{"id":1791394,"date":"2022-12-31T10:20:45","date_gmt":"2022-12-31T15:20:45","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=1791394"},"modified":"2022-12-31T14:56:16","modified_gmt":"2022-12-31T19:56:16","slug":"latest-fda-scandal-further-proves-why-we-cant-trust-them","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/latest-fda-scandal-further-proves-why-we-cant-trust-them\/","title":{"rendered":"Latest FDA Scandal Further Proves Why We Can\u2019t Trust Them"},"content":{"rendered":"<aside class=\"mashsb-container mashsb-main mashsb-stretched\"><div class=\"mashsb-box\"><div class=\"mashsb-count mash-medium\" style=\"&quot;\"><div class=\"counts mashsbcount\">20<\/div><span class=\"mashsb-sharetext\">SHARES<\/span><\/div><div class=\"mashsb-buttons\"><a class=\"mashicon-facebook mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fwww.conservativenewsdaily.net%2Fbreaking-news%2Flatest-fda-scandal-further-proves-why-we-cant-trust-them%2F\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Facebook<\/span><\/a><a class=\"mashicon-twitter mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/twitter.com\/intent\/tweet?text=&amp;url=https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=1791394&amp;via=ConservNewsDly\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Twitter<\/span><\/a><a class=\"mashicon-subscribe mash-medium mash-nomargin mashsb-noshadow\" href=\"#\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Subscribe<\/span><\/a><div class=\"onoffswitch2 mash-medium mashsb-noshadow\" style=\"display:none\"><\/div><\/div>\n            <\/div>\n                <div style=\"clear:both\"><\/div><\/aside>\n            <!-- Share buttons by mashshare.net - Version: 4.0.47--><div><img decoding=\"async\" class=\"ff-og-image-inserted\" style=\"display: none;\" src=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2022\/12\/ed01a1ad-94e1-48e9-b739-435103efa267-1110x740-1.jpg\" alt=\"image\" \/><\/div>\n<p>I take many pharmaceutical medications. Heart problems, cholesterol, and other maladies. Both my doctors and FDA are reliable in ensuring that these medications are safe and effective.<\/p>\n<p>Of course I know that the process is imperfect, the evidence for safety and effectiveness is sometimes sketchy, and I have even dropped using some of the drugs because I don\u2019t believe the benefits are worth the cost. I have read most of the disclosures and even looked at studies. \u201cproved\u201d The effectiveness of newer drugs.<\/p>\n<p>In other words, I don\u2019t blindly trust the process, but my cynicism is not unbounded. There are miracle drugs that can save lives or improve them, and I don&#8217;t hate pharmaceutical companies. They truly do save lives. Although they may be profitable, they provide great social benefits and make peanuts. \u00a0Apple alone was able to make 3x more profits than the entire pharmaceutical industry.<\/p>\n<p>But the FDA\u2019s process is sketchy and getting more politicized, or at the very least more obviously so. And the example of how Biogen\u2019s Alzheimer\u2019s drug Aduhelm has gone through the approval process proves it.<\/p>\n<p>Alzheimer\u2019s is a terrible disease. It takes away a person&#8217;s personality and ultimately their humanity. It can cause people to become shells of their former selves, even the most intelligent and vibrant. So it is an important priority to discover how to treat it. While scientists have many theories as to why the disease is declining, they are still unable to diagnose or explain the cause. The disease burden is rising with increasing aging in Western societies.<\/p>\n<p>Biogen claims they have a drug to slow down the process. The problem is that if it does anything at all, and that is in question, it doesn\u2019t do much. Yet the FDA not only approved it despite Biogen\u2019s own studies indicating that it didn\u2019t work, it did so over the objections of its independent advisory committee.<\/p>\n<p>The committee\u2019s objections were so strong that 3 of the members resigned in disgust. An <a href=\"https:\/\/www.cnn.com\/2022\/12\/29\/health\/biogen-aduhelm-alzheimers-drug-investigation\/index.html\" target=\"_blank\" rel=\"noopener\">18 month Congressional investigation found startling irregularities in the process of approving the drug<\/a>.<\/p>\n<blockquote>\n<p class=\"paragraph inline-placeholder\" data-uri=\"archive.cms.cnn.com\/_components\/paragraph\/instances\/paragraph_0B81E512-692C-7E89-1878-5F46693D33EE@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-analytics-observe=\"off\">The Committee on Oversight and Reform and Committee on Energy and Commerce both found that collaboration between Biogen and FDA was essential in the drug approval process. \u201cexceeded the norm in some respects.\u201d<\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"archive.cms.cnn.com\/_components\/paragraph\/instances\/paragraph_6A71E1E6-2CD8-5ABF-C2B2-5F709EBB52E5@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-analytics-observe=\"off\">Biogen had initially discontinued Aduhelm\u2019s clinical trials in\u00a0<a href=\"https:\/\/investors.biogen.com\/news-releases\/news-release-details\/biogen-and-eisai-discontinue-phase-3-engage-and-emerge-trials\" target=\"_blank\" rel=\"noopener\">March 2019<\/a>\u00a0after an independent committee found that it probably would not slow the cognitive and functional impairment \u2013 the decline in memory, language and judgment \u2013 that comes with Alzheimer\u2019s. However, in June 2019, Biogen and FDA began to work together. \u201cworking group\u201d To see if it could be saved.<\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"archive.cms.cnn.com\/_components\/paragraph\/instances\/paragraph_ECCA5190-64BD-D515-A50D-5FC15580F61E@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-analytics-observe=\"off\">The investigation found that the FDA and Biogen engaged in at least 115 meetings, calls and substantive email discussions from July 2019 to July 2020, including 40 meetings to guide Aduhelm\u2019s potential approval. The committees believe there were more meetings than that, but the FDA did not follow its own documentation protocol.<\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"archive.cms.cnn.com\/_components\/paragraph\/instances\/paragraph_D0D502C0-E2AB-02BB-4BF3-5F7F5902BFAE@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-analytics-observe=\"off\">Biogen collaborated with the agency to create a document that would be used to brief an independent advisory panel, which met in\u00a0<a href=\"https:\/\/www.fda.gov\/advisory-committees\/advisory-committee-calendar\/november-6-2020-meeting-peripheral-and-central-nervous-system-drugs-advisory-committee-meeting#event-information\" target=\"_blank\" rel=\"noopener\">November 2020<\/a>. Results from the trials were mixed. Only one showed a slight benefit to patients.<\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"archive.cms.cnn.com\/_components\/paragraph\/instances\/paragraph_3D13E94E-F966-63F0-62CD-5FAFCF8C5079@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-analytics-observe=\"off\">None of the participants were able to attend that meeting.\u00a0<a href=\"https:\/\/www.fda.gov\/media\/145691\/download\" target=\"_blank\" rel=\"noopener\">committee\u2019s members voted<\/a>\u00a0to say that the studies presented strong evidence that the drug was effective at treating Alzheimer\u2019s.<\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"archive.cms.cnn.com\/_components\/paragraph\/instances\/paragraph_75C68C03-536B-9FE4-B99E-5F9FB4C97176@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-analytics-observe=\"off\">According to a former FDA adviser, the meeting was not common. He had served on the committee for many years. Dr. Aaron Kesselheim\u00a0<a href=\"https:\/\/www.cnn.com\/2021\/09\/26\/politics\/alzheimers-drug-aduhelm-fda-approval\/index.html\" target=\"_blank\" rel=\"noopener\">told CNN in 2021<\/a>\u00a0It was unusual for the FDA to have a relationship with the company.<\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"archive.cms.cnn.com\/_components\/paragraph\/instances\/paragraph_80942559-A88D-C349-6221-5FA2B42E8297@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-analytics-observe=\"off\">\u201cThere was a strange dynamic compared to the other advisory committee meetings I\u2019ve attended,\u201d Harvard Medical School&#8217;s professor stated this. \u201cUsually, there\u2019s some distance between the FDA and the company, but on this one, the company and the FDA were fully in line with each other in support of the drug.\u201d<\/p>\n<\/blockquote>\n<p data-uri=\"archive.cms.cnn.com\/_components\/paragraph\/instances\/paragraph_80942559-A88D-C349-6221-5FA2B42E8297@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-analytics-observe=\"off\">All this effort was put into ensuring the approval of a drug that the company almost abandoned due to the initial failure of the clinical trials\u2013trials that had been halted due to the failure of the drug to show any benefit. They were able to obtain FDA approval only after statistical analysis revealed some modest benefits. Despite the sketchy results, the FDA worked tirelessly to get approval.<\/p>\n<p data-uri=\"archive.cms.cnn.com\/_components\/paragraph\/instances\/paragraph_80942559-A88D-C349-6221-5FA2B42E8297@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-analytics-observe=\"off\">There was huge money involved.<\/p>\n<blockquote>\n<p class=\"paragraph inline-placeholder\" data-uri=\"archive.cms.cnn.com\/_components\/paragraph\/instances\/paragraph_814B1375-7278-8E40-9055-5F44CFBDBD67@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-analytics-observe=\"off\">The investigation found that Biogen planned an aggressive marketing campaign to launch the drug, intending to spend more than $3.3 billion on sales and marketing between 2020 and 2024 \u2013 more than 2\u00bd times what it spent to develop Aduhelm.<\/p>\n<div class=\"related-content related-content--article\" data-uri=\"archive.cms.cnn.com\/_components\/related-content\/instances\/related-content-h_ba5224340db17167362f19b0f4188ea4-h_07bf6818029933742cf20c574577ad9e@published\" data-analytics-observe=\"off\">\n<p class=\"related-content__headline\"><span class=\"related-content__headline-text\">Aduhelm is a key driver of Medicare premiums. It costs $56,000 per annum.<\/span><\/p>\n<\/div>\n<p class=\"paragraph inline-placeholder\" data-uri=\"archive.cms.cnn.com\/_components\/paragraph\/instances\/paragraph_EE19C86D-8EE1-8A71-3A9F-5FC218B9C0DF@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-analytics-observe=\"off\">Dementia, including Alzheimer\u2019s, is one of the \u201ccostliest conditions to society,\u201d according to the Alzheimer\u2019s Association. In 2022 alone, Alzheimer\u2019s and other dementias cost the US $321 billion, including $206 billion in Medicaid and Medicare payments, the association says.<\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"archive.cms.cnn.com\/_components\/paragraph\/instances\/paragraph_90C0F36F-9842-233D-8315-5F96A094408F@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-analytics-observe=\"off\">Aduhelm\u2019s cost to patients and to Medicare would be significant, the new report says. It was one the major factors behind a\u00a0<a href=\"https:\/\/www.cnn.com\/2021\/11\/12\/health\/medicare-premium-hike\/index.html\" target=\"_blank\" rel=\"noopener\">big increase<\/a>\u00a0The report shows that Medicare premiums will rise to $202 in 2022 according to the\u00a0<a href=\"https:\/\/www.cnn.com\/2021\/11\/16\/politics\/aduhelm-alzheimer-medicare-increase\/index.html\" target=\"_blank\" rel=\"noopener\">Centers for Medicare and Medicaid Services<\/a>.<\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"archive.cms.cnn.com\/_components\/paragraph\/instances\/paragraph_95BB1FB1-D92B-F9F8-FFFE-5FA84A20ACD0@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-analytics-observe=\"off\">In anticipation \u201cpushback\u201d The report states that both payers as well as providers provided feedback. Biogen also wrote a narrative to help them sell the drug&#8217;s worth.<\/p>\n<\/blockquote>\n<p>The fact that Biogen wanted to make big bucks isn\u2019t a surprise. That is the company\u2019s job. And it is hardly surprising that they would hype the product\u2013that is what businesses do. It is the FDA\u2019s job to ensure that the pecuniary motives of the company aren\u2019t in conflict with the benefits to patients and society, and they clearly failed in this case. The drug&#8217;s safety and effectiveness were questionable. The independent panel also knew this. It was the FDA bureaucracy\u2013a creature of government\u2013that made the final decision.<\/p>\n<blockquote>\n<p class=\"paragraph inline-placeholder\" data-uri=\"archive.cms.cnn.com\/_components\/paragraph\/instances\/paragraph_918B8C8F-B283-F603-C907-5FC09A24B994@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-analytics-observe=\"off\">The FDA also approved this drug \u201cpeople with Alzheimer\u2019s disease,\u201d a far broader population than was studied in Biogen\u2019s clinical trials.<\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"archive.cms.cnn.com\/_components\/paragraph\/instances\/paragraph_4F282774-268E-CFAF-ADB6-5F3FA07C9B67@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-analytics-observe=\"off\"><strong>According to company documents, Biogen had accepted the broader indication. \u201cdespite internal reservations about the lack of evidence of clinical benefit for patients at disease stages outside of the clinical trials and an unknown safety profile,\u201d According to the report. Leaders were worried that the company would lose credibility. The company devised a communications strategy for dealing with this. \u201canticipated fallout,\u201d According to the report.<\/strong><\/p>\n<\/blockquote>\n<p data-uri=\"archive.cms.cnn.com\/_components\/paragraph\/instances\/paragraph_4F282774-268E-CFAF-ADB6-5F3FA07C9B67@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-analytics-observe=\"off\">This isn\u2019t just a story about the approval of one drug. Even in the best systems, processes can fail. However, a failure of this magnitude and obvious merited a congressional investigation. Other cases show government officials pushing drugs with questionable merit.<\/p>\n<p data-uri=\"archive.cms.cnn.com\/_components\/paragraph\/instances\/paragraph_4F282774-268E-CFAF-ADB6-5F3FA07C9B67@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-analytics-observe=\"off\">Vinay Prasad has been warning about the CDC and White House pushing Paxlovid to treat COVID. There is little evidence of its effectiveness and it doesn&#8217;t work for those who have been vaccinated. Paxlovid is the reason for all those instances of government officials who have been vaccinated and then get COVID again. The drug is not effective in shortening the time it takes for the disease to progress in some cases. The government insists on it.<\/p>\n<p data-uri=\"archive.cms.cnn.com\/_components\/paragraph\/instances\/paragraph_4F282774-268E-CFAF-ADB6-5F3FA07C9B67@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-analytics-observe=\"off\">Maybe because they bought tons of it before clinical trials were complete?<\/p>\n<blockquote class=\"twitter-tweet\" data-width=\"550\" data-dnt=\"true\">\n<p dir=\"ltr\" lang=\"en\">Do you want Paxlovid and a Biden white house?<br \/>\nThe product was purchased BEFORE the trial results were available<br \/>\nTrial results are not yet available for vaccine-eligible people. However, Biden administration continues to push relentlessly for the drug&#8217;s distribution<br \/>\nWho would ever do that with public money? <a href=\"https:\/\/t.co\/sLxtbdF2T9\" target=\"_blank\" rel=\"noopener\">https:\/\/t.co\/sLxtbdF2T9<\/a><\/p>\n<p>\u2014 Vinay Prasad MD MPH (@VPrasadMDMPH) <a href=\"https:\/\/twitter.com\/VPrasadMDMPH\/status\/1608529774162464772?ref_src=twsrc%5Etfw\" target=\"_blank\" rel=\"noopener\">December 29, 2022<\/a><\/p>\n<p>https:\/\/twitter.com\/VPrasadMDMPH\/status\/1608529774162464772?ref_src=twsrc%5Etfw<\/p><\/blockquote>\n<p>Prasad also raised the question as to why the FDA, CDC and the public health establishment have refused to conduct randomized controlled trials on COVID. The government is still uninterested in whether masks really work three years into the pandemic. \u201ctrials\u201d have\u00a0been extremely weak observational studies rather than RCTs. This pattern is based on the absurd assertion that RCTs would be unethical since, should masks fail, those unmasked would have been exposed unnecessarily to greater risk.<\/p>\n<p>It is absurd on the surface. It would be difficult to find volunteers to perform these studies unmasked. They have also done RCTs for much more dangerous tests. Every RCT that involves a medical device poses greater risks for patients.<\/p>\n<blockquote class=\"twitter-tweet\" data-width=\"550\" data-dnt=\"true\">\n<p dir=\"ltr\" lang=\"en\">This is huge news!<br \/>\nCluster RCT required for masks<br \/>\nPublic debate required on lockdowns<br \/>\nBoosters require RCT<br \/>\nThe presence of vax in patients with COVID is not supported<br \/>\nDialog was needed, but it was cut off.<br \/>\nMSM thinks this doesn&#8217;t matter\u2013 that is sad, and reflects their blind spot <a href=\"https:\/\/t.co\/rqGEWMPA2l\" target=\"_blank\" rel=\"noopener\">https:\/\/t.co\/rqGEWMPA2l<\/a><\/p>\n<p>\u2014 Vinay Prasad MD MPH (@VPrasadMDMPH) <a href=\"https:\/\/twitter.com\/VPrasadMDMPH\/status\/1608654334191104001?ref_src=twsrc%5Etfw\" target=\"_blank\" rel=\"noopener\">December 30, 2022<\/a><\/p>\n<p>https:\/\/twitter.com\/VPrasadMDMPH\/status\/1608654334191104001?ref_src=twsrc%5Etfw<\/p><\/blockquote>\n<p>These examples highlight a serious problem: the need to be committed to achieving pre-determined results regardless if there is evidence. It doesn&#8217;t matter if there is weak or insufficient evidence to get the desired result.<\/p>\n<p>Why? Although we can only speculate, it is likely that money is involved. It\u2019s hard to imagine another motive. There is an alternative. <a href=\"https:\/\/www.science.org\/content\/article\/fda-s-revolving-door-companies-often-hire-agency-staffers-who-managed-their-successful\" target=\"_blank\" rel=\"noopener\">revolving door<\/a>\u00a0Linking FDA bureaucrats and the companies they regulate can lead to lucrative jobs in the future.<\/p>\n<p>This is not surprising. People are motivated by money for obvious reasons. Be careful, though. Trust is the cornerstone of Western societies. The success of Western societies rests on trust. A reasonably good judicial and business system and an ethical government are just a few examples. It has never been perfect because\u2026human beings\u2026but compared to most places in the world where a bribe gets results, we have been blessed with relatively less corruption.<\/p>\n<p>Nearly every outcome in many countries is determined by bribes and personal loyalty. Here we can generally expect that people will do their jobs, and actually punish people who don\u2019t. We don\u2019t generally bribe police officers to get out of tickets, and we aren\u2019t generally pulled over in order to pay for a nice dinner for the cop. That\u2019s not true most places.<\/p>\n<p>People in positions of power or responsibility are expected to be accountable.<\/p>\n<p>The trust system is on the verge of collapse, which will cause social breakdown. All bets are off if our government becomes a protection racket.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>I take many pharmaceutical medications. Heart problems, cholesterol, and other maladies. Both my doctors and FDA are reliable in ensuring that these medications are safe and effective. Of course I know that the process is imperfect, the evidence for safety and effectiveness is sometimes sketchy, and I have even dropped using some of the drugs &hellip;<\/p>\n","protected":false},"author":1,"featured_media":1896428,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_mo_disable_npp":"","fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","fifu_image_alt":"Latest FDA Scandal Further Proves Why We Can\u2019t Trust Them","footnotes":""},"categories":[547],"tags":[5458,3680,8468,6455,3819,4633,6521],"class_list":["post-1791394","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-the-bongino-report","tag-bongino","tag-cant","tag-fda","tag-proves","tag-report","tag-scandal","tag-trust"],"fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","fifu_image_alt":"Latest FDA Scandal Further Proves Why We Can\u2019t Trust Them","_links":{"self":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/1791394","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=1791394"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/1791394\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/1896428"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=1791394"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=1791394"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=1791394"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}