Recall 10 Little Indians? Now There Are Seven
Jun 11, 2021 2:17:29 GMT
miamianne67 and c2crusher like this
Post by icemandios on Jun 11, 2021 2:17:29 GMT
"A Dangerous Precedent" - 3rd FDA Advisor Quits After Controversial Alzheimer's Drug Approval
My Comment: I've never been a fan of the FDA's practicing medicine. A bunch of bureaucrats sittingon their in their little government perches making decisions about what you can or can't, should or shouldn't get. About the only thing that made it halfway legit was the adcomm comprised of actual medical people.
Before the thalidomide disaster, the FDA was about determining safety. Just safety, not efficacy or relative equality or superiority. Just safety. And then that went badly for them.
So what does a good bureaucrat do when things go sour? They cover. And ever since then, they've done everything possible to C(T)A's. They adopted the posture and policy that it is far, far better to sacrifice some stranger's rescue drug on the chance they might approve another thalidomide fiasco. A thousand parents of deformed babies equals a class action lawsuit, while the FDA cannot be sued for denying an individual or a thousand individuals access to something that doesn't already exist. Therein is the ultimate CYA.
But as these things always go, practical matters come to bear. In a word or two, money and influence. And now we have, say, a drug that reduces psoriasis. Yes, it does that, but it also might cause kidney failure or heart failure or loss of feeling in the extremities, etc.
In short, things get approved that mitigate or cure one problem, but they have "acceptable" numbers of unacceptable side effects. To suggest that big pharma tends to get favored treatment on the risk/benefit continuum is, of course, just cynical. That is until this Biogen Alzheimer drug, the approval thereof, which has precipitated the resignation of 3 (so far) actual medical experts of the Adcomm panel for neurologic matters.
As a final note, I have actually listened to a FDA adcomm hearing wherein some youngish sounding FDA inquisitor grilled a drug company rep about the design of the trial. And one of the adcomm docs interrupted saying, "excuse me, but didn't you folks assist in and approve of the design of the ph3 trial?" And they had. Bureaucrats and doctors. The first wants no problems and thinks in terms of one size fits all. The second deals only with problems and recognizes that everybody is different, every situation can be different, and people can't wait for the best thing to come along when there is something good now.
1. Neurologist J.Perlmutter, a member of the FDA’s expert panel said he quit the committee “due to this ruling by FDA without further discuss with our advisory committee.”
2. Neurologist David Knopman of the Mayo Clinic.
3. Dr. Aaron Kesselheim, director of Brigham and Women’s Hospital’s Program on Regulation, Therapeutics, and Law, said Aduhelm’s approval didn’t just set “a dangerous precedent” for what kind of evidence an Alzheimer’s therapy would need to show to get the green light, “but even more broadly for the idea that a company can turn around and at the last minute seek [accelerated approval] when their primary clinical endpoints in their trials don’t reach the level needed for FDA approval,” he told STAT in an email.
In his letter of resignation to the FDA, Kesselheim said Biogen’s Aduhelm “was probably the worst drug approval decision in recent U.S. history.”
2. Neurologist David Knopman of the Mayo Clinic.
3. Dr. Aaron Kesselheim, director of Brigham and Women’s Hospital’s Program on Regulation, Therapeutics, and Law, said Aduhelm’s approval didn’t just set “a dangerous precedent” for what kind of evidence an Alzheimer’s therapy would need to show to get the green light, “but even more broadly for the idea that a company can turn around and at the last minute seek [accelerated approval] when their primary clinical endpoints in their trials don’t reach the level needed for FDA approval,” he told STAT in an email.
In his letter of resignation to the FDA, Kesselheim said Biogen’s Aduhelm “was probably the worst drug approval decision in recent U.S. history.”
My Comment: I've never been a fan of the FDA's practicing medicine. A bunch of bureaucrats sitting
Before the thalidomide disaster, the FDA was about determining safety. Just safety, not efficacy or relative equality or superiority. Just safety. And then that went badly for them.
So what does a good bureaucrat do when things go sour? They cover. And ever since then, they've done everything possible to C(T)A's. They adopted the posture and policy that it is far, far better to sacrifice some stranger's rescue drug on the chance they might approve another thalidomide fiasco. A thousand parents of deformed babies equals a class action lawsuit, while the FDA cannot be sued for denying an individual or a thousand individuals access to something that doesn't already exist. Therein is the ultimate CYA.
But as these things always go, practical matters come to bear. In a word or two, money and influence. And now we have, say, a drug that reduces psoriasis. Yes, it does that, but it also might cause kidney failure or heart failure or loss of feeling in the extremities, etc.
In short, things get approved that mitigate or cure one problem, but they have "acceptable" numbers of unacceptable side effects. To suggest that big pharma tends to get favored treatment on the risk/benefit continuum is, of course, just cynical. That is until this Biogen Alzheimer drug, the approval thereof, which has precipitated the resignation of 3 (so far) actual medical experts of the Adcomm panel for neurologic matters.
As a final note, I have actually listened to a FDA adcomm hearing wherein some youngish sounding FDA inquisitor grilled a drug company rep about the design of the trial. And one of the adcomm docs interrupted saying, "excuse me, but didn't you folks assist in and approve of the design of the ph3 trial?" And they had. Bureaucrats and doctors. The first wants no problems and thinks in terms of one size fits all. The second deals only with problems and recognizes that everybody is different, every situation can be different, and people can't wait for the best thing to come along when there is something good now.