{"id":42105,"date":"2014-03-06T09:58:12","date_gmt":"2014-03-06T14:58:12","guid":{"rendered":"https:\/\/www.bu.edu\/sph\/?p=42105"},"modified":"2020-09-17T10:30:31","modified_gmt":"2020-09-17T14:30:31","slug":"shine-lecturer-sidney-wolfe-fdas-drug-review-process-is-broken","status":"publish","type":"bu-article","link":"https:\/\/www.bu.edu\/sph\/news\/articles\/2014\/shine-lecturer-sidney-wolfe-fdas-drug-review-process-is-broken\/","title":{"rendered":"Shine Lecturer Sidney Wolfe: FDA\u2019s Drug Review Process is Broken"},"content":{"rendered":"\n
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March 6, 2014<\/div>\n\t\t\n\t\t\t\t
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When he turned 75 a few years ago, Dr. Sidney Wolfe\u2019s daughter and son-in-law presented him with a doll custom-made to look like him, with a button on it that played one sentence, over and over:<\/p>\n

\u201cIt\u2019s an outrage!\u201d<\/p>\n

\"Dr.<\/a>
Dr. Sidney Wolfe emphasizes a point during the 2014 Shine Lecture.<\/figcaption><\/figure>\n

On Wednesday, as he delivered the 2014 Cathy Shine Lecture at the BU School of Public Health, Wolfe credited his sense of outrage with keeping him going for more than 40 years as head of the Public Citizen Health Research Group, which works to highlight lapses in oversight by the Food and Drug Administration and physician oversight boards.<\/p>\n

Wolfe said lapses in the FDA\u2019s drug approval process are worse than ever now, as pharmaceutical companies exert increasing influence over medical care. He noted that the U.S. is one of only two countries that allow direct-to-consumer drug advertising.<\/p>\n

\u201cCompanies have extracted lots of concessions from the FDA, like faster approval times — or, if there\u2019s a safety problem, \u2018let\u2019s study it after (we approve it),\u2019\u201d Wolfe said.<\/p>\n

He argued that direct advertising by drug companies has done \u201can enormous amount of damage\u201d to physicians\u2019 prescribing practices and patients\u2019 reliance on questionable medications.<\/p>\n

In a talk entitled, \u201cDo Government Agencies Protect Patients?\u201d Wolfe described his organization\u2019s battles to convince the FDA to withdraw unsafe drugs from the market. It took the Public Citizen Health Research Group, which he co-founded with consumer activist Ralph Nader, 32 years to convince the FDA to ban the painkiller Darvon, which was found to be dangerous to the heart. Now, the group is working to get a black box warning added to testosterone-containing drugs, after a recent study found an increased risk of heart attack in men who took the drugs.<\/p>\n