Why I Don’t Believe In Science | THCB – By Michel Accad, MD – Feb 16, 2016
As a case in point, a few weeks ago the New England Journal of Medicine published the results of the SPRINT trial which had randomized patients with high blood pressure to one of two treatment protocols:
- high intensity therapy, to try to achieve a systolic blood pressure less than 120 mmHg, or
- low intensity treatment for a more modest reduction in blood pressure (less than 140 mmHg).
To the surprise of many, the trial was stopped early because the difference in mortality rates between the two groups was statistically strong enough to trigger an automatic termination.
High intensity was superior to low intensity, and continuing the trial could expose the low intensity treatment group to an excess risk of mortality if the trial kept going for another few years.
Luckily, SPRINT was a NIH-sponsored trial, so the usual suspicion that the results could have been rigged by profit-motivated pharmaceutical companies could not be raised. In many other ways (size, design, statistical methods, etc.) SPRINT seemed to follow some of the recommendations made by Ioannidis.
Nevertheless, many physicians seemed upset about the results, and some of their reactions seemed to betray biases of their own.
As soon as the abrupt trial termination was announced, Eric Topol and Harlan Krumholz, two academic leaders in cardiology, wrote an Op Ed pages in the New York Times in which they demanded that all patient-level data be made promptly available for review by the scientific community. Being NIH-sponsored, it seemed, was not good enough to satisfy the skeptics.
A trial can tell us that on average certain types of patients may do better with this treatment than that one, but a trial can tell us nothing about how the patient at hand will fare, and this patient invariably has certain characteristics that make him or her different from those patients enrolled in the trial. We are not clones, after all.
any physician worth the M.D. after their name have to use judgment to take care of patients, and clinical judgment is decidedly “unscientific.” After all, if we are allowed our own respective clinical judgments—and thankfully, so far, we are—there is no scientific explanation for any agreement or discrepancy among us. Judgments are decisions, not “discoveries.”
There is a cost to implementing new rules that must be added to an already horrendously expensive and lengthy clinical trial process, and if the aim is to get ever closer to scientific certainty, there is no end to the resources that could be employed to triple verify and vet everything that goes into a clinical trial
In fact, clinical research is extremely costly precisely because of perennial calls to make it “more rigorous” and more believable.
And these calls are not new: our healthcare system was born out of a desire to put snake oil salesmen out of business by making medicine ever more scientific.
But if that desire leads to a boundless commitment of resources and still remains unsatisfied, perhaps it’s time to reconsider its pre-suppositions.
Besides, I’m not sure that the academic community, whose living depends in large part on the conduct of research, is sufficiently impartial when it comes to determining the optimum cost of the scientific enterprise
In the comment section of a Health News Review blog post discussing the SPRINT trial, Mayo Clinic physician-scientist Victor Montori—a very well-respected champion of patient-centered medicine and “shared decision-making”—expressed a wish that “new pressure be applied to prevent [early trial termination] from ever happening again.”
Alan Cassels, a health policy researcher and the author of the article, agreed with Montori and added that “we should not cheer the decision to stop the trial, and sprint to erroneous conclusions about what it all means.” I have read similar remarks made in other venues online or in print.
not only do they demonstrate circular reasoning in regards to scientific validity (termination rules are precisely put in place to remove human bias), but they also implicitly express the view that seeking scientific clarity is worth risking some lives.
This, in my mind is a troubling position to take, and it points to a more general danger, which is that if we believe in science too strongly, we may end up not believing in patients anymore