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Monday, October 31, 2022

Health-Care Stocks Rally to Best Month Since 2020 on Haven Demand

 Health care stocks posted their best monthly gain since April 2020 as investors seek shelter in a weakening economy.

The S&P 500 Health Care Index rallied 9.6% in October, its best month in two and a half years and beating the greater benchmark’s 8% rise. Hospital operator Universal Health Services Inc. -- fresh off its best week on record -- and diabetes device maker Dexcom were among the top performers driving the sector higher.

The gains come as investors look for safe bets amid rising interest-rates and a looming recession. Pockets of the health sector, from insurers to large drugmakers, tend to do well in downturns as demand for their services isn’t swayed by the economic outlook.

While wipeouts from major tech stocks have been grabbing the headlines, earnings beats in health care have been rewarded more than any other sector, according to Asad Haider, a Goldman Sachs Group strategist.

He said health care’s defensive appeal and outflows from other sectors, including tech bellwethers, are helping bolster the stocks. Disappointing earnings from tech companies stand in contrast to the beats-and-raises from Biogen Inc., Gilead Sciences Inc., Merck & Co. Inc. and others, Haider wrote in a note to clients dated Friday.

The group has charged higher for the past four weeks, its longest weekly winning streak since December 2021.

And more earnings reports are coming. The best health performers this year are drug distributors McKesson Corp., which is expected to report earnings on Tuesday after a 57% rally this year, and Cardinal Health Inc., which is set to share results on Friday after a 47% gain.

Colombia's Oil Industry In Jeopardy As Cocaine Production Soars To New Record

 By Matthew Smith of OilPrice.com

Leftwing Senator Gustavo Petro’s electoral victory, which he was inaugurated as Colombia’s 34th president, saw a wave of optimism sweep across the strife-torn country. The term of President Petro’s predecessor Ivan Duque was marred by a spike in violence and crime, nationwide anti-government protests, a surge in the activity of illegal armed groups and soaring cocaine production.

Fallout from the 2020 COVID-19 pandemic, which caused Colombia’s GDP to contract by 7% that year and spiraling poverty, contributed to rising lawlessness, crime and violence. Alarmingly, cocaine production, which is a key driver of violence and illicit activity in Colombia, keeps soaring to new highs. This is symptomatic of a weak state that lacks a credible presence in many rural regions causing the internal security environment to deteriorate. Escalating insecurity will potentially roil Colombia’s post-pandemic economic recovery, one of the strongest in Latin America, while impacting the Andean country’s economically vital energy patch. For these reasons, Petro must act decisively to curb violence, lawlessness and illicit activities in a country that is falling once-again into chaos.

A key indicator of Colombia’s deteriorating domestic security is the recent announcement by the United Nations Office on Drugs and Crime (UNODC) that domestic cocaine output (Spanish) hit yet another record during 2021. That occurred despite decades of U.S. funded counter-narcotics operations, leaving Colombia as the world’s number one cocaine producer. UNDOC estimates that 2021 cocaine production grew 14% year over year to 1,400 metric tons, while the amount of land utilized for coca cropping surged by a whopping 43% to half a million acres. Burgeoning cocaine production, along with the vast profits that narcotics trafficking generates, was responsible for funding the immense escalation of Colombia’s multiparty asymmetric conflict during the 1980s. 

Cocaine profits have long funded various armed non-state groups in Colombia with soaring production responsible for a surge in the number of illegal armed groups, combatants and related violence since 2018. The vast earnings generated by cocaine in Colombia are thought to be as high as $12 billion annually, which is equivalent to 4% of the Andean country’s GDP. It is cocaine production and coca cropping, the leaf of the coca plant being a necessary precursor, as well as associated violence which is responsible for the 260,000 plus deaths that have occurred during Colombia’s armed conflict. Most of those casualties were civilians who also suffered forced displacement by various illegal armed groups, with it thought that as many as 8 million people having been forced to leave their homes. 

The recent spike in Colombia’s cocaine production, along with the associated escalation in violence linked to illegal armed groups was responsible for a sharp uptick in the number of civilians displaced during 2021. According to the UN, at least 74,000 Colombians were displaced during that year, which is more than double 2020. The volume of direct attacks against civilians during 2021 also trended higher, rising by 37% year over year to total of more than 2,400 occurrences. These worrying events underscore the growing violence gripping Colombia, most of which is associated with coca cultivation and the manufacture of cocaine. Massacres, which are another symptom of growing cocaine production, lawlessness, rising insecurity and an ineffective state, have surged since 2018. Colombian peace think-tank Indepaz recorded 85 massacres, which is the murder of three or more people in a single event, up until 9 October 2022. That is 10 greater than the same period a year earlier and more than double the 36 massacres recorded during 2019 before the pandemic.

It is the marked increase in cocaine production and associated violence from various illegal armed groups engaged in the manufacture of the narcotic that poses the greatest threat to the Colombian state, civil society and the economy. This becomes particularly apparent when the regions where coca is grown and much of the related violence occurs are also those rich in hydrocarbons. The Catatumbo region, located in the northwest near the Venezuelan border, is Colombia’s second major coca cultivating area and the country’s deadliest conflict zone. Aside from being a hotspot for the resurgent civil conflict, Catatumbo is also one of Colombia’s top oil producing areas with it believed to contain anywhere up to 17 million barrels of undiscovered oil reserves. The crucial 210,000 barrel per day Cano Limon Covenas oil pipeline passes through Catatumbo leaving it vulnerable to sabotage and the application of illicit valves used to steal petroleum. The escalation of cocaine related conflict in the region has seen such incidents rise significantly since 2020. 

Colombia’s southern Putumayo department is listed by UNDOC as being the fourth largest zone for coca cultivation. The region, which borders northern Ecuador, has long had significant presence of the now demobilized Revolutionary Armed Forces of Colombia (FARC – Spanish initials). Since the 2016 peace agreement between Bogota and the FARC a series of smaller illegal armed groups, mainly dissident FARC elements, and criminal organizations have sprung up in Putumayo. Those groups are primarily focused on coca cropping and cocaine production in a region that, because of its proximity to Ecuador, contains well-established extremely lucrative trafficking routes. As a result, violence is spiraling out of control in Putumayo with frequent clashes between various armed groups sparking massacres. Putumayo is also home to the Caguan-Putumayo Basin, Colombia’s second most prolific hydrocarbon basin with the country’s hydrocarbon regulator the National Hydrocarbon Authority (ANH – Spanish initials) estimating it contains oil reserves in excess of 365 million barrels.

While Petro plans to transition Colombia away from dependence on fossil fuel extraction by ending contracting for hydrocarbon exploration and banning hydraulic fracturing, the oil industry is currently an important economic driver. Petroleum is Colombia’s largest export accounting for 35% of all exports for the first seven months of 2022, valued at $13.8 billion. Hydrocarbon extraction also accounts for around 3% of Colombia’s GDP and generates a fifth of Bogota’s fiscal revenues. Those numbers make eliminating Colombia’s petroleum industry near impossible, particularly with Petro planning to significantly boost spending on social programs and poverty alleviation. In fact, his plans to hike taxes for Colombia’s oil industry will make it a more important source of income, particularly in a global economy besieged by an energy crisis and rampant inflation where guaranteeing energy security is now an imperative. Rising violence and conflict in Colombia fueled by soaring cocaine production will impact the economically crucial petroleum industry and roil the country’s post-pandemic economic recovery, further hurting an already suffering population.

https://www.zerohedge.com/economics/colombias-oil-industry-jeopardy-cocaine-production-soars-new-record

FDA warns of tracheostomy tube shortage

 U.S. Food and Drug Administration (FDA) said on Monday there was a shortage of tracheostomy tubes, a surgical device that helps patients to breathe, including those manufactured by ICU Medical.

The agency said the shortage was due to difficulties in raw material procurement and would most likely impact pediatric patients.

They will be affected by the limited supply of tubes with similar functionality as ICU Medical's Bivona, that are made from flexible silicone and easier to use in children.

The health regulator has recommended reusing tracheostomy tubes after following proper sanitary procedures in order to deal with the current shortage.

https://finance.yahoo.com/news/1-u-fda-warns-tracheostomy-200144187.html

Biohaven upped to Overweight from Neutral by Cantor

 Target $27

https://finviz.com/quote.ashx?t=BHVN&p=d

Monopar Announces Timeline of Upcoming Data Events for Validive, Camsirubicin, and MNPR-202

 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, will be presenting clinical data on camsirubicin and preclinical data on MNPR-202 in November and December, and is planning to report out the interim go/no-go analysis for its Validive Phase 2b/3 VOICE trial in Q1 2023.

November 2022:

Poster of Camsirubicin Phase 1b Clinical Trial Data to be Presented at CTOS 2022

Event: Connective Tissue Oncology Society (CTOS) Annual Meeting Conference
Date: November 16-19, 2022
Location: Vancouver Convention Centre, Vancouver, BC, Canada

December 2022:

Poster of MNPR-202 Preclinical Data to be Presented at ASH 2022

Event: 64th American Society of Hematology (ASH) Annual Meeting & Exposition
Date: December 10-13, 2022
Location: Ernest N. Morial Convention Center, New Orleans, Louisiana

Q1 2023:

Interim go/no-go Analysis for Validive Phase 2b/3 VOICE Clinical Trial

The Company plans to report out the interim go/no-go decision for its Validive Phase 2b/3 VOICE clinical trial in Q1 2023. All patients required for the interim analysis have been enrolled. Patient enrollment will continue, as will adding additional clinical sites (currently 71 sites across the U.S. and Europe), in preparation for a potentially positive interim analysis.

https://finance.yahoo.com/news/monopar-announces-timeline-upcoming-data-120000087.html

Reviva Enrollment Update for Pivotal Phase 3 Schizophrenia Study

  Enrollment ongoing at multiple sites in the US and Europe; site initiation in Asia expected in November 2022 -

- Enrollment on pace, with over 30% enrolled in the United States -

- Topline data for RECOVER evaluating brilaroxazine for schizophrenia expected in mid-2023 -

https://finance.yahoo.com/news/reviva-pharmaceuticals-announces-global-enrollment-120000187.html

Are Weight Loss Medications for Health or Thinness?

 #MyOzempicJourney has gone viral on TikTok. People are calling their doctor's offices requesting semaglutide (Ozempic) by name to get the same dramatic weight loss transformations they've seen online.

Sylvia Gonsahn-Bollie, MD

As an obesity expert who was an early adopter of the glucagon-like peptide 1 (GLP-1) agonists, the class of medication semaglutide belongs to, I have mixed feelings about its new popularity as well as other weight loss medications. However, I'll try to present a nonjudgmental view of the clinical considerations of weight loss medications. Specifically, I want to discuss the benefits and potential harms of using weight loss medications.

First, let's start with a bit of housekeeping on what we call these medications. Medications used to reduce weight or treat obesity are commonly called "weight loss medications." But the correct US Food and Drug Administration (FDA) term is "anti-obesity medications" or "AOMs."

The term "anti-obesity" can be offensive to some patients. So my preferred term is "metabolic medications," which emphasizes that "weight loss medications" do more than induce weight loss. Metabolic medications also improve metabolism and, for some medications, also improve cardiometabolic health. Therefore, in this piece, I'll use the terms "weight loss medications," "metabolic medications," and "anti-obesity medications" interchangeably.

Let's start with the benefits of metabolic medications.

Benefits of Weight Loss Medications

Treat the root cause of hormonally driven weight gain. Obesity is a complex medical disease with health consequences beyond the scale. In the past 10 years, our understanding of the pathophysiology of obesity has increased significantly. Fitness, healthy food choices, and other lifestyle changes are foundational to weight loss and obesity treatment. But for many people, these lifestyle changes aren't enough to lose and sustain weight. The development of medications that affect the incretin pathway, like GLP-1 agonists, is groundbreaking. GLP-1 agonists mimic the body's natural satiation pathway, which helps improve hunger, decrease energy intake, and improve glycemic control. Moreover, these medications suppress the body's "weight regain" mechanisms.

Provide more tools for metabolic equity. Everyone is not playing on the same metabolic playing field. We know this from studies of twins which show a genetic predisposition to gain weight or develop obesity. Additionally, weight regulation is more complex than "calories in vs calories out." Over 70 weight gain triggers make some people prone to gaining weight. A common misconception is that taking a weight loss medication is cheating or giving the patient an "unfair" weight loss advantage. However, the opposite is true. In a person with insulin resistance, diabetes, or obesity, metabolic medications only level the metabolic playing field by addressing the underlying weight gain triggers that prevent weight loss.

Result in less blame for "failed" lifestyle changes. "I failed my diet." I can't tell you how often I've heard this phrase or said it myself. People unfairly experience blame and shame when they don't lose significant weight through lifestyle changes or regain the weight. However, data shows most people will lose only 2%-5% of their body weight with lifestyle changes alone. Studies show that up to 80% of weight will be regained within 5 years. These sparse numbers are due to more than willpower. As I mentioned, powerful neuroendocrine pathways signal your body to regain the lost weight. Taking metabolic medications suppresses these pathways.

However, in addition to the benefits, the recent popularity of weight loss medications like semaglutide does highlight some potential harms.

Potential Harms of Weight Loss Medication

Weight bias. An obsession with thinness has been the standard of beauty in Western culture for over a century. As Dr Sabrina Strings highlights in her thought-provoking sociological book Fearing the Black Body, this preoccupation with thinness has both racist and sexist origins. Even the standard body mass index (BMI), the most commonly used tool for obesity screening, is biased. Prompting calls for body composition and other metabolic health indicators to be used for health assessment instead of the standard BMI, as I wrote in my previous Medscape column. The prevalence of weight bias in society and healthcare raises the question, "Are we using metabolic medications for thinness or health?" Obviously, as clinicians, our goal is health optimization. However, we must be careful not to let weight bias obscure our objective clinical assessment.

Furthermore, in the past decade, significant strides have increased the acceptance of body diversity and individualized healthy weight. However, people exploiting semaglutide and other medications off-label to become super-thin threatens the progress in body diversity acceptance. It also emphasizes the medications' weight loss properties, which can overshadow metabolic medications' life-saving benefits for people with a medical indication for taking semaglutide and other metabolic medications.

Health inequity. Newer GLP-1 agonists can markedly improve the health of people with diabetes or obesity. However, diverting metabolic medications to people for off-label or cosmetic use is causing medication shortages. Furthermore, the cost is prohibitive to people who need them most. The unjust access to newer anti-obesity medications worsens health inequity and health disparities.

Risky prescribing practices. The "street value" of an Ozempic prescription is $1200-$1500. The public views Ozempic as a safe drug, with "only stomach side effects." Scripts are given without essential prescreening and monitoring to decrease drug risks. However, it's easy to miss serious risks when selling prescriptions without screening and tracking. For example, GLP-1 agonists increase thyroid cancer risk in people with a specific family history. Again, it's easy to overlook this risk without taking a family history. Lastly, all medications have side effects. Although GLP-1 agonists like semaglutide have undergone extensive testing, there are still risks for new side effects. Therefore, people taking semaglutide and other metabolic medications need monitoring.

Unhealthy weight loss. One celebrity boasted about her "18% body fat" due to Ozempic. This body fat percentage is at the lower limit of normal. Fat is an essential body organ, especially for women, who need higher body fat levels than men. Anti-obesity medications are intended to reduce excess fat levels to improve metabolic health, not make people underweight. Furthermore, another undesired side effect of GLP-1 agonists is the loss of muscle mass. Using metabolic medications in the wrong population increases the risk for lowering body fat and muscle below healthy levels.

Weight regain. Whatever you do to lose weight, you've got to be able to do even more to maintain weight loss. Weight gain is your body's default mode. That's why weight regain is common. Unfortunately, studies also show weight regain with GLP-1 agonist cessation. Weight loss and obesity treatment require a comprehensive biopsychosocial approach to maintain weight loss and improve health. If people only take weight loss medications without other lifestyle changes, it's unlikely that the weight will stay off without the prescription.

As doctors and clinical prescribers, we can access the most innovative and effective weight loss and metabolic health improvement tools. Anti-obesity medications/metabolic medications are here to stay and will only improve as technology advances. Therefore, we must use our prescribing power to enhance people's lives for not only short-term weight loss, but also long-term health improvement. That starts with ensuring we prescribe appropriate medications to the right persons. When we give people "weight loss medications," we are also affecting their metabolic health.

Data, not societal trends, must guide our clinical judgment. The desire for people to alter their bodies to fit an ever-elusive beauty standard is as old as time. Last year, curvy was in. This year, thinness is back. That's why we clinicians must check our biases, so that we base our medical treatment on facts, not fads.

Sylvia Gonsahn-Bollie, MD, DipABOM, is an integrative obesity specialist who specializes in individualized solutions for emotional and biological overeating. Connect with her at www.embraceyouweightloss.com or on Instagram @embraceyoumd. Her bestselling book, Embrace You: Your Guide to Transforming Weight Loss Misconceptions Into Lifelong Wellness, is Healthline.com's Best Overall Weight Loss Book 2022 and one of Livestrong.com's picks for the 8 Best Weight-Loss Books to Read in 2022.

https://www.medscape.com/viewarticle/983004