'Unexplained Bleeding Linked to Rat Poison in Synthetic Cannabinoids'

 Unexplained bleeding in dozens of patients with a history of synthetic cannabinoid (SCB) use was linked to poisoning with brodifacoum, an anticoagulant often used in rat poison, Florida health officials reported.

In early December 2021, the Florida Poison Information Center Tampa notified the Florida Department of Health about three patients experiencing bleeding with an unclear cause, reported Nikki Coble, MPH, of the Florida Department of Health in Hillsborough County in Tampa, and colleagues.

"These patients resembled those from the nationwide incident of coagulopathy associated with SCB use that occurred in 2018, which included five patients from Florida who displayed similar signs, symptoms, and high-risk behaviors," Coble's group wrote in the Morbidity and Mortality Weekly Report (MMWR).

On December 7, epidemiology program managers at county health departments, including those in Pasco, Pinellas, and Polk counties, as well as emergency department physicians and medical examiners at Advent Health, St. Joseph Hospital, and Tampa General Hospital were informed about the three patients and asked to report any suspected cases. Additional notification and identification efforts included the issuance of a press release to help public awareness and the use of Florida's syndromic surveillance database.

Patients were interviewed and medical records were reviewed to collect information on signs and symptoms, marijuana or other drug use, product purchase locations, and potential exposure to prescription vitamin K oxidoreductase antagonists.

A total of 52 cases were ultimately identified (mean age 36, 76.9% men), 83% of which were confirmed, including four patients, with a mean age of 34, who died. Forty-seven of these patients reported using SCBs with similar purchase locations before symptom onset, Coble and team noted.

The most common symptoms were hematuria, abdominal pain, and hematemesis. International normalized ratio (INR) measurements -- which are used to determine how long blood takes to form a clot -- were elevated in all patients.

Five patients provided the SCB products they had smoked, four of which tested positive for brodifacoum, a long-acting vitamin K oxidoreductase antagonist.

All patients were treated with vitamin K1, administered by both oral and intravenous routes, which is used to treat vitamin K oxidoreductase antagonist coagulopathy.

"Communicating timely information to healthcare providers and the general public allowed for additional patient identification and was crucial to connecting with patients who needed medical care," Coble's group wrote.

However, they noted the potential issue of treatment expense with oral vitamin K1, which can top $65,000 a month. Two-thirds of the patients were uninsured, but 12 were ultimately enrolled in a local managed healthcare program, and a pharmaceutical company donated enough K1 tablets to treat all of the 52 patients.

Furthermore, diagnosis of brodifacoum poisoning was difficult, since required testing costs more than $750 per specimen and has a long turnaround time, given that it is only offered by a single private laboratory. Coble and team also said that there was a limited supply of the high doses of vitamin K1 during the extended period of time required for treatment, and that patient compliance can pose problems because of the high cost and cumbersome nature of the treatment.

"To help avert future distribution of brodifacoum-laced SCB products, local county law enforcement was informed of this incident and provided information regarding the locations where patients reported they had purchased SCB products," Coble and team noted.

Disclosures

The authors reported no conflicts of interest.

Primary Source

Morbidity and Mortality Weekly Report

Source Reference: Coble N, et al "Coagulopathy associated with brodifacoum poisoning -- Florida, December 2021" MMWR 2022; DOI: 10.15585/mmwr.mm7140a5.

https://www.medpagetoday.com/publichealthpolicy/publichealth/101103

Lyell Immunopharma Announces FDA Clearance of its IND for Cancer Treatment

 

• Autologous TIL therapy enhanced with Lyell’s Epi-R™ reprogramming technology designed to create polyclonal T cell populations with properties of durable stemness and improved function
  

• Phase 1 trial to initially enroll patients with relapsed and/or refractory metastatic or locally advanced melanoma and subsequently expand into non-small cell lung cancer and colorectal cancer

• Initial data presentation expected in 2024

https://finance.yahoo.com/news/lyell-immunopharma-announces-fda-clearance-200500701.html

Allogene Initiates Industry’s First Allogeneic CAR T Phase 2 Trial

 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer, today announced the initiation of the potentially pivotal Phase 2 clinical trial of ALLO-501A (ALPHA2 trial) in patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL). The Company is also in the process of initiating the EXPAND trial, which is intended to demonstrate the contribution of ALLO-647 to the standard fludarabine/cyclophosphamide lymphodepletion regimen. Assuming favorable outcomes and subject to discussions with the U.S. Food and Drug Administration (FDA), the Company expects these studies to support the regulatory approval of both ALLO-501A and ALLO-647.

https://finance.yahoo.com/news/allogene-therapeutics-initiates-industry-first-201500536.html

CVS Health expects lower Medicare performance rating to impact 2024

 CVS Health Inc said its largest health insurance plan for Medicare recipients received a lower performance rating from the Federal government program, sending shares of the company down around 5% in extended trade.

In a regulatory filing late on Thursday, CVS said the newly-released Star Ratings for Medicare Advantage plans in 2023 lowered the rating for the company's Aetna National PPO plan to 3.5 stars from 4.5.

The reduced rating means the plan, which includes more than 1.9 million members, is ineligible for performance-based bonus payments from the government in 2024 and is likely to impact earnings.

Medicare Advantage plans are run by private insurers and are an alternative to the original Medicare - a government program for older Americans.

Star Ratings are a performance and quality score given by the U.S. Centers for Medicare & Medicaid Services, since 2007, based on its annual consumer surveys.

Ratings range from one to five stars, with five representing the highest possible ranking, and are used by customers to decide which insurance plans they want to enroll. Enrollment typically drops with a drop in ratings.

CVS said it does not expect any impact to its 2022 earnings forecast from the rating change and expects to mitigate any financial impact on its preliminary 2023 outlook.

Evercore analysts wrote in a note the ratings were down for the overall health insurance industry, but the move was expected as part of normalizing elevated ratings that had reflected allowances related to disruptions from the pandemic.

CVS said it still aims to grow adjusted earnings per share "at low double-digit year-over-year rates in 2024."

The Woonsocket Rhode Island-based company added it was evaluating some capital deployment alternatives, including share repurchases, to mitigate any possible impact on 2024 earnings.

https://finance.yahoo.com/news/cvs-health-expects-lower-medicare-232201900.html

Biden Overhauls U.S. Policy on Marijuana, Pardons Prior Federal Offenses

 President Joe Biden took steps to overhaul U.S. policy on marijuana on Thursday by pardoning thousands of people with federal offenses for simple marijuana possession and initiating a review of how the drug is classified.

Biden said thousands of people with prior federal convictions could be denied employment, housing or educational opportunities and his executive action would relieve such "collateral" consequences.

Nearly 40 U.S. states have legalized marijuana use in some form, but it remains completely illegal in some states and at the federal level. Reclassification would be a first step toward wider legalization, a move backed by a majority of Americans, and usher in sweeping changes for companies and law enforcement and impact millions.

The president's decision fulfills a campaign promise and is likely to please members in his left-leaning political base ahead of the November midterm elections in which the president's fellow Democrats are defending control of the House of Representatives and Senate.

"Too many lives have been upended because of our failed approach to marijuana. It's time that we right these wrongs," Biden said.

He urged state governors to follow suit.

"Just as no one should be in a federal prison solely due to the possession of marijuana, no one should be in a local jail or state prison for that reason, either," Biden said.

A senior administration official said more than 6500 people with prior federal convictions could be affected by the pardons.

Shares of cannabis growers and sellers surged following Biden's comments, with Tilray Brands and Canopy Growth both jumping more than 20%.

Supporters welcomed the move and its impact on racial imbalances in the U.S. justice system.

"The United States will never justly legalize marijuana until it reckons with the outdated policies that equated thousands of young Black men with hardened drug pushers," said Al Sharpton, president of the National Action Network civil rights group.

"They were thrown behind bars for years on end for simple possession, a non-violent offense, for a substance that red states and blue states are now legalizing at a furious clip."

Some Republicans, who U.S. voters prefer over Democrats for addressing crime-related policies, criticized it.

"In the midst of a crime wave and on the brink of a recession, Joe Biden is giving blanket pardons to drug offenders— many of whom pled down from more serious charges," Republican Senator Tom Cotton said on Twitter. "This is a desperate attempt to distract from failed leadership."

BIG CHANGES AHEAD

The results of a classification review could have wide ramifications. At present, the drug falls under the same classification as heroin and LSD and is in a higher classification than fentanyl and methamphetamine, the president said.

If marijuana classification were to ease at the federal level, that could allow major stock exchanges to list businesses that are in the cannabis trade, and potentially allow foreign companies to begin selling their products in the United States.

While many states have legalized the medical or recreational use of cannabis, its illegal status under U.S. federal law has forced most major banks to deny their services to cannabis-related businesses.

The issue has forced U.S. marijuana companies to trade their shares over the counter or by listing in Canada, with the Nasdaq and New York Stock Exchange prohibited from listing them.

The president's action drew praise from some members of Congress and from the industry.

“The Progressive Caucus applauds this action by President Biden today to advance criminal and racial justice," said Representative Pramila Jayapal, who chairs a group of left-leaning lawmakers, in a statement.

"This represents a major step in righting the wrongs of the past and amending policies that have negatively impacted so many,” said Khari Edwards, head of corporate social responsibility at Ayr Wellness Inc, one of the top U.S. cannabis retailers.

Biden said he had directed Attorney General Merrick Garland to develop an "administrative process" to issue certificates of pardon to those who are eligible.

“The Justice Department will expeditiously administer the President’s proclamation, which pardons individuals who engaged in simple possession of marijuana, restoring political, civil, and other rights to those convicted of that offense," the department said in a statement.

Biden said certain rules needed to stay in place even as regulations around the country loosened.

"Finally, even as federal and state regulation of marijuana changes, important limitations on trafficking, marketing, and under-age sales should stay in place," Biden said.

The global cannabis industry is forecast to hit $55 billion in sales by 2026, with the U.S. market growing to $40 billion by then, up from $25 billion last year, according to cannabis focused research firm BDSA’s September projections.

Industry experts believe U.S. federal reforms could push those figures much higher.

https://www.usnews.com/news/top-news/articles/2022-10-06/biden-overhauls-u-s-policy-on-marijuana-pardons-prior-federal-offenses

Washington Gave $28M To Chinese Entities For Joint Research Since 2015: Report

 by Rita Li via The Epoch Times (emphasis ours),

Recently released findings show U.S. government agencies sent over $28 million in taxpayers’ dollars “directly to Chinese entities” for joint research over a five-year period ending 2021.

From fiscal years 2015 through 2021, “the CDC [Centers for Disease Control and Prevention], NIH [National Institutes of Health], and DOD [Department of Defense] provided 22 awards totaling $28.9 million directly to Chinese entities including universities and other research institutions,” the Government Accountability Office (GAO) said on Sept. 29 following a trove of analyses.

Researchers found the federal funding focused on “multiple scientific disciplines,” aiding Chinese entities in conducting research on “disease surveillance, vaccination studies, and the development of new drugs,” as well as “alternative technologies to propel vehicles such as drones.”

The release of its 38-page report (pdf) follows a January request from House Republican Conference Chairwoman Elise Stefanik (R-N.Y.) and Michael McCaul (R-Texas), the top Republican on the House Foreign Affairs Committee. They asked GAO to review federal funds provided to China or entities controlled by the Chinese Communist Party (CCP) for collaborative research, and U.S. contributions to multilateral institutions.

Stefanik described such funding as “troubling.”

“China’s deception and stonewalling of the truth behind the origins of COVID-19 has led to millions of senseless deaths and trillions of dollars in economic destruction across the globe,” the congresswoman said in a statement to The Epoch Times.

The three agencies awarded a total of 13 Chinese entities for joint publications, information sharing, and workshops, while 84 percent of the direct funding went to the University of Hong Kong, Peking University, and the Chinese Center for Disease Control and Prevention, known as the Chinese CDC.

Receiving almost $5 million from the NIH and the CDC over the past years, the Chinese CDC had been suppressing information about the outbreak domestically and snubbed U.S. offers of assistance, despite how any health data would have been crucial to formulate a more effective COVID-19 containment strategy and minimize the disease’s global spread.

“Even more frightening,” Stefanik continued, “we still have no idea how much total money has been sent to China due to lax reporting requirements. Make no mistake, the Chinese Communist Party’s deception throughout the pandemic confirmed that China is not a reliable partner.”

https://www.zerohedge.com/political/washington-gave-28m-chinese-entities-joint-research-2015-report

Hundreds Of Thousands Of Americans Sought Medical Care After COVID-19 Vaccination: CDC Data

 by Zachary Stieber via The Epoch Times (emphasis ours),

Hundreds of thousands of Americans sought medical care after getting a COVID-19 vaccine, according to Centers for Disease Control and Prevention (CDC) data released on Oct. 3.

Some 782,900 people reported seeking medical attention, emergency room care, and/or hospitalization following COVID-19 vaccination. Another 2.5 million people reported needing to miss school, work, or other normal activities as a result of a health event after getting a COVID-19 vaccine.

The reports were made to the CDC’s V-safe program, a new vaccine safety monitoring system to which users can report issues through smartphones.

The CDC released the data to the Informed Consent Action Network (ICAN) after being sued over not producing the data when asked by the nonprofit. ICAN posted a dashboard summarizing the data.

“It took numerous legal demands, appeals, and two lawsuits, and over a year, but the CDC finally capitulated and agreed to a court order requiring them to do what they should have done from day one, release the V-safe data to the public,” Aaron Siri, a lawyer representing ICAN in the case, told The Epoch Times in an email.

About 10 million people utilized V-safe during the period of time the data covers: Dec. 14, 2020, to July 31, 2022. About 231 million Americans received at least one vaccine doses during that time.

The V-safe users reported about 71 million symptoms.

The most commonly reported symptoms were chills (3.5 million), swelling (3.6 million), joint pain (4 million), muscle or body aches (7.8 million), headache (9.7 million), fatigue (12.7 million), and general pain (19.5 million).

About 4.2 million of the symptoms were of severe severity.

Users of V-safe filled in data for about 13,000 infants younger than two, reporting over 33,000 symptoms, including pain, loss of appetite, and irritability.

The data produced so far by the CDC does not include free-text responses, according to ICAN. The data covered fields where users checked boxes.

ICAN, founded by film producer Del Bigtree, said that the newly revealed data “reveals shocking information that should have caused the CDC to immediately shut down its COVID-19 vaccine program,” citing the percentage of people who reported needing to get care or missing school, work, or other normal activities, as well as the reported adverse events.

https://www.zerohedge.com/covid-19/hundreds-thousands-americans-sought-medical-care-after-covid-19-vaccination-cdc-data