I posted earlier on the Medicare plan to restrict the expensive, nonfunctional Alzheimer’s drug, Aduhelm, to clinical trials.
Here is a much better article with broader ramifications.
https://www.medpagetoday.com/neurology/alzheimersdisease/966…
**Medicare Plans to Restrict Coverage of New Alzheimer's Drug**
**— Proposal would cover aducanumab (Aduhelm) in patients on qualifying clinical trials**
**by Judy George, Senior Staff Writer, MedPage Today January 11, 2022**
**Monoclonal antibodies targeting amyloid beta in Alzheimer's disease, including the newly approved drug aducanumab (Aduhelm), would be covered for people with Medicare only if they are enrolled in qualifying clinical trials, according to CMS plans announced Tuesday....**
**Trials must address whether using anti-amyloid antibodies in Alzheimer's results in a statistically significant and clinically meaningful difference in decline in cognition and function, in addition to studying adverse events associated with treatment....This harm may range from headaches, dizziness, and falls, to other potentially serious complications such as brain bleeds...**
[end quote]
The mention of “clinically meaningful difference” is subtle but extremely important. It affects many other drugs, including cancer drugs, which measure physical factors that hypothetically correlate with desired clinically meaningful differences but do not necessarily produce the actual difference.
In the case of Aduhelm, it would force the clinical trials to measure cognition and function, not just the burden of amyloid beta in the brain (which can be measured by scans).
Biogen assumed that reducing amyloid beta clumps in the brain will improve cognition and slow the advance of Alzheimer’s disease because Alzheimer’s patients have a lot of amyloid beta. There’s no solid evidence that this is true, since many people without cognitive decline are found (on autopsy) to have a lot of amyloid in the brain. Also, Alzheimer’s disease is associated with tangles of tau protein in neurons that disrupt the function of the neuron but are completely unaffected by a drug that targets amyloid.
In the case of cancer, some (very expensive) chemotherapy drugs are correlated with Progression-Free Survival (PFS) but not necessarily with time to death. In that case, the treatment kills susceptible cancer cells but leaves mutated, resistant cancer cells that hide in a dormant state and then wake up later in a deadly metastatic form.
If the payers who control access to drugs, devices and procedures switched to evidence-based medicine where the criterion for approval was significant difference in the true endpoint (not a correlated but not necessarily causative factor), the practice of medicine would be dramatically changed. And payers (including Medicare) would save a huge amount of money.
See https://www.thennt.com/ and the book, “Ending Medical Reversal.” It’s rather startling how much medicine in this country is NOT evidence-based. Would people be willing to forego existing medical treatments that offer hope but NOT statistically-significant improvements, let alone cures?
As it is, under pressure from patient groups, the FDA already approves limited distribution of drugs without proof of efficacy if there’s no alternative as well as Emergency Use Authorizations. In addition, any drug that is already approved for any reason can legally be used off-label if a doctor prescribes it for any other reason.
Wendy