Author: bkellaway

Fauci dice que una vacuna contra COVID podría estar lista antes de lo esperado

Una vacuna contra COVID-19 podría estar disponible antes de lo esperado si los ensayos clínicos en curso producen resultados abrumadoramente positivos, dijo el doctor Anthony Fauci, funcionario de enfermedades infecciosas de más alto rango del país, en una entrevista con KHN.

Aunque se espera que dos ensayos clínicos en curso con 30,000 voluntarios terminen para fin de año, Fauci dijo que una junta independiente tiene la autoridad para finalizarlos semanas antes si los resultados provisionales son abrumadoramente positivos o, por el contrario, negativos.

La Junta de Monitoreo de Datos y Seguridad (DSMB) podría decir: “al momento, los datos son tan buenos que se puede decir que son seguros y efectivos”, explicó Fauci. En ese caso, los investigadores tendrían “la obligación moral” de finalizar el ensayo antes de tiempo y hacer que la vacuna esté disponible para todos en el estudio, incluidos los que recibieron placebos, y acelerar el proceso para administrarla a millones.

Los comentarios de Fauci, quien es director del Instituto Nacional de Alergias y Enfermedades Infecciosas, ocurren en un momento de creciente preocupación sobre si la presión política de la administración Trump podría influir en los reguladores federales y los científicos que supervisan la respuesta de la nación a la pandemia del nuevo coronavirus. Y erosionar la débil confianza del público en las vacunas.

Destacados expertos en vacunas han dicho que temen que Trump esté presionando por una aprobación temprana de una vacuna para ayudar a ganar la reelección.

Fauci dijo que confía en los miembros independientes del DSMB, que no son empleados del gobierno, para mantener las vacunas a altos estándares sin influencias políticas. Los miembros de la junta suelen ser expertos en inmunización y bioestadística, y suelen dar cátedra en las principales escuelas de medicina.

“Si estás tomando una decisión sobre la vacuna, es mejor asegurarse de tener muy buena evidencia de que es segura y efectiva”, dijo Fauci. “No me preocupa la presión política”.

La junta de seguridad analiza periódicamente los datos de un ensayo clínico para determinar si es ético continuar inscribiendo voluntarios, que se asignan al azar para recibir una vacuna experimental o una inyección de placebo (que no contiene la dosis de la vacuna). Ni los voluntarios ni los trabajadores sanitarios que los inyectan saben qué vacuna están recibiendo.

Los fabricantes ahora están probando tres vacunas contra COVID en ensayos a gran escala en los Estados Unidos. Los dos primeros estudios, uno dirigido por Moderna y los Institutos Nacionales de Salud y el otro dirigido por Pfizer y BioNTech, comenzaron a fines de julio.

Cada estudio fue diseñado para inscribir a 30,000 participantes. Los funcionarios de la compañía han dicho que ambos ensayos han inscrito aproximadamente la mitad de ese total. AstraZeneca, que ha estado ejecutando ensayos clínicos a gran escala en Gran Bretaña, Brasil y Sudáfrica, lanzó otro gran estudio con una vacuna en los Estados Unidos la primera semana de septiembre, en el que participan 30,000 voluntarios. Se espera que comiencen ensayos adicionales de vacunas este mes.

En ensayos de este tamaño, los investigadores sabrán si una vacuna es efectiva después de tan solo 150 a 175 infecciones, dijo el doctor Robert Redfield, director de los Centros para el Control y Prevención de Enfermedades (CDC), en una llamada con periodistas el viernes 28 de agosto.

“Puede ser sorprendente, pero el número de eventos que deben ocurrir es relativamente pequeño”, dijo Redfield.

En este momento, la junta de seguridad sólo tiene acceso a los datos del ensayo, dijo Paul Mango, subdirector de personal para Normas del Departamento de Salud y Servicios Humanos (HHS). En cuanto a cuándo estarán disponibles los resultados de la prueba, “no podemos determinar si será a mediados de octubre o diciembre”.

Las juntas de seguridad establecen “reglas de detención” al comienzo de un estudio, lo que deja muy claro sus criterios para finalizar un ensayo, dijo el doctor Eric Topol, vicepresidente ejecutivo de investigación de Scripps Research en San Diego y experto en el uso de datos en investigación médica.

Aunque la junta de seguridad puede recomendar detener un ensayo, la decisión final la toman los científicos que lo está realizando, dijo Topol.

Luego, un fabricante de vacunas podría solicitar a la Administración de Alimentos y Medicamentos (FDA) una autorización de uso de emergencia, que se puede otorgar rápidamente, o continuar a través del proceso regular de aprobación de medicamentos, que requiere más tiempo y evidencia.

Los que monitorean la seguridad también pueden detener un ensayo debido a preocupaciones de seguridad, “si parece que realmente está dañando a las personas en el brazo, o por una una gran cantidad de efectos secundarios”, dijo Fauci.

Fauci dijo que la gente puede confiar en el proceso, porque todos los datos que los monitores externos usaron para tomar sus decisiones se hacen públicos.

“Todo eso tiene que ser transparente”, dijo Fauci. “El único momento preocupante es si existe alguna presión para terminar el ensayo antes de tener suficientes datos sobre seguridad y eficacia”.

En las últimas semanas, Topol y otros científicos han criticado duramente a la FDA, acusando al comisionado Stephen Hahn de ceder ante la presión política de la administración Trump, que ha empujado a la agencia a aprobar los tratamientos para COVID más rápido.

Frenar los ensayos antes de tiempo plantea una serie de riesgos, por ejemplo,  hacer que una vacuna parezca más eficaz de lo que realmente es, dijo Topol.

“Si detienes algo antes, puedes obtener un beneficio exagerado que no es real, porque la evidencia menos positiva solo surge más tarde”, dijo Topol.

Detener los estudios antes de tiempo también podría evitar que los investigadores recluten más voluntarios de minorías. Hasta ahora, solo 1 de cada 5 participantes del ensayo son personas de raza negra o hispanos (de todas las razas). Dado que esos grupos se han visto más afectados por la pandemia que otros, es importante que constituyan una parte más importante de los ensayos de vacunas, agrego Topol.

La finalización temprana de los ensayos de vacunas también conlleva riesgos de seguridad, expresó el doctor Paul Offit, desarrollador de vacunas que forma parte de un panel asesor de los NIH sobre vacunas y tratamientos para COVID.

Un ensayo más pequeño y más corto podría no detectar efectos secundarios importantes de la vacuna, que podrían hacerse evidentes solo después de que millones de personas hayan sido inmunizadas, dijo Offit, director del Centro de Educación sobre Vacunas del Hospital de Niños de Philadelphia.

Los investigadores continuarán siguiendo a los voluntarios vacunados durante un año completo para detectar efectos secundarios a largo plazo, dijo Redfield.

Y Fauci reconoció que acortar un ensayo podría socavar la confianza del público en las vacunas contra COVID. Uno de cada tres estadounidenses no está dispuesto a recibir una vacuna contra el nuevo coronavirus, según una encuesta reciente de Gallup.

Esta historia fue producida por Kaiser Health News, un programa editorial independiente de la Kaiser Family Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Flamboyant cuttlefish save their bright patterns for flirting, fighting and fleeing

Don’t let the name fool you. Flamboyant cuttlefish (Metasepia pfefferi) look anything but flashy most of the time. Images and videos of the marine mollusks flashing bright purple and yellow hues litter the internet, perpetuating the idea that these animals are constantly putting on a show in the wild. But a new study proves just the opposite: Flamboyant cuttlefish spend most of their time looking like a pile of mud.

“These animals have superb camouflage,” says Roger Hanlon, a marine biologist at the Marine Biological Laboratory in Woods Hole, Mass. Specialized cells and structures in their skin allow the animals to instantly morph into ostentatious patterns, as well as blend in.

Keen to see how the animals balanced flamboyance with camo in nature, Hanlon organized two field studies in a cuttlefish habitat off the coast of North Sulawesi, Indonesia. Citizen scientist divers scouted the Lembeh Strait area over eight days in 2002 and again for 11 days in 2019, being careful to eavesdrop without disturbing the animals.  Video footage collected by the team now reveals intimate details of the species’ mating practices and defensive behaviors as well as what the animals do in their downtime. Hanlon and Gwendolyn McManus, a marine biology student at Northeastern University in Boston, describe the results in the August Journal of Experimental Marine Biology and Ecology.

The solitary species slowly ambles along the seafloor, foraging in a drab region of mud and sand between coral reefs. “It’s like a moonscape or a desert,” says Hanlon. Flamboyant cuttlefish take on the color and texture of their muddy seafloor backdrop and masquerade as a lump of sand or a rock. Like some other cephalopods, these cuttlefish spend most of their time incognito, reserving their displays for special occasions: confusing a predator, courting a mate and sparring with rival suitors.

cuttlefish in colorful form and in camouflage
Contrary to previous studies and scuba diver reports, flamboyant cuttlefish don’t parade around the ocean in full getup (left). They actually spend most days pretending to be rocks (right).L-R:  R. Hanlon, F. Bavendam

Flashing their good looks 24/7 would attract unwanted attention. But it comes in handy if their first line of defense — camouflage — fails. Then, both males and females will engage in a campaign of unpredictability. When confronted by a threat, the animal might quickly flash its colors to frighten the predator, sometimes in just 700 milliseconds. Next, it cycles through other confusing behaviors — jetting, shooting ink and reverting to camouflage — until it has eluded the enemy.

Males also show flamboyant displays to attract the ladies. After spotting a female in the distance, a male will flaunt bright colors and undulate their mantle stripes in a move called “the passing cloud.” Researchers also observed two types of gestures during this colorful routine: arm waving (reminiscent of a human bowing) and kissing (a tap on the female’s arm with his arms). “These displays are really elaborate and dynamic,” says Hanlon. “And they’re comparable to what some of the most sophisticated birds do and even some primates.”

Love triangles happen, and males sometimes guard females and fight off other males (SN: 5/12/17). In brawls, male body patterns split flirting and fighting. The side facing the female flashes the bright motif, while the side facing the male takes on an aggressive white pattern.

Video footage from field studies in Indonesia provides an inside look at the lives of flamboyant cuttlefish.

All of this pizzazz can put males at risk. Hanlon recalls an instance where a male swimming backward got scarfed up by a scorpion fish in the midst of his flamboyant display. “There’s the price you pay for displaying to a female not paying attention to where you’re going,” says Hanlon.

But the risk can come with reward — for some lucky guys. Eventually, a female may open her arms and mate for a quick three seconds. Figuring out exactly what flirting tactics a female uses to select her mate requires more data. “Does she focus on the male’s courtship dance? On his ‘kiss’ signal? Or on how bright his passing cloud is? It’s too soon to tell,” says Alex Schnell, a wildlife scientist at Cambridge University who was not affiliated with the study.

Males also got shot down a lot, as picky females appear largely unmoved by most of their showmanship. Of 108 kisses observed, only 20 led to something more. The observations hint that the most successful males might be the ones that worked the hardest and remained persistent.

The field observations fill in knowledge gaps about how these animals survive in the wild and contradict two previous studies in a lab and an aquarium, as well as photos and videos from scuba divers, that suggested that the animals displayed their flamboyant patterns more frequently. Looming humans, bright lights and higher density tanks may have shifted the behavior of a species that spends most of its time alone and under the radar.

Walmart Sued Over Opioids

Addiction Recovery Bulletin

Everyone knew! –  

August 24, 2020 – “Revelations concerning Walmart are not emerging because Walmart somehow chose to ‘come clean’ on its deplorable refusal to control how its nationwide pharmacies distributed opioids,” the complaint says. “Despite federal prosecutors contemplating an indictment of Walmart, Walmart failed to disclose this information to stockholders.”

The lawsuit is the second filed in Delaware Chancery Court by pension funds seeking access to the retail giant’s internal files under a state law giving corporate shareholders broad records inspection rights if they credibly suspect wrongdoing at the top.

Walmart didn’t immediately respond to a request for comment Monday. A company spokesman told Bloomberg in response to the earlier records suit that “Walmart takes its responsibility to shareholders seriously” and “there is no credible basis to conclude Walmart or its board engaged in any misconduct.”

more@BloombergLaw

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87% of people with eating disorders say symptoms are worse during COVID

Addiction Recovery Bulletin

Feast or Famine –  

August 28, 2020 – The study traces 129 people in recovery or treatment, providing a detailed look at a common scenario, and it joins growing indications that those with eating disorders are struggling. Beat, the UK charity, reportsroughly double the crisis hotline calls and online group attendance since the pandemic began. And a similar recent study of over 1,000 people in the UK and the Netherlands, published last month, reported that the pandemic is having “strong and wide-ranging effects” on eating disorder behaviors. The study participants reported feelings of being out of control, upended routines, low socialization and social support, and an increased preoccupation with food. Some also described concerning changes in access to healthcare, ranging from early discharge from inpatient programs to suspended treatment plans.

At least 13% of women experience an eating disorder during their lives. Experts expect this year’s eating disorder spinouts to have long-lasting effects.

“We must not underestimate the longevity of the impact of the pandemic. Individuals with experience of eating disorders will likely experience a long-term effect on their symptoms and recovery,” says lead author Dawn Branley-Bell, a psychology research fellow at Northumbria University.

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Even with a license to prescribe Buprenorphine many doctors are mum

Addiction Recovery Bulletin

Prejudice, Knowledge, or Ignorance? –

August 28, 2020 – As of 2018, only about 5% of physicians had a license to prescribe buprenorphine — despite increasing demand for the drug and an overdose crisis that killed 70,000 people in the United States last year alone.

“[Bupe] can be prescribed for pain without any of these regulatory requirements. When prescribing it for opioid use disorder, it’s layered with all these barriers. There’s a stigma around the medication,” said Beth Connolly, the project director of Pew’s substance use prevention and treatment initiative. ”It was really important to study what some of the barriers are, and whether people are actually prescribing it.” The study looked at the monthly buprenorphine patient volume for physicians licensed to prescribe the drug between April 2017 and January 2019. Just over 50% wrote at least one prescription during that time period. And most of the physicians who did regularly prescribe it didn’t hit their “patient cap,” in some cases prescribing to just a handful of patients.

The problem isn’t necessarily that individual doctors aren’t prescribing to as many patients as possible — it’s that so few doctors can prescribe buprenorphine at all, said Jeanmarie Perrone, the director of the Division of Medical Toxicology and Addiction Medicine Initiatives in the University of Pennsylvania’s Department of Emergency Medicine.

more@Inquirer

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Opioid crisis is ‘a product’ of U.S. health care

Addiction Recovery Bulletin

A working paper published by the National Bureau of Economic Research (NBER) argues that the decades-long U.S. opioid crisis is “a unique product of specific policies and features of the U.S. health care market” that remain in effect.

“Without the opioid epidemic, American life expectancy would not have declined in recent years,” the paper stated. “In turn, the epidemic was sparked by the development and marketing of a new generation of prescription opioids and provider behavior [that] is still helping to drive it.”

In December 1995, the FDA approved a new opioid known as Oxycodone. Subsequently, according to the National Institute on Drug Abuse (NIDA), “pharmaceutical companies reassured the medical community that patients would not become addicted to prescription opioid pain relievers, and health care providers began to prescribe them at greater rates.” A blizzard of prescriptions followed.

An estimated 21-29% of patients who are prescribed opioids for chronic pain end up misusing them, according to NIDA, while 8-12% develop an opioid use disorder.

Tens of millions of Americans became addicted to prescription opioids and tens of thousands died of overdoes in the two decades that followed. In recent years, the overdose crisis accelerated after synthetic opioids like fentanyl began flooding the U.S.

A lot of the problem has to do with regulation’

The pharmaceutical industry’s opportunism — enabled by the backing of politicians and federal regulators — along with the emerging medical consensus that opioids were highly effective for pain management, led to opioids taking hold in American society.

Furthermore, money pouring in from Big Pharma and a green light from D.C. provided American doctors with a financial incentive to prescribe more opioids.

“People have blamed all sorts of things, heroin from Mexico and fentanyl from China and economic decline and so on and so forth,” Dr. Janet Currie, a professor of economics and public affairs at Princeton University and one of the co-authors of the paper, told Yahoo Finance. “But really the issue is that a whole lot of people got addicted because they were prescribed pain medications which aren’t prescribed in the same way in other countries. They’re much more controlled.”

Opioids are prescribed and abused in the U.S. at a significantly higher rate than any other country.

“If you recognize that a lot of the problem has to do with regulation… most other countries, when they do allow opioid prescription, they don’t know how high doses of opioid prescriptions are but we do,” Currie said. “Most other countries don’t allow advertising medications direct-to-consumers but we do. There’s a whole list of things like that which have made things worse.”

‘The economic impact is also quite substantial’

Some research indicates a strong correlation between workforce participation and overdose rates. And last year, while testifying before the House Financial Services Committee, Federal Reserve Chair Jerome Powell spoke of adverse effects on the workforce.

Originally posted on Yahoo.com here

Casino Reopenings Bring Gambling Addiction Back Into Focus

Addiction Recovery Bulletin

LISTEN – They’ll always take your action at G.A. –

August 20, 2020 – But after reopening in mid-June, business is booming again, and counselors are concerned.

“Since they’ve reopened, our calls to the hotline number and to the agency have been on a steady increase,” says Bruce Jones, who heads the gambling program at Maryhaven.

That demand is reflected in big profits for casinos and racinos around the state.

“Keep in mind that because of COVID, they reduced numbers of availability on the machines and some of the poker rooms were closed, and they still set records, so they’re back strong,” Jones says.

Jones says that, according to figures he’s seen, Hollywood Casino Columbus brought in $18 million last month.

“People are venturing back, even taking the risk with the social distancing and everything,” he says.

Jones adds it’s not just the availability of gambling: an influx of federal cash may have contributed to the increase.

“I think it’s great that people received stimulus checks during this period, but it was not a good thing for a lot of people in recovery,” he says.

more@WOSU

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Taste for Money is for Anyone who is Planning to Live a Sober Life

Addiction Recovery Bulletin

Listings and Recommendations –  

August 23, 2020 – Some people don’t want to live in holes anymore and want to see the light of the day. Every addict’s story is something like that. However, beating addiction isn’t as easy. There are multiple ways to deal with addiction and work for sobriety. Recovery homes are places where people can find a semblance of peace and work on being sober.

Sober living homes are pockets of goodness where addicts can work on their growth. But finding good sober living homes or recovery homes isn’t easy. That’s why an app called Taste Recovery has been created, that searches for recovery homes efficiently.

more@DigiHerald

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‘We are all on the same team’: Police play softball with recovering addicts

Addiction Recovery Bulletin

WATCH – Hear the crack of the bat? –

August 23, 2020 – A team consisting of officers from local law enforcement agencies in Washington County took on a team of individuals involved in recovery from drug and alcohol addiction. The two teams squared off on the softball field Saturday night at the Canyon Softball Complex on West 2000 North in St. George.

The event was organized as a way to demonstrate the positive relationship between two groups of people that are sometimes viewed as mortal enemies, and to break the common stereotypes that can come with active addiction.

The game was organized by Ty Empey, with Hope Rising Detox and Rehabilitation, and included members of the Recovery Softball League that played against a law enforcement team that included players from five participating agencies, including the Washington City Police Department, the St. George Police Department, Adult Probation & Parole, the Washington County Sheriff’s Office and the Santa Clara-Ivins Police Department.

more@StGeorgeNews

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Chem-Free Sobriety: natural recovery from substance use disorders

Addiction Recovery Bulletin

MEDIA: Book Recommendation –  

April 28, 2020 –  Each story provides answers to the following questions: When did you start drinking or using drugs, and how did it progress? Looking back, when do you think it was mostly out of control? How are you able to not drink or use daily? What is your thought about medication-assisted treatment? Is there anything you want those struggling with addiction to know? What do you want lawmakers to know? Combining Suzanne Thistle’s 20 years of professional knowledge and 101 people with lived experience, Chem-Free Sobriety gives a practical approach to recovery from alcohol and drug use disorders. Family members, medical providers, and others will also be motivated by the insight gleaned from this book.

more@Amazon

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