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Robert Califf Nomination Moves Forward in Close Bipartisan Vote

Former U.S. Food and Drug Administration Commissioner Robert Califf is one step closer to returning to his old office after the Senate Health, Education, Labor and Pensions Committee advanced his nomination in a 13–8 bipartisan vote.

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Robert Califf Nomination Moves Forward in Close Bipartisan Vote

Former Food and Drug Commissioner Robert Califf is one step closer to returning to his old office after the Senate Health, Education, Labor and Pensions Committee advanced his nomination in a 13–8 bipartisan vote.

A cardiologist, Califf previously served as FDA commissioner in the administration of President Barack Obama. He held the role from February 2016 to January 2017. Current President Joe Biden, who served as vice president under Obama, tapped Califf for the role in the fall of 2021 as acting Commissioner Janet Woodcock’s temporary time in the role was running out.

“Dr. Robert Califf is one of the most experienced clinical trialists in the country and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic. I am confident Dr. Califf will ensure that the FDA continues its science and data driven decision-making,” Biden said in a statement when he nominated Califf.

Sen. Patty Murray, a Washington Democrat and chairperson of the HELP Committee, said that the men and women at the FDA “working diligently to ensure we have safe and effective vaccines, tests, treatments, and more, deserve a strong leader who will make sure science always comes first,”  Roll Call reported.

With the nod from the committee, Califf’s nomination now moves to the full Senate. The last time he appeared before the full body of the chamber, Califf was confirmed for the role in an 89–4 vote.

Win McNamee/Getty Images

While Califf has, so far, enjoyed bipartisan support, he also has some bipartisan opposition to returning to the head of the regulatory agency. Sen. Edward Markey, a Massachusetts Democrat, expressed concern about failures at the FDA to regulate opioid drugs effectively. In a public letter, Markey said he met with Califf in December to discuss his concerns over opioid regulation and sought commitments to strengthen regulations surrounding the approval of the drugs to include mandatory prescriber education and an independent advisory committee for opioid approvals.

“During our meeting, Dr. Califf did not commit to the decisive and comprehensive action necessary to ensure reforms that the FDA, under his leadership, would implement on opioid regulation. After years of agency failures and in the midst of a worsening opioid epidemic, we need FDA leadership that is fully committed to utilizing the agency’s full oversight authority to protect public health,” Markey wrote in his letter.

Sen. Bernie Sanders, a Vermont independent, also opposed advancing Califf’s nomination. Sanders has been an outspoken critic of high drug prices. In a statement announcing his opposition to Califf, Sanders said the FDA needs leadership “that is finally willing to stand up to the greed and power of the pharmaceutical industry.” Sanders said the FDA has become too close to the industry and expressed concern over Califf’s ties to the pharmaceutical industry.

“Shockingly, nine out of the last ten FDA Commissioners went on to work for the pharmaceutical industry or to serve on a prescription drug company’s board of directors,” Sanders said. “Unfortunately, Dr. Califf is not the exception to that rule. After leaving the FDA in 2017, he received consulting fees from Merck, Biogen and Eli Lilly. According to his financial disclosure form, he owns up to $8 million in the stocks of major drug companies. That is exactly the close relationship Big Pharma has exploited to regulate the FDA, instead of the FDA regulating them.”

BioSpace source:

https://www.biospace.com/article/robert-califf-fda-nomination-advances-after-positive-senate-committee-vote

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International

Carnival Cruise Line Crew Shortage Leads to Cancellations

Some popular onboard events won’t be happening.

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Some popular onboard events won't be happening.

Carnival Cruise Line (CCL) - Get Carnival Corporation Report has struggled to keep its ships fully staffed. That's due to a number of reasons, including crew being lost due to covid, the extended time it takes to onboard crew members, the Russian invasion of Ukraine, and some past crew simply not wanting to return to the company after the pandemic.

This problem is not unique to Carnival. Rival Royal Caribbean International (RCL) - Get Royal Caribbean Group Report has also experienced intermittent crew shortages while land-based hospitality businesses have also dealt with labor problems.

The cruise line has been upfront about these issues to make it clear to passengers that certain experiences might be different. Now, Carnival's brand ambassador John Heald has gone to Facebook to share some upcoming onboard changes the cruise line has made due to not having enough crew members.

Carnival

Carnival Cuts Popular Onboard Event

Both Carnival and Royal Caribbean run robust loyalty programs designed to entice customers to cruise on their lines repeatedly. The programs vary, but they both offer special events for members who hit various levels in the program.

Carnival calls its program "Very Important Fun Person” (VIFP) and passengers move up in the program by earning points for every night they sail. People with higher status levels get some added onboard perks, bragging rights, and access to special events. One of those perks has been suspended for now due to the staffing issues, CruiseHive reported. 

Normally cruises five nights or longer hold Diamond events -- parties for passengers who have achieved the Diamond level in the loyalty program. Those are very loyal passengers as Diamond requires 200 points (200 nights sailed in most cases).

Heald shared on his Facebook page that the Diamond parties have been canceled and Diamond-level guests will instead receive $50 of onboard credit. The cruise line has also canceled the Diamond/Platinum cocktail party and passengers who could have attended will instead receive two drink vouchers each.

"This is, of course, because of staff shortages," Heald wrote. "Because of the situation with the U.S. government, who are themselves short-staffed, we have a massive backlog of visas that the crew need to come to the U.S. and on to the ships to work."

Carnival has canceled the loyalty events through the end of June but could extend that date if the problem persists.

Carnival Forced to Make More Onboard Changes

The cruise line has also stopped operating its Cucina Del Capitano Italian restaurant as well as the elite Chef’s Table dining experience, according to Cruise Hive. Those will also be closed through the end of June, if not longer.

On some ships, Cucina Del Capitano may open for lunch while some of its signature dishes may be served for free in the main dining room.

"Carnival Cruise Line President Christine Duffy is working closely with the U.S. State Department, however, to expedite crew visas and improve onboard staffing, and it is hoped that the situation will improve quickly in the coming weeks and closures and onboard cancelations will end as the cruise industry moves into the busy summer season," the cruise news website reported.

A closed restaurant may not impact whether people choose to cruise or not. Loyalty programs, however, have very devoted customer bases who expect the perks they are used to.

Royal Caribbean has also tweaked its loyalty offerings due to the pandemic. It used to offer Diamond and higher-level members free drinks in the Diamond Lounge during an early evening happy hour. Instead, it now offers 4-6 free drinks per day depending upon your loyalty level.

 

 

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Government

European outbreak of monkeypox: what you need to know

There are some concerns of human-to-human transmission.

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Four new cases of monkeypox have been reported in the UK, bringing the total number of confirmed cases to seven. The UK Health Security Agency (UKHSA) is urgently looking for the source of the outbreak.

The first case in the current outbreak was confirmed on May 6. But this is not the first time monkeypox has been reported in the UK. Three cases were also reported in 2021 and one in 2018. However, these infections are rarely seen in the UK and are overwhelmingly linked to international travel from endemic areas, including parts of west and central Africa.

On May 18 five cases of monkeypox were reported in Portugal, with investigations into 20 further suspected cases. On the same day, the Spanish health authorities reported eight suspected cases in men who have sex with men.

This is the largest monkeypox outbreak ever seen in Europe. It is not known if the cases are linked.

Misnomer

Monkeypox, as the name suggests, was first found in laboratory monkeys in the late 1950s. However, scientists aren’t sure if monkeys are the main animal reservoirs (carriers of the virus), so the name may be a bit of a misnomer. The latest thinking is that the main reservoir is probably smaller animals, such as rodents.

Reservoirs of monkeypox have been found in rodents, such as the Gambian pouched rat. Laëtitia Dudous/Wikimedia Commons, CC BY-SA

Unlike COVID, monkeypox does not spread easily from human to human. It typically requires interaction with animals that carry the virus, or being in very close contact with infected people, or having contact with “fomites” (such as contaminated clothes, towels or furniture). Also unlike COVID, monkeypox is not known to spread asymptomatically. However, the evidence on monkeypox is thin, and the current outbreaks will provide new knowledge around its impact and transmission.

Monkeypox belongs to the same family of viruses as smallpox, but is less transmissible. People who catch it typically develop a fever and a distinctive rash and blisters. The disease is usually self-limiting, with symptoms disappearing after a few weeks. However, monkeypox can cause severe illness, with outbreaks typically showing a case-fatality rate (the proportion of people with the disease who die from it) of between 1% and 15%, with severe disease and death more likely among children.

Sexually transmitted?

The UKHSA says that some cases in the May 2022 outbreak cannot be explained by recent international travel, suggesting that there has probably been some “community transmission”. Four of the seven cases are in people who identify as gay, bisexual or other men who have sex with men. A UKHSA epidemiologist tweeted that this is “highly suggestive of spread in sexual networks”. The cases in Spain may also fall under similar consideration.

So the transmission here may be a little unusual compared with previous outbreaks. While there is a lot we don’t know about monkeypox, we do know the virus can be transmitted via close contact, for example, including prolonged skin-to-skin contact.

There is no evidence that it is a sexually transmitted infection in the manner of HIV or chlamydia. It’s more that, in the UK outbreak, the close contact during sexual or intimate activity may have been a key factor during transmission.

This may be the first time transmission of monkeypox via sexual contact or intimate activity has been documented. But the implications are not so significant in that we know close contact is required for transmission. The social dynamics around the transmission of infectious diseases means this finding may be most useful for the public health teams involved in “contact tracing” – finding other people who may have been exposed to the virus.

Very low risks for the general public

The monkeypox risks to the wider UK public are extremely low, and the NHS has specialist units that focus on treating these sorts of tropical infections. And, thankfully, there are ways of bringing the virus to heel.

The US Centers for Disease Control and Prevention highlights how the smallpox vaccine, cidofovir (an anti-viral drug), and vaccinia immune globulin can be used to control a monkeypox outbreak.

However, beyond the smallpox vaccine, there is no specific vaccine to protect against monkeypox. Some experts have suggested that stopping widespread vaccination against smallpox might have lowered population immunity against monkeypox, thus making cases and outbreaks more likely.

A 2019 meeting at Chatham House in London suggested that an unintended consequence of smallpox eradication could be that “emergent or re-emergent human monkeypox might fill the epidemiological niche vacated by smallpox”.

However, these imported monkeypox cases and other tropical infections (such as Ebola, malaria and Lassa fever) indicate a wider burden of disease elsewhere in the world, typically in low-income countries with limited access to healthcare. It may be that in a post-pandemic environment, we should give more consideration to understanding the local and global implications of Lassa, monkeypox, Ebola and other rare but serious pathogens.

Michael Head has received funding from the Bill & Melinda Gates Foundation and the UK Department for International Development.

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Science

Study: mRNA vaccines perform better against COVID-19 variants of concern

In a peer-reviewed study published May 17 in PLOS Medicine, scientists found that mRNA-based COVID-19 vaccines were superior to adenovirus vector-based…

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Study: mRNA vaccines perform better against COVID-19 variants of concern

 

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