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In assessing the validity of medical trials, an inactive control, or placebo, is considered essential in producing high-quality evidence. Randomized double-blind, placebo-controlled studies are, in fact, considered to be the "gold standard," as good as it gets in terms of epidemiologic studies.1 The assumption here is that the placebo is inert, i.e., is a substance that has no effect on your body.
The reason this is an assumption is that, typically, the contents of the placebo in a study are not disclosed — not to the subjects of the study nor in the subsequent peer-reviewed journal publication.
This leaves much room for "interpretation" when it comes to choosing placebos for studies and, as noted by investigative journalist Maryanne Demasi, Ph.D., who works as a researcher for the Nordic Cochrane Centre, which prides itself on producing "high-quality independent research and systematic reviews that are free from commercial sponsorship,"2 "sometimes a placebo is not a placebo."3
Placebo Ingredients Often Remain Undisclosed
When the contents of a placebo are not disclosed as a part of the study design, the study lacks transparency and its results may be skewed or misleading. Demasi mentions editor-in-chief emeritus of Clinical Therapeutics, Dr. Robert Shader, who, in 2017, raised concerns about a study published in the New England Journal of Medicine.4
Study participants with multiple sclerosis (MS) were randomly assigned to receive intravenous ocrelizumab or placebo every 24 weeks for at least 120 weeks. Ocrelizumab is a monoclonal antibody, an immunosuppressive drug used to treat MS, that was granted a breakthrough therapy (BT) designation by the U.S. Food and Drug Administration in 2016.5
Drugs with a BT designation receive an expedited development and review process. The study found ocrelizumab was associated with lower rates of disease progression than placebo, but as Shader noted:6
"There is no mention in the text of how the PBO [placebo] infusion was matched. Was it saline? Was it the same vehicle in which the monoclonal antibody was dissolved? Supplementary appendix content is cited, but here again, there is no further description of the PBO matching process."
Placebos May Contain Ingredients of Concern
Excipients, which are substances like coloring agents, preservatives and fillers that aid in drug delivery, are examples of substances in placebos that could have an unintentional active effect, although they're intended to be, by definition, inactive. Shader wrote:7
"Why do I think more information is needed about PBO preparation and packaging? The first point has to do with having the details needed for replication.
The second point is that PBOs may contain excipients that could be troublesome for certain patients or subjects. Examples are tartrazine (yellow dye No. 5), a known allergen, and lactose, a known cause of gastrointestinal symptomatology. Propylene glycol could also be a worry."
In another study cited by Shader, researchers conducted a randomized, double-blind, placebo-controlled trial of amitriptyline, topiramate and placebo in children and adolescents with migraine headaches. Again, the details of the placebo are not described. Shader noted:8
"Here again, the word placebo is used, but the PBO per se is not described. Did it match the active comparators in color and size? Since two different active agents were used, were two different PBOs used?
Was double-dummy packaging employed? According to the methods paper, the dosages of the two active agents were titrated based on the weight of the child or adolescent. There is no discussion of how the PBO was administered."
Vaccine Adjuvant Used as Placebo
One glaring example of a potentially harmful placebo took place in two trials in Merck's clinical development program for the quadrivalent human papillomavirus (HPV) vaccine (Gardasil). In a comment to the BMJ editor, researchers wrote:9
"Both trial publications state that they are reports of 'placebo-controlled' trials. However participants in the control arm of these trials did not receive an inert substance, such as saline injection.
Instead, they received an injection containing amorphous aluminium hydroxyphosphate (AAHS), a proprietary adjuvant system that is used in Gardasil to boost immune response. The use of a comparator that was neither an inert substance nor an efficacious vaccine against another disease demands explanation.
The clinical rationale for such a decision is unclear, as the trial arms do not mimic the real life choice of deciding whether or not to receive HPV vaccine, and it is incompatible with established ethical principles regarding the use of placebo in vaccine trials …
Furthermore, because AAHS is not inert, the choice of AAHS-containing control complicates the interpretation of efficacy and safety results in trials."
Indeed, trying to measure safety of a vaccine against the safety profile of a vaccine adjuvant will yield skewed results, as adjuvants may cause problems on their own. When I interviewed Dr. Thomas Cowan, a practicing physician and founding board member of the Weston A. Price Foundation, he explained:
"Adjuvant means 'helper.' These are added to [vaccines to] provoke a broad-spectrum antibody humoral immune response. Now, when you look at the definition of autoimmune diseases … they are characterized by an excessive antibody reaction.
That's how we diagnose them. If you have antibodies to antinuclear antibodies, that means you have lupus. If you have antibodies to rheumatoid factor, that means you have rheumatoid arthritis. If you have antibodies to your thyroid [hormone], that means you have Hashimoto's."
The problem with vaccine adjuvants is that they cannot selectively trigger the activation of antibodies against a specific virus.
"So, you have people walking around with nonspecific activation of their humoral immune system," Cowan says. "Yehuda Shoenfeld, editor-in-chief of Autoimmunity Reviews and The Journal of Autoimmunity, who has written hundreds of papers and books on how autoimmune diseases develop, basically says there's a syndrome called ASIA, which stands for 'Autoimmune Syndrome Induced by Adjuvants,' which is apparently going to be renamed 'Shoenfeld's Syndrome.'"
In short, an adjuvant cannot act as an effective placebo because it causes a response in the body — the opposite of what a placebo is intended for.
Controversial JUPITER Trial Placebo Still Unknown
The controversial JUPITER study, which was published in the New England Journal of Medicine in 2008,10 boasted that statin drugs could lower the risk of heart attack by 54%, the risk of stroke by 48%, the risk of needing angioplasty or bypass surgery by 46%, and the risk of death from all causes by 20%.
The funding for this study came from AstraZeneca, the maker of statin drug Crestor — and industry-funded claims of health benefits for highly profit-producing drugs need to be viewed with a healthy dose of skepticism. There were a number of reasons why the JUPITER study has received criticism, including the use of a statistical tool called relative risk reduction (RRR) to amplify statins' trivial beneficial effects.11
The study was also stopped early for unexplained reasons, which can lead to exaggerated benefits and downplayed risks while allowing the findings to be published earlier.12 Further, to this day, the ingredients of the placebo used in the trial remain unknown, and although Demasi has attempted to uncover them, so far she's been unsuccessful. She wrote:13
"I have made multiple appeals to a European drug regulator (Medicines Evaluation Board) to obtain information (Certificate of Analysis) regarding the ingredients of a placebo used in a controversial statin study (JUPITER trial), but so far, they have fallen on deaf ears.
So, too, have my requests to the trial's lead investigator, Dr. Paul Ridker. Medical journals will need to take responsibility and insist that published papers report on the methodological details of 'inactive' placebos."
The Junk Found in Vaccines
It's not only placebos that may contain active or dangerous components. Vaccines, too, may contain major contaminants and may not even contain antigens capable of creating immunity, according to a "vaccinegate" that occurred in Italy.14
In 2018, the Italian National Order of Biologists gave a grant to Corvelva, a group of independent researchers that support vaccine choice, to study seven childhood vaccines. The results of four of the vaccines were released in December 2018, showing that they were loaded with impurities, including:15
- 1.7 to 3.7 microgram of foreign chicken embryo DNA and human fetal DNA, found in the vaccine Priorix Tetra, which is used for protection against measles, mumps, rubella and varicella
- Bacterial DNA, human DNA, mouse DNA and aluminum, found in the Gardasil 9 vaccine for HPV
- Monkey DNA and tetanus phage, which may cause autoimmune disease, found in the Hexyon vaccine, which is used for protection against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and influenza B
Further, one of the vaccines, Infanrix Hexa, which is used for protection against diphtheria, tetanus, pertussis, polio, hepatitis B and haemophilus influenzae type b (Hib), did not contain the right form of antigens to be effective. As reported by Down to Earth:
"'The antigens are not present as soluble proteins as they are supposed to be, but as insoluble macromolecules. Due to the insolubility, they will not be recognized by the immune system of the body.
Hence the efficacy is doubtful. Also, its stay in the body can cause unknown toxicity,' says Loretta Bolgan, a consultant of the Italian parliamentary commission on army personnel and an expert on vaccination damage."
While some concerning compounds in vaccines occur as contaminants, others are intentionally added. According to Cowan in our interview:
"Why do they put all [these toxic additives] like dead fetal cells, glyphosate,1 aluminum, formaldehyde and a whole list as long as your arm of stuff [into the vaccine]? … Because [a saline and virus solution] doesn't create an antibody reaction. There's no antibody reaction to do anything … so you have to put aluminum or another adjuvant in it."
Details of 'Inactive' Placebos Need To Be Disclosed
In order for sound science to prevail, the components of placebos should be disclosed as a routine part of the study process. When humans are involved in clinical trials, failing to disclose placebo components violates informed consent, which is ethically and legally required.
Further, depending on what's actually in the placebo, the results of the trial could be incorrect or misleading, and without full disclosure, the study cannot be replicated, a necessity for the scientific process. Shader has been a pioneer toward this end, announcing the following in July 2017 in Clinical Therapeutics.16 Hopefully this will soon become the rule rather than the exception:17
"Effective January 1, 2018 (Issue 1, Volume 40), we will require that a full description of any placebo (PBO) or matched control used in a clinical trial be given in the Methods section. It will no longer be sufficient to simply indicate that a PBO was used.
This means that color; type (capsule or pill or liquid); contents (eg, lactose), including dyes; taste (if there is any); and packaging (eg, double-dummy) must be noted. For solid PBOs, shape must also be described, as well as whether the PBO is active or inactive."