For those who don't RTFA, he did the first experiment on Rh disease, which is an antigen response between a pregnant woman and her fetus:

"The paradox is that the antibody that you¡¯re injecting in mothers to mop up [the baby¡¯s] Rhesus-positive red cells, is an anti-Rhesus antibody ¡ª the very antibody you¡¯re seeking to prevent from forming in the mother, and that is a paradox and that scared a lot of people.¡±

And reading that they used prisoners and then his sister-in-law as the first human subjects....yikes, he sounds like a bit of a cowboy. But I guess that's how some discoveries are made?
posted by wenestvedt at 6:17 AM on November 2, 2022 [1 favorite]

I'm glad the technique works, and it's unquestionably saved a whole lot of lives, but jesus, this guy had a theory based on a single line in a textbook, went straight to human trials with a handful of semi-consenting prison inmates, and then smuggled his serum out of the country to inject into his pregnant sister-in-law? And it sounds like he never lost his license, or even faced censure from the medical board, because it worked. It's not like we're talking about 19th-century phlebotomy, either--this was mid-20th-century America, with a functioning FDA and nominal ethical standards.

I dunno, the whole story makes me deeply uncomfortable, even if the treatment turned out to be hugely beneficial. If this methodology was considered acceptable, how many doctors acted on hunches that were lethally wrong?
posted by Mayor West at 6:46 AM on November 2, 2022 [8 favorites]

That "cowboy" doctor is a bit tainted in his heroism, but James Harrison's thousand-plus plasma donations, due to his unusually strong Rh antibodies, helped an estimated 2.4 million babies, personally. Whoof.
posted by seanmpuckett at 6:51 AM on November 2, 2022 [10 favorites]

I don't think the human trials are necessarily such a big problem. Injecting antibodies doesn't seem like it could go horribly wrong. And saving babies seems pretty important. Sounds like the FDA took almost a decade to approve it, though, so it's not like it sped through.
posted by rikschell at 8:37 AM on November 2, 2022 [1 favorite]

My mother was a pediatrician who trained in the '70s. She once mentioned how glad she was that now they weren't seeing "blue babies" anymore -- children born with this syndrome.
posted by Countess Elena at 8:55 AM on November 2, 2022 [5 favorites]

Q. What could possibly go wrong?
A. Accepting a blood donation from someone who was Rh+ve but also infected with HCV Hepatitis C Virus: as the Irish Blood Transfusion Service Board BTSB did in 1977 . . . and then aliquoting that contaminated blood into a number of vials labelled "Anti-D" and delivering it to Rh-ve mums. This error, and another HCV-contaminated donation in 1996, and their cover-up cost Irish Tax Payers ?840 million in compensation claims as well as 1200 Irish women of child-bearing age who were exposed to the HCV contaminated blood. But, some of the HCV-exposed women seemed to have no evidence of having been so assaulted - perhaps because they had a particularly fizzy innate [first responder] immune system. That was/is of interest because 200 million people are infected with HCV world-wide and if we knew what aspect of innate immunity provided resistance - that would be a win . The immunology lab where I used to work secured research funding to explore this idea after I'd left - helping write the grant application was one of the last things I did there.
I blogged the sorry, shabby, story up II - III - IV - in 2016. Ireland was not alone in such culpable negligence either w.r.t. Anti-D or Factor VIII for haemophiliacs.
posted by BobTheScientist at 9:32 AM on November 2, 2022 [6 favorites]

yikes, he sounds like a bit of a cowboy. But I guess that's how some discoveries are made?

When you see well-meaning people¡ªand it really does seem like this guy was trying to do the right thing¡ªdoing crazy stuff to get around regulations, I think the knee-jerk response ought to be to look at the regulatory apparatus and why it's perceived to be so impossible to work with, rather than immediately castigating someone for not following the process.

The FDA is pretty fucking broken and this isn't exactly new. It doesn't surprise me that researchers might basically go rogue if they think they have a discovery that could literally save lives from day 1, since the alternative is trying to pitch your idea to a giant pharma company, who is only going to care if there's huge profit potential, so they can tiptoe it through a regulatory minefield staffed by people whose main concern seems to be avoiding scandal and the perception of danger by the public at all costs, actual calculus be damned, and all the while you have to watch people die unnecessarily while the bureaucratic wheels grind.

Bear in mind this is the FDA that ensures Americans can't even get modern goddamn sunscreen right now, and I'm sure things weren't any better in 1960. The system has been failing patients for decades.
posted by Kadin2048 at 10:02 AM on November 3, 2022 [1 favorite]

Kadin, what's this about sunscreen? I'm not finding what you mean with a quick google, except that apparently they declined to change standards in 2021. Are there really better sunscreens out there?

I suppose that the shadow of thalidomide is still pretty long at the FDA. At least, I would hope so.
posted by Countess Elena at 10:55 AM on November 3, 2022