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Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Friday, January 26, 2024

CAR T Could Be The Hero Of Tomorrow ... Or The Villain

If you're a hematologist or oncologist, chimeric antigen receptor T cells have been a source of wonder and relief. While it's still early days for CAR-T treatment, which was first approved by the Food and Drug Administration in 2017, over 10,000 people with blood cancer have been treated with CAR-T drugs, and hematologists tend to think of CAR-T as a game-changer.

We'll circle back to that in a minute, but first, there's been an interesting bit of news regarding CAR-T from a group of researchers in New York. These researchers are seeking an answer to a fairly simple question: What if we didn't have to age? No biggie, right? 

To be more accurate, what the researchers were actually investigating is senescent cells – old cells that no longer replicate which build up in the body over time, causing damage and harmful inflammation wherever they go. While not the only source of aging and human maladies, senescent cells certainly contribute heavily to the wear and tear our bodies suffer as we get older.

We already have drugs that can eliminate senescent cells, but as the researchers noted, these treatments require constant transfusions. But when they tested CAR T cells in mice after modifying them to target senescent cells, they discovered that the mice lived permanently healthier lives after just one treatment. Lower body weight, improved metabolism, increased physical activity, and best of all, this happened without causing tissue damage or toxicity. Older mice were rejuvenated and refreshed, while younger mice simply aged slower.

Now, humans live a lot longer than mice, so it's likely we'll need multiple transfusions over the course of our lifetimes to sustain the CAR T anti-aging effect, but we're still talking periods of years rather than days or even hours for current anti–senescent cell drugs. And if we've learned anything from the Ozempic debacle, people will absolutely line up to take a miracle drug, even if it means taking away from the people who actually need it.

And speaking of patients who actually need CAR T cells, they've been in the news for another, more interesting reason. The FDA has told the various CAR T manufacturers to add a warning to the labels of their respective drugs, noting that their anti-cancer products ... can cause cancer.

Since the first approval of a CAR T drug, the FDA has received 25 reports of rare blood cancers in patients who underwent CAR T treatment. In additions, multiple studies have been recently published that have noted a potential link between CAR T and new blood cancers.

Well, this is awkward.

It isn't actually as bad as it sounds. Ignoring the slight irony of people developing a new blood cancer after undergoing treatment for their initial blood cancer, 25 people is less than 1% of the total number of people who have received CAR T treatment. Also, it's still unknown whether or not the relationship between CAR T and these new blood cancers is causal or coincidental. The problem could very well be other things associated with cancer treatment, such as radiation or chemotherapy.

The solution then is really quite simple for cancer patients: Rather than bundling your cancer treatments all together, you should really order your chimeric antigen receptor T cells on their own. You know, à la CAR T.

I'll show myself out.

Friday, December 15, 2023

Shot Through The Butt, And You're To Blame

It's no big secret that there's a certain subset of Americans who treat their guns like Linus treats his blanket. Guns are sacred items to them, and not even Lucy could nag them out of it, since, you know, they have a gun. Kind of tough to tell them what to do.

While we can and do debate the necessity of carrying a gun with you whenever you leave the house, the fact is that it is currently legal in this country and they are technically allowed to do it. However, what can't be argued is physics, and MRI machines, being devices that emit powerful magnetic fields, are really not the place for you to bring a metal item capable of firing smaller metal items at a couple thousand miles per hour.

That brings us to a recent report from the Food and Drug Administration and a hapless 57-year-old woman who turned out to be quite the literal pain in the butt. Back in June 2023, the woman, whose name and location were not disclosed, reported to a medical center to receive an MRI. Her health care team interviewed her before the procedure, asking her if she had any forbidden items such as concealed weapons. She said she didn't.

This was a lie, as she did in fact have a concealed firearm on her person. And as the machine activated, physics took the wheel: The gun discharged, firing a single shot into the woman's butt. Oops.

Fortunately for her, the wound was described as "small" and "superficial," with the bullet only penetrating subcutaneous tissue. After taking a trip to a nearby hospital, the woman confirmed with the initial MRI testing site that she was fine and healing well.

And now, with the truth revealed, we will never again have to worry about gun owners bringing firearms into MRI machines, as it is clearly incredibly dangerous to them, the expensive medical equipment, and to the hapless medical workers just trying to do their job. Right? Gun owners? Where'd they go? They were just here a minute ago. 


Thursday, March 28, 2019

Another Post From My Actual Job

This one's about beer, which is always fun.

An OTC beer keeps the doctor away

There’s plenty of evidence that a beer or two every now and again is good for your health. But the owner of the Seery Athlone Brewing Company in Addison, Ill., may have taken things too far.



While the reason of its closure just a few months after its grand opening in December 2018 is technically still a mystery, we feel fairly safe in speculating that it had something to do with the fact that brewery owner James Stephen was making his beer at the same location as his main business – a pharmaceutical company engaging in testing of over-the-counter drugs.

In fact, the Food and Drug Administration sent Mr. Stephen a letter in August 2018 warning him that, among numerous other transgressions, fermenting beer literally 10 feet away from where drugs were being tested is a health hazard, for both the beer and the drugs. The FDA ordered the brewery shut down, but the intrepid Mr. Stephen soldiered on, to obviously limited success.



Our advice to Mr. Stephen? Go all in with the pharmaceutical theme. Who wouldn’t want to drink an ibuprofen IPA, ranitidine red ale, loratadine lambic, pseudoephedrine porter, or diphenhydramine doppelbock? You’ll make millions!