Adapted from Lecanemab in Early Alzheimer's Disease

Based on these results we could logically argue the placebo offers a lower risk of brain damage than lecanemab. There was an 80% lower risk of macrohemorrhage, no symptomatic brain swelling, and no serious infusion-related reactions with placebo! This placebo stuff is starting to sound pretty good. In fact, I could create a drug called Clintoncebo that has a normal saline base plus proprietary secrets. And if patients alternated Clintoncebo for lecanemab (e.g. 1 dose lecanemab, 2 weeks later Clintoncebo, 2 weeks later lecanemab) adverse neurological outcomes would just about halve.

Lecanemab is not meaningfully effective

The cognition of patients who received lecanemab continued to decline. It just declined ever-so-slightly less than the placebo group on a scale used to stage Alzheimer's that goes from 0 - 18 based on the results of questionnaires to test memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. That 0.45/18 difference is the same as a 2.5% absolute difference, 27% relative risk reduction. Meaning after 18 months of infusions every two weeks that seriously brain damaged 1.2% and caused 6.9% to withdraw from the study those who got the drug scored 2.5% better on a test given by those funded by the manufacturer in one study designed by the manufacturer that was paid for by the manufacturer whose results were processed by the manufacturer and whose study results were written by the authors in collaboration with medical writers hired by the manufacturer. That is insufficient to establish efficacy.

The authors claim "a definition of clinically meaningful effects in the primary end point of the CDR-SB score has not been established." Previously, a change of 1 (5.55%) was suggested. Professor Alberto Espay describes the difference between the two groups as "If 100 words represented perfect recall and we started the trial remembering 82, after 18 months with biweekly infusions, we could remember 75 or 76, and without, 73," in a petition to the FDA opposing lecanemab's approval.

They want $26,500 per year for this garbage drug

If the FDA fully approves a drug Medicare is required to pay for it. At last we arrive at what's really going on here. There are about 6.5 million Americans with Alzheimer's disease. If 10% of that population is treated with lecanemab Medicare will be forced to pay more than 17 billion dollars for this valueless drug that is neither safe nor effective. This is an attempted robbery of the American people via Medicare. It is a wealth transfer from the American government to Biogen and Eisai. Lecanemab doesn't help those with Alzheimer's; it steals money from those with Alzheimer's. The only ones who will benefit from its approval are the manufacturers. The opportunity cost of spending 17 billion dollars without saving one life while bankrupting Medicare will be felt throughout the country.

Lecanemab:

1) Did not improve cognition in patients with early Alzheimer's

2) Slowed decline a virtually unnoticeable 2.5% vs placebo in one manufacturer funded, designed, and processed study that had a 17.2% drop out rate and saw 6.9% of patients leave the treatment group because of adverse effects

3) Requires intravenous infusions every two weeks

4) Causes serious brain damage in 1.2% of patients

5) Caused symptomatic brain swelling in 2.8% of patients

6) Costs $26,500 per year

7) Will be covered by Medicare if the FDA fully approves it costing up to 17 billion per year if 10% of Alzheimer's patients are treated in the U.S.

8) Is noncurative

9) Does not offer a mortality benefit

10) Is a scam being perpetrated on the American people because of a dysfunctional drug approval and health insurance system

To approve such a drug because of a barely perceptible slowed rate of descent noted in one manufacturer-funded study is an act of madness. To waste $26,500 per year on it is a crime. Lecanemab is unsafe and impractical. On a macroeconomic level, it is an opportunity cost and scam exploiting weaknesses in our drug regulatory system. On a patient level, it severely damages the brain of about 1 in 100 who receive it. That's simply too high. Lecanemab is a story of absurd cost, perverse financial incentives, inadequate drug safety, dysfunctional government, statistical sleight of hand, and the illusion of progress while doing harm.

Best,

Dan

Dan Clinton is a Registered Nurse, Professional Nursing and NCLEX tutor, Researcher, Writer, Entrepreneur, Father, and author of "50 Great NCLEX-RN Practice Questions with Thoughtful, Informative Rationales." Dan strives to fulfill the American dream of succeeding through altruism, hard work, persistence, entrepreneurship, and ingenuity. As a professional tutor, Dan helps his clients reach (and often exceed) their goals. Dan has helped clients who had failed the NCLEX up to nine times previously succeed and begin their career as a Registered Nurse. Dan recently turned 39, making it hard for him to fool himself he's still 25ish.

Note: These newsletters speak generally about health topics and should not be interpreted as medical advice. Truly, the best advice if you have a medical concern is to discuss it with your doctor.