Clinical trials
oracknows | December 8, 2016Yesterday, I noted the passage of the 21st Century Cures Act, a Hobson’s choice of a bill for those of us who support increased biomedical research funding that basically said: You can have an increase in the NIH budget. You can have the Cancer Moonshot. You can have President Obama’s Precision Medicine Initiative and his brain mapping initiative. You can have additional funding to combat the opioid crisis. You can have all that, but only if you also accept a grab bag of longstanding pharmaceutical industry wishes, such as new pathways to approve drugs and devices with a lower standard of…
oracknows | December 7, 2016Well, it’s done.
Today, the Senate passed the 21st Century Cures Act, a bill designed to weaken the FDA and empower pharmaceutical companies, sending it to President Obama’s desk. There’s no way Obama won’t sign it, as it contains provisions funding his Precision Medicine Initiative, and he supported it all along. For all its flaws, I knew the bill’s passage was inevitable since after the election, when Senate Majority Leader Mitch McConnell stated that the bill was a priority. I knew it even more when the Senate linked the bill to the “Cancer Moonshot” initiative spearheaded by Vice…
oracknows | November 23, 2016Back in the day, Deepak Chopra used to be a frequent topic of this blog. He still pops up from time to time, such as when irony meters everywhere immediately self-destructed after Chopra criticized Donald Trump for being insufficiently evidence-based or when, after I wrote a post asking why medical conferences keep inviting Chopra to speak, Chopra was so displeased that he actually posted a video attacking me (and other skeptics who’ve criticized his pseudoscience). Unfortunately, Chopra truly is one of the most influential people in “integrative medicine” today. To be honest, I’ve never…
oracknows | November 17, 2016I’ve frequently written about what I like to refer to as “quackademic medicine,” defined as the infiltration of outright quackery into medical academia, particularly medical schools and academic medical centers. There’s no doubt that it’s a significant problem as hallowed institutions like Memorial Sloan-Kettering Cancer Center embrace nonsense, pseudoscience, and quackery in the name of “integrative medicine.” It goes far beyond MSKCC, however, with Dana-Farber and other elite institutions having apparently bought into the need to study prescientific vitalistic quackery.
One area that’s…
oracknows | November 13, 2016John Weeks has long been an activist for alternative medicine—excuse me, “complementary and alternative medicine” (CAM) or, as it’s more commonly referred to these days, “integrative medicine.” Despite his having zero background in scientific research or the design and execution of experiments and clinical trials, for some bizarre reason in May he was appointed editor of the Journal of Alternative and Complementary Medicine (JACM). It didn’t take him long at all to use his new post to launch a nasty broadside against CAM critics in general (such as yours truly) and those who criticized a…
oracknows | November 6, 2016Orac is currently hiding from the Federation in an undisclosed location (somewhere warm and out of the country, the better to avoid election news after having cast an absentee ballot), where he is charging his Tarial cells, the better to return fully recharged and ready to dive back into the massive piles of woo awaiting him when he returns. Since it’s only a brief respite, I had been planning on either reposting material from Orac’s other known hideout on the web, the better not to let this blog lie fallow and lack for Insolence, Respectful and not-so-Respectful, as indicated depending upon…
oracknows | October 19, 2016It’s been a while since I wrote about Stanislaw Burzynski, the Polish ex-pat physician who is not an oncologist but treats cancer patients in his Houston clinic with a mixture of a compound he calls “antineoplastons” (ANPs) and “gene-targeted” therapy. The former are really a mixture of various chemicals he isolated from the blood and urine back in the 1970s, including chemicals like phenylacetic acid (PA) and phenylacetyl glutamine (PAG), that he thought to be endogenous cancer suppressors but has never been able to demonstrate that they are, despite having had four decades to do so.…
oracknows | October 18, 2016Back when advocates of “alternative” medicine were busily trying to legitimize their quackery by first renaming it “complementary and alternative medicine” (CAM), long before CAM “evolved” into “integrative medicine,” they really believed that if their favorite woo were to be studied scientifically it would be shown to be efficacious. Thus was born the Office of Alternative Medicine in the NIH, which later became the National Center for Complementary and Alternative Medicine (NCCAM), which more recently became the National Center for Complementary and Integrative Health (NCCIH), thus utterly…
oracknows | October 13, 2016I knew it. I just knew it. I knew I couldn’t get through October, a.k.a. Breast Cancer Awareness Month, without a controversial mammography study to sink my teeth into. And I didn’t. I suppose I should just be used to this now. I’m referring to the latest opus from H. Gilbert Welch and colleagues that appeared in the New England Journal of Medicine last night, Breast-Cancer Tumor Size, Overdiagnosis, and Mammography Screening Effectiveness. Yes, it’s about overdiagnosis, something I’ve blogged about more times than I can remember now, but it’s actually a rather interesting take on the issue.…
oracknows | October 10, 2016As hard as it is for me to believe, I’ve been writing about homeopathy for more than a decade now. Regular readers, of course, know that homeopathy is quackery, utter pseudoscience based on prescientific vitalism based on two “laws”: the Law of Similars and the Law of Infinitesimals. The former states that, to relieve a symptom, you use a substance that causes that symptom in healthy people. There is, of course, no science or logic to support this as a general principle other than sympathetic magic. The latter Law states that to make a remedy stronger, you must dilute it. That in itself is…
oracknows | October 9, 2016There's a misconception that I frequently hear about evidence-based medicine (EBM), which can equally apply to science-based medicine (SBM). Actually, there are several, but they are related. These misconceptions include the idea that EBM/SBM guidelines are a straightjacket, that they are "cookbook medicine," and that EBM/SBM should be the be-all and end-all of how to practice clinical medicine. New readers might not be familiar with the difference between EBM and SBM, and here is not the place to explain the difference in detail because this post isn't primarily about that difference. The…
oracknows | October 3, 2016Whenever I refer to quackademic medicine and how the infiltration of quackery into medical academia has led to unethical clinical that are not only pseudoscientific wastes of money but potentially downright harmful to patients, two always come to mind. The first is the trial that tested the late Nicholas Gonzalez’s protocol for advanced pancreatic cancer, comparing it to standard-of-care chemotherapy. His protocol basically involves a combination of supplements (up to 150 a day), various vegetable juices, and, yes, the infamous coffee enema—several a day, actually. It’s basically a mystical,…
oracknows | October 2, 2016I first became more interested in dubious stem cell clinics nearly two years ago, when I learned that hockey legend Gordie Howe was undergoing stem cell therapy in Mexico to treat his stroke. Being from Detroit, I imbibed the hockey madness of this town growing up, and know that Detroiters hold Gordie Howe in incredibly high esteem. Prominent in stories about Howe were two companies: Stemedica Cell Technologies, a San Diego company marketing stem cell treatments for all manner of ailments, and Novastem a partner company in Mexico that uses Stemedica products. Also prominent in the stories was…
oracknows | September 29, 2016I’ve referred to so-called “right to try” laws as a cruel sham.on more than one occasion. Since 2014, these laws, all based on a template provided by the libertarian Goldwater Institute, have been proliferating at the state level with the help of lobbying by the aforementioned Goldwater Institute and a concept that makes it pitifully easy to caricature opposition to these laws as wanting to heartlessly snatch away from terminally ill patients the last chance at life while laughing and twirling one’s mustache like Snidely Whiplash. Not surprisingly, state legislatures all over the country have…
oracknows | September 29, 2016One of the things that first led me to understand the dangers of quackademic medicine was a trial known as the Trial to Assess Chelation Therapy, or TACT. Chelation therapy, as you might recall, is the infusion of a chelating agent, or a chemical that binds heavy metals and makes it easier for the kidney to secrete them, in order to treat acute heavy metal poisoning. Unfortunately, quacks of all stripes have latched on to chelation therapy to treat a number of diseases and conditions. For instance, antivaccine quacks like to use chelation therapies to treat autistic children using the…
oracknows | September 8, 2016I’ve frequently called “right to try” laws that are popping up in various states like so much kudzu, to the point where 31 states have passed them in a little over two years, an amazing pace, a cruel sham, given how incredibly unlikely they are to help a single patient. Basically, state-level right-to-try laws are the brainchild of the libertarian Goldwater Institute and all based on a template that it produced. Their purpose is not, as the Goldwater Institute claims, to help patients, but rather to weaken and ultimately neuter the FDA’s power to regulate drug approval and thereby help to…
oracknows | August 29, 2016About three months ago, I was displeased to see in a normally reliable source of medical news (STAT News) a story about a patient of cancer quack Stanislaw Burzynski, Neil Fachon, that fell victim to every trope that Burzynski’s used for 40 years to present himself to the press as a “brave maverick” doctor and researcher rather than the unethical quack that he is. Basically, as was the case of so many similar stories in the 1990s and more recently, the story was framed as one of a desperate patient battling the FDA to save his life, instead of what the story really represented was a desperate…
oracknows | August 23, 2016Here we go again.
Remember how I frequently say that naturopaths are relentless, how, whenever they attempt to get a naturopathic licensing bill passed in a state and fail, they’re soon back to try again. Basically, they keep trying until they succeed, and once they succeed, it’s game over for keeping their quackery from having the imprimatur of the state. Perhaps my favorite metaphor for this is that of the killer in a 1980s slasher flick, like Jason or Michael Myers, who frequently "dies" ta the end of one movie, only to come back the next movie to mow down another bunch of hapless teens.…
oracknows | August 21, 2016I've frequently written about various dubious and outright quack clinics in different parts of the word with—shall we say?—somewhat less rigorous laws and regulations than the US. Most commonly, given the proximity to the US, the clinics that have drawn my attention are located in Mexico, most commonly right across the border from San Diego in Tijuana for easy access by American patients. Sometimes, in the case of dubious stem cell clinics, they are located in countries like China, Argentina, or Kazakhstan. That's not to say that there aren't a lot of quack clinics right here in the US (…
oracknows | August 3, 2016It is an article of faith among believers in alternative cancer cures that conventional oncology consists mainly of a bunch of money-hungry surgeons and oncologists who want nothing more than to cut, poison, and burn patients with cancer and charge them enormous sums of money to do so for as long as they can until the poisonous chemotherapy finally kills them. It is an evil and malicious caricature, of course. People don’t endure four years of medical school, three to five years of residency, and three years of fellowship in order to be able to cut, poison, and burn without regard for whether…