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Today, the Government
Accountability Project (GAP) is releasing a new "white
paper" report, The
ABCs of Drug Safety: Accountability, Balance, and Citizen Empowerment,
which focuses on the severe problems with the current system for conducting and
regulating clinical trials. The report details the urgent need for
reform.
Today, the Government
Accountability Project (GAP) is releasing a new "white
paper" report, The
ABCs of Drug Safety: Accountability, Balance, and Citizen Empowerment,
which focuses on the severe problems with the current system for conducting and
regulating clinical trials. The report details the urgent need for
reform.
Click here to read a copy of the new report's
executive summary: https://www.whistleblower.org/doc/2008/ABCExecSum.pdfClick here to read a copy of the new report: https://www.whistleblower.org/doc/2008/ABCFinal040709.pdf
Mark Cohen, GAP Executive Director and coauthor of the
report, stated "The current clinical trial reform process is rife with
conflicts of interest that put trial subjects at risk and produce suspect data
on drug safety and efficacy. Making matters worse, federal oversight is wholly
inadequate."
The report examines a number of recent and historical
controversies with regard to clinical trial studies and institutional review
boards (IRBs) - analyzing how major players at both the corporate and FDA
levels have too often failed to perform their critical duties to safeguard
human health. More importantly, GAP's report proposes constructive
reforms to the overall process, calling for the empowerment of trial
participants, whistleblower protections for employees staffing trials and IRBs,
removal of financial conflicts of interest between parties, and trial biases in
favor of approval of proposed drugs. Specifically, our report advocates for:
IRB protocols have been a hot topic in the news. Two
weeks ago, it was uncovered at a House of Representatives hearing that the
Government Accountability Office, as part of a sting operation, created
multiple fake companies and drugs, submitted them for approval using three
third-party IRBs, and successfully received permission to begin clinical trial
use in patients. Also two weeks ago, the FDA released a progress report
regarding its Human Subject Protection and Bioresearch Monitoring Initiative. While some of its recommendations
represent progress, GAP still identifies major gaps to public safety.
"The FDA system of ensuring drug safety is a
work-in-progress," stated Sheila Fleischhacker, author of the report.
"Some of the FDA's new regulations are steps in the right
direction, but the overall process still has too many gaps that put the public
at risk. Our report can be viewed as a piece to continue the initiative's
modernizing and strengthening."
The Government Accountability Project (GAP) is a 30-year-old nonprofit public interest group that promotes government and corporate accountability by advancing occupational free speech, defending whistleblowers, and empowering citizen activists. We pursue this mission through our Nuclear Safety, International Reform, Corporate Accountability, Food & Drug Safety, and Federal Employee/National Security programs. GAP is the nation's leading whistleblower protection organization.
"If we don't act now, it will be too late," one mom warned. "I could not live with myself, as a mother, as a doctor, and as a human being, if we didn't do all we can to try and bring about the much-needed systemic change."
From Australia to Zimbabwe, mothers on Saturday peacefully occupied public spaces and called for urgent societal transformation to avert the worst impacts of the fossil fuel-driven climate emergency.
Joined by loved ones on the eve of Mother's Day, moms across the globe sat down in protest circles, where they highlighted the deadly consequences of the status quo and demanded lifesaving climate action.
"With our circles we convey that we refuse to look away, that we refuse to give up, and that we will do everything we can," Mother's Rebellion for Climate Justice said in a statement.
Participants made clear that children and impoverished people who bear the least responsibility for the climate crisis face the most harm, and that failing to fundamentally reform the global political economy threatens to decimate younger and future generations.
"Children are feeling betrayed because they see that governments are not doing enough, or are actively delaying meaningful climate action."
"Children are feeling betrayed because they see that governments are not doing enough, or are actively delaying meaningful climate action," said Marion, a mother and member of Doctors for Extinction Rebellion (Health for XR). "Those that are meant to protect and safeguard them, are ignoring and turning their backs on the children in this country, and on the children in the Global South who are already facing the impacts of a heating climate, as well as the fallout from environmental destruction and exploitation of resources."
"If we don't act now, it will be too late," Marion warned. "I could not live with myself, as a mother, as a doctor, and as a human being, if we didn't do all we can to try and bring about the much-needed systemic change."
Mothers' Rebellion, an offshoot of Extinction Rebellion launched last year in Sweden, describes itself as "a growing global community of women who want to be able to look our children in the eyes and say that we truly do all that we can." Fed up with "the lack of a powerful, transformative response from our politicians and leaders," the alliance "will not give up the fight for a sustainable present and future for the current and coming generations."
On Saturday, moms gathered in more than a dozen countries on every continent except Antarctica to build support for "the necessary changes to keep our planet healthy so that all its inhabitants can thrive," Extinction Rebellion Families (XR Families) explained.
Demonstrations took place in Australia, Costa Rica, Finland, Germany, India, Nigeria, Poland, Portugal, Sweden, Uganda, the United Kingdom, the United States, Zambia, and Zimbabwe.
\u201cGlobal #MothersDay "Mothers Rebellion"! Demands climate action across six continents. \nAll photos c/o @ExtinctionR \nhttps://t.co/yXO3mxm6lc\u201d— Antonia Juhasz (@Antonia Juhasz) 1684079271
"My heart aches when I think about the extreme heatwaves and devastating floods that my relatives in Malaysia have endured over the past few months," said Feng, a mother of two and member of XR Families. "It's not just about my family, but the countless others who are facing the brunt of climate change. That's why I will be at the Mothers' Rebellion, fighting for a livable planet for today’s children and all future generations. We owe it to them to take action now, before it's too late."
Kristine, a mother and member of Health for XR, said that "as healthcare professionals, it is our duty to identify and act on risks to children."
"As a mother and doctor, I cannot sit silently and watch this injustice to children across the world."
"Currently 85% of the burden of climate health impacts is falling on those under 5 years of age," said Kristine. "These health impacts include malnutrition, heat exposure, water scarcity, infectious diseases such as malaria and Lyme disease, and high levels of air pollution causing worsening asthma and childhood cancers."
"I am seeing these devastating impacts on children in my daily work, even in the U.K.," she continued. "As a mother and doctor, I cannot sit silently and watch this injustice to children across the world and that's why I will be at the Mothers' Rebellion and demand urgent climate action from world leaders."
According to XR Families:
Mothers' Rebellion wants a livable, socially just, inclusive world for all children. Almost all children on Earth are already exposed to at least one form of climate and environmental danger or stress. Mothers' Rebellion demand immediate action to reduce emissions to net-zero by 2025, starting with the phase-out of fossil fuels, and to protect and repair ecosystems whilst also addressing social inequality.
Approximately one billion children—nearly half the world’s 2.2 billion children—live in one of the 33 countries classified as [being at] "extremely high-risk" to the effects of climate change. These figures are likely to get worse as the impacts of climate change accelerate. The climate crisis is also affecting children's mental health. A global survey illustrates the depth of anxiety many young people are feeling about climate change. Nearly 60% of young people approached said they felt very worried or extremely worried. 83% think adults have failed to take care of the planet.
The Royal College of Pediatrics and Child Health is calling for child health to be a central theme in all climate change policy decisions. All children should have the right to clean air, safe water, sanitation, affordable and nutritious food, and shelter. The climate crisis is a child rights crisis, and governments should mobilize and allocate resources to protect those rights and include a child rights risk assessment as part of all climate policy decisions.
"I consider the crowning glory of my life to be in the presence of my four grandchildren," said Valerie, a retired doctor and Health XR member. "How, in my late autumn years, can I justify my existence on this beautiful planet if it is not dedicated to whatever action I trust may play a part in preserving it and its glorious biodiversity—for them and all the world's children, born and yet to be?"
"Nothing else in my life can take precedence over this," Valerie continued. "Science does not lie. I call upon all grandparents, parents, uncles, aunts and friends, older siblings, and those who work with young people in this ultimate expression of love for them—and for their children."
"Without a habitable planet, what value has everything else we may wish to bequeath to them?" she asked.
"Still a lot more to do but this is the impact of electing an environmentalist like Lula over a right-wing populist like Bolsonaro," said one observer.
Deforestation in Brazil's Amazon rainforest decreased by 68% this April compared with last year, according to preliminary government data published Friday.
The finding reflects positively on the administration of leftist Brazilian President Luiz Inácio Lula da Silva, who has vowed to make the destruction of the crucial ecosystem "a thing of the past."
As Reutersreported:
Official data from space research agency INPE showed that 328.71 square km (126.92 square miles) were cleared in the Brazilian Amazon last month, below the historical average of 455.75 square km for the month.
That interrupted two consecutive months of higher deforestation, with land clearing so far this year now down 40.4% to 1,173 square km.
Lula's victory last October over Brazil's far-right former president, Jair Bolsonaro, was hailed as a critical step toward rescuing the Amazon from more severe and possibly irreversible damage.
Parts of the Amazon, often referred to as the "lungs of the Earth" due to its unparalleled capacity to provide oxygen and absorb planet-heating carbon dioxide, recently passed a key tipping point after Bolsonaro intensified clearcutting of the tropical rainforest during his four-year reign. Bolsonaro's regressive policy changes pushed deforestation in Brazil to a 15-year high last year, helping to drive the country's greenhouse gas emissions to their highest level in almost two decades.
Most of the deforestation that occurred under Bolsonaro was illegal, fueled by logging, mining, and agribusiness companies that were given a green light by the ex-president and often used violence to repress Indigenous forest dwellers and other environmental defenders.
During a November speech at the United Nations COP27 climate summit in Egypt—his first on the international stage after defeating Bolsonaro—Lula said that "there's no climate security for the world without a protected Amazon," roughly 60% of which is located in Brazil.
"The crimes that happened [under Bolsonaro] will now be combated," said Lula, a Workers' Party member who previously served as Brazil's president from 2003 to 2010 and took office again on January 1. "We will rebuild our enforcement capabilities and monitoring systems that were dismantled during the past four years."
"We will fight hard against illegal deforestation. We will take care of Indigenous people," said Lula, who drastically reduced both deforestation and inequality when he governed the country earlier this century. "Brazil is emerging from the cocoon to which it has been subjected for the last four years."
As Reuters noted Friday, "Experts say it is still too early to confirm a downward trend, as the annual peak in deforestation from July to September lies ahead, but see it as a positive signal after rainforest destruction rocketed in late 2022."
"There are several factors, and the change in government might indeed be one of them," Daniel Silva, a conservation specialist at WWF-Brasil, told the outlet. "The environmental agenda has been resumed, but we know time is necessary for the results to be reaped."
"The environmental agenda has been resumed, but we know time is necessary for the results to be reaped."
Friends of the Earth campaigner and author Guy Shrubsole was quicker to give Lula credit.
"Still a lot more to do but this is the impact of electing an environmentalist like Lula over a right-wing populist like Bolsonaro," tweeted Shrubsole, whose books include The Lost Rainforests of Britain and Who Owns England?
Lula has taken important steps toward fulfilling his pledge to halt deforestation by 2030, though Reuters reported that the president "has faced continued challenges since taking office as [the] environmental agency IBAMA grapples with lack of staff," one lingering consequence of his predecessor's funding cuts.
Earlier this month, Lula secured "an 80 million-pound ($100.97 million) contribution from Britain to the Amazon Fund, an initiative aimed at fighting deforestation also backed by Norway, Germany, and the United States," Reuters noted. Last month, he "resumed the recognition of Indigenous lands, reversing a Bolsonaro policy, while announcing new job openings at the environment ministry and [the] Indigenous agency FUNAI."
Research has shown that granting land tenure to Indigenous communities is associated with improved forest outcomes.
Lula fully expected to face substantial opposition from corporate interests and right-wing Brazilian legislators.
The Washington Postreported last year that "a bloc of lawmakers with ties to agriculture could try to block Lula's environmental policies and pass legislation to facilitate land-grabbing and illegal mining."
Vox also explained that "deforestation is unlikely to stop altogether once Lula takes office."
"Bolsonaro's party still dominates Congress and will likely continue supporting the cattle industry, which is behind nearly all forest loss in the Brazilian Amazon," the outlet pointed out. "The country also faces an economic crisis and fallout from mismanaging the coronavirus pandemic, and it's not clear exactly how Lula will prioritize these competing crises."
Despite scientists' warnings that it will be virtually impossible to avert the worst consequences of the climate and biodiversity crises unless the world stops felling trees to make space for cattle ranching, monocropping, and other harmful practices, global efforts to reverse deforestation by 2030 are currently behind schedule and woefully underfunded.
"These findings fly in the face of Biden's preferred framing of international politics as a 'battle between democracies and autocracies,'" says the author of a new report.
President Joe Biden claims that the United States is leading "democracies" in a fight against "autocracies" to establish a peaceful international order, but his administration approved weapons sales to nearly three-fifths of the world's authoritarian countries in 2022.
That's according to a new analysis conducted by Security Policy Reform Institute co-founder Stephen Semler and published Thursday in The Intercept.
The U.S. has been the world's largest arms dealer since the end of the Cold War. Data released in March showed that the U.S. accounted for 40% of global weapons exports from 2018 to 2022.
As Semler explained:
In general, these exports are funded through grants or sales. There are two pathways for the latter category: foreign military sales and direct commercial sales.
The U.S. government acts as an intermediary for FMS acquisitions: It buys the materiel from a company first and then delivers the goods to the foreign recipient. DCS acquisitions are more straightforward: They're the result of an agreement between a U.S. company and a foreign government. Both categories of sales require the government's approval.
Country-level data for last year's DCS authorizations was released in late April through the State Department's Directorate of Defense Trade Controls. FMS figures for fiscal year 2022 were released earlier this year through the Pentagon's Defense Security Cooperation Agency. According to their data, a total of 142 countries and territories bought weapons from the U.S. in 2022, for a total of $85 billion in bilateral sales.
To determine how many of those governments were democratic and how many were autocratic, Semler relied on data from the Varieties of Democracy project at the University of Gothenburg in Sweden, which uses a classification system called Regimes of the World.
"Of the 84 countries codified as autocracies under the Regimes of the World system in 2022, the United States sold weapons to at least 48, or 57%, of them," Semler wrote. "The 'at least' qualifier is necessary because several factors frustrate the accurate tracking of U.S. weapons sales. The State Department's report of commercial arms sales during the fiscal year makes prodigious use of 'various' in its recipients category; as a result, the specific recipients for nearly $11 billion in weapons sales are not disclosed."
"The Regimes of the World system is just one of the several indices that measure democracy worldwide, but running the same analysis with other popular indices produces similar results," Semler observed. "For example, Freedom House listed 195 countries and for each one labeled whether it qualified as an electoral democracy in its annual Freedom in the World report. Of the 85 countries Freedom House did not designate as an electoral democracy, the United States sold weapons to 49, or 58%, of them in fiscal year 2022."
Despite the White House's lofty rhetoric, it is actively bolstering the military power of a majority of the world's authoritarian countries, from Saudi Arabia and the United Arab Emirates to dozens of others, including some overlooked by researchers at the University of Gothenburg.
For instance, the Varieties of Democracy project characterizes Israel as a "liberal democracy" even though human rights groups around the world have condemned it as a decidedly anti-democratic apartheid state. Washington, meanwhile, showers Israel with $3.8 billion in military support each year, resources that the government uses to violently dispossess and frequently kill Palestinians at will.
As Semler put it Saturday in his "Speaking Security" newsletter, "These findings fly in the face of Biden's preferred framing of international politics as a "battle between democracies and autocracies."
The president's narrative "lends itself more to a self-righteous foreign policy than an honest or productive one," Semler argued. "Dividing the world between democratic and autocratic countries—in the spirit of 'with us or against us'—makes conflict more likely and has had a chilling effect on calls for diplomacy and détente. It's also harder to cooperate with the international community while insisting you're locked in an existential fight with roughly half of them."