Category: Clinical Trials

Rituximab for Chronic Fatigue Syndrome: Jumping the Gun

Now that the XMRV myth has been put to rest,  patients with Chronic Fatigue Syndrome (CFS) are no longer jumping the gun to demand anti-retroviral treatments. But they are jumping the gun in new ways, based on very preliminary data coming out of Norway. A correspondent in Norway wrote to tell me patients from Norway with myalgic encephalitis/chronic fatigue syndrome (ME/CFS) are travelling...

/ January 8, 2013
Green coffee beans, the subject of a "clinical trial" conducted by Dr. Mehmet Oz.

The Great and Powerful Oz versus science and research ethics

Dr. Mehmet Oz conducted a (poor-quality) clinical trial of green coffee beans for weight loss. Somehow between taping his show and being a doctor, he forgot to get institutional review board approval for ethics. Oops!

/ January 4, 2013

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...

/ January 3, 2013

Isagenix Study Is Not Convincing

Isagenix is a wellness system sold by multilevel marketing. It consists of a suite of products to be used in various combinations for “nutritional cleansing,” detoxification, and supplementation to aid in weight loss, improve energy and performance, and support healthy aging. It allegedly burns fat while supporting lean muscle, maintains healthy cholesterol levels, supports telomeres, improves resistance to illness, reduces cravings, improves...

/ December 11, 2012

The NIH funding process: “Conformity” and “mediocrity”?

When we refer to “science-based medicine” (SBM), it is a very conscious choice to emphasize that good medicine should be based on a solid foundation of science. The name was coined to contrast the difference between the current evidence-based medicine (EBM) paradigm, which fetishizes randomized clinical trial evidence above all else and frequently ignores prior plausibility based on well-established basic science, and...

/ December 10, 2012

What does a new drug cost? Part II: The productivity problem

A few weeks ago I reviewed Ben Goldacre’s new book, Bad Pharma, an examination of the pharmaceutical industry, and more broadly, of the way new drugs are discovered, developed and brought to market. As I have noted before, despite the very different health systems that exist around the world, we all rely on private, for-profit, pharmaceutical companies to supply drug products and...

/ December 5, 2012

Now that Burzynski has gotten off in 2012, Burzynski The Movie will spawn a sequel in 2013

About a year ago, I became interested in a physician named Stanislaw Burzynski who has been treating cancer with compounds that he calls “antineoplastons” for over three decades without, in my opinion, ever having ever produced any compelling evidence that antineoplastons have significant anticancer activity. Although I had been vaguely aware of Burzynski and his activities, it was the first time that...

/ December 3, 2012

Journal of Clinical Oncology editorial: “Compelling” evidence acupuncture “may be” effective for cancer related fatigue

Journal of Clinical Oncology (JCO) is a high impact journal (JIF > 16)  that advertises itself as a “must read” for oncologists. Some cutting edge RCTs evaluating chemo and hormonal therapies have appeared there. But a past blog post gave dramatic examples of pseudoscience and plain nonsense to be found in JCO concerning psychoneuroimmunology (PNI) and, increasingly, integrative medicine and even integrations...

/ November 28, 2012

Ecstasy for PTSD: Not Ready for Prime Time

Hundreds of desperate combat veterans with Post-Traumatic Stress Disorder (PTSD) are reportedly seeking experimental treatment with an illegal drug from a husband-wife team in South Carolina. The Bonhoefers recently published a study showing that adding MDMA (ecstasy, the party drug) to psychotherapy was effective in eliminating or greatly reducing the symptoms of refractory PTSD. It was widely covered in the media, for...

/ November 27, 2012

Anecdotes: Cheaper by the Dozen

A loan officer sets up a meeting with an aspiring entrepreneur to inform him that his application has been denied. “Mr Smith, we have reviewed your application and found a fatal flaw in your business plan. You say that you will be selling your donuts for 60 cents apiece. “Yes” says Mr. Smith, “that is significantly less than any other baker in...

/ November 21, 2012