A Call for Improved Guidance on Research with Pregnant Women

This month, the thoughts of Christians around the world turn to a laboring mother in “a stable at midnight in Bethlehem in the piercing cold.” It seems an appropriate time to direct your attention to the work of the Second Wave Initiative, “a collaborative academic effort to advocate for, and help find, ethically and scientifically responsible solutions for increasing our knowledge base for the treatment of pregnant women who face medical illness.”

At the end of October, the Initiative submitted comments on the Department of Health and Human Services’ Advance Notice of Proposed Rulemaking (ANPRM) regarding revisions to the regulations governing human participation in federally-funded research, known as the Common Rule.  The Initiative’s comments, of which I am a co-signatory, call attention to the fact that the ANPRM fails to address “vagaries and constraints” in the current regulations “that make it difficult for researchers to feel comfortable understanding the parameters of responsible research with pregnant women.”

The Initiative recommends that HHS take the following five steps.

First, amend the Common Rule to allow for research in pregnant women, fetuses, and neonates that creates a minor increase over a minimal risk of harm, as is already permitted in children. The Initiative’s comments explain that the regulations currently provide that “any research that does not carry the potential for direct health benefit to pregnant woman or fetus is disallowed unless it involves ‘no more than minimal risk.’”  Some government officials have concluded from this that even pharmacokinetic studies — which involve nothing more risky than drawing blood and which are vital to determining dosing in pregnancy — are ruled out.

Second, eliminate the requirement that, with certain delineated exceptions, fathers must consent to research that “holds out the prospect of direct benefit solely to the fetus.” The current regulations do not require paternal consent where there is a prospect of direct benefit to the pregnant woman or, oddly, where there is no prospect of direct benefit to the pregnant woman or the fetus.  The regulations governing pediatric research seem more sensible, requiring that both parents give consent where the research involves greater than minimal risk and holds out no prospect of directly benefitting the child.

Third, amend the regulations so that they no longer label pregnant women as “vulnerable.” As Seton Hall Law’s Carl Coleman has explained, the Common Rule does not define vulnerability and the examples it gives of vulnerable populations are diverse.  With regard to pregnant women, “it is not clear why any special issues related to capacity or coercion would necessarily arise.”  The Initiative recommends changing the word “vulnerable” to “population meriting special regulation.”

Fourth, confirm that HHS’ proposed changes with regard to research that is excused from ethics review and research that is eligible for expedited review encompass research with pregnant women. The Initiative contends that explicit confirmation is necessary “to avoid inappropriate exceptionalism about pregnancy on the part of researchers and institutional review boards.”

Finally, “establish and formally charge a working group to propose new model language for the special regulation of clinical research with pregnant women that strikes a more appropriate and more just balance of rights, needs, and interests.” As I explained here, “[w]e lack data on the efficacy or safety or both of most drugs when used by pregnant women. … Without denying or dismissing the real moral conundrums that arise in maternal-fetal medicine, the information gap is deeper and wider than that.”  To the extent that the Common Rule creates unjustified barriers to desperately-needed, ethically-appropriate research, revisions must be made.

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….

Questioning Body Modification

[I've decided to put the whole post beneath the fold, since the topic reminds me of Leontius's Tale, and I don't want anyone to accidentally click through to something they don't want to see.]
Read more

High School Just Says No to Medical Marijuana

Remember the “Just Say No” and D.A.R.E. anti-drug campaigns way back in the day?  I do.  That’s when the high school kids would come to my elementary school, put on a play, and divide us into small groups for a talk on how we shouldn’t use drugs.  I think there was even a song in there somewhere.  Remember those bizarre zero-tolerance policy stories too?  The ones about a middle school student who was suspended for touching and refusing a proffered Adderall pill or a little kid who was suspended for bringing a camping utensil to school and then required to attend an alternative school for 45 days?

So what should parents and teachers do when a high school student may legally take medical marijuana lozenges to treat diaphragmatic and axial myoclonus, a rare condition which causes him to suffer seizures that can last for 24 hours, but may not legally do so when the seizures occur at school?  As The Colorado Independent reports, that’s the question facing a Colorado Springs teenager who needs to take such lozenges for seizures that can happen without warning and a high school that doesn’t want him to have the lozenges on its property.

You see, 15 states - Alaska, Arizona, California, Colorado, Hawaii, Maine, Michigan, Montana, Nevada, New Jersey, New Mexico, Oregon, Rhode Island, Vermont, and Washington — and the District of Columbia have legalized medical marijuana.  Nine states — Connecticut, Delaware, Idaho, Illinois, Maryland, Mississippi, New Hampshire, New York, and Oklahoma — have similar legislation pending.  In November 2000, 54% of Colorado voters approved the legalization of medical marijuana through Ballot Amendment 20.  The law went into effect on June 1, 2001.  (Nine years later, Governor Bill Ritter signed House Bill 1284 and Senate Bill 109 into law, providing a regulatory framework for dispensaries and addressing potential fraud and abuse.)

The Colorado Department of Public Health and Environment (CDPHE) maintains the Medical Marijuana Registry program which accepts and processes applications for Registry Identification cards.  The registration process is fairly straightforward.  Under 5 CCR 1006-2, an adult patient/applicant (over the age of 18) must submit a notarized application which includes name, address, date of birth, Social Security number, name and address of primary-care giver (if applicable), written documentation from the applicant’s physician confirming his or her debilitating medical condition, name and address of the applicant’s physician, and a copy of an identity document.  For a minor patient/applicant (under the age of 18), a parent residing in Colorado must submit written consent and the applicant’s name, address, date of birth, Social Security number, written documentation from two of the applicant’s physicians confirming his or her debilitating medical condition, the name and address of the two physicians, consent from the applicant’s parents residing in Colorado, and documentation from one of the physicians about the risks/benefits of the medical marijuana treatment.

In June 2010, CDPHE reported that 95,477 Coloradan patients possess valid Registry Identification cards… and only 24 of those patients — a mere 0.0251%  — are minors.  However, if you read the fine print in C.R.S.A. § 25-1.5-106(12)(B)(IV), you’ll note that “[a] patient or primary caregiver shall not: possess medical marijuana or otherwise engage in the use of medical marijuana in or on the grounds of a school or in a school bus.”  What should minors do if they’re still in school and need to take their medicine?

So maybe the Colorado Springs high school isn’t without reason for prohibiting this student from bringing his lozenges onto its property.  It’s an oversight on the part of the legislature to be sure and I wonder if any of the other 23 registered minors have experienced similar problems.  The obvious compromise would be to allow the student to go home and take his medicine as needed — The Colorado Independent reports that he switched schools last year to be closer to home for this very reason — and then return to school.  Yet until this past week the school told the student that this wasn’t an option.  Besides, it’s not a wholly satisfactory compromise if the student has to walk home while having a seizure.

Stillbirth: A “Largely Unstudied” Problem

While the ubiquitous pink ribbons (and pink everything else) ensure that everyone knows that October is Breast Cancer Awareness Month, less well known is that it is also Pregnancy and Infant Loss Awareness Month[1], proclaimed so by President Ronald Reagan in 1988.  As I wrote last October, about 1 in every 160 deliveries in this country ends in a stillbirth, and all too frequently no one can say why.  Stillbirth is a “largely unstudied …  problem in obstetrics.”

Encouragingly, the work of the physicians and scientists participating in the National Institute of Health’s Stillbirth Collaborative Research Network (SCRN) is beginning to bear fruit.  The August 2010 issue of the journal Obstetrics & Gynecology included an important article in which the SCRN investigators presented their “standardized method to assign probable and possible causes of death of stillbirths based on information routinely collected during prenatal care and the clinical evaluation of fetal death.”  Rigorously defining and more accurately determining causes of fetal death will both facilitate research and have useful clinical implications.  As the authors note, “[a]ccurately assigning a cause of fetal death is critically important for counseling grieving families.”

There will be much more to come from the SCRN, which has completed data collection on three distinct studies conducted between March 2006 and December 2009.  The first is a surveillance study designed “to assess the completeness of two reports of stillbirths: hospital labor and delivery logs and state vital statistics records. The data from the two sources will be linked statistically to determine incidence of stillbirth, the extent of under- or over-reporting, and factors associated with reporting.”  The second study entails a complete evaluation of 500 women and their 512 stillborn babies; the study also includes a control group of 1,932 women with live births.  The goal of this study was to develop and apply the method for determining cause of fetal death discussed above, with the ultimate goal of “determin[ing] maternal and fetal risk factors associated with increased risk of stillbirth.”  Finally, the SCRN conducted a follow-up study of the participants in the second study who experienced stillbirths, “to determine how many of the women have had subsequent pregnancies and subsequent pregnancy complications; how well women with a loss have resolved their grief and whether grief resolution is associated with the course and care of the pregnancy; and whether life-course stresses and environmental factors are associated with an increased risk of stillbirth.”

Research of the sort conducted by the SCRN is expensive and time consuming.  The SCRN investigators collected and are now analyzing 130,000 forms containing information provided by study participants and 120,000 maternal, fetal, and placental samples.  Stillbirth is an important public health problem but one that private sector actors lack the incentive or wherewithal or both to tackle.  Government support for research into what causes it and what can be done to prevent it is crucial — something for advocates to bear in mind as the struggle unfolds over funding for the National Institutes of Health for Fiscal Year 2011.

Photo Credit: I Should Be Doing Laundry via Flickr.

---

[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.  Cathy’s first and only grandson, Colin Joseph Mahoney, was stillborn at 39 weeks gestation on November 10, 2008.

Reform Rodeo

1. The American Medical Association: In the face of new health reform requirements that are now in effect, many of the top insurers have dropped child-only health plans.

2. Kaiser Health News Daily Report: Health Care reform’s elimination of discrimination based on pre-existing conditions has not fully materialized; In a sign of what could be a backlash against health care reform, the 3M corporation announced that it will stop offering its health insurance plan to retirees. Click here for the Daily Report.

3. In a sea of pessimism, the New England Journal of Medicine explores the lessons of a health care success story: Grand Junction, Colorado — one of the cities that Atul Gawande detailed in his celebrated article in the New Yorker.

4. At the Health Care Blog, Michael Lake explores recent trends in HIT, while providing many helpful links.

5. Webcast 1: On Tuesday, October 5th: Maggie Mahar and others will be participating in a webcast where they will discuss health care reform. Click here for Mahar’s overview on her Health Beat blog, including a link to the freely-accessible live stream.

PPACA and the Growing Shortage of Pediatric Subspecialists

Over the course of this year, a spate of articles and op eds have highlighted a growing shortage of pediatric subspecialists.  Earlier his month, Amy Mansue, CEO of Children’s Specialized Hospital here in New Jersey, addressed the problem in a very interesting post on the National Association of Children’s Hospitals’ With All Our Might blog.  Ms. Mansue describes a recent visit to Capitol Hill during which she discussed the implementation of the Patient Protection and Affordable Care Act, explaining to the staffers that:

[t]he differences between strategies to address the needs of the newly insured children versus strategies to address the needs of adults couldn’t be more different.  Start with the basic fact that there is a critical shortage of specialists in pediatrics, where the biggest issue facing adults is how to access primary care. There can be a utilization of physician extenders in the short run until more primary care physicians are trained; there is no similar ‘quick fix’ in pediatrics.

Pediatric neurologists and developmental-behavioral pediatricians are in especially short supply.  A survey of children’s hospitals conducted by the National Association of Children’s Hospitals and Related Institutions in December 2009 revealed average wait times of 9 weeks for an appointment with a pediatric neurologist and 13 weeks for an appointment with a developmental-behavioral pediatrician.  An earlier study published in Pediatrics found that, in addition to enduring long waits, parents and children also travel long distances to see these specialists–on average 73 miles to see a subspecialist in neurodevelopmental disabilities and 44 miles to see a developmental pediatrician.

This is concerning for a host of reasons, including the importance of early, appropriate intervention to the future success of children with developmental delays.  As I discussed previously here and here, the “right” medical diagnosis can be key to accessing needed services, as can a thorough written evaluation and a doctor willing to advocate on a child’s behalf.  This is true whether a family is fighting for publicly-provided disability benefits or special education services or to get a private insurance plan to pay for medically necessary therapies.

What explains the subspecialist shortage?  As Ms. Mansue puts it, “it is all about math.  There is no incentive to go through an additional decade of training to get paid less than what a pediatric nurse practitioner is now demanding in my home state of New Jersey.”  Congress has tried to change the equation.  PPACA provides for loan forgiveness of up to $35,000 per year for up to three years for pediatric subspecialists who “work for a provider serving in a [Health Professional Shortage Area] or medically underserved area, or among a medically underserved population that has a shortage of the specified pediatric specialty and a sufficient pediatric population, as determined by [HHS], to support the specified pediatric specialty.”  But funding for this measure has not yet been appropriated.  The federal government has also attacked the problem through its Children’s Hospitals Graduate Medical Education Payment Program, which provides funding for specialty training for pediatricians.  According to a recent New York Times op ed, however, this program’s funding is also uncertain, suggesting that an end to the shortage of pediatric subspecialists may not be in sight.

Professor Gaia Bernstein on ‘Intensive Parenting’ and the Law

According to Health Law Prof Blog, Seton Hall Law’s own Professor Gaia Bernstein and co-author Zvi Triger  led in SSRN Health Law Paper downloads last month for their paper, “Over Parenting,” forthcoming in U.C. Davis Law Review. In addition to taking the number one spot at SSRN, Professor Bernstein appeared in the New York Times, Forbes Magazine and Canada’s leading newspaper, The Globe and Mail, concerning her recent scholarship on “Intensive Parenting” and the Law. These articles follow on the heels of another recent article in the ABA Journal. (See all below).

Regarding the general perception that “Intensive Parenting” or “Helicopter Parenting” is a norm appropriate for unmitigated aspiration, The Times writes:

Bernstein and Triger are not so sure. They cite studies that suggest what we have discussed on Motherlode before, that what they call intensive parenting (which others dub helicopter parenting or smothering mothering) can cause more harm than good. It is creating an anxious, dependent generation, they write, and it can “seriously undermine one of the most important roles of parents, namely, nurturing a sense of independence and separation from the parent.”

They fear that the trend is already being codified into law. In custody cases, lawyers advise parents, particularly the one who might have had less day-to-day participation in the children’s lives, to enter what Bernstein calls “the race for involvement.”

“It becomes a strategy, to know all the teachers, coach little league, text your children 20, 30 times a day,” she said in an interview.

Professor Bernstein and her co-author have also cautioned that “the law repeatedly incorporates child-rearing practices into mandatory legal standards and that we should expect to see pressure on legislatures and courts to turn sophisticated child rearing practices used by Intensive Parenting adherents into legal standards. ‘Some child rearing practices are desirable social norms but not desirable legal standards,’ Professor Bernstein explained. “For example, some states now place women who consume alcohol during pregnancy under civil confinement. Would we want to see pregnant women who do not to take folic acid vitamins–which reduce the probability of birth defects– similarly placed under civil confinement?”

“The authors warn against use of the law to enforce Intensive Parenting. Although research has shown that Intensive Parenting has important advantages, a rising body of research has shown that Intensive Parenting can seriously undermine one of the most important roles of parents, namely, nurturing a sense of independence and separation from the parent.  Disconcertingly, this research also shows that deficiencies correlated with Intensive Parenting place this generation at a higher risk for anxiety disorders and making poor choices regarding alcohol and drug abuse and sexual relationships.”

“Intensive Parenting is largely a socio-economic construct. It is class, race, ethnicity and culturally dependent and tends to place its weight squarely upon the shoulders of women-who are still overwhelmingly responsible for the raising of children. A hasty and uncritical incorporation of such standards in a multicultural society would increase existing biases and force Intensive Parenting on those who may be financially unable or ideologically unwilling to adopt it.”

Read the New York Times article, Defining a Successful Parent.

Read the Forbes article, Custody Goes To The Craziest Parent.

Read the Globe and Mail article, Give Helicopter Parents a Break

Read the ABA Journal article, Courts Reward Helicopter Parents, Two Law Profs Say

Read more about Professor Bernstein’s “Over Parenting,” forthcoming in the U.C. Davis Law Review, here.

Recommended Reading: Recent Scholarship on Medical Decisionmaking for Children

Alicia Ouellette’s Shaping Parental Authority over Children’s Bodies (published in the Summer 2010 issue of the Indiana Law Journal and available on SSRN) highlights four “shaping cases,” including “a case involving a white father who used surgery to reshape the eyes of his adopted Asian child; another in which parents used human growth hormone to add a few inches onto the adult height of their young son; a third in which a mother consented to liposuction for her twelve-year old daughter; and the case of Ashley X, a young girl with profound disabilities whose parents elected to stunt her growth and remove her breasts and uterus in order to continue caring for her at home.”  Professor Ouellette argues that these cases reveal that the “traditional hierarchical model of the family at play in the health-care setting, which starts from an assumption of parental power” and “take[s] as a given that, absent grievous harm or death, parents have a right to modify a child’s body,” fails to adequately protect or respect children.  She advocates instead the adoption of a “trust-based construct,” under which parents would be conceived of as trustees of their children’s welfare (e.g., their need for food, safety, and nurturing) and developing autonomy rights (e.g., the right to self-determination that will be theirs once they reach adulthood).  Under Professor Ouellette’s trust-based construct, the four shaping cases she identifies would trigger third-party review, because of the potential for conflict between the parents’ trustee-like duties to their children and the parents’ personal interests.  This is not to say that the parents’ decision to “shape” their children would be overruled in all four cases; Professor Ouellette argues that the outcomes of the third-party reviews would likely vary.  Overall, this is a fascinating (and very readable) article in which facts that might seem sensationalistic at first blush are used as a launching pad for a thoughtful theoretical analysis with broad potential applicability.

Rachel Camp’s A Mistreated Epidemic: State and Federal Failure to Adequately Regulate Psychotropic Medications Prescribed to Children in Foster Care (forthcoming in the Temple Law Review and available on SSRN) also takes on the issue of medical decisionmaking for children, focusing on children in foster care for whom psychotropic medication has been recommended.  Professor Camp persuasively argues that parents whose children have been removed and placed in foster care have a right to consent before their children begin taking such medications, because they fall outside the bounds of “ordinary” medical care.  “[W]hen a parent is unwilling or unable to consent,” Professor Camp advocates for “[c]ourt review with an evidentiary burden on the party seeking the medication, not agency acquiescence[.]“  A meaningful and enforced consent requirement would “force[] a check on a system that has become complacent about how psychotropic medications are administered to children in care;” it could also “empower parents to parent — to assess risks, benefits, and make decisions for their children.”  Professor Camp’s article provides an excellent summary of the (startling) facts about the extremely high rates of use of psychotropic medication by children in foster care, a nuanced and thorough accounting of the possible explanations for these high rates, a helpful overview of the applicable law, and concrete recommendations for state-level legal and policy change.

Fast Food, Childhood Obesity & the Hidden Costs of that Free Toy

Late last month, a consumer advocate group called the Center for Science in the Public Interest (CSPI) announced its intention to sue McDonald’s for using toys to market Happy Meals to children.  In an open letter to McDonald’s, CSPI litigation director Stephen Gardner alleged the toys were part of an unfair and deceptive marketing tactic which gave children “pester power” and taught them unhealthy eating habits.  Mr. Gardner further alleged the company violated Massachusetts, New Jersey, Texas, and California consumer protection laws.  Apparently McDonald’s recent Shrek 3 toy promotion was the final straw (and, somehow, the risk of cadmium exposure isn’t a concern here).  In a follow-up press release, Mr. Gardner also compared McDonald’s to:

… the stranger in the playground handing out candy to children.  McDonald’s use of toys undercuts parental authority and exploits young children’s developmental immaturity — all this to induce children to prefer foods that may harm their health.  It’s a creepy and predatory practice that warrants an injunction.

McDonald’s must decide later this month whether it will continue its Happy Meal toys or succumb to pressure.  So far the company believes that “[g]etting a toy is just one part of a fun, family experience….”

Before you completely write-off this lawsuit and characterization as over-the-top theatrics, just remember that CSPI already has a proven track record.  In 2006, the group sued KFC for using partially hydrogenated oils to deep-fry its food.  KFC subsequently switched to a trans-fat-free frying oil.  That same year CSPI also negotiated a settlement agreement with the Kellogg Company which set certain nutrition standards for marketing to children.  Better not tell CSPI about Cracker Jack and removable tattoos or Topps baseball cards and chewing gum.

In all fairness, CSPI isn’t the only group focusing on marketing to children.  Earlier this year in California, the Santa Clara County Board of Supervisors banned the inclusion of toys with meals numbering 485 calories or more.  Granted, Supervisor Donald Gage voted against the ordinance because “[i]f you can’t control a 3-year-old child for a toy, God save you when they get to be teenagers.”  The Los Angeles Times has reported on the increasing number of fast food television advertisements directed at children, particularly non-white children.  Likewise, CNN has reported on successful junk food marketing campaigns through the use of cartoon characters.  Perhaps CSPI and its supporters should go after DreamWorks and other studios whose agents negotiate these marketing agreements.  Just a thought.

This concern over McDonald’s Happy Meals and developing good eating habits in children coincides with the Trust for America’s Health (TFAH) report “F as in Fat: How Obesity Threatens America’s Future 2010.”  The report found that 38 states have adult obesity rates above 25 percent, a sharp increase from 20 years ago when no state had an obesity rate above 20 percent.  (Click here to see how your state weighs in.)  According to TFAH executive director Jeffrey Levi:

[o]besity is one of the biggest public health challenges the country has ever faced, and troubling disparities exist based on race, ethnicity, region, and income….  Millions of Americans still face barriers — like the high cost of healthy foods and lack of access to safe places to be physically active — that can make healthy choices challenging.

The report suggested a connection between income disparities and adult obesity: “35.3 percent of adults earning less than $15,000 per year were obese compared with 24.5 percent of adults earning $50,000 or more per year.”  The report also showed that “more than 12 million children and adolescents are considered obese” and half of Americans believe this is an important issue to address.  However, rather than suggesting that consumers sue fast food and junk food companies, the report recommended investing in public health initiatives and prevention programs.

I’m not a parent, so I won’t preach about better parenting skills when it comes to “pester power” and how a child’s eating habits are determined as much by their parents as the cartoon characters selling the food.  I’ll just say that there was seldom any debate with my parents over the foods that I ate as a child.  Admittedly, there sometimes are no other alternatives.  Whether you’re a high school athlete on the road, a parent with no time to make dinner, or looking for an inexpensive meal, fast food is the cheap and easy way to go.  Perhaps the key is moderation?

Does this mean CSPI should hold the fast food (and junk food) companies responsible for the development of our eating habits, from childhood to adulthood?  The TFAH report also referred to obesity liability laws in 24 states protecting restaurants, manufacturers, and marketers from weight-related lawsuits.  Take note, CSPI.  (And you, dear reader, take note of Michael Ricciardelli’s post containing some staggering numbers relating to the healthcare costs of managing Type-2 diabetes, in which obesity plays a factor, and Professor Pasquale’s beverage tax utilitarian calculus.)

NIH Panel Recommends Medico-Legal Reform to Reduce Elective Repeat Cesarean Delivery Rate

In December 2009, an Arizona woman made the news when, in her ninth month of pregnancy, she left her husband and three sons behind and traveled to Phoenix, six hours away from her home, to await the birth of her fourth child.  She took these drastic measures because she wanted to give birth vaginally but her local hospital did not allow women who have had a cesarean section to attempt a vaginal delivery.

Last week, the NIH held a consensus development conference on vaginal birth after cesarean (”VBAC”) to evaluate, among other things, the sharp increase in elective repeat cesarean deliveries in the United States and the medical and non-medical factors that have caused it.  The panel convened by the NIH found that both a trial of labor in women who have had a prior cesarean and an elective repeat cesarean delivery have “important risks and benefits” that “differ for the woman and her fetus.”  A trial of labor is associated with a statistically significant increase in risk of uterine rupture and in risk of perinatal death.  Elective repeat cesarean delivery, on the other hand, is associated with a statistically significant increase in risk of maternal death.  Moreover, as the number of prior cesareans goes up, the risk of serious harm to both mother and baby does too, which is of particular concern to women who hope to have large families.  As the panel notes, these facts and figures pose “a profound ethical dilemma for the woman as well as her caregivers, because benefit for the woman may come at the price of increased risk for the fetus and vice versa.”

The panel concluded that for certain women — those with a “prior low transverse uterine incision” — a trial of labor is a reasonable choice, albeit one that it increasingly constrained by difficulty accessing clinicians and facilities able and willing to offer it. Among the non-medical barriers to VBAC is a recommendation made by the American College of Obstetricians and Gynecologists and the American Society of Anesthesiologists that women with a prior cesarean not be permitted to attempt a vaginal delivery unless the hospital has “immediately available” surgical and anesthesia personnel.  The panel concluded that this recommendation should be reassessed in light of “other obstetrical complications of comparable risk, risk stratification, and in light of limited physician and nursing resources.”

The panel also found that “medico-legal considerations add to, as well as exacerbate” barriers to VBAC.  Midwife Amy Romano, who writes the Science & Sensibility blog for Lamaze International, explains that because “lawsuits focus entirely on the counseling around [uterine] rupture rates, and doctors are sued if that counseling isn’t done or documented effectively, then the doctor has a financial incentive to focus on rupture likelihood[.]“  This steers women toward elective repeat cesarean delivery and exacerbates the already formidable liability barrier to VBAC.  The panel predicted that “caps on noneconomic damages and reductions in physician malpractice premiums would result in fewer cesarean deliveries” and recommended that these and other interventions to reduce the liability barrier be developed, implemented, and evaluated to determine their efficacy.

What about the Kids? Health Care Reform and Children

During the reconciliation process of the House and Senate bills, one of the issues likely to be raised is what to do with the Children’s Health Insurance Program, commonly known as CHIP.  Under the Senate bill, federal financing for CHIP would be extended for another 2 years past the current expiration date of 2013.  The House bill, on the other hand, would allow CHIP to come to a close in 2013 since the bill plans to expand coverage for children through Medicaid and through the health insurance exchange– where subsidized health insurance would be available.  Whether or not these health reform initiatives will be able to meet the medical needs of children is a matter of debate.

CHIP is a “state-federal partnership” that was created in 1997 under the Balanced Budget Act to help insure those children who are from families that earned too much to qualify for Medicaid.  Similar to Medicaid, the federal government matches state dollars spent on CHIP (average of 57% federal responsibility for Medicaid spending, 70% for CHIP), but unlike Medicaid, the allocations to states for CHIP is capped.  CHIP also places greater discretion in  individual state’s hands regarding eligibility requirements.

One of the first bills Obama signed as President was the Children’s Health Insurance Program Reauthorization Act, or CHIPRA, in February 2009.  CHIPRA added $33 billion in federal funds to use towards providing coverage to 4.1 million children via Medicaid and CHIP through the year 2013.

In 2007, over 80% of eligible children nationwide participated in Medicaid or CHIP. Currently, 29 million children are enrolled in Medicaid, 7 million in CHIP. If CHIP were to be allowed to expire and absorbed (at least partially) by an expansion of Medicaid, however, the lower reimbursement rates for Medicaid could mean that those children transferred would not have access to as many health care providers as they would have had under CHIP.  While Medicaid might seem to be a sufficient substitute, it would still leave gaps that CHIP had filled if the reform does not include higher reimbursement rates for Medicaid and automatic enrollment provisions, as proposed by the House. In addition, as it stands, because of the relatively low reimbursement rates from Medicaid, many doctors have ceased to accept either new or all Medicaid patients.

The alternate option of funneling children to the insurance exchange does not seem promising either.  Many children currently enrolled in CHIP could become uninsured if their families cannot afford the plans offered in the exchange, which is a concern– as many families will still have a hard time meeting the premiums– even after the proposed subsidies from the government.  Senators Jay Rockefeller of West Virginia and Bob Casey of Pennsylvania have proposed to avoid some of these issues by expanding CHIP until 2019, a move that they say would benefit our country’s children by ensuring their access to health coverage.

In considering the options, it would behoove us to remember that “a stitch in time saves nine,” and that the regular health maintenance of children– much more likely for those children who have insurance– will pay dividends in the form of less of those costly visits to the emergency room and hospital stays. We would also be advised to remember that uninsured children in the hospital have bbeen shown to face a 60% greater risk of death than those children who have either private or government health insurance.

Report: Uninsured Hospitalized Children Face a 6o Percent Increased Risk of Dying

Sometimes the numbers speak louder than words, and the words are just painful to hear: the New York Times’ Prescriptions reports that

Researchers analyzed data from more than 23 million children’s hospitalizations from 1988 to 2005.

Uninsured children who wind up in the hospital are much more likely to die than children covered by either private or government insurance plans, according to one of the first studies to assess the impact of insurance coverage on hospitalized children.

Researchers at Johns Hopkins Children’s Center analyzed data from more than 23 million children’s hospitalizations in 37 states from 1988 to 2005. Compared with insured children, uninsured children faced a 60 percent increased risk of dying, the researchers found.

On a regular basis writers on this blog have discussed health reform as a moral imperative: citing religious doctrine, philosophers, economists and statistics to show that health care, unlike the purchase of automobiles and designer shoes, is not correctly a conventional aspect of a market economy– that the distribution of healing and life itself should not be premised upon who is the best capitalist, or, for that matter, the child of the best capitalist. That uninsured hospitalized children face a 6o percent increased risk of dying says that in a way that I simply cannot add to. Lack of insurance kills.

The Times noted that “Although the research was not set up to identify why uninsured children were more likely to die, it found that they were more likely to gain access to care through the emergency room, suggesting they might have more advanced disease by the time they were hospitalized.”

According to the Times the study showed that “uninsured children were in the hospital, on average, for less than a day when they died.”

Which is to say that it was too late by the time they got there.

The Times noted that “Alison Buist, director of child health at the Children’s Defense Fund, a nonprofit advocacy organization,” said in response to the study’s findings:

If you wait until a child gets care at a hospital, you have missed an opportunity to get them the types of screening and preventive services that prevent them from getting to that level of severity to begin with.

The Times further noted that

The most common reasons for children being hospitalized were complications from birth, pneumonia and asthma. The study found that the reasons did not differ depending on insurance status.

Read the full NY Times article here.
Read the Report here.

Short Shrift for Stillbirth in Health Reform?

Short Shrift for Stillbirth?[1]

The health reform bill that cleared the Senate Finance Committee earlier this month — S. 1796 — incorporates at least two pieces of pending legislation relating to maternal and infant health.  Section 1631 of the bill, authorizing Medicaid coverage for services provided at freestanding birth centers, adopts the text of S. 1423, while Section 1802, authorizing grants to fund services to new mothers struggling with postpartum depression or psychosis, is derived from the Melanie Blocker Stokes MOTHERS Act, which the House passed in March.  Not making the cut was legislation currently pending in the House — H.R. 521 and H.R. 3212 — and Senate — S. 1445 — aimed at reducing the number of stillbirths and sudden unexpected infant and child deaths.

According to the Centers for Disease Control, there are about 25,000 stillbirths — defined by the CDC as the death of a fetus after 20 weeks of gestation or, if the gestational age is unknown, weighing 350 grams or more — in the United States each year.  About 1 in every 160 deliveries in this country ends in a stillbirth.  (Per the CDC, these numbers may be low estimates, because they are based on information contained in death certificates, which studies have shown underestimate the true incidence of stillbirth.)   All too frequently in these cases, no cause of death can be determined.  As Alan Goldenbach put it in a moving essay in the Washington Post: “[T]he most common result after a stillbirth is a doctor telling grieving parents, ‘I don’t have an answer for you.’”

Better data is a necessary first step to finding answers.  As the American Congress of Obstetricians & Gynecologists explains, inconsistencies in the evaluation and classification of stillbirths across jurisdictions frustrate data collection efforts.  The United States has the lowest stillbirth autopsy rate among developed countries, and other important elements of a thorough post mortem evaluation, including analysis of the placenta and umbilical cord and genetic testing, may be left undone.  In addition, recordkeeping is inadequate.  Death certificates are often filled out — incompletely — before any investigation into the cause of death is done.  All of these factors hinder research.

First introduced in June 2008 by then-Senator Barack Obama, and now sponsored by Senator Frank Lautenberg (D-NJ) and Representative Frank Pallone, Jr. (D-NJ), the Stillbirth and SUID Prevention, Education, and Awareness Act of 2009 (H.R. 3212 and S. 1445; H.R. 521 is similar) would, among other things, (1) establish “a task force to develop a national research plan to determine the causes of, and how to prevent, stillbirth” and (2) require the CDC to develop guidelines for increasing the performance of thorough postmortem stillbirth evaluations and to continue its efforts to develop and disseminate a standard protocol for stillbirth data collection and surveillance.  The Act would also expand pilot programs in metropolitan Atlanta and Iowa which supplement the current passive information-gathering system — which relies on death certificates — with an active system in which trained staff make regular visits to clinics and hospitals to gather data.  A study published in 2007 in Public Health Reports demonstrated that Atlanta’s active surveillance system captured more stillbirths than were reflected in death certificates and gathered better data about each one. Expanding the Atlanta and Iowa programs to additional jurisdictions and taking the other steps provided for by the Act would put us on the road to answers to the countless painful questions posed by each unexplained stillbirth.

---

[1] Credit for the idea and background research for this post goes to Catherine Finizio, the Administrator of Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy.  On November 10, 2008, Cathy’s first and only grandson, Colin Joseph Mahoney, was stillborn at 39 weeks gestation.

Next Page »