No regulations govern placebo composition. The composition of placebos can influence trial outcomes and merits reporting. There is no requirement to disclose the contents of placebo used in clinical trials. Medical journals do not require this information either.
The authors analyzed 167 clinical studies published in four of the most prestigious medical journals. Most of the clinical studies did not disclose the composition of the placebo. Only studies for 8% of pills and 26% of injections reported what was used as the placebo. For example, in the study on medication for cancer-acquired anorexia, it was found that the medication positively affects the GIT. However, lactose was used as the placebo. Cancer patients who are undergoing chemo and radiation therapy usually acquire lactose intolerance, which resulted in the medication which did not contain lactose comparing favorably with the “placebo”.
In 1930, in the northern Germany town of Lübeck, two physicians mounted a campaign to vaccinate newborn babies against tuberculosis. They used a BCG vaccine produced locally from a Parisian strain. The vaccine had become available as early as 1921, but its use was still not widely accepted.
Soon after receiving the vaccine, infants were becoming seriously ill and many died. In 12 months, of all the infants vaccinated, 208 became ill with tuberculosis and 77 died. The two physicians were arrested and put on trial. The court eventually found the two physicians guilty of murder. The newspapers publicized the trial throughout Europe, and the news of the disastrous vaccine campaign spread throughout the continent.
This tragedy actually led to the first published discussion on medical research using human subjects, approximately two decades before the Nuremberg Trial and the Code of Nuremberg. Julius Moses, a Member of German Parliament, called for a public accounting of medical science. He charged that the vaccine campaign was in fact not a clinical practice proven safe and effective but rather an experimental trial. Furthermore, he decried the conduct of the campaign as research in humans without their knowledge or permission.
In 2008, the USA discontinued adopting the Declaration of Helsinki (instead, it uses Good Clinical Practice, which does not restrict pharmaceutical companies as much as the Declaration of Helsinki).
For intramuscular and subcutaneous vaccinations, injections of sterile normal saline may serve as placebos, but researchers frequently choose other comparative agents. A review of the most recently published trials involving vaccines for children found a variety of comparators that took the place of placebos in children.
For example, a study of pneumococcal conjugate vaccine with nine serotypes (PCV-9) used the DTP-Hib vaccine as its comparator.
In another study, a novel oral cholera vaccine was compared to E. coli vaccine.
In another study on a vaccine for pneumococcus (PCV23), vaccines for hepatitis A and B were used as comparators.
In a fourth study, the study vaccine was compared to aluminum hydroxide combined with thimerosal.
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