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What journalists should know about lab-developed tests
Lab-developed tests (LDTs) are diagnostic tools widely used across health care to test blood, tissue or other samples for infectious diseases, genetic markers, or other biomarkers of many conditions. Unlike tests manufactured and marketed commercially, LDTs are designed and used within a single lab that meets certain stringent standards. According to researchers, they’re invaluable tools for…
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Medical device manufacturers often delay reporting adverse safety events, study says
Medical device manufacturers are required by the U.S. Food and Drug Administration to report within 30 days any adverse safety events like malfunctions that could injure someone. The agency compiles these events in a centralized database called the Manufacturer and User Facility Device Experience (MAUDE) and uses the information to decide whether to communicate any…
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Reporting duo investigates industry sway over the FDA
Reporters Jeanne Lenzer and Shannon Brownlee have been collaborating on articles that take aim at problems with medical evidence since they met at an AHCJ conference in 2005. Their latest work is a three-part series on industry influence at the FDA. It’s being published in The Lever, an investigative outlet focused on exposing corporate corruption.…
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Tips for covering the controversy surrounding pulse oximeters
The U.S. Food and Drug Administration in early January released a proposed guidance document advising how manufacturers should evaluate and label pulse oximeters used for medical purposes. Pulse oximeters — noninvasive devices placed on a finger and used to measure a patient’s blood oxygen level and pulse — are used commonly in medical settings. The…
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Reporters uncover conflicts and dubious data on latest Alzheimer’s drug
The Alzheimer’s drug donanemab, brand name Kisunla. Image by Eli Lilly and Company A blockbuster story in the September 25 issue of The BMJ found major concerns surrounding the approval process, efficacy, and safety of the newest Alzheimer’s drug, donanemab (brand name Kisunla). An analysis by independent investigative journalists Jeanne Lenzer and Shannon Brownlee revealed…
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What journalists should know before diving into drug investigations
Investigative journalists Jeanne Lenzer and Shannon Brownlee uncovered a trove of information about the recently approved Alzheimer’s drug donanemab, (brand name Kisunla). Their deeply reported article in the September 25 issue of The BMJ highlighted questionable clinical trial results to potentially unethical behavior — including payments and industry ties — among some FDA advisory committee…
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FDA to launch ‘active’ monitory system to improve medical device safety
A congressional watchdog agency has reported that the FDA is launching a surveillance system to actively look for safety problems with medical devices — 12 years after it was mandated to do so. The new system aims to detect potential safety issues nearly in real time by monitoring data like electronic health records and billing…
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