Author: Peter

The Food and Drug Administration could require drugmakers seeking speedy approvals of new treatments to begin confirmatory testing before gaining the agency’s clearance under legislation before Congress...the legislation would also expedite the process for withdrawing conditionally approved drugs...Contained in a massive, year-end federal spending bill, the provisions instruct the FDA to convene a seven-member council of agency officials to develop consistent policies and practices around accelerated approvals...READ MORE

When people needed critical COVID-19 testing and, later, vaccinations, many visited their local pharmacy to secure those services...As the healthcare industry continues to grapple with labor shortages and staffing issues, experts argue pharmacists are an underutilized resource that could play a much greater role in patient care. Pharmacists have high levels of trust with patients, who visit their local pharmacy more frequently than they go to other sites of care; pharmacists see patients three or four times more often than primary care doctors...A survey from CVS Health and Morning Consult, released in October, found that 61% of people would like to get a broader range of services at their local pharmacy. It also found that 74% of people trust their local pharmacist and agree they should be able to step in when primary care is not available...READ MORE

Hearses bearing the dead lined the driveway to a designated COVID-19 crematorium in the Chinese capital on Saturday while workers at the city's dozen funeral homes were busier than normal, days after China reversed tight pandemic restrictions...In recent days in Beijing the spread of the highly transmissible Omicron variant has hit services from catering to parcel deliveries. Funeral homes and crematoriums across the city of 22 million are also struggling to keep up with demand as more workers and drivers testing positive for coronavirus call in sick...China is yet to officially report any COVID deaths since Dec. 7 when the country abruptly ended many key tenets of its zero-COVID policy that had been championed by President Xi Jinping, following unprecedented public protests against the protocol...READ MORE

The care given in emergency departments came under fire yesterday with the release of a government study saying that 250,000 Americans die every year due to misdiagnoses...The findings spurred an immediate response from the president of the American College of Emergency Physicians, who questions the study’s veracity and methodology...Christopher S. Kang, M.D., president of the ACEP, said in a statement that “in addition to making misleading, incomplete and erroneous conclusions from the literature reviewed, the report conveys a tone that inaccurately characterizes and unnecessarily disparages the practice of emergency medicine in the United States.”...The study, conducted by Johns Hopkins for the Agency for Healthcare Research and Quality, states that among 130 million ED visits in the U.S. per year, 7.4 million patients are misdiagnosed. In addition, 2.6 million suffer an adverse event, and about 370,000 suffer serious harm from diagnostic errors...READ MORE

In yet another turn in the high-profile Zantac litigation, Sanofi and Pfizer agreed to settle a case set for trial in California...which comes after a U.S. District Judge ruled against the plaintiffs in the federal group of cases against the companies and others. Earlier this month, that ruling took out about 50,000 Zantac claims off the board.As for the California settlement, that lawsuit came in California Superior Court for Alameda County...The financial terms of the agreement were not revealed...READ MORE

The Drug Enforcement Administration has alleged that telehealth and digital pharmacy company Truepill unlawfully dispensed thousands of prescriptions for stimulant medications such as Adderall...The DEA announced last week that it served the startup with an order to show cause, which is an administrative action to determine whether a DEA certificate of registration should be revoked...Between September 2020 and September 2022, Truepill filled more than 72,000 controlled substance prescriptions, 60% of which were for stimulants including generic forms of Adderall, according to the DEA's investigation...READ MORE

Four felony drug charges were announced Friday against Mark Lawson after he resigned Monday as Sparks fire chief...The charges include possession of a controlled substance and sale of a controlled substance...A co-defendant listed in the case is Lance Forrester. As recently as 2020, Forrester was employed as a correctional officer with the state, according to Transparent Nevada...Arraignment is set for Jan. 31 in Sparks Justice Court...The charges seemed to take the city of Sparks by surprise. Lawson’s hiring was approved by the Sparks City Council on Nov. 28 with pay of $200,000 plus benefits...READ MORE

In the first year of the pandemic, 19 rural hospitals closed their doors. Yet in the years since, only six have. What these historic lows might suggest is deceptive, experts caution...In the decade leading up to 2020, the average margins of rural hospitals were on a downward trajectory, with more than 130 closing in that time. During the COVID-19 pandemic, existing challenges with limited staff and capacity got worse. But thanks to pandemic relief funds, rural hospitals received billions of dollars to offset mounting costs...With dwindling funds, rural hospitals are expected to return to pre-pandemic levels of profitability...READ MORE

The former Sparks fire chief accused of illegal possession and distribution of steroids says he never gave his resignation and wants to be reinstated...Mark Lawson’s lawyers said in a letter sent to Sparks officials this week he should be returned to his role and placed on paid administrative leave pending the outcome of his criminal case...They said Lawson maintains his innocence and threatened to file a civil lawsuit alleging he was “condemned, terminated and tried in the public” before criminal charges had been filed. But he is confident the criminal complaint will be dismissed...READ MORE

With the era of free COVID-19 vaccines winding down in the U.S., lawmakers are pressing Pfizer for a fair Comirnaty price tag and singling out the pharma giant for its “unseemly profiteering.”...Sen. Elizabeth Warren of Massachusetts and Vermont Sen.-elect Peter Welch blasted Pfizer’s purported Comirnaty pricing scheme—which could see the company charge between $110 and $130 per vaccine dose on the private market—as “pure and deadly greed.”...To date, more than 650 million COVID-19 vaccine doses have been administered in the U.S...Warren and Welch explained. But that “public health achievement” is “now at risk” thanks to Pfizer’s greed, they warned...READ MORE