Xolair for Chronic Itch: Magic Bullet or Marketing Hype?

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:

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The Ban on Federal Funding of Syringes — continued

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 edited volume stemming from the Petrie-Flom Center’s 2011 Annual ConferenceThe 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:

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

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 at 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

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.

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Impact of the Sequester on Health Care: By the Numbers

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

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

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?

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

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.

Israeli High Court of Justice Allows Sperm Donor to Take Back His Sample

As Ha’aretz reports, (H/T Melanie Mader and Nir Eyal) the Israeli High Court of Justice has just decided a fascinating reproductive technology case. As the article reports:

Galit is a 39-year-old single mother who has a three-year-old daughter conceived through a sperm donation. After giving birth, Galit (who preferred that her real name not be revealed) purchased five more samples of sperm from the same donor and paid an annual fee to store them for her. When Galit, who lives in Florida, decided to try to become pregnant again she bought a plane ticket to Israel for that purpose. But one night, she got a surprising phone call. “I was told coldly that the donor had changed his mind. He had changed his lifestyle, become religiously observant and had written a letter to the Health Ministry confirming this. The caller ended by saying, ‘Of course we will return the payment for storing the sperm’ – a small, negligible amount.” At first, Galit continues, “I thought someone was playing a prank on me. I felt that my feelings were being totally ignored. This was about my future children. Maybe I wouldn’t be able to have more children from that donor, and therefore my daughter would not have biological siblings.”

Galit launched a legal battle, which ended two weeks ago with a High Court of Justice ruling rejecting her request to receive the sperm she had paid for. The court found that the donor’s right to change his mind after making the donation takes precedence over the recipient’s right to use the sperm in order to give birth to biological siblings for her daughter.

As it happens, these are the exact issues I wrote about in 2008 in a pair of articles, The Constitution and The Rights Not to Procreate, 60 Stan. L. Rev. 1135 (2008) and The Right Not to Be a Genetic Parent, 81 S. Cal. L. Rev. 1115 (2008). I have yet to get a hold of a translation of the new judgment into English, but from the reporting it seems as though the Court agreed in part and disagreed in part with the analysis I offer in these papers (particularly the latter one):

They agree with me that there is a “Right Not to Be a Genetic Parent” and my argument that it is best conceived of as a right to avoid a kind of emotional distress from what I call “attributional parenthood” — the attribution by oneself, third parties, and/or the resulting child of unwanted parenthood. Where we seem to part ways is that I view this as a right capable of waiver, and argue that it should clearly be waiveable by contract, which there appears to be in this case, while the Israeli High Court appears to treat it more as an inalienable right.

I may have more to say once I’ve read the whole opinion in English, but for now one sociological fact: As Ellen Waldman among others has noted, and born out by my own time teaching there, Israel is an incredibly pro-natalist society that strongly funds and favors the use of reproductive technology and family formation in general. This case is thus interestingly at variance with others the Israeli judiciary has decided in the reproductive technology context, such as the Nachmani v. Nachmani case (involving a dispute over frozen pre-embryos) where the court has been more disposed to favoring the right to be a genetic parent and allowing reproduction despite disputes.

The article reports that Galit will seek rehearing in front of a larger panel of the High Court soon, so perhaps this is not the end of the litigation.

Twitter Round-Up (2/16-2/23)

By Casey Thomson

This week’s round-up discusses the upcoming cases relevant to bioethics in the Supreme Court, the benefits of the Physician Payment Sunshine Act, the surprisingly low effectiveness rate of this year’s flu vaccine, and the problems with ACA’s Accountable Care Organizations. See below for details and more summaries:

  • Frank Pasquale (@FrankPasquale) shared a post on what’s being called the “alcoholism vaccine” being developed at the Institute for Cell Dynamics and Biotechnology at Universidad de Chile. The vaccine, which would have to be administered every 6 months or year, would mimic the alcohol intolerance mutation that prevents the breaking down of acetaldehyde and produces an instant “hangover-type” state. (2/16)
  • Dan Vorhaus (@genomicslawyer) retweeted a timeline from the Center for Law and Bioscience at Stanford Law’s blog giving dates for the upcoming Supreme Court cases relating to biosciences. (2/17)
  • Frank Pasquale (@FrankPasquale) additionally included a piece on the Physician Payment Sunshine Act, a provision of the Affordable Care Act that would “[require] manufacturers of drugs, medical devices and biologics to report the monetary value of gifts and payments to doctors and teaching hospitals on a publicly accessible website.” The author of the piece, a family physician with 15 years of experience, discussed his support for the plan. (2/17)
  • Michelle Meyer (@MichelleNMeyer) retweeted a link explaining the scientific foundations of the Brain Activity Map Project, namely how it aims at “reconstructing the full record of neural activity across complete neural circuits” to better understand “fundamental and pathological brain processes.” (2/18)
  • Arthur Caplan (@ArthurCaplan) posted a news story on police arresting those involved in the illegal harvesting of eggs from women in Bucharest, Romania. The police reports claim that 11 suspects have been implicated in the trafficking, which would harvest the eggs to be sold to Israeli couples with fertility problems. (2/19)
  • Alex Smith (@AlexSmithMD) retweeted a link to his post on asking about a patient’s PPD (preferred place of death), noting that this is not one of the concerns often cited as part of advanced planning procedures. Such a practice was considered “vital” in the UK, in contrast. (2/20)
  • Alex Smith (@AlexSmithMD) shared a link to a post on the blog he co-runs, GeriPal, on “Five Things Patients and Physicians Should Question in Palliative Care and Geriatrics.” The post shares the two lists posted by the American Academy of Hospice and Palliative Medicine (AAHPM) and the American Geriatrics Society (AGS), which Smith claims “provide targeted, evidence-based recommendations to help physicians and patients have conversations about making wise choices about their care in order to avoid interventions that provide little to no benefit.” (2/21)
  • Arthur Caplan (@ArthurCaplan) also included a link reviewing the low effectiveness of this year’s flu vaccine: there was evidence that it was only effective in 56% of the cases, on the low end of the usual 50-70% effectiveness rate. His tweet noted that this was strong evidence in favor of mandating the vaccine for healthcare workers. (2/21)
  • Michelle Meyer (@MichelleNMeyer) posted an op-ed piece by The Wall Street Journal about the problems with Affordable Care Act’s Accountable Care Organizations (ACOs), namely their false assumptions: that success can come without changing doctor behavior, and without changing patient behavior, in a way that will save money. (2/23)

Job Opening: Touro College Jacob D. Fuchsberg Law Center

Touro College Jacob D. Fuchsberg Law Center invites applications from experienced health law teachers and scholars for the Kermit Gitenstein Distinguished Visiting Chair in Health Law and Policy. Touro is seeking a nationally-known professor in the field of health law and policy to fill the chair for the spring semester in 2014. The Gitenstein visiting professor will teach at least one course at the law school, deliver public lectures, and participate fully in faculty and student life. Touro Law Center is part of Touro College, which includes New York Medical College—one of the largest private health sciences universities in the nation. The visiting chair will have the opportunity to develop collaborative initiatives with the medical profession in general and New York Medical College in particular. Women, members of minority groups and others whose background will contribute to the diversity of the faculty are encouraged to apply.

Touro Law Center is a dynamic institution that is at the forefront of legal education in this country, dedicated to producing practice-ready graduates. Touro’s students have the unique opportunity to take advantage of the first-ever law campus in the United States—a law school adjacent to and working with both a federal courthouse and a state courthouse. The law school is located in Suffolk County, Long Island, approximately an hour outside of New York City.

Interested candidates should send a cover letter and resume at the earliest possible date for full consideration. Contact: Fabio Arcila, Jr., Appointments Committee Chair and Associate Dean for Research and Scholarship, at farcila@tourolaw.edu.

Touro College is committed to the principles of equal employment opportunity. Our practices and employment decisions regarding employment, hiring, assignment, promotion, compensation, and other terms and conditions of employment are not to be based on an employee’s race, color, sex, age, religion, national origin, disability, ancestry, military discharge status, sexual orientation, marital status, genetic predisposition, housing status, or any other protected status, in accordance with applicable law. Our policies are in conformance with Title IX, 1972 Education Amendments.

Final Tally on Insurance Marketplaces

By Nicolas Terry

The Commonwealth Fund, here, has a very useful update on state choices for their marketplace types. The importance of these exchanges is noted by the authors: “The Congressional Budget Office estimates that by the end of next year some 9 million people will have enrolled in plans offered through their state marketplace, rising to 25 million by 2022. The majority of the enrollees will also receive premium subsidies.”
The final tally?
  • State-run: 17 plus DC
  • State-federal partnership: 7
  • Federally-facilitated: 26

Professional Athletes and Personal Responsibility for Health

[Disclaimer: I am not involved in this, and the views expressed here are entirely my own.]

Concussions and Performance Enhancing Drugs (PEDs) have been the dominant subject of concern in the sports world recently, and for good reason, but I would like to highlight an often overlooked and more general problem.  Our athletes are rewarded for pushing their bodies to the brink to accomplish majestic feats, requiring physical perfection.  We laud playing through injuries to succeed at the pinnacle of sport, or recovering from injuries at super human speeds, only to return those bodies to the brutal punishment of competition.[1]  With these pressures, Concussions and PEDs can be viewed as mere symptoms of a culture that runs from the fans to the teams to the players themselves, asking them to sacrifice their bodies, sometimes, to the detriment of their long-term health.  In this new age of awareness about player health, we should be asking: Are athletes making properly informed rational choices about their health?  Or are there situations where neither the players nor their teams are properly incentivized to protect long-term player health due to the culture described above?

Some recent stories have exemplified the culture:

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Job Opening — Henry M. Jackson Foundation for the Advancement of Military Medicine Seeking Bioethicist

HJF is seeking a Bioethicist to provide support under an NIH-funded contract to the Division of AIDS (DAIDS) at the National Institute of Allergy and Infectious Diseases (NIAID), a component of NIH, located on Rockledge Drive in Bethesda, Maryland.  Under the NIH Contract, HJF’s separate operating division, HJF-DAIDS, provides scientific and operations support to DAIDS including the Basic Sciences Program (BSP). Responsibilities include researching and preparing background materials on bioethical issues relevant to NIH/NIAID research for use by NIAID staff; reviewing clinical trial protocols upon request; working with NIAID staff to identify, coordinate, and resolve issues concerning ethical principles and the application of United States and international regulations and ethical guidelines in international settings; providing expert input in planning and organizing stakeholder meetings on bioethics topics.  Excellent research, oral communication and writing skills needed, and experience and advanced training in bioethics required.

For more information and to apply, please see www.hjf.org and click on Careers.