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 have the greatest preclinical justification; and it’s a phase 1 trial, which means it is only trial of safety, not efficacy. How can unethical and scientifically dubious trials like this be stopped?
Antivaxers frequently object to the use of fetal cell lines to manufacture vaccines on "moral" grounds. Über-quack Joe Mercola lays down some astonishingly bad moral arguments based on pseudoscience.
Kylee Dixon is a 13-year-old girl with undifferentiated embryonal sarcoma of the liver whose mother stopped chemotherapy and has been treating her with CBD oil. The State of Oregon intervened to see that Kylee undergoes appropriate surgery. Where do "parental rights" end and the child's rights begin?
The ethics of pay-to-play clinical trials are a minefield. Last week the HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) stepped into that minefield. Are "pay-to-play" clinical trials ever ethically acceptable?
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 them ("pay-to-play"). These trials are not rigorous. Even more unfortunately, it appears that some universities are also running “pay-to-play” clinical trials that bear an uncomfortable resemblance to those run by for-profit clinics.
A recent case report of a spinal mass in a patient with spinal cord injury who received an olfactory mucosa implant shows that stem cells are not risk-free, even when done at a reputable hospital rather than at a for-profit quack stem cell clinics.
A week and a half ago, Orac got to travel to San Diego to participate in a panel discussion about the antivaccine movement. Even better, he got to meet two heroes of his, California Senator Richard Pan and Dr. Peter Hotez.
The grande dame of the antivaccine movement, Barbara Loe Fisher, is ranting again. This time, she is peddling both misinformed consent about vaccines and likening her struggle to social justice movements of the past as she portrays well baby visits as "vaccine battlegrounds" instigated by the AAP.
Orac has finally located the abstract published by Dr. Alberto Siller and Alberto Garcia, who are selling intra-arterial chemotherapy for the deadly brain tumor DIPG. Let's just say that he's...less than impressed by the results. Shades of Burzynski!