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Wednesday, February 8, 2023

Doctors warn vaginal rejuvenation wastes money, shows no benefit

 Lasers may seem like the way of the future — but not yet for your vagina.

Despite talk that vaginal laser treatment can tighten the vagina, improve sexual function and reverse incontinence, there is little evidence to support these claims. In a new article, published Monday in the Canadian Medical Association Journal, a pair of gynecologists asserted that laser devices for vaginal rejuvenation are no more effective than “sham” treatments.

Vaginal rejuvenation surgery encompasses a number of related procedures, but in broad terms refers to clinical attempts to firm up the skin around the vagina or to tighten the vaginal canal.

Vagina rejuvenation has become an “it” operation in recent years, touted by middle-aged celebrities and mothers looking to spice up their sex lives. In 2017, “Real Housewives of Orange County” star Kelly Dodd proudly announced she had a procedure — gushing it changed her life — as did her co-star Braunwyn Windham-Burke two years later.

While a noninvasive laser treatment could start as low as $700, some surgical rejuvenations — such as labiaplasty to reduce the size of the labia minora — resulting in so-called “designer vaginas,” can cost anywhere from $4,500 to $10,000.

Now, some of the procedures are being used to treat genitourinary syndrome of menopause. GSM symptoms include vaginal dryness, painful intercourse and a frequent urge to urinate. However, experts warn getting the procedure could be redundant and a waste of money.

Although such procedures appear to be safe, the paper’s co-authors, Blayne Welk and Erin Kelly, doctors and faculty members of the University of Alberta, noted that no controlled studies have been conducted to assess the efficacy of vaginal lasers for treating GSM.

“Vaginal rejuvenation procedures are being used for the treatment of urinary incontinence and GSM, as well as for less clear indications (e.g., vaginal tightening for better sexual satisfaction), without good evidence that it helps any of these conditions,” the authors noted in the paper.

In a comment to Medscape, Kelly reiterated that expensive and unproven laser procedures are being marketed to women as a viable solution.

“Many women present to the clinic having heard of vaginal laser procedures, having had vaginal laser procedures, or having been told they need vaginal laser procedures,” she told the publication. “My impression has been that these procedures are being marketed to women … without rigorous study.”

One prominent method of rejuvenation called vaginal laser ablation isn’t approved by the United States Food and Drug Administration, with “few high-quality studies” to support the use of vaginal energy devices to treat GSM, according to the authors. Meanwhile, the North American Menopause Society guideline recommends over-the-counter products instead to treat GSM, such as vaginal lubricants or supplementation with vaginal estrogen.

The treatment uses lasers to make tiny scratches on the wall of the vagina, which stimulates the growth of new blood vessels. However, this is only temporary and would require annual sessions because the lack of estrogen during menopause will allow the muscle to atrophy again — which would mean forking out more cash for more treatments.

Of the limited research available, the outcomes recorded have produced “low evidence” of benefit “with a high risk of bias.” Moreover, the FDA has reported that “vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain” is known to occur after such treatments.

Welk told Medscape he would like to see information about approved medical devices, including vaginal lasers, made available to the Canadian public — and beyond.

“Health Canada has an online database of approved devices, but no information around the evidence submitted during the approval process is available, nor are the indications for the various devices,” he said.

https://nypost.com/2023/02/08/doctors-warn-vaginal-rejuvenation-wastes-money-shows-no-benefit/

BioXcel Top Idea For 2023: Mizuho

 

  • Mizuho raised the price target on BioXcel Therapeutics Inc  from $24 to $38, with a Buy rating.
  • Since the analyst's previous model update last December, BTAI shares have meaningfully outperformed vs. its peers (+61% vs +8% for the XBI), based on increased bullishness ahead of the first Phase 3 data for lead asset Igalmi/BXCL501 in Alzheimer's disease (AD) agitation (expected in 1H23). 
  • The analyst revisited the BTAI model based on BXCL501 in schizophrenia, bipolar disorder, AD, and major depressive disorder (MDD), raising the peak sales estimate to $1.2 billion (vs. prior $936 million), with the most significant driver being a ~30% increase in AD agitation sales forecast to $814 million. 
  • The stock outperformance comes amid investor enthusiasm, with five more clinical data events expected this year.
  • Most recently, BioXcel announced topline data from its Phase 2 trial of BXCL701 combined with Merck & Co Inc's  Keytruda (pembrolizumab) in small cell neuroendocrine metastatic castration-resistant prostate cancer.
  • BXCL701 combo demonstrated a favorable response rate in this difficult-to-treat cancer.

Vistagen anxiety study remains on hold

 Pherin acquisition completed; all future royalty payment obligations related to PH94B and PH10 eliminated, three new drug candidates added to Vistagen’s pipeline

PH94B Phase 3 program for social anxiety disorder advancing towards important next steps

PH10 Phase 1 study initiated to facilitate plans for Phase 2B development of PH10 for major depressive disorder; FDA Fast Track designation granted

https://finance.yahoo.com/news/vistagen-provides-corporate-reports-fiscal-212000486.html

Annovis: Euro OKfor Phase 3 Study of Buntanetap for Parkinson's

 Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a clinical-stage drug platform company addressing neurodegenerative diseases, today announced approval for additional European clinical trial sites for the ongoing Phase 3 study of buntanetap for the treatment of Parkinson's disease ("PD").

https://finance.yahoo.com/news/annovis-bio-announces-approval-european-123000141.html

Avrobio jumps amid speculation of takeover interest

 

  • Avrobio Inc. (NASDAQ:AVRO) soared 23% amid a report that the company is exploring a possible sale after an approach from Novartis (NVS).
  • A takeover for the company may be valued at more than quadruple its market price before it popped on the takeover speculation, according to a Street Insider report, which cited an unidentified source. Avrobio (AVRO) is said to be working with Cowen and Wells Fargo on a potential sale.
  • AVRO hadn't responded to a Street Insider request for comment and Novartis (NVS) doesn't comment on market rumors and speculation.

States Need to Start Rolling Back Biden’s Medicaid, Food Stamp Expansions

 The official end of the COVID-19 emergency is near. That’s good news. It’s now up to the states to finish the job.

The House of Representatives voted Feb. 1 on a joint resolution ending the national COVID-19 emergency and a bill to terminate the Department of Health and Human Services’ public health emergency declaration.

At the same time, the Biden administration has also announced plans to end both of those emergencies in May.

At the start of the COVID-19 pandemic, policymakers took emergency steps to help mitigate its effects. Then-President Donald Trump in March of 2020 declared a national emergency, which opened up a variety of new authorities across the federal government. The secretary of HHS also declared a public health emergency, which allows the agency to waive certain requirements.

This cascade of emergency steps manifested itself at the state and local level as well.  

Congress also reacted by enacting a stream of temporary legislative changes as well. Notably, lawmakers passed the Families First Coronavirus Response Act of 2020, which linked several changes to the duration of the public health emergency. In that bill, Congress provided states with emergency federal Medicaid funding, but in exchange prohibited the states from removing individuals from the Medicaid program, regardless of eligibility changes.

The legislation also allowed states to increase food stamp allocations to beneficiaries and suspended work requirements on able-bodied individuals as a condition for receiving food stamps.

Also attached to the public health emergency, the Consolidated Appropriations Act of 2021 included changes to halt work-study requirements on college students as a condition of receiving food stamps.

The Biden administration has used the perpetual extension of these emergencies as a means to advance its radical agenda and undermine the basic design of these welfare programs. It already succeeded in expanding “temporary” Obamacare subsidies until 2024 and attempted, but failed, to extend its “temporary” child tax credit scheme.    

With the official end of the COVID-19 emergency in sight, now the work to restore normalcy falls to the states. Most urgent are those related to the Medicaid and food stamp programs.

The Omnibus Act of 2023 included a process for dialing back the federal emergency Medicaid match rate and for states to return to normal eligibility reviews and thereby officially delinking it to the end of the public health emergency.  

The unwinding process is set for April, but states can and should start sooner.

Medicaid enrollment skyrocketed during COVID-19. Enrollment is estimated to have increased 28% from February 2020 to September 2022. Some argue that between 5 million and 14 million individuals may lose Medicaid coverage if the freeze is lifted. However, not only will many have access to coverage elsewhere but, by restoring proper eligibility, states will be able to free up resources to ensure the program is serving those who it is intended to serve.  

The Omnibus Act of 2023 also ended the emergency food stamp allocations early. Originally set to stop once the public health emergency came to an end, now states are required to return to normal allocations starting in March. It’s worth noting that 17 states already ended emergency allotments, and South Carolina is scheduled to do so starting this month. The remaining states will need to act soon.

States will also need to be ready to restore work requirements for able-bodied individuals, including college students, as a condition of receiving food stamps.

States should consider other steps to integrate work more fully into welfare programs. With an economywide need for more workers, it’s a win-win: for employers looking for people to fill jobs and for individuals wanting to move out of the welfare state and into the workforce.

Twenty-four states and the District of Columbia either fully or partially exempt work as a condition of benefits for able-bodied individuals. That should be changed.

States must not be passive, but aggressive, in getting back to normal, especially when it comes to rolling back the Biden administration’s radical agenda.

The perpetual extensions of these emergencies have allowed the Biden administration to advance its liberal agenda under the guise of an “emergency” that Americans have long put behind them. It’s time to roll them back.

https://www.heritage.org/public-health/commentary/national-covid-19-emergency-will-soon-end-states-need-start-rolling-back