Category Archives: Public Health

Liability for Failure to Vaccinate

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By Art Caplan

Measles are breaking out all over Britain.  Getting fewer headlines is the fact that measles are back in the USA too.  In fact they are in our region.  A mini-epidemic is raging in Brooklyn.  Measles for cripes sake!  The disease that many of us over 60 had as kids that should never occur is back with a vengeance.  The reason for the diseases reappearance is simple—failure to vaccinate.  Maybe it is time to get tough on those whose choices put others at risk.

For decades, there has been a safe, effective vaccine that works exceedingly well against the measles–95% full protection for a kid who has been vaccinated– and nearly equally well at preventing transmission to others.  The more people have been vaccinated the tougher it is for measles to gain a foothold.

NY City health officials have reported 30 cases so far–26 in Borough Park and four more in Williamsburg.  The NY Daily News reports that the consequences of this outbreak have been dire:

“There have been two hospitalizations, a miscarriage and a case of pneumonia as a result of this outbreak,” a Health Department spokeswoman said. “All cases involved adults or children who were not vaccinated due to refusal or delays in vaccination.”

So far the outbreak has been among religious Jews some of whom shun getting the vaccine for their kids out of fear it causes autism Dr. Yu Shia Lin of Maimonides Medical Center in Borough Park told The News.

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Privacy and Progress and the Deidentification of Whole Genome Sequence Data

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[Posted on behalf of Elizabeth Pike and Kayte Spector-Bagdady from the Presidential Commission for the Study of Bioethical Issues - and cross-posted here.]

In the most recent issue of the Hastings Center Report, Drs. Amy Gutmann and James Wagner of the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission), contributed to the lively debate surrounding the identifiability of genetic data. In Found Your DNA on the Web: Reconciling Privacy and Progress, Gutmann and Wagner, Chair and Vice-chair respectively, argue that the paradigm of identifiability has become less relevant to individual privacy protections than restrictions on access and use.

In their commentary, Gutmann and Wagner continue the public deliberation of the Bioethics Commission’s report, Privacy and Progress in Whole Genome Sequencing, in which the Bioethics Commission took a forward-looking approach to the privacy concerns raised by whole genome sequencing—issues that have come to the forefront of this important science.

Under current law, health information that is deidentified—information for which there is “no reasonable basis” to believe it can identify an individual or that has been stripped of traditional identifiers—is afforded different legal protections than identifiable health information. However, whole genome sequence data are unique to only one person, making them more vulnerable to reidentification.

Recent articles have cast doubt on the extent to which whole genome sequence data can be deidentified. For example, in Identifying Personal Genomes by Surname Inference, published in Science in January, Melissa Gymrek, et. al. successfully uncovered full identities of 50 individuals.

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Hair, Stress, and the Law

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A new study has found a relationship between cortisol levels in our hair and prevalence of metabolic syndrome (a cluster of abnormalities that increase the likelihood of developing diabetes and heart disease). Here’s how the New York Times describes the study:

High levels of cortisol — the so-called stress hormone — have been associated with cardiovascular disease in some studies, but not in others. This may be because measuring cortisol in blood or saliva at one point in time may pick up acute stress, but it fails to account for long-term stress. . . . Now Dutch researchers have assessed cortisol levels over several months by analyzing scalp hair samples. . . . The researchers measured the cortisol content in hair samples corresponding to roughly three months of growth from 283 older men and women, average age 75. They also gathered self-reported data about coronary heart disease, stroke, peripheral artery disease, Type 2 diabetes, lung disease, cancer and osteoporosis. . . . Compared with those in the lowest quarter for cortisol, those in the highest quarter had about three times the risk for cardiovascular disease and diabetes.

In the actual paper, the researchers say little or nothing about “stress,” and if I recall correctly, the relationship between cortisol and stress can be complicated. But the research raises the possibility that we will someday identify reliable measurements of chronic stress over time. Of course, we may need more than just your hair. But in what I call the experiential future, such evidence—combined perhaps with other physiological, neurological, and psychiatric data—may enable us to make better assessments of chronic stress levels than we can now.

Better measurements of chronic stress could transform the way we measure damages in tort cases and measure punishment severity in criminal cases. Billions of dollars change hands every year based on difficult-to-verify assertions about pain and stress. Similarly, we adjust the severity of incarceration by changing the duration of sentences and pay almost no attention to the very different ways in which prisoners experience confinement. Measurements of stress levels could also help determine when an interrogation tactic constitutes torture.

Of course, forensic techniques encourage people to use countermeasures. In the cortisol-hair study, for example, one measurement was apparently affected by rates of shampooing while another was not. So I’m not suggesting there will be a silver bullet that solves all measurement problems. When evaluating the scientific research, however, it is important to remember just how bad we are at measuring stress levels now, despite the fact that we make such assessments every day. The technology need hardly be perfect to represent an improvement.

The Oregon Health Study and the Medicalization of Health Policy

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According to the website, the Oregon Health Study “is the first randomized controlled  experiment to examine the causal effects of having some type of insurance coverage versus having no insurance at all.”  The findings, released a few days ago, have unleashed a storm of commentary on what the investigators did and did not find in terms of links between coverage and health outcomes.  Writing  over at The Incidental Economist, Harold Pollack quotes Joseph Newhouse for the notion that the “Oregon Medicaid experiment ‘is a Rorschach test of people’s views on the ACA.’”  After the jump, I am going to try to defend that claim, although likely not in the way that good readers of Bill of Health might expect.

So here’s the funny thing: even though I am an attorney, an historian, and a bioethicist who researches health inequalities, stigma, and social justice, I actually am less of an expert on the delivery of health care services than virtually every blogger here, and likely a goodly portion of the readership, too.  When interviewing for a job as a prawf some years ago, I was asked for my opinion on the fate of the ACA (then still in Congress), and I had to shrug and say that I really was not up to date on all of the provisions of the bill nor of its likely passage, nor of its potential impact.  (No, I did not get the job!).

This is not because of anti-intellectualism, I believe (and hope!).  This is rather because of my engagement with the overwhelming evidence that access to health care services is simply not a prime determinant of health and its distribution in human populations.  In a seminal 2007 essay in Health Affairs, Paula Lantz, Richard Lichtenstein, and the good Dr. Pollack himself note that “Lack of access to health care is not the fundamental cause of health vulnerability or social disparities in health” (p. 1256).*  The authors go on to warn of the limits of medicalizing health policy, and suggest that if we want to use laws and policies to improve overall population health and compress health inequities, we need to go way beyond simply expanding access to basic health care services.

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Talking to Your Baby

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By Joanna Sax

In President Obama’s State of the Union address, he discussed creating affordable pre-school to all children.  Studies have shown that early childhood education is associated with academic success.  This is an important policy initiative; it’s also very expensive.

In an effort to reduce the disparity in the academic profiles of children, there may be some initiatives that can be started while the proposal for publicly funded early childhood education works its way through Congress.  One approach that is being tested is talking to your baby.

A recent NY Times article described a scientific study concerning how talking to your baby is correlated with achievements in school.  It turns out, according to the article, that low-income parents of children speak fewer words to their babies compared to high-income parents and that by the time the children are of school-age, the children from poorer families have heard millions of fewer words.  This means that by the time the child is 3, they have heard 10s of millions of fewer words and the article suggests that this is correlated with IQ and academic success.

This is an issue that can be addressed!  Creative problem solving can be used to create programs to educate lower-income parents to talk more to their babies.  The increase in words alone might provide advantages to lower-income children that they didn’t have before.  This study provides a good example of the application of a scientific study to address social, health and economic issues.

 

Live Blogging from FDA in the 21st Century Conference, Panel 8: Food, Supplement, and Tobacco Regulation

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[Live blogging off-the-cuff, so apologies in advance for any errors in summarizing, typos, etc]

Moderated by Emily Broad Leib, Harvard Law School

Robin Craig, Leslie Francis, and Erika George, University of Utah The FDA’s Authority Over Labeling: Current Ironies and Future Improvements:

Goal is to look at FDA authority over safety and labeling of Genetically Modified (GM) foods argue that FDA should do more, and argue for human right to food approach.

By GM we mean rDNA modification not husbandry and not careful selection.

FDA has moved to use guidance and policy. In particular two are relevant here. First, in food additives there is GRAS – Generally Recognized as Safe. E.g., Cinnamon was treated as GRAS. Manufacturers can self-determine a product is GRAS without notifying FDA, or, if in doubt, request a GRAS notice letter from FDA. This was proposed in 1997 and final review never issued, but this is how they do it. Has increased frequency of GRAS review request from FDA. But the process is voluntary and relies entirely on info from producer not scientific separate work by FDA.

In 1992, FDA issued a policy document related to GM foods. Stated no scientific evidence that GM foods have more safety concerns than existing husbandry techniques, so GM technology is NOT material information. This was NOT a conclusion that GM foods were GRAS.

In 1996, FDA issued a guidance for GM foods. Consultation process to determine whether there are material differences between GM version and non, voluntary process, encouraged to get consumer trust. Like GRAS totally voluntary, totally reliant on FDA data. 95 reported consultations between 1996 and 2012.

Alliance for Biointegrity v. Shalala, challenged in 2000 in D.D.C., court deferred to agency on safety questions and whether the info on GM was “material” and therefore needs to be disclosed.

Where would FDA get authority to regulate GM foods? May pose allergy risks? May be relevant to nutrition or quality. Maybe an additive not GRAS. But each of these arguments apply to specific GM food not GM foods as a whole.

Their argument: Consumers have a right to know so they can make their own consumption risks, and consumer or religious views are not merely preferences but a ground for the information that is material to consumers.

On why this is best understood as Human Right to Food. Adequate right to food is an HR right framed after WWII about enough food that is not adulterated and not against your faith or ethics (kosher, halal, vegan) and respectful of environment. U.S. is not part to Socioeconomic rights convention, which is most explicit protection of this right, but are signatories to other treaties that protect the right more indirectly.

Whole Foods has moved ahead on this as have others. Even if not a worry as GRAS, consumption may be inappropriate. We need a national strategy. More of a precautionary take that understands material to matter to consumers.

Jennifer Pomeranz, Yale, A Comprehensive Strategy to Overhaul FDA Authority for Misleading Food Labels:

Obesity and diabetes is the big problem in public health. And also people showing nutritional deficiencies because too much processed food. Current labeling is misleading makes people think food is healthier than they are. This is a unique public health problem. FDA has very weak authority and power here.

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Sleep No More: Sleep Deprivation, Doctors, and Error or Is Sleep the Next Frontier for Public Health?

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[Cross-Posted at Prawfsblawg]

How often do you hear your students or friends or colleagues talk about operating on very little sleep for work or family reasons? In my case it is often, and depending on the setting it is sometimes stated as a complaint and sometimes as a brag (the latter especially among my friends who work for large law firms or consulting firms). To sleep 7-8 hours is becoming a “luxury” or perhaps in some eyes a waste – here I think of the adage “I will sleep when I am dead” expresses that those who need sleep are “missing out” or “wusses.” My impression, anecdotal to be sure, is that our sleep patterns are getting worse not better and that many of these bad habits (among lawyers) are learned during law school.

One profession that has dealt with these issues at the regulatory level is medicine. In July 2011, the Accreditation Council for Graduate Medical Education (ACGME) – the entity Responsible for the accreditation of post-MD medical training programs within the United States – implemented new rules that limit interns to 16 hours of work in a row, but continue to allow 2nd-year and higher resident physicians to work for up to 28 consecutive hours. In a new article with sleep medicine expert doctors Charles A. Czeisler and Christopher P. Landrigan that just came out in the Journal of Law, Medicine, and Ethics, we examine how to make these work hour rules actually work.

As we discuss in the introduction to the article

Over the past decade, a series of studies have found that physicians-in-training who work extended shifts (>16 hours) are at increased risk of experiencing motor vehicle crashes, needlestick injuries, and medical errors. In response to public concerns and a request from Congress, the Institute of Medicine (IOM) conducted an inquiry into the issue and concluded in 2009 that resident physicians should not work for more than 16 consecutive hours without sleep. They further recommended that the Centers for Medicare & Medicaid Services (CMS) and the Joint Commission work with the Accreditation Council for Graduate Medical Education (ACGME) to ensure effective enforcement of new work hour standards. The IOM’s concerns with enforcement stem from well-documented non-compliance with the ACGME’s 2003 work hour rules, and the ACGME’s history of non-enforcement. In a nationwide cohort study, 84% of interns were found to violate the ACGME’s 2003 standards in the year following their introduction.

Whether the ACGME’s 2011 work hour limits went too far or did not go far enough has been hotly debated. In this article, we do not seek to re-open the debate about whether these standards get matters exactly right. Instead, we wish to address the issue of effective enforcement. That is, now that new work hour limits have been established, and given that the ACGME has been unable to enforce work hour limits effectively on its own, what is the best way to make sure the new limits are followed in order to reduce harm to residents, patients, and others due to sleep-deprived residents? We focus on three possible national approaches to the problem, one rooted in funding, one rooted in disclosure, and one rooted in tort law. I would love reactions to our proposals in the paper, but wanted to float the more general idea in this space.

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More on NSF and NIH Funding

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By Scott Burris

Here’s where some in Congress would like us to go:

ScienceInsider reports:

The new chair of the House of Representatives science committee has drafted a bill that, in effect, would replace peer review at the National Science Foundation (NSF) with a set of funding criteria chosen by Congress. For good measure, it would also set in motion a process to determine whether the same criteria should be adopted by every other federal science agency.

Whether or not you think of this as a partisan attack on science, it challenges the idea of science as an independent way of pursuing knowledge. The fact that this is even on the table, and could be taken seriously, shows how effective the attack on science has been.  It seems to reflect a terrible paradox:  on the one hand, social scientists are pissing some people off in a big way, which is a good sign we are doing something right in the inconvenient truth department; but on the other hand, I don’t see a lot of people rising to our defense, which suggest we matter to fewer people than we should.

This bill may or may not go anywhere, but anyone who cares about evidence-informed governance and the ability of the US to solve its problems ought to be concerned.

 

A Tale of Two Polities

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By Scott Burris

Last week, Northeastern University’s effort to convene a much-needed conference on the future of health policy was a casualty of the successful manhunt for the Boston Marathon bombers.  One hardly wants to make too much of a stymied conference given all the human damage of the bombing and its aftermath, but all of us who had gathered for the meeting regretted that we would not hear from the panelists, and sympathized with organizers who had put so much into planning it.  In recognition of that, I am summarizing here what I planned to say there.  It is a tale of two polities that seem to compete for existence in our perceptions of the politics of public health.

One public health is incredibly popular with citizens and lawmakers alike – demonstrated by polling and passage of legislation.  I’ve recently blogged on this here.  The other public health is the despised nanny state, big government, the sequestered and slashed-to-the bone struggling provider of essential services that don’t get no respect and don’t deserve the meager tax dollars we still pay in. We see this in budget cuts, in hyperbolic allegations of “corruption,” and in disingenuous advocacy for a radical caveat emptor regime for all legal products.

What do we make of these two radically different views of where public health now stands in the public’s regard? My claim is that the former is largely the truth – public health is popular, not despised – but the latter view is what is driving budgets and a lot of policy. The action points follow: a sustained fight to mobilize public support and win more battles over budgets and laws. I see three main strands of work:

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Post-doc/Instructor Positions in Medical Ethics at NYULMC

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The Division of Medical Ethics at the NYU Langone medical Center seeks to recruit two persons either as post-docs or instructors.

Applicants must demonstrate an excellent record of quality scholarship and teaching, and must have a PhD, JD, or MD. Successful applicants will be expected to demonstrate a strong scholarly career track in a sub-field of medical ethics/bioethics. The Division is especially interested in persons with research interests in neuroethics, reproductive technologies and ethics, public health ethics, transplantation ethics and mental health ethics. Continue reading →

While We Sleep?

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By Scott Burris

Nothing threatens a know-nothing more than the prospect of someone knowing something. Hence there has been increasing pressure on and from some in Congress to reduce government funding of social science research.  I hope every reader of this blog is aware that an appropriations rider added by Tom Coburn has drastically restricted NSF funding of political science research. That’s an ugly development, on par with the scandalous cuts to CDC that put paid to its gun research agenda years ago.

But the big funder of social and behavioral research in health is the NIH. In the past two weeks, I have heard via two different insiders that the agency is under pressure to significantly cut back on social and behavioral research, at least research with any important links to public policy. Now it is true that NIH does far too little policy-relevant research as it stands, but many fine researchers do important work related to law and policy with NIH support, and the important influence of law on health means we need more, not fewer, NIH-supported careers.

So I am hoping I am getting false information. What are you hearing?

Curbing Obesity: What Are We Doing?

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[Ed. Note: Posted on behalf of Sarah Fudin, who works in community relations for the George Washington University’s online Master of Public Health program, dubbed MPH@GW, which offers students the ability to earn their MPH online.] 

The whole world knows that Americans are increasingly becoming obese, but solving the problem isn’t as easy as pointing it out. While the individual implications of obesity have been painfully clear for some time, there has been more discussion in recent years of how obesity impacts the economy. According to an infographic by MPH@GW, “The Cost of Obesity,” lowering the national obesity rate by just five percent could eliminate 13 percent of the federal deficit over the next 20 years. Re-framing the obesity epidemic in economic terms could be a way to persuade Americans to tackle obesity through public health legislation.

Support for Anti-Obesity Laws

Although the conventional wisdom in recent years has been that the American public resists public health laws, a recent study indicates that the public might actually be more welcoming of legislation than first thought. The study demonstrated that Americans tend to support non-intrusive public health legislation — bans on smoking in public places, for instance, but not bans on smoking in private residences. The key factor in rallying public support for a bill seems to be that the bill’s authors understand the public’s values, which may mean that it will be easier to pass public health laws as our national conversation about obesity evolves.

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4/25: Boston-Wide Forum on Global Access Licensing of Biomedically Relevant Technologies

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by Adriana Benedict

Universities Allied for Essential Medicines (UAEM)
Boston-Wide Forum on Global Access Licensing of Biomedically Relevant Technologies

Thursday, April 25th, 3-5pm
Coffee and refreshments at 2:45pm; reception following the event
Harvard Medical School New Research Building – 77 Avenue Louis Pasteur
Seminar Room 1031

How do innovative medical technologies make their way to a global population, including patients in resource-limited settings? As centers of medical innovation, universities are well-placed to influence the global dissemination of the fruits of biomedical research and enhance access to advances in drug, vaccine, diagnostic and device technologies. In the past five years, several institutions in Boston and beyond have acknowledged this fact and taken bold steps to encourage the transfer of medical technologies to the developing world. Licensing provisions such as tiered, reduced and zero royalties for products sold in developing countries; march-in rights; agreements to agree; agreements not to patent or not to enforce patents in developing countries; and humanitarian licensing exceptions are just some of the strategies used to implement global access licensing of medical technologies.  Others can be found in UAEM’s Global Access Licensing Framework, as well as the multi-institution Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies.

In this Forum, technology transfer officials and academic research leaders from Harvard, MIT, Tufts, BU, Northeastern, Children’s Hospital and Partners Healthcare (MGH/BWH) will speak to their institutions’ philosophy and experience with global access licensing strategies. In an hour-long Q&A, the audience – including invited experts with significant experience in medical technology development – will contribute to the discussion. The Forum is open to the public; and researchers, entrepreneurs, university leaders and students are highly encouraged to attend.

UAEM is an international interdisciplinary student organization that works with universities to leverage academic research for global health. Since our founding in 2001, we have worked towards illuminating the poorly understood process that brings discoveries from the laboratory to widely accessible products and services meant to improve human health.

Registration through this link is appreciated, but not required.

This event is co-sponsored by grants from the Harvard Global Health Institute (HGHI), the HMS Division of Medical Sciences, and Harvard Law School Advocates for Human Rights.

Of Evergreening and Efficacy, Part II

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I wrote earlier this month about the case between Novartis and the Union of India, in which the Supreme Court of India affirmed denying a patent for Novartis’ anti-cancer drug Glivec. Adriana Benedict added an insightful post about the case last week.

In my last post, I talked about the theory behind the decision and what it means for a drug to be therapeutically efficacious. Today and tomorrow, I thought it would be interesting to focus on the practical outcome of the case. In other words, what does this case mean for the access to medicines more generally, both in India and around the world?

Judging by recent public comments, this will be a landmark case. On the Novartis website, where the company is hosting an impressive array of resources devoted to the Glivec patent case, it states that this “decision discourages innovative drug discovery essential to advancing medical science for patients.” Eric Althoff, a Novaris spokesman said, if “innovation is rewarded, there is a clear business case to move forward. If it isn’t rewarded and protected, there isn’t.” On the opposite side of the spectrum, Indian Trade Minister Anand Sharma called the ruling “a historic judgment” that reaffirmed the position of Indian law requiring substantive innovation for patent protection. The Supreme Court itself noted that the “debate took place within a very broad framework. The Court was urged to strike a balance between the need to promote research and development in science and technology and to keep private monopoly (called an ‘aberration’ under our constitutional scheme) at a minimum.”

Despite the controversy, this case won’t necessarily have a wide ranging impact. It involved some unusual elements, which require historical background in India’s patent system to understand.

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Twitter Round-Up (3/31-4/6)

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By Casey Thomson

This week’s slightly belated round-up concerns palliative care across cultures, the threat and problems of over-prescribing, and Big Pharma’s failure to create prices with the patient in mind. Read on for more from this week’s round-up.

  • Alex Smith (@AlexSmithMD) retweeted a piece on the lessons learned by Dr. Vvjeyanthi “V.J.” Periyakoil on how to approach palliative care for patients from a variety of backgrounds in ways that both extend life and fulfill the desires of the patient (in particular, reducing pain). (4/3)
  • Alex Smith (@AlexSmithMD) also retweeted an opinion piece in the NYT about the growing trend towards self- and over-medication, and the problems of overextending definitions of medical ‘conditions.’ As the piece’s author summarized: “The D.S.M. would do well to recognize that a broken heart is not a medical condition, and that medication is ill-suited to repair some tears.” (4/3)
  • Daniel Goldberg (@prof_goldberg) retweeted a link on two new wrongful death lawsuits against the NFL, which claim that the NFL withheld knowledge of the risks associated with concussions from players, that have been added to the string of other brain injury lawsuits filed against the league. (4/3)
  • Daniel Goldberg (@prof_goldberg) additionally retweeted a blog post on the striking results of a new study comparing male and female mortality amongst counties in the United States. While male mortality increased in only 34% of counties from 1992-1996 to 2002-2006, female mortality increased in 42.8%. This brings up questions concerning the cause of this demographic and largely geographic inequality, and what such a differential could mean on the health of dependents (children). (4/3)
  • Daniel Goldberg (@prof_goldberg) posted another article that put the recent New York “True Cost” campaign in historical context. The article called the campaign a “modern manifestation of…anxieties about the ‘contagion’ of working class and poor communities,” comparing it to the World War II-era venereal disease campaigns and the case of Typhoid Mary as all moralizing weapons aiming to instill shame rather than promote actual solutions to public health concerns. (4/4)
  • Arthur Caplan (@ArthurCaplan) linked to his own discussion of the problem with Novartis and India, noting that emphasis has been wrongly placed on patents when the concern should be on pharma’s hesitancy to create a pricing strategy that can provide medications for those who cannot afford huge prices. This unwillingness to do so, he claims, is violating a moral obligation. (4/4)

If Novartis’s “improved” version of Glivec is not more therapeutically efficacious, why is the Novartis decision such a big deal?

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By Adriana Benedict

Last week, Ryan Abbot blogged here about the Novartis case decided last Monday by the Supreme Court of India.  Since then, there have been a broad range of reactions to the case, but many of them appear to have left a lurking elephant in the room.

I’d like to attempt to provide some clarity to a question that seems to have created a lot of confusion surrounding the impact of the Novartis decision: If the older alpha crystalline form of imatinib mesylate (generic Glivec) is already available in India, and the newer beta crystalline form is not more therapeutically efficacious, then why does it matter whether or not Novartis can get a patent on the newer version of Glivec?  The simple answer is that for the most part, it doesn’t really, in terms of the availability of generic Glivec.  At most, it may make a difference for some Indian patients who will do better with the beta crystalline form.  And it will make some difference for Novartis, which will now forego a potential market of these Indian patients who would prefer to take (and can afford to pay for) the beta crystalline version.  But the alpha crystalline form of imatinib mesylate was already available in generic form in India, and it would have continued to be available in generic form in India regardless of the outcome of this case.  So why all the commotion?

First, the Novartis decision means that Indian generic manufacturers can now produce the beta crystalline form of imatinib mesylate with impunity.  This means that Novartis is likely to face competition in its production of the beta crystalline form, over which it would otherwise have held a global monopoly.  Indian generic manufacturers may now produce and export the beta crystalline form to other countries, which means that many more cancer patients in developing countries will have access to it.  Novartis’s markets in these countries may be disrupted through parallel importation of cheaper generics.

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Public Health Protection under the EPA Lead and Copper Rule

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Dr. Yanna Lambrinidou and Dr. Marc Edwards

It is generally safe to assume that, when it comes to contaminants in drinking water, consumers are protected by regulation and proactive water utilities.

One noteworthy exception is the federal law promulgated to protect the public from lead at the tap. Known as the Lead and Copper Rule (LCR), this law splits responsibility for minimizing exposures between utilities and consumers. The rationale for this “shared responsibility” approach is that in the majority of cases lead leaches into water from lead service lines (LSLs) (i.e., the pipes that connect water mains to individual homes) and lead-bearing home plumbing materials (e.g., lead solder, leaded brass). These sources of lead are often partly or fully inside the home – LSLs and lead solder were used routinely until 1986, and the use of leaded brass will continue to be legal until 2014. Moreover, differences in plumbing and water usage (e.g., volume, flow), make lead leaching in every house unique. Under the LCR, utilities are required to monitor a small number of homes considered “high risk” for lead in water, but consumers are responsible for having their own water tested and for adopting health-protective water-use practices that minimize the risk of exposure.

When utilities detect elevated lead levels in more than 10% of the homes they sample, they must tell consumers how to avoid exposure by, for example, flushing stagnant water before use and avoiding consumption of hot tap water (especially for reconstituting infant formula). They must also implement a LSL replacement program.  Although full LSL replacement is the only way to eliminate the risk from lead pipes, the LCR requires utilities to replace only the portion of a LSL that they own. The consumer-owned portion of the line is left in place, unless homeowners agree to pay for its removal, which can cost several hundred to several thousand dollars.

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