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carolyn maloney
House Dems Say FDA 'Inappropriately Collaborated' With Biogen on New Alzheimer's Drug
"I am hopeful these findings are a wake-up call for FDA to reform its practices and a call to action to my congressional colleagues to continue oversight of the pharmaceutical industry to ensure they don't put profits over patients," said Rep. Carolyn Maloney.
Dec 29, 2022
Nearly two years after a leading U.S. consumer advocacy group sounded the alarm on the matter, House Democrats released a report Thursday showing the Food and Drug Administration and pharma giant Biogen "inappropriately collaborated" prior to the controversial approval of a new $28,000-per-year Alzheimer's drug of questionable efficacy.
Originally carrying a $56,000 annual price tag for uninsured patients—which Biogen's then-CEO called "fair"—aducanumab, sold under the brand name Aduhelm, was approved by the FDA in June 2021. The approval came despite concerns that the drug—a monoclonal antibody treatment for patients with mild cognitive impairment caused by Alzheimer's—might not work, as well as safety trial data showing that a staggering 4 in 10 participants suffered potentially fatal brain bleeding and swelling after taking it.
"This report documents the atypical FDA review process and corporate greed that preceded FDA's controversial decision to grant accelerated approval to Aduhelm."
The new report, the result of an 18-month probe by the Democrat-led House Oversight and Reform Committee and the Energy and Commerce Committee, found that the FDA's approval process for Aduhelm was "rife with irregularities," including an "atypical" number of meetings and other contacts between the agency and the Cambridge, Massachusetts-based drugmaker.
The panel also found that Biogen and the FDA closely collaborated on a document written for outside advisers during the approval process, with at least one paragraph of the company's submission authored by agency officials.
On pricing, the lawmakers concluded that Biogen gave Aduhelm an astronomical price tag knowing that doing so would place the drug out of reach for many patients—even those with insurance—and would cost Medicare $12 billion per year.
"This report documents the atypical FDA review process and corporate greed that preceded FDA's controversial decision to grant accelerated approval to Aduhelm," outgoing House Energy and Commerce Committee Chair Frank Pallone (D-N.J.) said in a
statement.
\u201cNEW: Chairman @FrankPallone and House Oversight Chair @RepMaloney release report on the controversial review, approval, and pricing of Biogen\u2019s Alzheimer\u2019s drug Aduhelm. \n\nThe full report here \ud83d\udc47 https://t.co/0GxsdKIWZ4\u201d— Energy and Commerce Committee (@Energy and Commerce Committee) 1672338215
"While we all support the search for new cures and treatments to address devastating diseases like Alzheimer's, we must ensure that expediency does not take precedence over protocols that ensure the independence and scientific rigor of FDA," Pallone added. "Patient safety and drug efficacy must remain at the core of our nation's pharmaceutical regulatory review process."
House Oversight and Reform Committee Chair Carolyn Maloney (D-N.Y.), who will leave office when Republicans take over the lower chamber next week, said that "the number of patients and families impacted by Alzheimer's disease will continue to increase, and it is crucial that FDA and drug companies adhere to established procedures and conduct themselves with the transparency necessary to earn public trust."
"I am hopeful these findings are a wake-up call for FDA to reform its practices and a call to action to my congressional colleagues to continue oversight of the pharmaceutical industry to ensure they don't put profits over patients," she added.
The new report comes nearly two years after the consumer advocacy group Public Citizen warned of exactly the sort of questionable collaboration detailed in the publication.
"After aducanumab's two identical phase three trials were stopped in 2019 at the halfway point because a preliminary analysis found that they were unlikely to show the drug benefited Alzheimer's patients, the FDA and Biogen worked collaboratively to salvage the drug," the group wrote in January 2021. "They jointly relied on dubious analyses that over-emphasized the results of one phase three trial suggesting the drug may work at a high dose but disregarded data from the other phase three trial showing no benefit of the drug at any dose. The FDA and Biogen co-authored an unprecedented joint briefing document on aducanumab that was heavily biased in favor of the drug."
Reacting to the new report, Dr. Aaron Kesselheim—a former member of the FDA's outside advisory panel who voted against green-lighting Aduhelm and resigned after it was approved—told The Wall Street Journal Thursday that "I hope this inspires a full re-examination of the nature of the communications between FDA and industry."
"Lines of communication need to be at arm's length and transparent," he added, "so that there remains trust in the FDA's decisions."
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Campaigners to House Dems: Not Giving Big Oil Documents to the Senate Would Be an 'Epic Failure'
"Obviously the incoming Republican House majority that will control the documents as of January 3 has no interest in continuing to investigate Big Oil."
Dec 28, 2022
A House committee that has spent more than a year investigating the fossil fuel industry's climate disinformation efforts has reportedly decided not to hand the subpoenaed documents it compiled over to the Senate, a reversal that would likely spell the end of the probe as industry-friendly Republicans take over the chamber.
Investigative journalist Amy Westervelt reported for The Intercept over the weekend that Rep. Ro Khanna (D-Calif.), who helped lead the Big Oil probe, previously vowed to "release all the subpoenaed documents to the Senate to continue the investigation or at least finish reviewing them for pertinent information—a task the committee has not had the time or staff resources to complete."
"But the decision to release the documents has since been reversed, according to Khanna's press secretary," Westervelt wrote. "The committee also decided not to send letters to the Department of Justice or the White House requesting that the investigation continue, Khanna staffers said."
The decision by the House panel, which is headed by Rep. Carolyn Maloney (D-N.Y.), drew an outraged response from climate campaigners and watchdogs. Over the course of its investigation, the committee released more than 1,000 pages of documents, including internal emails and company memos further showing that the oil and gas industry is misleading the public about its role in the climate crisis and its supposed efforts to cut down on planet-warming emissions.
"The investigations into Big Oil will continue no matter what, but it should be a no-brainer for Rep. Maloney and Oversight Democrats to forward the Big Oil Files to the Senate and DOJ—or release them all now! The public deserves to know the truth," tweeted Jamie Henn, the director of Fossil Free Media.
The committee has until January 2 to turn over the documents to the Senate, which will be narrowly controlled by Democrats in the new session. On January 3, Republicans hostile to climate action and allied with oil and gas interests will take over the House.
"Committee members cannot allow their groundbreaking work to expose Big Oil's role in fueling the climate crisis to end by giving control of thousands of unexamined documents to Big Oil's defenders."
Rep. James Comer (R-Ky.), the incoming chair of the House Oversight Committee and a recipient of fossil fuel industry donations, has openly bashed the panel's Big Oil investigation, calling its latest report on the industry's climate lies "a partisan show designed to demonize America's energy producers and force radical Green New Deal policies on Americans."
Comer pledged to "return the Oversight Committee to its primary mission of conducting oversight over the Biden administration."
Richard Wiles, president of the Center for Climate Integrity, said in a statement Tuesday that "refusing to share the committee's findings with the Senate and others who can continue to investigate Big Oil's climate deception would be an epic failure by House Democrats."
"Over the last 15 months, the Oversight Committee has unearthed crucial new evidence that Big Oil companies continue to fuel the climate crisis and lie about it. But members have also made clear that they possess potentially thousands more documents that they have not had time to analyze," said Wiles. "Obviously the incoming Republican House majority that will control the documents as of January 3 has no interest in continuing to investigate Big Oil."
"Committee members cannot allow their groundbreaking work to expose Big Oil's role in fueling the climate crisis to end by giving control of thousands of unexamined documents to Big Oil's defenders," Wiles added. "Instead of fumbling the ball on the goal line, Democrats on the committee need to use their final days in the majority to pass along their documents and findings to colleagues in the Senate, officials at the Justice Department, and any other agency that has the power to hold Big Oil accountable."
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House Dems to Examine Rise in Anti-LGBTQ+ Extremism in 'First of Its Kind' Hearing
"Republicans on my committee and across the country will be forced to face the real-life impact of their dangerous agenda," said Rep. Carolyn Maloney.
Dec 12, 2022
Survivors of last month's deadly shooting at Club Q, an LGBTQ+ nightclub in Colorado Springs, Colorado, will be among those testifying this week when federal lawmakers hold a hearing on how a surge in bigoted legislation pushed by Republicans has been linked to an uptick in violent attacks on LGBTQ+ communities.
"The rise in anti-LGBTQI+ extremism and the despicable policies that Republicans at every level of government are advancing... are harming the LGBTQI+ community."
The U.S. House Oversight and Reform Committee, chaired by Rep. Carolyn Maloney (D-N.Y.), will convene the hearing on Wednesday morning, examining a number of Republican proposals as well as recent incidents of violence.
"From Colorado Springs to my own district in New York City, communities across the country are facing a terrifying rise of anti-LGBTQI+ violence and extremism," said Maloney in a statement. "Make no mistake, the rise in anti-LGBTQI+ extremism and the despicable policies that Republicans at every level of government are advancing to attack the health and safety of LGBTQI+ people are harming the LGBTQI+ community and contributing to tragedies like what we saw at Club Q."
The hearing comes less than a month after a shooter armed with an AR-15 style rifle entered Club Q and immediately began shooting, killing five people and injuring more than a dozen others.
Authorities have not yet publicly identified a motive, but the shooting has been investigated as a hate crime and the suspect has been charged with 305 criminal counts, including first-degree murder and bias-motivated crimes.
The committee will hear testimony from Michael Anderson, a bartender at Club Q, and James Slaught, a patron, as well as co-owner Michael Haynes.
"These attacks like the one at Club Q are designed to scare us from living authentically and honestly," Anderson told NBC News. "But to our community and to the world, just know this: We are not afraid, we are empowered, we are strong, and we are proud. Love will win."
The shooting intensified condemnation of Republicans who have pushed anti-LGBTQ+ rhetoric and legislation, including Rep. Lauren Boebert (R-Colo.). The congresswoman offered "prayers" to the victims, survivors, and their families after the attack, leading progressives to point out that she has aggressively promoted the loosening of gun control laws and has accused LGBTQ+ teachers, transgender people, and drag performers of "grooming" children throughout her political career.
One proponent of Boebert's "grooming" narrative, Gays Against Groomers founder Jaimee Mitchell, told FOX News host Tucker Carlson that shootings like the one at Club Q will not "stop until we end this evil agenda that is attacking children."
Republican state lawmakers last year introduced more than 340 pieces of legislation seeking to limit LGBTQ+ people's rights, including proposals to force transgender or gender non-conforming students to use bathrooms and join sports teams that correspond with their sex assigned at birth instead of their gender, to bar doctors from providing gender-affirming medical care to young transgender people, and to ban classroom discussions related to gender identity and sexual orientation in public schools.
Since Republican Florida Gov. Ron DeSantis signed his state's so-called "Don't Say Gay" bill into law earlier this year, social media posts accusing LGBTQ+ people of being "groomers" went up by more than 400%, the House Oversight Committee reported.
At this week's hearing, Maloney said, "Republicans on my committee and across the country will be forced to face the real-life impact of their dangerous agenda. I hope LGBTQI+ individuals across the country will see that Democrats in Congress are fighting for them and will continue to push for policies that protect and expand their ability to live authentically and safely."
The Hill reported that the hearing will be the "first of its kind." While Congress held hearings decades ago in support of anti-LGBTQ+ measures, said author and researcher Jason Colavito, Maloney's will be the first to call for protections for these communities.
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