Health experts warn China travel ban will hinder coronavirus response

The Trump administration’s decision to ban most foreign nationals who had been to China in the last two weeks from traveling to the United States amid an accelerating outbreak of a novel coronavirus there was preceded by calls for similar policies from conservative lawmakers and far-right supporters of the president. Public health experts, however, warn that the move could do more harm than good.
The administration’s public health emergency declaration also requires U.S. citizens returning from China to undergo some level of quarantine, depending on where they had been in China.
Before the announcement Friday, Sen. Tom Cotton (R-Ark.) had called for a ban on all commercial flights from China, and Rep. Paul Gosar (R-Ariz.) said the government should consider “implementing a temporary travel ban on travelers from China until the threat is resolved.”

Beyond Capitol Hill, Mike Cernovich, a prominent conspiracy theorist and early Trump supporter, had agitated on Twitter for a Chinese travel ban, as has Michael Savage, another conspiracy theorist and a radio host with white nationalist beliefs. “QUARANTINE! STOP TRAVELERS FROM CHINA NOW!” he said on Twitter last week.
The ban comes on top of moves by major U.S. airlines halting flights to and from mainland China.
The outbreak has sickened nearly 10,000 people, mostly in China, and killed more than 200. A few countries have responded by imposing full or limited travel bans. The Philippines, for instance, has banned travel from the city of Wuhan, the epicenter of the outbreak. Countries including the Bahamas, Mongolia, and Singapore have banned all travel from China.
Public health experts have warned that travel bans are not effective at stemming the spread of a virus and can make responding to an outbreak more challenging.
“From a public health perspective, there is limited effectiveness. And then there are a host of other reasons why they can actually be counterproductive,” said Catherine Worsnop, who studies international cooperation during global health emergencies at the University of Maryland.
The World Health Organization, which declared the outbreak a global health emergency this week, has recommended against any travel or trade restrictions in response to the outbreak. Member countries, however, do not have to comply with that guidance.
“Although travel restrictions may intuitively seem like the right thing to do, this is not something that WHO usually recommends,” said Tarik Jašarević, a WHO spokesperson. “This is because of the social disruption they cause and the intensive use of resources required,” he added.
Experts said travel bans could lead to a slew of downstream effects and risk complicating the public health response.
“There’s not only the financial toll on a country that is dealing with this outbreak, but this can discourage transparency, both in this outbreak and in the future,” Worsnop said.
Travel and trade restrictions can lead to dire economic consequences for countries involved, creating a disincentive for them to quickly disclose potential outbreaks to the WHO or other nations. They can hinder the sharing of information, make it harder to track cases and their contacts, and disrupt the medical supply chain, potentially fueling shortages of drugs and medical supplies in the areas hit hardest by the outbreak. They also send a punitive message, which could contribute to discrimination and stigmatization against Chinese nationals, experts warned.
Any effort and money spent crafting and enforcing travel and trade restrictions also take away already-stretched resources from public health measures that have been proven to be far more effective, experts said. Those measures include providing assistance to countries with weaker health systems, accelerating the development of a vaccine or rapid diagnostic test, and clearly communicating with the public about when and how to seek care.

But for politicians, those responses might not feel as tangible an action as enacting a travel ban. During the 2013-2014 Ebola outbreak, there was a flurry of calls for a U.S. ban on travel from the affected countries, including from Donald Trump, then a private citizen.
“People want their government to do something when these outbreaks are happening, and adopting a border restriction is a visible policy that people think works,” Worsnop said.
Enacting such a ban would go directly against the recommendation of the WHO, which has said countries must inform the organization of any travel restrictions they put in place.
“Adopting these restrictions undermines the cooperative approach we need to respond to this kind of outbreak, specifically by undermining the authority of the WHO, which has recommended against these restrictions,” Worsnop said.
Worsnop said she is hopeful that the WHO will be able to hold countries accountable for disregarding its guidance, including pressing countries for scientific justification for their travel policies and calling out governments that have gone against its recommendations.
“Unfortunately, [governments] face domestic and international pressures, and have faced few costs in the past for not following WHO recommendations,” she said.

Health experts warn China travel ban will hinder coronavirus response

Gilead Offers Experimental Drug for Coronavirus Treatments, Testing

Gilead Sciences Inc. said on Friday that it had provided doses of an experimental antiviral drug to doctors for the emergency treatment of a small number of patients infected by the new coronavirus.
Gilead, based in Foster City, Calif., also said it has formalized an agreement with Chinese authorities to conduct a clinical trial of the drug remdesivir in patients infected with the coronavirus.
Health authorities have been searching for a treatment for China coronavirus infections, which lack an approved drug or vaccine. Several drugmakers have said they are trying to develop a vaccine, which could prevent but not treat infections.
Researchers had been hoping to study whether Gilead’s remdesivir and other antivirals could work as treatments.
Unlike some of the other antivirals being examined, Gilead’s drug isn’t approved for use in humans by regulators in the U.S. or internationally.
Separately, the drug was administered to an infected patient in Washington state, researchers reported in the New England Journal of Medicine on Friday. The man, 35 years old, had traveled to Wuhan, the Chinese city where the outbreak started, and after returning to the U.S. was the first person in the country to test positive for the China coronavirus.
The patient was given remdesivir on the seventh day of his hospitalization, Jan. 26, and the following day the patient’s clinical condition improved. As of Jan. 30, the patient remains hospitalized, but “all symptoms have resolved with the exception of his cough, which is decreasing in severity,” the researchers wrote.
On the day he was treated with the Gilead drug, the patient’s fever reached 39.4 degrees Celsius (102.9 degrees Fahrenheit). The following day it dropped to 37.3 degrees Celsius (99.1 degrees Fahrenheit) and declined into the normal range over subsequent days, the paper said.
“Before treatment he had high fevers and was getting sicker,” George Diaz, the patient’s attending physician at Providence Regional Medical Center Everett, said in an interview on Friday. “After treatment, he had reduced fevers and no longer required oxygen; his lungs cleared up, and he generally felt better.”
Dr. Diaz cautioned, however, that the drug has to be studied in large clinical trials to determine whether it is an effective treatment for the coronavirus.
A Gilead spokeswoman declined to say how many patients are receiving the drug or where they are based. In clinical trials of Ebola patients, the drug was less effective than rival treatments. In animal studies, the drug helped lessen lung disease in mice infected with Middle East respiratory syndrome, a coronavirus known as MERS.
https://www.marketscreener.com/GILEAD-SCIENCES-4876/news/Gilead-Sciences-Offers-Experimental-Drug-for-Coronavirus-Treatments-Testing-29923511/

U.S. Declares Public Health Emergency for Coronavirus

Citing the U.S. cases of novel coronavirus, including one case of human-to-human transmission and several unknown factors, the U.S. Department of Health and Human Services declared a public health emergency in the U.S. on Friday.
Beginning on February 2, 2020 at 5 p.m. Eastern time, the U.S. government will be enacting several temporary measures involving U.S. citizens returning from China back to this country, HHS Secretary Alex Azar announced at a press conference of President Trump’s Novel Coronavirus Task Force:

• U.S. citizens returning from Hubei province within 14 days, the epicenter of the outbreak in China, will be medically quarantined for up to 14 days
• All U.S. citizens returning from China within 14 days, once medically cleared in airport screening, will be asked undergo mandatory self-isolation for up to 14 days once medically cleared
• Foreign nationals considered to pose a risk of transmitting novel coronavirus will be denied entry to the country

These actions were described by officials as “prudent, targeted and temporary,” and mainly designed to reduce the burden of screening on public health officials screening for novel coronavirus.
Azar reiterated the government’s position that risks to the U.S. from the coronavirus remain low. “Our job is to keep it that way,” he added.
“Safety of the American people” was repeated over and over during the briefing, but Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, cited the “unknown aspects of this particular outbreak” as the chief reasons why this was necessary from a medical standpoint.
While the novel coronavirus has killed far fewer people than seasonal flu, the difference, Fauci said, was “unknown” versus “certainty.” Whereas with novel coronavirus, he cited asymptomatic transmission, and the inability to detect the illness when patients are asymptomatic, as a major factor.
“One of the problems is when a virus is transmitted in an asymptomatic way, it puts a terrible burden on the screening process,” Fauci said. “We still have a low risk to the American public, but we want to keep it at a low risk … because there are so many unknowns here.”

CDC Director Robert Redfield, MD, also emphasized the limitations of current novel coronavirus testing, adding that of the six cases we have seen in the U.S., a number were asymptomatic, but only one was picked up by airport screening, while the rest were “picked up by astute doctors.”
Fauci also cited the “unknown accuracy” of current diagnostic testing.
“If we absolutely had an accurate test that was very sensitive and very specific, we could test people and we’re good to go,” he said, adding “it’s not a test that’s absolute,” unlike, for example, an HIV test — which can determine with 100% accuracy if a person has HIV in their blood.
Fauci gave another example: “Ebola doesn’t get actively transmitted unless you’re very ill,” he said.
Redfield added that the self-isolation for U.S. citizens returning from China was the standard for the 2014 Ebola outbreak in West Africa, and “98% of the American public voluntarily accepted the importance of this.”

Officials stressed that this is not a “travel ban,” as all U.S. carriers to China have been taking down passenger flights, such that it has been a “market response by airlines and voluntary decisions taken by travelers.”
So far, there are 12 cases of human-to-human transmission outside China, and Redfield said they are most concerned with “expansion of sustained community human-to-human transmission,” such as the type occurring inside China.
“This is a precautionary message and action put out today,” he said, adding that it is “intended to keep this virus from causing significant consequences to the American public.”
A seventh U.S. case of novel coronavirus was confirmed by the CDC late Friday in Santa Clara County, California. This was a travel-associated case, with the man reporting travel history to Wuhan, according to NBC Bay Area. He is currently “self-isolated,” never having become sick enough to be hospitalized, the report said.
https://www.medpagetoday.com/infectiousdisease/publichealth/84662

FDA OKs Aimmune’s peanut allergy drug

Aimmune Therapeutics (NASDAQ:AIMT) +21.7% after-hours on news the Food and Drug Administration approved its Palforzia drug for patients with peanut allergies.

The oral medication is indicated for the mitigation of allergic reactions, including anaphylaxis, that occur with accidental exposure to peanuts, but it is not an emergency treatment of the reactions, the company says.

Aimmune says Palforzia is the first FDA-approved therapy for peanut allergy or for any food allergy.

Peanut allergies affect more than 1.6M children and teens in the U.S. alone.

https://seekingalpha.com/news/3537073-fda-oks-aimmunes-peanut-allergy-drug

Biogen gears up for Alzheimer’s drug launch

There are serious doubts about whether the FDA will approve Biogen’s Alzheimer’s candidate aducanumab – but is gearing up to file it with the regulator and is already looking ahead to a potential launch.
Chief executive officer Michel Vounatsos said that the company plan to file its dossier of clinical evidence for aducanumab with the FDA “as soon as possible” in a conference call with analysts as the troubled pharma announced its full year results.
The dry figures on display belie the drama that unfolded in 2019. In March, Biogen axed phase 3 development of aducanumab after deciding that it wasn’t working, only to stun markets in October by announcing plans for a filing after seeing what looks like a beneficial effect in certain patients at a high dose.
Earlier this week, the FDA even approved a re-dosing study for Alzheimer’s patients formerly enrolled on the abandoned trials, and could start receiving the drug again as early as March.
Meanwhile, Biogen is remaining coy about exactly when it plans to file its dossier with the FDA, although the company is already gearing up in case the regulator gives a positive decision.

Cited by Reuters, Vounatsos said: “We are actively preparing for the potential launch of aducanumab with an initial focus on the United States.”
Alfred Sandrock, executive vice president of research and development said the company has had a “high level of constructive engagement” with the FDA, adding that “it’s basically a matter of putting together documentation”.
The company is already factoring in launch costs in its guidance for 2020, saying it expects to spend up to 20.5% of total revenue as it ramps up its sales force to market the drug.
After a filing, the medical community and investors will get a strong indication about whether aducanumab is approvable if the FDA convenes a meeting of its expert advisors, which is highly likely in the case of a novel drug.
Any new drug for Alzheimer’s would be a major achievement as there has been nothing new to hit the market since 2003, and available treatments only help manage symptoms instead of slowing or halting progression.
If aducanumab is approved, it will be in the nick of time for Biogen, which could see its blockbuster multiple sclerosis pill Tecfidera face generic competition for the first time this year.
A key decision in a patent dispute is expected this week but in the meantime sales grew in Q4, and were up 5% to $1.2 billion.
Biogen has just launched a follow-up drug to Tecfidera called Vumerity, which is less likely to produce the gastrointestinal side-effects that cause some patients to quit.
After a launch in October it’s too early to say whether Vumerity has been a success with sales of just $5 million – but Vounatsos said it has had positive reception from health insurers.
Competition is tough though with Novartis’ Mayzent and Merck KGaA’s Mavenclad among recent MS launches.
Biogen said Q4 sales were up 4% compared with the same period last year, and total revenues grew 17% to $14.4 billion.

Biogen gears up for Alzheimer’s drug launch

University of Pennsylvania researchers nab grant for CAR-T prostate cancer test

The University of Pennsylvania, which has helped pioneer cell therapy approaches to blood cancers, has nabbed an ACGT grant to help battle solid tumors.
The research team has been handed a $500,000 grant from Alliance for Cancer Gene Therapy (ACGT), and follows on from the 2004 grant it gave Penn’s Carl June, M.D., one of the predominate scientists involved in CAR-T research.
His work helped pave the work for this type of cell therapy to halt a number of blood cancers, but the latest grant is geared toward its next-gen work: Solid tumors. This has proven a much harder nut to crack for CAR-T, but the Penn U. scientists are hoping this grant will help them on their way.

The ACGT grant was awarded to Joseph Fraietta, Ph. D, assistant professor of microbiology and a T-cell biologist with expertise in tumor immunology and translational medicine, and Naomi Haas, M.D., director of the Prostate and Kidney Cancer Program, associate professor of medicine.
“The goal of the ACGT-funded study is to overcome prostate cancer’s stubborn resistance to CAR T-cell therapy,” the University said in a statement.

Drs. Fraietta and Haas are exploring approaches for re-engineering T-cells to enable them to induce safe, long-term remission for advanced, metastatic prostate cancer patients.
“The grant from ACGT will help us advance our clinical work in a very novel way,” said Dr. Fraietta. “If we can unlock the epigenetic code that controls the fate and function of T-cells, it could be a game changer.”
Both Haas and Fraietta will explore the connection between nutrient availability and epigenetic programming, and how these factors influence the viability of T-cells and their anti-tumor functionality.
“For so many years, chemotherapy, radiation and surgery were the traditional treatments for cancer. For prostate cancer, there’s also hormone therapy,” said Honeycutt. “Unfortunately, as the cancer progresses, it often stops responding to these traditional treatments. New cell and gene therapy approaches like the ones Drs. Fraietta and Haas are employing offer new hope to all cancer patients. ACGT has been dedicated to funding innovative science that harnesses the power of cell and gene therapy and transforms how cancer is treated. The work of Drs. Fraietta and Haas is a great example of this promise.”
https://www.fiercebiotech.com/biotech/university-pennsylvania-researchers-nab-grant-for-car-t-prostate-cancer-test

No kickback: Novartis Kymriah travel assistance program gets nod from HHS

Normally, a pharma company paying a patient to take its drug looks suspicious—like a kickback—and it’s considered so under federal law. But HHS has just made a special ruling for a novel therapy.
The federal health agency now allows Novartis to pay for travel, lodging, meals and other out-of-pocket expenses for Medicare and Medicaid patients taking its CAR-T therapy Kymriah, the department’s Office of Inspector General said in an advisory opinion (PDF).
The so-called Kymriah Travel Assistance Program assists “eligible low-income patients” with expenses incurred during their travel to receive the drug—and the ensuing post-infusion monitoring phase—at one of some 100 designated treatment centers across the U.S. under an FDA-required safety program.

HHS issued the ruling at the special request of Novartis because otherwise the scheme could be punishable under anti-kickback statue of the Social Security Act. Generally, federal regulators view that these payments could unfairly steer patients to a particular drug and result in increased costs to the federal health system. But Novartis managed to persuade them.
In making the request, Novartis argued that rural patients living far from a treatment center could suffer from significant health risks or even death if they couldn’t afford travel. Because of its potentially dangerous side effects, such as cytokine release syndrome, patients who get Kymirah are monitored for at least a month.

“Due to the nature of the patient population and the serious safety risks associated with Kymriah therapy, financially needy patients may need enhanced support to access their prescribed treatment,” Novartis said in a statement shared with FiercePharma.
Several limitations have been put on the program. For example, patients must live more than two hours’ driving distance or 100 miles from the nearest available center. In addition, Novartis promises not to advertise the arrangement. Patients will not learn about it until they have been diagnosed with on-label indications and are prescribed Kymriah.
Still, while patients might not be tipped off beforehand, caregivers are aware of the existence of the program. Therefore, they may choose Kymriah over Gilead Sciences’ rival drug Yescarta for some patients.

Regulators made it clear that the ruling is meant only for this Kymriah program. Gilead didn’t immediately respond to a FiercePharma request about whether it’s seeking a similar opinion for Yescarta.
Currently, Kymriah is trailing behind Yescarta sales-wise, even though it was the first CAR-T therapy approved. In the third quarter, the Novartis drug sold $79 million, and that number went up in the fourth quarter to $96 million. In comparison, Yescarta generated $118 million in Q3.
It wasn’t so long ago when drugmakers paid up millions of dollars to settle federal allegations that they used donations to patient charities as kickbacks to cover copays for their medicines. These include Astellas coughing up $100 million, Amgen $24.75 million, Jazz Pharma $57 million, Lundbeck $52.6 million and Alexion $13 million, among others. Two charities—Good Days and Patient Access Network Foundation—also recently shelled out a combined $6 million to close U.S. Department of Justice claims.
https://www.fiercepharma.com/marketing/not-kickback-hhs-allows-novartis-kymriah-travel-assistance-program-for-public-patients