Tag Archives: FDA

Ethics Group Asks SEC to Probe Musk Claims About ‘Gruesome’ Neuralink Monkey Trials

“It seems obvious to everyone but Elon Musk that Neuralink’s device is unsafe,” said one critic. “Now he is deliberately misleading investors and the public by outright lying about the company’s monkey experiments.”

By Brett Wilkins. Published 9-21-2023 by Common Dreams

Animal 15. Photo: PCRM

After obtaining records showing a dozen monkeys were euthanized in “gruesome” trials, a national physicians group on Wednesday asked the U.S. Securities and Exchange Commission to investigate claims made by Elon Musk, owner of the biotech firm Neuralink, about the company’s experimental brain implants.

Physicians Committee for Responsible Medicine (PCRM) requested an SEC probe into possible securities fraud committed by Musk when he claimed that “no monkey has died as a result of a Neuralink implant” during testing of the company’s implantable brain-computer interfaces (BCI), and that the animals who died were all already terminally ill when chosen for experiments.

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Democratic AGs Fight Back Against GOP Attacks on Abortion Pill Access

“In a time when reproductive healthcare is under attack, our group of 23 attorneys general strongly believe we should be encouraging companies and providers to offer easily accessible, safe, and confidential healthcare as broadly as possible.”

By Julia Conley.  Published 2-16-2023 by Common Dreams

Mifepristone The pill is one of two used in medication abortions. Photo: Robin Marty/flickr/CC

Warning that Republican-led states have launched an effort to keep millions of people from accessing lifesaving medications, 23 Democratic state attorneys general on Thursday sent a letter to officials at CVS and Walgreens to assure the pharmacies that they can legally dispense and mail mifepristone and misoprostol, the pills used in medication abortions.

The attorneys general of Oregon, California, and Washington spearheaded the letter two weeks after their Republican counterparts in 20 states told the pharmacies that they could be in violation of the Comstock Act, dating back to the 1870s, if they deliver the pills to patients by mail. Continue reading

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In ‘Crisis Moment’ for Abortion Rights, Biden Weighs Declaring Public Health Emergency

“This is a five-alarm fire,” said Sen. Elizabeth Warren, “and we cannot wait to respond.”

By Jake Johnson  Published 6-16-2022 by Common Dreams

Demonstration in front of SCOTUS May 3 2022 Photo: Janni Rye/Wikimedia Commons/CC

With the right-wing U.S. Supreme Court expected to overturn Roe v. Wade as soon as this month, President Joe Biden is reportedly weighing a number of executive orders to protect abortion rights at the federal level—including declaration of a national public health emergency—as progressive lawmakers and rights groups push him to act.

The New York Times, citing unnamed administration officials, reported Thursday that “some of the ideas under consideration include declaring a national public health emergency, readying the Justice Department to fight any attempt by states to criminalize travel for the purpose of obtaining an abortion, and asserting that Food and Drug Administration regulations granting approval to abortion medications preempt any state bans.” Continue reading

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‘Reckless’ FDA and Big Pharma Greed Blamed for Medicare Premium Hike

“All Part B Medicare beneficiaries soon will be forced to bear significant financial burden as a direct result of the FDA’s reckless decision.”

By Jake Johnson.  Published 11-16-2021 by Common Dreams

Janet Woodcock, acting commissioner of the Food and Drug Administration. Screenshot: FDA

Medicare Part B recipients will soon be hit with one of the biggest premium increases in the history of the government program, a hike driven in large part by the Food and Drug Administration’s scandalous approval of a costly—and, according to many experts, dubious—Alzheimer’s drug.

Last week, the Centers for Medicare and Medicaid Services (CMS) announced that monthly Medicare Part B premiums will be raised to $170.10 in 2022, up from this year’s level of $148.50. Continue reading

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Dismissing Need for Abortion Access, Ted Cruz Claims Pregnancy Is Not ‘Life-Threatening’—Despite Alarming Maternal Mortality Rate in US

“Ted Cruz has never been pregnant and clearly knows nothing about maternal mortality rates in the U.S. or in Texas.”

By Julia Conley, staff writer for Common Dreams. Published 9-3-2020

Photo: Mikasi/cc/flickr

Reproductive rights advocates rebuked Sen. Ted Cruz on Thursday after he claimed that pregnancy is “not a life-threatening” condition for women while arguing that medication abortions should not be available in the United States.

After joining 20 of his GOP colleagues in writing a letter to the Food and Drug Administration (FDA) calling on the agency to ban mifepristone and misoprostol, which are used in early pregnancy to induce an abortion, the Texas Republican tweeted that the pills are “dangerous” and unnecessary for women’s health. Continue reading

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‘Completely Out of Control’: China Says ‘US Epidemic’ Threat to Rest of the World

In the coming fall and winter, the US epidemic will likely run rampant, and more countries and regions will be forced to suffer because of the US.’

By Common Dreams   Published 7-5-2020

New Florida Daily COVID-19 Infections: March 1, 2020 to July 4, 2020. (NY Times screenshot)

A Chinese state-controlled newspaper has blamed the Trump administration’s mishandling of the COVID-19 pandemic to cause the spread of the virus to go “completely out of control.”

Describing the disease as a “U.S. epidemic”, the paper warned that the administration’s failure poses a threat to the rest of the world. “Lies are dominating US society’s recognition of the epidemic,” the Global Times wrote. Continue reading

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A small trial finds that hydroxychloroquine is not effective for treating coronavirus

A trial of an anti-malaria drug in France found different results from a similar study last month. Liliboas / Getty Images

Katherine Seley-Radtke, University of Maryland, Baltimore County

On Saturday the Food and Drug Administration approved the use of two antimalarial drugs, hydroxychloroquine and a related medication, chloroquine, for emergency use to treat COVID-19. The drugs were touted by President Trump as a “game changer” for COVID-19.

However, a study just published in a French medical journal provides new evidence that hydroxychloroquine does not appear to help the immune system clear the coronavirus from the body. The study comes on the heels of two others – one in France and one in China – that reported some benefits in the combination of hydroxychloroquine and azithromycin for COVID-19 patients who didn’t have severe symptoms of the virus. Continue reading

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‘This Is a Massive Scandal’: Trump FDA Grants Drug Company Exclusive Claim on Promising Coronavirus Drug

“It is insane and unacceptable,” said Bernie Sanders. “We will not tolerate profiteering. Any treatment or vaccine must be made free for all.”

By Julia Conley, staff writer for Common Dreams. Published 3-24-2020

Coronavirus. Photo: CDC

As healthcare providers across the U.S. desperately attempt to treat a rapidly growing number of patients with the coronavirus, a pharmaceutical company with ties to the Trump administration has been granted exclusive status for a drug it is developing to treat the illness—a potential windfall for the company that could put the medication out of reach for many Americans.

As The Intercept reported Monday, the Food and Drug Administration granted Gilead Sciences “orphan” drug status for remdesivir, one of several drugs being tested as potential treatments for the coronavirus, officially known as COVID-19. The designation is generally reserved for drugs that treat rare illnesses affecting fewer than 200,000 Americans—but companies can be eligible if the designation, as in this case of a rapidly spreading virus, is made before a disease spreads beyond that limit. Continue reading

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FDA Raids in Florida Suggest Trump Admin. Policy Change That Benefits Big Pharma

News of the raids follows the president’s nomination of a former drug company executive to serve as secretary of the Department of Health and Human Services

By Jessica Corbett, staff writer for CommonDreams. Published 11-20-2017

Raids by federal agents in Florida suggest a policy shift that will make it more difficult for Americans to access low-cost prescription medications. (Photo: Chris Potter/ccPix.com/Flickr/cc)

The U.S. Food and Drug Administration (FDA) raided nine stores in Central Florida that assist customers with placing orders for low-cost prescription drugs from Canada and other countries, Kaiser Health News reported Monday, suggesting a shift away from a long-standing policy that benefited consumers but was strongly condemned by the pharmaceutical industry.

“The storefronts primarily serve seniors who prefer in-person assistance with buying medicines from Canada and other countries, rather than using an internet site,” Kaiser reports. Bill Hepscher, co-owner of six of the stores raided last month, estimates his business serves about 10,000 people a year, and that Florida has about 20 stores similar to his. His stores are located around Tampa Bay and Orlando. Continue reading

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Sanders Puts Block on Obama’s Big Pharma Nominee for FDA

‘We need someone who will work to substantially lower drug prices, implement rules to safely import brand-name drugs from Canada and hold companies accountable who defraud our government.’

By Nadia Prupis, staff writer for Common Dreams. Published 1-26-2016

Bernie Sanders joined two other senators in blocking Obama's nomination for FDA chief. (Photo: Gage Skidmore/flickr/cc)

Bernie Sanders joined two other senators in blocking Obama’s nomination for FDA chief. (Photo: Gage Skidmore/flickr/cc)

Senator Bernie Sanders put a hold on President Barack Obama’s nominee to take over the Food and Drug Administration (FDA) on Tuesday, joining with two other senators who have also objected to Dr. Robert M. Califf’s nomination, citing his ties to corporate drug manufacturers.

“Dr. Califf’s extensive ties to the pharmaceutical industry give me no reason to believe that he would make the FDA work for ordinary Americans, rather than just the CEOs of pharmaceutical companies,” Sanders said in a statement on Tuesday. “We need someone who will work to substantially lower drug prices, implement rules to safely import brand-name drugs from Canada and hold companies accountable who defraud our government.” Continue reading

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