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Sheryl D Baldwin @jaderesearch
, 9 tweets, 8 min read Read on Twitter
Before hysteria and lack of technical and manufacturing understanding drive @JNJNews stock in the ground let me explain some facts. I’ve worked in ultratrace element analysis & material specs, industrial& pharma. @CNBC @WSJ @US_FDA
Mined minerals have traces of contaminants. 1
Abt 1971 ultra trace analyses took quantum technical leap to detect ppb, parts per billion levels. There was mercury in tuna fish scare, till 40 year old can fr @smithsonian analyzed had same levels. New tech would have found levels undetectable b4. @CNBC @WSJ @JNJNews 2.
3. Sourcing of materials matters. Industrial grade, technical grade are lower purity than stringent pharmaceutical grade specifications. Old USPharmacopeia approved & required test methods 4 heavy metals weren’t sensitive or specific. @CNBC @WSJ @JNJNews
4. Given the timing of the memo referenced early 70s is exactly when new sensitive methods came available, & applied to materials like talc showing detectable contaminant not observed by older methods. Common occurence then. @CNBC @WSJ @US_FDA @JNJNews But USP methods remained.
5. There are also different grades,with higher levels in industrial & tech grades than pharma. Again the standard pharma methods were USP, less sensitive than new ultra trace techniques. @CNBC @WSJ @JNJNews Internal memoes suggest situation monitored comparing USP & new technique
6. Having done exactly such analyses in that era and been responsible for specs and standard analytical procedures for 10 product lines all grades, global production sites, I can virtually guarantee this is how this situation likely unfolded. @CNBC @WSJ @JNJNews
7. Journalists have little to no grasp of statistics let alone statistical quality control, USP standards, 21 CFRgoverning @US_FDA rules & regs,GLP, GMP all relevant here. @CNBC @WSJ @JNJNews @ForbesTech Journalists should understand technical subjects before yelling “Wolf”
8. I havent reviewed actual data but read published reports, but my technical& professional exper. in biotech & pharma manufacturing, lab analysis (70s-90) specs in pharma old USP vs newer techniques, reg compliance all suggest simpler explanation described. @CNBC @WSJ @JNJNews
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