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.
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.“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.
With FDA accelerated approval, insurance and Medicare will be required to cover it....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.
If the results of one study can be "reanalyzed" why not the follow-up study, too?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.
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.
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?
Risk for patients. Probably no risk at all for the people who voted on the 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.www.reuters.com
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."
Outrage, in this circumstance, is justified. Both these major consumer brands and the FDA seem unable or unwilling to protect not just adult consumers, but vulnerable infants – who absorb metals more readily than adults and consume more food relative to their body weight.
Protecting babies and children isn't a priority in the US. Protecting profitable and powerful corporations is.An opinion piece, but making some good points:
Why Are There Dangerous Levels of Arsenic and Lead in American Baby Food?
The New York attorney general said on Saturday Johnson & Johnson had agreed to pay $230m to settle claims it helped fuel the opioid crisis.
Johnson & Johnson said in a statement that the settlement “is not an admission of liability or wrongdoing by the company”.
It added that its actions “relating to the marketing and promotion of important prescription pain medications were appropriate and responsible”.
A new analysis of more than 50 previously secret, corporate-backed scientific studies is raising troubling questions about a history of regulatory reliance on such research in assessing the safety of the widely used weed killing chemical known as glyphosate, the key ingredient in popular Roundup herbicide.
In a 187-page report released Friday, researchers from the Institute of Cancer Research at the Medical University of Vienna in Austria said a thorough review of 53 safety studies submitted to regulators by large chemical companies shows that most do not comply with modern international standards for scientific rigor, and lack the types of tests most able to detect cancer risks.
Shoddy science is almost always the case when you rely on profit-driven corporations to do the "research."...the new finding of flaws in industry studies means regulatory assurances about glyphosate safety in Europe and the United States have been based, at least in part, on shoddy science.
Mainstream media has been critical of the process around this drug, so there may actually be a bit of "symbolic housecleaning" to make the FDA and others look like they care.I am sure the conclusion will be ''it's safe and effective''
US Food and Drug Administration Acting Commissioner Dr. Janet Woodcock on Friday requested an investigation by the US Department of Health and Human Services Office of Inspector General into the controversial approval of the Alzheimer's disease drug Aduhelm.www.cnn.com
He’s not anti vax. In fact he recommends an alternative schedule and has no qualms vaccinating on cdc schedule. He just doesn’t force all patients to do so.
Anti-Vax Pediatrician Is Back in Business, Kind Of
— Restrictions will require previously suspended doctor to stay mum on vaccine protocols
"Thomas was accused of failing to properly vaccinate his patients and spreading misinformation about the benefits of his recommended immunization schedule. The board's original emergency suspension order against the self-proclaimed "vaccine-friendly" doctor cited at least eight different cases of alleged patient harm and gross negligence -- all stemming from their lack of immunizations."
We need @teacozy to pop up again and explain the true meaning of "anti-vax". According to teacozy, @Turquesa is anti-vax.He’s not anti vax. In fact he recommends an alternative schedule and has no qualms vaccinating on cdc schedule. He just doesn’t force all patients to do so.