Michelle Mello

Recent Research Highlights

Survey finds public support for legal interventions to fight obesity, noncommunicable diseases

March 5, 2013

The public is very supportive of government action aimed at changing lifestyle choices that can lead to obesity, diabetes, and other noncommunicable diseases—but they’re less likely to support such interventions if they’re viewed as intrusive or coercive, according to a new Harvard School of Public Health (HSPH) study. The study also found that support was higher for interventions that help people make more healthful choices, such as menu labeling requirements, than for interventions that penalize certain choices or health conditions, such as charging higher insurance premiums for obese individuals.

“Policymakers everywhere are looking for ways to use legal and policy levers to stem the rising tide of health care costs related to obesity and chronic disease,” said Stephanie Morain, a doctoral candidate in health policy at Harvard University, who led the study. “They should be heartened by these findings—the public does see this as an appropriate role for government.”  That public support is important, the study authors wrote, because it may affect people’s willingness to comply with the law.

The study appears in the March 2013 issue of Health Affairs.

 In recent years, lifestyle choices such as overeating, physical inactivity, and alcohol and tobacco use have led to troubling increases in chronic ailments in the U.S. In response, health departments and legislative bodies have adopted policies aimed at combating the behavioral risk factors that lead to ill health, such as banning trans fats in restaurants, raising taxes on cigarettes, and screening schoolchildren for high body mass index.

But some have criticized such interventions, saying that they impinge on personal choice and exceed the scope of governmental authority.  So the HSPH researchers decided to examine which factors play into public support for so-called “new-frontier” public health initiatives.

For the study, co-authors Morain and Michelle Mello, professor of law and public health in the HSPH Department of Health Policy and Management, analyzed the results of an online survey of 1,817 American adults conducted in October 2011 by Knowledge Networks (now part of GfK), a professional survey organization. In the survey, respondents were asked about their support for various types of public health policies, as well as the factors that influenced their support. There were questions about seven noncommunicable health conditions and 14 specific strategies to address them.

The researchers found a high level of support—between 70% and 90%—for government action on each of seven areas: preventing cancer, heart disease, childhood and adult obesity, and tobacco use; helping people control their diabetes; and reducing alcohol consumption.

Support was quite high for interventions that facilitate healthy choices, such as increasing the affordability of fruits and vegetables or requiring more instruction in public schools about the health risks of obesity. However, support waned when government actions were viewed as focusing on penalties or on limiting choices—such as adding insurance surcharges for obese individuals or making it illegal to smoke in private spaces.

The researchers also found that African-Americans and, to a lesser extent, Hispanics, are significantly more likely than whites to support government action to address noncommunicable diseases.

In addition, the survey indicated that people are much more supportive of government public health initiatives if they believe that “people like me” can influence public health priorities and if they think that public health officials understand the public’s values.

“The message for public health officials and legislators is, if you want the public to buy in to these legal interventions, you’ve got to engage them early on,” said Mello. “You’ve also got to communicate about policies in a way that resonates with the public’s values.  For example, how does the intervention support healthy choices?  Why is it fair?”

The study was supported by a grant from the Greenwall Foundation.

 “Survey Finds Public Support for Legal Interventions Directed at Health Behavior to Fight Noncommunicable Disease,” Stephanie Morain and Michelle M. Mello, Health Affairs, March 2013. The full article is available here through April 5, 2013. Thereafter, it can be accessed at www.healthaffairs.org.

Study Reveals Complexities of Disclosing and Compensating for Medical Mistakes

When disclosing a medical error to patients, healthcare providers should follow up with a proactive offer of compensation—but patients’ responses may not be as straightforward as they might expect.  According to a study by Harvard School of Public Health (HSPH) researchers and colleagues, two thirds of patients expect compensation following a harmful medical error, and three quarters are likely to accept even modest compensation offers.  But offering full compensation can prompt suspicion that the provider is motivated by a desire to avoid a lawsuit, rather than a desire to do the right thing.  To preserve trust in physicians, the authors recommend clearly separating disclosure and compensation discussions and leaving physicians out of talks about money. The study appears in the December 2012 issue of Health Affairs (click here for the abstract).  The study was conducted by Michelle Mello, JD, PhD, Professor of Law and Public Health in the Department of Health Policy and Management at HSPH; Lindsey Murtagh, JD, MPH, a former HSPH Research Associate who is now an Associate at the law firm Hogan Lovells in Washington, DC; Penny Andrew, MBChB, LLB, a former Commonwealth Fund Harkness Scholar who is currently the clinical lead for quality at Waitemata District Health Board in New Zealand; and Thomas Gallagher, MD, a professor in the Departments of Medicine and Bioethics and Humanities at the University of Washington.  The researchers were supported by grants from the Robert Wood Johnson Foundation and the Commonwealth Fund, and in-kind support from the National Science Foundation’s TESS program.

 

Institute of Medicine Report Discusses Ethical Concerns Surrounding Postmarketing Regulation of New Drugs

The tumult arising from revelations of serious safety risks associated with widely prescribed drugs, including Avandia,  Vioxx, and Celebrex, has led to widespread recognition that improvement is needed in our national system of ensuring drug safety. Notwithstanding federal legislation in 2007 that strengthened the authority of the Food and Drug Administration (FDA) in the postmarketing period,critical weaknesses in the national system persist.

Central to these weaknesses are dilemmas surrounding not only the science but also the ethics of drug-safety research, many of which came to the fore in the heated public debate about the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) trial, which compared the cardiovascular outcomes of long-term treatment with rosiglitazone with those of pioglitazone (Actos, Takeda) in patients with type 2 diabetes. At the request of the FDA, an Institute of Medicine (IOM) committee was convened to examine the ethics and science of FDA-required postmarketing safety research. In an article published in The New England Journal of Medicine in September 2012, 3 members of the IOM committee review the key ethics findings from the committee’s May 1, 2012, report and offer some reflections on the challenges ahead.  Read the article here and access the IOM’s full report, “Ethical and Scientific Issues in Studying the Safety of Approved Drugs,” here.

What Works in Medical Liability Reform?

April 2010 — Report to the Medicare Payment Advisory Commission

Michelle Mello and Allen Kachalia of Harvard Medical School synthesize the available empirical evidence about how effective traditional tort reforms, including noneconomic damages caps, are in reducing medical liability costs, reducing defensive medicine, improving physician supply, and improving quality of care.  This report to the Medicare Payment Advisory Commission also examines the potential of several more innovative reforms, including health courts, safe harbors for adherence to evidence-based practice guidelines, noneconomic damages schedules, subsidized reinsurance, enterprise liability, and disclosure-and-offer programs.  Read the report here.

Puffing in Public Housing Poses Serious Health Risks to Tenants

June 2010 – Researchers examine risks and consequences of cigarette smoking to all inhabitants of multiple-unit housing; challenge status quo

BOSTON, MA — In an effort to protect children from harmful tobacco smoke exposure, health and medical professionals are pushing for a ban on smoking in public housing in a report appearing in the June 17, 2010 issue of the New England Journal of Medicine.

Over 7 million people are served by public housing in the U.S., with 4 in 10 units occupied by families with children.  On July 17, 2009, the U.S. Department of Housing and Urban Development (HUD) issued a memorandum that strongly encouraged local Public Housing Authorities (PHAs) to implement no-smoking policies in some or all of their public housing units.  While surveys indicate that 4 in 5 nonsmokers prefer smoke-free building policies, and many private landlords throughout the country have made their housing units smoke-free, only about 4% of PHAs have banned smoking in the units they manage. The article gives specific guidance on policy options for PHAs and HUD to protect all residents from tobacco smoke exposure and clarifies that there are no legal barriers to banning smoking in public housing. “HUD has taken an important step,” says coauthor Michelle Mello, J.D., Ph.D. of the Harvard School of Public Health, “but it could do more to prod lagging PHAs to take action.”  More

Who Pays the Costs of Medical Errors?

December 2007—Patient safety advocates argue that the high costs of hospital adverse events (injuries due to medical management) create a “business case for patient safety.”  That is, health care organizations that invest in technologies and systems improvements to enhance patient safety will reap a financial return.  There is little question that medical injuries involve large costs, but do hospitals themselves actually pay these costs?   If they are able to shift them to others, such as patients and health insurers, then their financial incentives for safety improvement may be inadequate.

To investigate this, Harvard School of Public Health researchers examined data on 465 medical injuries that occurred in 24 hospitals in Utah and Colorado to determine where the associated costs and expenses fell.  One hundred twenty-seven of these injuries were judged to be due to negligence.  The researchers estimated how much each injury would generate in health care costs, lost income, lost household production, burial costs, and noneconomic loss (“pain and suffering”), and modeled how much of these costs would be absorbed by the hospital versus patients, health insurers insurers, and disability insurers.  They also examined how much hospitals paid in malpractice insurance premiums, which capture the hospital’s projected risk of incurring injury-related costs.

The study found that on average, for every patient treated, the hospitals generated injury-related total costs of $2,013 and negligent-injury-related costs of $1,246 (in 2005 dollars).  However, hospitals bore only 22% of these costs; the rest were shifted to other parties.  On average, hospitals externalized injury-related costs in the amount of $1,775 per admission ($1,066 per admission for negligent injuries).

The authors concluded that “Injuries due to medical management in the hospital are associated with substantial societal costs, yet only a small proportion of these costs are borne by hospitals.” The largest factor explaining hospitals’ ability to shift these costs to other parties is the low percentage of injuries that result in malpractice claims and receive compensation through the tort liability system.  A secondary factor is that most health insurers are willing to reimburse hospitals for the cost of extra health care services that are necessitated by medical injuries.

These findings call the “business case for safety” into question-hospitals absorb little of the costs of injuries, yet adopting interventions to prevent injuries is costly, so the financial incentives cut against such investments.  The authors suggest a series of changes to reimbursement rules and the tort liability system to address the problem and bolster incentives for patient safety.

The study appears in the December 2007 issue of the Journal of Empirical Legal Studies.  Electronic reprints are available from Dr. Mello.  Read more here

Study Casts Doubt on Claims That the Medical Malpractice System Is Plagued By Frivolous Lawsuits

Press release, May 2006: The debate over medical malpractice litigation, which raged during the last presidential campaign, continues as a hot-button political and health care issue in the U.S.  One popular justification for tort reform is the claim that “frivolous” medical malpractice lawsuits—those lacking evidence of substandard care, treatment-related injury, or both—enrich plaintiffs’ attorneys and drive up health care costs. A new study by researchers from the Harvard School of Public Health (HSPH) and Brigham and Women’s Hospital challenges the view that frivolous litigation is rampant and expensive.  The researchers analyzed past malpractice claims to judge the volume of meritless lawsuits and determine their outcomes. Their findings suggest that portraits of a malpractice system riddled with frivolous lawsuits are overblown. Although nearly one third of claims lacked clear-cut evidence of medical error, most of these suits did not receive compensation. In fact, the number of meritorious claims that did not get paid was actually larger than the group of meritless claims that were paid. The findings appear in the May 11, 2006 issue of The New England Journal of Medicine.  read more     read the paper

Survey finds public support for legal interventions to fight obesity, noncommunicable diseases

Embargoed for release: Monday, March 4, 2013, 4:00 PM ET

The public is very supportive of government action aimed at changing lifestyle choices that can lead to obesity, diabetes, and other noncommunicable diseases—but they’re less likely to support such interventions if they’re viewed as intrusive or coercive, according to a new Harvard School of Public Health (HSPH) study. The study also found that support was higher for interventions that help people make more healthful choices, such as menu labeling requirements, than for interventions that penalize certain choices or health conditions, such as charging higher insurance premiums for obese individuals.

“Policymakers everywhere are looking for ways to use legal and policy levers to stem the rising tide of health care costs related to obesity and chronic disease,” said Stephanie Morain, a doctoral candidate in health policy at Harvard University, who led the study. “They should be heartened by these findings—the public does see this as an appropriate role for government.”  That public support is important, the study authors wrote, because it may affect people’s willingness to comply with the law.

The study appears in the March 2013 issue of Health Affairs.

In recent years, lifestyle choices such as overeating, physical inactivity, and alcohol and tobacco use have led to troubling increases in chronic ailments in the U.S. In response, health departments and legislative bodies have adopted policies aimed at combating the behavioral risk factors that lead to ill health, such as banning trans fats in restaurants, raising taxes on cigarettes, and screening schoolchildren for high body mass index.

But some have criticized such interventions, saying that they impinge on personal choice and exceed the scope of governmental authority.  So the HSPH researchers decided to examine which factors play into public support for so-called “new-frontier” public health initiatives.

For the study, co-authors Morain and Michelle Mello, professor of law and public health in the HSPH Department of Health Policy and Management, analyzed the results of an online survey of 1,817 American adults conducted in October 2011 by Knowledge Networks (now part of GfK), a professional survey organization. In the survey, respondents were asked about their support for various types of public health policies, as well as the factors that influenced their support. There were questions about seven noncommunicable health conditions and 14 specific strategies to address them.

The researchers found a high level of support—between 70% and 90%—for government action on each of seven areas: preventing cancer, heart disease, childhood and adult obesity, and tobacco use; helping people control their diabetes; and reducing alcohol consumption.

Support was quite high for interventions that facilitate healthy choices, such as increasing the affordability of fruits and vegetables or requiring more instruction in public schools about the health risks of obesity. However, support waned when government actions were viewed as focusing on penalties or on limiting choices—such as adding insurance surcharges for obese individuals or making it illegal to smoke in private spaces.

The researchers also found that African-Americans and, to a lesser extent, Hispanics, are significantly more likely than whites to support government action to address noncommunicable diseases.

In addition, the survey indicated that people are much more supportive of government public health initiatives if they believe that “people like me” can influence public health priorities and if they think that public health officials understand the public’s values.

“The message for public health officials and legislators is, if you want the public to buy in to these legal interventions, you’ve got to engage them early on,” said Mello. “You’ve also got to communicate about policies in a way that resonates with the public’s values.  For example, how does the intervention support healthy choices?  Why is it fair?”

The study was supported by a grant from the Greenwall Foundation.

“Survey Finds Public Support for Legal Interventions Directed at Health Behavior to Fight Noncommunicable Disease,” Stephanie Morain and Michelle M. Mello, Health Affairs, March 2013