Month: February 2013

Xolair for Chronic Itch: Magic Bullet or Marketing Hype?

Jonathan Darrow Leave a comment

By Jonathan J. Darrow

Earlier this week, the New York Times reported that Xolair (omalizumab), a monoclonal antibody approved in 2003 to treat allergic asthma, had recently shown efficacy in relieving hives patients of chronic itch (See Laurie Tarkan, Drug to Treat Asthma Could Relieve Hives Patients of a Chronic Itch, Study Says, N.Y. Times, Feb. 25, 2013, at A5).  The article noted that a Phase 3 trial (usually, the final phase before FDA approval) showed that a monthly injection of Xolair “significantly reduced hives and itchiness.” Quoting the lead author of the study, the article reported that Xolair “is the magic bullet patients have been waiting for for the last 40 years.”  Is it?

An initial concern is the large number of conflicts of interest associated with the study. An examination of the Phase 3 trial as published in the New England Journal of Medicine (NEJM), on which the New York Times article is based, reveals that the trial was “[f]unded by Genentech and Novartis,” both of which sell Xolair.  The lead author and at least one other co-author of the study have received consulting fees from one or both companies, while another of the co-authors (Karin Rosen) is the medical director for Genentech.  Conflicts of interest, however, do not necessarily mean that the drug is in fact ineffective.  To determine efficacy, one must look at the evidence.

The NEJM study reports that test subjects received either placebo or Xolair at doses of either 75 mg, 150 mg, or 300 mg.  Starting from a baseline itch-severity score of about 14, the data were as follows:

Read More

The Ban on Federal Funding of Syringes — continued

Temple University Center for Public Health Law Research Leave a comment

People arguing that our federal government spends “too much” sound more and more like cynics by Oscar Wilde’s famous definition: knowing the price of everything and the value of nothing.

I’m neither for big government nor small government. I’d like government that does important things effectively and efficiently. One very effective and efficient way to spend federal money would be on syringe exchange, probably the single most effective non-medical intervention we’ve ever devised to fight HIV. Unfortunately, the Congress that has endless time and energy to debate symbols has no time or energy to end the ban on paying for syringes with federal funds.

amfAR has put out a very nice short film on this, as part of its renewed effort to convince Congress to end the ban.  It makes a convincing case, with simple stories and basic facts. Pass it on.

The Globalization of Health Care: Legal and Ethical Issues – Now Available from OUP

The Petrie-Flom Center Staff Leave a comment

The edited volume stemming from the Petrie-Flom Center’s 2011 Annual Conference – The Globalization of Health Care: Legal and Ethical Issues, I. Glenn Cohen, ed. (Oxford University Press, 2013) – is now available for purchase through the publisher, Amazon, or other outlets.  You can also download the introduction and front matter for free here.

The Globalization of Health Care: Legal and Ethical Issues is the first book to offer a comprehensive legal and ethical analysis of the most interesting and broadest reaching development in health care of the last twenty years: its globalization. It ties together the manifestation of this globalization in four related subject areas – medical tourism, medical migration (the physician “brain drain”), telemedicine, and pharmaceutical research and development, and integrates them in a philosophical discussion of issues of justice and equity relating to the globalization of health care. The time for such an examination is right. Medical tourism and telemedicine are growing multi-billion-dollar industries affecting large numbers of patients. The U.S. heavily depends on foreign-trained doctors to staff its health care system, and nearly forty percent of clinical trials are now run in the developing world, with indications of as much of a 10-fold increase in the past 20 years. NGOs across the world are agitating for increased access to necessary pharmaceuticals in the developing world, claiming that better access to medicine would save millions from early death at a relatively low cost. Coming on the heels of the most expansive reform to U.S. health care in fifty years, this book plots the ways in which this globalization will develop as the reform is implemented. The book features leading academics from across the world and different academic disciplines (law, philosophy, medicine, public health, government, business and geography) and outside academia to provide an international and interdisciplinary perspective.

TOC below the fold:

Read More

Apr 4: Dan Brock delivering the Gay Lecture on “The Future of Bioethics”

Nir Eyal Leave a comment

Please join the Division of Medical Ethics for:

The 2013 George W. Gay Lecture in Medical Ethics

Dan W. Brock, PhD
Frances Glessner Lee Professor of Medical Ethics, Department of Global Health and Social Medicine, HMS

“The Future of Bioethics”
Thursday, April 4, 2013
4:00 PM

Harvard Medical School

Tosteson Medical Education Center

Carl W. Walter Amphitheater
260 Longwood Avenue, Boston

Please pass this invitation along to other interested friends and colleagues.
RSVP to DME@hms.harvard.edu.

The George W. Gay Lecture is the oldest endowed lectureship at Harvard Medical School, and quite possibly the oldest medical ethics lectureship in the United States. The lectureship was established in 1917 by a $1,000 gift from Dr. George Washington Gay, an 1868 graduate of HMS. Since its inception, many of the nation’s most influential physicians, scientists, researchers and social observers, including Erich Fromm, Felix Frankfurter, Margaret Mead, Elizabeth Kübler Ross, E.O. Wilson, and Joshua Lederberg have given the Gay Lecture. Elie Wiesel, Marian Wright Edelman, Paul Krugman, Nicholas Kristof and Donald Berwick have given recent Gay Lectures.

Flu Vaccine Mandates for Health Care Workers

Temple University Center for Public Health Law Research Leave a comment

According to officials, the worst of this year’s devastating flu season should be over in most parts of the country. But in early January, the flu had hit 47 of 50 states. According to the CDC, a total of 78 influenza-associated pediatric deaths have been reported. Throughout this terrible flu season, there’s been much talk about vaccination mandates for health care workers.

States have started passing legislation regulating health care worker flu vaccination, and an increasing number of hospitals have started implementing policies in attempt to reach the Healthy People 2020 goal of having 90 percent of health care workers vaccinated. Only two-thirds of health care workers were vaccinated against the flu last year. This can leave patients at risk and hospitals short-staffed because of absenteeism.

Read More

Impact of the Sequester on Health Care: By the Numbers

kbooth Leave a comment

By: Katie Booth 

The looming sequester will have a significant impact on health care, including cuts to Medicare, FDA, CDC, NIH, and Affordable Care Act programs. Budget cuts could slow down the drug approval process, impede the tracking of infectious diseases, and lead to layoffs for hundreds of thousands of workers in the health care sector. Read on for sequestration by the numbers…

Medicare:

  • Medicare cut by 2% ($11 billion) (not set to begin until April 1st, 2013, unlike other sequestration cuts, which are set to begin on March 1, 2013)
  • Physicians’ payments cut by 2%
  • Hospital Medicare reimbursement cut by $5.8 billion
  • Hospitals could end up with especially large cuts under the sequester because other parts of healthcare system run on longer term contracts
  • Loss of almost 500,000 health care sector jobs in the first year of the sequester according to an American Medical Association and American Hospital Association study, including job losses for 40,000 practitioners such as physicians and dentists

FDA:

  • FDA cut by 8% ($318 million)
  • FDA public funding cut by $206 million
  • FDA industry user fees cut by $112 million (for an interesting discussion of user fee cuts and the sequester, see Patrick O’Leary’s Bill of Health blog post)
  • Cuts by department (assuming 8% across-the-board cuts): $71 million to Foods, $39 million to Human Drugs, $17 million to Biologics, $11.3 million to Animal Drugs, and $26.5 million to Devices
  • Longer drug approval process is likely
  • Layoffs and furloughs likely
  • 2,100 fewer food safety inspections

Read More

Conference — After the Storm: New Directions in Health Policy and Law at NEU Law

The Petrie-Flom Center Staff Leave a comment

From the Northeastern University School of Law Program on Health Policy and Law:

Join us for a day of informative discussion and exploration with some of the nation’s leading policymakers and researchers in health policy and law. Engage in conversations that examine the new directions for health policy and law, regionally, nationally and globally in the wake of the tumultuous events of 2012, including the Supreme Court’s ACA decision and the US Presidential Election.

April 19, 2013. Please see conference website for agenda and registration information.

Experiential Training in Health Law?

crobertson Leave a comment

By Christopher Robertson

Many law schools are thinking about experiential education, and health law would seem to be a great opportunity.  There is a bewildering range of ways to implement experiential training, from simulation-based courses, to in-house clinics, along with placement clinics and hybrid clinics, and externships too.  Many of these seem to blur together on the margins.

The Center for the Study of Applied Legal Education’s 2010-11 Survey of Applied Legal Education (available on SSRN) found that of the 156 law schools responding, 17 had clinics whose “single predominate substantive focus” was defined as “health law,” which amounts to 1.5% of all clinics in the study.  (See p7.)  Also listed were 24 “elder law” clinics and 20 “disability law” clinics, which I suspect may overlap.  The report also shows 29 field placement programs (out of 145 schools responding), which focus on health law.  (See p8.)  In particular, I am aware of Harvard’s Health Law and Policy Clinic.   And SLU’s excellent health law program places clinic students in hospital settings.  I have come across other programs at Pitt, Suffolk, GW, and Northeastern.

We do not have a health law clinic at University of Arizona, but I have helped place my JD students in unofficial externships with the Tucson Family Advocacy Program, a medical-legal partnership that addresses some of the social determinants of health (e.g., a letter to a landlord to stop a roach infestation, to help address chronic child asthma).  Some of my students have also externed in the general counsel’s office of our academic hospital.  I also like to bring students with me to our clinical bioethics meetings, and some of those interactions have led to research projects and student presentations to the committee.  I have also engaged some of our top law students in helping me lead discussion sections for undergrads on some of the big health law cases, such as Jacobson, Griswold, Roe, and Raich.  (I firmly believe that teaching is a kind of experiential education, which develops core lawyering skills.)

I would love to hear from our readers in the comments section .  Do you know of other experiential education programs that focus on health law?  What do you do?  What works well?

Petrie-Flom Interns’ Weekly Round-Up: 2/09-2/22

The Petrie-Flom Center Staff Leave a comment

By Hyeongsu Park and Kathy Wang

  • In an unexpected reversal of policy, Florida Governor Rick Scott announced his support for a three year expansion of Medicaid in Florida. Once a critic of the federal health care proposals, Governor Scott joins a growing number of Republican officials who have swapped sides on the Medicaid expansion debate.
  • While considering the terms of health care packages, the Obama administration decided that mental health care coverage must be a component in health care insurance. This mandate was met with mixed reactions, as health insurance plans have been also split into multiple tiers offering varying degrees of services and provisions.
  • In a unanimous decision, the Supreme Court reinforced the authority of the Federal Trade Commission to block hospital mergers under antitrust legislation. While hospitals have been arguing that these mergers allow for a broader provision of services, the FTC pointed out it also increases hospital leverage with insurance companies, potentially raising prices.
  • A Kentucky hospital and 11 cardiologists are facing a lawsuit backed by hundreds of individuals over the use of unnecessary, risky procedures over more than two decades of operations.
  • The FDA recently released warnings strongly advising against the use of codeine for children. Codeine had been used as pain relievers after the removal of tonsils or adenoids, but there had been a series of overdoses and deaths even when it was prescribed within an acceptable range.
  • A controversial piece of legislation pending in Texas offers the possibility of allowing doctors to place do not resuscitate (DNR) orders on their patients if the patients are deemed “medically ineffective.”
  • A recent NPR debate showcased various experts considering the question of whether we should prohibit the genetic engineering of babies, and to what extent parents’ choices could constitute genetic engineering.