HealthLawProf Blog

Worth Reading This Week

Ezekiel Emanuel & Jerry Menikoff, Reforming the Regulations Governing Research with Human Subjects, NEJM

Tim Greaney, The Affordable Care Act and Competition: Antidote or Placebo? SSRN/Oregon Law Review

Kate Greenwood, The Ban on 'Off-Label' Pharmaceutical Promotion: Constitutionally Permissible Prophylaxis Against False or Misleading Commercial Speech? SSRN/AJLM

John M. Golden, WARF's Stem Cell Patents and Tensions between Public and Private Sector Approaches to Research, SSRN/JLME

[NPT] 

 

IoM and the Device Industry

Interesting piece in the New York Times by Barry Meier, here, on the device industry's preemptive attack on an Institute of Medicine report prepared for the FDA. [NPT]

Millennium Goals and a Norwegian’s Cognitive Dissonance

This month, the United Nations Department of Economic and Social Affairs released its Millennium Development Goals Report. It detailed how the international community was progressing towards its collective targets to address poverty, diseases, infant mortality, inequality, environmental harm and other problems set out in the Millennium Development Goals. While it acknowledges some progress in many areas, there is a long way to go:  

• The poorest children have made the slowest progress in terms of improved nutrition
• Opportunities for full and productive employment remain particularly slim for women
• Being poor, female or living in a conflict zone increases the probability that a child will be out of school
• Advances in sanitation often bypass the poor and those living in rural areas
• Improving the lives of a growing number of urban poor remains a monumental challenge
• Progress has been uneven in improving access to safe drinking water

The same day I read the report, I also viewed the appalling video “Knights Templar 2083” posted (but now deleted and I am unable to relocate it) by Anders Behring Breivik. The video complemented his manifesto, reported on here. As you may know, Breivik is the Norwegian right-winger who murdered 76 people in Oslo in order stop the Norwegian Labor Party from “driving its ideology” and “deconstructing Norwegian culture and mass-importing Muslims,” according to his reported statement in court. The video reveals the foundations of Breivik’s worldview: the supposed post-WWII institutionalization of Marxist views that is leading to the “deconstruction” of European culture though national governments and bodies like – you guessed it – the United Nations.  

All I can say is that I wish Breivik had been born in a developing country to a single mother suffering from AIDS, malnutrition, and a lack of access to clean water. Or had grown up in an indigenous community where the effects of colonization had wiped out most of his ancestors and deprived them of their lands. Then perhaps he would have really understood what cultural annihilation is all about, and even the role that white, Christian European men may have played in it. The response to his actions should not be fear; it needs to be renewed support for inclusive and compassionate programs that celebrate life and human dignity, programs that the Millennium Goals are designed to generate.

[MM]

Proposed Rulemaking for Regulations Governing Medical Research

Thanks to Ellen Fox at the VA for reporting that HHS has proposed major changes to the "Common Rule" that governs medical research on people. You can find the notice of the proposed changes at the HHS website. Ezekiel Emanuel and Jerry Menikoff have an article on the proposal in the New England Journal of Medicine.

[DO]

Worth Reading This Week

Nan Hunter, Health Insurance Reform and Intimations of Citizenship, SSRN/U.Pa. L.Rev.

Tim Greaney, Regulating to Promote Competition in Designing Health Insurance Exchanges, SSRN/Kansas Journal of Law & Public Policy

Orly Lobel & On Amir, Healthy Choices: Regulatory Design and Processing Modes of Health Decisions, SSRN

Eric Helland et al, Tort Liability and the Market for Prescription Drugs, SSRN

[NPT] 

 

Private Equity & British Care Homes

In earlier posts I have discussed the “care/profit tradeoff in nursing homes,” focusing on the role of private equity firms in reducing costs by limiting the liability of their enterprises. Cutting nursing staff and increasing the risk of elder neglect isn’t so costly for private equity barons when “complex corporate structures . . . obscure who controls their nursing homes.” One firm constructed a particularly notable series of corporate moats between itself and the nursing home which it first controlled, and then rented land to.

Daniel JH Greenwood has called a good deal of private equity activity a form of looting, and I have explored its shortcomings in a review of a book on the topic. Sadly, it appears that the private equity influence in Britain is undermining a key part of its health care system. Having stacked various care homes with debt in order to buy them, many private equity firms have abandoned (or are about to abandon) the homes:

[A new] report, delving into the running and funding of the care industry, reveals that the collapse of Southern Cross may not be a one-off, as a number of other social care companies are also on the brink. Private equity takeovers of public services that use similar high risk business models, could leave taxpayers picking up the bill for more company failures. The in-depth study of privatisation shows that the second largest care provider, Four Season, is also in severe financial difficulties and others may follow. If both Southern Cross and Four Seasons were to collapse, around 1,150 nursing and residential care homes would be at risk of closure, affecting nearly 50,000 vulnerable people and their families and hitting over 60,000 staff.

Another of the top four largest residential care home operators is Barchester Healthcare - a sister company to Castlebeck, the operators of the Bristol care home exposed by a Panorama documentary . . . for patient abuse . The home owners have admitted that serious wrongdoing took place at Bristol. The report shows that Barchester and other operators of care homes, have repeatedly changed ownership, often through private equity firms buying, consolidating and selling companies. The UK’s largest union is warning that the Government must tackle the crisis in the care industry.

However disruptive the private equity takeovers have been, they have fulfilled their main purpose: huge gains for a few entities that bought and sold at the right time:

Southern Cross was floated on the stock market by Blackstone, which obtained a 400% return in two years on its acquisition. Southern Cross is now at risk of collapse. Allianz Capital Partners made a return of 100% by acquiring Four Seasons in 2004 for £775 million, selling it four years later for £1.4bn - the business then collapsed in value.

3i private equity fund brought a 38% stake in Care Principles for £1.5m in 1997, the remaining amount in 2005 and sold to to Three Delta in 2007 for £270m - a return of 390%. Tunstall was acquired by Bridgepoint Capital in 2005 for £225m, merged with Bridgepoint Investment and sold on after three years for £514m.

Here are more details on Southern Cross. This story and other critical commentary suggest that the goal for owners has been rapid profit rather long term investment in more efficient processes. When the “music stopped” in the acquisition game, it was left with mounting debts.

Chris Sagers’ article “The Myth of Privatization” (59 Admin. L. Rev. 37) suggests that there is very little difference between “public” and “private” operationally, except that “one of them lacks even a nominal obligation toward the public interest.” I have seen little evidence to contradict that idea in the eldercare industry. Further research may reveal more support for Daniel JH Greenwood’s diagnosis of the rise of private equity:

The success of private equity firms challenges mainstream corporate governance theory: according to standard agency cost analysis, this should not have happened. Agency problems—the shorthand term for the tendency of fiduciaries in a capitalist system to work for themselves as well as, or instead of, their clients—cannot be solved by adding an additional layer of extremely highly paid agents supported by an ideology that justifies the most extreme forms of self-interestedness. Therefore, private equity is unlikely to be an innovative solution to the age-old agency problem.

Instead, it is better understood as a clever bit of legal arbitrage: by reclassifying agents as principals, it allows former fiduciaries to instead view themselves, and be viewed by others, as entitled to look out only for themselves. And look out for themselves they have: the private equity managers have extracted hitherto unseen sums from our corporations, appropriating for the private benefit of a handful of individuals surplus that otherwise might have gone to other corporate participants, including consumers, ordinary employees, taxpayers and investors in the public securities markets, or might have been devoted to increasing productivity or innovation for the benefit of future generations.

The basic private equity technique, like the basic hedge fund technique, appears to be to borrow money in order to increase potential returns or losses. If the loans were correctly priced, this would not create new value under standard valuation theories, nor would it be a service that could possibly warrant the high fees typically charged in the hedge fund and private equity worlds. The simplest explanation is that either lenders or fund investors are mispricing risk and have done so for several years at a stretch, contrary to the claims of the efficient market theorists.

This explanation suggests, moreover, that private equity is simply the modern equivalent of the pyramid schemes, margin loans and highly leveraged utility holding companies of the 1920s. Like those earlier edifices built on borrowed money, the contemporary schemes are likely to be highly unstable: if the underlying assets decline in value or fail to provide expected income by even small margins, the lenders are likely to take losses out of scale with their potential profits. Once lenders wake up to this possibility—most likely only after losses have begun—they are likely to cut back lending rapidly, which will, in turn, make the underlying assets both less valuable and less saleable still, thus beginning a new round of lender panic. Any minor downturn, in short, runs the risk of starting a self-reinforcing cycle of credit and business contraction. The rise of private equity in its present form, then, appears to be another step towards the pre-New Deal world of inequality and instability.

And don’t forget about the role of private equity in influencing our political process. Blackstone billionaire Pete Peterson helped fuel concerns about government spending, while doing very little to advocate for increased taxes on the wealthy. And now we see that the CLASS Act—an innovative program to promote full funding for future long-term-care in the US–is likely to be on the chopping block. The primary value of both care homes and care plans to P/E firms appears to be their susceptibility to rapid sales and purchases. The P/E firm’s employees can earn massive bonuses if the value of entities goes up, and can’t lose those bonuses even if things eventually fall apart. It is a heads they win, tails they win scenario. The losers include all the other stakeholders in firms which are treated primarily as ATMs for fleeting owners.

 

Position Opening: Garwin Distinguished Visiting Professor of Law and Medicine

The Southern Illinois University School of Law is seeking nominations and applications for the Garwin Distinguished Visiting Professor of Law and Medicine for the 2012-13 academic year.  Established in 1996, the Garwin Professorship is funded in part by a grant from the Garwin Family Foundation which was established in 1993 for the purposes of fostering education and academic research.  Support for the position includes a competitive salary, benefits, travel allowance, housing for one year, and a research assistant.

With 35 faculty members and approximately 350 students, the Southern Illinois University School of Law enjoys one of the best student-faculty ratios of any law school in the country.  The School, and it's Center for Health Law and Policy (established in 2004), offer an outstanding health law program with a variety of courses as well as co-curricular and extra-curricular activities.  This includes a unique M.D./J.D. dual degree program offered in conjunction with the SIU School of Medicine. The School of Law also offers an LL.M. in Health Law and Policy, as well as a Masters of Legal Studies in Health Law and Policy. In conjunction with the American College of Legal Medicine, the School of Law participates in the publication of the Journal of Legal Medicine (since 1981) and Legal-Medical Perspectives (since 2000). The School also hosts each year (since 1992) the National Health Law Moot Court Competition, the only national competition focusing on health law issues. Since 1999, the School has also sponsored the annual SIH/SIU Health Policy Institute. Additionally, beginning in 2006, the School of Law has hosted each spring the John and Marsha Ryan Bioethicist in Residence.

Minimum Qualifications:  Applicants must possess the Juris Doctor degree or its equivalent from a nationally-accredited law school, be currently on the faculty of an accredited school of law or other graduate professional school, and have an outstanding national reputation as a health law/policy scholar and teacher.  Factors to be considered in assessing candidates for the Garwin Visiting Professorship include the following: scholarly and teaching record, honors received (e.g. awards, fellowships, etc.), participation and leadership in national and international organizations, letters of recommendation and other factors relevant to assessing qualifications for this position.

Areas of Concentration: Health law and policy including without limit any of the following – medical malpractice, food and drug law, public health law, and bioethics and the law, and possibly in the area of torts. Duties & Responsibilities:  (a) classroom instruction; (b) research and publication involving legal analysis of a high quality; (c) a public lecture. Deadline for application: October 15, 2011 or until position is filled.

To apply or nominate a candidate:  Applications may be submitted electronically at http://law.siu.edu/employment or by U.S. mail.  A completed application will require a letter of application, a resumé, and the contact information for three references.  The letter should be addressed to:

Professor W. Eugene Basanta, Chair, Garwin Visiting Professor Search Committee, Southern Illinois University School of Law, Mail code 6804, 1150 Douglas Drive,Carbondale, Illinois  62901

Applications and nominations may be submitted on line at http://www.law.siu.edu/employment/.

SIUC is an affirmative action/equal opportunity employer that strives to enhance its ability to develop a diverse faculty and staff and to increase its potential to serve a diverse student population.  All applications are welcomed and encouraged and will receive consideration. 

Guest Blogger Eleanor D. Kinney: Greetings from Puerto Vallarta!!

  El 18 de Julio

 

 

There is a country south of the border – the United Mexican States – with a per capita GNP less than one- third that of the United States (See Figure 1).  Yet that country, Mexico, has committed to universal health coverage for all its citizens as a matter of right.  With amendments of 2003, the Mexican constitution recognizes a constitutional right to health and health care.  Further, Mexico has adopted many of the international and regional human rights treaties that recognize an international human right to health (U. Minn).

 

 

The Mexican Constitution of 1917 (as amended to 2003) has two provisions regarding health and health care in its con­stitution. Constitución Política de los Estados Unidos Mexicanos [Constitution], as amended, Diario Oficial de la Federación [D.O], art. 4, 5 de Febrero de 1917 (Mex.).  One provision establishes a “right to health protec­tion” and sets forth what subordinate federal statutory law will authorize: 

Every person has the right to health protection. The law will describe the basis and means for access to health care services and will establish the concurrence of the Fed­eration and the federative entities in matters of public health. Boys and girls have the right to satisfy their nutrition, health, and education needs and for healthy recreation for their total development.

Figure 1 Relevant Statistical Indicators for the United States, Canada and Mexico
	Per capita GDP 2010*		Per Capita Health Expenditures, 2007**
	$s	Rank	$s	% of GDP	Rank
Mexico	15,224	47th	823	5.9	29th
United States	47,084	6th	7,290	16.0	1st
Canada	39,699	10th	3,895	10.1	5th
Sources:   *World Bank Group, 2010 **Organization for Economic Cooperation and Development, 2007

As discussed in my last blog entry, the Mexican Congress amended the Ley General de Salud to establish the System for the Social Protection in Health (SPSS) to establish the Seguros Popular for Mexico’s uninsured.  Ley General de Salud [The General Law of Health], as amended, art. 18, Diario Oficial de la Federación [D.O.], 7 de Febrero de 1984 (Mex).  The Seguros Popular initiative includes a universal health insurance scheme called the System for Social Protection in Health (SSPS). The health insurance scheme is financed jointly by the federal government, the states and higher income enrollees.

SSPS covers an essential package of personal health services for low risk, high probability illnesses and injuries. The services include ambulatory primary care and hospitalization for secondary care. The package of essential services is covered by funds at the state level. For the most part, services are provided through a network of providers who work for the state and federal public health sectors. The package of catastrophic interventions includes low-probability, high cost illnesses and injuries including cancers, cardiovascular disease, stroke, severe injuy and HIV-AIDS. Covered services include long-term rehabilitation, neo-natal intensive-care, organ transplantation, and dialysis. These tertiary care services are more limited and funded at the federal level.    (See F. Knaul and H. Arreola 2006).

With implementation starting in January 2004, the a seven year transition period during which SP will be offered on a progressive and voluntary basis to all Mexicans who are not already enrolled one of Mexico’s social insurance institutions. The aim was to have universal coverage in Mexico by 2012. There has been much progress in achieving this goal.  This progress and other aspects of the SSPS and SP are detailed on the website of the Comisión Nacional de Protección Social en Salud and the commission’s annual reports.  (See Comisión Nacional de Protección Social en Salud, Informe de Resultado del Segundo Semestre de 2009 (2009).

Before the Seguros Popular, more than 50 percent of Mexico’s population was uninsured (Knaul et. al., 2003).  Half of the Mexican population was at risk for catastrophic out of pocket medical costs and very limited access to health care services. The express purpose of Seguro Popular was to address this access problem for the poorest members of Mexican society. 

The big question for Seguros Popular generally and SSPS in particular is whether Mexico will be able to carry them off over the long term. The goal of extending coverage seems to be quite achievable. The real question will be if these coverage expansions can be absorbed by the Mexican health care sector and, in particular, the public provider network that serves the informal worker sector?  Also, can they be absorbed without unduly raising the cost of health care services in Mexico?  Finally, with the care provided under the initiative be of high quality? Fortunately, the Comisión Nacional de Protección Social en Salud is well aware of these issues and have been careful to evaluate coverage expansions and other aspects of the initiative.  

It is most interesting compare Mexico to its Northern neighbors, the United States and Canada. Clearly Mexico is more attuned to Canada with its guarantee of health coverage as a matter of right. Seemingly absent from the Mexican experience is the discussion of “government takeovers” of health care and concerns that government sponsored health bill bankrupt the country. One gets the sense that the Mexican government and the people of Mexico believe that health coverage for all people is important a country’s development and are willing to put universal coverage as a national priority.  

Hasta la Vista! 

 Eleanor D. Kinney

 

Electricty Rate Hikes Weighed Against Disease Prevention

The Environmental Protection Agency is finalizing two Clean Air Act regulations.  The Cross-State Air Pollution Rule requires 27 states to improve air quality by reducing power plant emissions that contribute to ozone and/or fine particle pollution. The Power Plant Mercury and Air Toxics Rule will limit mercury, acidic gases and other toxic pollution emanating from power plants, keeping 91 percent of the mercury in coal from being released to the air. Currently, there are no national limits on the amount of mercury and other toxic air pollution released from power plant smokestacks.

 Many operators of older power plants are lobbying for exemptions to the rules, as reported in yesterday’s Environment and Energy Daily newsletter. Out in front of this effort is the National Association of Regulatory Utility Commissioners (NARUC), who is meeting next week to consider passing a resolution (available here on Page 20) that would call on Congress for more flexibility in implementing the rules.

The American Lung Association, American Public Health Association, Asthma and Allergy Foundation of America and Physicians for Social Responsibility Trust for America’s Health is urging NARUC in a letter sent last week to reject taking this stance, claiming the rules will prevent asthma, heart attacks and premature deaths.

As suggested some of my previous postings, Congress has been very sympathetic to industry’s claims about the economic burdens of pollution regulations, with several proposals on the table to weaken or delay them. It is a values discussion couched in cost benefit calculations: how much does the prevention of premature deaths or asthma benefit society in dollars, so that it can be compared to the monetary costs of higher electricity rates in areas served by older plants? If Congress steps in to delay the rules, it would be helpful if the proponents explicitly discussed those trade-offs, but they rarely do.

[MM]

Attempted Suicide Is Not a Crime--Unless You're Pregnant

I've written before about a murder prosecution in Indianapolis against a woman who swallowed rat poison in a suicide attempt while she was 33 weeks pregnant. If convicted, she would receive a minimum sentence of 45 years in prison, with the possibility of capital punishment. The trial court judge refused to dismiss the charges, and the court of appeals will consider the motion to dismiss next month. Nada Stotland and I wrote about the case in today's Indianapolis Star.

In about two weeks, I'll be filing an amicus brief on behalf of the American College of Obstetricians and Gynecologists, other medical groups, and individuals in support of the motion to dismiss charges. Many professors of medicine, bioethics and law have agreed to participate.  Others interested in doing so should contact me at dorentli@iupui.edu

[DO]

Auditing Studies of Anti-Depressants

Marcia Angell has kicked off another set of controversies for the pharmaceutical sector intwo recent review essays in the New York Review of Books. She favorably reviews meta-research that calls into question the effectiveness of many antidepressant drugs:

Kirsch and his colleagues used the Freedom of Information Act to obtain FDA reviews of all placebo-controlled clinical trials, whether positive or negative, submitted for the initial approval of the six most widely used antidepressant drugs approved between 1987 and 1999—Prozac, Paxil, Zoloft, Celexa, Serzone, and Effexor. . . .Altogether, there were forty-two trials of the six drugs. Most of them were negative. Overall, placebos were 82 percent as effective as the drugs, as measured by the Hamilton Depression Scale (HAM-D), a widely used score of symptoms of depression. The average difference between drug and placebo was only 1.8 points on the HAM-D, a difference that, while statistically significant, was clinically meaningless. The results were much the same for all six drugs: they were all equally unimpressive. Yet because the positive studies were extensively publicized, while the negative ones were hidden, the public and the medical profession came to believe that these drugs were highly effective antidepressants.

Angell discusses other research that indicates that placebos can often be nearly as effective as drugs for conditions like depression. Psychiatrist Peter Kramer, a long-time advocate of anti-depressant therapy, responded to her last Sunday. He admits that “placebo responses . . . have been steadily on the rise” in FDA data; “in some studies, 40 percent of subjects not receiving medication get better.” But he believes that is only because the studies focus on the mildly depressed:

The problem is so big that entrepreneurs have founded businesses promising to identify genuinely ill research subjects. The companies use video links to screen patients at central locations where (contrary to the practice at centers where trials are run) reviewers have no incentives for enrolling subjects. In early comparisons, off-site raters rejected about 40 percent of subjects who had been accepted locally — on the ground that those subjects did not have severe enough symptoms to qualify for treatment. If this result is typical, many subjects labeled mildly depressed in the F.D.A. data don’t have depression and might well respond to placebos as readily as to antidepressants.

Yves Smith finds Kramer’s response unconvincing:

The research is clear: the efficacy of antidepressants is (contrary to what [Kramer's] article suggests) lower than most drugs (70% is a typical efficacy rate; for antidepressants, it’s about 50%. The placebo rate is 20% to 30% for antidepressants). And since most antidepressants produce side effects, patients in trials can often guess successfully as to whether they are getting real drugs. If a placebo is chosen that produces a symptom, say dry mouth, the efficacy of antidepressants v. placebos is almost indistinguishable. The argument made in [Kramer's] article to try to deal with this inconvenient fact, that many of the people chosen for clinical trials really weren’t depressed (thus contending that the placebo effect was simply bad sampling) is utter[ly wrong]. You’d see the mildly/short-term depressed people getting both placebos and real drugs. You would therefore expect to see the efficacy rate of both the placebo and the real drug boosted by the inclusion of people who just happened to get better anyhow.

Felix Salmon also challenges Kramer’s logic:

[Kramer's view is that] lots of people were diagnosed with depression and put onto a trial of antidepressant drugs, even when they were perfectly healthy. Which sounds very much like the kind of thing that Angell is complaining about: the way in which, for instance, the number of children so disabled by mental disorders that they qualify for Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI) was 35 times higher in 2007 than it was in 1987. And it’s getting worse: the editors of DSM-V, to be published in 2013, have written that “in primary care settings, approximately 30 percent to 50 percent of patients have prominent mental health symptoms or identifiable mental disorders, which have significant adverse consequences if left untreated.”

Those who would defend psychopharmacology, then, seem to want to have their cake and eat it: on the one hand it seems that serious mental health disorders have reached pandemic proportions, but on the other hand we’re told that a lot of people diagnosed with those disorders never really had them in the first place.

That is a very challenging point for the industry to consider as it responds to concerns like Angell’s. The diagnosis of mental illness will always have ineradicably economic dimensions and politically contestable aims. But doctors and researchers should insulate professional expertise and the interpretation of maladies as much as possible from inappropriate pressures.

How can they maintain that kind of independent clinical judgment? I think one key is to assure that data from all trials is open to all researchers. Consider, for instance, these findings from a NEJM study on “selective publication:”

We obtained reviews from the Food and Drug Administration (FDA) for studies of 12 antidepressant agents involving 12,564 patients. . . . Among 74 FDA-registered studies, 31%, accounting for 3449 study participants, were not published. Whether and how the studies were published were associated with the study outcome. A total of 37 studies viewed by the FDA as having positive results were published; 1 study viewed as positive was not published. Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies). According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive. Separate meta-analyses of the FDA and journal data sets showed that the increase in effect size ranged from 11 to 69% for individual drugs and was 32% overall. (emphasis added).

Melander, et al. also worried (in 2003) that, since “The degree of multiple publication, selective publication, and selective reporting differed between products,” “any attempt to recommend a specific selective serotonin reuptake inhibitor from the publicly available data only is likely to be based on biased evidence.” Without clearer “best practices” for data publication, clinical judgment may be impaired.

Full disclosure of study funding should also be mandatory and conspicuous, wherever results are published. Ernest R. House has reported that, “In a study of 370 ‘randomized’ drug trials, studies recommended the experimental drug as the ‘treatment of choice’ in 51% of trials sponsored by for-profit organizations compared to 16% sponsored by nonprofits.” The commodification of research has made it too easy to manipulate results, as Bartlett & Steele have argued:

One big factor in the shift of clinical trials to foreign countries is a loophole in F.D.A. regulations: if studies in the United States suggest that a drug has no benefit, trials from abroad can often be used in their stead to secure F.D.A. approval. There’s even a term for countries that have shown themselves to be especially amenable when drug companies need positive data fast: they’re called “rescue countries.” Rescue countries came to the aid of Ketek, the first of a new generation of widely heralded antibiotics to treat respiratory-tract infections. Ketek was developed in the 1990s by Aventis Pharmaceuticals, now Sanofi-Aventis. In 2004 . . . the F.D.A. certified Ketek as safe and effective. The F.D.A.’s decision was based heavily on the results of studies in Hungary, Morocco, Tunisia, and Turkey.

The approval came less than one month after a researcher in the United States was sentenced to 57 months in prison for falsifying her own Ketek data. . . . As the months ticked by, and the number of people taking the drug climbed steadily, the F.D.A. began to get reports of adverse reactions, including serious liver damage that sometimes led to death. . . . [C]ritics were especially concerned about an ongoing trial in which 4,000 infants and children, some as young as six months, were recruited in more than a dozen countries for an experiment to assess Ketek’s effectiveness in treating ear infections and tonsillitis. The trial had been sanctioned over the objections of the F.D.A.’s own reviewers. . . . In 2006, after inquiries from Congress, the F.D.A. asked Sanofi-Aventis to halt the trial. Less than a year later, one day before the start of a congressional hearing on the F.D.A.’s approval of the drug, the agency suddenly slapped a so-called black-box warning on the label of Ketek, restricting its use. (A black-box warning is the most serious step the F.D.A. can take short of removing a drug from the market.) By then the F.D.A. had received 93 reports of severe adverse reactions to Ketek, resulting in 12 deaths.

The great anti-depressant debate is part of a much larger “re-think” of the validity of data. Medical claims can spread virally without much evidence. According to a notable meta-researcher, “much of what medical researchers conclude in their studies is misleading, exaggerated, or flat-out wrong.” The “decline effect” dogs science generally. Statisticians are also debunking ballyhooed efforts to target cancer treatments.

Max Weber once said that “radical doubt is the father of knowledge.” Perhaps DSM-VI will include a diagnosis for such debilitating skepticism. But I think there’s much to be learned from an insistence that true science is open, inspectable, and replicable. Harvard’s program on “Digital Scholarship” and the Yale Roundtable on Data and Code Sharing* have taken up this cause, as has the work of Victoria Stodden.

We often hear that the academic sector has to become more “corporate” if it is to survive and thrive. At least when it comes to health data, the reverse is true: corporations must become much more open about the sources and limits of the studies they conduct. We can’t resolve the “great anti-depressant debate,” or prevent future questioning of pharma’s bona fides, without such commitments.

*In the spirit of full disclosure: I did participate in this roundtable.

The "July Effect" Confirmed

It has long been suspected that July is not a good time to seek medical care at a teaching hospital as new trainees join the care teams. Dr. John Young and colleagues writing in the Annals of Internal Medicine, here, demonstrate this is no myth. Such "cohort turnover" does indeed lead to the chillingly labelled "August killing season." Concentrating on what the researchers viewed to be high-quality studies they found considerable correlation between cohort turnover and increased mortality. A similar negative picture emerged with regard to increased hospital stays, hospital bills and other efficiency metrics. How do we fix this? The researchers suggest looking at workload burdens during the turnover and also staggering the way the cohorts move in and out of the system. So, there's another one to add to the process reform list. [NPT]

 

Guest Blogger Eleanor D. Kinney: Greetings from Puerto Vallarta!!

 El 10 de Julio

Greetings from Puerto Vallarta!! 

 

I am your guest blogger for July. I will be blogging from South of the Border – precisely from Puerto Vallarta, Jalisco, Mexico. My major topic in my guest blog will be health care in Mexico. There is much to learn from colleagues south of the border.

Mexico has a relatively advanced health care sector with morbidity and mortality patterns of modern industrialized countries. While there is still poverty in Mexico, with persistence of diarrheal and other infectious disease indicative of third world countries, there is greatly increasing morbidity and mortality from coronary artery disease, diabetes and other chronic diseases that plague more developed countries. See World Health Organization, Country Cooperation Strategy:  Mexico (2006). Indeed, Mexico is now experiencing a tremendous epidemic of diabetes. Elizabeth Barclay, In Mexico, Diabetes Strains Lives and Budgets, New York Times, June 12, 2007.   

Mexico's social security system provides direct health care services to about 50 percent of the population who work or have a family member who work in the formal economic sector. The Mexican Institute of Social Security (Instituto Mexicano de Seguro Social (IMSS)) covers approximately 80 percent of these private sector beneficiaries. The Institute of Security and Social Services for State Workers (Instituto de Seguridad y Servicios Sociales para los Trabajadores del Estado (ISSSTE)) covers government workers and accounts for 17 percent of the beneficiaries. There are separate systems that provide health coverage and care sponsored by the Secretariat of National Defense (Secretaría de Defensa Nacional), the Secretariat of the Navy (Secretaría de Marina), and Mexican Petroleum (Petróleos Mexicanos (Pemex)).   These programs are financed with contributions from employees, employers, and/or government. See Tim L. Merrill and Ramón Miró (ed.), Mexico: A Country Study. Washington: GPO for the Library of Congress (1996).  

In 2003, the Mexican Congress amended the Ley General de Salud to establish the System for the Social Protection in Health (SPSS) for the uninsured population who were not otherwise eligible for coverage under IMSS or ISSSTE. Ley General de Salud [The General Law of Health], as amended, art. 18, Diario Oficial de la Federación [D.O.], 7 de Febrero de 1984 (Mex). The reform includes the Seguro Popular (SP), which is a health insurance scheme financed jointly by the federal government and the states. SP will expand health care coverage to the entire population of Mexico by 2012, starting with the poorest families. Specifically, the reform includes five actions: (1) legislation establishing entitlement to coverage for eligible families; (2) creation of explicit benefits packages; (3) funds to state ministries of health in proportion, calculated on the basis of eligible families within the state; (4) division of federal resources flowing to states into separate funds for personal and non-personal health services; and, (5) creation of a fund to protect families against catastrophic health expenditures.

In 2009, Mexico had an uninvited opportunity to showcase its public health and health care delivery capabilities in the H1N1 flu pandemic of 2009. That spring, Mexico experienced outbreaks of influenza-like illness (ILI). On April 12, 2009, Mexico confirmed an outbreak of ILI occurred in La Gloria in the state of Veracruz and reported this outbreak to the World Health Organization (WHO). Later in April, outbreaks of severe pneumonia in Distrito Federal (Mexico City) and San Luis Potosi precipitated increased surveillance throughout the country. The high fatality rate of the novel influenza A (H1N1) infection among younger, previously healthy people was particularly disturbing.

The WHO announced that this outbreak of influenza A (H1N1) virus in Mexico and the United States marked the beginning of a worldwide pandemic. Mexico reacted quickly and aggressively in its surveillance and social distancing measures. The Mexican government cooperated immediately with international health organizations and neighboring countries to address the flu outbreak. By mid- April, the Mexican government issued a national epidemiologic alert to all influenza-monitoring units and hospitals asking that they test and report all cases of severe respiratory illness. On April 24, the government ordered that all schools and large public gatherings, such as soccer games in Mexico City and surrounding areas, be closed or suspended for about ten days. By May, Mexican authorities reported that the outbreak had likely peaked in late April. WHO publically acknowledged that Mexico had been cooperative and forthright in addressing the influenza A (H1N1) outbreak.  World Health Organization, “Influenza-Like Illness in the United States and Mexico,” April 24, 2009. Mexico’s decisive actions did much to mitigate the spread of the H1N1 flu pandemic throughout the world. 

In my next blog entry, I am going to talk more about Mexico’s efforts to extend universal coverage for all its citizens being with the poorest. The third blog entry will address portability of health insurance across the borders and will focus on making Medicare fully portable. The final blog entry will assess the impact of the North American Free Trade Agreement (NAFTA) on the Mexican health care sector.  

 I look forward to comments and discussion.  

 Hasta la Vista! 

-Guest Blogger Eleanor Kinney

  

Introducing Guest Blogger Eleanor D. Kinney

We are very pleased to welcome our Guest Blogger for July, Eleanor D. Kinney. Here is her bio:

Eleanor D. Kinney is the the Hall Render Professor of Law Emeritus and founding director of the William S. and Christine S. Hall Center for Law and Health at Indiana University School of Law – Indianapolis.  She is also an adjunct professor in the Schools of Medicine and Public and Environmental Affairs.  A widely published author and respected lecturer on the subjects of America’s health care system, medical malpractice, health coverage for the poor, and issues in administrative law, Professor Kinney is author or co-author of numerous law review articles, peer-reviewed health policy articles, book chapters and book reviews. She recently published Protecting American Health Care Consumers (Duke University Press 2002) and edited the Guide to Medicare Coverage Decision-Making and Appeals (ABA Publishing 2002).

Professor Kinney received her J.D. and B.A. (with distinction in history) from Duke University.  She also has a masters degree in public health from the University of North Carolina – Chapel Hill and a masters degree in European history from the University of Chicago.  After graduating from law school, she practiced law for four years at Squire, Sanders & Dempsey in Cleveland, Ohio and then worked as an estate planning officer for Duke University Medical Center. After earning her master’s degree in public health, she served as program analyst for the U.S. Department of Health and Human Services in Washington, D.C.  She received an award from the DHHS Office for Civil Rights for Distinguished Performance on the New York City Health and Hospitals Corporation Investigation for 1979‑1980.  Before joining the IU faculty in 1984, she was Assistant General Counsel of the American Hospital Association.

Professor Kinney has served as a consultant to the Administrative Conference of the United States, President Clinton’s Task Force for Health Care Reform, and the Indiana Commission on Health Care for the Working Poor. She has been appointed by the governor of Indiana to the Executive Board of the Indiana State Department of Health and to other task forces and advisory boards.  During 1999-2000, Professor Kinney was a Fulbright Fellow at the National University of La Plata in La Plata, Argentina.  In 2005-2006, Professor Kinney served as Chair of the American Bar Association's Section on Administrative Law and Regulatory Practice and was inducted as a fellow of the Section in 2007. 

In 2010, she received the Jay Healey Award for Excellence in Teaching, Health Law Professor’s Section of the American Society for Law, Medicine and Ethics. In 2022, she received the IUPUI Senior Woman’s Leadership Award. In 2000, she received Distinguished Alumna Award for Lifetime Achievement from her alma mater, Emma Willard School. In 1986, she was awarded the Best New Professor Award by the Student Bar Association of Indiana University School of Law – Indianapolis.  Professor Kinney is a member of the American Law Institute. 

Professor Kinney’s current research interests focus on the realization of the international human right to health, free trade policy and health care, improved administrative law and procedures for a reformed health law system and an improved system for the resolution of medical malpractice claims.

Your Health Insurance Exchanges Primer

A few months ago predicting the actual date for the announcement of the ACO proposed rule, here, was (almost) as exciting as awaiting a new product announcement from Apple. Well, just as Apple spoiled "Christmas" the other month by pre-announcing the contents of a Steve Jobs product presentation, so Secretary Sibelius, here, has told us that the Exchanges rule is being published today with a summary that somewhat desperately tries to make them appear more user-friendly than the frankly geeky mechanisms they truly are. There are some good resources for the Exchanges newbie, including Julie Appleby's March primer in the Washington Post, here and Sarah Kliff writing for Politico, here. For more detail I recommend Jon Kingsdale and John Bertko writing in Health Affairs, here and, of course, the masterful Tim Jost writing for the Commonwealth Fund, here. Update, HHS site now has Exchanges overview plus links to NPRMs, here. [NPT]

 

Worth Reading This Week

Dwight Golann, Dropped Medical Malpractice Claims: Their Surprising Frequency, Apparent Causes, And Potential Remedies, Health Affairs (Health Aff July 2011 vol. 30 no. 7 1343-1350 Subscription)

Marc A. Pfeffer & Marianne B. Bowler, Access to Safety Data — Stockholders versus Prescribers, NEJM

Tine Hansen-Turton, Jamie Ware, and Frank McClellan, Nurse Practitioners in Primary Care, SSRN/Temple L.Rev.

[NPT]

Poor Man's Privacy Law May Have Teeth

I am not a big fan of data breach statutes whether legislated by the states (usefully collected here) or the federal government, for example Sec. 13402 HITECH and regulations made thereunder (outlined here). Practically, they seem to embrace a "horse bolted after we left the barn door unlocked" approach to data protection. And,from a policy perspective, they strike me as a lazy post hoc (and sometimes sectoral) legislative responses to a problem that deserves a more comprehensive and integrated regulatory model.

However, as we continue to wait (and wait) on the Senate's Committee on Commerce, Science, and Transportation Committee for some good news about privacy reform (here), at least one state has demonstrated that a breach notification statute can have some teeth. This week the Indiana Attorney General announced a settlement with WellPoint Inc., (here) in which the company will pay $100,000 to the state and accept responsibility for credit monitoring and identity theft protection for affected consumers. According to the Attorney General "This case should be a teaching moment for all companies that handle consumers' personal data: If you suffer a data breach and private information is inadvertently posted online, then you must notify the Attorney General's Office and consumers promptly. Early warning helps minimize the risk that consumers will fall victim to identity theft… The requirement to notify the Attorney General 'without unreasonable delay' is not fulfilled by having me read about the breach in the newspaper." Now, we are not talking about penalties of the size being thrown around by the newly energized Office of Civil Rights ($865,500 from UCLA this week for HIPAA violations, here), but maybe I should give breach notification statutes a second chance. [NPT]

 

Beyond Innovation and Competition, Health IT Edition

Last year I published a piece called “Beyond Innovation and Competition,” questioning the dominance of those values. Economists celebrate innovation and competition as the main source of future growth. Innovation has become the central focus of Internet law and policy. While leading commentators sharply divide on the best way to promote innovation, they routinely elevate its importance. Business writers have celebrated search engines, social networks, and tech startups as model corporations, bringing creative destruction and “disruptive innovation” in their wake. Maximum innovation is the goal, and competition is billed as the best way of achieving it. Players in the vast and dynamic tech marketplace are supposed to constantly strive to innovate in order to attract consumers away from rivals.

In the piece, I explain how both competition and innovation can be as destructive as they are constructive. There are many social values (including privacy, transparency, predictability, and stability), and companies can compete for profits in ways that erode those values. In an era of inequality and hall-of-mirrors stock market valuations, innovations of marginal or negative impact on society at large can be vastly overvalued by a stampede of fickle investors.

The shortcomings of the innovation and competition story also play out in health information technology. Stimulus legislation in 2009 provided many carrots and sticks for doctors to digitize their recordkeeping systems, ranging from bonuses now to reimbursement haircuts later this decade if they fail to implement the technology. Congress structured the incentives to encourage a competitive and innovative marketplace in health information technology. But many doctors are shying away from implementation, in part because they fear that the fast and loose ethics of the market can’t mesh with a medical culture of constant commitment to quality care.

Susan Jaffe’s article for the Center for Public Integrity examines doctors’ fears about adopting any given software suite. According to Jaffe, “570 different electronic health systems certified by private organizations for non-hospital settings may be used to qualify for the” stimulus funds. The long-term consequences of the choice make the jam-shopping examples in Barry Schwartz’s book The Paradox of Choice seem quaint:

The systems can vary in appearance, content, organization and special features. Some can be customized by users in different ways, at no cost or some cost, or not at all. Some are compatible with other systems now, eventually or, some critics say, maybe never. . . . The costs of the systems remain daunting, despite the bonuses, particularly in areas that have been hit hard by an ailing economy.

The pricetag varies widely depending on the type and size of the medical practice, whether new computers are purchased and the extent of customization, among other things. Software alone can cost from $2,000 to $10,000 per doctor. All told, the cost jumps to about roughly $20,000 per doctor, according to a regional extension center consultant who advises physicians in northeast Ohio. On top of that, manufacturers charge hefty annual fees for technical support and periodic upgrades that together can amount to about 35 percent of the upfront costs. The systems are priced in a way that does not make comparison shopping “easy or necessarily valid,” said Dottie Howe, a spokeswoman for the Ohio regional extension center. There is no basic price because each company offers different components, features, options, and level of technical support. . . .

Most manufacturers will also charge the doctors to move the information in their current system to the new one. There could be extra [ongoing, monthly] charges to connect to other systems too.

Doctors have also been burned by sharp operators that emphasize slick salesmanship over solid service:

[T]he Southwest Family Physicians group is worried . . . They bought an electronic health record system five years ago that is now nearly obsolete. The manufacturer was taken over by another company that provides minimal technical support . . . “The salesman said ‘you’re buying a Cadillac, this is going to be the greatest thing,’ ” [one doctor] recalled. But that system can’t display an X-Ray image or send a prescription electronically to a pharmacy. “We’ve got the Model T Ford,” he said.

It does appear that regional extension centers are doing some work to keep pricing reasonable. Jaffe’s article focuses on Ohio, where five “preferred vendors” “agreed to charge prices ‘as good as or better than’ prices offered to other regional extension centers, to provide onsite assistance when a practice turns on its electronic health record system for the first time, offer technical support for at least six years, and limit annual cost increases for continuing technical support, among other things.” But consider the bizarrely proprietary nature of pricing data:

Whether the five preferred vendors offer a better deal than their non-preferred competitors is not known because the state regional extension center doesn’t have pricing information from non-preferred vendors, said Howe, the spokeswoman for the state’s regional extension center. Pricing from the preferred vendors are confidential, she said. And despite their preferred status, the five companies do not guarantee that eligible health care providers who purchase their systems will receive the government’s bonus payments.

I discussed the troubling degree of secrecy in health care before, and I’m very sad to see it persist here. The doctors in Jaffe’s story are making reasonable demands: to be able to understand the nature of the commitment they are making, to avoid big financial losses, and not to be burned by fly-by-night operators attracted only by the government subsidy money. They want to assure that the basic health care values of access, cost-control, and quality are reflected in the software they use.

We are seeing the opening stages of a battle between a medical sector committed to maintaining its own autonomy and traditions, and a tech sector that wants to commoditize health data in as standardized a form as futures markets homogenized corn grades, or credit scores tranched residential mortgage backed securities. Commenting on the demise of Google Health, an informatics expert said that “Google is unwilling, for perfectly good business reasons, to engage in block-by-block market solutions to health-care institutions one by one, and expecting patients to actually do data entry is not a scalable and workable solution.” To be sure, the company can’t expect to make the same profit margins in the health sector as it does in the online ad business. But the “instant millions” ethos of Silicon Valley doesn’t fit well with a sector where we are in principle committed to serving everyone, regardless of ability to pay.

Economist John Van Reenen has observed that the US has a particularly innovative economy in part because our markets are so good at crushing badly run firms. It’s probably good that garden equipment suppliers, toothpaste makers, and pie bakers know they can be out of business in a month or two if they’re “off their game” for a short time. But if I just entrusted three years of medical records to a vendor who suddenly went out of business, I’d take little comfort in the idea that a marginally better competitor had knocked it out of the market. The transition to a new vendor can be slow and costly—doctors in Jaffe’s story speak of seeing 1/3 to 1/2 less patients over weeks or months as they learn a new system.

At a Yale SOM Health Care conference in 2009, the Chief Medical Officer of a major player in the field once remarked to me that choosing an HIT vendor is “like a marriage—you don’t end the relationship lightly.” I first thought that remark was self-serving. But the more one examines the HIT field, the more important it appears to get standard recordkeeping, support capabilities, and interoperability right at the outset, rather than leaving doctors to negotiate the wreckage of several generations of battling systems. Think about how chaotic online music sales seemed before iTunes. Perhaps Apple (whose iPads are already beloved by many docs) is going to bring a swift and highly profitable order to this field, too. I hope the ONC and other decisionmakers will well-regulate whatever behemoth eventually emerges, vindicating the public values that competition and innovation are unlikely to promote. 

[FP]

Electronic Medical Records Overhyped?

Many policy experts and public officials have touted electronic medical records for their promise in promoting safer, higher quality, and lower cost health care.  At the same time, critics have challenged the claims that have been made on behalf of e-records.  A new study demonstrates that computerizing prescriptions will not reduce medication errors as easily as has been thought.  

[DO]

Worth Reading This Week

Barry Furrow, Health Reform and Ted Kennedy: The Art of Politics...and Persistence, SSRN/New York University Journal of Legislation and Public Policy

Brietta Clark, Using Law to Fight a Silent Epidemic: The Role of Health Literacy in Health Care Access, Quality, and Cost, SSRN/Annals of Health Law 

Bradley Areheart, Disability Trouble, SSRN/Yale Law & Policy Review

Art Caplan, Book Review, Vaccination: Facts Alone Do Not Policy Make, Health Affairs (subscription)

[NPT]