October, 30 2008, 04:01pm EDT
Public Citizen Petitions FDA to Ban Avandia, Cites Life-Threatening Toxicity as Top Diabetes Associations Advise Against Use
Risks Outweigh Benefits of the Diabetes Drug;
WASHINGTON
The Food and Drug Administration (FDA) should
immediately ban the dangerous diabetes drug Avandia because it can
cause death from liver failure and has many other life-threatening
risks that far outweigh its benefits, Public Citizen said in a petition
filed today with the agency.
New research released by Public Citizen about the drug,
used to treat Type 2 diabetes, comes as a working group with
representatives from the American Diabetes Association (ADA) and the
European Association for the Study of Diabetes, unanimously advised
against using Avandia, whose generic name is rosiglitazone, because of
their concerns about the drug's risks. This statement appears in the
newly published issue of Diabetes Care, the ADA's peer-reviewed
medical journal. Despite a significant decrease in its use since
publication of a study linking it to increased risk of heart attacks,
approximately 10,000 prescriptions a day are still filled for this
unacceptably dangerous drug, which is sold by Glaxo-SmithKline.
Public Citizen has identified 14 cases of
Avandia-induced liver failure, including 12 deaths. These cases were
derived from the FDA Adverse Event Reporting System after careful
review of the agency's MedWatch forms, which are submitted to the
agency when adverse drug reactions are suspected.
Liver toxicity is only the most recently noted danger
of Avandia; Public Citizen has encouraged diabetes sufferers to avoid
taking the drug because it increases the risk of heart attack
approximately 40 percent, doubles the risk of heart failure and bone
fractures, and increases the risk of anemia and vision loss from
macular edema, a swelling of the retina caused by fluids accumulating
in the eye. There were 39 times more reports of macular edema per
million prescriptions filled for Avandia than for an older diabetes
drug, glipizide.
Avandia prescriptions fell sharply following a May 2007 study published in The New England Journal of Medicine
connecting the drug with increased heart attack risk. In 2006, the
number of people taking the drug peaked at 13.2 million. Since then,
that number has dropped to 4.6 million for the last full year. This
means that about 10,000 prescriptions a day are still being filled for
this dangerous drug.
"The scientific consensus against Avandia is
overwhelming," said Dr. Sidney Wolfe, director of Public Citizen's
Health Research Group. "The timing of these findings should give the
FDA the momentum it needs to act swiftly to prevent further needless
deaths and health damage by banning this drug."
Safer, more effective drugs for Type 2 diabetes include
metformin (brand name Glucophage) and glipizide (brand name Glucotrol).
Pioglitazone (sold as Actos), a drug in the same family as Avandia, is
not recommended, as it shares most of Avandia's toxicities - except for
the risk of heart attack - and the ADA does not number it among the
preferred therapies for most diabetics.
The full petition is available at https://www.citizen.org/publications/release.cfm?ID=7614.
Public Citizen is a nonprofit consumer advocacy organization that champions the public interest in the halls of power. We defend democracy, resist corporate power and work to ensure that government works for the people - not for big corporations. Founded in 1971, we now have 500,000 members and supporters throughout the country.
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Trump Ripped for 'Absurdly Low' and 'Racist' Refugee Cap Prioritizing White South Africans
"Let's call this what it is—white supremacy disguised as refugee policy," said the head of the Haitian Bridge Alliance.
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After months of reporting, President Donald Trump's administration on Thursday officially announced that it is restricting the number of refugees for this fiscal year to 7,500, with most spots going to white South Africans—a policy swiftly denounced by human rights advocates and Democrats in Congress.
"This decision doesn't just lower the refugee admissions ceiling. It lowers our moral standing," said Krish O'Mara Vignarajah, president and CEO of Global Refuge. "For more than four decades, the US refugee program has been a lifeline for families fleeing war, persecution, and repression. At a time of crisis in countries ranging from Afghanistan to Venezuela to Sudan and beyond, concentrating the vast majority of admissions on one group undermines the program's purpose as well as its credibility."
The Trump administration's notice in the Federal Register doesn't mention any groups besides Afrikaners, white descendants of Europeans who subjected South Africa's majority Black population to a system of apartheid for decades. Multiple rich Trump backers—including Tesla CEO Elon Musk, venture capitalist David Sacks, and Palantir founder Peter Thiel—spent time in the country during those years.
The 7,500 cap, initially reported earlier this month, is a significant drop from both the 40,000 limit that was previously reported as under consideration by the Republican administration, and the more than 100,000 allowed under former Democratic President Joe Biden.
Four congressional Democrats who serve as ranking members on related committees—Reps. Jamie Raskin (Md.) and Pramila Jayapal (Wash.), along with Sens. Dick Durbin (Ill.) and Alex Padilla (Calif.)—issued a joint statement condemning the new cap, which they noted is "an astonishing 94% cut over last year and the lowest level in our nation's history."
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The four lawmakers continued:
The administration has brazenly ignored the statutory requirement to consult with the House and Senate Judiciary Committees before setting the annual refugee admissions ceiling. That process exists to ensure that decisions of such great consequence reflect our nation's values, our humanitarian commitments, and the rule of law, not the racial preferences or political whims of any one president.
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Amy Fischer, Amnesty International USA's director for refugee and migrant rights, also tied Thursday's announcement to the broader agenda of the president—who, during his first term, faced global condemnation for policies including the forcible separation of families at the southern border.
"Setting this cap at such an absurdly low number and prioritizing white Afrikaners is a racist move that will turn the US's back on tens of thousands of people around the world who are fleeing persecution, violence, and human rights abuses," said Fischer. "Refugees have a human right to protection, and the international community—including the United States—has a responsibility to uphold that right."
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Republican Party officials are now using their "connections" to the Trump administration to threaten journalists into dropping critical coverage.
That's what Doug Bock Clark, a reporter for ProPublica, recently discovered as he worked on a feature-length story on the rise of Paul Newby, the Republican chief justice of North Carolina's Supreme Court, who has become one of the most quietly influential jurists in the nation.
The piece published Thursday examines how Newby, a born-again Christian who was elected to the bench in 2004, believes he was called by God to exact what he calls "biblical justice."
Over the past two decades, Clark wrote that Newby has "turned his perch atop North Carolina’s Supreme Court into an instrument of political power" and "driven changes that have reverberated well beyond the borders of his state."
Newby's most significant contribution has been the landmark decision that legalized partisan gerrymandering in North Carolina, a state that had long had some of the strongest laws in the country against partisan redistricting.
The change led the state's Republican-controlled Legislature to draw up wildly slanted maps that netted the GOP an additional six seats in the US House of Representatives in 2024, handing the party a national trifecta at the beginning of President Donald Trump's second term, which has allowed him to wield extraordinary power almost totally free of oversight from Congress.
It's just one of the ways, Clark said, that "Newby has provided a blueprint for conservatives to seize most of the nation’s state supreme courts, which have increasingly become the final word on abortion rights, LGBTQ+ rights and voting rights."
The report drew from more than 70 interviews with those who know Newby professionally and personally. But he was unable to get in contact with Newby himself.
"I reached out to Newby multiple times during the course of my reporting and was even escorted out of a judicial conference while trying to interview him," Clark wrote on social media. "The court’s communications director and media team also didn’t respond to detailed questions."
When Clark attempted to contact Newby's daughter for comment, he instead received an ominous message from that aforementioned communications director, Matt Mercer.
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He continued: “I’m sure you’re aware of our connections with the Trump administration, and I’m sure they would be interested in this matter. I would strongly suggest dropping this story.”
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