domingo, 24 de octubre de 2021

Las pastillas del abuelo / Doctora

Doctora 2

En los momentos en que quiero escapar 

De mi propia piel, vos sos mi doctora

Con mi panza y tu panza rozándose

No hay poeta que no haga una canción

Tirando a matar, dándonos changüí

Puro razonar, puro frenesí

De mi propia piel, vos sos mi doctora

Con mi panza y tu panza rozándose

No hay poeta que no haga una canción

Tirando a matar, dándonos changüí

Puro razonar, puro frenesí


viernes, 22 de octubre de 2021

Ratón de biblioteca: Dopesick / Beth Macy



Beth Macy takes us into the epicenter of America's twenty-plus year struggle with opioid addiction. From distressed small communities in Central Appalachia to wealthy suburbs; from disparate cities to once-idyllic farm towns; it's a heartbreaking trajectory that illustrates how this national crisis has persisted for so long and become so firmly entrenched. 

Beginning with a single dealer who lands in a small Virginia town and sets about turning high school football stars into heroin overdose statistics, Macy endeavors to answer a grieving mother's question-why her only son died-and comes away with a harrowing story of greed and need. From the introduction of OxyContin in 1996, Macy parses how America embraced a medical culture where overtreatment with painkillers became the norm. 


Todo sobre OxyContin en PHARMACOSERIAS

In some of the same distressed communities featured in her bestselling book Factory Man, the unemployed use painkillers both to numb the pain of joblessness and pay their bills, while privileged teens trade pills in cul-de-sacs, and even high school standouts fall prey to prostitution, jail, and death.

 Through unsparing, yet deeply human portraits of the families and first responders struggling to ameliorate this epidemic, each facet of the crisis comes into focus. In these politically fragmented times, Beth Macy shows, astonishingly, that the only thing that unites Americans across geographic and class lines is opioid drug abuse. But in a country unable to provide basic healthcare for all, Macy still finds reason to hope-and signs of the spirit and tenacity necessary in those facing addiction to build a better future for themselves and their families. Ver


jueves, 21 de octubre de 2021

Aduhelm: FDA 'probably the worst drug approval decision in recent US history'


(CNN) Dr. Aaron Kesselheim had been on an advisory committee for the US Food and Drug Administration for a half-dozen years, but he had never been to a meeting like this one.

The FDA establishes advisory committees to assist the federal agency with one of its most important duties: deciding whether to approve the distribution of new drugs. The stakes of these decisions are enormous. Based on the outcome of the FDA's deliberations, patients may gain access to lifesaving medicines, and manufacturers may reap billions in profits. Kesselheim, a professor at Harvard Medical School, was one of the members of this committee because of his expertise on pharmaceuticals that address diseases of the brain, including Alzheimer's, the irreversible, progressive brain disorder that destroys memory and thinking skills, and eventually causes death. Alzheimer's is the sixth leading cause of death in the United States.

The public meeting, conducted as an all-day video call on November 6, 2020, concerned the application for aducanumab, a drug that would be marketed under the name Aduhelm by the company Biogen, which is based in Cambridge, Massachusetts. Aduhelm, if effective, would address one of the most pressing needs in modern medicine: to slow the symptoms of Alzheimer's disease. 

Research into Alzheimer's treatments has long been an exercise in frustration, with no new drugs approved since 2003. The field of Alzheimer's research had proved so difficult that it was dubbed by some with the macabre nickname of the "Valley of Death."

In light of this record, and the need to improve it, Kesselheim was looking forward to examining the prospects for Biogen's new drug. "The great thing about advisory committees is that they are independent, and they don't have a stake in the outcome," he said. "We were just an independent group providing their opinion."

As in all advisory committee meetings, this one included several representatives of the FDA and of the applying pharmaceutical company. Dr. Billy Dunn, the director of neuroscience at the FDA, spoke at length on the call, and Samantha Budd Haeberlein, a senior vice president of Biogen, led the representatives for the company. What was unusual about this meeting, though, according to Kesselheim, was the apparent relationship between the FDA and company representatives.

"There was a strange dynamic, compared to the other advisory committee meetings I've attended," Kesselheim said. "Usually there's some distance between the FDA and the company, but on this one the company and the FDA were fully in line with each other in support of the drug."

Dunn in particular was outspoken in his support for the effectiveness of the drug, calling some of the evidence in its favor a "home run," while opponents of approval described the same evidence as inconclusive or worse. Dunn noted further that the FDA "has determined that it is appropriate to exercise the broadest flexibility in applying the statutory standards for these conditions."

From a regulatory perspective, drugs can work in two ways: They can work to treat disease or they can address a surrogate measure for the disease. Take heart attacks, for example. A drug can directly reduce the chances of heart attack or it can address a surrogate for heart attack -- like cholesterol.

At the November meeting, according to Kesselheim, the issue was treatment of Alzheimer's itself, not any surrogate. "The discussion at the committee related to the clinical benefits of the drug" -- that is, whether it slowed the cognitive decline of Alzheimer's patients, he said.

Most of the meeting was devoted to analysis of Biogen's own studies of the effectiveness of Aduhelm. The results were not promising in terms of clinical outcomes. Indeed, two of Biogen's major studies of people taking Aduhelm had been shut down before they were completed because they showed no significant benefit to patients. (Aduhelm, which is injected intravenously, also caused significant side effects, including brain swelling in about a third of patients. Brain swelling, at a minimum, can produce painful headaches as well as more serious problems, including, in rare cases, death.)

In light of this, the advisory committee voted, with one member voting uncertain but no one dissenting, to recommend that the FDA reject the drug.

Seven months later, in June, the FDA gave Biogen final approval to treat patients with Aduhelm in all stages of Alzheimer's disease. Reflecting the confidence in its judgment, the agency even acted on an accelerated basis





The financial implications are huge as well. Aduhelm will be extremely expensive, as an intravenous treatment that will cost about $56,000 per year, plus several thousand more in related expenses. Given the number of Alzheimer's patients in the United States, the cost for widespread use of this treatment could quickly run into the many billions of dollars -- much of which would go to Biogen and its partner in the project, Eisai, a Japanese pharmaceutical company. If Aduhelm is approved as a treatment by Medicare, which is currently weighing the issue, the taxpayers will pay much of the tab.

At its core, though, the controversy about Aduhelm raises a fundamental question: Did the FDA approve a drug that doesn't help people -- and if so, why?


miércoles, 20 de octubre de 2021

Brasil: El "escándalo" Proxalutamida Kintor



La Comisión Nacional de Ética en la Investigación deBrasil (CONEP), por sus siglas en portugués) investiga la muerte de unos 200 pacientes ingresados en diferentes centros del país que participaron sin saberlo ni ser informados en un estudio irregular para probar en pacientes de covid la proxalutamida, una droga experimental que se aplica para algunos tipos de cáncer, informa el diario El País.(Ver)

La proxalutamida, que no está registrada en Brasil y no se utiliza en ningún tratamiento en el país. 

Pese a ello, el pasado mes de julio la Agencia Nacional de Vigilancia Sanitaria (Anvisa) de Brasil autorizó la realización de un estudio clínico para evaluar la seguridad y eficacia del medicamento proxalutamida en la reducción de la infección provocada por el coronavirus.

Pero los pacientes que participaron en dicho estudio fueron utilizados como cobayas y ni tan siquiera fueron informados de que estaban participando en él.

La CONEP también había autorizado a principios de año la realización de otros estudios sobre la proxalutamida, pero en en el que se realizó en el Estado de Amazonas implicó a más personas de las que se habían aprobado inicialmente (645 participantes, cuando el número permitido era de 294), y se llevó a cabo con "pacientes de cuidados intensivos gravemente enfermos".

"Hay indicios de irregularidades en el estudio, así como transgresiones de las normas vigentes sobre ética en investigación con seres humanos", asegura un informe de la CONEP.

El pasado 9 de octubre, investigadores de la Red Latinoamericana y del Caribe de Educación en Bioética de la Unesco hicieron público un documento en el que señalan que este podría ser uno de los "episodios más serios y graves de infracción ética" y de "violación de los derechos humanos" de pacientes en la historia de América Latina. Familias de varias de las personas afectadas ya han presentado una demanda y exigen que se aclare el caso. (Ver)

ha promocionado repetidamente un estudio brasileño de que afirma una tasa de efectividad tan alta del fármaco que los especialistas farmacéuticos han dicho que "es difícil de creer"

Concretamente, el estudio de Brasil señala que la proxalutamida tiene una reducción del 92% en el riesgo de mortalidad entre los pacientes hospitalizados con COVID-19. Ver

Denúncia sobre proxalutamida é uma das mais graves da história da América Latina, diz Unesco 

Teste com medicamento teve 200 mortes no Amazonas; coordenador de estudo nega irregularidades Folha de  S.Paulo

La Agencia Nacional de Vigilancia Sanitaria (Anvisa) suspendió este jueves la importación de la droga proxalutamida a Brasil, aún no se ha abierto una investigación por parte de la órgano. El medicamento se usa para tratar tumores de próstata y bloquea la acción de las hormonas masculinas. La información es de Reuters. 

La decisión de suspender la compra de proxalutamida fue tomada por unanimidad por el directorio de Anvisa. La investigación debe ser realizada por la Junta Colegiada de Anvisa ordenó la Gerencia General de Inspección e Inspección Sanitaria (GGFIS). La intención es comprender el propósito de importar este producto en Brasil.(Ver)