Historical perspectives on advertising and the meme that personal oral hygiene prevents dental caries.

The consensus of a leading scientific panel in 1930 was that oral hygiene products could not prevent dental caries. Their view was that dental caries prevention required the proper mineralisation of teeth and that vitamin D could achieve this goal. Over a hundred subsequent controlled trials, conducted over seven decades, largely confirmed that this scientific panel had made the right decisions. They had, in 1930, when it comes to dental caries, correctly endorsed vitamin D products as dental caries prophylactics and oral hygiene products as cosmetics. And yet, despite this consistent scientific evidence for close to a century, an opposing conventional wisdom emerged which thrives to this day: oral hygiene habits (without fluoride) protect the teeth from dental caries, and vitamin D plays no role in dental caries prevention. This historical analysis explores whether persistent advertising can deeply engrain memes on dental caries prevention which conflict with controlled trial results. The question is raised whether professional organisations, with a dependence on advertising revenues, can become complicit in amplifying advertised health claims which are inconsistent with the principles of evidence-based medicine.

[A Multi-arm Placebo-controlled Study with Glutamic Acid Conducted in Rostock in 1953/1954]. / Eine Rostocker Placebo-kontrollierte mehrarmige Studie mit Glutaminsäure bei Kindern und Jugendlichen 1953/54.

A Multi-arm Placebo-controlled Study with Glutamic Acid Conducted in Rostock in 1953/1954 Glutamic acid was commonly used in the treatment of intellectually disabled children in the 50s. Koch reported first results of an observation of 140 children treated with glutamic acid in 1952. In this line is the multi-arm placebo-controlled study reported here. The original study protocols were available. 58 children with speech problems who attending a school of special needs received glutamic acid, or vitamin B, or St.-John's-wort. The effect of glutamic acid was in few cases an improvement of attention. On the other hand restlessness and stutter increased. The majority of all reported a weight loss. The treatment with vitamin B showed a positive effect concerning concentration. The treatment with St.-John's wort was stopped caused by headache and vomiting in eight of nine cases. The results of the study reported here are unpublished. The reason may be that until the 60s the effects of glutamic acid in the treatment of intellectually disabled children were in generally overestimated.

The first documented controlled trial in history.

 The first reported controlled human trial was conducted 2500 years ago by the Biblical judge Gideon Ben Yoash, who challenged God's Angel: "I will put a fleece of wool on the threshing floor. If there is dew on the fleece only, and it is dry on all the ground, then I will know that Thou wilt deliver Israel through me, as Thou hast spoken". In the control part of the trial he asked the Angel to keep the wool dry while the ground around it will be soaked with morning dew. It is unfortunate that these principles were not practiced for thousands of years thereafter, as many medical challenges could have been solved earlier.  

Clinical research before informed consent.

Clinical research with patient-subjects was routinely conducted without informed consent for research participation prior to 1966. The aim of this article is to illuminate the moral climate of clinical research at this time, with particular attention to placebo-controlled trials in which patient-subjects often were not informed that they were participating in research or that they might receive a placebo intervention rather than standard medical treatment or an experimental treatment for their condition. An especially valuable window into the thinking of clinical investigators about their relationship with patient-subjects in the era before informed consent is afforded by reflection on two articles published by psychiatric researchers in 1966 and 1967, at the point of transition between clinical research conducted under the guise of medical care and clinical research based on consent following an invitation to participate and disclosure of material information about the study. Historical inquiry relating to the practice of clinical research without informed consent helps to put into perspective the moral progress associated with soliciting consent following disclosure of pertinent information; it also helps to shed light on an important issue in contemporary research ethics: the conditions under which it is ethical to conduct clinical research without informed consent.

Efficacy and enlightenment: LSD psychotherapy and the Drug Amendments of 1962.

The decline in therapeutic research with lysergic acid diethylamide (LSD) in the United States over the course of the 1960s has commonly been attributed to the growing controversy surrounding its recreational use. However, research difficulties played an equal role in LSD psychotherapy's demise, as they frustrated researchers' efforts to clearly establish the efficacy of treatment. Once the Kefauver Harris Drug Amendments of 1962 introduced the requirement that proof of efficacy be established through controlled clinical trials before a drug could be approved to market, the value of clinical research became increasingly dependent on the scientific rigor of the trial's design. LSD psychotherapy's complex method of utilizing drug effects to catalyze a psychological treatment clashed with the controlled trial methodology on both theoretical and practical levels, making proof of efficacy difficult to obtain. Through a close examination of clinical trials performed after 1962, this article explores how the new emphasis on controlled clinical trials frustrated the progress of LSD psychotherapy research by focusing researchers' attention on trial design to the detriment of their therapeutic method. This analysis provides a new perspective on the death of LSD psychotherapy and explores the implications of the Drug Amendments of 1962.

Placebo, a historical perspective.

Substances and interventions with no specific therapeutic effect have been in use since the dawn of history. The term placebo has first been mentioned in the Scriptures, but it was not until the 19th century that it appeared in a medical context. Although lay people like Voltaire, and physicians such as Sir William Osler, have raised the possibility that much of what physicians did had no specific therapeutic effect, this notion was not shared by the public at large or by the medical profession. It was only by the end of the 18th century that a placebo-controlled trial has been conducted, repudiating the therapeutic effect of mesmerism. The advent, in the late 1940s, of effective treatments, which also had serious adverse effects, made the distinction between placebo and putative, active drug effects more relevant and urgent, and cleared the way for double-blind, randomized, placebo-controlled trials. This in turn triggered an ethical debate on the use of placebo, both in research and in clinical practice. Anthropologists, sociologists, physiologists, and medical researchers are all focusing their efforts on understanding the mechanism, role and modulating factors of placebo.