U.S. regulators have approved the first long-acting drug combo for HIV, monthly shots that can replace the daily pills now used to control infection with the AIDS virus.
Thursday’s approval of the two-shot combo called Cabenuva is expected to make it easier for people to stay on track with their HIV medicines and to do so with more privacy. It’s a huge change from not long ago, when patients had to take multiple pills several times a day, carefully timed around meals.
also read: Second patient cured of HIV, say doctors
“That will enhance quality of life” to need treatment just once a month, said Dr. Steven Deeks, an HIV specialist at the University of California, San Francisco, who has no ties to the drug’s makers. “People don’t want those daily reminders that they’re HIV infected.”
Cabenuva combines rilpivirine, sold as Edurant by Johnson & Johnson’s Janssen unit, and a new drug — cabotegravir, from ViiV Healthcare. They’re packaged together and given as separate shots once a month. Dosing every two months also is being tested.
The U.S. Food and Drug Administration approved Cabenuva for use in adults who have had their disease well controlled by conventional HIV medicines and who have not shown signs of viral resistance to the two drugs in Cabenuva.
The agency also approved a pill version of cabotegravir to be taken with rilpivarine for a month before switching to the shots to be sure the drugs are well tolerated.
ViiV said the shot combo would cost $5,940 for an initial, higher dose and $3,960 per month afterward. The company said that is “within the range” of what one-a-day pill combos cost now. How much a patient pays depends on insurance, income and other things.
Studies found that patients greatly preferred the shots.
“Even people who are taking one pill once a day just reported improvement in their quality of life to switch to an injection,” said Dr. Judith Currier, an HIV specialist at the University of California, Los Angeles. She consults for ViiV and wrote a commentary accompanying one study of the drug in the New England Journal of Medicine.
Deeks said long-acting shots also give hope of reaching groups that have a hard time sticking to treatment, including people with mental illness or substance abuse problems.
“There’s a great unmet need” that the shots may fill, he said.
Also read: Can COVID-19 vaccines be mixed and matched?
Separately, ViiV plans to seek approval for cabotegravir for HIV prevention. Two recent studies found that cabotegravir shots every two months were better than daily Truvada pills for keeping uninfected people from catching the virus from an infected sex partner.
The Biden administration has taken quick steps to keep the United States in the World Health Organization and reinforce financial and staffing support for it — part of his ambition to launch a full-throttle effort to fight the COVID-19 pandemic in partnership with the world.
Biden, just hours after his inauguration Wednesday, made good on a campaign pledge and revoked a Trump administration order that would have pulled the U.S. out of the U.N. health agency this summer. Early Thursday, his top medical adviser on the pandemic, Dr. Anthony Fauci, was dispatched to show new U.S. support for WHO.
Here’s a look at the U.N. health agency and its handling of the pandemic:
WHAT IS WHO?
Established in 1948, the Geneva-based agency brings together 194 U.N. members under the founding principle that health is a human right. Today, it counts over 7,000 staffers working in more than 150 countries.
It is the only health agency in the world with the authority to coordinate a global response to public health threats like like COVID-19 — but also works on the gamut of health issues like polio, maternal health care, tobacco and sugar consumption and even addiction to video games.
WHO’s current two-year budget is $5.84 billion — about half that of the U.S. Centers for Disease Control and Prevention. WHO is currently headed by Tedros Adhanom Ghebreyesus. He’s an Ethiopian microbiologist and malaria expert who is both the first African to run the agency, and the first WHO chief who is not a medical doctor. His first term is up next year and whether or not he gets a second could depend largely on who the U.S. supports.
WHY DID THE US ANNOUNCE PLANS TO LEAVE WHO?
To be clear, the United States hasn’t left WHO.
But the Trump administration, triggering a one-year notification process required by Congress, announced plans to leave on July 6. The U.S. also cut all funding to WHO, stripping it of funds from the country that has long been — and by a longshot — its biggest donor.
The Trump administration faulted the agency for three main reasons: its allegedly slow response to the pandemic after it emerged in Wuhan, China, in late 2019; its alleged kowtowing to and excessive praise of China’s government; and administration claims that WHO had criticized Trump’s suspension of entries of people from China to the U.S. as the pandemic spread.
Officials at WHO did raise questions about the use of travel bans — out of concern they might hamper medical aid efforts — but didn’t specifically criticize U.S. policy. The agency has been traditionally averse to public criticism of member states, particularly one as influential as the United States.
An Associated Press investigation last June found top WHO officials repeatedly lauded China in public even as they privately complained that Beijing was withholding critical outbreak data from them, including the new virus’ genetic sequence. And a report issued to the media this week by a panel convened by WHO concluded the agency could have acted quicker to stem the emerging coronavirus and might have labeled it a pandemic sooner.
WHAT CAN BE EXPECTED FROM THE BIDEN ADMINISTRATION?
The administration wants to show the United States resuming work with its international partners in health care after a largely go-it-alone approach under Trump.
In his pre-dawn address on Thursday to the WHO’s executive board, Fauci said the U.S. will resume full funding for WHO and maintain its staff support for it, while announcing the U.S. will join its efforts to get COVID-19 vaccines, diagnostics and therapeutics to people in need around the world.
One of the key questions will be what kind of reforms — long sought by many member countries, health advocates and even some WHO leaders themselves — that the new administration might seek. The WHO has numerous reviews in motion about its handling of the pandemic and how it can change to strengthen its ability to respond to future ones.
Fauci expressed support for WHO reform, but didn’t provide specifics.
The U.S. has long played an outsized role at WHO, including placing senior doctors in key positions and directing policies in programs ranging from AIDS to malaria to nutrition. Biden’s decision to keep the U.S. in the U.N. agency may lend some much-needed credibility to WHO after it came under heavy criticism on multiple fronts last year.
Battered by criticism that the 2020 census was dangerously politicized by the Trump administration, the U.S. Census Bureau under a new Biden administration has the tall task of restoring confidence in the numbers that will be used to determine funding and political power.
Picking up the pieces of a long, fractious process that spooled out during a global pandemic starts with transparency about irregularities in the data, former Census Bureau directors, lawmakers and advocates said.
They advised the new administration to take more time to review and process population figures to be sure they get them right. The high-stakes undertaking will determine how many congressional seats and Electoral College votes each state gets as well as the distribution of $1.5 trillion in federal spending each year.
“We are optimistic that things at the Census Bureau will be better. The question is whether the damage caused by the Trump administration can be rectified,” said Marc Morial, president and CEO of the National Urban League. Morial’s organization, along with other advocacy groups and municipalities, sued former President Donald Trump’s administration last year over a decision to end the once-a-decade head count early.
According to critics, that damage includes a failed effort to add a citizenship question to the 2020 census questionnaire and a Trump order to figure out who is a citizen and who is in the U.S. illegally. They say another Trump directive to exclude people in the country illegally from the apportionment of congressional seats, shortened schedules to collect and process data, and four political appointments to top positions inside the bureau also threatened the count’s integrity.
Census workers across the country have told The Associated Press and other media outlets that they were encouraged to falsify responses in the rush to finish the count so the numbers used for determining how many congressional seats each state gets could be produced under the Trump administration. Census Bureau officials said such problems were isolated.
Census advocates were heartened Wednesday by President Joe Biden’s quick revocations of Trump’s order to produce citizenship data and the former president’s memo attempting to exclude people in the U.S. illegally from the apportionment count. The Biden administration also has pledged to give the Census Bureau the time it needs to process the data.
“President Biden’s swift action today finally closes the book on the Trump administration’s attempts to manipulate the census for political gain,” said Dale Ho, director of the ACLU’s Voting Rights Project, who argued against the legality of the apportionment memo before the Supreme Court last year. The high court ruled that any challenge was premature.
After the bureau missed a year-end deadline for turning in the apportionment numbers, it said the figures would be completed as close to the previous deadline as possible. Trump administration attorneys recently said they won’t be ready until early March because the bureau needs time to fix irregularities in the data.
There will be flaws, likely undercounts of communities of color and overcounts of whites, but “they will just have to ‘bake the best cake possible’ through identifying and correcting the errors they can find,” said Rob Santos, president of the American Statistical Association.
Still, Arturo Vargas, CEO of the NALEO Educational Fund, said he’s worried about the accuracy of the data on the nation’s Latino population because the Trump administration’s efforts created widespread distrust that may have discouraged participation.
Trump’s four political appointments to the Census Bureau last year were denounced by statisticians and Democratic lawmakers worried they would politicize the once-a-decade head count. The Office of Inspector General last week said two of them had pressured bureau workers to figure out who is in the U.S. illegally before Trump left office, with one whistleblower calling the effort “statistically indefensible.” Then-Census Bureau Director Steven Dillingham ordered a technical report on that effort but halted it after blowback. He resigned this week after Democratic lawmakers and civil rights groups called for his departure.
The bureau’s new interim chief, Deputy Director Ron Jarmin, didn’t respond to a request for an interview. He will report to Biden’s new pick to head the Commerce Department — which oversees the Census Bureau — Rhode Island Gov. Gina Raimondo.
Former Census Bureau Director Kenneth Prewitt said he’s optimistic the final product will be as accurate as past censuses, especially now that Jarmin is at the helm.
“They know how to do it right. It just takes time,” said Prewitt, who served in the Clinton administration.
Another former bureau director, John Thompson, said the exit of Trump’s appointees will help eliminate distractions to finishing the 2020 census, but the agency needs to hold a public forum to discuss what anomalies bureau statisticians have found in the data and what they’re doing to fix them ahead of the apportionment numbers being turned in.
“Clearly, confidence in the census has been shaken,” said Thompson, who led the agency during part of the Obama administration.
U.S. Sen. Brian Schatz, a Democrat from Hawaii, asked Biden to set up a nonpartisan commission to review the apportionment data to make sure it’s fair and accurate before it’s delivered to the House of Representatives.
“The Census Bureau faced a number of challenges with the 2020 Census,” Schatz said in a letter. “Some, like the pandemic, were beyond the agency’s control. However, the Trump Administration actively interfered with the agency’s operations.”
Despite facing pressures from their political bosses, the Census Bureau’s career staff did a good job of resisting the Trump administration’s most questionable orders by coming forward when they found errors in the data without worrying about the deadline and by whistleblowing to the inspector general when they felt pressured to produce citizenship of dubious accuracy, according to Morial, Santos and Thompson.
“They deserve to be honored,” Santos said.
Facebook is passing the buck for its indefinite suspension of former president Donald Trump to a quasi-independent oversight board, setting up a major test of the recently established panel.
The social media giant said Thursday that it believes it made the right decision to suspend Trump after he incited his supporters to storm the U.S. Capitol in a deadly assault on Jan. 6. But it said it’s referring the matter to the oversight board for what it called an “independent judgment” on upholding the decision.
Facebook’s panel is intended to rule on thorny content issues, such as when posts constitute hate speech — or if the decision to ban a world leader was the right one. It is empowered to make binding rulings — that is, ones that can’t be overturned by CEO Mark Zuckerberg — on whether posts or ads violate the company’s rules. Any other findings will be considered “guidance” by Facebook. The board does not set Facebook policies or decide if the company is doing enough to enforce them in the first place.
Its 20 members, which will eventually grow to 40, include a former prime minister of Denmark, the former editor-in-chief of the Guardian newspaper, along with legal scholars, human rights experts and journalists such as Tawakkol Karmanm, a Nobel Laureate and journalist from Yemen, and Julie Owono, a digital rights advocate.
The first four board members were directly chosen by Facebook. Those four then worked with Facebook to select additional members. Facebook also pays the board members’ salaries.
Twitter, by contrast, permanently banned Trump from its platform. CEO Jack Dorsey defended his company’s Trump ban in a philosophical Twitter thread last week, saying that resulting risk to public safety created an “extraordinary and untenable circumstance” for the company.
But he acknowledged that shows of strength like the Trump ban could set dangerous precedents, even calling them a sign of “failure.” He suggested that Twitter needs to find ways to avoid coming to have to make such decisions in the first place and lamented the fact that they highlight the extraordinary power that Twitter and other Big Tech companies can wield without accountability or recourse.
For the first time in more than a decade, Republicans are waking up to a Washington where Democrats control the White House and Congress, adjusting to an era of diminished power, deep uncertainty and internal feuding.
The shift to minority status is always difficult, prompting debates over who is to blame for losing the last election. But the process is especially intense as Republicans confront profound questions about what the party stands for without Donald Trump in charge.
Over the past four years, the GOP’s values were inexorably tied to the whims of a president who regularly undermined democratic institutions and traded the party’s long-standing commitment to fiscal discipline, strong foreign policy and the rule of law for a brash and inconsistent populism. The party now faces a decision about whether to keep moving in that direction, as many of Trump’s most loyal supporters demand, or chart a new course.
Maryland Gov. Larry Hogan, one of the few Republican elected officials who regularly condemned Trumpism, evoked President Ronald Reagan in calling this moment “a time for choosing.”
“We have to decide if we’re going to continue heading down the direction of Donald Trump or if we’re going to return to our roots,” Hogan, a potential 2024 White House contender, said in an interview.
“The party would be much better off if they were to purge themselves of Donald Trump,” he added. “But I don’t think there’s any hope of him completely going away.”
Whether the party moves on may come down to what Republicans such as Texas Sen. Ted Cruz do next.
Cruz spent weeks parroting Trump’s baseless claims of election fraud, which helped incite the deadly riot at the U.S. Capitol. Republican elections officials in several battleground states that President Joe Biden carried have said the election was fair. Trump’s claims were roundly rejected in the courts, including by judges appointed by Trump.
Cruz on Wednesday acknowledged Biden’s victory but refused, when pressed, to describe it as legitimate.
“He won the election. He is the president. I just came from his inauguration,” Cruz said in an interview.
Looking forward, Cruz said Trump would remain a significant part of the political conversation, but that the Republican Party should move away from divisive “language and tone and rhetoric” that alienated suburban voters, particularly women, in recent elections.
“President Trump surely will continue to make his views known, and they’ll continue to have a real impact, but I think the country going forward wants policies that work, and I think as a party, we need to do a better job winning hearts and minds,” said Cruz, who is also considering a White House run.
In the wake of the Capitol riot Jan. 6, a small but notable faction of high-profile Republicans is taking a stronger stance against Trump or seeking distance from him.
The Senate’s top Republican, Mitch McConnell, said on the eve of the inauguration that the pro-Trump mob that stormed the Capitol was “provoked by the president.” Even Mike Pence, Trump’s vice president and long considered his most devoted cheerleader, skipped Trump’s departure ceremony to attend Biden’s inauguration.
Trump has retreated to his South Florida club, where he has retained a small group of former White House aides who will work out of a two-story guest house on the Mar-a-Lago grounds. In addition to advisers in Washington, Trump will have access to a well-funded political action committee, the Save America PAC, that is likely to inherit tens of millions of dollars in donations that flooded his campaign coffers after his election loss.
Those close to Trump believe he will lay low in the immediate future as he focuses on his upcoming impeachment trial for inciting the riot. After that, he is expected to reemerge, likely granting media interviews and finding a new home on social media after losing his powerful Twitter bullhorn.
While his plans are just taking shape, Trump is expected to remain politically active, including trying to exact revenge by backing primary challenges against Republicans he believed scorned him in his final days. He continues to leave the door open to another presidential run in 2024. Some friends believe he might even flirt with running as a third-party candidate, which would badly splinter an already fractured GOP.
Trump issued an ominous vow as he left the White House for the last time as president: “We will be back in some form.”
Many in the GOP’s die-hard base continue to promote conspiracy theories, embrace white nationalism and, above all, revere Trump’s voice as gospel.
Trump loyalists in states such as Michigan, Pennsylvania and Wyoming expressed outrage and disappointment in the 10 Republicans who voted with Democrats to impeach Trump last week. One of them, Michigan Rep. Peter Meijer, said he bought body armor to protect himself from a wave of threats from Trump supporters.
In Wyoming, state GOP Chairman Frank Eathorne raised the possibility of secession this week and criticized Wyoming Rep. Liz Cheney, another Republican who backed Trump’s impeachment.
“The Republican National Committee views President Trump as our party leader into the future. ... The (state party) agrees,” Eathorne said, noting that Trump “represents the timeless principles” that the state and national GOP stand for.
Trump left office with a 34% approval rating, according to Gallup — the lowest of his presidency — but the overwhelming majority of Republicans, 82%, approved of his job performance. Even as some try to move on, Trump’s continued popularity with the GOP’s base ensures he will remain a political force.
Despite the GOP’s many challenges, they’re within reach of retaking one or both chambers of Congress in next year’s midterm elections. Since the 2006 midterms, the party in the White House has lost on average 37 House seats. Currently, Democrats hold a 10-seat House majority and they’re tied with Republicans in the Senate.
Hogan, the Maryland governor, said that the GOP may be at one of its lowest points ever, but noted that Reagan reclaimed the White House for Republicans just six years after President Richard Nixon was forced to resign in disgrace.
“Obviously, (Trump) still has got a lock on a pretty good chunk of the Republican base, but there are an awful lot of people that were afraid to speak out for four years — unlike me —who are now starting to speak out,” Hogan said.
Still, there are plenty of hurdles ahead. Primary challenges could leave the party with congressional nominees next year who are even further to the right, potentially imperiling the GOP’s grip on races they might otherwise win.
More immediately, Senate Republicans, including McConnell, are wrestling with whether to convict Trump of high crimes and misdemeanors as outlined in last week’s House impeachment. The Senate could ultimately vote to ban Trump from ever holding office again.
“I hope that Republicans won’t participate in this petty, vindictive, final attack directed at President Trump,” Cruz said. “We should just move on.”