NY Health Commish Mary Bassett suddenly quits

 New York state Health Commissioner Dr. Mary Bassett unexpectedly announced Friday she will leave her job after just over one year running the state responses to COVID-19 and monkeypox under Gov. Kathy Hochul.

“I am leaving now so the next commissioner can have the chance to lead this great department for a full four-year term under the leadership of Gov. Hochul,” Bassett said Friday about her decision to bolt by the end of the month.

The timing of her departure contrasts with the six-year tenure of her predecessor, Dr. Howard Zucker, as well as Bassett’s own four years leading the New York City Health Department under Mayor Bill de Blasio.

Bassett said she will return to Harvard University, where she previously led the François-Xavier Bagnoud (FXB) Center for Health and Human Rights before taking an official leave of absence to take the New York gig.

Her resignation becomes official Jan. 1.

Bassett previously made her name in public health through AIDS work that included 17 years on the faculty at the University of Zimbabwe.

“Throughout her time in my administration — from the onset of the Omicron variant and through mpox and polio outbreaks — she has worked tirelessly to keep New Yorkers informed, healthy and safe. I am proud that she brought her world-renowned expertise in equity and public health to the State Department of Health,” Hochul said in a statement.

While Bassett is a world-renowned public health expert, her tenure was not without controversy.

Bassett faced criticism for resisting efforts to investigate controversial nursing home policies during the pandemic under disgraced ex-Gov. Andrew Cuomo, who resigned in August 2021 amid a litany of scandals including an alleged cover-up of COVID-19 deaths.

“The agency still has PTSD from the Cuomo years,” a former state Health Department official told The Post Friday.

Cuomo critics say Bassett never fulfilled hopes to have a full accounting of what happened in nursing homes under his administration. 

“The fact that Dr. Bassett saw no need to look back at the DOH’s response during COVID including the deadly decision to flood New York nursing homes with over 9,000 covid patients says all you need to know about her priorities,” said Janice Dean, a Fox News meteorologist who lost her in-laws to COVID-19 in a nursing home, and has been an outspoken critic of Cuomo’s handling of the crisis.

Bill Hammond, a senior fellow for health policy at the Empire Center for Public Policy, noted that Hochul did not task her own health commissioner with overseeing a controversial review of state pandemic policies including nursing homes that remains ongoing.  

“She took over during what should be a turning point for the Health Department – a global pandemic that hit New York especially early and especially hard and rattled confidence in its public health system,” Hammond said. 

“Dr. Bassett resisted the idea of unwinding past events –- which would be crucial to learning the right lessons – and made no obvious effort to better prepare the state for future viruses,” he added.

But some issues facing Bassett were of Hochul’s making, too, including the implementation of controversial vaccine mandates as the healthcare industry struggled with staffing issues.

Bassett will return to Harvard University next year.

J. Messerschmidt/NY Post

The DOH also got entangled under Bassett’s watch in an alleged pay-to-play scheme involving the purchase of COVID-19 rapid tests from a company linked to $300,000 in donations to Hochul’s reelection campaign.

While Bassett helped improve the Health Department after a decade under Cuomo, the former official said she struggled at times.

“Bassett only understood half the job. She was great at public health but didn’t know much about regulating hospitals and nursing homes,” the source said.

Hochul has denied wrongdoing and Bassett has never been personally tied to the decision-making that led to the controversial purchases at prices much higher than those paid by California for the same tests, which the Times Union revealed last summer.

Dean said she was pessimistic about who Hochul will pick to replace Bassett.

“Maybe the next health commissioner will care more about wanting to find out what went wrong in the spring of 2020 that took the lives of so many elderly New Yorkers, but under Kathy Hochul’s leadership, we won’t hold our breath,” she said.

While it remains unclear exactly what spurred Bassett’s final decision to leave New York for Massachusetts again, Bassett suggested Friday that it took time to make up her mind.

“This was a very difficult decision,” she said.

https://nypost.com/2022/12/02/dr-mary-bassett-leaving-nys-department-of-health-after-kathy-hochul-election-win/

Drug shortage swells to national emergency, forcing doctors to find new ways to treat patients

 The nationwide shortage of basic antibiotics and critical medications that treat chronic conditions and bacterial infections has become the latest issue to hit the medical world. Consequently, it is forcing many doctors to rely on alternative medicines to treat patients.

"What was once an unthinkable situation—a shortage of basic antibiotics such as amoxicillin and Augmentin to treat ear and skin infections or even medications such as Albuterol to treat asthma—is now a harsh reality," New York City-based emergency room physician Dr. Robert Glatter told FOX Business. 

Even the "shortage of basic medications such as children’s Tylenol—integral to treating fever and mild to moderate pain—is impacting our ability to provide care for our patients," Glatter said. 

Currently, the Food and Drug Administration (FDA) has a list of more than 180 current or resolved drug shortages.

He said there have been shortages of antivirals such as Tamiflu, which is used to treat high-risk patients with influenza, as well as diabetic medications such as Ozempic due to the "inappropriate and off-label use" of the medication for weight loss and cosmetic purposes. 

Glatter predicted that the drug shortage problem rippling throughout the U.S. could last for at least another year, if not longer.

Gastroenterologist and obesity medicine specialist Dr. Christopher McGowan said he is facing shortages of critical drugs used during surgery. 

"IV fluid is an ongoing issue where we sometimes have a supply for one week or two weeks and that's it," McGowan said. "We're always nervous that we could run out of fluid, which is such a critical thing." 

There have also been intermittent shortages of key anesthesia medications that are used for most procedures and surgeries, and critical pain medications such as fentanyl, he added.  

As a result, McGowan said doctors "are being forced to use alternatives that may not be first line or the optimal treatment for the condition or scenario, or in the best interest of the patient." 

Major drugstore chains have also been feeling the effects, especially as flu season ramps up. 

Rite Aid told FOX Business that the company has been facing some "constraints" with certain amoxicillin products due to an industry-wide shortage. Although it is not experiencing shortages of Tamiflu at this time, the company is facing a high demand for over-the-counter cold and flu medication "due to high illness incidence."

Walgreens also told FOX Business that the company has seen an increased demand for over-the-counter medications. 

Earlier this month, the FDA issued a notice warning that there is a shortage of Adderall, which is used to treat attention deficit hyperactivity disorder and narcolepsy. 

The ongoing issue has drawn the ire of Republican lawmakers. 

Several lawmakers on the GOP Doctors Caucus spoke out about the amoxicillin shortage with Rep. Brad Wenstrup, one of the co-chairmen of the GOP Doctors Caucus, telling Fox News Digital that no "patient or American family should have to worry about finding a necessary and simple antibiotic like amoxicillin."

According to federal health officials, intermittent or reduced availability of certain products can occur for many reasons, including manufacturing and quality problems, delays and discontinuations. 

However, Glatter said that the problem is in part because the U.S. is currently facing challenges in obtaining raw materials. For instance, source materials for manufacturing the active pharmaceutical ingredients in the majority of drugs come from China, which is dealing with limited production and output of raw materials involved in pharmaceutical manufacturing due to rigid lockdown measures, Glatter said. 

The U.S. is also dependent on India for a significant number of generic medications, but India also relies on China for the raw materials used to produce active pharmaceutical ingredients, he added.  

"Herein lies the problem: We don’t have control of the precious drugs that ultimately are integral to patient care in the U.S.," Glatter said. 

McGowan agreed the issue of sourcing materials can be playing into this, but said there are multiple areas in the supply chain that can be impacted.  

In the case of the Wegovy shortage, the contract manufacturer in charge of filling the syringes, had to halt production due to a manufacturing issue, which disrupted the entire supply chain. That, coupled with the initial overwhelming demand, led to a nationwide shortage, according to McGowan.

Still, companies and federal health officials are doing what they can to make sure patients still get the medications they need. The FDA told FOX Business that the agency "recognizes the potential impact that reduced availability of certain products may have on health care providers and patients." 

The federal agency does not manufacture drugs nor can it "require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug" the FDA said. However, "the public should rest assured the FDA is working closely with numerous manufacturers and others in the supply chain to understand, mitigate and prevent or reduce the impact of intermittent or reduced availability of certain products."

The FDA also said that manufacturers should expect the availability of drugs to continue to increase in the near future.

Meanwhile, Rite Aid said it is currently working with suppliers to meet demand and "mitigate shortages where possible." The company also said its pharmacists can work with a customer’s physician to recommend alternative antibiotics or medications. 

The company also recommended that customers talk to pharmacists about over-the-counter options if they do not see their preferred cold or flu treatment products on the shelf.

Walgreens said that it is prepared to continue meeting the needs of its customers and that it is working with a "diverse set of suppliers and distributors to ensure our patients have the products they need most." 

https://www.foxbusiness.com/lifestyle/drug-shortage-swells-national-emergency-forcing-doctors-find-new-ways-treat-patients

FDA Expands List of Getinge IABP System and Component Shortages

 The US Food and Drug Administration (FDA) today issued a letter to healthcare providers describing a current shortage of Getinge intra-aortic balloon pump (IABP) catheters and other components.

Earlier this week, the agency announced shortages of the company's Maquet/Datascope IAB catheters, new Cardiosave IABP devices, and Cardiosave IABP parts. The new notification adds Getinge Maquet/Datascope IABP systems to the list.

The company's letter explains that "ongoing supply chain issues have significantly impacted our ability to build intra-aortic balloon pumps, intra-aortic balloon catheters, and spare parts due to raw material shortages."

It also offers guidance on maintaining Cardiosave Safety Disks and lithium-ion batteries in the face of the shortages. "In the event that you need a replacement pump while your IABP is undergoing service, please contact your local sales representative who may be able to assist with a temporary IABP."

Providers are instructed to inform the company through its sales representatives "if you have any underutilized Maquet/Datascope IAB catheters or IABPs and are willing to share them with hospitals in need."

The shortages are expected to continue into 2023, the FDA states in its letter.

https://www.medscape.com/viewarticle/984943

Higher Potency of Fentanyl Affects Addiction Treatment, Screening

 As fentanyl-related overdose deaths continue to increase, clinicians should take note of important differences that set the drug apart from the other drugs of misuse — and the troubling reality that fentanyl now contaminates most of them.

"It would be fair to tell patients, if you're buying any illicit drugs — pills, powder, liquid, whatever it is, you've got to assume it's either contaminated with or replaced by fentanyl," said Edwin Salsitz, MD, an associate clinical professor at the Icahn School of Medicine at Mount Sinai, New York, during a presentation on the subject at the 21st Annual Psychopharmacology Update presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

In many if not most cases, he noted, patients become addicted to fentanyl unknowingly. They assume they are ingesting oxycodone, cocaine, or another drug, and have no realization that they are even exposed to fentanyl until they test positive for it — or overdose.

Meanwhile, the high potency of fentanyl can overcome the opioid blockade of addiction treatment therapies — methadone and buprenorphine — that take away the high that users get from less potent drugs such as heroin.

"Fentanyl is overcoming this blockade that methadone and buprenorphine used to provide," Salsitz said. "With fentanyl having such a higher potency, patients are saying 'no, I still feel the fentanyl effects,' and they continue feeling it even with 200 milligrams of methadone or 24 milligrams of buprenorphine."

"Wooden Chest Syndrome"

Among the lesser-known dangers of fentanyl is the possibility that some overdose deaths may occur as the result of a syndrome previously reported as a rare complication following the medical use of fentanyl in critically ill patients — fentanyl-induced chest-wall rigidity, or "wooden chest syndrome," Salsitz explained.

In such cases, the muscles of respiration become rigid and paralyzed, causing suffocation within a matter of minutes — too soon to benefit from the overdose rescue medication naloxone.

In one recent study published in Clinical Toxicology, nearly half of fentanyl overdose deaths were found to have occurred even before the body had a chance to produce norfentanyl, a metabolite of fentanyl that takes only about 2-3 minutes to appear in the system, suggesting the deaths occurred rapidly.

In the study of 48 fentanyl deaths, no appreciable concentrations of norfentanyl could be detected in 20 of the 48 overdose deaths (42%), and concentrations were less than 1 ng/mL in 25 cases (52%).

"The lack of any measurable norfentanyl in half of our cases suggests a very rapid death, consistent with acute chest rigidity," the authors reported.

"In several cases fentanyl concentrations were strikingly high (22 ng/mL and 20 ng/mL) with no norfentanyl detected," they said.

Salsitz noted that the syndrome is not well known among the addiction treatment community.

"This is different than the usual respiratory opioid overdose where there's a gradual decrease in the breathing rate and a gradual decrease in how much air is going in and out of the lungs," Salsitz explained.

"With those cases, some may survive for an hour or longer, allowing time for someone to administer naloxone or to get the patient to the emergency room," he said. "But with this, breathing stops and people can die within minutes.

"I think that this is one of the reasons that fentanyl deaths keep going up despite more and more naloxone availability out there," he said.

Clearance May Take Longer

In toxicology testing for fentanyl, clinicians should also note the important difference between fentanyl and other opioids — that fentanyl, because of its high lipophilicity, may be detected in urine toxicology testing up to 3 weeks after last use. This is much longer than the 2- to 4-day clearance observed with other opioids, possibly causing patients to continue to test positive for the drug weeks after cessation.

This effect was observed in one recent study of 12 opioid use disorder patients in a residential treatment program who had previously been exposed to daily fentanyl.

The study showed the mean amount of time of fentanyl clearance was 2 weeks, with a range of 4-26 days after last use.

The authors pointed out that the findings "might explain recent reports of difficulty in buprenorphine inductions for persons who use fentanyl, and point to a need to better understand the pharmacokinetics of fentanyl in the context of opioid withdrawal in persons who regularly use fentanyl."

Though the study was small, Salsitz said "that's not a stumbling block to the important finding that, with regular use of fentanyl, the drug may stay in the urine for a long time."

Salsitz noted that similar observations have been made at his center, with clinicians logically assuming that patients were still somehow getting fentanyl.

"When we initially found this in patients, we thought that they were using on the unit, perhaps that they brought in the fentanyl, because otherwise how could it stay in the urine that long," he noted. "But fentanyl appears to be more lipophilic and gets into the fat; it's then excreted very slowly and then stays in the urine."

Salsitz said most practitioners think of fentanyl as a short-acting drug, so "it's important to realize that people may continue to test positive and it should be thought of as a long-acting opioid."

Opiate Screening Tests Don't Work

Salsitz warned of another misconception in fentanyl testing — the common mistake of assuming that fentanyl should show up in a test for opiates — when in fact fentanyl is not, technically, an opiate.

"The word opiate only refers to morphine, codeine, heroin and sometimes hydrocodone," he explained. "Other opioids are classified as semisynthetic, such as oxycodone, or synthetics, such as fentanyl and methadone, buprenorphine."

"In order to detect the synthetics, you must have a separate strip for each one of those drugs. They will not show up positive on a screen for opiates," he noted.

The belief that fentanyl and other synthetic and semisynthetic opioids will show positive on an opiate screen is a common misconception, he said. "The misunderstanding in toxicology interpretation is a problem for many practitioners, [but] it's essential to understand because otherwise false assumptions about the patient will be considered."

Another important testing misreading can occur with the antidepressant drug trazodone, which Salsitz cautioned may falsely test as positive for fentanyl on immunoassays.

"Trazodone is very commonly used in addiction treatment centers, but it can give a false positive on the fentanyl immunoassay and we've had a number of those cases," he said.

Salsitz had no disclosures to report. The Psychopharmacology Update was sponsored by Medscape Live. Medscape Live and this news organization are owned by the same parent company.

https://www.medscape.com/viewarticle/984942

Single Chest X-Ray Could Predict 10-Year CVD Risk

 A single chest x-ray could predict a patient's 10-year risk of dying from a heart attack or stroke, say researchers who presented the results of their deep-learning model at the Radiological Society of North America (RSNA) 2022 Annual Meeting.

Current American College of Cardiologists (ACC) and American Heart Association (AHA) guidelines recommend estimating 10-year risk of major adverse cardiovascular events (MACE) to determine whether a patient should receive statins to help prevent atherosclerotic cardiovascular disease (ASCVD). Statins are recommended for patients with a 10-year risk of 7.5% or higher, the authors note.

The current ASCVD risk score is determined with nine factors: age, sex, race, systolic blood pressure, hypertension treatment, smoking, type 2 diabetes, and a lipid panel.

Not All Data Points Available in EHR

But not all of those data points may be available through the electronic health record, "which makes novel and easier approaches for population-wide screening desirable," lead researcher Jakob Weiss, MD, a radiologist affiliated with the Cardiovascular Imaging Research Center at Massachusetts General Hospital and the AI in Medicine program at the Brigham and Women's Hospital in Boston, said.

Chest x-ray images, on the other hand, are commonly available. The images carry rich information beyond diagnostic data but have not been used in this type of prediction model because AI models have been lacking, Weiss said.

The researchers trained a deep-learning model with single chest x-rays only.

They used 147,497 chest x-rays from 40,643 participants in the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial, a multicenter, randomized controlled trial designed and sponsored by the National Cancer Institute.

Weiss acknowledged on Tuesday that the population used to train the model was heavily White and that that should be a consideration in validating the model.

They compared their model's ability to predict 10-year ASCVD risk with the standard ACC/AHA model.

"Based on a single chest radiograph image, deep learning can predict the risk of future cardiovascular events independent of cardiovascular risk factors and with similar performance to the established and guideline-recommended ASCVD risk score," Weiss said.

Tested Against Independent Group

They tested the model against an independent group of 11,430 outpatients (average age, 60 years; 42.9% male) who underwent a routine outpatient chest x-ray at Mass General Brigham and were potentially eligible to receive statins.

Of those 11,430 patients, 1096, (9.6%) had a major adverse cardiac event over the median follow-up of 10.3 years.

There was a significant association of CXR-CVD risk and MACE among patients eligible to receive statins, the researchers found (hazard ratio [HR], 2.03; 95% CI, 1.81 – 2.30; P < .001), which remained significant after adjusting for cardiovascular risk factors (adjusted HR, 1.63; 95% CI, 1.43 – 1.86; P < .001).

Some of the variables were missing in the standard model, but in a subgroup of 2401 patients, all the variables were available.

They calculated ASCVD risk in that subgroup using the standard model and the CXR model and found that the performance was similar (c-statistic, 0.64 vs 0.65; P = .48) to the ASCVD risk score (adjusted HR, 1.58; 95% CI, 1.20 – 2.09; P = .001).

Ritu R. Gill MD, MPH, associate professor of radiology at Harvard Medical School in Boston, Massachusetts, who was not part of the study, told Medscape Medical News, "The predictive algorithm is promising and potentially translatable and could enhance the annual medical checkup in a select population.

"The algorithm was developed using the PLCO cohort with radiographs, which are likely subjects in the lung cancer screening arm," she said. "This cohort would be at high risk of cardiovascular diseases, as smoking is a known risk factor for atherosclerotic disease, and therefore the results are expected.

"The algorithm needs to be validated in an independent database with inclusion of subjects with younger age groups and adjusted for gender and racial diversity," Gill said.

David Cho, MD, a cardiologist at University of California, Los Angeles, Health, in Burbank, who also was not part of the study, told Medscape Medical News, "This work is a great example of AI being able to detect clinically relevant outcomes with a widely used and low-cost screening test.

"The volume of data needed to train these models is already out there," Cho said. "It just needs to be mined."

He noted that this tool, if validated in randomized trials, could help determine risk among patients living in places where access to specialized cardiac care is limited.

Weiss and Cho have disclosed no relevant financial relationships. Gill has received research support from Cannon Inc and consultant fees from Imbio and WorldCare Inc.

Radiological Society of North America (RSNA) 2022 Annual Meeting: Abstract T3-SSCH04-1. Presented November 29, 2022.

https://www.medscape.com/viewarticle/984910

US State Dept: China's COVID protests die down as cities ease restrictions

 

Protests in China against the world's toughest COVID-19 curbs are dying down because they have had an effect, U.S. Deputy Secretary of State Wendy Sherman said on Friday, as Beijing further eased testing requirements and quarantine rules.

"I think we have seen the protests die down now in China and the reason they've died down is they actually had an effect," she told an audience in Washington.

"Now the Chinese are loosening up their COVID restrictions a bit."

https://www.marketscreener.com/news/latest/U-S-says-China-s-COVID-protests-die-down-as-cities-ease-restrictions--42465407/

US to end mpox emergency declaration

 

Mpox is expected to no longer be considered a public health emergency in the United States from Feb. 1, 2023, the U.S. health department said on Friday.

The months-long declaration was meant to tackle the largest ever outbreak of cases in the country. The move signals that the crisis, which led to a spate of cases mostly among men who have sex with men, has come under control and would no longer require an emergency status meant to shore up funding and tools to fight the disease.

https://www.marketscreener.com/news/latest/United-States-to-end-mpox-emergency-declaration--42465537/