20 Hard Questions at FDA Science Forum on Device Safety, Genetic Risks, Health Impacts, Patient Protection & Recalls

I was home recovering from pneumonia and sorry to miss the first FDA Science Forum in 10 years, so asked the following questions (in a little more than 140 characters) in the webinar chat box. About half were read out loud in the public sessions. Now following up with the FDA media office.

  1. #FDAScienceForum on Engineers: "That didn't work: back to work." Why we need engineers in charge of all parts of FDA, all federal agencies.
  2. Qs for #FDAScienceForum: 1. Will digital dentistry screen #meddevice biocomp for #gensusceptible patients e.g. dental amalgam Hg toxicity?
  3. #FDAScienceForum Q2: Who at FDA working on #PrecisionDevices - tolerated by each child, adult, and older adult in which they are installed?
  4. #FDAScienceForum Q3: When will FDA recognize genetic variation requires a different approach to risk assessment and #meddevice approval?
  5. #FDAScienceForum Q4: Every individual's #genetic #immune #methylation and #detox profile is also a snowflake. How do we protect snowflakes?
  6. #FDAScienceForum Q6: How update #CDC on #PCR to recognize band variation for #Lyme, coinfections over lifecycle?
  7. #FDAScienceForum Q7: Re data reporting platforms big question is are they, or how soon can they, integrate medical and dental information?
  8. #FDAScienceForum Q8: Re public health emergencies how can we get greater attention to accelerating rates of Lyme disease? How balance threat
  9. #FDAScienceForum Q9: How do we recognize and respond to domestic threats for the existing pandemics like #Lyme? Costs, impacts off the chart
  10. #FDAScienceForum Q10: For Dx, Tx and remediation network for hidden epidemic of #mercury toxicity, can these same principles be applied?
  11. #FDAScienceForum Q11: @BrainScope is great for #TBI Dx. What about similar Tx modalities as for PT for TBI? External therapy devices?
  12. #FDAScienceForum Q12: How can we accelerate external EEG & #ultrasound R&D & testing to restore healthy #brain electrical functioning?
  13. #FDAScienceForum Q13: Given #military challenges from TBIs & jaw trauma, PHS still use dental amalgam fillings? #Mercury raise risk of harm?
  14. #FDAScienceForum Q14: Could research be replicated after putting amalgam in mice to see #mercury impact body, brain? http://t.co/W5TGrS2zpZ
    #FDAScienceForum Q14: Could research be replicated after putting amalgam in mice to see #mercury impact body, brain? pic.twitter.com/W5TGrS2zpZ
  15. #FDAScienceForum Q15a.What is FDA doing for #PrecisionDevices: Genetic risk tolerance vs. toxicity of installed dental and medical devices?
  16. #FDAScienceForum Q15b. Should devices that are not right for an individual methylation or immune system be recalled in the individual?
  17. #FDAScienceForum Q16 How will dental device reassignment be covered? No medical necessity in dental insurance, appeals & Dr letters denied.
  18. #FDAScienceForum Q17 Should health insurance be responsible to replace incompatible dental devices? Already pays diseases #PrecisionDevices
  19. #FDAScienceForum Q18 Need Medical and Dental Device Illness Compensation Fund, or FDA recall devices for #gensusceptible or systemwide?
  20. #FDAScienceForum Q19 Has FDA "still studying the safety of dental amalgam" created a global burden of disease for genetically susceptible?
  21. #FDAScienceForum Q19b Why patients, families, employers, health plans and governments which pick up tab for amalgam reassignment ?
  22. #FDAScienceForum Q20 Can FDA handle NHTSA Takata-like recall for amalgam, start limited, expand to include all needed? #PrecisionDevices