Ohio Man Who Identifies As Female Faces Charges For Being Naked In Locker With Young Girls Present

 by Mimi Nguyen Ly via The Epoch Times,

A man who identifies as a female has been charged with public indecency for allegedly being naked while in the presence of young girls, in the women’s locker room of a YMCA in Ohio.

The man, Darren C. Glines, 31, of Fairborn, was charged with three counts of indecent exposure for three separate incidents spanning 2021–2022 that were reported by three different people.

Glines has not had gender reassignment surgery. He identifies as transgender and uses the name Rachel, local station WHIO reported.

Under Ohio law, public indecency is a misdemeanor of the fourth degree.

The three incidents occurred on Sept. 26, 2021, Nov. 7, 2022, and between Nov. 30, 2021, and Nov. 30, 2022, according to the complaint (pdf) obtained by the Daily Caller.

In the third incident, the person who filed the complaint reported that “at least three female juveniles were present when the naked man was in their vicinity.”

Glines “was identified by the reporting persons and the Xenia police were able to identify the identification via their investigation,” according to the court document.

The president of the Xenia City Council, Williams Urshcel, shared at a recent public gathering that one of the women that complained was told by the front desk at the YMCA facility that Glines “is actually a woman, and that you shouldn’t be disturbed by this.”

But a spokesperson for the city said Urshel’s comments were not authorized by or on behalf of the rest of the City Council, the city mayor, the city manager, and the law director.

The city’s law department doesn’t plan to bring charges against the YMCA over the matter, the spokesperson added.

The YMCA of Greater Dayton told WHIO in a statement that it will comply with legal mandates but also continue to protect the privacy and safety of its members.

“Under no circumstance will we investigate an individual’s birth identity and then assign individuals to locker rooms,” the statement reads.

“That would be counter to the law, counter to respect for all people and it is not who or what we are as an organization.”

The YMCA of Greater Dayton told Dayton Daily News that non-discrimination laws in Ohio allow people to use facilities that align with their gender identity.

It added that locker room guidelines in its facilities ask people to “remain properly covered while in public areas of the locker room.”

https://www.zerohedge.com/medical/ohio-man-who-identifies-female-faces-charges-being-naked-locker-room-while-young-girls-were

Magenta Therapeutics to Explore Strategic Alternatives

 Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company focused on improving stem cell transplantation, today announced that it has completed a review of its business, including the status of its programs, resources, and capabilities. Magenta has made the determination to halt further development of its programs and conduct a comprehensive review of strategic alternatives focused on maximizing shareholder value.

As part of this review process, Magenta will explore potential strategic alternatives that may include, but are not limited to, an acquisition, merger, business combination, or other transaction. There can be no assurance that this review process will result in Magenta pursuing a transaction or that any transaction, if pursued, will be completed on attractive terms. Magenta has not set a timetable for completion of this review process and does not intend to comment further unless or until the Board of Directors has approved a definitive course of action, the review process is concluded, or it is determined that other disclosure is appropriate.

https://finance.yahoo.com/news/magenta-therapeutics-explore-strategic-alternatives-210500832.html

Munger: Why America should ban crypto

 In the U.S. in recent years, privately owned companies have issued thousands of new cryptocurrencies, large and small. These have later become publicly traded without any governmental pre-approval of disclosures.

In some cases, a big block of cryptocurrency has been sold to a promoter for almost nothing, after which the public buys in at much higher prices without fully understanding the pre-dilution in favor of the promoter.

All this wild and wooly capitalism is much like that described in a remark often attributed to Mark Twain, who was thought to have said that "a mine is a hole in the ground with a liar on top."

Celebrities have been accused of promoting cryptocurrencies for their own benefit.

Such wretched excess has gone on because there is a gap in regulation. A cryptocurrency is not a currency, not a commodity, and not a security. Instead, it’s a gambling contract with a nearly 100% edge for the house, entered into in a country where gambling contracts are traditionally regulated only by states that compete in laxity. Obviously the U.S. should now enact a new federal law that prevents this from happening.

Two interesting precedents may guide us into sound action. In the first precedent, the communist government of China recently banned cryptocurrencies because it wisely concluded that they would provide more harm than benefit. And, in the second precedent, from the early 1700s, England reacted to a horrible depression that followed the blow up of a promotional plan to get vast profits by using slow-moving sailing ships to trade with very poor people halfway around the world.

Charlie Munger, vice chairman of Berkshire Hathaway Inc., speaks during the Daily Journal Corp. shareholder meeting in Los Angeles, California, U.S., on Thursday, Feb. 14, 2019. Munger discussed investing, banks, China, and health care at the meeting (Patrick T. Fallon/Bloomberg / Getty Images)

What the English Parliament did in its anguish when this crazy promotion blew up, was direct and simple: It banned all public trading in new common stocks and kept this ban in place for about 100 years. And, in that 100 years, England made by far the biggest national contribution to the march of civilization as it led strongly in both the Enlightenment and the Industrial Revolution and, to boot, spawned off a promising little country called the United States.

What should the U.S. do after a ban of cryptocurrencies is in place? Well, one more action might make sense: Thank the Chinese communist leader for his splendid example of uncommon sense.

Mr. Munger is vice chairman of Berkshire Hathaway.

https://www.foxbusiness.com/money/america-should-ban-crypto

Cardiorenal disease biotech Mineralys Therapeutics sets terms for $150 million IPO

 Mineralys Therapeutics, a Phase 2 biotech developing an in-licensed therapy for cardiorenal disorders, announced terms for its IPO on Thursday.

The Radnor, PA-based company plans to raise $150 million by offering 10 million shares at a price range of $14 to $16. At the midpoint of the proposed range, Mineralys Therapeutics would command a fully diluted market value of $574 million.

Mineralys is developing medicines to target diseases driven by abnormally elevated aldosterone, focused on cardiorenal disorders. Its sole candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI) licensed from Mitsubishi Tanabe that is initially being developed for uncontrolled hypertension. The company completed a Phase 2 proof-of-concept trial of lorundrostat for uncontrolled hypertension and resistant hypertension in 2022 and plans to initiate a randomized, double-blind, placebo-controlled Phase 2 trial in the 1H23, followed by a Phase 3 trial in the 2H23.

Mineralys Therapeutics was founded in 2019 and plans to list on the Nasdaq under the symbol MLYS. BofA Securities, Evercore ISI, Stifel, Guggenheim Securities, Credit Suisse, and Wells Fargo Securities are the joint bookrunners on the deal. It is expected to price during the week of February 6, 2023.

Relevant Profile: MLYS   

https://www.renaissancecapital.com/IPO-Center/News/97225/Cardiorenal-disease-biotech-Mineralys-Therapeutics-sets-terms-for-$150-mill

Wither CBD?

 Anyone who’s been paying attention to the FDA’s evolving thinking on cannabidiol (a derivative of cannabis also known as CBD) shouldn’t have been at all surprised at the agency’s January 26, 2023 announcement that there are too many unknowns about CBD products to regulate them as foods or supplements under the agency’s current structure and called on Congress to create new rules for the massive and growing market. And, specifically, per FDA Deputy Commissioner (and Chair of the agency’s CBD working group) Dr. Janet Woodcock, “We have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm.”

This is entirely consistent with what the FDA said in its pre-pandemic March 2020 missive “FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity.” It was an unambiguous regulatory finger-wagging at an exuberant but still-nascent industry that still just doesn’t get it. Alas, a lot of bad science doesn’t equal even a little good science.

he 2020 FDA statement begins, “Over the past year, the U.S. Food and Drug Administration has embarked on a comprehensive evaluation of cannabidiol (CBD) products, with a focus on educating the public about the risks and unknowns of these products, gathering the science needed to better understand both these safety concerns and potential benefits to inform our regulatory approach, as well as taking steps when necessary to address products that violate the law in ways that raise a variety of public health concerns.”

Translation: There’s no good science and we’re going to start writing enforcement letters. And they have. Too many for some, too few for others.

The agency continues, “Today, we are providing updates on our efforts in this area, including several new steps in areas of education, research, and enforcement with the ultimate goal of continuing to protect the public health and working to provide market clarity.”

Translation: It’s going to be a slow process and we’re obviously going to have to help you. Ignore the need for real science at your own peril. Oh, and about those claims, “… we are concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two rare, severe pediatric epilepsy disorders, no other CBD products have been evaluated or approved by the FDA.”

Safety issues? “There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your health care provider.”

Translation: We think there may very well be safety issues such as:

“… potential liver injury, interactions with other drugs and male reproductive toxicity, as well as side effects such as drowsiness. In addition, there is still much we do not know about other potential risks. For example, other than the approved prescription drug, we know little about the potential effects of sustained and/or cumulative use of CBD, co-administration with other medicines, or the risks to vulnerable populations like children, pregnant and lactating women, the elderly, unborn children, and certain animal populations. This does not mean that we know CBD is unsafe …”

Translation: But we have our suspicions.

“To address the questions and concerns we’ve already raised, we’re seeking reliable and high-quality data.”

Translation: We don’t have it because it doesn’t exist.

“This includes data on, among other things: the sedative effects of CBD; the impacts of long-term sustained or cumulative exposure to CBD; transdermal penetration and pharmacokinetics of CBD; the effect of different routes of CBD administration (e.g., oral, topical, inhaled) on its safety profile; the safety of CBD for use in pets and food-producing animals; and the processes by which “full spectrum” and “broad spectrum” hemp extracts are derived, what the content of such extracts is, and how these products may compare to CBD isolate products.”

Translation: It’s time for the proponents of CBD, including many highly vocal patients, physicians, pharmacists, manufacturers, and distributors, to become part of the solution.

“Given the importance of answering these questions, we’re exploring a number of ways to address the data gaps as quickly as possible. This includes encouraging, facilitating, and initiating more research on CBD, providing venues for industry and researchers to share new data with the agency and identifying opportunities to further collaborate with our federal partners at Centers for Disease Control and Prevention, Substance Abuse and Mental Health Services Administration and National Institute on Drug Abuse on this important issue.”

Translation: It’s a complicated issue that extends beyond the exclusive boundaries of the FDA – or of existing FDA authorities.

In March 2020, the FDA predicted a long and winding road.

“In the coming days, we are re-opening the public docket we established for our May 2019 public hearing. The docket provides a valuable conduit for submission of scientific data on CBD to the agency, so we have decided to extend the comment period indefinitely to allow the public to comment and to share relevant data with the agency. As the agency continues to move forward to explore viable pathways for CBD products outside the drug context, this extension will allow stakeholders to continue to provide relevant data as research in this area evolves.”

Translation: Key word, “indefinitely.”

And in conclusion: “We recognize the significant public interest in CBD, and we must work together with stakeholders and industry to develop high-quality data to close the substantial knowledge gaps about the science, safety, and quality of many of these products. We are committed to working efficiently to further clarify our regulatory approach to these products – as always, using science as our guide and upholding our rigorous public health standards.”

Nearly three years later, Dr. Woodcock has issued an honest and consistent statement: “The FDA will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate. We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities. The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.

Keep calm and carry on.

Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest and a Visiting Professor at the University of Paris School of Medicine.

https://www.realclearhealth.com/articles/2023/01/31/wither_cbd_111456.html

Gilead profit beats Street expectations on COVID and HIV sales

Gilead Sciences Inc on Thursday reported a higher-than-expected fourth-quarter profit driven by strong demand for its HIV and cancer drugs, while COVID-19 antiviral Veklury had sales that were double Wall Street estimates.

The U.S. biotech company said adjusted profit rose to $1.67 per share, ahead of analyst expectations of $1.50, according to Refinitiv data, and up from 69 cents per share a year earlier, when it took $1.85 billion in charges mostly for a legal settlement.

Quarterly revenue rose 2% to $7.4 billion, topping analysts' estimates of $6.64 billion.

It forecast 2023 sales of $26 billion to $26.5 billion, ahead of analyst expectations of $25.8 billion, and adjusted earnings of $6.60 to $7 per share. The midpoint of the earnings forecast is also above analysts' estimates for $6.73 per share.

Sales of COVID-19 treatment remdesivir, sold under the brand name Veklury, were $1 billion, far beyond the $511 million analysts had expected even as they slowed 26% from the previous year.

While Veklury sales declined by about half in the United States and Europe as COVID hospitalization rates fell, they tripled in other international markets.

Gilead's HIV sales increased 5% to $4.8 billion in the quarter, with Biktarvy rising 15% to $2.9 billion versus the $2.8 billion analysts expected.

Descovy sales rose 13% to $537 million, outstripping the analysts' forecast of $495 million.

Gilead's cancer franchise also saw sales increase by 71% to $419 million. Yescarta, a CAR-T lymphoma treatment, booked $337 million, while leukemia and lymphoma treatment Tecartus came in at $82 million.

https://www.marketscreener.com/quote/stock/GILEAD-SCIENCES-INC-4876/news/Gilead-profit-beats-Street-expectations-on-COVID-and-HIV-sales-42883863/

New Blood Pressure Target in Primary Care

 I'm Dr Neil Skolnik. Today we are going to talk about the new Blood Pressure Targets in Adults With Hypertension: A Clinical Practice Guideline From the AAFP (American Academy of Family Physicians). There are very few things that we treat more often than hypertension, so you'd think the guidelines would have been clear a long time ago. Less than 10 years ago, in 2014, JNC 8 recommended target blood pressure (BP) for individuals under 60 to be < 140/90, and for those older than 60, < 150/90.

Then, based primarily on the SPRINT trial (which included only people with or at significantly elevated risk for atherosclerotic cardiovascular disease), in 2017 the American Heart Association's hypertension guidelines lowered the target BP to < 130/80 for most individuals. It's a little more nuanced than that, but most of us don't remember the nuance. I've written about my reservations with that statement in the AHA's journal, Circulation.

Now the AAFP has updated its recommendations and they recommend a BP < 140/90. This is not a small change, as it often takes additional medication to achieve lower BP targets, and additional medicines lead to additional adverse effects. I'm going share with you some details from the new guideline, and then I'm going share my opinion about it.

The AAFP guideline applies to adults with hypertension, with or without cardiovascular disease. In the comprehensive literature review, the trials ran for an average of 3.7 years, and about 75% of the patients in the trials did not have preexisting cardiovascular disease.

The key to their recommendations is that target BPs lower than 140/90 did not show a statistically significant decrease in total mortality. In regard to serious adverse events, though, lower targets led to a nominal increase that didn't reach statistical significance. Serious adverse events were defined as death or events that required hospitalization or resulted in significant disability. In regard to all other adverse events, including syncope and hypotension, there was a significant increase, with a relative risk of 1.44 (a 44% increase in adverse events). This reflected an absolute risk increase of 3% compared with the standard target group (specifically 9.8% vs 6.8%), with a number needed to harm of 33 over 3.7 years.

Another potential harm of low BP targets was the need for an average of one additional medicine to reach lower BP targets. One systematic review cited an eightfold higher withdrawal rate due to adverse events in the lower target BP groups.

The AAFP guidelines said that in the comprehensive review of the literature, while there was no difference in mortality or stroke with lower BP targets, a small additional benefit was observed in myocardial infarction — a 16% lower incidence, with a number needed to treat of 137 over 3.7 years.

So that's the background. Let me now go over the specifics of the AAFP recommendations.

AAFP gives a strong recommendation for a standard BP target of < 140/90. They go on to say — and grading this next statement as a weak recommendation — that while treating to a lower BP target does not provide additional mortality benefit, a target BP of < 135/85 can be considered to lower the risk for MI, noting that lower BP may increase harms. They state that the lower BP target could be considered based on patient preferences and values.

The AAFP guideline is incredibly helpful. The difference in the recommendations of two large societies — American Heart Association (AHA) and AAFP — stems from two things. I believe that AHA focused on the composite endpoints in trials such as SPRINT, which only included high-risk patients, and the AAFP uses mortality as the driving endpoint in a broader group of patients that included both high- and lower-risk patients.

In addition, it appears that the two organizations weigh adverse events differently in coming to their conclusions. Clearly, we see more adverse events when aiming for a lower BP level, and in my experience, patients care a lot about adverse events.

Interestingly, the International Society of Hypertension recommends an "essential" BP target of < 140/90 for most individuals, and for those under 65, they provide the option of an "optimal" BP of < 130/80. Remember that for certain comorbidities, there are also other guidelines out there. The American Diabetes Association this year revised its target BP to < 130/80 for people with diabetes; for prevention of recurrent stroke, guidelines from the AHA/American Stroke Association in 2021 recommend BP < 130/80, and the International Society for Hypertension as well as the AHA recommends a BP of < 130/80 for those with established atherosclerotic cardiovascular disease.

To repeat, though, the main topic for today is that as a general target, the AAFP guidelines recommend a BP < 140/90.

Neil Skolnik is Professor, Department of Family Medicine, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia; Associate Director, Department of Family Medicine, Abington Jefferson Health, Abington, Pennsylvania

Disclosure: Neil Skolnik, MD, has disclosed the following relevant financial relationships:
Serve(d) on the advisory board for: AstraZeneca; Teva; Eli Lilly and Company; Boehringer Ingelheim; Sanofi; Sanofi Pasteur; GlaxoSmithKline; Merck; Bayer
Serve(d) as a speaker or a member of a speakers bureau for: AstraZeneca; Boehringer Ingelheim; Eli Lilly and Company; GlaxoSmithKline
Received research grant from: Sanofi; AstraZeneca; Boehringer Ingelheim; GlaxoSmithKline; Bayer
Received income in an amount equal to or greater than $250 from: AstraZeneca; Teva; Eli Lilly and Company; Boehringer Ingelheim; Sanofi; Sanofi Pasteur; GlaxoSmithKline; Merck; Bayer

https://www.medscape.com/viewarticle/987184