Publisher’s Platform: FDA and FSIS – Hey, President Biden, ask your food safety leadership to visit Makayla and Lucas

I am speaking (virtually) at the Food and Drug Law Institute (FDLI) Conference this week: https://www.fdli.org/2021/03/2021-food-and-dietary-supplement-safety-and-regulation-conference-agenda/.

My guess is that there will be a few FDA and FSIS people in attendance.

My roll is to bring some reality about why it is a bad idea to poison your customers and what the FDA and FSIS leadership should be doing about it.

Exposure to Romaine: 4/11/18 (7 years old)

Days in hospital: 39 (4/18/18 through 5/26/18)

Diagnoses:

• E. coli O157:H7 Shiga toxin (STEC E coli)
• Hemolytic uremic syndrome (HUS)
• Acute renal failure requiring prolonged hemodialysis (1 month of dialysis inpatient, and 1 month of outpatient intermittent dialysis)
• Acute respiratory failure requiring chest tube, intubation and mechanical ventilation
• Ventilator acquired pneumonia
• Severe hemolytic anemia from HUS requiring multiple blood transfusions
• Pancreatitis
• Feeding difficulties requiring prolonged use of nasogastric feeding tube
• Chronic hypertension and proteinuria related to HUS, requiring medication

Prognosis:

• Chronic kidney stage 3, with hypertension and proteinuria; damage from HUS, will likely require greater than one kidney transplant over her lifetime
• Chronic gastrointestinal difficulties secondary to pancreatitis and prolonged need for feeding tube
•Cognitive deficits related to prolonged intensive care stay and residual effects from HUS encephalopathy – learning disabilities and need for close follow-up of cognitive function
• Females requiring kidney transplantation are at high risk if they become pregnant – Mikayla will not likely ever be able to bear her own children
• Multiple blood transfusions cause problems with kidney matching for transplantation, may risk waiting for transplant and increased risk for death from kidney failure
• After transplantation, Mikayla will require immunosuppressant drugs for her lifetime, placing her at high risk for acquiring infectious diseases as well as cancer

Here is a link to all she and her family went through and will go through forever: JARBOE Makayla

Exposure to Romaine: 10/11/18 (2 years old)

Days in hospital: 51 (10/21/18 through 12/11/18)

Days in rehab: 80 (12/11/18 through 3/1/19)

Diagnoses:

• E. coli O157:H7 Shiga toxin (STEC E coli)
• Hemolytic uremic syndrome (HUS)
• Acute renal failure requiring dialysis
• Acute hemolytic anemia from HUS causing multiple blood transfusions
• Acute respiratory failure requiring intubation and mechanical ventilation
• Severe neurologic damage (severe encephalopathy, brain damage, seizures, multiple episodes of brain hemorrhage, loss of cognitive function, non-verbal)
• Insulin dependent diabetes related to steroids to treat brain swelling
• Chronic hypertension related to HUS

Prognosis:

• Permanent brain damage (no hope to regain significant cognitive function)
• Damage to visual cortex (permanent damage to sight)
• Unable to feed self (permanent tube feeding via G-tube)
• Dystonia of extremities (severe contractures, severe pain)
• Quadriplegia (severe dystonia), wheelchair bound
• Chronic kidney stage 3, damage from HUS, likely transplant candidate if survives >10 years
• Requires 24-hour, 100% assistance for all activities of daily living – risk of aspiration and death at all times

Here is a link to all he and his family went through and will go through forever: PARKER Lucas