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Bench to bedside in a bad way (on the virtue of clinical trials)

Andrew Gelman recently wrote about Columbia surgery professor’s research missconduct. I haven’t looked into the details but it seems like the retracted papers were all about lab research with no true clinical relevancy. In that context, this part of the post stuck out:

Can you imagine, you come to this guy with cancer of the spleen and he might be pushing some unproven treatment supported by faked evidence? Scary.

I can’t tell whether this was supposed to be a joke or if Gelman truly believes that faking mouse experiments directly leads to using unproven treatments, but in case it’s the latter I have to say that the logic is stretched. Yes, the kind of person who has no qualms about fake data is probably not all that rigorous about the evidence for surgical procedures, but for all we know he could be a master surgeon with excellent technique and great outcomes who also happens to have been a bad judge of character and trusted a bad actor. I suspect it’s the latter: the kind of multi-tasking surgery “superstar” that the professor in question seems to be tends to spend a lot more time in the the operating room (or, for another kind of a superstar, the board room), than the lab.

Now, if he were a medical oncologist or any other kind of doctor that gives cancer treatment then maybe things would have been more dubious — that kind of research tends to jump to clinic too quickly and without merit. But unless you’re transplanting pig’s hearts and working on other large animals, the lab is so far removed from the operating room that it is extremely unlikely any such evidence could be used to back up actual surgical treatment.

Incidentally, that last link is to Siddharta Mukherjee’s abomination of an article titled “The Improvisational Oncologist” (subtitle: “In an era of rapidly proliferating, precisely targeted treatments, every cancer case has to be played by ear.") from the May 2016 edition of The New York Times Magazine (it’s a gift link so feel free to read it; caveat lector) and it describes actual scientific and medical malpractice of bringing half-baked — though, admittedly, not faked — ideas from the lab into clinic. Gelman didn’t comment on his blog back then, but he did praise Mukherjee the following year for a New York Times opinion piece “A Failure to Heal” (another gift link there) that is about — wait for it — clinical trials that show the treatment that you thought would work doesn’t. These kinds of trials tend to be called “negative” but there’s nothing negative about them! They bring positive value to the world. Maybe our improvisational oncologist learn something in those 18 months that separate the two texts?

To be clear, what Mukherjee artfully called “improvisational oncology” was (lab) bench to (hospital) bedside medicine, which is distinct from bench to bedside research: the concept of bringing laboratory findings to clinical practice quickly, but still with some semblance of a clinical trial that includes a pre-specified protocol, informed consent and regulatory oversight. You know, all the stuff that decreases the odds of laboratory malfeasance endangering patient care. I say decreases the odds and not prevents them completely because we do have a case of a bad actor completely destroying an entire field of clinical research (Alzheimer’s disease). Can you imagine the damage that kind of shenanigans would do if we didn’t have clinical trials standing between the lab and the commercial drug market?

COI statement: I am involved in a [course about clinical trials][6 and think they are the best thing that has happened to medicine since a cloth merchant wanted to take a closer look at some garments so there is some bias involved, but then again say what you’ll do and do as you say is both a major tenet of clinical trialists and good general practice.

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