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For Immediate Release
April, 07 2009, 11:26am EDT
Contact:
Dylan Blaylock,202.408.0034 ext. 137,dylanb@whistleblower.org
New Report Urges FDA Clinical Trial 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.
WASHINGTON
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:
- Greater
Whistleblower Protections for all Involved Parties:
Stronger anti-retaliation measures for those with evidence of wrongdoing
and threats to public health are essential to weed out bad faith parties. - Legal
Recourse for Injured Trial Participants: The Supreme
Court held that state court personal injury lawsuits against medical
device makers are preempted if the product is FDA approved. Congress must
intervene on patient's behalves, and ensure adequate protections to
trial participants of such devices. - Federal
Government Protections of all Clinical Trial Participants: An estimated 40 percent of
studies and over five million research participantsare leftuncovered each year. - Legislative
Reform of IRBs: A number of structural, financial,
procedural, and regulatory gaps plague the IRB system. - Greater Monitoring of IRB "Informed Consent" Practices: The
current IRB system focuses almost exclusively on the review of consent
forms. Yet, the law does not require IRBs to regularly observe consent
interviews or the conduct of study protocols. - "Non-Inferiority Trial" Reform: The
FDA currently permits the drug industry to prove the efficacy of a new
drug by comparing it to a previously approved drug for the same
indication, even where comparison to a placebo would not endanger the
subject. Rather than requiring the new drug to be superior to the
comparator drug, if the new drug is within a margin of inferiority the FDA
deems acceptable, the agency will approve it. Approval of such a drug adds
no value for patients but it does provide a mega-dollar benefit to drug
companies.
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.
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"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."
May 14, 2023
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."
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"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."
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\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
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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.
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"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.
May 13, 2023
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.
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"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.
May 13, 2023
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."
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