Tune into the @TheIHI Turn on the Lights podcast to hear @RFRedberg discuss the importance of evidence-based medicine with hosts @donberwick and @KedarMate https://t.co/GRqzXb84n7
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. ⤵️ https://t.co/bL4qpjlzdt
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: https://t.co/KNiDXv4alK
#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. https://t.co/UAk1JkXk78
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." https://t.co/Sk73bHBxOA
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
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: https://t.co/COx4IECLaW
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: https://t.co/GVEmTGwHAh
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
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
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.
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. https://t.co/y5bf68wzgR
Patients with rare, serious diseases deserve increased investment in rare disease research and access to drugs that work, not weakened regulatory standards that will allow ineffective drugs onto the market.
The Promising Pathway Act conflates “the essential goal of getting patients access to more drugs that work with the misguided goal of simply getting them more drugs.” Read more from advocates incl. @HollyLynchez@reshmagar who, like #NORD, oppose the act: https://t.co/TGPwhOoyP6