Results for: "right-to-try"
In the age of the COVID-19 pandemic, can we trust the CDC and FDA any more?
Since the COVID-19 pandemic reached the US, increasing concern has been expressed about the politicization of the CDC and FDA due to pressure from the Trump administration to downplay the severity of the pandemic and push out treatments and a vaccine as fast as possible, potentially at the expense of safety. This has led me to a disturbing question: Can I trust...
Does convalescent plasma work against COVID-19? Who knows?
Last night, the FDA issued an emergency use authorization (EUA) for convalescent plasma to treat COVID-19, even though there are no randomized clinical trials demonstrating efficacy and safety. Does this plasma work? Who knows? But that didn't stop the FDA from issuing the EUA, almost certainly as a result of intense political pressure from the Trump Administration.
Cell-cultured meat: Earth’s savior or just a $600 burger?
Cell-cultured meat raises may issues, including safety, environmental impact, cost, and our current technology's ability to manufacture it. Most importantly, when it finally hits the supermarket, will consumers buy it?
Hydroxychloroquine and azithromycin versus COVID-19: Grift, conspiracy theories, and another bad study by Didier Raoult
On Friday, Prof. Didier Raoult posted another study of azithromycin and hydroxychloroquine used against COVID-19. It is a single arm observational study of patients with mostly mild (or even asymptomatic) disease that is painfully uninformative with respect to the question of this treatment's effectiveness. That didn't stop America's Quack Dr. Oz and other grifters from touting Raoult's study, as well as a...
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...
HB 4710: Licensing and expanding the scope of practice of acupuncturists in Michigan
Last week, HB 4710, a bill to license acupuncturists, was considered by the Michigan House of Representatives Health Policy Committee. If passed into law, HB 4710 would do far more than license the quackery that is acupuncture. It would also expand the scope of practice of acupuncturists to include homeopathy, "health coaching", and dietary advice, and is yet another example of what...
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.
“Right to try” laws create tremendous legal uncertainties; FDA expanded access preferable
The Goldwater Institute and the Kochs pushed "right to try" laws in an attempt to get rid of FDA oversight of access to investigational drugs. Instead, they created tremendous legal uncertainties, making the FDA's expanded access program preferable for all.
My Cancer Free Life: A reality series designed to promote Stanislaw Burzynski’s quackery
Stanislaw Burzynski has been selling a dubious treatment known as antineoplastons to desperate cancer patients since the late 1970s. Unfortunately, there are those who are all too willing to promote the myth of a Brave Maverick Doctor who can cure cancer. Several years ago, it was Eric Merola. Now it's Uchenna Agu, a reality TV star turned producer. He plans on making...
A right to science
Unless forced to do so, the state and federal governments will continue to base law and policy on bad science. Maybe it's time for a constitutional amendment guaranteeing a "right to science."