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) Operation Desert Value http://drugwonks.com/blog/operation-desert-value I’ve just returned from a visit to the UAE and Kuwait where I had the privilege of speaking with medicines regulators and pricing authority representatives from those two nations. The topic of conversation was the value of innovation – and the urgency of rewarding it through timely approvals and appropriate pricing and reimbursement. As Yale economist William Nordhaus has written, "The social productivity of health care spending might be many times that of other spending.” Insha'Allah. Wed, 17 Dec 2014 08:43:07 -0600 http://drugwonks.com/blog/operation-desert-value Ezekiel Emanuel: Why I Hope To Die At 75 http://drugwonks.com/blog/ezekiel-emanuel-why-i-hope-to-die-at-75 Focus on living a meaningful life Fri, 12 Dec 2014 13:04:47 -0600 http://drugwonks.com/blog/ezekiel-emanuel-why-i-hope-to-die-at-75 Suing a Cure http://drugwonks.com/blog/suing-a-cure Have a cure for something? We will see you in court.. Thu, 11 Dec 2014 16:04:37 -0600 http://drugwonks.com/blog/suing-a-cure Are all men created "equivalent? http://drugwonks.com/blog/are-all-men-created-equivalent Bioequivalence is going mainstream. Ever since the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee concluded in April of 2010 (in an 11-2 vote) that current bioequivalence standards are not sufficient for narrow therapeutic index (NTI) drugs, there’s been a growing focus and understanding on the fact that less variability equals better predictability. (“Equivalent” doesn’t mean the same thing as “identical.”) “All men are created equivalent” just doesn’t have the same ring, does it? This is an urgent public health issue – and it’s got momentum. Thu, 11 Dec 2014 08:20:02 -0600 http://drugwonks.com/blog/are-all-men-created-equivalent Who Are The Most Powerful People in Healthcare? http://drugwonks.com/blog/who-are-the-most-powerful-people-in-healthcare People with cancer. That's who/ Wed, 10 Dec 2014 13:12:57 -0600 http://drugwonks.com/blog/who-are-the-most-powerful-people-in-healthcare How do you say "biosimilar quality" in Hindi? http://drugwonks.com/blog/how-do-you-say-biosimilar-quality-in-hindi At the same time that regulators in France, Germany, Belgium and Luxembourg are suspending the marketing approval of 25 generic drugs due to concerns over the quality of data from clinical trials conducted by India's GVK Biosciences, another Indian firm, Zydus Cadila, has launched a biosimilar of Adalimumab (an anti-TNF-α monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases, including rheumatoid arthritis, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and ulcerative colitis.) Bad timing and, perhaps, bad science. Wed, 10 Dec 2014 08:32:49 -0600 http://drugwonks.com/blog/how-do-you-say-biosimilar-quality-in-hindi Missouri and PDMPs -- The Don't Show Me State http://drugwonks.com/blog/missouri-and-pdmps-the-don-t-show-me-state According to the New York Times, Missouri is the only state in America that has declined to keep a prescription drug database — the primary tool the other 49 states use to identify people who acquire excess prescriptions for addictive painkillers and tranquilizers, as well as the physicians who overprescribe them … Not having the database has not only hampered Missouri’s ability to combat prescription drug abuse, but also attracted people from neighboring states looking to stockpile pills and bring them home to take themselves or sell to others, according to law enforcement officials, legislators and data compiled by a prescription drug processing firm. One of the reasons the Show Me State has remained the Don't Show me State are unfounded concerns over privacy and Big Brotherism. The good news is that Republican State Representative Holly Rehder is drafting a bill to change that. Mon, 08 Dec 2014 06:38:39 -0600 http://drugwonks.com/blog/missouri-and-pdmps-the-don-t-show-me-state ACA: Pennywise and Pound Foolish? http://drugwonks.com/blog/aca-pennywise-and-pound-foolish President Barack Obama is fully vested in the claim that his Affordable Care Act is a success. During a recent news conference, he pointed to the supposedly salutary effect the ACA has had on mitigating rising health care costs. "Health care inflation has gone down every single year since the law passed, so that we now have the lowest increase in health care costs in 50 years," Obama said. The Centers for Medicare and Medicaid Services have reported exactly that for the past several years. But his praise is misplaced. Thanks is not due to the ACA but rather to increased access to prescription drugs, which help folks manage illnesses and stay out of the hospital. The ACA actually threatens to increase health care spending by keeping these vital prescription drugs out of reach for many Americans. If policymakers are serious about slowing runaway health care costs, they need to ensure that sick people have good access to prescription medicines that will make them better. Fri, 05 Dec 2014 09:17:42 -0600 http://drugwonks.com/blog/aca-pennywise-and-pound-foolish HIV Impact With and WIthout Expensive New Medicines http://drugwonks.com/blog/hiv-impact-with-and-without-expensive-new-medicines What would HIV look like if we had said no to new medicines? Tue, 02 Dec 2014 16:40:55 -0600 http://drugwonks.com/blog/hiv-impact-with-and-without-expensive-new-medicines High Cancer Drug Prices Are NOT Making Health Care Costs 'Unsustainable" http://drugwonks.com/blog/high-cancer-drug-prices-are-not-making-health-care-costs-unsustainable The fact is, cancer drugs, as a percentage of what people spend, of cancer care and total health care spending is small. Mon, 01 Dec 2014 10:31:46 -0600 http://drugwonks.com/blog/high-cancer-drug-prices-are-not-making-health-care-costs-unsustainable Has health care improved with reclassification of hydrocodone? http://drugwonks.com/blog/has-health-care-improved-with-reclassification-of-hydrocodone This Sunday, the Boston Globe asked, “Has health care improved with reclassification of hydrocodone?” Here’s the response of the dynamic Cindy Steinberg, policy chair for the Massachusetts Pain Initiative and national director of policy and advocacy for the US Pain Foundation: No. Severely restricting access to the most commonly used and highly effective pain medication is unjustly punishing the millions of law-abiding citizens who struggle to live with pain every day while doing little to solve the problem of abuse and addiction. Mon, 01 Dec 2014 07:48:27 -0600 http://drugwonks.com/blog/has-health-care-improved-with-reclassification-of-hydrocodone Do High Priced Drugs Drive Up Healthcare Spending? http://drugwonks.com/blog/do-high-priced-drugs-drive-up-healthcare-spending New medicines reduce what we would have spent on treating patients using older technologies.. Sun, 30 Nov 2014 09:40:41 -0600 http://drugwonks.com/blog/do-high-priced-drugs-drive-up-healthcare-spending Why High Drug Prices Are Good For Us and the Economy http://drugwonks.com/blog/why-high-drug-prices-are-good-for-us-and-the-economy New Medicines Slow Spending, Improve Health, Saves Money Fri, 28 Nov 2014 14:00:07 -0600 http://drugwonks.com/blog/why-high-drug-prices-are-good-for-us-and-the-economy Got HIV/AIDS? ACA doesn't care. http://drugwonks.com/blog/got-hiv-aids-aca-doesn-t-care According to a story in the Austin Statesman, Federal law doesn’t deliver HIV care as promised.” The ACA, per the story, “brought a lot of hope … but the law didn’t live up to expectations” because … “the plans on the federally created health insurance exchange, the Internet-based marketplace where consumers can compare and buy health plans, didn’t offer affordable ways to buy the life-saving medications” or allow patients to see “physician with expertise in HIV and AIDS. David Wright, one of the first physicians in Central Texas to treat AIDS patients, said, “For a lot of patients, it actually created more barriers. It’s kind of overwhelming.” Tue, 25 Nov 2014 06:21:40 -0600 http://drugwonks.com/blog/got-hiv-aids-aca-doesn-t-care Process and Innovation http://drugwonks.com/blog/process-and-innovation One of the often-overlooked benefits of biosimilars is that it will drive innovation in manufacturing. Competition is the mother of invention. Or, in the case of Amgen, reinvention. They’ve just launched a biologics manufacturing facility in Singapore that required one-quarter of the capital investment of a conventional operation, will operate one-third cheaper and took half the time to build.But, the big question remains – will better and less costly manufacturing technologies (assuming they are approved by leading global regulators) lead to lower costs? More specifically, will it make off-patent biologics more price competitive with their biosimilar cousins? Mon, 24 Nov 2014 10:47:59 -0600 http://drugwonks.com/blog/process-and-innovation Important Victory in Opioid Abuse Deterrence http://drugwonks.com/blog/important-victory-in-opioid-abuse-deterrence Thu, 20 Nov 2014 12:46:10 -0600 http://drugwonks.com/blog/important-victory-in-opioid-abuse-deterrence Grubernomics http://drugwonks.com/blog/grubernomics Gruber got a pass from the media because his analysis reinforced the liberal narrative. Joe DiMasi, not so lucky Thu, 20 Nov 2014 11:52:35 -0600 http://drugwonks.com/blog/grubernomics PCMA on FDA and Biosimilars: Wrong, Wrong, and Wrong http://drugwonks.com/blog/pcma-on-fda-and-biosimilars-wrong-wrong-and-wrong The Pharmaceutical Care Management Association (PCMA), an organization that represents the nation's leading pharmacy benefit managers (PBMs), which administer prescription drug plans for over 210 million Americans, released a new white paper investigating FDA’s influence on drug prices and competition in the pharmaceutical marketplace. The PCMA argues that competition within branded drugs is undervalued in FDA priorities and that FDA’s structures and regulations fundamentally hinder competition.The report's bias and ignorance can be summed up via this segment, “Without a statutory and regulatory agenda for the FDA that carefully examines the agency’s effect on pharmaceutical competition, some consumer welfare may be unnecessarily lost.” Note to PCMA -- the FDA does not factor issues such as "competition" into it's regulatory calculations. Facts cannot be ignored because they are inconvenient. Thu, 20 Nov 2014 08:29:28 -0600 http://drugwonks.com/blog/pcma-on-fda-and-biosimilars-wrong-wrong-and-wrong Joe vs. the Volcano http://drugwonks.com/blog/joe-vs-the-volcano Much chatter about the Tuft’s Center’s new number for the cost of drug development. Here’s the thoughtful comment from those lovely folks at Médecins Sans Frontières,“The pharmaceutical industry-supported Tufts Center for the Study of Drug Development claims it costs US$2.56 billion to develop a new drug today; but if you believe that, you probably also believe the earth is flat.” NGO’s can poo-poo the important work of Joe DiMasi and crew this as much as they like – but serious analysis can’t just be tsk-tsked away by using the “industry-supported” evasion. Here’s the news – and it’s important. Wed, 19 Nov 2014 06:39:34 -0600 http://drugwonks.com/blog/joe-vs-the-volcano Pain advocates to Massachusetts Governor-Elect: "Listen up!" http://drugwonks.com/blog/pain-advocates-to-massachusetts-governor-elect-listen-up “Charlie Baker vows to tackle state opiate problem,” was the Boston Globe headline two days after Election Day. It’s good to hear from our newly elected governor that he plans to take steps to curb the ongoing problem with illegal use of prescription medication in our state. There’s little doubt that too many lives are being harmed by drug abuse and addiction. But in a quest to fix one problem, policymakers need to consider the potential unintended negative consequences for the patients for whom these medications are a lifeline. Gov.-elect Baker said in that Globe interview that he plans to convene a coalition of lawmakers, health care providers and labor leaders to confront the opioid crisis in our state. Representatives of the pain community — an estimated 1.2 million Massachusetts residents live with chronic pain — must be included in these discussions as well. Tue, 18 Nov 2014 06:19:23 -0600 http://drugwonks.com/blog/pain-advocates-to-massachusetts-governor-elect-listen-up