Celiac disease is not reduced by breast feeding or delaying the introduction of gluten

October 19, 2014- Interviewed by Steven E. Greer, MD

Alessio Fasano, MD of Harvard discusses his 10-year-long study in children testing whether the delayed introduction of gluten into the diet reduced the eventual incidence of celiac disease. Dr. Fasano is most responsible for raising awareness of gluten intolerance after his 2003 NEJM and Archives of Internal Medicine papers were published.

FDA CDER Director on Benlysta for lupus and adaptive clinical trials.

(In 108iHD)

Janet Woodcock, MD, Director of the FDAs new drug division, CDER, discusses with Steven Greer, MD the first drug approved to treat lupus in 50 years, Benlysta (belimumab). The BLISS trials were somewhat innovative in that the second trial was adapted to use seropositive markers to ensure that true-lupus patients were enrolled, thereby decreasing the chances of a non-responder. This led to a discussion of adaptive clinical trials that change during the enrollment after interim looks.

Stacy Ardoin, MD, Carlos Lozada, MD: Benlysta (belimumab) for lupus

Lupus has been a challenging disease with little clinical progress for decades. This may change soon if a new drug branded as Benlysta (belimumab) is approved. The series of BLISS trials met the primary endpoints. CurrentMedicine.TV moderated a roundtable discussion with two lupus experts, Carlos Lozada and Stacy Ardoin, to discuss the strengths and limitations of the trials, and whether safety concerns might arise.

David Wofsy, MD: Guidelines for industry funding of medical societies

Dr. Wofsy discusses the recent article in JAMA, which he co-authored, on the handling of industry payments to medical societies. A similar paper a few years ago caused significant changes in the way academic medical centers handled industry payments.

The IOM recently published a similar report.

Senator Grassley and others have also been targeting corruption in medicine. All of these factors make it likely that industry-funded research, academic publications, and medical meetings will continue to undergo major transformations.

Steven Cummings, MD: The denosumab FREEDOM trial

Dr. Steven Cummings, director of the San Francisco Coordinating Center and faculty of UCSF, and principle investigator of the Amgen FREEDOM trial, discusses the results of the trial. FREEDOM looked at 8,500 postmenopausal patients and followed them for three years. The outcome measures were fracture rates in different areas (vertebral, nonvertebral, hip). The study showed a strong efficacy for twice-yearly subcutaneous injected denosumab with minimal adverse events (infection being the main concern). There were no reports of ONJ as has been reported with high doses of bisphosonates.