PART 2, FAKING MEDICAL REALITY
PLACEBO WASHOUT: ANOTHER OUTRAGEOUS MEDICAL COVERUP
FEBRUARY 24, 2012. Here is yet another way to do medical studies that guarantee a waterfall of lies will spread out far and wide. Another way to make the studies look good when they aren't.
Let's say you went into a school to see if it was a good place for your child to acquire a real education. And you were shown overall performance records of the students on standardized tests, and these records looked quite impressive.
Upon inquiring a little further, though, you came across an interesting point. The head of the school believed that some students just didn't perform well on tests-and so he had excused them from taking any exams.
Shocked, you said to him, "Your performance records are a sham. They don't reflect the truth. You've stacked the deck."
And he replied, "Not at all. I've merely kept statistics on those pupils who have the ability to take tests. That's the important population. The others shouldn't be tested at all. In this venue, they don't count."
Keep that analogy in mind as we proceed.
I want to alert you to a staggering medical practice in clinical trials of psychiatric drugs.
It's called "placebo washout."
Basically, it works this way. Before a drug company starts to test the effectiveness of a new medicine they want to market, they bring together all the volunteers-and they give them a sugar pill.
They tell them, "We're going to give you a sugar pill."
After a ten-day period on the placebo, the researchers weed out the people who improved, got better, feel better. They dump them from the ensuing clinical trial. Bye bye.
They don't want these people around for the real clinical trial that is to follow.
Of course, they claim there are good reasons for this washout strategy. But the fact is, eliminating these volunteers from the study makes it far more likely that the drug being tested will look good, when it shouldn't.
First, in case you don't believe placebo washout is a real and widespread practice, here are two references that unequivocally state it is:
RP Greenberg et al, PMID 857037, PubMed-indexed for Medline;
and JG Rabkin et al, "Baseline Characteristics of 10-day placebo washout responders in antidepressant trials," PMID.
It's real. They give everybody a sugar pill, and then they dismiss all those who got better on it.
Then they get down to the actual clinical trial. They divide the remaining volunteers into two groups. Those who will receive the drug, and those who will be given another placebo.
Nobody is told which group they're going to be in. That's the whole point. Blinding the study enables researchers to compare the number of people who get better on the drug with those who get better on the placebo.
You see, it's common knowledge that some people will get better on anything. That's why they form the two groups. They have to prove (to the FDA) the drug is performing better than the sugar pill.
General estimates vary on what percentage of people get better on placebos. 35-45%, some researchers say, is a rule of thumb. Sometimes the % is higher.
But wait! The researchers ALREADY kicked out the people who got better on the sugar pill during the 10-day preliminary washout!
What's going on here?
Well, in the actual clinical trial, where half the people get the placebo and half get the medicine, some people who get the placebo-armed with the hope that they might be getting the medicine-will feel better, even though they're only swallowing sugar pills.
And the researchers must show that more people who are getting the drug are feeling better than those who are getting the placebo.
That's the whole reason for this type of clinical trial.
"See, 47 people who took the drug feel better. And only 22 people who took the sugar pill feel better. Therefore, the drug really works."
Sure it works. Because you already kicked out all the people who felt better on a placebo in the washout phase.
In effect, you did a screening. You "cut out the competition."
It's like saying, "We have a great runner on our team. His times in the 100-meter dash are exceptional...there's only one thing. In track meets, we insist he run only 80 meters and you have to imagine it's 100."
The FDA, which approves all drugs for public use, knows all about the placebo washout con job. Researchers know this. Shrinks know this. Drug companies know this. Even some medical reporters know this.
And yet, the practice goes on.
Placebo washout is on the order of saying, "Yes, we tested the new plane and it performs magnificently. Of course, we didn't put it into the air. We rolled it across the runway."
If there are any psychiatrists out there who are reading this, any researchers who want to defend placebo washout, I suggest we set up a debate with Dr. Peter Breggin, psychiatrist and author. But I warn you. Buckle up. It'll be a bumpy ride.
Placebo washout. Rigging the game. Stacking the deck. The bigger the lie and the more obvious it is, the harder it is to believe that's what's you're looking at. Until you LOOK.
In my 30 years as a reporter, I've come across maybe 100 scandals that could cause a significant sector of the medical cartel to burst into flames and blow away in the wind. This is one of those.
Of course, media, government, and drug corporations make sure such a thing never happens. And when I say media, I'm including publications you'd think would love to watch a really good fire. Turns out they have no stomach for it.
NOTE: In case you're still a little shaky on this scam, let me lay it out this way:
A drug company has a new drug, Gx, for depression. It's not on the market yet. For that they need FDA approval, and the approval rests on the results of a clinical trial the company is going to launch.
The company signs up 500 volunteers, all of whom meet mainstream criteria for a diagnosis of clinical depression.
The company brings together the 500 volunteers and administers them a sugar pill (placebo) for 10 days. Everybody knows it's a sugar pill.
After 10 days, the company discovers which of the 500 people responded well to the pill: placebo effect. Let's say 80 people did. They feel better. Boom. They're dumped from further consideration. They're gone.
Why? Because chances are very good that, were they allowed on to the next phase, those among them who ended up with the sugar pill would have said, "Wow, I feel better. I feel less depressed."
And THAT means the people who were given the actual drug, Gx, would be "up against stiffer competition" from the group who took the placebo.
After those 80 people were booted from the placebo washout phase, with 420 volunteers left, they were divided into 2 groups of 210 each, and then 210 got the drug, Gx, and 210 got a sugar pill. None of the volunteers knows what they're getting. This phase of the trial goes on for 6 weeks. At the end of that period, the study is "unblinded," and everyone knows who got which pill. Now, among the placebo group of 210, it turns out that 60 showed significant improvement, and among the group of 210 who got Gx, 85 showed improvement.
The researchers conclude, "Those on Gx performed significantly better than those on placebo. This drug is good."
But had those original 80, who were kicked to the side of the road after the placebo washout phase, been included in this later phase, the conclusions of the researchers could have turned out quite badly for the drug and the drug company. Gx could have performed no better than the sugar pill. It could have done worse.
And this is called SCIENCE.