Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariMichael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of June. The selections feature topics ranging from physicians’ views of the Sunshine Act; to a biomarker-based drug development case study of CETP inhibitors, to the potential return on public investment in detecting adverse drug effects. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Chimonas S, DeVito NJ, Rothman DJ. Bringing Transparency to Medicine: Exploring Physicians’ Views and Experiences of the Sunshine Act. Am J Bioeth. 2017;17(6):4-18.
  2. Dong K, Boehm G, Zheng Q. Economic Impacts of the Generic Drug User Fee Act Fee Structure. Value Health. 2017;20(6):792-8.
  3. Hey SP, Franklin JM, Avorn J, Kesselheim AS. Success, Failure, and Transparency in Biomarker-Based Drug Development: A Case Study of Cholesteryl Ester Transfer Protein Inhibitors. Circ Cardiovasc Qual Outcomes. 2017;10(6).
  4. Huybrechts KF, Kesai RJ, Park M, Gagne JJ, Najafzadeh M, Avorn J. The Potential Return on Public Investment in Detecting Adverse Drug Effects. Med Care. 2017;55(6):545-51.
  5. Sommers BD, Maylone B, Blendon RJ, Orav EJ, Epstein AM. Three-Year Impacts Of The Affordable Care Act: Improved Medical Care And Health Among Low-Income Adults. Health Aff (Millwood). 2017;36(6):1119-28.
  6. ‘t Hoen EFM, Boulet P, Baker BK. Data exclusivity exceptions and compulsory licensing to promote generic medicines in the European Union: A proposal for greater coherence in European pharmaceutical legislation. J Pharm Policy Pract. 2017;10:19.

Copenhagen Conference: Legal Perspectives on Synthetic Biology and Gene Editing

Join us at the Centre for Information and Innovation Law (CIIR) Faculty of Law, University of Copenhagen on 20 November, 2017 to discuss Legal Perspectives on Synthetic Biology and Gene Editing.

CALL FOR PAPERS

Emerging technologies in Synthetic Biology and Gene Editing offer incredible opportunities and promising solutions to some of the most urgent challenges faced by humanity, such as climate change, environmental protection, growing population, renewable energy and improved health care. But the emerging applications also raise exceptional ethical, legal and social questions.

This conference marks the final phase of the participation of the Copenhagen Biotech and Pharma Forum (CBPF) Research Group at the Centre for Information and Innovation Law (CIIR) in the cross-faculty research project BioSYNergy. In accordance with the goals of this large cross-faculty project on Synthetic Biology, the event explores legal perspectives on synthetic biology, systems biology and gene editing. Dealing with the legal responses to ethical and scientific challenges raised by emerging life science technology. Continue reading

The Problematic Patchwork of State Medical Marijuana Laws – New Research

By Abraham Gutman

The legal status of medical marijuana in the United States is unique. On one hand, the Controlled Substance Act of 1970 classifies marijuana as a Schedule I drug with no acceptable medical use and high potential for abuse. On the other hand, as of February 1, 2017, 27 states and the District of Columbia have passed laws authorizing the use of medical marijuana. This discrepancy between federal and state regulation has led to a wide variation in the ways that medical marijuana is regulated on the state level.

In a study published today in Addiction, our team of researchers from the Temple University Center for Public Health Law Research and the RAND Drug Policy Research Center finds that state laws mimic some aspects of federal prescription drug and controlled substances laws, and regulatory strategies used for alcohol, tobacco and traditional medicines.

In the past, studies on medical marijuana laws have focused on the spillover effect of medical marijuana to recreational use and not on whether the laws are regulating marijuana effectively as a medicine. Using policy surveillance methods to analyze the state of medical marijuana laws and their variations across states, this study lays the groundwork for future research evaluating the implementation, impacts, and efficacy of these laws.

The study focuses on three domains of medical marijuana regulation that were in effect as of February 1, 2017: patient protections and requirements, product safety, and dispensary regulation.

Here’s some of what we found:

Continue reading

How the FDA Produces Knowledge (and Is Not So Weird)

Credit: SalFalko

The Federal government has wrested billions of dollars from the drug and device industry in settlements of claims that the companies broke the law by promoting their products “off-label” for uses not approved by the FDA.  In response, companies have asserted that promotions are a form of speech, protected by the First Amendment. Speech regulations are especially worrisome when motivated by paternalism.  This argument has received some traction in the courts, and is now getting a favorable look by the Trump administration.

I have argued (here, here, and here) that this law is not actually a speech regulation.  Nor is it paternalistic.  Instead, it is simply a vanilla regulation of a behavior (shipment of product in interstate commerce), which depends on various sources of evidence (including speech) as revealing whether the actor has an illicit intent (an unapproved use of the product).  The pre-market approval system, which requires that companies prove safety and efficacy for all intended uses, solves a collective action problem to produce information as a public good.  This is our key social mechanism for producing knowledge about safety and efficacy.  If this law is unconstitutional in the off-label context, the entire pre-market approval system would seem to be as well.

In a new piece out on SSRN, my physician co-author Victor Laurion develops the example of the drug Seroquel XR, to show how a federal prosecution for off-label promotion caused the company to perform scientific research on two new indications (general anxiety disorder and major depression).  A detailed discussion of the regulatory record shows how physician prescribing was improved by this public information, regardless of whether the FDA approved the new indication.  In this way, the FDA protects the liberty of physicians and patients to try drugs for new uses, even while holding companies to the proof of any uses that they actually intend.  The fact that the company’s intention is shown by speech evidence is immaterial. Continue reading

FDA v. Opana ER: Opioids, Public Health, and the Regulation of Second-Order Effects

Earlier this month, the FDA announced that it is asking Endo Pharmaceuticals to remove the opioid Opana ER from the market.  Opana ER is an extended-release pain reliever often abused by those who take it.  While opioid abuse is nothing new, and many opioids leave those who take them addicted to narcotics or heroin, Opana ER is particularly dangerous because of how people misuse it.  The pill was designed to prevent would-be abusers from crushing and snorting it —  a popular means of ingesting prescription opioids.  Without the ability to crush and snort the drug, however, abusers turned to dissolving the pills and injecting them intravenously, leading to outbreaks of Hepatitis C, HIV, and other blood-borne diseases.  In Indiana’s Scott County, for instance, the prevalence of HIV has skyrocketed since the introduction of Opana ER to the local population, with 190 new cases since 2015.

While this foray into public health is somewhat surprising — given the anti-regulatory stance of the current administration and its billionaire backers — it is precisely the type of initiative the FDA should be taking.  Public health is a central part of the FDA’s mission statement, which notes that the agency “is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.”  Traditionally, though, the FDA’s efforts to ensure safety and efficacy have been limited to the narrow context of individual patients taking medications as directed under physician supervision.  As the FDA noted in its Opana ER press release, this is the first time it has requested that an opioid be taken off the market as a result of its susceptibility to abuse and the associated public health consequences.

Continue reading

Webinar, 6/28: Procedural Aspects of Compulsory Licensing under TRIPS

I am very happy to host yet another webinar with J. Wested at the University of Copenhagen. This time we will debate procedural issues in compulsory licensing with H. Grosse Ruse-Kahn (University of Cambridge) & M. Desai (Eli Lilly). Further information on our webinar series is available at here, here, and below:

Procedural Aspects of Compulsory Licensing under Trade-Related Aspects of Intellectual Property Rights (TRIPS)

Wednesday 28. June 2017
4-6 p.m (CEST)
Sign-up & questions: Jakob.blak.wested@jur.ku.dk

This webinar on “TRIPS and the life sciences” will approach the question of compulsory licensing by looking at the technical and procedural requirements applied by courts when evaluating a petition for a compulsory license.  

The balancing of the instrumental application of patent rights as a stimulator of innovation and the public interest in having access to these innovations form a controversial trajectory of discourse, which is as old as patent law. Compulsory licenses are one of the means that have been applied throughout the history of patent law, to condition this complex intersection of interests. The TRIPS agreement is no exception and art 31 contains the provision for member states to grant CL. In 2013, the Indian authorities granted a compulsory license to NATCO Pharmaceuticals for Bayers patented pharmaceutical product Carboxy Substituted Diphenyl Ureas, useful for the treatment of liver and kidney cancer. This decision raised several issues regarding the procedures and requirements to be met in order to grant a compulsory license. Furthermore, in January 2017 an amendment to TRIPS agreement entered into force allowing compulsory licensors to export their generic pharmaceuticals to least developed countries, further recalibrating the intersection of the monopoly power of the patent and public interest. Continue reading

Conflict of Interests Disclosures Come to PubMed

By Christopher Robertson

Scholars and policymakers have long been concerned that the biomedical science literature — and thus the practice of medicine — is biased by the companies who fund research on their own products.  Prior research has shown that industry-funded studies tend to produce results favorable to their company sponsors.  One solution is disclosure of industry funding, so that physicians and other consumers of the biomedical literature can weigh scientific findings accordingly.

My prior work with Aaron Kesselheim, Susannah Rose, and others has found that adding such disclosures to biomedical abstracts could make a big difference — physicians understand them and will rely upon them.  Nonetheless, most journals bury the disclosures at the end of articles, which are often hidden behind paywalls and not nearly as salient as the methods and findings displayed in the abstract.  For the Institutional Corruption Lab of the Edmond J. Safra Center, I worked with a team of hackers to create a browser extension that proves the feasibility of adding those disclosures into PubMed, a Federal government database of the scientific literature.

Thankfully, that browser extension is becoming obsolete, as the National Library of Medicine (part of the NIH) has begun implementing such disclosures themselves, right in PubMed.   A search reveals that nearly 80,000 abstracts now have such tags.  While a lot in absolute terms, it is a small minority of the 17 million abstracts covered by PubMed.  Commentators have suggested that as much as 70% of the funding for clinical trials comes from industry, so we should expect millions of abstracts to have such disclosures.

Thus we are still a long way from comprehensive and effective disclosure.  There are two problems. Continue reading

Patenting Bioprinting Technologies in the US and Europe – The Fifth Element in the Third Dimension

By Timo Minssen

I am happy to announce the publication of our new working paper on  “Patenting Bioprinting Technologies in the US and Europe – The 5th element in the 3rd dimension.” The paper, which has  been co-authored by Marc Mimler, starts out by describing the state of the art and by examining what sorts of bioprinting inventions are currently being patented. Based on our findings we then discuss what types of future innovations we can expect from the technological development and how far these would and/or should be protectable under European and US patent laws.

The paper is forthcoming in: RM Ballardini, M Norrgård & J Partanen (red), 3D printing, Intellectual Property and Innovation – Insights from Law and Technology. Wolters Kluwer, but the working paper is already available on SSRN. Continue reading

Innovation and Intellectual Property Policies in European Research Infrastructure Consortia

By Timo Minssen

I am happy to announce the publication of our collaborative paper with Helen Yu and Jakob Wested on “Innovation and intellectual property policies in European Research Infrastructure Consortia (part I)” in the Journal of Intellectual Property Law and Practice (Oxford University Press). Taking the European Spallation Source ERIC as an example, our paper investigates ERIC Regulations and EU policies and discusses what issues and perspectives ERICs need to consider in their IPR policies to balance the core-objectives of multiple stakeholders and achieve sustainability in various research areas, including the health and life sciences.

The authors would like to express their special gratitude to Dr. Ohad Graber Soudry, Head of Legal, European Spallation Source ESS-ERIC in Lund, Sweden, for all his support and valuable comments. This paper is supported by the CoNeXT project (see http://conext.ku.dk/ last visited July 23, 2016) under the University of Copenhagen’s Excellence Program for Interdisciplinary Research.

Abstract:

Research and innovation are key pillars of the EU’s strategy to create sustainable growth and prosperity in Europe. Research infrastructures (RIs) are central instruments to implement this strategy. They bring together a wide diversity of expertise and interests to look for solutions to many of the problems society is facing today, including challenges in the health and life sciences. To facilitate the creation and operation of such RIs, the EU adopted legal frameworks for European Research Infrastructure Consortia (ERIC). On August 31, 2015, the European Spallation Source (ESS) was established as an ERIC. Under the ERIC Regulations and ESS Statutes, the European Spallation Source ERIC is required to adopt various policy documents relating to the operation and management of the facility. These cover a wide variety of issues such as user access, public procurement, intellectual property rights (IPR), data management, and dissemination. One of the main goals of the ESS policies is to ensure that the research environment at ESS is compatible with a wide variety of international users’ obligations to multiple stakeholder-interests. But how can these policies best be aligned with the EU objective to achieve economic growth and scientific excellence by encouraging international research collaborations? The complex relationship between scientific excellence, innovation, and IPRs must be carefully considered. Taking the European Spallation Source ERIC as an example, this article investigates ERIC Regulations and EU policies and discusses what issues and perspectives ERICs need to consider in their IPR policies to balance the core-objectives of multiple stakeholders and achieve sustainability. In Part II, we will analyze and compare the different IPR policies of the various ERICs in a subsequent article.

New Drug Pricing Bill from Democrats Balances Innovation, Access

By Rachel Sachs

Yesterday, a group of 20 Democrats in both the House and Senate introduced the Improving Access to Affordable Prescription Drugs Act, a 129-page bill designed to lower drug costs while increasing innovation and promoting transparency.  The bill aims to accomplish a number of different goals, and in this post I’ll go through the different functions it serves and consider some notable provisions.  For those who are interested, here’s a provision-by-provision summary.  This is going to be a very long post, so I apologize in advance.

On the whole, I think there’s a lot to like in this bill, particularly in its promotion of innovation and in the way in which it seeks to curtail bad actors within the industry.  However, I don’t agree with all of its provisions (as you’ll see) and I view some of its proposals as kludge-y solutions to kludge-y problems our complex system has created.  I’m not yet sure whether I see that as a bad thing, to be clear – it works to create meaningful change within a system that was cobbled together over decades, mostly accidentally.  But it isn’t the platonic ideal of a value-based pricing system, or anything similar.

Continue reading

Bold New Policies for The Brave New Biologies: IPRs and Innovation in Synthetic Biology and Gene editing

Research Seminar at the University of Copenhagen debating intellectual property and innovation in synthetic biology, systems biology & gene editing.

New technologies in biology offer a brave new world of possibilities. Promising solutions to some of the most urgent challenges faced by humanity: climate change, environmental protection, growing population, renewable energy and improved health care. Scientific and technological progress has been remarkable. Simultaneously, emerging life science technologies raise outstanding ethical, legal and social questions.

In this research seminar, Prof. Esther Van Zimmeren from the University of Antwerp joins Prof. Timo Minssen, Postdoc Ana Nordberg and Ph.D. Student Jakob Wested from the Centre for Information and Innovation Law, debating bold new policies for intellectual property law and incentive to life science innovation.

Programme

15:00 – 15:10 Welcome
Prof. Timo Minssen, CIIR, Faculty of Law, University of Copenhagen.
15:10 – 15:30 Waiting for the Rumble in the Jungle: – An overview of current CRISPR/CAs9 patent disputes, central legal issues and some thoughts on conditioning the innovation system.
PhD Student Jakob Wested, CIIR, Faculty of Law, University of Copenhagen.
15:30 – 15:50 From FRAND to FAIR for Synthetic and Systems Biology? The Implications of Openness, IP Strategies, Standardization and the Huawei-case.
Prof. Esther van Zimmeren, Faculty of Law, University of Antwerp.
15:50 – 16:10 Keeping up with the technologies: IP Law and Regulation in the age of gene editing.
Postdoc Ana Nordberg, CIIR, Faculty of Law, University of Copenhagen.
16.10 – 17.00 Questions and panel debate

Time: 13 March 2017, 15:00 – 17:00

Venue: Meeting Room 7A-2-04 , Faculty of Law, Njalsgade 76, DK-2300 Copenhagen S

Registration:
The event is free to attend. Registration is mandatory. Please use this registration form no later than Monday, 13 March 2017, 11:00 at the latest.

Organizer: Copenhagen Biotech & Pharma Forum, at CIIR, Faculty of Law, University of Copenhagen

Manufacturers Of Biosimilar Drugs Sit Out The ‘Patent Dance’

This new post by Claire Laporte appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017.

Believe it or not, the Patient Protection and Affordable Care Act (Obamacare, or here, ACA) has intellectual property provisions. In addition to establishing mandates, subsidies and insurance exchanges, the ACA also created a new pathway for the approval of biosimilar drugs, which are akin to generic drugs. That pathway appears in a corner of the ACA that has its own title: the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA is rich with intellectual property (IP) provisions that are now the subject of litigation in the Supreme Court.

Background: Generic Drugs And Biosimilars

Many of us take generic drugs for granted, but we have them only because the Hatch-Waxman Act (1984) provided an abbreviated pathway by which FDA could approve them. Under this pathway, a generic drug could be approved based on the safety and efficacy of the branded drug, plus a showing by the generic that it was essentially identical to the branded drug. This pathway also included provisions by which generic drug manufacturers could challenge the validity of patents protecting the branded drug. […]

Read the full post here.

Call for Papers – European Pharmaceutical Law Review (EPLR)

Dear Colleagues,

I am happy to announce that I have just joined the Board of Editors of the new journal “European Pharmaceutical Law Review” (EPLR). One of my first tasks is to spread the news about our “Call for Papers”. Further information is available here.

The European Pharmaceutical Law Review (EPLR) reports on key legislative developments in the EU and the Member States, and identifies and analyses important judgments that shape the interpretation and application of EU pharmaceutical law, in particular those by the European Courts, international courts and tribunals such as the WTO’s Dispute Settlement Body, and higher national courts.

In order to establish itself as a forum for dialogue between different stakeholders in pharmaceutical regulation and governance, it will invite contributions from academics, practitioners, regulators and civil society representatives. Topics covered by EPLR include:

  • Pharmaceutical law and policy in all jurisdictions (regional, national, international);
  • Commission decisions (EMA opinions) and regulatory guidelines;
  • National EU, and International Jurisprudence;
  • Medical devices;
  • Borderline cases: pharmaceuticals/food/cosmetics/chemicals
  • Patents /Trademarks;
  • Health Technology Assessment and pricing/reimbursement;
  • Digital health/Big data;

All contributions will be subject to double blind peer-review before acceptance for publication and are required to conform to the author guidelines.

We are looking forward to receive and review the first submissions!

Best wishes/ Timo

PhRMA, Marathon Is Why You Can’t Have Nice Things

By Rachel Sachs

Yesterday, the FDA approved a steroid, deflazacort, for the treatment of Duchenne Muscular Dystrophy (DMD).  DMD is a rare, heartbreaking, and ultimately fatal genetic disease with few if any real treatments, and the steroid may be helpful to patients.  Deflazacort’s sponsor, Marathon, has offered the drug at a list price of $89,000 per year.  High, but actually much lower than the typical prices charged for new orphan drugs, which can easily run to $300,000 or more per year.

Here’s the big problem: deflazacort isn’t really a new drug.  As the Wall Street Journal and Endpoints have pointed out, the drug is approved in many other countries, and its list price is about $1,000-$1,600 in Canada and the UK.  Patients have been importing the drug and accessing it since the 1990s.  Now, patients will pay many times those prices for the same product they had already been purchasing.

But the drug had not previously been approved in the United States, and surely Marathon conducted new clinical trials to demonstrate the drug’s benefit?  Not clearly.  Marathon mostly relied on clinical trial data from the 1990s that had not been fully analyzed.  In return, Marathon gets 1) a seven-year market exclusivity period for the drug (as required by the Orphan Drug Act) and 2) a valuable priority review voucher (as required by law for rare pediatric diseases).

This is not acceptable.  Full stop.  It is the worst sort of gaming that other companies have engaged in over the years.  And at a time when the drug industry is under fire for its high prices, PhRMA cannot afford to have its members (of which Marathon is one) acting this way.  If PhRMA and patient groups funded by pharmaceutical companies are serious about drug pricing, here are three things they should do/encourage right now:

Continue reading

Looking Forward: The Next Generation of Biosimilars

Looking Forward: The Next Generation of Bio
similars

February 7, 2017 12:00 PM

Description

Many of today’s important medications are biological products made from living organisms, manufactured through biotechnology, derived from natural sources, or produced synthetically. Biosimilars are a type of biological product approved by FDA on the basis of being highly similar to an already approved biological reference product, like a generic drug.

This panel of experts will discuss the current state of biosimilars in the healthcare ecosystem and what comes next from a technical and legal perspective. Topics include how the next generation of biosimilars can improve patient access to standard-of-care therapies, the concept of “biobetters,” economic and intellectual property considerations, and policy approaches to support existing and future biosimilars.

Panelists

This event is free and open to the public. Lunch will be provided.

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

National Survey Suggests that Off-Label Status is Material to Informed Consent

By Christopher Robertson

As many readers of this blog know, the FDA requires that, prior to entering the market, companies prove safety and efficacy for each intended use of their products, but physicians are then free to prescribe the products for any other uses.  (Companies are not allowed to promote off-label uses however.)

A recent national survey by Consumer Reports includes two interesting findings:

  1. About two-thirds (63%) of Americans “would not take a doctor prescribed medication that has been approved by the FDA, but not for their specific condition.”
  2. Almost all Americans (94%) “say they have never been told by a physician that a medication they were taking was not approved by the FDA for their condition.”

Patients are right to be skeptical of off-label uses, though they may not appreciate just how common they are.  In fact, most off-label use is unsupported by scientific evidence as to safety and efficacy.  A new report by the FDA illustrates several off-label uses that were subjected to rigorous clinical trials and turned out to be ineffective or dangerous.   For example, Aliskiren is approved for treatment of hypertension and was used off-label for prevention of congestive heart failure (CHF) complications.  A large trial showed that, although it did not significantly improve CHF mortality, it did significantly increase rates of kidney failure for CHF patients.  We do not know how many other off-label uses would fail if similarly tested.   Continue reading

An Alternative Point of View: The Societal Benefits of the Amgen v. Regeneron Injunction

Special Guest Post by Beau H. Miller, Jefferies

This article was originally published as part of research issued by the Jefferies Biotechnology Equity Research group.

Since the Amgen v. Regeneron ruling that resulted in Judge Robinson of the District Court of Delaware granting a permanent injunction removing Regeneron’s Praluent from the market (pending appeal), there have been a number of media and twitter commentaries providing their insights on the case.

These reactions have overall been of the opinion that it is a “shocking” precedent for a judge to remove an FDA-approved drug from the market for patent infringement – a remedy which patent owners, even pharmaceutical manufacturers, are justly able to obtain under the circumstances outlined in eBay v. MercExchange.

Given this, there are a few facts that have been overlooked in these reviews that lead us to disagree with some of the conclusions they reach, and also which led us to anticipate an injunction in this case. Continue reading

Looking Forward: The Next Generation of Biosimilars

Looking Forward: The Next Generation of Bio
similars

February 7, 2017 12:00 PM

Description

Many of today’s important medications are biological products made from living organisms, manufactured through biotechnology, derived from natural sources, or produced synthetically. Biosimilars are a type of biological product approved by FDA on the basis of being highly similar to an already approved biological reference product, like a generic drug.

This panel of experts will discuss the current state of biosimilars in the healthcare ecosystem and what comes next from a technical and legal perspective. Topics include how the next generation of biosimilars can improve patient access to standard-of-care therapies, the concept of “biobetters,” economic and intellectual property considerations, and policy approaches to support existing and future biosimilars.

Panelists

This event is free and open to the public. Lunch will be provided.

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

MONDAY (1/23)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law. Continue reading

Preventing a post-antibiotic world

By Kevin Outterson

Nick Bagley and I have an op-ed in today’s New York Times calling for serious economic incentives for antibiotics, delinking revenues from sales volumes with a $4 billion prize system.

From the piece:

On Friday, the Centers for Disease Control and Prevention released a disturbing report about the death of an elderly woman in Washoe County, Nev. What killed her wasn’t heart disease, cancer or pneumonia. What killed her were bacteria that were resistant to every antibiotic doctors could throw at them.

This anonymous woman is only the latest casualty in a war against antibiotic-resistant bacteria — a war that we are losing. Although most bacteria die when they encounter an antibiotic, a few hardy bugs survive. Through repeated exposure, those tough bacteria proliferate, spreading resistance genes through the bacterial population. That’s the curse of antibiotics: The more they’re used, the worse they get, especially when they’re used carelessly. […]

Read more here.