Tag: syndicated

Blog Posts (939)

July 21, 2014

Facebook’s Emotion Experiment: Implications for Research Ethics

Robert Klitzman and Paul S. Appelbaum
July 20, 2014

DALLAS BUYERS CLUB meets SCIENTIFIC INTEGRITY


DALLAS BUYERS CLUB  is a biopic about an unlikely hero, directed by Québécois Jean-Marc Valle and written by Craig Borten and Melisa Wallack. In case you get a call from your local AIDS-Walk coordinator, remember 50,000 cases of AIDS (Acquired Immune Deficiency Syndrome) still occur in the USA annually. Transmission is largely preventable with education, testing and early intervention. Ethnic peoples of color are disproportionately affected in new cases. Thirty-five years ago, I never imagined AIDS would be the defining disease of my career and then some.  After my AIDS-Walk call, I pulled out my notes on Dallas Buyers Club, which screened October, 2013 at the Mill Valley Film Festival. It has won three Oscars and too many to count other awards.

The year 2013, brought a number of film releases with main characters who had significantly degenerate moral fiber. You know them, good acting, sex, drugs, brutality prominent but few redeeming qualities.  Dallas Buyers Club (DBC) is not one of those films. Its lead character is definitely a degenerate, but develops moral fiber.  If “The Star” of a film is the person who undergoes the most change, Ron Woodroof (Matthew McConaughey) may be the star of the millennium. His character moves from self-serving reprobate to enlightened self-interest. In the process, he believably expands compassion for others. The compassion fall-out includes Jared Leto, (Rayon) who well plays a stereotype of a transgender woman whose script, in contrast to Woodroof’s, traverses only the narrow ground between dying and dying more.


Dr. Eve Saks (Jennifer Gardner) spoke particularly to me. She had that deer in the headlights feel to her -- as she decided to which side of the road she would jump -- with her patients, or with her retrograde moving profession. Her subtle portrayal of an overwhelmed newbie was reminiscent of my internship at Cook County Hospital, Chicago in 1985.  I saw 17 hospitalized patients with AIDS, within my first 35 days. Fortunately, I had good role modeling by Drs. Ron Sable, Renslow Sherer and Dr. Jonathan Mann. 


Among those 17 patients was an 8 year old girl with Leukemia, AIDS and tuberculosis - the later was diagnosed on autopsy, which brings me to the bioethical point. Four years before that autopsy, I was told in medical school that miliary or disseminated tuberculosis no longer existed -- that was then, this was now.  Diseases change and so should the manner of treating and studying them and their cures.  In medicine it’s not “location, location,” but “observation, observation.”

DBC is about how AIDS, science, research and Federal Drug Administration regulations were forced to change. The change was pushed by the autonomy of people who ran the most risk of dying from AIDS and their allies.  The principle of justice requires equipoise or the equitable distribution of burdens and benefits.  The job of clinicians is to understand and communicate the burdens and benefits so that individuals, who can, are able to exercise their autonomy. When there is no proven cure, those with life threatening illnesses and intact decisional capacity, now, can choose through the informed consent process, to run the risks of clinical research protocols, whose outcomes are as yet unproven.  Access to such trials is currently a health disparity. Navigating the clauses in the three proceeding sentences is the job of bioethics in new diseases, therapies and research.  This is how we learned that oral anti-virals could reduce HIV/AIDS vertical transmission from mother to child. 

Data safety monitors (DSM), augment institutional review boards and were given teeth during the rise of the AIDS epidemic.  DSM allowed tracking of acceptable burdens associated with research, on vulnerable persons while the studies are in progress.  DSM also can stop studies where the burdens outweigh the benefits, or the benefit is so clear that lifesaving therapies should not be with-held to complete the research.  This acceptability should be consistent with the 2013 World Medical Association amended Declaration of Helsinki on Medical research. Significantly this amendment references identifiable human material or data. This would recognize the privacy of genomic material correcting ethical violations associated with HeLa cells and other genetic technologies. Consider, non-small-cell lung cancer, the most ubiquitous cancer in the world.  In that case, we look at the value of Palliative Care, genomic-bio-marker driven therapy and clinical trials, all three at once. The criteria for treatment look like a menu at an over stocked diner, but bioethics helps to navigate them.   Such protocols would not be possible without changes in policy and procedure reflected by the struggles of those affected by HIV/AIDS and the bioethical analysis accompanying them.

Set in 1985, the story is sandwiched between the year before AZT was found effective (the first of the anti-viral drugs used in HIV/AIDS) and the year after, Robert Gallo and Luc Montagnier both discovered HIV-1 as the agent causing AIDS.  The footprints of the Dallas Buyers Club are everywhere.

references:

Dallas Buyers Club (35mm) directed by Jean-Marc-Vallee (2013) Focus Features (USA) 116 min

Some other films about the HIV/AIDS epidemic:

How to Survive A Plague (35mm) David France (2012) Sundance theatrical/IFC (USA) 109min

Philadelphia(35mm) directed by Jonathan Demme (1993) Tri Star (USA) 125 min

Yesterday (35mm) directed by Darrell Roodt(2004)HBO USA ( South Africa) 96 min ( Zulu, English  subtitled)

The Declaration of Helsinki http://www.wma.net/en/30publications/10policies/b3/  accessed July 16, 2014 2013

HIV/AIDS statistics USA http://www.cdc.gov/hiv/statistics/basics/ataglance.html accessed July 16, 2014.

World Association of Bronchoscopy and Interventional Pulmonology Academy : Small Sample Tissue Acquisition and Processing for Diagnosis and Biomarker-driven Therapy of NSCLC. Bioethical issues video commentary. http://www.wabipacademy.com/site/webcast/clinicalstem1/step40
July 19, 2014

Do Oregon and North Dakota Healthcare Surrogates Perform Better?

In most states an individual can appoint a healthcare agent not only without the consent of the agent but also without even discussing the appointment with the agent.  In fact, many healthcare surrogates fulfill the role of substitute decision mak...
July 18, 2014

Is complicity important in Hobby Lobby decision?

ontinued litigation will not unite the country but compromise can. Forcing individuals and their companies to act against deeply held religious belief should not be done and will only inflame partisan rancor.
July 18, 2014

Safeguarding Children in Emergencies through Ethical Pediatric Research

Tomorrow, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) will present its recommendations on pediatric medical countermeasure (MCM) research at the 10th Annual Pediatric Bioethics Conference in Seattle. The conference, hosted by the Treuman Katz Center for Pediatric Bioethics at the Seattle Children’s Hospital, takes place July 18 and 19, 2014; its […]
July 18, 2014

Pope Cited by NRLC before Senate Judiciary Committee

Many of my (pro-liberty) positions on end-of-life medical treatment issues do not endear me to the National Right to Life Committee.   But I do aim to produce careful and circumspect scholarship.  Consequently, I was pleased to see the presi...
July 17, 2014

Great but “unaffordable” new drugs

I’ve posted several times on the challenges posed by new drugs that work, but cost the moon.  It’s one thing when an expensive drug is only marginally effective.  It’s another when the drug looks really good, like Kalydeco for cystic fibrosis or Sovaldi for hepatitis C.  I’ve suggested here and here that both drugs are worth high prices, although pushback from payers on the price... // Read More »
July 17, 2014

Nature Isn’t What It Used To Be

Gregory E. Kaebnick
July 17, 2014

She Ain’t Heavy, She’s My Brother

by Sean Philpott-Jones, Director of the Center for Bioethics and Clinical Leadership Actress Laverne Cox made history last week when she was nominated for an Emmy for Outstanding Guest Actress for her role on the hit show “Orange is the New Black.” Ms. Cox is the first openly transgender actress to receive an Emmy nomination. While […]
July 17, 2014

Only a Third Who Express a Preference to Die at Home, Actually Die at Home

There is a well-known discrepancy between people's preferences to die at home and their likelihood to actually die at home.  This has already been measured several times.  Now, there is additional confirmation. Last week, the UK Office of Na...

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