Category Archives: Covering medical studies

Alzheimer’s drug approved Monday by FDA raises questions for journalists

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.

Beakers

Photo: Knowing Roger via Flickr

Part two of two parts; the first ran Thursday, June 10.

There’s still a great deal we don’t yet understand about aducanumab (brand name Aduhelm) or its longer-term effects. If early-stage Alzheimer’s disease is diagnosed in time for someone to begin taking the drug, are the potential adverse effects cumulative? Could long-term toxicity build up over time? How long might the drug stave off development of the plaque, and how long might it slow down the process of cognitive decline, if at all, and how will clinicians assess its benefit in patients? Continue reading

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

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

New tip sheet helps you find sources during virtual conferences

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.

Photo: Roy Blumenthal via Flickr

As someone who was used to covering multiple medical conferences in person each year, 2020 was a big shift. I had to adapt to covering conferences virtually.

On the one hand, it was great: I got to sit in my home, eat my own (far less expensive) food, and watch many of the presentations on my own time instead of racing from one end of a convention center to another. Continue reading

Pfizer lays out timeline for its COVID-19 vaccine and a new flu vaccine

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.

Vial of Pfizer’s COVID-19 vaccine

Photo: Arne Müseler via Flickr

In a teleconference announcing the company’s first-quarter 2021 earnings earlier this month, Pfizer laid out its timeline for when different versions of its COVID-19 vaccine may become available for various populations. The company also said it is working on two approaches for an mRNA-based flu vaccine (similar technology as the COVID-19 vaccine), with plans to run clinical trials in the third quarter.

By the end of May, the New York City company expects to submit a biologics license application (BLA) asking the FDA to fully approve the vaccine rather than continue its use under an emergency use authorization (EUA). Continue reading