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Saturday, July 1, 2023

Caution Is Needed on Drug Touted as Opioid Game-Changer

 The Biden administration’s much-heralded effort to promote distribution of buprenorphine may not be a game changer in our battle to subdue the opioid crisis. This new campaign resembles yet another social experiment in our national clash with addiction, especially when coupled with so-called harm reduction policies that promote drug abuse.

Buprenorphine is a narcotic drug that is marketed under the brand name Subutex. Suboxone is the brand name of a drug that combines buprenorphine and the overdose reversal drug naloxone. Physicians long needed a special waiver to write buprenorphine prescriptions, which the federal government recently abolished in a bid to increase distribution.

\Because it is an opioid, buprenorphine can be a highly effective tool for curbing cravings in patients with opioid use disorder (OUD). When dispensed properly and with therapeutic structure, buprenorphine is indeed invaluable. Many patients report that the drug significantly curbs their cravings for opioids, thus improving their prospects for recovery and overall quality of life.

I have learned from my experience as a Colorado state judge who presided over drug and DUI courts that public health theory sometimes diverges from the realities of practice. I am aware that many people with OUD have a history of misusing buprenorphine in pursuit of euphoria.

Furthermore, the French study cited as evidence to support the efficacy of buprenorphine to treat OUD stated that they achieved their results with daily supervised dosing for 6 months. Supervision and structured accountability are key ingredients to help ensure success.

Do not mistake me. I do not say that buprenorphine should be withheld from patients it can help. My point is a modest one – we should ensure that buprenorphine is dispensed by qualified persons with expertise in OUD, and in practices able to provide necessary oversight and support for patients. All these changes – abolition of the waiver and dubious drug promotion policies – bear the hallmarks of another social experiment without due consideration of consequences.

Many of the benefits of this new buprenorphine policy will likely be offset by a lack of therapeutic support and other disastrous drug policy implementations under the guise of harm-reduction. Harm reduction, as a therapeutic intervention, has been greatly distorted by self-anointed experts.

For instance, San Francisco’s Linkage Center was supposed to be a revolutionary intervention where people could safely use dangerous and addictive drugs, so they could be effectively linked to treatment services. This $19 million dollar boondoggle resulted in 18 people receiving treatment out the 23,000 who visited this site to use drugs. Mayor London Breed closed the center less than one year after it opened, and it is doubtful that extra buprenorphine would have offset this travesty.

In 2020 Oregon passed Measure 110, which eliminated criminal penalties for possession of controlled substances such as heroin, cocaine, oxycodone, and methamphetamine.  By 2022, the overdose rate in Oregon increased by 700%. When asked for an explanation, Dr. Andrew Mendenhall, a chief proponent, said, “It’s important to recognize that the Measure 110 experiment came during a perfect storm, and that its benefits may not be seen for several more years.” So, was drug legalization an experiment and is the new buprenorphine policy a similar social experiment?

Or consider the poster campaign New York City’s public health department ran proclaiming that the intentional illicit consumption of fentanyl is empowering, if used safely. In reality, ingesting fentanyl is life-threatening, and this false advertising only further promotes self-destructive behavior. Once a person becomes addicted, boundaries, person responsibility, and wise decision-making are exponentially compromised.

No surprise that the health department’s own data show the overall overdose death rate per 100,000 residents grew from 31.6 in 2020 to 39.4 in 2021. Unfortunately, black New Yorkers, suffered the highest increase in overdose deaths per 100,000 as the number grew from 39.8 deaths in 2020 to 53.5 in 2021.

In addition to their ill-advised poster campaign New York City officials are now offering free drug paraphernalia, including crack pipes in vending machines, which are funded by taxpayer dollars. Even though the vending machines are offering Narcan to reverse overdoses, there is absolutely no need to furnish smoking utensils.

People with a severe substance use disorder need little encouragement to continue ingesting dangerous drugs and these harm reduction policies only breed the progression of a potentially fatal disorder. If we truly care about a vulnerable population, we should promote self-efficacy, independence, sobriety, and a true belief in the miracle of recovery.

Katharine “Katie” Sullivan serves on the Board of Recovery for America Now Foundation, was as an Acting Assistant Attorney General and a senior advisor to the White House Domestic Policy Council under President Trump. She previously served 11 years as a Colorado State Trial Court Judge

https://www.realclearhealth.com/articles/2023/06/29/caution_is_needed_on_drug_touted_as_opioid_game-changer.html

Supreme Court to consider scope of workplace bias law

 The U.S. Supreme Court on Friday agreed to decide whether workers can bring discrimination lawsuits based on unwanted workplace transfers that were allegedly motivated by bias, an issue that can make or break many cases.

The justices took up a case involving St. Louis police officer Jatonya Muldrow, who is seeking to revive claims that she was transferred to an undesirable post to make way for a male officer. Muldrow appealed a lower court's ruling that the conduct by the police department could not form the basis of a discrimination lawsuit.

The Supreme Court will hear the case in its next term, which begins in October.

Many of the thousands of discrimination lawsuits filed each year involve workers who allege they were transferred for discriminatory reasons, including as a way to force them to quit their jobs.

President Joe Biden's administration in May urged the court to take up the issue, saying rulings by lower courts dismissing such litigation misinterpreted federal anti-discrimination laws that only apply to "adverse employment actions" driven by bias.

The Supreme Court on Friday took no action on a separate case questioning whether paid suspensions count as adverse employment actions under Title VII of the Civil Rights Act of 1964.

The lower courts said that to state a claim under Title VII, workers must show that they suffered a material harm or significant change in their employment status such as a firing, demotion or decrease in pay.

Muldrow has said she was transferred out of an intelligence unit by a new supervisor who wanted a man in the position. The department has said officers are routinely transferred and the plaintiff's supervisor transferred more than 20 officers when he took over the unit.

https://www.marketscreener.com/news/latest/U-S-Supreme-Court-to-consider-scope-of-workplace-bias-law--44244641/

Ionis: Potential Benefit of SPINRAZA in Infants and Toddlers After Gene Therapy

 Ionis Pharmaceuticals announced that its partner Biogen presented new data highlighting the potential benefit of SPINRAZA® (nusinersen) in infants and toddlers living with spinal muscular atrophy (SMA). Interim results from the RESPOND study showed improved motor function in most participants treated with SPINRAZA following treatment with Zolgensma® (onasemnogene abeparvovec). The data were presented at the SMA Research & Clinical Care Meeting hosted by Cure SMA.

RESPOND is an ongoing two-year, Phase 4 open-label study to evaluate clinical outcomes and safety following treatment with SPINRAZA in infants and toddlers with SMA who have unmet medical needs after treatment with Zolgensma. Interim efficacy results at six months from 29 study participants treated with SPINRAZA show: Improvements in motor function in most participants as measured by increased mean total Hammersmith Infant Neurological Examination Section 2 (HINE-2) score from baseline. Participants with two SMN2 copies (n=24) improved by a mean of over 5 points on HINE-2. All participants with three SMN2 copies (n=3) improved; a mean change from baseline was not calculated due to the small number of participants.

Most participants (25/27) with investigator-reported suboptimal motor function at baseline improved. After a median of 230.5 days in the study, serious adverse events (AEs) were reported in 13/38 (34%) participants. No serious AEs were considered related to SPINRAZA or led to study withdrawal.

No new emerging safety concerns have been identified in enrolled participants who received SPINRAZA after Zolgensma. Additional interim clinical outcomes from the RESPOND study are being presented at the conference. New Analysis Evaluating Real-World Impact of SPINRAZA: A systematic literature review and meta-analysis evaluating real-world impact of SPINRAZA for infantile-onset SMA was presented and highlights the importance of generating real-world evidence to achieve a comprehensive understanding of the treatment benefits of SPINRAZA.

Improvements in motor function and motor milestones observed in real-world studies were greater than or comparable to those observed in clinical trials, and patients continued to improve with longer duration of SPINRAZA treatment.

https://www.marketscreener.com/quote/stock/IONIS-PHARMACEUTICALS-IN-25500637/news/Ionis-Pharmaceuticals-Inc-Announces-New-Data-Highlight-Potential-Benefit-of-SPINRAZAA-in-Infants-44246593/

First trial over Zantac cancer claims set for November

 The first U.S. trial over claims that discontinued heartburn drug Zantac causes cancer is now expected to take place in California state court on Nov. 13, a lawyer for plaintiffs in the litigation said Friday.

Plaintiffs in the litigation claim that Zantac causes nine forms of cancer, including colorectal, breast and bladder cancer.

A trial in a case brought by a different plaintiff had been expected next month, but it was called off after the pill's British drugmaker GSK Plc, the only defendant in the case, settled for an undisclosed amount without admitting liability.

Thousands of lawsuits over Zantac have been filed in California against GSK, Sanofi SA, Pfizer Inc and Boehringer Ingelheim, which all sold the drug at various times.

The trial is meant to serve as a test of the claims' strength, and its outcome could shape negotiations toward a broader settlement.

Not all the companies, which have repeatedly denied that Zantac can cause cancer, are named in each lawsuit. Which specific case will go to trial in November has not yet been determined, according to a spokesperson for GSK.

First approved in 1983, Zantac became the world's best selling medicine in 1988 and one of the first-ever drugs to top $1 billion in annual sales. It was originally sold by a forerunner of GSK.

In 2019, some manufacturers halted Zantac sales over concerns that its active ingredient, ranitidine, degraded over time to form a chemical called NDMA. While NDMA can be present in low levels in food and water, research has found it causes cancer in larger amounts.

The FDA in 2020 withdrew from the market all remaining brand name Zantac and generic versions.

The drugmakers scored a major victory in December, when a federal judge threw out all of the Zantac cases in U.S. federal court, some 50,000, after finding the opinions of the plaintiffs' expert witnesses linking the drug to cancer were not backed by sound science.

The remaining cases are in state courts, most of them in Delaware, where more than 70,000 cases are pending.

https://www.marketscreener.com/quote/stock/GSK-PLC-9590199/news/First-trial-over-Zantac-cancer-claims-set-for-November-44245890/

Sandoz: An Unbranded Version Of Humira Is Also Available At Discount

 SANDOZ: AN UNBRANDED VERSION OF HUMIRA IS ALSO AVAILABLE AT AN 81% DISCOUNT BELOW CURRENT HUMIRA LIST PRICE ALONGSIDE HYRIMOZ

https://www.marketscreener.com/news/latest/SANDOZ-AN-UNBRANDED-VERSION-OF-HUMIRA-IS-ALSO-AVAILABLE-AT-AN-8-8230--44246673/

Disney accused in lawsuit of 'systematically' paying women less than men in California

 Walt Disney has been accused of systematically underpaying women in California in a lawsuit that alleges the company's female employees in the state earned $150 million less than their male counterparts over an eight year period.

The Friday filing in Los Angeles County Superior Court seeks to persuade the judge to certify a four-year-old civil suit as a class action, covering some 12,500 current or former fulltime female Disney employees who held positions below the level of vice president.

An analysis of Disney's human resource data from April 2015 through December 2022 has found female Disney employees were paid roughly 2% less than male counterparts, the filing said. It was conducted by David Neumark, a University of California Irvine professor and labor economist.

Disney disputes the findings.

"The plaintiffs' assertions about an alleged pay gap between women and men are simply false, which we will demonstrate through the litigation," said Shawna M. Swanson, associate general counsel and head of the employment law function for Disney.

The original suit was filed by LaRonda Rasmussen in 2019, after she learned that six men with the same job title earned substantially more, including one recent hire with several years less experience, who earned $20,000 more, according to the complaint. Nine current or past Disney employees have joined the suit.

"Several of the named plaintiffs, they do love the Disney brand, they just want to be paid fairly," said Lori Andrus, the plaintiffs' lead attorney.

Lower pay for women in California would breach the state's Equal Pay Act and the Fair Employment & Housing Act. 

https://www.marketscreener.com/quote/stock/WALT-DISNEY-COMPANY-THE-4842/news/Disney-accused-in-lawsuit-of-systematically-paying-women-less-than-men-in-California-44246568/

EV charging firms oppose Texas' 'premature' plan to mandate Tesla standard

 A group of EV charger makers and operators is pushing back against Texas' plan to mandate the inclusion of Tesla technology in charging stations, saying it is "premature," according to a document seen by Reuters and a source aware of the matter.

Reuters reported last week that Texas would require charging companies to include both Tesla's North American Charging Standard (NACS) as well as the nationally recognized rival Combined Charging Standard (CCS) technology to be eligible for a state program to electrify highways using federal dollars.

Washington followed suit, and standards organization SAE International has said it aims to make an industry standard configuration of Tesla's charging connector in six months or less, adding momentum to Tesla CEO Elon Musk's hope of making NACS the national charging technology.

But five electric vehicle charging companies, including operator ChargePoint Holdings and manufacturer ABB , and a clean energy association have written to the Texas Transportation Commission, calling for more time to re-engineer and test Tesla's connectors.

Texas' plan "risks the successful deployment" of the first phase of federal funds being rolled out, they said in the letter sent to the chairman of the commission on Thursday, which was seen by Reuters.

"Time is needed to properly standardize, test, and certify the safety and interoperability of Tesla connectors across the industry," they said.

The source directly aware of the matter told Reuters that some of these organizations are planning to reach out to the federal government with the issue soon.

The Texas Department of Transportation, ChargePoint, ABB and other signatories FreeWire, EVBox and FLO did not immediately respond to Reuters' requests for comment.

Another signatory, Americans for Affordable Clean Energy, an association of truck stops and convenience stores, could not be reached immediately.

Tesla, the dominant EV maker in the United States, has scored a string of victories for its charging technology in recent weeks, starting with Ford Motor saying it would adopt NACS. General Motors, Rivian Automotive and a raft of auto and charging companies did the same, on concerns of losing out on customers if they offer only CCS.

Tesla's Superchargers account for about 60% of the total number of fast chargers in the United States, according to the U.S. Department of Energy, and the deals will allow non-Tesla users to use the company's large charging network.

But concerns remain about how smoothly the two charging standards would talk to each other and whether having both standards in the market would raise costs for vendors and customers.

Charging companies have to re-work several aspects of NACS connectors, including extending the cable length and ensuring adequate temperature ranges, as well as get certifications for specific parts, the companies said in the letter.

The companies also highlighted the need for a strong supply chain of NACS cables and connectors that comply with the requirements.

https://www.marketscreener.com/quote/stock/TESLA-INC-6344549/news/EV-charging-firms-oppose-Texas-premature-plan-to-mandate-Tesla-standard-letter-44246329/