| Galling Disregard for Science |
| 'The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged. The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if continued to completion, were unlikely to show the drug benefitted Alzheimer’s disease patients. Moreover, the integrity of the FDA’s review of the marketing application for Aduhelm was dangerously corrupted by the unprecedented and inappropriately close collaboration between Biogen and the FDA during the analyses of data from the key clinical trials of the drug after the termination of the phase 3 clinical trials because of futility. |
| CMS must not compound the FDA’s egregious error in approving Aduhelm on June 7, 2021. Given the lack of scientific evidence that Aduhelm provides any clinically meaningful benefit in terms of cognitive function outcomes in Alzheimer’s disease patients, the drug cannot possibly be deemed reasonable and necessary for treatment of such patients. I urge CMS to issue a national coverage determination that excludes Aduhelm from coverage under the Medicare program. It’s imperative to put patients and consumers before Big Pharma profits.' |
| Discriminates Against Down Syndrome |
| 'I have recently become aware of a new Alzheimer’s drug called aducanumab and that CMS has proposed coverage that excludes people with Down syndrome and other intellectual and developmental disabilities. I understand the need to make sure treatments are safe, but this is the wrong path forward. CMS must abandon the proposed CED process because it discriminates against people with intellectual and developmental disabilities now and into the future. Having Down syndrome should not prevent a patient from accessing Alzheimer’s treatments. If one patient covered by Medicare or Medicaid can access an Alzheimer’s treatment, every patient covered by Medicare or Medicaid should be able to if their doctor believes it’s right for them.' |
| Same Access for Down Syndrome |
| 'We know that [our family member is] more likely than other people to develop Alzheimer’s disease, so even though there’s no cure now, it’s very important to me that [they have] access to any treatments that will be developed in the future. |
| I’ve become aware that the Centers for Medicare & Medicaid Services might exclude [them] from clinical trials related to new Alzheimer’s treatments. I strongly believe that CMS should not move forward with any coverage process that excludes people with Down syndrome and other disabilities. If people on Medicare or Medicaid without disabilities can access new treatments, people with disabilities who are covered should have the same access.” |
| Health Equity for Down Syndrome |
| 'Having Down syndrome should not prevent a patient from accessing Alzheimer’s treatments. As a matter of health equity, if CMS covers Alzheimer’s treatments for any Medicare/Medicaid recipients, then it must cover these treatments for all of them. When a physician determines that a treatment is right for a covered patient, then that patient should have access regardless of race, ethnicity, religion, income, geography, gender identity, sexual orientation, or disability.' |
| Galling Disregard for Science |
| 'The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged. The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if continued to completion, were unlikely to show the drug benefitted Alzheimer’s disease patients. Moreover, the integrity of the FDA’s review of the marketing application for Aduhelm was dangerously corrupted by the unprecedented and inappropriately close collaboration between Biogen and the FDA during the analyses of data from the key clinical trials of the drug after the termination of the phase 3 clinical trials because of futility. |
| CMS must not compound the FDA’s egregious error in approving Aduhelm on June 7, 2021. Given the lack of scientific evidence that Aduhelm provides any clinically meaningful benefit in terms of cognitive function outcomes in Alzheimer’s disease patients, the drug cannot possibly be deemed reasonable and necessary for treatment of such patients. I urge CMS to issue a national coverage determination that excludes Aduhelm from coverage under the Medicare program. It’s imperative to put patients and consumers before Big Pharma profits.' |
| Discriminates Against Down Syndrome |
| 'I have recently become aware of a new Alzheimer’s drug called aducanumab and that CMS has proposed coverage that excludes people with Down syndrome and other intellectual and developmental disabilities. I understand the need to make sure treatments are safe, but this is the wrong path forward. CMS must abandon the proposed CED process because it discriminates against people with intellectual and developmental disabilities now and into the future. Having Down syndrome should not prevent a patient from accessing Alzheimer’s treatments. If one patient covered by Medicare or Medicaid can access an Alzheimer’s treatment, every patient covered by Medicare or Medicaid should be able to if their doctor believes it’s right for them.' |
| Same Access for Down Syndrome |
| 'We know that [our family member is] more likely than other people to develop Alzheimer’s disease, so even though there’s no cure now, it’s very important to me that [they have] access to any treatments that will be developed in the future. |
| I’ve become aware that the Centers for Medicare & Medicaid Services might exclude [them] from clinical trials related to new Alzheimer’s treatments. I strongly believe that CMS should not move forward with any coverage process that excludes people with Down syndrome and other disabilities. If people on Medicare or Medicaid without disabilities can access new treatments, people with disabilities who are covered should have the same access.” |
| Health Equity for Down Syndrome |
| 'Having Down syndrome should not prevent a patient from accessing Alzheimer’s treatments. As a matter of health equity, if CMS covers Alzheimer’s treatments for any Medicare/Medicaid recipients, then it must cover these treatments for all of them. When a physician determines that a treatment is right for a covered patient, then that patient should have access regardless of race, ethnicity, religion, income, geography, gender identity, sexual orientation, or disability.' |
| Galling Disregard for Science |
| 'The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged. The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if continued to completion, were unlikely to show the drug benefitted Alzheimer’s disease patients. Moreover, the integrity of the FDA’s review of the marketing application for Aduhelm was dangerously corrupted by the unprecedented and inappropriately close collaboration between Biogen and the FDA during the analyses of data from the key clinical trials of the drug after the termination of the phase 3 clinical trials because of futility. |
| CMS must not compound the FDA’s egregious error in approving Aduhelm on June 7, 2021. Given the lack of scientific evidence that Aduhelm provides any clinically meaningful benefit in terms of cognitive function outcomes in Alzheimer’s disease patients, the drug cannot possibly be deemed reasonable and necessary for treatment of such patients. I urge CMS to issue a national coverage determination that excludes Aduhelm from coverage under the Medicare program. It’s imperative to put patients and consumers before Big Pharma profits.' |
| Discriminates Against Down Syndrome |
| 'I have recently become aware of a new Alzheimer’s drug called aducanumab and that CMS has proposed coverage that excludes people with Down syndrome and other intellectual and developmental disabilities. I understand the need to make sure treatments are safe, but this is the wrong path forward. CMS must abandon the proposed CED process because it discriminates against people with intellectual and developmental disabilities now and into the future. Having Down syndrome should not prevent a patient from accessing Alzheimer’s treatments. If one patient covered by Medicare or Medicaid can access an Alzheimer’s treatment, every patient covered by Medicare or Medicaid should be able to if their doctor believes it’s right for them.' |
| Same Access for Down Syndrome |
| 'We know that [our family member is] more likely than other people to develop Alzheimer’s disease, so even though there’s no cure now, it’s very important to me that [they have] access to any treatments that will be developed in the future. |
| I’ve become aware that the Centers for Medicare & Medicaid Services might exclude [them] from clinical trials related to new Alzheimer’s treatments. I strongly believe that CMS should not move forward with any coverage process that excludes people with Down syndrome and other disabilities. If people on Medicare or Medicaid without disabilities can access new treatments, people with disabilities who are covered should have the same access.” |
| Health Equity for Down Syndrome |
| 'Having Down syndrome should not prevent a patient from accessing Alzheimer’s treatments. As a matter of health equity, if CMS covers Alzheimer’s treatments for any Medicare/Medicaid recipients, then it must cover these treatments for all of them. When a physician determines that a treatment is right for a covered patient, then that patient should have access regardless of race, ethnicity, religion, income, geography, gender identity, sexual orientation, or disability.' |
| Galling Disregard for Science |
| 'The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged. The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if continued to completion, were unlikely to show the drug benefitted Alzheimer’s disease patients. Moreover, the integrity of the FDA’s review of the marketing application for Aduhelm was dangerously corrupted by the unprecedented and inappropriately close collaboration between Biogen and the FDA during the analyses of data from the key clinical trials of the drug after the termination of the phase 3 clinical trials because of futility. |
| CMS must not compound the FDA’s egregious error in approving Aduhelm on June 7, 2021. Given the lack of scientific evidence that Aduhelm provides any clinically meaningful benefit in terms of cognitive function outcomes in Alzheimer’s disease patients, the drug cannot possibly be deemed reasonable and necessary for treatment of such patients. I urge CMS to issue a national coverage determination that excludes Aduhelm from coverage under the Medicare program. It’s imperative to put patients and consumers before Big Pharma profits.' |
| Discriminates Against Down Syndrome |
| 'I have recently become aware of a new Alzheimer’s drug called aducanumab and that CMS has proposed coverage that excludes people with Down syndrome and other intellectual and developmental disabilities. I understand the need to make sure treatments are safe, but this is the wrong path forward. CMS must abandon the proposed CED process because it discriminates against people with intellectual and developmental disabilities now and into the future. Having Down syndrome should not prevent a patient from accessing Alzheimer’s treatments. If one patient covered by Medicare or Medicaid can access an Alzheimer’s treatment, every patient covered by Medicare or Medicaid should be able to if their doctor believes it’s right for them.' |
| Same Access for Down Syndrome |
| 'We know that [our family member is] more likely than other people to develop Alzheimer’s disease, so even though there’s no cure now, it’s very important to me that [they have] access to any treatments that will be developed in the future. |
| I’ve become aware that the Centers for Medicare & Medicaid Services might exclude [them] from clinical trials related to new Alzheimer’s treatments. I strongly believe that CMS should not move forward with any coverage process that excludes people with Down syndrome and other disabilities. If people on Medicare or Medicaid without disabilities can access new treatments, people with disabilities who are covered should have the same access.” |
| Health Equity for Down Syndrome |
| 'Having Down syndrome should not prevent a patient from accessing Alzheimer’s treatments. As a matter of health equity, if CMS covers Alzheimer’s treatments for any Medicare/Medicaid recipients, then it must cover these treatments for all of them. When a physician determines that a treatment is right for a covered patient, then that patient should have access regardless of race, ethnicity, religion, income, geography, gender identity, sexual orientation, or disability.' |
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