Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of investigational medicines before they hit the market. But do they have sufficient independence from the companies they are meant to regulate? Maryanne Demasi investigates
From FDA to MHRA: are drug regulators for hire?
Tag: aducanumab
Alzheimer’s latest drug and science journalism’s memory problem
In July, the medical community was rocked by a disappointing reminder of science’s weakest link: the humans doing the work. The journal Science had shared that its six-month investigation supported the findings of whistleblower Matthew Schrag, who first noted altered images in a high-impact paper on Alzheimer’s, published in Nature in 2006. That paper is still flagged on Nature as under review, but the damage has already been done. Alzheimer’s drugs for the last decade and a half have been developed around claims without as much evidence as initially believed—which might also explain why they haven’t been working, leading people to pour false hope into useless and often expensive treatment plans for declining loved ones.
Alzheimer’s latest drug and science journalism’s memory problem
Medicare Part B premiums to decrease for the first time in over a decade
The Biden administration on Tuesday announced that Medicare Part B premiums will decrease in 2023, marking the first time this cost has been lowered in more than a decade.
Medicare Part B premiums to decrease for the first time in over a decade
Next year it will go back up because Biogen will probably raise the price of Aduhelm. I guess $5 is another can, or two, of cat food. 🤷🏼♀️
Biden Hikes Medicare Prices And Funnels Profits to Private Insurers
The largest-ever Medicare premium increase will pad the pockets of insurance executives who donated millions to the president’s election campaign.
Biden Hikes Medicare Prices And Funnels Profits to Private Insurers
Related:
Medicare limits coverage of controversial Alzheimer’s drug to those in clinical trials
Biden Nominates (Pharma) Industry Insider Robert Califf to Head the FDA
After nearly ten months without a permanent commissioner, US President Joe Biden has nominated Robert Califf, former head of the Food and Drug Administration (FDA), to lead the agency once again. Although some in the research community are opposed to the nomination because of Califf’s ties to industry, others welcome a permanent director after such a long delay, particularly amidst the COVID-19 pandemic, in which the agency plays a crucial part.
Biden Nominates (Pharma) Industry Insider Robert Califf to Head the FDA
Medicare officials say costly Alzheimer’s drug to blame for large monthly jump in premium
Medicare officials say costly Alzheimer’s drug to blame for large monthly jump in premium
The increase guarantees that health care will gobble up a big chunk of the recently announced Social Security cost-of-living allowance, a boost that had worked out to $92 a month for the average retired worker, intended to help cover rising prices for gas and food that are pinching seniors.
Related:
Biogen probes death of Aduhelm user after brain swelling
Cost and controversy are limiting use of new Alzheimer’s drug
They’re lying about Pfizer—The road to Aduhelm: What one ex-FDA adviser called ‘probably the worst drug approval decision in recent US history’ for an Alzheimer’s treatment
Worse yet, according to the critics, the FDA gave Aduhelm accelerated approval in June, another possibility that had not been raised before the committee. (In notable contrast, the FDA did not act in an accelerated fashion when it finally approved the Pfizer/BionTech vaccine for Covid-19 in August.)**
…
Carome believes the shift at the FDA began in earnest in 1992, when the funding stream for the government agency changed. Under an act of Congress that year, the pharmaceutical industry paid “user fees” to support its regulators. The idea was that since the companies would benefit from the FDA’s decisions, they should cover the costs. User fees now pay for roughly 45% of the FDA’s budget.
“The politicians like user fees, because that means they don’t have to allocate taxpayer money,” Carome said, “but what this has done is encourage the agency to become a partner with industry. This has led to regulatory capture of the agency, which is now looking at best interests of the company rather than the best interests of public health.”
**They’re lying about this!? The FDA fast tracked Pfizer’s jab AND accelerated it’s review! The advisory committee didn’t even hold another meeting about the updated data from clinical trials! How is that not different?!
Pfizer, BioNTech’s coronavirus vaccine candidates get FDA’s ‘fast track’ status
FDA Reassigns Staff to Accelerate Full Approval for Pfizer’s COVID-19 Vaccine
Covid-19: FDA set to grant full approval to Pfizer vaccine without public discussion of data
A Legacy of Corruption in the FDA and Big Pharma
By Liam Cosgrove | Mises Wire | September 11, 2021
Our healthcare system is broken, a fact nobody would have disputed in precovid days. Regulatory capture is a reality, and the pharmaceutical industry is fraught with examples. Yet we trusted private-public partnerships to find an optimal solution to a global pandemic, assuming a crisis would bring out the best in historically corrupt institutions.
A Legacy of Corruption in the FDA and Big Pharma
Trust the $cience! 🙄
Ms. Cat’s Chronicles 