{"id":37556,"date":"2021-07-12T18:32:28","date_gmt":"2021-07-13T01:32:28","guid":{"rendered":"https:\/\/lapost.us\/?p=37556"},"modified":"2021-07-12T18:32:28","modified_gmt":"2021-07-13T01:32:28","slug":"house-panels-press-biogen-for-documents-on-controversial-alzheimers-drug","status":"publish","type":"post","link":"https:\/\/lapost.us\/?p=37556","title":{"rendered":"House panels press Biogen for documents on controversial Alzheimer&#8217;s drug"},"content":{"rendered":"<p>&nbsp;<\/p>\n<p>Two House committees on Monday requested a slew of documents from the pharmaceutical company Biogen as part of an investigation into the controversial approval of its Alzheimer&#8217;s treatment.<\/p>\n<p>House Energy and Commerce Committee Chairman Frank Pallone Jr. (D-N.J.) and House Oversight Committee Chairwoman Carolyn Maloney (D-N.Y.) wrote to Biogen CEO Michel Vounatsos on Monday requesting the documents concerning the Alzheimer&#8217;s drug, Aduhelm.<\/p>\n<p>\u201cWe are concerned by reports of an atypical approval process for Aduhelm amid significant questions about the drug\u2019s clinical benefit, and the steep $56,000 annual price tag, which will have serious implications for seniors, federal health care programs, and future Alzheimer\u2019s research,&#8221; the lawmakers wrote.<\/p>\n<p>The letter points to\u00a0<a href=\"https:\/\/click1.email.thehill.com\/rljwyhjflccpshscpkgllpwwljpbcjcqqvlfhtbcrnjctl_immymmvhvwydhdyvgmdm.html?a=&amp;b=40637\" target=\"_blank\" rel=\"noopener\" data-saferedirecturl=\"https:\/\/www.google.com\/url?q=https:\/\/click1.email.thehill.com\/rljwyhjflccpshscpkgllpwwljpbcjcqqvlfhtbcrnjctl_immymmvhvwydhdyvgmdm.html?a%3D%26b%3D40637&amp;source=gmail&amp;ust=1626221844973000&amp;usg=AFQjCNEpwIavg9DHpkJ82oZbnWG2yHxAWA\">reporting from Stat<\/a>\u00a0finding that Biogen engaged in &#8220;a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm.&#8221;<\/p>\n<p>Among the documents requested are documents relating to Project Onyx and records of all calls and meetings between Biogen and Food and Drug Administration officials related to the drug.<\/p>\n<p><strong>Background:\u00a0<\/strong>The congressional letter is the latest turn in the controversy surrounding the FDA&#8217;s approval of the drug, both over the price and whether the evidence on its effectiveness justified approving it.<\/p>\n<p>Acting FDA Commissioner Janet Woodcock last week requested an inspector general investigation as well.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; Two House committees on Monday&#46;&#46;&#46;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[16],"tags":[],"class_list":["post-37556","post","type-post","status-publish","format-standard","hentry","category-health"],"_links":{"self":[{"href":"https:\/\/lapost.us\/index.php?rest_route=\/wp\/v2\/posts\/37556","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lapost.us\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lapost.us\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lapost.us\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/lapost.us\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=37556"}],"version-history":[{"count":1,"href":"https:\/\/lapost.us\/index.php?rest_route=\/wp\/v2\/posts\/37556\/revisions"}],"predecessor-version":[{"id":37557,"href":"https:\/\/lapost.us\/index.php?rest_route=\/wp\/v2\/posts\/37556\/revisions\/37557"}],"wp:attachment":[{"href":"https:\/\/lapost.us\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=37556"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lapost.us\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=37556"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lapost.us\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=37556"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}