GSK pushes FDA to require approval for weight-loss supplements
WASHINGTON GlaxoSmithKline, which markets the only over-the-counter diet pill approved by the Food and Drug Administration, is pressing the agency to require supplement companies making weight-loss claims to conduct clinical studies to prove their products work, then win government approval before they can be marketed, according to The Star-Ledger. Under current regulations, the makers of diet pills face no such requirements.
If the FDA agrees with GSK, it essentially could eliminate competition for the company’s diet pill Alli and potentially open up challenges to numerous health-related claims made for a variety of dietary supplements.
Reclassifying the way dietary supplements are regulated and requiring more rigorous FDA oversight would advance public health, GSK argued, “since millions of Americans are currently relying on these unproven and ineffective dietary supplements to lose weight and reduce the risk of disease.”
The petition by GSK, filed jointly with the American Dietetic Association and two other health groups that receive financial support from the company, has provoked a strong backlash from the supplement industry.
“The effect of this would be to make it illegal to market dietary supplements for weight loss. The only products marketed for weight loss would be drugs,” said Michael McGuffin, president of the American Herbal Products Association, a group representing supplement companies.
Annual AHS meeting showcases new migraine solutions
BOSTON It may look like a pillow for robots, but a new device uses magnetic pulses to provide relief for migraine headaches.
It’s among the latest technologies for treating migraines being presented this weekend at the annual meeting of the American Headache Society.
New drugs being tested include CGRP antagonists, designed for migraine patients who don’t respond to the more popular triptans.
Another new technology is occipital nerve stimulation, where an electrode is inserted under the skin in back of the neck, using electrical impulses to stop the nerve signals that cause the perception of pain.
The device that looks like a robot pillow uses transcranial magnetic stimulation. Held to the back of the head as a migraine headache starts, it sends two magnetic pulses to the brain, thus blocking the migraine headache.
Kemeta completes first test of fat metabolism monitor
MESA, Ariz. Kemeta on Tuesday announced the successful completion of its first clinical testing of their Fat Burn Monitor, a monitor that measures a person’s fat metabolism immediately after exercise by measuring acetone on the breath.
“The Kemeta product allows our patients to monitor their daily progress, providing the needed immediate feedback to keep them motivated to continue their weight management regimen,” stated John Hernried, Obesity Treatment Center Medical Group medical director and principal investigator on the project.
The 11-week IRB-approved study showed that individuals can receive an immediate indication of their fat burn rate by simply blowing into the Kemeta device. The study also showed a greater-than-90-percent correlation of the Fat Burn Monitor to the Gas Chromatograph, an industry standard bench-top tool used for breath analysis.
The device functions by measuring the concentration of the chemical acetone in the breath. Acetone is produced as fat is metabolized in the body. The simple non-invasive acetone measurement allows the user to track the success of their weight management program.
“This initial study with the OTCMG indicates the efficacy of our technology,” stated Barb Landini, Kemeta vice president of research and development and clinical testing.
The product is expected to reach front-end retailers sometime in 2009, the company stated.