Monday, October 1, 2018

FDA approves treatment for metastatic cutaneous squamous cell carcinoma

Bloomberg News (9/28) reported the Food and Drug Administration approved Regeneron Pharmaceuticals Inc.’s and Sanofi’s Libtayo (cemiplimab-rwlc) for the treatment of “a deadly form of skin cancer.” The article points out that “it’s the first drug to come out of the companies’ 2015 partnership to research therapies that use the body’s immune system to fight various malignancies.”
Reuters (9/28, Babu) reported the Food and Drug Administration approved Sanofi SA’s and Regeneron Pharmaceuticals Inc.’s Libtayo (cemiplimab-rwlc) for the treatment of metastatic cutaneous squamous cell carcinoma “in patients whose condition has not improved following surgery or chemotherapy.” The article added that “metastatic cutaneous squamous cell carcinoma is the second-most common form of skin cancer, which accounts for an estimated 7,000 deaths in the United States each year.”
According to MedPage Today (9/28, Ingram), Richard Pazdur, M.D., the director of the FDA’s Oncology Center of Excellence, said in a statement, “This type of cancer can be difficult to treat effectively when it is advanced and it is important that we continue to bring new treatment options to patients.” Dr. Pazdur added, “We’re continuing to see a shift in oncology toward identifying and developing drugs aimed at a specific molecular target. With the Libtayo approval, the FDA has approved six immune checkpoint inhibitors targeting the PD-1/PD-L1 pathway for treating a variety of tumors, from bladder to head and neck cancer, and now cutaneous squamous cell carcinoma.

Thursday, September 27, 2018

GET YOUR FLU SHOT!

Nearly 80,000 died of flu last year, CDC says

The AP (9/26, Stobbe) reports about 80,000 Americans died of the flu and related complications this past winter – “the disease’s highest death toll in at least four decades” – according to CDC Director Robert Redfield, M.D. Dr. Redfield said, “I’d like to see more people get vaccinated. ... We lost 80,000 people last year to the flu.” Daniel Jernigan, M.D., “a CDC flu expert,” explained that while the flu detected this year appears to be a less aggressive strain, officials still “don’t know what’s going to happen, but we’re seeing more encouraging signs than we were early last year.” The AP adds that in recent years, “flu-related deaths have ranged from about 12,000 to – in the worst year – 56,000, according to the CDC.”
Fortune (9/26, Shoot) reports the flu vaccine “turned out to not be very effective” last year, which contributed to “the sudden increase in flu-related deaths.” After the last flu season, “the CDC began using a new methodology for ranking severity of flu seasons,” classifying the 2017-2018 winter as “a high severity season across all age groups,” the only season to receive a high severity classification.

Thursday, September 20, 2018

Senate passes opioids package

Several outlets reported on the Senate’s passage of legislation to address the opioid epidemic. Colby Itkowitz writes in the Washington Post (9/17) that the Senate “overwhelmingly” passed a package of bills aimed at the nation’s opioid epidemic Monday by a 99 to 1 vote. The package includes 70 bills covering $8.4 billion in funding for programs across multiple agencies. The legislation requires the U.S. Postal Service to screen packages from overseas, typically China, for synthetic opioids and provides greater access to treatment.
The Wall Street Journal (9/17, Andrews, Subscription Publication) reports the package provides funding to the National Institutes of Health to research a nonaddictive pain medication. Another provision clarifies that the FDA has the authority to require prescriptions for opioids to be packaged in set amounts, such as three or seven days.
The AP (9/17, Fram) reports the package creates “new federal grants for treatment centers, training emergency workers and research on prevention methods.” The House passed its own package earlier this summer.
Afghan minorities seek plastic surgery to blend in with others
Cosmetic surgery has become more widely available in Kabul, Afghanistan, and many of surgeon Zalmai Khan Ahmadzai's patients are Hazara -- a long-persecuted religious and ethnic minority with Asian-like features -- who want to look more like other Afghans.

BEWARE OF SURGERY IN FOREIGN COUNTRIES - JUST BECAUSE IT'S CHEAP DOES NOT MEAN IT IS GOOD

Jane Park, 22, from Edinburgh, has described how she was left with searing pain all over her body after Turkish surgeons performed a "Brazilian bum-lift which involves the removal of fat from one part of the body to enlarge her bottom.
 She said: "They take fat from unwanted places and put it back into your bottom. When I woke up from surgery I was very cold and sore.
"I looked in the mirror and I was swollen from head to toe. I could barely open my eyes - it was horrible. It makes me feel sick looking at it.
 Park from Edinburgh suffered a drastic reaction when her bum-lift surgery ended with complications. (ITV)    
"I thought I was going to die, I didn't know what was wrong with me and they said it was a reaction to the local anaesthetic," she told the programme.
Jane became a social media celebrity after winning the Euromillions in 2017, and has since earned 43,000 Instagram followers who she keeps up-to-date with swimsuit photo shoots and glamour poses.
She added that she idolised celebrities on social media and that body image was very important to her before making the trip to Turkey in 2017 for the dramatic surgery.

She added: "I saw loads of celebrities on social media, there was your Kim Kardashians, and people in the UK who had had it done, and it seemed like an idea to lose weight. I had been looking at Instagrams of surgeons and clinics and researched the celebrities who all said it was fine."
But the American Society of Plastic Surgeons (ASPS) reported early this month that the procedure has the highest death rate for any kind cosmetic surgery.
Some 20,000 buttock augmentation procedures using fat grafting were performed in 2017, said ASPS. One in 3,000 people who undertook the bum-lift in the US died afterwards.

"Patient safety is the highest priority for board-certified plastic surgeons," said Dr Jeffrey Janis, President of ASPS. "The task force is concerned with the high mortality rate of this operation and is aggressively investigating ways to make this procedure safer. This new warning emphasises the continued risk that is being encountered with this procedure."
The risks are so great that Dr Gerard Lambe of the British Association of Aesthetic Plastic Surgeon (BAPS) told presenters Eamonn Holmes and Ruth Langsford he decided not to undertake similar procedures at his own practice.
Ms Park idolised celebrities who had undertaken the surgery and travelled to a clinic in Turkey where TOWIE stars Lauren Goodger and Amber Dowding, as well as Chloe Khan, from The X Factor and Celebrity Big Brother have both reportedly had surgery. (ITV)
He said: "We use (fat transfers) often to correct things in breasts, and it started in Brazil where you would take fat from other areas in this way. It would have been taken from the flank area, processed, washed and injected back in.

"People tend to want to go bigger and bigger, that's the trend - then you have to put the fat deeper. When you put the fat very deep into the muscle there are veins, and if the fat gets into those veins that's when you get very serious complications. Fat flies around the circulation, it can block the lungs, block the heart, and lead to very serious illness."
Ms Cambridge died after receiving bum lift surgery at the Elite Aftercare clinic in Izmir, according to reports. Her exact cause of her death is unknown.

Her partner Scott Franks said in tribute to the 29-year-old from Leeds:“How can this happen am I dreaming?”

“Two days ago I was happy. Now I’m a broken man and will be forever. I’m hurt so bad and this is only the start. My life has crashed," he wrote on social media on Tuesday.
A neighbour of Miss Cambridge told LeedsLive: She didn't need it, she didn't. She was a beautiful woman, absolutely stunning, and your heart goes out to those three little ones.
"Young people like her need telling, all these TV shows and celebrities are putting pressure on these girls to go out and have these expensive treatments."
The family are still waiting to return her body to the UK
MD Anderson Study of Silicone Implants Raises New Concerns
The largest ever study of silicone breast implants has found the devices are generally safe but associated with a slightly higher risk of a few rare diseases, a controversial conclusion that quickly reheated the seemingly settled issue.
The finding by MD Anderson Cancer Center researchers was disputed Friday by many experts, including federal health regulators, who have nevertheless scheduled a public meeting of medical advisers next year to consider implant safety. The study was based on the outcomes of nearly 100,000 patients who received one of the devices since they returned to the market in 2006.
“These findings aren’t meant to suggest implants caused these problems,” said Dr. Mark Clemens, an MD Anderson professor of plastic surgery and the senior investigator of the study. “They’re associations, which underscore the need for more research in this area, but do provide key safety information for women and their providers to consider when thinking about cosmetic or reconstructive surgery with breast implants.”

Sunday, August 19, 2018

FDA: Avoid ‘energy-based’ vaginal treatment
For vaginal treatment, including cosmetic or for menopause or incontinence, the FDA recommends staying away from "energy devices" that include radiofrequency and laser. Treatment using energy-based therapies for the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse and recurring/chronic pain, the agency states.