Posts Tagged ‘pharmaceuticals’
“By temporarily disrupting the order of the brain, a new order forms. And that order may have incredible value at either the level of mental health and psychology or the level of creativity.”*…
But, Zoe Cormier warns, if the means of that constructive disruption are industrialized and turned into aggressively-marketed products, we could be in for trouble…
Welcome to the strange new world of “psychedelic capitalism,” where dozens of start-ups have already raised millions (and in some cases billions) of dollars to commercialize psilocybin (the psychedelic ingredient in magic mushrooms), DMT (found in the Amazonian brew ayahuasca), mescaline (peyote’s active component), and LSD—despite the fact that all of these “classic psychedelics” are still ranked as Schedule I drugs under the federal Controlled Substances Act. Manufacturing any of these drugs without a license can still land you a long prison sentence. But marketing one, even though they all remain illegal and none have passed all the clinical trials required for approval? That can make you a millionaire…
The days when mind-bending psychedelics were seen as appealing only to drug dealers, nut jobs, and hippies are over. Today, serious-minded people interested in randomized controlled trials and stock valuations are leading the charge.
The “psychedelic renaissance” we’ve awaited for half a century—the promised era when acid, shrooms, and peyote would be brought back into legitimate research and legal access—is finally here. But will it turn out to be worth the wait? Or the hype?
Because it’s not like we ever stopped enjoying them: In the West, hippies, scientists, “healers,” and others have used psychedelics continuously for seven decades. And before we got our hands on them, Indigenous cultures used psychedelics for thousands of years as ritual sacraments. Now dozens of start-ups want to standardize, commercialize, alter, patent, and market these ancient compounds—and they stand to make a fortune doing so.
Will old-school profit-centered tactics bring down decades of dogged work by activists, scientists, and reformers to have these drugs reassessed for their virtues? Will we experience another nasty, research-smothering backlash?…
The profiteers have arrived; get ready for Psychedelics Inc.: “The Brave New World of Legalized Psychedelics Is Already Here,” from @zoecormier @thenation.
* Michael Pollan, in conversation with Tim Ferriss on Ferriss’ blog
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As we tune in, we might spare a thought for Ellen Swallow Richards; she died on this date in 1911. The first female student admitted to MIT, she became its first female faculty member. A chemist, she did pioneering work in sanitary engineering, but is best remembered for her experimental research in domestic science, which laid the foundation for the new science of home economics, of which she is considered founder. She was one of the first ecofeminists, believing that women’s work within the home was not just vital to the economy, but also a critical aspect of our relationship to the earth.
“If locusts are ravenous sociopaths, cicadas are more like frat boys – clumsy, loud, and obsessed with sex”*…
… and they are, themselves, the object of other species’ obsessions…
This spring’s emergence of periodical cicadas in the eastern U.S. will make more than a buzz. Their bodies—which will number in the billions—will also create an unparalleled food fest for legions of small would-be predators, including many birds and mammals. But some animals may benefit more than others, and any boost predator populations get from the coming buffet of winged insects will likely be short-lived, researchers say.
Tiny chickadees and mice have been known to wrestle these chunky bugs for a quick snack. Raptors, fish, spiders, snakes and turtles will gulp them down when given the chance. Captive zoo animals, such as meerkats, monitor lizards and sloth bears, will do so as well if the insects show up in their enclosure. Observers have even reported seeing domestic cats trap two cicadas at once, one under each forepaw.
This spring, three species of cicadas (collectively referred to as Brood X or Brood 10) will crawl out of the ground where they have spent the previous 17 years. They will coat the limbs and leaves of trees, sing, mate, lay eggs and then die. Uneaten corpses and body parts will add nutrients to the soil, bolstering the ecosystem and its denizens long after the boisterous insects disappear. But the famous periodicity of cicada broods can set some predators up for feast-then-famine scenarios—population booms followed by food insecurity and then sudden drops in numbers.
“In response to this superabundance of food, a lot of the predator populations have outrageously good years,” says Richard Karban, a University of California, Davis, entomologist who studies periodical cicadas. “But then the next year, and in the intervening years, there’s no food for them, so their populations crash again.”
Predators could be part of the reason that these slow-flying, defenseless and colorful cicadas emerge periodically instead of perennially. Over millennia, synchronized periodic emergences as a dense mob could have led to higher adult survival rates. Thus, the insects evolved to adopt their unusual life cycle—most of which is spent feeding underground—explains University of Connecticut evolutionary biologist and ecologist Chris Simon, who studies cicadas. “The predators are really important in driving the whole story,” she says. The success of the species effectively banks on sheer volume…
Most bird species do not travel to take advantage of cicada emergences… They live and eat in the same areas year after year, picking off the insects opportunistically instead of traveling to the cicada motherlode… cuckoos are an exception: they migrate to take advantage of insect outbreaks all over the country…
Despite all the eager predators, the life-cycle gamble on high-volume emergences pays off for periodical cicadas. Most survive predation to mate and then drop dead to the forest floor. But even if they go uneaten, their ecosystem impact does not stop there. Cicada bodies contain about 10 percent nitrogen, which is more than the concentration found in dead leaves and other typical forest litter, says Louie Yang, a University of California, Davis, entomologist, who studies resource pulses and phenological shifts. Plants such as American bellflowers will take up the nitrogen from the dead cicadas, and herbivorous mammals and insects will selectively feed on the higher-nitrogen fertilized leaves, he adds.
Patterns such as this one illustrate the ecological lens that periodical cicadas can provide on biological communities and evolutionary timelines. “I love the reciprocity of the whole system,” Yang says. “I think this kind of stuff happens all the time, but it’s usually hard to see. When these pulse events happen, it makes it really obvious—we can see that pulse pass through the system.”…
Billions of emerging insects will likely trigger predator population surges: “Brood X Cicadas Could Cause a Bird Baby Boom.”
Oh, and given climate change, 17-year cicadas could become 13-year cicadas: “The cicadas are coming. And they’re changing dramatically.”
* Catherine Price, 101 Places Not to See Before You Die
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As we bear the buzz, we might recall that it was on this date in 1923 that insulin became publicly available for use by diabetics. Frederick Banting had discovered insulin in 1921, and refused to put his name on the patent. He felt it was unethical for a doctor to profit from a discovery that would save lives. He and his co-inventors, James Collip and Charles Best, sold the insulin patent to the University of Toronto for a mere $1. They wanted everyone who needed their medication to be able to afford it.
Today, Banting and his colleagues would be spinning in their graves: Their drug, which many of the 30 million Americans with diabetes rely on, has become the poster child for pharmaceutical price gouging.
The cost of the four most popular types of insulin has tripled over the past decade, and the out-of-pocket prescription costs patients now face have doubled. By 2016, the average price per month rose to $450 — and costs continue to rise, so much so that as many as one in four people with diabetes are now skimping on or skipping lifesaving doses…
“You’re mugging old ladies every bit as much if you pinch their pension fund”*…
Who benefits from the commercial biomedical research and development (R&D)? Patients-consumers and investors-shareholders have traditionally been viewed as two distinct groups with conflicting interests: shareholders seek maximum profits, patients – maximum clinical benefit. However, what happens when patients are the shareholders?…
Adding investments by governmentally-mandated retirement schemes, central and promotional banks, and sovereign wealth funds to tax-derived governmental financing shows that the majority of biomedical R&D funding is public in origin. Despite this, even in the high-income countries patients can be denied access to effective treatments due to their high cost. Since these costs are set by the drug development firms that are owned in substantial part by the retirement accounts of said patients, the complex financial architecture of biomedical R&D may be inconsistent with the objectives of the ultimate beneficiaries…
It has been estimated that of the total $265 billion spent annually on biomedical research worldwide, over a third – $103 billion comes from public sources. Nevertheless, as public input capital is allocated predominantly into early stage research, nearly all output – medicines – is ultimately brought to the market by private firms. Importantly, these firms are not independent agents. They have owners-shareholders to report to. Until the end of the previous century the major type of owners-shareholders were individual households. At the turn of the millennium, however, they have been displaced by institutional investors, the largest of which are public retirements schemes or quasi-public funds, such as occupational pensions.
First, government money underwrites the basic R&D that goes into drug discovery and development, then public pension monies fund the private companies that bring those drugs to market. As the private companies are solving for highest profits, as opposed to optimal public health, those drugs are often priced out of the reach of the very people whose pension contributions funded their development. Drugs “priced out of reach” is certainly not a new phenomenon; AIDS drugs (to take one example) were priced by Western pharma companies at prices that rendered them inaccessible to most citizens of low-income countries in Africa and Asia. The pensioners in wealthy nations were, effectively, living off of the misery of those in poorer companies.
But the dynamic has continued, deepened– and come home to roost. Now patients in high-income countries are denied access to effective treatments due to their high cost, while these costs are being set by the drug development firms, owned in substantial part by the retirement accounts of those same patients, and benefiting from direct and indirect governmental support.
Investing in one’s own misery– the painful irony of pharma funding: “Pension and state funds dominating biomedical R&D investment: fiduciary duty and public health.”
[Image above: source]
* Ben Elton, Meltdown
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As we untangle unintended consequences, we might send healthy birthday greetings to Charles Value Chapin; he was born on this date in 1856. A physician and epidemiologist, he was a pioneer in American public health. He co-founded in first bacteriological laboratory in the U.S. (in 1888) in Providence, were he was Superintendent of Health– a position he held for 48 years. In 1910, he established Providence City Hospital where infectious disease carriers could be isolated under aseptic nursing conditions; his success inspired similar health control measures throughout the U.S. A professor (at Brown) and prolific writer, his impact on health policy and practice was so broad that he was hailed as “the Dean of City Public Health Officials.”
“Gain not base gains; base gains are the same as losses”*…
When inventor Frederick Banting discovered insulin in 1921, he refused to put his name on the patent. He felt it was unethical for a doctor to profit from a discovery that would save lives. Banting’s co-inventors, James Collip and Charles Best, sold the insulin patent to the University of Toronto for a mere $1. They wanted everyone who needed their medication to be able to afford it. [see here]
Today, Banting and his colleagues would be spinning in their graves: Their drug, which many of the 30 million Americans with diabetes rely on, has become the poster child for pharmaceutical price gouging.
The cost of the four most popular types of insulin has tripled over the past decade, and the out-of-pocket prescription costs patients now face have doubled. By 2016, the average price per month rose to $450 — and costs continue to rise, so much so that as many as one in four people with diabetes are now skimping on or skipping lifesaving doses…
Why Americans ration a drug discovered– and given free to the world– in the 1920s: “The absurdly high cost of insulin, explained.”
* Hesiod (See also Proverbs 28:20: “he that maketh haste to be rich shall not be innocent”)
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As we ponder pleonexia, we might send healing birthday greetings to Edward Lawrie Tatum; he was born on this date in 1909. A geneticist, he shared half of the Nobel Prize in Physiology or Medicine in 1958 with George Beadle for showing that genes control individual steps in metabolism. During World War II, his work was of use in maximizing penicillin production, and it has also made possible the introduction of new methods for assaying vitamins and amino acids in foods and tissues. Tatum and Joshua Lederberg (the winner of the other half of the 1958 Nobel award), discovered genetic recombination in bacteria.
His discoveries were made freely available to the scientific community.
“If you don’t have a plan, you become part of somebody else’s plan”*…
In 1955, a bank executive and a New York society photographer found themselves in a thatch-roofed adobe home in a remote village in the Mazateca mountains. Gordon Wasson, then a vice president at J.P. Morgan, had been learning about the use of mushrooms in different cultures, and tracked down a Mazatec healer, or curandera, named María Sabina. Sabina, about 60 at the time, had been taking hallucinogenic mushrooms since she was a young child . She led Wasson and the photographer, Allan Richardson, through a mushroom ceremony called the velada.
“We chewed and swallowed these acrid mushrooms, saw visions, and emerged from the experience awestruck,” Wasson wrote in a Life magazine article, “Seeking the Magic Mushroom.” “We had come from afar to attend a mushroom rite but had expected nothing so staggering as the virtuosity of the performing curanderas and the astonishing effects of the mushrooms.”
Appointing himself as one of the “first white men in recorded history to eat the divine mushrooms,” Wasson inadvertently exposed much of the Western world, and the burgeoning counterculture movement, to psychedelic mushrooms. On the other side of the globe, the Swiss drug company Sandoz received 100 grams of the mushrooms from a botanist who had visited Sabina on one of Wasson’s return trips. They went to the lab of Albert Hofmann (see here) the Swiss chemist who first synthesized LSD. In 1963, Hofmann traveled to Mexico with pills containing synthetic psilocybin, the active compound in magic mushrooms.
“We explained to María Sabina that we had isolated the spirit of the mushrooms and that it was now in these little pills,” Hofmann said during an interview in 1984. “When we left, María Sabina told us that these tablets really contained the spirit of the mushrooms.”
Hofmann’s pills were the first indication that while people can have spiritual and transcendent experiences from eating the mushrooms themselves, they can also have such experiences with a man-made version of just one of the mushroom’s compounds: psilocybin.
This development is particularly relevant today, as scientists study psychedelic mushrooms as potential treatment options for those who suffer from severe depression, addiction, and more. In clinical trials, such as those ongoing at Johns Hopkins University and Imperial College London, participants don’t eat caps or stems. They consume synthetic psilocybin, made in a lab by chemists in a way similar to how Hofmann first made his psilocybin.
It’s a necessary hurdle: Psilocybin mushrooms can be grown relatively easily, and aren’t expensive to produce. But researchers have to source their psilocybin from highly regulated labs because natural products vary, and researchers need consistency in chemical composition and dosage in order to do controlled studies. Clinicians need to know how much of a drug they’re giving to a patient, how long it takes to kick in, and how long it lasts; they also need to be sure their drug isn’t tainted with other chemicals. It also helps to be able to mass-produce large amounts and not be threatened by variables, like weather, that affect agricultural products.
As psilocybin moves closer to becoming a legal medicine meeting all the regulatory requirements, doctors won’t be writing prescriptions for mushroom caps or stems—and this will come at a certain cost. Johns Hopkins researchers have claimed they’ve paid labs $7,000 to $10,000 per gram of psilocybin, whereas the street price of magic mushrooms is around $10 per gram. Besides the cost of chemical materials, the steep sticker price comes from the labor required to adhere to the U.S. Food and Drug Administration’s strict drug-making standards, known as Current Good Manufacturing Practice.
It’s an unprecedented moment, and psychedelic culture must reckon with what it means for a magic mushroom to become a synthetic pill, to be picked up at your local pharmacy or from a doctor. There’s some wariness in the psychedelic community about what synthetic psilocybin represents: big business, questionable investors, and patents on experiences they think shouldn’t have a price tag or a profit margin. Since it’s a known natural compound, psilocybin itself cannot be patented, but the way it’s made and used can be. Already there are organizations applying for patents for their synthesis process, and innovators coming up with new ways to make large amounts of synthetic psilocybin, all seeking protection for their intellectual property…
The truth is, there is money to be made in psychedelics, and investors are flocking to back startups in the psychedelic and mental health spaces. The current antidepressant medication market was valued at $14 billion in 2018 and is estimated to grow to $16 billion in the next three to five years. Any drug company that can compete stands to become very wealthy…
As magic mushrooms make the shift from recreational drug to mental health treatment, patients won’t be eating caps and stems, but a synthetic product made in a lab—one that pharma companies can patent and from which they can profit: “Get Ready for Pharmaceutical-Grade Magic Mushroom Pills.”
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As we ponder the profound, we might recall that it was on this date in 1956 that city authorities in the California beach town of Santa Cruz announced a total ban on the public performance or playing of rock and roll music, calling it “detrimental to both the health and morals of our youth and community.”
It may seem obvious now that Santa Cruz’s ban on “Rock-and-roll and other forms of frenzied music” was doomed to fail, but it was hardly the only such attempt. Just two weeks later in its June 18, 1956 issue, Time magazine reported on similar bans recently enacted in Asbury Park, New Jersey, and in San Antonio, Texas, where the city council’s fear of “undesirable elements” echoed the not-so-thinly-veiled concerns of Santa Cruz authorities over the racially integrated nature of the event that prompted the rock-and-roll ban… (source)
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