The fight against Antimicrobial Resistance: Important recent publications

One of my previous blogs discussed the growing threat of antimicrobial resistance (AMR). I concluded that antimicrobial resistance is a growing and complex threat involving multifaceted legal, socio-economic and scientific aspects. This requires sustained and coordinated action on both global and local levels.

A recent medical review on drug resistant tuberculosis supports these findings and provides further fodder to the debate. In their study, which was published in April 2014 in The Lancet – Respiratory Medicine, the authors analyzed the epidemiology, pathogenesis, diagnosis, management, implications for health-care workers, and ethical and medico-legal aspects of extensively drug-resistant tuberculosis and other resistant strains. In particular, the authors discussed the increasing threat of functionally untreatable tuberculosis, and the problems that it creates for public health and clinical practice. The paper concludes that the growth of highly resistant strains of tuberculosis make the development of new drugs and rapid diagnostics for tuberculosis—and increased funding to strengthen global control efforts, research, and advocacy—even more pressing.

This was also recognized in the recent WHO’s Global Surveillance Report on AMR, which was published this April. It is the first WHO report that studied the problem of AMR on a global level. Noting that resistance is occurring across many different infectious agents, the report concentrates on antibiotic resistance in seven different bacteria responsible for common, serious diseases such as bloodstream infections (sepsis), diarrhoea, pneumonia, urinary tract infections and gonorrhoea. The results demonstrate a wide-spread growth of resistance to antibiotics, especially “last resort” antibiotics. In particular the report reveals that this serious threat is no longer a mere forecast for the future. AMR is a contemporary problem in every region of the world and has the potential to affect anyone, of any age, in any country. Consequently the WHO report concludes that antibiotic resistance is now a major threat to public health that needs to be tackled on a global level.

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Bumps on the Road Towards Clinical Trials Data Transparency- A recent U-Turn by the EMA?

By Timo Minssen

In a recent blog I discussed the benefits and potential draw-backs of a new “EU Regulation on clinical trials on medicinal products for human use,” which had been adopted by the European Parliament and Council in April 2014. Parallel to these legislative developments, the drug industry has responded with its own initiatives providing for varying degrees of transparency. But also medical authorities have been very active in developing their transparency policies.

In the US, the FDA proposed new rules which would require disclosure of masked and de-identified patient-level data. In the EU, the EMA organized during 2013 a series of meetings with its five advisory committees to devise a draft policy for proactive publication of and access to clinical-trial data. In June 2013 this process resulted in the publication, of a draft policy document titled “Publication and access to clinical-trial data” (EMA/240810/2013).

Following an invitation for public comments on this document, the EMA received more than 1,000 submissions from stakeholders. Based on these comments the EMA recently proposed “Terms of Use” (TOU) and “Redaction Principles” for clinical trial data disclosure.

In a letter to the EMA’s executive director Dr. Guido Rasi, dated 13 May 2014, the European Ombudsman, Emily O’Reilly, has now expressed concern about what seems to be a substantial shift of policy regarding clinical trial data transparency. Continue reading

#BELHP2014 Panel 2, Potential Problems and Limits of Nudges in Health Care

[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: "Behavioral Economics, Law, and Health Policy."  This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

By Matthew L Baum

In this next installment of today’s live-blogging of the conference (and with all of the caveats of live-blogging mentioned by my colleagues and my apologies for any errors or misrepresentations) we have Professors David Hyman (DH), Mark White (MW) and Andrea Freeman (AF) in a panel moderated by Glenn Cohen (GC) on the “Potential Problems and Limits of Nudges in Health Care”.

The panel began with DH, H. Ross & Helen Workman Chair in Law and Director of the Epstein Program in Health Law and Policy, University of Illinois College of Law, and a talk entitled, “what can PPACA teach us about behavioral law and economics” (Patient Protection and Affordable Care Act). DH began with the observation that nudges often work quite well… “unless they don’t”. While many nudges are “sticky”, i.e. they influence behavior in the way they were intended, others are “slippery”, i.e. they fail to influence behavior in the way they were intended. His talk set out to illustrate the phenomenon, and to pose two questions. The first was an empirical question: what makes a nudge sticky vs slippery? The second was philosophical: is it meaningful to talk about a “failed nudge” or when we do, do we really just mean failed marketing? He focused on an analysis of PPACA as a case study.

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Summer Course for Professionals in “Pharma Law & Policy” at the University of Copenhagen

Stay abreast with recent developments and trends determining the legal and regulatory framework of the European pharmaceutical industry.

What are the most significant current issues shaking and shaping the pharmaceutical industry today? The business environment and legal framework relevant to the pharmaceutical industry continues to change rapidly in the face of constant challenges posed by competition, politics and technological innovation. Considering the highly lucrative and competitive nature of the industry, it is more important than ever for professionals working with legal and regulatory aspects of drug development to stay abreast of the most recent developments.

This course provides a broad and practical understanding of the ‘hot topics’ and will present and analyse these topics from scientific, legal and policy perspectives.

Further information about the course is available here.

Course content

The course begins with a general overview of the current scientific and legal trends in pharmaceutical R&D, organisation and policy. This is followed by a review of the hot topics through a combination of lectures, discussions, group work and case studies. The course is designed to allow room for the issues and challenges crucial to the participants’ daily work and practice.

Participants

The course is designed for professionals working with legal issues and/or regulatory aspects of drug development, decision-makers, administrators and health care practitioners within both the public and private sectors, e.g.:

  • Legal departments in the pharmaceutical industry.
  • Law firms dealing with patent and competition law in the pharmaceutical industry.
  • Branch organizations in the pharmaceutical sector.
  • Health care professionals and decision makers.
  • Bank and finance consultants working with risk and investment in the pharmaceutical industry.

Credit – especially for lawyers and trainee solicitors

This course meets the Danish requirements for compulsory supplementary training for lawyers and trainee solicitors.

Course dates

5 days, 18 – 22 August 2014, 9:00 – 17:00 at the University of Copenhagen, Frederiksberg Campus.

Course director

Timo Minssen, Associate Professor, Dr., LL.M., M.I.C.L., Centre for Information and Innovation Law, Faculty of Law, University of Copenhagen

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Petrie-Flom Intern’s Weekly Round-Up, 4/18-4/25

By Chloe Reichel

This Thursday the Food and Drug Administration (FDA) proposed new regulations for the sale of e-cigarettes. These regulations would prohibit sales to minors and make health warnings on packages mandatory.

This Wednesday a law was passed in Vermont that requires the labeling of genetically modified foods. Vermont is the first state to pass such a regulation.

Estimations for state spending on Medicaid have been reduced by the Congressional Budget Office. The office is now predicting that the cost of Medicaid expansion will be $46 billion, compared with their previous estimate of $70 billion.

Researchers at King’s College London have grown human skin in the lab from stem cells. Animal rights proponents herald these developments as a potential end to testing on animals.

Sovaldi, a medication for hepatitis C that costs $1,000 for one day’s dosage, has had the most successful drug launch ever. From its FDA approval in December to March 31, its manufacturer sold $2.27 billion worth of the drug, though the drug has faced criticism for its high price.

The FDA is considering banning electrical stimulation devices, used to discourage aggressive behavior in people with disabilities. Students from the Judge Rotenberg Educational Center testified against the use of these devices, though some parents of children at the Center and administrators there defend the use of these devices.

Following an audit of Illinois Medicaid expenditures, it was found that the program paid $12 million for medical services for dead people. These findings have led some to support stricter scrutiny in determining Medicaid eligibility.

Pervasive use of pesticides and genetically modified seeds in Hawaii has led to unrest among the state’s residents. Groups have been organizing to prevent the cultivation of genetically modified crops, and in Hawaii County such a law has already been adopted.

Petrie-Flom Intern’s Weekly Round-Up, 4/4-4/11

By Chloe Reichel

Following the release of information on Medicare billing practices, it was revealed that approximately 4,000 physicians each billed over $1 million in 2012. This data may shed light on medical billing procedures.

Despite a proposed 1.9 percent cut to the Medicare Advantage program, these cuts will not be implemented. On Monday the Centers for Medicare and Medicaid Services announced that funding to Medicare Advantage will increase by an average of .4 percent in 2015.

Though genetic testing is becoming cheaper and more accessible, many Americans refrain from getting tested. This is because the Genetic Information Nondiscrimination Act does not protect consumers from discrimination for life, disability, and long-term care insurance plans.

On Friday, Kathleen Sebelius, current Secretary of Health and Human Services, will resign from her role. Sebelius oversaw the oft-criticized implementation of the Affordable Care Act. Sylvia Mathews Burwell, director of the White House Office of Management and Budget, has been selected by President Obama to fill the role. Burwell served in the Clinton administration, and was president of the Walmart Foundation, prior to her work with the Obama administration.

This Thursday the European Parliament debated a petition that would prevent the allocation of EU funds for research, aid, and public health programs that involve the destruction of human embryos. The petition had 1.8 million signatures, and is seen as a sign of popular support for social conservatism.

Hawaii’s extensive health system has led to excellent health outcomes for the state’s residents and the state’s budget, since the state has some of the lowest healthcare costs in the nation. Hawaii has near-universal health insurance coverage, and starting forty years ago, has required employers to provide health benefits to their employees.

On Saturday, Maryland legislators voted to decriminalize possession of small amounts of marijuana. Those found in possession of less than 10 grams of marijuana will now be charged with civil fines, as opposed to criminal penalties.

Petrie-Flom Intern’s Weekly Round-Up, 3/21-3/28

By Chloe Reichel

The Hobby Lobby case that is currently before the Supreme Court may have effects far beyond the contraceptives mandate stemming from the Affordable Care Act. Other health care services and non-discrimination provisions may also be at stake.

Deadlines will be extended for people who need more time to complete their enrollment in insurance plans through HealthCare.gov. Those who apply will be given until mid-April to complete their applications.

Social media efforts led to the provision of an experimental drug to treat a young boy’s life-threatening infection. Bioethicists are now debating the ethics of this case and its implications for future social media interactions.

Due to stringent approval processes, researchers interested in studying marijuana face difficulty in attempting to do so. Despite growing interest in researching the substance, it can take years for researchers to begin their studies on marijuana.

Enrollment in health insurance policies through the Affordable Care Act reflect vast differences in the legislation’s implementation across the country. State-by-state enrollment data varies widely, and overall enrollment statistics neglect this important variation.

Tanning salons in New York are now forbidden from making claims about the health effects of their services. Previously, tanning salons in New York suggested that “sunlight prevents cancer,” a misleading statement considering the negative health effects of tanning.

Changes to Medicare’s policy manual have shifted the agency’s policies on paying for care used to maintain, rather than improve, patients’ health. Medicare will now pay for physical therapy, nursing care, and services for patients with chronic diseases.

Responding to a statewide public health crisis, Governor Deval Patrick has proposed a ban on the the opiate Zohydro. He has also suggested designating $20 million in funds for the purpose of bolstering treatment and recovery programs.

New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives

Please find attached a ppt presentation on “New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives” given on March 7, 2014 at the Broad Institute of MIT and Harvard.  The presentation was followed by a discussion moderated by US patent attorney Melissa Hunter-Ensor, Partner at Saul Ewing, Boston.

I started out by emphasizing increasing problems of antimicrobial resistance (AMR) on a global level, providing new statistics and facts. This was followed by a discussion of main reasons for these alarming developments, such as inappropriate use in agriculture and medicine, insufficient precautions, lack of education, climate change, travel behavior, insufficient collaboration and funding of R&D, scientific complexities, and the problem that incentives provided by the traditional innovation system model often fail in the case of antibiotics.

Next the presentation focused on a variety of solution models that could be discussed to fight AMR. These include both conservational and preventive approaches comprising use limitations, increased public awareness, and better hygiene, but also reactive push & pull strategies, such as increased investments, new collaborative models for R&D in antibiotics, prizes, “sui generis” IP-related incentives, regulatory responses and new pathways for approval.

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Petrie-Flom Intern’s Weekly Round-Up, 2/28-3/7

By Chloe Reichel

The majority of people in La Crosse, Wisconsin have advance directives. The initiative to increase the utilization of advance care planning began as a way of helping patients, but resulted in large decreases in health care expenditures.

Due to Texas’ recently passed regulations on abortion clinics, two clinics closed this week. Abortion clinics in Texas are required to have a physician with admitting privileges at a hospital within 30 miles of the clinic under the new regulations.

A new law passed recently in Arizona would limit access to medication used for medical abortions. Planned Parenthood of Arizona filed a lawsuit this Wednesday to contest the law.

An HIV-positive baby treated with aggressive drugs immediately after birth was reportedly cured of the disease. This is the second such case of this treatment working, and is a promising development for the future of HIV treatment.

On Wednesday it was announced that Americans will be allowed to keep insurance plans that are not compliant with the Affordable Care Act. These plans will continue to be offered for the next two years.

Two surveys have found that uninsured Americans largely have not signed up for insurance following the implementation of the Affordable Care Act. Some suggest that the changes to the new healthcare law that have occurred since its adoption may be responsible for these low rates of enrollment.

In Washington state, people who operate medical marijuana dispensaries are worried about the effects of the state’s recent legalization of recreational marijuana. They worry that the increased demand for marijuana will put smaller dispensaries out of business.

Twenty-six states have introduced mandatory programs that emphasize private long-term care over nursing homes. Many states have modeled their plans after Tennessee, but long-term care in this state is suboptimal for many residents.

Capsule Endoscopy Instead of Colonoscopy? The FDA Approves the PillCam COLON

By Jonathan J. Darrow

In January, the Food and Drug Administration (FDA) approved the use of the PillCam COLON 2 as a minimally-invasive means of viewing the colon, a development that is sure to be welcomed by U.S. patients who currently undergo an estimated 14 million colonoscopies each year.  While the approval represents a major step forward, the PillCam is unlikely to supplant current procedures just yet.

The colon has traditionally been examined via optical colonoscopy, a procedure perceived by many to be uncomfortable and embarrassing that involves insertion through the rectum of a 5-6 foot long flexible tube as part of an examination that can take 30 to 60 minutes. Air must be pumped in through the rectum in a process called “insufflation.” Sedatives and pain medication are generally used to help relieve discomfort. In contrast, the PillCam COLON contains a power source, light source, and two tiny cameras encapsulated in an easy-to-swallow pill that produces no pain or even sensation as it moves through the colon. Reflecting the absence of discomfort, one report from a clinical researcher noted that a few patients have insisted on X-rays to confirm that the device had passed in their stool (FDA Consumer). The pill takes about 30,000 pictures before passing naturally from the body, which usually occurs before the end of its 10-hour battery life.

The safety record of capsule endoscopy, the category to which the PillCam COLON belongs, so far appears to compare favorably with the alternatives. Capsule endoscopy may be less likely to produce accidental colonic perforations or other serious complications, which occur in less than 1% of traditional colonoscopies despite the best efforts of the treating physician. Tears of the colon wall can in turn “rapidly progress to peritonitis and sepsis, carrying significant morbidity and mortality.” (Adam J. Hanson et al., Laparoscopic Repair of Colonoscopic Perforations: Indications and Guidelines, 11 J. Gastrointest. Surg. 655, 655 (2007)). Splenic injury or other serious complications also occur rarely with optical colonoscopies. Unlike “virtual colonoscopy,” which uses computed tomography (CT) to peer into the body, capsule endoscopy does not involve bombarding the body with radiation. A leading study published in the New England Journal of Medicine reported no serious adverse events among 320 subjects given the PillCam COLON, and concluded that use of the device was “a safe method of visualizing the colonic mucosa through colon fluids without the need for sedation or insufflation.” Continue reading

Petrie-Flom Interns’ Weekly Round-Up, 2/14-2/21

By Chloe Reichel

1) Belgium’s recent vote to legalize euthanasia for children has drawn international debate and criticism. The law would allow terminally ill children to end their lives, provided that they have parental consent.

2) Lawmakers in California have proposed adding a warning label on soda and juice that has sugar added and over 75 calories per 12 ounces. The labels would warn against the health risks associated with consuming sugary beverages.

3) The Food and Drug Administration announced today that it will hold a meeting on the topic of changing the over-the-counter monograph system. Currently, the processes of publishing and changing a monograph are very time consuming.

4) Monsanto is producing new strains of vegetables without using GMOs. Instead, they are selectively crossbreeding different varieties of plants.

5) A recent study conducted by a group at Stanford University released findings that seriously injured patients with insurance are less likely to be transferred to trauma centers than uninsured patients. The group hypothesized that this difference in trauma care can be explained by the fact that non-trauma center hospitals have a financial incentive to keep insured patients under their care.

6) The sale and use of electronic cigarettes will be regulated in Beverly Hills, as decided by the Beverly Hills City Council earlier this week. Los Angeles passed similar legislation this December.

7) Enrollment in health insurance plans for one fifth of people who have registered under the Affordable Care Act was not completed, due to their failure to pay the first premium. Some insurers have granted more time for subscribers to pay their premiums.

8) Wendy Davis recently said that she would support restricting abortion access to the first twenty weeks of pregnancy, but filibustered last year against a bill containing that provision because of the wording of the bill and the other restrictions included within it.

Petrie-Flom Interns’ Weekly Round-Up, 1/31-2/7

By Chloe Reichel

1) On February 11, the FDA will launch its “Real Cost,” anti-smoking campaign. The $115-million campaign is geared toward discouraging teenagers from smoking by emphasizing the “personally relevant” effects of smoking.

2) Lawsuits against the manufacturer of Pradaxa, Boehringer Ingelheim, have revealed internal documents about the dangers of the drug. The drug, a blood thinner, has been associated with over 1,000 deaths.

3) By October 2014, CVS will no longer sell tobacco products. CVS has decided to implement this ban because, increasingly they see their role as providing health care, and tobacco products cause negative health effects.

4) Naxolone, a drug that is used to reverse the effects of opiate overdoses, is now available to patients in California through their doctors. Prior to the creation of this law, the drug was much less widely available–primarily it was administered in emergency rooms.

5) Following the implementation of the Affordable Care Act, between 1 to 2 million Americans have enrolled in Medicaid. A study from Avalere Health states that this number increased only partially because of the ACA.

6) This Thursday, the Food and Drug Administration released regulations to guarantee that infant formula is safe for consumption. The regulations stipulate that certain nutrients are included in the product, and require tests for pathogens.

Action of Ohio Controlling Board on Medicaid Expansion

According to Professor Wilson R. Huhn of the University of Akron School of Law, the Ohio governor’s action expanding Medicaid in Ohio is valid. He writes:

On Monday, October 22, at the urging of Governor Kasich, the  Controlling Board of the Ohio Legislature voted 5-2 to accept $2.5  billion in federal funding to expand Medicaid in the State of Ohio.  Under the laws of Ohio this action was valid.

The Controlling Board is a state agency created by statute. The agency  has two principal powers: it can transfer funds and authorize purchases  by state agencies, and it can decide to accept federal funding on behalf of these agencies. Section 131.35(A)(5) of the Ohio Revised Code  states: “Controlling board authorization for a state agency to make an expenditure of  federal funds constitutes authority for the agency to participate in the federal program providing the funds ….”

Two advocacy organizations (the Buckeye Institute and the 1851 Center  for Constitutional Law) as well as several Ohio lawmakers have announced that they intend to challenge the legality of the action of the  Controlling Board. They contend that the action of the Board violates  Section 127.17 of the Ohio Revised Code, which provides that the Board  is bound by the intent of the Ohio General Assembly. The challengers  quite correctly point out that both houses of the General Assembly voted not to accept federal funding to expand Medicaid. Governor Kasich  vetoed this bill, but the challengers argue that despite the Governor’s  veto it’s clear that the General Assembly did not want the Controlling  Board to accept federal funding to expand Medicaid.

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Educating ELSI

By Matthew L Baum

“Examining the intersection of law and health care, biotech & bioethics”

- the subtitle of the Bill of Health blog.

I approach this intersection like many of my fellow students: outfitted with the tools and spectacles of a specific discipline. Whether that is health law, policy, medicine, engineering, philosophy, genetics, or cognitive science, none of us have had the ideal education that would enable not only an approach, but an inhabitation of this intersection.

What would that ideal education be? To consider the ideal education for a citizen, Rousseau conducts an elaborate thought experiment giving that education to a fictional young boy named Emile (hence the title of the work: Emile, or On Education). Let us begin a similar experiment to consider the ideal education for someone to inhabit the intersection of law and health care, biotech & bioethics.

Let’s call our fictional young person, ELSI.

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Our Bodies, Our Cells: FDA Regulation of Autologous Adult Stem Cell Therapies

By Mary Ann Chirba, J.D., D.Sc., M.P.H. and Alice A. Noble, J.D., M.P.H.

Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This month’s announcement of a cloned human embryo from a single skin cell [1] came on the heels of Sir John B. Gurdon and Dr. Shinya Yamanaka’s receipt of the 2012 Nobel for Physiology and Medicine for their work with induced pluripotent stem cells. Pluripotent stem cells can be embryonic or induced. Embryonic stem cells (ESCs) can generally be obtained from human embryos or by cloning embryos through somatic cell nuclear transfer (SCNT), as was done for Dolly.  Gurdon and Yamanaka demonstrated that pluripotent cells may also be formed by reprogramming adult cells to an embryonic state, resulting in induced pluripotent stem (iPS) cells without having to use eggs or cloning, or destroy embryos. However derived, pluripotent cells are capable of differentiating into virtually any cell type in the human body. This imbues them with great promise for scientific breakthroughs and medical advances, but also raises serious ethical, legal and safety concerns about their use.

Less controversial are “multipotent” adult stem cells (ASCs) which do not involve embryos or raise as many safety concerns as pluripotent cells.  ASCs are found throughout the body.  Their ability to differentiate is more limited than pluripotent cells but is vast nonetheless. The NIH’s clinicaltrials.gov site lists some 4500 ASC trials as compared with 27 for embryonic stem cells and 21 for induced pluripotent stem cells. Recent announcements of new stem cell treatments usually involve ASCs, such as last month’s news that a toddler born without a trachea received a new one made from her own adult stem cells.  It is therefore no surprise that ASCs have captured the attention of researchers, investors, physicians, patients and – increasingly – regulators, both here and abroad.

A growing number of physicians routinely offer treatments involving ASCs to their patients which can be performed in their offices.  Autologous adult stem cells, used to treat a variety of conditions, are harvested from the patient, processed, and returned to the same patient. It is no surprise that moving ASCs from laboratories to physician offices raises complex questions of law. We consider one of the more pressing ones: to what extent can the FDA regulate a physician’s ability to treat a patient with that patient’s own stem cells?  In the coming months, the D.C. Circuit Court of Appeals will hear oral arguments on this very issue in United States v. Regenerative Sciences.[2]

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Medical Malpractice, the Affordable Care Act and State Provider Shield Laws: More Myth than Necessity?

By Mary Ann Chirba and Alice A. Noble

Given the ambitions and reach of the Affordable Care Act, confusion about its intended and inadvertent impact is inevitable. Since its enactment in 2010, the ACA has raised legitimate and less grounded concerns among various stakeholders ranging from individuals and employers facing coverage mandates to States deciding whether and how to implement the Act’s Medicaid expansions. One item has received far less attention even though it weighs heavily on any provider engaged in the clinical practice of medicine: the ACA’s impact on medical malpractice liability. The Act does little to address medical malpractice head on. Nevertheless, physicians and other providers, the states and even some members of Congress have expressed concern that the Act will increase a provider’s exposure to medical malpractice liability.

In response, the American Medical Association has drafted model legislation to shield providers from newly created malpractice claims resulting from the ACA. It would prevent malpractice claimants from using federal or state practice guidelines, quality measures, reimbursement criteria and the like to establish or define the standard of care without expert testimony. In Congress, a version of this model, H.R. 1473, was introduced in the House of Representatives in 2012, and again in April of 2013 [link: http://beta.congress.gov/bill/113th-congress/house-bill/1473/cosponsors].

In April, the governor of Georgia signed H.B. 499 [link: http://www.legis.ga.gov/legislation/en-US/display/20132014/HB/499] into law, becoming the first state to pass legislation based on the AMA model act.

This came on the heels of a Medical Association of Georgia Advocacy Brief [link: http://www.mag.org/sites/default/files/downloads/issue-brief-provider-shield2-2013.pdf] stating that the ACA’s “guidelines” concerning health care quality measures; payment adjustments; hospital value-based purchasing; and value-based payment modifiers “will raise [the medical malpractice] standard to unreasonable levels by exposing physicians to a number of new liabilities….” [Emphasis added]

It is too early to tell whether states will follow Georgia’s lead and enact similar measures. What is clear is that such “standard of care protection” or “provider liability shield” legislation raises interesting questions about the ACA’s impact on state medical malpractice law.

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Happy Public Health Week: “We’re Good Enough, We’re Smart Enough, and Doggone It, People Like Us”

By Scott Burris

We may be living in a golden age of group-think. A weekly reminder is poor Paul Krugman railing against the apparently universal belief in America and Europe that we’ve got to cut budgets right now or disaster will strike. He calls this a Zombie idea, a false claim that has been falsified with plenty of stakes in the heart, silver bullets and blows to the head, but will not stay in the grave.

Closer to home for us in public health is the claim that Americans don’t like government rules regulating their behavior and meddling with their preferences.  Cass Sunstein and Richard Thaler have delivered some solid blows to the idea that paternalism typically messes with solid preferences. As we celebrate Public Health Week, I want to highlight two recent papers that show that Americans, like the children in Mary Poppins, actually like their nannies, who do some pretty great things.

Public Health Law Research has recently posted the manuscript of a paper that Evan Anderson and I have prepared for the Annual Review of Law and Social Science. The paper describes the dramatic rise of law as a tool of public health since the 1960s in five major domains: traffic safety, gun violence, tobacco use, reproductive health and obesity.  These topical stories illustrate both law’s effectiveness and limitations as a public health tool. They also establish its popularity by the most apt of metrics – the willingness of legislators to enact it. The one picture worth a thousand words, below, depicts the rapid adoption of a variety of interventions by state legislatures. (By the way, the five examples also show that public health law research can and does influence the development and refinement of legal interventions over time.)

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Reducing Gun Violence in America

Typically, we would avoid such a shameless plug for our researchers — we’d be a little more subtle. But, we can’t help it this time. This book is the best $10 you’ll spend all year.

A little less than a month ago, Johns Hopkins University convened more than 20 of the world’s leading experts on gun violence and policy to summarize their research and recommend policy changes. This 282-page book features empirical research from the leading experts in the field covering the topics of mental health and gun violence, gun law enforcement, high-risk guns, international case studies of responses to gun violence, the Second Amendment, public opinion on gun policy, and concludes with a summary of the recommendations for reforms to Federal policies.

Chapter 3, “Preventing Gun Violence Involving People with Serious Mental Illness,” features research conducted by Jeffrey Swanson, PhD, and his team of researchers based at Duke University. The research presented was funded by PHLR and the National Science Foundation.

Seriously. Check it out.

PHLR Annual Meeting Post-Mortem

This past week, PHLR hosted 150 researchers, lawyers, public health practitioners and others for our fourth annual meeting. With our theme for the conference in mind, “Driving Legal Innovation,” our attendees shared results of evaluations of laws and regulations, offered up suggestions for new ways to use law to improve health, and attacked head on the issues facing the United States and our public health.

While you wait for more multimedia content, here are a few highlight moments: Continue reading

Part I- Fragmentation in Health Care: The Patient’s Perspective

This past September, I had the unfortunate and ironic experience of transitioning from conducting research on the American healthcare system to being a patient in the American healthcare system.  In September, I was diagnosed with testicular cancer, while working as a research assistant for Professor Einer Elhauge, scouring the Affordable Care Act for regulatory powers with potential for defragmenting our national healthcare system.

Professor Elhauge, recently described fragmentation as a systemic lack of coordination between physicians, as well as between physicians and hospitals.  This fragmentation results in increased medical cost and medical errors.  My experience as a patient has led me to believe that defragmentation could help reduce other, less quantifiable, emotional and psychological costs to patients.  I will attempt to demonstrate this through recounting the first half of my story.[1]

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