Tag Archives: fda

FDA warns that breast implants are not “lifetime devices”: Tips for covering this story

About Kerry Dooley Young

Kerry Dooley Young (@kdooleyyoung) is AHCJ's core topic leader on patient safety. She has written extensively about the Food and Drug Administration, medical research, health policy and quality measurements. Her work has appeared in Medscape Medical News, Congressional Quarterly/CQ Roll Call and Bloomberg News.

Photo by Docteur Spitalier Philippe via Flickr

The Food and Drug Administration (FDA) announced last week a series of steps meant to address long-standing concerns about breast implants. These include new labeling with a boxed warning about risks, a patient decision checklist and updated silicone gel-filled breast implant rupture screening recommendations.

These actions follow years of efforts by patient advocates and journalists to make public information about risks associated with breast implants, including a rare form of cancer of the immune system.

Laurie McGinley of the Washington Post offered a broad overview of the issue in her 2019 story about an earlier step the FDA took that helped pave the way for last week’s announcement. The FDA in 2019 issued a draft guidance document that offered recommendations for makers of breast implants about addressing potential risks. In 2020, the FDA issued a final version of this guidance document, a tool the FDA often uses to tell companies what it expects of them in terms of manufacturing, testing and promoting their products.

Last week, the FDA leveraged its authority over the regulation of medical devices to ensure that doctors discuss risks associated with breast implants with patients seeking them.

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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