Category: Clinical Trials
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...
“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...
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...
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...
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...
The evolving story of the harms of anti-inflammatory drugs
Owing to summer vacation, today’s post updates a 2011 post and a 2013 post with some new information. Anti-inflammatory drugs are among the most well-loved products in the modern medicine cabinet. They can provide good pain control, reduce inflammation, and eliminate fever. We give non-steroidal anti-inflammatory drugs (NSAIDs) in infancy, continuing through childhood and then adulthood for the aches and pains of...
Ethical Failures
It is summer vacation for me in Eastern Oregon at Sunriver. Unbelievable geology, fantastic hikes, great biking, wonderful golf, delicious beer and good food. The thesaurus fails me for superlatives. It is hard to get too riled up about all things SCAM to produce a blog entry when I could be doing one or all of the above. I really...
Update on Cholesterol and Statins
The consensus of mainstream medicine is that a high blood level of LDL cholesterol is a major risk factor for cardiovascular disease and that lowering high levels can help with prevention and treatment. Statins have been proven effective for lowering cholesterol levels and for decreasing cardiovascular and all-cause mortality. I recently wrote about the new guidelines for statin therapy. Currently half of...
Chiropractic and Stroke: The question is not answered
I am off to Chicago for 5 days to wow the SMACC crowd with my ID/SBM acumen. I hope. Given that most of my multiple-personalities do not seem to be able to get any work done, I am forced to write a brief post this week, limited by the battery life on my MacBook Air. Whatever I get down on paper? pixels?...