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Sunday, March 1, 2020

As coronavirus deaths rise in Italy, government prepares economic support

The head of Italy’s Civil Protection Agency said the cumulative number of confirmed cases of the virus had jumped to 1,694 from 1,128 on Saturday, virtually all of them coming to light since Feb. 20 in the worst such contagion in Europe.
Of that number, 83 people had fully recovered, while 140 patients were in intensive care. The vast majority of those who have tested positive have few, if any symptoms.
Around 90% of all cases are concentrated in the wealthy northern regions of Lombardy, Veneto and Emilia Romagna. The government has ordered that schools and universities must remain closed there for a second week, with large public gatherings still banned in an effort to halt the contagion.
As the human toll grows, the government is increasingly worried about the economic outlook. Economy Minister Roberto Gualtieri announced the cabinet would approve this week 3.6 billion euros ($3.5 billion) of measures to help companies.
This came on top of an aid-package worth 900 million euros that was unveiled on Friday for the worst-impacted zones.
“I want to reassure Italians that we are well aware of the problems and dangers,” Gualtieri said, adding that if additional help was needed it would have to come at a European level.
Opposition politicians said the proposals were far too limited, with the head of the far-right League, Matteo Salvini, demanding “at least 20 billion euros” of additional spending.

FLIGHTS CUT

One of the hardest hit sectors is likely to be tourism, which accounts for 13% of gross domestic product, with hotels reporting mass cancellations even in cities with few or no coronavirus cases, such as Rome.

Underscoring the challenges, Turkey on Sunday banned all flights to and from Italy, while both the United States and Japan advised their citizens not to travel to swathes of the north, including tourist hotspots like Venice and Verona.
Cinemas, discos and theaters, including Milan’s prestigious La Scala opera house, must remain shuttered in the three hardest-hit regions for a further week, while museums will be allowed to reopen to a limited number of visitors.
For the first time, a church in the heart of Rome announced that it was closing as a precautionary measure after a priest who had been working there came down with the virus.
The St. Louis of the French in Piazza Navona is particularly popular with tourists because it houses paintings by Caravaggio.
A Roman Catholic news agency said the 43-year-old priest had returned to Paris by car in the middle of February and tested positive for the virus on Friday. Only two cases of the disease have come to light so far in Rome — two Chinese tourists in January — and it was not clear where the priest was infected.
Pope Francis said on Sunday he had a cold and would have to skip a week-long Lenten spiritual retreat for the first time in his papacy. The Vatican has played down speculation he might have coronavirus, saying he only had a “slight indisposition”.
The contagion has also hit the sporting world, forcing the cancellation this weekend of five top flight Serie A matches, which followed a similar disruption last week.
The chief executive of Inter Milan, which is vying for the Serie A title, warned on Sunday that the season might not finish at all if any more matches are postponed.
https://www.reuters.com/article/us-china-health-italy/coronavirus-deaths-rise-in-italy-government-prepares-economic-support-idUSKBN20O257

What US Hospitals Should Do Now to Prepare for a COVID-19 Pandemic

Eric Toner, MD, and Richard Waldhorn, MD | February 27, 2020
The World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC) have called on health systems around the world to prepare for a possible COVID-19 pandemic. The purpose of this article is to offer to American hospital administrators and clinicians specific judgment on what hospitals should do to prepare for a COVID-19 pandemic. This is an update of a similar perspective related to pandemic influenza, published in 2006.1 These recommendations derive from the authors’ analysis of the consequences of a flu pandemic, review of many existing hospital plans, analysis of the federal government’s recommendations, and meetings with a number of leaders in health care, public health, and emergency management. Recognizing that any such recommendations must be based on numerous untestable assumptions, any of which can be reasonably challenged, we propose specific actions and priorities for the purpose of making the discussion of hospital pandemic preparedness issues more operationally useful. This commentary pertains to hospitals, but long-term care facilities, outpatient clinics, medical offices, and other healthcare facilities must also urgently prepare.

The Argument for Urgent Preparedness

The current COVID-19 epidemic looks very much like an early influenza pandemic in many important respects. It is spreading from person to person efficiently, much like influenza, including some degree of pre-symptomatic spread. Although the true case fatality rate is as yet uncertain, all evidence suggests that it is as severe as, if not more severe than, influenza pandemics of the last century. The case fatality rate (CFR) of confirmed COVID-19 patients in China is estimated to be 1-3%, although this may not account for all mildly symptomatic or asymptomatic infections. In some regions of China outside Hubei, the CFR has been less than 1%. For comparison, the CFR of the 2009 influenza pandemic was around 0.1%, the 1968 and 1957 pandemics in the United States were about 0.5%, and the CFR of the 1918 pandemic was estimated to be 2.5 % in the United States.
Because it will take considerable time to fully understand the epidemiology of COVID-19, it is reasonable to begin preparations using a model we have studied extensively for decades and that seems similar to COVID-19—pandemic influenza. The threat of a novel influenza pandemic has stimulated international, national, and local planning and preparedness efforts for years. In the event of a 1918-scale flu pandemic, hospitals would be flooded with sick patients seeking care.
The impact of a COVID-19 pandemic on hospitals is expected to be severe in the best of circumstances. Currently, US hospitals routinely operate at or near full capacity and have limited ability to rapidly increase services. There are currently shortages of healthcare workers of all kinds. Emergency departments are overcrowded and often have to divert patients to other hospitals.
In recent years, there has been a reduction in the overall number of hospitals, hospital beds, and emergency rooms. During an epidemic, the healthcare workforce would be greatly reduced. Healthcare workers would face a high risk of infection because of contact with infected patients; many would need to stay home to care for sick relatives, and, in the absence of vaccine, others might fear coming to work lest they bring a lethal infection home to their families. The provision of medical services to both COVID-19 and non–COVID-19 patients may be adversely affected in most communities.
Detailed modeling projections for COVID-19 have not yet been released by the US government or WHO; however, the US Department of Health and Human Services (HHS) released official planning assumptions for pandemic influenza, ranging from a moderate pandemic like 1968 or 1957, to one based on a very severe pandemic like 1918.2 These may be the best tools we have at the moment. They differ by more than 10-fold in the number expected to need hospitalization, intensive care, and mechanical ventilation (see Table 1).

Table 1

HHS pandemic planning assumptions

Moderate Scenario (1968-like) Very Severe Scenario (1918-like)
38 M needing medical care 38 M needing medical care
1 M hospitalizations 9.6 M hospitalizations
200,000 needing ICU 2.9 M needing ICU
As a comparison, there are about 46,500 medical ICU beds in the United States and perhaps an equal number of other ICU beds that could be used in a crisis. Even spread out over several months, the mismatch between demand and resources is clear.
Some patients in China have been treated with extracorporeal membrane oxygenation (ECMO), and some US medical centers with this technology are preparing to use it as well. For US hospitals with this capability, it would be prudent to think through how this scarce resource would be allocated if demand exceeds resources.

Preparedness Defined

Based on such calculations, it would seem that preparing for a pandemic of even moderate severity is a difficult challenge. For the purpose of this analysis, we use the following definition of preparedness:
Every hospital, in collaboration with other hospitals and public health agencies, will be able to provide appropriate care to COVID-19 patients requiring hospitalization while maintaining other essential medical services in the community, both during and after a pandemic.
This definition recognizes that what constitutes “appropriate care” and the criteria for hospital admission may well change during a pandemic.

The Top Priorities

Individual hospitals and groups of hospitals involved in regional coordination of pandemic preparedness should focus their initial preparedness efforts in the following priority areas:
  1. Comprehensive and realistic planning based on actual CDC FluSurge projections in each hospital, and collaborative planning among all hospitals in a region (eg, healthcare coalitions).
  2. Limiting the nosocomial spread of the virus to (1) protect the healthcare workers and, thus, maintain a hospital workforce; (2) prevent the hospital from being a disease amplifier; and (3) protect the non–COVID-19 patients from infection, so as to maintain the ability to provide essential non–COVID-19 health care.
  3. Maintaining, augmenting, and stretching the hospital workforce.
  4. Allocating limited healthcare resources in a rational, ethical, and organized way so as to do the greatest good for the greatest number.

Specific Priority Actions to Be Taken

To implement the priority goals above, hospitals should undertake the following specific actions:
  1. Employing a comprehensive and realistic planning process:
    • Employ at least 1 full-time hospital emergency manager in each hospital.
    • Dedicate a full-time infection prevention practitioner to work on infection prevention aspects of the preparations, including education, training, and exercises.
    • Designate a medical director to work closely with the emergency manager and infection prevention practitioner.
    • Create a pandemic preparedness committee (or use an existing emergency management committee) that includes representatives of all clinical and support departments as well as senior administrators.
    • Participate in a local healthcare coalition, which includes neighboring hospitals, local public health agencies, and emergency management. Members of multi-hospital health systems should integrate system-wide planning with local planning with other local hospitals.
    • We do not yet have modeling tools or planning assumptions for COVID-19. CDC has developed FluSurge 2.0, which can be used in conjunction with HHS planning assumptions to guide planning for both a moderate and severe pandemic.3 Note that the default assumptions in FluSurge are based on a 1968-like pandemic. To model a severe pandemic, FluSurge allows the assumed number of hospitalizations to be modified to correspond to the HHS planning assumptions for a severe pandemic.
    • Be able to make 30% of licensed bed capacity available for COVID-19 patients on 1 week’s notice. About 10-20% of a hospital’s bed capacity can be mobilized within a few hours by expediting discharges, using discharge holding areas, converting single rooms to double rooms, and opening closed areas, if staffing is available. Another 10% can be obtained within a few days by converting flat spaces, such as lobbies, waiting areas, and classrooms.4
    • Collaborate in regional plans to be able to make at least 200% of licensed bed capacity in the region available for COVID-19 patients on 2 weeks’ notice.
    • Use telephone and internet-based advice lines to reduce unnecessary visits to the hospital emergency department.
  2. Limiting the nosocomial spread of the virus:
    • The CDC has provided good technical guidance on infection control for COVID-19 in healthcare facilities.5
    • Limit the accidental contamination of the hospital environment by implementing respiratory etiquette and by using simple surgical masks for everyone entering the facility (staff, patients, and visitors) during a pandemic. Assuming re-supply may be difficult during a pandemic, stockpile enough masks for 3 weeks.
    • Prevent staff from getting infected by training healthcare workers on the use of personal protective equipment (PPE) and infection control procedures and by stockpiling a supply of PPE. PPE availability is currently limited, but hospitals should purchase what they can, recognizing that a local outbreak could last at least several weeks to several months. Given the preeminent need to protect healthcare workers, we feel the highest level of protection available should be used. We call for the use of N95 respirators for healthcare workers with direct contact with COVID-19 patients. This is in concert with the CDC’s COVID-19 guidelines. Powered air-purifying respirators (PAPRs) should be available for use in high-risk aerosol-generating procedures.
    • Limit the number of staff who are exposed to COVID-19 patients by cohorting (dedicated staff in dedicated units) (see Figure 1). Utilize overtime and long shifts for staff in the COVID-19 units to limit the number of staff needed. When possible, use staff who are immune (recovered) in the COVID-19 units.
    • Prevent infected staff from working (except with COVID-19 patients) by tracking staff who are sick and testing for COVID-19, if possible, and keeping a log of staff who have had confirmed COVID-19.

    Figure 1

    Cohorting

    Figure 1: Cohorting

  3. Maintaining, augmenting, and stretching the hospital workforce:
    • Vaccinate all staff for influenza to reduce the burden of that disease.
    • Organize in-home childcare for well children of healthcare workers if schools are closed, using screened volunteers.
    • Provide medical daycare for sick family members.
    • Allay fear through open, honest, and transparent planning and careful training.
    • Shift clinical staff to highest-need areas from areas that may be closed or quiet; employ “just in time” education and “buddy teaming.”
    • Augment clinical staff with nontraditional personnel, employing “just in time” education and “buddy teaming.” Use (1) medical professionals with prior clinical experience (eg, administrators, researchers, retirees, etc); (2) related health professionals (eg, dentists, veterinarians, emergency medical technicians, etc); (3) nonclinical hospital personnel; and (4) nonclinical outside personnel. Specific training and operating procedures for each group must be created in advance.
    • Coordinate plans with other hospitals in the region to recruit and use volunteers.
  4. Allocating limited healthcare resources in a rational, ethical, and organized way so as to do the greatest good for the greatest number through deferral of nonemergency care and, if necessary, institution of alternative patient care routines.
    • Prioritize which services and types of procedures can be deferred, for how long, and with what consequences and create an alternative plan for patients who will be deferred. Create a process for refining and updating this plan as circumstances change. Create a process to track deferred patients.
    • Plan for the graceful transition to contingency and crisis standards of care. In a severe pandemic, not all patients in need of intensive care will be able to be accommodated in the ICU. Normal staffing ratios and standard operating procedures will not be able to be maintained.
    • Plan for alternative sites to provide ICU-like care within the hospital (eg, catheterization lab, catheterization recovery, OR, PACU, endoscopy units, etc).
    • Implement contingency and crisis standards, which will be justified when conventional standards cannot be maintained despite the use of all available resources, including mutual aid arrangements. The legal and ethical framework for these decisions should be considered well in advance of a crisis. Alterations in hospital policy and procedures should be implemented by an active decision of the hospital leadership in consultation with the medical staff and civil authorities.
    • Create criteria/clinical guidelines for use (or denial) of resource-intensive services (eg, admission, mechanical ventilation, invasive monitoring) based on national guidelines, such as the Crisis Standards of Care report6 in regional collaboration with other hospitals.
    • Establish a process for triage of patients competing for limited resources, including admission, early discharge, and life support. These decisions should not be made solely by 1 person. The criteria used to make these decisions should be created in advance and formally sanctioned by the medical staff and hospital administration.

How to Proceed

Although a COVID-19 pandemic seems all but inevitable, there is still uncertainty about its severity in the United States. Time will tell, but, in the meantime, hospitals should not delay. In the event of a pandemic, the predictable costs of not preparing, in human, societal, and political terms, would be huge. Decision makers at all levels—including hospital CEOs and their boards and state and federal officials—should consider these issues and how to proceed. Several of the first priority items (comprehensive and collaborative planning, discussing allocation of scarce resources, and planning education and training) take substantial time. Hospitals should begin these actions now.

References
  1. Toner E, Waldhorn R. What hospitals should do to prepare for an influenza pandemic. Biosecur Bioterror 2006;4(4):397-402. http://www.centerforhealthsecurity.org/our-work/publications/2006/what-hospitals-should-do-to-prepare-for-an-influenza-pandemic. Accessed February 25, 2020
  2. US Department of Health and Human Services. Pandemic Influenza Planhttps://www.cdc.gov/flu/pandemic-resources/pdf/pan-flu-report-2017v2.pdf. Accessed February 25, 2020.
  3. Centers for Disease Control and Prevention. FluSurge 2.0. Reviewed August 22, 2016. https://www.cdc.gov/flu/pandemic-resources/tools/flusurge.htm. Accessed February 25, 2020.
  4. Hick JL, Hanfling D, Burstein JL, et al. Health care facility and community strategies for patient care surge capacity. Ann Emerg Med 2004;44(3):253-261.
  5. Centers for Disease Control and Prevention. Coronavirus Disease 2019 (COVID-19). Infection control. Reviewed February 24, 2020. https://www.cdc.gov/coronavirus/2019-ncov/infection-control/index.html. Accessed February 26, 2020.
  6. Hanfling D, Hick J, Stroud C, eds. Committee on Crisis Standards of Care. Crisis Standards of Care: A Toolkit for Indicators and Triggers. Washington, DC: National Academies Press; 2013. http://www.acphd.org/media/330265/crisis%20standards%20of%20care%20toolkit.pdf. Accessed February 25, 2020.
http://www.centerforhealthsecurity.org/cbn/2020/cbnreport-02272020.html

NMC Health hires Moelis for debt restructuring

NMC Health, the UAE healthcare company, has hired Moelis & Co to advise on a debt restructuring, three sources familiar with the matter said on Sunday.

The sources said NMC had hired Moelis in relation to its ability to meet debt obligations.
Britain’s Financial Conduct Authority (FCA) said on Feb. 27 it would investigate the finances of NMC Health, whose shares were suspended on the London Stock Exchange last week.
NMC, part of the FTSE 100 index of leading shares has said it would cooperate with the FCA and any other relevant authorities. It had earlier said it was focused on providing clarity to the market as to its financial position.
The company’s shares have lost more than half of their value since last December when U.S. based short-seller Muddy Waters first questioned its financial statements. NMC’s own review of its finances is being led by former FBI boss Louis Freeh.
Standard Chartered, First Abu Dhabi Bank and HSBC are among the banks that provided debt to the company, the three sources familiar with the situation said. The size of the loans could not be immediately determined.
NMC declined to comment on the hiring of Moelis or its ability to meet debt obligations. Moelis did not immediately respond to a request for comment outside working hours.
Spokespeople for HSBC and Standard Chartered declined to comment while First Abu Dhabi Bank did not immediately respond to a request to comment.
In the year that ended December 31, 2018, NMC Health entered a syndicated facility of $2 billion to settle an existing syndicated loan and for acquisition purposes, NMC has said in filings to the stock exchange.
The company’s troubles have also been compounded by doubts over the size of shareholdings of major investors, including founder and former co-chair BR Shetty and former vice-chairman Khaleefa Butti Omair Yousif Ahmed Al Muhairi. These issues are also being looked into under a separate legal review.
Shetty founded NMC Health in mid-1970s and built it into the largest private healthcare company in the United Arab Emirates.
https://www.marketscreener.com/FTSE-100-7392/news/NMC-Health-hires-Moelis-for-debt-restructuring-sources-30090662/

Mike Bloomberg has a lot of bad ideas for health care

It took Mike Bloomberg three months and $400 million, but he finally qualified for a Democratic debate. The former New York mayor earned his place on stage in Las Vegas on Feb. 19 after surging to second place in the polls, just behind Sen. Bernie Sanders, I-Vt.
But like many wealthy hopefuls before him, Bloomberg lost big in Sin City. His opponents attacked him on a variety of issues, including health care. Notably, former Vice President Joe Biden critiqued Bloomberg for his past criticisms of ObamaCare, which he now claims to support.
Biden only scratched the surface. Bloomberg has a long record on health care that Democratic voters may find objectionable. His past statements reveal a distaste for ObamaCare and comfort with the type of government rationing that would characterize “Medicare-for-all.”

Unlike Sanders, Bloomberg has promised “to achieve universal coverage” by improving ObamaCare, not replacing it. In particular, he has pledged to protect ObamaCare from Republican attacks. Clips of President Trump critiquing ObamaCare were featured in a campaign ad that Bloomberg’s campaign spent over $41 million to air 46,000 times.
But as Biden pointed out in last week’s debate, Bloomberg hasn’t always been such a staunch defender of ObamaCare. In a speech given a few months after President Obama signed his health plan into law, Bloomberg called ObamaCare “a disgrace.” He also dismissed it as “another program that’s going to cost a lot more money” but do “absolutely nothing to fix the big health care problems in this country.”
Bloomberg was particularly concerned that the bill would give coverage to millions of people without doing anything to expand the nation’s physician supply. Without a sufficient number of doctors, Bloomberg predicted the newly insured would continue flocking to emergency rooms.

Bloomberg’s proposal to build on ObamaCare wouldn’t fix any of the problems he previously complained about. He has proposed a “Medicare-like public option,” wherein the federal government would charter a new health plan to compete against private plans. According to his campaign, this would “increase competition in the private insurance market, pushing down premiums for all.”

But that’s not what would happen. Unlike a government-run plan, private insurers don’t have the power to underpay providers. Medicare’s reimbursement rates to healthcare providers are about 40 percent lower than those paid by private insurance. Nor can private insurers draw on the U.S. Treasury to help pay out claims. They have to set premiums high enough to cover their costs.
Given the chance, many Americans would jump to an artificially cheap public plan. Within a decade, nearly 7 million uninsured people would gain coverage through the public option, according to a study by KNG Health Consulting. By that time, the United States is projected to be short nearly 122,000 doctors.
That sounds like a recipe for long waits and overcrowded hospitals — just as the Bloomberg of a decade ago predicted.
Bloomberg’s response to care crunches like these is what we might expect from a master of the universe like him — rationing by government officials who know best. A video released on Feb. 17 showed Bloomberg in 2011 saying providers should deny treatment to older patients, citing the example of a 95-year-old with prostate cancer.
Government-dominated health systems abroad routinely prioritize treatment for younger people — who will live, work, and pay taxes longer. That means denying care for elderly people, no matter how desperately they need it.
In the United Kingdom, for example, many of the National Health Service’s regional governing bodies restrict access to cataract removal until patients have lost a certain amount of sight. One in five Canadians 55 or older say they have significant issues accessing health care.

I have some personal experience with the damaging effects of rationing. In Canada, my mother died of colon cancer after doctors denied her treatment to accommodate younger patients.
Bloomberg wants voters to believe he can bring moderation back to the White House. But his plan for health care features the same affinity for government overreach that has been his calling card throughout his political career.
https://www.foxnews.com/opinion/sally-pipes-mike-bloomberg-bad-ideas-for-health-care

Iran Battles Coronavirus — and the Black Market for Medical Supplies

Iranian authorities have seized millions of medical supplies being hoarded by black-market traders, an effort to alleviate their own shortfall as they battle to contain the world’s second-deadliest national coronavirus outbreak.
The death toll from the epidemic in Iran rose to 54 people Sunday, the health ministry said, up from 43 the previous day. The number of confirmed cases rose 65% from the day before to 978.
The country is suffering from a shortage of critical medical supplies, caused partly by an import ban on a variety of products aimed at boosting Iran’s domestic industry in the face of U.S. sanctions. The import ban on protective masks was lifted last week, and an import tariff of 55% was lowered to 5%.
As the epidemic has spread, traders and smugglers have stocked up on supplies in order to sell them at inflated prices, government officials say. Some consumers and health clinics have been forced to buy them from the black market.
In the past week, Iranian police have responded by confiscating more than 27 million hygienic items, including 6.7 million masks — about four days’ worth of domestic production — from hoarders, arresting at least 70 people. In the past 48 hours, they have confiscated more than 10 million gloves, 10 tons of disinfectant and 9,000 gallons of dialysis machine acid, said the police chief for economic crimes, Mohammadreza Moghimi.
Authorities have also temporarily closed down dozens of pharmacies for hoarding and overcharging for masks.
The push has implicated Iran’s biggest online retailer.
In a news broadcast, state television reporters followed agents from the country’s judiciary into a warehouse belonging to Digikala, where they found a stock of what the company said was 34,000 protective masks, despite not having a license to sell them. Digikala in a statement denied breaking any regulations.
Iranian Health Minister Saeed Namaki in a letter to President Hassan Rouhani said once the coronavirus took hold in China, he ordered the customs bureau to ban exports of masks and assigned colleagues to stock up on them in case they were needed for an outbreak in Iran.
“Unfortunately, a small amount was purchased and the rest of the products went to the black market,” Mr. Namaki wrote in the letter published Saturday by the semiofficial Mehr news agency.
Faced with a public-health crisis, Iranian authorities have ordered hospitals to focus on coronavirus patients and other emergency cases. They have canceled public events such as Friday prayers.
“If people follow the instructions, avoid hanging out and socializing, traffic and stop traveling, we will see the outcome in the next three, five days or next week,” health ministry spokesman Kianoush Jahanpour said on state television.
Experts have questioned the official Iranian statistics and suggested that the actual number of cases may be in the tens of thousands, based on the number of deaths and cases abroad originating from Iran.
Experts say the official number might reflect insufficient surveillance and a lack of ability to detect the virus. Some Iranians have said they are reluctant to get tested out of fear of contracting the virus in hospitals. Iranian authorities have denied misleading the public about the epidemic.
The sharp increase in cases on Sunday shows the results of stepped-up surveillance and more willingness among Iranians to be tested, the health ministry said.
The coronavirus has spread from Iran, primarily via travelers who visited the holy pilgrimage city of Qom, to at least 12 other countries, including Armenia, which on Sunday reported its first case.
Mr. Rouhani in a phone call Saturday with Russian President Vladimir Putin said, “We are moving toward complete control of the situation.”
But the head of Tehran’s coronavirus management operations, Alireza Zali, said, “We will definitely be dealing with this virus for a considerable period.”
Iran’s deputy health minister for treatment, Qassem Janbabaei, said that in the best-case scenario, Iran would be dealing with the virus until the Iranian New Year on March 19, but possibly until late June, according to the Young Journalists Club state news agency.

https://www.marketscreener.com/news/Iran-Battles-Coronavirus-and-the-Black-Market-for-Medical-Supplies–30090773/

Big Drugmakers Warn About Coronavirus Impact on Business

Some of the world’s biggest drugmakers have begun warning that their businesses could be affected by the spread of the coronavirus.
AstraZeneca PLC, Merck & Co. and Pfizer Inc. are among the companies that said recently the epidemic could affect supplies for certain drugs or sales, depending on how long the epidemic lasts.
To get ahead of any disruptions to supplies from China, some pharmaceutical companies have begun looking for alternative sources of drug ingredients and supplies, according to industry officials and experts.
Drugmakers have begun discussing the potential impact after saying for weeks they were monitoring their distribution lines and had sufficient supply. Companies typically avoid discussing their supply chains, but they have been under pressure from Wall Street to provide more information as the epidemic spreads, especially since it started in China, a major source of drug ingredients and a fast-growing market for medicines.
“Our whole industry is in one way or other way connected with China, but you would expect us to be much better placed,” Mylan NV President Rajiv Malik said Thursday on a conference call with analysts and investors.
Some Mylan products could be in short supply if “the situation persists” for another few months, Mr. Malik said. He said Mylan’s top 25 products don’t depend on China, however, and expressed confidence in the company’s ability to employ alternative sources for drug ingredients.
Pfizer said in a filing on Thursday that the virus could hurt its operations, including manufacturing and supply chain, and could negatively impact its financial results but that it depends on future developments of the outbreak.
Pfizer said the majority of its products and raw materials are sourced from countries besides China, but some does come from China, though the company said it hasn’t seen a disruption to supplies so far.
Teva Pharmaceutical Industries Ltd. bases its manufacturing network for its drug ingredients, known as active pharmaceutical ingredients or API, out of Europe and India, not China, according to Chief Executive Kare Schultz.
“We do use some raw materials and APIs that come out of China [but] in some cases we have dual supply so if we can’t get materials from China we can get them from somewhere else,” he said in a recent interview.
The threat that the novel coronavirus poses for prescriptions has renewed a cause for concern because of China’s role as a big supplier of drug ingredients.
“There is no such thing as a simple supply chain anymore,” said Steven Lynn, a former FDA official who consults with drugmakers on quality and compliance. “Things are coming from all over the world. If one part of that breaks down, then you’re scrambling.”
The Food and Drug Administration said Thursday a drug has gone into shortage because of difficulties obtaining an ingredient from a site affected by the coronavirus. It didn’t disclose which drug or its manufacturer.
How much multinational drugmakers depend on China-sourced ingredients is unclear. Policy makers often cite a figure that 80% of drug materials are imported overseas, but the FDA said it can’t track how much is from China.
China has also emerged in recent years as one of the biggest markets for some major drugmakers. Drug sales in China totaled $137 billion in 2018, and are expected to rise 3% to 6% annually for the next several years, according to health-care data firm Iqvia.
AstraZeneca generated 21% of its sales in China last year. Releasing its forecast for 2020 performance, the company said last month it expects an unfavorable impact from a slower China business lasting up to a few months due to the novel coronavirus.
Merck said in a securities filing Wednesday its first-quarter sales will suffer due to the epidemic in China, although not enough to be material. It said it was unclear if the outbreak will affect sales for the rest of the year.
Merck also said the epidemic has had a limited effect on its supplies of raw materials coming from China and ability to ship medicines into the country.

https://www.marketscreener.com/ASTRAZENECA-PLC-4000930/news/Big-Drugmakers-Warn-About-Coronavirus-Impact-on-Business-30090740/?countview=0

FDA allows new coronavirus testing tech before it gets emergency approval

The FDA is determined to step up the pace of coronavirus testing in the US to cope with the recent coronavirus outbreak, and it’s willing to greenlight technology at an early stage to make that happen. The regulator said it will allow new diagnostic tech to be used to test for COVID-19 before an Emergency Use Authorization request has gone through a review. This will only apply to validated methods from labs that are certified to handle “high-complexity” tests in line with key requirements, the FDA said, and doesn’t amount to lowering standards — this is only to ensure there’s “wide availability” of testing options.
There’s currently just one emergency authorization for COVID-19 in use by the CDC and public health labs, the FDA added. Early US tests were hurt by kits that included a bad reagent that rendered the tests ineffective.
To some degree, this is damage control. On top of the problems with early tests, there have been criticisms of the safety behind the evacuation process and the ability of scientists to speak freely about the current situation. Still, the expedited access could significantly improve testing and give a clearer assessment of who’s infected.
https://www.engadget.com/2020/02/29/fda-allows-early-coronavirus-testing-tech/