Most people spend a full third of their lives asleep, yet most of us do not have the faintest idea what sleep does to our bodies and our brains. Sleep remains one of the secrets of science. 1 However, there is ample evidence indicating that difficulty in falling asleep and non-restorative sleep are associated with the risk of cardiovascular disease in adults and young children. Statistically, after adjusting for lifestyle factors, age and chronic conditions, researchers ...

The US Food and Drug Administration (FDA) recently has asked whether it has been using the right methods to improve device quality. To answer that question, the agency has developed and embarked on a plan to reduce the number of recalls related to failed devices. The problem, according to FDA, lies in the fact that, in the past, there was more focus on compliance than on quality. Based on this account, it could be argued that FDA knows more about quality than industry or ...

I thought I was technologically savvy; at any given moment, I was juggling an iPhone, laptop, Blackberry, Kindle, iPad and who knows what other piece of technology I didn't actually need. Then, to my surprise, I encountered other "popular" forms of technology of which I was completely unaware. For instance, when interviewing potential candidates at a recent conference, I was handed business cards printed on the back with little boxes containing Rorschach-like images. Afte...

Could anyone imagine a medical condition that would warrant administering a stool specimen from a donor? Such treatment would seemingly belie the "Above all, do no harm" axiom thought to be part of the Hippocratic oath. 1 It just so happens that such treatment first occurred more than 50 years ago, and continues today. In 1958, doctors in Denver, Colorado, administered donor feces by enema to patients with fulminant, life-threatening pseudomembranous enterocolitis, an ac...

In an age of smartphones, tablet computers and wireless communication, one could be forgiven for assuming the digital generation is risk aware and especially cautious when it comes to managing sensitive electronic data and information. On the contrary, much education is needed to create appropriate levels of risk awareness and encourage risk-averse behavior. Regulatory professionals have access to and manage highly sensitive and confidential company data and information...

A new first-of-its-kind database, the European Evidence Database on New Technologies ( EVIDENT ), is now accessible for all government-appointed Health Technology Assessment (HTA) agencies in Europe, related regional agencies and not-for-profit organizations. The database permits HTA agencies to register Additional Data Collection (ADC) studies they have undertaken to fill gaps in HTA-related information as well as search for studies being registered by other HTA agencie...

After a physical several years ago, my wife learned that red and white blood cells were detected in her urine. The doctor ordered an intravenous pyelogram to determine the cause. In this test, an iodine-containing contrast material is injected into the bloodstream and a series of X-rays are then taken at timed intervals. The resulting films allow the radiologist to view the entire urinary tract. Unfortunately, the diagnosis revealed evidence of bladder cancer, a well-di...

The EU health technology assessment network (EUnetHTA) has released for public comment five draft European methodology guidelines for relative effectiveness assessment of pharmaceuticals: Guideline on direct and indirect comparisons   Guideline on clinical endpoints Guideline on Health related quality of life (HRQoL) Guideline on safety Guideline on internal validity The primary objective of these guidelines is to assist national HTA assessors in E...

In the past, I have written about many creatures in the animal kingdom, and several of them were on the top of the most hated and feared list. Rats, spiders and snakes are prime examples. My earlier article about spiders described how spider webs could be used to fashion artificial ligaments or tendons. 1 Tarantulas, another arachnid in that species, may prove valuable in treating a number of pathologies. This article will describe them, their venom, mechanisms of acti...

In a recent The New England Journal of Medicine review of the past 200 years of surgery, author Atul Gawande, MD, MPH, mentioned that Joseph Lister's seminal work on antisepsis was regarded with overwhelming skepticism by the medical profession. 1 This was despite the fact Lister's work was heralded in a series of articles he wrote for The Lancet . However, this same journal found the alleged breakthrough as a method neither original nor beneficial. 2 Ignac Semmelw...

Many of my previous articles for RAPS have featured a host of disparate animals that are or could be used in medicine or in medical research, including leeches, maggots, rats, spiders, whipworms, Gila monsters and zebrafish. Now, there is new evidence to include Burmese pythons on this distinguished list. This snake species may be used to develop drugs to treat human heart disease. 1 In anticipation of this event, it would be prudent to know more about  Burmese pyth...

The European Commission is  requesting input  from stakeholders, including drug and device companies, as to "how the consultation with stakeholders in the Health Technology Assessment (HTA) network's activities could be facilitated."  An "informal" HTA network of member state entities that conduct relative effectiveness work-such as the UK's NICE and Germany's IQWiG-was mandated in 2011 "to support collaboration between Member States in developing and sha...