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New research suggests biases play a role in FDA drug approval
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.
Speaking in front of Congress earlier this week, Dr. Anthony Fauci said he is "cautiously optimistic" that a coronavirus vaccine will be developed. He believes "it will be when and not if." He even ambitiously stated one could be ready by the end of this year.
With an unprecedented number of researchers focused on a singular goal, a vaccine is certainly possible. Yet it would be the quickest vaccine ever produced. Balancing urgency with caution is never easy, and the stakes couldn't be higher.
The FDA drug approval process is notoriously expensive and cumbersome. Pharmaceuticals take many years and hundreds of millions (even over one billion) of dollars to bring to market. Safeguards are in place to ensure new drugs are effective while side effects are minimized. Still, the road to approval is never a straight line, as new research published in Strategic Management Journal by Texas McCombs Associate Professor, Francisco Polidoro Jr., points out.
Polidoro reviewed 291 FDA-approved drugs over the course of 35 years. He discovered that new drugs take longer to be approved if similar drugs already treat the targeted disease. This cumbersome process costs manufacturers up to $1 million per day.
When Polidoro writes, "research thus far has overlooked the possibility that cognitive effects might also shape selection," he's pointing out an overlooked factor in research fields: scientists and agencies are subject to the same human tendencies as everyone else. We trust what we know and treat the unknown with suspicion.
Why vaccines are absolutely necessary | Larry Brilliant | Big Think
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.
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.
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 recently explained to Big Think that the process is not so clear-cut.
"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."
These data points shed light on the FDA's thought process: a drug only needs to perform better than placebo and 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.
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
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.
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.
Polidoro describes the trend succinctly:
"Regulators search for solutions in the neighborhood of what they already know. They have a harder time when the next big thing emerges."
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."
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.
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How would the ability to genetically customize children change society? Sci-fi author Eugene Clark explores the future on our horizon in Volume I of the "Genetic Pressure" series.
- A new sci-fi book series called "Genetic Pressure" explores the scientific and moral implications of a world with a burgeoning designer baby industry.
- It's currently illegal to implant genetically edited human embryos in most nations, but designer babies may someday become widespread.
- While gene-editing technology could help humans eliminate genetic diseases, some in the scientific community fear it may also usher in a new era of eugenics.
Tribalism and discrimination<p>One question the "Genetic Pressure" series explores: What would tribalism and discrimination look like in a world with designer babies? As designer babies grow up, they could be noticeably different from other people, potentially being smarter, more attractive and healthier. This could breed resentment between the groups—as it does in the series.</p><p>"[Designer babies] slowly find that 'everyone else,' and even their own parents, becomes less and less tolerable," author Eugene Clark told Big Think. "Meanwhile, everyone else slowly feels threatened by the designer babies."</p><p>For example, one character in the series who was born a designer baby faces discrimination and harassment from "normal people"—they call her "soulless" and say she was "made in a factory," a "consumer product." </p><p>Would such divisions emerge in the real world? The answer may depend on who's able to afford designer baby services. If it's only the ultra-wealthy, then it's easy to imagine how being a designer baby could be seen by society as a kind of hyper-privilege, which designer babies would have to reckon with. </p><p>Even if people from all socioeconomic backgrounds can someday afford designer babies, people born designer babies may struggle with tough existential questions: Can they ever take full credit for things they achieve, or were they born with an unfair advantage? To what extent should they spend their lives helping the less fortunate? </p>
Sexuality dilemmas<p>Sexuality presents another set of thorny questions. If a designer baby industry someday allows people to optimize humans for attractiveness, designer babies could grow up to find themselves surrounded by ultra-attractive people. That may not sound like a big problem.</p><p>But consider that, if designer babies someday become the standard way to have children, there'd necessarily be a years-long gap in which only some people are having designer babies. Meanwhile, the rest of society would be having children the old-fashioned way. So, in terms of attractiveness, society could see increasingly apparent disparities in physical appearances between the two groups. "Normal people" could begin to seem increasingly ugly.</p><p>But ultra-attractive people who were born designer babies could face problems, too. One could be the loss of body image. </p><p>When designer babies grow up in the "Genetic Pressure" series, men look like all the other men, and women look like all the other women. This homogeneity of physical appearance occurs because parents of designer babies start following trends, all choosing similar traits for their children: tall, athletic build, olive skin, etc. </p><p>Sure, facial traits remain relatively unique, but everyone's more or less equally attractive. And this causes strange changes to sexual preferences.</p><p>"In a society of sexual equals, they start looking for other differentiators," he said, noting that violet-colored eyes become a rare trait that genetically engineered humans find especially attractive in the series.</p><p>But what about sexual relationships between genetically engineered humans and "normal" people? In the "Genetic Pressure" series, many "normal" people want to have kids with (or at least have sex with) genetically engineered humans. But a minority of engineered humans oppose breeding with "normal" people, and this leads to an ideology that considers engineered humans to be racially supreme. </p>
Regulating designer babies<p>On a policy level, there are many open questions about how governments might legislate a world with designer babies. But it's not totally new territory, considering the West's dark history of eugenics experiments.</p><p>In the 20th century, the U.S. conducted multiple eugenics programs, including immigration restrictions based on genetic inferiority and forced sterilizations. In 1927, for example, the Supreme Court ruled that forcibly sterilizing the mentally handicapped didn't violate the Constitution. Supreme Court Justice Oliver Wendall Holmes wrote, "… three generations of imbeciles are enough." </p><p>After the Holocaust, eugenics programs became increasingly taboo and regulated in the U.S. (though some states continued forced sterilizations <a href="https://www.uvm.edu/~lkaelber/eugenics/" target="_blank">into the 1970s</a>). In recent years, some policymakers and scientists have expressed concerns about how gene-editing technologies could reanimate the eugenics nightmares of the 20th century. </p><p>Currently, the U.S. doesn't explicitly ban human germline genetic editing on the federal level, but a combination of laws effectively render it <a href="https://academic.oup.com/jlb/advance-article/doi/10.1093/jlb/lsaa006/5841599#204481018" target="_blank" rel="noopener noreferrer">illegal to implant a genetically modified embryo</a>. Part of the reason is that scientists still aren't sure of the unintended consequences of new gene-editing technologies. </p><p>But there are also concerns that these technologies could usher in a new era of eugenics. After all, the function of a designer baby industry, like the one in the "Genetic Pressure" series, wouldn't necessarily be limited to eliminating genetic diseases; it could also work to increase the occurrence of "desirable" traits. </p><p>If the industry did that, it'd effectively signal that the <em>opposites of those traits are undesirable. </em>As the International Bioethics Committee <a href="https://academic.oup.com/jlb/advance-article/doi/10.1093/jlb/lsaa006/5841599#204481018" target="_blank" rel="noopener noreferrer">wrote</a>, this would "jeopardize the inherent and therefore equal dignity of all human beings and renew eugenics, disguised as the fulfillment of the wish for a better, improved life."</p><p><em>"Genetic Pressure Volume I: Baby Steps"</em><em> by Eugene Clark is <a href="http://bigth.ink/38VhJn3" target="_blank">available now.</a></em></p>
A leading British space scientist thinks there is life under the ice sheets of Europa.
- A British scientist named Professor Monica Grady recently came out in support of extraterrestrial life on Europa.
- Europa, the sixth largest moon in the solar system, may have favorable conditions for life under its miles of ice.
- The moon is one of Jupiter's 79.
Neil deGrasse Tyson wants to go ice fishing on Europa<div class="rm-shortcode" data-media_id="GLGsRX7e" data-player_id="FvQKszTI" data-rm-shortcode-id="f4790eb8f0515e036b24c4195299df28"> <div id="botr_GLGsRX7e_FvQKszTI_div" class="jwplayer-media" data-jwplayer-video-src="https://content.jwplatform.com/players/GLGsRX7e-FvQKszTI.js"> <img src="https://cdn.jwplayer.com/thumbs/GLGsRX7e-1920.jpg" class="jwplayer-media-preview" /> </div> <script src="https://content.jwplatform.com/players/GLGsRX7e-FvQKszTI.js"></script> </div>
Water Vapor Above Europa’s Surface Deteced for First Time<span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="9c4abc8473e1b89170cc8941beeb1f2d"><iframe type="lazy-iframe" data-runner-src="https://www.youtube.com/embed/WQ-E1lnSOzc?rel=0" width="100%" height="auto" frameborder="0" scrolling="no" style="position:absolute;top:0;left:0;width:100%;height:100%;"></iframe></span>
Scientists discover burrows of giant predator worms that lived on the seafloor 20 million years ago.
- Scientists in Taiwan find the lair of giant predator worms that inhabited the seafloor 20 million years ago.
- The worm is possibly related to the modern bobbit worm (Eunice aphroditois).
- The creatures can reach several meters in length and famously ambush their pray.
A three-dimensional model of the feeding behavior of Bobbit worms and the proposed formation of Pennichnus formosae.
Credit: Scientific Reports
Beware the Bobbit Worm!<span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="1f9918e77851242c91382369581d3aac"><iframe type="lazy-iframe" data-runner-src="https://www.youtube.com/embed/_As1pHhyDHY?rel=0" width="100%" height="auto" frameborder="0" scrolling="no" style="position:absolute;top:0;left:0;width:100%;height:100%;"></iframe></span>
The idea behind the law was simple: make it more difficult for online sex traffickers to find victims.
- SESTA (Stop Enabling Sex Traffickers Act) and FOSTA (Allow States and Victims to Fight Online Sex Trafficking Act) started as two separate bills that were both created with a singular goal: curb online sex trafficking. They were signed into law by former President Trump in 2018.
- The implementation of this law in America has left an international impact, as websites attempt to protect themselves from liability by closing down the sections of their sites that sex workers use to arrange safe meetings with clientele.
- While supporters of this bill have framed FOSTA-SESTA as a vital tool that could prevent sex trafficking and allow sex trafficking survivors to sue those websites for facilitating their victimization, many other people are strictly against the bill and hope it will be reversed.
What is FOSTA-SESTA?<span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="723125b44601d565a7c671c7523b6452"><iframe type="lazy-iframe" data-runner-src="https://www.youtube.com/embed/WBaqDjPCH8k?rel=0" width="100%" height="auto" frameborder="0" scrolling="no" style="position:absolute;top:0;left:0;width:100%;height:100%;"></iframe></span><p>SESTA (Stop Enabling Sex Traffickers Act) and FOSTA (Allow States and Victims to Fight Online Sex Trafficking Act) were signed into law by former President Trump in 2018. There was some argument that this law may be unconstitutional as it could potentially violate the <a href="https://constitution.congress.gov/constitution/amendment-1/" target="_blank">first amendment</a>. A criminal defense lawyer explains this law in-depth in <a href="https://www.youtube.com/watch?v=RoWx2hYg5uo&t=38s" target="_blank" rel="nofollow">this video</a>. </p><p><strong>What did FOSTA-SESTA aim to accomplish?</strong></p><p>The idea behind the law was simple: make it more difficult for online sex traffickers to find victims. FOSTA-SESTA started as two separate bills that were both created with a singular goal: curb online sex trafficking. Targeting websites like Backpage and Craigslist, where sex workers would often arrange meetings with their clientele, FOSTA-SESTA aimed to stop the illegal sex-trafficking activity being conducted online. While the aim of FOSTA-SESTA was to keep people safer, these laws have garnered international speculation and have become quite controversial. </p><p><a href="https://www.businesswire.com/news/home/20180321006214/en/National-Anti-Trafficking-Coalition-Celebrates-Survivors-Senate-Passes" target="_blank" rel="noopener noreferrer">According to BusinessWire</a>, many people are in support of this bill, including the National Center for Missing and Exploited Children and World Without Exploitation (WorldWE). </p><p>"With the growth of the Internet, human trafficking that once happened mainly on street corners has largely shifted online. According to the National Center for Missing & Exploited Children, 73 percent of the 10,000 child sex trafficking reports it receives from the public each year involve ads on the website Backpage.com."</p><p>As soon as this bill was <a href="https://www.pivotlegal.org/sesta_fosta_censoring_sex_workers_from_websites_sets_a_dangerous_precedent" target="_blank" rel="noopener noreferrer">signed into law</a>, websites where sex workers often vetted and arranged meetings with their clients could now be held liable for the actions of the millions of people that used their sites. This meant websites could be prosecuted if they engaged in "the promotion or facilitation of prostitution" or "facilitate traffickers in advertising the sale of unlawful sex acts with sex trafficking victims." </p><p><strong>The bill's effects were felt around the world — from Canadians being unhappy with the impact of this American bill to U.K. politicians considering the implementation of similar laws in the future.</strong> </p><p>Heather Jarvis, the program coordinator of the Safe Harbour Outreach Project (SHOP), which supports sex workers in the St. John's area, <a href="https://www.cbc.ca/news/canada/newfoundland-labrador/heather-jarvis-website-shutdown-1.4667018" target="_blank" rel="noopener noreferrer">explained to CBC in an interview</a> that the American bill is impacting everyone, everywhere: "When laws impact the internet — the internet is often borderless — it often expands across different countries. So although these are laws in the United States, what we've seen is they've been shutting down websites in Canada and other countries as well."</p><p>Jarvis suggests in her interview that instead of doing what they aimed to do with the bill and improving the safety of victims of sex trafficking or sexual exploitation, the website shutdowns are actually making sex workers less safe. </p><p>While <a href="https://gizmodo.com/the-uk-wants-its-own-version-of-fosta-sesta-that-could-1827420794" target="_blank" rel="noopener noreferrer">one U.K. publication</a> refers to FOSTA-SESTA as "well-intentioned but ultimately deeply-flawed laws," it also mentions that politicians in the United Kingdom are hoping to pursue similar laws in the near future. </p>
Has FOSTA-SESTA done more harm than good?<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yNTUxMzY5Ny9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY2ODUyNDc4OX0.dSEEzcflJJUTnUCFmuwmPAIA0f754eW7rN8x6L7fcCc/img.jpg?width=1245&coordinates=-68%2C595%2C-68%2C595&height=700" id="69d99" class="rm-shortcode" data-rm-shortcode-id="734759fa254b5a33777536e0b4d7b511" data-rm-shortcode-name="rebelmouse-image" alt="sex worker looking online for a job" data-width="1245" data-height="700" />
Is this really going to help, or is this bill simply pushing sex work and sex-related content further into the dark?
Credit: Евгений Вершинин on Adobe Stock<p>While <a href="https://www.businesswire.com/news/home/20180321006214/en/National-Anti-Trafficking-Coalition-Celebrates-Survivors-Senate-Passes" target="_blank">supporters of this bill</a> have framed FOSTA-SESTA as a vital tool that could prevent sex trafficking and allow sex trafficking survivors to sue those websites for facilitating their victimization, many other people are strictly against the bill and hope it will be reversed.</p><p><strong>One of the biggest problems many people have with this bill is that it forces sex workers into an even more dangerous situation, which is quite the opposite of what the bill had intended to do.</strong> </p><p>According to <a href="https://www.theglobeandmail.com/canada/article-anti-trafficking-activists-cheer-but-sex-workers-bemoan-shutdown-of/" target="_blank" rel="noopener noreferrer">Globe and Mail</a>, there has been an upswing in pimps sending sex workers messages that promise work - which puts sex workers on the losing end of a skewed power-dynamic, when before they could attempt to safely arrange their own meetings online. </p><p><strong>How dangerous was online sex work before FOSTA-SESTA? </strong></p><p><a href="https://www.beyond-the-gaze.com/wp-content/uploads/2018/01/BtGbriefingsummaryoverview.pdf" target="_blank" rel="noopener noreferrer">The University of Leicester Department of Criminology</a> conducted an online survey that focused on the relative safety of internet-based sex work compared with outdoor sex work. According to the results, 91.6 percent of participants had not experienced a burglary in the past 5 years, 84.4 percent had not experienced physical assault in the same period, and only 5 percent had experienced physical assault in the last 12 months. </p><p><a href="https://www.pivotlegal.org/sesta_fosta_censoring_sex_workers_from_websites_sets_a_dangerous_precedent" target="_blank" rel="noopener noreferrer">PivotLegal</a> expresses concerns about this: "It is resoundingly clear, both from personal testimony and data, that attacking online sex work is an assault on the health and safety of people in the real world. In a darkly ironic twist, SESTA/FOSTA, legislation aimed at protecting victims of and preventing human trafficking for the purposes of sexual exploitation, will do the exact opposite."</p><p><strong>Websites are also being hypervigilant (and censoring more content than needed) because they can't possibly police every single user's activity on their platform.</strong> </p><p>Passing this bill meant any website (not just the ones that are commonly used by sex traffickers) could be held liable for their user's posts. Naturally, this saw a general "tightening of the belt" when it came to what was allowed on various platforms. In late 2018, shortly after the FOSTA-SESTA bill was passed, companies like Facebook slowly began to alter their terms and conditions to protect themselves. </p><p>Facebook notably added sections that express prohibited certain sexual content and messages:</p><p style="margin-left: 20px;"><em>"Content that includes an implicit invitation for sexual intercourse, which can be described as naming a sexual act and other suggestive elements including (but not limited to):</em></p><p style="margin-left: 20px;"><em>– vague suggestive statements such as: 'looking forward to an enjoyable evening'</em></p><p style="margin-left: 20px;"><em>– sexual use of language […]</em></p><p style="margin-left: 20px;"><em>– content (self-made, digital or existing) that possibly portrays explicit sexual acts or a suggestively positioned person/suggestively positioned persons."<br><br> </em></p><p>Additionally, sections like this were also added, prohibiting things that could allude to sexual activity: </p><p style="margin-left: 20px;"><em>"Content in which other acts committed by adults are requested or offered, such as:</em></p><p style="margin-left: 20px;"><em>– commercial pornography</em></p><p style="margin-left: 20px;"><em>– partners that share fetishes or sexual interests"</em></p><p>Facebook wasn't the only website to crack down on their policies — the Craigslist classifieds section being removed and Reddit banned quite a large number of sex-worker related subreddits. </p><p><strong>Is FOSTA-SESTA really helpful?</strong> </p><p>This is the question many people are facing with the FOSTA-SESTA acts being passed just a few years ago. Is this really going to help, or is this bill simply pushing sex work and sex-related content further into the dark? Opinions seem to be split down the middle on this — what do you think?</p>