Ads and Labels From Early 20th-Century Health Fraud Promotions.

Ten advertisements and labels from the American Medical Association (AMA) Historical Health Fraud and Alternative Medicine Collection illustrate false health beliefs perpetuated in 20th-century medical quackery promotions. This article canvasses some of the claims made and responses to these ads and labels.

["Holtos," a Patented Medicine of the Late Edo Era--Wrapping Style, Statement of Medicine Efficacy, and Tablet Form].

Holtos is a medicine that was patented by Kan-sei-do, a pharmacy in Osaka, and sold as a Western medicine from the late Edo era to the Meiji era. It is similar to the patented medicine Uluus, which sold well using the katakana brand name. This article introduces HOLTOS products marketed beginning in the late Edo era and makes a comparative study with Uluus products. The features of Holtos include more indications of what the drug can be used to treat in order to emphasize its versatility. There was also a slight increase in size of the tablet sold at the same price as Uluus, and other improvements such as embossing the name "Holtos" on the surface of the tablet. These reasons lead to the conclusion that Holtos was a patented medicine that imitated Uluus. Furthermore, it has been confirmed that strategic measures were taken by Holtos to outlast competition in the market.

Health Canada and the pharmaceutical industry: a preliminary analysis of the historical relationship.

In the past two decades, Health Canada has been accused of favouring the pharmaceutical industry over the public in areas of pharmaceutical policy. This orientation has been tied to the introduction of user fees by the industry in 1994 that help finance key aspects of drug regulation. This paper provides a preliminary examination of the history of the relationship starting in 1939 until the mid-1980s in an attempt to discern whether 1994 really represented a key turning point. Clientele pluralism, a theory that explains the relationship between the state and interest groups, is used to explain the nature of the events described.

A continuing black hole? The FDA boxed warning: an appeal to improve its clinical utility.

The boxed warning is increasingly utilized by the Food and Drug Administration (FDA) as a clinical warning to prescribers of dangerous adverse drug reactions. As these warnings have expanded, we feel the utility and application of boxed warnings are becoming more nebulous. The use of drugs following issuance of a boxed warning has been variable. Droperidol sales decreased 10-fold in the year following the warning, yet there has been essentially no change in the methadone usage over a similar time period after its boxed warning. Including more information, such as estimation of incidence for the adverse drug reaction, would be more clinically useful to the prescriber. Reasonable standards using supplemental databases outside of the FDA (such as national poison center data) could be helpful in developing an integrated and balanced approach to boxed warnings.

Geriatric psychopharmacology: evolution of a discipline.

The development of geriatric psychopharmacology was built on advances in geriatric psychiatry nosology and clinical pharmacology and on increased investment in aging research by the National Institute of Mental Health and by academic institutions. Application of the US Food and Drug Administration's geriatric labeling rule provided further impetus. Developments in the knowledge about 3 principal classes of medications (antidepressants, antipsychotics, and treatments for Alzheimer's disease) illustrate the trajectory of geriatric psychopharmacology research. Nonetheless, the loss of information about age effects that has resulted from applying age exclusion criteria in studies limited to either younger adults or geriatric patients is regrettable. Antidepressant trials have moved from studying younger and medically well "geriatric" samples to focusing on "older old" persons and those with significant medical comorbidity including coronary artery disease, cerebrovascular disease, and dementia. Increased specificity is reflected in studies of relationships between specific neuropsychological deficits, specific brain abnormalities, and antidepressant responsiveness. Clinical trials in older adults have demonstrated that the efficacy of antipsychotic medications continues across the lifespan, but that sensitivity to specific side effects changes in older age, with poor tolerability frequently mitigating the benefits of treatment. Treatments for Alzheimer's disease have fallen within the purview of geriatric psychopharmacology. The research focus is increasingly shifting from treatments to slow the course of cognitive decline to studies of early diagnosis and of interventions designed to prevent the development of deficits in vulnerable individuals. The importance of geriatric psychopharmacology will grow further as the average lifespan increases all over the world.

An unusual personalized cough mixture from the early twentieth century.

There is no way at this point to determine the financial or marketing impact of the personalized cough mixture upon the Randall Drug Store. Nor can there be an estimate of the influence that the likeness of Dr. Randall's daughter on the label might have had upon sales or use of the product. However, in an era of uncertainty and naiveté regarding health options in general and medicinal products in particular, it could be assumed that this photograph-adorned personalized cough mixture bottle would have been promoted in-store by Dr. Randall with confidence, and used with assurance by purchasers. This uniquely presented cough mixture was no doubt a point of pride for the pharmacist, as well as his lovely daughter.

The new Food and Drug Administration drug package insert: implications for patient safety and clinical care.

The United States Food and Drug Administration (FDA) is the scientific, regulatory, and public health agency that regulates many products, including food products, drugs, medical devices, radiation emitting devices, and cosmetics for the federal government of the United States. The FDA's mission is to assure that consumer products made and sold in the United States are safe, effective, and pure. The purpose of the package insert (also known as prescription drug product insert or professional labeling) is to provide detailed drug information compiled and distributed by the drug manufacturer, after FDA review and approval. In 2006, the standard format for the package insert was changed in an attempt to make it more user-friendly and a more efficient resource tool for practitioners. According to the Institute of Medicine, in-hospital adverse drug reactions occur at a rate of 400,000 per year and incur $3.5 billion of extra hospital expense. It is expected that the new package insert format will enhance rapid access to important pharmacologic information and improve patient safety by decreasing medication errors.

FDA's proposed rule for pregnancy and lactation labeling: improving maternal child health through well-informed medicine use.

For the US Food and Drug Administration (FDA), the May 29,2008 publication of the Proposed Rule for Pregnancy and Lactation Labeling for Human Prescription Drug and Biological Products heralded both an end and a beginning. It marked an end to the labeling initiative process that produced the Proposed Rule and the beginning of FDA's second-generation approach to labeling drugs and biologics for use during pregnancy, breastfeeding, and the childbearing years. These proposed changes reflect the extensive input and feedback FDA collected from clinicians and experts, and are designed to facilitate informed counseling about and prescribing of medicines for women who are pregnant, breastfeeding, or of childbearing potential. The prescription drug label is FDA's communication tool-it is the place to clearly convey what is known about the safe and effective use of a drug in various populations. With development and implementation of the Physician Labeling Rule (PLR), FDA transformed the prescription drug label into a better communication tool in which information is better organized, clearly presented, and more easily located. The Proposed Rule for Pregnancy and Lactation Labeling is the final piece of PLR, creating a detailed and defined framework in which to present what is and is not known about the use of drugs during pregnancy and breastfeeding.