Efforts have continued...
January 30, 2020: An email was sent to Dr. Jeff Shuren, Director of the FDA, Center for Devices & Radiological Health (CDRH) regarding the lack of protective measures when it comes to Blood products, donations and Testing.
January 31, 2020: Dr. Shuren kindly responded to my e-mail acknowledging my inquiry, then directed me to Abiy Desta, Ombudsman for CDRH-FDA.
January 31, 2020: Abiy Desta emailed with an acknowledgment of my inquiry and brief discussion with Dr. Shuren. Offered to speak by phone.
February 5, 2020: Phone conversation with Abiy Desta, CDRH
February 11, 2020: Follow up e-mail from Abiy Desta, provided info on the Lyme test kits. The CDRH has cleared several test kits for Lyme disease, the latest clearance accrued in January of 2020. The link provided will take you to the list of FDA cleared test kits: Mr. Desta also stated that the Center for Disease Control (CDC) is the federal agency responsible for developing guidelines for the testing of Lyme disease, including guidelines for testing Mothers to be. FDA will differ to CDC on this issue.
February 28, 2020: E-mail sent to CBER Ombudsman, for follow up and still waiting for answers.
February 28, 2020: E-mail from Howard Balick, Special Assistant to the Associate Director of QA, US FDA/CBER. Acknowledging my inquiry, and stated a "response is in progress"
March 2, 2020: Sent reply to Mr. Balick, thanking him for looking into this, and I would be awaiting his reply.
March 13, 2020: E-mail inquiry to FDA, CBER. Responded by Patricia Harley, Consumer Safety Officer, Center for Biologics Evaluation and Research (CBER). Response: "Thank you for your inquiry to the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) Ombudsman. Your inquiry was forwarded to CBER’s Office of Communication, Outreach and Development (OCOD) for reply. One of seven centers within FDA, CBER is responsible for the regulation of many biologically‐derived products including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products. We are still working on a response concerning blood donation. Sorry for the delay.
March 13, 2020: Thank you reply sent to Patricia Harley
March 24, 2020: NO RESPONSE, NO ANSWERS Sent follow up e-mail...
"Mr. Balick,
I understand we have a National emergency with the COVID-19 virus, however the Lyme Disease epidemic is still exploding.
It’s imperative to simultaneously address Lyme Disease. The questions & concerns I presented to you are extremely disturbing and in my opinion TOP PRIORITY. Especially now, when Doctors may try Plasma Therapy from convalesced patients for COVID-19 treatment. I need answers, please. This is about SAVING LIVES...keeping infections contained & free from transmission. The CDC & FDA have history of the realization of Blood Transfusion transmission of Babesia, Borellia, HIV... why not Borrelia Burgdorferi and other Co-infections? Time keeps passing while people are suffering and dying.... Do you realize that Lyme Disease has been identified as a health concern since the 1960’s.
The numbers of infected is increasing, while the budget is decreasing.
Point Blank... 3 things
1. The FDA needs to fast track a reliable test for Lyme Disease.
2. The FDA must mandate all blood donations be screened for Lyme (Borrelia).
3. Every pregnant woman needs to be routinely tested for Lyme Disease.
Not your department, but the CDC needs major reform of their treatment guidelines. I would appreciate answers to the concerns I have. Just because we have Corona Virus, doesn’t minimize the Lyme problem. Both cause harm to humans, both can cause long term damage, both kill people."
April 6, 2020: No further response received from the FDA. Follow up e-mails will be sent out again today & copied to all people mentioned above.
**As a result of COVID-19, experimental treatments are taking place, such as Convalescent Plasma Therapy. Again, providing sick patients with anti-bodies from recovered Covid patients with the potential of contaminated or exposure to other pathogens. Making a sick person more sick! ***All Blood needs to be screened***