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Saturday, January 18, 2020

Experts warn over scale of China virus as US airports start screening

The true scale of the outbreak of a mysterious SARS-like virus in China is likely far bigger than officially reported, scientists have warned, as countries ramp up measures to prevent the disease from spreading.
Fears that the virus will spread are growing ahead of the Lunar New Year holiday, when hundreds of millions of Chinese move around the country and many others host or visit extended  living overseas.
Authorities in China say two people have died and at least 45 have been infected, with the outbreak centred around a seafood market in the central city of Wuhan, a city of 11 million inhabitants that serves as a major transport hub.
But a paper published Friday by scientists with the MRC Centre for Global Infectious Disease Analysis at Imperial College in London said the number of cases in the city was likely closer to 1,700.
The researchers said their estimate was largely based on the fact that cases had been reported overseas –- two in Thailand and one in Japan.
The virus—a new strain of coronavirus that humans can contract—has caused alarm because of its connection to SARS (Severe Acute Respiratory Syndrome), which killed nearly 650 people across mainland China and Hong Kong in 2002-2003.
China has not announced any travel restrictions, but authorities in Hong Kong have already stepped up detection measures, including rigorous temperature checkpoints for inbound travellers from the Chinese mainland.
The US said from Friday it would begin screening flights arriving from Wuhan at San Francisco airport and New York’s JFK—which both receive direct flights—as well as Los Angeles, where many flights connect.
And Thailand said it was already screening passengers arriving in Bangkok, Chiang Mai and Phuket and would soon introduce similar controls in the beach resort of Krabi.
Two deaths
No human-to- has been confirmed so far, but Wuhan’s health commission has said the possibility “cannot be excluded”.
A World Health Organization doctor said it would not be surprising if there was “some limited human-to-human transmission, especially among families who have close contact with one another”.
Scientists with the MRC Centre for Global Infectious Disease Analysis—which advises bodies including the World Health Organization—said they estimated a “total of 1,723” people in Wuhan would have been infected as of January 12.
“For Wuhan to have exported three cases to other countries would imply there would have to be many more cases than have been reported,” Professor Neil Ferguson, one of the authors of the report, told the BBC.
“I am substantially more concerned than I was a week ago,” he said, while adding that it was “too early to be alarmist”.
“People should be considering the possibility of substantial human-to-human transmission more seriously than they have so far,” he continued, saying it was “unlikely” that animal exposure was the sole source of infection.
Local authorities in Wuhan said a 69-year-old man died on Wednesday, becoming the second fatal case, with the disease causing  and damage to multiple organ functions.
After the death was reported, online discussion spread in China over the severity of the Wuhan coronavirus—and how much information the government may be hiding from the public.
Several complained about censorship of online posts, while others made comparisons to 2003, when Beijing drew criticism from the WHO for underreporting the number of SARS cases.
“It’s so strange,” wrote a web user on the social media platform Weibo, citing the overseas cases in Japan and Thailand. “They all have Wuhan pneumonia cases but (in China) we don’t have any infections outside of Wuhan—is that scientific?”

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Trump Plan to Strengthen Social Security Involves Cutting Disability Benefits

Social Security, America’s top social program, is in some pretty big trouble.
Every year, the Social Security Board of Trustees releases a report that examines the short-term (10-year) and long-term (75-year) outlook for the program. Since 1985, just two years after the last bipartisan overhaul of Social Security, the trustees have cautioned that the long-term outlays of the program would outpace its incoming revenue. In other words, the trustees have raised the red flag that Social Security’s $2.9 trillion in asset reserves (i.e., its net-cash surpluses built up since inception) could be completely gone very soon.
By the latest projection, the program’s asset reserves will be exhausted by 2035, which could lead to a cut to retired worker benefits of up to 23%. That’s a problem when roughly a third of current retirees are almost wholly reliant on Social Security for their income.
Fixes are needed, and President Donald Trump hasn’t shied away from offering his take.
President Trump giving remarks in the White House from behind the presidential podium.
IMAGE SOURCE: OFFICIAL WHITE HOUSE PHOTO BY SHEALAH CRAIGHEAD.

Trump has mostly focused on indirect solutions to improve Social Security

For the most part, Trump has cautioned that direct fixes to the Social Security program are akin to political suicide. Before becoming president, Trump had this to say at the Conservative Political Action Conference (CPAC) in March 2013:
As Republicans, if you think you are going to change very substantially for the worse Medicare, Medicaid, and Social Security in any substantial way, and at the same time you think you are going to win elections, it just really is not going to happen… What we have to do and the way we solve our problems is to build a great economy.
Understanding that direct fixes to the program would leave some group of folks worse off than they were before, Trump has generally avoided flashy direct solutions. Rather, he’s primarily focused his efforts on improving the U.S. economy.
The passage of the Tax Cuts and Jobs Act (TCJA) is a prime example, with the expected growth from the TCJA expected to lead to higher payroll tax collection. The 12.4% payroll tax on earned income is Social Security’s workhorse, providing $885 billion of the $1 trillion collected in 2018. In each of the past two years, Social Security’s net-cash surplus has come in slightly ahead of the trustees’ expectations, suggesting that Trump’s tactics have, at least in the very short term, played a role in staving off the inevitable.
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The president’s plan to strengthen Social Security involves tightening SSDI’s belt

It’s also clear that indirect solutions are a temporary fix to a $13.9 trillion problem that just keeps growing. Knowing this, we’ve also begun to see policy proposals introduced over the past year from the Trump administration that would directly aim to reduce Social Security program outlays over the next decade. More specifically, these proposals are targeted at minimizing Social Security Disability Income (SSDI) outlays.
For example, the president released his fiscal 2020 budget proposal for the federal government on March 11, 2019 (the federal fiscal year ends on Sept. 30). Presidential budget proposals are almost always talking points that begin discussion in Congress, but rarely do they offer any meat on the bone in relation to a final spending bill. That, nevertheless, didn’t stop Trump from facing harsh criticism after his call to implement changes to the Social Security program that would reduce outlays by $26 billion over the next decade.
Though the president’s proposals were aimed at reducing inefficiencies with the program, a significant portion of the savings ($10 billion in total over 10 years) was to be realized from changing a single SSDI rule. This rule change would reduce the amount of retroactive pay disabled workers could recover to six months from 12 months, thereby saving $3.6 billion over the first five years and $10 billion by 2029.
But this wasn’t the last we heard from the Trump administration on SSDI benefit reductions. This past November, another rule change was proposed that would make medical reviews more common for some of the 8.4 million workers currently receiving a Social Security disability benefit.
Right now, applicants for SSDI have their chance of medical improvement placed into one of three categories — expected, possible, or not expected — with medical reviews for the first two categories of applicants being conducted within 18 months and three years, respectively. The new Trump administration proposal wants to create a new category, “medical improvement likely,” which would trigger a medical review every two years. The expectation here is that more workers would be removed from the SSDI program and pushed back into the labor force, ultimately saving $2 billion in SSDI outlays over 10 years. Of course, the increased frequency of reviews would eat up $1.8 billion of “savings” over the decade.
The point is, SSDI cuts appear to be very much in Donald Trump’s playbook as a means of improving Social Security’s long-term outlook.

Here’s why SSDI cuts are highly unlikely (at least anytime soon)

However, just because proposals meant to reduce SSDI outlays are on the table, it doesn’t mean they’re going to be implemented. In fact, the chance of Trump actually getting either of these SSDI proposals passed into law is virtually zero at the moment.
For one, the current party breakdown in Congress is unlikely to lead to any resolutions on Social Security. Democrats have a majority in the House and would unquestionably reject any proposal that would reduce SSDI payouts. And even if, by some miracle, one or both of these proposals reached the Senate, it’s unclear if there would be enough bipartisan support to get a bill to Trump’s desk for his signature.
Secondly, we’re in the midst of an election year, and there’s no chance that President Trump would risk losing votes by highlighting a proposal that would cut Social Security benefits. Should he win a second term, the idea of reducing program expenditures is probably on the table. But for the time being, he’s likely to follow his own advice offered at CPAC in 2013 and avoid direct solutions entirely.
Third, and finally, even if the Trump administration sought unilateral rule changes without consulting Congress, a lawsuit would almost certainly be filed to stop it from being implemented, leading to a drawn-out legal battle.
On one hand, the 8.4 million disabled workers currently receiving SSDI can breathe a sigh of relief in the short term. But should Trump be re-elected, a battle could begin brewing, with disability benefits clearly in the crossfire.

Next week’s watch list

Earnings reports:  Abbott Laboratories (NYSE:ABT), Johnson & Johnson (JNJ) on January 22.
IPO lockup expirations: Livongo Health (NASDAQ:LVGO) Health Catalyst (NASDAQ:HCAT), Castle Biosciences (NASDAQ:CSTL) all see their share lockups expire on January 21.
Companies forecast to make a quarterly payout change include Allergan (NYSE:AGN) to $0.76 from $0.74, Healthcare Services (NASDAQ:HCSG) to $0.2013 from $0.20.
FDA watch: The action date for Epizyme’s (NASDAQ:EPZM) tazemetostat for epitheloid sarcoma arrives next week. Merck (NYSE:MRK) also has a PDUFA date coming up on DIFICID. Meanwhile, Forty Seven (NASDAQ:FTSV) and Bellicum Pharmaceuticals (NASDAQ:BLCM) are both expected to present Phase 1 results at the ASCO GI Cancers Symposium running from January 23-25 in San Francisco.
Short report: The list of stocks heading into the trading week with an elevated level of short interest as a percentage of total float includes Health Insurance Innovations (NASDAQ:HIIQ), Mallinckrodt (NYSE:MNK), Accelerate Diagnostics (NASDAQ:AXDX), Akcea Therapeutics (NASDAQ:AKCA), Intrexon Corp (NASDAQ:XON), AMAG Pharmaceuticals (NASDAQ:AMAG), Lannett Company (NYSE:LCI), Clovis Oncology (NASDAQ:CLVS), OptiNose (NASDAQ:OPTN) and Ligand Pharmaceuticals (NASDAQ:LGND).

Machine keeps transplant livers alive for a week

With current technology, a human liver donated for transplant can only be kept alive for 24 hours, and often, if the liver is damaged or diseased, it cannot be considered for transplant. That could soon change. Liver4Life, a Wyss Institute project, has developed a liver perfusion machine that can preserve injured human livers for one week and can even repair damage.
In a paper published in Nature Biotechnology, researchers from University Hospital Zurich, ETH Zurich and the University of Zurich, explain how the perfusion machine mimics core bodily functions in order to keep livers alive. The device injects insulin and glucagon to control glucose levels, a function usually overseen by the pancreas. In place of the kidneys, a dialysis membrane provides waste removal. An oxygenator fills the role of the lungs. Nutrient infusions replace the bowels, and a pump serves as a stand-in heart. The machine moves the liver continuously to mimic movements that would be caused by the diaphragm.
The researchers first tested the perfusion machine using pig livers. Then, they obtained 10 human livers that were declined for transplantation by all hospitals in Europe and would have otherwise been discarded. Six of the 10 livers recovered to full function and were successfully preserved for one week. That’s much longer than is possible with the current methods, which entail cooling a liver to reduce metabolic function. The six livers also showed a decrease in injury and inflammation markers, usually after one or two days in the machine.
There is plenty of work to do before livers preserved in this machine can be transplanted into humans, but the technology could make more livers available for transplantation. That could save the lives of many patients suffering from liver disease and various cancers.
Going even further, because livers are known to regenerate, the technology might one day make it possible to remove a small piece of healthy liver from a patient, grow it in a perfusion machine and transplant the regenerated liver back into the original patient, while removing the remaining diseased portion. Or, a healthy donor liver might be split apart. Each piece could then be grown in the perfusion machine, yielding more than one transplantable organ.

Star Trek-inspired medical bed could make X-rays more affordable

X-ray scans are unavailable for most people on Earth (two thirds of them, according to 2012 WHO data), in part due to the sheer cost of the machines themselves. The superheated filament in conventional X-ray machines requires so much energy and heat that it costs millions of dollars just to keep the patient safe. Nanox might just have a way to make these scans widely available, though. It’s introducing the Nanox.Arc, an X-ray machine that looks like a Star Trek biobed and promises to lower the cost to low five-digit figures.

Where familiar X-ray techniques are effectively analog and involve bulky arrays of rotating tubes, Nanox is using a digital system that’s much cooler and can get away with stationary tubes that are much smaller and cheaper. The only thing that needs to move is the gantry holding the X-ray ring as it scans different parts of your body.
The business model could shake things up, too. Instead of asking customers to buy machines outright, Nanox is hoping to offer devices on a “pay-per-scan” basis where the company offers AI-based analysis and cloud services to clinics and hospitals. That would entail recurring costs, but it could still be far more affordable than purchasing a machine costing orders of magnitude more.
Nanox didn’t say when it expected to make the scanner available, although it did hope to deploy 15,000 units in the “near term.” It just got $26 million in extra funding from Foxconn, though, and it has a clear goal: it wants to give everyone a X-ray scan per year as a preventative step. Ideally, you’d spot cancer and other hidden medical issues early enough to get effective treatment, rather than waiting until there are conspicuous signs of trouble.

Drugmakers slash prices to be eligible for China’s bulk-buy program

Global pharmaceutical majors and generic drugmakers chopped by 53% on average prices of some of their off-patent products in the latest bidding round under China’s national bulk-buy program, government officials said late on Friday.
Beijing has been pushing forward the program where drugmakers have to go through a bidding process and cut prices low enough to be considered over generic copies and be allowed to sell their products at public hospitals via large-volume government procurement.
Some global firms such as AstraZeneca (AZN.L) and Merck (MRK.N) have already cautioned about intensifying price pressures on their mature brands in the world’s second largest drug market, as China expands the usage of the program.
In the latest bidding on Friday that involved 33 drugs and 122 companies, Bayer (BAYGn.DE) slashed the price of its popular diabetes treatment Acarbose to 0.18 yuan ($0.0262) per pill, 78.5% lower than the price ceiling set by the government in December last year, elbowing some Chinese generic providers out of the tender, according to a Reuters calculation based on the preliminary results released by the authority overseeing the program.
“Products that won bids in this round of centralized procurement saw a huge price drop, which squeezes out unreasonable overpricing that has existed in drug distribution for a long time,” the authority said in a statement published alongside the preliminary result on Friday.
Sale prices of over 100 types of commonly used drugs are on average about 17 to 18 times of their manufacturing costs, the statement said.
Chinese copycats won bids for most of the 33 drugs, including generic versions for drugs ranging from Johnson & Johnson’s (JNJ.N) prostate cancer treatment Zytiga to Eli Lilly’s (LLY.N) erectile dysfunction treatment Cialis, the results showed.
In Friday’s bidding, for products with two bid winners, 60% of the government procurement volume can be shared among the winners, according to official document detailing the tender rules released in December. For products with four winners and more, as much as 80% of the volume can be shared among the companies.
In the first round of the nationwide implementation of the bulk-buy program in September, global drugmakers including Sanofi (SASY.PA) and Eli Lilly managed to cut some prices low enough to levels close to those offered by local generic makers.

With Introduction of Biosimilars, Biologics Prices Have Decreased

The net prices of biologic agents have decreased following the introduction of biosimilar or other alternatives, according to a study published in JAMA Network Open.
Researchers specifically assessed the originator biologics Neupogen® (filgrastim), Neulasta® (pegfilgrastim), Remicade® (infliximab), and insulin glargine; these were the only biologics that had had competition from biosimilars (filgrastim-sndz, filgrastim-aafi, pegfilgrastim-jmdb, infliximab-dyyb, and infliximab-abda) or other within-molecule substitutes (tbo-filgrastim and insulin glargine) during the study period.
They used pricing data from January 2007 to June 2018 from SSR Health, which provides quarterly estimates of list prices, net prices, Medicaid discounts, and discounts from other payers for branded products with U.S. sales reported by publicly traded companies.

Comparison of list and net prices before and after biosimilar introduction

List and net prices of filgrastim increased in parallel each year by a mean of 5.1% and 6.1%, respectively, until the introduction of a biosimilar in 2015. List prices then stagnated and net prices began to decrease by a mean of −7.7% annually.
List and net prices of pegfilgrastim also increased annually by a mean of 7.5% and 4.9%, respectively, until the introduction of a first biosimilar in 2018, after which list prices stagnated and net prices decreased by −7.4%.
List and net prices of infliximab both increased in parallel by a mean of 6.0% from 2007 to 2013, after which net prices started to decrease by a mean of −1.3% per year. After the introduction of a biosimilar in 2017, net prices decreased further to a mean of −13.6% per year.
From 2007 to 2014, list and net prices of insulin glargine increased annually by a mean of 14.7% and 8.8%, respectively. From 2015 to 2019, list price growth slowed to a mean of 5.8% annually. Net prices began to decline by a mean of −14.4% annually in 2015 and further decreased by −23.5% in 2017 following the entry of a substitute agent.
Overall, Medicaid discounts increased by 20.1 percentage points for filgrastim, 31.2 percentage points for pegfilgrastim, 33.8 percentage points for infliximab, and 35.2 percentage points for insulin glargine. For other payer types (non-Medicaid), discounts increased by 20.3 percentage points for filgrastim, 23.4 percentage points for pegfilgrastim, 50.6 percentage points for infliximab, and 76.1 percentage points for insulin glargine.