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    Helen Brooke Taussig: An Often Overlooked Advocate for Drug Safety

    This article reviews the biography of Dr. Helen Brooke Taussig and discusses her successful efforts in the 1960s to prevent the drug “thalidomide,” the cause of wide-spread and serious birth defects in Europe, from being FDA-approved for use in the US. Introduction In the late 1950s and early 1960s, the drug thalidomide sent shock waves worldwide when it was proven that an allegedly harmless substance given to pregnant mothers as a sedative to combat morning sickness...
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    Curiosity: One of Life’s Most Valuable Commodities

    This article discusses the value in human curiosity for learning, living a more meaningful life and as an important tool for professional success. The author reviews several books on curiosity that outline why we are curious, explains different types of curiosity and suggests how we might not lose our curiosity as we age. Introduction While working for a medical device company, I frequently had the opportunity to interview new job candidates. One question I asked was...
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    Visualizing Data

    This article discusses the history of making data visual and suggest ways to keep viewers of visual data engaged. The author offers thoughts on software programs and books that may serve as good sources for learning more about visual data presentation. Introduction As part of management review, teaching, panel meetings, budgets or during an inspection by notified bodies or regulatory agencies, regulatory affairs personnel are frequently called upon to provide data to di...
  • Grammar, Logic and Rhetoric: the Trivium

    This article discusses the intellectual benefits of a “liberal arts” education focused on its three foundational elements: grammar, logic and rhetoric and reviews ways in which the skills learned by studying “the Trivium” could benefit regulatory professionals in carrying out their tasks. Introduction The term “liberal arts” denotes the seven branches of knowledge that provide an introduction to a lifetime of learning. The concept is classical, but the term liberal arts...
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    Salt: Needed, Widely Used, Often Misunderstood

    This article discusses dietary salt needs, the history of salt use and why its use should be studied to further investigate links to cardiovascular disease. The author cites a potential study on salt intake aimed at determining the unhealthy consequences of high salt intake and closes by reviewing recent studies suggesting that too much salt in the diet can lead to a variety of cardiovascular problems, including high blood pressure and the potential for heart attack or st...
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    Four Gone, but not Forgotten

    This article discusses the lives and work of four important scientists who have passed on and who are in danger of passing out of the important annals of medical history if not appropriately remembered. The author frames this discussion with opinions about the importance of knowing about and giving credit to research “heroes” no longer with us as well as noting the importance of their discoveries and contributions, most of which created the foundations for today’s medical...
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    Shaking Palsy, aka Parkinson's Disease, is Still a Mystery

    This article discusses disease etiology, history and symptoms of Parkinson's disease as well as ongoing research and new treatment options. Introduction There are hundreds of diseases named after a person. These are called "eponymous diseases," and a small sample includes Crohn's disease, Salmonellosis, Huntington's disease, Hodgkin's lymphoma, Lou Gehrig's disease, Tourette's syndrome and the well-known Alzheimer's disease and Parkinson's Disease (PD). PD is one of...
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    Mistake-Proofing the Workplace

    This article discusses mistakes, or human errors, made in the pharmaceutical or medical device workplace and provides the definition of a mistake. The authors also present how mistakes are made, whether such errors are the actual "root cause" of defects, the social and company consequences of errors, and what can be done to minimize errors. Introduction On his first job working for a large pharmaceutical company, one of the authors, Max Sherman, was responsible for th...
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    Is Increasing Antibiotic Resistance Driving Bacteriophage Therapy Closer to Being a Reality?

    This article reviews the history of bacteriophage discovery, biology, and potential medical uses, and discusses therapeutic pros and cons compared to and potentially replacing antibiotics due to increasing antibiotic resistance. The article also highlights the future of phage therapy and the need for more scientific investigation and clinical trials prior to approval for human use and the possible patenting and regulatory issues impacting bacteriophage development. The U...
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    Syphilis: a Mysterious and Serious Ancient Disease

    This article alerts regulatory professionals to the continued presence of what may be a "forgotten" disease–syphilis. Although syphilis is unique and may be considered a "relic" of the past, it does not belong in the dust bin of history. To the contrary, regulatory professionals may wish to know more about its controversial medical history, epidemiology and clinical manifestations as syphilis remains a serious public health threat in many parts of the world. These issues...
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    Medicine's Unsung Heroes

    This article introduces readers to Boyd Woodruff, a legend in the field of microbiology, and discusses his groundbreaking achievements in antibiotic development and Merck's research laboratories. Introduction Most or all of us who work in the pharmaceutical industry know about Alexander Fleming and that in 1929, he astutely recognized the organism responsible for penicillin. We also are likely acquainted with Selman Waksman, the scientist who discovered streptomycin i...
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    Alligators and Crocodiles: New Indications for Use?

    This article provides current research in drug development and describes crocodilians, their immune function, the search for new antibiotics, antimicrobial peptides (also known as host defense peptides) and future research for anti-cancer agents. Introduction Many years ago, John R. Brinkley, who had been called America's most dangerous huckster, recommended a number of concoctions to treat erectile dysfunction. Included among them were rhinoceros horn and boiled alli...