Lack of Disclosure of “Placebo” Ingredients in Clinical Trials

There are lots of ways to manipulate clinical trials.  One way is to not use a true placebo:

“When the FDA issued its approval of Merck’s BLA for Gardasil on June 8, 2006, its decision was based on a review of Merck’s data from five separate clinical trials, each of which included efficacy and safety assessments for Gardasil. Four of the five trials approached their efficacy and safety studies in similar fashion, comparing Gardasil against a “placebo” that contained an active ingredient, with one trial comparing Gardasil against what the CBER reviewers described as a “saline placebo.” All together, these five trials  examined a total of close 12,000 subjects who received at least one dose of Gardasil and compared their outcomes to roughly 10,000 subjects who received up to three injections of what Merck and CBER officials agreed to describe as a “placebo.”

“But what is a placebo, really? One definition describes a placebo as “an innocuous or inert medication; given as a pacifier or to the control group in experiments on the efficacy of a drug.” The operative term here is the word inert. But in four of the five trials, Gardasil placebos contained a substance called an adjuvant, “a substance which enhances the body’s immune response to an antigen.” According to one of the trial publications, most of the Gardasil trial placebos actually contained an “amorphous aluminium hydroxyphosphate sulfate adjuvant… and was visually indistinguishable from vaccine.”   So although the majority of the placebo treatments in the Gardasil trials did not include Gardasil VLPs, they were by no means inert. In control populations representing nearly 95% of all “placebo” recipients, the study subjects received a formulation that actually included an immunologically active (and potentially harmful) aluminum adjuvant.

“One of the five trials, however, was different. In this trial, the only one that examined a younger population of nine-to-fifteen year olds, the placebo recipients did not receive an aluminum adjuvant. By contrast, and according to most of the FDA documentation, the nearly 600 control subjects in this trial received a formulation most commonly described as either a “non-alum placebo” or a “saline placebo.” The safety results of this trial deserve special notice, since it’s the only trial that compared Gardasil to a solution that could reasonably be described as “inert.”

“But even that assumption would overstate the case. Although the “saline placebo” did contain water and sodium chloride (ordinary table salt), the FDA was incorrect to suggest that there were no other active ingredients. According to the published description of this trial’s methods, “The placebo used in this study contained identical components to those in the vaccine, with the exception of HPV L1 VLPs and aluminum adjuvant, in a total carrier volume of 0.5 mL.” Formulations like this, which are made up of everything in the vaccine except its immunologically active components, are sometimes called a “carrier solution.” The correct description of the placebo as a “carrier solution” rather than a “saline placebo” was provided only once in the CBER review, buried in a table on page 301. Nowhere in either the CBER review or the published account of the trial can one find any description of this placebo’s ingredients.

“It is possible, however, to infer the composition of the carrier solution from Merck’s Gardasil package insert, which lists the vaccine’s immunologically inactive ingredients. These include: “yeast protein, sodium chloride [table salt], L-histidine [an amino acid], polysorbate 80 [an emulsifier], sodium borate, and water for injection.” At least one of these chemicals, sodium borate, is a chemically reactive toxin, one that has many industrial uses as an active ingredient. These include applications as: a replacement for mercury in gold mining; an insecticide and fungicide; and a food additive that is now banned in the United States. …”

“Placebo fraud rocks the very foundation of modern medical science; thousands of clinical trials invalidated

“You know all those thousands of clinical trials conducted over the last few decades comparing pharmaceuticals to placebo pills? Well, it turns out all those studies 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. …”

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