geoffrey modest medical blogs

  The FDA is currently seeking a review of their very recent recommendations approving the new Biogen drug aducanumab, which purportedly helps treat Alzheimer’s disease. This FDA review request was engendered by a STAT analysis suggesting significant drug company shenanigans (see  https://edition.pagesuite.com/popovers/dynamic_article_popover.aspx?artguid=a5dc1cb2-8885-45ed-97ed-c0736cd1d87f&appid=1165   )    Details:  -- acting FDA Commissioner Janet Woodcock just asked the independent Office of Inspector General (OIG) for an investigation into the approval of aducanumab by the FDA, within just one month of its approval  -- the OIG does have broad power to subpoena internal documents and conduct interviews under oath as well as pursue potential criminal violations through the Department of Justice  -- this current potential investigation is quite unusual in the FDA, though the OIG is currently assessing the monitoring of the sa...

The FDA just issued an alert on breast implant- associated  anaplastic large cell lymphoma (BIA-ALCL):    --see  https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm630863.htm  for the letter to providers    --see  https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm481899.htm  for the medical device report Details: --660 cases of BIA-ALCL have been reported (note: this is undoubtedly an underestimate, since many were probably not reported as noted in the advisory) --BIA-ALCL is a lymphoma that arises in the fibrous scar (the "capsule") that develops around the implant. it is not a "breast cancer" --median age 53, 8.5 years from last implant to diagnosis (this timing is from the last one; several patients have had multiple implant replacements, mostly for capsular contracture), 425 textured implants/39 smooth (196 not specified),...

​if you thought that the FDA was approving too many drugs without adequate testing, just look at the approval process for medical devices!!! (see  medical device approval jama2015  in dropbox, or JAMA. 2015;314(6):604-612). The process is a tad complex. Studies are designated as "pivotal" if they were used by the FDA for premarket evaluation of safety and effectiveness as the primary basis for approval; others done premarketing were considered "non-pivotal". Premarket approval is the primary way that novel devices are approved -- those devices which support/sustain life, prevent illness, or prevent unreasonable risk to the patient. The overall process also allows for post-market approval studies, including for changes made to the devices through supplemental applications. The current study assessed this overall process, given the increasing concerns that high-risk devices make it into the market without adequate testing: the FDA has indeed been accepting more “flex...

these 2 headlines came across my desk today.  related?? turns out that medical devices much less regulated than drugs.  Geoff Big Changes to Heart Devices OK’d Without New Data      Many of the high-risk implantable cardiac devices in use today were approved through a supplement pathway that does not require new clinical data on the safety and effectiveness of changes made to the products since their original approval, a review of an agency database showed.   Read more Dangerous Rapid Calcification Observed in Pediatric Patients After Aortic Valve Replacement By Larry Husten Pediatric cardiac surgeons at Boston Children's Hospital are warning about a potentially fatal problem in children and young adults who received a bioprosthetic cardiac valve. The surgeons initially became concerned when a young, asymptomatic patient died suddenly after her valve underwent rapid calcification, only 7 months after a routine follow-up echocardiogram found...