Category: Clinical Trials

Choosing Wisely: Changing medical practice is hard

One of the hardest things to do in medicine is to change practice in the face of scientific evidence that what you're doing isn't working. Quacks never change, but medicine does. The change might be slower and messier than we would like, but change does happen. Choosing Wisely is an initiative designed to bring about change by discouraging the use of interventions...

/ October 19, 2015

The Amarin case: off-label promotion and a double standard for prescription drugs vs. dietary supplements

A recent court decision enjoined the FDA from threatening prosecution against a drug manufacturer for off-label promotion of a prescription drug. Based on this and an earlier decision by an appellate court, it appears that the FDA can no longer prosecute a pharmaceutical manufacturer for a truthful and non-misleading off-label promotion to health care professionals, at least within the jurisdiction of the...

/ October 15, 2015

October is National Chiropractic Health Month!

October is National Chiropractic Health Month (NCHM) and chiropractors can’t resist the opportunity to overstate, obfuscate, and prevaricate in celebration. They do this in the face of some unfortunate (for them) statistics revealed by a recent Gallup Poll. The Poll was paid for by Palmer College of Chiropractic as part of an effort to increase the chiropractic share of the health care...

/ October 1, 2015

The Worst Homeopathy Study. Ever

I run across a lot of information in my feeds that I need to save for further evaluation. The study “Does additional antimicrobial treatment have a better effect on URTI cough resolution than homeopathic symptomatic therapy alone? A real-life preliminary observational study in a pediatric population“, I saved with the file name, ‘jaw droppingly stupid’. The worst homeopathy clinical trial ever doesn’t...

/ September 18, 2015

Battle of the feds: FTC tells FDA to do its job regulating homeopathy

Last month, the Society for Science-Based Medicine submitted a comment to the Food and Drug Administration (FDA) in response to its request for public comments on the agency’s current regulation (actually, lack of regulation) of homeopathic drugs. As the SFSBM pointed out, the FDA has, without legal authority, exempted homeopathic drugs from the safety and efficacy requirements applicable to other drugs under...

/ September 3, 2015

“Precision medicine”: Hope, hype, or both?

I am fortunate to have become a physician in a time of great scientific progress. Back when I was in college and medical school, the thought that we would one day be able to sequence the human genome (and now sequence hundreds of cancer genomes), to measure the expression of every gene in the genome simultaneously on a single “gene chip,” and...

/ August 31, 2015

Taxpayers Fund Scientology Research on Gulf War Veterans

The “Hubbard protocol” is Scientology’s religion-based, pseudoscientific “detoxification” treatment used in its Narconon program to treat drug addiction. It was dreamed up by a science fiction writer with no medical training. Now it is being studied as a treatment for veterans suffering from Gulf War illness. Our limited public money for research is being wasted on a study with no scientific merit....

/ August 25, 2015

How should we treat DCIS?

I’ve written more times than I can remember about the phenomenon of overdiagnosis and the phenomenon that is linked at the hip with it, overtreatment. Overdiagnosis is a problem that arises when large populations of asymptomatic, apparently healthy people are screened for a disease or a condition, the idea being that catching the disease at an earlier stage in its progression will...

/ August 23, 2015

An Alternative to Appendectomy: Antibiotics

My title doesn’t refer to alternative medicine, it refers to an alternative within medicine: treating appendicitis with antibiotics instead of surgery. You may be surprised to learn that patients with appendicitis don’t always automatically need an appendectomy. A recent randomized controlled trial in Finland compared surgery to medical treatment. History of appendicitis treatment There is an excellent, detailed history of appendicitis available...

/ August 18, 2015

The 21st Century Cures Act: The (Somewhat) Good, The (Mostly) Bad, and The (Very) Ugly

The approval of new drugs and medical devices is a process fraught with scientific, political, and ethical landmines. Inherent in any such process is an unavoidable conflict between rigorous science and safety on the one side, which tend to slow the process down by requiring large randomized clinical trials that can take years, versus forces that demand faster approval. For example, patients...

/ August 10, 2015