A Plea to the FDA: Clinical Trials and Risks to Our Children

May 25, 2022 • by Carol Taccetta, MD, FCAP

“Times of crisis and fear can call forth bad science, even science we know in retrospect to be unethical.”

Bill Clinton, October 3, 19951

At age 19, I was diagnosed with thyroid cancer with lymph node metastases. The radioactive iodine therapy (I-131) I received was a miracle treatment in my eyes, and planted the seeds of passion for a career in medicine, specifically, drug development. My decision to take the radioactive concoction was the prototype for many more benefit-risk assessments to come. For decades, I considered myself fortunate to have benefited from drug research, and used that positive approach to help others. But, over the past two years, due to my interest in understanding the regulations and ethics surrounding Emergency Use Authorizations (EUAs) and medical countermeasures (MCM), I delved more into our country’s history of medical experimentation. I learned of, and became horrified at, the unethical I-131 experiments performed by my own government on newborns, children, pregnant women and other vulnerable populations starting in the 1950s.2 Zero benefit, all risk. Had I not come across this information before? Or had I seen it only to then block it out, too painful to contemplate the abuse that preceded my successful treatment?

The Federal Policy for the Protection of Human Subjects, also called the “Common Rule,” was published in 1991, and, along with the other subparts in 45 CFR 46, is intended to protect humans in research “conducted, supported, or otherwise subject to regulation by any Federal department or agency,” including the vulnerable populations of children and pregnant women.3 It was influenced by the Belmont Report, which was influenced by The Nuremburg Code.4 Over the past year, I’ve tried to find out which agency is responsible for enforcing the regulatory protections of 45 CFR 46 as applies to our government sponsored, conducted or regulated covid-19 clinical trials, as well as request that its additional protections be provided for the vulnerable subpopulations of pregnant women, fetuses and children.

I started off with a letter writing campaign, which led to my filing a Citizen’s Petition (https://www.regulations.gov/document/FDA-2022-P-0086-0002), which led to the FDA’s response (https://www.regulations.gov/document/FDA-2022-P-0086-0024), which led to my most recent response to them, below.*

The Food and Drug Administration (FDA) stated in their response back to me that they do “not administer or enforce the regulations in 45 CFR Part 46.” The Office for Human Research Protections (OHRP), the last I heard, is “check[ing] all jurisdictional authorities”:

From: OHRP DCO <ohrp-dcoemails@hhs.gov>

Subject: Complaint #00647348 is on hold

Date: July 13, 2021 at 4:48:27 AM PDT

To: This message is to inform you that Complaint number 00647348 has changed to a “hold” status, while the Division of Compliance and Oversight checks all jurisdictional authorities.

Thanks OHRP DCO Staff

I’ve asked the FDA to immediately clarify to which category of risk our children fall under 21 CFR 50 (as they do enforce this regulation): this risk category greatly affects critical issues such as informed consent and risk: benefit assessment.5 *

1 https://ehss.energy.gov/ohre/roadmap/whitehouse/appa.html

2 https://ehss.energy.gov/ohre/roadmap/roadmap/part3.html

3 https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html

4 https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

5 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50

Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER)

Food and Drug Administration

Dept. of Health and Human Services (HHS)

To:

Peter.Marks@fda.hhs.gov

Cc:

Phillip.Kurs@fda.hhs.gov

Stephen.Ripley@fda.hhs.gov

(Public email addresses)

April 21, 2022

Dear Dr. Marks,

Please see my response below to the March 24, 2022 FDA’s Response Letter to my Citizen’s Petition (Docket No. FDA-2022-P-0086):1,2

Regarding your response, “We note that Petitioner states that the requests are “per 45 CFR 46”; however, FDA does not administer or enforce the regulations in 45 CFR Part 46, and those regulations do not control the requested actions. Therefore, the analysis in this response focuses instead on the statutory and regulatory provisions relevant to the requested actions,” I need clarification, please.1

In addition to submitting an Emergency Use Authorization (EUA), all three manufacturers of currently approved (BLA) or authorized (EUA) covid-19 ‘vaccines’ submitted an Investigational New Drug application (IND), thus subject to federal regulation (investigational product regulations): Pfizer Inc. IND number 19736; ModernaTX, Inc. IND number 19745; JanssenBiotech, Inc. IND number 22657.3-5

The Federal Register states “FDA is adopting HHS subpart D [45 CFR 46], as directed by Congress, with only those changes necessary due to differences between FDA’s and HHS’s regulatory authority.”6 Regarding the concerns later outlined in my petition, the OHRP initially informed me: “The issues in [my] complaint fall under federal regulations used by the FDA, therefore OHRP will not be able to pursue the matter on your behalf,” then “Complaint number 00647348 has changed to a “hold” status, while the Division of Compliance and Oversight checks all jurisdictional authorities” (both communications attached to this email). 21 CFR 50 states: “HHS subpart D provides protections for children involved in HHS-conducted or HHS-supported research. If an FDA-regulated clinical investigation is not conducted or supported by HHS, HHS subpart D does not impose requirements on the investigation.”6 I have shown in my petition how the covid-19 ‘vaccine’ trials are HHS conducted or supported research.2

I continue to seek clarification regarding which HHS agency is responsible for the enforcement of 45 CFR 46 for covid-19 clinical trials conducted or supported by HHS; but, until that time, will now focus specifically on 21 CFR 50 as its enforcement seems to be clear.

Per your response, “Additionally, FDA regulations require that an IRB must review clinical investigations involving children as subjects covered by 21 CFR Part 50, subpart D and only approve those clinical investigations involving children as subjects that satisfy the criteria in 21 CFR Part 50, subpart D, Additional Safeguards for Children in Clinical Investigations. As explained in the preamble to the final rule, “[t]hese safeguards are intended to ensure that the rights and welfare of children who participate in clinical investigations are adequately protected.”1,6

What is needed now, is clarification as to which risk category the covid-19 ‘vaccine’ investigations belong. Here are the options:6

50.51 Clinical investigations not involving greater than minimal risk.*
50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
50.53 Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects’ disorder or condition.
50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

*”Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”7

Certainly, myocarditis and anaphylaxis warnings, alone, would automatically place covid-19 ‘vaccine’ pediatric research in the “greater than minimal risk” category.8-11

“Administration of experimental drug products is neither “normal” or “routine” and thus is not “minimal” risk.”12

Other than the obvious concern of safety, critical elements of informed consent and assent hinge, and have always hinged, on appropriate risk classification of the trials, per 21 CFR 50. Whether children continue to receive “investigational [IND] vaccines” under the auspices of a formal clinical trial or as part of a mass vaccination program, it is critical for the FDA to immediately clarify to which category of risk our children fall: 21 CFR 50.51, 50.52, 50.53, or 50.54.3-5

Sincerely,

Carol Taccetta, MD, FCAP

1 https://www.regulations.gov/document/FDA-2022-P-0086-0024

2 https://www.regulations.gov/document/FDA-2022-P-0086-0002

3 https://www.fda.gov/media/144412/download

4 https://www.fda.gov/media/144636/download

5 https://www.fda.gov/media/146303/download

6 https://www.federalregister.gov/documents/2001/04/24/01-10008/additional-safeguards-for-children-in-clinical-investigations-of-fda-regulated-products