FDA approves new Alzheimer’s drug, but controversy persists

About Liz Seegert and Tara Haelle

Liz Seegert (@lseegert) is AHCJ’s topic leader on aging. Her work has appeared in NextAvenue.com, Journal of Active Aging, Cancer Today and other outlets. Tara Haelle (@TaraHaelle) is medical studies core topic leader, helping journalists translate evidence into accurate information.

Beta-amyloid plaques and tau in the brain.

National Institute on Aging/National Institutes of HealthBeta-amyloid plaques and tau in the brain.

Part one of two parts; the second runs tomorrow, Friday, June 11.

You might think that the first new drug to treat Alzheimer’s in 18 years — and the first to treat underlying disease and not just symptoms — would be heralded by patients, families, and medical professionals alike. After all, the FDA’s approval on Monday of  aducanumab (brand name Aduhelm) sounds like a tremendous breakthrough for the estimated 6 million Americans, and 50 million people globally, who suffer from the disease.

However, because of the supporting clinical data on its effectiveness, the drug has been controversial from the start. Drug maker Biogen actually halted its parallel Phase 3 studies, ENGAGE and EMERGE, because they failed to meet their primary endpoints. Those original endpoints were a change in the Clinical Dementia Rating-Sum of Boxes (CDR-SB), which is similar to a composite endpoint because it assesses improvement in multiple different domains. Continue reading

Stigmatizing language, inclusive solutions and telehealth big topics in health IT

About Karen Blum

Karen Blum is AHCJ’s core topic leader on health IT. An independent journalist in the Baltimore area, she has written health IT stories for publications such as Pharmacy Practice News, Clinical Oncology News, Gastroenterology & Endoscopy News, General Surgery News and Infectious Disease Special Edition.

Ensuring diversity, equity and inclusion has been a major theme at medical conferences this year, and the American Medical Informatics Association’s recent Virtual Clinical Informatics Conference was no exception. Hospitals and health systems shared some of their projects to promote diversity and equity across the field of health IT.

Here are three examples:

Stigmatizing language in electronic health records

Hospitalist and informaticist Subha Airan-Javia of the University of Pennsylvania was caring for a patient in a long-term acute care unit last summer when she read in the chart that the patient had refused his morning medications. When she talked to the patient, he said he didn’t refuse but declined to take his medications because he didn’t understand why some of them were ordered. He wanted to talk to the doctor first. Continue reading

New report details growth shifting ethnic, racial makeup of older adults

About Liz Seegert

Liz Seegert (@lseegert), is AHCJ’s topic leader on aging. Her work has appeared in NextAvenue.com, Journal of Active Aging, Cancer Today, Kaiser Health News and other outlets. She is a senior fellow at the Center for Health Policy and Media Engagement at George Washington University and co-produces the HealthCetera podcast.

Row of older men sitting on a bench

Photo: Carlos Ebert via Flickr

One in seven Americans is now 65 or older, comprising an increasing share of the U.S. population, according to the latest Profile of Older Americans. The annual summary of vital statistics from the Administration on Community Living (ACL) illustrates the shifting demographics of community-dwelling elders, including income, living arrangements, education, health, and caregiving. The summary also includes special sections on COVID-19 and mental health. Continue reading

How well do clinical studies take sex and gender differences into account?

About Tara Haelle

Tara Haelle (@TaraHaelle) is AHCJ's medical studies core topic leader, guiding journalists through the jargon-filled shorthand of science and research and enabling them to translate the evidence into accurate information.

Silhouette of a couple walking

Photo: meltwater via Flickr

The history of inequity in medical studies is long and harrowing, and it continues today. But at least today, there is more awareness of the history and the present-day problems that persist. For example, the Endocrine Society recently released a scientific statement demanding more research into sex differences for the sake of public health.

The fact that males and females — not to mention individuals who do not identify as either binary category — do not respond the same way to different diseases, drugs and other interventions has been a relatively new development in the history of clinical trials. As recently as 1977, women of childbearing age were explicitly excluded by the FDA from phase 1 and 2 drug trials. In practice, that often extended to phase 3 trials and other types of studies for various reasons. Continue reading

Goodbye to the big/little organization that makes a huge difference

About Jeff Porter

Jeff Porter is the director of education for AHCJ and plays a lead role in planning conferences, workshops and other training events. He also leads the organization's data collection and data instruction efforts.

Jeff Porter (left) with 1972 Olympic runner Jeff Galloway during the Health Journalism 2012 conference in Atlanta.

Jeff Porter (left) with 1972 Olympic runner Jeff Galloway during the Health Journalism 2012 conference in Atlanta.

Monday will be my final day as AHCJ’s director of education, as announced some weeks ago. I plan to help my able successor, Katherine Reed, but my time for day-to-day operations will close.

My retirement marks 20 years of work in the nonprofit world in bringing resources and training to journalists. Before that, I spent 21 years in the newspaper business, covering or editing almost everything newspapers cover.

During my newspaper career, I had a near-deadly stroke that gave me some perspective on what’s important: other people.

My background is small-town Arkansas. I’m the son of a schoolteacher and a telephone company worker. I didn’t comprehend until years later how fortunate I was to have a rather idyllic childhood. I have strong feelings about cornbread recipes and a passion for distance running. To this day, my wife Laura and I go back to our hometown, try to spoil our grandsons there and drive by the house where I grew up. Continue reading