Tag: clinical trials
To unblind or not to unblind? That is the question about clinical trials of COVID-19 vaccines
Antivaccine alternative health tycoon Joe Mercola claims that the unblinding of participants in the clinical trials of Moderna and Pfizer COVID-19 vaccines was intended to "blow up the trials" and undermine the science, making it impossible ever to identify long term adverse events. What he's really doing is deceptively oversimplifying complex ethical and scientific issues surrounding these trials in the middle of...
Dubious stem cell trials for autism and the darker side of quackademic medicine
Despite a lack of evidence, Duke University is all-in on stem cells for autism, thanks to a billionaire benefactor and a highly dodgy for-profit Panama stem cell clinic. How did this come to be and what will be the outcome? Whatever the answers to these questions, it is clear that arrangements like the one between Duke University and The Stem Cell Institute...
HCQTrial.com: Astroturf and disinformation about hydroxychloroquine and COVID-19 on steroids
Late last week, a "study" published on HCQTrial.com by an anonymous source claiming to be a group of PhD scientists went viral. It claimed that countries that used hydroxychloroquine to treat COVID-19 had a 79% lower fatality rate than those who didn't. It was horrible science and quickly debunked on Twitter by several epidemiologists. That didn't stop it from going viral. Disinformation...
More evidence that acupuncture doesn’t work for chronic pain
Acupuncture is a theatrical placebo whose real history has been retconned beyond recognition. A new systematic review of systematic reviews of acupuncture for chronic pain highlights that conclusion and catalogues the many weaknesses in the design of acupuncture clinical trials.
The Apple Heart Study
A recent study involving the Apple Watch raises some interesting points about modern clinical trials. It also has some implications and conclusions about screening for atrial fibrillation (a. fib).
Spinning a negative acupuncture study: Same as it ever was
Investigators at M.D. Anderson Cancer Center reported the results of a trial of acupuncture for xerostomia (dry mouth) secondary to radiation therapy for head and neck cancers. It was a negative trial, but investigators still tried to spin it as positive, but with a twist. There was a large difference between results found at M.D. Anderson and the second site in China....
Would you pay $1 million to enroll in a phase 1 clinical trial of an “anti-aging” gene therapy?
Libella Gene Therapeutics, LLC made the news last week for announcing a "pay-to-play" trial of its telomerase-based anti-aging gene therapy. What was shocking about the announcement was not that it was a "pay-to-play" trial, given that such trials have become all too common, but rather the price of enrollment: $1 million. Worse, the trial is being conducted in Colombia; the therapy doesn't...
Federal “right-to-try” over a year later: Still a failure and still about the money (and weakening the FDA)
Federal "right-to-try" legislation was passed and signed into law by President Trump over a year ago. Advocates promised that lots of terminally ill people who were dying then would be saved by having the right to "try" experimental therapies outside of the context of clinical trials. That has not happened. This should come as no surprise, because right-to-try was never about getting...
For-profit stem cell clinics, universities, and “pay-to-play” clinical trials for autism
Stem cell therapies show great promise, but as yet the vast majority of that promise has not been validated in rigorous clinical trials. Unfortunately, for-profit stem cell clinics are running clinical trials that require patients to pay to be part of it. These trials are not rigorous. Even more unfortunately, it appears that some universities are also running "pay-to-play" clinical trials that...
The FDA’s accelerated drug approval program is failing to protect cancer patients
Drug approval is a process that should be and, for the most part, is rooted in rigorous science. However, there is always a countervailing pressure to approve new drugs rapidly, particularly in cancer. That's why the FDA created the accelerated approval program in the early 1990s. Unfortunately, increasingly this approval process appears to be failing us in oncology. Reform is needed.