May, 18 2011, 01:20pm EDT
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Public Citizen to FDA: Dangerous Alzheimer's Drug Should Be Pulled Immediately From Market
Higher Dose of Aricept Has Serious Adverse Effects, Isn’t Effective
WASHINGTON
A drug used to treat moderate or severe cases of Alzheimer's disease should be removed from the market immediately because of its risk of serious adverse effects and its lack of effectiveness, Public Citizen and an eminent geriatrician from Johns Hopkins said in a petition filed today with the Food and Drug Administration (FDA).
Donepezil, also known as Aricept, has been approved by the FDA in a dose of 5 to 10 milligrams (mg) for patients with mild to moderate cases of Alzheimer's disease and in a dose of 10 or 23 mg for patients with moderate to severe Alzheimer's. Public Citizen is calling for the 23-mg dose to be immediately pulled from the market.
"Data show that the 23-mg dose of donepezil is significantly more toxic than the 10-mg dose," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "Combined with its lack of improved clinical benefits, this leads to only one conclusion: that the 23-mg dose should be immediately withdrawn from the market."
Public Citizen is also asking the FDA to warn doctors and patients against taking 20 mg of the drug (two 10-mg pills) a day, even if Aricept 23 is removed from pharmacy shelves.
Dr. Thomas Finucane, professor of medicine in the Division of Gerontology and Geriatric Medicine at The Johns Hopkins University School of Medicine and staff physician at the Johns Hopkins Bayview Medical Center, stated that "Cholinesterase inhibitors such as Aricept have gained multibillion-dollar success due primarily to two factors: the understandable desperation of those who care for patients with Alzheimer's disease, and a relentless promotional campaign by drug companies." Finucane is a co-petitioner with Public Citizen to ban Aricept 23.
"When clinicians consider whether to initiate a therapeutic trial of a largely ineffective drug, the risk of harm should be a prominent consideration," Finucane said. "The clearly increased risk of harm from Aricept 23-mg compared to Aricept 10-mg is so great, coupled with the lack of any evidence of improved benefit, that I believe it should not have been approved for sale to the families and caregivers of Alzheimer patients."
The only clinical trial of donepezil submitted to the FDA for approval of the 23-mg dose compared it to the 10-mg dose and failed to prove that the higher dose was more effective. In three of four tests, on either a cognitive or functional level, there was no significant difference between the 10- and 23-mg doses. In the fourth test, the improvement over the 10-mg dose was only two points on a 100-point scale, which is not clinically important, Wolfe said.
Increased adverse effects of the 23-mg dose of donepezil compared to the 10-mg dose include a slowed pulse rate, nausea, vomiting, diarrhea, urinary incontinence, fatigue, dizziness, agitation, confusion and anorexia. Vomiting - which occurred more than 3.5 times as often in patients taking the 23-mg dose than those taking the 10-mg dose - is a particularly dangerous side effect for patients with Alzheimer's disease because it can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture and even death, Wolfe said. Overall, patients taking the 23-mg dose stopped taking the drug because of adverse effects more than twice as often as those taking the 10-mg dose. Additionally, because of the drug's very long half-life, it can stay in patients' systems for about two weeks after they stop taking the drug. So, those who suffered adverse effects may not have immediate relief after they stop treatment, Wolfe said.
"With no evidence of an added advantage in benefit to patients, the clear increase in risk should have been more than adequate grounds for denying approval, a conclusion reached by both the FDA medical officer and statistician," Wolfe said. "It is inexcusable that the FDA approved this higher dose. Its prompt removal would belatedly fulfill the agency's mission to allow only drugs whose benefits outweigh their risks to be marketed."
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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US Healthcare Workers Back From Gaza Tell Harris and Biden: 'End This Madness'
"Every day that we continue supplying weapons and munitions to Israel is another day that women are shredded by our bombs and children are murdered with our bullets."
Jul 26, 2024
As President Joe Biden and Vice President Kamala Harris met with Israeli Prime Minister Benjamin Netanyahu at the White House on Thursday, dozens of American healthcare workers who recently volunteered in the Gaza Strip urged the U.S. leaders to do everything in their power to end Israel's assault on the enclave, citing the horrors they witnessed firsthand.
In an open letter addressed to Biden, Harris, and First Lady Jill Biden, 45 physicians, surgeons, and nurses wrote that "we wish you could see the nightmares that plague so many of us since we have returned: dreams of children maimed and mutilated by our weapons, and their inconsolable mothers begging us to save them."
"We wish you could hear the cries and screams our consciences will not let us forget," the letter reads. "We cannot believe that anyone would continue arming the country that is deliberately killing these children after seeing what we have seen."
The healthcare workers called on the Biden administration to "withhold military, economic, and diplomatic support from the state of Israel and to participate in an international arms embargo of both Israel and all Palestinian armed groups until a permanent cease-fire is established, and until good-faith negotiations between Israel and the Palestinians lead to a permanent resolution of the conflict."
"We are not politicians. We do not claim to have all the answers," they continued. "We are simply physicians and nurses who cannot remain silent about what we saw in Gaza. Every day that we continue supplying weapons and munitions to Israel is another day that women are shredded by our bombs and children are murdered with our bullets. President Biden and Vice President Harris, we urge you: End this madness now!"
This is an open letter addressed to @POTUS, @VP , and @FLOTUS signed by 45 American physicians and nurses, about what we saw while working in Gaza. Please feel free to distribute. A PDF can be downloaded from the link and/or QR code on page 1. pic.twitter.com/LHVvmeAFad
— Feroze Sidhwa (@FerozeSidhwa) July 25, 2024
The letter was released as Netanyahu, fresh off his widely condemned address to the U.S. Congress, met separately on Thursday with Biden and Harris, the presumptive Democratic presidential nominee.
In remarks following her meeting with Netanyahu, Harris said that "what has happened in Gaza over the past nine months is devastating," pointing to "the images of dead children and desperate, hungry people fleeing for safety, sometimes displaced for the second, third, or fourth time."
"We cannot look away in the face of these tragedies," the vice president added. "We cannot allow ourselves to become numb to the suffering. And I will not be silent."
Harris said she told Netanyahu directly to "get this deal done"—referring to a cease-fire agreement with Hamas—but, as expected, she did not break with the administration on supplying arms to the Israeli military.
While there has been no obvious policy change from the administration now that Harris has taken over for Biden at the top of the Democratic Party's presidential ticket, Trita Parsi of the Quincy Institute for Responsible Statecraft argued that the vice president "clearly broke with Biden on Israel in terms of rhetoric and tone."
Parsi also contended that there was "a substance shift."
"Biden has disingenuously claimed that Hamas blocked a cease-fire deal," Parsi wrote on social media. "By saying that she urged Netanyahu 'to clinch the deal,' Kamala pointed to the real obstacle."
BREAKING: VP Harris speaks after meeting with Israeli PM Netanyahu
Harris calling for an immediate cease-fire deal to free the hostages.
The VP saying she “will not be silent" about the suffering in Gaza, the "devastating" loss of life and the "dire" humanitarian crisis. pic.twitter.com/Fe5QPoOuFh
— MSNBC (@MSNBC) July 25, 2024
In their letter to Harris and Biden, the healthcare workers wrote that Israel "has directly targeted and deliberately devastated Gaza's entire healthcare system" and "targeted our colleagues in Gaza for death, disappearance, and torture." According to figures from the United Nations Human Rights Office, Israeli forces have killed one in every 40 healthcare workers in the Palestinian territory since October as diseases spread and the number of Gazans killed or wounded continues to grow by the hour.
The healthcare workers expressed the view that—based on available evidence and their experiences—"the death toll from this conflictis many times higher than what is reported by the Gaza Ministry of Health," which currently stands at over 39,100.
"We also believe this is probative evidence of widespread violations of American laws governing the use of American weapons abroad, and of international humanitarian law," they continued. "We cannot forget the scenes of unbearable cruelty directed at women and children that we witnessed ourselves."
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'Tragic Outcome' for Gig Workers as California Supreme Court Hands Win to Uber, DoorDash
"Today's ruling only strengthens our demand for the right to join together in a union so that we can begin improving the gig economy for workers and our customers," the case plaintiff said.
Jul 25, 2024
Labor advocates on Thursday decried a ruling by the California Supreme Court upholding a lower court's affirmation of a state ballot measure allowing app-based ride and delivery companies to classify their drivers as independent contractors, limiting their worker rights.
The court's seven justices ruled unanimously in Castellanos v. State of California that Proposition 22, which was approved by 58% of California voters in 2020, complies with the state constitution. Prop 22—which was overturned in 2021 by an Alameda County Superior Court judge in 2021—was upheld in March 2023 by the state's 1st District Court of Appeals.
The business models of app-based companies including DoorDash, Instacart, Lyft, and Uber rely upon minimizing frontline worker compensation by categorizing drivers as independent contractors instead of employees. Independent contractors are not entitled to unemployment insurance, health insurance, or compensation for business expenses.
There are approximately 1.4 million app-based gig workers in California, according to industry estimates.
While DoorDash hailed Thursday's ruling as "not only a victory for Dashers, but also for democracy itself," gig worker advocates condemned the decision.
"Over the last three years, gig workers across California have experienced firsthand that Prop 22 is nothing more than a bait-and-switch meant to enrich global corporations at the expense of the Black, brown, and immigrant workers who power their earnings," plaintiff Hector Castellanos, who drives for Uber and Lyft, said in a statement.
"Prop 22 has allowed gig companies like Uber, Lyft, and DoorDash to deprive us of a living wage, access to workers compensation, paid sick leave, and meaningful healthcare coverage," Castellanos added. "Today's ruling only strengthens our demand for the right to join together in a union so that we can begin improving the gig economy for workers and our customers."
Lorena Gonzalez, president of the California Federation of Labor Unions, AFL-CIO, said that "we are deeply disappointed that the state Supreme Court has allowed tech corporations to buy their way out of basic labor laws despite Proposition 22's inconsistencies with our state constitution."
"These companies have upended our social contract, forcing workers and the public to take on the inherent risk created by this work, while they profit," she continued. "A.B. 5 granted virtually all California workers the right to be paid for all hours worked, health and safety standards, unemployment insurance, workers compensation, and the right to organize."
"Rideshare and delivery drivers deserve those rights as well," Gonzalez stressed.
The Gig Workers Rising campaign said on social media that "Uber and other app corporations spent $220 million to buy this law, and they did it by tricking Californians."
Prop 22's passage in November 2020 with nearly 59% of the vote was the culmination of what was by far the most expensive ballot measure in California history. App-based companies and their backers outspent labor and progressive groups by more than 10 to 1, with proponents pouring a staggering $204.5 million into the "yes" campaign's coffers against just $19 million for the "no" side.
"Voters were told the initiative would provide us with 'historic new benefits' and guaranteed earnings," said Gig Workers Rising. "But since it went into effect, drivers have seen our pay go down, learned the benefits are a sham, and have to accept unsafe rides because of the constant threat of being 'deactivated,' kicked off the app with little explanation or warning."
"If Uber really cared about good benefits and fair wages, it could make that happen tomorrow," the campaign added. "Instead, it has shown it would rather slash pay, bamboozle voters, and put drivers' lives and livelihoods in danger—all while promising $7 billion in stock buybacks to banks and billionaires."
Veena Dubal, a law professor at the University of California, Irvine who focuses on labor and inequality, toldCalMatters that Thursday's ruling was "a really tragic outcome," but "it's not the end of the road."
Dubal's sentiment was echoed by some California state legislators, who said the ruling presents an opportunity to act.
"While this decision is frustrating, it must also be motivating," said state Senate Labor Committee Chair Lola Smallwood-Cuevas (D-28). "I'm more determined than ever to ensure that all workers—including our diverse and Black, Indigenous, and people of color-led gig workforce—have the basic protections of workers compensation, paid sick leave, family leave, disability insurance, and the right to form a union."
Prop 22 has served as a template for lawmakers in other states seeking to deny or limit basic worker rights, benefits, and protections.
In Massachusetts, app-based companies have been fighting for years to get a measure to classify drivers as contractors on the state ballot. In 2022, Lyft made the largest political donation in state history—$14.4 million—to a coalition funding one such proposal.
Last month, Uber and Lyft reached an agreement with the office of Massachusetts Attorney General Andrea Campbell, a Democrat, to pay $175 million to settle a lawsuit filed in 2020. As part of the deal, the companies also agreed to increase driver pay and provide paid sick leave, accident insurance, and some health benefits. The agreement does not address how app-based gig workers should be classified.
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Young Voters Tell Kamala Harris to 'Fight for Our Future'
"This is your chance to energize young people and our communities to vote, mount one of the greatest political comebacks in decades, and deliver a resounding defeat to the far-right agenda of Trump and Vance."
Jul 25, 2024
Four youth-led groups on Thursday urged Vice President Kamala Harris, the presumptive Democratic presidential nominee, to "fight for our future" by pursuing a policy agenda the coalition unveiled in a March letter to U.S. President Joe Biden.
It's been less than a week since Biden left the race and endorsed Harris, who is expected to face former Republican Donald Trump and his running mate, U.S. Sen. JD Vance (R-Ohio), in the November election. Since then, she's racked up endorsements from Democratic members of Congress and progressive groups focused on issues including climate, labor, and reproductive rights.
March for Our Lives, which was launched after the 2018 mass shooting at Marjory Stoneman Douglas High School in Parkland, Florida, honored Harris with the group's first-ever endorsement on Wednesday, calling her "the right person to stand up for us and fight for the country we deserve."
"To defeat Trump, you must rebuild support and enthusiasm among young voters."
The gun violence prevention organization is part of the youth-led coalition behind the new letter, which also includes the climate-focused Sunrise Movement; Gen-Z for Change, which advocates on a range of issues; and the national immigrant network United We Dream Action.
"You have an urgent and important task. To defeat Trump, you must rebuild support and enthusiasm among young voters," the coalition told Harris on Thursday, noting that she sought the Democratic nomination during the last cycle. "You should build on your 2020 campaign platform where you put forward a strong vision to make the economy work for everyday people and ensure a livable future for us all."
The groups urged Harris to support the Green New Deal, Medicare for All, and the Reverse Mass Incarceration Act. They pushed her to expand pathways to citizenship, keep families together, end fossil fuel subsidies, and create good, union jobs. They also called on her to prioritize gun violence prevention and investments in public health solutions and green, affordable housing.
"Democrats are at a critical crossroads with young people," the coalition wrote to Harris on Thursday. "Polls showed Biden and Trump neck-and-neck among young voters."
ANew York Times/Siena College poll conducted July 22-24 shows Trump leading Harris 48% to 47% among likely voters and 48% to 46% among registered voters—differences that fall within the margin of error.
Forbesnoted Thursday that "Democrats are far more enthusiastic about Harris than they were Biden, the Times/Siena survey found, with nearly 80% of voters who lean Democrat saying they would like Harris to be the nominee, compared to 48% of Democrats who said the same about Biden three weeks ago."
The outlet also pointed to two other polls conducted by Morning Consult and Reuters/Ipsos since Biden dropped out, which both show Harris with a narrow lead over Trump.
"You have an opportunity to win the youth vote by turning the page and differentiating yourself from Biden policies that are deeply unpopular with us, such as approving new oil and gas projects, denying people their right to seek refuge and asylum, and funding the Israeli government's killing of civilians in Gaza," the youth coalition highlighted Thursday. "You must speak to the economic pain young people are facing from crushing student debt and skyrocketing housing and food prices."
Looking beyond November, the groups told Harris—who could be the first Black woman and person of Asian descent elected to the country's highest office—that "you could be a historic president. Not just because of who you are, but what you can accomplish."
"Young people are energized and ready to organize against fascism and for the future we deserve," they concluded. "This is your chance to energize young people and our communities to vote, mount one of the greatest political comebacks in decades, and deliver a resounding defeat to the far-right agenda of Trump and Vance."
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