Review of Reconsidering Law and Policy Debates: A Public Health Perspective

Reconsidering Law and Policy Debates: A Public Health Perspective, edited by John Culhane, is a superb collection of thought-provoking essays which features some of the most well-regarded health law scholars in the US. It also includes contributors from schools of public health, public affairs, and public administration. The chapters are uniformly well-written and instructive. Though I cannot in this brief review give consideration to all of the essays, I will try to highlight contributions related to some of my own areas of interest in the intersection between public health and medico-legal research.

Several authors focus on the difficult questions raised by extreme inequality. For example, Vernellia R. Randall’s Dying While Black in America reflects on the disturbing disparity between white and black death rates in the US. A black American male can expect to live seven years less than a white American male, and black women face a four-year gap. Randall explores a number of potential explanations, including discriminatory policies and practices, lack of language and culturally competent care, inadequate inclusion in healthcare research, and hidden discrimination in rationing mechanisms. Randall argues that these disparities will never be addressed effectively until the legal system develops doctrines that can deter not only intentional discrimination, but also “negligent discrimination in healthcare:”

Negligent discrimination in healthcare would occur when healthcare providers failed to take reasonable steps to avoid discrimination based on race when they knew or should have known that their actions would result in discrimination. An example of this would be decisions to close inner-city hospitals and move them to the suburbs. (86)

Randall expertly characterizes race as a key “social determinant of health” in the United States. Countering the many current legal doctrines that promote the legitimation of discrimination, Randall envisions the type of guarantees of equality that will be necessary to realize the antisubordination and antisubjugation principles that animate the 14th Amendment properly understood.

Diane E. Hoffman also addresses stunning inequalities, this time on a global level. Hoffman’s long engagement with end-of-life care informs a consistently sensitive and insightful public health perspective. Considering the situation in the United States, Hoffman concludes that “it is not as all clear that we would want to give the state a public health justification for taking on end-of-life care,” because “we might have trouble reining in the government and preventing it from implementing increasingly more coercive measures” (59). This judgment is particularly pertinent in a political environment where extreme inequality and ever-lower taxes on the wealthiest have imperiled many important health programs for the aged.

However, Hoffman comes to a different conclusion in the case of many developing countries, where the question is less one of rationing access to life extending technologies than it is one of extending access to basic treatments for pain. In a sobering series of statistics, Hoffman presents a tragic panorama of human suffering. In India, only 1% of the 1.6 million people enduring cancer pain each year are likely to receive any type of pain medication. Morphine dispensaries are rare; Calcutta, with 14 million residents, has only one. Though nearly half its population is extremely poor, India is not an outlier. While developing countries account for 80% of world population, they use only 6% of the morphine consumed each year. Sometimes, shortages of medical personnel help explain the problem: for example, in Sierra Leone, there is only one doctor for every 54,000 people (as opposed to a 1:350 ratio in the US). But Hoffman gives several examples of easily preventable policies and business practices that keep painkillers out of the hands of the world’s poorest individuals. This is a truly neglected global crisis, generating levels of suffering that are rarely encountered or even imagined in the developed world.

Returning to the US, the last two chapters in the book are very interesting contributions to ongoing debates about the nature and role of tort doctrine. Elizabeth Weeks Leonard expertly deconstructs the usual dichotomy between tort law’s individualism and the population focus of public health. As she notes, cases involving asbestos, lead paint, silicone breast implants, the Dalkon shield, hazardous autos, tobacco, firearms, Phen-Fen, OxyContin, and Vioxx have all combined efforts by individuals to secure compensation for injuries with broader strikes against destructive products and practices. Weeks succeeds in demonstrating the “counterintuitive fit between tort law and public health law” (189), arguing that each “offers approaches to addressing inevitable conflicts in organized society between individual interests and community needs.”

Jean Macchiaroli Eggen tries to make the fit better by focusing on punitive damages. Toward the end of her chapter, she proposes that states solve the “plaintiff windfall problem” in punitive damages by requiring that “the portion of the punitive award the plaintiff does not receive [due to split-recovery statutes and other measures] be allocated to a state or private program that will enhance the deterrence of the conduct that gave rise to the warden the particular case.” The contributions of both Weeks Leonard and Macchiaroli Eggen would be of great interest to tort classes and seminars considering the difficult issues raised by judicial efforts to address public health concerns.

John Culhane is to be commended for bringing together such an illustrious group of contributors to address public health, an issue that has been neglected in law schools. Knowing full well that factors like income, race, pollution, and even commute length may have a far greater impact on health than, say, dispute resolution methods used by insurance companies, law professors nevertheless tend to focus on purely legal topics. (I am as guilty of this as anyone, and credit this book (and many interventions by Daniel Goldberg) for pushing me to do more to consider the social determinants of health in my own work.) Well after the sturm und drang surrounding the constitutionality of the ACA has dissolved, we will still face problems of balancing liberty, equality, and welfare that this book’s thoughtful contributors address. Their voices deserve to be heard in those future, more substantive, debates.

Ag-Gag: A Black-Boxed Food Supply

I recently discussed the OIRA’s contribution to some terrible incidents in egg safety. Denis Sterns has written a challenging article on the bigger picture, explaining “Why Food in the United States May Never be Safe:”

This article . . . interrogates the idea of food safety by opening the question of whether a rational economic actor in a free market for food can reasonably be expected to invest in improving the safety of the food products he makes and sells. It is precisely the lack of (cr)edibility in the market – i.e., the absence of reliable quality signals, the lack of traceability, the high degree of anonymity, and the destruction of trust – that creates the structural impediments and powerful disincentive for improving the quality and safety of food. . . . Recall the huge public uproar, and swift policy changes, that followed the release of video of “downer” cattle being abused at a California meat plant. To obtain the video, the Humane Society had to sneak someone inside the plant to secretly record the offending conduct.

The secrecy of some food suppliers is very troubling. Stearns proposes constant surveillance of their actions: “With video cameras always in place . . . one can only expect that most of the shocking conditions that are found after the fact of an outbreak would be less likely to occur in the first place.” Stearns also criticizes FDA’s “wholly voluntary and largely ineffective” traceback regulations, which would make it easier to find the source of contaminated food. (Maybe the FDA is too busy chasing down raw milk co-ops.)

Unfortunately, Big Meat appears all too eager to hide their actions from both concerned citizens and animal rights activists. Consider the rash of legislation designed to deter actions like the Humane Society’s:

The animal advocacy group Mercy for Animals sent an undercover investigator to E6 Cattle Company in Texas, where he filmed calf abuse over a two-week period. To prevent such whistleblowing, several states have passed so-called “Ag-gag” laws that would make it illegal to clandestinely film inside slaughterhouses, sparking what animal rights activists fear will be a nationwide trend. . . . “They’re trying to criminalize someone being an eyewitness to a crime,” Jeff Kerr, [PETA]’s general counsel, said.

One of Chinese dissident Ai WeiWei’s biggest “offenses” against the Chinese government was trying to publicize the names of the children killed when shoddy schools collapsed after an earthquake. Criminalization of exposes of contamination and animal abuse in America’s heartland could be one more step toward the convergence of Chinese and US politico-economic structures.

X-Posted: Concurring Opinions.

What’s for Dinner Tonight? Not Armadillo I Hope

Perhaps not Health Reform per se, but I guess tonight’s post could be considered somewhat of a public service announcement.

Don’t eat armadillos. And don’t touch them either.

Ok, not being a doctor, perhaps I shouldn’t be telling other people what to do from a health perspective. But adventurous as I may be from a culinary perspective, armadillo won’t be on my menu any time soon. And no, I don’t care if my extreme couponing daughter has a buy one get one free. No armadillos.

According to a recent article in The New England Journal of Medicine there is a link between frequent handling and/or the eating of armadillos and leprosy. Yes, leprosy. Known officially as Hansen’s disease and made graphically unforgettable by movies such as Papillon and Ben Hur, it can be transmitted to humans via armadillo. And apparently, there are about 150 cases reported in the U.S. each year. Though many of these cases have been contracted outside the United States and brought back as painful souvenirs from India and other warm parts of the earth, some of these cases have occurred in people who have not left the states or even been in frequent contact with someone who had. The armadillo had long been suspected, but a team of international scientists led by the National Hansen’s Disease Programs in Baton Rouge, La. found a link.

The Associated Press reports that

DNA samples were taken from 33 wild armadillos in Arkansas, Alabama, Louisiana, Mississippi and Texas….

Scientists also took skin biopsies from 50 leprosy patients being treated at a Baton Rouge clinic. Three-quarters had never had foreign exposure, but lived in Southern states where they could have been exposed to armadillos.

An analysis found that samples from the patients and armadillos were genetically similar to each other and were different from leprosy strains found elsewhere in the world. The unique strain was found in 28 armadillos and 25 patients.

Of the 15 patients for whom researchers had information, seven said they had no contact with armadillos; eight said they did, including one who routinely hunted and ate them.

While the work did not document direct transmission from animal to human, “the evidence is pretty convincing that it happens,” said Dr. Brian Currie, an infectious disease expert at Montefiore Medical Center in New York, who had no role in the study.

Leprosy, it is said, is relatively difficult to catch and is treatable, especially if caught early. But in the risk/reward scheme of things, it’s difficult to imagine any situation other than imminent starvation in which eating an armadillo–or even touching them for that matter– could possibly be worthwhile.

The AP: “‘Leave the animals alone,’ advised lead researcher Richard Truman of the National Hansen’s Disease Programs.”

Medicaid Incentives for Healthy Behavior: Turning That Cigarette Back Into Cold Hard Cash

The Centers for Medicare and Medicaid Services (CMS) recently announced a $100 million program through which states can reward Medicaid enrollees who adopt healthy behaviors. The grant program is part of the Patient Protection and Affordable Care Act and allows states to offer incentives for tobacco cessation, controlling or reducing weight, lowering cholesterol or blood pressure, and avoiding the onset of diabetes or improving management of the condition. The goal of the program is prevention, as spending on chronic conditions is said to account for more than 75 percent of annual healthcare expenditures in the U.S.

According to CMS Administrator Dr. Donald Berwick,

With the right incentives, we believe that people can change their behaviors and stop smoking or lose weight. Not only can preventive programs help to improve individuals’ health, by keeping people healthy we can also lower the nation’s overall health care costs.

States are not limited to direct cash incentives– proposed plans could include waiving premiums, deductibles and coinsurance payments, or offering coupons or gift certificates for weight management classes or tobacco cessation counseling.

CMS has based the program on data suggesting a short-term change in behavior when people are offered monetary incentives. Current research shows that while people may be internally motivated to make healthier decisions because of future consequences, they don’t often weigh those delayed outcomes with the immediate reward of engaging in the behavior. For example, knowing that smoking increases lung cancer risk 20 years from now isn’t always going to stop someone from smoking a cigarette. The benefit of monetary incentives is therefore their immediacy– they replace one unhealthy reward with another less harmful one. In short, CMS is betting that someone would put down that cigarette right now if you just paid them to.

But the experience of making healthy decisions seems to align more with what Mark Twain opined in Following the Equator,

He had had much experience of physicians, and said “the only way to keep your health is to eat what you don’t want, drink what you don’t like, and do what you’d druther not.

Though an individual may make a healthy choice now because they would prefer a cash incentive, that doesn’t automatically change their instinctual behavior. Someone could theoretically be convinced to take a grocery store gift card instead of buying a fast food dinner, but that does not change how much they enjoy the taste of a cheeseburger. In many circumstances, people engage in certain behaviors simply because they like to. For this very reason, critics are quick to point out that monetary incentives are unlikely to spur long-term changes in unhealthy habits. Critics also note that there is little research on whether these incentives will be successful in the Medicaid beneficiary population.

What may redeem the initiative from these criticisms is that CMS is candidly calling it a  ”demonstration program,” designed to figure out which strategies produce long-term behavioral changes. By allowing states to develop their own programs and keep data on the experience, CMS seems to be hedging its bets, wagering that at least one program will provide a successful model. Further, CMS can use the data to evaluate other factors such as the administrative costs incurred by states in rendering the programs.

Could $100 million federal grant dollars be used to support preventative health in a different way? Of course. But as long as this money is being set aside to incentivize healthy behavior, we may get an answer to whether external motivators spur long term behavior change. I, for one, would love to know just how much money it costs to convince someone to stop smoking, or to consistently trade in that Big Mac for some broccoli. It almost has to be cheaper than what we’re doing right now.

Childhood Obesity: A Problem Worth Solving

[Ed note: We are pleased to welcome Regina Ram to Health Reform Watch. Regina is finishing her first year as a law student at Seton Hall. She graduated from Drexel University with a B.S. in Biological Sciences and minors in Psychology and Anthropology. She completed a Masters in Public Health from Boston University in 2010 with a focus on Health Law, Bioethics and Human Rights. As a graduate student, Regina worked as a legislative advocate for Dana-Farber Cancer Institute and also supported a SAMHSA funded research program to integrate substance abuse treatment into primary care settings. As an undergraduate, she worked as a healthcare writer and authored emerging technology evidence reports on health devices and procedures.]

Just recently, the New York Times published an article describing the attempt of parents in Philadelphia to change the poor eating habits of the city’s children. A concerned group of parents in a North Philadelphia neighborhood takes turns standing outside of corner stores near a K-8 school in the mornings. They don safety vests and walkie-talkies, and their goal is to discourage kids from stopping at corner stores to buy snacks like soda and candy before school. The article likens the parents to foot soldiers fighting in a national battle over the diets of children.

As dramatic as that may sound, statistics from the Centers for Disease Control and Prevention (CDC) support the metaphor. Nationwide, obesity rates have more than tripled over the past 30 years in both children and adolescents. Long-term consequences include higher risk for heart disease, type 2 diabetes, stroke, several types of cancer, and osteoarthritis in adulthood. More immediate effects include social and psychological problems like stigmatization and poor self-esteem. Further, caring for these health conditions has significant economic effects on the U.S. health care system. All of these statistics portray a battle well worth waging.

But is a group of parents patrolling a convenience store at 8:00 A.M. going to stop childhood obesity? Probably not. Even if the program dissuades kids from buying morning snacks, that behavior is unlikely to continue once parents are gone. Is it a step in the right direction? Certainly. The Surgeon General’s report on overweight and obesity notes that “families and communities lie at the foundation of the solution to the problem.”

However, any successful solution to decrease childhood obesity rates has to involve parents and communities as components of more comprehensive interventions. The causes of obesity in children are multi-factorial, ranging from diet and exercise to genetic and social factors including socioeconomic status and the built environment. The wide array of contributing factors points to the need for an interplay between public and private action to address childhood obesity.

Outside of the home, schools are a key setting for public health efforts to reduce childhood obesity rates. In particular, the National School Lunch Program can be an effective tool in improving the diets of school-age children. Just this year, the U.S. Department of Agriculture announced recommendations to overhaul the nutrition criteria of food programs for the first time in 15 years. The recommendations include limiting salt intake and the use of starchy vegetables, offering only reduced fat milk and using whole grains. Introducing children to healthier foods can help them understand what to eat and why, and that goes much further towards changing future patterns of behavior.

External factors like marketing and advertising also weigh on children’s decisions to eat certain foods. Recent litigation cases (one noted by Jennifer Jascoll here on the HRW website) have focused on the effectiveness of this advertising on children, as well as the disproportionate impact of such advertising on children of lower socioeconomic status. A New York City Councilman recently proposed a bill to ban fast food toys for meals over 500 calories. Children are generally more vulnerable to social messages, and restricting marketing is a case where benefits clearly outweigh the costs.

While involved parents and communities like the one in Philadelphia are undoubtedly an asset, it is going to take a more orchestrated effort to decrease rates of childhood obesity. Parents need to be empowered to make healthy choices and encourage healthier lifestyles for their children. At the same time, schools need to be working hand in hand with the community to ensure that the messages given at school correspond with the messages children hear outside. However unwieldy the issue seems, any action is to be applauded as preferable to no action at all.

(Note: for a more in-depth discussion of the economic consequences of obesity, see Michael Ricciardelli’s article here on HRW)

Time To Tighten That Belt….

Keep an eye out for the April edition of the American Journal of Medicine.  In it, the Los Angeles Times and U.S. News Health Blog report that you will find a new study from the Centers for Disease Control and Prevention (CDC) which identifies the “diabetes belt.”  Almost 26 million Americans - that’s 8% of the population - have type-2 diabetes, the most common form of diabetes (as opposed to type-1) often connected with weight and physical activity.  In a county-by-county census, the CDC  identifies 644 counties in 15 states where the type-2 diabetes rates are higher (11%) than the national average (8.5%).  Ethnicity, age, weight, and a sedentary lifestyle were found to be key factors.

The Los Angeles Times describes the “belt” as stretching “down the southeastern seaboard, ’round the silty Mississippi Delta and following the Appalachian Mountains north across Tennessee, Kentucky and West Virginia” and including parts of Pennsylvania (but stopping short of New Jersey).  Dr. Lawrence Phillips, who studies diabetes at Emory University, told Reuters that

[s]ince diabetes is one of what we call the silent killer diseases … it’s important for the public to be aware that this is a problem….  What this does is to give health care providers ammunition. A provider can say, ‘We’re in the diabetes belt. All of these things are increased in part because of the way we live, and all of these things can be improved to a certain extent. Our risks can be decreased … by eating healthier and to the extent that we can, being less sedentary.’”

The “diabetes belt” appears to overlap with the decades-old “stroke belt” and the recently identified “heart failure belt.” Be sure to check out whether your home state falls within one of these belts.  And then remember to tighten yours.

Navigating Vaccine Policy in New Jersey

[Ed Note: This article was originally published in print and online by The Record, New Jersey's most awarded newspaper.]

NEW JERSEY’S immunization law attempts to strike a balance between protecting public health and the accommodation of religious observance. Children must be vaccinated as a condition of school attendance, but the requirement is waived if the vaccination “interferes with the free exercise of the pupil’s religious rights.”

Last summer, the Department of Health and Senior Services amended its regulations to simplify the process for obtaining this exemption. Several legislators, pointing to New Jersey’s drop in childhood immunization rates, have filed a resolution to force the withdrawal or amendment of this relaxed standard.

Emotions on this topic run high. New Jersey can, however, craft a policy that protects the public health while accommodating those who feel most passionately about avoiding childhood vaccinations.

Under such a policy, permissible exemptions could fall into three categories: medical exemptions for children with conditions, such as immune disorders, that render vaccinations inappropriate (the department estimates that about 0.2 percent of children fit this category last year); exemptions for those with genuine religious reasons to refuse vaccinations (the department estimates that about 0.8 percent of children fit this category last year), and exemptions for those who categorically oppose vaccines on non-religious principles. The first two categories combined amount to only 1 percent of children.

Fueling fears

It is, then, growth in the size of the final category that fuels fears that childhood immunizations could drop to levels threatening population health. The adoption of two practical steps can allay those fears.

First, some factual background. New Jersey’s immunization rates have been dropping. The department’s figures show that the rate of children under 3 with complete age-appropriate vaccinations has dropped from about 80.5 percent in 2007 to about 67.2 percent in 2009. The drop is significant, and may pose a threat to our “herd immunity” - the level of population vaccination necessary to block outbreaks of infectious diseases.

Public health officials recommend vaccine levels at least in the mid-80 percent to low-90 percent level to protect “herd immunity.” This is important stuff: children who are not immunized because they’re too young or medically compromised are at risk if overall rates drop to unsafe level.

Routine vaccinations are safe

Almost all medical and public health experts believe that routine vaccinations are safe and appropriate for almost all children. Even so, we can reach safe levels of childhood immunizations while respecting the strongly felt contrary views of vaccine deniers. Two steps are necessary.

1) Primary care focus. The American Academy of Family Physicians has encouraged primary care providers to remind parents of immunization schedules, provide accurate vaccine education and open their scheduling to encourage primary care visits.

Here in New Jersey, Summit Medical Group has reported that such programs raised its patients’ childhood immunization rates from 84 percent to 97 percent from 2008 to 2010. If primary care providers focus on the reminders, education and open scheduling that achieve such dramatic level of improvement, we’re mostly there.

Restricting exemptions

2) Tightened process for non-medical exemptions. This step is more controversial. Let’s be candid and admit that religious exemptions are sometimes employed by those with strong non-religious objections to vaccinations.

Further, let’s admit that it is uncomfortable for the state to pass judgment on the sincerity of claims of sincere religious belief. A 2001 study published in the American Journal of Public Health provides a way out of this conflict.

It found that non-medical vaccine exemptions can be minimized when states take minor steps as requiring parents to file annually, and at that time to receive accurate information on risks and benefits of immunizations. Such processes can tip the balance toward immunization for two groups of parents.

First, parents without strong objections but for whom doctors’ appointments for vaccinations were inconvenient may find that it is now easier on balance to comply with the law. Second, those confused by the controversy may have their fears addressed by public health information provided.

The article found that these simple steps can increase the level of immunization, while respecting the views of those parents with implacable objections to vaccinations. Objecting parents can simply accept the information, and file the annual reports.

These two steps could raise immunizations to safe levels without the need to force the hands of parents with strong religious or other principled objections. If, as the studies suggest, vehement objectors are relatively few, population health and personal beliefs can be accommodated.

A “Sputnik Moment”? Hopes for Renewed Drug Development With A Little Help From Our NIH Friends

In his State of the Union Address, President Obama tried to spark the “creativity and imagination” of the American people when he proclaimed

[t]his is our generation’s Sputnik moment.  Two years ago, I said that we needed to reach a level of research and development we haven’t seen since the height of the Space Race.  And in a few weeks, I will be sending a budget to Congress that helps us meet that goal.  We’ll invest in biomedical research, information technology, and especially clean energy technology… an investment that will strengthen our security, protect our planet, and create countless new jobs for our people.

Now I don’t know what came first — the chicken or the egg — but President Obama’s speech about investing in biomedical research and technological innovation follows National Institutes of Health (NIH) Director Francis Collins’ proposal to create a National Center for Advancing Translational Sciences (NCATS) to encourage drug discoveries and facilitate translational research in compounds overlooked by or abandoned by pharmaceutical manufacturers.  So does Dr. Collins’ proposal qualify as a “Sputnik moment”?

You might not have realized it, given those never-ending TV and magazine advertisements for prescription products (whose side effects sometimes sound worse than their benefits, but that’s another blog post), but pharmaceutical manufacturers have reduced their investment in researching and developing drugs.  According to the New York Times, pharmaceutical manufacturers spend over $1 billion developing a drug, with some “typically spend[ing] twice as much on marketing as on research” though that’s “a business model that is increasingly suspect.”  (For a brief overview of the research and development process, click here.)  The Pharmaceutical Research and Manufacturers of America (PhRMA) estimates that its members spent $45.8 billion in 2009 in research alone.

Even so, the number of drugs approved by the Food and Drug Administration (FDA) has dropped over the last 15 years and that’s not due to a lack of scientific information or higher FDA standards.  In November 2010, Forbes health blogger Matthew Herper reported on  the annual meeting of the American Society of Human Genetics at which Dr. Collins

implored his colleagues in genetics to work to develop new treatments for rare diseases. His point was that the NIH and the Food and Drug Administration are increasingly able to handle preclinical and early clinical drug development, and that with these first steps taken medicines are more likely to be brought to market by large pharmaceutical companies.

Mr. Herper also noted that a few organizations, such as the Cystic Fibrosis Foundation and the Multiple Myeloma Research Foundation, have taken a similar route in pushing along research  until a pharmaceutical manufacturer picks up the slack.  Then a month later, Arthur H. Rubenstein, dean of the University of Pennsylvania School of Medicine and chair of the NIH Translational Medicine and Therapeutics Working Group, told the Wall Street Journal Health Blog, “[b]asic science has exploded but it has not translated into benefit for the public.  The question was what to do about it.”

In stepped NIH to ease, in the words of the WSJ Health Blog, the “mounting frustration that a wealth of new information about the molecular basis of diseases hasn’t produced more new therapies.”  On December 7, 2010, NIH’s Scientific Management Review Board (SMRB) voted 12-1 in favor of adding NCATS to NIH.  Dr. Collins notified Health and Human Services Secretary Kathleen Sebelius of the decision.  Then on January 14, 2011, Secretary Sebelius sent a letter to Congress.  However, the decision to add NCATS  meant dismantling one of the 27 NIH centers and institutes, per the requirements of a 2006 law (”27″ is the “magic number”).  The lone SMRB dissenter, Jeremy Berg, director of the National Institute of General Medical Sciences, said he was “concerned that the implications for the rest of NIH hadn’t been adequately discussed.”

And therein lies some of the controversy.  NIH envisions NCATS as a link between basic discovery research and therapeutics care by:

• providing a visible, central locus for access to resources, tools, and expertise related to translational medicine;
• streamlining and improving the process of therapeutics development;
• serving as a catalyst, resource, and convener for collaborative interactions by supporting novel and innovative partnerships between multiple key stakeholders, including academia, government, industry, venture capitalists, and non-profit organizations;
• expanding the pre-competitive space by, among other things, enabling and providing incentives for greater sharing of scientific information and publication of negative results;
• supporting and strengthening translational medicine and therapeutics research, including providing access to services and resources for high-throughput screening, assay development, medicinal chemistry, and preclinical modeling;
• training translational research investigators; and
• enhancing communication among all stakeholders.

PhRMA Senior Vice President David E. Wheadon supports NCATS because

[c]ollaboration — including industry, NIH and academia — is one element driving innovation in drug development, particularly early stage — and ‘bold and ambitious’ proposals, such as Dr. Collins’, will be key to how we collectively progress in discovering novel compounds for addressing patients’ unmet medical needs….

The fact remains that biopharmaceutical research companies today and in the future will play a pivotal role: Our companies create the vast majority of new medicines from start to finish and, for the remainder, in close collaboration with academia and NIH, fulfill the critical final phase that transforms promising molecules into actual medicines for patients.

The WSJ Health Blog notes that NCATS isn’t NIH’s first foray into developing drugs.  In 2009, NIH created the Therapeutics for Rare and Neglected Diseases (TRND) program for basic research on rare diseases.  This early stage of drug development, WSJ Health Blog notes, is “expensive, time-consuming… prone to failure” and often not worth the effort for pharmaceutical manufacturers since the related market is small.

However, this time NIH must restructure several programs to accommodate NCATS, including the Molecular Libraries screening program, TRND, and the National Center for Research Resource’s (NCRR) Clinical and Translational Science Awards.  NCATS would house all three programs, along with the in-the-works Cures Acceleration Network (a drug-development program created by the Patient Protected and Affordable Care Act).

Staff members and researchers connected with the NIH community aren’t too thrilled over the restructuring, particularly with respect to NCRR.  If you visit Feedback NIH, the online forum for public commentary on NIH initiatives, you can read through the 1,100+ lengthy NCATS-related comments.  You’ll also see the “Separating Fact & Fiction” post by Dr. Francis Collins, which begins:

[b]y now, many of you have read the recent New York Times article or related news coverage, about NIH’s plan to establish the National Center for Advancing Translational Sciences (NCATS).

While we are pleased that the news media have recognized NIH’s efforts as a significant development for translational research, the Times article contains some misleading statements that we would like to clarify. Those statements suggest that a much larger shakeup of NIH is underway than is actually contemplated.

So, to set the record straight, we want to share with you what we know at this point in time…

(internal links removed).  The “we” includes Members of the Institute and Center Directors NCATS Working Group.  The post attempts to clear up concerns about budget cuts (House Republicans have already promised to cut the discretionary spending that supports NIH), the security of existing programs, and the misconception that NCATS will be a drug company.

Despite the negative responses, Dr. Collins remains optimistic.  In an interview with ScienceInsider, he emphasized that

the NIH director is called upon to look for scientific opportunities that aren’t being met and to figure out how to make them happen, and that sometimes requires moving things forward at a rapid pace, and that affects a lot of people.

And of course change is always distressing, especially if people aren’t quite sure where it’s going. So I understand the anxiety that currently exists.

But let’s wait a year and see when this has all taken shape how people feel at that point. Will they say at that point that projects or programs at NCRR got dealt a bad deal? I bet they won’t. Will they say they’re excited about the translational science opportunities that are taking shape in the form of this new center? I bet they will.

Perhaps if purse strings weren’t so tight and the healthcare reform debate was settled — or if NIH wasn’t limited to 27 centers and institutes — the creation of NCATS might not upset so many people.  Yet has Dr. Collins displayed a little of that “Sputnik moment” spirit by accelerating the development of drugs for diseases and other areas overlooked by pharmaceutical manufacturers?  Sure.  Just don’t expect him to take us to the moon.

Short Circuited Surge Capacity: Lessons from the Blizzard for Public Health

Bad weather recently caused massive failures at Heathrow Airport, and brought chaos to air travel in the New York area. Both scenarios suggest an intriguing set of dilemmas in health law and policy. We should be doing much more to prepare for sudden, disruptive events in both the transportation and health sectors. But economic short-termism rules the roost, undercutting the infrastructural investments that a more enlightened America would make.

Stuart Altman has wisely compared hospitals and airlines, and worried that many of the former would suffer the fate of legacy carriers:

By 2025 the need for general hospitals to cross-subsidize [i.e., use payments from the well-insured to pay for others' care] will greatly increase, but their ability to do so will be diminished. U.S. hospitals could begin to resemble U.S. airlines: severely cutting costs, eliminating services, and suffering financial instability. . . .

There are numerous similarities between the airline and hospital industries. Both comprise companies that built a complex infrastructure and provided cross-subsidized services. Both were protected by a lack of price transparency and limited competition. In the recently deregulated airline industry, price competition and specialized airlines have emerged that do not have to serve all cities and can focus on the most profitable routes. They need not charge higher prices for these routes to make up for losses incurred elsewhere. Similarly, in the hospital industry, specialty hospitals have emerged that can focus on the most profitable patients and do not have to treat the uninsured or provide money-losing services.

The new specialty hospitals, like the new low-cost carriers, are not saddled with fixed costs from old plant and equipment and do not have to contend with excess capacity that resulted from historical changes in demand.* Both use their inherent cost advantages to compete for more price-sensitive consumers. Legacy airlines cannot raise fares to cover costs because price-sensitive customers can now obtain transparent price information on the Internet and shop for the lowest fares. California is now requiring, and many advocacy organizations are encouraging, hospitals to post their prices on the Internet. Hospital patients, facing increased copayments, deductibles, and other out-of-pocket costs, could begin to behave more like airline passengers. . . .

Because of increased price transparency and specialized competition, legacy airlines could not raise prices sufficiently to cover their costs. Between 1 October 2001 and 31 December 2003, they cut costs by $12.1 billion. They stopped serving some locales and reduced seat capacity. They cut labor costs, services, and amenities. Nevertheless, from 2001 through 2003, the legacy airlines lost $24.3 billion, while the low-cost carriers reported profits of $1.3 billion.

The past few years have witnessed a recovery for many airlines pushed to the brink after 9/11. They filled more seats in each plane (leading to higher “load factors”) and otherwise “cut the fat” (sometimes endangering passengers in the process). Nate Silver observes that filling up planes has some positive effects on prices and the environment, but also sets in motion dynamics that few fully consider until the unexpected strikes:

[L]oad factors have been rising steadily. A decade ago, they were closer to 70 percent, which permitted quite a bit more slack in the event of cancellations. At a 70 percent load factor, there are 2.3 passengers for every available seat, which means, roughly speaking, that one day’s worth of cancellations might take two days to clear through the system. At an 82 percent load factor, on the other hand, there are 4.6 passengers for every seat — roughly twice as many — so one day’s worth of cancellations might require four or five days to get everyone home.

The societal trade-offs here are tough, and airlines need flexibility in determining how far they should go to crowd planes and maximize profits. But in the realm of healthcare, I am much more concerned that a long series of hospital closures will leave the system disastrously overwhelmed in case of an infectious disease outbreak, terrorist attack, or extreme weather event. Like airlines, hospitals have been cutting their surge capacity in order to improve the bottom line. As I noted over four years ago, the asymmetry between projected demand and supply for something as fundamental as ventilators is shocking. A 2006 estimate suggested that only 5,000 spare ventilators would be available to as many as 742,500 people in need in the case of a serious pandemic.

In a 2005 article in the Journal of Contemporary Health Law and Policy, Lance Gable et al. discuss surge capacity as “the number of critical casualties arriving per unit of time that can be managed without compromising the level of care,” and propose ways of increasing “the availability of skilled health professionals to supplement the existing health workforce.” I applaud their approach and attention to the problem (astonishingly, it is the only article in the Westlaw JLR database with “surge capacity” in the title). But I also worry that scarce physical space is going to cause as large a problem at hospitals as personnel shortages. Like its airports, New York’s community hospitals are fraying:

In New York’s many community hospitals, which provide an essential first line of defense in the effort to safeguard public health, the danger of failure is particularly acute. Combine growing costs, decreasing revenues, and high debt loads, and you can’t dig out. Then what happens? “If you’ve accumulated any reserve over time,” an executive at a major local hospital says, “the first thing you do is eat it up. Then you cut costs on staffing and support services, sometimes below levels you know are safe. Then you stop spending money to keep your physical plant and equipment up to date. The condition of the physical plants of many New York City hospitals is staggering. Then, when there’s nothing else you can do, you declare bankruptcy. That’s the life cycle of a New York hospital.”

Given all these strains, hospitals may have to choose between community service and solvency in the wake of a major outbreak of illness. Vickie J. Williams’s article “Fluconomics” presciently examined the bad financial incentives that hospitals would face in case of a serious outbreak of infectious disease:

[W]e currently have no means of ensuring that hospitals acting as isolation, quarantine, and treatment centers in a pandemic will survive the loss of revenue that they will experience in protecting the public’s health. Our hospitals depend on a fragmented financing system that presumes the hospital’s ability to shift costs from low-paying public payors to higher-paying private payors, and from less lucrative cases to more lucrative, often elective, procedures.

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Anti-Smoking Efforts Light Up

In an effort to discourage Americans from smoking, the Food and Drug Administration (FDA) recently unveiled a proposal requiring cigarette packages and advertisements to display large, color graphic warnings.  The proposal calls for nine warning statements accompanied by a color graphic depicting the health consequences of smoking, such as addiction, stroke and heart disease, cancer, open sores, harm to children via second-hand smoke, harm during pregnancy, and death.  (Click here and here to see the 36 proposed statements and color graphics.)  Members of the public can submit their comments to the FDA until January 11, 2011.  The FDA will make its selection in June 2011.  Come October 2012, the warnings will cover 50% of the front and back of a cigarette package, and 20% of the space of a cigarette advertisement.

So what brought about this change?  You may have missed the news last summer, but a new law called the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) gave the FDA the authority to regulate tobacco products and required these large, graphic modifications to cigarette packages and advertisements.  According to FDA Commissioner Margaret Hamburg, “every pack will become a mini-billboard that tells the truth about smoking.”  The American Academy of Physicians notes that

[t]he FDA has taken several steps since it was given authority to regulate the tobacco industry last year. The agency already has prohibited the use of the terms ‘light,” “low” and “mild” in cigarette marketing and packaging; banned cigarettes with fruit, candy, and spice flavors; and restricted the sale and marketing of tobacco products so that young people are less likely to be exposed to tobacco ads.

Approximately 20% of Americans smoke.  The government hopes to reduce that number to 12% by 2020.

In August 2009, R.J. Reynolds Tobacco Company (maker of Camel, Pall Mall, Doral, Kool, Winston, and Salem) and several other tobacco companies filed a lawsuit in the Western District of Kentucky to “protect their First Amendment right to communicate with adult tobacco consumers products.”  ¶51 of the complaint stated that

[b]ecause the Act virtually eliminates Plaintiffs’ ability to communicate to adult consumers through advertising, the only remaining vehicle for such communication is product packaging. But the Act destroys this as well, seizing a substantial portion of Plaintiffs’ packaging for a Government-drafted anti-tobacco message–including, for cigarette packaging and advertising, the use of shocking, graphic color imagery–as well as other mandated information….

The tobacco companies didn’t win on that point.  Obviously.

However, America won’t be the first country to employ “scare tactics” (and I use that phrase in a neutral way).  Canada, England, Brazil, Thailand, Turkey, and Australia are among the 39 countries to cover their cigarette packages with graphic warning labels that “tell it like it is” (that phrase was less neutral).  Last month, the Canadian Cancer Society released its “Cigarette Package Health Warnings: International Status Report” which summarized health warning requirements by country/jurisdiction and showed graphic labels from around the world.  (Ironically, the report comes across as a little competitive when it compares the size of the graphic labels.)

Yet supporters and critics alike question the effectiveness of this approach.

Take our neighbors to the north.  Although The Wall Street Journal reported that smoking rates dropped 3% among Canadians after their graphic warning labels appeared, the newspaper also noted how “other tobacco prevention measures, such as cigarette tax increases and new restrictions on public smoking, came at the same time.”  On NPR’s All Things Considered, David Sweanor, a law professor at the University of Ottawa, observed that

[w]hat we see with these sorts of warnings is that it does increase motivation…. People are more aware of the risks. They are wanting to quit. But that has to be combined with services that make it more likely.

Professor Sweanor went on to say that the desired outcome — fewer smokers – has been disappointing because the “[Canadian] government hasn’t provided enough access to smoking cessation programs.”

At home, The Wall Street Journal interviewed Jonathan Whiteson, medical director of NYU Langone Medical Center’s cardiac and pulmonary wellness and rehabilitation program, who suggested the labels should promote a “positive message” emphasizing the benefits of a smoke-free life, because

[w]hen we emphasize feeling good, the sense of mastery that comes from making a behavioral change or the promise of an enhanced chance of avoiding heart disease or cancer — that [produces] a much more positive and effective response from patients.

Mr. Whiteson added that smokers already are aware of the negative consequences of smoking, but just might be in denial about them.  He also noted how the public generally becomes desensitized to shocking images.

So could reverse psychology work better?  A relatively recent study published in the Journal of Experimental Psychology found that certain smokers who based their self-esteem on smoking were not deterred by death-related warnings.  Instead, the study found that

warning messages that were unrelated to death effectively reduced smoking attitudes the more recipients based their self-esteem on smoking. This finding can be explained by the fact that warnings such as ”Smoking brings you and the people around you severe damage” and ”Smoking makes you unattractive” may be particularly threatening to people who believe the opposite, namely that smoking allows them to feel valued by others or to boost their positive self-image. To the degree that warning messages undermine the high smoking-based self-esteem, smoking may be devalued.

I was interested to come across this study because Prescriptions, a NY Times blog, recently wrote about R.J. Reynolds’ special-edition packs of Camel linking the cigarettes with hip images of certain American cities, including the Williamsburg neighborhood in Brooklyn.  The Williamsburg package says

Some call it the most famous hipster neighborhood.  But it’s not about hip. It’s about breaking free. It’s about last call, a sloppy kiss goodbye and a solo saunter to a rock show in an abandoned building.  It’s where a tree grows.  It’s Camel in the Williamsburg corner of Brooklyn.

If self-esteem and smoking are connected for some people… well, I can see a spin-off warning statement and graphic there which might be an effective deterrence.  Can you?

Alongside the FDA graphic warnings proposal, the Department of Health and Human Services has announced other tobacco-related projects in the works, including:

• The Affordable Care Act is giving Americans in private and public health plans access to recommended preventive care, like tobacco use cessation, at no additional cost.
• The American Recovery and Reinvestment Act (ARRA) invested $225 million to support local, state and national efforts to promote comprehensive tobacco control and expand tobacco quitlines.
• The Prevent All Cigarette Trafficking Act (PACT) aims to stop the illegal sale of tobacco products over the Internet and through mail order, including the illegal sale to youth. [...]
• The Children’s Health Insurance Program Reauthorization Act (CHIPRA) raised the federal cigarette tax by 62 cents per pack.  Raising the price of tobacco products is a proven way to reduce tobacco use, especially among price-sensitive populations such as youth.

Just as an FYI, check out this NY Times article about ongoing efforts in other countries to restrict the the marketing of cigarettes.

Health Care and Disparity in a “Post-Racial” Era

Seton Hall Law School recently hosted the Third National People of Color Conference, which was convened to “address critical national and global issues through the lens of legal scholarship that explicitly and implicitly examines contemporary racial context.”

The conference brought together over 400 judges, law professors, lawyers and students to our campus over the course of  four days and featured panels and speeches by people such as the Reverend Jesse Jackson; the Honorable Cory Booker, Mayor of Newark, New Jersey; Professor Derek Bell, Visiting Professor at New York University School of Law; Kathleen Martinez, Assistant Secretary of Labor for Disability Employment; The Honorable Joseph A. Greenaway, U.S. Court of Appeals, Third Circuit; Gay McDougall, United Nations Independent Expert on Minority Issues; Keith Harper, former Appellate Justice of the Mashantucket Pequot Tribal Nation; and just too many other smart and interesting people to list here. (A good account of the Conference in Diverse Magazine can be found here).

Involved in some of the on site prep work, I was unable to attend nearly as much as I would have liked. But I did have the opportunity to listen to a number of thought provoking presentations, including speeches by Jesse Jackson, Mayor Booker, Keith Harper and Katleen Martinez.

In considering the theme of the conference, “Our Country, Our World in a ‘Post-Racial’ Era,” it was made clear time and time again that despite the rhetoric that has bounced about our nation since President Obama took office, when looking at numerical indicators for well being in the United States racial identity, ethnicity, gender, sexual identity, and disability status matter.

I realize that I am saying nothing new here–nor am I saying it as well as I heard it. But I think it also bears repeating.

It is also worth noting, when looking at the disparity in health care access, utilization, and quality of received care, that here in New Jersey as a response to a budget crisis, the state recently summarily stripped over 12,000 legal immigrants of their right to health care through Medicaid. Our Center for Social Justice here at Seton Hall Law has sued the State of New Jersey for doing so as a violation of both the state and federal constitutions as a matter of, among other things, equal protection. Such actions by the state assuredly do not bode well for the health care variance numbers below; and maybe, when considering the disparities in health care, “equal protection,” in the largest sense of the word, is the appropriate lens through which to view this.

But it is also, within the context of anyone’s verbal meanderings about a supposed “post-racial” society, important to note that news of the suit was featured in the Wall Street Journal, Star Ledger, Asbury Park Press, The Record, The Daily Record, The Courier Post, Home News & Tribune, The Jersey Journal, MSNBC, PolitickerNJ, Newsday, Immigration Prof Blog and other media throughout New Jersey, New York, Pennsylvania, and Connecticut.

Reader’s comments were decidedly not kind. Having done a great deal of work with and for immigrant communities, the urban disenfranchised, Guantanamo Detainees, and others unpopular and unjustly treated, we’re used to it here at Seton Hall Law. But I invite anyone entertaining delusions about a “post-racial” era to take a look at the comments. Or, for that matter, the comments on almost any newspaper article that deals with immigration– or race.

Having said that, I also invite you to take a look at the following numbers and study results from HHS’ Agency for Healthcare Research and Quality. Below that, you’ll find a really interesting lecture from a Health Care Disparities Class at Case Western Reserve University from Professor Insoo Hyun. The video is courtesy of the Case Center for Reducing Health Disparities and their well produced blog and resource center.

As for the studies and numbers, though just a small sampling, I’ll let them speak for themselves:

Identifying Disparities in Care

Access to Primary Care

Primary care is the underpinning of the health care system, and research studies have shown that having a usual source of care raises the chance that people receive adequate preventive care and other important health services. Data from AHRQ’s Medical Expenditure Panel Survey (MEPS) reveal that:

• About 30 percent of Hispanic and 20 percent of black Americans lack a usual source of health care compared with less than 16 percent of whites.
• Hispanic children are nearly three times as likely as non-Hispanic white children to have no usual source of health care.
• African Americans and Hispanic Americans are far more likely to rely on hospitals or clinics for their usual source of care than are white Americans (16 and 13 percent, respectively, v. 8 percent).

Diagnosis and Treatment

Race and ethnicity influence a patient’s chance of receiving many specific procedures and treatments. Of nine hospital procedures investigated in one study, five were significantly less common among African American patients than among white patients; three of those five were also less common among Hispanics, and two were less common among Asian Americans. Other AHRQ-supported studies have revealed additional disparities in patient care for various conditions and care settings including:

• Heart disease. African Americans are 13 percent less likely to undergo coronary angioplasty and one-third less likely to undergo bypass surgery than are whites.
• Asthma. Among preschool children hospitalized for asthma, only 7 percent of black and 2 percent of Hispanic children, compared with 21 percent of white children, are prescribed routine medications to prevent future asthma-related hospitalizations.
• Breast cancer. The length of time between an abnormal screening mammogram and the followup diagnostic test to determine whether a woman has breast cancer is more than twice as long in Asian American, black, and Hispanic women as in white women.
• Human immunodeficiency virus (HIV) infection. African Americans with HIV infection are less likely to be on antiretroviral therapy, less likely to receive prophylaxis for Pneumocystis pneumonia, and less likely to be receiving protease inhibitors than other persons with HIV. An HIV infection data coordinating center, now under development, will allow researchers to compare contemporary data on HIV care to examine whether disparities in care among groups are being addressed and to identify any new patterns in treatment that arise.
• Nursing home care. Asian American, Hispanic, and African American residents of nursing homes are all far less likely than white residents to have sensory and communication aids, such as glasses and hearing aids. A new study of nursing home care is developing measures of disparities in this care setting and their relationship to quality of care.

Looking Beyond Income and Insurance

Disparities in health care are often ascribed to differences in income and access to insurance. Research has shown these to be important, but by no means the only factors. For instance, the proportion of Hispanic Americans with a usual source of care has declined substantially over the past decade (from 80 percent in 1986 to 70 percent in 1996). Insurance coverage has also declined, and the lack of insurance in some groups is dramatic (among Hispanic men, for instance, 37 percent have no health insurance). Nonetheless, declines in insurance coverage explained only one-fifth of the change in access to a usual source of care.

In another recent study, AHRQ-funded researchers in Boston examined the quality of care provided to hospital patients with congestive heart failure or pneumonia. Quality of care was measured both by physician review and by adherence to standards of care. The researchers found no difference in quality of care for patients from poor communities compared with other patients, after adjusting for other factors. They did find, however, that African American patients received a lower quality of care than white patients.

Physician Decisionmaking

A small study of physicians’ decisions about whether to refer patients for cardiac catheterization, a diagnostic procedure for heart disease, provides supportive evidence that factors other than insurance and income can influence the quality of care people get. This study, which used actors portraying similar economic backgrounds, found that black women were significantly less likely than white men to be recommended for referral, despite reporting the same symptoms. (Differences between other groups studied were not statistically significant.)

Hospital Characteristics

In the Boston study of the quality of care, quality for African American patients was lower in nonteaching than in teaching hospitals. In another study, white patients were more likely than Hispanic and African American patients to receive invasive cardiac procedures in hospitals performing a high volume of such procedures, a factor strongly associated with the quality of cardiac care.

Developments In Domestic and Global HIV/AIDS Strategies

The White House recently released its HIV/AIDS strategy to reduce the number of new infections in the United States by 25% over the next five years.  During a press conference, President Obama observed that “[t]he question is not whether we know what to do, but whether we will do it.  Whether we will fulfill those obligations… to prevent a tragedy.”  Those obligations primarily concern reducing the number of new infections through HIV prevention programs, increasing access to and quality of care for those living with HIV, and decreasing HIV-related health disparities.  Right now there are 56,000 new infections in the United States every year.  Approximately 1.1 million Americans are living with HIV, but 1 in 5 don’t know it.

Advocates have criticized both the administration and Congress for failing to adequately fund HIV/AIDS efforts at home and abroad.  A recent AIDS Healthcare Foundation (AHF) “Who’s Better on AIDS?” advocacy advertisement unfavorably compared President Obama’s track record to that of President Bush.  (In 2003, the Bush administration implemented the President’s Emergency Plan for AIDS Relief (PEPFAR), a multibillion dollar initiative which has proved successful in lowering the AIDS death rate in Africa, though not the rate of HIV infection).   Michael Weinstein, President of AHF, told CNN that:

“when you see what this administration has done on AIDS, you have to give them very low grades.”

Obama has “consistently underfunded AIDS” programs, Weinstein said.  The president “did not mention the word AIDS for the first five months of his administration.  This national AIDS strategy has been worked on for 15 months, [and] I think it could have been done in 15 minutes.  There’s nothing new in it.”

Weinstein [also] criticized the administration’s intention to redirect money to those groups at greatest risk of contracting HIV/AIDS.  “It’s not good to pit one group against another and it’s unnecessary,” he said.  “The bottom line is that we should be seeking to get all sexually active people to get an HIV test.”

Some recent Canadian research also suggests another bottom line: treating people with HIV reduces the number of new infections.  And there the treatment is free.

The Center for Disease Control (CDC) recently presented its findings that heterosexuals living below the poverty line ($10,000 or less) in American cities were twice as likely to be infected with HIV as their higher-income neighbors.  The statistics translate to 1 in 42 people (the national average is 1 in 222 people).  Most studies focus on sexual orientation, race, and/or intravenous drug use.  None of those factors were included here though.  Kevin Fenton, a CDC HIV/AIDS expert, said that “HIV clearly strikes the economically disadvantaged in a devastating way.”  Researchers found that the risk of spreading HIV came from a lack of access to medical care and unawareness of infection.  Dr. Carlos del Rio, Chair of Global Health at Emory University’s Rollins School of Public Health, frames the issue differently as “[y]ou can talk about ‘Can we decrease the HIV burden in the United States?’  I would say, ‘What can we do to decrease poverty in the United States?’”

The 18th International AIDS Conference took place last week in Vienna, Austria.  Policymakers, researchers, advocates, and persons living with HIV met to draw attention to the epidemic and assess the global response to it.  According to the Associated Press, Julio Montaner, President of the International AIDS Society and Chairman of the Conference, opened the event by pointing to how:

the G-8 group of rich nations has failed to deliver on a commitment to guarantee so-called universal access and warned this could have dire consequences.

“This is a very serious deficit,” Montaner said.  “Let’s rejoice in the fact that today we have treatments that work … what we need is the political will to go the extra mile to deliver universal access.”

With the global economic crisis in full swing, AIDS activists are concerned about developed countries reducing their foreign aid, including funding for AIDS assistance.

In its annual report released last week, the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the Kaiser Family Foundation found that global AIDS spending has “flattened.”  Although public and private sources contributed $15.9 billion in 2009, the amount was $7.7 billion short of the estimated $23.6 billion needed to combat AIDS in low and middle-income countries.  Contributing governments included the U.S. (58%), United Kingdom (10.2%), Germany (5.2%), the Netherlands (5%), France (4.4%), and Denmark (2.5%).  The report noted that “without U.S. funding, international AIDS assistance from donor governments would have significantly declined between 2008 and 2009.”

BP Isn’t Alone — Other Risks Lurk Beneath the Gulf Waters

Photo by kenhodge13 via Flickr

This isn’t Health Reform per se, but it’s hard to believe that that much oil in an eco-system (never mind the dispersants released which “had “no toxicity studies” done to support their use“) isn’t going to adversely impact public health long and short term. Time Magazine:

The question is what shape the impact of that catastrophe will take — mentally, physically, emotionally — on the people of the Gulf, now and for generations to come. Much is unknown about the long-term health dangers of an oil spill; few spills have been studied in this way.

A group of doctors and scientists who gathered in New Orleans on June 22 and 23 for a conference on the issue, hastily put together by the Institute of Medicine, came to the inevitable conclusion that a massive, multilateral effort must be launched now to track the health effects of the spill over time — and that researchers were already falling behind. “We have an unknown number of people exposed to an unknown danger,” said Dr. Lynn Goldman, a professor at the Bloomberg School of Public Health at Johns Hopkins University, at the conference. “There has not been preparedness in the public-health community for dealing with something of this magnitude.”

According to Daily Finance:

From the few studies of past spills, one of them by the National Institute for Occupational Safety and Health (NIOSH) after the Exxon Valdez spill, certain acute symptoms were expected, and already Gulf residents and cleanup workers are experiencing them: headaches, nausea, vomiting, diarrhea, throat irritation, eye pain, coughing or choking and dizziness.

Of greater concern is a more recent study of those exposed in Spain after the 2002 Prestige oil tanker spill, which found an increase in DNA damage. Other potential long-term risks include lung, kidney and liver damage.

Time also notes that “In the wake of the Exxon Valdez spill, the small Alaskan fishing port of Cordova saw a rise in domestic abuse, alcoholism and eventually suicide.”

And now perhaps more?

Brace yourself.  In the wake of the BP disaster (seriously, it’s not a “spill” anymore) an AP investigation has discovered there are 27,000 abandoned gas and oil wells in the Gulf of Mexico, some of which date back to the 1940s.  3,500 of those wells have been “temporarily abandoned” — as in, a company has told our government that it plans to reuse or permanently close a well within 12 months.  The now infamous BP well was being capped for temporary abandonment when it blew (click here to see how much land the oil would cover if it the blowout had occurred near you).  Yet three-quarters of the 3,500 temporarily abandoned wells have been left in limbo, anywhere from one year to 40.

Abandoned wells, including those “permanently” abandoned, can weaken from exposure to sea water, underground pressure, poor workmanship, age, and other factors.  The AP reporters found that neither industry nor government officials are in the habit of inspecting them.  Eric Kazanis, a U.S. Mineral Management Service petroleum engineer (whose department was recently renamed the Bureau of Ocean Energy Management, Regulation, and Enforcement), said that “[o]nce a well is plugged with cement, it’s no longer a risk….  It’s not supposed to leak.”

Yet warnings on the environmental risks of abandoned wells — published by the Government Accountability Office, the Environmental Protection Agency, and even the former Mineral Management Service — have been repeatedly ignored.  The AP reporters found that:

[s]tate officials estimate that tens of thousands [of wells] are badly sealed, either because they predate strict regulation or because the operating companies violated rules.  Texas alone has plugged more than 21,000 abandoned wells to control pollution, according to the state comptroller’s office.

Offshore, but in state waters, California has resealed scores of its abandoned wells since the 1980s.

In deeper federal waters, though… the official policy is out-of-sight, out-of-mind.

In light of this stunning revelation, Colorado Senator Mark Udall (a proponent for renewable energy)  immediately wrote to Interior Secretary Ken Salazar asking if any of the abandoned wells are in federally regulated waters, what environmental threat they might pose, and how the department may be obligated to respond.

Let’s hope the response is a little faster than what we’ve been witnessing in the Gulf so far.  By the way, BP is expected to attempt to “bottom kill” its well in the next couple of weeks.  I’m not holding my breath on either count. But perhaps– considering the the acute symptoms of exposure, Gulf residents should.

San Francisco Has Cancer on the Brain

Recently, the San Francisco Chronicle reported that the city’s Board of Supervisors has thrown its hat into the ring of the great cell phone brain cancer debate.  The Board voted 9-1 in favor of an ordinance requiring local retailers to display specific absorption rate (SAR) notices detailing radiation levels in cell phones.  SAR measures the rate at which radiofrequency electromagnetic energy is absorbed in a body when using a cell phone.  The FCC requires that cell phones sold in the U.S. not exceed a SAR level of 1.6 watts per kilogram.  (If you’re curious about your own cell phone, check out CNET’s SAR level list for voice calls).  Mayor Gavin Newsom is expected to sign off on the ordinance and his spokesman says “this is a very reasonable and quite modest measure that will provide greater transparency and information to consumers for whom this is an area of interest or concern.” If this really does come through, it won’t affect retailers until 2011 or so.

Meanwhile, the industry trade group CTIA-The Wireless Association has issued a statement admonishing and punishing the Board for its vote:

“CTIA and the wireless industry are disappointed that the San Francisco Board of Supervisors has approved the so-called ‘Cell Phone Right-to-Know’ ordinance.  Rather than inform, the ordinance will potentially mislead consumers with point of sale requirements suggesting that some phones are ’safer’ than others….  [A]ll phones sold legally in the U.S. must comply with the Federal Communications Commission’s safety standards….  While we have enjoyed bringing our three day fall show to San Francisco five times in the last seven years, which has meant we’ve brought more than 68,000 exhibitors and attendees and had an economic impact of almost $80 million to the Bay Area economy, the Board of Supervisors’ action has led us to decide to relocate our show [starting in 2011].”

So is this just fear-mongering or does San Francisco’s Board know something that the rest of us don’t?  According to the 10 year Interphone study conducted by the World Health Organization’s International Agency for Research on Cancer and published online last month by the International Journal of Epidemiology, there is no conclusive evidence supporting or disaffirming any connection between cell phones and the risk of brain tumors.  The study was not without controversy, though, even among the researchers themselves — and it had nothing to do with industry trade organizations– the Mobile Manufacturers’ Forum and the GSM Association– contributing funds for the study.  Last month, the Wall Street Journal reported that the Interphone researchers were puzzled by their data because

[t]he result is a strange set of numbers.  Many levels of cellphone use appeared to reduce the chance of developing a tumor.  Only the people who talked on cellphones the most had a significantly greater chance of developing glioma [a type of tumor] - 40% greater - than those who didn’t use cellphones.

The use of cell phones might reduce the chance of developing a brain tumor?  Go figure.  For now, our very own FDA supports the Interphone study and refers to others which have shown no increased health risk.

Perhaps San Francisco politicians and consumers, like the rest of us, are really just facing a case of caveat emptor.  However, until there is a study which can definitively support or disaffirm any connection between cell phones and the risk of brain tumors,  I wouldn’t mind knowing whether one phone has a higher or lower SAR level than another.  CTIA needn’t worry though.  Having such information won’t make me break my contract with AT&T or stop me from eagerly awaiting the arrival of my iPhone 4 (whose SAR level, according to FCC documents, appears to be lower than my current iPhone 3G but higher than the iPhone 3GS).  At least I’ve now given some thought about the risks to which I may be exposing myself.  So too have the folks in San Francisco.

Petro-spills, Public Health, and Trade Secrecy

Is BP (and the government) performing an unauthorized experiment on public health and the environment? That’s the unsettling conclusion one might draw, given the use of dispersants in the Gulf.

As Tom Dickinson’s excellent Rolling Stone article describes the issue,

On May 14th, two days after the first video of the gusher was released, the government allowed BP to apply a toxic dispersant that is banned in England at the source of the leak – an unprecedented practice in the deep ocean. “The effort should be in recovering the oil, not making it more difficult to recover by dispersing it,” says Sylvia Earle, a famed oceanographer and former NOAA chief scientist who helped the agency confront the world’s worst-ever oil spill in the Persian Gulf after the first Iraq War. The chemical assault appeared geared, she says, “to improving the appearance of the problem rather than solving the problem.”

Now we are learning that the some of the dispersants had “no toxicity studies” done to support their use, and we cannot even find out what is in them:
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