By Peter A. McCullough, MD, MPH

The medical world was stunned by the bold announcement of Project Stargate, a $500B investment in artificial intelligence promising >100,000 American jobs. The capper was Oracle CEO Larry Ellison painting a vision of using the technology to characterize a cancer and come up with an mRNA vaccine within 48 hours.

Cancer is a very complicated field in medicine that takes decades of training for oncologists to understand and present to patients. America deserved a top doctor to explain the possibilities of what AI could do for cancer care. As an internist who cares for patients with cancer, I can tell you AI would improve healthcare by:

1. Fetching and assembling all the cancer diagnosis and treatment records of patients who are scattered across the country and have their documents in disparate systems

2. Assembling and analyzing a myriad of images from many different hospitals (CT, PET, MRI) and assessing the stage and temporal progression of disease

3. Integrating dozens if not hundreds of blood tests used to monitor the toxicity of chemotherapy regimens

4. Pulling the complex genetic and histopathology results and integrating with the information above to characterize where any given patient is at the present time with cancer

5. Surveying hundreds if not thousands of cancer treatment protocols aiding the physician team in selection—including surgery, chemotherapy, radiation, natural supplements

You can see NOT on this list is a 48 hour jump to a mRNA vaccine as monotherapy for cancer. The reality is that Moderna is testing mRNA products in very late stage metastatic cancer. Moderna announced a year ago:

Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, in patients with resected high-risk melanoma (stage III/IV) following complete resection. In this planned analysis occurring with a median follow-up of approximately three years, adjuvant treatment with mRNA-4157 (V940) in combination with KEYTRUDA continued to demonstrate a clinically meaningful improvement in recurrence-free survival (RFS), reducing the risk of recurrence or death by 49% (HR=0.510 [95% CI, 0.288-0.906]; one-sided nominal p=0.0095) compared with KEYTRUDA alone. mRNA-4157 (V940) in combination with KEYTRUDA also continued to demonstrate a meaningful improvement in distant metastasis-free survival (DMFS), compared with KEYTRUDA alone, reducing the risk of developing distant metastasis or death by 62% (HR=0.384 [95% CI, 0.172-0.858]; one-sided nominal p= 0.0077).

~40% of patients appeared to have little or no response to the mRNA that produces several proteins designed to stimulate an immune response against the cancer. mRNA-4157 has all the limitations of COVID-19 vaccines including inability to target specific tissue and no way to shut off production of its protein library which over time is likely to cause systemic toxicity.

Because about 38% of cancers use an immune “checkpoint” to hide from the human immune system. Vaccines of any type for cancer would have to be used in combination chemotherapy. PD-1 inhibitors are highly toxic. Adverse effects from KEYTRUDA (pembrolizumab) can occur when the immune system attacks healthy organs and tissues. This can lead to serious or life-threatening problems, and in some cases, death.

Types of toxicity

• Skin reactions: rashes, dermatitis, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

• Endocrine issues: thyroid disorders, type 1 diabetes, and hypophysitis.

• Colitis: immune-mediated colitis.

• Pneumonitis: immune-mediated pneumonitis.

• Hepatotoxicity: liver toxicity, including hepatitis.

• Renal dysfunction: kidney dysfunction and nephritis.

• Infusion reactions: anaphylaxis and hypersensitivity.

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Peter A. McCullough, MD, MPH

President, McCullough Foundation

http://www.mcculloughfnd.org

IPAK-EDU is grateful to Courageous Discourse™ with Dr. Peter McCullough & John Leake as this piece was originally published there and is included in this news feed with mutual agreement. Read More