Tag Archives: fda

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

FDA promises crackdown on researchers who fail to properly register and report studies

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: Ferrous Büller via Flickr

For two decades, researchers have been required to register clinical trials that use any U.S. federal funding at ClinicalTrials.gov before they begin the study. The requirement grew out of a 1997 law aiming to increase transparency with studies that tested drugs, procedures or other treatments on people.

Researchers had to include the planned protocol, including endpoints, when registering their trial. If the endpoints changed during the trial, their registration had to be updated, including the reasons for the change. As of 2007, the law required all trial registrations to be completed within a year after the trial began, regardless of the trial results. Continue reading

Biogen submits BLA for an Alzheimer’s drug with a controversial past

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.

Photo: GollyGforce via Flickr

Could an Alzheimer’s drug finally be on the horizon? Possibly ― if the FDA agrees with data from several Biogen clinical trials ― but approval is still far from a sure bet.

The company, on July 9, submitted its biologics license application (BLA) for aducanumab, an investigational treatment for the disease. The submission includes clinical data from Phase 3 EMERGE and ENGAGE studies, as well as the Phase 1B PRIME study. Biogen has requested an accelerated review, potentially putting the medication on a path for a final decision by March 2021. However, data from these Phase 3 trials are not without controversy in the scientific community.

“Aducanumab, a so-called monoclonal antibody designed to target amyloid plaque in the brain, has been one of the most closely watched drugs in development for several years,” according to Bloomberg News. Continue reading

U.S. vaccine safety system needs greater visibility, webcast panelists say

About Bara Vaida

Bara Vaida (@barav) is AHCJ's core topic leader on infectious diseases. An independent journalist, she has written extensively about health policy and infectious diseases. Her work has appeared in the National Journal, Agence France-Presse, Bloomberg News, McClatchy News Service, MSNBC, NPR, Politico, The Washington Post and other outlets.

PHOTO: SELF MAGAZINE VIA FLICKR

As state legislators have grappled with policies to address vaccine hesitancy, public health officials and journalists could do more to emphasize that the United States has a well-established and effective vaccine safety surveillance system, policy experts told AHCJ members during a Nov. 21 webcast.

The U.S. engages several agencies and organizations, including the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the Health Resources and Services Administration, and the National Academy of Medicine, plus eight health care systems and seven academic hospitals in monitoring vaccine safety. Continue reading