It seems that this damned placebo effect is getting in the way of developing and authorising new psychiatric drugs. It creates a ‘therapeutic bias'(!) and so the experimenters are experimenting with ways of controlling for it in trials, for example ‘SPCD, sequential parallel comparison design’. These are proving to be not (yet) up to the task, sufficient to be acceptable by bodies such as the RDA. The following is from The Placebo Effect Is Hobbling New Psychiatric Drugs
“The FDA’s rejection cast doubt upon the design, still in use in more than a dozen trials, as a weapon against the placebo effect.
That’s big news because the effect, also called the placebo response, has been growing stronger over the years in clinical studies that randomly assign patients to either an active drug or placebo. When the effect is high, it’s hard to know if a drug just isn’t good enough, if there are errors in the data, or if the participants taking the placebo—an inert pill meant to make them believe they’re getting the real thing—fared unusually well because of their expectations.
It’s a testament to the power of our minds to improve our health, at least temporarily. Many factors boost placebo response. “Most people, whether they know it or not, are biased to believe that they will receive the active drug even if they are told that they have a 50 percent chance of getting placebo, and this ‘therapeutic bias’ increases the placebo response,” says John Krystal, the chair of the psychiatric department at the Yale School of Medicine in New Haven, CT.”
Pain is a subjective state – that’s why practitioners typically ask us to ‘scale’ our experience of it, from a ‘1’ (slight) to a ’10’ (unbearable). And while it’s easy to see why the experience of pain is useful in an evolutionary sense (‘keep your hand out of the fire!’) it’s difficult to account for what mechanism is responsible for this experience. Different analgesics may have different effects (and affects) for different people, and some don’t seem to contraindicate – it seems you can ingest an opioid at the same time as paracetemol.
A recent ‘meta-study’ claims that placebo are NOT, in fact, on par with conventional antidepressant medications, as we have reported numerous times in this blog. It seems, however, that this study should be read with certain caveats, most particularly that “The review’s authors have acknowledged that almost 80% of the studies they analysed had been funded by the pharmaceuticals industry.” (Fawning Coverage of New Antidepressants Review Masks Key Caveats) Confirmation bias, anyone?
From the earliest days of placebo research the practitioner-patient relationship has been at the heart of theorising about its effectiveness in therapy (and in life!)
Here’s an article that explores ‘the conversation’ and its beneficial placebo effects.
” … it’s no surprise that chronic arthritis and back pain are the second and third most common non-acute reasons that people go to the doctor and that pain costs America up to $635 billion annually. The pain remedies developed by the pharmaceutical industry are only modestly effective, and they have side effects that range from nausea and constipation to addiction and death.
What’s often overlooked is that the simple conversation between doctor and patient can be as potent an analgesic as many treatments we prescribe.”
… and …
“It’s clear that how doctors and nurses communicate their treatment can have profound effects on how patients experience the results of that treatment. Yet the conversation between doctors and patients is one of the least valued aspects of medical care. Insurance reimbursements for tests and medical procedures dwarf reimbursements for talking to patients or spending time thinking about what ails them. And the pharmaceutical industry, with its direct-to-consumer advertising, has promulgated the fallacy that every ailment must be met with a pill — brand name, of course.”
We note an interesting ‘counter narrative’ emerging – that is, scepticism about the commonly held view that drug treatments designed for mood disorders such as depression often engage the Placebo Effect. In this counter-narrative,
“Drug trials don’t show much in the way of classic placebo effects. The rise in placebo responses over the years is more likely due to the supportive factors in drug trials…and increasing problems with enrollment.”
The new finding—no upward trend in placebo responses—is unexpected and certain to be contested. Meanwhile, it stands as a rebuke to a popular narrative. By that account, drug effects had been hyped, expectations soared, and the inflated hopes were reflected in rising placebo response rates.”
This is fine, except the counter-narrative also resonates with challenges about the efficacy of conventional ‘gold-standard’ ‘blind’ ‘placebo controlled’ drug trials, where it has been shown that trials funded by drug companies (who by definition have a vested interest in their outcome) are 30% more likely to return ‘favourable’ results than trials which are not funded in this way. The ‘placebo effect’ might be the design and execution of the trial itself, not the actual function and efficacy of the placebo …!
“Antidepressants are supposed to work by fixing a chemical imbalance, specifically, a lack of serotonin in the brain. Indeed, their supposed effectiveness is the primary evidence for the chemical imbalance theory. But analyses of the published data and the unpublished data that were hidden by drug companies reveals that most (if not all) of the benefits are due to the placebo effect. Some antidepressants increase serotonin levels, some decrease it, and some have no effect at all on serotonin. Nevertheless, they all show the same therapeutic benefit. Even the small statistical difference between antidepressants and placebos may be an enhanced placebo effect, due to the fact that most patients and doctors in clinical trials successfully break blind. The serotonin theory is as close as any theory in the history of science to having been proved wrong. Instead of curing depression, popular antidepressants may induce a biological vulnerability making people more likely to become depressed in the future.”
More on the continuing critique of widespread prescription of antidepressants here.
If a drug company treats a doctor to a nice lunch and a presentation on their newest products, is prescribing affected? Doctors generally think not, but the research evidence overwhelmingly says yes. And if these events do affect doctors’ decisions on patient care, should we be worried?
Couldn’t they just prescribe placebos? Of course not! Where’s the profit in that?
Placebo beats pill for all but most severely depressed, study shows.
“Antidepressants are little better than placebos except for in severely clinically depressed samples,” Johnson said. “The implication was that medical doctors are overprescribing antidepressants because most patients are not severely depressed.”
“I grew up in Marin County, California—a hotbed of holistic health, where “healers” of all stripes (legitimate or not) thrived. My own father was an acupuncturist who treated most of my ailments with tiny silver needles or stinky Chinese herbs. I went to the doctor only for routine physicals and shots required for school. Thus, I grew up believing that my body had the power to heal itself.
Once I left home and moved to the more conservative burbs of Santa Clara County, I came to realize that the average person considered alternative medicine to be a placebo at best—and an outright sham at worst. But perhaps placebos have been getting a bad reputation. New research into the placebo effect suggests that our expectations and beliefs can play a much bigger role in healing than previously thought.”
” … Drug companies have a strong financial incentive to game (i.e. fake) drug testing. To develop a new drug, they invest over a billion dollars and many years, with the reward contingent upon negotiating a sequence of RCTs, which opens the path to a patent-protected monopoly.”