Welcome to the New Drugwonks.com http://drugwonks.com/index DrugWonks.com | Debating Today's Drugs Policies en-us Thu, 06 Sep 2007 09:55:48 -0500 Sat, 03 Aug 2013 11:20:34 -0500 http://blogs.law.harvard.edu/tech/rss Psyclone WMS 4.4.9 info@drugwonks.com (drugwonks) cpernice@psycloneinc.com (Christopher Pernice) Obama's Precision Medicine Proposal: Guess Who Hates It? http://drugwonks.com/blog/health-plans-vs-obama-s-precision-medicine-proposal What good is personalized medicine if people can't use them? Fri, 23 Jan 2015 13:28:06 -0600 http://drugwonks.com/blog/health-plans-vs-obama-s-precision-medicine-proposal Cognitive Dissonance Over Opioids http://drugwonks.com/blog/cognitive-dissonance-over-opioids Are opioids “bad?” Certainly they can be addictive and that fact can’t be understated. That’s precisely why they are controlled substances. And still nascent abuse deterrent technologies are helping to further decrease the opportunities for improper use. But the value of opioids is that, when used as directed, they are highly effective in combatting the scourge of pain. The truth, of course, is that opioids aren’t bad. The problem is that they’re not perfect nor are they perfectly safe – just like 100% of the prescription drugs on the market. Fri, 23 Jan 2015 08:37:50 -0600 http://drugwonks.com/blog/cognitive-dissonance-over-opioids When Lawyers Play Doctor http://drugwonks.com/blog/when-lawyers-play-doctor When it comes to medicine, who should make decisions about safety and efficacy – and on what evidence should those choices be made? At present, the Food & Drug Administration has the responsibility to determine approvals and labeling language based on a scientific review of the evidence. Should this authority be ceded to the tort bar? Wed, 21 Jan 2015 08:39:25 -0600 http://drugwonks.com/blog/when-lawyers-play-doctor Bach to the Future http://drugwonks.com/blog/bach-to-the-future Time and again, the dangerous idiots of healthcare reform claim that there's no difference between so-called "me-too" drugs, and that they're simply a way for drug companies to turn a quick profit. The New York Times,in an editorial, claimed that "the nation is wasting billions of dollars on heavily marketed drugs that have never proved themselves in head-to-head competition against cheaper competitors." Wrong. A recent op-ed in the New York Times, (Why Drugs Cost So Much, NYT, January 14, 2015) by Peter Bach is only the latest in a series of such bandwagon drivel – and he should know better. Tue, 20 Jan 2015 08:42:48 -0600 http://drugwonks.com/blog/bach-to-the-future Does Cutting Drug Prices Kill People? http://drugwonks.com/blog/why-high-priced-drugs-are-really-free Price cuts allow PBMs and health systems to profit at the expense of people's lives. Fri, 16 Jan 2015 11:18:28 -0600 http://drugwonks.com/blog/why-high-priced-drugs-are-really-free Deterring Opioid Abuse: A Success Story http://drugwonks.com/blog/deterring-opioid-abuse-a-success-story The gain in pain is plainly in the main. Abuse of opiate-based prescription painkillers such as oxycodone and morphine peaked around 2010-2011 and now may be on the decline in the United States, according to an analysis of databases designed to track illicit use of the drugs. New laws, programs and policies, such as prescription tracking systems and the reformulation of oxycodone to make it harder to abuse, may be combining to reverse the once-growing trend, researchers said. "I think we're at an inflection point and we're starting to turn this steamship around," said Dr. G. Caleb Alexander, co-director of the Johns Hopkins’ Center for Drug Safety and Effectiveness, who was not involved in the research. Now we need to continue to move (and act) beyond the rhetoric and pursue additional solutions. And at the top of the list is the foundation of the Hamburg Manifesto -- prescriber education. Thu, 15 Jan 2015 08:06:59 -0600 http://drugwonks.com/blog/deterring-opioid-abuse-a-success-story E&C Show and Tell http://drugwonks.com/blog/e-c-show-and-tell Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.) previewed on Tuesday the goals of legislation they plan to release this month as part of their 21st Century Cures initiative.
 The bill will seek to “modernize clinical trials to streamline the approval of drugs and devices,” in part by reducing paperwork and promoting adaptive trials. It will also help FDA “better integrate the patient perspective into the regulatory process,” including using public-private partnerships to strengthen science around biomarkers and patient-reported outcomes.
 Wed, 14 Jan 2015 06:26:07 -0600 http://drugwonks.com/blog/e-c-show-and-tell Brill not so bril http://drugwonks.com/blog/brill-not-so-bril The review of Steven Brill’s “What Ails Us” (NYT Book Review, January 11, 2015), refers to the pharmaceutical industry’s back-room negotiations to "gut" comparative effectiveness under Obamacare. The truth is that the Recovery Act of 2009 provided $1.1 billion for patient-centered health research (also known as comparative effectiveness research) – and that’s only part of the story. Tue, 13 Jan 2015 07:01:25 -0600 http://drugwonks.com/blog/brill-not-so-bril Fil in the blanks http://drugwonks.com/blog/fil-in-the-blanks The filgrastim adcomm isn’t the end of the debate. There are still many issues yet to be determined via FDA guidance (such as nomenclature) and corporate strategy (read, “pricing”). As BIO’s Jim Greenwood said, “This week’s advisory committee meetings facilitated important discussion of the scientific approach of reviewing biosimilar applications and we encourage this positive momentum, however, we believe the appropriate way to develop policy on such a significant new approval pathway is through published guidance documents with the opportunity for public comment, rather than through single-application advisory committee meetings.” One issue that’s taking a back seat to the approval of biosimilars is the requirement for new thinking on their post-approval safety and surveillance. Biologics aren’t the new kid on the block anymore. While it’s important to pursue ways to expedite 21st century cures (as well as the eponymous legislation), it’s equally important to focus on the details of 21st century follow-on products (both biosimilars and non-biologic complex drugs). Just as the FDA has been diligently pursuing patient-centered drug development, so too must it develop new strategies and tactics (“guidelines”) for patient-centered pharmacovigilance of biosimilars and NBCDs (such as Copaxone). It’s also time for NORD and all the other patient and disease organizations who were so wonderfully outspoken on the urgency of expediting the FDA review process for new therapies and cures to hoist the banner of follow-on safety. Mon, 12 Jan 2015 06:58:50 -0600 http://drugwonks.com/blog/fil-in-the-blanks Islam's Bigotry Against Scientific Genuis At Root Of Extremism http://drugwonks.com/blog/islam-s-bigotry-against-scientific-genuis-at-root-of-extremism Monstrous certainty is the source of evil Fri, 09 Jan 2015 11:55:47 -0600 http://drugwonks.com/blog/islam-s-bigotry-against-scientific-genuis-at-root-of-extremism Biosimilar Filgrastim and a Call for a Nomenclature Safety Net http://drugwonks.com/blog/biosimilar-filgrastim-and-a-call-for-a-nomenclature-safety-net If Sandoz, a world-class company with a stellar record for cGMPs, in their highly reviewed and internally scrutinized licensing application confuses batches of their biosimilar, what can we expect in the real world after marketing? If Sandoz can’t track different lots of their experimental drug, what will the reality be in the real world? Another cry for sanity in the debate over nomenclature. Biosimilars are here to stay -- and we need a nomenclature safety net. Wed, 07 Jan 2015 08:42:33 -0600 http://drugwonks.com/blog/biosimilar-filgrastim-and-a-call-for-a-nomenclature-safety-net The Three Things Drug Companies Must Do To Get Products To Patients http://drugwonks.com/blog/the-three-things-drug-companies-must-do-to-get-products-to-patients Value, value, value Tue, 06 Jan 2015 16:46:07 -0600 http://drugwonks.com/blog/the-three-things-drug-companies-must-do-to-get-products-to-patients Calling Dr. Ackerman http://drugwonks.com/blog/calling-dr-ackerman According to Inside Health Policy, an American Medical Association internal council report reveals the group is leaning toward a naming scheme where biosimilars and their reference products would share the same International Nonproprietary Names (INN). The report says that unique names may suggest different active ingredients within the products and go against standard nomenclature. This stance differs from that of the innovator biologics industry and a handful of specialty physician groups, which argue that shared naming would improperly imply interchangeability. Wrong. Assigning differential naming to biosimilar products will certainly prove challenging to the various constituents of the drug compendia community — but it will be crucial for pharmacovigilance. In the real world, how can we not have separate names when there are going to be four categories of products? Tue, 06 Jan 2015 07:49:17 -0600 http://drugwonks.com/blog/calling-dr-ackerman Will Patients Get New Meds FDA Approved? http://drugwonks.com/blog/will-patients-get-new-meds-fda-approved Not if the health insurance industry has anything to do with. Mon, 05 Jan 2015 15:14:00 -0600 http://drugwonks.com/blog/will-patients-get-new-meds-fda-approved 41 -- FDA's Proudest Prime Number http://drugwonks.com/blog/41-fda-s-proudest-prime-number The Food and Drug Administration approved 41 first-of-a-kind drugs in 2014, including a record number of medicines for rare diseases, pushing the agency's annual tally of drug approvals to its highest level in 18 years. FDA drug approvals are considered a barometer of industry innovation and the federal government's efficiency in reviewing new therapies. Last year's total was the most since the all-time high of 53 drugs approved in 1996. Mon, 05 Jan 2015 08:04:00 -0600 http://drugwonks.com/blog/41-fda-s-proudest-prime-number 12 Years a Slave http://drugwonks.com/blog/12-years-a-slave Sun, 04 Jan 2015 06:07:25 -0600 http://drugwonks.com/blog/12-years-a-slave Repressive Tolerance Returns To Brandeis http://drugwonks.com/blog/repressive-tolerance-returns-to-brandeis Brandeis used to stand up against suppression of free speech. Tue, 30 Dec 2014 14:08:59 -0600 http://drugwonks.com/blog/repressive-tolerance-returns-to-brandeis The Express Scripts' Polar Express http://drugwonks.com/blog/the-express-scripts-polar-express Baby, it’s cold outside – if you’re suffering from Hep C. A recent article in the Washington Post, “One company’s battle to stop the wave of high priced drugs,” could more accurately have been titled, “One company’s battle to stop innovation.” Tue, 30 Dec 2014 08:58:22 -0600 http://drugwonks.com/blog/the-express-scripts-polar-express "Free" Health Care with a side of Maple Syrup http://drugwonks.com/blog/free-health-care-with-a-side-of-maple-syrup Vermont's single-payer fantasy collapses when it's discovered there's no such thing as "free" health care. Tue, 23 Dec 2014 08:15:33 -0600 http://drugwonks.com/blog/free-health-care-with-a-side-of-maple-syrup A WISH LIST TO HELP THE CHRONICALLY ILL http://drugwonks.com/blog/a-wish-list-to-help-the-chronically-ill The ACA has made care unaffordable for millions. Mon, 22 Dec 2014 11:49:29 -0600 http://drugwonks.com/blog/a-wish-list-to-help-the-chronically-ill