A federal appeals court has ordered the Environmental Protection Agency (EPA) to ban the pesticide chlorpyrifos, which former Administrator Scott Pruitt refused to do last year.
The decision is a major win for environmentalists and health advocates. The EPA’s own research, as recently as 2016, linked chlorpyrifos to developmental and neurological disorders, especially in children and infants.
The Court of Appeals for the 9th Circuit said the Federal Food, Drug and Cosmetic Act, the federal law governing pesticides, requires the EPA to ban the allowance of a pesticide on food if it finds any harm from exposure to it.
Since the EPA’s research found such harm, the Trump administration violated the law when Pruitt didn’t act to revoke “tolerances” of chlorpyrifos, the regulatory term for amounts of pesticide residue allowed on food.
“There was no justification for the EPA’s decision in its 2017 order to maintain a tolerance for chlorpyrifos in the face of scientific evidence that its residue on food causes neurodevelopmental damage to children,” Judge Jed Rakoff wrote in the 2-1 opinion in the case, titled League of United Latin American Citizens v. Andrew Wheeler. [Continue reading…]
Court orders Trump EPA to ban harmful pesticide
Pharma’s investment in boosting profits more than health
Just a few years ago, infection with the hepatitis C virus guaranteed a slow and certain death for many. Available treatments were effective in about half of all patients, and the side effects could be awful. Things changed in 2014, when a new medication called Harvoni was approved to treat the infection. With cure rates approaching 99 per cent and far fewer side effects, the medication became an instant blockbuster. Sales topped $13.8 billion in 2015.
But then an odd thing happened – sales began to drop precipitously. Harvoni, in conjunction with four other hepatitis C drugs, is projected to generate only $4 billion this year, a three-fold decline in as many years. Part of this decline is due to new competitors entering the market. But according to analysts at Goldman Sachs, another reason could be that the drug’s cure-rate erodes its own market.
In a private report leaked to news outlets in April 2018, the Goldman Sachs analysts caution against investments in pharmaceutical or biotechnology companies aiming to develop outright cures, and cite Harvoni as a case study. It’s a simple point to make – if profit is your goal, then a product that eradicates its own demand might not be a wise investment. [Continue reading…]
The marvel of LED lighting is now a global blight to health
By Richard G ‘Bugs’ Stevens, Aeon
Light pollution is often characterised as a soft issue in environmentalism. This perception needs to change. Light at night constitutes a massive assault on the ecology of the planet, including us. It also has indirect impacts because, while 20 per cent of electricity is used for lighting worldwide, at least 30 per cent of that light is wasted. Wasted light serves no purpose at all, and excessive lighting is too often used beyond what is needed for driving, or shopping, or Friday-night football.
The electric light bulb is touted as one of the most significant technological advancements of human beings. It ranks right up there with the wheel, control of fire, antibiotics and dynamite. But as with any new and spectacular technology, there are invariably unintended consequences. With electric light has come an obliteration of night in much of the modern world; both outside in the city, and indoors during what was once ‘night’ according to the natural position of the Sun.
Life has evolved for several billion years with a reliable cycle of bright light from the Sun during the day, and darkness at night. This has led to the development of an innate circadian rhythm in our physiology; that circadian rhythm depends on the solar cycle of night and day to maintain its precision. During the night, beginning at about sunset, body temperature drops, metabolism slows, hunger abates, sleepiness increases, and the hormone melatonin rises dramatically in the blood. This natural physiological transition to night is of ancient origin, and melatonin is crucial for the transition to proceed as it should.
We now know that bright, short-wavelength light – blue light – is the most efficient for suppressing melatonin and delaying transition to night-time physiology; meanwhile, dimmer, longer-wavelength light – yellow, orange, and red, from a campfire or a candle, for example – has very little effect. Bright light from the Sun contains blue light, which is a benefit in the morning when we need to be alert and awake; but whether we are outdoors or indoors, when bright, blue light comes after sunset, it fools the body into thinking it’s daytime.
Pregnant women say they miscarried in immigration detention and didn’t get the care they needed
Two weeks after arriving in the US seeking asylum, E, 23, found herself in a detention cell in San Luis, Arizona, bleeding profusely and begging for help from staff at the facility. She was four months pregnant and felt like she was losing her baby. She had come to the US from El Salvador after finding out she was pregnant, in the hopes of raising her son in a safer home.
“An official arrived and they said it was not a hospital and they weren’t doctors. They wouldn’t look after me,” she told BuzzFeed News, speaking by phone from another detention center, Otay Mesa in San Diego. “I realized I was losing my son. It was his life that I was bleeding out. I was staining everything. I spent about eight days just lying down. I couldn’t eat, I couldn’t do anything. I started crying and crying and crying.”
Stuck in detention and having lost her baby, E says she wouldn’t have come to the US seeking a safer life if she’d known what would happen. She asked that her full name not to be used out of fear of repercussions while in detention and for her family back home.
“My soul aches that there are many pregnant women coming who could lose their babies like I did and that they will do nothing to help them,” she said.
About a week after speaking with BuzzFeed News, E gave up her fight for asylum, accepted voluntary departure, and was deported back to El Salvador. [Continue reading…]
A massive study solidifies the link between air pollution from cars and diabetes
It’s fairly well known that a bad diet, a lack of exercise, and genetics can all contribute to type 2 diabetes. But a new global study points to an additional, surprising culprit: the air pollution emitted by cars and trucks.
Though other research has shown a link between diabetes and air pollution in the past, this study is one of the largest of its kind, and it’s unique because it both is longitudinal and includes several types of controls. What’s more, it also quantifies exactly how many diabetes cases in the world are attributable to air pollution: 14 percent in 2016 alone. In the United States, it found, air pollution is responsible for 150,000 cases of diabetes.
The study, published in The Lancet Planetary Health, linked data from 1.7 million American veterans who had been followed for a median of 8.5 years with air data from the EPA and nasa. It also aggregated past international research on diabetes and air pollution to devise a model to estimate diabetes risk based on the level of pollution, and it used the Global Burden of Disease study to estimate how many years of healthy life were lost due to this air-pollution-induced diabetes. Globally, 8.2 million years of healthy life were lost in 2016 to pollution-linked diabetes, it showed. [Continue reading…]
How the pharmaceutical drug economy became a racket controlled by Wall Street
Donald Trump’s plan to lower prescription drug prices, announced May 11 in the Rose Garden, is a wonky departure for the president. In his approach to other signature campaign pledges, Trump has selected blunt-force tools: concrete walls, trade wars, ICE raids. His turn to pharmaceuticals finds him wading into the outer weeds of the 340B Discount program. These reforms crack the door on an overdue debate, but they are so incremental that nobody could confuse them with the populist assault on the industry promised by Trump the candidate, who once said big pharma was “getting away with murder.”
With his May 11 plan, Trump is, in effect, leaving the current pharmaceutical system in place. Increasingly, its most powerful shareholders are the activist managers of the hedge funds and private equity groups that own major stakes in America’s drug companies. They hire doctors to scour the federal research landscape for promising inventions, invest in the companies that own the monopoly licenses to those inventions, squeeze every drop of profit out of them, and repeat. If they get a little carried away and a “price gouging” scandal erupts amid howls of public pain and outrage, they put a CEO on Capitol Hill to endure a day of public villainy and explain that high drug prices are the sometimes-unfortunate cost of innovation. As Martin Shkreli told critics in 2015 of his decision to raise the price of a lifesaving drug by 5,000 percent, “this is a capitalist society, a capitalist system and capitalist rules.” That narrative, that America’s drug economy represents a complicated but beneficent market system at work, is so ingrained it is usually stated as fact, even in the media. As a Vox reporter noted in a piece covering the May announcement of Trump’s plan, “Medicine is a business. That’s capitalism. And we have seen remarkable advances in science under the system we have.”
This is a convenient story for the pharmaceutical giants, who can claim that any assault on their profit margins is an assault on the free market system itself, the source, in their minds, of all innovation. But this story is largely false. It owes much to the rise of neoliberal ideas in the 1970s and to decades of concerted industry propaganda in the years since.
In truth, the pharmaceutical industry in the United States is largely socialized, especially upstream in the drug development process, when basic research cuts the first pathways to medical breakthroughs. Of the 210 medicines approved for market by the FDA between 2010 and 2016, every one originated in research conducted in government laboratories or in university labs funded in large part by the National Institutes of Health. Since 1938, the government has spent more than $1 trillion on biomedical research, and at least since the 1980s, a growing proportion of the primary beneficiaries have been industry executives and major shareholders. Between 2006 and 2015, these two groups received 99 percent of the profits, totaling more than $500 billion, generated by 18 of the largest drug companies. This is not a “business” functioning in some imaginary free market. It’s a system built by and for Wall Street, resting on a foundation of $33 billion in annual taxpayer-funded research. [Continue reading…]
Have we forgotten how to die?
In a review of seven books on death and dying, Julie-Marie Strange writes:
James Turner was twenty-five when his four-year-old daughter Annice died from a lung condition. She died at home with her parents and grandmother; her sleeping siblings were told of her death the next morning. James did everything to soothe Annice’s last days but, never having encountered death before, he didn’t immediately recognize it. He didn’t know what to do or expect and found it hard to discuss things with his wife Martha. The family received many condolences but kept the funeral private. Losing a child, often described as the hardest bereavement to bear, changed James Turner forever.
Death in the twenty-first century is typified by the paradox contained in this story. Although we greedily consume death at a distance through fiction, drama and the media, we are hamstrung by it up close and personal. In 1955 the commentator Geoffrey Gorer declared that death had become more pornographic than sex. It was, he said, the new taboo and mourning had become “indecent”. Since then, matters have arguably got worse. The decline in institutional Christianity left a spiritual and existential vacuum, while the rise in individual materialism has fragmented family networks and communities. Shared rites of passage that publicly validated grief have receded, and the space of death has moved increasingly from the home to the hospital.
Focusing on the US and, to a lesser extent, Northern Europe, Haider Warraich’s Modern Death: How medicine changed the end of life identifies how far-reaching these changes are. A physician and clinical researcher, Warraich is well placed to observe the dubious implications of an expanded medicalization of death. Most people want to die at home, but the majority continue to die in hospital, surrounded by medical equipment. In general, life expectancy in the past century has increased, but so has the use of medicine to prolong it artificially. Definitions of death have grown more complicated – does it lie in brain function or in the heart and lungs? – and are openly contested. And despite what Warraich calls medicine’s “obsession” with preventing or delaying death, there is no clear provision for bereaved families. That task waits to be taken up. Kathryn Mannix agrees in With the End in Mind: Dying, death and wisdom in an age of denial, suggesting that it “has become taboo to mention dying”. Through a “gradual transition”, Mannix says, we have lost the vocabulary for talking about death and depend instead on euphemism, lies and ambiguity; she wants us to “reclaim” a language of death.
This is a recurring theme among these seven books. For some, our inability to talk straight about death and dying is partly about the mystery of the end. Andrew Stark, in The Consolations of Mortality: Making sense of death, identifies the decline in religion in the West and the idea of the afterlife as pivotal to our lack of confidence in confronting death. Robert McCrum, in Every Third Thought: On life, death and the endgame, speculates that ageing and death present a particular conundrum to self-assured baby boomers, who try to give death the slip (“let’s talk about it another time . . .”). In From Here to Eternity: Travelling the world to find the good death, Caitlin Doughty expands the problem into a generic Western culture of death “avoidance” – we duck awkward conversations with the dying, hand our corpses to corporate professionals and, worst of all, treat grief with embarrassment and shame. Kevin Toolis, in My Father’s Wake: How the Irish teach us to live, love and die, describes a veritable “Western Death Machine”, in which public services, health professionals, the media and corporate bodies all conspire towards the removal of death and dying from the purview of ordinary people. A former war correspondent, Toolis has seen more than his fair share of death and is here to shake us out of our complacency. [Continue reading…]
Psychedelic medicine may become available sooner than you expect
Just how soon might psychedelic-assisted psychotherapy be available aboveground, to the many people who stand to benefit from it? Before the F.D.A. approves a new medicine, the drug must survive testing for safety and efficacy in a three-stage sequence of trials, each of them involving a larger sample and more rigorous methods. When researchers recently brought to the F.D.A. the results of Phase 2 clinical trials of cancer patients who were given psilocybin and MDMA, they were stunned by the positive response of the regulators. Regulators told them they could move forward to Phase 3 with MDMA, the last step before F.D.A. approval. The F.D.A. is still considering when psilocybin trials can move into Phase 3. The agency wouldn’t comment on drugs in the approval process, but a researcher who attended one of these meetings told me the regulators seemed untroubled by the illicit status of the drugs in question or by the unique challenges of controlling studies of psychedelics. These meetings took place before a Trump-appointed F.D.A. commissioner was sworn in; it remains to be seen how the Justice Department under Jeff Sessions would respond to F.D.A. approval of psychedelics. The researchers felt heartened by the F.D.A.’s response. The message the scientists took away from the meeting was that they should raise their sights and not limit themselves to treating cancer patients, but rather test the drugs on the much larger population of patients suffering from major depression.
Thus encouraged, the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit that has been working for federal approval of psychedelics since 1986, will begin Phase 3 trials of MDMA-assisted psychotherapy this summer for the treatment of post-traumatic stress disorder, involving more than 200 volunteers at 16 sites in the United States, Canada and Israel. Later this year, pending F.D.A. approval, two Phase 3 trials of psilocybin — one for the treatment of major depression and the other for “psychospiritual distress” in cancer patients — are expected to get underway at Hopkins, N.Y.U. and a half-dozen other sites around the country.
Phase 3 trials, which typically involve hundreds of subjects at dozens of sites, can cost tens of millions of dollars — a cost ordinarily borne by the big pharmaceutical companies that stand to profit from approval. But Big Pharma has not demonstrated significant interest in psychedelics, and it’s not hard to see why: Psychedelic therapy is a rather square peg to fit into the round hole of psychopharmacology as we now know it. Patents on the molecules in question — LSD, psilocybin and MDMA — have long since expired (psilocybin comes from a common mushroom); the drugs, if approved, don’t need to be taken more than a few times; and as the C.I.I.S. program recognizes, psychedelic-assisted psychotherapy is a novel hybrid of pharmacology and talk therapy, making it uncharted territory for a pharmaceutical industry organized around the selling of pills.
But the obstacle of funding Phase 3 trials appears to have been recently surmounted. The Psychedelic Science Funders Collaborative (P.S.F.C.), a new Bay Area-based consortium of philanthropists including the hippie-soap entrepreneur David Bronner, the author and tech investor Timothy Ferriss and other donors both in and out of the tech community, has helped raise more than $63 million in charitable contributions, an amount that could be sufficient to complete the trials. The two main beneficiaries of these funds will be MAPS and Usona Institute, a nonprofit medical-research organization that is sponsoring forthcoming psilocybin trials. Rebekah Mercer, the Trump funder behind Cambridge Analytica and Breitbart, is also a donor to MAPS.
There is at least one corporation betting that psychedelic therapy will soon become a business. Founded in London by George Goldsmith, a health care industry consultant, and Ekaterina Malievskaia, a physician, Compass Pathways aims to become the world’s first psychedelic pharmaceutical company. (The couple, who are married, were inspired to expand access to psilocybin after Malievskaia’s college-age son was successfully treated by an underground guide with the drug for a debilitating case of depression.) Compass aims to be much more than a drug company, however. The company is developing a complete treatment package — consisting of a training program for therapists; protocols for orchestrating the entire experience; and the medicine itself — that it hopes to sell to health care institutions and national health services, first in Europe and then in the United States.
Its initial therapeutic target is treatment-resistant depression (patients who have failed to respond to at least two previous treatments); after an advisory process with the European Medicines Agency (the E.U.’s drug-regulating body), it has decided to conduct trials in eight to 10 sites across Europe. It is also in discussions with the F.D.A. to organize trials here. According to Goldsmith, Compass has already raised $13 million from investors in the United States and Europe, many of them from the tech community (Peter Thiel is an investor) but also institutional investors in the health care sector.
Phase 3 trials will take at least three years, but access to psychedelic therapy could come sooner than that. Under “expanded access” or “compassionate use” programs, patients who stand to benefit from therapies still deemed experimental can gain access to them before trials are complete. In the case of MDMA, this could happen as soon as 2020. [Continue reading…]
Glyphosate shown to disrupt microbiome ‘at safe levels’, study claims
A chemical found in the world’s most widely used weedkiller can have disrupting effects on sexual development, genes and beneficial gut bacteria at doses considered safe, according to a wide-ranging pilot study in rats.
Glyphosate is the core ingredient in Monsanto’s Roundup herbicide and levels found in the human bloodstream have spiked by more than a 1,000% in the last two decades.
The substance was recently relicensed for a shortened five-year lease by the EU. But scientists involved in the new glyphosate study say their results show that it poses “a significant public health concern”.
One of the report’s authors, Daniele Mandrioli, at the Ramazzini Institute in Bologna, Italy, said significant and potentially detrimental effects from glyphosate had been detected in the gut bacteria of rat pups born to mothers, who appeared to have been unaffected themselves.
“It shouldn’t be happening and it is quite remarkable that it is,” Mandrioli said. “Disruption of the microbiome has been associated with a number of negative health outcomes, such as obsesity, diabetes and immunological problems.”
Prof Philip J Landrigan, of New York’s Icahn School of Medicine, and also one of the research team, said: “These early warnings must be further investigated in a comprehensive long-term study.” He added that serious health effects from the chemical might manifest as long-term cancer risk: “That might affect a huge number of people, given the planet-wide use of the glyphosate-based herbicides.” [Continue reading…]
More than 95% of world’s population breathe dangerous air, major study finds
More than 95% of the world’s population breathe unsafe air and the burden is falling hardest on the poorest communities, with the gap between the most polluted and least polluted countries rising rapidly, a comprehensive study of global air pollution has found.
Cities are home to an increasing majority of the world’s people, exposing billions to unsafe air, particularly in developing countries, but in rural areas the risk of indoor air pollution is often caused by burning solid fuels. One in three people worldwide faces the double whammy of unsafe air both indoors and out.
The report by the Health Effects Institute used new findings such as satellite data and better monitoring to estimate the numbers of people exposed to air polluted above the levels deemed safe by the World Health Organisation. This exposure has made air pollution the fourth highest cause of death globally, after high blood pressure, diet and smoking, and the greatest environmental health risk. [Continue reading…]
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