Posts Tagged ‘FDA’

ENVIRONMENTAL GROUPS SUE FDA FOR FORMALDEHYDE USE

Tuesday, August 8th, 2017

The Environmental Working Group (EWG) and Women’s Voices for the Earth allege that the Food and Drug Administration has failed to act on dangerous hair straighteners which contain unsafe levels of  formaldehyde, in a motion filed July 28th in federal district court.  This is an addendum to the groups’ lawsuit against the FDA for its failure to act on a six-year-old petition requesting an investigation into popular hair smoothing treatments that are still sold in stores and salons. These straighteners – often known as keratin treatments or by the name of one prominent brand, Brazilian Blowout – contain formaldehyde, a known human carcinogen and potent allergen.

“The FDA has failed to protect stylists and consumers from exposure to formaldehyde,” said Melanie Benesh, a legislative attorney at EWG. “Since at least 2008, the agency has known about the health hazards associated with these hair straightening products and done nothing. Despite the complaints, the FDA has yet to take action to regulate these products.”  High levels of formaldehyde make many keratin hair straightening treatments a serious health threat for both clients and salon workers. These treatments involve liquids applied to hair, which are then heated using blow dryers and straightening irons. The high temperatures of these hair styling tools cause the liquids to release formaldehyde into the air. (more…)

FDA: GIVING DRUG “ECSTASY” A TRIAL

Wednesday, November 30th, 2016

ecstacy

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.”

TURNING BACK THE HANDS OF TIME!

Tuesday, September 27th, 2016

hands-2

*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.