People susceptible to the placebo effect may be limiting drug approvals
washingtonpost.com
washingtonpost.com
From the article:
> Winkler’s research told him that between 5 and 40 percent of psoriasis patients feel their symptoms are alleviated when taking placebo pills.
Between 5 and 40 is a lot of variation!
The placebo effect has many causes, you don't know witch percent of the general population will react to the no-treatment, you don't know how the subgroup you selected will react to the no-treatment, you don't know if just going to the doctor once a week as part of the study will change how the people fell, how they sleep, eat, whatever. There are too many variables, and in a serious study it's impossible to eliminate all of them. The best second option is a double blind control group, so you hope that whatever affect the subject affect in approximately the same weight to the control group.
[1] Make 100 double blind studies. In half of them use the screening method to avoid placebo susceptible people and in the other half use the usual mix of people. But make these selection double blind, so the doctors don't know if they are running the normal or the filtered study. Then analyze the 100 studies an see if the 50 filtered studies have more success than the 50 unfiltered.
P.S. What about if the drug is better to the people that has no the genes they are blaming for the placebo effect, but it will kill half of the people with these genes?
That's what the phase 2 trial is for. And in any case, you can just require a genetic test for the drug.
There's really nothing special about placebo effect here. Imagine a population of patients divided into two groups, A and B, with group A smaller but responding to the treatment much more effectively than B. Then if you can identify members of A, you can run a study that demonstrates effectiveness on A much easier than on B, and the drug can be approved for treatment of only group A (at first). This happens in real life all the time.
This whole article seems like a lot of self-serving bullshit. A real drug (with real side effects!) absolutely should be expected to perform well above a placebo. If you can't do way better than a purely psychological treatment, your drug is crap.
I mean, its not a popular opinion, but once the door is opened to start questioning either side of this argument, the sky is the limit.
If 50% of people had placebo and the drug had a real effect on 10%, then:
- Placebo results: 50% - Drug results: 50% + 10% * 50% = 55%
To detect a difference of 5%, you need way more people than to detect a difference of 10%, so your testing is now costlier and possibly slower.
In the extreme, drugs that only benefit a few, or with relatively small but real improvements, will never get tested or fail testing, because of these placebo-folks
If a drug cures 10% of people with an issue, and does not cure 90% of them, is it still worth trying out on people?
Is it still worth researching to try to whittle down diagnoses to hone in on those 10% instead of just claiming it to be a failed drug?
I know it's completely unethical to prescribe a placebo (and I assume knowing it is a placebo erases said effects) but how nice would it be to have the ability to experience some relief without the cost and side effects of a real medication!
The first is that the FDA and similar organizations are demanding ever-increasing amounts of data and expense. The cost of drug approval has doubled, accounting for inflation, over the past ten to fifteen years alone.
The second item is that near all drugs have limited cost-benefit ratios - they simply don't make much of a difference. The reason for this is that most therapies do not address root causes, but rather proximate causes. Try making a damaged machine run better and longer without repairing the actual damage. It isn't easy, and the results are marginal. It is the same in biology. The reason why most therapies address proximate causes is because most research starts with the end stage disease and works backwards down the chain of cause and effect in cellular biochemistry in search of causes. At each new step in the chain, typically someone tries to build a therapy. And usually fails for the above reasons.
If a therapy provides an actual cure, no-one is standing on the sidelines talking about placebo effects. Look at, for example, the very effective cure for multiple sclerosis achieved through aggressive immune ablation. Is there anyone in that situation arguing that, oh, we must account for the placebo effect? Of course not. That would be dumb. Because the effect is very large, very beneficial, and very robust.
The problem is that too much medical development is aiming at the outset for results that are small, marginal, and only achieved in some patients.
having worked in BigCo-s i'm sure it is isn't the testing itself, it is E/S/VP salaries and travel budget :) For the testing itself : 100 people * $1K/day * 100 days = $10M, i.e. peanuts.
There's also the Placebo Paradox: it's unethical for a doctor to prescribe placebos, but it's also unethical for a doctor not to use a treatment that works.
Blew my mind!
So an ethical doctor can just prescribe medicine. It should work through its intended action + placebo :)
Make a pill which prevents the placebo effect, among those susceptible to it. Administer it just before any other placebo/non-placebo medications.
A tic-tac printed with a pharmaceutical company logo should be sufficient as the anti-placebo-effect pill, as long as a clear explanation of its expected effect is provided.
Regardless, what if high placebo responders believed they weren't high responders (aka, "advertising doesn't affect me")? They would expect the first pill to have no effect, and thus the second placebo would. Or what if they expect it to wear off by the time of the second pill?
The placebo effect is well known, understanding it is fundamental to designing a trial, and it has been studied a lot.
It strains credulity to suppose that a hard partition like this (one quarter of humans respond weakly, period), if it existed, would not have been discovered long ago. You wouldn't need to find genes or proteins or any of that stuff, you'd just need to check if placebo response in individuals is reasonably consistent over time.
Gee. I wonder why he didn't like it? Perhaps it called into question his self-annointed genius?
I presume the conventional wisdom is to give the drug the credit but technically that feels incorrect. Or is this factored in? If so, how?