Dan Markingson: a study in research misconduct

As someone who has worked in research ethics for many years, I feel that I have a pretty good understanding of how and where things go wrong in the research ethics review process. Such a process can never be perfect – human judgment is involved and there will inevitably be problems that slip through the net. However, the events surrounding Dan Markingson’s recruitment into an industry-sponsored trial of Seroquel (quetiapine) and his subsequent death are less an issue of what slips through the net and much more an indictment of the corrosive powers of commercial interests which make a mockery of the safety net of human research ethics review.

Briefly, in November 2003 a mentally ill young man named Dan Markingson was recruited by psychiatrists at the University of Minnesota into a profitable, industry-funded study of antipsychotic drugs. His doctors used the threat of involuntary commitment to force Dan, who was mentally incapable of giving informed consent, into the study over the objections of his mother, Mary Weiss.

For months Weiss tried desperately to get him out of the study, warning the psychiatrists that Dan’s condition was deteriorating and that he was in danger of killing himself, to no avail. On May 8, 2004, Dan committed suicide.

Carl Elliott has been writing on this case for a long period, as has Howard Brody.

I recommend their excellent analyses: Carl Elliott, “Making a Killing,” in Mother Jones, this piece by Howard Brody, and finally a referenced summary of the Dan Markingson investigation with links to court documents can be found here.

Finally, while I am ambivalent about the plethora of online petitions that come into my email inbox on a daily basis, I feel that this is one that deserves support. Mary Weiss (the mother of Dan Markingson) and others have started a petition to Minnesota Governor Mark Dayton, asking for an external investigation into the events surrounding Dan’s death.

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Who is cancer prevention for, anyway?

In the era of biocitizenry—when how you manage your medical risk is part and parcel of good citizenship—identity is a crucial mediator. Who you are is who you are like, and who you are like is whose narrative you can slip into: celebrity greases the deal. Whether that narrative is a comfortable glove that fits you just right, or a bus you jump on in a hurry, only to realize later that it took you just where you needed to go—or in the opposite direction—may be both a metaphysical question, and one with real consequences.

Angelina Jolie’s revelation in the NY Times of her carrier status for the BRCA mutation and of her choice of prophylactic double mastectomy was well-measured. She highlighted several important facts that frame the diversity of people’s experience and choices to set a context for her own moving personal narrative, such as that the BRCA gene mutation is responsible for a small share of breast cancers, that access to the test is hindered by its cost (Myriad’s patent as the most significant driver of that cost went unnamed), that the biggest disease burden is borne in lower-income countries, that the choice of approaches to prevention is personal and best discussed with your physician. Her physician blogged the treatment regime, but only after the news cycle and blogosphere were forced to content themselves for a day with the policy issues of patents (read Leila Jamal at The Berman Institute’s Bioethics Bulletin on the Myriad patents and the case before the Supreme Court), access (read s.e. smith’s harrowing account at xojane of knowing her BRCA status but being unable to afford preventive treatment), and what may have been the source of her self-reported 87% lifetime risk of breast cancer (Tiffany O’Callaghan interviewing Allison Kurian at The New Scientist), as well as the misogyny flung Jolie’s way (you may want to skip the tumblrs filling with variants of the “poor Brad” meme from twitter).

s.e. smith

Most women choosing double mastectomy as a prophylaxis for breast cancer are not women with the BRCA mutation. If there were a sweepstakes for bravery, Jolie’s worthy competitor would be Peggy Orenstein, who wrote two weeks ago in the NY Times Magazine about how her advocacy for early detection via mammography screening was transformed as she came to understand the depth and extent of breast cancer overdiagnosis. The issue of overdiagnosis, to be clear, isn’t about the distress and uncertainty that comes with false positives. It’s about unnecessary medical treatment: surgery, radiation, and chemotherapy for breast cancers that would never have killed if left alone. The recent Canadian Task Force on Preventive Health Care update of the similar US body’s guidelines quantifies overdiagnosis for women undergoing screening in their 40s as 10 cancers treated unnecessarily for every life saved. Jolie faces visceral misogyny from her so-called fan base; Orenstein faces the ire of the screening advocates. I’m not sure which is worse.

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Lawsuit Filed Against South Carolina Alleging Violation of Child’s Rights

This week Advocates for Informed Choice and the Southern Poverty Law Center, with the help of two private law firms, filed what promises to be a groundbreaking lawsuit.  According to the press releases, “M.C.,” a child adopted as a toddler in South Carolina, had been born with atypical sex anatomy and assigned female.  Now eight years old, M.C. has rejected his assignment, and identifies as a boy.  Like a similar case of sex reassignment in Colombia that led that nation’s highest court to issue of the first of what would be, over 1999-2000, a series of decisions prohibiting unnecessary normalizing surgeries and specifying the limits of parental consent to such surgeries, the case could set a new precedent regarding the performance of normalizing surgeries in the US.

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Living with Dying

I didn’t mean to write about death in my first blog for IJFAB, but it is too much on my mind to ignore. A close and valued friend finally succumbed to cancer, experiencing not the several months of life that she, and I, believed were left, but falling away in a matter of just a few short weeks. Before I last left the country (I work abroad) we had joked about ‘hope and recovery’ – even knowing the latter would never happen – and wondered whether a mutual friend, a documentary maker who has filmed extensively in hospices, would be interested in working with Gill to record the final months. We were all involved in a funded project called Living with Dying and it seemed appropriate, as good academics, to turn our concerns to didactic purposes. In our exchanges of emails whilst I was away, Gill never ceased to think strategically about future possibilities and her last mail to me – sent the day before she lapsed into semi-consciousness – expressed real disappointment at the failure to secure a further grant. When I returned to the UK 2 days later and phoned to arrange a visit, a young doctor came on the phone to gently tell me that Gill had died a few hours before. I was very shaken but immensely grateful that she had not cited patient confidentiality as a reason to withhold the news. It is always uncertain being a friend rather than family, and I wish the putative hierarchy were more often sidestepped.

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The Luck of the Draw: The Fiscal and Moral Confusion of American Hospitals

The fact that Americans, without any increases in quality or quantity of services, pay much more for medical care than anyone in “peer” nations (and elsewhere) is something that is, outside of certain sociopolitical circles,  no longer up for debate.

It is also most likely not surprising that health care bills are among the leading causes of bankruptcies and other kinds of financial disasters for Americans, nor surprising that millions of Americans are still uninsured or underinsured.  And yet, the complicated, overly bureaucratic, profit-centered, and opaque chaos that too often passes for medical care within the United States has one more surprise in store.

A few days ago, the Centers for Medicare and Medicaid Services released a database that, for the first time, makes public the amounts the majority of American hospitals charge for the one hundred most common procedures.  As Jeffrey Young and Chris Kirkham report in The Huffington Post:

“the Obama administration shared the data in advance with The Huffington Post, The New York Times and The Washington Post. What emerges through a preliminary analysis is a snapshot of an incoherent system in which prices for critical medical services vary seemingly at random — from state to state, region to region and hospital to hospital.”

For example, Young and Kirkham note that “[w]hen a patient arrives at Bayonne Hospital Center in New Jersey requiring treatment for the respiratory ailment known as COPD, or chronic obstructive pulmonary disease, she faces an official price tag of $99,690.  Less than 30 miles away in the Bronx, N.Y., the Lincoln Medical and Mental Health Center charges only $7,044 for the same treatment, according to a massive federal database of national health care costs …”

Why is this happening?  After all, in a largely market-driven health care industry, ought there not be at least a market-based justification for these discrepancies?  Yet the writers suggest that there are neither explanatory reasons nor regulating principles for these staggering differences in cost, which hospitals have, until now, kept well- hidden.  In fact, even the argument that differences in local economies and labor costs have something to do with the extreme price fluctuations fails:  a lot of the significant price differentials are geographically and socioeconomically proximate.

Who is harmed?  The category of individuals most harmed by these inconsistencies is, more or less, everyone who is not covered by the Veterans Administration system, Medicaid, or Medicare (which either have discounts set by law, or else negotiate for lower prices for prescriptions and medical treatments).  Health insurance companies simply base their costs on the prices established by the hospitals without much further inquiry, forcing those fortunate enough to be insured to pay more for their benefits, while those without any insurance at all are charged the astronomical, and, as we can now see, disturbingly varying and unreasonable sticker prices  –  which, of course, most individuals are simply unable to pay.

This leaves me with several questions:  Why is there not some kind of institutional accountability for both private and public hospitals for how, and how much, they charge for services?  In an era of the internet and Wikileaks, why, and by whom, have they been allowed to continue with these unjustifiable practices that seem to belie all claims of either market-based justifications or, frankly, of rationality itself?  Importantly, how have their actions remained this kind of a sick, and well-guarded, trade secret?  And, of course, now that we know  —  what is next?

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CFP: Special Issue on Transnational Reproductive Travel

Vol 7, No. 2: Special issue on Transnational Reproductive Travel

The deadline for submission for this issue is June 1, 2013.

Guest Editors: Françoise Baylis and Jocelyn Downie

The transnational fertility industry is a multibillion-dollar global industry that continues to grow exponentially, with few guidelines or regulations. Indeed, it has been suggested that “internationalization has made oversight laughable… regulators are dogs with no teeth” (Carney 2011).

At the heart of this industry are women who sell their ova and gestational services. Typically these women – poor women or immigrant women in low or middle income countries or students in middle and high income countries – have few options to earn the money they need to live and pay their bills. The purchasers are single women or men and heterosexual or homosexual couples who travel abroad to reduce costs, to access better quality care, to access medical resources otherwise not available in their home country, to reduce wait times, to avoid legal prohibitions on particular services or to avoid legal or professional prohibitions on access by particular demographic or social groups.

Arguably, this industry flourishes, in part, by capitalizing on differences in legal regimes, differences in wages and standards of living, and differences in cultural and ethical norms. A feminist perspective calls into question the role of exploitation, coercion, vulnerability, and inequity in transnational reproductive travel (at least as it is currently practiced and is being developed).

The aim of this special issue is to make a positive contribution from an explicitly feminist perspective to the ethical debates surrounding transnational reproductive travel. Contributions analyzing aspects of the debate that, to this point, have received insufficient, if any, attention are particularly welcome.

The Guest Editors invite submissions on any topic related to transnational reproductive travel.

Potential topics for this volume include:

  • Does transnational reproductive travel increase or threaten women’s autonomy? Does reproductive outsourcing to low and middle income countries benefit women by increasing employment opportunities or further subjugate women who are at increased risk of exploitation and coercion?
  • How does transnational contract pregnancy increase or cloud our understanding of vulnerability? What is the same and what is different, from a feminist perspective, about the vulnerability of those who purchase gestational services and the women who provide these services?
  • From a feminist perspective, what rules should govern the import and export of reproductive tissues whether for reproductive or research use?
  • When the motivation for transnational reproductive travel is to avoid domestic legal or professional ethical constraints, should health care providers in the traveler’s home state facilitate transnational travel with a view to promoting access to safe and effective interventions, or should they actively discourage such travel?
  • Should women be compensated for their reproductive labour? If so, what would be a fair wage for providing eggs or 9 months of gestational services?
  • National self-sufficiency and the harmonization of laws are two strategies that have been suggested to reduce the need for individuals and couples to travel abroad. How might either of these strategies be evaluated from a feminist perspective?

Authors who plan to submit papers are encouraged to contact the Guest Editors prior to submission.

All papers must be submitted in IJFAB style. Please consult this page for style guidelines.

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War Crimes That We Should Be Discussing More Actively

From Democracy Now – Ten Years Later, U.S. Has Left Iraq with Mass Displacement & Epidemic of Birth Defects, Cancers

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US Woman Denied Dental Care Because She is Pregnant

In this New York Times story, Catherine Saint Louise tells of a 34 year old women, in her second trimester, denied urgent dental care because she did not have a note from her doctor. Weeks later when she was finally seen, two abscessed teeth had to be removed. She was bed ridden on pain killers.

This story raises two issues. First, pregnant women and their fetuses deserve evidence based care and treatment. But given the persistent exclusion of pregnant women from research, much of their medical care remains guess work. And, as this story illustrates, their care can be undermined by outdated views of risk management. We know that maternal periodontal disease is linked to preterm birth, low birthweight, and preterm low birthweight. Best practice requires timely treatment and management of periodontal disease during pregnancy. Something this young women was unjustly denied.

Second, we must weigh the benefits and risks in deciding whether to take medication or other health treatment during pregnancy. Too often this doesn’t happen. Risk, in the simplest sense, drives behavior during pregnancy.  Many risks are not quantified or balanced against the potential benefits of an activity. One woman in New Zealand has “suspected” listeria from hummus; and hummus along with all prepared dips are added to the Dangerous Foods list.  Many pregnant women stop using anti-depressants and blood pressure medication during pregnancy; when in many cases leaving the underlying medical condition untreated is in fact more dangerous for both the mother and the fetus.

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Drug Patent Rejected in India

India’s Supreme Court has recently denied an appeal by the Swiss pharmaceutical company Novartis, which was seeking patent protection for its cancer drug, Glivec.  India’s Commerce and Industry Minister, Anand Sharma, claims that it’s necessary to strike a balance between the social obligation to provide affordable medicine and supporting innovation in research and development through providing patent protection.

Glivec_400mg--621x414

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Transitions in Law: What Struggles Over Policy Changes Affecting Transgender Persons Reveal

The State of California recently banned discrimination against transgender patients in the provision of health insurance.  It was only the third state to do so. Lack of access to health care is common for transgender persons.  Reasons include—but are not limited to—fear of encountering stigma, employment discrimination which limits access to health insurance, and insurance providers refusing to cover medically necessary care.

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In the state of Missouri, 5% of transgender adults report that they were refused EMT care, 13% report that they were refused Emergency Room care, and 24% report that they were refused care in a doctor’s office.  The context of California’s policy change is thus one of serious health disparities for transgender patients and constitutes a step forward in public policy including transgender folks in our moral community and giving credence to their health care needs.

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Objectifying the Ephemeral: Visualizing Pain

Several weeks ago, I heard an interesting report on visualizing pain on NPR’s “Morning Edition.” Here’s their published article on the story:

“Doctors Use Brain Scans To ‘See’ And Measure Pain” 

The notion of objectively measuring the subjective is compelling. Evidence for ephemeral sensations like pain offers potentials for verifying experiences of particularly vulnerable patient populations. Accounts by patients whose experiences are often doubted or denied — patients like women, children, people with disabilities — can gain veracity through visible displays in brain scans. In this article, the AP notes special benefits for those who might literally lack a voice or the communication abilities to report pain: babies, people with dementia, people with paralysis that impedes speech. The AP also identifies potential benefits in understanding neurological differences between, say, physical and emotional pain, and in developing new treatments that act more directly on specific pain mechanisms and reduce dangers of addiction to medication.

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Weight Loss and the Mentally Ill

A common reason that those suffering from serious mental illness are “noncompliant” with medication is the side effect of weight gain. Of those who stay on their medication, weight gain can be the most distressing side effect. According to the National Institutes of Health, mentally ill people are 50% more likely to be overweight/obese than the general population. Weight gain has significant negative health implications and is one reason why on average mentally ill people die younger than non-mentally ill people.

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