DOD & Active-Duty Service Women Used in Breast Cancer Clinical Trials
Ethical? Informed Consent and 21 CRF 50.23 General Exemptions
DOD & Active-Duty Service Women Used in Clinical Trials
On the 5th of April, 2021 Dr. David Martin delivered an episode from his Butterfly of the Week channel where he talked about the Department of Defense (DoD) and Active-Duty Service Women in Breast Cancer clinical trials.
This story is amplified - With his permission.
On Jan 23rd, 2023 - in a publicly released statement it was noted that the “DOD is among the United States' largest federal sponsors of biomedical research. For fiscal year 2021, DOD's appropriations included about $1.5 billion for 36 research programs known collectively as CDMRP. This represents a significant increase from CDMRP's initial appropriation in 1992 of $210 million for a breast cancer program.” DoD Biomedical Research Appropriations The FY23 appropriations are also reflected in the Fiscal Year 2023 (FY23) Omnibus Cancer Moonshot℠ Funds
While the DoD involvement in cancer research may be new to some - a brief review of earlier press releases shed light on this ongoing effort. The inscrutable nature of these actions demands review.
With an Oct 2nd, 2018 release the public learned about - yet another involvement of the Department of Defense (DoD) and breast cancer research. DoD and Breast Cancer In this specific press release - The ‘bullet point’ not only raised questions over the amount of the funding going through the DoD — to provide clinical research that would be broadly applicable to the general public - but it also raised questions as to ‘who’ was in the trials. Risk of breast cancer among enlisted Army women occupationally exposed to volatile organic compounds
Are these trials using active-duty service women from within our Armed Forces? If the answer is yes— how many and why? Tricare Special Programs and Clinical Trials Are there any benefits to using this cohort? BENEFITS OF WORKING WITH MILITARY POPULATIONS IN CLINICAL TRIALS A 2017 highlights the inquiry into military participation and research. Health Research Participation: Experiences and Decisions of Military Members In one such body of research the DOD - Military Medicine acknowledges some of the challenges Military Medicine Challenges With Engaging Military Stakeholders for Clinical Research at the Point of Care in the U.S. Military Health System
Recipients of the DoD funding also chimed in. Peter L. Hoang, CEO of Taplmmune had the following to say about his gratitude to the DOD:
"I am delighted that the U.S. Department of Defense has again chosen to support our technology and therapeutic platform with another funding commitment. This grant speaks to the strength and quality of the DoD's relationship with Dr. Knutson and the Mayo Clinic. This new 380-patient trial will be the largest to date for TapImmune, and I note that the Department of Defense has now awarded almost $30 million in grants to study our novel vaccine candidates in Phase 2 clinical studies. We are grateful to the DoD for their continued efforts to support the development of new and potentially life-saving treatment modalities for women suffering from breast cancer. Press Release
Tying a few threads together we can see how the DoD also has a mission “…To end breast cancer for Service members, Veterans, and the general public by funding innovative, high-impact research through a partnership of scientists and consumers” CDMRP _ Mission and per the CDRMP “… The DOD Peer Reviewed Breast Cancer Research Program (BCRP), established in 1992 as a result of breast cancer advocacy and congressional support, has received more than $3.7B in congressional appropriations through FY20. Research supported by the BCRP has led to the development of new standard of care treatments, diagnostic and imaging approaches, risk assessment tests, and resources for the breast cancer research and patient communities. For example, preclinical research supported by the BCRP contributed to four FDA-approved drugs: trastuzumab, palbociclib, ribociclib, and abemaciclib” CDRMP
The public should pay closer attention to the research that underscores the need for such studies and justifies the need for DoD involvement. In part, referencing studies that supported the statements that there was an increased prevalence of breast cancer among this cohort within the armed forces, Zhu K, Devesa SS, Wu H, et al, 2019 contributed to these findings. The study is worthy of closer inspection for another time - but worthy nonetheless. A question for another article - Why is breast cancer higher in the DOD? More screening? Is this accurate and how is the Department of Veterans Affairs assigning veterans disability ratings and benefits among this cohort? DoD Justification
Interdependent Funding Streams
As one examines the web of interconnected, interdependent funding streams and DoD involvement - namely the use of service women being used in clinical trials - a key funding trail leads us to the U.S. Army Medical Research and Development Command (USAMRDC). USARMRDC Here we find that “US Department of Defense (DOD) received an appropriation from Congress, and specifically a part of this appropriation that went to a part of the Army known as the Medical Research Material Command Center Medical Research
Much of this funding was for vaccine trials targeting breast cancer.
Informed Consent
The proverbial elephant in the room - Informed Consent. How much of the background information already cited was made available to the women in these trials? Ethics aside - and ethics are a significant issue not to be dismissed but to the topic of Informed Consent — of the “…over 1500 clinical trials on vaccines related to breast cancer and other cancers…that have been done in the Defense Department” how many trial participants were able to provide truly informed consent? How does the public determine the answer to this question? CDMRP Funding FY23
To dig further into this issue a key piece of legislation. 21 CFR section 50.23 21 CFR 50.23 is relevant. The “Exception from general requirements”
Was the DoD able to ‘leverage’ any part of CFR 21 50.23?
Is vaccine research and testing being conducted on our active-duty women in Military?
The above question is key but it can also be rephrased to ask why there is so much research and funding running through the DOD and specifically — directed at this population, in this instance. CDMRP FY23 Breast Cancer Research Program (BCRP) Is it ethical to allow our armed forces (active duty) to be part of and subject to these types of trials? Further, are these health issues necessarily and disproportionally unique to the DoD? DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS
There are numerous companies involved in this type of research and one was highlighted in the original Martin 2021 episode— that of Anixa Biosciences. Anixa Biosciences Announced Patent Issued for its Breast Cancer Vaccine with notable scientist and “…lead inventor on the patent is Dr. Vincent Tuohy of the Department of Inflammation and Immunity at the Cleveland Clinic's Lerner Research Institute” Anixa As one looks into Dr. Tuohy you will find, in part, his interest in key ‘triggers’ for breast cancer and his patents can be found in two patents Patent Patent 2
These patents target, in part, a mechanism of action that addresses the protein of lactation. In one such clinical trial for Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer the sponsor and collaborators are the DoD Sponsors and Collaborators George T. Budd United States Department of Defense In layman’s terms they are trying to prevent [emphasis on the word prevent] this form of breast cancer - metastatic disease, targeting a cohort of women who have had their children and do not plan to breastfeed any longer. Is this the same cohort of military women in the clinical trials? What is the number of women who fall into this category?
It is well worth one’s time to review the Congressional Directed Medical Research Programs (CDRMP) CDRMP The CDRMP ‘program’ is, in part, a means for the federal government to fund research - and in the case of breast cancer – runs this research through DoD. “The Congressionally Directed Medical Research Programs (CDMRP) is a global funding organization that fosters novel approaches to biomedical research in response to the expressed needs of its stakeholders–the American public, the military, and Congress. CDMRP originated in 1992 when Congress first appropriated funds to the Department of Defense (DoD), specifically for breast cancer research.” CDMRP is now “located under the US Army Futures Command Army Futures Command and within US Army Medical Research and Development Command (USAMRDC). Since it first originated in fiscal year 1992 (FY92), CDMRP has been responsible for managing more than $15.94 billion (B) in funding targeted for congressionally directed research areas/topics.” CDMRP Funding
Opacity
Should breast cancer research primarily be conducted by the US Military? Could it be that the protocols and “opacity’ of this research have anything do with suspending informed consent? This goes back to the ‘incentives’ behind this type of research.
Looking at the statements from Dr. Amit Kumar, Chief Executive Officer of Anixa "We are pleased that this key patent has been issued for technology, which we hope may eliminate breast cancer," Dr Kumar It would be reasonable to surmise that Dr. Kumar is indeed grateful to the DOD for a funded clinical trial, at US taxpayer expense, run through the DOD.
Dr. Amit Kumar, CEO of Anixa goes on to state "We are pleased that the FDA has authorized us to commence human clinical trials of our potentially paradigm-shifting vaccine for the prevention of breast cancer. This approval triggers a cascade of events and activities, that will eventually lead to recruitment of patients and initiation of the trial." Dr Kumar
Ethics
Is it ethical to allow the first line defenders of our Nation to also be subjected to the ‘first line risk’ of clinical trials “that benefit corporations.” Martin, 2021. Are corporations benefiting from research conducted on our women in service and then using the ‘results’ for applicability to the general public? Why?
What’s on the horizon?
I will continue to ask if our Department of Veterans Affairs is prepared for the types of potential vaccine injuries that could occur from the testing of these products. Vaccine injuries do occur from clinical trials. Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults The topic of vaccines (and gene therapies - mRNA platforms) and associated mechanisms of injuries is front and center in our public debates. Adding this topic to the proverbial ‘town square’ is critical.
To any reader asking why we are raising the alarm on vaccine and breast cancer research — this recap and discussion addresses the issue of the involvement of the DoD - not the legitimacy of the research itself.
The point is not that there could or could not be legitimate application of this type of research – the point is as follows:
(1) “Why, since 1992 did Congress decide that breast cancer research be funded by the military?
(2) Is it “…unethical that we subject people who have already volunteered their lives in service to this country, to actually be cannon fodder for companies doing clinical research that they, alone, will benefit from…” Martin, 2021
Does CFR 21 § 50.23 Exception from general requirements provide an ‘out clause’ for informed consent? Is DoD research and testing on this cohort being done to provide a broader public service benefit - off the backs of this cohort?
The interdependent issues raised here - raise more questions.
Keep Digging!
P.S. Most of the current articles in my Substack address our Armed Forces, Veterans Issues, COVID challenges (which consume a lot of bandwidth) and our Defense Posture. The rest of my articles go into Nonlinear Warfare, Foresight Development, and threats to our Nations Security - and our Future. In some cases - these issues are one and the same - they are interdependent - complex - and their complexity must be understood.
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Recap of some of the sources:
https://cdmrp.health.mil/bcrp/
https://cdmrp.health.mil/pubs/annreports/2020annrep/2020annreport.pdf
https://rpx-patents.s3.amazonaws.com/US/0502b-US9327026B2/US9327026B2.pdf
Good questions. Very odd to submit active duty service members to anything experimental, specifically because the outcome is not yet known. There could be issues with combat readiness that are not accounted for in the experimental design. Informed consent is another huge issue altogether.
Good questions.
Husband reaches 19 years of service in May. Looking forward to his retirement.