{"id":174408,"date":"2021-06-13T19:03:14","date_gmt":"2021-06-13T23:03:14","guid":{"rendered":"https:\/\/z3news.com\/w\/?p=174408"},"modified":"2021-07-26T15:53:56","modified_gmt":"2021-07-26T19:53:56","slug":"icer-fda-failed-to-protect-patients-from-unproven-alzheimers-treatment-with-known-harms","status":"publish","type":"post","link":"https:\/\/z3news.com\/w\/icer-fda-failed-to-protect-patients-from-unproven-alzheimers-treatment-with-known-harms\/","title":{"rendered":"ICER: FDA failed to protect patients from unproven Alzheimer’s treatment with known harms"},"content":{"rendered":"

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\n(Natural News<\/a>) The Food and Drug Administration<\/em> (FDA) drew criticisms after granting Alzheimer\u2019s disease drug Aduhelm a conditional approval<\/a>. It allows the drug scientifically known as aducanumab to be prescribed and used while its maker Biogen conducts a post-marketing, phase 4 confirmatory study that could take years to complete.<\/p>\n

Aduhelm is the first Alzheimer\u2019s medication approved by the FDA since 2003.<\/p>\n

According to the\u00a0influential Institute for Clinical and Economic Review (ICER), the FDA\u00a0\u201chas failed in its responsibility to protect patients and families from unproven treatments with known harms\u201d in approving Aduhelm.<\/p>\n

ICER questions Aduhelm\u2019s effectiveness<\/p>\n

The FDA, which announced the approval on June 7, said that the drug was the first to treat the underlying mechanism in Alzheimer\u2019s. But ICER didn\u2019t see it that way.<\/p>\n

ICER argued that Aduhelm was effectively approved on the strength of a biomarker \u2013 removing amyloid from the brain \u2013 rather than clinical outcomes, which is puzzling as other drugs have been shown to remove amyloid from the brain yet failed to help patients.<\/p>\n

In a statement, ICER said the view of many experts was that current evidence is not enough to support the use of Aduhelm in Alzheimer\u2019s patients, and the FDA had \u201cmoved the goalposts\u201d by not holding Biogen\u2019s drug to the standards of other therapies.<\/p>\n

\u201cThe avenue forward has seemed clear. Another study would be needed to reduce the substantial uncertainty about the drug\u2019s effectiveness, a requirement of even greater priority because of the drug\u2019s common and potentially serious side effects,\u201d said the ICER, which deliberates on the cost-effectiveness of new medicines.<\/p>\n

ICER pointed to brain swelling and potential bleeding seen in approximately 30 percent of patients treated with Aduhelm. (Related:\u00a0Alzheimer\u2019s breakthrough: scientists discover omega-3s override the bad gene causing Alzheimer\u2019s.<\/a>)<\/p>\n","protected":false},"excerpt":{"rendered":"

(Natural News)
\n The Food and Drug Administration (FDA) drew criticisms after granting Alzheimer\u2019s disease drug Aduhelm a conditional approval. It allows the drug scientifically known as aducanumab to be prescribed and used while its maker Biogen conducts a post-marketing, phase 4 confirmatory study that could take years to complete.
\nAduhelm is the first Alzheimer\u2019s medication approved by the FDA since 2003.
\nAccording to the\u00a0influential Institute for Clinical and Economic Review (ICER), the FDA\u00a0\u201chas failed in its responsibility to protect patients and families from unproven treatments with known harms\u201d in approving Aduhelm.
\nICER questions Aduhelm\u2019s effectiveness
\nThe FDA, which announced the approval on June 7, said that the drug was the first to treat the underlying mechanism in Alzheimer\u2019s. But ICER didn\u2019t see it that way.
\nICER argued that Aduhelm was effectively approved on the strength of a biomarker \u2013 removing amyloid from the brain \u2013 rather than clinical outcomes, which is puzzling as other drugs have been shown to remove amyloid from the brain yet failed to help patients.
\nIn a statement, ICER said the view of many experts was that current evidence is not enough to support the use of Aduhelm in Alzheimer\u2019s patients, and the FDA had \u201cmoved the goalposts\u201d by not holding Biogen\u2019s drug to the standards of other therapies.
\n\u201cThe avenue forward has seemed clear. Another study would be needed to reduce the substantial uncertainty about the drug\u2019s effectiveness, a requirement of even greater priority because of the drug\u2019s common and potentially serious side effects,\u201d said the ICER, which deliberates on the cost-effectiveness of new medicines.
\nICER pointed to brain swelling and potential bleeding seen in approximately 30 percent of patients treated with Aduhelm. (Related:\u00a0Alzheimer\u2019s breakthrough: scientists discover omega-3s override the bad gene causing Alzheimer\u2019s.)
\nExperts also questioned the FDA\u2019s decision to approve the drug for all Alzheimer\u2019s patients, rather than just the patients with mild cognitive impairment (MCI) and mild dementia \u2013 which are included in Biogen\u2019s studies of the drug.
\nDementia specialist Robert Howard of University College London (UCL) said that the FDA has \u201csidestepped available clinical trial outcomes data that indicate the drug probably doesn\u2019t work.\u201d
\n\u201cFDA approval closes the door on further placebo-controlled trials of aducanumab that might have helped to resolve disputes about efficacy quickly and cleanly,\u201d Howard said. \u201cNow, we\u2019ll wait a decade before it becomes obvious to everyone that there are no benefits \u2013 only high healthcare costs \u2013 associated with the treatment.\u201d
\nBiogen slammed over decision to price Aduhelm at\u00a0$56,000 per year
\nMeanwhile, Biogen has been taking flak over its decision to price Aduhelm at $56,000 per year. ICER said a fair price would be in the $2,500 to $8,300 range while analysts at Evercore ISI expected it to be set at around $10,000.
\nMichel Vounatsos, Biogen\u2019s chief executive,\u00a0defended\u00a0Aduhelm in an open letter on the company\u2019s website.
\nThe company has \u201cengaged extensively with health economists, public health experts and payers about Aduhelm \u2013 and we have examined other recent biologic drug innovations,\u201d Vounatsos said. \u201cConsistent with our pricing principles, we have established a price for Aduhelm that reflects the overall value this treatment brings to patients, caregivers and society \u2013 and one that will enable continuous innovation.\u201d
\nVounatsos recently told CNBC that the drug\u2019s price will allow the company to further invest in its pipeline of medicines for other diseases.\u00a0Vounatsos\u00a0stressed that it was time to \u201cinvest\u201d in Alzheimer\u2019s treatment when asked if he expected pushback from patients for the high price of Aduhelm.
\nCompany executives said the total price figure for the new treatment is \u201csubstantiated\u201d by the value it is expected to bring to patients, caregivers and society. They insisted the price is \u201cresponsible,\u201d noting the disease costs the U.S. billions each year.
\nMore than 6 million Americans are living with the disease, according to\u00a0estimates by the Alzheimer\u2019s Association.\u00a0The company said it currently has the capacity to provide 1 million patients with the drug annually, with more than 900 sites in the U.S. ready to implement the new medicine. (Related:\u00a0Coming wave of Alzheimer\u2019s patients threatens to bankrupt U.S. health care system, says leading Alzheimer\u2019s doctor.)
\nBiogen has committed not to raise the price of Aduhelm over the next four years and said it has agreed to access deals with some payers \u2013 including the Veterans Health Administration, CVS Health and the National Association of Free and Charitable Clinics (NAFC) \u2013 while negotiations are ongoing with Cigna and other groups.
\nAnalysts at GlobalData think that Biogen will have challenges rolling out Aduhelm in the U.S., but are still predicting sales of $5.6 billion in 2027. Shares of Biogen surged as high as 60 percent following FDA\u2019s announcement.
\nAside from the high price, another issue is its dosing by monthly infusion, as clinics that can provide this are not available in all areas. Side effects such as amyloid-related imaging abnormalities (ARIAs) could also be a barrier to uptake, according to Alessio Brunello, managing analyst at GlobalData.
\n\u201cPhysicians will also be obliged to do regular MRIs on patients to see if they have ARIA reactions, which could be a limitation, as repeated MRIs represent an additional economic burden,\u201d Brunello said.
\nFollow\u00a0Alzheimers.news\u00a0for more news and information related to\u00a0Alzheimer\u2019s disease.
\nSources include:
\nPharmaPhorum.com
\nTheHill.com
\nCNBC.com<\/p>\n","protected":false},"author":689,"featured_media":174428,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"sfsi_plus_gutenberg_text_before_share":"","sfsi_plus_gutenberg_show_text_before_share":"","sfsi_plus_gutenberg_icon_type":"","sfsi_plus_gutenberg_icon_alignemt":"","sfsi_plus_gutenburg_max_per_row":"","_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":"","_ppma_block_editor_authors":""},"categories":[291,359],"tags":[],"ppma_author":[933],"class_list":["post-174408","post","type-post","status-publish","format-standard","has-post-thumbnail","category-alzheimers","category-fda","entry"],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\n\t\t