So far, so good. The company, naturally enough, has been trying to see just how far this idea can go, and has been pursuing the hypothesis that the Seraph device might be able to filter out circulating tumor cells. These are the ones that have broken loose from an original cancer mass (often through mutations in their surface adhesion protein pathways) and wander off to start metastatic disease in distant organs. Attempted to clear these out seems like a worthy investigation, and indeed the FDA allowed ExThera to try the device on five patients in Oklahoma as a preliminary study.
Well, so far, so good there, too. But here’s where things go off the rails, terribly. As Carreyrou details, ExThera’s then-Chief Medical Officer (Sanja Ilic) met a Croatian doctor who wanted to try this idea out in a dozen patients. This work has been published, in a paper that is very light on details and certainly contains no dramatic stories of any cures, but it supposedly gave all kinds of positive results. They were positive enough that a member of the company’s board (John Preston) pitched them to a billionaire investor of his acquaintance (Alan Quasha) who put up money to start up a clinic in Antigua. Why Antigua? Well, how about utter lack of any regulatory oversight? Speeds things up, you know. Move fast and break things, amIright?
Problem is, in biomedicine some of the things you break are human beings. ExThera ended up selling thousands of the blood filters to the billionaire’s private equity firm (Quadrant Management, and its new brand Quadrant Clinical Care), and collecting large usage fees from them, and Quadrant began charging desperate cancer patients and their families $45,000 a pop to fly down to the Caribbean for a miracle cure. Well, that’s per single course of treatment, let’s be clear. Patients were encouraged to go through multiple rounds of filtration, naturally. Quadrant’s clinic also urged its customers to stop taking their chemotherapy drugs, for reasons that are not clear to me, except for perhaps malevolent incompetence. Carreyrou has obtained recordings of Preston and Ilic telling potential customers about previous patients who experienced remarkable turnarounds, and that seems to have fetched a steady stream of applicants.
What they found in Antigua was. . .well, sadly, about what you might have expected:
The clinic Quadrant had hired lacked modern medical equipment, and the doctor in charge, a surgeon named Joey John, was making incisions under some patients’ collarbones to install dialysis catheters without using any medical imaging or sufficient anesthesia, according to two people familiar with what the ExThera team encountered. Dr. Chow (ExThera’s Chief Medical Officer) witnessed patients bleeding profusely and, in one case, screaming in pain. He was also alarmed to learn that a patient was forgoing chemotherapy, a pillar of cancer care, for an experimental treatment.
ExThera had flown in Sarah Mobbs, a nurse who had experience treating Covid patients with the filter, to help administer the therapy. Company officials had told Ms. Mobbs that she would be assisting with a cancer study. But when she arrived at Dr. John’s clinic, she saw no signs of the guardrails that would normally accompany a clinical trial, three people with knowledge of the matter said. There was no treatment plan, no oversight from a medical board to ensure the supposed study was conducted safely and ethically. There wasn’t even an oncologist on site.
Dr. Chow, to his credit, warned the company that this operation was unethical and unsafe and urged them to shut it down. Both Ilic and Preston apparently have no further connection with ExThera. But Quadrant Clinical Care? They’re still taking in patients and still processing their payments. After all, they bought a lot of blood filters – and at a cost of about a thousand dollars each, with revenues of $45,000 per round of treatment, why would they stop? The article goes into great and excruciating detail about the treatment of one patient in particular (David Hudlow) who was put through conditions that would appear to have further shortened his already-shortened lifespan and put him (and his wife) through a tremendous amount of needless suffering before he died. I have no reason to think that the article’s descriptions of these are inaccurate, and if they are indeed as described they amount to multiple types of malpractice along with a callous and reckless disregard for human life and human dignity.
This sort of thing is the exact opposite of the medical goal of primum non nocere (first do no harm). Quadrant’s clinicians seem to have not worried for a moment about the obvious and severe harm that they were causing their patients just so long as the payments (which were due up front) came in. And here, folks, is where we talk about the Regulatory State, which is an entity that is much in the news thanks to recent political developments.
There has long been a romanticized vision floating around of what medical progress would be like if only the bureaucrats and paper-pushers would get out of the way. There is talk of an “invisible graveyard” of patients who died before the slow, painful process of regulated medical research could get around to helping them. And you know what? They’re right – up to a point. If you just look at the successful treatments, then yes, you can say that If Only We’d Sped That One Up we would have saved more lives. But too many of the Invisible Graveyard people don’t do the full bookkeeping on all the stuff that doesn’t work (or worse, makes people worse). The clinical trial system contains those failures and isolates them from the general population of patients, while at the same time providing real evidence for their failure and thus solid reasons to go away and try something else.
If you kick out the jams and let Anyone Try Anything, what you get is the Quadrant Clinical Care facility in Antigua. Hell, that’s actually a best case. The rationale behind this one (as mentioned) might work, and is definitely worth further study. But depleting desperate people of their savings to treat an endless stream of random patients is not “further study”. No one at the Antigua facility seems to have the faintest understanding of how you generate reliable clinical data, and no one there appears to give a damn that they don’t. Because that’s not the point of the place. This is a private equity investment from people who know nothing at all about medical practice, and its point is to make cash now.
I’ve said this before, and I’m saying it again: if you destroy the horrible bureaucratic regulatory state out of your libertarian convictions, out of lack of understanding, out of spite and revenge, this is what you get. At best this is what you get. Past the ExTheras and Quadrants of the world are a horde of predators who don’t even care as much as they did. Turn them loose, and they will do what they do, because (sadly) that’s what many people are like. Homo homoni lupus: man is a wolf to man, and the point of laws and regulations is to keep the wolves at bay. Will we?
