Saturday, May 4, 2019
Killer Asteroid Flattens New York in Simulation Exercise
After devastating the French Riviera in 2013, destroying Dhaka in 2015 and saving Tokyo in 2017, an international asteroid impact simulation ended Friday with its latest disaster—New York in ruins.
Despite a simulated eight years of preparation, scientists and engineers tried but failed to deflect the killer asteroid.
The exercise has become a regular event among the international community of "planetary defense" experts.
The latest edition began Monday near Washington, with the following alert: an asteroid roughly 100 to 300 meters (330 to 1,000 feet) in diameter had been spotted and according to rough calculations had a one percent chance of hitting the Earth on April 29, 2027.
Each day during the conference, some 200 astronomers, engineers and emergency response specialists received new information, made decisions and awaited further updates from the organizers of the game, designed by a NASA aerospace engineer.
As fictional months ticked by in the simulation, the probability of the giant space rock crashing into Earth rose to 10 percent—and then to 100 percent.
NASA launched a probe in 2021 to examine the threat up close. In December that year, astronomers confirmed it was headed straight to the Denver area and that the western US city would be destroyed.
The major space powers of the United States, Europe, Russia, China and Japan decided to build six "kinetic impactors"—probes meant to hit the asteroid to change its trajectory.
It took time to build the impactors and wait for the right launch window. The impacts were set for August 2024.
Three impactors managed to hit the asteroid. The main body was deflected, but a smaller fragment broke off and continued on a deadly path, this time towards the eastern US.
Washington considered sending a nuclear bomb to deflect the 60-meter rock—repeating a successful strategy that saved Tokyo last year—but it was crippled by political disagreements.
All that remained was to prepare for impact.
With six months to go, experts could only predict that the asteroid was headed to the New York area. With two months to go, it is confirmed the city will be destroyed.
Evacuation!
The asteroid will enter the atmosphere at a blistering 69,000 kilometers per hour (43,000 miles per hour) and explode 15 kilometers (9.3 miles) above Central Park.
The energy of the blast will be 1,000 times that of the nuclear bomb dropped on Hiroshima.
It will destroy everything within a 15 kilometer "unsurvivable" radius, scientists said.
Manhattan will be completely razed. Windows as far as 45 kilometers away will shatter and damage will extend as far out as 68 kilometers from the epicenter.
The questions raised by the scenario were endless.
How do authorities evacuate ten million people? Moving people to safety from hurricanes has shown the task's difficulty.
"Two months may not be enough time to really evacuate, because you're evacuating people who are stuck, who have to rebuild their lives where they're going. You're going to have fleets of U-hauls," said Brandy Johnson, an "angry citizen" in the exercise, referring to the rental moving trucks.
Who will pay? Who will host those displaced? How will authorities protect everything from nuclear and chemical installations to works of art?
And how will citizens behave in the face of an end-of-the-world scenario?
"If you knew your home was going to be destroyed six months from now, and that you weren't going back again, would you keep paying your mortgage?" asked Victoria Andrews, NASA's deputy planetary defense officer.
by Ivan Couronne, Phys.org | Read more:
Image: Asteroid Bennu/NASA
Despite a simulated eight years of preparation, scientists and engineers tried but failed to deflect the killer asteroid.
The exercise has become a regular event among the international community of "planetary defense" experts.The latest edition began Monday near Washington, with the following alert: an asteroid roughly 100 to 300 meters (330 to 1,000 feet) in diameter had been spotted and according to rough calculations had a one percent chance of hitting the Earth on April 29, 2027.
Each day during the conference, some 200 astronomers, engineers and emergency response specialists received new information, made decisions and awaited further updates from the organizers of the game, designed by a NASA aerospace engineer.
As fictional months ticked by in the simulation, the probability of the giant space rock crashing into Earth rose to 10 percent—and then to 100 percent.
NASA launched a probe in 2021 to examine the threat up close. In December that year, astronomers confirmed it was headed straight to the Denver area and that the western US city would be destroyed.
The major space powers of the United States, Europe, Russia, China and Japan decided to build six "kinetic impactors"—probes meant to hit the asteroid to change its trajectory.
It took time to build the impactors and wait for the right launch window. The impacts were set for August 2024.
Three impactors managed to hit the asteroid. The main body was deflected, but a smaller fragment broke off and continued on a deadly path, this time towards the eastern US.
Washington considered sending a nuclear bomb to deflect the 60-meter rock—repeating a successful strategy that saved Tokyo last year—but it was crippled by political disagreements.
All that remained was to prepare for impact.
With six months to go, experts could only predict that the asteroid was headed to the New York area. With two months to go, it is confirmed the city will be destroyed.
Evacuation!
The asteroid will enter the atmosphere at a blistering 69,000 kilometers per hour (43,000 miles per hour) and explode 15 kilometers (9.3 miles) above Central Park.
The energy of the blast will be 1,000 times that of the nuclear bomb dropped on Hiroshima.
It will destroy everything within a 15 kilometer "unsurvivable" radius, scientists said.
Manhattan will be completely razed. Windows as far as 45 kilometers away will shatter and damage will extend as far out as 68 kilometers from the epicenter.
The questions raised by the scenario were endless.
How do authorities evacuate ten million people? Moving people to safety from hurricanes has shown the task's difficulty.
"Two months may not be enough time to really evacuate, because you're evacuating people who are stuck, who have to rebuild their lives where they're going. You're going to have fleets of U-hauls," said Brandy Johnson, an "angry citizen" in the exercise, referring to the rental moving trucks.
Who will pay? Who will host those displaced? How will authorities protect everything from nuclear and chemical installations to works of art?
And how will citizens behave in the face of an end-of-the-world scenario?
"If you knew your home was going to be destroyed six months from now, and that you weren't going back again, would you keep paying your mortgage?" asked Victoria Andrews, NASA's deputy planetary defense officer.
by Ivan Couronne, Phys.org | Read more:
Image: Asteroid Bennu/NASA
Friday, May 3, 2019
Stop Crushing on the Generals
The two-star army general strode across the stage in his rumpled combat fatigues, almost like George Patton—all that was missing was the cigar and riding crop. It was 2017 and I was in the audience, just another mid-level major attending yet another mandatory lecture in the auditorium of the Command and General Staff College at Fort Leavenworth, Kansas.
The general then commanded one of the Army’s two true armored divisions and had plenty of his tanks forward deployed in Eastern Europe, all along the Russian frontier. Frankly, most CGSC students couldn’t stand these talks. Substance always seemed lacking, as each general reminded us to “take care of soldiers” and “put the mission first,” before throwing us a few nuggets of conventional wisdom on how to be good staff officers should we get assigned to his vaunted command.
This time, though, the general got to talking about Russia. So I perked up. He made it crystal clear that he saw Moscow as an adversary to be contained, checked, and possibly defeated. There was no nuance, no self-reflection, not even a basic understanding of the general complexity of geopolitics in the 21st century. Generals can be like that—utterly “in-the-box,” “can-do” thinkers. They take pride in how little they discuss policy and politics, even when they command tens of thousands of troops and control entire districts, provinces, or countries. There is some value in this—we’d hardly want active generals meddling in U.S. domestic affairs. But they nonetheless can take the whole “aw shucks” act a bit too far.
General It-Doesn’t-Matter-His-Name thundered that we need not worry, however, because his tanks and troops could “mop the floor” with the Russians, in a battle that “wouldn’t even be close.” It was oh-so-typical, another U.S. Army general—who clearly longs for the Cold War fumes that defined his early career—overestimating the Russian menace and underestimating Russian military capability. Of course, it was all cloaked in the macho bravado so common among generals who think that talking like sergeants will win them street cred with the troops. (That’s not their jobanymore, mind you.) He said nothing, of course, about the role of mid- and long-range nuclear weapons that could be the catastrophic consequence of an unnecessary war with the Russian Bear.
I got to thinking about that talk recently as I reflected in wonder at how the latest generation of mainstream “liberals” loves to fawn over generals, admirals—any flag officers, really—as alternatives to President Donald Trump. The irony of that alliance should not be lost on us. It’s built on the standard Democratic fear of looking “soft” on terrorism, communism, or whatever-ism, and their visceral, blinding hatred of Trump. Some of this is understandable. Conservative Republicans masterfully paint liberals as “weak sisters” on foreign policy, and Trump’s administration is, well, a wild card in world affairs.
The problem with the vast majority of generals, however, is that they don’t think strategically. What they call strategy is really large-scale operations—deploying massive formations and winning campaigns replete with battles. Many remain mired in the world of tactics, still operating like lieutenants or captains and proving the Peter Principle right, as they get promoted past their respective levels of competence.
If America’s generals, now and over the last 18 years, really were strategic thinkers, they’d have spoken out about—and if necessary resigned en masse over—mission sets that were unwinnable, illegal (in the case of Iraq), and counterproductive. Their oath is to the Constitution, after all, not Emperors Bush, Obama, and Trump. Yet few took that step. It’s all symptomatic of the disease of institutionalized intellectual mediocrity. More of the same is all they know: their careers were built on fighting “terror” anywhere it raised its evil head. Some, though no longer most, still subscribe to the faux intellectualism of General Petraeus and his legion of Coindinistas, who never saw a problem that a little regime change, followed by expert counterinsurgency, couldn’t solve. Forget that they’ve been proven wrong time and again and can count zero victories since 2002. Generals (remember this!) are never held accountable.
Flag officers also rarely seem to recognize that they owe civilian policymakers more than just tactical “how” advice. They ought to be giving “if” advice—if we invade Iraq, it will take 500,000 troops to occupy the place, and even then we’ll ultimately destabilize the country and region, justify al-Qaeda’s worldview, kick off a nationalist insurgency, and become immersed in an unwinnable war. Some, like Army Chief General Eric Shinseki and CENTCOM head John Abizaid, seemed to know this deep down. Still, Shinseki quietly retired after standing up to Secretary of Defense Donald Rumsfeld, and Abizaid rode out his tour to retirement.
Generals also love to tell the American people that victory is “just around the corner,” or that there’s a “light at the end of the tunnel.” General William Westmoreland used the very same language when predicting imminent victory in Vietnam. Two months later, the North Vietnamese and Vietcong unleashed the largest uprising of the war, the famed Tet Offensive.
Take Afghanistan as exhibit A: 17 or so generals have now commanded U.S. troops in this, America’s longest war. All have commanded within the system and framework of their predecessors. Sure, they made marginal operational and tactical changes—some preferred surges, others advising, others counterterror—but all failed to achieve anything close to victory, instead laundering failure into false optimism. None refused to play the same-old game or question the very possibility of victory in landlocked, historically xenophobic Afghanistan. That would have taken real courage, which is in short supply among senior officers.
Exhibit B involves Trump’s former cabinet generals—National Security Advisor H.R. McMaster, Chief of Staff John Kelley, and Defense Secretary Jim Mattis—whom adoring and desperate liberals took as saviors and canonized as the supposed adults in the room. They were no such thing. The generals’ triumvirate consisted ultimately of hawkish conventional thinkers married to the dogma of American exceptionalism and empire. Period.
Let’s start with Mattis. “Mad Dog” Mattis was so anti-Iran and bellicose in the Persian Gulf that President Barack Obama removed him from command of CENTCOM. Furthermore, the supposedly morally untainted, “intellectual” “warrior monk” chose, when he finally resigned, to do so in response to Trump’s altogether reasonable call for a modest troop withdrawal from Afghanistan and Syria. Helping Saudi Arabia terror bomb Yemen and starve 85,000 children to death? Mattis rebuked Congress and supported that. He never considered resigning in opposition to that war crime. No, he fell on his “courageous” sword over downgrading a losing 17-year-old war in Afghanistan. Not to mention he came to Trump’s cabinet straight from the board of contracting giant General Dynamics, where he collected hundreds of thousands of military-industrial complex dollars.
Then there was John Kelley, whom Press Secretary Sarah Sanders implied was above media questioning because he was once a four-star marine general. And there’s McMaster, another lauded intellectual who once wrote an interesting book and taught history at West Point. Yet he still drew all the wrong conclusions in his famous book on Vietnam—implying that more troops, more bombing, and a mass invasion of North Vietnam could have won the war. Furthermore, his work with Mattis on Trump’s unhinged, imperial National Defense Strategy proved that he was, after all, just another devotee of American hyper-interventionism.
So why reflect on these and other Washington generals? It’s simple: liberal veneration for these, and seemingly all, military flag officers is a losing proposition and a formula for more intervention, possible war with other great powers, and the creeping militarization of the entire U.S. government. We know what the generals expect—and potentially want—for America’s foreign policy future.
by Danny Sjursen, The American Conservative | Read more:
Image: Sgt. Mallory S. VanderSchans HQMC Combat Camera/Released
The general then commanded one of the Army’s two true armored divisions and had plenty of his tanks forward deployed in Eastern Europe, all along the Russian frontier. Frankly, most CGSC students couldn’t stand these talks. Substance always seemed lacking, as each general reminded us to “take care of soldiers” and “put the mission first,” before throwing us a few nuggets of conventional wisdom on how to be good staff officers should we get assigned to his vaunted command.
This time, though, the general got to talking about Russia. So I perked up. He made it crystal clear that he saw Moscow as an adversary to be contained, checked, and possibly defeated. There was no nuance, no self-reflection, not even a basic understanding of the general complexity of geopolitics in the 21st century. Generals can be like that—utterly “in-the-box,” “can-do” thinkers. They take pride in how little they discuss policy and politics, even when they command tens of thousands of troops and control entire districts, provinces, or countries. There is some value in this—we’d hardly want active generals meddling in U.S. domestic affairs. But they nonetheless can take the whole “aw shucks” act a bit too far.General It-Doesn’t-Matter-His-Name thundered that we need not worry, however, because his tanks and troops could “mop the floor” with the Russians, in a battle that “wouldn’t even be close.” It was oh-so-typical, another U.S. Army general—who clearly longs for the Cold War fumes that defined his early career—overestimating the Russian menace and underestimating Russian military capability. Of course, it was all cloaked in the macho bravado so common among generals who think that talking like sergeants will win them street cred with the troops. (That’s not their jobanymore, mind you.) He said nothing, of course, about the role of mid- and long-range nuclear weapons that could be the catastrophic consequence of an unnecessary war with the Russian Bear.
I got to thinking about that talk recently as I reflected in wonder at how the latest generation of mainstream “liberals” loves to fawn over generals, admirals—any flag officers, really—as alternatives to President Donald Trump. The irony of that alliance should not be lost on us. It’s built on the standard Democratic fear of looking “soft” on terrorism, communism, or whatever-ism, and their visceral, blinding hatred of Trump. Some of this is understandable. Conservative Republicans masterfully paint liberals as “weak sisters” on foreign policy, and Trump’s administration is, well, a wild card in world affairs.
The problem with the vast majority of generals, however, is that they don’t think strategically. What they call strategy is really large-scale operations—deploying massive formations and winning campaigns replete with battles. Many remain mired in the world of tactics, still operating like lieutenants or captains and proving the Peter Principle right, as they get promoted past their respective levels of competence.
If America’s generals, now and over the last 18 years, really were strategic thinkers, they’d have spoken out about—and if necessary resigned en masse over—mission sets that were unwinnable, illegal (in the case of Iraq), and counterproductive. Their oath is to the Constitution, after all, not Emperors Bush, Obama, and Trump. Yet few took that step. It’s all symptomatic of the disease of institutionalized intellectual mediocrity. More of the same is all they know: their careers were built on fighting “terror” anywhere it raised its evil head. Some, though no longer most, still subscribe to the faux intellectualism of General Petraeus and his legion of Coindinistas, who never saw a problem that a little regime change, followed by expert counterinsurgency, couldn’t solve. Forget that they’ve been proven wrong time and again and can count zero victories since 2002. Generals (remember this!) are never held accountable.
Flag officers also rarely seem to recognize that they owe civilian policymakers more than just tactical “how” advice. They ought to be giving “if” advice—if we invade Iraq, it will take 500,000 troops to occupy the place, and even then we’ll ultimately destabilize the country and region, justify al-Qaeda’s worldview, kick off a nationalist insurgency, and become immersed in an unwinnable war. Some, like Army Chief General Eric Shinseki and CENTCOM head John Abizaid, seemed to know this deep down. Still, Shinseki quietly retired after standing up to Secretary of Defense Donald Rumsfeld, and Abizaid rode out his tour to retirement.
Generals also love to tell the American people that victory is “just around the corner,” or that there’s a “light at the end of the tunnel.” General William Westmoreland used the very same language when predicting imminent victory in Vietnam. Two months later, the North Vietnamese and Vietcong unleashed the largest uprising of the war, the famed Tet Offensive.
Take Afghanistan as exhibit A: 17 or so generals have now commanded U.S. troops in this, America’s longest war. All have commanded within the system and framework of their predecessors. Sure, they made marginal operational and tactical changes—some preferred surges, others advising, others counterterror—but all failed to achieve anything close to victory, instead laundering failure into false optimism. None refused to play the same-old game or question the very possibility of victory in landlocked, historically xenophobic Afghanistan. That would have taken real courage, which is in short supply among senior officers.
Exhibit B involves Trump’s former cabinet generals—National Security Advisor H.R. McMaster, Chief of Staff John Kelley, and Defense Secretary Jim Mattis—whom adoring and desperate liberals took as saviors and canonized as the supposed adults in the room. They were no such thing. The generals’ triumvirate consisted ultimately of hawkish conventional thinkers married to the dogma of American exceptionalism and empire. Period.
Let’s start with Mattis. “Mad Dog” Mattis was so anti-Iran and bellicose in the Persian Gulf that President Barack Obama removed him from command of CENTCOM. Furthermore, the supposedly morally untainted, “intellectual” “warrior monk” chose, when he finally resigned, to do so in response to Trump’s altogether reasonable call for a modest troop withdrawal from Afghanistan and Syria. Helping Saudi Arabia terror bomb Yemen and starve 85,000 children to death? Mattis rebuked Congress and supported that. He never considered resigning in opposition to that war crime. No, he fell on his “courageous” sword over downgrading a losing 17-year-old war in Afghanistan. Not to mention he came to Trump’s cabinet straight from the board of contracting giant General Dynamics, where he collected hundreds of thousands of military-industrial complex dollars.
Then there was John Kelley, whom Press Secretary Sarah Sanders implied was above media questioning because he was once a four-star marine general. And there’s McMaster, another lauded intellectual who once wrote an interesting book and taught history at West Point. Yet he still drew all the wrong conclusions in his famous book on Vietnam—implying that more troops, more bombing, and a mass invasion of North Vietnam could have won the war. Furthermore, his work with Mattis on Trump’s unhinged, imperial National Defense Strategy proved that he was, after all, just another devotee of American hyper-interventionism.
So why reflect on these and other Washington generals? It’s simple: liberal veneration for these, and seemingly all, military flag officers is a losing proposition and a formula for more intervention, possible war with other great powers, and the creeping militarization of the entire U.S. government. We know what the generals expect—and potentially want—for America’s foreign policy future.
by Danny Sjursen, The American Conservative | Read more:
Image: Sgt. Mallory S. VanderSchans HQMC Combat Camera/Released
[ed. Do read the comments. Not sure why the author blames the 'Left' for enabling what most Conservatives accept without reservation. See also: Smedley Butler and the Business Plot.]
Buspirone Shortage in Healthcaristan
There is a national shortage of buspirone.
Buspirone is a 5HT-1 agonist used to control anxiety [ed. trade name: Buspar]. Unlike most psychiatric drugs, it’s in a class of its own – there are no other sole 5HT-1 agonists on the market. It’s not a very strong medication, but it’s safe, it’s non-addictive, it’s off-patent, and it works well for a subset of patients. Some of them have been on it for years.
Now there’s a national shortage. My patients can’t get it, or have to go hunting from pharmacy to pharmacy until they find one that has it. I’ve told people find a source to stockpile a supply so they don’t run out. It feels like we’re living in the Soviet Union.
How did this happen? The New York Times writes:
Sure, generic drug manufacturing is pretty consolidated. Most individual generic drugs are now manufactured only by one or two companies. If one of those few companies gets greedy (like Martin Shkreli did with Daraprim), they can increase prices by orders of magnitude without a lot of competitors to push back. And if one of those few companies suffers a shock (like the FDA closing the buspirone factory), it makes sense that there might not be enough competitors to pick up the slack.
But how come this is only happening in pharmaceuticals? How come (in capitalist countries) there are almost never meat shortages, bread shortages, laptop shortages, or chair shortages? Is there something unusual about the pharmaceutical landscape that predisposes it to this sort of thing?
I am not an expert in this area and may be getting some of it wrong. But from Berndt, Conti, and Murphy (2017) and a Berndt, Conti, and Murphy (2018), I gather that a big part of the story is the Generic Drug User Fee Amendments (GDUFA) of 2012 and 2017.
The story goes something like this. The FDA demanded that generic drug manufacturers pass FDA inspection before setting up shop. But the FDA didn’t have enough inspectors to review manufacturers in a timely manner. So companies kept asking the FDA for permission to enter the generics market, and the FDA kept telling them there was a several year waiting period. In 2012, Congress recognized the problem. Politicians, FDA officials, and industry leaders agreed on a new policy where generic drug manufacturing companies would pay the FDA lots of money (about $300 million last time anyone checked), and the FDA would use that money to hire inspectors so they could clear their backlog of applications.
The good news is, the FDA hired lots more inspectors and they are now pretty good at responding to generic drug applications in a timely way. The bad news is that the fees to the companies were designed in a way that subtly encouraged monopolies in generic drug markets. I don’t understand all the specifics, but there seem to be two main problems.
First, if you manufacture a drug, the FDA will charge you a fee, but the fee doesn’t scale linearly with how much of the drug you produce. So suppose Martin Shkreli owns a very big Daraprim factory. The FDA might charge him $1 million per year to fund their inspectors. Suppose you are a small businessman who is angry at Martin Shkreli’s fee hike, and you want to open a competing Daraprim factory in your small town, using your small amount of personal savings. Probably your factory will be much smaller than Martin Shkreli’s. But the FDA will still charge you the same $1 million per year. At worst this means you make no profit; even at best, Shkreli’s economy of scale gives him a big advantage over you. So you may decide not to enter the market at all. From the second paper:
Second, traditional economics suggests that if some company has a monopoly on a product that people really need (like a medication), they will charge very high prices. But many generic drugs are produced by only one company each – and Shkrelis aside, most of them charge affordable prices. Why? Berndt et al argue it is because of the possibility of competition: if Shkreli raises his prices too high, some other company can move in and undercut him. But FDA licensing procedures make this undercutting harder than it could be: it will take months to years, and thousands to millions of dollars, for the other company to move in (at which point Shkreli can just say “Haha, no” and lower his prices again, meaning the undercutter would lose all the money they put in).
Historically, the system has worked anyway – because lots of companies are sitting on pre-existing FDA approval to make certain drugs. If a company had ever made a drug in the past, they had FDA permission to make it again whenever they wanted. So if Shkreli raises prices on Daraprim, some other company that made Daraprim ten years ago can set up a new factory tomorrow and undercut him. This helped prevent would-be Shkrelis in most markets, and provided a safety valve for shocks like the one creating the buspirone shortage today.
But GDUFA weakened this system by mandating that any company with FDA approval to manufacture a drug pay yearly inspection fees to the FDA, whether or not they were actively manufacturing it. That turned FDA approval for drugs you weren’t actively manufacturing into a liability; you were paying fees, but not making a profit. Companies started voluntarily cancelling their FDA approvals for older drugs so they wouldn’t have to pay the fees. That meant monopolists lost a lot of their potential competition. And that cleared the way for people like Shkreli to hike prices.
You get more of what you subsidize and less of what you tax. Unfortunately, the FDA is inadvertently taxing companies for being in the generic drug business. And it’s taxing them more if they’re not a monopolist with economies of scale. That means we get fewer companies in the generics industry, and more monopolists.
So my very tentative guess as to why buspirone is more plagued by shortages than bread or chairs is because number one, the need for FDA approval makes it hard for new companies to enter the buspirone industry, and number two, the FDA’s fee structure favors large-scale monopolies over small-scale competitors.
Buspirone is a 5HT-1 agonist used to control anxiety [ed. trade name: Buspar]. Unlike most psychiatric drugs, it’s in a class of its own – there are no other sole 5HT-1 agonists on the market. It’s not a very strong medication, but it’s safe, it’s non-addictive, it’s off-patent, and it works well for a subset of patients. Some of them have been on it for years.
Now there’s a national shortage. My patients can’t get it, or have to go hunting from pharmacy to pharmacy until they find one that has it. I’ve told people find a source to stockpile a supply so they don’t run out. It feels like we’re living in the Soviet Union.
How did this happen? The New York Times writes:
The main reason for the buspirone shortage appears to be interrupted production at a Mylan Pharmaceuticals plant in Morgantown, W.Va., which produced about a third of the country’s supply of the drug. The Food and Drug Administration had said the facility was dirty and that the company failed to follow quality control procedures.So the FDA shut down a major buspirone factory. But government agencies – ones that are a lot less nice than the FDA – shut down methamphetamine factories all the time without creating methamphetamine shortages. Why is the buspirone market so vulnerable? The Times again:
Rock bottom prices for some generic drugs are also contributing to the crisis. Consolidation among wholesalers has led to the creation of three buying consortium behemoths that purchase 90 percent of the generic pharmaceutical products in the United States, said Adam Fein, a consultant and chief executive of Drug Channels Institute. These “monster” buyers have squeezed manufacturers on prices, and “some of those generic manufacturers are deciding the profit is so low they can’t make money, and they’re exiting the category,” Dr. Fein said.Is this really how economics works? There’s a medicine that millions of people desperately need? But nobody will produce it because they can’t make a profit? Huh? Isn’t the usual solution to just raise the price? And people will buy it at the higher price, because they need it so badly? And then you will make more profit, and can keep on making the medication? Isn’t “nobody will supply this product, it’s too cheap” just the economics version of “nobody goes there anymore, it’s too crowded”?
Sure, generic drug manufacturing is pretty consolidated. Most individual generic drugs are now manufactured only by one or two companies. If one of those few companies gets greedy (like Martin Shkreli did with Daraprim), they can increase prices by orders of magnitude without a lot of competitors to push back. And if one of those few companies suffers a shock (like the FDA closing the buspirone factory), it makes sense that there might not be enough competitors to pick up the slack.But how come this is only happening in pharmaceuticals? How come (in capitalist countries) there are almost never meat shortages, bread shortages, laptop shortages, or chair shortages? Is there something unusual about the pharmaceutical landscape that predisposes it to this sort of thing?
I am not an expert in this area and may be getting some of it wrong. But from Berndt, Conti, and Murphy (2017) and a Berndt, Conti, and Murphy (2018), I gather that a big part of the story is the Generic Drug User Fee Amendments (GDUFA) of 2012 and 2017.
The story goes something like this. The FDA demanded that generic drug manufacturers pass FDA inspection before setting up shop. But the FDA didn’t have enough inspectors to review manufacturers in a timely manner. So companies kept asking the FDA for permission to enter the generics market, and the FDA kept telling them there was a several year waiting period. In 2012, Congress recognized the problem. Politicians, FDA officials, and industry leaders agreed on a new policy where generic drug manufacturing companies would pay the FDA lots of money (about $300 million last time anyone checked), and the FDA would use that money to hire inspectors so they could clear their backlog of applications.
The good news is, the FDA hired lots more inspectors and they are now pretty good at responding to generic drug applications in a timely way. The bad news is that the fees to the companies were designed in a way that subtly encouraged monopolies in generic drug markets. I don’t understand all the specifics, but there seem to be two main problems.
First, if you manufacture a drug, the FDA will charge you a fee, but the fee doesn’t scale linearly with how much of the drug you produce. So suppose Martin Shkreli owns a very big Daraprim factory. The FDA might charge him $1 million per year to fund their inspectors. Suppose you are a small businessman who is angry at Martin Shkreli’s fee hike, and you want to open a competing Daraprim factory in your small town, using your small amount of personal savings. Probably your factory will be much smaller than Martin Shkreli’s. But the FDA will still charge you the same $1 million per year. At worst this means you make no profit; even at best, Shkreli’s economy of scale gives him a big advantage over you. So you may decide not to enter the market at all. From the second paper:
President of the Pharma & Biopharma Outsourcing Association, Gil Roth, remarked, ‘We have a single generic client that we do a short run of production for. Why are we charged the same as a Teva facility that pumps out a billion tablets?’ Another commented, ‘At least a flat tax is based on a percentage, either of revenue or profit. This is a flat fee, which makes it a regressive tax on smaller businesses, both contract manufacturers and small generics companies’I think the fee might even be per factory, which encourages companies to concentrate all their manufacturing at a single site – like the Mylan one that just got shut down, thus affecting the whole country’s buspirone supply.
Second, traditional economics suggests that if some company has a monopoly on a product that people really need (like a medication), they will charge very high prices. But many generic drugs are produced by only one company each – and Shkrelis aside, most of them charge affordable prices. Why? Berndt et al argue it is because of the possibility of competition: if Shkreli raises his prices too high, some other company can move in and undercut him. But FDA licensing procedures make this undercutting harder than it could be: it will take months to years, and thousands to millions of dollars, for the other company to move in (at which point Shkreli can just say “Haha, no” and lower his prices again, meaning the undercutter would lose all the money they put in).
Historically, the system has worked anyway – because lots of companies are sitting on pre-existing FDA approval to make certain drugs. If a company had ever made a drug in the past, they had FDA permission to make it again whenever they wanted. So if Shkreli raises prices on Daraprim, some other company that made Daraprim ten years ago can set up a new factory tomorrow and undercut him. This helped prevent would-be Shkrelis in most markets, and provided a safety valve for shocks like the one creating the buspirone shortage today.
But GDUFA weakened this system by mandating that any company with FDA approval to manufacture a drug pay yearly inspection fees to the FDA, whether or not they were actively manufacturing it. That turned FDA approval for drugs you weren’t actively manufacturing into a liability; you were paying fees, but not making a profit. Companies started voluntarily cancelling their FDA approvals for older drugs so they wouldn’t have to pay the fees. That meant monopolists lost a lot of their potential competition. And that cleared the way for people like Shkreli to hike prices.
You get more of what you subsidize and less of what you tax. Unfortunately, the FDA is inadvertently taxing companies for being in the generic drug business. And it’s taxing them more if they’re not a monopolist with economies of scale. That means we get fewer companies in the generics industry, and more monopolists.
So my very tentative guess as to why buspirone is more plagued by shortages than bread or chairs is because number one, the need for FDA approval makes it hard for new companies to enter the buspirone industry, and number two, the FDA’s fee structure favors large-scale monopolies over small-scale competitors.
by Scott Alexander, Slate Star Codex | Read more:
Image: WebMD
[ed. On a drug/pharma/FDA rant this week.]
Thursday, May 2, 2019
Make America Trip Again
Nearly every human society has figured out how to get high. This behavior isn’t limited to Homo Sapiens—a number of animals also do recreational drugs. So why do we and some of our finned and hoofed brethren seek to escape normal consciousness? Well, as an active participant in normal consciousness, I don’t find the mystery too great: normal consciousness often sucks. Our brains are powerful problem-solving machines that evolved to protect and pass along our genes. In many situations, achieving that goal is unrelated to being happy.
“The mental healthcare system is so badly broken, it doesn’t even qualify as a system.” This indictment, coming from Tom Insel, the former director of the National Institute of Mental Health, is not due to lack of effort. The U.S. spends over $200 billion on mental healthcare treatment each year, double what we spent in 2005. American suicides are at a fifty year high and increasing at an increasing rate. Over 70,000 Americans died of drug overdoses in 2017, twice as many as did in 2007.
Our best responses to depression, addiction, and PTSD haven’t changed much. SSRI’s, introduced in the 1980s, work only with some forms of depression, have not improved, and carry side-effects that their users hate. Only 8 to 12 percent of Alcoholics Anonymous (AA) members get sober after the first year, and the organization has resisted the introduction of more effective drug-based treatments. Talk-based therapy is expensive, time-consuming, and often ineffective.
Rather than throw up their hands in the face of maladies that are affecting tens of millions of Americans and hundreds of millions more worldwide, researchers are turning back to a class of compounds that have were exiled from the medical establishment over 40 years ago.
Classical psychedelics were administered to over 10,000 people in research settings in the 1950s and ’60s. Acting primarily on the 5HT2A subtype of serotonin receptors and sharing a similar chemical structure, classical psychedelics are generally thought of as psilocybin (the active ingredient in magic mushrooms), LSD, mescaline, and DMT. MDMA (i.e. Molly or Ecstasy) shares some features, but is neurotoxic at high doses and can lead to dependencies not seen in the classical psychedelics. Classical psychedelics share more than just structure and method of action, they are anti-addictive (they help users break addictions and don’t create dependencies themselves), non-toxic, and generally affect the mind far more than they affect the body. (Someone tripping on a high dose of LSD will exhibit normal vital signs, and the only external evidence of the experience is pupil dilation). (...)
Recent psychedelic research has demonstrated the ability of psychedelics to beat our current best treatments for depression, addiction, PTSD, smoking, alcoholism, and existential anxiety. A lot of these studies are conducted by highly-motivated researchers on small samples and may not generalize. But the promise of psychedelics across such a wide range of ailments may indicate that mental illnesses aren’t as varied as the Diagnostic and Statistical Manual of Mental Disorders would have us believe. The ability of psychedelics to help people with treatment-resistant mental illness (those that persist after two or more forms of treatment have been attempted) may foreshadow even better results in populations with less severe conditions. David Nutt, Britain’s former director of the Advisory Council on the Misuse of Drugs, told me over email that these results are “almost certain” to generalize. (...)
After showing so much promise as a therapeutic tool and revealing deep truths about the mind (the discovery of LSD’s similarity to serotonin arguably kicked off modern neuroscience), LSD, psilocybin, and mescaline are Schedule I drugs: they have high potential for abuse and no accepted medical uses. Research significantly dropped off in 1966 and froze in 1976.
What happened?
Nixon declared the start of the “War on Drugs” in 1971, but the first shots were fired far earlier. The United States has a long history of criminalizing drugs associated with social undesirables, detailed in Johann Hari’s book Chasing the Scream. Premonitions of the war to come can be found in late 19th century. Fears of Chinese immigrants using opium to seduce white women contributed to the Chinese Exclusion Act in 1882. A 1914 New York Times headline informed their readers that “Negro Cocaine ‘Fiends’ Are a New Southern Menace.” This climate led to the passage of the Harrison Act the same year, which effectively criminalized cocaine and heroin.
Harry Anslinger, the fanatical and viciously racist founder of the Federal Bureau of Narcotics, is the founding father of the drug war. In the 1920s, Anslinger prosecuted 35,000 doctors for prescribing controlled drugs to addicts, overriding a Supreme Court decision (this would not be the first time drug enforcers ignored judicial opinion) and ceding control of addictive drugs to the black market. After successfully pushing for marijuana criminalization in 1937, Anslinger took his show on the road. Invoking fears of Chinese “Communist heroin”, he threatened to cut other countries off from American foreign aid and markets if they didn’t adopt drug laws similar to America’s. In the words of a retired DEA agent, “He was truly the founder of international drug enforcement.”
There is a tendency to see the backlash to psychedelics as an avoidable tragedy brought on by the “antics” of Timothy Leary and other evangelizers. While psychedelics may have seemed poised to become a part of the mainstream, the infrastructure to criminalize substances in the face of all evidence was built long before Leary emerged on the scene.
The history of the psychedelic 1960s is well-documented in Martin Lee and Bruce Shlain’s Acid Dreams: the Complete Social History of LSD. The media narrative went something like this: an extremely promising drug (LSD) was being used responsibly and to great effect by pioneering therapists and intellectuals. Along come reckless scientists like Timothy Leary and counter-culture populists like Ken Kesey, who heave psychedelics over the wall separating the educated classes from the great unwashed. In response to the social and public health crisis that resulted from millions of people turning on, tuning in, and dropping out the government steps in, first when the FDA regulated acid as an experimental drug in 1962, then when California banned it in 1966, with the final nail coming with the 1970 Controlled Substances Act, which inaugurated the modern war on drugs. (...)
James Fadiman told me that he thinks Compass is attempting to control part of the psilocybin market, but they’re also trying to move things forward as fast as possible and get governments and insurance companies to cover the cost, which compares favorably with decades of SSRI treatment.
Rick and others in the psychedelic establishment (yes, there is such a thing) claim not to be worried about Compass. One reason Rick isn’t particularly concerned is that Compass has a competitor from Usona, a nonprofit that is also trying to do psilocybin therapy. The idea is, if Compass charges too much, Usona can compete. But Usona has struggled to get its own source of Good Manufacturing Practices (GMP) psilocybin, a requirement for FDA approval. Compass is trying to patent its method of manufacturing psilocybin, which could ensure that it has a significant cost advantage over competitors, who would need to develop their own means of making GMP psilocybin. The reality is that nonprofits don’t have many of the advantages of a venture-funded for-profit. To go through the FDA, an enormous amount of startup capital is required, erecting a large barrier to entry that nonprofits will struggle to surmount. MAPS needed to raise $27 million to take MDMA through FDA approval. (...)
The pushback to Compass Pathways is sometimes framed as the overreaction to the mainstreaming of a previously fringe movement: Compass is just doing business as usual in a space where business is unusual. Rick sees the entrance of for-profit players like Compass as a healthy sign for psychedelics: people think they’re a good investment. The allure of tax revenues and big returns helped legalize marijuana. But legal marijuana became quickly became commercialized marijuana, leading to some of the problems we face with alcohol and tobacco: powerful industry lobbies resisting regulation and misleading labeling and advertising. As one marijuana entrepreneur said at an alcohol industry conference, “I fundamentally believe that it is Big Alcohol and Big Tobacco that will be my future employer.”
Given the way for-profit companies have handled drugs, skepticism is warranted. Researchers, advocates and practitioners who have spent decades working to make psychedelics safely available to more people are understandably terrified of a company focused on the bottom line moving too fast and setting the movement back. Compass is running studies with 400 people in eight countries based off of research done with a very small group of people. Psilocybin poses psychological risks that MDMA doesn’t, and MAPS therapists undergo substantially more training.
At the same time, 300 million people around world experience depression, and Compass has moved faster than Usona. It may be the case that MAPS training and protocols are overkill, and that the Compass approach is safe and far more scalable and cost-effective. As Compass embarks on larger scale research, Katherine MacLean sincerely hopes for their success. For the sake of all the people who could be helped by psilocybin treatment, I do too.
The final approach may be the best we can hope for in the near term. An excellent series from Psymposia lays out the future of MDMA. MAPS has established a public benefit corporation that has the exclusive rights to conduct MDMA therapy for five years, should the treatment get approved by the FDA. The public benefit corporation is separate from MAPS, but MAPS is the sole shareholder. Any profits from the corporation go back into MAPS research, which is publicly available. From what I can tell, Rick is genuinely committed to making psychedelic therapy available to as many people as possible (MAPS has hired a patent lawyer to develop anti-patent strategies to ensure that nobody can patent the use of MDMA). The way to get there seems to be by jumping through expensive and onerous hoops to prove the safety and efficacy of psychedelics to the FDA.
There are still risks and drawbacks to the MAPS approach. If the FDA Phase III trials are successful, only MAPS’ GMP MDMA will be re-scheduled by the DEA. And legal risks for recreational users could persist as re-scheduling won’t necessarily change criminal penalties associated with the drug. For the five years that MAPS has a monopoly on MDMA therapy, only therapists trained by MAPS will be able to conduct therapy or trainings of their own, creating a potential bottleneck in the number of people who can legally provide MDMA-assisted therapy. The associated costs are considerable. Training for this therapy can cost more than $9,000. The current protocols for MDMA treatment involve many therapy sessions with a two-person co-therapy team that can cost up to $15,000 altogether. There are strict requirements on prospective MDMA-assisted therapy clinic: two MAPS-trained therapists, a prescribing physician who can obtain a DEA Schedule I license, access to a lab for bloodwork, and a cardiologist. Clinics must be established businesses with the facilities to meet therapeutic and security standards.
[ed. Looks like it's heading the same way of ketamine treatments. Expensive regimens only the rich can afford. But... baby steps. See also: Women Who Microdose Mushrooms, and It Happened to Her (because I just finished Cat Marnell's How to Murder Your Life.)]
“The mental healthcare system is so badly broken, it doesn’t even qualify as a system.” This indictment, coming from Tom Insel, the former director of the National Institute of Mental Health, is not due to lack of effort. The U.S. spends over $200 billion on mental healthcare treatment each year, double what we spent in 2005. American suicides are at a fifty year high and increasing at an increasing rate. Over 70,000 Americans died of drug overdoses in 2017, twice as many as did in 2007.
Our best responses to depression, addiction, and PTSD haven’t changed much. SSRI’s, introduced in the 1980s, work only with some forms of depression, have not improved, and carry side-effects that their users hate. Only 8 to 12 percent of Alcoholics Anonymous (AA) members get sober after the first year, and the organization has resisted the introduction of more effective drug-based treatments. Talk-based therapy is expensive, time-consuming, and often ineffective.Rather than throw up their hands in the face of maladies that are affecting tens of millions of Americans and hundreds of millions more worldwide, researchers are turning back to a class of compounds that have were exiled from the medical establishment over 40 years ago.
Classical psychedelics were administered to over 10,000 people in research settings in the 1950s and ’60s. Acting primarily on the 5HT2A subtype of serotonin receptors and sharing a similar chemical structure, classical psychedelics are generally thought of as psilocybin (the active ingredient in magic mushrooms), LSD, mescaline, and DMT. MDMA (i.e. Molly or Ecstasy) shares some features, but is neurotoxic at high doses and can lead to dependencies not seen in the classical psychedelics. Classical psychedelics share more than just structure and method of action, they are anti-addictive (they help users break addictions and don’t create dependencies themselves), non-toxic, and generally affect the mind far more than they affect the body. (Someone tripping on a high dose of LSD will exhibit normal vital signs, and the only external evidence of the experience is pupil dilation). (...)
Recent psychedelic research has demonstrated the ability of psychedelics to beat our current best treatments for depression, addiction, PTSD, smoking, alcoholism, and existential anxiety. A lot of these studies are conducted by highly-motivated researchers on small samples and may not generalize. But the promise of psychedelics across such a wide range of ailments may indicate that mental illnesses aren’t as varied as the Diagnostic and Statistical Manual of Mental Disorders would have us believe. The ability of psychedelics to help people with treatment-resistant mental illness (those that persist after two or more forms of treatment have been attempted) may foreshadow even better results in populations with less severe conditions. David Nutt, Britain’s former director of the Advisory Council on the Misuse of Drugs, told me over email that these results are “almost certain” to generalize. (...)
After showing so much promise as a therapeutic tool and revealing deep truths about the mind (the discovery of LSD’s similarity to serotonin arguably kicked off modern neuroscience), LSD, psilocybin, and mescaline are Schedule I drugs: they have high potential for abuse and no accepted medical uses. Research significantly dropped off in 1966 and froze in 1976.
What happened?
Nixon declared the start of the “War on Drugs” in 1971, but the first shots were fired far earlier. The United States has a long history of criminalizing drugs associated with social undesirables, detailed in Johann Hari’s book Chasing the Scream. Premonitions of the war to come can be found in late 19th century. Fears of Chinese immigrants using opium to seduce white women contributed to the Chinese Exclusion Act in 1882. A 1914 New York Times headline informed their readers that “Negro Cocaine ‘Fiends’ Are a New Southern Menace.” This climate led to the passage of the Harrison Act the same year, which effectively criminalized cocaine and heroin.
Harry Anslinger, the fanatical and viciously racist founder of the Federal Bureau of Narcotics, is the founding father of the drug war. In the 1920s, Anslinger prosecuted 35,000 doctors for prescribing controlled drugs to addicts, overriding a Supreme Court decision (this would not be the first time drug enforcers ignored judicial opinion) and ceding control of addictive drugs to the black market. After successfully pushing for marijuana criminalization in 1937, Anslinger took his show on the road. Invoking fears of Chinese “Communist heroin”, he threatened to cut other countries off from American foreign aid and markets if they didn’t adopt drug laws similar to America’s. In the words of a retired DEA agent, “He was truly the founder of international drug enforcement.”
There is a tendency to see the backlash to psychedelics as an avoidable tragedy brought on by the “antics” of Timothy Leary and other evangelizers. While psychedelics may have seemed poised to become a part of the mainstream, the infrastructure to criminalize substances in the face of all evidence was built long before Leary emerged on the scene.
The history of the psychedelic 1960s is well-documented in Martin Lee and Bruce Shlain’s Acid Dreams: the Complete Social History of LSD. The media narrative went something like this: an extremely promising drug (LSD) was being used responsibly and to great effect by pioneering therapists and intellectuals. Along come reckless scientists like Timothy Leary and counter-culture populists like Ken Kesey, who heave psychedelics over the wall separating the educated classes from the great unwashed. In response to the social and public health crisis that resulted from millions of people turning on, tuning in, and dropping out the government steps in, first when the FDA regulated acid as an experimental drug in 1962, then when California banned it in 1966, with the final nail coming with the 1970 Controlled Substances Act, which inaugurated the modern war on drugs. (...)
Compass Pathways is the controversial startup that recently secured FDA approval for psilocybin as a breakthrough treatment. Originally a nonprofit, Compass has been criticized for capitalizing on the work of academic and nonprofit researchers to develop their business. A Quartz investigation describes how Compass courted researchers as a nonprofit, then iced them out and transferred its intellectual property to the company’s founders before transitioning to for-profit status. When a charity is dissolved, it is required to distribute its assets to other charities, a requirement Compass appears to have violated. The conditions Compass puts on research it sponsors are “restrictive contracts even by pharmaceutical industry standards, according to John Abramson, lecturer in health care policy at Harvard Medical School, and have the potential to distort the publicly available body of scientific knowledge.” David Nutt told me via email that this practice is “necessary under current commercial funding routes to [a] successful clinical trial outcome.” (The idea is that competitors could piggy-back off of Compass’s research and undercut the resulting products). The company only requires a weekend of training for its therapists and does not require them to have personal experience with psilocybin. (...)
James Fadiman told me that he thinks Compass is attempting to control part of the psilocybin market, but they’re also trying to move things forward as fast as possible and get governments and insurance companies to cover the cost, which compares favorably with decades of SSRI treatment.
Rick and others in the psychedelic establishment (yes, there is such a thing) claim not to be worried about Compass. One reason Rick isn’t particularly concerned is that Compass has a competitor from Usona, a nonprofit that is also trying to do psilocybin therapy. The idea is, if Compass charges too much, Usona can compete. But Usona has struggled to get its own source of Good Manufacturing Practices (GMP) psilocybin, a requirement for FDA approval. Compass is trying to patent its method of manufacturing psilocybin, which could ensure that it has a significant cost advantage over competitors, who would need to develop their own means of making GMP psilocybin. The reality is that nonprofits don’t have many of the advantages of a venture-funded for-profit. To go through the FDA, an enormous amount of startup capital is required, erecting a large barrier to entry that nonprofits will struggle to surmount. MAPS needed to raise $27 million to take MDMA through FDA approval. (...)
The pushback to Compass Pathways is sometimes framed as the overreaction to the mainstreaming of a previously fringe movement: Compass is just doing business as usual in a space where business is unusual. Rick sees the entrance of for-profit players like Compass as a healthy sign for psychedelics: people think they’re a good investment. The allure of tax revenues and big returns helped legalize marijuana. But legal marijuana became quickly became commercialized marijuana, leading to some of the problems we face with alcohol and tobacco: powerful industry lobbies resisting regulation and misleading labeling and advertising. As one marijuana entrepreneur said at an alcohol industry conference, “I fundamentally believe that it is Big Alcohol and Big Tobacco that will be my future employer.”
Given the way for-profit companies have handled drugs, skepticism is warranted. Researchers, advocates and practitioners who have spent decades working to make psychedelics safely available to more people are understandably terrified of a company focused on the bottom line moving too fast and setting the movement back. Compass is running studies with 400 people in eight countries based off of research done with a very small group of people. Psilocybin poses psychological risks that MDMA doesn’t, and MAPS therapists undergo substantially more training.
At the same time, 300 million people around world experience depression, and Compass has moved faster than Usona. It may be the case that MAPS training and protocols are overkill, and that the Compass approach is safe and far more scalable and cost-effective. As Compass embarks on larger scale research, Katherine MacLean sincerely hopes for their success. For the sake of all the people who could be helped by psilocybin treatment, I do too.
The final approach may be the best we can hope for in the near term. An excellent series from Psymposia lays out the future of MDMA. MAPS has established a public benefit corporation that has the exclusive rights to conduct MDMA therapy for five years, should the treatment get approved by the FDA. The public benefit corporation is separate from MAPS, but MAPS is the sole shareholder. Any profits from the corporation go back into MAPS research, which is publicly available. From what I can tell, Rick is genuinely committed to making psychedelic therapy available to as many people as possible (MAPS has hired a patent lawyer to develop anti-patent strategies to ensure that nobody can patent the use of MDMA). The way to get there seems to be by jumping through expensive and onerous hoops to prove the safety and efficacy of psychedelics to the FDA.
There are still risks and drawbacks to the MAPS approach. If the FDA Phase III trials are successful, only MAPS’ GMP MDMA will be re-scheduled by the DEA. And legal risks for recreational users could persist as re-scheduling won’t necessarily change criminal penalties associated with the drug. For the five years that MAPS has a monopoly on MDMA therapy, only therapists trained by MAPS will be able to conduct therapy or trainings of their own, creating a potential bottleneck in the number of people who can legally provide MDMA-assisted therapy. The associated costs are considerable. Training for this therapy can cost more than $9,000. The current protocols for MDMA treatment involve many therapy sessions with a two-person co-therapy team that can cost up to $15,000 altogether. There are strict requirements on prospective MDMA-assisted therapy clinic: two MAPS-trained therapists, a prescribing physician who can obtain a DEA Schedule I license, access to a lab for bloodwork, and a cardiologist. Clinics must be established businesses with the facilities to meet therapeutic and security standards.
by Garrison Lovely, Current Affairs | Read more:
Image: Nick Sirotich[ed. Looks like it's heading the same way of ketamine treatments. Expensive regimens only the rich can afford. But... baby steps. See also: Women Who Microdose Mushrooms, and It Happened to Her (because I just finished Cat Marnell's How to Murder Your Life.)]
Screenplay Software Adds Tool to Assess a Script’s Inclusiveness
One of the most widely used screenplay programs in Hollywood has a new tool to help with gender equality and inclusion.
In an update announced Thursday, Final Draft — software that writers use to format scripts — said it will now include a proprietary “Inclusivity Analysis” feature, allowing filmmakers “to quickly assign and measure the ethnicity, gender, age, disability or any other definable trait of the characters,” including race, the company said in a statement.
It also will enable users to determine if a project passes the Bechdel Test, measuring whether two female characters speak to each other about anything other than a man. The Final Draft tool, a free add-on, was developed in collaboration with the Geena Davis Institute on Gender in Media at Mount Saint Mary’s University, which has been at the forefront of studying the underrepresentation of women on screen.
In a statement, Geena Davis said the update “will make it easier for readers, writers and creative execs to more easily use a gender and intersectionality lens when evaluating scripts prior to greenlight, casting and production.”
The Final Draft feature comes almost a year after similar programs were instituted in other screenplay apps, starting with Highland software. The idea then came from Christina Hodson, a screenwriter (“Bumblebee,” the forthcoming “Batgirl,”), who reasoned that if scripts were the blueprint for blockbusters and indies alike, “it made sense to me that we can do a lot ourselves, before they even leave our desk.” She approached software makers, who developed and released tools in a matter of weeks.
Final Draft, the industry leader, took a more measured approach, Scott McMenamin, the company’s president, said in an email. “We just wanted to make sure we got this right,” he wrote, “which is why we didn’t release it right out of the gate” with the most recent update, Final Draft 11, in September 2018.
by Melena Ryzik, NY Times | Read more:
Image: Final Draft
[ed. For all aspiring screenwriters. Who knew industry standard screenwriting software existed?]
In an update announced Thursday, Final Draft — software that writers use to format scripts — said it will now include a proprietary “Inclusivity Analysis” feature, allowing filmmakers “to quickly assign and measure the ethnicity, gender, age, disability or any other definable trait of the characters,” including race, the company said in a statement.
It also will enable users to determine if a project passes the Bechdel Test, measuring whether two female characters speak to each other about anything other than a man. The Final Draft tool, a free add-on, was developed in collaboration with the Geena Davis Institute on Gender in Media at Mount Saint Mary’s University, which has been at the forefront of studying the underrepresentation of women on screen.In a statement, Geena Davis said the update “will make it easier for readers, writers and creative execs to more easily use a gender and intersectionality lens when evaluating scripts prior to greenlight, casting and production.”
The Final Draft feature comes almost a year after similar programs were instituted in other screenplay apps, starting with Highland software. The idea then came from Christina Hodson, a screenwriter (“Bumblebee,” the forthcoming “Batgirl,”), who reasoned that if scripts were the blueprint for blockbusters and indies alike, “it made sense to me that we can do a lot ourselves, before they even leave our desk.” She approached software makers, who developed and released tools in a matter of weeks.
Final Draft, the industry leader, took a more measured approach, Scott McMenamin, the company’s president, said in an email. “We just wanted to make sure we got this right,” he wrote, “which is why we didn’t release it right out of the gate” with the most recent update, Final Draft 11, in September 2018.
by Melena Ryzik, NY Times | Read more:
Image: Final Draft
[ed. For all aspiring screenwriters. Who knew industry standard screenwriting software existed?]
Wednesday, May 1, 2019
The Biggest Bias In Tech That No One Talks About
I was recently chatting with two young men who were telling me of their struggle to hire older employees.
“The rest of our office is young. They just don’t fit with our culture,” the first one admitted.
“Our industry is brand new,” said the second. “Older candidates don’t bring any relevant experience, but come with a higher paycheck.”
And then: “I’m not sure if an older employee would be able to adapt and learn quickly in our fast-paced work culture.”
I nodded in agreement. All these things made sense. Then one of them interjected: “I don’t want to feel like we have an office mom!”
Suddenly I felt a pit at the bottom of my stomach. I am a real-life mom. Oblivious to my reaction, the two men went on talking, genuinely trying to find a solution. One said: “We actually did hire an older employee recently. I was nervous about whether he would fit in, but so far, it’s going okay. He’s 40.”
The sinking feeling in my gut turned to all-out panic. Throughout this conversation I had been picturing a gray haired 60 year old. But no, “old” in tech is someone in their 40s. Until this point, I’d never thought of myself as too old for tech, but as a woman in her late 30s who is also a mother to three young children, I suddenly realized what others might be thinking when I walk in the room.
The data says ageism starts young in tech
There’s no getting past the fact that tech is a young industry. Studies show that age bias is rampant in tech not just once one hits their 40s, but by age 36. When VC firm First Round Capital polled a wide range of US startup founders in The 2018 State of Startups report, age was cited as the strongest investor bias against founders, with 89% of founders saying older people face discrimination in tech, followed by gender. And older women have double the odds. In a 2017 Indeed survey, 43 percent of tech workers said that fear of losing their jobs due to age is a real fear. (...)
Pregnancy and ageism create a double penalty for women
Ageism impacts everyone, but women bear the unfair brunt of this trend. In this same survey of early stage founders, the amount of capital raised by male founders peaked between ages 30 and 45. But for female founders, the amount raised doesn’t spike until the late 30s and it peaks soon after, by age 45. Founders of both sexes experience a drop off in funding after they hit their 45th birthday. For women, this means a very narrow window in which to maximize their fundraising. (...)
Why is youth so coveted in tech?
Unlike other industries, tech’s hallmark is change and innovation. For this reason, professional experience is not valued as much as the ability to think outside the proverbial box. Fresh young talent has a leg up in an industry where bold new ideas are valued above all else. Tech is an industry of and in disruption, not beholden to status quo ways of doing things.
In the war for talent, tech culture targets young recruits, particularly those that don’t have family obligations at home. Tech campuses are built like all-inclusive resorts, enabling — no, encouraging — recruits to stay on campus as much as possible, a la The Circle, Dave Eggers dystopian novel circa 2013. Apple Park, Apple’s multibillion-dollar new campus in Cupertino, is colloquially known as “the Spaceship Campus” because of its design — but also because it’s a self-contained destination one could conceivably stay airlocked inside forever.
These tech cultures offer “work-life balance” only in the sense that you can theoretically manage your entire life from campus, with no need to go elsewhere to exercise, do errands, eat out or meet up with friends (why be friends with people outside of work, after all?). The caveat here is these perks tend to fall short if your life responsibilities happen to include small people who are dependent on you. (...)
But what are we collectively missing out on because of all this?
But the even bigger issue is that tech’s myopic view causes it to miss out on many billion dollar opportunities.
The stats on this opportunity are things we’ve all heard before: baby boomers control more than ⅔ of the disposable income in the US and will inherit $15 Trillion over the next two decades.
What is surprising is that the tech industry hasn’t taken more notice of this rapidly growing market underserved by tech. Instead, VCs are distracted by apps for millennials like private chefs, valet parking and skipping the line while clubbing (yes, there is a new app for this).
What about instead building technology focused on working parents, second careers, menopause, retirement and senior care?
by Maren Thomas Bannon, Forbes | Read more:
Image: Getty
“The rest of our office is young. They just don’t fit with our culture,” the first one admitted.
“Our industry is brand new,” said the second. “Older candidates don’t bring any relevant experience, but come with a higher paycheck.”
And then: “I’m not sure if an older employee would be able to adapt and learn quickly in our fast-paced work culture.”I nodded in agreement. All these things made sense. Then one of them interjected: “I don’t want to feel like we have an office mom!”
Suddenly I felt a pit at the bottom of my stomach. I am a real-life mom. Oblivious to my reaction, the two men went on talking, genuinely trying to find a solution. One said: “We actually did hire an older employee recently. I was nervous about whether he would fit in, but so far, it’s going okay. He’s 40.”
The sinking feeling in my gut turned to all-out panic. Throughout this conversation I had been picturing a gray haired 60 year old. But no, “old” in tech is someone in their 40s. Until this point, I’d never thought of myself as too old for tech, but as a woman in her late 30s who is also a mother to three young children, I suddenly realized what others might be thinking when I walk in the room.
The data says ageism starts young in tech
There’s no getting past the fact that tech is a young industry. Studies show that age bias is rampant in tech not just once one hits their 40s, but by age 36. When VC firm First Round Capital polled a wide range of US startup founders in The 2018 State of Startups report, age was cited as the strongest investor bias against founders, with 89% of founders saying older people face discrimination in tech, followed by gender. And older women have double the odds. In a 2017 Indeed survey, 43 percent of tech workers said that fear of losing their jobs due to age is a real fear. (...)
Pregnancy and ageism create a double penalty for women
Ageism impacts everyone, but women bear the unfair brunt of this trend. In this same survey of early stage founders, the amount of capital raised by male founders peaked between ages 30 and 45. But for female founders, the amount raised doesn’t spike until the late 30s and it peaks soon after, by age 45. Founders of both sexes experience a drop off in funding after they hit their 45th birthday. For women, this means a very narrow window in which to maximize their fundraising. (...)
Why is youth so coveted in tech?
Unlike other industries, tech’s hallmark is change and innovation. For this reason, professional experience is not valued as much as the ability to think outside the proverbial box. Fresh young talent has a leg up in an industry where bold new ideas are valued above all else. Tech is an industry of and in disruption, not beholden to status quo ways of doing things.
In the war for talent, tech culture targets young recruits, particularly those that don’t have family obligations at home. Tech campuses are built like all-inclusive resorts, enabling — no, encouraging — recruits to stay on campus as much as possible, a la The Circle, Dave Eggers dystopian novel circa 2013. Apple Park, Apple’s multibillion-dollar new campus in Cupertino, is colloquially known as “the Spaceship Campus” because of its design — but also because it’s a self-contained destination one could conceivably stay airlocked inside forever.
These tech cultures offer “work-life balance” only in the sense that you can theoretically manage your entire life from campus, with no need to go elsewhere to exercise, do errands, eat out or meet up with friends (why be friends with people outside of work, after all?). The caveat here is these perks tend to fall short if your life responsibilities happen to include small people who are dependent on you. (...)
But what are we collectively missing out on because of all this?
But the even bigger issue is that tech’s myopic view causes it to miss out on many billion dollar opportunities.
The stats on this opportunity are things we’ve all heard before: baby boomers control more than ⅔ of the disposable income in the US and will inherit $15 Trillion over the next two decades.
What is surprising is that the tech industry hasn’t taken more notice of this rapidly growing market underserved by tech. Instead, VCs are distracted by apps for millennials like private chefs, valet parking and skipping the line while clubbing (yes, there is a new app for this).
What about instead building technology focused on working parents, second careers, menopause, retirement and senior care?
Image: Getty
How to Fly a Plane in an Emergency Situation
As a professional pilot, I spend four or five days a year in multimillion-dollar flight simulators being examined by specialized training pilots. Since professional pilots already know how to fly, much of the testing focuses on what are called “non-normal situations.” Let’s imagine you find yourself on an airplane, in the sky, without a pilot. You are in a non-normal situation.
A useful guide to your initial actions if you’re in such a pickle is a simple mnemonic called ANC: Aviate, Navigate, Communicate. (Aviation is as acronym-laden a field as any I’ve come across.)
So, aviate. You need to keep the plane in the safe, stable flight you found it in.
Use the control wheel and the horizon displayed on the attitude indicator to level the wings. If it’s gin-clear outside and the real horizon is obvious to you, feel free to use it.
Next, take a look at the altimeter and the vertical speed indicator. Pick an altitude as your target—a simple number near your current altitude, like 10,000 or 15,000 feet. If you’re climbing away from your target, then very gently push the control column forward—that is, away from you—until you’ve stopped climbing. If you’re descending, then pull the control column back, toward you, until you’re not descending anymore. Be gentle, as it’s easy to overcorrect. Porpoising, or repeatedly ascending above and then descending below your target altitude, is a common problem for new pilots.
Now look at the airspeed indicator. Pick a target speed toward the higher end of the safe range. It’s impossible to give numbers for every airplane, but try 100 knots in a small plane, 250 knots in a small airliner, and 280 knots in something like a 747. If your speed is higher than your target, pull the throttles or thrust levers back slightly to reduce power. If it’s lower, then add power.
The goal is to reach an equilibrium in which your speed and altitude are safe and stable. Note the pitch attitude and power setting at which this occurs. The problem, as you’ll soon realize, is that the inputs required to correct one aspect of your flight path will almost certainly upset another one. For example, if you’ve just changed your power setting, then your pitch may have changed, and perhaps you’ve started to inadvertently climb or descend. Or, if you’ve accidentally lowered your pitch attitude, you’ll soon see your speed increasing and your altitude dropping.
The best way to catch such unintended changes early is to move your eyes between the primary instruments in a consistent pattern. This pattern is called the scan and the scan is, unfortunately, much easier said than done, in part because it can seem repetitive at first, and in part because you must keep scanning at the same time as you’re doing everything else you need to do. In fact, getting the scan right is one of the hardest parts of pilot training. It’s hardly overstating it to ask you to imagine that every remaining word in this article is followed by the command “Scan!” (...)
Now it’s time to navigate a safe flight path (in relation to mountains, storms, air traffic zones, and other aircraft) and communicate with the folks who need to know what you’re doing, or who can help you to achieve a safe outcome. For a trained pilot, navigation is a more immediate priority than communication (hence the order of the mnemonic, first A, then N, and last of all C). But for you the opposite is true, because unless you can see an airport right in front of you, you’re going to need outside help to remain clear of terrain and to find a runway.
For that reason, we’ll talk about communication first, and return to navigation afterward. For now, if you can see mountains or other obstacles in your path, turn away from them, climb (by adding power and lifting the nose of the plane), or both.
by Mark Vanhoenacker, Wired | Read more:
Image: markk
A useful guide to your initial actions if you’re in such a pickle is a simple mnemonic called ANC: Aviate, Navigate, Communicate. (Aviation is as acronym-laden a field as any I’ve come across.)
So, aviate. You need to keep the plane in the safe, stable flight you found it in.
Use the control wheel and the horizon displayed on the attitude indicator to level the wings. If it’s gin-clear outside and the real horizon is obvious to you, feel free to use it.
Next, take a look at the altimeter and the vertical speed indicator. Pick an altitude as your target—a simple number near your current altitude, like 10,000 or 15,000 feet. If you’re climbing away from your target, then very gently push the control column forward—that is, away from you—until you’ve stopped climbing. If you’re descending, then pull the control column back, toward you, until you’re not descending anymore. Be gentle, as it’s easy to overcorrect. Porpoising, or repeatedly ascending above and then descending below your target altitude, is a common problem for new pilots.Now look at the airspeed indicator. Pick a target speed toward the higher end of the safe range. It’s impossible to give numbers for every airplane, but try 100 knots in a small plane, 250 knots in a small airliner, and 280 knots in something like a 747. If your speed is higher than your target, pull the throttles or thrust levers back slightly to reduce power. If it’s lower, then add power.
The goal is to reach an equilibrium in which your speed and altitude are safe and stable. Note the pitch attitude and power setting at which this occurs. The problem, as you’ll soon realize, is that the inputs required to correct one aspect of your flight path will almost certainly upset another one. For example, if you’ve just changed your power setting, then your pitch may have changed, and perhaps you’ve started to inadvertently climb or descend. Or, if you’ve accidentally lowered your pitch attitude, you’ll soon see your speed increasing and your altitude dropping.
The best way to catch such unintended changes early is to move your eyes between the primary instruments in a consistent pattern. This pattern is called the scan and the scan is, unfortunately, much easier said than done, in part because it can seem repetitive at first, and in part because you must keep scanning at the same time as you’re doing everything else you need to do. In fact, getting the scan right is one of the hardest parts of pilot training. It’s hardly overstating it to ask you to imagine that every remaining word in this article is followed by the command “Scan!” (...)
Now it’s time to navigate a safe flight path (in relation to mountains, storms, air traffic zones, and other aircraft) and communicate with the folks who need to know what you’re doing, or who can help you to achieve a safe outcome. For a trained pilot, navigation is a more immediate priority than communication (hence the order of the mnemonic, first A, then N, and last of all C). But for you the opposite is true, because unless you can see an airport right in front of you, you’re going to need outside help to remain clear of terrain and to find a runway.
For that reason, we’ll talk about communication first, and return to navigation afterward. For now, if you can see mountains or other obstacles in your path, turn away from them, climb (by adding power and lifting the nose of the plane), or both.
by Mark Vanhoenacker, Wired | Read more:
Image: markk
[ed. I learned to fly because of a couple "non-normal" situations. One time my pilot kept falling asleep, dropping several hundred feet at a clip. It was early evening and he'd been flying all day. He kept making lame jokes, like... "just wanted to check out that muskrat den" and "that's why they call us bush pilots, because we fly from bush to bush, haha." Funny. I had to keep nudging him and feeding him cigarettes to stay awake, and even on final approach he was still nodding off. Another time, another pilot, caught above the clouds, solidly socked in. We had to descend into a mountain range and weren't exactly sure where we were (above this valley or that one?). A small hole opened up and we dove into it like a screaming Japanese zero. It closed immediately and then we were flying blind into... somewhere. I wondered briefly if we'd feel anything, slamming into the side of a mountain. Finally broke through a few hundred feet above ground. In the wrong valley. After that I told myself I'd never get in those situations again without having some type of knowledge or control. But of course, never say never.]
Why Is Iced Coffee So Gay?
In late January, during the Polar Vortex that held America by the throat with an icy grasp, a picture of a man wearing a massive coat with his hood up while battling his way through a snowstorm went viral. It sounds unremarkable, except that, in 2°F weather, he was death-gripping an iced coffee.
The picture, fairly innocuous aside from the man’s choice of caffeinated beverage, was shared by the City of New York’s Twitter feed and paired with an incredulous caption. How could an individual in this freezing weather, the tweet suggested, be drinking an iced coffee? It’s obvious, people responded: He’s gay.
Obviously there’s no way commenters could’ve known this man’s sexuality. Honestly, I’m not sure anyone even knows who he is. But none of that matters, after all; what was clear to the corner of the Internet known as Gay Twitter, and to the site Gay Star News,was that this man was just exercising his rights—nay, his duty—as a gay man to drink iced coffee. Iced coffee, you see, is gay culture [ed. note: can confirm].
In a piece published last October on the LGBTQ website New Now Next, it was noted that for the past two years on social media there’s been a steady flow of jokes and memes about the gay community’s affinity for iced coffee. According to NNN, iced coffee is gay because: portability (cute cups), easy consumption (it’s cold) and customization (you can pump it full of sugar, or sugar-free syrup that is definitely not giving you diabetes). The site compared it to the stereotype of suburban moms and their consumption of pinot grigio; iced coffee is a gay crutch. (...)
“I think the joke sort of originated as gays drinking iced coffee in the winter,” Stryker explains. “Like, gays will do ridiculous things and there’s something so counterculture about drinking an iced coffee during the winter.” It’s also, he says, a sign of resisting homogenization. “Hot coffee is so normcore. Like, it’s for dads and old people commuting on the train.”
For Sam, iced versus hot coffee is the perfect symbolism between queer and straight culture. Essentially, iced coffee has become a queer avatar, and a way for gay people to signpost themselves against the uniformity of heterosexuality. (...)
While there are some codes that were very specific, such as the hanky code which signaled specific sexual proclivities, Dr. Bengry says that mostly the signposting was subtle, such wearing a red tie or a pinky ring. Usually, though, they had something to do with subverting gender norms. For example, wearing color was a subversion of the dark suits men were accustomed to wearing, while anything ostentatious or extravagant, such as using a scent or perfume, was associated with women. “The codes associated with a gendered difference,” he adds, “could then signal a sexual difference.”
The picture, fairly innocuous aside from the man’s choice of caffeinated beverage, was shared by the City of New York’s Twitter feed and paired with an incredulous caption. How could an individual in this freezing weather, the tweet suggested, be drinking an iced coffee? It’s obvious, people responded: He’s gay.
Obviously there’s no way commenters could’ve known this man’s sexuality. Honestly, I’m not sure anyone even knows who he is. But none of that matters, after all; what was clear to the corner of the Internet known as Gay Twitter, and to the site Gay Star News,was that this man was just exercising his rights—nay, his duty—as a gay man to drink iced coffee. Iced coffee, you see, is gay culture [ed. note: can confirm].In a piece published last October on the LGBTQ website New Now Next, it was noted that for the past two years on social media there’s been a steady flow of jokes and memes about the gay community’s affinity for iced coffee. According to NNN, iced coffee is gay because: portability (cute cups), easy consumption (it’s cold) and customization (you can pump it full of sugar, or sugar-free syrup that is definitely not giving you diabetes). The site compared it to the stereotype of suburban moms and their consumption of pinot grigio; iced coffee is a gay crutch. (...)
“I think the joke sort of originated as gays drinking iced coffee in the winter,” Stryker explains. “Like, gays will do ridiculous things and there’s something so counterculture about drinking an iced coffee during the winter.” It’s also, he says, a sign of resisting homogenization. “Hot coffee is so normcore. Like, it’s for dads and old people commuting on the train.”
For Sam, iced versus hot coffee is the perfect symbolism between queer and straight culture. Essentially, iced coffee has become a queer avatar, and a way for gay people to signpost themselves against the uniformity of heterosexuality. (...)
While there are some codes that were very specific, such as the hanky code which signaled specific sexual proclivities, Dr. Bengry says that mostly the signposting was subtle, such wearing a red tie or a pinky ring. Usually, though, they had something to do with subverting gender norms. For example, wearing color was a subversion of the dark suits men were accustomed to wearing, while anything ostentatious or extravagant, such as using a scent or perfume, was associated with women. “The codes associated with a gendered difference,” he adds, “could then signal a sexual difference.”
by Alim Kheraj, GQ | Read more:
Image: City of NY
[ed. News you can use.]
Tuesday, April 30, 2019
Offshore Drilling in the Arctic and Atlantic on Ice (for Now)
Trump administration puts offshore drilling expansion in Arctic, Atlantic on ice (ArsTechnica).
The Coastal Zone Management Act of 1972 is an Act of Congress passed in 1972 to encourage coastal states to develop and implement coastal zone management plans (CZMPs). This act was established as a United States National policy to preserve, protect, develop, and where possible, restore or enhance, the resources of the Nation's coastal zone for this and succeeding generations.
The Coastal Zone Management Act (CZMA) of 1972 showed that the United States Congress “recognized the importance of meeting the challenge of continued growth in the coastal zone”. Under this act two national programs were created, the National Coastal Zone Management Program (CZMP) and the National Estuarine Research Reserve System. Out of 35 eligible states, only 34 have established management programs; Washington State was the first state to adopt the program in 1976.
The Coastal Zone Management Program (CZMP), also called the National Coastal Zone Management Program, was established under the Coastal Zone Management Act of 1972 and is administered by NOAA’s Office for Coastal Management (OCM). This program is designed to set up a basis for protecting, restoring, and establishing a responsibility in preserving and developing the nation’s coastal communities and resources, where they are under the highest pressure. The vision of the CZMP is to ensure that “the nation’s coast and oceans, including the Great Lakes and island territories, are healthy and thriving for this and future generation”. Their mission is “to ensure the conservation and responsible use of our nation’s coastal and ocean resources”.
The key goals of the National CZM program include: “protecting natural resources, managing development in high hazard areas, giving development priority to coastal-dependent uses, providing public access for recreation, coordinating state and federal actions”. Ultimately the outcomes from the CZMP are for “healthy and productive coastal ecosystems, and to have environmentally, economically, and socially vibrant and resilient coastal communities”.
The National Estuarine Research Reserve System is the second programs established by the Coastal Zone Management Act of 1972 and is also administered by the National Oceanic and Atmospheric Administration (NOAA). NERRS is a network of 28 areas within the nation and various coastal states, which spans more than 1 million acres. These areas are used for long-term research, water-quality monitoring, education, and coastal stewardship.
[ed. For a good example of how dumb and short-sighted politicans (and the electorate in general) are in Alaska, look no further than the Coastal Zone Management Act. The state had a first-rate Coastal Management Program for over 30 years before it withdrew from the Act in 2011 because of extensive lobbying by extractive resource industries, and perceptions that locally affected communities had too much influence in the decision-making process (horrors). So now Alaska is the only eligible state in the US (out of 35) without a Coastal Management Program, greatly diminishing its ability to influence and condition any federal activity that occurs along it's shorelines. A short history of the hows and whys this came about can be found here: Why did Alaska eliminate the Alaska Coastal Management Program? (pdf).]
The Coastal Zone Management Act (CZMA) of 1972 showed that the United States Congress “recognized the importance of meeting the challenge of continued growth in the coastal zone”. Under this act two national programs were created, the National Coastal Zone Management Program (CZMP) and the National Estuarine Research Reserve System. Out of 35 eligible states, only 34 have established management programs; Washington State was the first state to adopt the program in 1976.The Coastal Zone Management Program (CZMP), also called the National Coastal Zone Management Program, was established under the Coastal Zone Management Act of 1972 and is administered by NOAA’s Office for Coastal Management (OCM). This program is designed to set up a basis for protecting, restoring, and establishing a responsibility in preserving and developing the nation’s coastal communities and resources, where they are under the highest pressure. The vision of the CZMP is to ensure that “the nation’s coast and oceans, including the Great Lakes and island territories, are healthy and thriving for this and future generation”. Their mission is “to ensure the conservation and responsible use of our nation’s coastal and ocean resources”.
The key goals of the National CZM program include: “protecting natural resources, managing development in high hazard areas, giving development priority to coastal-dependent uses, providing public access for recreation, coordinating state and federal actions”. Ultimately the outcomes from the CZMP are for “healthy and productive coastal ecosystems, and to have environmentally, economically, and socially vibrant and resilient coastal communities”.
The National Estuarine Research Reserve System is the second programs established by the Coastal Zone Management Act of 1972 and is also administered by the National Oceanic and Atmospheric Administration (NOAA). NERRS is a network of 28 areas within the nation and various coastal states, which spans more than 1 million acres. These areas are used for long-term research, water-quality monitoring, education, and coastal stewardship.
by Wikipedia | Read more:
Image: Orjan F. Ellingvag/Corbis via Getty Images
Monday, April 29, 2019
The High Life
Willie Nelson is sitting on a couch at his home, a modest cabin that overlooks his 700 acres of gorgeous Texas Hill Country, when he reaches into his sweatshirt and produces a small, square vaporizer, takes a hit and exhales slowly. “Wanna puff?” he asks.
Nelson’s wife, Annie, setting down a cup of coffee on a DVD case working as a coaster in front of him, speaks up. “Careful with that, babe,” she says. “You have to sing tonight.”
Nelson nods and puts it away. He turns 86 this spring and has a history of emphysema, so Annie, who’s been with Willie for 33 years, tries to get him to look out for his lungs, especially on show days. This can be a problem. “He’s super-generous,” she says, “and if there’s somebody around, he’ll want to offer it and do it with them to make them feel comfortable.”
Nelson says he stays high “pretty much all the time.” (“At least I wait 10 minutes in the morning,” Keith Richards has said.) His routine, Annie says, is to “take a couple of hits off the vape and then, an hour or two later, he might want a piece of chocolate. That keeps it going. So not a ton [of pot] . . . but he is Willie Nelson.” Annie recently bought Nelson an expensive version of a gravity bong — a fixture of high school house parties, which can shoot an entire bowl of weed into your lungs in one hit. “You can use ice water, which helps cool it off,” Annie says. “And no paper really helps.”
In addition to being the world’s most legendary country artist, Willie Nelson might also be the world’s most legendary stoner. Before Snoop or Cheech and Chong or Woody Harrelson, there was Willie. He has been jailed for weed, and made into a punchline for weed. But look at him now: Still playing 100 shows a year, still writing songs, still curious about the world. “I’m kind of the canary in the mine, if people are wondering what happens if you smoke that shit a long time,” he says. “You know, if I start jerking or shaking or something, don’t give me no more weed. But as long as I’m all right . . .”
Years before weed became legal, he spoke about the medical benefits and economic potential of weed if it were taxed and the profits were put toward education. “It’s nice to watch it being accepted — knowing you were right all the time about it: that it was not a killer drug,” says Nelson. “It’s a medicine.” (...)
Sitting with Nelson, you get used to long silences. “Oh, pickin’ a little,” he says when asked about what he’s been up to. He also just finished an album, Ride Me Back Home. The first song is about the 60 horses on his property, which Nelson bought at auction and saved from slaughterhouses. Nelson had showed me some of the horses when I visited five years ago. “Billy Boy is still here,” he says. “We lost Roll Em Up Jack. Wilhelmena the mule is gone. Uh, rattlesnake got her. Babe, you got any of that CBD coffee?”
Nelson is talking about Willie’s Remedy, the coffee that is sold by his cannabis company, Willie’s Reserve. The idea for a weed business started a few years ago; Nelson had bronchitis and he couldn’t smoke, so Annie started making him weed chocolates. The recipe took some perfecting — Nelson kept eating too many and getting too high, so she had to lower the dosages to five milligrams. She lent some to a friend, and big business came knocking. They were skeptical — “We don’t want to become the Wal-Mart of cannabis,” says Annie, who headed the negotiations. They wanted to keep in line with Nelson’s Farm Aid organization, supporting family farmers. Willie’s Reserve is now available in six states, and it’s proving “fairly lucrative,” Nelson says. It hasn’t been easy — since the drug is still federally prohibited, “the regulations change like chameleons,” says Annie. “The edibles are actually harder [to produce legally] than the flower. You have to have specific kitchens. You have to have specific licenses that take years to get.”
Nelson’s official title is “CTO: chief tasting officer.” The company even had business cards made up. He explains: “If I find something that’s really good, I say, ‘This is really good.’ ” Despite 65 years of pot use, Nelson is not a connoisseur; he shrugs when asked for his favorite Willie’s Reserve strains. His famous stash, he says — the weed that he used to keep in a Hopalong Cassidy lunchbox on his bus — is a bunch of random kinds that have been given to him by fans or thrown onto the stage. Willie’s Reserve VP Elizabeth Hogan has been trying for years to figure out what kind of weed Nelson likes. The response, Hogan says, is usually “ ‘I claim ’em all’ ” or “ ‘Pot’s like sex — it’s all good, some is great.’ ” (“He’s kind of a sativa dude,” says Annie. “He’s already funny, so it just makes him funnier.”)
Pot has been Nelson’s exclusive drug of choice since around 1978, when he gave up cigarettes and whiskey. He’d had pneumonia four times, and his hangovers had gotten nasty. Plus, he could be a mean drunk. “I had a pack of 20 Chesterfields, and I threw ’em all away and rolled up 20 fat joints, stuck ’em in there,” he says. “I haven’t smoked a cigarette since. I haven’t drank that much either, because one will make me want the other — I smoke a cigarette, I wanna drink a whiskey. Drink a whiskey, want a cigarette. That’s me. I can’t speak for nobody else.”
He has no doubt where he’d be without pot: “I wouldn’t be alive. It saved my life, really. I wouldn’t have lived 85 years if I’d have kept drinking and smoking like I was when I was 30, 40 years old. I think that weed kept me from wanting to kill people. And probably kept a lot of people from wanting to kill me, too — out there drunk, running around.”
Nelson uses the phrase “delete and fast-forward” a lot. It’s the title of a recent song of his, and it means forgive, forget and move on — a way to get through painful times. Weed, he says, helps him delete and fast-forward. “You don’t dwell on shit a lot. The short-term thing they talk about is probably true, but it’s probably good for you.”
Nelson’s wife, Annie, setting down a cup of coffee on a DVD case working as a coaster in front of him, speaks up. “Careful with that, babe,” she says. “You have to sing tonight.”
Nelson nods and puts it away. He turns 86 this spring and has a history of emphysema, so Annie, who’s been with Willie for 33 years, tries to get him to look out for his lungs, especially on show days. This can be a problem. “He’s super-generous,” she says, “and if there’s somebody around, he’ll want to offer it and do it with them to make them feel comfortable.”
Nelson says he stays high “pretty much all the time.” (“At least I wait 10 minutes in the morning,” Keith Richards has said.) His routine, Annie says, is to “take a couple of hits off the vape and then, an hour or two later, he might want a piece of chocolate. That keeps it going. So not a ton [of pot] . . . but he is Willie Nelson.” Annie recently bought Nelson an expensive version of a gravity bong — a fixture of high school house parties, which can shoot an entire bowl of weed into your lungs in one hit. “You can use ice water, which helps cool it off,” Annie says. “And no paper really helps.”In addition to being the world’s most legendary country artist, Willie Nelson might also be the world’s most legendary stoner. Before Snoop or Cheech and Chong or Woody Harrelson, there was Willie. He has been jailed for weed, and made into a punchline for weed. But look at him now: Still playing 100 shows a year, still writing songs, still curious about the world. “I’m kind of the canary in the mine, if people are wondering what happens if you smoke that shit a long time,” he says. “You know, if I start jerking or shaking or something, don’t give me no more weed. But as long as I’m all right . . .”
Years before weed became legal, he spoke about the medical benefits and economic potential of weed if it were taxed and the profits were put toward education. “It’s nice to watch it being accepted — knowing you were right all the time about it: that it was not a killer drug,” says Nelson. “It’s a medicine.” (...)
Sitting with Nelson, you get used to long silences. “Oh, pickin’ a little,” he says when asked about what he’s been up to. He also just finished an album, Ride Me Back Home. The first song is about the 60 horses on his property, which Nelson bought at auction and saved from slaughterhouses. Nelson had showed me some of the horses when I visited five years ago. “Billy Boy is still here,” he says. “We lost Roll Em Up Jack. Wilhelmena the mule is gone. Uh, rattlesnake got her. Babe, you got any of that CBD coffee?”
Nelson is talking about Willie’s Remedy, the coffee that is sold by his cannabis company, Willie’s Reserve. The idea for a weed business started a few years ago; Nelson had bronchitis and he couldn’t smoke, so Annie started making him weed chocolates. The recipe took some perfecting — Nelson kept eating too many and getting too high, so she had to lower the dosages to five milligrams. She lent some to a friend, and big business came knocking. They were skeptical — “We don’t want to become the Wal-Mart of cannabis,” says Annie, who headed the negotiations. They wanted to keep in line with Nelson’s Farm Aid organization, supporting family farmers. Willie’s Reserve is now available in six states, and it’s proving “fairly lucrative,” Nelson says. It hasn’t been easy — since the drug is still federally prohibited, “the regulations change like chameleons,” says Annie. “The edibles are actually harder [to produce legally] than the flower. You have to have specific kitchens. You have to have specific licenses that take years to get.”
Nelson’s official title is “CTO: chief tasting officer.” The company even had business cards made up. He explains: “If I find something that’s really good, I say, ‘This is really good.’ ” Despite 65 years of pot use, Nelson is not a connoisseur; he shrugs when asked for his favorite Willie’s Reserve strains. His famous stash, he says — the weed that he used to keep in a Hopalong Cassidy lunchbox on his bus — is a bunch of random kinds that have been given to him by fans or thrown onto the stage. Willie’s Reserve VP Elizabeth Hogan has been trying for years to figure out what kind of weed Nelson likes. The response, Hogan says, is usually “ ‘I claim ’em all’ ” or “ ‘Pot’s like sex — it’s all good, some is great.’ ” (“He’s kind of a sativa dude,” says Annie. “He’s already funny, so it just makes him funnier.”)
Pot has been Nelson’s exclusive drug of choice since around 1978, when he gave up cigarettes and whiskey. He’d had pneumonia four times, and his hangovers had gotten nasty. Plus, he could be a mean drunk. “I had a pack of 20 Chesterfields, and I threw ’em all away and rolled up 20 fat joints, stuck ’em in there,” he says. “I haven’t smoked a cigarette since. I haven’t drank that much either, because one will make me want the other — I smoke a cigarette, I wanna drink a whiskey. Drink a whiskey, want a cigarette. That’s me. I can’t speak for nobody else.”
He has no doubt where he’d be without pot: “I wouldn’t be alive. It saved my life, really. I wouldn’t have lived 85 years if I’d have kept drinking and smoking like I was when I was 30, 40 years old. I think that weed kept me from wanting to kill people. And probably kept a lot of people from wanting to kill me, too — out there drunk, running around.”
Nelson uses the phrase “delete and fast-forward” a lot. It’s the title of a recent song of his, and it means forgive, forget and move on — a way to get through painful times. Weed, he says, helps him delete and fast-forward. “You don’t dwell on shit a lot. The short-term thing they talk about is probably true, but it’s probably good for you.”
by Patrick Doyle, Rolling Stone | Read more:
Image: James Minchin III for Rolling Stone
The Antibiotics Industry is Broken—But There’s a Fix
Last week, the biotech company Achaogen announced that it was filing for bankruptcy. That might not seem like much news: businesses crash and burn all the time. But Achaogen, founded in 2002, was an antibiotics company. Its first drug, Zemdri (plazomicin), was approved by the Food and Drug Administration last June.
The world is running out of useful antibiotics because the rise of antibiotic resistance in bacteria is undermining them, and big firms are disinclined to make more. In 2018 alone, three large legacy pharma firms closed their antibiotic research programs. So the collapse of even a small business that stepped up to make a new antibiotic is a blow.
Achaogen hit all the marks that should have signaled success. It recruited experienced developers, targeted an infection that the World Health Organization considers a critical unmet need, stuck with its compound through 15 years of testing, scored several rounds of public investment and private philanthropy, and got its drug approved. Yet the market didn’t reward the company for producing a new antibiotic: on the day the FDA announced its decision, its stock price actually dropped by 20 percent. Almost a year later, it has earned less than $1 million on the drug, not enough to stay alive.
The larger story of the Achaogen bankruptcy is that the financial structures that sustained antibiotic development for decades are broken. If we want new antibiotics, we’re going to have to find new ways to pay for them. And that will involve hard choices with big dollar signs attached.
Successful drug development relies on an extremely simple assumption. If you spend the industry-standard amounts of time and money to achieve a new drug—generally accepted to be 10 to 15 years and at least $1 billion—you will end up with a product to which you can assign a high enough price, or sell in enough volume, to earn back that R&D budget, reward investors, and turn a profit.
That math works for most of the products of the pharmaceutical industry, from old drugs that people take every day—antidepressants, beta-blockers, statins—to the newest cancer therapiesknown as CAR-T, which can cost almost $500,000 per dose. But antibiotics don’t fit that equation. Unlike cancer drugs, most antibiotics are inexpensive; the few with high price tags are reserved for rare hospital use. And unlike drugs to treat chronic diseases, people take antibiotics for only short periods of time.
There’s another way in which antibiotics are unlike all other categories of drugs. A daily dose of Lipitor causes the world no harm—but every dose of antibiotics poses a risk of encouraging bacteria to adapt and develop resistance. So these new medications are caught in a conundrum: their fiscal promise and their social value are at odds. Public health implicitly asks physicians “to use older drugs as long as possible so that we don't add a new level of resistance,” says Kathy Talkington, who directs the Pew Charitable Trusts’ Antibiotic Resistance Project. “And the other challenge is that antibiotics lose their effectiveness over time” as resistance develops.
Past research by the Pew Trusts has shown that almost all of the companies doing research on new antibiotics—at least 90 percent—are small in pharma terms, with a market capitalization of less than $100 million. More than half are pre-revenue, still working on their first product. They don’t have a built-up infrastructure, or a steady revenue stream, which means they can quickly get overextended. (Achaogen’s last public offering in February, meant to generate three months of emergency cash, offered 15 million shares at $1 each. Its stock price the day before the FDA approval was $12.)
Because this situation is common, the policy conversation around getting new antibiotics has focused on offering support to small companies. So far, that has meant what are called “push” incentives, making grants that fund very early stage research. The largest provider of push incentives is CARB-X, an internationally funded public-private partnership based in Boston that has given more than $100 million to small pharmas since it was launched in 2016.
As it happens, Achaogen got CARB-X money. It also received funds from BARDA, the US government’s Biomedical Advanced Research and Development Authority. These were substantial grants, enough to get the company over the “valley of death” between discovery and commercialization. But they weren’t enough, because it turns out there’s a second deadly valley—after commercialization but before profitability, whenever that arrives.
Which means it’s time to talk about other, more controversial enticements to get more antibiotics on the market. These so-called “pull” incentives (the alternative to push) don’t pay R&D costs up front; instead, they reward R&D done well. Short version: they gift pharma companies huge wads of cash.
Maryn McKenna, ArsTechnica | Read more:
Image: Getty/Bloomberg
The world is running out of useful antibiotics because the rise of antibiotic resistance in bacteria is undermining them, and big firms are disinclined to make more. In 2018 alone, three large legacy pharma firms closed their antibiotic research programs. So the collapse of even a small business that stepped up to make a new antibiotic is a blow.
Achaogen hit all the marks that should have signaled success. It recruited experienced developers, targeted an infection that the World Health Organization considers a critical unmet need, stuck with its compound through 15 years of testing, scored several rounds of public investment and private philanthropy, and got its drug approved. Yet the market didn’t reward the company for producing a new antibiotic: on the day the FDA announced its decision, its stock price actually dropped by 20 percent. Almost a year later, it has earned less than $1 million on the drug, not enough to stay alive.The larger story of the Achaogen bankruptcy is that the financial structures that sustained antibiotic development for decades are broken. If we want new antibiotics, we’re going to have to find new ways to pay for them. And that will involve hard choices with big dollar signs attached.
Successful drug development relies on an extremely simple assumption. If you spend the industry-standard amounts of time and money to achieve a new drug—generally accepted to be 10 to 15 years and at least $1 billion—you will end up with a product to which you can assign a high enough price, or sell in enough volume, to earn back that R&D budget, reward investors, and turn a profit.
That math works for most of the products of the pharmaceutical industry, from old drugs that people take every day—antidepressants, beta-blockers, statins—to the newest cancer therapiesknown as CAR-T, which can cost almost $500,000 per dose. But antibiotics don’t fit that equation. Unlike cancer drugs, most antibiotics are inexpensive; the few with high price tags are reserved for rare hospital use. And unlike drugs to treat chronic diseases, people take antibiotics for only short periods of time.
There’s another way in which antibiotics are unlike all other categories of drugs. A daily dose of Lipitor causes the world no harm—but every dose of antibiotics poses a risk of encouraging bacteria to adapt and develop resistance. So these new medications are caught in a conundrum: their fiscal promise and their social value are at odds. Public health implicitly asks physicians “to use older drugs as long as possible so that we don't add a new level of resistance,” says Kathy Talkington, who directs the Pew Charitable Trusts’ Antibiotic Resistance Project. “And the other challenge is that antibiotics lose their effectiveness over time” as resistance develops.
Past research by the Pew Trusts has shown that almost all of the companies doing research on new antibiotics—at least 90 percent—are small in pharma terms, with a market capitalization of less than $100 million. More than half are pre-revenue, still working on their first product. They don’t have a built-up infrastructure, or a steady revenue stream, which means they can quickly get overextended. (Achaogen’s last public offering in February, meant to generate three months of emergency cash, offered 15 million shares at $1 each. Its stock price the day before the FDA approval was $12.)
Because this situation is common, the policy conversation around getting new antibiotics has focused on offering support to small companies. So far, that has meant what are called “push” incentives, making grants that fund very early stage research. The largest provider of push incentives is CARB-X, an internationally funded public-private partnership based in Boston that has given more than $100 million to small pharmas since it was launched in 2016.
As it happens, Achaogen got CARB-X money. It also received funds from BARDA, the US government’s Biomedical Advanced Research and Development Authority. These were substantial grants, enough to get the company over the “valley of death” between discovery and commercialization. But they weren’t enough, because it turns out there’s a second deadly valley—after commercialization but before profitability, whenever that arrives.
Which means it’s time to talk about other, more controversial enticements to get more antibiotics on the market. These so-called “pull” incentives (the alternative to push) don’t pay R&D costs up front; instead, they reward R&D done well. Short version: they gift pharma companies huge wads of cash.
Maryn McKenna, ArsTechnica | Read more:
Image: Getty/Bloomberg
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