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Amazon warns face-mask sellers about price gouging amid coronavirus fears

Amazon has reportedly sent warnings to sellers of medical face masks on its platform who it says are not in compliance with its policies, warning that price gouging will result in their removal from the marketplace.

Emails obtained by Wired show that the company has warned sellers against gouging prices on the items amid the outbreak of a novel form of coronavirus from China, which has led to a global spike in purchases of face masks.

The company has also deleted some listings of the items that were sharply raised in price amid the outbreak, a company consultant told Wired. Amazon representatives did not immediately return a request for comment from The Hill.

“If you price gouge — charge too much for these masks, they sometimes take you down,” said the consultant, Ed Rosenberg.

“This is a hard one for Amazon, because they do not want its customers to be taken advantage of,” he added. “But there is also supply and demand, and sellers should be able to charge more if they pay more and demand is high.”

More than 2,500 people have died, mostly in China, amid the coronavirus outbreak, which is thought to have originated in the country’s Wuhan province. Tens of thousands of people across the country have reported or confirmed cases of the disease.

Health officials in several other countries including the U.S. have implemented screenings of travelers arriving from China, though U.S. health officials have not recommended face masks for the purpose of preventing contraction of the disease.

https://thehill.com/policy/technology/484594-amazon-warns-face-mask-sellers-about-price-gouging-amid-coronavirus-fears

San Francisco declares state of emergency over coronavirus

San Francisco Mayor London Breed (D) declared a state of emergency for the city on Tuesday amid concerns over the international coronavirus outbreak.

While no coronavirus cases have been confirmed in San Francisco, “the global picture is changing rapidly, and we need to step-up preparedness,” Breed said in a statement.

“We see the virus spreading in new parts of the world every day, and we are taking the necessary steps to protect San Franciscans from harm,” she added.

The new state of emergency will allow city officials to assemble resources and personnel to expedite emergency planning measures and boost the ability to deploy a rapid response to a potential coronavirus case in the city.

The move follows a similar declaration from Santa Clara County earlier this month. The declaration is effective immediately for seven days and will be voted on by the board of supervisors on March 3.

The statement from Breed comes amid stark warnings from U.S. health officials over the chances of an outbreak of the virus in the U.S.

“As more and more countries experience community spread, successful containment at our borders becomes harder and harder,” Nancy Messonnier, director of the Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases, said Tuesday.

“It’s not a question of if this will happen but when this will happen and how many people in this country will have severe illnesses,” she added. “Disruption to everyday life might be severe.”

More than 77,000 coronavirus cases have been confirmed in China, where the virus was first detected, but more than 2,000 cases have been identified in other countries. Fifty-seven cases have been confirmed in the U.S., including 40 people who had been repatriated to the country from the Diamond Princess cruise ship.

Some lawmakers have expressed skepticism that the administration is taking bold enough action to curb the risk of the virus spreading in the U.S., with some saying the $2.5 billion it requested in in emergency coronavirus funding was insufficient.

“It seems to me at the outset that this request for the money, the supplemental, is lowballing it, possibly, and you can’t afford to do that,” Sen. Richard Shelby (R-Ala.), chairman of the Senate Appropriations Committee, told Health and Human Services Secretary Alex Azar during a hearing on the agency’s budget request.

https://thehill.com/policy/healthcare/484602-san-francisco-declares-state-of-emergency-over-coronavirus

US soldier in South Korea tests positive for coronavirus

A U.S. soldier stationed in South Korea has tested positive for the new coronavirus, the first known case of a U.S. service member testing positive for the new virus.

United States Forces Korea said in a statement Tuesday that a soldier stationed in Camp Carroll had tested positive and is currently in quarantine at his off-base residence.

“USFK is implementing all appropriate control measures to help control the spread of COVID-19 and remains at risk level ‘high’ for USFK peninsula-wide as a prudent measure to protect the force,” the military said in its statement.

COVID-19 refers to the disease caused by the coronavirus. The outbreak has spread from China to other parts of the world in a span of several months.

The latest development comes a day after a U.S. military dependent in South Korea tested positive for the virus after visiting a store on Camp Walker, a military base in the southeast city fo Daegu.

USFK promptly raised its risk level from moderate to high.

The Trump administration has come under fire from public health officials and lawmakers alike over its response to the outbreak. Trump himself tweeted on Monday night that the virus was “very much under control.”

But as stocks plunged for the second day in a row on Tuesday amid a tidal wave of concerns over the outbreak, Republican and Democratic lawmakers chided the White House for its apparent lack of preparation. Their remarks came the same day a top U.S. health official warned the spread of the virus in the U.S. was inevitable.

Still, other Trump officials sought to quell concerns, with White House economic adviser Larry Kudlow claiming the the administration had contained it.

The news of the soldier’s diagnosis came just as Democratic presidential candidates were addressing how they would respond to the outbreak on the debate stage in South Carolina. Meanwhile, Trump took to Twitter again on Tuesday night to assure the public his administration was doing what was necessary to respond to the health crisis.

“CDC and my Administration are doing a GREAT job of handling Coronavirus, including the very early closing of our borders to certain areas of the world,” Trump tweeted.

“It was opposed by the Dems, “too soon”, but turned out to be the correct decision,” he added. “No matter how well we do, however, the Democrats talking point is that we are doing badly. If the virus disappeared tomorrow, they would say we did a really poor, and even incompetent, job. Not fair, but it is what it is. So far, by the way, we have not had one death. Let’s keep it that way!”

China has been the epicenter of the new coronavirus outbreak, which was first identified in the city of Wuhan, in Hubei province. The country has seen more than 2,000 deaths linked to the virus.

South Korea has seen the highest number confirmed coronavirus cases outside China.

https://thehill.com/policy/healthcare/484646-us-soldier-in-south-korea-tests-positive-for-coronavirus

Alabama city rejects federal plan to bring in coronavirus patients

The federal government has abandoned plans to transfer patients infected with the new strain of coronavirus to a city in Alabama after local and state officials say they were not kept abreast of the plans, according to a CNN report.

HHS was considering using a Federal Emergency Management Agency Center for Domestic Preparedness in Anniston, Ala., as a backup location for Americans who have contracted the new virus, dubbed COVID-19.

The patients transported primarily would have been COVID-19 patients who tested positive for the virus while on the Diamond Princess cruise ship. There were 53 confirmed COVID-19 cases in the U.S. as of Feb. 24, 36 of whom were patients evacuated from the cruise ship in Japan.

But local and state officials said at a news conference in Anniston Feb. 24 that they were not informed of the details of the plan. Anniston Mayor Jack Draper said that despite meetings with HHS, city and county officials were not informed of what would be expected of them, first responders, healthcare personnel and community partners.

“We’re simply not prepared to help our fellow citizens at this time who have been diagnosed with this disease,” Mr. Draper said.

On Feb. 22, HHS sent a news release “notifying the State of Alabama that [the patients] were scheduled to begin transporting to Alabama as early as Wednesday,” Alabama Gov. Kay Ivey said, according to CNN.

Initially, local city officials considered taking legal action to stop the transfer. But on Feb. 23, HHS released a statement saying the FEMA Center for Domestic Preparedness in Anniston “was one site determined to be suitable and effective [for housing coronavirus patients], but is not needed at this time,” according to CNN.

City officials said they have decided not to pursue legal action.

https://www.beckershospitalreview.com/public-health/alabama-city-rejects-federal-plan-to-bring-in-coronavirus-patients.html

Biohaven Pharmaceuticals EPS misses by $0.92

Biohaven Pharmaceuticals (NYSE:BHVN): Q4 GAAP EPS of -$2.85 misses by $0.92.

Cash balance of $316.73M

Press Release

https://seekingalpha.com/news/3545559-biohaven-pharmaceuticals-eps-misses-0_92

Rapid MRI Tops 3D Mammo for Dense Breast Screening

A 10-minute MRI for breast cancer screening in women with dense breasts was associated with improved cancer detection compared with digital breast tomosynthesis (DBT), a cross-sectional study found.

Among the more than 1,400 average-risk women in the study, the rate of invasive cancer detection was 11.8 per 1,000 women with abbreviated breast MRI, as compared with 4.8 per 1,000 with DBT, also known as 3D mammography (P=0.002), Christiane Kuhl, MD, PhD, of the University Hospital Aachen in Germany, and colleagues reported.

Abbreviated MRI had a sensitivity of 95.7% and specificity of 86.7% for detecting cases of either invasive cancer or ductal carcinoma in situ (DCIS), compared to sensitivity and specificity rates of 39.1% and 97.4%, respectively, for 3D mammography.

“The significantly higher sensitivity of abbreviated breast MRI was associated with a reduced specificity, but with a PPV [positive predictive value] that was not significantly different from that of DBT,” the group wrote in JAMA.

In the MRI arm, 7.5% received recommendations for additional imaging based on positive findings versus 10.1% for the DBT arm (P=0.02). Notably, PPV values were still relatively low with both modalities: at 19.6% in the MRI arm and 31.0% with DBT (P=0.15).

“Women and referring physicians should be aware that having a screening abbreviated breast MRI, especially a baseline examination, may lead to additional benign biopsy findings, 6-month follow-up recommendations, or both,” wrote Kuhl and coauthors. “On the other hand, DBT, but not abbreviated breast MRI, may require further imaging after initial screen-detected abnormalities.”

In an accompanying editorial, Anna Tosteson, ScD, of Dartmouth College and Norris Cotton Cancer Center in Lebanon, New Hampshire, noted that “the promise” of abbreviated MRI — it takes less than 10 minutes — is the improved cancer detection minus the cost and time constraints associated with conventional MRI.

“However, abbreviated breast MRI still requires the contrast-enhancing agent used in full-protocol breast MRI and thus carries the same gadolinium-associated risks,” she said.

Tosteson pointed out that the improved detection rate with abbreviated MRI — seven additional cancers per 1,000 women screened — compares favorably to results of a recent trial that randomized women with dense breasts and a negative mammogram to supplemental ultrasound or DBT imaging. There, adding ultrasound yielded an additional two detected cancers per 1,000 women screened over DBT.

But in the current trial, the so-called EA1141 study, accelerated MRI also introduced more biopsies (107) to reach that goal compared with 3D mammography (29).

“Overall, the cascade of care ensuing from an abbreviated breast MRI callback would likely also be more costly because of the more involved and expensive types of additional imaging and procedures,” said Tosteson.

Writing in an editorial in JAMA Surgery, Lisa Newman, MD, MPH, and Cheng-Har Yip, MBBS(Mal), wrote that, compared with conventional MRI, the shorter patient time with abbreviated MRI and reduced reading time from the radiologist could be potential cost-savers, but also highlighted the additional biopsies in the accelerated MRI arm.

“All of these findings would be expected to have cost implications,” Newman and Yip wrote.

From December 2016 to November 2018, Kuhl and colleagues randomized 1,444 women ages 40 to 75 to first undergo accelerated MRI followed by DBT, or vice versa, at 47 centers in the U.S. and one in Germany. All women included in the trial had an average risk of breast cancer and had dense breasts on their most recent mammogram. In, all 77% had heterogeneously dense breasts and 15% had extremely dense breasts.

Screening detected 19 invasive breast tumors in 17 women. Abbreviated MRI cancer in all 17 of the women while DBT detected cancer in seven. When including cases of DCIS, these numbers were 22 and 9, respectively.

One serious limitation of accelerated MRI for breast cancer screening, the study authors noted, is the lack of available MRI units to regularly screen such a large population (over 40% of U.S. women have dense breasts).

“Although abbreviated breast MRI does not require specific additional equipment beyond what is used for regular breast MRI, given the current limited availability of breast MRI in general for screening the relatively small number of women at high risk of breast cancer, the ability of centers to offer abbreviated breast MRI may be limited until more MRI units are added,” they wrote.

Disclosures

The study was in part funded by grants from the National Cancer Institute. The ECOG-ACRIN Cancer Research Group, which coordinated the study, received funding from Bracco Diagnostics.

Tosteson reported having no conflicts of interest.

Newman disclosed having served on the mammography screening advisory committee for the American Society of Breast Surgeons. Yip had no disclosures.

Dementia Screening: Evidence is Lacking, Says USPSTF

Not enough evidence for benefit that exceeds potential harms exists to recommend screening older adults who don’t have signs of cognitive impairment, the U.S. Preventive Services Task Force (USPSTF) said Tuesday.

In its final statement on the subject, the USPSTF concluded that “the current evidence is insufficient to assess the balance of benefits and harms of screening for cognitive impairment in older adults,” wrote task force chair Douglas Owens, MD, of Stanford University in California, and colleagues in JAMA.

“The task force is calling for more research to address this serious issue,” Owens said in a statement. “Research is especially needed on whether screening and early detection of cognitive impairment helps patients, caregivers, and doctors make decisions about healthcare or plan for the future.”

The recommendations apply to community-dwelling adults, ages 65 or older, without signs of cognitive impairment, and update similar guidelines that were published in 2014. A draft version of the new recommendations were available for public comment in fall 2019.

In an accompanying evidence report, Carrie Patnode, PhD, MPH, of Kaiser Permanente in Portland, Oregon, and colleagues, looked at cognitive screening utility, cognitive testing accuracy, harms of screening, interventions for people with cognitive interventions, and harms of those interventions.

In some areas, like testing accuracy, evidence was clear: “Screening instruments can adequately detect cognitive impairment,” Patnode and colleagues wrote.

But in other areas, “the studies aren’t out there that address the questions,” said Ronald Petersen, PhD, MD, of the Mayo Clinic in Rochester, Minnesota, in an interview with MedPage Today.

Only one trial focused on the utility of screening in primary care and it failed to demonstrate benefit or harm, noted Petersen and Kristine Yaffe, MD, of the University of California San Francisco, in an accompanying editorial.

That study — the IU CHOICE trial — was designed and funded to address the lack of empirical data in the previous USPSTF review.

IU CHOICE faced “many, many challenges” including recruitment and retention problems, said Petersen, who wasn’t involved with the trial. Of 134 people who screened positive for dementia, only 46 people (34%) received subsequent evaluation. “The study was underpowered,” Petersen said. “I think it speaks to the fact that studies like this are very difficult to do.”

The 12-month follow-up period in IU CHOICE also may have been too short, Petersen and Yaffe noted. “When you’re assessing cognitively unimpaired people, you really need to follow these people for years,” Petersen said. “The outcome is going to be down the road somewhere.”

In their review of interventions, Patnode and colleagues looked at 224 randomized trials and three observational studies, and concluded that FDA-approved treatments like acetylcholine esterase inhibitors and memantine had common, known adverse effects and showed short-term benefits only.

Overall, Patnode’s group found no empirical evidence that screening for cognitive impairment improves patient or caregiver outcomes or causes harm. “It remains unclear whether interventions for patients or caregivers provide clinically important benefits for older adults with earlier detected cognitive impairment or their caregivers,” they wrote.

Potential harms in diagnosing dementia should “include uncertainty about the meaning of a diagnosis and the inability to accurately advise patients about prognosis,” observed Carol Brayne, MD, of University of Cambridge in England, in an editorial in JAMA Internal Medicine.

In the U.K., older adults with unplanned hospital admissions have been screened for dementia, a policy withdrawn because its benefit was unclear, Brayne noted.

“Risk reduction for cognitive impairment includes stopping smoking and moderating alcohol intake; promoting healthful diet and physical activity; and preventing and managing hypertension, cardiovascular disorders, diabetes, and depression,” she wrote. “Clinicians can recommend these approaches to reduce risk to all older adults without the need for any cognitive screening.”

It’s important that physicians, patients, and families understand that the USPSTF recommendation “does not imply that people with memory or related cognitive problems should not be assessed,” said Howard Fillit, MD, executive director and chief science officer at the Alzheimer’s Drug Discovery Foundation in New York, who was not part of the task force. “In fact, about 10% of people with cognitive impairment have a reversible cause.”

“The question, from a population health societal perspective, is not whether or not there should be screening, but what population should be screened,” Fillit told MedPage Today. “Certainly people with complaints of memory impairment should be screened and assessed, especially individuals 75 and over, in whom cognitive impairment is highly prevalent.”

Primary care physicians have limited time with patients during office visits and this report might give them a reason to not include cognitive screening in their assessment, Petersen and Yaffe pointed out. “It would be a mistake if clinicians did not consider the value of screening for cognitive impairment on a case-by-case basis,” they wrote.

The American Academy of Neurology (AAN) recommends that neurologists and other physicians providing neurological care should screen patients age 65 and older yearly for cognitive impairment and issued new metrics in September 2019 to improve patient care in this area.

Last Updated February 25, 2020

Disclosures

The research was funded by the Agency for Healthcare Research and Quality (AHRQ) to support the USPSTF. All USPSTF members disclosed receiving travel reimbursement and an honorarium for participating in USPSTF meetings. One task force member disclosed support from Healthwise.

Petersen disclosed relevant relationships with Roche, Merck, Biogen, Eisai, Genentech, GE Healthcare, the GHR Foundation, and the Mayo Clinic Foundation for Medical Education and Research. Yaffe disclosed relevant relationships with Alector, Eli Lilly, the Beeson Scholars Program, the Global Council of Brain Health, the Doris Duke Charitable Fund, and the Alzheimer’s Disease Drug Discovery Fund.

Brayne disclosed no relevant relationships with industry.