Category: Conflicts of Interest

Maybe For-Profit Hospitals Aren’t So Bad

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By Shailin Thomas

For-profit hospitals have taken their fair share of flack over the years. Much maligned by many in the medical community, they are seen as money-hungry corporate machines that pervert the medical profession by putting the bottom line before patient care. This skepticism of profit-driven hospitals feels right. Medicine has long been the purview of charitable organizations and religious institutions. It’s supposed to be a calling — a public service to which practitioners are drawn — not a check to cash at the bank.

As for-profit hospitals proliferated, there was research done suggesting they had quality and cost issues stemming from their profit motives. For-profit hospitals had higher mortality rates, employed fewer trained professionals per bed, and were more expensive than their non-profit and government counterparts. Researchers speculated that this was the result of duties owned to shareholders by corporate leaders or compensation incentives for executives based on profitability rather than quality of care. These studies seemed to confirm what many thought they already knew: medicine and money don’t mix well.

More recent studies, however, suggest that for-profit hospitals may have turned over a new leaf. Since 2010, for-profit hospitals have out-performed non-profits in the “Top Performer” evaluation carried out by The Joint Commission — an organization that accredits hospitals in the US — with a higher percentage of for-profit hospitals qualifying for the honor than non-profits. A study published in JAMA from the Harvard T.H. Chan School of Public Health found that hospitals that converted from non-profit to for-profit improved their financial position by increasing their total margins and experienced no change in mortality rates.

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NEW REPORT: Protecting and Promoting the Health of NFL Players – Legal and Ethical Analysis and Recommendations

The Petrie-Flom Center Staff Leave a comment

fphs_lawethics_coverThe Football Players Health Study at Harvard University today released a set of legal and ethical recommendations to address a series of structural factors that affect NFL player health. The Football Players Health Study is a research initiative composed of several ongoing studies examining the health and wellbeing of NFL players.

The newly released report, nearly 500 pages long, is based on analysis performed over two years by researchers from the Petrie-Flom Center at Harvard Law School, and is unprecedented both in scope and focus. (Read the executive summary).

This is the first comprehensive analysis of the legal and ethical obligations of various stakeholders that influence the health of NFL players. While clinical interventions are essential, players’ health is also affected by the environment in which players work.

The report reviews and evaluates the roles of 20 relevant stakeholders, including the NFL, NFL Players Association (NFLPA), players, and Club (team) doctors.  In total, the report makes 76 recommendations.

Highlights of the key proposals are summarized below: Read More

Confidentiality or Public Disclosure: Trump’s Gastroenterologist and an Ethical Dilemma

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By Brad Segal

“If elected, Mr. Trump, I can state unequivocally, will be the healthiest individual ever elected to the presidency,” proclaimed Dr. Harold Bornstein. The gastroenterologist’s letter, released on the candidate’s website nine months ago, stumbles from the outset with a typo (“To Whom My Concern,”), then steamrolls over the most basic descriptions of health (medical school teaches us that vital signs are, well, vital), omits information pertinent to the public discourse (why does it fail to mention the medical reason exempting Trump from the Vietnam draft?), and strangely emphases non-medicalized traits (“His physical strength and stamina are extraordinary”). Most experts agree that this medical record, if we can even call it that, is at best hyperbole. It draws grandiose conclusions without medical justification. Even Dr. Bornstein conceded, “In the rush, I think some of those words didn’t come out exactly the way they were meant.”

Just this morning the Trump campaign released a second letter from Dr. Bornstein. But this time the doctor rather humbly concludes, “In summary, Mr. Trump is in excellent physical health.”  These letters from Dr. Bornstein’s letter demonstrate a modern-day moral dilemma in providing care for a party nominee. At conflict is the physician’s professional duty to respect patient confidentiality, and his or her obligations to care for society more broadly.

First, patient-doctor confidentiality is not merely a byproduct of the law—it is a moral obligation grounded in the core tenants of the medical profession. To put it simply, if a patient comes to expect that his doctor will tell the entire community about the patient’s most embarrassing bodily defects, the patient may understandably deny his worsening symptoms of poor health at the next office visit. In the long run, erosion of trust in the medical system could endanger the public’s health–everyone is thus better off when doctors uniformly respect patient privacy. It is important to point out, however, that an informed and competent person can voluntarily waive one’s right to patient-doctor confidentiality, such as when a patient gives a physician the permission to provide updates to family members. Or when then-candidate John McCain instructed his physicians all 1,100 pages in his medical records.

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Hospitals Should Think Before Performing Searches for Law Enforcement

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By Shailin Thomas

In 2012, a Jane Doe suspected of transporting drugs was detained by U.S. Customs and Border Protection (CBP) agents without a warrant, and brought to University Medical Center in El Paso, Texas. Medical Center personnel — under the direction of the law enforcement agents — performed an X-ray, CT scan, and cavity search before determining that the woman was not in fact carrying any controlled substances. A few months after suffering this traumatic — and possibly illegal — event, the woman received a $5400 bill from the Medical Center for the services rendered as part of the search.

While the woman was compensated to some extent — she settled lawsuits with University Medical Center and the CBP to the tune of $1.1 million and $475,000, respectively — her story, and stories like hers, raise important questions about the ways in which hospitals should (or shouldn’t) work with law enforcement to perform invasive searches.

It’s understandable why hospitals and medical professionals are inclined to cooperate with law enforcement requests for invasive procedures and cavity searches — law-abiding citizens often don’t want to obstruct law enforcement agents from doing their jobs. But in the course of bringing suit against University Medical Center, Edgar Saldivar of the ACLU of Texas noted that the hospital and many of its personnel didn’t know where the obligation to assist the CBP stopped. Many medical professional don’t know that — according to the CBP’s own Personal Search Handbook — they are under absolutely no obligation to comply with requests by law enforcement to perform cavity searches with or without a warrant.

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Sex Markers in Official Documentation – Between Biology and Self-Identification

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A recent civil action filed by LAMBDA Legal highlights a debate ongoing for the past several years on the issue of “sex-markers” in official documentation to the U.S courts. In different instances, plaintiffs and interest groups have sought to challenge the state’s sex-binary classification system when issuing official identification documents such as passports, birth certificates, driver’s licenses and more. Litigation and advocacy around sex-markers in official documentation may be roughly distinguished between groups advocating for easier access to the existing Male /Female categories (“M/F”), mostly by and for the trans community, and to groups asking to break the M/F distinction altogether in favor of an unspecified category: ”X”/”MF”/Unknown/Unspecified. This group is not seeking better access to the existing M/F categories, but is rather pursuing the goal of creating an all-inclusive new category for those who do not identify as males or females, sometimes also referred to as “third sex” or “third gender”.

These challenges were sometimes fruitful in generating administrative adjustments. For example, in 2011 it became possible to mark “X” instead of M/F on passports in Australia. In 2013 Germany approved a change in legislation that allows leaving the “sex” checkbox in birth certificates empty. These developments were presented very positively in the media with headlines like: “Germany got it right by offering a third gender option on birth certificates” in the Guardian, or: “Germany allows ‘indeterminate’ gender at birth” in the BBC, that portrayed them as victories for intersex and LGBT activists. Although the wish to open up sex categories in official documentation seems to be in line with progressive politics, some Intersex advocacy organizations have had misgivings about this line of advocacy. One argument is that being an Intersex or a Trans person does not necessarily dictate a non-specified gender identity and so conjoining intersexuality and transgenderism with non-specified gender identity is incorrect to say the least.

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When Law and Medical Ethics Conflict: The Case of Mohammad Allan

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By Maayan Sudai

Mohammad Allan was an administrative detainee in Israel, a Palestinian who had been hunger striking since June 16 to protest his indefinite incarceration. Allan’s health has been deteriorating gradually, and the latest examinations raised concerns that he suffered irreversible brain damage. The crisis in Allan’s health created a tangle for the Israeli government, since releasing Allan was feared to serve as a precedent that would encourage more hunger strikes and symbolize submission to this type of protest, whereas force-feeding him might be considered unethical-illegal torture. This dilemma has brought a head-on clash between Israeli government officials and the Israeli National Medical Association, and led to an internal split between medical professionals regarding their positions on the ethics of the controversial practice of force-feeding.

In the midst of Allan’s health deterioration, the Israeli parliament passed a new law called “Hunger Strike Damage Prevention Act” also known as the “force-feeding law”. The law allows doctors to force-feed prisoners in immediate and imminent danger of irreversible severe damage or death, with a court order. The court could allow such force-feeding after hearing the prisoner (if possible) and an ethics committee recommendation. Moreover, the forced feeding should be carried out in a dignified manner, avoiding pain and suffering for the prisoner. It was declared that physicians will not be forced to comply with force-feeding under this law if they refuse.

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The Ethics of Punking the Diet-Research Media Complex (and Millions of Readers)

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Scale

By Michelle Meyer

A remarkable new “sting” of the “diet research-media complex” was just revealed. It tells us little we didn’t already know and has potentially caused a fair amount of damage, spread across millions of people. It does, however, offer an opportunity to explore the importance of prospective group review of non-consensual human subjects research—and the limits of IRBs applying the Common Rule in serving that function in contexts like this.

Journalist John Bohannon, two German reporters, a doctor and a statistician recruited 16 German subjects through Facebook into a three-week randomized controlled trial of diet and weight loss. One-third were told to follow a low-carb diet, one-third were told to cut carbs but add 1.5 ounces of dark chocolate (about 230 calories) per day, and one-third served as control subjects and were told to make no changes to their current diet. They were all given questionnaires and blood tests in advance to ensure they didn’t have diabetes, eating disorders, or other conditions that would make the study dangerous for them, and these tests were repeated after the study. They were each paid 150 Euros (~$163) for their trouble.

But it turns out that Bohannon, the good doctor (who had written a book about dietary pseudoscience), and their colleagues were not at all interested in studying diet. Instead, they wanted to show how easy it is for bad science to be published and reported by the media. The design of the diet trial was deliberately poor. It involved only a handful of subjects, had a poor balance of age and of men and women, and so on. But, through the magic of p-hacking, they managed several statistically significant results: eating chocolate accelerates weight loss and leads to healthier cholesterol levels and increased well-being. Read More

Athlete concussion under-reporting and pressure from stakeholders

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By: Christine Baugh

As concussions are increasingly seen as a public health problem, under-reporting and under-diagnosis of concussion is recognized as one barrier to improving the safety of sports participation. A number of studies have previously characterized the extent of under-reporting of concussions among athletes, particularly at the collegiate level. Furthermore, existing research has examined the applicability of theories of behavior change to concussion reporting and created relevant frameworks for examination. Although a growing body of evidence suggests that reporting (or not reporting) a concussion is a decision actively made by the athlete weighing relevant factors, the extent to which interpersonal, intrapersonal, environmental, or policy factors influence athletes’ decisions about whether or not to report a concussion is not fully understood.

A recent study, on which I am a co-author, titled “Concussion under-reporting and pressure from coaches, teammates, fans, and parents,” published in Social Science and Medicine aimed to understand one possible contributory factor to athlete under-report of concussion: pressure on athletes from relevant stakeholders. (Abstract available here.) The survey-based study queried a sample of 328 athletes from 19 contact or collision sports teams (notably excluding football and hockey teams) at 4 colleges in the northeast region of the United States. Among other things, the study asked athletes whether they experienced pressure to return to play after a head impact, specifically asking about pressure from coaches, teammates, parents, and fans. Read More

New browser app shines light on conflicts of interest

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By: Christine Baugh

A new Google Chrome extension puts the spotlight on conflicts of interest. The browser app, available for free download here, was created at the Hacking iCorruption hackathon event held March 27-29 in Cambridge, MA. The event, co-sponsored by the Edmond J. Safra Center for Ethics at Harvard University and the MIT Center for Civic Media (hosted at the MIT Media Lab) brought together individuals with a variety of backgrounds and skills to work toward the common mission of fighting institutional corruption, in this case by creating practical tools. This project was one of several exciting tools created at the hackathon (information about other projects available here), and it won first prize among the projects.

The Chrome extension, called Unearth, puts funding and conflict of interest information on the abstract page of PubMed research articles. Christopher Robertson, Associate Professor of Law at the University of Arizona James E. Rodgers College of Law and Edmond J. Safra Center Fellow who was a member of the Unearth team, explains the rationale for the browser extension in this Youtube video. In short, conflict of interest and funding disclosures are often placed at the end of a research article and are generally unavailable on the abstract page. This makes it impractical for physicians and other research scientists to pay appropriate attention to this important information. Research from the Cochrane Collaboration has demonstrated that research studies funded by industry generally describe “greater benefits and fewer harmful side effects” than their non-industry funded counterparts. Thus, taking the source of research funding into account when reading a new research study is critical. Although the extension currently only works for open access articles from PubMed Central, this includes several million research articles for which funding and conflict of interest information was previously much more difficult to obtain. Additionally, the developers plan on expanding the breadth of coverage in the coming weeks. Read More

Unexpected Channels of Patient Misinformation

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by Vadim Shteyler

As a medical student on the wards, physicians often recounted stories of horrifying acts of paternalism from the days of their training. Though paternalism is far from abolished, the progress we have made as a profession has become a source of some pride. On the wards, autonomy has become exalted as a sacred right and invoking paternalism can end most debates. Though autonomy is a complicated and frequently debated concept, most agree that the cultural shift is a step in the right direction. And though perhaps we should be proud of our steps towards protecting the way patients receive information in clinic, we should be more aware of other sources of patient information as well.

Of course, it may not come as a surprise that a lot of the medical information available to patients is less than accurate. With the Internet, ubiquitous misinformation about anything should be expected. However, when we think about the sources of that misinformation we often think about random websites found during quick Google searches, Wikipedia, sensationalized media coverage, and pharmaceutical advertisements (the later will be discussed further below). A few recent studies are bringing attention to more surprising culprits: Hospitals and Academic Institutions. Read More