FDA Grants 'Breakthrough Therapy' Status to Psychoactive Psilocybin Mushrooms, Says Startup
By Dan Nosowitz
Various parts of the cannabis plant have already received full FDA approval; a drug consisting of cannabidiol, better known as CBD, has already been approved to treat two rare forms of epilepsy. Researchers have been pushing for years for relaxed legal status to study the possible medicinal benefits of hallucinogenic drugs, and now the FDA has given psilocybin—magic mushrooms—a conditional form of research approval, according to Compass Pathways, the company granted that approval.
Allowing researchers to study the effects of otherwise banned substances is tricky; the DEA's legal definition of schedule 1 drugs requires that they have "no accepted medical use." That's an immediate barrier to study, and also throws the drug into question if an "accepted medical use" is discovered. Can the drug even be a schedule 1 drug in that case? The DEA has generally refused to remove substances from the list, regardless of research, though CBD—which is not psychoactive at all—was recently rescheduled.
Anyway! Psilocybin has been casually used both recreationally and medicinally for decades, and international studies have indicated that controlled, somewhat low-level doses of psilocybin can be useful in treating depression. Earlier this month, researchers at Johns Hopkins wrote an analysis of existing studies, recommending that psilocybin be re-classified to enable more thorough study.
Compass Pathways says they have received designation as a Breakthrough Therapy treatment. That's the official name (rather than a hype-filled description) for an FDA program designed to expedite the approval process for drugs that have proved promising in treating serious conditions. As part of that designation, Compass Pathways will be able to conduct the largest North American clinical trial of psilocybin ever done: 216 patients with treatment-resistant depression.
From an agricultural perspective, growing psilocybin mushrooms is not particularly difficult, and guides abound online. But these mushrooms are not legally grown at any reasonable scale, and it's proved insanely expensive to buy approved psilocybin extract. This Quartz piece reveals that it can take up to a year for researchers to actually get their needed material, and that the price per gram can reach 13 times the street value. Compass Pathways actually grows their own and provides it at no charge to other researchers, because it can be so hard to get.
But this preliminary FDA approval, though very far from anything like decriminalization, might edge that door open a bit more for researchers who want to find out if psilocybin actually can help people.
Reposted with permission from our media associate Modern Farmer.
Many people shop online for everything from clothes to appliances. If they do not like the product, they simply return it. But there's an environmental cost to returns.
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EcoWatch Daily Newsletter
By Dolf Gielen and Morgan Bazilian
John Kerry helped bring the world into the Paris climate agreement and expanded America's reputation as a climate leader. That reputation is now in tatters, and President-elect Joe Biden is asking Kerry to rebuild it again – this time as U.S. climate envoy.
Energy Is at the Center of the Climate Challenge<p>The <a href="https://science2017.globalchange.gov/chapter/1/" target="_blank">effects of climate change</a> are already evident across the globe, from <a href="https://theconversation.com/100-degrees-in-siberia-5-ways-the-extreme-arctic-heat-wave-follows-a-disturbing-pattern-141442" target="_blank">extreme heat waves</a> to <a href="https://science2017.globalchange.gov/chapter/12/" target="_blank">sea level rise</a>. But while the challenge is daunting, there is hope. Solar and wind power have become the <a href="https://www.irena.org/publications/2020/Jun/Renewable-Power-Costs-in-2019" target="_blank">cheapest forms of power generation globally</a>, and technology progress and innovation continue apace to support a transition to clean energy.</p><p>In the U.S. under a Biden administration, long-term national climate legislation will depend on who controls the Senate, and that won't be clear until after two run-off elections in Georgia in January.</p><p>But there is no shortage of <a href="https://www.bloomberg.com/features/2020-biden-climate-change-advice/" target="_blank">ideas for ways Biden</a> could still take action even if his proposals are blocked in Congress. For example, he could use executive orders and direct government agencies to tighten regulations on greenhouse gas emissions; increase research and development in clean energy technologies; and empower states to exceed national standards, <a href="https://www.reuters.com/article/us-autos-emissions-california/defying-trump-california-locks-in-vehicle-emission-deals-with-major-automakers-idUSKCN25D2CH" target="_blank" rel="noopener noreferrer">as California did in the past with auto emission standards</a>. A focus on a just and equitable transition for communities and people affected by the decline of fossil fuels will also be key to creating a sustainable transition.</p><p>The U.S. position as the world's largest oil and gas producer and consumer creates political challenges for any administration. U.S. forays into European energy security are often treated with suspicion. Recently, France blocked <a href="https://www.wsj.com/articles/frances-engie-backs-out-of-u-s-lng-deal-11604435609" target="_blank">a multi-billion dollar contract</a> to buy U.S. liquefied natural gas because of concerns about limited emissions regulations in Texas.</p><p>Strengthening cooperation and partnerships with like-minded countries will be critical to bring about a transition to cleaner energy as well as sustainability in agriculture, forestry, water and other sectors of the global economy.</p>
Creating a Global Sustainable Transition<p>How the world recovers from COVID-19's economic damage could help drive a lasting shift in the global energy mix.</p><p>Nearly one-third of Europe's US$2 trillion economic relief package <a href="https://www.bloomberg.com/news/articles/2020-07-21/eu-approves-biggest-green-stimulus-in-history-with-572-billion-plan" target="_blank" rel="noopener noreferrer">involves investments that are also good for the climate</a>. The European Union is also strengthening its 2030 climate targets, though each country's energy and climate plans will be critical for successfully implementing them. The <a href="https://joebiden.com/clean-energy/" target="_blank" rel="noopener noreferrer">Biden plan</a> – including a $2 trillion commitment to developing sustainable energy and infrastructure – is aligned with a global energy transition, but its implementation is also uncertain.</p><p>Once Biden takes office, Kerry will be joining ongoing <a href="https://www.un.org/en/conferences/energy2021/about#:%7E:text=The%20overarching%20goal%20of%20the,2030%20Agenda%20for%20Sustainable%20Development.&text=Accelerate%20delivery%20of%20United%20Nations,related%20issues%20at%20all%20levels." target="_blank" rel="noopener noreferrer">high-level discussions on the energy transition</a> at the U.N. General Assembly and other gatherings of international leaders. With the U.S. no longer obstructing work on climate issues, the G-7 and G-20 have more potential for progress on energy and climate.</p><p>Lots of technical details still need to be worked out, including international trade frameworks and standards that can help countries lower greenhouse gas emissions enough to keep global warming in check. <a href="https://www.carbonpricingleadership.org/what" target="_blank" rel="noopener noreferrer">Carbon pricing</a> and <a href="https://www.csis.org/analysis/how-can-europe-get-carbon-border-adjustment-right" target="_blank" rel="noopener noreferrer">carbon border adjustment taxes</a>, which create incentive for companies to reduce emissions, may be part of it. A consistent and comprehensive set of national energy transition plans will also be needed.</p><p>The global shift to <a href="https://www.irena.org/publications/2019/Jan/A-New-World-The-Geopolitics-of-the-Energy-Transformation" target="_blank">clean energy will also have geopolitical implications for countries and regions</a>, and this will have a profound impact on wider international relations. Kerry, with his experience as secretary of state in the Obama administration, and Biden's plan to make the climate envoy position part of the National Security Council, may help mend these relations. In doing so, the U.S. may again join the wider community of countries willing to lead.</p>
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By Maria Caffrey
As we approach the holidays I, like most people, have been reflecting on everything 2020 has given us (or taken away) while starting to look ahead to 2021.
We Need More Than Listening<p>By now we have all become sadly accustomed to the current administration sidelining scientists, most prominently Dr. Anthony Fauci, because the facts they provide do not fit with the political rhetoric of the moment.</p><p>I have <a href="https://www.csldf.org/2019/08/22/csldf-helps-climate-scientist-maria-caffrey-fight-for-scientific-integrity/" target="_blank">my own history</a> of filing a scientific integrity complaint with the National Park Service (which falls under the Department of the Interior) after senior ranking employees attempted to censor one of my scientific reports. I know all too well the damage and pain that these actions cause, not just for the individual scientist, but also because these <a href="https://www.ucsusa.org/resources/attacks-on-science" target="_blank" rel="noopener noreferrer">attacks on science</a> over the last few years have undermined sound, evidence-based decision making.</p><p>President-elect Biden has repeatedly said that he will <a href="https://thehill.com/homenews/521638-trump-biden-will-listen-to-the-scientists-if-elected" target="_blank" rel="noopener noreferrer">listen to the scientists</a>. While this is certainly a welcome change, listening can only take us so far. This past week Lauren Kurtz from the <a href="https://www.csldf.org/" target="_blank" rel="noopener noreferrer">Climate Science Legal Defense Fund</a> and my colleague <a href="https://www.ucsusa.org/about/people/gretchen-goldman" target="_blank" rel="noopener noreferrer">Gretchen Goldman</a> published <a href="https://www.scientificamerican.com/article/ten-steps-that-can-restore-scientific-integrity-in-government/" target="_blank" rel="noopener noreferrer">an article</a> listing 10 actions the new administration should implement to show their commitment to strengthening government science:</p><ol><li>Clearly prohibit political interference and censorship.</li><li>Protect scientists' communication rights.</li><li>Acknowledge that attempts to violate scientific integrity, even if ultimately not fruitful, are still violations.</li><li>Protect federal scientists' right to provide information to Congress and other lawmakers.</li><li>Commit to incorporating the best science as part of agency decisions.</li><li>Elevate agency scientific integrity policies to have the full force of law.</li><li>Publicly release anonymized information about scientific integrity complaints and their resolutions at every agency.</li><li>Institute an intra-agency workforce, potentially under the White House <a href="https://www.ucsusa.org/sites/default/files/2020-09/strengthening-science-and-si-at-ostp.pdf" target="_blank" rel="noopener noreferrer">Office of Science and Technology Policy</a>, to coordinate scientific integrity efforts across agencies, foster discussion of policy improvements, and standardize criteria for policies across agencies.</li><li>Strengthen whistleblower protections.</li><li>Ensure that policies cover all actors who will be dealing with science.</li></ol>
Time for Action<p>I have spoken to many scientists, particularly federal scientists, who are eager to turn the page so they can hurry back to the work they had been doing before this administration, but I urge caution in assuming that things can be "normal" again.</p><p>Before Trump, I naively thought the scientific integrity policies established during the <a href="https://obamawhitehouse.archives.gov/blog/2016/12/19/scientific-integrity-policies-update" target="_blank">Obama administration</a> would be sufficient. I never imagined that any administration could so willfully ignore and attack expert advice and evidence that is intended to protect us and our public lands.</p><p>I have personally witnessed how hard our federal scientists work. They put in long hours with minimal pay (far less that what they could get if they worked in private industry) to pursue one simple goal: to make things better for the nation.</p><p>We need stronger scientific integrity policies to protect these people and their work. But more than that, we need stronger scientific integrity laws because they also benefit society.</p>
By Andrea Germanos
Environmental campaigners stressed the need for the incoming Biden White House to put in place permanent protections for Alaska's Bristol Bay after the Trump administration on Wednesday denied a permit for the proposed Pebble Mine that threatened "lasting harm to this phenomenally productive ecosystem" and death to the area's Indigenous culture.
<div id="da98c" class="rm-shortcode" data-rm-shortcode-id="478a197b7c59c92787c92bec92f1ac39"><blockquote class="twitter-tweet twitter-custom-tweet" data-twitter-tweet-id="1331662923710693376" data-partner="rebelmouse"><div style="margin:1em 0">Bristol Bay forever, Pebble mine never. #NoPebbleMine #SaveBristolBay https://t.co/CBQ9zuy8A5</div> — Save Bristol Bay (@Save Bristol Bay)<a href="https://twitter.com/SaveBristolBay/statuses/1331662923710693376">1606328156.0</a></blockquote></div>
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OlgaMiltsova / iStock / Getty Images Plus
By Gwen Ranniger
In the midst of a pandemic, sales of cleaning products have skyrocketed, and many feel a need to clean more often. Knowing what to look for when purchasing cleaning supplies can help prevent unwanted and dangerous toxics from entering your home.