NYC reportedly sells nearly $225M worth of COVID supplies for just $500K

 City officials auctioned off nearly $225 million worth of surplus COVID-19 medical equipment and safety gear for just $500,000 — or a paltry 0.2 cents on the dollar, according to a stunning report Tuesday.

The bargain-basement sales included nearly 3,000 mechanical ventilators that cost taxpayers $12 million but were unloaded as “non-functioning medical equipment for scrap metal” at a rock-bottom price of just $24,600 on Jan. 24, according to nonprofit news website The City.

It reportedly took 28 truckloads for a Long Island junk dealer to haul off the once-scarce devices, which former Mayor Bill de Blasio had predicted would help the Big Apple “beat this crisis and prepare for the next.”

“This is a story about doing the impossible,” de Blasio bragged on April 21, 2020. “We’d never made a ventilator before — and so we made thousands. We learned it would take a year — and so we did it in a month.”

Nearly 3,000 ventilators costing taxpayers for $12 million were sold for only $24,600 on January 24th.

James Messerschmidt

De Blasio’s administration also overpaid for items that included 50,000 face shields at $6.70 each, compared to an average price at the start of the pandemic of $3.67, The City said, citing information from city Comptroller Brad Lander.

They’re now part of a massive lot of 701,000 face shields that were reportedly put up for auction last week with an opening bid of just $1,000, or 0.14 cents each.

The City blamed the epic markdowns on de Blasio’s decision to waive any oversight of his panic purchases, preventing then-Comptroller Scott Stringer from scrutinizing the emergency contracts.

One contract, for $9.1 million, reportedly went to controversial, New Jersey-based Digital Gadgets for ventilators that the company failed to deliver, then provided the city with N95 masks instead.

City officials auctioned off nearly $225 million worth of surplus COVID-19 medical equipment and safety gear for just $500,000.

Paul Martinka

But the first masks it delivered were “poor quality or not FDA-certified,” even though the company charged $4 each while the average price was $3.10, according to Lander.

Digital Gadgets is owned by Charlie Tebele, a major donor to de Blasio and Gov. Kathy Hochul, who are both Democrats.

Last year, Tebele’s company was revealed to have charged the state $637 million — nearly twice the going rate — for COVID-19 test kits in a deal that critics have called “pay-for-play.”

State Senate Majority Leader Andrea Stewart-Cousins (D-Yonkers) said last month rejected Republican calls for an investigation, saying she took Hochul “at her word” that no wrongdoing was involved.

Some of the stuff the de Blasio administration bought came with expiration dates, including 2,800 cases of hand-sanitizing wipes that officials tried to sell for $56,000 on Jan. 12 even though the shelf life was set to end on Jan. 31, The City said.

An internal July 2022 email reportedly showed that an official with the Department of Citywide Administrative Services — which is handling the sales — voiced concern that if the public found out, it would lead to a probe into “over-buying during COVID.”

The email also said DCAS had “crafted talking points” following “direct consultation” with Mayor Eric Adams’ office, according to The City.

DCAS spokesperson Nick Benson told The City that the pandemic-related spending spree was needed to create a 90-day stockpile of supplies during “a dark and difficult time for all New Yorkers.”

“Thankfully, New Yorkers and our heroic frontline medical workers came together to avert some of the worst-case scenarios,” Benson added.

Benson also said that some surplus items were given away to Ukraine, Indonesia, Ghana, Haiti, South Africa or nonprofit organizations, and that auctioning off the rest for a pittance “is required by the city charter.”

During an unrelated, afternoon news conference at City Hall, Adams blamed the losses on a bureaucratic requirement that surplus purchases be sold off after 90 days.

“That’s just a bad rule,” he said. “COVID created an environment that none of us expected and so, we had to purchase far more than what we would have traditionally purchased.”

“So, somewhere in the charter rule, we need to state that under certain circumstances, we are not forced with, ‘Hey, it’s 90 days, let’s get rid of this stuff, no matter what the cost is that’s associated with it.'”

https://nypost.com/2023/02/21/nyc-sells-224-5m-worth-of-covid-19-supplies-for-just-500k/

Biden declines to veto Apple Watch ban

 President Biden has upheld an International Trade Commission (ITC) ruling that could result in an import ban on the Apple Watch, according to AliveCor, a medical device company that has accused Apple of patent infringement.

The California startup said it was informed of Biden’s decision by the Office of the U.S. Trade Representative (USTR) on Tuesday. It’s the first ITC ruling against Apple to clear presidential review.

A USTR spokesperson tole The Hill that the decision was made by U.S. Trade Representative Katherine Tai, and noted that presidents typically delegate ITC matters to their top trade official.

The administration’s decision to uphold a potential ban on imports of the tech product sets the stage for a high-stakes legal battle.

The ITC ruled in December that Apple infringed on AliveCor’s wearable electrocardiogram patents. While the commission called for a ban on Apple Watch sales, the order is on hold amid a dispute before the Patent Trial and Appeal Board, which recently ruled that AliveCor’s patents were invalid. 

“This decision goes beyond AliveCor and sends a clear message to innovators that the U.S. will protect patents to build and scale new technologies that benefit consumers,” AliveCor CEO Priya Abani said in a statement. 

Both companies hope to bring the legal issues before an appeals court. The process could take up to 18 months before various orders take effect.

Presidents don’t typically veto ITC decisions. But in 2013, then-President Obama vetoed a potential ban on iPhone and iPad imports after the ITC ruled that Apple infringed on Samsung’s patents. 

Following the most recent ITC ruling, Apple hired the former chairwoman of the ITC to lobby on its behalf, in an apparent effort to secure a presidential veto. The tech giant, along with its allies in Congress, warned that a ban would undermine public health. 

“The patents on which AliveCor’s case rest have been found invalid, and for that reason, we should ultimately prevail in this matter,” Apple said in a December statement. 

The dispute dates back to 2018, when Apple launched Apple Watch models with built-in electrocardiogram sensors, forcing AliveCor to cancel sales of its heart monitoring accessory. AliveCor said that it first shared its technology with Apple in 2015 in an effort to secure a partnership.

https://thehill.com/policy/technology/3867669-biden-declines-to-veto-apple-watch-ban-setting-up-court-battle-company/

East Palestine mayor: Biden Ukraine visit ‘biggest slap in the face’

 The mayor of East Palestine, Ohio, on Monday said that President Biden’s visit to Ukraine was the “biggest slap in the face” as his town continues to deal with the chemical fallout from a train derailment.

During an appearance on Fox News, East Palestine Mayor Trent Conaway was asked to give his thoughts on Biden’s surprise visit to Kyiv on Monday while he is in Poland for an international trip.

“That was the biggest slap in the face that tells you right now, he doesn’t care about us,” Conaway told host Jesse Watters. “So … he can send every agency he wants to but I found that out this morning and one of the briefings that he was in the Ukraine giving millions of dollars away to people over there, not to us and I’m furious.”

“Yeah, Presidents Day in our country. He’s … over in Ukraine,” he added. “So that tells you what kind of guy he is.” 

Biden made the visit to Kyiv to visit Ukrainian President Volodymyr Zelensky just days before the first anniversary of Russia’s invasion of the country. 

Biden said the surprise trip was meant to show U.S. support and solidarity for Ukraine while he also announced an additional $500 million in aid to the country. 

Conaway’s remarks come as prominent GOP figures in the past day have criticized Biden for neglecting domestic issues such as immigration and national security with his surprise trip to Ukraine. 

“We have a lot of problems accumulating here in our own country that he is neglecting,” Florida Gov. Ron DeSantis (R) said during a Fox News interview, noting ongoing issues plaguing the country such as poverty, immigration and national security. 

The GOP has also been critical of the Biden administration’s handling of the derailment of a Norfolk Southern train carrying toxic chemicals near the Pennsylvania state line earlier this month. The incident caused a massive fire and prompted authorities to evacuate about half of the 4,800 residents in the surrounding area.

Norfolk Southern has said some of the rail cars were carrying hazardous materials including vinyl chloride, combustible liquids, butyl acrylate and benzene residue, as well as other nonhazardous materials. 

The East Palestine Fire Department last week informed village residents that they are able to return to their homes, but cautioned them to avoid the area surrounding the railway as residents questioned whether the air and water around them is safe for people, pets and livestock in the aftermath of the incident.

In response, Norfolk Southern Railway announced it will launch a $1 million charitable fund initiative to help the East Palestine community, which included providing more than 100 air purifiers for residents to use in their homes.

https://thehill.com/homenews/3867552-east-palestine-mayor-biden-ukraine-visit-biggest-slap-in-the-face/

Over 1 Million Gallons Of Contaminated Water Excavated From Ohio Train Derailment Site

 by Katabella Roberts via The Epoch Times (emphasis ours),

Around 15,000 pounds of contaminated soil and 1.1 million gallons of contaminated water have been excavated from the site of a train derailment earlier this month in East Palestine, Ohio, train operator Norfolk Southern said on Feb. 20.

The announcement comes shortly after a state senator warned people living in close proximity to the derailment not to drink or bathe in the water.

Norfolk Southern said that the excavated contaminated soil and water will be transported to landfills and disposal facilities that are “designed to accept it safely in accordance with state and federal regulations.”

“Additionally, a series of pumps have been placed upstream to reroute Sulphur Run around the derailment site,” the carrier said. “The affected portion of Sulphur Run has been dammed to protect water downstream.”

“Environmental teams are treating the impacted portions of Sulphur Run with booms, aeration, and carbon filtration units,” Norfolk Southern said, adding that those teams are “also working with stream experts to collect soil and groundwater samples to develop a comprehensive plan to address any contamination that remains in the stream banks and sediment.”

The train, carrying about 50 freight cars, was traveling from Madison, Illinois, to Conway, Pennsylvania, on Feb. 3 when it derailed in East Palestine.

State officials ordered the evacuation of a 1-mile radius surrounding the crash site shortly after the incident but lifted those evacuation orders after crews burned the chemicals onboard, which included vinyl chloride, ethylhexyl acrylate, ethylene glycol monobutyl ether, and butyl acrylate, in a controlled release on Feb. 6.

An environmental company is removing dead fish downstream from the site of the train derailment that forced people to be evacuated from their homes in East Palestine, Ohio, on Feb. 6, 2023. (Alan Freed/Reuters)

Concerns over Cancer-Causing Pollutants

The controlled release also sent phosgene and hydrogen chloride into the air.

At the time the order was lifted, officials declared that it is safe for residents to return to the area after monitoring the air and water in surrounding communities and claiming they were not affected.

https://www.zerohedge.com/medical/over-1-million-gallons-contaminated-water-excavated-ohio-train-derailment-site

Dexcom G7 CGM to Be Available to Medicare Beneficiaries at Launch

 

• U.S. Centers for Medicare & Medicaid Services has approved coverage for Dexcom G7, the most accurate,¹ easy-to-use CGM system that helps people with diabetes gain greater control of their health.
• Introduced to the world yesterday in a Super Bowl ad, Dexcom G7 eliminates routine fingersticks^* and builds on the trusted performance of Dexcom CGM, which is clinically proven to lower A1C and increase time in range.^2-6
• The approval of Medicare coverage for Dexcom G7 further solidifies Dexcom as the most covered and reimbursed CGM brand on the market.⁷
• People with diabetes in the US, including Medicare patients, can visit Dexcom.com/G7 today to get started with Dexcom G7.

https://investors.dexcom.com/news/news-details/2023/Dexcom-G7-Continuous-Glucose-Monitoring-System-Will-Be-Available-to-Medicare-Beneficiaries-at-Launch/default.aspx

TB Treatment Strategy Has Potential to Drastically Slash Therapy Duration

 An 8-week tuberculosis (TB) treatment strategy where additional therapy is reserved only for persistent disease or at relapse led to less overall treatment and similar clinical outcomes compared with the standard 6-month approach, an open-label randomized study showed.

In the TRUNCATE-TB trial, a primary outcome event -- a composite of death, continued treatment, or active disease at 96 weeks -- was recorded in 3.9% of those on standard 6-month rifampin-based regimens, as compared with 5.8% of participants assigned to an 8-week strategy with bedaquiline (Sirturo) plus linezolid, which required subsequent monitoring for retreatment.

The adjusted 0.8-percentage point difference (97.5% CI -3.4 to 5.1) between those two arms met criteria for non-inferiority, Nicholas Paton, MD, of the National University of Singapore, reported here at the Conference on Retroviruses and Opportunistic Infections

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Overall, 86% of participants in the bedaquiline-linezolid arm no longer required further therapy after 8 weeks, and the mean total treatment time was more than halved in this group compared with standard treatment (85 vs 180 days), according to the findings, which were published simultaneously in the New England Journal of Medicineopens in a new tab or window.

TB treatment has been the same for 30 years, Paton told MedPage Today following his presentation, "with people just thinking, 'Carry on and try and do it more fastidiously.'"

"Many people were opposed to doing the trial initially, because they said: 'No, you can't do that, it's not safe, it's unethical' -- all those kind of things," said Paton. "I think what TRUNCATE-TB has done is challenged the treatment paradigm to say there might be an alternative way of doing this."

Efficacy of the 8-week strategy was consistent across subgroups, including in groups with markers of severe disease or at high risk for relapse.

Another 8-week strategy tested in the trial, which involved high-dose rifampin plus linezolid, failed to demonstrate noninferiority to the standard approach, with 11.4% reporting a primary outcome event (adjusted 7.4-percentage point difference, 97.5% CI 1.7-13.2). In this group, the average total treatment time was 106 days.

"We now need to look at how we can learn further from the trial about the biomarkers for selecting people who might do better with the 8-week regimen, and who might need a bit longer," Paton said, though he cautioned that even if the length of treatment is shortened, patients still need to be monitored due to the risk for risk of relapse.

In an editorialopens in a new tab or window that accompanied the paper, Véronique Dartois, PhD, of the Center for Discovery and Innovation in Nutley, New Jersey, and NEJM editor-in-chief Eric Rubin, MD, PhD, of Brigham and Women's Hospital in Boston, said while a 2-month TB regimen "might not be revolutionary," it could be very helpful.

"Our current treatment regimen for tuberculosis, which goes by the somewhat ironic name of 'directly observed therapy, short course,' is anything but short," they wrote. "Perhaps the biggest accomplishment of this trial is a step forward in the adaptive clinical trial design that may help to accelerate regimen development and to rapidly test many more 2-month therapies that are selected on the basis of recent treatment-shortening trial results."

Dartois and Rubin highlighted the two cases of drug resistance in the bedaquiline-linezolid arm, as compared with none in the standard-treatment group. One of the drug-resistant patients who relapsed at week 52 had isoniazid resistance and missed 14 days of treatment (12 days consecutively). The other relapsed at week 36. Both had phenotypic and genotypic resistance to bedaquiline, as well as to clofazimine.

"Bedaquiline has a long terminal half-life that generates lingering subtherapeutic concentrations for several months after the end of therapy, which results in de facto monotherapy and a prolonged window for the potential acquisition of drug resistance in cases of relapse," Dartois and Rubin explained. "Although a much larger number of patients would need to be treated to detect any significant difference, the small number of cases of drug resistance in this trial does not pose substantial concerns."

No safety signals were seen, the researchers said, with similar rates of respiratory disability, grade 3/4 adverse events (AEs), and serious AEs between groups.

Despite a black-box warning with bedaquiline due to increased mortality reported in earlier trials, and dose-limiting toxic effects reported with linezolid, Dartois and Rubin noted that toxicity with the combination "appeared to be quite limited" in the trial.

"In fact, this is one of many trials that suggest that the original concerns about bedaquiline might be overstated, at least for patients who undergo prescreening with electrocardiography," they said.

TRUNCATE-TB included 674 adult participants with rifampin-susceptible pulmonary TB in the intention-to-treat population. Patients were randomized to standard rifampin-based treatment -- rifampin and isoniazid for 24 weeks with pyrazinamide and ethambutol for the first 8 weeks (n=181) -- or to one of four 8-week strategy groups:

• High-dose rifampin plus linezolid (n=184)
• High-dose rifampin plus clofazimine (n=78)
• Rifapentine-linezolid (n=42)
• Bedaquiline-linezolid (n=189)

Each 8-week strategy group also received isoniazid, pyrazinamide, and ethambutol (except the rifapentine-linezolid group, which received levofloxacin instead of ethambutol). After 8 weeks, those with persistent clinical disease or who missed doses could continue treatment to week 12, at which point patients with persistent clinical disease or who had an adverse event could be switched to the standard 24-week regimen.

The researchers noted that while the follow-up visits after completion of treatment may represent an additional burden, "only a few participants discontinued visits or reported difficulty with prolonged follow-up."

Participants were enrolled at 18 sites in Indonesia, the Philippines, Thailand, Uganda, and India, and ranged in age from 18 to 65 years, with a majority (57%) age 18 to 34 years.

Overall, 62% were men, 49% were former or current smokers, and median body mass index (BMI) was 19, with under-nutrition recorded in 43% (BMI <18.5). Half had 25-50% chest involvement on x-ray, and about 60% were deemed intermediate risk for relapse, with 12% high risk.

The trial design had early stopping rules for two of the 8-week strategy groups, and ultimately the efficacy analysis included the standard 6-month treatment arm versus the bedaquiline-linezolid and high-dose rifampin/linezolid strategy arms.

The non-inferiority margin for the primary outcome was set at 12 percentage points, and the study's main secondary outcomes were total treatment time, grade 3/4 AEs, and acquired drug resistance.

Deaths before 96 weeks occurred in 1.1% of the standard-treatment group, 0.5% of the bedaquiline-linezolid strategy group, and 2.7% of the high-dose rifampin/linezolid strategy group. Ongoing treatment at this timepoint was observed in 1.1%, 2.6%, and 2.7%, respectively.

Active disease at 96 weeks was seen in 0.6% of patients in the standard-therapy group, 1.6% of those in the bedaquiline-linezolid strategy group, and 2.2% of the high-dose rifampin/linezolid strategy group.

Participant-based secondary endpoints found that those assigned to the strategy groups reported a higher level of motivation to adhere to the 8 weeks of treatment, according to the researchers.

Disclosures

The study was funded by the Singapore National Medical Research Council and others. Study drugs were provided by Sanofi, Janssen, and Pfizer.

Paton reported grants from Janssen. Co-authors reported grants from Gilead and working on clinical trials at the National University of Singapore.

Dartois and Rubin had nothing to disclose.

Primary Source

New England Journal of Medicine

Source Reference: opens in a new tab or windowPaton NI, et al "Treatment strategy for rifampin-susceptible tuberculosis" N Engl J Med 2023; DOI: 10.1056/NEJMoa2212537.

Secondary Source

New England Journal of Medicine

Source Reference: opens in a new tab or windowDartois V, Rubin EJ "Shortening tuberculosis treatment -- a strategic retreat" N Engl J Med 2023; DOI: 10.1056/NEJMe2300413.

https://www.medpagetoday.com/meetingcoverage/croi/103197

Doxycycline Fails to Protect Women Against STIs

 Researchers were scratching their heads over findings that doxycycline prophylaxis failed to prevent sexually transmitted infections (STIs) among African cisgender women, unlike its success among men who have sex with men.

In a trial conducted among 449 women in Kenya who were taking daily pre-exposure prophylaxis (PrEP) to prevent HIV infection, 50 of the women randomized to doxycycline around the time of sexual activity became infected with pathogens causing gonorrhoea or chlamydia, as compared with 59 women in the standard-of-care group (RR 0.88, 95% CI 0.60-1.29, P=0.51), reported Jenell Stewart, DO, MPH, of Hennepin Healthcare and the University of Minnesota in Minneapolis.

"None of the women in the study contracted HIV, so we assume they were adherent in taking their PrEP, so we keep asking ourselves, 'Why was doxycycline not effective in preventing other sexual transmitted diseases, such as chlamydia and gonorrhea?'" Stewart told MedPage Today at the annual Conference on Retroviruses and Opportunistic Infections

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The failure comes after several studies that have shown doxycycline prophylaxis markedly reduced rates of STIopens in a new tab or window among men and transgender women who have sex with men, she said.

So what went wrong? Stewart suggested that it might be anatomy: Endocervical tissue may differ from urethral, rectal, and pharyngeal tissues. She also hypothesized that there could be resistance pathogens that muted the effectiveness of doxycycline in the groups tested. And, Stewart noted, doxycycline might have been taken by women in the standard-of-care contingent through clinics outside the study, which would have skewed results.

She also suggested that adherence to doxycycline might have been imperfect.

"We were trying to reduce the use of antibiotics in this study so the cisgender women were taking doxycycline when they were having sexual contact, whereas the PrEP for HIV was daily," she said. "It is pretty clear that doxycycline is not the answer for preventing sexually transmitted infections among this population of cisgender women in Africa."

In the study, Stewart and colleagues randomly assigned 225 non-pregnant women to standard of care (quarterly STI testing and treatment) and another 224 women to 200-mg doxycycline within 72 hours of sexual activity. Women were followed for 12 months during 2020-2022. If a woman became pregnant during the trial, doxycycline therapy was discontinued.

At baseline, the median age of the women was 24 years, and the median duration of HIV PrEP was about 7 months. Two-thirds of the women were single, 69% had prior pregnancies, 61% were using hormonal contraception, and 37% reported transactional sex. About 18% of the women had a sexually transmitted disease at the start of the trial, mostly chlamydia. Quarterly visits were completed by 95% of the women in the prophylaxis cohort and by 98% of the women receiving standard of care.

About 78% of the women said they had used doxycycline in weekly surveys, indicating a sexually active group. There were 80 pregnancies in the study, 44 among women in the doxycycline group and 36 in the standard-of-care group.

No severe adverse reactions were reported by the women taking doxycycline, although four women in the group reported having experienced social harms related to taking the drug.

Overall, STIs were detected in 109 women during the study, including 85 cases of chlamydia, 31 cases of gonorrhoea, and one case of syphilis (eight women had both a chlamydia and gonorrhoea infection). Chlamydia occurred in 35 women in the doxycycline group and 50 women in the standard-of-care group (RR 0.73, 95% CI 0.47-1.13). Gonorrhoea occurred in 19 and 12 women, respectively (RR 1.64, 95% CI 0.78-3.47).

"The burden of sexually transmitted infections on cisgender women is large and growing," Stewart said. "Sexually transmitted infection prevention interventions remain needed."

In commenting on the study, press conference moderator Landon Myer, MD, of the University of Cape Town, South Africa, called it a "hugely important study in an area that requires greater interest."

However, "I don't think the problem is the drug," he told MedPage Today. "I think the reason the trial failed to show a significant difference is probably due to drug resistance or to adherence. We have more work to do to find the answer."

Disclosures

Stewart and Myer disclosed no relationships with industry.

Primary Source

Conference on Retroviruses and Opportunistic Infections

Source Reference: opens in a new tab or windowStewart J, et al "Doxycycline postexposure prophylaxis for prevention of STIs among cisgender women" CROI 2023.

https://www.medpagetoday.com/meetingcoverage/croi/103206