Post by icemandios on Jun 16, 2021 18:34:16 GMT
June 16, 2021 07:08 AM EDTUpdated 09:06 AM FDA+
New Alzheimer's drug approval fallout: Public Citizen seeks removal of FDA's Woodcock, Cavazzoni and Dunn
Zachary Brennan
Senior Editor
As Capitol Hill begins to wake up to the financial and scientific mess behind the FDA’s approval of Biogen’s new controversial Alzheimer’s drug Aduhelm, nonprofit watchdog Public Citizen is now calling for the top three FDA officials who are responsible to be removed from their positions.
Xavier Becerra
In a letter to HHS Secretary Xavier Becerra on Wednesday, the group highlighted the “litany of flaws” in the FDA’s approval of the new drug, including the “unprecedented, inappropriately close” collaboration between the FDA and Biogen in the analysis of key trial data, basing approval on an unvalidated surrogate endpoint, not following the advice of its expert advisory committee (3 members of which have since resigned), and the wide label that the agency granted.
Patrizia Cavazzoni
In addition to requesting that Becerra seek the resignations or the removal of acting FDA commissioner Janet Woodcock, CDER Director Patrizia Cavazzoni, and Office of Neuroscience director Billy Dunn because of the approval, Public Citizen also wants Becerra to direct the next FDA commissioner to consider withdrawing the Aduhelm approval.
Becerra has not said much publicly on the approval, although he did tell Politico that “because the FDA is entitled to a great deal of deference and independence in the way that it acts, I think all of us are looking to hear just how the FDA operates based on the science.”
Billy Dunn
But that explanation might not be enough for Public Citizen.
“New leadership of the FDA and CDER is a prerequisite for restoring the agency’s credibility and reversing the slide in the agency’s standards for ensuring the safety and effectiveness of new drugs,” Michael Carome, director of Public Citizen’s Health Research Group, wrote to Becerra.
Carome explains how the agency explicitly signaled to the adcomm members that it did not intend to use the accelerated approval pathway, but nevertheless did so anyway “based on an unvalidated and highly suspect surrogate outcome.”
Instead, FDA should have convened the committee again to discuss whether the reduction of amyloid-beta plaques was an appropriate surrogate outcome to justify this accelerated approval, the group added.
“The committee also should have been asked whether approval of the drug under such circumstances — assuming there was a sound rationale for doing so — should have been limited to a subset of Alzheimer’s disease patients, such as those with mild Alzheimer’s disease,” Carome wrote.
He also said the approval has raised false hope for millions of Alzheimer’s disease patients and their families, threatens to bankrupt Medicare because of the drug’s $56,000 per year price tag (in addition to the costs of serial MRI scans necessary to monitor for the drug’s adverse effects on the brain), and will impede for years the development of other experimental treatments for this disease.
New Alzheimer's drug approval fallout: Public Citizen seeks removal of FDA's Woodcock, Cavazzoni and Dunn
Zachary Brennan
Senior Editor
As Capitol Hill begins to wake up to the financial and scientific mess behind the FDA’s approval of Biogen’s new controversial Alzheimer’s drug Aduhelm, nonprofit watchdog Public Citizen is now calling for the top three FDA officials who are responsible to be removed from their positions.
Xavier Becerra
In a letter to HHS Secretary Xavier Becerra on Wednesday, the group highlighted the “litany of flaws” in the FDA’s approval of the new drug, including the “unprecedented, inappropriately close” collaboration between the FDA and Biogen in the analysis of key trial data, basing approval on an unvalidated surrogate endpoint, not following the advice of its expert advisory committee (3 members of which have since resigned), and the wide label that the agency granted.
Patrizia Cavazzoni
In addition to requesting that Becerra seek the resignations or the removal of acting FDA commissioner Janet Woodcock, CDER Director Patrizia Cavazzoni, and Office of Neuroscience director Billy Dunn because of the approval, Public Citizen also wants Becerra to direct the next FDA commissioner to consider withdrawing the Aduhelm approval.
Becerra has not said much publicly on the approval, although he did tell Politico that “because the FDA is entitled to a great deal of deference and independence in the way that it acts, I think all of us are looking to hear just how the FDA operates based on the science.”
Billy Dunn
But that explanation might not be enough for Public Citizen.
“New leadership of the FDA and CDER is a prerequisite for restoring the agency’s credibility and reversing the slide in the agency’s standards for ensuring the safety and effectiveness of new drugs,” Michael Carome, director of Public Citizen’s Health Research Group, wrote to Becerra.
Carome explains how the agency explicitly signaled to the adcomm members that it did not intend to use the accelerated approval pathway, but nevertheless did so anyway “based on an unvalidated and highly suspect surrogate outcome.”
Instead, FDA should have convened the committee again to discuss whether the reduction of amyloid-beta plaques was an appropriate surrogate outcome to justify this accelerated approval, the group added.
“The committee also should have been asked whether approval of the drug under such circumstances — assuming there was a sound rationale for doing so — should have been limited to a subset of Alzheimer’s disease patients, such as those with mild Alzheimer’s disease,” Carome wrote.
He also said the approval has raised false hope for millions of Alzheimer’s disease patients and their families, threatens to bankrupt Medicare because of the drug’s $56,000 per year price tag (in addition to the costs of serial MRI scans necessary to monitor for the drug’s adverse effects on the brain), and will impede for years the development of other experimental treatments for this disease.