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The problem is not that the companies did not share the data with the FDA. It's that the FDA relies on industry for the data, while shirking it's own regulatory duty.

Chemical Giants Hid Dangers of ‘Forever Chemicals’ in Food Packaging
And a new peer reviewed study published today in Environmental Science and Technology:
Study Finds Alarming Levels of ‘Forever Chemicals’ in US mothers’ Breast Milk
Though the study checked a relatively small sample size, the contamination cut across socioeconomic and geographic groupings, which is “what makes the issue so difficult on an individual level”, Sathyanarayana said.
“What it speaks to is that the chemicals are so ubiquitous that we can’t really predict who will have the highest exposures,” she added.
The study also runs counter to a chemical industry claim that its newer generation of PFAS that are still in use do not accumulate in humans.
You can read the abstract and supporting information here, but the full study requires an account or payment:
https://pubs.acs.org/doi/10.1021/acs.est.0c06978
 

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FDA Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works
The approval came despite a scathing assessment in November by the FDA’s outside panel of neurological experts. The group voted “no” to a series of questions on whether reanalyzed data from a single study submitted by Biogen showed that the drug was effective.
“The FDA gets the respect that it does because it has regulatory standards that are based on firm evidence. In this case, I think they gave the product a pass,” said Alexander, a researcher at Johns Hopkins University.
Well, when you look at the cost of a drug that may or may not have a negligible effect on slowing (not reversing) mental decline - per the one reanalyzed study 0.39 on an 18-point score of cognitive and functional ability in people with very mild dementia - you realize that someone is benefitting, it's just not the patient.
...analysts have estimated the drug could cost between $30,000 and $50,000 for a year’s worth of treatment.
The new medicine is made from living cells that will have to be given via infusion at a doctor’s office or hospital.
With FDA accelerated approval, insurance and Medicare will be required to cover it.
With FDA approval, aducanumab is certain to be covered by virtually all insurers, including Medicare... Both the FDA and Medicare are barred from considering cost when reviewing a new drug or treatment.
If the results of one study can be "reanalyzed" why not the follow-up study, too?
Under terms of the so-called accelerated approval, the FDA is requiring the drugmaker to conduct a follow-up study to confirm benefits for patients. If the study fails to show effectiveness, the FDA could pull the drug from the market, though it rarely does so.
 

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FDA Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works



Well, when you look at the cost of a drug that may or may not have a negligible effect on slowing (not reversing) mental decline - per the one reanalyzed study 0.39 on an 18-point score of cognitive and functional ability in people with very mild dementia - you realize that someone is benefitting, it's just not the patient.


With FDA accelerated approval, insurance and Medicare will be required to cover it.


If the results of one study can be "reanalyzed" why not the follow-up study, too?

Analysis: U.S. FDA faces mounting criticism over Alzheimer’s drug approval
"In approving the first new Alzheimer’s drug in nearly 20 years, the U.S. Food and Drug Administration is taking its biggest risk yet with a strategy that allows new therapies onto the market without strong evidence that they work, regulatory and scientific experts say."
 

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Discussion Starter · #445 ·

Analysis: U.S. FDA faces mounting criticism over Alzheimer’s drug approval
"In approving the first new Alzheimer’s drug in nearly 20 years, the U.S. Food and Drug Administration is taking its biggest risk yet with a strategy that allows new therapies onto the market without strong evidence that they work, regulatory and scientific experts say."
Risk for patients. Probably no risk at all for the people who voted on the approval.
 
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