Exemplary quotes regarding FDA approval and use of the accelerated approval pathway
| When FDA approved aducanumab, it … | |
| … made the right decision. | • ‘Ultimately, the sole authority to approve Aduhelm based on the degree to which it reduced beta amyloid plaque in AD patients was the FDA’s. GAP firmly believes that this decision was well grounded, reasonable, and overwhelming good for patients.’ (Alzheimer’s patient advocacy organization) • ‘Furthermore, analysis of two of the trials DID SHOW modest clinical benefit, hence the FDA’s ultimate approval of the drug.’ (Clinician or other health care worker) |
| … made the wrong decision. | • ‘As a retired physician as well as caretaker of a [PHI Redacted] who lived with dementia for 12 years, I was appalled at the FDA decision to approve this drug in the face of a lack of evidence for its clinical effectiveness. There is essentially no good evidence that this drug helps.’ (Family member/caregiver of person living with Alzheimer’s disease; Clinician or other health care worker) • ‘This drug does not show clinical benefits. The CMS decision will limit the potential harms. Aduhelm (aducanumab) should have never been approved in the first place, but this decision from CMS will protect the public from access to an ineffective and dangerous drug.’ (Clinician or other health care worker) |
| FDA’s use of the accelerated approval pathway was … | |
| … appropriate/justified. | • ‘I feel that the FDA made the right decision at the time the decision was made. The follow-up clinical trial and history well tell us if this was the right thing for AD patients, just as similar opportunities have been given to cancer patients in previous FDA accelerated approval decisions.’ (Clinician or other health care worker) • ‘The Food and Drug Administration’s (FDA) use of the accelerated approval pathway (AAP) to approve Aduhelm for the treatment of AD was an informed and appropriate exercise of the authority vested in the FDA by Congress.’ (Alzheimer’s patient advocacy organization) |
| … inappropriate/unjustified. | • ‘There is no justification to approve or to pretend the trial did not happen and approved on the accelerated approval pathway. That is not the back-up if a trial fails. … There is no expert consensus that that plaque reduction coincides with some slowing of cognitive decline. In fact, the evidence to date is to the contrary.’ (Family member/caregiver of person living with Alzheimer’s disease) • ‘The FDA’s accelerated approval of this drug also appears not to have taken into account the significant health risks and side effects that are likely to arise for patients on this drug in exchange for a minimal or nonexistent benefit.’ (Self-identified member of the general public/taxpayer) |
| When FDA approved aducanumab, it … | |
| … made the right decision. | • ‘Ultimately, the sole authority to approve Aduhelm based on the degree to which it reduced beta amyloid plaque in AD patients was the FDA’s. GAP firmly believes that this decision was well grounded, reasonable, and overwhelming good for patients.’ (Alzheimer’s patient advocacy organization) • ‘Furthermore, analysis of two of the trials DID SHOW modest clinical benefit, hence the FDA’s ultimate approval of the drug.’ (Clinician or other health care worker) |
| … made the wrong decision. | • ‘As a retired physician as well as caretaker of a [PHI Redacted] who lived with dementia for 12 years, I was appalled at the FDA decision to approve this drug in the face of a lack of evidence for its clinical effectiveness. There is essentially no good evidence that this drug helps.’ (Family member/caregiver of person living with Alzheimer’s disease; Clinician or other health care worker) • ‘This drug does not show clinical benefits. The CMS decision will limit the potential harms. Aduhelm (aducanumab) should have never been approved in the first place, but this decision from CMS will protect the public from access to an ineffective and dangerous drug.’ (Clinician or other health care worker) |
| FDA’s use of the accelerated approval pathway was … | |
| … appropriate/justified. | • ‘I feel that the FDA made the right decision at the time the decision was made. The follow-up clinical trial and history well tell us if this was the right thing for AD patients, just as similar opportunities have been given to cancer patients in previous FDA accelerated approval decisions.’ (Clinician or other health care worker) • ‘The Food and Drug Administration’s (FDA) use of the accelerated approval pathway (AAP) to approve Aduhelm for the treatment of AD was an informed and appropriate exercise of the authority vested in the FDA by Congress.’ (Alzheimer’s patient advocacy organization) |
| … inappropriate/unjustified. | • ‘There is no justification to approve or to pretend the trial did not happen and approved on the accelerated approval pathway. That is not the back-up if a trial fails. … There is no expert consensus that that plaque reduction coincides with some slowing of cognitive decline. In fact, the evidence to date is to the contrary.’ (Family member/caregiver of person living with Alzheimer’s disease) • ‘The FDA’s accelerated approval of this drug also appears not to have taken into account the significant health risks and side effects that are likely to arise for patients on this drug in exchange for a minimal or nonexistent benefit.’ (Self-identified member of the general public/taxpayer) |
Exemplary quotes regarding FDA approval and use of the accelerated approval pathway
| When FDA approved aducanumab, it … | |
| … made the right decision. | • ‘Ultimately, the sole authority to approve Aduhelm based on the degree to which it reduced beta amyloid plaque in AD patients was the FDA’s. GAP firmly believes that this decision was well grounded, reasonable, and overwhelming good for patients.’ (Alzheimer’s patient advocacy organization) • ‘Furthermore, analysis of two of the trials DID SHOW modest clinical benefit, hence the FDA’s ultimate approval of the drug.’ (Clinician or other health care worker) |
| … made the wrong decision. | • ‘As a retired physician as well as caretaker of a [PHI Redacted] who lived with dementia for 12 years, I was appalled at the FDA decision to approve this drug in the face of a lack of evidence for its clinical effectiveness. There is essentially no good evidence that this drug helps.’ (Family member/caregiver of person living with Alzheimer’s disease; Clinician or other health care worker) • ‘This drug does not show clinical benefits. The CMS decision will limit the potential harms. Aduhelm (aducanumab) should have never been approved in the first place, but this decision from CMS will protect the public from access to an ineffective and dangerous drug.’ (Clinician or other health care worker) |
| FDA’s use of the accelerated approval pathway was … | |
| … appropriate/justified. | • ‘I feel that the FDA made the right decision at the time the decision was made. The follow-up clinical trial and history well tell us if this was the right thing for AD patients, just as similar opportunities have been given to cancer patients in previous FDA accelerated approval decisions.’ (Clinician or other health care worker) • ‘The Food and Drug Administration’s (FDA) use of the accelerated approval pathway (AAP) to approve Aduhelm for the treatment of AD was an informed and appropriate exercise of the authority vested in the FDA by Congress.’ (Alzheimer’s patient advocacy organization) |
| … inappropriate/unjustified. | • ‘There is no justification to approve or to pretend the trial did not happen and approved on the accelerated approval pathway. That is not the back-up if a trial fails. … There is no expert consensus that that plaque reduction coincides with some slowing of cognitive decline. In fact, the evidence to date is to the contrary.’ (Family member/caregiver of person living with Alzheimer’s disease) • ‘The FDA’s accelerated approval of this drug also appears not to have taken into account the significant health risks and side effects that are likely to arise for patients on this drug in exchange for a minimal or nonexistent benefit.’ (Self-identified member of the general public/taxpayer) |
| When FDA approved aducanumab, it … | |
| … made the right decision. | • ‘Ultimately, the sole authority to approve Aduhelm based on the degree to which it reduced beta amyloid plaque in AD patients was the FDA’s. GAP firmly believes that this decision was well grounded, reasonable, and overwhelming good for patients.’ (Alzheimer’s patient advocacy organization) • ‘Furthermore, analysis of two of the trials DID SHOW modest clinical benefit, hence the FDA’s ultimate approval of the drug.’ (Clinician or other health care worker) |
| … made the wrong decision. | • ‘As a retired physician as well as caretaker of a [PHI Redacted] who lived with dementia for 12 years, I was appalled at the FDA decision to approve this drug in the face of a lack of evidence for its clinical effectiveness. There is essentially no good evidence that this drug helps.’ (Family member/caregiver of person living with Alzheimer’s disease; Clinician or other health care worker) • ‘This drug does not show clinical benefits. The CMS decision will limit the potential harms. Aduhelm (aducanumab) should have never been approved in the first place, but this decision from CMS will protect the public from access to an ineffective and dangerous drug.’ (Clinician or other health care worker) |
| FDA’s use of the accelerated approval pathway was … | |
| … appropriate/justified. | • ‘I feel that the FDA made the right decision at the time the decision was made. The follow-up clinical trial and history well tell us if this was the right thing for AD patients, just as similar opportunities have been given to cancer patients in previous FDA accelerated approval decisions.’ (Clinician or other health care worker) • ‘The Food and Drug Administration’s (FDA) use of the accelerated approval pathway (AAP) to approve Aduhelm for the treatment of AD was an informed and appropriate exercise of the authority vested in the FDA by Congress.’ (Alzheimer’s patient advocacy organization) |
| … inappropriate/unjustified. | • ‘There is no justification to approve or to pretend the trial did not happen and approved on the accelerated approval pathway. That is not the back-up if a trial fails. … There is no expert consensus that that plaque reduction coincides with some slowing of cognitive decline. In fact, the evidence to date is to the contrary.’ (Family member/caregiver of person living with Alzheimer’s disease) • ‘The FDA’s accelerated approval of this drug also appears not to have taken into account the significant health risks and side effects that are likely to arise for patients on this drug in exchange for a minimal or nonexistent benefit.’ (Self-identified member of the general public/taxpayer) |
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