2021: a Medical Year in Review
At the end of each December, everyone with a Substack newsletter is mandated to write a year in review post. So here we go.
The COVID year in review is the easy part here:
Omicron spreads like measles (meaning faster than basically any virus we’ve ever seen)
The vaccines do a great job of preventing death and hospitalization
It’s unclear why no one seems to have learned anything about the importance of testing
Cases don’t matter as much as hospitalizations and death
Fluvoxamine seems good
Paxlovid will be good if we can ever get it, but it’s too expensive
But a lot happened in the medical world apart from COVID during 2021. Here are what I think are the most important medical stories of 2021.
An amazingly effective drug for obesity
Participants in this trial injected semaglutide once a week and lost about 15% of their body weight over a year. That’s the equivalent of a 200 pound person losing 30 pounds in a safe and effective manner.
Semaglutide has a track record of safety in patients with diabetes and cardiovascular risk, so it gives me confidence in the safety of this drug when used in a lower risk population for weight loss.
A safe and effective weight loss drug is a new tool in medicine that we shouldn’t ignore just because it doesn’t conform to some of our classic weight loss narratives. Semaglutide helps patients lose weight without drastically changing their lives or rolling the dice with some shady supplement that has no quality assurance.
It’s a big deal!
The FDA is the anti-Goldilocks
The United States Food and Drug Administration has made a series of questionable approval decisions over the past year. And they’ve made mistakes on both sides - they have approved things that they shouldn’t have and they’ve been stingy with approvals that would have made a big difference for our society.
On the approved-that-shouldn’t-have-been side, we have a few examples:
Aduhelm - an Alzheimer’s drug that doesn’t really seem to work much, perhaps because its mechanism of action may be wrong. It also causes a lot of side effects, including brain swelling. Oh, and it costs $56,000 a year.
Inclisiran - a cholesterol lowering drug that only needs to be given twice a year via injection. Here’s the problem - we don’t know whether it prevents heart attacks or strokes. When we have multiple types of medicines to treat heart disease patients, approving this drug without a trial demonstrating it actually prevents heart attacks is wrong
Molnupiravir - a COVID treatment that works by causing mutations in the SARS-CoV-2 virus, potentially leading to acceleration of viral evolution and risk of variants with immune escape and higher virulence. I don’t understand why you would take this risk for a drug that doesn’t work all that well.
On the other hand, the FDA has been too slow to approve things that could make a real difference for us:
Testing, testing, testing - why the hell don’t we have cheap and available rapid testing? Why do we lag behind Europe so much on this? It’s because the FDA hasn’t approved a lot of tests that are available across the Atlantic Ocean. I don’t know whether our pandemic trajectory would be wildly different with approval of these tests, but a lot of us have been spending too much money on Binax or just don’t have tests available when we want to know whether our symptoms are COVID or not.
Fluvoxamine - an antidepressant that’s been around for a long time that is a cheap, safe, and effective treatment against COVID. Unfortunately, it’s not approved by the FDA for COVID treatment. But don’t just take my word for it. Other doctors are submitting fluvoxamine to the FDA’s emergency use authorization pathway for COVID treatments.
It adds up to an agency that feels like it gets too many big things wrong to have credibility.
I had a friend text me that he thought all of these decisions were defensible, except for probably Aduhelm, which doesn’t seem like it passes the smell test.
But even if you grant the FDA the most generous interpretation of its big picture decisions over the past year, you still end up with approval of a questionable Alzheimer’s drug that could cost us $29 billion a year, or more than 75% of the total amount Medicare spends on drugs in a year.
It has a very, “other than that, Mrs. Lincoln, what did you think of the play?” feel to it.
Genetic engineering is coming: the rise of CRISPR
You may have heard the line, “the future is already here, it’s not just not evenly distributed.”
That’s what I think when it comes to genetic engineering. With the development of Nobel Prize winning discovery of CRISPR gene editing technology, we now have the ability to directly edit our genes.
This has been tested in humans with a genetic problem called transthyretin amyloidosis and (in tiny sample sizes) seems safe and effective.
There are a lot of brilliant people working on this gene editing technology for a huge variety of different disorders - from sickle cell anemia to coronary artery disease.
CRISPR holds tremendous promise, even if the technology is in its infancy:
“Further clinical programs involving CRISPR-Cas9–based gene-editing strategies are planned by many investigators for a wide range of diseases; these programs may make use of the potential not only to knock out expression of harmful protein products but also to insert genes to produce functional proteins where mutations cause pathologic deficiencies.”
We may look back in 20 years and think that everything we’ve been arguing about in 2021 is trivial compared to our ability to edit the human genome.
I think it’s one of the biggest things in science, and we should all be aware of its transformative potential - as well as the tremendous downside risk of playing God.
2021 has been a year of tremendous change
Looking back on the past year, I was struck by the fact that even though the pandemic doesn’t seem like it’s changed all that much, a lot has happened in the medical world.
But also, and most important: thank you for reading this newsletter over the past year!
I’ve had a ton of enjoyment writing this and engaging with my readers. Thank you for supporting this project and giving me the feedback that’s inspired me to keep writing.
Coming early in January - my predictions for the upcoming year.
Happy New Year!
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