DNA Leftovers: Research and Difficulties in Obtaining Consent

What happens to a blood sample, or tissue from a biopsy, once the procedure is done and a nurse walks away with it? Most patients simply assume that it is used for whatever medical test their doctor ordered, but they do not consider what happens afterwards. Contrary to what most assume, tissue and other bodily matters that are the “leftovers” of a medical procedure can be used for research purposes. In fact, under the old Common Law Rule, researchers do not need to notify or obtain permission from patients before using such leftovers. The only limitation is that the bio-specimen must be non-identifiable. However, in recent years, scientists have discovered a way to re-identify anonymous samples by relying on DNA testing and publicly available information. Ethical concerns about re-identifying bio-specimens are reminiscent of concerns that surround the famous case of Henrietta Lacks, who died in 1951; yet, her so-called “immortal cells” are still used in laboratories to this day.

In order to address these concerns, the Department of Health and Human Services (“HSS”) has recently proposed a rule that would change the consent requirements. In particular, the rule would require researchers to obtain very broad consent for use of all bio-specimens, even those that are anonymous. In short, patients would be consenting to the use of their tissue and other bodily matters in all potential and unknown future research. The consent would also include permission for the researchers to access the patient’s identifying information. HHS has not yet released a template for the consent form. And while this rule would be a step forward in mitigating ethical concerns, critics say that even stricter requirements must be in place to ensure truly “informed” consent.

Sources: http://mobile.nytimes.com/2015/12/30/opinion/your-cells-their-research-your-permission.html?smid=tw-share&referer=&_r=2; http://www.hhs.gov/ohrp/humansubjects/regulations/nprmhome.html

The Zika Virus and the Moral Dilemma

With the spread of Zika virus across the Catholic dominant South and Latin Americas, restrictions on women’s access to contraceptives and abortions has made its way to the forefront of the discussion.

Medical professionals and researchers suspect that the mosquito borne virus is directly responsible for the increased reporting of infants born with microcephaly, a rare neurological condition causing an infant’s head to be significantly smaller than the heads of other children of the same age and sex.  While research is still underway to determine if Zika virus actually causes microcephaly, the correlation between the two has prompted warnings from health organizations such as the World Health Organization (WHO) and the Center for Disease Control (CDC).  Such warnings advise women to avoid travel to countries affected by the virus and, for women presently living in affected countries, to postpone pregnancy.

For women living in the affected countries, heeding the health organizations’ warning is problematic.  Of the countries affected by Zika virus, a significant majority of people are Catholic.  The Catholic Church prohibits the use of birth control and abortion. Furthermore, many of the countries affected by Zika virus prohibit abortion except in instances where the pregnancy poses a risk to the mother.  Critically, these prohibitions have remained in place, despite the correlation between Zika virus and microcephaly, and both the Catholic Church, and various governments have refused to lessen such restrictions. As a result, women are being faced with an impossible predicament: seeking an illegal and religiously prohibited abortion or giving birth to an infant who may suffer from microcephaly.

Source: http://www.latimes.com/world/mexico-americas/la-fg-global-zika-abortion-story.html

Body-Hacking: The New Implants

The futuristic version of body modification has arrived and it is known as body-hacking. With body-hacking a person integrates technology, such as LED lights or a microchip, into his or her body. The various technologies are no longer only being used for medical purposes, but are now implanted based on personal preference.

Neil Harbisson, a pioneer in the body-hacking movement, is a colorblind artist who convinced doctors to implant a camera in the back of his head. The camera coverts dominant colors into musical notes, which allows Mr. Harbisson to listen to colors. A medical ethics committee in Europe opposed the procedure, but Mr. Harbisson found a doctor who agreed to perform it under the condition of anonymity. The medical ethics committee is not alone in disapproving the procedure—on multiple occasions people have tried to rip the mechanism out of Mr. Harbisson’s head. As a result of the backlash from his procedure, he formed the Cyborg Foundation to advocate for “cyborg rights.”

Laws have not caught up with these technologies and most alarming is the fact that non-medical professionals are performing the procedures. In addition, some believe that body-hackers are not considering the security risks of technological implantation, especially those carrying microchips with personal information. The ethical questions raised by the body-hacking movement include whether it is acceptable to cut open human beings, without a medical necessity, and experiment on them with these technologies. Body-hackers also face the possibility of social ostracism. Is society willing to accept someone who, for example, has a perfectly healthy eye but undergoes surgery to obtain infrared vision? As the movement gains momentum, this question may be answered sooner than we think.



The Use of Fetal Tissue From Abortions For Research: Acceptable or Exploitation?

Planned Parenthood was subject to national attention and scrutiny in late 2015 after videos surfaced that allegedly showed Planned Parenthood employees discussing the sale of fetal tissue from abortions for research. In response, an investigative panel was formed by the House of Representatives. In its first hearing, the panel engaged in a heated debate on the use of any fetal tissue, not just from abortions, for research purposes. While it seems that everyone can agree that this practice raises ethical concerns, there is sharp disagreement about what should and should not be permissible. Especially in the case of elective abortions, many argue that fetal tissue should not be used for research under any circumstances, even with the woman’s consent. One advocate even took the position that a woman who elects to have an abortion should not have the ability to give consent in the first place. Other opponents of fetal tissue research argued that such research could create an industry that may exploit a vulnerable and voiceless population. On the other hand, those who support the research took a utilitarian approach and explained the importance of tissue research for scientific advancements that could benefit a vast number of people.

While the panel’s focus may seem narrow to some, it implicates a host of ethical and legal questions: What right should a patient have to dictate what happens to his or her bodily tissue after a medical procedure? Should the answer depend on whether the procedure was elective or medically necessary? Should the potential benefit of fetal tissue research outweigh the risk of exploitation? What is our duty to protect vulnerable populations, such as women seeking abortions and their unborn fetuses? For now, these questions remain unanswered. The panel, however, will meet again in the next few months to hear arguments of additional witnesses and further discuss the issues at hand.

Sources: http://www.bioedge.org/bioethics/panel-on-infant-lives-meets-in-washington/11793; https://www.washingtonpost.com/news/powerpost/wp/2016/03/02/house-fetal-tissue-research/; http://docs.house.gov/meetings/IF/IF04/20160302/104605/HHRG-114-IF04-Wstate-LeeP-20160302.pdf

High School Football: Is there Informed Consent?

In the wake of increasing publicity about concussions sustained by football players, bioethicists are debating whether public school tackle football programs should be banned.  According to some bioethicists, students under age 18 cannot give informed consent because the human brain is not fully developed before then.  In addition, bioethicists cite concerns about pressure from student football player’s parents to succeed so that they may become professional athletes. Furthermore, coaches and doctors may not have the best interests of the player at heart since they are torn between putting the player’s health first and maximizing the interest of the “football industry.”  Risks faced by young players, according to Dr. Bennet Omalu, who first identified Chronic Traumatic Encephalopathy (CTE) in football players, include “major depression, memory loss, suicidal thought and actions, loss of intelligence as well as dementia later in life [and] drug and alcohol abuse as the child enters his 20s, 30s and 40s.” As a result, some bioethicists believe that “primordial prevention” efforts should be made to ban public support for high school football programs to remedy the “environmental, economic, social and behavioral conditions, cultural patterns of living known to increase the risk of disease.” Such efforts include opposition to public support for bonds to build stadiums or athletic facilities for junior or senior high school football, but would allow for the continuation of private football programs.

Despite these concerns, support for public school football programs is deeply ingrained in American culture and the sport is a popular national past time.  In addition, without such programs, students may not be able to earn additional credit for playing the sport, which may negatively impact some students.

Source: http://www.bioedge.org/bioethics/should-high-school-football-be-banned/11693

Patient Interaction Early and Often

American medical schools have used a standard curriculum since 1910, influenced by the Flexner Report: two years of theory and science in the classroom followed by two years rounding on patients in the hospital under the supervision of an attending physician.  This method is striking in that medical students forgo patient interaction in their first two years of training.  However, this traditional model is being challenged by a handful of medical professionals whose efforts to expose medical students to patients in the first year of medical school is being endorsed by the American Medical Association.

At the forefront of this hands-on-educational model is the Northwell School of Medicine at Hofstra University.  Cited in a recent article in Modern Healthcare, Hofstra’s medical school immerses medical students in patient care by assigning students to work as emergency medical technicians (EMTs) during their first year.  Advocates for the new model of medical school claim that such exposure to critical patients early in the training will promote better empathy, compassion, and teamwork when treating patients.

Other notable programs bucking the original medical school model by exposing their students to patients earlier in their education include Vanderbilt University School of Medicine’s program coined Curriculum 2.0 and Icahn School of Medicine at Mount Sinai’s Longitudinal Clinical Experience courts.

Such changes appear warranted, for the physician-patient encounter is at the pinnacle of health care.  While the positive outcomes are still being assessed, one thing is clear: the old guard has acquiesced to the new model: medical students interacting with patients early and often.

Source: http://www.modernhealthcare.com/article/20160130/MAGAZINE/301309980?utm_source=modernhealthcare&utm_medium=email&utm_content=20160130-MAGAZINE-301309980&utm_campaign=am

Prion Proteins Gone Rogue: Looking at the Impact of John Collinge’s Study on Transmissibility

A study conducted in January 2015 by John Collinge and his team of pathologists has opened the door to the theory that rogue proteins, known as amyloids, might share properties of misfolded proteins, known as prions, including their transmissibility.

The study was conducted on autopsied brains from four individuals who were previously injected with growth hormones. All four individuals died in their 40’s or 50’s as a result of Creutzfeldt-Jakob disease, a rare disease caused when the brain is contaminated by a prion. The study discovered that while the individuals died at relatively young ages, their brains were scarred with white plaque that is typically seen in people with Alzheimer’s, a disease that generally affects much older individuals. Collinge and his team concluded that this white plaque was a result of prion transmission from the growth hormone injections. This conclusion has stirred some controversy in the scientific field, as it suggests that Alzheimer’s may be transmissible from one person to another. It raises the possibility that certain aspects of amyloid-β protein can be transferred through medical procedures where fluid or tissue from one person is introduced into another, such as a blood transfusion or organ transplant.

Collinge published his findings in the September issue of Nature. Careful to not stir panic in the public and scientific community, Collinge stressed that the study did not conclude that Alzheimer’s is contagious, but rather brought to light how some medical procedures can transfer amyloid-β proteins without our knowledge. The results of the study have trickled down to worldwide academic discussions and a push for further understanding of putative amyloid seeds and varying strains of amyloids. Some members of the scientific community raised concern about creating premature panic when there could be other biological explanations. Collinge’s study used a small number of subjects, the subjects had no symptoms of Alzheimer’s prior to death, and their conditions may have been caused by the presence of other proteins.

It is unquestionable that Collinge’s study has highlighted the unknown and the need for further research. If his transmissibility theory proves to be true, it means amyloid seeds stick to metal surgical instruments and are not removed by normal sterilization. Consequently, the seeds may be transferred during surgery, whereby they remain in the body for years, spreading into plaque and inducing other pathological changes that cause neurodegenerative diseases.

Source: http://www.nature.com/news/the-red-hot-debate-about-transmissible-alzheimer-s-1.19554

Ethical Questions Raised When Patients Engaged in Sales

A new phenomena is beginning to blur the ethical line between patient and sales representatives.  It involves drug companies using patients with a given disease, most commonly hemophilia, to induce others with the same disease to buy certain medicines. This blurs the line between patient and salesperson, without disclosing the potential conflict of interest. Pharmaceutical companies believe that by hiring patients with a particular disease to sell a company product to others with the same disease, the company improves services by having someone who understands the patient from their own perspective. But if you ask some people, such a tactic simply seems mercenary.

On the one hand, only a patient who is taking a certain treatment can truly advise another patient about their experiences with that treatment. On the other hand, some patients have stopped attending support group meetings because they are having difficulty distinguishing between sales pitches and genuine patient experiences because of the growing use of patient representatives by pharmaceutical companies.  This is more disturbing still in that the benefit to the patient representative is rarely disclosed.  Some in the pharmaceutical industry have been prosecuted for taking patients out to dinner or buying them presents to solicit their business. In the past, this was a very common practice. However, drug companies and pharmacies are no longer allowed to do this; so, they seem to have moved on to the tactic addressed in the article herein summarized. Pharmaceutical companies are inserting themselves into a tightknit community of people with a particular disease and blurring the line between ethics and business practices.

Source: http://www.nytimes.com/2016/01/14/business/hemophilia-patient-or-drug-seller-dual-role-creates-ethical-quandary.html?_r=0

A Potential Solution to the Emergency Room Data Problem Surrounding Violent Police Encounters

Recent studies have shown that while federal and national research groups keep scads of statistics, there is no reliable national data on how many people are shot by police officers each year. Recognizing the vital role the healthcare system plays in amassing data about violent injuries, criminologist Joseph Richardson recently proposed that emergency room staff should collect information about such injuries, not just fatalities, independent from police investigations. Richardson highlights the need for such data by pointing to a 2009 survey of academic emergency physicians, which revealed that although a majority of respondents had seen cases of excessive use of force by police, the group largely failed to report such findings. Without hospital reported information, data about violent police encounters relies heavily on police gathered information, which seems to be inadequate, especially with respect to survivors of police involved shootings

Doctors and nurses attribute physicians’ failure to report excessive use of force by police to concerns about logistics and consequences, specifically, difficulties associated with putting a standardized data collection approach into practice. Richardson’s findings from interviews at Prince George’s Hospital Center revealed two major barriers to gathering such information: the presence of police anytime a victim is under arrest and the need to provide testimony in court.

Although some hospital staff report feeling an ethical responsibility to document police-involved violence, others worry that such a requirement would compromise emergency care. For example, Dr. James Augustine, an American College of Emergency Physicians board member, worries that such a requirement would “muddle” hospitals’ missions, although he recognizes that the collection of such data is feasible since trauma centers nationwide already collect and submit information to the National Trauma Data Bank.

Despite early opposition, Richardson’s proposal recognizes police violence as a public health issue and highlights the vital role emergency room healthcare providers could play in addressing it. Only time will tell whether or not emergency departments will step in and capitalize on their unique access to compile an alternative data source.

Source: http://www.npr.org/sections/health-shots/2016/02/04/465568899/could-hospital-ers-provide-missing-data-on-police-shootings

Infertility Treatments Are Not Covered for Wounded Veterans

Veterans who were wounded during service receive free health care provided by the Department of Veterans Affairs (“VA”). However, the care does not include in vitro fertilization (“IVF”) to assist with fertility issues resulting from injuries sustained in combat or training. Congress passed a law in 1992 that prohibits the VA from providing IVF to veterans, forcing thousands of veterans to pay out of pocket to start a family.

IVF is, however, provided to active military service members. Unlike the VA, the Defense Department provides such services in seven hospitals if an active member’s infertility is a result of an injury sustained in service. The Defense Department hopes to expand their coverage of fertility services to a wider population, but it would nonetheless exclude veterans who receive services through the VA. Many wounded service members do not undergo IVF while in active military status because they are concerned about recovery and rehabilitation. By the time they consider procreation, they are retired or discharged from the military, placing them in veteran status and without coverage for IVF.

Senator Patty Murray has made several attempts to change the 1992 law, most recently by introducing a bill that would allow IVF to be covered by the VA. At a Senate Committee meeting, the VA expressed support for the bill as long as it would receive the necessary funding to provide such services. However, Ms. Murray withdrew her bill after amendments were made by Republicans that would ban the VA from working with Planned Parenthood and other centers that provide both fertility treatments and abortions.

For the time being, veterans with fertility issues are left with few options. Some fertility centers and clinics offer wounded veterans a discounted rate for IVF. But even with the discounted rate, many couples cannot afford the treatment and are forced to either abandon their hopes of a family or resort to other measures, such as taking out a loan.