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The 'gold standard' in nutritional and medical studies is the random controlled trial (RTC) which relies on the fact that neither the experimenters nor the subjects are aware of which subjects are getting the actual intervention or are receiving a placebo (an inert preparation that is indistinguishable from the real substance being tested, be it a pill, an injection, etc.). The idea is that this will control for the bias of both the experimenters and the subjects so that their preconceived notions don't affect the results of the trial.

But a recent controversy has lead many to question the validity of many these studies. It turns out unscrupulous scientists have figured out a way to manipulate the results by using placebos that aren't actually inert substances. The ingredients of the placebos used in trials are often not disclosed (the information being carefully protected, as some researchers and reporters have discovered). It seems that placebo tampering is yet another way for some scientists to manipulate the data to show their drugs are more effective and have less side effects than they actually do.

Join us on this episode of Objective:Health as we look into the implications of placebo tampering. Can we trust any science at all at this point?

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Running Time: 00:27:39

Download: MP3 — 24.9 MB

Here's the transcript of the show:

Elliot: Hello everyone and welcome to this week's edition of Objective: Health. I'm your host today. My name is Elliot and I'm joined by Erica and Doug. Welcome.

Doug and Erica: Hellos.

Elliot: We also have Damian on the wheels of steel as usual. Hey Damian.

Damian: Hello.

Elliot: Today, in this week's edition of the show we are going to be looking at a very interesting topic, something I didn't even think about previously before reading a couple of articles that have just come out on some of the big news health websites. This is on the topic of placebo. We've done several shows on the placebo effect or the nocebo effect previously on our older edition of the Health & Wellness Show.

But this week we're going to be looking at it from a little bit of a different angle and this is related to whether a placebo is actually a placebo in every single case. I'm assuming that everyone is familiar with the concept of a placebo, but just in case some audience members aren't, essentially in a research study or when scientists or researchers are trying to identify or assess the efficacy, whether a drug works or it has any side effects or whether it's able to do what it is intended to do, they compare it against a placebo. So a placebo is meant to be an inert, biologically inactive substance which is meant to have pretty much no effect on the human body.

An example would be if I was a pharmaceutical company and I had developed a new drug to treat heart disease, what we would be doing would be to take a wide body of people with heart disease and we would split them into two. We would give half of them the drug and we would give half of them the placebo and then at the end of the trial we would assess whether they still had heart disease, whether they had an increased risk of morbidity, whether there were any horrible side effects, and we would compare that with the placebo.

Now ordinarily the placebo, as I said, is a biologically inactive substance. It's an inert substance. The people who took the placebo should be in the same place that they were before they took the placebo. Does that make sense? Whereas on the other hand we can compare the results of a drug or a vaccine or some other kind of therapy against that as a control. But we've been led to believe that all placebos are biologically inert, are inactive and are not going to have any significant effects on the human body. The question is, is this really the case?

You would think that this is something so obvious, you would think that the research bodies who run these trials and use these placebos, you would think that they would publish what was contained within the placebo. The problem is they don't. A couple of articles have come out recently, as I said towards the start of the show, talking about this very problem and actually looking at how in many placebos, these could in fact contain certain excipients which are in no way biologically inactive, which actually can exert very detrimental effects on the body and this would, rightly so, introduce a whole host of problems in terms of determining the efficacy of drugs, in terms of determining the safety of drugs because as we will be examining in today's show, certain things which are considered placebos may actually be causing side effects in and of themselves.

Doug: The first article that came out that was bringing up the controversy was on crossfit.com. Damian I think you've got that one. It's called Sometimes a Placebo is Not a Placebo and it's by a PhD. Her name is Maryanne Demassi. She brings up a couple of different instances where placebos have not in fact been placebos. One of her main points in the article is that, like you were saying Elliot, a lot of times these placebos are not actually inert substances, that they are giving active substances in the placebo. Now whether that is just a dye or sometimes they put a flavouring in it to make it bitter so it's a more convincing placebo. It actually tastes like a bitter medicine.

But then other times it seems like they're going above and beyond that, not just to change the colour and change the taste, but are actually putting in active stuff. The one that actually stood out to me was that there was a vaccine trial...

Erica: It's for Gardasil.

Doug: Yeah, it was a Gardasil vaccine, that's right. And what they were doing is instead of giving an inert saline solution, which is generally what they do, they were giving a solution that had the excipients from the vaccine in it. So it had the aluminum adjuvant in there as well as a number of other things. So essentially what they're doing is, if they're going to look at the vaccine, once they've injected some people with the vaccine and they say "Well how many of these side effects that these people are having also showed up in the placebo group?" And lo and behold, they had the same kind of reaction so it's not because of the vaccine. It's because the placebo group was getting that as well, except that the placebo group wasn't actually a placebo group.

They were being injected with these excipients. So that basically means that they can erase a lot of the side effects that are there by saying both the placebo group and the active ingredient group had this percentage of headaches or whatever. "Okay we can write that off because that obviously wasn't because of the vaccine because the placebo got it too." But that's not the case. It probably was something that was caused by the excipients.

Elliot: It's amazing because the adjuvant part of the vaccine, in this case aluminium hydroxyphosphate apparently, is the portion of the vaccine which is meant to elicit or initiate an immune response in the body and that is theoretically the thing which causes someone to build up an antibody response. It kicks the immune system into action because it is a toxin. It's deadly.

Doug: Yeah.

Elliot: So the idea is that actually a lot of these alternative vaccine researchers who have come out and spoken out against the dangers of vaccine have rightly pointed out that perhaps the most likely culprit in terms of causing vaccine-adverse reactions, in terms of autoimmunity, paralysis, many other kinds of really, really horrible side effects that can be developed after having a vaccine, are likely due to the adjuvant.

So you've got the placebo group which is given the adjuvant and then you've got the vaccine group who are given the vaccine with the adjuvant. But if the adjuvant is the thing which is most like to cause the side effects, and both groups experience side effects - rightly so because they were being injected with a toxin - then in the research community, you can rightly point out that because both the control group and the study group experience a similar rate of side effects, it must be due to some other factor because that control group is the placebo group. It's a great way to get your vaccine onto the market, right!?

Doug: Yeah.

Elliot: It's a great way to convince the research community and the public at large and all of the public health sectors in different countries, that your vaccine is as safe as a placebo because people are under the wrong impression that the placebo is inert. In this case it's not! It's a toxin!

Doug: Really, this is an obvious manipulation. This is yet another way for them to fudge the data in order to get something that may not be safe, onto the market, to make their money. Once they discover 'Oh my god, so many people are having bad reactions to this, we have to take it off the market,' well it doesn't matter. They've made their money. Everything's cool.

So it's yet another example of how devious these things can be. We've talked a lot about it on the show, about how pharmaceutical companies will often do these things to fudge data, to get the results that they want. If they have negative reactions they throw that data away and only publish the positive or mostly positive stuff or any number of different things that they do to try and manipulate the data that's going out there, to convince people that it's a safe drug, that it's an effective drug when in fact it's not.

Erica: I also think it's a way to discredit the idea of the placebo effect. This is the first time I've read a lot about placebos in these types of vaccine and drug trials, but especially with pain, surgery and whatnot - and for those who are interested we have done a show in the past about that - but a way to discredit this idea of mind over matter, the placebo effect. I feel like it's legitimate. Your thoughts affect how you respond to pain and whatnot, so I wonder if it's more of a 'let's just muddy the waters a little bit and discredit the whole idea behind the placebo effect being a real potential for healing for people'.

Doug: In getting prepared for the show we were reading a bunch of different things about placebo and the more I read about it, the more I actually wonder if the whole way of doing these trials with the placebo control group is even legitimate because it seems like there is a placebo effect going on regardless of whether or not there is an active substance there. So yeah, if it's a placebo there's a placebo effect, but even if there's not a placebo, if it actually is an active substance, there's still a placebo effect. I guess that's why they designed these trials, to try and eliminate that placebo effect from taking the drug.

So they want to know how effective the drug is so they do it against a placebo group so that they can take out that data and say, 'this is how much of the drug is actually effective versus somebody's mind just thinking that it's effective and having an effect'. It's just making me wonder how legitimate that actually is, especially when I read recently something I didn't realize. Apparently placebos are becoming more effective. They've actually done studies where they are showing how over time placebos have actually started to become more effective at causing the placebo effect and that there are a number of drugs that are failing placebo trials now because they can't prove that their drug is more effective than the placebo because the placebo is so good. I'm starting to question the whole placebo control thing, I guess is what it is.

Elliot: Well what's really interesting is the PhD who wrote this article, Maryanne, made several requests to the lead authors of, I think a couple of different trials, but one of them was for a statin study called the Jupiter trial and she made official requests to get the certificate of analysis for the placebo to identify exactly what was going on, what was contained within it and she says that it's almost impossible to get hold of any information about what they put in these things!

So you'd think it was just a sugar pill or something like that but apparently these drug companies hold onto it. They covet it. It's almost like they've got something that they want to hide.

Doug: Yeah.

Elliot: And they're not letting go. And understandably what that would demonstrate is that actually if this was completely transparent and if a lot of the time the placebos in all of these studies were genuinely inert and did not have side effects in and of themselves, then you would think that these companies would be more than willing to give out the information and be transparent because actually it's in favour of their drug but because they are so unwilling, it really indicates and I think it's pretty clear that there is some degree of conscious manipulation going on. Maybe someone in a board room at some meeting a couple of decades ago said, 'Here's a really good idea. This is a great way to actually improve the appearance of safety of the drug. Let's just stick some really horrible substance in the placebo as well'.

Doug: Exactly. If it was just a sugar pill I feel like they would be a lot more up front about it. But the fact that they're not, like you're saying, it indicates that there's something dodgy going on in the background there for sure.

Erica: She also raises the serious issue of informed consent. So if you're part of a drug trial, I know they don't tell you beforehand, but are they telling you, 'this placebo is going to have these inert ingredients, are you okay with that?'

Doug: If you're going into a trial you know there's a chance that you may get the active drug but you may actually get nothing and that's what you are giving your informed consent based on. Are they telling the people who are enrolled in the trial what's in the placebo? I doubt it! If they're not telling anybody else they're probably not telling them either.

Erica: Is this only done in drug trials? I'm not in that area, it's not my wheelhouse, but is it just when they're testing drugs? Is that the mode of operation that they use? We're kind of surprised by this information because you don't ever get that in casual reading, that this is a drug trial and we're going to use a placebo.

Doug: I think any time it's a random controlled trial, there's a placebo group.

Erica: They use a placebo.

Doug: Yeah. That's the standard for it. That's considered the gold standard. I know in nutrition, which is more my wheelhouse, they often talk about how random control trials are the gold standard. But in a nutrition study it's very difficult to do a placebo group because you always know what you're eating, unless you're going to blindfold people and grind it into a paste or something like that and make it unrecognizable. So I think it is something that is more standard with drug trials.

In fact the blog of Malcolm Kendrick - I almost said Gladwell - who has a great blog by the way. It's dr.malcolmkendrick.org. He put up a blog about this placebo thing after this CrossFit article came out. His big thing is statins. He has been integral in exposing the scam that is statins. I recommend anybody to go to his site and take a look at a lot of the stuff that he has done because he digs into the science quite a lot. But he actually was talking about placebos in one of his blogs. He lists off a number of different studies on different forms of statins. The total adverse effects from, for instance, Lovastatin, was 13.6% and from the placebo it was 13.8%. The total adverse effect from Simvastatin was 6%, placebo was 6%.

It just keeps on going down and there's barely any difference between the placebo and the statin on all these trials! It just seems obvious that they're fudging them. One of them, total adverse effects from Rosuvastatin is 83.3%. The placebo 80.4%. Okay, why are 80.4% of the people in the placebo group having adverse effects? From a placebo?! 80.4% are having adverse effects and there's nothing in it?! Come on!! How stupid do they think we are?

Elliot: That smells fishy.

Doug: Yeah, it absolutely does.

Elliot: Really, we've spoken about statins on numerous occasions, but if you really have an inert substance compared with a statin, a statin is a drug which is one of the drugs with the most side effects, with the most adverse effects in terms of personality changes, in terms of digestive issues, in terms of fatigue and muscle pain and weakness. They are well known and well established. It does not sit right that you would have a similar rate of adverse effects in a control group. It makes you really wonder whether they're giving both groups statins or not! {laughter}

Doug: Yeah, seriously.

Elliot: What they're giving them, who knows?

Doug: A different statin. {laughter} Kendrick even says how can the adverse effects of a placebo range from 2.7% to 8.4%? How's that possible? Definitely something fishy going on there. I've only got a vague memory of this. I don't remember which journal it was. It was a medical journal. The head person from the medical journal - this isn't a very good story because I don't remember it very well - {laughter} but basically the head person of some medical journal actually came out and said that the majority of medical studies out there are actually bunk. You can't trust them at all and I think this is a good indication, at least partly, one of many reasons why that is.

Elliot: Indeed. And then you have to question as well how much fudging of the numbers goes into it as well. Is it that in some of these they've buffed up the placebo with some other horrible thing or is it just in some of them that they've just produced the numbers out of thin air? How do you know?

Doug: I get the impression that that actually does go on.

Elliot: Yeah, there are stories!

Doug: I heard of ones where as soon as somebody starts having a major adverse effect they kick them out of the trial. {laughter} 'Don't write that down! That guy was never here.' {laughter} It's unbelievable.

Elliot: They put them down as voluntary discontinuation because they were not compliant, something like that. How easy would it be? You only need two research scientists to collude like that.

Erica: And then they're not disclosing what's in the placebo. I'm back to the whole issue with why this article was written, that they're not going to disclose it, so you're not going to find it in the reference material 'Oh, the placebo contains...' so some proprietary secret.

Doug: Yeah, why would you keep that secret? The placebo? Of all the details of the study, what exactly is proprietary about - 'Oh, don't let them know what placebo we were usin!. It was a very secret, special placebo!' {laughter} No, that doesn't make any sense.

Elliot: So it's all a bit of a mess isn't it?

Doug: Yeah, it really is.

Elliot: It is indeed. But essentially it reinforces what we've been learning time and time again about big pharma, about many of these large agencies actually, but particularly about big pharma in this context. You can't always trust what they say. In fact I think probably 99% of the time you can't trust what they say. You have to go from a results-based model, so see what works, see what doesn't work and actually if there's another way of doing things which is going to cause you potentially less harm, for instance in statins, do you really need to have a statin? Maybe it would be good for you to look at all of the side effects. Now of course we can't give medical advice, but if you could look at the side effects and then also look at other lifestyle interventions that might be effective at doing that as well. If the aim is to improve cardiovascular health, there are many different things that you can do to improve cardiovascular health aside from taking a drug, right?

So yeah, that's what we're all about on this show and we like to promote thinking outside of the box. Does anyone else have anything to add to this?

Doug: Just one thing I was going to say quickly, it's just something that came to me. I think one thing that people could do would be to look for testimonials of people who have actually been on the drugs, rather than reading the side effects from mainstream sources like WedMD which are really just pharmaceutical mouthpieces. Try and find some real people out there who actually have experience with these kinds of things because that's how you're going to get more of an idea of what the drug actually does to people.

Elliot: I think that's excellent advice. So if no one's got anything else to add, I guess I'll have to say good-bye. So thank you for all of the audience tuning in to this week's edition of the show. If you liked it, hit the red button below. Like and subscribe to our page. You can share it if you found it interesting and comment. If you have any requests, videos that you'd like us to do or anything you'd like us to talk about, we can take a look at that and see if it's possible or not. Just pop us an email or pop us a comment in the comment section below.

I want to thank Doug, Erica and Damian on the wheels of steel for making sure this all works smoothly.

Damian: You're welcome.

Elliot: Thanks Damian, as usual. We will see you next week.

Doug: Bye everybody.