The Ultimate Quacks (Part 1)


 

We already know that clinical trials are rife with fraud. Most of the clinical trials used by pharmaceutical companies to win FDA approval of their drugs, for example, are funded by pharmaceutical companies. And it is a verifiable fact that most clinical trials tend to find results that favor the financial interests of whatever organization paid for them. So what’s to stop Big Pharma from scheming up the perfect placebo that would harm patients just enough to make their own drugs look good by comparison?

It now appears that all those thousands of clinical trials conducted over the last few decades comparing pharmaceuticals to placebo pills must now be completely thrown out as utterly non-scientific. And why? Because the placebos used in the studies weren’t really placebos at all, rendering the studies scientifically invalid. This is the conclusion from researchers at the University of California who published their findings in the October issue of the Annals of Internal Medicine. They reviewed 167 placebo-controlled trials published in peer-reviewed medical journals in 2008 and 2009 and found that 92 percent of those trials never even described the ingredients of their placebo pills.

Why is this important? Because placebo pills are supposed to be inert. But nothing is inert, it turns out. Even so-called “sugar pills” contain sugar, obviously. And sugar isn’t inert. If you’re running a clinical trial on diabetics, testing the effectiveness of a diabetes drug versus a placebo then obviously your clinical trial is going to make the diabetes drug look better than placebo if you use sugar pills as your placebo.

Some placebo pills use olive oil which may actually improve heart health. Other placebo pills use partially-hydrogenated oils which harm heart health. Yet only 8 percent of clinical trials bothered to list the placebo ingredients at all!

It turns out there are absolutely no FDA rules regarding the choice or composition of placebos used in clinical trials. Technically, a clinical trial director could use eye of newt or lizard’s legs as placebo and would not even be required to mention such nefarious details in the trial results ala Shakespeare. That would cause trouble, trouble, boil and bubble!

Placebos are usually provided by the very same company funding the clinical trial! Do you detect any room for fraud in this equation? How drug companies can fake clinical trials with selected placebo pills

Placebo performance strongly influences whether drugs are approved by the FDA, by the way. As the key piece of information on its regulatory approval decisions, the FDA wants to know whether a drug works better than placebo. That’s the primary requirement! If they work even 5% better than placebo, they are said to be “efficacious” (meaning they “work”). This is true even if the placebo was selected and used specifically to make the drug look good by comparison. You see, if there are no regulations or rules regarding placebo, then none of the placebo-controlled clinical trials are scientifically valid.

Be well

Dr Sundardas

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