Prologue
Monstera BioSciences
Don Levy, MD, PhD, Director
U.S. Food and Drug Administration Center for Drug Evaluation and Research
Dear Dr. Levy,
I am writing in response to your letter dated October 2, 2024, in which the FDA declined approval to market our transformational new weight loss product, ephaloma-copiramate.
With all due respect, I am astounded and disturbed by your department’s decision and the impact it may have on the well-being of this great nation.
As you are no doubt aware, more than 42 percent of the U.S.
population is afflicted with obesity. The obese and their host of chronic illnesses—from high blood pressure to type 2 diabetes, coronary heart disease, and cancer—cost this country $173 billion annually.
The obese demand more frequent and intensive medical attention than their normal-sized counterparts, threatening the ability of everyday Americans to access necessary care; and the strenuous act of moving, lifting, and rolling them puts healthcare workers—78 percent of whom are women—at unconscionable physical risk.
Obesity epidemic be damned. Our country is entering the fourth decade of a war on fat, and we are losing.
Years of education on nutritious eating and healthy active lifestyles have failed to penetrate the bulging layers of ignorance, denial, and inertia swallowing up our common sense.
The obese masses have proven themselves incapable of lifting themselves out of their physical and rational decline when doing so demands prolonged effort and sacrifice.
Something must be done to help them—help all of us—pave the way to a healthier, happier country.
With ephaloma-copiramate, Monstera BioSciences has done just that.
Not since Pfizer and BioNTech manufactured the first Covid vaccine has a pharmaceutical product had the potential to annihilate such a nasty and virulent pestilence.
We at Monstera BioSciences are blazing the trail into a future unburdened by the ugly consequences of immoderation.
With this product, we have the ability to eradicate obesity forever.
I understand the FDA has concerns about the safety of the product as a result of the disturbing situation regarding clinical trial participant no.
82941, whose acquired taste for human flesh made national headlines last year.
Although we take these concerns extremely seriously, we can assure you that the alleged “dangerous side effects” observed in the course of the patient’s treatment were wholly unrelated to the product being trialed.
To prove this, we have contracted Prentice & Darrow LLP, an independent firm specializing in impartial liability inquiries, to conduct a thorough investigation into the alleged unintended impacts of ephaloma-copiramate.
Through interviews with the participant’s friends and family, along with careful review of the patient’s online writings, personal health journals, and other evidence, this investigation will prove that the participant was deeply disordered and morally compromised long before the start of the trial, and that the violent deaths reported in the media have no bearing on the safety of this lifesaving product.
I look forward to presenting the investigators’ full findings as part of our formal appeal. I have no doubt it will alter your thinking on this matter.
Whether in a year, a decade, or a century, we will overturn CDER’s decision.
We must, for the greatest health and happiness of the country.
Sincerely,
Cecil H. Smith, PhD
Founder & Chief Science Officer