May, 18 2011, 01:20pm EDT
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its lack of improved clinical benefits, this leads to only one conclusion: that the 23-mg dose should be immediately withdrawn from the market."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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UN Chief Warns of Israel's Syria Invasion and Land Seizures
United Nations Secretary-General António Guterres stressed the "urgent need" for Israel to "de-escalate violence on all fronts."
Dec 12, 2024
United Nations Secretary-General António Guterres said Thursday that he is "deeply concerned" by Israel's "recent and extensive violations of Syria's sovereignty and territorial integrity," including a ground invasion and airstrikes carried out by the Israel Defense Forces in the war-torn Mideastern nation.
Guterres "is particularly concerned over the hundreds of Israeli airstrikes on several locations in Syria" and has stressed the "urgent need to de-escalate violence on all fronts throughout the country," said U.N. spokesperson Stephane Dujarric.
Israel claims its invasion and bombardment of Syria—which come as the United States and Turkey have also violated Syrian sovereignty with air and ground attacks—are meant to create a security buffer along the countries' shared border in the wake of last week's fall of former Syrian President Bashar al-Assad and amid the IDF's ongoing assault on Gaza, which has killed or wounded more than 162,000 Palestinians and is the subject of an International Court of Justice genocide case.
While Israel argues that its invasion of Syria does not violate a 1974 armistice agreement between the two countries because the Assad dynasty no longer rules the neighboring nation, Dujarric said Guterres maintains that Israel must uphold its obligations under the deal, "including by ending all unauthorized presence in the area of separation and refraining from any action that would undermine the cease-fire and stability in Golan."
Israel conquered the western two-thirds of the Golan Heights in 1967 and has illegally occupied it ever since, annexing the seized lands in 1981.
Other countries including France, Russia, and Saudi Arabia have criticized Israel's invasion, while the United States defended the move.
"The Syrian army abandoned its positions in the area... which potentially creates a vacuum that could have been filled by terrorist organizations," U.S. State Department spokesperson Matthew Miller said at a press briefing earlier this week. "Israel has said that these actions are temporary to defend its borders. These are not permanent actions... We support all sides upholding the 1974 disengagement agreement."
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Sanders Says 'Political Movement,' Not Murder, Is the Path to Medicare for All
"Killing people is not the way we're going to reform our healthcare system," he said. "The way we're going to reform our healthcare system is having people come together."
Dec 12, 2024
Addressing the assassination of UnitedHealthcare CEO Brian Thompson and conversations it has sparked about the country's for-profit system, longtime Medicare for All advocate Sen. Bernie Sanders on Wednesday condemned the murder and stressed that getting to universal coverage will require a movement challenging corporate money in politics.
"Look, when we talk about the healthcare crisis, in my view, and I think the view of a majority of Americans, the current system is broken, it is dysfunctional, it is cruel, and it is wildly inefficient—far too expensive," said Sanders (I-Vt.), whose position is backed up by various polls.
"The reason we have not joined virtually every other major country on Earth in guaranteeing healthcare to all people as a human right is the political power and financial power of the insurance industry and drug companies," he told Jacobin. "It will take a political revolution in this country to get Congress to say, 'You know what, we're here to represent ordinary people, to provide quality care to ordinary people as a human right,' and not to worry about the profits of insurance and drug companies."
Asked about Thompson's alleged killer—26-year-old Luigi Mangione, whose reported manifesto railed against the nation's expensive healthcare system and low life expectancy—Sanders said: "You don't kill people. It's abhorrent. I condemn it wholeheartedly. It was a terrible act. But what it did show online is that many, many people are furious at the health insurance companies who make huge profits denying them and their families the healthcare that they desperately need."
"What you're seeing, the outpouring of anger at the insurance companies, is a reflection of how people feel about the current healthcare system."
"What you're seeing, the outpouring of anger at the insurance companies, is a reflection of how people feel about the current healthcare system," he continued, noting the tens of thousands of Americans who die each year because they can't get to a doctor.
"Killing people is not the way we're going to reform our healthcare system," Sanders added. "The way we're going to reform our healthcare system is having people come together and understanding that it is the right of every American to be able to walk into a doctor's office when they need to and not have to take out their wallet."
"The way we're going to bring about the kind of fundamental changes we need in healthcare is, in fact, by a political movement which understands the government has got to represent all of us, not just the 1%," the senator told Jacobin.
The 83-year-old Vermonter, who was just reelected to what he says is likely his last six-year term, is an Independent but caucuses with Democrats and sought their presidential nomination in 2016 and 2020. He has urged the Democratic Party to recognize why some working-class voters have abandoned it since Republicans won the White House and both chambers of Congress last month. A refusal to take on insurance and drug companies and overhaul the healthcare system, he argues, is one reason.
Sanders—one of the few members of Congress who regularly talks about Medicare for All—isn't alone in suggesting that unsympathetic responses to Thompson's murder can be explained by a privatized healthcare system that fails so many people.
In addition to highlighting Sanders' interview on social media, Congressman Ro Khanna (D-Calif.) pointed out to Business Insider on Wednesday that "you've got thousands of people that are sharing their stories of frustration" in the wake of Thompson's death.
Khanna—a co-sponsor of the Medicare for All Act, led in the House of Representatives by Congressional Progressive Caucus Chair Pramila Jayapal (D-Wash.)—made the case that you can recognize those stories without accepting the assassination.
"You condemn the murder of an insurance executive who was a father of two kids," he said. "At the same time, you say there's obviously an outpouring behavior of people whose claims are being denied, and we need to reform the system."
Two other Medicare for All advocates, Reps. Maxwell Frost (D-Fla.) and Alexandria Ocasio-Cortez (D-N.Y.), also made clear to Business Insider that they oppose Thompson's murder but understand some of the responses to it.
"Of course, we don't want to see the chaos that vigilantism presents," said Ocasio-Cortez. "We also don't want to see the extreme suffering that millions of Americans confront when your life changes overnight from a horrific diagnosis, and people are led to just some of the worst, not just health events, but the worst financial events of their and their family's lives."
Sen. Elizabeth Warren (D-Mass.)—a co-sponsor of Sanders' Medicare for All Act—similarly toldHuffPost in a Tuesday interview, "The visceral response from people across this country who feel cheated, ripped off, and threatened by the vile practices of their insurance companies should be a warning to everyone in the healthcare system."
"Violence is never the answer, but people can be pushed only so far," she continued. "This is a warning that if you push people hard enough, they lose faith in the ability of their government to make change, lose faith in the ability of the people who are providing the healthcare to make change, and start to take matters into their own hands in ways that will ultimately be a threat to everyone."
After facing some criticism for those comments, Warren added Wednesday: "Violence is never the answer. Period... I should have been much clearer that there is never a justification for murder."
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"In Gaza, the scale of the tragedy is incomprehensible," wrote Thibaut Bruttin, director general of Reporters Without Borders.
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Reports released this week from two organizations that advocate for journalists underscore just how deadly Gaza has become for media workers.
Reporters Without Borders' (RSF) 2024 roundup, which was published Thursday, found that at least 54 journalists were killed on the job or in connection with their work this year, and 18 of them were killed by Israeli armed forces (16 in Palestine, and two in Lebanon).
The organization has also filed four complaints with the International Criminal Court "for war crimes committed by the Israeli army against journalists," according to the roundup, which includes stats from January 1 through December 1.
"In Gaza, the scale of the tragedy is incomprehensible," wrote Thibaut Bruttin, director general of RSF, in the introduction to the report. Since October 2023, 145 journalists have been killed in Gaza, "including at least 35 who were very likely targeted or killed while working."
Bruttin added that "many of these reporters were clearly identifiable as journalists and protected by this status, yet they were shot or killed in Israeli strikes that blatantly disregarded international law. This was compounded by a deliberate media blackout and a block on foreign journalists entering the strip."
When counting the number of journalists killed by the Israeli army since October 2023 in both Gaza and Lebanon, the tally comes to 155—"an unprecedented massacre," according to the roundup.
Multiple journalists were also killed in Pakistan, Bangladesh, Mexico, Sudan, Myanmar, Colombia, and Ukraine, according to the report, and hundreds more were detained and are now behind bars in countries including Israel, China, and Russia.
Meanwhile, in a statement released Thursday, the International Federation of Journalists (IFJ) announced that at least 139 Palestinian journalists and media workers have been killed since the war in Gaza began in 2023, and in a statement released Wednesday, IFJ announced that 104 journalists had perished worldwide this year (which includes deaths from January 1 through December 10). IFJ's number for all of 2024 appears to be higher than RSF because RSF is only counting deaths that occurred "on the job or in connection with their work."
IFJ lists out each of the slain journalists in its 139 count, which includes the journalist Hamza Al-Dahdouh, the son of Al Jazeera's Gaza bureau chief, Wael Al-Dahdouh, who was killed with journalist Mustafa Thuraya when Israeli forces targeted their car while they were in northern Rafah in January 2024.
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