Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

FDA Approves Aducanumab for Alzheimer’s Disease: An Unethical Decision?

By Beatrice Brown

On June 7, 2021, the U.S. Food and Drug Administration (FDA) announced the accelerated approval of aducanumab (Aduhelm), a biologic manufactured by Biogen for the treatment of Alzheimer’s disease.

The FDA’s decision, which went against the near-unanimous opinion of its own advisory committee following its meeting in November 2020, has been embroiled in controversy over whether the available evidence demonstrated benefits that outweigh the risks of the drug. Namely, questions remain whether: 1) the conflicting evidence from the two pivotal trials is sufficient to suggest clinical benefit worthy of approval; and 2) the surrogate measure used to justify its accelerated approval is actually correlated with clinical benefit.

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Hundred dollar bills rolled up in a pill bottle

Aducanumab: A Bitter Pill to Swallow

By Emily Largent

On June 7, the U.S. Food and Drug Administration (FDA) used the Accelerated Approval pathway to approve aducanumab, which will go by the brand name Aduhelm, to treat patients with Alzheimer’s disease (AD). Aducanumab, developed by Biogen, is the first novel therapy approved for AD since 2003. This news has left many experts stunned.

I have at least one colleague, Dr. Jason Karlawish, who has publicly stated that he will not prescribe aducanumab. Other clinicians have said they will only prescribe it reluctantly. These are individuals who have dedicated decades of their lives to treating patients with AD, to conducting path-breaking research and serving as investigators in clinical trials, and to advocating for public policies that will better serve AD patients and their families. Many have also seen their own families affected by AD. My colleagues are hardly indifferent to the suffering wrought by AD and would like to have a meaningful treatment to offer to patients and their families. But, they have concluded, aducanumab is not it.

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Senior citizen woman in wheelchair in a nursing home.

COVID-19 and Dementia Care: Lessons for the Future

By Marie Clouqueur, Brent P. Forester, and Ipsit V. Vahia

Alongside the COVID-19 epidemic in the U.S., the country faces another public health epidemic: dementia, and particularly Alzheimer’s disease.

Currently one in nine older adults in the U.S. — 6.2 million — have Alzheimer’s disease. The number of adults with Alzheimer’s in the U.S. will increase rapidly as the Baby Boomers age — it is expected to double by 2050.

The COVID-19 pandemic has exacerbated the situation. Acute, surging demand for dementia care services will turn into a persistent problem if we do not increase our capacity for services and better support our frontline workers. We have a chance now to reflect and take action to prepare for what is coming.

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President Joe Biden and Vice President Kamala Harris.

Symposium Introduction: Recommendations for a Biden/Harris Health Policy Agenda

By Erin C. Fuse Brown

This digital symposium explores recommendations for the Biden/Harris administration’s health policy agenda. We asked leading health law scholars to describe one health policy action the administration should pursue, beyond the pandemic response. Their recommendations make up this symposium. The responses range from concrete policy changes to broad reform ideas and can be grouped into three categories, those that (1) Reverse and Restore; (2) Reinforce; (3) Reform.

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Temporary entrance in front of New York hospital during COVID-19 pandemic.

Institutional Reforms Needed to Strengthen Health Care Post-Pandemic

By Marissa Wagner Mery

COVID-19 has highlighted that pandemic preparedness and management requires a strong, well-functioning health system.

Shoring up the health system and its workforce should be a national priority post-pandemic. First and foremost, we must recognize that the greatest asset of the health system is its people, and the system must reflect this. Second, our hospital-based, competition-driven health care landscape should be reformed to better meet the needs of our communities.

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hands on keyboard of laptop computer.

How Preclinical Medical Students Have Embraced Advocacy Amid Virtual Education

By Tarika Srinivasan

On February 28th, 2020, after an hour of incessantly refreshing my email inbox, I received an acceptance letter to my dream medical school. That same day, a conference in the city I would soon call home became the superspreader nexus from which up to 300,000 COVID-19 infections have been traced.

The ensuing months, which were meant to be an exercise in pomp and circumstance, were marked by a steady stream of anxiety, frustration, and disappointment associated with virtual learning.

As first-year medical students, it is hard not to feel that we comprise the bottom rung of a long, rigid hierarchy. We are fully aware of the limited role we play in this pandemic; we lack the useful clinical skills of a final-year medical student or an employed resident. Our presence in the hospital is more of a liability than an asset.

We witnessed classes of fourth-years graduating early to serve on the front-lines of the spring first wave (though reception to this call of duty ranged from appreciation to apprehension). We imagined that in a few short years, we too might be deemed so “essential” that folks would be clamoring to have us serve on the wards.

But, despite our limited skills, we preclinical students decided we could not simply wait in the wings for our cue. Though we were dedicated to the didactic portion of our curriculum, we were itching to be involved in the action. Thus, we sought to expand the scope of what medical students could do during a pandemic.

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Physical therapist helps person in wheelchair.

How the COVID-19 Pandemic Has Changed Caregiver Education and Training

By Elizabeth Hansen

As a Physical Therapy Practice Leader, I help patients at the rehabilitation level of care — patients who have sustained a significant injury or disease that has life-changing implications.

Caregivers play an important role in the discharge of these patients from the in-patient context back to the home. They take on the burden of learning the techniques and interventions recommended by the clinical team. They may be learning how to use and maintain new equipment, such as power wheelchairs, feeding tubes, and lifts.

During the COVID-19 pandemic, I have noticed increased distress among both health care providers and family caregivers as patients are getting ready to discharge home, due in large part to challenges posed by the pandemic to family health care education.

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DUQUE DE CAXIAS,(BRAZIL),MAY,20,2020: doctors take care of patients with covid-19 and an intensive care unit (ICU) at hospital são josé specialized in the treatment of covid-19.

From Pain to Progress: Nursing After the Pandemic

By Victoria L. Tiase and William M. Sage

America’s nurses are a powerful force for good — four million strong, universally trusted, increasingly diverse, serving every community across the country, with an overall economic impact greater than the total output of the median American state. However, the pain of pandemic nursing is real and widespread. Urgent attention to nursing’s vulnerabilities is required for the profession to help the U.S. emerge from the confluence of the worst public health crisis in over a century and the most severe economic decline since the Great Depression.

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ANDOVER,HAMPSHIRE/UNITED KINGDOM-NOVEMBER 6 2019:A district nurse visits a ninety-four year old patient at his home to treat for pulmonary edema and head/brain injury.

Challenges Facing Home Health Caregivers During COVID-19 Pandemic

By Vicki Hoak

The pandemic has emphasized the value of home health caregivers. Their contribution has been overshadowed for decades, but now it is very clear how important their work is to the well-being of older Americans, people with disabilities, and medically-fragile children.

As families were urged to stay at home to stop the spread of COVID-19, home care agencies and their staff became all the more important for preventing the spread of COVID-19 and protecting the most vulnerable from the disease. Home health aides offer clients one-to-one care and continual monitoring of changes in conditions — all in the safety of one’s own home.

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