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Innovative drugs are sometimes held up due to old-fashioned human biases.
- When new drugs are similar to popular drugs on the market, FDA approval takes up to 75 percent longer.
- Texas McCombs Professor Francisco Polidoro Jr. reviewed 291 drugs over a 35-year period.
- Polidoro believes that potential coronavirus treatments or vaccines could help the FDA improve upon this longstanding bias.
Why vaccines are absolutely necessary | Larry Brilliant | Big Think<span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="7f681e7e08a6ac9cea06ae50e6bbd7b5"><iframe type="lazy-iframe" data-runner-src="https://www.youtube.com/embed/ffiw6K3rjiU?rel=0" width="100%" height="auto" frameborder="0" scrolling="no" style="position:absolute;top:0;left:0;width:100%;height:100%;"></iframe></span><p>That leaves us in a bind: our brain simultaneously seeks novelty and is resistant to change. Installing a new app on your phone is easy. Discovering a cheaper phone that performs better than your current brand brings with it layers of anxiety. This low-stakes example is amplified when the same cognitive process plays out in life-or-death situations, as is the case in drug development.</p><p>Polidoro begins his article with one question: "How does knowledge about different technologies that exist in a domain affect the time it takes for regulatory agencies to review an innovation in that domain?" While drug discovery and development typically produces a high failure rate around the world, the FDA approves "the vast majority of new drug applications." This makes the agency an ideal case study for his question. </p><p>Polidoro focuses his research on the time between submission of a new drug application and FDA approval. Clinical trials have been conducted; the drug has met certain criteria. While we assume FDA approval implies that the drug works, journalist Robert Whitaker <a href="https://bigthink.com/mind-brain/antidepressants-dangers" target="_self">recently explained to Big Think</a> that the process is not so clear-cut. </p><p style="margin-left: 20px;">"Let's say you have a drug that provides a relief of symptoms in 20 percent of people. In placebo it's 10 percent. How many people in that study do not benefit from the drug? Nine out of 10. How many people are exposed to the adverse effects of the drug? 100 percent. They'll pass that drug because it meets this small standard of benefit over placebo. And they're not subtracting the risk; they're just warning of the risk."</p><p>These data points shed light on the FDA's thought process: a drug only needs to perform better than placebo <em>and</em> the agency approves most new drugs. Inherent biases are already on display. Polidoro writes that innovative drugs are subject to another: new drugs take 75 percent longer to be approved when going up against popular pre-existing drugs. </p>
This picture taken on May 23, 2020 shows a laboratory technician holding a dose of a COVID-19 novel coronavirus vaccine candidate ready for trial on monkeys at the National Primate Research Center of Thailand at Chulalongkorn University in Saraburi.
Photo by Mladen Antonov/AFP via Getty Images<p>From a consumer perspective, this might make sense: if other drugs already perform the same function, why flood the market with new drugs? Of course, this has to be measured on a case-by-case basis. If the pre-existing drug has numerous side effects, and a new drug minimizes risk, you'd want that on the shelves sooner than later.</p><p>However, the reverse is also true, especially when patents are considered. Pharmaceutical companies are notorious for attempting to extend patents by changing a single molecule. Even such a seemingly small change can produce negative effects downstream. While the clinical trial threshold appears to be high, it's impossible to gauge long-term effects of any drug. We don't have decades to wait before releasing a drug to market. </p><p>Polidoro <a href="https://medium.com/texas-mccombs/new-era-requires-new-approach-to-drug-approvals-b814eae9418" target="_blank">describes</a> the trend succinctly: </p><p style="margin-left: 20px;">"Regulators search for solutions in the neighborhood of what they already know. They have a harder time when the next big thing emerges."</p><p>He expects the pipeline to approval for COVID-19 treatments or vaccines to run more smoothly than with past examples. The urgency will allow regulators to be less cautious in the hopes of helping the greatest number of people, a trend that could set a new precedent. "It may be more complicated for them at first," he concludes, "but in the long run, we will all be better off."</p><p>The scientific process will always be beholden to human habits. For now, it's the best process we have. Time will tell if Polidoro's optimism pans out. </p><p>--</p><p><em>Stay in touch with Derek on <a href="http://www.twitter.com/derekberes" target="_blank">Twitter</a>, <a href="https://www.facebook.com/DerekBeresdotcom" target="_blank">Facebook</a> and <a href="https://derekberes.substack.com/" target="_blank">Substack</a>. His next book is</em> "<em>Hero's Dose: The Case For Psychedelics in Ritual and Therapy."</em></p>
Stop touching doorknobs, elevator buttons, and touch-screens.
- The CDC says your hands spread germs on objects like tables, ATM machines, elevator buttons, and door handles.
- Hygiene Hand is a tool to help avoid direct contact with shared surfaces.
- After a successful funding round on Kickstarter, the Hygiene Hand is now available to everyone.
The larger the stakes and scope, the less likely a conspiracy theory is to be true.
- During times of high anxiety, not unlike the situation we find ourselves in now, there is a rise in conspiracism. Conspiracy theories provide comfort where there is uncertainty.
- As author Michael Shermer points out, history has shown that this way of thinking is sometimes warranted, but not in the case of coronavirus. One factor that has helped recent coronavirus conspiracy theories grow, he says, is the shrinking political middle and an increased polarization to the far left and far right.
- "The further out you go in the extreme nature of a conspiracy theory the less likely the theory is to be true," says Shermer. Actual conspiracies happen on a more localized, more narrowly-focused level.
A Cornell Health physician has blended rap and medicine to better educate kids on coronavirus guidelines.
- Dr. Clarke's rap music video "Stop Corona" aims to convey key information about COVID-19 to certain hard-to-reach youth demographics.
- Clark has created many "health-hop" songs and videos over the years with topics that address smoking to asthma to H1N1.
- Music helps us remember information better through a process called "chunking," through which we take individual pieces of information and group them together into larger units.
A doctor at Cornell Health is educating the kids on COVID-19 by meshing rap music with medicine.
John Clarke, director of occupational medicine at Cornell Health, always felt called to rap. He began writing music when he was just 8 years old and later majored in music at Columbia University. Though his talent scored him a recording deal when he was younger, he ultimately decided to take a career path toward medicine. But he never stopped writing, producing, and performing rap music. Now he regularly drops beats on health-related topics carving out a genre he calls "health-hop."
His most recent video is "Stop Corona," which he hopes will convey key information about COVID-19 to certain hard-to-reach youth communities.
"For certain demographics, something like a rap video will resonate," Clarke said to the Cornell Chronicle. "And there's a science behind why songs are effective for teaching. Rhythm and rhyme stimulate memory. Music stimulates several parts of the brain at the same time. So a lot of time it's easier to remember songs than it is to remember just facts."
Music helps us remember information better through a process called "chunking," through which we take individual pieces of information and group them together into larger units. It works like this: Our short term memory can only hold about seven units of information at a time, but we can cram more material into each of those units by putting them into bigger chunks. This allows us to store more content. By linking words and phrases in a tune, music allows us to chunk lyrics. In this way we can attach, say, medical guidelines to melody and rhythm and make it easier to recall later.
Clark's 2-minute song urges listeners "not to be a case" by being "careful who gets in your personal space" and "not to touch your eyes, your nose or your face." Real medical guidelines are rewritten into rhyme and put to a beat.
"I first researched in-depth about the disease, how it spreads and the way it presents, so my message is consistent with what I would tell a patient as a doctor," Clarke said. "In health-hop, you're limited in the scope of words you can use to rhyme. It's a challenge, but it's a challenge I enjoy."
The power of health-hop
Clark told the Chronicle that he first began creating health-hop around 20 years ago as a doctor in Jamaica, Queens.
"We had a large population of asthmatics, many of whom were young. And a lot of their parents were young as well," he said. "This was a culturally sensitive approach to delivering a health message. I created a rap song, we showed it at a high school, and it went really well. We showed that this is an effective way of appealing to that audience."
Clark has created many health-hop songs and videos over the years with topics that address smoking to asthma to H1N1, the last of which won a U.S. Department of Health and Human Services sponsored contest in 2009 and became a public service announcement for swine flu safety.
Clarke said that in addition to helping educate and inform, rap music provides a creative outlet for him to balance with the more rigid, methodical field of medicine.
Clark's 14-year-old son, an aspiring rapper himself, helped write and perform "Stop Corona". Additionally his three younger children also appear in the video.
"Having someone their age be part of the message is a really good way to connect with that audience," Clarke said.
Sadly about a week after filming the video, the Cornell Chronicle reports that Clarke's wife's parents became ill with coronavirus and died a short time later. They were the first two COVID-19-related fatalities in Tompkins County, NY, where the Clark family lives and works. The "Stop Corona" video concludes with a dedication in their memory.
"I knew they would have wanted us to spread this message, and they would have been proud of their grandchildren," Clarke said. "...It's really critical that folks listen to preventive strategies – the quarantine, the handwashing, all of the things I outline in the video. Even if you're not doing it to protect yourself, do it to help protect other more vulnerable members of the community whose immune systems may not be as strong."
The physical action of handwashing plus the properties of soap is a one-two punch for the virus.
- A common recommendation from experts to help protect against coronavirus is to wash your hands often, but why? It turns out that each time you do it is an effective two-pronged attack.
- As Kate the Chemist explains, the virus has a weak outer membrane. By using the proper handwashing technique, you're actually breaking through that membrane and ripping the virus apart.
- Soap is an important part of the equation because of its two sides: the hydrophobic side (which grabs onto the virus), and the hydrophilic side (which grabs onto the water). Washing your hands with soap for at least 20 seconds allows the virus to be rinsed away.