COVID-19: NY Rolls Back Contact Tracing Requirements For Local Health Departments

 New York State will no longer require local health departments to perform contact tracing of positive COVID-19 cases amid the rise of the Omicron variant that has been rapidly spreading in record numbers.

New York Gov. Kathy Hochul and acting Department of Health Commissioner Mary Bassett announced on Tuesday, Jan. 11 that with the recent unprecedented rise of new infections, it has become impractical for officials to allocate resources toward contact tracing.

Previously, New Yorkers who tested positive for COVID-19 were contacted by state or local health officials who questioned them about anyone they had close contact with, who were then notified.

Instead, moving forward, healthcare workers are being advised to concentrate their efforts on vaccinating New Yorkers, COVID-19 testing, and sharing information about isolation and quarantining.

“Our approach to contact tracing is changing because of the winter surge,” Bassett said. "The number of people testing positive has been setting records across our state … Our nation, and the world.

“Even today, we received welcome numbers, but they are fourfold higher in terms of positive tests than the beginning of September.”

Officials noted that New York has been setting records for the number of COVID-19 tests being administered across the state, which made it imprudent to continue intensive contact tracing, though local health departments will still have the option to do so.

“Omicron is very contagious, as we’ve been discussing, and many more people are being tested, so that results in a very large number of people testing positive,” Bassett said. “We're dealing with a very short window for intervention to disrupt transmission, which is the point of contact tracing in the first place.

“We’re moving to more self-management when someone tests positive or is exposed, and a less active outreach,” she continued. “Our guidance remains aligned with the CDC (Centers for Disease Control and Prevention), so we’re focusing on helping state and local health department staffs focus on where we can make the biggest difference, and that’s in testing and vaccination.”

Hochul noted that New York has seen approximately 12,000 new cases daily, making it “impossible to do contact tracing as we’ve had in the past.”

“We are going to be allowing counties to decide if they want to contact trace. Everyone knows someone who had it, whether it's themselves, friends, or family, so it doesn’t make sense to have the resources of local public health departments on contact tracing,” she said.


“It feels good that we’re seeing a positive trend (in cases), and it’s a very positive trend we’re seeing,” Hochul continued. “I’m so looking forward to letting the public know when we can start rolling back other mandates and requirements that we’ve had to put in [place to protect people.” 

https://dailyvoice.com/new-york/somers/news/covid-19-ny-rolls-back-contact-tracing-requirements-for-local-health-departments/823687/

Danaher Expects 4Q Revenue Above Guidance

 Industrial conglomerate Danaher Corp. said Tuesday it expects fourth-quarter revenue to come in above its earlier guidance.

The company said estimated revenue rose at high-teens to low-20s percent pace in the latest quarter compared with last year, with adjusted core revenue growth estimated to be in the high-teens percent range.

The company previously forecast adjusted core revenue growth in the low-to-mid teens percent range.

"Our team delivered an outstanding finish to 2021, with better-than-expected results across all three reporting segments led by Life Sciences and Diagnostics," Chief Executive Rainer Blair said in a statement.

Revenue in the company's life sciences division was boosted by increased demand for respiratory and non-respiratory testing, Mr. Blair said.

https://www.marketscreener.com/quote/stock/DANAHER-CORPORATION-12295/news/Danaher-Expects-4Q-Revenue-Above-Guidance-37516147/

Black Diamond Shares Rally on FDA Green Light for Study

 Shares of Black Diamond Therapeutics Inc. jumped more than 20% in premarket trading Tuesday after the precision-oncology company received U.S. Food and Drug Administration approval for a study of its BDTX-1535 cancer therapy.

The Cambridge, Mass., company said it expects to initiate a Phase 1 study of BDTX-1535 in the first quarter and to provide a clinical update in the second half of 2023.

Black Diamond said BDTX-1535 is designed as an irreversible, mutant selective, brain-penetrant inhibitor of oncogenic mutations of epidermal growth factor receptor, or EGFR, expressed in glioblastoma multiforme and intrinsic and acquired resistance EGFR mutations in non-small cell lung cancer.

https://www.marketscreener.com/quote/stock/BLACK-DIAMOND-THERAPEUTIC-102588721/news/Black-Diamond-Shares-Rally-Premarket-on-FDA-Green-Light-for-Study-37516535/

Review of COVID-19 tests remains top priority -acting U.S. FDA chief

 The U.S. Food and Drug Administration is focused on reviewing at-home and other COVID-19 tests, particularly those that can be manufactured at scale, Acting FDA Commissioner Janet Woodcock said at a Senate hearing on Tuesday

https://www.marketscreener.com/quote/stock/ORASURE-TECHNOLOGIES-INC-10373/news/Review-of-COVID-19-tests-remains-top-priority-acting-U-S-FDA-chief-37519066/

FDA amends J&J vaccine fact sheet to include rare bleeding risk

 The U.S. Food and Drug Administration on Tuesday amended the fact sheet for Johnson & Johnson's COVID-19 vaccine to include a rare risk of immune thrombocytopenia, a bleeding disorder.

"Reports of adverse events following use of the Janssen COVID-19 vaccine under emergency use authorization suggest an increased risk of immune thrombocytopenia during the 42 days following vaccination," the regulator said in a letter to J&J's arm, Janssen Biotech Inc.

The symptoms include easy bruising or tiny blood spots under the skin, or unusual or excessive bleeding, the FDA said.

The amendment fact sheet follows similar moves for the vaccine by other regulators, including that of European Medicines Agency in October https://www.reuters.com/business/healthcare-pharmaceuticals/eu-finds-jj-covid-shot-possibly-linked-another-rare-clotting-condition-2021-10-01.

Both the J&J and AstraZeneca vaccines, which are based on a similar platform, have previously been associated with another very rare combination of blood clotting and low platelet counts, known as thrombosis with thrombocytopenia syndrome.

The U.S. Centers for Disease Control and Prevention had also last month recommended Americans choose https://www.reuters.com/business/healthcare-pharmaceuticals/blood-clot-rates-after-jj-vaccine-higher-than-previous-estimates-cdc-advisers-2021-12-16 to receive one of two other authorized COVID-19 vaccines from Pfizer-BioNTech over J&J's single-dose shot, due to the rare but sometimes fatal risk.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/U-S-FDA-amends-J-J-vaccine-fact-sheet-to-include-rare-bleeding-risk-37521793/

No vax, pay tax, says Canada's Quebec as health system struggles

 

Quebec, Canada's second most populous province, is planning to force adults refusing to get COVID-19 vaccinated pay a "health contribution" in a move likely to spur a debate about individual rights and social responsibility.

Premier Francois Legault told reporters at a briefing on Tuesday that the proposal, details of which were still being finalised, would not apply to those who cannot get vaccinated for medical reasons.

Unvaccinated people put a financial burden on others and the provincial finance ministry is determining a "significant" amount that unvaccinated residents would be required to pay, Legault said, adding that such an amount would not be less than C$100 ($79.50).

Governments globally have imposed movement restrictions on the unvaccinated and few have levied fines on the elderly, but a sweeping tax on all unvaccinated adults could be a rare and controversial move.

While such a tax could be justified in the context of a health emergency, McGill University medicine and health sciences professor Carolyn Ells said, whether it survives a court challenge would depend on the details.

But Ells expressed surprise that the government was taking such a "dramatic" step now, when options such as further expanding vaccine mandates remain.

Provinces across Canada are tackling an exponential rise in COVID-19 cases that has forced tens of thousands of people into isolation and burdened the healthcare sector.

The highly transmissible Omicron variant has made it difficult for restrictive measures to curb the spread and health experts have stressed the importance of getting double and tripled vaccinated.

Quebec has been one of the worst-hit, regularly recording the highest daily count of coronavirus cases of all provinces and having several thousand healthcare workers off their jobs.

"The vaccine is the key to fight the virus. This is why we're looking for a health contribution for adults who refuse to be vaccinated for non-medical reasons," Legault said.

Legault said that even though the province has about 10% unvaccinated people, they account for about 50% of those in intensive care units.

Legault and his CAQ party face a provincial election in October.

On Monday, Canadian Prime Minister Justin Trudeau said that the federal government had secured enough COVID-19 vaccine doses for all eligible Canadians to receive a booster as well as a fourth dose.

Last month, Quebec said it had "no choice" but to allow some essential workers to continue working even after testing positive for COVID-19 to prevent staff shortages from impeding its healthcare services. It has also imposed curbs on gathering.

https://www.marketscreener.com/news/latest/No-vax-pay-tax-says-Canada-s-Quebec-as-health-system-struggles--37521448/

Medicare plans to restrict access to controversial, pricey Alzheimer’s drug Aduhelm to patients in clinical trials

 Medicare plans to cover the controversial, pricey Alzheimer’s drug Aduhelm, but only for certain patients enrolled in clinical trials, the agency announced on Tuesday.

The proposed move would likely mean some patients will not be able to access the Biogen drug, which is the first Alzheimer’s treatment approved in nearly two decades. Since it got the green light this summer, doctors and scientists have raised questions about whether it actually works, government watchdogs have begun investigating whether the Food and Drug Administration followed proper procedure to approve it, and policy experts have questioned whether it is effective enough to justify its hefty price tag.

Medicare officials don’t require participation in clinical studies for beneficiaries very often — there are only about two dozen other health care products with a similar designation, called a Coverage with Evidence Development, listed on Medicare’s website. Most are for medical devices or diagnostic imaging, and are less restrictive than the policy Medicare announced Tuesday.

But it would also serve to limit the patient population for the drug considerably, since clinical trials are usually run mostly out of major medical centers that are equipped to jump through the additional bureaucratic hoops required.

“In a clinical trial, where only certain centers participate, there would be a geographic component to patient access,” said James Chambers, an associate professor of medicine at Tufts University who studies coverage policies.

Medicare will also limit those who can get the drug to people who have mild forms of cognitive impairment.

The new proposal is not final, and could still change substantially before it’s finalized later this spring.

Even if it’s finalized, it’s not clear yet whether the policy will improve the drug’s abysmal sales numbers. A number of prominent hospitals and academic medical centers have refused to administer the drug at all.

https://www.statnews.com/2022/01/11/medicare-aduhelm-proposed-decision/