@UCSF-based team working to promote high-value care within the U.S. health care system.
San Francisco, CA
Joined August 2021
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New research from our team in @bmj_latest finds that medical device adverse events are still being reported within summary reports that are frequently incomplete, inaccurate, and delayed, despite FDA's decision in 2019 to end a similar program due to transparency concerns
Permitting medical device manufacturers to submit bulk summary reports of adverse events to the US Food and Drug Administration, rather than reporting individual cases, often fails to promptly detect potential safety signals, finds new study in The BMJ
bmj.com/content/395/bmj-2026…
Tune into the GeriPal podcast to hear more from @RFRedberg on the evidence for statins in older adults! #deprescribing
New guidelines make 90%+ of #OlderAdults eligible for #statins, but should they take them? New PREVENT risk calculator, STAREE trial findings, and the safety of #deprescribing after 75 with @RFRedberg, Tim Anderson & Mike Rich.
- bit.ly/GeriPalEp420
@AlexSmithMD | @EWidera
Tune into the @TheIHI Turn on the Lights podcast to hear @RFRedberg discuss the importance of evidence-based medicine with hosts @donberwick and @KedarMate podcasts.apple.com/us/podcas…
Important piece on MitraClip in @KFFHealthNews – serious adverse events, three recalls, questions of biased data and conflicts of interest and inconsistent evidence of effectiveness raise concerns about use of the device
NEW: The story of MitraClip, a device Dr. Oz helped invent to treat faulty heart valves, is a cautionary tale about the science, business, and regulation of medical technology.
@DavidHilzenrath & @hollyhacker report. ⤵️ kffhealthnews.org/news/artic…
Investing time to generate mortality data for MCEDs is in patients' best interest - moving forward without evidence that MCEDs save patient lives is not and likely to be harmful, as @RFRedberg & coauthors wrote in @JAMAInternalMed: doi.org/10.1001/jamainternme…
#News After a decade of drama, Grail goes public with high hopes for its multi-cancer blood test but also many issues yet to settle. trib.al/YiZ5w4Z
Moving forward with MCED tests without evidence that they save patient lives is inappropriate. Medicare coverage of MCEDs should require high-quality evidence, from RCTs, of mortality benefit from these tests @CMSGov
Grail CEO Bob Ragusa told STAT: "Adding Galleri to standard of care screening creates a powerful and efficient cancer screening system." trib.al/srl2vdv
New study shows that implantable loop recorders were associated with higher costs, greater use of anticoagulation and higher odds of hemorrhagic stroke, but not with a decrease in mortality. Read more in @Open_HeartBMJ: doi.org/10.1136/openhrt-2024…
These findings highlight the need for an RCT to determine if there is any net benefit for #ILR to patients for secondary stroke prevention. @HRSOnline @ACCinTouch @CardiacEPS
More from Angela Lu, @RobinZJi, Marley Magee, @jsross119, @reshmagar, @RFRedberg & Sanket Dhruva in #HAScholar: doi.org/10.1093/haschl/qxae0…
This study builds on prior research in @JAMA_current by the author team that found that financial conflicts of interest are common but rarely disclosed by public commenters on NCDs: doi.org/10.1001%2Fjama.2023.…
Analysis of public comments on @CMSGov National Coverage Determinations for therapeutic medical devices finds most of the cited articles were funded by manufacturers who would profit from an NCD expanding coverage.
Patients deserve high-quality, accurate drug information. Join Steven Woloshin and @RFRedberg for a conversation on how to better communicate the benefits and risks of drugs at #DIA2024 in San Diego next Tuesday @DrugInfoAssn @Arnold_Ventures
The continued underrepresentation of women in clinical trials is unacceptable - As @jholtzman3 & @RFRedberg write in @JAMAInternalMed, the time is now for @FDADeviceInfo to decline to review applications based on trials that under-enroll women
A new study found that the number of women enrolled in high-risk medical device trials has not increased from 2010 to 2020. trib.al/bNdi1ov
Read more from Drs. Holtzman and Redberg (@UCSFCardiology) here: doi.org/10.1001/jamainternme…
From Sanket Dhruva & @RFRedberg: Given harms of overdiagnosis, early is not always better for cancer. Liquid biopsy trials must show reduction in all-cause death to claim they save lives - Only then will we know if healthy people benefit from these tests @US_FDA @FDADeviceInfo
The potential for irreversible harms from liquid biopsy blood tests is significant, in addition to the staggering cost. trib.al/ymtN64z
Critical reporting from @PittsburghPG on the use of an unapproved medical device in patients without their informed consent. post-gazette.com/news/health…
Physicians need more education on FDA drug and device regulation. Sanket Dhruva, @akesselheim, and @RFRedberg explain the results of their recent @Health_Affairs research and propose solutions @medpagetoday @genevievefri
medpagetoday.com/opinion/sec…
New national survey published in @Health_Affairs finds that doctors often lack understanding of FDA regulation of drugs and medical devices. They also want more regulatory action for FDA post-market requirements.
Read more by authors Sanket Dhruva, Steven Woloshin, @akesselheim, @RobinZJi, Zhigang Lu, @JonathanDarrow, @RFRedberg: doi.org/10.1377/hlthaff.2023…
Incredible reporting from @ProPublica w/insights from @DeviceEvents and @RFRedberg. @RFRedberg raises concerns about delays in reporting and how they compromise patient safety. @FDADeviceInfo
The FDA’s complaint-tracking system for medical devices allowed Philips to obscure when it knew about dangerous CPAPs.
New reporting shows the regulatory lapses extend to many devices and companies. propublica.org/article/how-t…