Welcome to the New Drugwonks.com http://drugwonks.com/index DrugWonks.com | Debating Today's Drugs Policies en-us Thu, 06 Sep 2007 10:55:48 -0400 Sat, 03 Aug 2013 12:20:34 -0400 http://blogs.law.harvard.edu/tech/rss Psyclone WMS 4.4.9 info@drugwonks.com (drugwonks) cpernice@psycloneinc.com (Christopher Pernice) Clinton Campaign Considered Targeting FDA's Califf http://drugwonks.com/blog/clinton-campaign-considered-targeting-fda-s-califf Fri, 21 Oct 2016 14:45:21 -0400 http://drugwonks.com/blog/clinton-campaign-considered-targeting-fda-s-califf Insurance is Just Another Word For Nothing Left to Lose http://drugwonks.com/blog/insurance-is-just-another-word-for-nothing-left-to-lose Fri, 21 Oct 2016 13:18:36 -0400 http://drugwonks.com/blog/insurance-is-just-another-word-for-nothing-left-to-lose ​Limiting co-pay assistance is against medicine’s tradition of benevolence http://drugwonks.com/blog/limiting-co-pay-assistance-is-against-medicine-s-tradition-of-benevolence Fri, 14 Oct 2016 16:43:54 -0400 http://drugwonks.com/blog/limiting-co-pay-assistance-is-against-medicine-s-tradition-of-benevolence Insurers not covering new cancer treatments http://drugwonks.com/blog/insurers-not-covering-new-cancer-treatments Poor insurance coverage is causing cancer patients to miss out on cutting-edge technologies that use gene analysis to determine the best treatments — a fact a former commissioner of the Food and Drug Administration is calling another example of Obamacare’s failure to provide Americans with high-quality health care. Thu, 13 Oct 2016 13:49:31 -0400 http://drugwonks.com/blog/insurers-not-covering-new-cancer-treatments Anthem Health Covers Massages But Not New Drug For Muscular Dystrophy http://drugwonks.com/blog/anthem-health-pays-for-massages-but-not-new-drug-for-muscular-dystrophy Tue, 11 Oct 2016 14:20:10 -0400 http://drugwonks.com/blog/anthem-health-pays-for-massages-but-not-new-drug-for-muscular-dystrophy Artificial Intelligence and 21st Century Pharmacovigilance http://drugwonks.com/blog/artificial-intelligence-and-21st-century-pharmacovigilance Artificial intelligence has an unimaginable potential. Within the next couple of years, it will revolutionize every area of our life, including medicine — and pharmacovigilance. Usually, we make sense of the world around us with the help of rules and processes that build up a system. The world of Big Data is so huge that we will need artificial intelligence to be able to keep track of it. Thu, 06 Oct 2016 08:01:07 -0400 http://drugwonks.com/blog/artificial-intelligence-and-21st-century-pharmacovigilance Abuse Deterrent Opioids? Trick or Treat! http://drugwonks.com/blog/abuse-deterrent-opioids-trick-or-treat The FDA has announcing a public meeting to discuss scientific and technical issues relating to formulation development and pre-market evaluation of opioid drug products with abuse-deterrent properties Wed, 05 Oct 2016 09:47:49 -0400 http://drugwonks.com/blog/abuse-deterrent-opioids-trick-or-treat Amy's Army http://drugwonks.com/blog/amy-s-army Fri, 30 Sep 2016 14:36:52 -0400 http://drugwonks.com/blog/amy-s-army BMJ slings mud at FDA -- for shame! http://drugwonks.com/blog/bmj-slings-mud-at-fda-for-shame Any former FDAer who tried to inappropriately influence an agency decision on behalf of a client would become persona non grata – and rightly so. What the authors seem not to understand is that there’s a world of difference between expert navigation and conflicts of interest. Wed, 28 Sep 2016 20:56:28 -0400 http://drugwonks.com/blog/bmj-slings-mud-at-fda-for-shame Will Mylan CEO School Congress On Rigged Drug Pricing System? http://drugwonks.com/blog/will-mylan-ceo-school-congress-on-rigged-drug-pricing-system Wed, 21 Sep 2016 08:44:26 -0400 http://drugwonks.com/blog/will-mylan-ceo-school-congress-on-rigged-drug-pricing-system FDA's Woodcock Sends Patients Strong Message With Exondys 51 Approval http://drugwonks.com/blog/fda-s-woodcock-sends-patients-strong-message-with-exondys-51-approval Mon, 19 Sep 2016 13:19:05 -0400 http://drugwonks.com/blog/fda-s-woodcock-sends-patients-strong-message-with-exondys-51-approval Sarepta and the Value of Adaptive Clinical Trials http://drugwonks.com/blog/sarepta-and-the-value-of-adaptive-clinical-trials Here’s a new op-ed from the Cleveland Plain Dealer. It speaks directly to today’s FDA approval of Sarepta. Consider what the editor chose to add to my attribution at the bottom of the article:\, “Peter J. Pitts, a former FDA associate commissioner, is the president and co-founder of the Center for Medicine in the Public Interest. CMPI receives some funding from biopharmaceutical firms, which could benefit from adaptive trials.” I suggested that he also add that adaptive trials benefit patients. He declined. I wonder what the parents of children with Duchenne muscular dystrophy would say? Mon, 19 Sep 2016 12:28:04 -0400 http://drugwonks.com/blog/sarepta-and-the-value-of-adaptive-clinical-trials When is access not access? http://drugwonks.com/blog/when-is-access-not-access Further proof that having access to health insurance isn't the same thing as getting access to the healthcare you need. Sat, 17 Sep 2016 20:52:53 -0400 http://drugwonks.com/blog/when-is-access-not-access Amundsen turns frosty on biosimilars http://drugwonks.com/blog/amundsen-turns-frosty-on-biosimilars When it comes to biosimilars, where is True North? An interesting new paper on the value of biosimilars from the folks at Amundsen Consulting. The paper is appropriately titled, “Who Saves?” The answer isn’t what patients want to hear. Fri, 16 Sep 2016 14:26:31 -0400 http://drugwonks.com/blog/amundsen-turns-frosty-on-biosimilars UN Panel Proposes To Stifle Medical Progress http://drugwonks.com/blog/un-panel-proposes-to-stifle-medical-progress Thu, 15 Sep 2016 13:51:07 -0400 http://drugwonks.com/blog/un-panel-proposes-to-stifle-medical-progress Forrest Gump for UN Secretary-General http://drugwonks.com/blog/forrest-gump-for-un-secretary-general Just when you thought it was impossible for the United Nations to be less relevant comes The Report of the United Nations Secretary-General’s High-Level Panel on Access to Medicines. What’s the UN’s answer to broader access to medicines? Doing away with patents. Disregarding intellectual property. Compulsory Licensing. A triple-play of nonsense and unintended consequences. But we’ve heard it all before. Wed, 14 Sep 2016 15:49:25 -0400 http://drugwonks.com/blog/forrest-gump-for-un-secretary-general Allergan's Social Contract: Replace Rebates With Increased Patient Protection From Drug Prices http://drugwonks.com/blog/allergan-s-social-contract-replace-rebates-with-increased-patient-assistance Thu, 08 Sep 2016 13:41:15 -0400 http://drugwonks.com/blog/allergan-s-social-contract-replace-rebates-with-increased-patient-assistance FDA's Seven Year Itch http://drugwonks.com/blog/fda-s-seven-year-itch Almost seven years to the day of the FDA's November 2009 two-day Part 15 hearing on social media, a new Part 15 meeting on off-label communications, Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing Wed, 31 Aug 2016 20:05:18 -0400 http://drugwonks.com/blog/fda-s-seven-year-itch ICERs Sins of Omission http://drugwonks.com/blog/icers-sins-of-omission Tue, 30 Aug 2016 17:47:28 -0400 http://drugwonks.com/blog/icers-sins-of-omission JAMA's Pizza Principle http://drugwonks.com/blog/jama-s-pizza-principle Drug firms have discovered a powerful new mind-control technology that threatens to topple our healthcare system: a free slice of pizza. That’s the implication — but not the actual findings — of a new study in JAMA Internal Medicine. Tue, 30 Aug 2016 12:55:56 -0400 http://drugwonks.com/blog/jama-s-pizza-principle