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Tuesday, March 31, 2020

Mask middlemen: Pop-up brokers seek big paydays in frenzied market

Brian Kolfage, a Florida military veteran, recently convinced Americans to donate millions of dollars for a privately built wall on the U.S. southern border. Now he has jumped into a new venture: hawking millions of protective face masks that are in critically short supply during the coronavirus pandemic.

About a month ago, Kolfage formed a business called America First Medical, which offers on its website and in social media pitches to broker large-volume sales of high-grade masks known as N95s. He said he charges about $4 each – several times the pre-pandemic prices but a few dollars less than some hospitals, nursing homes and first responders are now paying.
Though he hasn’t yet found buyers, Kolfage says he’s found masks all over the world, including stockpiles hidden away in warehouses in Japan and Eastern Europe. If a deal goes through, he will collect a commission between 1% and 3%, depending on the size of the order, he said.
He said he’s performing a public service. “We’re the ones out there kissing the frogs and doing all the work that these hospitals and others can’t do,” Kolfage, 38, told Reuters. “We’re the ones making these connections. If the hospital wants to pay the money, that’s up to them.”
Kolfage aims to be one of the new mask middlemen. As the novel coronavirus has spread around the world, an improvised, chaotic market has sprung up. Brokers claim to have access to tens or even hundreds of millions of masks — generally outside the normal supply channels and at prices much higher than the former retail price of about $1 each.
High-volume deals – even with low-percentage commissions – could bring big paydays for the middlemen. And these brokers could help ease critical shortages if they succeed in encouraging manufacturers and traders sitting on scarce supplies to sell them where they’re needed.
But the frenzy also has broken down standard quality controls, opening the market to an influx of masks of uncertain origin and effectiveness, medical suppliers and healthcare industry officials say. As supplies run ever lower, hospitals and nursing homes are being deluged with offers, and some say they have no choice but to pursue the promising leads while hoping to sidestep the scams.
The hot commodity in the mask trade is the N95 device, sturdier than surgical masks and better able to filter out much smaller particles such as the coronavirus. Health experts say lower-quality or ill-fitting masks are more likely to let airborne pathogens through, exposing healthcare workers to a virus that has killed nearly 39,000 people across the globe and infected close to 800,000.
Reuters spoke to five new mask brokers, three in the United States and two in China, which is the world’s largest mask manufacturer and accounts for about half of global production. These middlemen described a wild marketplace, in which they seek to quickly connect sellers and buyers before competitors can move in and sell stockpiles out from under them.
Jake Mei, an owner of a pump supply firm in Houston, Texas, said in one LinkedIn posting that he had 8 million masks, two models made by industrial giant The 3M Company, for sale, at $4.10 to $4.20 a mask. “Good price and quick delivery!” he promised. In an interview, however, he said he’s having trouble finding inventory.
None of the middlemen would disclose suppliers or customers, and Reuters could not independently confirm their access to vast stashes. All said manufacturers were setting base prices, which they said accounted for the bulk of recent price increases.
Kolfage told Reuters that the masks he finds – which he says are not from China – are of good quality, certified by the U.S. Food and Drug Administration. And he’s not price gouging, he said, but rather charging a commission far lower than other brokers. Reuters is aware of prices higher than his, including those that New York Governor Andrew Cuomo recently said had risen from 85 cents to $7 apiece.
“This is just an impossible situation to manage,” Cuomo said publicly on March 22, ‘describing a bidding war over medical equipment thats pitting states against states, in which prices can rise within 20 minutes.
On March 23, President Donald Trump signed an executive order prohibiting hoarding and price gouging of medical supplies, and Attorney General William Barr said the Justice Department had launched a national task force to investigate such schemes.
If you “have a big supply of toilet paper in your house, this is not something you have to worry about,” Barr said at a White House briefing that day. “But if you are sitting on a warehouse with masks, you will be hearing a knock on your door.”
A U.S. Department of Justice spokesman declined to comment on the mask trade. The FDA did not comment, except to describe how it has eased some requirements during the crisis and opened the door to sales of masks that meet other countries’ standards. Betsy Lordan, a Federal Trade Commission spokeswoman, said there is no federal law against price gouging, and the FTC has not pursued such cases in past disasters.
Christian Fjeld, who worked on FTC legislation as a staffer in both the House and Senate, says a patchwork of state laws aim to stop companies from charging prices generally defined as “excessive” or “unconscionable.”
But “they are squishy terms,” said Fjeld, now vice president of ML Strategies, a Washington lobbying firm. If high prices are being set by suppliers in a scarce market, he said, it would be tough to make a case that the sellers are gouging.
Some mask brokers appear to be counterfeiters or selling substandard knock-offs, according to a major manufacturer, 3M of St. Paul, Minnesota, and a major hospital supplier, Premier Inc, of Charlotte, North Carolina.
Chaun Powell, Premier vice president of strategic supplier engagement, said some pitches from suppliers, offering masks by the millions of uncertain provenance, have struck the company as highly suspicious.
“Our stealth company is currently supplying bulk quantities” of N95 masks, said one pitch forwarded to Premier. “If you know of any buyers who would be interested, (the supplier would) love to cut you in on the transactions.” Premier declined to disclose the sender’s name.
Powell said his company has issued warnings to its customers about pop-up brokers. But he said some clients are considering these offers anyway, placing orders and hoping for the best.
“It really demonstrates the level of desperation in our supply chain,” he said. “They’re trying to evaluate which is better — to have a faulty mask or no mask.”
The pitches from mask brokers have poured in at an increasing rate as the shortage has grown critical, Powell said.
“In the past five days we’ve had 70 different solicitations,” he said on March 24. “It seems everybody has a friend or a cousin who knows somebody in China who is producing these masks.”
3M recently issued a public statement warning that products being marketed under its name could be counterfeit.
“3M has strict quality standards, and therefore products that have missing straps, strange odors, blocked valves, misspelled words, etc. are likely not authentic 3M respirators,” a company statement said.
One mainstream distributor said that legitimate 3M products also are being diverted out of normal channels by manufacturers or others who want to profit from runaway prices. “The question is, how did the stuff get diverted in the first place?” said Michael Einhorn, president of Dealmed, a supply company in Brooklyn, New York. “There’s something fundamentally wrong with the supply chain.”
“A million people in their garage” seem to have access to the products when authorized distributors do not, Einhorn said. “They’re flipping it to a guy, who’s flipping it to another guy. By the time it ends up in a hospital, 10 people have touched it and made money.”
3M said it has not raised its prices in the pandemic but says it can’t control what others are charging. On March 25, 3M Chief Executive Officer Mike Roman sent a letter to Attorney General Barr and other officials saying the company wanted to help crack down on counterfeiters and profiteers.
Kolfage and other brokers told Reuters they are running clean operations. Kolfage said buyers’ funds will be held in escrow by a law firm and the products inspected by an independent verification firm before any transaction closes.
The impromptu market thrives on scarcity. Two weeks ago, leaders of a trade group for nursing homes said thousands of their members were about to run out.
“There just isn’t enough out there,” said Dr. David Gifford, chief medical officer at the American Health Care Association.
A survey by Premier released last Wednesday showed that 25% of hospitals that responded said they were down to less than a day’s supply of masks.
The chaotic market compounds the challenges faced by besieged hospitals such as Holy Name Medical Center in Teaneck, New Jersey. Twenty-two Covid-19 patients have died at the facility, which now has 139 patients presumed to have the virus, according to hospital figures as of Sunday.
Staff members have been forced to go outside their normal supply chains to keep medical gear in stock, according to Adam Jarrett, chief medical officer.
One recent shipment of 1,000 masks turned out to be substandard and lacked FDA certification. The vendor agreed to replace them with good ones, he said.
Jarrett said his staff has been able to find enough to keep up a four-day supply while avoiding sketchy offers.
“Anyone who we think may have a product, we are chasing it down,” he said. “We’ve seen offers of a million masks, but you’ve got to buy all million, at $9 each”? or about nine times the pre-crisis level. “There are absolutely unscrupulous people out there doing bad (stuff), but we’ve been smart enough to steer clear of those.”
In non-emergency situations, manufacturers are required to submit lengthy applications to receive FDA certification, including test results and engineering drawings.
Given the shortage, the FDA recently said it would not object to the sale of masks for medical purposes that come from a variety of other countries even though they are not certified to meet U.S. standards.
The new mask brokerage business has roots abroad, where manufacturers are setting the base price and traders are snapping up scarce supplies.
An executive at a Shanghai trading firm said some traders there are sitting on stockpiles of tens of millions of masks. Those that are N95-standard and FDA-approved are “the unicorn” that everybody is looking for.
“These are traders that are basically just hoarding to see if the price goes up. It’s like the stock market,” said Justin Huang, chief operating officer of JH Consulting Group. “If they have an inventory that they got at two dollars, they can sell it now for four, or they can maybe sell it at five tomorrow.”
Businessman Paul Bhang, from the Chinese city of Hangzhou, said he recently plunged into the mask sales business with a friend.
“A lot of people are not qualified to do this – I’m not qualified,” he said. But Bhang said he needed the money and believes he can connect factories directly with buyers.”Whatever they produce daily, it’s sold out,” Bhang said. “The factories don’t care who customers are now.”
“In an ordinary situation,” he said, “we would go and check the factories and their documents, but now we can only see the photos.”
Another newcomer to the mask market is Kolfage.
A U.S. Air Force veteran who lives with his family in Florida, Kolfage lost his legs and right arm in a rocket attack during the Iraq war. After owning and selling right-wing news websites, he set up a fundraiser that capitalized on Trump’s quest to build a barrier on the U.S.-Mexican border, We Build the Wall The effort pulled in $25 million from donors starting in December 2018.
So far, Kolfage has built two wall sections on private land, in New Mexico and Texas. He said he didn’t take any compensation for a year but now is now being paid $10,000 a month as president of the nonprofit running the wall project.
In his new venture, he said, it’s all about speed. On March 3, the day his website was registered, Kolfage posted a picture on Instagram of piles of boxes labeled 3M sitting in a warehouse, saying he had 300 million N95s available to ship to the United States.
“…Trying to reach the U.S. government and arm up our docs with the proper equipment. Message me please,” he wrote, tagging Trump and the U.S. Department of Homeland Security.
The supplies, Kolfage said, were owned by a wealthy businessman who wanted to sell the whole lot for $3 each and triple his investment. “These were in Japan at the airport in Osaka ready to be loaded onto a plane,” said Kolfage, who according to 3M is not one of the company’s authorized dealers.
He couldn’t find a buyer fast enough. The opportunity is “long gone,” he told Reuters on Monday.
“It’s their sandbox,” he said of suppliers. “It’s a seller’s market right now on these things.”

Over 5,000 Surgery Centers Can Now Serve As Hospitals in COVID-19 Crisis

The Trump administration cleared the way Monday to immediately use outpatient surgery centers, inpatient rehabilitation hospitals, hotels and even dormitories as makeshift hospitals, health care centers or quarantine sites during the coronavirus crisis.
The Centers for Medicare & Medicaid Services announced it is temporarily waiving a range of rules, thereby allowing doctors to care for more patients.
Hospitals and health systems overwhelmed with COVID-19 patients will be able to transfer people with other medical needs to the nation’s 5,000 outpatient surgery centers, about half of which are affiliated with hospitals. This will give the country thousands of additional hospital beds and operating rooms, some of which have ventilators or anesthesia gas machines that could be repurposed as ventilators.
Outpatient surgery centers will be allowed to treat patients with other critical needs — such as serious injuries, cancer or heart attacks — unrelated to COVID-19, allowing hospitals to conserve scarce resources and reduce the risk of infection to these patients.
Until now, federal regulations allowed outpatient surgery centers to care for patients for a maximum of 24 hours.
“Transferring uninfected patients will help hospital staffs to focus on the most critical COVID-19 patients, maintain infection control protocols, and conserve personal protective equipment,” the agency said in a statement.
Many outpatient surgery centers had closed after being told to halt elective procedures. A coalition of anesthesiologists in recent weeks called for them to stop performing nonessential surgery and assist hospitals.
The waivers “will allow hospitals to save more lives” by performing “surgeries and procedures that can’t wait until the pandemic is over,” said Bill Prentice, CEO the Ambulatory Surgery Center Association, an industry group.
Before the CMS announcement, the California Ambulatory Surgery Association had expressed its willingness to help.
The outpatient centers “want to be part of the solution as the entire healthcare industry must rise to meet this enormous challenge,” said Michelle George, president of the California Ambulatory Surgery Association, in a statement issued Monday morning. “We have valuable resources to lend to this crisis — whether it is staff, space, equipment, supplies or other capabilities. ASCs are coordinating with the public health teams on local and regional levels to identify how their facilities can be utilized most effectively on a case by case basis.”
Advocates who have pushed for surgery centers to assist hospitals praised the move.
“This is a great step in fighting this pandemic,” said Dr. Adam Schlifke, an anesthesiologist and clinical assistant professor at Stanford University in California.
“We recognize that it’s going to be hard,” Schlifke said. “It’s extremely complicated, but we are here to support all the surgery centers that will need to convert as a result of this order.”
The waivers will allow hospitals to hire local physicians and health care providers to address potential surges; transfer critical equipment, including telemedicine equipment, to doctors’ offices; and provide meals and child care for their health care workers.
Hospitals will be able to triage sick patients at community locations, then send them to the most appropriate facility, according to CMS.
“Front-line health care providers need to be able to focus on patient care in the most flexible and innovative ways possible,” said CMS Administrator Seema Verma. “This unprecedented temporary relaxation in regulation will help the health care system deal with patient surges by giving it tools and support to create nontraditional care sites and staff them quickly.”
Even with additional facilities, hospitals and health care systems could run out of staff, especially as health providers become sick with COVID-19. Although surgery centers typically employ their own nurses, they tend to share surgeons with local hospitals.
More than a dozen states and health care associations had requested waivers. The CMS move means that other states will no longer need to apply for waivers.
Texas had taken the lead in recent days, even before the new announcement, by permitting hospitals to use off-site facilities. Texas Gov. Greg Abbott last week signaled his interest in using outpatient surgery centers to expand care by ordering them to tell the state how many ventilators they possess.
Among other sweeping changes:
  • Ambulances will be allowed to transport patients to outpatient surgery centers, community mental health centers, federally qualified health centers, physician’s offices, urgent care facilities and any locations furnishing dialysis services when a dedicated kidney failure treatment center isn’t available. Hospitals will be able to charge for services provided outside their four walls and emergency departments can use telehealth services to evaluate sick people.
  • Physician-owned hospitals can temporarily increase their number of licensed beds, operating rooms and procedure rooms, according to CMS.
  • Instead of going to crowded emergency rooms, patients could go to off-site locations to be evaluated by emergency health care providers using telemedicine. That change will help preserve space in the emergency room for those who need it most. CMS will allow health providers to treat more patients via apps or telephone and bill at the same rate as in-person visits.
  • Physician assistants and nurse practitioners will be allowed to order tests and medications that may have previously required a physician’s order, as long as state law allows it. Also, certified registered nurse anesthetists will no longer have to work under the supervision of a doctor, freeing up physicians to focus more on patients and less on supervising.
  • To reduce the need for patients with health problems unrelated to COVID-19 to go to a doctor’s office or hospital, doctors will be allowed to monitor patients remotely with devices that can measure a patient’s oxygen saturation levels using pulse oximetry.
Health care experts have been suggesting the administration offer such waivers for weeks. The country has “got to muster all reasonable facilities and personnel,” said Arthur Caplan, a bioethics professor at NYU Langone Medical Center. “The best way to ration is to avoid it by stretching resources and sharing.”
More Than 5,000 Surgery Centers Can Now Serve As Makeshift Hospitals During COVID-19 Crisis

Battelle deploys decontamination system for reusing N95 masks

Battelle received an emergency go-ahead from the FDA over the weekend to deploy its decontamination system for personal protective equipment (PPE), allowing healthcare workers to clean and reuse scarce N95 respirator masks.
The system is currently operating at Battelle’s Ohio facility—capable of processing up to 80,000 masks per machine, per day, within what looks like a large metal shipping container—and has been working to help stretch supplies for the OhioHealth system based in Columbus.
Using concentrated hydrogen peroxide vapor, the filters are gassed for two and a half hours to destroy bacteria, viruses and other contaminants, including the novel coronavirus SARS-CoV-2. According to the company, the system can clean the same N95 mask up to 20 times without degrading its performance.
The FDA had first OK’d the use of the system on Saturday but initially limited its use to 10,000 masks per day, according to Republican Ohio Gov. Mike DeWine, who called on the agency to unlock the system’s full decontamination capacity. DeWine also said this would have limited Battelle’s plans to deploy machines to the hard-hit New York metro area as well as Washington state and Washington, D.C.
Within hours, and after President Donald Trump also urged the FDA to approve the equipment on Twitter, FDA Commissioner Stephen Hahn tweeted late Sunday evening that the agency had issued an amended authorization.
In the near term, Battelle’s facility plans to begin decontaminating respirator masks for three other central Ohio health systems this week.
Battelle previously engaged with the FDA from 2014 to 2016 to study the use of its decontamination machine in the midst of a potential pandemic and PPE shortage. Currently, the company is exploring its use outside of N95 masks to other equipment such as ventilator components.

COVID-19: Race to repurpose everything from antiviral to anticancer discoveries

Jonathan Dordick, Ph.D., and his lab mates at Rensselaer Polytechnic Institute (RPI) weren’t thinking about coronaviruses when they initially developed their “viral trap,” a DNA-based nanotechnology designed to capture and kill viruses floating in the bloodstream. But as the COVID-19 pandemic started to unfold, they realized they may be able to transform their invention into a potential solution to the relentless virus—and they got to work on a plan to do so.
“We have something that can be tailored specifically to the virus,” said Dordick, professor of chemical and biological engineering at RPI, in an interview with FierceBiotechResearch. “There has been very rapid research that has come out in the last couple of months about the proteins on the surface of the coronavirus. Once we know their approximate location on the surface, and what the receptor is [on cells] that the virus targets, it allows us to very quickly tailor this DNA nanostructure” to COVID-19, he said. Dordick’s team has developed a research proposal, which includes testing the viral trap technology in animal models of COVID-19, he added.
RPI is one of several institutions stepping up with ideas of how to take existing research and pivot it toward potential solutions to COVID-19. And these ideas are not just bubbling up in academia. Some biotech startups are taking existing antiviral discoveries—or even technologies they initially developed to address very different diseases, like cancer—and offering to deploy them toward defeating the coronavirus.
It may take several months or even years for these efforts to bear fruit, at which point this pandemic may have ended, but that’s no deterrent, many scientists say. “We will see new viruses being passed from animals to humans again,” predicted Christian Peters, M.D., Ph.D., CEO of Pinpoint Therapeutics, in an interview with FierceBiotechResearch. Pinpoint is one of the companies that’s putting plans in place to target COVID-19. “We must have an armamentarium of different drugs with different mechanisms so we’re ready for the future that’s to come,” Peters said.

RPI’s viral trap is adaptable to a range of viruses due to its design, Dordick explained. The technology entails folding pieces of DNA into a five-point star that mimics the latching locations on human cells that viruses must bind to in order to infect their hosts. In a Nature Chemistry paper published in November 2019, they described how they used the folded DNA to rapidly detect the dengue virus in blood.
The next step would be to use the same nanotechnology platform to kill the virus once it’s snared in the trap. “In detecting the virus, we’re also preventing it from binding to its receptor,” he said. “We showed that the DNA binds to the proteins on the surface of the dengue virus, preventing them from infecting the target cell. In that way, we can inhibit the infection process.” Dordick’s team has shown that a similar approach is effective in preclinical models of influenza A and Zika virus, as well.
As for startup Pinpoint Therapeutics, it was founded on the discovery that drugs designed to combat the malaria virus may also have promise in fighting cancer—and now its scientists are taking their antiviral know-how and applying it to COVID-19. Pinpoint is developing drugs that inhibit PPT1, a pathway targeted by a class of antimalarial drugs known as chloroquines.
If that sounds familiar, it’s because President Donald Trump created a bit of an uproar earlier this month when he latched onto reports about the potential use of chloroquine against COVID-19 and said the U.S. would make it available by prescription “almost immediately.” Questions have since emerged about the effectiveness of the drug against the virus due to disappointing clinical trial results in China, but the FDA did issue emergency use authorization for the use of hydroxychloroquine in COVID-19 patients Monday.
Pinpoint’s approach revolves around a process called “autophagy,” in which cells recycle components so they can survive being attacked. Researchers at the University of Pennsylvania discovered that inhibiting PPT1 slows tumor growth—a finding that led to the formation of Pinpoint, which is now optimizing PPT1 inhibitors to test in cancer. Pinpoint has received seed funding from Kairos Ventures, which in February kicked in $1 million in debt funding to help accelerate the search for candidate drugs.
Peters said that the company’s scientific team realized inhibiting PPT1 would also interrupt the ability of COVID-19 to replicate. And because the drugs could have as much as 1,000-fold more potency than standard malaria treatments when it comes to inhibiting PPT1, the hypothesis is that they could be more effective against COVID-19 than hydroxychloroquine is.
Although it will take several months to complete the laboratory and animal studies needed to identify drug candidates against COVID-19, Peters believes the insights they gain will remain relevant, even if the pandemic has resolved by that time. “It’s important to look not just at the anti-viral components, but also at the anti-inflammatory properties that these drugs might have. The synergistic effects of less virus replication and less inflammation may actually be very beneficial in the treatment of coronaviruses.” And because there are so many viruses that are closely related to COVID-19, and there’s a risk that novel viruses will continue to emerge, Pinpoint’s scientists believe any new products that come from their research will find a place in the market, he said.

Some researchers who have devoted their careers to understanding coronaviruses are finding their expertise in high demand during this pandemic. One of them is Ralph Baric, Ph.D., professor of microbiology and immunology at the University of North Carolina (UNC) at Chapel Hill. Early discoveries in his lab led to Gilead Sciences’ remdesivir, the investigational antiviral that’s now in clinical trials for COVID-19. Gilead, meanwhile, is making the drug available on a compassionate use basis for patients fighting COVID-19.
Now, another COVID-19 candidate has emerged from Baric’s lab. The drug, called EIDD-2801, is being developed by Ridgeback Biotherapeutics and Emory University’s nonprofit biotechnology company Drug Innovations at Emory (DRIVE).
UNC and Emory researchers described EIDD-2801 last week in a study that was preprinted on the Cold Spring Harbor Laboratory site bioRxiv. The researchers reported that the drug has “broad spectrum antiviral activity” against COVID-19 and several related viruses, including MERS-CoV. In mice infected with MERS-CoV or SARS-CoV, the drug decreased the viral load and improved lung function, they reported in the study (PDF).
EIDD-2801 is a ribonucleoside analog that’s designed to prevent RNA viruses from replicating. Ridgeback was already preparing for clinical trials of the drug in influenza when it and DRIVE’s scientists “immediately recognized that EIDD-2801 had the potential for treating COVID-19,” George Painter, Ph.D., director of the Emory Institute for Drug Development and CEO of DRIVE, said in a statement.
The rapidly unfolding COVID-19 pandemic has inspired the scientific community to come up with solutions that will have the potential to save lives in the future, RPI’s Dordick said. “The key question after we get through this tragedy is, ‘how will we avoid it again?’” Dordick said. “Will we have to shut everything down again, or can we have directed therapeutic development? I think we’re learning the lesson that we need rapid vaccine development and rapid therapeutic development. We’re going to learn an awful lot about what we can do.”

Biotech Investors: Mark Your Calendar For These April PDUFA Dates

The FDA worked overtime through the coronavirus (COVID-19) crisis, framing new guidelines for approving SARS-CoV-2 diagnostic tests, reviewing tests and treatments.
Even amid its response to the emergency, the agency went about its business as usual. Bristol-Myers Squibb Co’s BMY 2.48% combo therapy was approved for advanced liver cancer.
Two new molecular entities – Novartis AG’s NVS 0.68% Isturisa oral tablets for adults with Cushing’s disease and Sanofi SA’s SNY 2.17% Sarclisa, in combination with omalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma – were approved during the month.
Here are the key PDUFA dates scheduled for April.
Acceleron, Bristol-Myers Squibb Seek Label Expansion For Anemia Drug
  • Company: Acceleron Pharma Inc XLRN 5.09% and Bristol-Myers Squibb Co BMY 2.48%
  • Type of Application: sBLA
  • Candidate: Luspatercept
  • Indication: myelodysplastic syndromes
  • Date: April 4
The sBLA for Luspatercept, sponsored by Acceleron and Celgene, which has since then been acquired by Bristol-Myers Squibb, was accepted for review by the FDA in June 2019, with the agency setting a PDUFA action date of April 4.
In early December, the companies said the FDA cancelled a review of the BLA by the Oncologic Drugs Advisory Committee, which was scheduled for Dec. 18.
Luspatercept, an erythroid maturation agent, has already been approved for treating anemia in patients with beta thalassemia, who require regular red blood cell transfusions.

Go Or No-Go For Urogen’s Kidney Cancer Drug?

  • Company: Urogen Pharma Ltd URGN 1.76%
  • Type of Application: NDA
  • Candidate: UGN-101 (mitomycin gel)
  • Indication: low-grade upper tract urothelial cancer, or LG UTUC
  • Date: April 18
The FDA accepted the NDA for review Dec. 19 and granted priority review status. UGN-101 already has Orphan Drug, Fast Track and Breakthrough Therapy designations.
“If approved, UGN-101 would be the first non-surgical treatment option for LG UTUC,” the company had said.

FDA To Rule On Sanofi’s Vaccine For Bacterial Form Of Meningitis

  • Company: Sanofi SA SNY 2.17%
  • Type of Application: BLA
  • Candidate: MenQuadfi
  • Indication: vaccine for meningococcal meningitis
  • Date: April 25

Neurocrine’s Parkinson’s Drug Under FDA Scanner

  • Company: Neurocrine Biosciences, Inc. NBIX 5.5%
  • Type of Application: NDA
  • Candidate: Opicapone
  • Indication: Parkinson’s disease
  • Date: April 26
Opicapone, a once-daily, oral, selective catechol-O-methyltransferase inhibitor is being evaluated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes. The FDA accepted the regulatory application in July.

Can United Therapeutics’ Drug-Device Combo For Hypertension Scale Regulatory Hurdle?

  • Company: United Therapeutics Corporation UTHR 2.31%
  • Type of Application: NDA
  • Candidate: Trevyent
  • Indication: pulmonary arterial hypertension
  • Date: April 27
Trevyent is a drug-device combination product that combines two-day, single use, disposable PatchPump technology with treprostinil, for the subcutaneous treatment of PAH.
The company, however, indicated in its Feb. earnings release it received a mid-cycle information request from the FDA, noting several deficiencies in the NDA. Although the company has given a written response, based on interactions with the FDA, it said the PDUFA date could be extended beyond April.

Pfizer’s Combo Therapy To Treat Colorectal Cancer Awaits Clearance

  • Company: Pfizer Inc. PFE
  • Type of Application: sNDA
  • Candidate: Braftovi in combination with Bristol-Myers’ Erbitux
  • Indication: metastatic colorectal cancer
  • Date: April (date not specified)
The Braftovi-Erbitux combo is being evaluated as a treatment option for patients with advanced BRAFV600E-mutant metastatic colorectal cancer, following one or two lines of therapy. The FDA accepted the sNDA for review on Dec. 18.

Group Testing Is Our Surefire Secret Weapon Against Coronavirus

Group testing all Americans every day is our surefire secret weapon to save potentially millions of lives and immediately restart the economy. Group testing is a super efficient way of finding out who’s infected and who’s not. Iceland’s doing it. Israel’s doing it. Even Nebraska’s doing it. The President needs to implement this policy immediately with the help of the military. It’s that simple.

We are doing the unimaginable to escape coronavirus, from shuttering stores and restaurants, to mandating quarantines, to stopping international travel. Now some states are demanding that out-of-state visitors quarantine for two weeks. And President Trump Saturday tweeted he was considering quarantining New Jersey, New York, and Connecticut, before backing off that idea. My wife and I took a drive today to Crane’s Beach, which is an hour north of Boston. We found the beach closed to all but locals. Soon the small towns will use their police to keep big city “foreigners” out. Then we might see different parts of cities seal themselves off. For example, Queens, Brooklyn, and the Bronx could close the bridges and tunnels from and to Manhattan.
If you woke up a year ago to today’s reality, you’d think you were somehow transported into a dystopian movie. Not yet Mad Max, but heading that way.
Fortunately, there is a foolproof way to defeat coronavirus. The president simply needs to make it happen. Here’s the secret weapon.
Group Test Every American Every Day.
As I’ve written and as Iceland is showing, testing every American every day and giving those who test negative a badge for the day to work, shop, frequent restaurants, etc. will let us separate those who are healthy from those that are sick and let those who are healthy go back to work, shop, reopen their businesses, and, most important, rehire the workers they have just fired. Equally important, it will give workers and employers the confidence they need that participating in the economy and reopening their business is fully safe.
I’ve received three sets of negative responses to this proposal.
The first: “Testing everyone every day is impossible. We can just test people who have symptoms and if they are positive, trace their contacts.”
This approach is fraught with problems. We’re not China, South Korea, Hong Kong, Taiwan, or Singapore. We don’t have an electronic record of where everyone was over the past two or so weeks, let alone with whom they interacted. And we can’t confiscate people’s cell phones and download their contact lists. Hence, contact tracing will be poor at best. Moreover, infected people may be asymptomatic. Hence, they’ll never get tested in the first place and have two weeks or more to spread the infection. To make matters even worse, the current PCR test produces a false negative between 14 percent and 30 percent of the time depending on which study you read. Hence, many infected people are being told they aren’t infected when they are. When this happens, they head off to spread the infection, which they will continue to do for days or weeks if they don’t land in a hospital with worse symptoms.
The second objection to daily universal testing is that it’s too costly. This can’t possibly be true compared to the cost of having so many people become terribly sick or die, not to mention destroying the economy.
The third concern with testing everyone every day is that there aren’t enough testing kits, labs, testing machines, reagents, etc. available. This is where the miracle of group testing comes in. It’s an old idea developed by a Harvard economist named Robert Dorfman during WWII. I’m old enough to have met Professor Dorfman when I was in grad school. But I never knew anything about group testing until yesterday, let alone that Dorfman was responsible for the idea.
Dorfman was tasked with figuring out how to efficiently test new recruits for syphilis. The test, a blood test, was expensive. Dorfman proposed drawing blood from a group of recruits, say 20, and mixing it together. Then you’d test the batch. If syphilis wasn’t found, it meant that one test had cleared 20 recruits. If the test came back positive, you could split the sample into 10 and 10 and run another test using extra blood retained from the original blood draw. If one of the two blood groupings tested negative, you’d know the problem was in the remaining 10 and split those 10 into two groups of 5. If both of the tests of 10 were positive, you’d move to four tests of 5 recruits. And so on.
The point is that if the share of recruits with syphilis was low, group testing could dramatically reduce the number of tests needed to separate the healthy from the sick. And it could still identify precisely who was sick.
What worked in WWII for syphilis can work today for coronavirus. This is the marvelous insight of three French economists — Christian Gollier, Jean-Luc Travernier, and Olivier Gossner — from the Toulouse School of Economics, the National Institute of Statistics and Economic Studies, and the Ecole Polytechnique, respectively. They sent me and other economists, including The Hoover Institute’s John Cochrane, their papers yesterday. John wrote about the group testing idea in his blog. But we academics are behind the curve. Governor Ricketts of Nebraska adopted group testing several days ago.
There is now a 15-minute coronavirus test. What we need to do is group-household test each day. The method is simple. A testing mobile, manned by military personnel, would come to your street early each morning. The members of your household and maybe another 9 (the best number is yet to be determined) would be invited to provide a swab sample. All the swabs of all the households would be collectively used to test if any of the swabs was positive. Fifteen minutes later your group of households would either be cleared to go to work and frequent stores, restaurants, and other establishments for the day or not. If you’re cleared, you’d get a green bracelet that would automatically change to red after 24 hours. Those with green bracelets would be returned to normal society. If your group of households tested positive, subgroup testing would be done, on the spot, until it was discovered which of your group’s 10 households was infected and which weren’t. Those households that were infected (had one or more infected members) would need to go into quarantine.
The military is the only group that can conduct this critical mission across the country efficiently and effectively in the time required. The military personnel doing the testing would be extensively trained, have protective gear, and follow a protocol would be established to limit, to the maximum extent possible, uninfected people becoming infected in the course of the testing. The public fully trusts our women and men in uniform and will comply with their instructions.
Yes, the testing won’t be perfect. But by limiting the number of tests, we can better ensure that the people doing the testing are the best qualified and that the testing is done at the highest level. And yes, some infected people will spend the day at work, in restaurants, in shops, etc. But workplaces, shops, and restaurants would take temperatures before letting people enter, continually disinfect surfaces, and implement the best social-distancing practices.
Initially, the best we may be able to do is test every household once a week. But over time, we can get to daily testing. And, as the tests improve, we’ll reach the point that less frequent testing is needed.
This can all be started very rapidly, maybe in time for Easter — the president’s proposed date to restart the economy!
PS, Here’s an email from an Atlanta doc that I received after writing the above.
I agree 100% with all you say about coronavirus and agree with Paul Romer. Please be as vocal as possible about mass screening of the population. And start today. Any positives we remove today will impact the level of disease we see in 3-4 weeks.
STOP testing sick people at the end. The treatment is not different.
START screening the population. Remove the fuel and the fire will go out. I am a doctor and waiting for this to crest in Atlanta. We could have a huge impact on the crest if we started screening the population now and isolated positives. Instead they test sick people after the fact. I don’t want to see all of these patients and healthcare workers die.
Israel is now using pooled testing of 60 samples to screen. If the pool is negative all are negative. We do this to screen our blood supply. Handsomely pay a biotech firm to work on this strategy. But with pools of 60, you can screen a lot faster than 1 by 1.

Reusing N95 Masks Against COVID-19 Coronavirus? The Risks And Options

This is not like the time that you miscalculated your underwear count when traveling and tried to make a single pair of underwear go for as long as possible. With the COVID-19 coronavirus pandemic, many healthcare professionals are faced with the horrible reality that they don’t have access to enough N95 face masks to properly protect themselves and have to reuse N95 masks way beyond guidelines. The associated risks of reusing N95 masks don’t just apply to health care professionals but to practically everyone out there wearing such masks.
There are reasons why some items are designed as “single-use” or “limited use.” For example, would you consider re-using the same sheets of standard toilet paper through multiple trips to the toilet? Of course, disposable N95 masks are not exactly the same as toilet paper. Using a N95 mask more than once may still fall within the manufacturer’s guidelines for that given mask. And while not using toilet paper according to guidelines poses risks to your butt, not following guidelines for N95 respirators could put more than your butt on the line. With the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) spreading, straying from guidelines could put the butts of everyone whom you contact on the line, which is a lot of people if you are a health care professional. Note that in this case, butt is the proverbial butt and not the actual butt. If you are wearing an N95 respirator on that end of the body, you are doing it wrong and should absolutely throw the mask away immediately.
The question of mask reuse during a pandemic was already extensively addressed over a baker’s dozen years ago. Consider what a National Academies of Science Engineering and Medicine Report from 2006 entitled Reusability of Facemasks During an Influenza Pandemic: Facing the Flu offered as one conclusion: “The committee could not identify or find any simple modifications to the manufacturing process that would permit disposable N95 respirators to be reused without increasing the likelihood of infection.”
When it comes to N95 masks, what you don’t see can help or hurt you. As I described on Saturday for Forbes, the mask doesn’t just consist of layers of relatively simple materials like paper towels or commonly used fabric. Like many introverts, the mask is more complex than it may seem. It typically consists of polypropylene fibers woven in ways to create tortuous paths challenging for small particles to travel through without getting stuck. The fibers also have electrostatic charges that further help the particles stick to the fibers. You can’t see all of these things when the mask is filtering air before it reaches your nose and mouth. You also can’t see how these features degrade over use and time. Bending the mask, getting the mask wet from your hot, hot breath, and having different things land on the mask like air pollutants, moisture, or a musk rat can hasten the degradation of the mask.
Moreover, you can’t see all of the viruses that may accumulate in the mask during use, because they are teeny-weeny. The N95 mask is a filter and not Captain America’s shield or Iron Man’s face plate. Viruses don’t just bounce off of the mask but instead get trapped inside it. That’s why you’ve got to be super careful when handling a mask that has been used. If the outside of the mask ends up touching your face while you are removing the mask, you will actually be rubbing on your face something that collects and concentrates viruses from the air.
Wondering why you can’t just find some way of cleaning the disposable N95 mask? Well, as you probably know or at least should know, washing used disposable toilet paper doesn’t quite work. If you use soap and water, the toilet tissue can readily disintegrate. If you use milder cleaning methods like just spraying some hand sanitzer on it or yelling at it, well, do you really want to use it again? Again, N95 masks and TP are not exactly the same. However, some of the issues with the tissues can translate somewhat to disposable N95 masks. Here was another finding from the NASEM report: “Any method of decontaminating a disposable N95 filtering facepiece respirator must remove the viral threat, be harmless to the user, and not compromise the integrity of the various elements of the respirator. The committee found no method of decontamination that met all three criteria.”
So, got it? In “normal” pandemic situations, science says that you should not be reusing N95 masks. But. But. The current pandemic isn’t even a “normal” pandemic situation. Yes, despite the NASEM report from over 13 years ago, despite warnings that N95 mask shortages may be a problem, did hospitals and health care systems really prepare to appropriate levels? Did they maintain adequate stockpiles to account for the additional demand that would occur with an epidemic? Did they have systems in place to make sure that their health care professionals would be protected according to what science has been saying? The current situation makes you wonder.
Well, the NASEM report did also provide recommendations on what to do if N95 mask shortages were to lead to situations where such mask reuse would be necessary. Of course, the committee may have been thinking that this could occur somewhere later during a pandemic rather than near the beginning.
For example, take a look at the letter accompanying the following tweet from when COVID-19 cases were just starting to really rise in New York City:
Saman Nematollahi @TxID_Edu
This is a very scary message from @Columbia
They will run out of ICU beds and PPE soon @Atul_Gawande @EricTopol @CMichaelGibson @drsanjaygupta @CNN @mlipsitch @MackayIM @CarlosdelRio7 @kevinmd @NIHDirector
View image on Twitter
Just one N95 mask for each employee is not exactly in line with the NASEM report guidance.
The first NASEM report recommendation for reuse was to “protect the respirator from external surface contamination when there is a high risk of exposure to influenza (i.e., by placing a medical mask or cleanable faceshield over the respirator so as to prevent surface contamination but not compromise the device’s fit).” Even though the SARS-CoV2 is not the same as the flu virus, repeat is not the same as the flu virus, in this case, you may be able to replace “influenza” with “SARS-CoV2.” This is where do-it-yourselfers (DIY) who don’t have the materials and technical capabilities to replicate N95 masks may be best able to help. If they can create something that can shield or protect the N95 respirator without suffocating the user, which incidentally would be a bad thing, then this could potentially extend the effective lifetime of the respirator. Note the emphasis on the word potentially.
The second NASEM report recommendation was to “use and store the respirator in such a way that the physical integrity and efficacy of the respirator will not be compromised.” This certainly means no head butting, planned or unintentional, while wearing the respirators. But even more subtle pressure to the mask could end up deforming it somewhat. Also, the mask is not a condom or a diaphragm. You shouldn’t keep it in your pocket, wallet, purse, handbag, or fanny pack. Instead, the Centers for Disease Control and Prevention (CDC) website suggests that you “hang used respirators in a designated storage area or keep them in a clean, breathable container such as a paper bag between uses.” Also, store respirators as you would make bed arrangements for an overnight school class trip. Don’t have respirators pushed against each other: “To minimize potential cross-contamination, store respirators so that they do not touch each other and the person using the respirator is clearly identified. Storage containers should be disposed of or cleaned regularly.
“Can’t touch this” applies to everything. Minimize touching the respirator with anything that may in any way deform, contaminate, or be contaminated by the mask. The third NASEM report recommendation was to “practice appropriate hand hygiene before and after removal of the respirator and, if necessary and possible, appropriately disinfect the object used to shield it.” The CDC website recommends that you “use a pair of clean (non-sterile) gloves when donning a used N95 respirator and performing a user seal check. Discard gloves after the N95 respirator is donned and any adjustments are made to ensure the respirator is sitting comfortably on your face with a good seal.”
While there is no established method of cleaning these disposable N95 masks, some have looked at different approaches. A study published in a 2009 issue of the Annals of Occupational Hygiene evaluated five possible decontamination methods: ultraviolet germicidal irradiation (UVGI), ethylene oxide, vaporized hydrogen peroxide (VHP), microwave oven irradiation, and bleach. Two of the approaches didn’t work very well. For example, microwave oven irradiation caused the samples to melt. By the way, a N95 mask is not like cheese. Melting it doesn’t make it better. The most promising options were UVGI, ethylene oxide (EtO), and VHP, but the evidence at the time was far from conclusive.
These three approaches have since gotten more attention. For example, the ABSA International website has a link to the preprint of a manuscript has been accepted to Applied Biosafety, the association’s journal. In this case, ABSA stands for the Association for Biosafety and Biosecurity‎ and not for the Association of Bulgarian Schools in America. The manuscript described how a team from Duke University put a cohort of N95 respirators through VHP treatment and subsequently conducted testing. The testing suggested that the masks were adequately decontaminated and retained their structural integrity and function. The manuscript also cited a 2016 study for the U.S. Food and Drug Administration (FDA) that had similar conclusions.
The findings from these studies are encouraging in what’s currently a desperate situation. However, it does not mean that getting new N95 masks shouldn’t still be a priority. N95 masks aren’t cars, where used ones may replace new ones. So many things could happen during the wearing of mask that could limit what such a decontamination procedure can do. For example, what if the mask gets splashed by liquids such as blood or other body fluids? What if the mask gets bent in any way? What if the load of microbes in the mask is so high that decontamination is tougher?
If you’ve been wearing your N95 mask for more than the manufacturer’s guidelines (or more than five times if there is no specific guidance for that mask), your mask may not really be that effective anymore. In fact, it may have become more like a sponge for microbes. The more you reuse your mask, the greater the risk. Not just for you but also for all those who come into contact with you.
Might telling people that they can reuse their N95 masks well beyond normal guidelines be a bit like telling people that they can go to a lengthy battle wearing nothing but one pair of underwear? It could them a false sense of re-assurance while leaving them very much exposed.
The only real solution to the shortage is to fix the shortage as soon as possible. Manufacturers must make many, many, many more legitimate and National Institute for Occupational Safety and Health (NIOSH)-approved N95 respirators as quickly as possible. Hospitals and health care systems need to purchase them and provide them to health care professionals without any delay. Time spent negotiating or pretending that other approaches are adequate means more and more potential deaths that could have been averted. It is a sad statement that the wealthiest country in the world can’t even provide basic pandemic protection to health care professionals, the most important people in the fight against the pandemic.

A Day In The Coronavirus-Driven Feeding Frenzy Of N95 Mask Sellers And Buyers

You never know what a new day will bring. What started as an early morning call with a friend to help get N95 masks to hospitals in desperate need turned into a roller coaster of contacts in a frenzied, pandemic-driven market. For the next 10 hours, I sat in on calls between brokers selling masks and potential buyers, watching the psychology of market pressures play out in real time as millions of masks changed hands in a matter of hours.
The buyers—from state government purchasing departments and hospital systems representing facilities throughout the Northeast, Midwest and California—expressed desperation for masks to protect their healthcare workers, but in the end not a single deal was completed with any of these groups, and millions of masks were earmarked to leave the country, purchased by foreign buyers.
In the interest of brevity, I’m going to summarize what I learned below and then jump into a bit more detail. 
  • Millions of N95 masks have been available throughout the U.S., Canada and the UK during the pandemic, according to brokers trying to sell them.
  • The high price point per mask, driven by extreme demand, has contributed to an overwhelmed reaction among potential buyers, especially in the U.S.
  • Scrutiny surrounding these deals is high because of ongoing scams and claims of price-gouging, both of which are triggering emotionally charged reactions and fear of making deals.
  • Millions of masks are being purchased by foreign buyers and are leaving the country, according to the brokers, while the domestic need remains alarmingly high.
My main contact in this frenzy was a medical supplies broker named Remington Schmidt who spends nearly every working hour of the day on phone calls trying to make deals between potential buyers and sellers with personal protective equipment (PPE) available to sell in the U.S. and abroad.
“This is the craziest market I’ve ever seen,” he told me between calls while scanning through a stream of text messages from sellers and other brokers.
Like most brokers in this market, Remington represented other products before the COVID-19 outbreak and jumped into action to sell masks when the need arose. Just a couple of weeks ago he was selling hazmat suits.
When contacting potential buyers, Remington needs two things to secure a deal with a seller: a letter of intent to purchase and proof of funds.
“If you are working with a seller who has masks but you can’t quickly show proof of funds, someone else is going to buy them,” he told me.
And I watched that happen repeatedly throughout the day. Buyers from state procurement departments and hospital systems expressed desperate need for masks, but the deals bogged down when it came to providing proof that they could commit and follow through. In the meantime, another buyer provided proof of funds and the masks were gone, sometimes within the hour.
The masks in play are those we’ve been hearing about in every press conference since the pandemic began: N95 3M brand masks, mainly in model types 1860 and 8210, which, according to 3M, are “NIOSH (National Institute of Occupational Safety and Health) approved for at least 95% filtration efficiency against certain non-oil based particles.” Some buyers are also looking for alcohol-based sanitizer sprays, hospital gowns and a few other items, but mostly the demand is for N95 masks. And the demand is only getting more intense as hospitals rapidly run low on the supplies they have due to increased need for masks to protect staff as numbers of COVID-19 infections, and suspected infections, increase each day.
Remington explained that his business is all about networks. “It’s a contact to contact to contact market.” Through his network of contacts, he finds a seller with masks in a warehouse—several million masks in each lot—and attempts to link the product with buyers in need.
I felt like I was getting whiplash throughout the day by the insane pace of negotiations and how often the price point changed as the market frenzy continued. Prices ranged from anywhere between $6 – $7 per mask depending on volume and location. The same masks were selling for closer to $4 just a week before.
Remington received text updates from his network about ever-changing quantities of masks in Houston, New Jersey, Miami, Los Angeles and other U.S. cities, along with cities in Canada and the UK. I was astounded by the numbers of masks at these locations. At one point he received an update that 43 million masks were available in New Jersey, in the same time-frame that federal and state leaders were saying in press conferences that they were “scouring the globe” for masks. But the masks in New Jersey, along with many million more, didn’t go to any domestic buyer. Instead, according to the broker, they were all purchased by foreign buyers.
“Most of the masks are leaving the country,” he told me.
That is not the case in countries that have cracked down on exports, he added, but as of now the U.S. is allowing many types of medical supplies to leave the country even as states and hospital systems are expressing desperate need for masks and other PPE.
While he is aware of brokers selling masks that will leave the country, Remington doesn’t participate in those deals. “This is a national crisis and we need these masks in the country,” he said.
Scrutiny in the market is sky high. People are understandably concerned about being taken in scams. The insanity of this market has created opportunities for fraudsters claiming to sell everything from masks to hospital gowns to ventilators, and every potential buyer is on guard to avoid being the next victim. More than once, a representative from a potential buyer also noted concerns about price gouging.
“Some people don’t understand that the market sets the price,” Remington said.
I read through a list of mask lots sent to him from U.S. sellers along with their expected price points and, at that time, none were under $6 per mask. This is clearly a seller’s market and price is driven by demand.
Added to this, potential buyers trying to secure PPE for their medical personnel are often not empowered to make fast, high-dollar deals, no matter how desperately they’d like to close a deal and get masks to those in need. I listened to the range of emotions playing out in negotiations and it seemed to me that the domestic procurement process is simply unprepared to operate in this frenzied market. Individuals want to do the right thing, but the systems in which they operate are hamstrung by rules that weren’t created to approve enormous transactions in hours or less.
By the end of the day, roughly 280 million masks from warehouses around the U.S. had been purchased by foreign buyers and were earmarked to leave the country, according to the broker — and that was in one day.
To his knowledge none of the masks had been purchased by buyers in the U.S.
Remington told me that his focus now is to try to sell masks to federal agencies like FEMA responsible for securing PPE so the items can go directly to the states that will distribute to hospitals, but it’s been extremely challenging to close a deal and the number of “middle men” in the negotiations keeps rising.
“Many people are marking up the prices in the middle,” he said. “People are just trying to make as much money as possible.”

States Begin To Move COVID-19 Patients From Hospitals To Nursing Facilities

Last week, I suggested that in the wake of the coronavirus pandemic, nursing homes may need to take patients from over-burdened hospitals. At the same time, care settings such as assisted living facilities (ALFs) might have to accept nursing home residents who must be relocated to make room for those post-acute patients. Now, it looks like that is beginning to happen.
Massachusetts has designated 12 nursing facilities to take COVID-19 patients, and the state is beginning to move nursing home residents, starting with 147 in a Worchester facility. And the American Health Care Association, a trade group representing much of the nursing home industry, agrees with these changes, as long as they are managed carefully.
New York is doing this in a very different way. In an effort to free-up desperately-needed hospital beds, it has ordered all nursing facilities to accept hospital discharges, even those who have tested positive for COVID-19.
The crucial difference
The crucial difference: Massachusetts is organizing a system where only designated facilities take coronavirus patients discharged from hospitals. New York wants all nursing facilities to take these patients. The issue:  How to make this work while still protecting extremely vulnerable residents and patients at nursing facilities who do not have coronavirus. These transfers should not happen if they put current residents at risk.
The idea of using certain nursing facilities to offload some of the hospital burden was not mine alone. David Grabowksi, a professor of health policy at the Harvard University Medical School, made an even more detailed proposal in a March 25 column in JAMA (paywall). And Anne Tumlinson of the consulting firm ATI Advisory has made similar suggestions.
Equipment and skilled staff
The first priority should be to identify those facilities that already have ventilators, the staff skilled at managing them, and strong infection controls. It is essential to protect current residents, who are at extremely high risk form COVID-19. Remember, a typical nursing home may include both a skilled nursing facility (SNFs) that provides post-acute services such as rehabilitation and a unit for long-stay residents with severe functional of cognitive limitations.
In some cases, these units may be separate enough. But using SNFs to care for COVID-19 patients may require the facilities to move long-stay residents, many of whom have dementia or functional limitations, to other facilities. Some may go to other nursing homes, others to assisted living, and some back home.
Freeing up beds
What about post-acute patients, who may be in skilled nursing facilities (SNFs) for a few days to a few weeks. They must also be moved out before COVID-19 patients are allowed in. For them, those SNFs not designed for COVID-19 may be a good alternative.
Because so many hospitals have stopped doing elective surgeries, especially knee and hip replacements, the demand for that common SNF rehab has fallen off sharply. That may free-up more beds for non-COVID hospital discharges.
As I noted when I first raised the idea, even in the best of circumstances these moves will be incredibly disruptive to residents, their families, staffs, and the facilities themselves. But in a pandemic where hospital beds may be insufficient to handle the need, designated skilled nursing facilities are a smart alternative.
Issues to be resolved
But a number of complicated issues still have to be resolved.
How should the system handle someone who is suspected of having coronavirus but has not tested positive? Where should they stay? There is no room in hospitals. And nursing homes without intensive infection control are inappropriate. Until we have enough test kits and technology to read those tests within hours rather than days, this will remain a critical problem.
Then, there is staff. If aides, nurses, and techs are going to be required to treat sicker patients with more complex conditions, they need to be trained. And if they are going to be asked to care for COVID-19 patients, they absolutely must have essential personal protective equipment, such as masks, gowns, and gloves. Without the training and the equipment, this idea is a non-starter.
Finally, there is the matter of payment. Many long-stay nursing home residents are in those facilities only because it is where Medicaid will pay for their care. The current crisis is an ideal opportunity to change that. States should expand their home and community based programs for frail older adults and younger people with disabilities. They should pay enough for settings other than nursing homes so these vulnerable people can get the care they need in the safest and most appropriate place possible.
The system can make this shift work, but only if hospitals, nursing homes, assisted living facilities, home care agencies, states, and the federal government work together. And they don’t have much time.

Vaccine From The 1920s Is Now Being Tested For Use Against Coronavirus

Researchers in a handful of countries are testing a century-old tuberculosis vaccine to see if it can give a boost to the immune system to help it fight off the novel coronavirus now causing the COVID-19 pandemic.
Clinical trials of the Bacille Calmette-Guerin (BCG) vaccine, which was first developed in the early 1920s, are planned in Europe and Australia to see if it can help reduce the prevalence and severity of COVID-19 symptoms.
Researchers from the Murdoch Children’s Research Institute (MCRI) in Melbourne are currently working to enroll 4,000 healthcare workers from hospitals around Australia in one study.
“This trial will allow the vaccine’s effectiveness against COVID-19 symptoms to be properly tested, and may help save the lives of our heroic frontline healthcare workers,” MCRI Director Professor Kathryn North said in a release.
A separate large-scale study is planned to include older patients and health care workers at several hospitals in Germany and similar trials are in the works in the Netherlands, the UK and Greece.
This work is very different from the efforts underway to develop a vaccine to confer specific immunity to the novel coronavirus, SARS-CoV2. BCG has a spotty track record giving immunity against even the disease it was developed for, tuberculosis. But as one of few tools available to fight that disease, it has stuck around for decades and a number of studies have shown that it seems to offer other benefits.
“There has been a long history of reports of BCG producing a series of beneficial immune responses,” Gonzalo H. Otazu from New York Institute of Technology’s Department of Biomedical Sciences told me. “For instance, a study in Guinea-Bissau found that children vaccinated with BCG were observed to have a 50 percent reduction in overall mortality, which was attributed to the vaccine’s effect on reducing respiratory infections and sepsis.”
A WHO review in 2014 gave the findings that BCG may reduce overall mortality a very low confidence rating, however. Other reviews have been more favorable.
Still, researchers hope that BCG could be a bridge that suppresses the overall impact of the coronavirus pandemic until a new, targeted vaccine is ready.
Scientists at the Max Planck Institute for Infection Biology developed the vaccine candidate VPM1002 based off of BCG earlier this century, which will be used for the trial starting soon in Germany. VPM1002 has been shown to protect the respiratory tracts of mice from viral infections.
“In addition, VPM1002 can be manufactured using state-of-the-art manufacturing methods which would make millions of doses available in a very short time”, says Adar C. Poonawalla, CEO and Executive Director, Serum Institute of India in a statement.
Otazu has been working with researchers to look at possible correlations between national BCG vaccination policies and the impact of COVID-19 on a country’s population.
“We found that there was a reduction in the number of deaths attributed to COVID-19 per million inhabitants in countries that have universal BCG vaccination (usually at birth) compared to the countries that never established such policy,” he said. “The earlier the establishment of such policy, the stronger the reduction in mortality, consistent with a protection to the elderly population which is more severely affected by COVID-19.”
Italy and the United States, two of the countries hit hardest by the pandemic, do not have universal BCG vaccination policies.
Otazu and his colleagues have produced a paper outlining their findings that is awaiting peer review. He stresses that “although correlations are strong, our study is correlational and does not demonstrate the effectiveness of BCG against COVID-19.”
BCG, if it works at all, may not be able to help everyone touched by COVID-19. It is not recommended for people with compromised immune systems or pregnant women.
We should know more about how helpful it may be for the rest of us in just a few months.

The scramble to reinvent the ventilator

As Smiths Group delays its split partly so it can focus on ventilator production, the US FDA grants emergency authorisation to other breathing devices to treat Covid-19.
The lack of mechanical ventilators to treat Covid-19 patients is a pressing problem across the world. A wide variety of efforts are being made by medtechs and non-medtech companies, regulators and academic researchers to accelerate production of approved devices, repurpose other breathing systems for emergency use, and to build new ventilators from scratch.
The engineering conglomerate Smiths Group today said it would delay the separation of its medtech unit, which had been scheduled for mid-year, partly so it can focus on the delivery of ventilators and other critical care devices. The company is part of the VentilatorChallengeUK alliance, from which the UK government has ordered 10,000 units.
The VentilatorChallengeUK consortium also includes Airbus, BAE Systems, Ford, Rolls-Royce, McLaren and Siemens, and is working to source and assemble parts for two ventilator designs, one of which is from Smiths Group. This device, made in the UK, is a portable ventilator usually used in ambulances and not typically used for long-term intensive care.
This consortium is only one of many deals in which engineering groups outside the medtech sector are retooling facilities to build breathing equipment. The US diversified company General Electric is working with Ford, which is to manufacture a simplified GE ventilator with the aim of producing 50,000 units by early July. Separately GE said it was adding manufacturing lines to its own ventilator production sites and increasing the number of shifts so the devices can be produced around the clock.
Even so, workers at GE’s aviation factory in Lynn, Massachusetts staged a protest yesterday, demanding that the company reconfigure its aircraft manufacturing facilities to make ventilators there, too.
Other groups including Mercedes and Dyson are also developing their own breathing devices more or less from scratch, in collaboration with various academic groups. And Medtronic has made the design schematics of one of its ventilators available for free, to allow other manufacturers to build and release the device.
Even so, other initiatives will be necessary. Aware that US demand for ventilators will explode within days, the FDA is allowing breathing devices and their accessories not normally used in hospital contexts to be deployed in the fight against Covid-19.
Last week the agency issued an emergency use authorisation – a temporary permission that exists as long as America is in a state of emergency – for devices including anaesthesia gas machines and positive pressure breathing devices that have been modified for use as ventilators.
The devices that are eligible for inclusion under this EUA are those that are not currently marketed in the US, or that are currently marketed but have been subject to an alteration that would usually need a new 510(k) clearance application.
So far EUAs have been granted to ventilators made by two Chinese companies, Beijing Aeonmed and Mindray, and by the US group Vyaire Medical.
But many other companies could benefit. The table below summarises the companies with the most US approvals, from 2014 to date, of the kinds of respiratory devices now eligible for emergency authorisation, once they have been modified to work as ventilators.
Makers of modifiable devices eligible for EUAs
Company No of approvals
Resmed 24
Philips 12
Fisher & Paykel Healthcare 8
Getinge 6
General Electric 6
Hill-Rom 5
Hamilton Company 5
Mindray Medical International 4
3B Medical 4
Vyaire Medical 3
Drägerwerk 3
Medtronic 3
Thornhill Medical 3
Apex Medical 3
Drive Devilbiss Healthcare 3
Note: includes only manufacturers with at least 3 approved devices.
Source: EvaluateMedTech, FDA. 
It is no surprise to see Resmed way out in front. A large part of the company’s business is the manufacture of continuous positive airway pressure (CPAP) machines, which force air into sleep apnoea patients’ lungs as they sleep. CPAP machines would not be used as standard therapy for hospitalised patients who cannot breathe on their own, but ought to be reasonably easy to tweak so as to work in that way.
Resmed also makes ventilators for use when patients are awake, but this business is almost entirely focused on home care rather than the large machines found in hospitals; but again, these devices could be repurposed for the ICU. Resmed has said it is doing all it can to increase production of its ventilators and other respiratory devices and intends to double or triple its ventilator output, and scale up ventilation mask production more than tenfold.
The Philips devices that fall into the FDA’s categories came entirely though its 2008 acquisition of Respironics. One example is the Trilogy Evo portable ventilator, designed to be used initially in the hospital setting but then to be taken home by patients once they recover. The Dutch group also plans to double production of its hospital ventilators by mid-May and quadruple it by the third quarter of 2020.
These efforts are praiseworthy, but it still takes time to build these machines, and whether the overwhelming short-term demand can be met is in doubt. Some in industry insiders have been particularly sceptical about non-specialists attempting to develop their own ventilators without expert assistance.
And even the established respiratory tech developers could run into difficulty since the global supply chains for the components used in ventilator manufacture have been disrupted by the pandemic – as has staffing. Time will tell how much the obvious determination on the part of these various players can accomplish.