I was at the ARDD conference this week and talked to Andrea Maier and they are struggling in getting the placebo of generic Rapamune for a reasonable price. Is there someone who may know someone who could manufacture or provide the placebo to a reasonable price? All suggestions are welcome!
Its an interesting question. This IMO was one of the problems behind the disappointing PEARL trial.
In the case of PEARL the decisions taken to ensure an effective placebo meant that the trial did not really tell us anything that we didn’t already know.
I must admit I think we can get more from people doing more N=1 experiments like my 16xaccelerator Rapamycin associated with frequent blood tests. Placebo can only go so far and once you have material shifts in biomarkers you can start with the idea that it is not a placebo.
Yes, the lack of cheap placebo increases the risk that things go wrong in trials. For example this was also one reason why I just did N=1 without placebo because I couldn’t find a placebo supplier. So we may miss important data without RCT this way or that things delay or in worst case trials are canceled. So here we really need to put our heads together and try to find a solution. I see a risk that the many upcoming Rapamycin trials will face this problem soon also. Like Jonathan An’s periodontal disease trial, Yousin Suh’s ovarian aging trial, Eric Verdin’s Rapamycin trial etc.
I agree that N=1 without placebo is also interesting but the field needs RCTs. Now we have a chance in moving the field forward thanks to researchers and funding for these trials. So let’s not lose this important opportunity.
Can’t you just put the Rapamycin tablet in a non-transparent 00 capsule with a filler? Then the placebo is just the 00 capsule with filler?
I’d be pulling the capsule apart to see if I was placebo or real …. At placebo-world.com I suspect the 80 Lactose/sucrose hard tablets might be a reasonable look similar tab … they are 7.80 pounds cost.
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@AnUser: Yes, this is a potential solution. At the ARDD conference we were some who discussed this solution. One problem is that the Rapamune tablet is triangle shaped and if you put that in a capsule it may become too big and hard to swallow. If there could be a triangle shaped capsule then that could be the solution. But then someone needs to go through all Rapamune packages, opening them and putting them in a capsule. It feels like an unnecessary step and can be quite much work. The easiest thing is most likely to just manufacture a placebo tablet which looks like Rapamune is my guess.
@DrFraser: Big thanks for the recommendation of the web site! I will contact them and see if they can make a placebo Rapamune. Will get back if they can provide it or not.
If you really want a placebo rapamune I assume it has to be enteric coated to get the texture right, which is probably why the cost is so high. It makes sense that the other trial used compounded rapamycin. I don’t know what Brad Stanfield trial uses.
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Will contact Brad and check. Thanks for pointing me at that direction.
As an aside, the placebo-world.com site is an absolute hoot! They are actually selling placebos to the public and has the great promotional statement “The placebo effect - It doesn’t work for everyone, but science has demonstrated time and again that placebos can work for a sizeable proportion of the population. Will they, could they work for you?”
Impressive business idea … I’m stupidly prescribing active drugs at much higher cost.
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In one sense when buying drugs from a non regulated source it could be a placebo.
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