Tag: human studies ethics
CRISPR and the Ethics of Gene Editing
If you have not heard of CRISPR yet, you should have. This is a truly transformative technology that allows for cheap and easy gene editing. It makes a powerful technology easily accessible. Powerful biological technology, like stem cells to give another example, always seem to provoke profound hope and fear. The ability to manipulate human biology comes with it the hope of...
Dr. Oz Doubles Down on Green Coffee Bean with a Made-for-TV Clinical Trial
“One of the most important discoveries I believe we’ve made that will help you burn fat – green coffee bean extract” – Dr. Oz, September 10, 2012, Episode “The Fat Burner that Works” Dr. Mehmet Oz may be biggest purveyor of health pseudoscience on television today. How he came to earn this title is a bit baffling, if you look at his...
Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 2
NB: If you haven’t yet read Part 1 of this blog, please do so now; Part 2 will not summarize it. … At the end of Part 1, I wrote: We do not need formal statistics or a new, randomized trial with a larger sample size to justify dismissing the Gonzalez regimen. In his editorial for the JCO, Mark Levine made a...
My NCCAM Wish List
For a number of reasons, well-argued many times here on SBM, it would be beneficial to American citizens if the National Center for Complementary and Alternative Medicine (NCCAM) were abolished. This does not seem to be in the cards anytime soon. Here, then, are my suggestions for making the Center less dangerous and less of a marketing tool for pseudomedicine than it...
Human Subjects as Political Pawns
When it comes to “alternative medicine” trials, it seems that the NIH is willing to experiment on people in ways that would be unthinkable for real biomedical research. The federal Office for Human Research Protections (OHRP) has posted a preliminary determination letter, dated May 27, 2009, addressing some of the charges we had made against the politics-driven NIH Trial to Assess Chelation...
“Chelation Therapy”: Another Unethical “CAM” Trial Sponsored by Taxpayers
Please forgive the promotion of our own work and the facile evasion of a full-length blog, but two of your faithful bloggers are co-authors of an article published this week: Why the NIH Trial to Assess Chelation Therapy (TACT) Should Be Abandoned Kimball C. Atwood IV, MD; Elizabeth Woeckner, AB, MA; Robert S. Baratz, MD, DDS, PhD; Wallace I. Sampson, MD Medscape J...
The Ethics of “CAM” Trials: Gonzo (Part VI)
Part V of this Blog argued that the NCCAM-sponsored trial of the “Gonzalez regimen” for cancer of the pancreas is unethical by numerous criteria.† To provide an illustration, it quoted a case history of one of the trial’s subjects, who had died in 2002.¹ It had been written by the subject’s friend, mathematician Susan Gurney. A similar story was told on ABC 20/20 in 2000, albeit...
The Ethics of “CAM” Trials: Gonzo (Part V)
Part IV of this blog ended by observing that the NIH-funded trial of the “Gonzalez regimen” for cancer of the pancreas,† to have begun in March, 1999, was in trouble almost as soon as it started. As originally designed, it was to have been a randomized, controlled trial comparing gemcitabine, the standard chemotherapy, to the “Gonzalez regimen” of pancreatic enzymes, “supplements,” twice-daily coffee enemas, and other purported...
The Ethics of “CAM” Trials: Gonzo (Part II)
Laetrile and the Politics of NIH-Sponsored trials of “Alternative Cancer Treatments” Part I of this blog ended by asking how, in light of the implausible and arduous nature of the “Gonzalez regimen” for cancer of the pancreas, and the unconvincing “best case series,” the NIH could ever have decided to fund a trial of it.† This entry will begin to answer that question. In so...
Chinese Researcher Reports First Gene-Edited Babies
A Chinese scientist announces first gene-edited babies, setting off a discussion of the science and ethics of using CRISPR on humans.