Hello my loves. I’ve missed you. Sorry for the lack of newsletters. I’ve been trying to focus on making friends and keeping my job. I’m learning a new category (machine learning and artificial intelligence) and that takes up a lot of time and mental energy! But here it is a Sunday and I’m working and took a break to browse Facebook and I came across this article.
It’s a good article. Well-reported. Important. And yet. It’s making me really heated. Here’s why.
Yes, overtreatment is a problem. Treatments that aren’t evidence based, treatments that evidence shows are actually on-net harmful, are a problem. But here’s the thing. And this is often the problem with good reporting. Stronger FDA standards is a solution worse than the problem it seeks to solve.
And this is a thing I see a lot, where a reporter will do an awesome job researching a problem, and a great job presenting the problem, and then just completely fumble when presenting a solution. And the solution is almost always “more government.”
In this case, the reporter is trying to make the case that the solution to doctors recommending treatments that have been conclusively shown in studies to be ineffective is stronger FDA oversight. Except that the “uniquely rigorous” FDA reviewed Theranos’s finger-stick blood-test technology and underlying testing system, yet didn’t catch that they don’t work.
It’s not just that the FDA is poorly run and has major conflict of interest problems, though that’s certainly true. No, the main two problems with this solution are that it will kill people and won’t fix the problem. It’ll kill people because “move oversight” means fewer drugs get to market, and the ones that do get there later. Meaning people die of curable diseases. It also means the cost of developing new drugs remains hella high. Which means only drugs that can make bank get developed in the first place. So if you’ve got a condition that’s not going to be extremely profitable to treat, you’re shit out of luck.
So that’s how “greater oversight” for the FDA kills people, in a nutshell. But it won’t fix the problem because the truth is that no amount of FDA oversight can reveal what we all really need to know, which is, “Does it work?” No amount of controlled studies can replicate getting a drug out there and seeing what it does.
It’s especially weird when the writer makes the case against their own solution within the article.
The larger issue has nothing to do with Provenge specifically but about the way it gained FDA approval. Therapies are frequently approved for use based on clinical trials that can’t actually prove whether they work. “Clinical trials almost all have issues like this one,” Berliner says, “and it’s very hard to do randomized controlled trials after drugs are approved.” According to a new paper in the Journal of the American Medical Association Oncology, even when cancer drugs clearly do work in trials, they often don’t work or work substantially less well in the real world, perhaps because subjects in trials are not representative of typical patients. Berliner is hoping to expand and improve registries that track large numbers of real-world patients as an additional source of information. “I’ve been here for 15 years producing these reports,” she says, “and I’m getting frustrated.”
The problem we need to fix isn’t a knowledge problem anyway. We know these drugs and procedures don’t work. It’s a process problem. As in, part of the process of practicing medicine MUST BE to incorporate evidence into your treatment plans. When evidence surfaces that a treatment doesn’t work, you need to STOP RECOMMENDING THAT FUCKING TREATMENT.
Ideology is a helluva drug.