Monday, 09 Dec 2019

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RheumNow Podcast – Drug Ad Transparency (6.7.19)

Dr. Jack Cush reviews the news and journal articles of note from this past week on

  1. FDA sent an "untitled"letter to "R3 Stem Cell" for touting birth tissue products as Rx for ailments (without scientific evidence). FDA also won a case against "US Stem Cell clinics" for adulterated & misbranded stem cell products
  2. Transparency is coming? The Prices will soon be Included in TV Drug Ads. HHS Secretary Alex Azar has finalized regulations requiring drug companies to disclose list prices of medications costing more than $35 for a month’s supply.
  3. Korean Natl Claims Database examined RA & risk of opportunistic infx- OI, H zoster & candidiasis are seen in early RA. SIR for OI in early RA=1.14 (95% CI, 1.05‐1.23). H zoster (1.12), candidiasis (2.40); Age, steroids & comorbidity increased OI risk 
  4. CDC has updated its recommendations for TB testing of health care personnel. All HCP should be tested initially but after TB risk assessment, there is no need for routine or serial TB testing in the absence of exposure or ongoing risk of TB. 
  5. Metformin, was given to a mouse model Sjogrens (NOD)/ShiLtJ mice) & reduced salivary inflammation, IL-6,TNFα, IL-17 mRNA, improved salivary flow rate, suppressed effector T cells, inducec regulatory T cells & B cell diff. Why are mice so easy, SS so tough?
  6. UK Clinical Practice Database matched 62,234 pts with and without gout showing more venous thromboembolic events in gout (0.373 vs 0.27 per 100 Pt-yrs) (aHR 1.25, 95% CI 1.15–1.35) - not affected by ULT & not significant while in hospital (aHR 1.01)
  7. Low Remission/LDA Rates with TNF inhibitors in Rheumatoid Arthritis   
  8. Proinflammatory Diets May Increase CRP and RA Onset 
  9. FDA Public Review of CBD Oil   
The author has received compensation as an advisor or consultant on this subject

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