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Op-Ed:
Fauci should have followed Gov. Lujan Grisham’s lead: delete all
messages after 24 hours
[The Center Square] David Williams |
Taxpayers Protection Alliance
Alzheimer’s Disease
inflicts a truly terrible toll on people. Today, roughly 6 million
Americans and their families are coping with the confusion and memory
loss brought on by this irreversible illness. The number of sufferers in
the U.S. is expected to swell to around 14 million by the middle of the
century. |
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 Fortunately, there is hope on the horizon for victims of this
devastating disease. The Food and Drug Administration (FDA) has just approved
the medication aducanumab (created by Biogen), which may slow the progression of
Alzheimer’s. The medication’s approval is a far greater achievement than the
treatment of any one disease. With aducanumab now approved, the FDA is showing
that it is willing to offer sufferers of debilitating diseases a chance to have
a better future. The approval of this drug is a good sign that the FDA may be
willing to put people, not bureaucracy, first.
Most medications evaluated by the FDA attract little attention
outside of healthcare newsletters and periodicals. But the fight over aducanumab
spilled over into the mainstream media where doctors and reporters have spilled
plenty of ink over the promising drug. The main issue is not with safety because
side effects appear to be manageable. Rather, there’s considerable controversy
over whether the medication actually succeeds in its goal of slowing the
progression of Alzheimer’s. Early on, the medication showed mixed results and
early evidence was not nearly good enough for the FDA to justify approval. In
March 2019, Biogen discontinued its development of the medication after study
results painted a disappointing picture for Alzheimer’s patients.
At the time, the drug producer was only examining data from patients that had
completed drug trials in December 2018. But there was a cohort of patients that
continued taking the drug until March 2019 and a recent reanalysis of the data
including these longer-term patients found promising results. In the “EMERGE”
trial, patients randomly assigned aducanumab had a 23 percent improvement in
cognitive functioning (via the Clinical Dementia Rating–Sum of Boxes test)
compared to non-takers. These results reinforce an earlier (smaller study) which
found that half of the Alzheimer’s patients taking the maximum dosage of
aducanumab for a year no longer tested positive for plaque. Now, these results
should be taken with not just a grain, but a mountain, of salt. In the twin
trial that happened alongside “EMERGE,” there was no discernible, positive
result for Alzheimer’s patients. [ to
top of second column] |
And this is where the mammoth controversy comes in.
The supporters and opponents of the medication can cite their own
preferred studies in telling their own sides of the story. But just
because there is some legitimate evidence pointing in both
directions does not mean the FDA should have nixed the medication.
After all, Alzheimer’s is a fatal disease with no options currently
on the table to slow its progression. Surely, patients and their
families should be able to make an informed decision to take a drug
that could give them a chance to hold onto their memories for a bit
longer. But the FDA is notoriously risk averse even when examining
medications to treat fatal diseases. A 2019 study conducted by MIT
researchers found that FDA statistical standards too often result in
the rejection of medications that could slow down severe,
life-threatening diseases such as pancreatic cancer.
Now, it is entirely possible that something better and more
cost-effective might come along in the future that can beat back
Alzheimer’s. But, drug companies will be more reluctant to put
billions of dollars in research and development on the line if they
sense that the FDA will reject product approval even with promising
evidence.
By approving aducanumab, the FDA may be turning a corner and showing
that the agency is on the side of innovation and compassion. For the
sake of the next life-changing drug, people across the country hope
approving aducanumab is just the beginning.
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