July, 19 2011, 12:13pm EDT

Government Must Investigate Human Experiments That Test a Dangerous Novartis Drug
Studies of Canakinumab Put Trial Subjects in Harm’s Way, Raise Red Flags Because Children Are Involved
WASHINGTON
The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), which is housed in the U.S. Department of Health and Human Services, should suspend studies of a dangerous drug and promptly investigate allegations that these studies are unethical and fail to comply with federal regulations that protect human subjects, Public Citizen said today in letters to the two agencies.
One of the studies involves children, which raises serious ethical concerns and appears to violate special federal regulations designed to protect children in research, said Dr. Michael Carome, deputy director of Public Citizen's Health Research Group. The drug, canakinumab, also known as Ilaris, is manufactured by Novartis and approved by the FDA only for treating a group of rare serious genetic disorders called cryopyrin-associated periodic syndromes, which cause widespread inflammation in the body.
Public Citizen told an FDA advisory committee in June that it should not approve the drug for treatment of gouty arthritis attacks. The advisory committee agreed and voted against approval. Now, the FDA should investigate the ongoing studies, which are testing the drug in subjects with such conditions as heart disease and diabetes, the letters said.
"Since even a single dose of canakinumab has many serious risks, including the known risk of life-threatening infections and possibly cancer due to suppression of the immune system, further clinical trials of this drug should proceed only if there is a reasonable basis justifying these great risks to subjects," Carome said. "For at least two of the ongoing studies, such a justification is lacking."
The studies Public Citizen cited in its letters are unnecessarily risky for the subjects, yet the FDA was aware of and possibly endorsed the trials.
Public Citizen is calling upon the FDA and OHRP to suspend the two studies pending the outcome of their investigations.
In one study sponsored by Novartis, which started in April 2011, 7,200 adult patients who have had heart attacks are being given injections of canakinumab or a placebo every three months. The subjects are to be followed for three years to see if the drug decreases the chances of further heart attacks, strokes and death from cardiovascular disease.
However, given the apparent lack of any preliminary data regarding potential benefits of this dangerous drug in preventing heart attacks and strokes, there is no reasonable justification for initiating such a large trial in heart attack patients, and the known risks of the research do not outweigh the expected benefits, Carome said.
In a different study funded by the National Institutes of Health, 66 patients, ranging in age from six to 45 years old, with newly diagnosed type-1 diabetes are being given monthly injections of canakinumab or a placebo for one year to see if their pancreases still produce insulin. The study began in October 2010.
In this second study, the involvement of children raises additional serious ethical and regulatory concerns, Carome said. The significant risks of monthly canakinumab injections are not offset by any prospect of reasonably foreseeable benefits to the children, which may be a violation of research standards, Carome said.
Public Citizen also is asking the FDA to assess all other ongoing clinical trials involving canakinumab to determine whether the predictable risks to subjects outweigh the potential benefits of the research.
A search of the website ClinicalTrials.gov shows that Novartis also is conducting studies of canakinumab in subjects with type-2 diabetes, osteoarthritis and polymyalgia rheumatica, among others, with several studies involving repeated dosing over a prolonged time period.
"Just one dose of canakinumab has many serious risks. The dangers of taking this drug will only be magnified in human subjects exposed to multiple doses over a prolonged period of time," Carome said.
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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AOC Warns of 'Chaos Vibes' as Far-Right GOP Agitates to Oust McCarthy, Shut Down Government
U.S. Rep. Jamaal Bowman told the Republican House speaker that "if you don't stand up to this harmful element of your own party, you will allow them to destroy you and us in the process."
Sep 12, 2023
As far-right Congressman Matt Gaetz on Tuesday signaled that he wasn't impressed by House Speaker Kevin McCarthy's bid to appease MAGA Republicans by launching an impeachment inquiry into U.S. President Joe Biden, progressive Rep. Alexandria Ocasio-Cortez suggested that GOP extremist lawmakers appear most interested in causing chaos.
"So let me get this straight: Republicans are threatening to remove their own speaker, impeach the president, and shut down the government on September 30th—disrupting everyday people's paychecks and general public operations," Ocasio-Cortez (D-N.Y.), a member of the House Committee on Oversight and Accountability, said on social media. "For what? I don't think even they know. Chaos vibes."
The congresswoman's comments came alongside a video of Gaetz (R-Fla.), a member of the right-wing House Freedom Caucus, telling McCarthy (R-Calif.) on the House floor: "I rise today to serve notice—Mr. Speaker you are out of compliance with the agreement that allowed you to assume this role. The path forward for the House of Representatives is to either bring you into immediate total compliance or remove you."
It took 15 rounds of voting for McCarthy to be elected speaker—and that only came after he agreed to a rule allowing a sole member of the chamber to bring a "motion to vacate" forcing a vote on his removal, which just requires a simple majority.
As USA Todayreported:
Gaetz said on the House floor Tuesday that McCarthy did not put the House in a position to succeed as the government approaches a looming September 30 shutdown date and still needs to pass 11 appropriations bills.
The Florida lawmaker called on McCarthy to hold votes on individual spending bills instead of a continuing resolution, a short-term extension GOP leadership has been considering to avert a shutdown. Gaetz said he will move to oust the speaker if a vote is held on the stopgap measure.
"September 30 is rapidly approaching and you have not put us in a position to succeed. There is no way to pass all the individual appropriations bills now and it's not like we didn't know when September 30 was going to show up on the calendar," he said.
As for the McCarthy kicking off House members' return to Capitol Hill on Tuesday by directing the Oversight, Judiciary, and Ways and Means committees to launch an impeachment inquiry into Biden related to his son's business dealings and legal issues—despite the lack of any proof of wrongdoing by the president—Gaetz said, "This is a baby step following weeks of pressure from House conservatives to do more."
Ocasio-Cortez was not the only progressive to respond on social media to Gaetz's remarks. In a lengthy post on X, formerly Twitter, Rep. Jamaal Bowman (D-N.Y.) said: "Holy cow. All HELL is breaking loose on the floor of the House. Matt Gaetz is threatening to launch a 'mutiny' against Kevin McCarthy and oust him from power. To the speaker of the House: This is what you created."
"You are the worst kind of coward and now you reap what you sow," Bowman told McCarthy. The congressman charged that the speaker has kowtowed to the demands of "the most EXTREMIST zealots" in the Republican Party, who "have lied, intimidated, and strong-armed their dangerous political ends," which has come "at the cost of our institutions and democracy."
"Instead of leadership, you have shown nothing but cowardice," he added in his message to McCarthy. "You care about nothing except your own power. You might be speaker today, but if you don't stand up to this harmful element of your own party, you will allow them to destroy you and us in the process. Mr. Speaker, grow a backbone. Because until then, you do not SPEAK for anyone."
Other members of Congress on Tuesday blasted the impeachment inquiry, which many critics have called an attempt to harm Biden's chances of being elected next year and help Trump, who is the GOP's 2024 front-runner, despite facing four criminal cases and arguments that inciting the January 6, 2021 insurrection constitutionally disqualifies him from holding office again.
Trump, the first U.S. president to ever be impeached twice, "has been weighing in behind the scenes in support of the House GOP push to impeach" Biden, according toPolitico. In addition to weekly conversations with House GOP Conference Chair Elise Stefanik (R-N.Y.), the first member of Republican leadership to back impeachment, the ex-president "had dinner at his golf club in Bedminster, New Jersey, with Rep. Marjorie Taylor Greene (R-Ga.), an ally of Trump and McCarthy."
Greene, who said last month that "I will not vote to fund the government unless we have passed an impeachment inquiry," welcomed McCarthy's move on Tuesday to launch the Biden probe without holding a vote. She also got into an online spat with Gaetz about which of them has been pushing harder for an impeachment inquiry targeting the president.
In a series of early Tuesday posts on X, Ian Sams, the White House spokesperson for oversight and investigations, said that "McCarthy is being told by Marjorie Taylor Greene to do impeachment, or else she'll shut down the government."
"Opening impeachment despite zero evidence of wrongdoing by POTUS is simply red meat for the extreme right-wing so they can keep baselessly attacking him," Sams added, pointing to previous comments from Gaetz and House Oversight Committee Chair James Comer (R-Ky.). "They admit it."
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"It is the totally reasonable demand that autoworkers, who have made enormous financial sacrifices over the past 40 years, finally receive a fair share of the record-breaking profits their labor has generated," he said.
Sep 12, 2023
U.S. Sen. Bernie Sanders on Tuesday blasted corporate media coverage of United Auto Workers' contract demands and looming strike, echoing a video released last week by the UAW amid negotiations with vehicle manufacturers Ford, General Motors, and Stellantis.
A short list of media conglomerate control the vast majority "of what the American people see, hear, and read," and that is clearly on display with the labor conflict between the union and the "Big Three," Sanders (I-Vt.) argued in a statement, highlighting that "the major reasons as to why autoworkers might go out on strike have been rarely, if ever, the focus of the corporate media's coverage."
"In the first half of 2023, the Big Three automakers made a combined $23 billion in profits—up 80% from the same time period last year," Sanders noted. "But if you've watched any corporate news coverage of the pending strike by 150,000 autoworkers, you've heard more about the strikes' potential negative effects on the economy and a litany of excuses why very well-compensated CEOs just can't make a fair deal."
The chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee continued:
You won't hear that last year the CEO of General Motors raked in about $29 million in total compensation, the CEO of Ford made approximately $21 million, and the CEO of Stellantis pocketed over $25 million. In fact, over the last four years pay for those CEOs has increased by more than 40%.
You won't hear that over the past decade these same companies made some $250 billion in profits in North America alone.
You won't hear that the average starting wage at the Big Three today is around $17 an hour—less than a number of nonunion auto plants around the country—and that the top wage is $32.32 an hour.
You won't hear that, unbelievably, over the last 20 years, the average wage for American autoworkers has decreased by 30% after adjusting for inflation.
You won't hear that autoworkers at the Big Three are earning less today than they did 15 years ago.
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Along with his statement calling out the corporate media, Sanders on Tuesday published an opinion piece in The Guardian urging Americans to "stand in solidarity with the UAW and create an economy that works for all, not just the privileged few."
In the event of a strike later this week, "the UAW members will be fighting not only for themselves but against a corporate culture of arrogance, cruelty, and selfishness causing massive and unnecessary pain for the majority of working families throughout the country," the senator stressed. "Their fight against corporate greed is our fight. Their victory will resonate all across the economy, impact millions of workers from coast to coast and help create a more just and equitable economy."
Sanders' remarks follow a September 7 video in which UAW president Shawn Fain spends about four minutes debunking a recent "NBC Nightly News" story, calling out corporate media coverage more broadly, and sharing some facts about the industry.
"You don't see big, splashy nightly news segments on how consumers will be impacted by companies choosing to spend billions on executive salaries, and stock buybacks, and special dividends," Fein said. "You only hear these concerns when the working class stands up and demands a fair share of the value we produce."
"But the autoworkers and working people of this country know what's really going on. We live it," he explained. "We know firsthand what it's like not to be able to afford the cars we produce. We know what it's like to live paycheck to paycheck while the companies we work for make out like bandits. We know what it's like for our communities to be decimated and our families to be torn apart by plant closures."
The UAW announced last month that 97% of participating members at "Big Three" voted to authorize a strike if a contract deal isn't reached by September 14.
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"We've never been so proud to be part of this movement and community," said SWAN of Orlando.
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Volunteers who regularly help protect abortion clinic patients in Florida from crowds of pro-forced pregnancy protesters were able to deliver a check for $193,000 to Center of Orlando for Women on Tuesday, helping the reproductive healthcare center pay state fines that threatened to bankrupt it.
Volunteers with Stand With Abortion Now (SWAN) of Orlando raised the money in less than two weeks, after the Florida Agency for Healthcare Administration (AHCA) accused the clinic of violating the state's 24-hour waiting period for people seeking abortion care.
The law requires people to have two medical appointments 24 hours apart in order to obtain an abortion, and the clinic has maintained it had attempted to contact the AHCA to find out when the measure went into effect—but instead of providing the information the agency ordered the facility to pay $1,000 each for 193 alleged violations.
"We got to hand over $193,000 to our clinic today to save them from unjust AHCA fines meant to shut them down!" said SWAN on social media. "We've never been so proud to be part of this movement and community."
The makers of the podcast "Repros Fight Back" called SWAN's crowdfunding effort "a powerful display of love, community, and solidarity" that will keep one of Orlando's last abortion clinics open.
The clinic escorts delivered the funds to the facility days after the state's right-wing Supreme Court heard oral arguments in a case challenging Florida's 15-week abortion ban. If the court does not overturn the law, a six-week abortion ban signed by Republican Gov. Ron DeSantis—who is also running for the GOP's presidential nomination—will go into effect.
SWAN volunteers rallied outside the state Supreme Court last week during the hearing.
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