Sense of Humor - part the second

Yet another series, based on a previous essay: the NYT sometimes displays a cruel sense of humor in printing contradictory reports on topics of national interest.

Today's duet: does the Deep State really impeded progress or stifle it? Two reports, one about Ketamine and the other about sweatheart regulation. It's hard to take the NYT seriously, at times.

The first deals with Matthew Perry's OD death by Ketamine, and puts the spotlight on what FDA approval really means.

Because the Food and Drug Administration approved ketamine for one purpose — sedating patients during surgery — more than 50 years ago, doctors can prescribe it for other uses.

So, it was perfectly legal to give Perry ketamine in any amount they wanted. The fact that he died as a result may be criminal, but charging them for over-prescribing is iffy. IOW, FDA isn't really some Deep State actor putting handcuffs on drug companies. As the report implies, may haps it's not such a good thing to have off-label prescribing? But, of course, that would entail forcing drug companies and FDA to fully test (at least one PII trial) some drug for each indication. There are drugs that already go through that regimen, but not for clinical reasons. It's all about the money. Insurers generally don't cover off-label use, so getting FDA's OK for a large use population can worth the grief.

That brings us to clearly corrupt conflict of interest by a C-suite FDA critter. It's a very long report, and smells to high heaven. He is head of device approval at FDA, and she (Wifey) is a lawyer working for companies seeking approval of devices. While the Perry story is about one sad fuck up, this one is about myriad corrupt events.

Their job is to protect the public health. They're doing the opposite. Anybody who doesn't see that is not looking.
-- Paula Cofer

Among other things, it reports that FDA, much after the fact, admits that the two engaged in conflict of interest activities. She actually backed Theranos, of all things.

Her partner at the helm of the firm's life sciences team began representing Theranos, the discredited blood testing company, in 2015, demanding that the F.D.A. halt an inspection at its sites in California.

Up to 1962, before the Kefauver-Harris Amendment, FDA's remit was safety. Yet, under his involvement

Reports of device-related injuries soared to 900,000 in 2023, up from about 190,000 in 2012, according to Device Events, a company that makes F.D.A. data user-friendly for subscribers.

Now, that's doin the job Sparky.

So, yeah, FDA is all about persecuting drug companies in a Socialist frenzy. Sure.