "conscious brain" realized what happened.</p><p>Similarly, the nervous system has reflexes that protect individual cells in the body.</p><p>"The nervous system evolved because we need to respond to stimuli in the environment," said Dr. Tracey. "Neural signals don't come from the brain down first. Instead, when something happens in the environment, our peripheral nervous system senses it and sends a signal to the central nervous system, which comprises the brain and spinal cord. And then the nervous system responds to correct the problem."</p><p>So, what if scientists could "hack" into the nervous system, manipulating the electrical activity in the nervous system to control molecular processes and produce desirable outcomes? That's the chief goal of bioelectronic medicine.</p><p>"There are billions of neurons in the body that interact with almost every cell in the body, and at each of those nerve endings, molecular signals control molecular mechanisms that can be defined and mapped, and potentially put under control," Dr. Tracey said in a <a href="https://www.youtube.com/watch?v=AJH9KsMKi5M" target="_blank">TED Talk</a>.</p><p>"Many of these mechanisms are also involved in important diseases, like cancer, Alzheimer's, diabetes, hypertension and shock. It's very plausible that finding neural signals to control those mechanisms will hold promises for devices replacing some of today's medication for those diseases."</p><p>How can scientists hack the nervous system? For years, researchers in the field of bioelectronic medicine have zeroed in on the longest cranial nerve in the body: the vagus nerve.</p>
The vagus nerve<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yNTYyOTM5OC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY0NTIwNzk0NX0.UCy-3UNpomb3DQZMhyOw_SQG4ThwACXW_rMnc9mLAe8/img.jpg?width=1245&coordinates=0%2C0%2C0%2C0&height=700" id="09add" class="rm-shortcode" data-rm-shortcode-id="f38dbfbbfe470ad85a3b023dd5083557" data-rm-shortcode-name="rebelmouse-image" data-width="1245" data-height="700" />
Electrical signals, seen here in a synapse, travel along the vagus nerve to trigger an inflammatory response.
Credit: Adobe Stock via solvod<p>The vagus nerve ("vagus" meaning "wandering" in Latin) comprises two nerve branches that stretch from the brainstem down to the chest and abdomen, where nerve fibers connect to organs. Electrical signals constantly travel up and down the vagus nerve, facilitating communication between the brain and other parts of the body.</p><p>One aspect of this back-and-forth communication is inflammation. When the immune system detects injury or attack, it automatically triggers an inflammatory response, which helps heal injuries and fend off invaders. But when not deployed properly, inflammation can become excessive, exacerbating the original problem and potentially contributing to diseases.</p><p>In 2002, Dr. Tracey and his colleagues discovered that the nervous system plays a key role in monitoring and modifying inflammation. This occurs through a process called the <a href="https://www.nature.com/articles/nature01321" target="_blank" rel="noopener noreferrer">inflammatory reflex</a>. In simple terms, it works like this: When the nervous system detects inflammatory stimuli, it reflexively (and subconsciously) deploys electrical signals through the vagus nerve that trigger anti-inflammatory molecular processes.</p><p>In rodent experiments, Dr. Tracey and his colleagues observed that electrical signals traveling through the vagus nerve control TNF, a protein that, in excess, causes inflammation. These electrical signals travel through the vagus nerve to the spleen. There, electrical signals are converted to chemical signals, triggering a molecular process that ultimately makes TNF, which exacerbates conditions like rheumatoid arthritis.</p><p>The incredible chain reaction of the inflammatory reflex was observed by Dr. Tracey and his colleagues in greater detail through rodent experiments. When inflammatory stimuli are detected, the nervous system sends electrical signals that travel through the vagus nerve to the spleen. There, the electrical signals are converted to chemical signals, which trigger the spleen to create a white blood cell called a T cell, which then creates a neurotransmitter called acetylcholine. The acetylcholine interacts with macrophages, which are a specific type of white blood cell that creates TNF, a protein that, in excess, causes inflammation. At that point, the acetylcholine triggers the macrophages to stop overproducing TNF – or inflammation.</p><p>Experiments showed that when a specific part of the body is inflamed, specific fibers within the vagus nerve start firing. Dr. Tracey and his colleagues were able to map these relationships. More importantly, they were able to stimulate specific parts of the vagus nerve to "shut off" inflammation.</p><p>What's more, clinical trials show that vagus nerve stimulation not only "shuts off" inflammation, but also triggers the production of cells that promote healing.</p><p>"In animal experiments, we understand how this works," Dr. Tracey said. "And now we have clinical trials showing that the human response is what's predicted by the lab experiments. Many scientific thresholds have been crossed in the clinic and the lab. We're literally at the point of regulatory steps and stages, and then marketing and distribution before this idea takes off."<br></p>
The future of bioelectronic medicine<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yNTYxMDYxMy9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYzNjQwOTExNH0.uBY1TnEs_kv9Dal7zmA_i9L7T0wnIuf9gGtdRXcNNxo/img.jpg?width=980" id="8b5b2" class="rm-shortcode" data-rm-shortcode-id="c005e615e5f23c2817483862354d2cc4" data-rm-shortcode-name="rebelmouse-image" data-width="2000" data-height="1125" />
Vagus nerve stimulation can already treat Crohn's disease and other inflammatory diseases. In the future, it may also be used to treat cancer, diabetes, and depression.
Credit: Adobe Stock via Maridav<p>Vagus nerve stimulation is currently awaiting approval by the US Food and Drug Administration, but so far, it's proven safe and effective in clinical trials on humans. Dr. Tracey said vagus nerve stimulation could become a common treatment for a wide range of diseases, including cancer, Alzheimer's, diabetes, hypertension, shock, depression and diabetes.</p><p>"To the extent that inflammation is the problem in the disease, then stopping inflammation or suppressing the inflammation with vagus nerve stimulation or bioelectronic approaches will be beneficial and therapeutic," he said.</p><p>Receiving vagus nerve stimulation would require having an electronic device, about the size of lima bean, surgically implanted in your neck during a 30-minute procedure. A couple of weeks later, you'd visit, say, your rheumatologist, who would activate the device and determine the right dosage. The stimulation would take a few minutes each day, and it'd likely be unnoticeable.</p><p>But the most revolutionary aspect of bioelectronic medicine, according to Dr. Tracey, is that approaches like vagus nerve stimulation wouldn't come with harmful and potentially deadly side effects, as many pharmaceutical drugs currently do.</p><p>"A device on a nerve is not going to have systemic side effects on the body like taking a steroid does," Dr. Tracey said. "It's a powerful concept that, frankly, scientists are quite accepting of—it's actually quite amazing. But the idea of adopting this into practice is going to take another 10 or 20 years, because it's hard for physicians, who've spent their lives writing prescriptions for pills or injections, that a computer chip can replace the drug."</p><p>But patients could also play a role in advancing bioelectronic medicine.</p><p>"There's a huge demand in this patient cohort for something better than they're taking now," Dr. Tracey said. "Patients don't want to take a drug with a black-box warning, costs $100,000 a year and works half the time."</p><p>Michael Dowling, president and CEO of Northwell Health, elaborated:</p><p>"Why would patients pursue a drug regimen when they could opt for a few electronic pulses? Is it possible that treatments like this, pulses through electronic devices, could replace some drugs in the coming years as preferred treatments? Tracey believes it is, and that is perhaps why the pharmaceutical industry closely follows his work."</p><p>Over the long term, bioelectronic approaches are unlikely to completely replace pharmaceutical drugs, but they could replace many, or at least be used as supplemental treatments.</p><p>Dr. Tracey is optimistic about the future of the field.</p><p>"It's going to spawn a huge new industry that will rival the pharmaceutical industry in the next 50 years," he said. "This is no longer just a startup industry. [...] It's going to be very interesting to see the explosive growth that's going to occur."</p>
The first rule of Vulture Club: stay out of Portugal.
So you're a vulture, riding the thermals that rise up over Iberia. Your way of life is ancient, ruled by needs and instincts that are way older than the human civilization that has overtaken the peninsula below, and the entire planet.
"The Expanse" is the best vision I've ever seen of a space-faring future that may be just a few generations away.
- Want three reasons why that headline is justified? Characters and acting, universe building, and science.
- For those who don't know, "The Expanse" is a series that's run on SyFy and Amazon Prime set about 200 years in the future in a mostly settled solar system with three waring factions: Earth, Mars, and Belters.
- No other show I know of manages to use real science so adeptly in the service of its story and its grand universe building.
Credit: "The Expanse" / Syfy<p>Now, I get it if you don't agree with me. I love "Star Trek" and I thought "Battlestar Galactica" (the new one) was amazing and I do adore "The Mandalorian". They are all fun and important and worth watching and thinking about. And maybe you love them more than anything else. But when you sum up the acting, the universe building, and the use of real science where it matters, I think nothing can beat "The Expanse". And with a <a href="https://www.rottentomatoes.com/tv/the_expanse" target="_blank">Rotten Tomato</a> average rating of 93%, I'm clearly not the only one who feels this way.</p><p>Best.</p><p>Show.</p><p>Ever. </p>
Contrary to what some might think, the brain is a very plastic organ.
As with many other physicians, recommending physical activity to patients was just a doctor chore for me – until a few years ago. That was because I myself was not very active.