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) 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 Today's Mylan Moment: Drug Prices Are Rigged By PBMs and Insurers http://drugwonks.com/blog/today-s-mylan-moment-drug-prices-are-rigged-by-pbms-and-insurers Mon, 29 Aug 2016 12:07:49 -0400 http://drugwonks.com/blog/today-s-mylan-moment-drug-prices-are-rigged-by-pbms-and-insurers Bee Smart About Drug Pricing http://drugwonks.com/blog/bee-smart-about-drug-pricing Republican voters hate Obamacare, but they hate high prescription drug prices even more. Health care scholar Avik Roy recently pointed to the polls as a reason the GOP must develop a “clear plan to tackle the high and rising price of branded prescription drugs.” He proposed a number of measures aimed at reining in supposedly greedy pharmaceutical firms. But Roy, like many others who have weighed in on the cost of medicines, overlooks two key points. First, the very real financial pain many Americans feel at the pharmacy counter is the fault of insurers – not drug companies. Second, the obsessive focus on cost obscures the vastly higher value of new drugs. Mon, 29 Aug 2016 11:13:34 -0400 http://drugwonks.com/blog/bee-smart-about-drug-pricing EpiPen 'Outrage' Update http://drugwonks.com/blog/epipen-outrage-update Thu, 25 Aug 2016 14:33:51 -0400 http://drugwonks.com/blog/epipen-outrage-update Why Is The Media Sticking It to the EpiPen http://drugwonks.com/blog/why-is-the-media-sticking-it-to-the-epipen Once again the Big Pharma narrative trumps truth Wed, 24 Aug 2016 16:08:26 -0400 http://drugwonks.com/blog/why-is-the-media-sticking-it-to-the-epipen Mylan's "Perfect Storm of Stupidity" http://drugwonks.com/blog/mylan-s-perfect-storm-of-stupidity It’s as though Turingfreude never made it to Mylan HQ. Dramatically raising prices on Epipen during a political cycle? Really? That’s the new dictionary definition of (among other things) being tone deaf. And to make matters even worse, the head honcho at Mylan, Heather Bresch is the daughter of US Senator Joe Manchin (D, WVA). That’s gotta be embarrassing. Wed, 24 Aug 2016 15:53:58 -0400 http://drugwonks.com/blog/mylan-s-perfect-storm-of-stupidity If you’re taking a biologic, you’ve got a friend in Pennsylvania http://drugwonks.com/blog/if-you-re-taking-a-biologic-you-ve-got-a-friend-in-pennsylvania When it comes to protecting and advancing the public health, some states are leaders, others laggards. Consider biosimiars. On July 20, Pennsylvania Governor Tom Wolf signed into law Senate Bill 514, which allows pharmacists to substitute for a brand name biological product a less expensive biosimilar product that has been deemed interchangeable by the FDA. Pennsylvania is the twenty third state to enact such a law. Wed, 17 Aug 2016 11:06:24 -0400 http://drugwonks.com/blog/if-you-re-taking-a-biologic-you-ve-got-a-friend-in-pennsylvania Embracing Satan's PDUFA http://drugwonks.com/blog/satan-s-pdufa Yesterday’s public meeting on the FDA’s PDUFA VI Commitment Letter was a love-fest (mostly) – but as Theresa Mullin, Director of CDER’s Office of Strategic Programs, wisely noted, “the devil is in the details. Indeed. Tue, 16 Aug 2016 08:23:21 -0400 http://drugwonks.com/blog/satan-s-pdufa Why ICER Can't Be Trusted http://drugwonks.com/blog/why-icer-can-t-be-trusted ICER generates mythical facts and hides the truth about drug spending Mon, 15 Aug 2016 11:59:06 -0400 http://drugwonks.com/blog/why-icer-can-t-be-trusted Bayer exonerated per Essure. Where's the MSM coverage? http://drugwonks.com/blog/bayer-exonerated-per-essure-where-s-the-msm-coverage A federal judge in White Plains has dismissed 1,225 lawsuits against Bayer Healthcare Pharmaceuticals that were filed by women who claimed that the company’s contraceptive device injured them. Fri, 12 Aug 2016 14:13:00 -0400 http://drugwonks.com/blog/bayer-exonerated-per-essure-where-s-the-msm-coverage