Less Evidence, More Pills?
Posted on Wednesday, August 8th, 2018
Some folks like to say that the difference between conventional medicine and holistic, regulative, or other unorthodox therapies is that the former is “proven,” the latter is not.
Yet as we’ve seen before, this isn’t exactly true.
Research has shown that only about 20% of orthodox medical practices are based on “gold standard evidence,” randomized, double-blind, placebo-controlled studies. The rest, note Sanjaya Kumar and David Nash in their book Demand Better!, is “based upon a combination of less reliable studies, unsystematic observation, informed guesswork and conformity to prevailing treatments and procedures used by most other clinicians in a local community.”
New research in JAMA offers another view of just how weak the evidence for FDA-approved medicine can be.
This Yale-based study evaluated the evidence backing the approval of the 46 “breakthrough” drugs approved since the implementation of the US Food and Drug Administration (FDA) Safety and Innovation Act of 2012. This act was designed to speed the availability of drugs and biologics intended to treat serious or life-threatening conditions.
All told, the authors analyzed 89 trials. More than half the drugs – 54% – were approved without any double-blind testing. Nearly half were approved without a randomized trial or comparison to a placebo. Only 22% of all trials measured actual improvement.
And more than half of all approvals were based on a single pivotal trial.
Considering how many drugs which went through the usual approval process have turned out later to cause harmful, even life-threatening “side effects” – nearly 1/3 of all drugs approved between 2001 and 2010, according to one study – one can only guess how many of these fast-tracked drugs will turn out to be more problematic than assumed.
But these are for life-threatening conditions, some may object. The risks are worth it.
We respectfully disagree. What is needed, in our opinion, is the radically different approach of regulative, biological medicine, where the goal is more than just to stop symptoms, creating the illusion of health. The goal is to give the body what it needs to restore proper self-regulation, detoxify, and heal. Symptom-focused pharmaceuticals only interfere with this process.
But if one chooses to go the route of conventional medicine, we think they at least deserve therapies that have some robust evidence supporting them and their safety.