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Saturday, February 8, 2020

Cal. hospital pushed end-of-life care on cancer patients, oncologist’s suit claims

An oncologist is suing a California medical center, claiming that physicians there pressure patients to opt for end-of-life care and that the hospital has retaliated against him for speaking out against its practices, according to The Modesto Bee.
Dr. Robert Williams, who has had privileges at Doctors Medical Center in Modesto since 2003, alleges in the lawsuit that there have been several instances where in-house physicians at the hospital told patients to begin end-of-life care. In some of these cases, the patients were not given cancer treatments or care they needed, and in some, hospital providers recommended hospice care for cancer patients who were not terminally ill or were in cancer remission, the suit, which was filed last week, claims.
Dr. Williams also claims that he faced repercussions when he spoke out about these policies at the hospital. Nurses and hospitalists told patients he was crazy and did not follow his orders for treatment, Dr. Williams alleges.
He also claims the medical center wants to revoke his privileges. It restricted his hospital privileges in July 2018, and the suit alleges he was told not to speak with his patients once they were admitted. Dr. Williams claims he was informed Jan. 9 that the hospital’s medical executive committee was investigating him for “creating (a) hostile work environment,” the Bee reports.
Dr. Williams’ attorney filed moved to prevent disciplinary action against him, and a hearing on the matter is scheduled for March 19 in Stanislaus County Superior Court in California.
In his lawsuit, Dr. Williams seeks an unspecified amount of general, special and punitive damages for several reasons, including “emotional distress.” Fifty-one unamed defendants are also included in the lawsuit.
The hospital issued the following statement Feb. 5 to the Bee: “While we don’t comment on pending litigation, at Doctors Medical Center, decisions on end-of-life care are made by the patient, the family or its representative and the treating physician.”
https://www.beckershospitalreview.com/legal-regulatory-issues/california-hospital-pushed-end-of-life-care-on-cancer-patients-oncologist-s-lawsuit-claims.html

Coronaviruses can remain on surfaces for up to 9 days

Coronaviruses can persist on inanimate surfaces and remain infectious at room temperature for up to nine days, according to a study published Feb. 6 in the Journal of Hospital Infection. 
Researchers analyzed 22 studies on coronaviruses, including literature on SARS and MERS. An analysis revealed that the viruses normally survive on surfaces between four and five days, but can remain infectious for up to nine days. Low temperatures and high air humidity increase the lifespan.
In human-to-human transmission, coronaviruses incubate for two to 10 days and can spread via airborne droplets and contaminated hands or other surfaces. However, surface disinfection procedures using 62 to 71 percent ethanol, 0.5 percent hydrogen peroxide or 0.1 percent sodium hypochlorite are effective against coronaviruses within 1 minute.
“Different coronaviruses were analysed, and the results were all similar,” Eike Steinmann, study author and head of the Department for Molecular and Medical Virology at Ruhr-Universität Bochum in Germany, said in the news release.
https://www.beckershospitalreview.com/quality/coronaviruses-can-remain-on-surfaces-for-up-to-9-days-study-finds.html

‘We’re definitely not prepared’: Africa braces for new coronavirus

At a Chinese-run hospital in Zambia, some employees watched as people who recently returned from China showed up with coughs but were not placed in isolation. A doctor tending to those patients has stopped coming to work, and health workers have been ordered not to speak publicly about the new virus that has killed hundreds around the world.
The virus that has spread through much of China has yet to be confirmed in Africa, but global health authorities are increasingly worried about the threat to the continent where an estimated 1 million Chinese now live, as some health workers on the ground warn they are not ready to handle an outbreak.
Countries are racing to take precautions as hundreds of travelers arrive from China every day. Safeguards include stronger surveillance at ports of entry and improved quarantine and testing measures across Africa, home to 1.2 billion people and some of the world’s weakest systems for detecting and treating disease.
But the effort has been complicated by a critical shortage of testing kits and numerous illnesses that display symptoms similar to the flu-like virus.
“The problem is, even if it’s mild, it can paralyze the whole community,” said Dr. Michel Yao, emergency operations manager in Africa for the World Health Organization.
Those growing worried include employees at the Sino-Zambia Friendship Hospital in the mining city of Kitwe in northern Zambia, near the Congo border. Chinese companies operate mines on the outskirts of the city of more than half a million people. One company is headquartered in Wuhan, the city at the center of the virus outbreak. Hundreds of workers traveled between Zambia and China in recent weeks.
“We’re definitely not prepared. If we had a couple of cases, it would spread very quickly,” physiotherapist Fundi Sinkala said. “We’re doing the best we can with what resources we have.”
The Sino-Zambia Friendship Hospital, or Sinozam, a low-slung facility near the city’s train station, has taken some precautions, including checking patient temperatures with infrared thermometers and establishing isolation areas. Employees wear masks. Gloves, disinfectant and oxygen inhalers have been stockpiled. Sinozam treats many Chinese in Kitwe and its precautions go further than other hospitals in the area.
But the employees and others familiar with the matter, some of whom spoke anonymously under the new rules, say some Chinese patients checked in with coughs and fevers but did not get placed in isolation.
Visiting Zambian health officials concluded the patients did not merit special treatment and did not take samples to test for the virus. After the people recovered, they were sent home with antibiotics, employees said.
On Wednesday, the hospital set up a new fever clinic, to which people arriving with a high temperature are now ushered to right away. It’s “unfortunate” the ward wasn’t set up earlier, Sinkala said.
Two people familiar with the matter say a doctor tending to the sick has fallen ill. Dr. Yu Jianlan has not come to work in the past week and hospital administrators have not explained her absence, Sinkala said. The other person spoke on condition of anonymity for fear of retribution.
Hospital administrator Li Zhibing said there were no patients with a fever and said Yu had a urinary tract infection, not a fever. But a notice posted by the Zambia-China Cooperation Zone, which manages the hospital, quoted an employee as saying on Jan. 27 that the facility “probably sees 120 fever patients a day, and at least 70 of them are carrying germs” of various diseases.
Earlier this week, a Zambian official acknowledged for the first time that his country was following up on an unspecified number of suspected cases. Zambia is one of 13 African countries identified by WHO as a high priority because of busy travel links with China.
Copperbelt provincial health director Dr. Robert Zulu, who oversees Kitwe and the surrounding region, told The Associated Press he would not discuss details, citing privacy. But he added, “when any case is confirmed, you will be informed.”
Crucially, no one in Zambia has been able to test for the virus so far. Like most African countries, it has been waiting for a substance known as a reagent, which labs require to confirm whether a patient is infected. Labs in just six of Africa’s 54 countries were equipped as of mid-week. That means a wait of two or more days to know whether a sample shipped to South Africa or even outside the continent tests positive.
Without testing, officials are “just relying on the symptoms” and whether they persist. “But from what we are learning right now, some people show hardly any symptoms at all,” Sinkala said, calling that the hospital’s biggest worry.
Zambia is one of the additional countries WHO planned to equip by the end of the week. As of Friday, WHO emergencies chief Dr. Mike Ryan said 28 labs across the continent could diagnose the new virus.
Adding to concerns at Sinozam, three employees say Zambian health officials visited on Tuesday and have been testing the bodies of two Chinese patients that have been in the morgue for days, though some added it was out of an overabundance of caution.
Li, however, dismissed the accounts of testing the bodies as “rumors.” He said one died last month of malaria and the other of a heart attack. The bodies are still there because family members in China wish to come and pay respects but cannot because of the outbreak, he said.
Zambia’s health ministry spokesman, Dr. Abel Kabalo, called the employee accounts of events at the hospital “very strange.” He vowed that if Zambia confirms a case, authorities “will definitely inform the world.”
It’s “pointless to hide information,” Kabalo said.
The WHO says countries are obligated to inform it of any confirmed cases and are requested to report suspected cases as well. The WHO chief has publicly urged countries to share information. So far, African countries appear to be complying, a WHO adviser on health security, Dr. Ambrose Talisuna, told reporters.
Several African nations such as Ghana, South Africa and Ethiopia have announced their precautions, including updates on negative test results for suspected cases and demonstrations of surveillance and quarantine capabilities. Ethiopian Airlines, however, faces questions by some in Africa about why it continues to operate more than 30 China flights a week while other African airlines have suspended theirs.
Adding to the difficulties in diagnosing the new virus are numerous diseases in Africa with symptoms that include fever or coughing or both.
It’s impossible to diagnose the new virus by symptoms alone, Gates Foundation CEO Mark Suzman said, adding that there is a “significant likelihood” that the virus will be confirmed in Africa. And there is a risk that “panic overtakes good public health and good science.”
The foundation has committed up to $20 million to help health authorities in Africa and South Asia, another vulnerable region, improve their disease surveillance, isolation and treatment for the virus.
Concerns are high among some in Kitwe. A local pharmacy manager, Edward Goma, estimated that his business had sold more than 800 face masks in the past few days.
“So far everyone is scared,” he said. And yet he has not noticed the stricter surveillance measures seen in other countries, beyond temperature checks at the international airport an hour’s drive away.
The 15th Metallurgical Construction Group, based in Wuhan, said on its website that its overseas operations in Zambia and Congo must purchase masks, disinfect living quarters and workspaces daily and check workers’ temperatures three times a day.
Chinese employees are temporarily barred from returning to Africa, while those in Zambia are not allowed to go to China, said Li, the hospital administrator.
Chinese embassies in Zambia and elsewhere in Africa have been unusually outspoken, giving news conferences and television interviews to discuss their response to the outbreak. Embassies require arriving Chinese citizens to declare where they have been in China. They also urge citizens to voluntarily isolate themselves for 14 days.
“We are now practicing hygiene, even in the mines,” said the Kitwe-based president of the Mine Workers Union of Zambia, Joseph Chewe. “Any report of a person with coronavirus here will be very disastrous.”
‘We’re definitely not prepared’: Africa braces for new coronavirus

WHO: Transmission of new coronavirus outside of China could increase

The World Health Organization’s director-general cautioned Saturday that transmission of the new coronavirus outside of China may increase and countries should prepare for that possibility.
“It’s slow now, but it may accelerate,” Tedros Adhanom Ghebreyesus said during a press conference in Geneva. “So while it’s still slow there is a window of opportunity that we should use to the maximum in order to have a better outcome, and further decrease the progress and stop it.”
Tedros’s warning came after health authorities in Singapore announced they had diagnosed the infection in a man with no travel history to China and no known link to other cases in Singapore.
Singaporean authorities suggested — but did not order — that large public events be canceled or deferred. If public events are held, temperature screening of attendees should be conducted and people who are unwell should be turned away, they said.
In Germany, health officials announced the 12th case in a cluster of transmission of the new virus — known provisionally as 2019-nCoV — that began when a Chinese woman who works for a German car parts supplier traveled to the company’s head office in Bavaria for meetings. The latest case is the wife of an employee of the company, who himself was confirmed as having the infection last week.
Also on Saturday, British health officials announced that five Britons who were at a ski resort in France were infected. The five — four adults and a child — had been in contact with a British man who had recently been in Singapore. That man was confirmed as a case on Thursday.
As of Saturday, there have been 34,598 confirmed cases in China and 288 cases reported by 24 countries outside of China, Tedros said. There have been roughly 730 deaths, most in China. It was reported Saturday that an American man who had been infected with the virus and treated in China had died.
The WHO has been insisting that containment of the virus — stopping the outbreak — was still the goal of the response. China has used unprecedented measures to try to stop the spread, including quarantining entire cities that are home to tens of millions of people.
The WHO has pointed to the fact that although cases of infection with this coronavirus have been detected outside of China, transmission of the virus in other countries has been limited.
During the press conference on Saturday, the head of WHO’s health emergencies program, Dr. Mike Ryan, said at this point it’s not clear why little transmission has occurred outside of China.
“The question remains as to whether we’re in a lag phase and the rate of infection [outside China] may pick up, or whether we’re seeing what is the natural history of the disease. It’s way too soon to tell,” Ryan said.
Infectious diseases expert Michael Osterholm warned that it is unwise to conclude that just because the world hasn’t yet seen outbreaks in other countries they won’t happen. It takes several generations of transmission — an imported case passed on to two others, who then infect two others and so on — before an outbreak takes off, he said.
“What we’re watching is the public health community trying to catch up to the speed of the virus,” said Osterholm, who is the director of the University of Minnesota’s Center for Infectious Diseases Research and Policy.
WHO cautions that transmission of the new coronavirus outside of China could increase

Biotechs in San Diego Join Race to Combat Coronavirus

Chinese scientists on Jan. 10 shared online the genetic sequence of a deadly strain of coronavirus. The next day, Inovio Pharmaceuticals whipped up a potential vaccine.
A crop of life sciences companies are rushing to combat the coronavirus outbreak, triggering big movements in their stocks and millions in grant funding. Part of the race is playing out in San Diego, home to Inovio’s research and development division, with others locally turning toward the disease.
The Coalition for Epidemic Preparedness Innovations awarded up to a $9 million grant to support Inovio’s vaccine. It’s in preclinical testing and could move into human trials by early summer.
While regulators could fast-track Inovio’s program, analysts have cautioned that a vaccine might not be approved for the wider public for at least a year.
“We’re going to move as fast as we can,” Inovio CEO Joseph Kim said over the phone.
Inovio’s technology revolves around DNA. So, the company only needed the genetic profile of the virus, instead of a sample of it, to develop a vaccine.
“We were able to rapidly respond,” Kim said. “This is a great opportunity for us to demonstrate the power of our DNA medicines platform.”
The new coronavirus, known as 2019-nCoV, originated in the Chinese city Wuhan. As of Feb. 5, more than 27,000 people worldwide have been infected, and 563 people have died from the disease. It lacks an approved vaccine or treatment.
Other drugmakers pursuing 2019-nCoV vaccines include Moderna, a Massachusetts company that also secured grant money.
Some pharmaceuticals want to repurpose existing drugs for 2019-nCoV.
Gilead Sciences in late January struck an agreement with Chinese authorities to test its experimental drug for the Ebola virus in coronavirus patients. The company is headquartered in Foster City, Calif.
Kim said Inovio’s work on related viruses prepared the company for 2019-nCoV.
In 2018, the Coalition for Epidemic Preparedness Innovations — the same Norwegian group that awarded Inovio the recent grant — gave the company $56 million to support clinical testing of vaccines for Lassa fever and Middle East Respiratory Syndrome, which also fall into the coronavirus family.
Inovio is based in Pennsylvania but has more than 165 employees in San Diego, the center of its 2019-nCoV endeavor.
Kim noted the company could land additional grant money to offset 2019-nCoV vaccine development and clinical testing costs. As such, he believes the potential vaccine could be profitable.

Virus Could Dissipate

But 2019-nCoV could dissipate before drugmakers reach the market with vaccines, leaving little demand. This has happened with other viruses.
“This is not an established market where you know you’re going to be able to sell a certain number of drugs,” said John McCamant, editor of the Medical Technology Stock Letter that’s aimed at investors.
He added the outbreak brought volatility to some biotech stocks. Certain investors are hunting for companies poised to benefit from coronavirus, while others are betting against these stocks.
Inovio saw stock trading volumes swell on Jan. 24 following the grant announcement. Its stock price also jumped, but the gains were largely erased by Feb. 5, with shares closing at $3.56.

Investor Interest

Investors are watching other Inovio programs. Its furthest along is VGX-3100, currently in a late-stage clinical trial to treat precancerous cervical lesions and infection brought on by HPV, or human papillomavirus.
With coronavirus spreading, another stock that’s been heavily traded: Aethlon Medical, amid speculation that the San Diego company could set its sights on 2019-nCoV. Its device has regulatory clearance to treat life-threatening viruses without approved therapies.
CEO Timothy Rodell said it’s unclear whether the company’s blood-filtration device could be of use for a virus that affects the respiratory system and digestive tract.
“We’re looking to be prepared if, in fact, it turns out we could be helpful,” Rodell said. “And we’re going to continue to do that with this epidemic, and incidentally with all the other epidemics to come.”
In late January, the World Health Organization declared 2019-nCoV a global emergency. Rodell, a physician by training, noted for perspective that the flu is deadlier and more widespread.
This influenza season in the U.S. has seen an estimated 19 million cases of flu, 180,000 hospitalizations and 10,000 deaths, according to the Centers for Disease Control and Prevention.
San Diego’s Ligand Pharmaceuticals helps pharmaceuticals discover and develop medicines — including for coronavirus. Its technology to boost drug solubility is baked into Gilead’s drug that’s undergoing testing for 2019-nCoV.
Other Ligand programs could shape additional coronavirus treatments in the works, the firm said. Unlike other companies associated with battling Coronavirus, Ligand’s stock avoided volatility.
Matt Foehr, president and chief operating officer of Ligand, said it’s too early to say whether coronavirus will be a major business driver.
“Time will tell,” he said.
Biotechs in San Diego Join Race to Combat Coronavirus

Despite Calls to Lower Drug Prices, Over 600 Medications Saw Increases in January

Even as lawmakers debate and malign proposed plans to lower the costs of prescription drugs in the United States, since the start of the year, prices have increased on more than 600 prescription drugs by an average of 5.2%.
That figure is based on an ongoing pricing analysis conducted by the organization GoodRx. According to the report, 100 different drug manufacturers increased prices on 619 drugs in the month of January. That is slightly higher than the first month of 2019, which saw 486 brand drugs increased by an average of 5.2%. In 2018, there were price increases on 580 branded drugs by an average of 8%, GoodRx reported.
Like last year, the price increases in January 2020 happened over the course of the month in something of a slower rollout. It was a similar pattern as to 2019’s price increases, the group said. The year before though, almost 90% of all price increases happened during the first week of January, GoodRx said.
January is the most common month for drug companies to increase prices. In fact, on Jan. 1, 2020, there were more than 250 drugs that saw an increase in price between 1% and 10%, with the average increase falling at about 5%. Over the past four years, the median increase has been 9% and 10%, according to an analysis conducted by healthcare research firm 3 Axis Advisors.
Some of the drugs that saw price increases during the month of January are among the costliest of medications according to their list prices, GoodRx noted. Among those is Humira, the blockbuster rheumatoid arthritis treatment, which saw a price hike of 7.4% this year. That followed increases of 9.7% in 2018 and 6.2% in 2019.
Other drugs that GoodRx singled out for increases this year include:
  • Xarelto: 4.9% increase
  • Spiriva: 6% increase
  • Myalept: 9.9% increase
  • Juxtapid: 9.9% increase
  • Jardiance: 4.9% increase
  • Januvia: 4.9% increase
  • Flovent: 3% increase
  • Eliquis: 6% increase
  • Chantix: 5% increase
  • Breo Ellipta: 3% increase
As drug prices continue to play a central role in U.S. electoral politics, many drug companies have pledged to keep price increases below 10%. However, there were also a couple of outlier drugs that saw price increases above 10% this year, GoodRx said. The group pointed to the antidepressant Marplan, which saw a 14.9% increase and ADHD treatment Cotempla XR, which increased 12.3%.
The list price is the price set by drug manufacturers and is then negotiated by payers. The list price is rarely the retail price a consumer pays.
https://www.biospace.com/article/more-than-600-drugs-saw-price-increases-in-january-analysis-shows/

Biotech Q4 Earnings: Restructuring, Overall Growth Are Themes

It was a busy week for biotech quarterly and annual reports. Here’s a look at some of the top stories.
Bristol-Myers Squibb announced fourth-quarter revenues of $7.9 billion, hitting a total of $26.1 billion for the full year. The big news for the year, of course, was its $74 billion acquisition of Celgene. At this time, the company is still reorganizing the assets and operations from that deal, although it also took time this week to announce that with drug development accelerator BioMotiv it was jointly launching Anteros Pharmaceuticals to focus on a new class of drugs for fibrotic and inflammatory diseases.
BioMotiv and Bristol-Myers Squibb inked a Strategic Partnership Agreement in September 2019. The intellectual property involved in the launch was developed at Yale University and in-licensed by Bristol-Myers Squib, and now is assigned to Anteros. This is the first company that has come out of the Strategic Partnership deal. The agreement allows Bristol-Myers Squibb to become a limited partner with BioMotiv with an option to invest further in selected projects. Once a preclinical candidate is identified, Bristol-Myers has the option to acquire the company from BioMotiv.
“By all measures, 2019 was a transformative year for Bristol-Myers Squibb as we progressed our strategy through the acquisition of Celgene, delivered strong operational and financial performance, and continued to drive important science for patients,” said Giovanni Caforio, Bristol-Myers Squibb’s chairman and chief executive officer.
AbbVie reported net revenues of $8.704 billion for the quarter, an increase of 4.8% on a reported basis from the same period last year. For the full year, the company reported $33.296 billion in revenue, up from $32.753 billion in 2018. The biggest news for last year was its acquisition of Ireland-based Allergan for $63 billion.
“Our strong performance this quarter completes another excellent year for AbbVie,” said Richard A. Gonzalez, chairman and chief executive officer of AbbVie. “The launches of Skyrizi and Rinvoq are going extremely well, and we are entering 2020 with substantial momentum. We also look forward to completing the planned Allergan acquisition in the first quarter.”
Novo Nordisk announced its operating profit increased by 11% for the full year in Danish kroner and by 6% at constant exchange rates (CER). The company’s Diabetes and Obesity care sales grew by 10% in kroner and 6% CER, driven by Diabetes care of 4% CER and Obesity by 42% CER. Biopharma sales increased by 7% by kroner and 4% at CER.
“We are very satisfied with the financial performance in 2019,” said Lars Fruergaard Jorgensen, president and chief executive officer of Novo Nordisk. “The results reflect an accelerated sales growth in International Operations and a strong launch of Ozempic in particular in North America Operations and Region Europe. The Rybelsus launch in the USA is off to a good start, and we are pleased with the CV label indication for Ozempic in the USA, and the EU recommendation to approve Rybelsus, all for the benefit of patients.”
Merck reported fourth quarter sales globally of $11.9 billion, an increase of 8%. The full-year 2019 sales were $44.6 billion, up 11%. The sales were somewhat overshadowed by the announcement the company was spinning off products from its Women’s Health, Legacy Brands, and Biosimilars businesses. It plans to launch a new, independent, publicly-traded company to handle those products. No name for the new company has been announced.
“Over the past several years, we have purposefully shifted the focus of our efforts and resources to our best opportunities for growth,” said Kenneth C. Frazier, chairman and chief executive officer of Merck.
Frazier added, “This has led to the exceptional results we are reporting today. Given the opportunities now in front of us, we believe we can benefit from even greater focus. At the same time, we believe additional resources and focus will help ensure that our expansive portfolio, including many trusted and medical important products, reach their full potential.”
The argument is that the spinoff will result in two independent growth companies. They are expected to have improved strategic and operational focus, more flexibility to respond to customer needs and the market, simplified operating models, optimized capital structures and resource allocation, and better financial profiles for “unique and compelling investment cases.”
The new company will decrease Merck’s Human Health manufacturing footprint by about 25% and the number of Human Health products by about 50%.
https://www.biospace.com/article/q4-roundup-bristol-myers-squibb-abbvie-novo-nordisk-merck-gsk-and-sanofi/