{"id":14480,"date":"2020-04-01T15:28:27","date_gmt":"2020-04-01T19:28:27","guid":{"rendered":"http:\/\/jimbovard.com\/blog\/?p=14480"},"modified":"2020-04-01T15:28:27","modified_gmt":"2020-04-01T19:28:27","slug":"its-time-to-track-the-fda-death-toll","status":"publish","type":"post","link":"https:\/\/jimbovard.com\/blog\/2020\/04\/01\/its-time-to-track-the-fda-death-toll\/","title":{"rendered":"It&#8217;s Time to Track the FDA Death Toll"},"content":{"rendered":"<h3>Mises Institute, April 1, 2020<\/h3>\n<h2 class=\"page-title\"><a href=\"https:\/\/mises.org\/wire\/its-time-track-fdas-death-toll\">It&#8217;s Time to Track the FDA&#8217;s Death Toll<\/a><a href=\"http:\/\/jimbovard.com\/blog\/wp-content\/uploads\/2014\/06\/Logo-Mises-Institute.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignright wp-image-7180 size-full\" src=\"http:\/\/jimbovard.com\/blog\/wp-content\/uploads\/2014\/06\/Logo-Mises-Institute.jpg\" alt=\"\" width=\"200\" height=\"100\" srcset=\"https:\/\/jimbovard.com\/blog\/wp-content\/uploads\/2014\/06\/Logo-Mises-Institute.jpg 200w, https:\/\/jimbovard.com\/blog\/wp-content\/uploads\/2014\/06\/Logo-Mises-Institute-150x75.jpg 150w\" sizes=\"auto, (max-width: 200px) 100vw, 200px\" \/><\/a><\/h2>\n<div id=\"slideshow\" class=\"group-image-wrapper field-group-html-element pull-left\">\n<div class=\"image border-secondary\">\n<div id=\"flexslider-1\" class=\"flexslider optionset-node-slideshow flexslider-processed\">\n<div class=\"flex-viewport\">\n<ul class=\"slides\">\n<li><a href=\"http:\/\/jimbovard.com\/blog\/wp-content\/uploads\/2020\/04\/fda-notapp1.png\"><img loading=\"lazy\" decoding=\"async\" class=\"alignleft wp-image-14481 size-full\" src=\"http:\/\/jimbovard.com\/blog\/wp-content\/uploads\/2020\/04\/fda-notapp1.png\" alt=\"\" width=\"240\" height=\"180\" srcset=\"https:\/\/jimbovard.com\/blog\/wp-content\/uploads\/2020\/04\/fda-notapp1.png 240w, https:\/\/jimbovard.com\/blog\/wp-content\/uploads\/2020\/04\/fda-notapp1-150x113.png 150w\" sizes=\"auto, (max-width: 240px) 100vw, 240px\" \/><\/a><span class=\"date\">by <\/span><span class=\"author\"><a href=\"https:\/\/mises.org\/profile\/james-bovard\" rel=\"author\">James Bovard<\/a><\/span><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"body-content clearfix\">\n<p>The Food and Drug Administration helped turn the coronavirus from a deadly peril into a national catastrophe. Long after foreign nations had been ravaged and many cases had been detected in America, the FDA continued blocking private testing. The FDA continued forcing the nation\u2019s most innovative firms to submit to its command-and-control approach\u00a0notwithstanding the pandemic. South Korean is in a far better situation dealing with coronavirus, because its government did not preemptively cripple private testing.<\/p>\n<p>One of the clearest lessons from the current pandemic is that nothing has changed at one of the nation\u2019s most powerful regulatory agencies. The FDA is repeating the same mistakes and showing the same arrogance that I chronicled decades ago in articles for the <em>Wall Street Journal<\/em>, the\u00a0<em>American Spectator<\/em>, and other publications.<\/p>\n<p>Dr. David Kessler, who became FDA commissioner in 1990, quickly sought to intimidate the companies that his agency regulates. A laudatory <em>Washington Post<\/em> article concluded, &#8220;What he cannot accomplish with ordinary regulation, Kessler hopes to accomplish with fear.&#8221; Kenneth Feather of the FDA&#8217;s drug advertising surveillance branch boasted: &#8220;We want to say to these companies that you don&#8217;t know when or how we&#8217;ll strike. We want to eliminate predictability.&#8221;<\/p>\n<p>Dr. Kessler&#8217;s heavy-handed tactics battered the American medical device industry\u2014one of the nation&#8217;s export superstars. An American Electronics Association survey found that &#8220;40% [of medical device companies] reduced the number of U.S. employees because of FDA delays, 29% increased their investment in foreign operations, and 22% moved U.S. jobs overseas.&#8221; The survey also found that &#8220;57% of the firms said the FDA had applied guidance instructions retroactively to some of their submissions,&#8221; as Biomedical Market Newsletter reported.<\/p>\n<p>The FDA&#8217;s stonewalling of new medical devices was sometimes politically motivated. A 1994 report by the Medical Device Manufacturers Association noted, &#8220;It is not unusual for [FDA] reviewers to express the position that excessive requests [for additional information] are made because of a concern or fear about how a particular member or members of Congress will react&#8221; to the approval of a new device. Sacrificing lives was a small price to pay for bureaucrats to avoid bothersome interrogatories from Capitol Hill.<\/p>\n<p>FDA employees also sowed fear with a deluge of official Warning Letters (up more than 300 percent\u00a0since Dr. Kessler took office) to private companies. Once the FDA issues a Warning Letter, it can seize a company&#8217;s products or get a court injunction to paralyze its operations. The FDA refused to establish clear guidelines or rules for issuing its letters. As a result, manufacturers could find themselves in a nightmare at the whim of a midlevel FDA employee.<\/p>\n<p>Dr. Kessler did not spare the First Amendment in his grab for power, and cancer patients and other seriously ill people suffered as a result. Doctors, hospitals,\u00a0and researchers often discover after FDA approval that a drug to treat one disease is also effective at treating other diseases. Drug companies have routinely publicized this news, alerting physicians to other possible ways to save lives. American Medical Association vice president Roy Schwarz estimated that &#8220;off-label&#8221; uses of drugs account for up to 60 percent\u00a0of all drugs prescribed.<\/p>\n<p>But in 1991\u00a0Dr. Kessler prohibited pharmaceutical companies from informing doctors of new uses for approved drugs. He announced that the FDA would enforce the ban with seizures, injunctions, and prosecutions. Though the agency never finalized its proposed regulations, it warned companies that they would face its wrath if they violated the draft proposals. Dr. Kessler, in a speech before the Drug Information Association, said: &#8220;I would urge all members of the pharmaceutical industry to take a long and hard look at their promotional practices. I do not expect companies to wait until this guidance becomes final to put their advertising and promotional houses in order.&#8221; The question of off-label treatments is becoming a key issue again as doctors search for effective treatments for the COVID-19 coronavirus.<\/p>\n<p>The FDA even suppressed medical textbooks as part of its attempt to restrict what Americans learned about new treatments. In 1992, the FDA cracked down on a company for distributing, for free, portions of <em>Cancer, Principles and\u00a0Practice of Oncology<\/em>.\u00a0In 1993, the FDA stopped a pharmaceutical company from distributing free copies of <em>The Chemotherapy Source Book<\/em>\u2014even though the company had already received FDA approval to give away thousands of copies. The FDA claimed that when a drug company gives doctors free textbooks that mention an off-label use of its products\u00a0the drugs become subject to seizure.<\/p>\n<p>Under Kessler, the FDA became far more restrictive in approving new drugs and medical devices. Stanford University professor Dale Geringer observed, &#8220;In terms of lives, it&#8217;s quite possible that the FDA bureaucracy could be killing on the order of three to four times as many people as it saves.&#8221; One study estimated that 150,000 heart attack victims may have lost their lives as a result of the FDA&#8217;s delays in approving the emergency blood-clotting drug TPA. National Cancer Institute officials accused the FDA of being &#8220;mired in a 1960&#8217;s philosophy of drug development, viewing all new agents as\u2026poisons.&#8221;<\/p>\n<p>Dr. Kessler bragged that his reforms had given FDA employees &#8220;a place where, once again, the good guys could win.&#8221; And how could Americans be sure that FDA enforcement agents were the good guys? Because they worked for the government.<\/p>\n<p>Dr. Kessler declared in 1992: &#8220;If members of our society were empowered to make their own decisions\u2026then the whole rationale for the [FDA] would cease to exist.&#8221; Kessler derided &#8220;freedom of choice&#8221; as an illusion unless people are presented only with\u00a0government-approved choices. But the FDA \u201cliberated\u201d people by shielding them from information, devices, and drugs that could have saved their lives.<\/p>\n<p>Many Americans could die in the coming weeks and months thanks to the FDA\u2019s blockade on coronavirus testing. Should we consider those victims as martyrs for the principle of bureaucratic supremacy? The FDA\u2019s current commissioner, Stephen Hahn, conceded last week: \u201cThere are always opportunities to learn from situations like this one.\u201d Perhaps the clearest lesson is that it is time to track the death toll of FDA regulatory debacles.<\/p>\n<\/div>\n<div class=\"view view-term-landing view-id-term_landing view-display-id-author_box audience author-box view-dom-id-60bd8b2927f50326482f376c65b556dd\">\n<div class=\"view-header\">Author:<\/div>\n<div class=\"view-content\">\n<div class=\"views-row views-row-1 views-row-odd views-row-first views-row-last\">\n<div class=\"ds-2col-custom-fluid column node node-person-profile view-mode-author_box  clearfix\">\n<div class=\"panel-body\">\n<div class=\"group-top col-xs-12\">\n<p class=\"author-box__name\"><a href=\"https:\/\/mises.org\/profile\/james-bovard\">James Bovard<\/a><\/p>\n<p>James Bovard is the author of ten books, including 2012\u2019s <em>Public Policy Hooligan<\/em>, and 2006\u2019s <em>Attention Deficit Democracy<\/em>. He has written for the <em>New York Times<\/em>, <em>Wall Street Journal<\/em>, <em>Playboy<\/em>, <em>Washington Post<\/em>, and many other publications.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Mises Institute, April 1, 2020 It&#8217;s Time to Track the FDA&#8217;s Death Toll by James Bovard The Food and Drug Administration helped turn the coronavirus from a deadly peril into a national catastrophe. Long after foreign nations had been ravaged and many cases had been detected in America, the FDA continued blocking private testing. The [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":14481,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[391,2310,2284,2311,2306,402,1959,2312,2308,2309,2307],"class_list":["post-14480","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","tag-censorship","tag-chemotherapy","tag-coronavirus","tag-dale-geringer","tag-david-kessler","tag-fda","tag-food-and-drug-administration","tag-heart-attacks","tag-medical-devices","tag-off-label-uses","tag-testing"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>It&#039;s Time to Track the FDA Death Toll - James Bovard<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/jimbovard.com\/blog\/2020\/04\/01\/its-time-to-track-the-fda-death-toll\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"It&#039;s Time to Track the FDA Death Toll - James Bovard\" \/>\n<meta property=\"og:description\" content=\"Mises Institute, April 1, 2020 It&#8217;s Time to Track the FDA&#8217;s Death Toll by James Bovard The Food and Drug Administration helped turn the coronavirus from a deadly peril into a national catastrophe. 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Bovard\u2019s writings have been publicly denounced by FBI director Louis Freeh, the Secretary of Agriculture, the Secretary of Housing and Urban Development, the Postmaster General, and the chiefs of the U.S. International Trade Commission, the Drug Enforcement Administration, the Equal Employment Opportunity Commission, and the Federal Emergency Management Agency, as well as by many congressmen and other malcontents.\",\"sameAs\":[\"http:\\\/\\\/www.jimbovard.com\",\"https:\\\/\\\/www.facebook.com\\\/jim.bovard\",\"https:\\\/\\\/x.com\\\/jimbovard\"],\"url\":\"https:\\\/\\\/jimbovard.com\\\/blog\\\/author\\\/admin\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"It's Time to Track the FDA Death Toll - James Bovard","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/jimbovard.com\/blog\/2020\/04\/01\/its-time-to-track-the-fda-death-toll\/","og_locale":"en_US","og_type":"article","og_title":"It's Time to Track the FDA Death Toll - James Bovard","og_description":"Mises Institute, April 1, 2020 It&#8217;s Time to Track the FDA&#8217;s Death Toll by James Bovard The Food and Drug Administration helped turn the coronavirus from a deadly peril into a national catastrophe. Long after foreign nations had been ravaged and many cases had been detected in America, the FDA continued blocking private testing. 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The Wall Street Journal called Bovard \"the roving inspector general of the modern state\" and Washington Post columnist George Will called him a \"one-man truth squad.\" His 1994 book, Lost Rights: The Destruction of American Liberty, received the Free Press Association\u2019s Mencken Award as Book of the Year. His Terrorism &amp; Tyranny won the Lysander Spooner \"Best Book on Liberty in 2003\" award. He received the Thomas Szasz Award for Civil Liberties work, awarded by the Center for Independent Thought and the Freedom Fund Award from the Firearms Civil Rights Defense Fund of the National Rifle Association. Bovard\u2019s writings have been publicly denounced by FBI director Louis Freeh, the Secretary of Agriculture, the Secretary of Housing and Urban Development, the Postmaster General, and the chiefs of the U.S. International Trade Commission, the Drug Enforcement Administration, the Equal Employment Opportunity Commission, and the Federal Emergency Management Agency, as well as by many congressmen and other malcontents.","sameAs":["http:\/\/www.jimbovard.com","https:\/\/www.facebook.com\/jim.bovard","https:\/\/x.com\/jimbovard"],"url":"https:\/\/jimbovard.com\/blog\/author\/admin\/"}]}},"_links":{"self":[{"href":"https:\/\/jimbovard.com\/blog\/wp-json\/wp\/v2\/posts\/14480","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jimbovard.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/jimbovard.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/jimbovard.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/jimbovard.com\/blog\/wp-json\/wp\/v2\/comments?post=14480"}],"version-history":[{"count":1,"href":"https:\/\/jimbovard.com\/blog\/wp-json\/wp\/v2\/posts\/14480\/revisions"}],"predecessor-version":[{"id":14482,"href":"https:\/\/jimbovard.com\/blog\/wp-json\/wp\/v2\/posts\/14480\/revisions\/14482"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/jimbovard.com\/blog\/wp-json\/wp\/v2\/media\/14481"}],"wp:attachment":[{"href":"https:\/\/jimbovard.com\/blog\/wp-json\/wp\/v2\/media?parent=14480"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/jimbovard.com\/blog\/wp-json\/wp\/v2\/categories?post=14480"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/jimbovard.com\/blog\/wp-json\/wp\/v2\/tags?post=14480"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}