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US Senator Joe Manchin calls for a new FDA Commissioner to replace current (acting) one who “has repeatedly ignored public health concerns and shown a dereliction of duty” over opioids and aducanumab

Key Democrat Manchin Bashes FDA Leader on Alzheimer’s Approval (Bloomberg):

Senator Joe Manchin, a moderate Democrat considered a crucial vote within the party’s slim Senate majority, said Janet Woodcock, the temporary head of the Food and Drug Administration, should be quickly replaced with a permanent leader.

Manchin blasted an FDA decision to approve the controversial Alzheimer’s therapy Aduhelm despite conflicting evidence that the Biogen Inc. drug works and an overwhelmingly negative vote against the therapy by agency advisers. The FDA ruling led three members of that panel to quit in protest…

Manchin urged U.S. President Joe Biden to nominate “acceptable permanent leadership to ensure Americans are protected from harmful drugs and that scientific recommendations are considered when approving new medications.” … Manchin wrote Biden a letter earlier this year ripping into the agency for its “long track record approving dangerous opioids without considering public health.” On Thursday, he wrote that

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KHN’s ‘What the Health?’: The ACA Lives

Can’t see the audio player? Click here to listen on SoundCloud. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts.

For the third time in nine years, the Affordable Care Act has survived a constitutional challenge at the Supreme Court. In a 7-2 decision, the court ruled that the states and individuals who filed the latest challenge lacked standing to sue.

Meanwhile, Democratic lawmakers are looking for ways to expand health benefits as they pull together spending plans on Capitol Hill. And criticism is growing of the Food and Drug Administration, which approved a controversial drug to treat Alzheimer’s disease over the recommendation of its own expert outside advisers.

This week’s panelists are Julie Rovner of KHN, Joanne Kenen of Politico, Mary Ellen McIntire of CQ Roll Call and Rachel Cohrs of Stat.

Among the takeaways from this week’s episode:

  • The ACA
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Ten days left to submit proposals to the Wellcome Trust for Workplace Mental Health 2021

Dear Colleagues,

Wellcome are delighted to announce the launch of our Workplace Mental Health 2021 Request for Proposals.

Businesses all over the world are increasingly thinking about how they can most effectively support the mental health of their staff, even more so in light of the Covid-19 pandemic. However, despite growing interest and investment in workplace mental health, we still have so much to learn about what works.

In 2020, we asked ten global research teams to review the evidence behind a sample of promising approaches for preventing anxiety and depression in the workplace, focusing on younger workers. The research spanned a broad range of approaches ranging from employee autonomy to breaking up excessive sitting to financial wellbeing interventions. You can read a summary of the findings from this commission on our website.

Now we are looking to commission up to 20 research teams to review the evidence behind other … Read the rest

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Corte Suprema se niega a revocar ACA, por tercera vez

La Corte Suprema se negó por tercera vez a revocar la Ley de Cuidado de Salud a Bajo Precio (ACA) el jueves 17 de junio, desestimando una demanda presentada por un grupo de fiscales generales estatales republicanos que alegaban que un cambio realizado por el Congreso en 2017 había vuelto inconstitucional a toda la ley.

Por 7 a 2 votos, los jueces ni siquiera llegaron a los méritos del caso, resolviendo que los estados e individuos demandantes, dos personas de Texas cuentapropistas, carecían de “argumentos” para llevar el caso a los tribunales.

“No procederemos más allá”, escribió el juez Stephen Breyer. “Ni los individuos ni los demandantes estatales han demostrado que el daño que sufrirán o hayan sufrido sea ‘razonablemente atribuible’ a la ‘conducta supuestamente ilegal’ de la que se quejan”.

Los dos jueces disidentes, Samuel Alito y Neil Gorsuch, no estuvieron de acuerdo. “Los estados han demostrado claramente que … Read the rest

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First, do no harm? Six reasons to approach anti-amyloid drug Aduhelm cautiously, if at all

6 ways the FDA’s approval of Aduhelm does more harm than good (STAT News):

Like many people, I was shocked when the Food and Drug Administration ignored the advice of its neurological drugs advisory panel and broadly approved Biogen’s new drug, Aduhelm, even for populations never included in the clinical trials to assess the drug.

I am not a casual bystander to this controversial decision. I am a physician who has been treating people with Alzheimer’s since 1982; an early researcher into the biology of amyloid, the brain protein that Aduhelm targets; someone with a strong personal family history of dementia … As I formulate my responses to my own patients, here are six recurring themes:

  1. Pull of desperation
  2. Elbowing aside existing treatments
  3. Amyloid reduction alone is no help
  4. An uninterpretable trial
  5. Trials and labeling disconnect
  6. Cost and equity issues

Bottom line. The FDA’s approval of Aduhelm raises more

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Unvaccinated, Homebound and Now Hospitalized With Covid in New York City

Dr. Leora Horwitz treats fewer and fewer covid patients at NYU Langone Medical Center in New York City. Still, she thinks there are too many.

And they almost all have something in common.

“I’ve only had one patient who was vaccinated, and he was being treated for cancer with chemotherapy,” she said, reflecting recent research on the vaccines’ limited effectiveness for cancer patients. “Everyone else hasn’t been vaccinated.”

While taking care of those seriously ill with covid, she asks patients, with sympathy and respect: Why not get vaccinated? A few of them told the internist and hospital researcher that they’re concerned about vaccine safety. But mainly, she said, the responses break down into two groups: One comprises people who have been planning to get vaccinated but didn’t get around to it yet. The second highlights a disturbing deficiency in the pandemic response: those eager to get vaccinated but unable to … Read the rest

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Being Vaccinated Doesn’t Mean You Must Go Maskless. Here’s Why.

For more than a year, public health officials have repeatedly told us that masks save lives. They’ve warned us to keep our distance from our neighbors, who’ve morphed into disease vectors before our eyes.

Now they are telling us that if we’re vaccinated, we no longer need to wear masks or physically distance ourselves in most cases — even indoors. To many people, myself included, this seems hard to reconcile with so many long months of masking and physical distancing and sacrificing our social lives for fear of covid-19.

What is an anxious, pandemic-weary (and wary) soul to do?

First, it’s important to stress that the dramatic rollback of mask-wearing and physical distancing recommended last month by the Centers for Disease Control and Prevention — a policy California has adopted starting Tuesday as part of a broader reopening — applies only to people who have been fully vaccinated.

Even if … Read the rest

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Growing backlash against the FDA approval of unproven Alzheimer’s treatment Aduhelm, by Biogen

ICER Issues Statement on the FDA’s Approval of Aducanumab for Alzheimer’s Disease (Institute for Clinical and Economic Review):

The Institute for Clinical and Economic Review (ICER) believes that the FDA, in approving aducanumab (Aduhelm™, Biogen) for the treatment of Alzheimer’s disease, has failed in its responsibility to protect patients and families from unproven treatments with known harms.

Our review of the evidence was concordant with that of many independent experts: current evidence is insufficient to demonstrate that aducanumab benefits patients. The avenue forward has seemed clear: another study would be needed to reduce the substantial uncertainty about the drug’s effectiveness, a requirement of even greater priority because of the drug’s common and potentially serious side effects.

However, instead of waiting for such a trial, the FDA chose to move the goalposts and approve aducanumab based on the surrogate outcome of removing amyloid from the brain rather than the patient-centered outcome

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En crisis de salud mental, el 911 ahora no siempre responde con policías

Cuando Kiki Radermacher, terapeuta de salud mental, llegó a una casa de Missoula, Montana, por una llamada de emergencia al 911 a fines de mayo, el hombre que había pedido ayuda estaba atrincheado en una esquina, gritándole a los policías.

 La casa que estaba alquilando iba a venderse. Había llamado al 911 cuando el miedo de quedarse sin hogar lo hizo tener pensamientos suicidas.

“Le pregunté: ‘¿Quieres sentarte conmigo?’”, recordó Radermacher, miembro del equipo móvil de respuesta a crisis de la ciudad. Luego ayudó al hombre a encontrar un servicio de apoyo. “Realmente queremos empoderar a las personas para encontrar soluciones”.

Missoula comenzó a enviar a este equipo especial en llamadas de emergencia de salud mental en noviembre como un proyecto piloto, y el próximo mes el programa se volverá permanente.

Es una de las seis iniciativas de respuesta móviles a crisis en Montana, que comenzó como una prueba en … Read the rest

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Doctor on Call? Lawmakers Debate How Much to Pay for Phone Appointments

It took covid-19 to give millions of Americans the option of telling their doctor about their aches and pains by phone.

But now that more doctors and patients are returning to in-person appointments, policymakers across the country are divided over how much taxpayer money to keep spending on phone appointments. Although they were a lifeline for Medicaid and Medicare patients who don’t have the technology for video visits, critics say they don’t provide the same level of patient care and aren’t worth the same price.

In California, the Democratic-controlled legislature wants the state’s Medicaid program for low-income people — called Medi-Cal — to keep paying for phone calls at the same rate as for video and in-person visits, a policy that began during the pandemic. But Democratic Gov. Gavin Newsom’s budget plan directs Medi-Cal to reduce the rate.

Medi-Cal paid for a whopping 2.4 million phone appointments from March 1, … Read the rest

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