December, 22 2021, 03:36pm EDT
For Immediate Release
Contact:
Tim Shenk
Press Officer
Direct: 212-763-5764
E-mail: tim.shenk@newyork.msf.org
MSF Responds to FDA Approval of COVID-19 Treatment Nirmatrelvir/Ritonavir
WASHINGTON
The US Food and Drug Administration (FDA) today gave emergency use authorisation (EUA) for the oral antiviral candidate nirmatrelvir (PF-07321332) in combination with ritonavir, produced by the US pharmaceutical corporation Pfizer, for the early treatment of people with mild to moderate COVID-19 who are at increased risk of developing severe disease. With vaccination rates lagging behind in many parts of the world, people are left unprotected against COVID-19 and access to recommended, easy-to-administer medicines is critical. However, as with COVID-19 vaccines, high-income countries are tying up the available supply of nirmatrelvir/ritonavir through advance purchase agreements with Pfizer and leaving limited-to-no supply available in the near-term for low- and middle-income countries. As generic production of nirmatrelvir/ritonavir is only anticipated by the middle of next year, access for low- and middle-income countries is precarious.
Pricing is also expected to be a barrier to access. Pfizer, the only manufacturer currently producing this treatment, has still not disclosed a price for the antiviral though many countries continue to grapple with rising COVID-19 cases. The only indication of potential pricing of the medicine comes from a recently announced agreement with the US government for the purchase of 10 million treatment courses for US$5.29 billion - which amounts to around $529 per treatment course, an exorbitant price.
While Pfizer is expected to apply a 'tiered pricing' strategy for supplying low- and middle-income countries, this market segmentation could result in limited access for many middle-income countries. These same countries may also be excluded from an existing voluntary license, thus facing eventual patent barriers that block the entrance of more affordable generics. MSF highlighted this limitation in response to the recently announced voluntary license between Pfizer and the UN-backed Medicines Patent Pool on nirmatrelvir/ritonavir, which offers supply to only 95 countries by generic companies that take up the license, covering just 53% of the world's population and excluding many upper middle-income countries with manufacturing capacity, such as Argentina, Brazil, China, Malaysia and Thailand.
As there is no patent yet on nirmatrelvir and as ritonavir has been off patent since last year*, there is currently a window of opportunity for manufacturers, particularly in the countries excluded from the voluntary license, to establish generic production and supply domestically. Governments should reject patent applications on this life-saving medicine and use all possible measures to remove obstacles, including the use of compulsory licensing, to ensure no barriers for generic production globally. Generic companies in countries like Bangladesh and India are already developing generic versions of this drug, and other countries should follow suit.
Mihir Mankad, Senior Global Health Advocacy and Policy Advisor at MSF-USA:
"To tackle the global COVID-19 pandemic, there needs to be global access to COVID-19 medicines such as the now-FDA-approved antiviral treatment, nirmatrelvir/ritonavir, produced by Pfizer.
"Many low- and middle-income countries, including those in which MSF works, are grappling with overburdened healthcare systems and low rates of COVID-19 vaccination due to extreme inequity in global vaccine access and challenges to implement vaccination and potentially vaccine-evasive and/or more transmissible variants such as currently feared for Omicron. Easy-to-administer oral treatments could ease the burden on overwhelmed hospitals and other essential healthcare services, save lives, and serve as a key tool for health workers trying to manage this pandemic.
"We are deeply concerned by Pfizer's business-as-usual approach and rich countries' repeated hoarding of limited supplies, which may leave low- and middle-income countries with virtually no access to this treatment for at least the first half of 2022. Governments in low- and middle-income countries need to be in the driver's seat instead of companies, and should take immediate steps to ensure sufficient, timely and equitable access to nirmatrelvir/ritonavir. The global health priority must be to increase the supply of affordable treatments for all people in all countries--including by allowing the production and supply of lifesaving, affordable generic medicines for everyone who needs them.
"With patent applications still pending, countries should stand firm and refuse to grant any patents on nirmatrelvir/ritonavir, while generic companies should start preparing to produce the medicine without waiting for Pfizer's permission. If Pfizer is really interested in ensuring global access to this treatment, it should make clear that it will not stand in the way of generic production and competition anywhere, and refrain from imposing intellectual property barriers everywhere for the duration of pandemic.
"One additional way to ensure that everyone in need everywhere has access to COVID-19 therapeutics is for all governments to support the "TRIPS Waiver" proposed by India and South Africa at the World Trade Organization, which seeks to allow countries to remove all major intellectual property barriers in an effort to enable and expand broad global production of lifesaving COVID-19 medical tools."
Doctors Without Borders/Medecins Sans Frontieres (MSF) is an international medical humanitarian organization created by doctors and journalists in France in 1971. MSF's work is based on the humanitarian principles of medical ethics and impartiality. The organization is committed to bringing quality medical care to people caught in crisis regardless of race, religion, or political affiliation. MSF operates independently of any political, military, or religious agendas.
LATEST NEWS
Who Should Pay for Climate Damage? Majority of the World Agrees: Big Oil
"As governments debate how to finance climate action, they can be confident that making polluters pay is not only fair, but also far more popular and effective than placing the burden on ordinary citizens."
Nov 04, 2024
A multinational survey commissioned by Greenpeace International and published Monday revealed that a majority of respondents favor making fossil fuel companies pay for being the main cause of the climate emergency.
Greenpeace International's Stop Drilling, Start Paying campaign commissioned the strategic insight agency Opinium Research to survey 8,000 adults in eight countries—Australia, Argentina, France, Morocco, Philippines, South Africa, the United Kingdom, and the United States—ahead of this month's United Nations Climate Change Conference, also known as COP29, in Baku, Azerbaijan.
"Asked about who should bear the most responsibility for climate change impacts, the most popular option across all eight countries in the survey was making oil and gas companies pay, with high-emitting countries and global elites ranked second and third," Greenpeace International said in a summary of the survey, adding that "60% of all surveyed countries see a link between profits of the oil and gas industry and rising energy prices."
The survey also found that two-thirds or more of respondents are angry about Big Oil CEOs getting huge bonuses even as their products exacerbate the planetary emergency; fossil fuel expansion; industry disinformation; and the "historic and ongoing role of oil and gas companies in conflict, war, and human rights violations."
Eight in 10 respondents said they were worried about climate change. However, more than twice as many people surveyed in the Global South said the climate emergency has personally affected them than respondents in the Global North.
According to Greenpeace International:
Imposing a fair climate damages tax on extraction of fossil fuels by OECD countries—proposed by the charity Stamp Out Poverty and supported by 100 NGOs, including Greenpeace International—is one example of a tax on big polluters. This could generate $900 billion by 2030... This would be key for annual climate-related loss and damage costs, estimated to be between $290-$580 billion by 2030 in low-income countries, as well as for reducing the emission of heat-trapping greenhouse gases and adapting to the impacts of the climate crisis in all countries.
"This research shows how taxing the wealthy polluters-in-chief—companies like Exxon, Chevron, Shell, Total, Equinor, and Eni—has become a mainstream solution among people, cutting across borders and income levels," said Stop Drilling, Start Paying co-chair Abdoulaye Diallo. "As governments debate how to finance climate action, they can be confident that making polluters pay is not only fair, but also far more popular and effective than placing the burden on ordinary citizens for a crisis for which they bear little or no responsibility."
The Opinium survey was published on the same day that Amnesty International called on the richer countries most responsible for the climate emergency to "fully pay for the catastrophic loss of homes and damage to livelihoods" in Africa.
"African people have contributed the least to climate change, yet from Somalia to Senegal, Chad to Madagascar, we are suffering a terrible toll of this global emergency which has driven millions of people from their homes," said Samira Daoud, Amnesty's regional director for West and Central Africa. "It's time for the countries who caused all this devastation to pay up so African people can adapt to the climate change catastrophe."
Keep ReadingShow Less
Erasing 'Any Sign of Life,' Israeli Demolition Teams Razing Entire Villages in Lebanon
"This is a scorched-earth policy, a violation of the Geneva Conventions," said one reporter.
Nov 04, 2024
As the death toll from Israel's 13-month assault on Lebanon passed 3,000, satellite imagery analyses published by multiple media outlets in recent days revealed that nearly a quarter of all buildings in 25 municipalities in the southern part of the Mideastern country have been destroyed or damaged in a ferocious campaign that has left entire villages in ruins.
Satellite photos examined by The Washington Post, Reuters, and the Financial Times showed vast destruction caused by Israeli bombing and controlled demolitions of towns and villages, many of whose residents are among the more than 1.2 million people forcibly displaced by the war.
"There are beautiful old homes, hundreds of years old," Meiss al-Jabal Mayor Abdulmonem Choukeir toldReuters. "Thousands of artillery shells have hit the town, hundreds of air strikes. Who knows what will still be standing at the end?"
Meiss al-Jabal native Fatima Ghoul toldThe Washington Post that "everything has been reduced to rubble" in the town of 8,000 inhabitants. Footage circulating on social media Monday showed large portions of the village, which has been inhabited for many hundreds of years, turned to dust in a simultaneous series of demolition explosions.
According to the Post:
Satellite imagery from Kfar Kila shows freshly turned soil where olive groves once stood, suggesting a clearance operation by Israeli forces. Dozens of crushed buildings line the town's main road. The destruction is most intense near the Israeli border. The village centers in nearby Ayta al-Shab, Mhaibib and Ramyeh have also been decimated, the imagery reveals.
Videos published on social media show a series of controlled explosions in at least 11 villages. In a video published to X on October 22, half a dozen buildings fall in an instant after an explosion, covering the 400-year-old village of Ayta al-Shab in dust clouds and debris. In drone footage published online the next day, an Israeli flag flies over the town—now reduced to a sea of broken trees and collapsed concrete.
In one video verified by the Post, IDF troops cheer the demolition of a mosque in the village of Dharya, with one soldier exalting, "What a moment!" while others break out in religious song.
Religious and culturally important buildings are protected under international law. Scorched-earth tactics and disproportionate attacks are war crimes under international law.
"Even if civilians are not inside, those types of buildings don't lose their protection," former U.S. Department of Defense attorney Sarah Harrison told the Post.
A spokesperson for the Israel Defense Forces claimed the IDF was obliterating Lebanese towns and villages because Hezbollah—the political and paramilitary group based in Lebanon—is turning "civilian villages into fortified combat zones." Hezbollah denied the accusation.
Retired Lebanese Armed Forces Gen. Akram Kamal Srawi told the Financial Times that "there are two reasons Israel is using this detonations strategy."
The first reason, he claimed, is that the IDF is clearing the way for a possible deeper invasion of Lebanon.
"The second is that Israel has adopted a scorched earth strategy in order to wage psychological warfare on Hezbollah's base people by televising these detonations and weaken support for the group—which will never work," he added.
Israel began attacking Lebanon at almost the same time it launched its war on Gaza in response to the Hamas-led October 7, 2023 attack on Israel. Hezbollah has fired at least hundreds of rockets and other projectiles at Israel in a sustained yet measured campaign in solidarity with Gaza, where Israel's bombing, invasion, and siege have left more than 155,000 Palestinians dead, maimed, or missing and millions more displaced, starved, and sickened in a war that the International Court of Justice is investigating for possible genocide. At least scores of Israelis have been killed or wounded by Hezbollah's cross-border attacks.
In addition to the at least 3,002 people killed by Israel's onslaught, Lebanon's Health Ministry says that more than 13,000 others have been injured. The ministry does not distinguish between Hezbollah fighters and civilians. Critics say neither does the IDF.
"We're a family of artists, my father is well-known, and our home was a known cultural home," Lebanon Philharmonic Orchestra conductor Lubnan Baalbaki told Reuters after viewing satellite images confirming the destruction of his family home.
"If you have such high-level intelligence that you can target specific military figures, then you know what's in that house," Baalbaki added. "It was an art house. We are all artists. The aim is to erase any sign of life."
Keep ReadingShow Less
Add $24 Million Worth of Pro-Trump Tweets to Elon Musk's Campaign Giving Total
"Given the sheer frequency of Elon Musk's posting of disinformation and partisan rhetoric, it is almost inevitable that he will be one of the top spreaders of election-related disinformation in this cycle," one expert said.
Nov 04, 2024
Since richest-man-alive and X-owner Elon Musk endorsed former Donald Trump for president in July, he has emerged as the No. 1. financial backer of Republican candidate's campaign. But his support hasn't only come in outright donations. His tweets in support of the former president, according to a new analysis ,are worth a total of $24 million.
In a report published Monday, the Center for Countering Digital Hate (CCDH) found that Musk's political posts between July 13 and October 25 received over twice as many views as U.S. "political campaigning ads" run on X during that time. If any of those advertisers had wanted to reach the same number of people as Musk, they would have had to pay $24 million.
"X has long dropped its pretense to be anything but a loudspeaker for its owner's opinions, personal vendettas, and conspiracies," CCDH wrote on the platform as it shared the report.
Since he endorsed Trump, Musk made a total of 746 posts that mentioned key terms such as "Donald Trump," "Kamala Harris," "voting," or "ballots." These posts were viewed a total of 17.1 billion times compared with 7.7 billion times for all paid political ads.
What's more, at least 87 of Musk's election-themed posts between January 1 and October 23 contained "false or misleading about the presidential election."
These were seen 2 billion times, and none of them was appended by a "community note," a mechanism by which X users can fact-check or provide context to inaccurate posts.
CCDH pointed to two main genres of misleading tweet shared by Musk: those claiming that the Democratic Party was importing immigrant voters and those claiming that U.S. voting systems are not reliable.
For example, on September 18, Musk wrote: "The Dem administrative state is flying millions of future voters directly into swing states. They are being sent to cities and towns throughout Ohio, Pennsylvania, Wisconsin, and Arizona. Given that this is a sure path to permanent one-party rule, it is a very smart strategy."
Musk made more than 66 posts along these lines that were seen nearly 1.3 billion times.
Fact-checkers say these claims are false because it takes years for an immigrant to become a U.S. citizen and to be able to vote, and there would be no guarantee that such a person would vote for the Democrats. Existing laws already penalize noncitizens who vote with either deportation or incarceration.
In an example of the second category of lie, Musk wrote on September 4 that "not requiring ID, combined with mail in voting, makes it completely impossible to prove fraud (obviously)."
Musk has made 19 of these types of posts targeting either mail-in or electronic voting, which were viewed almost 532 million times. However, research has shown that voter fraud related to either mail-in voting or drop boxes is exceedingly rare. A full 36 states mandate that voters show an ID before voting, while 14 others have other ways of confirming identity, such as checking a signature against one on file. In all states, voter fraud is against the law.
"Given the sheer frequency of Elon Musk's posting of disinformation and partisan rhetoric, it is almost inevitable that he will be one of the top spreaders of election-related disinformation in this cycle," CCDH founder Imran Ahmed toldCNN.
"He is using the platform to persuade people that elections are rigged," Ahmed continued, adding "it is such a tragic waste of a phenomenally powerful tool."
Keep ReadingShow Less
Most Popular