Posts Tagged ‘FDA’


Wednesday, November 30th, 2016


Ecstasy and Molly are “street names” for the 1980’s illicit party/rave drug, clinically known asmethylenedioxymethamphetamine (MDMA).   Its effects include increased empathy, euphoria, and heightened sexuality.  While therapeutic uses for the Schedule 1 drug may seem contradictory, the Federal Drug Administration has approved a large-scale, Phase 3 clinical trial of the drug  to treat patients with post-traumatic stress disorder.

Six previous trials, funded by the Multidisciplinary Association for Psychedelic Studies (MAPS), have involved 130 patients.  This next phase, also funded by the non-profit, will include a minimum of 230 patients.  According to MAPS, “Our highest priority project is funding clinical trials of 3,4-methylenedioxymethamphetamine (MDMA) as a tool to assist psychotherapy for the treatment of posttraumatic stress disorder (PTSD).”  The organization believes that drug therapy in conjunction with psychotherapy can help people “overcome PTSD, and possibly other disorders as well,” explaining, “MDMA is known for increasing feelings of trust and compassion towards others, which could make an ideal adjunct to psychotherapy for PTSD.”

While the F.D.A. declined to comment,Dr. Charles R. Marmar, head of Psychiatry at New York University’s School of Medicine, spoke with The New York Times.  “If they can keep getting good results, it will be of great use. PTSD can be very hard to treat. Our best therapies right now don’t help 30 to 40 percent of people. So we need more options.”  However, he cautions about potential abuse, “Prolonged use can lead to serious damage to the brain.”  MAPS acknowledges that in MDMA-assisted psychotherapy, MDMA is only administered a few times, “unlike most medications for mental illnesses which are often taken daily for years, and sometimes forever.”


Tuesday, September 27th, 2016


*Unretouched photos of subject, age 47

In spite of our anti-aging regimens, hands often betray us, revealing the truth about our chronological ages.  Like the face, hands gradually lose their volume over time, resulting in thin and wrinkled skin as well as unsightly veins and tendons (chords).  While injecting a dermal filler is an obvious treatment for restoring volume to our hands and faces, which filler is best?  We recently discovered that only one has been approved by the FDA for hands:  Radiesse.

Radiesse is different from traditional hyaluronic fillers, as it contains calcium hydroxylapatite (CaHA), a substance that is identical to what’s naturally found in the body. When injected into the skin, these unique, patented, microspheres initially perform as a filler and, ultimately, stimulate new collagen production.  Over time, though, the body gradually absorbs the Radiesse itself, leaving behind one’s own collagen.  Los Angeles dermatologist, Dr. Helen Fincher, chooses it for her patients’ hands because, “Radiesse is a quick-fix for those bony veiny hands that were hard to treat in the past.  It provides a nearly instant natural result with minimal pain and downtime.”

Radiesse lasts up to twelve months in most patients and is relatively less-expensive than other dermal fillers.  Typically a single treatment costs $800; however, this varies based on provider’s location and the quantity needed.


Thursday, July 7th, 2016

CryotheraphyWe’ve all heard about the cool Hollywood health craze, cryotherapy.  New York’s KryoLife claims that whole body cryotherapy (WBC) “improves skin tone, reduces signs of aging, manages pain, lowers inflammation, improves athletic performance and can mitigate depression.”  Its been promoted by celebrities such as Derek Hough (above), Minka Kelly, Mandy Moore, and Lindsay Lohan.  However, the U.S. Food and Drug Administration recently has put the “treatment” on ice.  “Given a growing interest from consumers in whole body cryotherapy, the FDA has informally reviewed the medical literature available on this subject,” says Aron Yustein, M.D., a medical officer in the FDA’s Center for Devices and Radiological Health.  “We found very little evidence about its safety or effectiveness in treating the conditions for which it is being promoted.”

According to its report, the FDA was unable to find evidence that WBC effectively treats diseases or conditions like Alzheimer’s, fibromyalgia, migraines, rheumatoid arthritis, multiple sclerosis, stress, anxiety or chronic pain.   “Based on purported health benefits seen in many promotions for cryotherapy spas, consumers may incorrectly believe that the FDA has cleared or approved WBC devices as safe and effective to treat medical conditions,” says Yustein. In fact, no WBC device has been cleared or approved by the agency in support of these claims.