Navigating the New Field of International Health Law, Featuring Gian Luca Burci, Legal Counsel for WHO

This lecture, “Navigating the New Field of International Health Law,” will explore the intersection of health and international law and the emergence of International Health Law as a practice area. Featuring Gian Luca Burci, Legal Counsel for the World Health Organization, this program will focus on the growing interactions between health policy and various areas of international law, including international business transactions, intellectual property, international security, and human rights law. The program is sponsored by the Seton Hall Law Center for Health & Pharmaceutical Law & Policy and the International Law program at Seton Hall Law.

The event will take place at Seton Hall Law, Newark, NJ, on Wednesday, February 22, 6 to 7 p.m.  There is no charge. 1 New Jersey CLE credit will be available. Click here to make your reservation or for more information, please contact Sara Simon, Director, Healthcare Compliance Certification Program, at sara.simon@shu.edu or call 973-642-8190.

Research, the Avian Flu and Bioterrorism

In their zeal to keep us all alive, it seems fair to say that public health officials love bioterrorism preparedness measures. In fact, the only thing they might love planning for more is pandemics. So last month, when researchers at two different facilities revealed they were able to mutate the virulent H5N1 avian flu strain to pass between mammals simply through the air, the NIH was highly concerned.

The discovery is alarming because avian flu is considered one of the world’s deadliest pathogens, with a 60% mortality rate. But while avian flu viruses have infected humans in the past, those infections have come directly from birds. If the virus can be mutated into an airborne pathogen, the consequences can be catastrophic.

Two research teams (one led by Ron Fouchier of Erasmus Medical Center in the Netherlands, and the other by Yoshihiro Kawaoka of the University of Wisconsin) engineered the new bird flu strains. After growing the H5N1 strain for several generations, the scientists discovered the exact genetic mutations that allowed the virus to be transmitted by air between ferrets. The results could be easily duplicated if the teams publish their studies with full details.

The National Science Advisory Board for Biosecurity (NSABB), a U.S. government advisory panel that is run out of the NIH, asked the journals Science and Nature to delay publication of the research. The NIH released the following details in a press release:

Due to the importance of the findings to the public health and research communities, the NSABB recommended that the general conclusions highlighting the novel outcome be published, but that the manuscripts not include the methodological and other details that could enable replication of the experiments by those who would seek to do harm. The NSABB also recommended that language be added to the manuscripts to explain better the goals and potential public health benefits of the research, and to detail the extensive safety and security measures taken to protect laboratory workers and the public.

The request has sparked a debate about if and when it is appropriate to have oversight of dual-use research. As defined by the NSABB, dual-use research of concern is research that is “reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to public health and safety, agricultural crops and other plants, animals, the environment or materiel.”   A good synopsis of the bioethical implications of such research is considered by Alan Rozenshtein on lawfareblog.com.

One of the research team leaders, Ron Fouchier, responded that the NSABB’s advice amounted to one-country domination of a discussion with worldwide impact. At the same time, he conceded that the mutant strain is “probably one of the most dangerous viruses you can make.” The professor who oversees biosafety for University of Wisconsin, William Mellon, responded that the research is “society’s best defense against a pathogen that has shown time and time again that, in nature, it can adapt to human hosts with dire consequences for global public health.”

Science and Nature were slower to respond. Last month, Science Editor-in-Chief Bruce Alberts noted the journal’s initial hesitation to acquiesce to the NSABB recommendation-

“We strongly support the work of the NSABB and the importance of its mission for advancing science to serve society…At the same time, however, Science has concerns about withholding potentially important public-health information from responsible influenza researchers. Many scientists within the influenza community have a bona fide need to know the details of this research in order to protect the public, especially if they currently are working with related strains of the virus.”

Nature‘s Editor-in-Chief Philip Campbell replied along the same lines:

“We have noted the unprecedented NSABB recommendations that would restrict public access to data and methods and recognise the motivation behind them. It is essential for public health that the full details of any scientific analysis of flu viruses be available to researchers. We are discussing with interested parties how, within the scenario recommended by NSABB, appropriate access to the scientific methods and data could be enabled.”

The issue at hand is as one scientist, Peter Palese, opined in Nature: “We need more people to study this potentially dangerous pathogen, but who will want to enter a field in which you can’t publish your most scientifically interesting results?”

Just last week, both teams of researchers announced in an open letter published in Science and Nature that they agreed to pause their work for 60 days. In the meantime, the teams propose to discuss the benefits and safety measures of their work in an international forum for discussion and debate within the scientific community. The researchers stated in the open letter,

“We realize that organizations and governments around the world need time to find the best solutions for opportunities and challenges that stem from the work. To provide time for these discussions, we have agreed on a voluntary pause of 60 days on any research involving highly pathogenic avian influenza H5N1 viruses leading to the generation of viruses that are more transmissible in mammals.”

Where, when and how these discussions will take place on an international level remains to be seen, but the NSABB appears to have made its point.

An unintended effect of the recommendations is that they have called into question the role and purpose of the NSABB. The NSABB was created in 2004, as a response to the 2001 anthrax attacks and the subsequent public outcry for regulation of research with implications for bioterrorism. As past president of the American Society for Microbiology, Ronald Atlas, put it, “[t]here was a sense, whether right or wrong, that if the community did not act to protect the integrity of science, government would overreach and there would be censorship.” Instead of regulating scientific research directly, the NSABB panel of scientists was given the role of offering advisory opinions on sensitive issues.

Since 2004, the NSABB has only been asked to review six papers. Two of those papers, released in 2005, described the reconstruction of the deadly 1918 influenza virus. The NSABB recommended that the papers clearly define the public-health benefits of the research, but no other advice was given. This is partly why the NSABB’s current recommendation is unprecedented.

According to Amy Patterson, director of the NIH, a draft policy for dual-use research should be presented by the U.S. government this spring. The draft should present a comprehensive framework for the oversight of such research, and create a local review component. As she states it,

“Whatever system is put in place needs to have both aspects: some consideration up front when the work is funded, but also a component of local oversight and review. It starts with the investigator — he or she knows best what is emerging out of their work. But we also need a level of institutional review to provide a second set of eyes taking a fresh look. The earlier something is recognized, the more options for management you have.”

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, stated that the draft plan may require scientists to apply online for access to critical information, after explaining their need for details on dual-use research. As of right now, it is unclear who would judge the validity of such requests. It is worth noting that at least one other institution, the University of Maryland’s Center for International and Security Studies, has outlined potential oversight systems already.

The dilemma of dual-use research is already a global problem, and therefore requires a global solution. The World Health Organization commented after the H5N1 mutations, stating a deep concern about the possible misuses of the research. The WHO was quick to note the critical need for such scientific knowledge, but concluded that “such research should be done only after all important public health risks and benefits have been identified and reviewed, and it is certain that the necessary protections to minimize the potential for negative consequences are in place.”

As Laurie Garrett, senior fellow for global health at the Council on Foreign Relations, notes in a thorough review of international mechanisms for oversight of dual-use research, the first problem is that there are “no consistent, internationally agreed-upon regulations governing synthetic biology.” The only review that does currently exist is the “toothless” Biological Weapons Convention(BWC) from 1975, to which 165 states are party.

Last month, U.S. Secretary of State Hillary Clinton attended a BWC summit, and stated-

“The nature of the problem [dual-use research] is evolving. The advances in science and technology make it possible to both prevent and cure more diseases, but also easier for states and nonstate actors to develop biological weapons. A crude, but effective, terrorist weapon can be made by using a small sample of any number of widely available pathogens, inexpensive equipment, and college-level chemistry and biology. Even as it becomes easier to develop these weapons, it remains extremely difficult . . . to detect them, because almost any biological research can serve dual purposes. The same equipment and technical knowledge used for legitimate research to save lives can also be used to manufacture deadly diseases.”

The need for global cooperation on this issue is crucial.

In truth, it seems that pandemics fascinate most of society, and not just public health professionals. Last year saw the release of the movie Contagion, with a plot line appealing enough to enlist the acting talents of Gwyneth Paltrow and Matt Damon (for a great comparison of the movie to real-world issues, see  W. Ian Lipkin’s op-ed for the New York Times). Further, avian flu remains a present threat. Just this month, Chinese health authorities confirmed a bird-flu-related death, Indonesia reported the third death related to bird flu in three months, and there are reports of avian flu among birds in India. Given that H5N1 remains such a threat without the consideration of bioterrorism, the need for regulations on dual-use research is seemingly more apparent than ever.

The Needle (Exchange) and the Damage Done

As those nationwide prepared for their holiday gift exchange, American lawmakers inexplicably put an end to a different type of exchange:  a life-saving and successful public health tool called needle exchange.

House Republicans fought for, and won, a ban on federal funding for needle exchange programs in a massive spending bill passed in December that will fund the federal government until the fall of 2012.  The ban prevents the federal government from spending money funding needle exchange programs not only in the United States, but also restricts the State Department from funding syringe programs internationally.  Providing federal funding to such programs had been banned from 1988 to 2009, until finally the ban was ended after the election of Barack Obama.  Now it’s back.

These programs focus on high drug-use neighborhoods, providing free clean needles to intravenous drug users in an effort to prevent the spread of blood-borne diseases, including HIV/AIDS.  They are often accompanied by HIV counseling and testing, and typically also provide referrals to drug users for treatment.  After much debate about their effectiveness, data have shown that the programs drastically reduce infection rates and do not increase illegal drug use.  Further, the programs, which currently exist in 33 states, are widely supported by the scientific and public health community, from the CDC to the AMA to the National Academy of Sciences.  When the Washington, D.C. Department of Health looked at the efficaciousness of its needle exchange programs, 800,000 needles had been exchanged, 5000 HIV tests had been offered, and 900 people had been referred to drug treatment.  Unsurprisingly, the number of new HIV/AIDS infections dropped 60 percent in Washington, a city devastated by the HIV/AIDS epidemic.  In New York, the numbers of intravenous drug users with HIV have dropped from 50 percent in the 1980s to 16 percent today, following the implementation of a needle exchange program.

Not only do they make scientific sense, but they also make fiscal sense:  needle exchange programs reduce health spending in the long run.  According to a 2002 report by the Institute of Medicine, needle exchange programs save between $3,000 and $50,000 for each infection prevented.

But the news was not all baffling over the holidays.  In New Jersey, state lawmakers approved a bill allowing pharmacists to sell needles and syringes without a prescription, and it now awaits Governor Chris Christie’s signature.  Although previously against needle exchanges, Christie has said he has an open mind and will carefully review the bill.  And unsurprisingly, according to the New Jersey State Health Department, more than 40 percent of the state’s HIV or AIDS cases were a result of intravenous drug users’ use of contaminated needles.

When it comes to such common sense policy that is effective in reducing new infections, provides support and outreach to those struggling with addiction, is supported by data and the scientific community, and provides smart savings on health care costs in the long run, the ban on such a policy is not only confounding and irresponsible, but dangerous to us all.

Sources:

Clean Needles in New Jersey, N.Y. Times Editorial, Dec. 14, 2011, available at http://www.nytimes.com/2011/12/15/opinion/clean-needles-in-new-jersey.html?_r=1 (last accessed Jan. 3, 2012).

Emily Badger, Feds Poke Hole in Needle Exchange Funding, Miller-McCune, Dec. 20, 2011, available at http://www.miller-mccune.com/health/feds-poke-hole-in-needle-exchange-funding-38518/ (last accessed Jan. 3, 2012).

Kristen Gwynne, Risking Lives:  In 2012 Spending Deal, House GOP Slaps Ban on Federally Funded Syringe Exchange Programs, AlterNet, Dec. 16, 2011, available at http://www.alternet.org/newsandviews/article/749233/risking_lives%3A_in_2012_spending_deal,_house_gop_slaps_ban_on_federally_funded_syringe_exchange_programs/ (last accessed Jan. 3, 2012).

N.J. Lawmakers Approve Sales of Needles, Action News, Dec. 5, 2011, available at http://abclocal.go.com/wpvi/story?section=news/local&id=8455789 (last accessed Jan. 3, 2012).

Sarah Barr, Needle-Exchange Programs Face New Federal Funding Ban, Kaiser Health News, Dec. 21, 2011, available at http://www.kaiserhealthnews.org/Stories/2011/December/21/needle-exchange-federal-funding.aspx (last accessed Jan. 3, 2012).

Will Durant, The Story of Civilization, and Immunization and Human Subject Research, or “I Never Promised You a Rose Garden”

I am reading Will Durant’s Story of Civilization as of late–actually, I’ve been reading the splendid 11 volume set off and on since I first bought it at a garage sale some twenty years ago. The work of a lifetime, Durant and his collaborating wife, Ariel, published these volumes between 1935 and 1975–and few things are so well written. A gifted storyteller, Durant’s prose is lively, personal and terribly witty;  the march of civilization not so much an inexorable plodding of dates, but a series of movements punctuated by the fits and starts, foibles and peccadilloes of an all too human race. For the work, in effect “a biography of civilization” which is said to have put its publisher,  Simon & Schuster, on the map, Durant and his wife were awarded the Pulitzer Prize for General Non-Fiction in 1968 and the Presidential Medal of Freedom in 1977. It is no small point of alumni pride that for a number of years, early in his career, Will Durant attended and taught at Seton Hall.

At present I am reading The Age of Napoleon, and I cannot help but offer here some characteristic lines from Durant’s work. Of Benjamin Constant (1767- 1816), sometime aide to Napoleon, he writes:

… born in Switzerland, educated in a dozen cities, and finally embattled in France, so littered his life with unpaid debts, discarded mistresses, and political somersaults that it would hardly be profitable to dally with him here had he not come close to history in many frays, been loved to distraction by notable women, and been able to describe his faults with such eloquence, subtlety, and impartiality as might help us understand our own….

He came of a titled Swiss-German family that traced its pedigree through 800 years. We need go back no further than his father, who was so occupied with his own sins that he had little time to supervise his son’s…  On October 25, at Lausanne, [Henriette de Chandieu] gave birth to Benjamin; a week later she died, the first of many women who suffered from his irregularities. The father entrusted the boy to various tutors, carelessly chosen. One tried by beatings and fondlings to make the boy an infant prodigy in Greek. When the beatings endangered Benjamin’s health, he was transferred to a second tutor, who took him to a brothel in Brussels. His third tutor gave him a good knowledge of music, and, for the rest, relied on him to educate himself through reading. Benjamin read eight or ten hours a day, permanently injuring his eyes and his faith. He spent a year at the University of Erlangen, then he was transferred to Edinburgh, where he felt the final flurry of the Scottish Enlightenment; but there too he took to gambling, which became second only to sex in disordering his life. (p. 302-304, footnotes omitted).

Of a woman more than twice Constant’s age (the intellectual beauty, Isabella van Tuyll, who famously rejected Boswell decades prior) twice taken to educating the young man in “the wiles of women and the lies of men,” Durant tells us that she told Benjamin,

If I knew a young and robust person who would love you as much as I do, and who is no more stupid than I am, I would have the generosity to say ‘Go to her!’

Durant: “To her surprise and indignation, he soon found a young and robust person.”

And what does this have to do with Health Reform? Absolutely nothing, except to say that Durant’s work, which happens to chronicle the advances as well as the missteps of medicine in every age and most places, would make a great addition to your library.

Consider this account of vaccinations for small pox in England, while thinking a moment about human subject research, informed consent, and the foundation of experimental medicine and immunology:

In 1806 London recorded a singular event: it had gone a full week without a death from smallpox– that pustulous, feverish, face-marring, and infectious disease which had once been epidemic in England, and might again at any time swell into a deadly plague.

A modest English physician, Edward Jenner–addicted to hunting, botany, composing poetry, and playing the flute or the violin-made the miracle week possible by a decade of inoculations that finally overcame the conservatism of British society. The prevention of smallpox by inoculation with weakened virus from a smallpox-infected human being had been practiced by the the ancient Chinese; Lady Mary Wortley Montagu had found it customary in the Constantinople of 1717; on her return to England she recommended the procedure there. It was tried upon criminals, then upon orphans, with considerable success. In 1760 Drs. Robert and Daniel Sutton reported that in thirty thousand cases of smallpox inoculation they had twelve hundred fatalities. Could a surer method of preventing smallpox be found?

Jenner was led to a better way by noting that many milkmaids in his native Gloucestershire contracted cowpox from infected nipples of cows, and that these women were thereafter immune to smallpox. It occurred to him that a like immunity might be established by inoculating with a vaccine (vacca is Latin for cow) made from a virus of pox-infected cow. In a paper published in 1798 Jenner recounted a venturesome procedure which laid the foundations of experimental medicine and immunology.

…I selected a healthy boy, about eight years old, for the purpose of inoculation for [with] the Cow Pox. The matter was taken from a sore on the hand of a dairymaid who was infected by her master’s cows, and it was inserted, on the 14^th of may, 1796, in the arm of the boy…. On the seventh day he complained of uneasiness…. And on the ninth he became a little chilly, lost his appetite, and had a slight headache…. On the following day he was perfectly well….

I order to ascertain whether the boy, after feeling so slight an affection of the system from the Cow Pox virus, was secure from the contagion of the Small Pox, he was inoculated, the 1^st of July following, with variolous matter [variola is Latin for smallpox] immediately taken from a pustule…. No disease followed…. Several months afterwards he was again inoculated with variolous matter, but no sensible effect was produced in the constitution.

Jenner went on to describe twenty-two other cases of similar procedure with completely satisfactory results. He met with condemnation for what seemed to be human vivisection, and he tried to atone for using a consenting minor by building a cottage for him and planting a rose garden for him with his own hands. In 1802 and 1807 Parliament voted Jenner £ 30,000 to improve and spread his methods. In the course of the nineteenth century smallpox almost disappeared from Europe and America, and when it occurred it was in unvaccinated individuals. Vaccination was applied to other ailments, and the new science of immunology shared with other medical advances, and with public sanitation, in giving modern communities as much health as is allowed by the harassments of poverty, the fertility of ignorance, the recklessness of appetite, and the patient inventiveness of disease. (p. 392-2, footnotes omitted).

As for the leap in immunology, Jenner’s work, was not universally acclaimed– at least not early on. In addition to the above mentioned moral approbation he weathered with the help of the time-tested gift of roses, the feared potential “side-effects” of his vaccine were chronicled in this caricature from 1802, entitled “The COW-POCK– or– The Wonderful Effects of the New Inoculation! Vide– the Publication of y Anti-Vaccine Society,” which is said to depict Jenner vaccinating patients who feared it would make them sprout cowlike appendages.

School-based Health Centers, Mental Health Care and the ACA

On October 20, 2010, Jamarcus Bell, a freshman at Hamilton Southeastern High School in suburban Indianapolis, hung himself.  He was 14.

In a lawsuit filed last week, his mother, Natalie Moore, alleged that Bell was repeatedly bullied by other students because of his race, “perceived homosexuality,” and “emotional disability,” and that the school corporation was aware of the bullying and did nothing to stop it and prevent his death.  Brian Smith, the district’s superintendent, responded this week, denying Moore’s allegations, and argued that “teachers and administrators took multiple steps to assist the student and his family.”  Notwithstanding the merit of the lawsuit, this is yet another headline in what has clearly become a nationwide epidemic of bullying.  Parents are concerned, schools are scrambling, and state legislatures are eyeing changing the laws:  Michigan’s legislature just approved an anti-bullying bill which will likely be signed into law by the governor in the near future.

Mental health services are at the heart of the debate:  are schools doing enough to not only prevent bullying, but also to ensure that students have an adequate support system?

Just 125 miles southeast of the Hamilton Southeastern School District, in Hamilton County, Ohio, Oyler School is also receiving public attention.  But not because it is the latest in a string of schools marred by alleged bullying incidents; rather, the school on the west side of Cincinnati is a school that has instituted an innovative system that may represent the future.

Just more than a decade ago, Oyler represented much of what was wrong with schools located in impoverished urban areas:  more than 80 percent of its students did not reach tenth grade, it had declared an academic emergency, and was the lowest performing school in Cincinnati.  Last year, the high school graduation rate was 82 percent, and the attendance rate is now 94 percent.  So how did the school turn its fate around so quickly?

Oyler adopted a community-based approach, in which the school persuaded various health care providers to relocate their offices directly at the school.  Today, the providers are housed in a full-blown health center, complete with a full-time nurse practitioner and a part-time pediatrician.  There is a vision clinic, a dental clinic, and six mental health counselors — including three full-time psychologists.  The clinic offers more than just healthcare services:  preschool, daycare, and afterschool programs are available.  It also assists families in applying for Medicare, attaining bus passes, and even provides dinner to families.  Taxpayers do not foot the bill for the services; the school simply reorganizes resources to keep costs down.  Of course, poverty still grips the school — 92 percent of children are on subsidized lunches and 112 students are homeless — but the students are having their health needs fully addressed.  As a result, Oyler has become a model for other schools in Cincinnati, and officials from Tennessee and New York City have recently visited.

The federal government has picked up on the school-based health center idea.  Under the Affordable Care Act, the federal government offered grants to schools to assist in creating and updating school-based health centers like the one at Oyler:  these centers bring the services to the students, relocating health services, including mental health services, into schools.  After receiving over 350 applications in 2010, the U.S. government awarded $95 million in grant money this past summer to 278 school districts and programs to expand such clinics.

This will build on the amount of school-based clinics that existed nationwide prior to the passage of the ACA.  According to the National Assembly on School-Based Health Care, prior to the awards this summer, there were 1900 school-based health centers providing a spectrum of health care services to nearly two million children and adolescents in 44 states and the District of Columbia.  School-based health centers offer everything:  prescriptions, treatment, education, and screenings.

Additionally, for those wondering how to combat the nation’s growing problem of bullying, three-fourths of the school-based health centers offer mental health services:  from completing assessments to crisis intervention to offering therapy.  And, with more and more stories like those of Jamarcus Bell dominating national headlines, placing mental health services where they are most needed – our nation’s schools – could be a vital tool in the fight against bullying.

Sources:

Affordable Care Act (ACA) Grants for School-Based Health Centers Capital (SBHCC) Program, grants.gov.

Chris Kenning, Cincinnati’s Oyler Elementary Finds Winning Formula to Fight Poverty, Louisville Courier-Journal, Apr. 23, 2011.

Chris Sikich, Superintendent Says HSE Acted to Prevent Bullying, Indianapolis Star, Dec. 1, 2011.

Dan McFeely, Hamilton Southeastern Sued Over Bullying After Student’s Death, Indianapolis Star, Nov. 29, 2011.

Joy Resmovits, School-Based Health Care Programs Receive $95 Million From Affordable Care Act, Huffington Post, July 14, 2011.

Oyler’s School Based Health Attracts National Attention, Local 12, WKRC Cincinnati, Nov. 29, 2011.

School District Releases Letter Regarding Lawsuit Over Student’s Suicide, Fox 59 News, Nov. 30, 2011.

Suit Links Suicide to School Bullying, Nov. 30, 2011.

The Facts:  Funding for School-Based Health Centers Under the Affordable Care Act, National Assembly on School-Based Health Care.

The Global Burden of Stillbirth

As a teenager in the late 1980s, I was a huge fan of the model Christy Turlington Burns.  As I’ve blogged about before, in 2011 there’s much more to admire about her than her enduring beauty.  Over the weekend, Turlington Burns and others representing her advocacy organization, Every Mother Counts, ran the ING New York City Marathon to, in her words, “make the vital connection for people that so many pregnant women live far from health services around the world and that distance does make a difference [in the prevention of maternal mortality]. Simply put, we want to run so that others don’t have to…”

Just as distance makes a difference in the prevention of maternal mortality, it also makes a difference in the prevention of stillbirth.[1] In the introduction to a special series of articles that ran in The Lancet in April of this year, Zoe Mullan and Richard Horton note that 98% of the estimated 2.64 million stillbirths each year, “occur in low-income and middle-income countries, and in places such as south Asia and sub-Saharan Africa, at least half of them take place during labour or birth.”  In addition to reducing maternal and newborn mortality rates, then, closing the literal and figurative distance between pregnant women and childbirth care would prevent many stillbirths from occurring.

In a pair of important articles – Stillbirths: What Difference Can We Make and At What Cost? and Stillbirths: How Can Health Systems Deliver for Mothers and Babies — The Lancet’s Stillbirths Series Steering Committee delves into the prevention question in detail.  The Steering Committee systematically assessed 35 potential interventions to determine (1) whether they were effective at reducing the stillbirth rate and (2) “whether they are affordable and implementable in low-income and middle-income countries.”   The following ten interventions passed the Committee’s test and were strongly recommended for implementation: “periconceptional folic acid fortification, insecticide-treated bednets or intermittent preventive treatment for malaria prevention, syphilis detection and treatment, detection and management of hypertensive disease of pregnancy, detection and management of diabetes of pregnancy, detection and management of fetal growth restriction, routine induction to prevent post-term pregnancies, skilled care at birth, basic emergency obstetric care, and comprehensive emergency obstetric care.”  Of these, the Committee recommended that skilled care at birth and emergency obstetric care take priority, both because they were the most effective at reducing the number of stillbirths and because they additionally benefit women and newborn babies.

The Stillbirths Series Committee estimated that “[i]n 68 countries accounting for 92% of the worldwide burden of stillbirths in 2008, universal coverage of care (99%) with intervention packages in 2015 could save up to 1.1 million (45%) third-trimester stillbirths, 201,000 (54%) maternal deaths, and 1.4 million (43%) neonatal deaths at an additional cost of US $2.32 per person, which is well below the WHO and World Bank criteria for cost-effectiveness.”  While it seems only fair to consider this “triple return for every dollar invested” in determining funding priorities, the tragedy of stillbirth does not always “count.”

The World Health Organization’s Global Burden of Disease analysis, for example, which aims to “provide[] a comprehensive and comparable assessment of mortality and loss of health due to diseases, injuries and risk factors for all regions of the world[,]” does not factor in stillbirths.  The WHO explains on its website that “[p]erinatal mortality, defined as number of stillbirths and deaths in the first week of life per 1,000 live births, is a useful additional indicator, and work is ongoing to improve estimates of stillbirth rates, a major component of perinatal mortality.”  The United Nations’ Millennium Development Goals similarly fail to include reducing the rate of stillbirths.  This should change.  In the words of Mullan and Horton in The Lancet, “stillbirths matter to people” and “stillbirth prevention should be placed as highly on global and national health agendas as prevention of maternal and neonatal deaths.”

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[1] I thank Catherine Finizio, the Administrator of Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, for keeping me focused on this important issue.  (My prior posts are here and here.)  Cathy’s grandson, Colin Joseph Mahoney, was stillborn at 39 weeks gestation on November 10, 2008.

Are Fat Taxes All the New Rage?

The world’s first fat tax is finally here. Well, it’s not actually here (New Jersey’s Star Ledger Newspaper took the time to say “fat chance” to such a plan working in the U.S.), but it has been officially enacted in Denmark.

The tax applies to all foods that have a saturated fat content greater than 2.3%. The tax rate is 16 Danish kroner per kilogram of saturated fat (roughly $1.29 per pound). Danish officials expect the tax to generate somewhere between 1.5  billion and 2.75 billion Danish kroner annually. According to the Danish Agriculture and Food Council, a family with two adults and two children that does not change their eating habits can expect to pay an extra 1000 kroner a year (a little less than $200).

Interestingly enough, the goal of the tax is not to target obesity. The obesity rate in Denmark is 13.4%, which is 2.1% less than the European average. The last time the U.S. had obesity rates as low as Demark was in the 1970s. Instead, the fat tax is aimed at increasing the Danish life expectancy of 79 by three years over the next decade.

This type of legislation is not new for Danes. Denmark was actually the first country to institute a ban on trans fats in 2003, and last year the country instituted a 25% tax on sugary items like ice cream, chocolate and sweets. Sin taxes for soda, alcohol and cigarettes also exist. Advocates of these taxes note the benefit to preventative health and also the advantage of filling the government’s coffers. According to the secretary general of the European Public Health Alliance, Monika Kosinska,

“Denmark will not only increase general health amongst the population but will also ease the burden on the public health care system and increase its resources at a time of recession when [European] Member States are cutting public expenditure.”

Benefits aside, the criticisms of the new tax are numerous. In an article for The Atlantic, Edward Tenner notes the rich irony that Denmark, one of the world’s foremost producers of butter, cheese and bacon, is the first country to implement a tax on fat. Critics include, of course, the numerous producers of affected foods like butter, milk, cheese, meat and oil. One CEO of a Danish meat manufacturing company called the tax a bureaucratic nightmare.

Producers are required to pay the tax, and these costs will be passed on to consumers, suggesting that more Danes will shop abroad. Denmark’s central association of margarine producers (MIFU), has already filed a complaint with the European Union (EU) Commission arguing that the tax is noncompliant with EU free trade rules.

Other critics note that the tax may not be high enough to actually change behavior.

Given the similarity to soda taxes (previously discussed on this blog), it’s worth referring to a 2009 article published in the New England Journal of Medicine by Kelly Brownell and his team. They considered the public health and economic benefits of taxing high-sugar beverages and found that the 5% soda taxes that many U.S. states have enacted are too small to affect consumption. Their team proposed that a sugar tax on beverages would have to be much higher to lower soda consumption, at around 1 cent per ounce of beverage.

A 2007 study by the Forum for Health Economics and Policy focused on the ability of a fat tax to change behavior and found that a 10% fat tax on dairy would not reduce consumption by even one percent. The authors suggest that the tax rate would have to be much higher, but even a 50% tax may only reduce fat intake by 3%.

Some critics have offered suggestions on how to better address the problem both of obesity and shortened life-spans. Dr. Mike Rayner, Director of Oxford University’s Health Promotion Research Group, argues that Danes may switch from high fat foods to other unhealthy foods. He proposes that the overall unhealthiness of food should be taxed instead, not just a single nutrient. Simultaneously lowering taxes on fruits and vegetables could promote a healthier behavior change.

Dr. Yoni Freedhoff, medical director of the Bariatric Medical Institute in Ottawa, points to the public health issue of obesity as a societal problem. He notes,

“If we want to have legislation that deals with this problem, perhaps legislation that would deal with advertisement to children and zoning laws for fast foods around school would be a better place to start than a tax that is simply going to raise money and will not, in fact, change anything.”

NYU professor Marion Nestle finds the fat tax to be troubling for a different reason. To see individual behavior change, she argues that we must change the behavior of corporations “that make and market unhealthful products, spending vast fortunes to make them available, desirable and socially acceptable.” She cites a recent Lancet article on food environment factors that sees food processing, cost and marketing as drivers of consumption. She concludes, “[G]overnments seriously concerned about reducing rates of chronic disease should also consider ways to regulate production of unhealthy products, along with the ways they are marketed.”

Despite the multitude of criticisms, several other European countries have expressed a desire to follow suit– including France, Finland, Romania, Sweden, Norway, and even Britain. Americans should also be watching this social health experiment. But given that our country’s favorite condiment is mayonnaise, maybe the Star Ledger is right– it may not be time for a U.S. fat tax just yet.

It’s Been Over 50 Years Since the Discovery of Methicillin Resistant Staphylococcus Aureus (MRSA): An Anniversary No One is Celebrating

[Ed. Note: We are pleased to welcome Tara J. Hopper to HRW. She is a candidate for a Master of Laws (LL.M) degree in Health Law here at Seton Hall Law, having  recently graduated from Nova Southeastern University Shepard Broad Law Center, where she received her Juris Doctor with a concentration in Health Law. She also holds a Masters of Social Work (M.S.W.) with an emphasis in mental health from Barry University.  She has worked as a mental health therapist, a mental health advocate and legislative advocate for the Advocacy Center for Persons with Disabilities, Inc., as well as  ChildNet, Inc., and as the Senior Legislative Aide to Florida State Senator Walter "Skip" Campbell while he was acting as Senate Chair of the Committee on Children and Families. She became a strong advocate for creating awareness of, and drafting legislation to help protect patients from, methicillin resistant staphylococcus aureus (MRSA) after her best friend died of MRSA at the age of 33 in 2008. ]

On October 2, 1960, Dr. Patricia Jevons discovered new strains of Staphylococcus Aureus. These strains were later described as Methicillin Resistant Staphylococcus Aureus (MRSA) after being introduced through the British Medical Journal on January 14, 1961. Thus, the discovery of MRSA was fifty-one years ago this month, and the year 2011 marks the 50^th anniversary of when MRSA received its name and, as such, in a sense, came into being.

Unlike other anniversaries where people come together and celebrate, October 1, 2011 marks the third year in a row where MRSA survivors, family and friends of MRSA victims, and policy-makers, gather together to promote MRSA Awareness and to remember and honor loved ones who have been lost to MRSA. World MRSA Day is October 2^nd, and October has been declared World MRSA Awareness Month. The 2011 theme for World MRSA Day is “The MRSA Epidemic – A Call to Action,” and focuses on MRSA as a public health crisis.

MRSA is a bacterial infection that is resistant to penicillin type antibiotics, and for this reason, MRSA has been called a ‘super-bug.’  MRSA acquired within a healthcare setting is referred to as a Healthcare-Associated Infection (HAI), if contracted within the community it is referred to as a Community Associated Infection (CA).

Risk factors for acquiring HAI-MRSA include having a history of hospitalizations or surgeries, living in a long-term care facility such as a nursing home, recent use or long-term use of antibiotics, and having had a previous MRSA infection or colonization.

Risk factors for having acquired CA-MRSA include playing contact sports, sharing equipment or towels at a gym, using illegal intravenous drugs, and living in crowded, unsanitary conditions such as a jail or other institution. Your chances are also increased for developing CA-MRSA if you do not keep a pre-existing wound covered by a bandage, or you have a weakened immune system. It is believed that approximately 1% of the community’s population are “MRSA carriers” and are unaware that they have MRSA because they do not have an infection or any MRSA symptoms.  However, MRSA carriers can pass MRSA on to other people who may not have the immune system or antibiotic resistance to fight it.  In addition, people who have certain illnesses such as diabetic foot ulcers and cystic fibrosis have an increased risk of death when tested positive for MRSA.

MRSA infections become invasive when the MRSA infection is isolated in an area of the body that is normally sterile such as the blood, bone, lymph nodes, brain, heart, liver, spleen, kidneys, pancreas, ovaries, and various bodily fluids.  If an invasive MRSA infection is then left untreated, MRSA can spread throughout the entire body.  It is unusual for MRSA to be successfully treated after it spreads to multiple parts of the body.  When there is a delay in treatment for an invasive MRSA infection, the fatality rate of MRSA patients significantly increases. Early MRSA detection through mandatory screening allows for treatment of MRSA before it becomes invasive.

Some World MRSA Day activists argue that there has been such an exceptional increase in the incidence of MRSA that MRSA should be declared an ‘epidemic.’ However, MRSA has yet to be declared an epidemic by any state or federal authority.  Some experts argue that when data is inadequate to determine whether or not there has been an exceptional increase in the incidence of a disease that a “clear temporal increase” in the incidence should be sufficient to declare an epidemic.  Because MRSA screening and MRSA reporting requirements are not mandatory, except in a few states, it is likely that data is inadequate to determine the actual incidence of the disease.

However, recent data regarding MRSA related deaths show that The Center for Disease Control reported in 2007 that “approximately” nineteen thousand people die from MRSA every year. Other studies report that antibiotic resistant germs such as MRSA contribute to the death of approximately 70,000 hospitalized Americans each year.  It is unclear, due to a lack of historical data on MRSA, to fully understand the increase in incidence, and figure out how many people need to die in order to justify MRSA being declared an epidemic.

When issues reach epidemic status, federal dollars usually follow so that proper precautions can be taken, and further research can be done to find a cure and/or remedy.  With many government agencies tightening their belts across the nation, one may surmise that declaring MRSA an epidemic would be disfavored based on the funding requirements alone.  Although an increase in MRSA research funding can promote the development of new antibiotics for MRSA, MRSA research funding does not appear to be a strong federal priority.  In 2010, it was reported that scientists at the University of Nottingham in the UK researched cockroaches and locusts and found that tissues from their brain and nervous system of these bugs killed more than ninety percent of the MRSA in the study. Wouldn’t it be ironic if the MRSA Superbug ends up meeting its eternal demise through the use of antibiotics from actual bugs? Hopefully, through an increase in MRSA awareness, MRSA funding and research will increase so that MRSA related deaths can decrease.

Recent trends of state legislatures show both proposals and adoption of MRSA screening and reporting legislation that promote the early identification of MRSA, and preventing the spread of MRSA. Opponents of MRSA screening legislation argue that it is too costly, impractical and inconvenient. However, MRSA detection plates are available at only a little more than $1.50 per plate, and screening requires only a simple nasal swab to detect MRSA. Recent advancements in MRSA detection devices make it possible to receive test results within 50 and 75 minutes, whereas test results were previously only available within 18 to 48 hours. This shortened time in obtaining test results gives a hospital the ability to isolate and treat the MRSA patient before MRSA is spread to other parts of the hospital.

Although there are legal concerns that screening and reporting requirements may increase hospital liability in medical malpractice suits, MRSA screening upon admission would also be advantageous to hospitals in order to show that the patient had acquired MRSA before entering their facility, therefore, decreasing their opportunity for liability in these instances.  MRSA reporting may initially have a negative impact on hospitals that report higher MRSA rates, but when following MRSA screening procedures and MRSA prevention guidelines such as those provided by The Society for Healthcare Epidemiology of America (SHEA), it is likely that a hospital’s MRSA numbers will significantly decrease.  After the adjustment period is over, hospitals may be happy to report just how MRSA-free their facility has become, and everyone will benefit from such a decrease in this life-threatening infection.

Concerns About HPV Vaccinations and Bachmann Backlash

Truth: Human Papillomavirus (HPV) vaccines are also administered to boys.

When I came across The Washington Post’s article I found myself in shock after reading just the title. But then again, I realized, I don’t really know much about HPV, and so when the media, magazine advertisements and commercials for vaccines are so expressly targeted at females, I’ve had no reason to interpret these messages to mean that boys too can receive the benefits (and/or side effects) from vaccination. And this, perhaps, is the larger point: In a busy world with incomplete personal knowledge, it’s not really all that difficult to have media/celebrity inspired misconceptions about a drug.

Many types of the viruses associated with HPV are sexually transmitted, resulting in genital infections that may go away without any treatment but can also persist for many years; the viruses are thus categorized as either high-risk or low-risk HPVs. High-risk HPVs are less common, but they can cause cell abnormalities, and even result in cancer. Low-risk HPVs cause genital warts and other infections which may go away even if left untreated. Currently, Gardasil and Cervarix are the only two vaccines that have been approved by the Food and Drug Administration.

HPV has been the recent topic of political debate. In 2007, Texas governor Rick Perry was the first to take steps in an attempt, which was ultimately not successful, to mandate the vaccination for all middle school girls within his state as a prerequisite to school attendance. Such a state-mandated requirement is controversial because it is said to encroach on parental rights and, perhaps, upon religious rights as well.

Currently, only Virginia and the District of Columbia have successfully made HPV vaccination a requirement for school admission (though parents may rather easily opt-out of such requirements through various available provisions). Many members of society stand against the mandatory imposition or even the recommendation for children to receive HPV vaccination shots at the age of 11 or 12. Republican presidential candidate Michele Bachmann has said, “To have innocent little 12-year-old girls be forced to have a government injection through an executive order is just flat-out wrong. That should never be done. That’s a violation of a liberty interest. That’s — little girls who have a negative reaction to this potentially dangerous drug don’t get a mulligan. They don’t get a do-over.”

During her recent interview on NBC Today, co-host Matt Lauer sought to clear up Bachmann’s thoughts regarding Perry’s proposed statute and motivations behind his push. She said she believed that “crony capitalism” could likely have been the cause of the great push for the requirement for vaccination. She noted that “the Governor’s former chief of staff was the chief lobbyist for this drug company [Merck],” and that the same the drug company– which manufactures Gardasil– contributed to Perry’s campaign. She also suggested that the direct action the Governor chose to take in signing an executive order to mandate the vaccination rather than going through legislature to have a law passed may be further evidence of his attempt to appease Merck. In recent days, the New York Times has asked if the genesis behind Perry’s push for vaccination may have come from closer to home. The Times writes:

One potential explanation that has received far less attention is the influence exerted on Mr. Perry by a close confidante with expertise in women’s health: his wife, Anita Thigpen Perry, a nurse, country doctor’s daughter, and career-long advocate for victims of sexual assault who has been a vocal proponent of immunizations.

In the Matt Lauer interview,  Bachmann relayed an anecdote of a mother who had approached her crying and told her that after her little daughter received the vaccine, she suffered from mental retardation.

The side effects of mandatory vaccinations  would seem to be an inevitable spin-off  discussion in an era of health care reform dominated by litigation and controversy  revolving around  that other individual mandate, health insurance; but Bachmann has been roundly criticized as irresponsible for making/repeating the seemingly unfounded connection between mental retardation directly resulting from the vaccination. The statement lacks scientific validity, something that medical experts have been very quick to emphasize– particularly concerned with the rippling effects that her assertion/story may have in the minds of the public: “when politicians or celebrities raise alarms about vaccines, even false alarms, vaccination rates drop”.

All the more reason why the public ought to play active and responsible roles in obtaining factual information regarding health care options.  On the flip side, one might hope that those possessing the ability to influence and sway the public in any which way ought would practice discretion and be thoughtful about what they say and how these words may be received.

Health care experts have responded to Bachmann’s controversial story by offering monetary wagers if she could prove, with solid evidence, that a vaccine recipient developed a mental disability in response to the HPV vaccine. Some have labeled these offers as cynical and insincere, and chances are Bachmann will not take them up. Regardless, such reactions evidence the strong and persistent aftermath of Bachmann’s statement, and the understanding on the part of those familiar with public health of just how detrimental to vaccination rates such a statement can be. Ms. Bachmann refuses to apologize or retract.

For Vietnam, Sharp Increase in Infant Fatalities by Hand, Foot, and Mouth Disease

[Ed. Note: We are pleased to welcome Clarissa Gomez to HRW. She is a first year student at Seton Hall University School of Law and graduated in December, 2010 from The College of New Jersey with a B.A. in English and Women and Gender Studies, and a minor in Law, Philosophy and Politics. While she is fairly new to the world of health law, she is currently a representative for the SHU Health Law Forum. Being well-traveled and witnessing the healthcare disparities throughout the world, she has high interest in international healthcare regarding access to treatment and disease prevention, as well as those issues regarding womens' health.]

The World Health Organization (WHO) recently reported information regarding the current outbreak of Hand, Foot and Mouth Disease (HFMD) in Vietnam. While Avian influenza and Severe Acute Respiratory Syndrome (SARS) have been the two leading outbreak diseases in Vietnam over the past eight years, HFMD is the topic of the country’s current health concerns.  Traditionally, HFMD has been common in Vietnam and there have been reports of larger-scale outbreaks from time to time, but so far this year the infection and death toll statistics are already significantly higher than usual. More than 42,000 individuals have been sickened this year, a vast increase from the 10,000 to 15,000 cases that have been reported on average per year since 2008. The main targets of HFMD have been children three years old or younger, and so far 98 children have died from the disease– that is already about triple the  average annual number of chidren’s deaths.

Earlier this year I had the privilege of traveling the dusty, motorcycle-infested streets of Vietnam. After witnessing first-hand the severe lack of sanitary rules to govern sidewalk phở eateries and other food vendors, along with the knowledge that HFMD is most often spread from person to person through contact with virus-contaminated surfaces like unwashed hands, the recent report by WHO is not shocking. The virus can survive for a long period of time in the environment or sewage, which adds to the difficulty in preventing and controlling its spread. Children have the highest risk for infection since they lack the protection of antibodies that are developed within a person’s body with age. While no vaccine or specific treatment exists, the disease has generally been described as mild and quickly recoverable. So, then, what is surprising is the drastic increase in deaths from previous years; it is unclear what may account for this, and the Vietnamese Ministry of Health further warns that the number of cases will likely increase even more in the coming months as children most at risk resume preschool and kindergarten.

I had quite the experience traveling on the train called the “Reunification Express”;  it allows one to travel from north to south Vietnam and vice versa. I was told, and to my surprise, that the train had been modernized and had seen many improvements over the past few years. Suffice it to say, it was no Amtrak. The bathroom consisted of a toilet bowl with a hole that led directly to the train tracks and ground. I could only imagine where the goods of those who used it for relief ended up. Issues of personal hygiene and sanitary practices are at the forefront of the outbreak of HFMD, which is why I mention the train facilities above. The WHO report attributed the spread of HMFD to contact with fluid in blisters or infected feces. As disgusting as it sounds, encountering bodily waste on the street is not a terribly rare or shocking event in rural Vietnam. Perhaps it is a lack of — or disregard for– these everyday public health lifestyle practices that can, and most likely does, account for the statistics being reported by WHO.

Fortunately, the Ministry of Health is closely monitoring the situation and precautionary measures have already been implemented throughout the country in order to reduce further spread of the disease. All health care facilities have received guidelines for surveillance, prevention and treatment of the disease; training courses are being conducted for preventive medicine staff as well as pre-school teachers, and a nation-wide public awareness campaign on television and other means of media are relaying preventative measures to the citizens.

Increased standards of both personal hygiene and environmental care are crucial to the prevention of HFMD, as there is no specific medication administered to combat the disease. It is hopeful, then, that the campaign for heightened awareness will not only prevent the further spread of the virus and lessen the number of casualties due to HFMD, but that Vietnam as a country will benefit as well. Despite the numerous public health issues I encountered, it is, among the countries I’ve visited, one of my favorites.  And since my most recent trip, I hold Ho Chi Minh and Hanoi as two must go-to cities that I desire to travel back to in the future…but I just may not plan my trip between the months of March to May and September to December. Why? Southern Ho Chi Minh city has been one of the hardest hit by HFMD and these months are when the rates of infection are highest.

As tourism accounts for a relatively small but steadily increasing and significant portion of Viet Nam’s economy, it is not hard to believe that the institution of increased sanitary and public health measures, which one might presume will lessen the occurrence and spread of infectious diseases, will ultimately help Viet Nam from both a substantive health and an economic perspective.

Photo Credit: 1, by anjči via Flickr; 2 & 3, Clarissa Gomez

Apples and Fries: The New Look of McDonald’s Happy Meals (Toys Still Included)

Responding to pressure from parents and consumer groups, McDonald’s announced on Tuesday its “Commitments to Offer Improved Nutrition Choices” and serve up more nutritionally-balanced meal options, particularly for children.  Starting in September, Happy Meals will have apple slices and a smaller serving of French Fries (1.1 ounces instead of 2.4 ounces).  The company stated that “[b]y adding fruit in every Happy Meal, McDonald’s hopes to address a challenge children face in meeting the recommended daily consumption of produce” and noted that “[f]or those customers who prefer a side choice of apples only, two bags of apple slices will be available, upon request.”   McDonald’s vice president Ben Stringfellow has said that the company is considering other fruit choices such as “pineapple spears, raisins and carrot sticks.”  Other planned  changes in the next year include a 10% sodium reduction in chicken products, new beverage options of fat-free chocolate milk and 1% low fat white milk (in addition to the traditional sodas),  and increased access to nutrition information through mobile apps for iPhone, iPad, Blackberry, and Android devices.

Once the nutritional changes take effect, a Happy Meal with chicken nuggets will shrink from 530 calories and 23 grams of fat to 435 calories and 17 grams of fat.  Samantha Graff, director of legal research at Public Health Law and Policy, told Prescriptions, The New York Times health blog, that “McDonald’s has taken an extremely important step to help parents who want to please their kids while providing them with at least minimally nutritious food. We think it’s a terrific move.”  In an opinion piece, Chris Woolston, a writer for Booster Shots, the Los Angeles Times health blog, wonders whether healthier McDonald’s meals are the answer as

[t]o reshape their kids’ diets, parents need to make more meals at home, where they can write the menus and control the ingredients and portion sizes. If more healthful Happy Meals translate into more trips to the golden arches — as McDonald’s obviously hopes — the end result may be something other than happiness.

Sure, for companies like McDonald’s, it’s about the bottom line.  For parents, it’s about the health of their children.  Good, responsible eating does start in the home… but why let it end there?

(Click on these links for two posts from Booster Shots on calorie labeling and the push among health experts for a public calorie database.)

Take Them Away: Has Severe Childhood Obesity Really Come to This?

As a follow up to my previous post on junk food marketing to children and my earlier post on MyPlate — and any other post that I’ve written about children and fast food or junk food — I would like to direct your attention to a commentary recently published in the Journal of the American Medical Association which has caused quite a stir.  In “State Intervention in Life-Threatening Childhood Obesity,” Dr. David Ludwig (Director of the Optimal Weight for Life Program at Children’s Hospital in Boston, Massachusetts) and lawyer Lindsey Murtagh (Research Associate for the Department of Health Policy and Management at Harvard School of Public Health) confront severe childhood obesity — which is “characterized by a body mass index (BMI) at or beyond the 99th percentile” — with what appears to be a wild and rash line of thought: remove severely obese children from their homes and place them into foster care.

In their commentary, Dr. Ludwig and Ms. Murtagh write that

[s]tate intervention may serve the best interests of many children with life-threatening obesity, comprising the only realistic way to control harmful behaviors. Child protective services typically provide intermediate options such as in-home social supports, parenting training, counseling, and financial assistance, that may address underlying problems without resorting to removal. These less burdensome forms of legal intervention may be sufficient and therefore preferable in many cases. In some instances, support services may be insufficient to prevent severe harm, leaving foster care or bariatric surgery as the only alternatives. Although removal of the child from the home can cause families great emotional pain, this option lacks the physical risks of bariatric surgery.

However, the authors also acknowledge that

removal from the home does not guarantee improved physical health, and substantial psychosocial morbidity may ensue. Thus, the decision to pursue this option must be guided by carefully defined criteria… with less intrusive methods used whenever possible.

Reading through the commentary, one senses an exasperated tone more than anything else.  After all, the authors cite a mind-numbing statistic: there are approximately 2 million severely obese children in the United States.  And how should we treat this epidemic?  With bariatric surgery you say?  And so the authors wonder aloud whether “removal from the home may be justifiable from a legal standpoint because of imminent health risks and the parents’ chronic failure to address medical problems.”

Let’s set aside the legal arguments for a minute and discuss the heart of the matter: America’s eating habits.  Specifically, America’s childrens’ eating habits.   In a response post on MSNBC, Arthur Caplan, Director of the Center for Bioethics at the University of Pennsylvania, criticized Dr. Ludwig and Ms. Murtagh by focusing on other obesity-causing factors, such as the unhealthy “food culture,” that pervades the United States.  Professor Caplan wrote

I am not letting parents off the hook. But, putting the blame for childhood obesity on the home and then arguing that moving kids out of homes where obesity reigns is the answer is short-sighted and doomed to fail. We need the nation to go on a diet together and the most important places to start are at the grocery store, schools and media.

On Booster Shots, the Los Angeles Times health blog, Chris Woolston wrote that removing children from their homes and placing them into foster care will not fix poor eating habits because

[c]hildhood obesity is complicated. Fast food, sodas, TV, video games — many staples of modern life are pushing kids in the wrong direction. While researching a book on this topic a few years ago, I spoke with several moms who were tackling their child’s weight troubles with varying levels of success. One considered putting locks on her cabinets to keep her son from sneaking food in the middle of the night.

Her son was definitely on the large side — beyond that, really — but it’s not because his mom didn’t care. And even if someone had placed him in a foster home it wouldn’t have solved his problems. As a rule, those places have food in their cupboards, too.

Hear, hear.  Wake up, folks.  We need a food culture revolution with healthier and affordable alternatives.  One which teaches our children to choose healthy foods and to eat in moderation.  Because what else must we do before everyone finally, in the words of Professor Caplan, “[d]emonize[s] the companies that sell and market food that is not nutritious” and “[p]ut[s] exercise back on the menu for all school kids”?  Institute state programs that remove severely obese children from their homes and place them into foster care?  Oh, wait….

Sunscreen Labeling Rules Revamped

Last month, the Food and Drug Administration (FDA) released new regulations for sunscreen manufacturers to update rules from over 30 years ago. The new regulations, which will take effect in 2012, require that sunscreen manufacturers prove certain labeling claims before they can be used on packaging. In an effort to avoid consumer confusion, the FDA is regulating when sunscreens can claim broad-spectrum protection or water resistance and is also setting a sun protection factor (SPF) cap at 50.

According to the new rules, only sunscreens that block both ultraviolet A (UVA) and ultraviolet B (UVB) rays can be labeled to have broad spectrum protection. While UVB rays are the primary cause of sunburn, UVA rays contribute to skin cancer risk and premature aging. Sunscreens that are not broad spectrum or with SPF values less than 15 will be given the following warning label:

Skin Cancer/Skin Aging Alert:  Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

In addition, sunscreens can no longer be labeled as waterproof or sweatproof, and manufacturers cannot use the term “sunblock” on their packaging. The FDA remains concerned with exaggerated claims, as no sunscreen can block the sun entirely, nor are any of them completely waterproof. Instead, sunscreens can be called “water resistant” and must be marked as either 40 or 80 minutes, depending on how long the SPF protection will last. Finally, the FDA is requiring any sunscreens with rates above SPF 50 be labeled as “SPF 50+”, given that data suggest no additional protection above that level.

In issuing these new regulations, the FDA is targeting rising skin cancer rates among Americans. The Centers for Disease Control and Prevention (CDC) reports that skin cancer is the most common form of cancer in the United States with 58,000 new cases diagnosed and around 8,000 deaths per year. The hope is that the new regulations will make it easier for consumers to choose the best sun protection and that this will help decrease the incidence of skin cancer.

As welcome as these new regulations are, they are subject to two major criticisms. The first is that the amount of sunscreen used by manufacturers to determine SPF values is not consistent with actual use by consumers. In testing, two milligrams of lotion are used for every square centimeter of skin. Scientific American reports that most people use only one fifth to one half of that quantity, meaning that their skin is not fully protected at the labeled SPF level. Secondly, the FDA assumes for designation purposes that consumers will always follow the directions on their sunscreen products. In practice, sunscreen users fail to reapply as often as directed (which is at least every two hours during sun exposure).

Even with these limitations, the new system is a marked improvement to the 1978 regulations. Consumers can protect themselves even before the new regulations take effect in 2012– the FDA recommends that individuals use sunscreen with an SPF of at least 15 and a broad spectrum rating to protect from the full range of sunlight. In addition to purchasing the right sunscreen products and following directions, the FDA encourages that people wear proper clothing and limit sun exposure to help protect skin from UV rays.

The Junk Food Marketing Debate: A First Amendment Right or Just Making Sure Kids Aren’t What They Eat?

Remember the Omnibus Appropriations Act of 2009 (H.R. 1105) that President Obama signed on March 11, 2009?   No?  Good, me neither, but my excuse is that I was busy applying to law schools.  If you and I had been paying closer/any (take your pick) attention, we would have seen that the Act included, among other things, a provision calling for the Federal Trade Commission, the Centers for Disease Control and Prevention, the Food and Drug Administration, and the Department of Agriculture to create an Interagency Working Group on Marketed Food to Children (“Working Group”) composed of representatives from each agency.  The Working Group would research and recommend standards for the marketing and advertising of food to children age 17 years and younger.   These recommendations would be presented to Congress down the road.

Well, a couple of years passed, but in April 2011 the Working Group released its 26-page “Preliminary Proposed Nutrition Principles to Guide Industry Self-Regulatory Efforts” for public comment (which you can submit by clicking here before July 14). The Working Group notes that

… in the FTC’s 2008 study on Marketing Food to Children and Adolescents, three food categories — breakfast cereal, restaurant foods, and snack foods — represented approximately 70% of food marketing expenditures directed to children under 12. Similarly, three categories of foods — carbonated beverages, restaurant foods, and non-carbonated beverages — represented 69% of the food marketing expenditures for adolescents ages 12-17 year….  [Overall] [t]he categories most heavily marketed to children and adolescents, ages 2 -17 years are: breakfast cereals; snack foods; candy; dairy products; baked goods; carbonated beverages; fruit juice and non-carbonated beverages; prepared foods and meals; frozen and chilled deserts; and restaurant foods. The Working Group is therefore recommending that the food industry focus its efforts on ensuring that any advertising or marketing of food products within these ten categories meet the nutrition principles set out below. (Emphasis added.)

The Working Group focuses on two nutritional principles “that both improve the nutritional quality of foods marketed to children and can be feasibly implemented by industry with sufficient time to accomplish reformulation,” namely, “Meaningful Contribution to a Healthful Diet” (Principle A)  and “Nutrients with Negative Impact on Health or Weight”  (Principle B).  Principle A ensures that foods marketed to children contain two or more of the following food groups: “fruit, vegetable, whole grain, fat-free or low-fat milk products, fish, extra lean meat or poultry, eggs, nuts and seeds, or beans.”  Principle B ensures that foods marketed to children have limited amounts of saturated fat, trans fat, sodium, and added sugars.  The Working Group makes sure to point out (several times in fact) that its recommendation are based on the 2010 Dietary Guidelines for Americans.

Really, this all sounds quite sensible, if not a little over-protective… but considering, as The Washington Post has reported, that Type 2 diabetes has significantly increased among people age 20 years and younger, what else can this country do to curb obesity and poor eating habits?  Even if we could reduce the cost of nutrient-rich and quality foods so that everyone could afford them, how do we neutralize the marketing of junk food to children?  In a report last month, NPR noted how

[the Working Group] broke from the past by seeking to include 12- to 17-year-olds in its guidelines. Traditionally, limits on marketing focused on the very young. But the government sought to expand them to older children, in part because they are heavy consumers of social media, cell phone messages and online games — the new frontier for ads.

That new frontier of advertising to children through online games — also known as “advergaming” (forgive my use of Wikipedia but Merriam-Webster doesn’t list the word) — includes Asylum 626 and Hotel 626, two advergames sponsored by Doritos.  As NPR reported,

“[w]hat we’re talking about are very complicated and very subtle forms of marketing that aren’t always clear as such,” says Kathryn Montgomery, a professor of communications at American University and an advocate for limiting food ads to teens.

[...]

Montgomery says such ads work subliminally and use friends to influence other friends.

But efforts to restrict ads to teens draw lots of opposition from the food and advertising industries. The industries say the overlap between teen and adult audiences makes the proposed restrictions impractical.

Critics, including the U.S. Chamber of Commerce, have questioned the constitutionality and logic of the Working Group’s nutritional proposals.  The Hill’s Healthwatch has reported that some critics see a First Amendment issue because

“[w]hat they’re doing is trying to simultaneously … suppress speech, while insulating it from judicial review,” said Northwestern law Professor Martin Redish, one of the panelists at a Chamber of Commerce discussion Thursday. “Because if these regulations were truly just advisory, there would be no case or controversy.”

[...]

“Industry’s rights are being violated here,” Redish said, “but there’s something deeper and darker that’s going on: The government is treating us like sheep.”

While constrained to commercial speech, Redish said that attitude has broader implications. People, he said, “can’t be sheep in the commercial realm and then all of a sudden, in the political realm, they’re free-thinking adults who can make basic choices.”

NPR has reported that other critics question the logic behind the proposal and the implicated age range.

Elaine Kolish directs an industry-funded program called the Children’s Food and Beverage Advertising Initiative. For the past five years this initiative sponsored its own voluntary standards that focus only on the 12-and-under set.

“You know, we let kids drive and we let them hold jobs when they’re 16. They can get married in some states, and they can join the military with permission, and they can be held criminally responsible for their actions in a number of situations,” she says. “So I think that the notion that you’d have to have nutrition standards that say you can’t let a kid see an ad for a french fry but you can let them join the military doesn’t really make a lot of sense.”

So where do we go from here?  Is industry self-regulation the answer to making products that better fit on MyPlate?  As I’ve noted in a previous post about McDonald’s Happy Meal toys, sometimes the answer can be stricter parenting (just say “no”).  Yet how can parents instill and maintain healthy eating habits in their kids when advertisements for unhealthy food bombard them through television, social media, and online games?

A Pyramid No More: You Are A Plate of Quadrants and A Dairy Circle

Step aside, food pyramid, there’s a new dietary guide in town: MyPlate.  During a press conference on Thursday, First Lady Michelle Obama and Department of Agriculture Secretary Tom Vilsack released MyPlate –whose color-coded quadrants of fruits, vegetables, grains, and protein — plus dairy circle — are intended to serve as “a quick, simple reminder for all of us to be more mindful of the foods that we’re eating.”  MyPlate replaces the 2005 MyPyramid and the 1992 “old school” USDA Food Pyramid, both of which have been criticized as misleading or difficult to understand (I dare say that the MyPyramid color scheme was a little reminiscent of a similarly confusing color-coded federal government alert system).  MyPlate complements the federal government’s 2010 Dietary Guidelines for Americans, released earlier this year, which reminds consumers about:

Balancing Calories

• Enjoy your food, but eat less.
• Avoid oversized portions.

Foods to Increase

• Make half your plate fruits and vegetables.
• Make at least half your grains whole grains.
• Switch to fat-free or low-fat (1%) milk.

Foods to Reduce

• Compare sodium in foods like soup, bread, and frozen meals — and choose the foods with lower numbers.
• Drink water instead of sugary drinks.

MyPlate is meant to be an “easy-to-understand visual cue.”  Among the noticeable changes to the food guide are the absence of the “fats, oils, & sweets” section which once sat atop the 1992 food pyramid and the relabeling of the 2005 MyPyramid sections of “milk” to “dairy” and “meat and beans” to “protein.”  The AP reports that

[t]he guidelines and the icon were subject of lobbying by food industries who want to see their products promoted and not discouraged. Fruit and vegetable growers were celebrating their victory over half of the plate Thursday, while dairy producers said they were also pleased with the cup beside it. The president of the beef industry group National Cattleman’s Beef Associaton, Bill Donald, said he is not concerned about the elimination of the word “meat” because beef is so associated with the word “protein.”

According to the New York Times, MyPlate is the brainchild of the Department of Agriculture, the First Lady’s Child Obesity Task Force, and other federal health officials.  During the press conference, First Lady Obama noted that

[w]hen mom or dad comes home from a long day of work, we’re already asked to be a chef, a referee, a cleaning crew. So it’s tough to be a nutritionist, too. But we do have time to take a look at our kids’ plates. As long as they’re half full of fruits and vegetables, and paired with lean proteins, whole grains and low-fat dairy, we’re golden. That’s how easy it is.

Nutritionists cautiously welcomed MyPlate.  For instance, Marion Nestle, a New York University professor, told the New York Times that

“[i]t’s better than the pyramid, but that’s not saying a lot”….

Dr. Nestle praised the plate for being generally easy to understand, but she said that labeling a large section of the plate “protein” was confusing and unnecessary, because grains and dairy products also are important sources of protein and most Americans get far more protein than they need.

But she said the emphasis on fruits and vegetables was a significant step.

Dawn Jackson Blatner, a registered dietician in Chicago, told The Wall Street Journal Health Blog that “we went from something that was complex and hard for people to remember to something that is very visual, clear and based in science. People don’t eat off a pyramid, they eat off a plate.”  Except maybe for the people who designed the original food pyramid.

It’s early days yet, folks, but I agree with Ms. Blatner.  At least the food guide finally looks more like my dinner plate and less like a jumble of colors and pyramidal fragments.  Be sure to click here for an article from the Los Angeles Times to learn how other countries have visualized their food guides.

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