HealthLawProf Blog

Guest Blogger Gaia Bernstein - Patients: the New Unexpected Players in Patent Litigation

When people think about patent litigation they think about patent owners, they think about savvy technological competitors – they do not think about patients. For sure, everyone realizes that patients have strong interests in patented products, such as drugs or medical tests. And all agree that the goal of the patent system is to encourage innovation and eventually benefit patients. But, no one thinks of patients as active players in the patent playfield.

It is time to change the way we view patent litigation. In my article: The Rise of the End User in Patent Litigation, which is forthcoming in the Boston College Law Review, I show that end users are playing an increasingly growing role in patent litigation. End users are those who use patented technologies for personal consumption or in business. End users do not manufacture or sell patented technologies. Patients are prominent among these end users. 

Patients were among the plaintiffs suing to invalidate Myriad Genetics’ patents on several breast cancer genetic mutations in order to increase public access to the genetic tests. The tests at that time cost around $3000. The Supreme Court decided the case – Association for Molecular Genetics v. Myriad Genetics – in 2013. Patients also repeatedly challenge settlement agreements  -- called pay for delay agreements – between manufacturers of patented drugs and generic manufacturers. Under these agreements, patented drug manufacturers compensate generic manufacturers not to enter the market to the detriment of patients who now cannot benefit from lower priced drugs. And, in another example, a group of Fabry disease patients asked the National Institute of Health (”NIH”) to use its march-in power to grant licenses to other producers to address manufacturing problems at the patent owner’s facilities that caused a shortage of the patented drug. When the NIH refused the patients filed suit for damages against the patent owner and others in federal court.

My article shows that end users, including patients, are unique players in the patent playfield.  First, they lack the technological expertise that is critical in patent cases, where showing patent invalidity or non-infringement depends on sophisticated technological understanding of the patented invention and any competitive products. Second, they are usually unaware of the existence of the patented technology until later in the life of the patent, when the technology achieves mainstream adoption. Because of that they are limited in their ability to use the less expensive Patent Office procedures in lieu of litigation. Third, they are usually (although not in cases of patients of chronic diseases) one-time players and would prefer to settle with patent owners than endure the exorbitant costs of patent litigation.

Since patients, like other end users of patented technologies, are uniquely situated, they tend to be at a disadvantage compared to the traditional players of the patent playfield – the patent owner and her competitors.  My article argues for the need for procedural reforms to place patients, among other end users, on equal footing in patent litigation.  For more on ways to address the imbalance – see my follow up post.

-Guest Blogger Gaia Bernstein

[cross posted on Health Reform Watch]

Registering for Organ Donation--How Much Does It Matter?

All of those efforts to persuade people to authorize postmortem organ donation seem to be paying off. Whether one gives consent when renewing a driver's license or by signing up at Donate Life America, the results are impressive. In 2012, 45 percent of American adults were included in state organ donation registries, and 40 percent of organ donations after death came from these "designated donors." That's a more than doubling of the 19 percent rate of designated donors among posthumous organ donors in 2007.

But the increase in donor designation has not translated into a meaningful increase in organ transplantation. There were 22,053 transplants from 8,085 deceased donors in 2007 and 22,187 transplants from 8,143 deceased donors in 2012.

Why hasn't donor designation translated into more organs? Is it because organ procurement organizations would have obtained consent from family members anyway for individuals who registered for donation? A survey of organ procurement organizations suggests strong agreement between registered donors and their families. Or maybe family wishes matter more than the decedent's wishes despite legal rules that recognize the priority of the decedent's wishes. Or perhaps other factors are hiding the effect of donor designation. Maybe it's too soon to see an effect from donor designation. It will be interesting to see how the data play out over the next few years.

[cross-posted at PrawfsBlawg and orentlicher.tumblr.com]

Published This Week

Yaniv Heled, On Patenting Human Organisms or How the Abortion Wars Feed into the Ownership Fallacy, 36 Cardozo Law Review __ (2014).

David Orentlicher, The Future of the Affordable Care Act: Protecting Economic Health More than Physical Health?, 51 Houston L. Rev. 1057 (2014).

Eric M. Fish, Shiri A Hickman, Humayun J Chaudhry, State Licensure Regulations Evolve to Meet Demands of Modern Medical Practice, SSRN.

I. Glenn Cohen, Make it Work!: Breyer on Patents in the Life Sciences,128 Harvard L. Rev. 55 (2014).

Jacquelyn Shaw, Of Mitochondria and Men: Why Brain Death is Not the Death of the Human 'Organism as a Whole', SSRN. 

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Guest Blogger Professor Mary Crossley: Health Reform and the Mission of Nonprofit Hospitals

Ever since 1969, when the IRS established the “community benefit” standard for hospital tax exemption, nonprofit hospitals have been able to achieve federal tax exemption without any precise accountability for the benefits they provided. The ACA’s passage, however, ushered in significant changes to federal tax-exemption standards for hospitals.  The new § 501(r) of the Internal Revenue Code requires hospitals to take numerous measures, including establishing written financial assistance policies, limiting the amount charged to patients eligible for financial assistance, and limiting their use of “extraordinary collection actions” against patients. These requirements responded to concerns about how some purportedly “charitable” hospitals treated uninsured patients and, more generally, hospitals’ lack of transparency regarding indigent care.  They stop well short, however, of requiring hospitals to provide any particular quantum of free care to patients unable to pay.

Section 501(r) also incorporates a different tack, requiring that at least once every three years, a hospital conduct a “community health needs assessment” (CHNA) and adopt an “implementation strategy” to respond to the needs identified by the assessment. The needs assessment requirement is novel as a matter of federal tax policy, but is similar to mandates previously existing in a number of states.

As announced in the statute and fleshed out in Proposed Regulations issued by the IRS in April 2013, the CHNA requirement entails a series of steps.  In identifying and prioritizing community health needs, a hospital must take into account “input from persons who represent the broad interests of the community served by the hospital facility, including those with special knowledge of or expertise in public health.” Once the assessment is completed, the hospital must make a report on it “widely available to the public” and adopt an “implementation strategy” to meet the community health needs it identified. Finally, it must report to the IRS how it is “addressing the needs identified” and “a description of any such needs that are not being addressed together with the reasons why such needs are not being addressed.”  As a result of this new requirement, sometime in the past few years most of the nearly 3000 nonprofit hospitals in the US have completed their inaugural CHNA.

The CHNA requirement reflects a conceptual shift in the quid pro quo required of hospitals in return for the substantial financial benefit of federal tax exemption. In responding to the long-standing community benefit standard, hospitals mostly simply did what hospitals traditionally do (i.e., provide emergency and acute care services to patients), but provided those services for some patients who were uninsured and unable to pay and for patients whose insurance didn’t pay enough to fully cover the cost of hospital care (e.g., Medicaid and Medicare). Today, by contrast, the CHNA requirement calls for hospitals to look beyond the acute care needs of their patients and to assess and respond to the health needs of their community.

It’s not entirely clear, though, what that change will mean in practice and how meaningful hospitals’ community-oriented activities will be. Without a doubt, the specific steps that the ACA and the Proposed Regulations establish for conducting a CHNA are more definite than IRS guidance under the community benefit standard. But when it comes to substance – what needs to identify and prioritize, how to respond to those needs, and how to evaluate the impact of a hospital’s response – hospitals are left with a great degree of leeway.  One concern is that a hospital could simply jump through the hoops of completing the CHNA process, but then prioritize needs in a way that is hospital-centric (rather than community-centric) and fail to evaluate seriously the impact of its activities.

Hospitals’ reluctance to do more than the law clearly requires is understandable, because some hospitals may see efforts to address community health needs – rather than the health needs of hospital patients – as lying outside their mission. For example, the mission statement of one nonprofit hospital (pulled from the web) states: “The mission of ___ is to provide competent, innovative, and accessible emergency and acute care services for the residents of ____. We are caring people operating an extraordinary community hospital.” This hospital’s mission clearly is to provide traditional hospital services to people in a particular community, but such a hospital may need to enlarge its articulated mission in order to encompass community health needs.

Nudging hospitals toward a deeper understanding of and greater responsibility for health in the communities they serve could prove to be an important component in health reform’s attempt to shift our country’s orientation from a system that responds to ill health to a system that promotes good health. But it may not be an easy process for many hospitals, as they are called on to re-examine their missions and to adapt their own conceptions of their roles in the community.

-Guest Blogger Professor Mary Crossley

tenBroek Symposium and Supported Decisionmaking

Every year, the National Federation of the Blind sponsors a symposium on the legal rights of people with disabilities.  Named in honor of Jacobus tenBroek, the symposium brings together legal scholars, disability rights lawyers, lawyers from many federal agencies, and many others from disability rights organizations, to discuss current developments in disability law.  As might be expected for a symposium named after Dr. tenBroek, the symposium emphasizes the right to be in the world. The full description of the symposium can be found here.  Two themes from the symposium might be of particular interest to health lawyers.

First, Olmstead-type litigation is alive and well, in two directions.  One of the most exciting developments is the use of Olmstead to challenge sheltered workshops that provide people with disabilities the "opportunity" to work for sub-minimum wages in working conditions that may be substandard and in jobs that may be boring at best.  On April 8, 2014, the Department of Justice entered into a settlement agreement with the state of Rhode Island to the effect that the state's system of sheltered facilities violated Olmstead's integration mandate.  The DOJ has also intervened in a class action in Oregon challenging that state's sheltered workshops, Lane v. Kitzhaber, 841 F.Supp. 2d 1199 (D. Or. 2012).  This use of Olmstead to challenge settings for individuals who are not institutionalized is a tremendous development.  More traditional Olmstead suits and continuing as well: for example, challenges in both Florida and Texas to nursing home rather than community based placements for children and adults with intellectual disabilities.  

In another direction, however, so-called "reverse"-Olmstead litigation represents efforts to keep institutions available for those who might want to continue to live in them; litigation in progress includes Carey et. al. v. Christie-1:12-cv-02522-RMB-AMD-(D.N.J. 2012) and Sciarrillo ex rel. St. Amand v. Christie, 2013 WL 6586569 (2013).  The theory of this litigation is the second prong of the Olmstead integration mandate:  that the individuals do not oppose the community placement.  Litigants seek to turn this into a positive right to remain institutionalized, a contention that courts have rejected to date.

Another major development concerns supported decisionmaking.  tThe Convention on the Rights of Persons with Disabilities (CRPD) Article 12 provides for full legal personhood for people with disabilities.  Guardianship and other forms of rights-deprivation fly in the face of this mandate.  "Supported" decisionmaking--a methodology that enables people with disabilities to work with others to make their decisions, in a manner that enables rather than taking away rights--is a means to achieve such legal personhood.  In a landmark Virginia case last fall, Jenny Hatch, a person with Down syndrome, won the right to supported decision making despite her parents' efforts to protect her by imposing guardianship.  Proponents of supported decisionmaking are developing model support agreements and are planning evidence-based work about the effects of different mechanisms.   Information about the Jenny Hatch litigation and associated efforts can be found here.

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FDA Regulation of E-Cigarettes—A Gateway to Teaching Administrative Law

 

It’s likely that most readers of this blog already know that the FDA just announced its intent to extend its regulatory powers to E-Cigarettes.   E-Cigarettes have proven to be a "high interest" topic in both my "Constitutional Issues in Health Law" and "Legal Issues in Human Subject Research Classes."  The struggle between the FDA and those it wishes to regulate raise questions about the powers of all three branches of Government.  It can serve as a proxy for all administrative agencies in an Admin Class or as a direct source of study in a public health, environmental or (of course) food & drug law class.

The FDA's current struggles include energy drinks, body building supplements and truth in calorie reporting (no more hiding calories by assuming unrealistic serving sizes).

But back to E-Cigarettes.  

Here is the text of the proposed rule.  And here is the Campaign for Tobacco-Free Kids’ list of reasons why the FDA is justified—and should—be able to do this.

The FDA’s relationship with regulating tobacco products has been a complicated one.  This book review by Margaret Gilhooley can bring you up to date on the history of FDA’s failed attempts to obtain jurisdiction.  It was not until June 22, 2009 that the FDA finally did get regulatory power when President Obama signed the Family Smoking Prevention and Tobacco Control Act (FSPTCA) that the FDA got any authority to regulate tobacco products—and that only through the filter (sorry) of protecting children.   And that still remains the outer limit—protecting children. 

So any regulation of E-Cigarettes has to be along the lines of making them less available to minors.  That’s why what sounds like a relatively weak reason—“even if they are harmless, they are a gateway for children to real cigarettes” is important because that is the statutory basis of the FDA’s power.  It’s not surprising that the FDA’s announcement has been met with immediate protest from Vapers.  New York’s ban (and remember, all the FDA’s done is to announce it intends to assert its authority to look into the product’s safety) has sparked considerable push-back based on issues of “personal liberty.” Apparently this anti-regulation movement is not restricted to the U.S.

   Vapers have had little success persuading cities to exempt e-cigarettes from public spaces, but they have been able to prevent outright bans and to allow the creation of “vaping lounges” –-the English majors among you know these better as modern day equivalent of a legal opium den—perhaps inhabited by today’s Keats, Shelleys and Coleridges.  We even have them in Lubbock.  

The FDA’s goal is to build on the actions of the cities that are equating e-cigarettes with “old style” tobacco to keep e-cigarettes as an “adults only” product.

 

Guest Blogger Professor Gaia Bernstein: Direct to Consumer Genetic Testing and the Over-Production of Genetic Information

23andMe, the Internet genetic testing company, which offered genetic testing for health conditions and ancestry, has received extensive publicity in recent months. In November 2013, the FDA ordered 23andMe to stop marketing its health-related genetic test results to customers because their product is a “device”, which requires FDA approval. In its letter to 23andMe the FDA focused on the harms of consumers’ interpretation of genetic test results without the appropriate medical guidance.

And for sure, consumers’ independent interpretation of genetic results is potentially harmful. But, another important concern not addressed by the FDA is the need to regulate and constrain the production of genetic information in the first place – at the time that a consumer decides which tests to take. Direct to consumer genetic testing companies, like 23andMe, usually offers a battery of multiple tests that the consumer purchases without careful selection of what information is desirable to her. And, although genetic information can help improve and control health outcomes, not all genetic information is made equal and not all tests results are similarly desirable for all people. In my essay Direct to Consumer Genetic Testing: Gatekeeping the Production of Genetic Information, I discuss the problem of indiscriminate production of genetic information and argue for the need for a medical gatekeeper not just for the interpretation of genetic test results but earlier on to guide consumers through the selection of tests.

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The Delay of ICD-10

As part of the “Protecting Access to Medicare Act of 2014,” Congress provided that DHHS may not set ICD-10 as the code standard before October 15, 2015.  October 15, 2014 had been the day set by DHHS for ICD-10 implementation.  For health care systems that have invested a great deal in being ready for the shift from ICD-9 to ICD-10 in 2014, the delay is likely to be a costly one.  Estimates range as high as $6.6 billion. 

"ICD" stands for the "International Classification of Diseases"; a common classification system enables standardized billing, care comparisons, and a common framework within which to observe public health trends.  ICD-10, copyrighted by the WHO, has been in development for over 30 years.  It was endorsed by the World Health Assembly in 1990 and first used in WHO member states as early as 1994.  It was field tested by the American Hospital Association and the American Health Information Management Association over 10 years ago and has been in use in Europe for at least 10 years.  The original federal rule requiring ICD-10 codes was promulgated in 2009, for an original implementation date of 2013. 

So why the delay? Many physicians, especially physicians in smaller offices, are concerned about the cost and time involved in learning a new way to code.  They claim that a shift from only 13,000 to over 68,000 codes is unwieldy and unnecessary. They also point out that the WHO is expected to release ICD-11 in the next several years and ask whether it might not be just as well at this point for the US to move straight to ICD-11 when it is available.

But there is much to lose by Congress’s concession to strong lobbying from physician groups.  ICD-10 contains more fine grained diagnoses,  is based on understandings of disease that are rooted in at least more contemporary science than ICD-9, and encompasses new technologies that remain unaccounted for in ICD-9.  It allows for better comparative and public health data.  This is not an issue just for techies. Congress’s capitulation is yet another illustration of why quality and cost effectiveness in US health care are so difficult to achieve.

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Guest Blogger Professor Deborah L. Forman: Introducing The ABA's Draft Model Act Governing Assisted Reproductive Technology Agencies

The use of assisted reproductive technology to create families is often described as collaborative reproduction.   Intended parents, gamete donors and surrogates can all play a role in the process.  Assisted reproduction typically involves collaboration among various professionals as well, including physicians, mental health professionals, attorneys and, increasingly today, agencies.  

Agencies typically act as facilitators; they recruit egg donors and surrogates, screen candidates for physical and mental suitability, and match donors and surrogates with intended parents. The terms of a particular egg donation or surrogacy may be negotiated by the agency, though they are ultimately reviewed and memorialized by attorneys representing the parties.  If the match is successful and a pregnancy results, agencies continue to play a role supporting the relationship, ensuring payments are made, and assisting in resolution of any disputes that arise.  In other words, agencies occupy a very important position in the collaborative reproduction process; their conduct can make or break the experience for the participants. 

A high quality agency can provide invaluable service to its clients.  Unfortunately, unscrupulous agencies, those that fail to adhere to ethical principles, and those that are merely incompetent, can wreak havoc on the lives of surrogates, donors and intended parents, causing financial losses and emotional harm.  In one well-publicized case, the owner of a California surrogacy agency, Surrogenesis, embezzled $2 million dollars from intended parents.

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The Game of Succession

It is almost always dramatic when a well-known figure resigns. So it was this week, one leader gone and another swiftly nominated. Almost inevitably the process and new nominee were subject to conservative sniping. Then, Secretary Sebelius resigned! While the press suggested a tainted legacy, the opposition began to salivate over further damaging health reform during the succession hearings. Nominee Burwell has impeccable credentials, even if being a "manager's manager" may work better as alliteration than a call to arms. Of course, the list of ACA tasks to get right over the next couple of years is daunting and goes well beyond leading a team of web developers. The administration has flagged some of the most controversial parts of the law by delaying them and things will likley be more difficult the second time around. However, the greatest expectation of the nominee is highlighted in the White House press release, "Sylvia was confirmed unanimously by the Senate to lead the OMB less than a year ago, and has a record of building bipartisan consensus to get things done." Here's to optimism!

Health Insurance, Socioeconomic Status, and Health

Earlier this week, I wrote about the link between health insurance and health and suggested that socioeconomic factors such as education and wealth can be much more important for health than access to health care. There are some interesting studies in this area.

For example, researchers looked at health outcomes in England under that country’s National Health Service (NHS) and found that the higher the socioeconomic status of a person, the lower the death rate. People in the highest civil service grade for government employees had a mortality rate about half that of people in the lowest civil service grade, even though they all had good access to health care. In addition, the gap in mortality rates among men in England by socioeconomic status has actually widened over time since the introduction of the NHS in 1948.

Or consider an interesting policy experiment in Canada during the 1970s. For four years, the province of Manitoba guaranteed a minimum annual income for all residents of Dauphin, a small, rural city. Health status improved significantly. When Dauphin residents were compared with residents of other rural communities in Manitoba, the data showed that while people in Dauphin were more likely to be hospitalized before implementation of the minimum income program, the gap in hospitalization rates disappeared by the end of the program. The decline largely occurred for hospitalizations that tend to be sensitive to levels of income security.

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Guest Blogger Professor Mary Crossley: The Rankings are Here!

No, not those rankings that law professors love to hate, the rankings published by the (former) magazine that shall not be named.  I’m talking about the County Health Rankings, released on March 26^th.  For the fifth year, the Robert Wood Johnson Foundation has partnered with the University of Wisconsin Population Health Institute to crunch data from across 29 health-linked factors to give counties a snapshot of their residents’ health, relative to other counties in their state. They’ve included several new factors this year, including housing, transportation, and access to mental health providers.

The County Health Rankings differ markedly from the most well-known law school rankings.  The methodology and underlying data are transparent. Counties are not surveyed on their opinions of how healthy other counties are.  And counties are not ranked higher if they spend more per resident on health.

The Rankings reinforce several messages that seem just now to be sinking in with the American public. Social, economic and environmental factors are as important in determining health as insurance status and medical care received.  Where you live can matter as much to your health as how you live. While many of us are used to bemoaning the racial and ethnic health disparities that doggedly persist in the U.S., we may be less aware of striking geographic disparities that these rankings illuminate. According to the County-by-County Blog, “The Rankings show us that people living in the least healthy counties have twice the premature death rates than those living in the healthiest counties. There are also twice as many children living in poverty and teen births in the least healthy counties as in the healthiest counties.”  And while some counties have one mental health provider for every 72 residents, some have only one mental health provider per 55,989 residents. My jaw dropped when I read that.

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Will the Uninsured Become Healthier Once They Receive Health Care Coverage?

The Affordable Care Act might not bend the cost curve or improve the quality of health care, but it will save thousands of lives, as millions of uninsured persons receive the health care they need. At least that’s the conventional wisdom. But while observers assume that ACA will improve the health of the uninsured, the link between health insurance and health is not as clear as one may think. Partly because other factors have a bigger impact on health than does health care and partly because the uninsured can rely on the health care safety net, ACA’s impact on the health of the previously uninsured may be less than expected.

To be sure, the insured are healthier than the uninsured. According to one study, the uninsured have a mortality rate 40% higher than that of the insured. However, there are other differences between the insured and the uninsured besides their insurance status, including education, wealth, and other measures of socioeconomic status.

How much does health insurance improve the health of the uninsured? The empirical literature sends a mixed message. On one hand is an important Medicaid study. Researchers compared three states that had expanded their Medicaid programs to include childless adults with neighboring states that were similar demographically but had not undertaken similar expansions of their Medicaid programs. In the aggregate, the states with the expansions saw significant reductions in mortality rates compared to the neighboring states

On the other hand is another important Medicaid study. After Oregon added a limited number of slots to its Medicaid program and assigned the new slots by lottery, it effectively created a randomized controlled study of the benefits of Medicaid coverage. When researchers analyzed data from the first two years of the expansion, they found that the coverage resulted in greater utilization of the health care system. However, coverage did not lead to a reduction in levels of hypertension, high cholesterol or diabetes.

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Thank You to March's Guest Bloggers

HealthLawProf Blog would like to thank our March guest bloggers Professor Jonathan Kahn and Associate Professor Ann Marie Marciarille. Here is a short recap of thier posts:

 Professor Jonathan Kahn posted the following: Privatizing Biomedical Citizenship, Race in a Bottle, Pills for Racism?!, and Regulating Direct-to-Consumer Genomics.

 Associate Professor Ann Marie Marciarille posted the following: The New Hampshire Solution, Who Is Wasting What?, Teeth-Whitening at the Supreme Court, and Five Hundred Word Book Review: REINVENTING AMERICAN HEALTH CARE by Ezekiel Emanuel.

 

 

Published This Week

Rebecca J. Cook, Bernard Dickens, Reducing Stigma in Reproductive Health, 125 Int'l J. of Gynecology and Obstetrics 89 (2014).

Michael Frakes, The Surprising Relevance of Medical Malpractice Law, 81 U. of Chi. L. Rev. (Forthcoming 2014).

David Orentlicher, Health Care Reform and Efforts to Encourage Healthy Choices by Individuals, N. Carolina L. Rev. (Forthcoming).

Rebecca Dresser, Drugs and The Death Penalty, 44 Hastings Center Report 9 (2014).

Joseph Regalia, Drew Cass, Navigating the Law of Defense Counsel Ex Parte Interviews of Treating Physicians, SSRN.

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Guest Blogger Professor Deborah L. Forman: Labor and Delivery: A Spectator Sport?

As abortion clinics close in Texas and the Supreme Court ponders whether the contraceptive mandate in the ACA infringes the religious freedom of Hobby Lobby, women’s reproductive rights have come under attack from another quarter—unwed fathers.  Last Fall, Olympic-champion skier Bode Miller succeeded in wresting custody of his infant child from the mother after a New York magistrate determined Sarah McKenna had engaged in “misconduct” by daring to move to New York to complete her education while pregnant with Miller’s child.  Although the decision was subsequently overturned, the mother lost custody for several months.  More recently, a New Jersey man sued for the right to attend his child’s birth after the mother, his estranged ex-fiancée, objected to his request to be notified when she went into labor and barred him from the delivery room.  (Plotnick v. DeLuccia, N.J. Super. Ct. Ch. Div., No. FD-16-00008-14, 11/19/13, released 3/10/14.)

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A Call out to the "Invicible" Young Adults--What You Don't Know About Childhood Diseases Could Prevent You From Having Any Children

 

One thing we’ve all heard during the discussion of the affordable care act is that young people don’t worry a lot about their health.  It’s therefore likely that few young adults ever think about whether or not they received adequate vaccination.

Perhaps if they better understood the consequences, they would do so.  What you've heard is true many childhood diseases are much more serious for adults than for children.    For a general overview look here.  Here’s some information about chickenpox.

Outbreaks of Mumps are being reported all over the country.  This week there are 116 cases in and near Ohio State University in Columbus. Fordham University in New York reported 11 in late February.   Just today, the NYC Board of Health reported 21 cases of Measels and Rubella (German Measels) isn't likely to be far behind.  These numbers may seem small—until you appreciate that Mumps used to be a very common childhood disease in the United States but is now very rare because of a highly effective vaccine. Unfortunately, many parents have chosen not to vaccinate their child against Mumps because of concerns about the MMR vaccine—that now turn out to be the result of fraudulent scientific data.       This piece put out by the Center for American Progress explains how states responding to political pressure from parents have been remarkably lax in enforcing mandatory vaccination laws for school children.  At this point, almost anyone with a concern to claim an exemption.  

So back to Mumps.  Few had heard of it, and no one knew what should really be the main attention grabber.   It can impair fertility—even to the extent of causing sterility.  There hasn't been a lot of research done recently and permanent sterility is rare- probably no more than 10%.  But why chance it when it can be prevented?  

And  that’s not the worst of it.   Measels and Rubella carry even greater risks for young adults.   A case of Rubella early in pregnancy caries with a 20% chance of serious birth defects.   The risk of permanent hearing loss after measels is highest in children under 5 and adults over 20. 

The good news on the public health front is that it’s never too late to be vaccinated.   And preventive vaccination (even for childhood diseases) is covered under the Affordable Act.  Young adults would be wise to look into their own vaccination status.  If pediatric records aren’t available, a blood test can measure antibodies that show the presence (or absence) of vaccination against many serious childhood diseases that are coming back to infect young adults.  But if vaccination laws continue to be lax, long after the reason for so many people's misgivings has turned out to be a fraud, we will not be able to get ahead of what should to everyone be a very frightening trend

Obesity and Taxes

Cigarette taxes have proved to be an effective strategy to reduce smoking, so one might think (as many experts do) that soda taxes would be an effective strategy to reduce obesity. Consumption of soft drinks seems to be an important risk factor for obesity, and people are sensitive to the price of their colas.

Moreover, soda taxes reflect the lessons of behavioral economics. People often over-indulge in activities that provide short-term gratification but impose significant harm in the long-term. Imposing a tax on unhealthy drinks supplies an immediate disincentive to the consumption of those drinks and can overcome the difficulty people have in postponing gratification. 

However, two new articles in Health Economics question the effectiveness of soda taxes. One study based on UK data, the other on US data, come to the same conclusion--we should not expect much of an impact from taxes on sugary soft drinks. It seems that raising taxes on some beverages simply results in consumers switching to other beverages and replacing the forgone calories with other calories. And to make things worse, beverage taxes often are regressive.

The news is disappointing and adds to a growing list of disappointing policies for weight loss. Under the Affordable Care Act, for example, restaurants must disclose calorie information to customers. With better information, diners would know which salads really are healthy and which others are not. But researchers have not found mandates for calorie disclosure by restaurants (as in New York and Seattle) to be effective.

Legislative fixes for obesity are tempting and probably necessary. But lawmakers need to take better account of medical understanding before they act.

[cross-posted at PrawfsBlawg and orentlicher.tumblr.com]

Mobile Health Conference

This Friday at Drexel. More details are here.

 

Affordable Care and the Lessons of History

The Affordable Care Act (ACA) seems to be gaining steam. After a rocky start in October, the new health insurance exchanges reached the government's enrollment goal of 7 million. As ACA's provisions continue to take effect, its status should solidify and transform the U.S. health care system in important ways.

Yet there also are reasons to be cautious about ACA's long-term prospects. The Act's basic framework may not have taken sufficient account of the lessons from history. After watching health insurers torpedo the Clinton plan in 1994, President Obama took care to secure support for ACA from the insurance industry, as well as drug companies, physicians, and other important interest groups. But there may have been more important lessons from the country's history with other public benefit programs, including Medicare, Medicaid, and food stamps.

As NPR and the New York Times reminded us with their ACA updates last week, federal-state partnerships can have serious drawbacks compared to programs operated by the federal government. Some states effectively meet the needs of their residents, but others do not. Just as Texas had the highest percentage of uninsured people under pre-ACA health care, Texas continues to lag other states under ACA in terms of access to health care coverage. Similarly, when states were responsible for setting eligibility standards for food stamps, the program reached counties with only 59 percent of the U.S. population. After a decade of state oversight, Congress established uniform eligibility standards.

Benefit programs also fare better when they are perceived by the public as having been earned. Medicare and Social Security have enjoyed strong support because they are funded in part by payroll deductions. Medicaid, on the other hand, with its funding from general revenues, often is viewed as providing handouts.

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