HHS announced a 14.5 % increase in the Medicare premium for 2022. One-half of the increase was for the purpose of paying for a drug called Aduhelm. The FDA approved Aduhelm to treat Alzheimer’s disease. Aduhelm is made by Biogen of Cambridge, Massachusetts. A one-year treatment for the drug is $28,200. Medicare estimated that Aduhelm would cost it $30 billion in one year.
Here is the rub. Adulhelm does not work; it is a complete fraud; it is unsafe and ineffective. The FDA states that “health fraud drug products are articles of unproven effectiveness that claim to treat disease or improve health.” By its own definition, the FDA is an accomplice to health fraud. You might think that I am engaging in hyperbole. You might think that certainly the safety and effectiveness of Aduhelm are supported by scientific studies. Well, the safety and effectiveness of Aduhelm were studied, but the drug was found to be both ineffective and unsafe. Indeed, during its 2019 medical trials, Aduhelm was found so clearly unsafe and ineffective that the clinical trials were suspended.
Despite the fact that the Aduhelm was shown to be unsafe and ineffective in trials, Biogen sought FDA approval for the drug anyway. The 11-member FDA panel of expert scientists voted not to approve the drug. The vote was 10 voting no and one voting not certain. Thus, none of the members of the FDA’s own advisory panel voted to approve Aduhelm. How could they approve it? The studies were clear; it does not work. Yet, the FDA approved it anyway. Three FDA panel members resigned in protest of the FDA decision.
One FDA panel member who resigned, Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, stated that “[t]his might be the worst approval decision that the FDA has made that I can remember.” The New York Times reported:
He said the agency’s approval of the drug, aducanumab, which is being marketed as Aduhelm, a monthly intravenous infusion that Biogen has priced at $56,000 per year, was wrong “because of so many different factors, starting from the fact that there’s no good evidence that the drug works.”
Incidentally, Biogen later dropped the price to $28,200 after all the bad press. The New York Time article further reveals:
Two other members of the committee resigned earlier this week, expressing dismay at the approval of the drug despite the committee’s overwhelming rejection of it after reviewing clinical trial data in November.
The committee had found that the evidence did not convincingly show that Aduhelm could slow cognitive decline in people in the early stages of the disease — and that the drug could cause potentially serious side effects of brain swelling and brain bleeding. None of the 11 members of the committee considered the drug ready for approval: Ten voted against and one was uncertain.
Beyond the steep price tag of the drug, additional costs to screen patients before treatment and for regular MRIs required to monitor their brains for problems could add tens of thousands of dollars to the tab. Medicare is expected to shoulder much of the bill.
“Giving patients a drug that doesn’t work and of course has important risks that are going to require multiple MRIs at a price of $56,000 a year is putting patients in a really challenging position and putting doctors in a difficult position as well,” Dr. Kesselheim said.
So, there you have it. The FDA has approved an ineffective and dangerous drug for the purpose of enriching a company to the tune of $30 billion per year at taxpayers’ and medicare participants’ expense. The FDA is a captured agency engaging in criminal fraud. The FDA cannot be trusted.
“For the love of money is the root of all evil: which while some coveted after, they have erred from the faith, and pierced themselves through with many sorrows.” 1 Timothy 6:10.