Sunday, February 15, 2009

News of Note this past week

~ Gender disparities persist in treatment of stroke. Guess which direction this one cuts.

~ TANSTAAFL: Pfizer to disclose payments to doctors, researchers starting in 2010. All right, let’s hear it!

~ Second Stryker sales rep pleads guilty to misbranding a medical device. A

felony.

~ Ovaries can be safely saved in some endometrial cancers.

~ 9 flawed genes found in risk of heart attack. Ah, the plot thickens!

~ Are you what you eat?: Mediterranean diet could cut risk of dementia. Quick! Get me some fish and olive oil.

~ Bone drugs may help fight breast cancer. Nice added benefit.

~ Damaged spinal cords in mice improved by transplants of neural stem cells produced with human induced pluripotent stem cells. We can rebuild them .

~ Are fears over bioterrorism stifling scientific research?

~ Naturally occurring brain protein may slow or stop the progress of

Alzheimer’s.

~ Gene therapy offers hope of cure for HIV: bone marrow transplant breakthrough.

~ GM goats raised to produce human breast milk. Just had to include this

story, in light of the one right below!

~ FDA approves drug made in milk of genetically altered goats. This is the first time such a drug has been approved. They also looked back at 7 generations of the goats to look for adverse effects on the animals.

~ Epilepsy group asking lawmakers to prohibit pharmacies from switching prescribed meds to generics amid reports of increased seizure incidence with generics over brand name epilepsy meds. Hmmm . . .thought generics were supposed to be bioequivalent. Seems that is not always the case!

~ Wacky names for newly discovered fruit fly genes. Examples? “Cheap Date,” “I’m not Dead Yet” (otherwise known as INDY). Who said scientists have no sense of humor?


[Thank you to Lisa von Biela, JD candidate, 2009, UMN, Editor of the BioBlurb, from which this content is partially taken and edited. BioBlurb is a weekly electronic publication of the American Bar Association's Committee on Biotechnology, Section of Science & Technology Law. Archived issues of the BioBlurb, as well as further information about the Committee on Biotechnology, are available here.]


The position of France regarding stem cells

France is a country that has come in a bit late into bioethics discussions, specially in the matter of new therapies. Regarding stem cells, whether adult, embryonic or other, France's position has not been all that clear.

The adult stem cells
While the debate about origin of the stem is not a major problem, (whether placenta, umbilical cord, or adult stem cells), we think, nevertheless, that it would be important to store the collection of adults stem cells (whether placenta, umbilical cord, or our fabrics) for easy availability, while preserving their multipotency and respecting autonomy of individuals. Their effectiveness is being newly revealed every day, whether by transplant, cell therapy or cotton candy .

The embryonic stem cells
A law passed in August 6 2004 relating to bioethics prohibits the research on the embryo. Consequently, it prevents the possibility of sampling of embryonic stem cells (stadium morula, blastocyste). The policies of France are contradictory, our lawmakers have chose not recognize or reconcile the laws for fear of accusations of hypocrisy (In fact, we think they wished not to go against the strong scientific lobbies fighting to obtain the authorization of the research on the embryo); for it is this same law that allows the importation of lines of embryonic stem cells into French territory, and such was the case after the entry in force of the law.

Otherwise says, the legislation of 2004 gives themselves good conscience close to landa citizens and inquiring doctors. It forbids the research on the embryo to satisfy the one and it satisfies the others for not to prevent them from do their work in importation of the lines of stem cells. The research ban on the embryo in France does not hold for the legislator of 2004 recommends it in the other countries and in end on his territory in importation of the lines of embryonic stem cells obtained by this legally forbidden bias.

Which lack of courage? Which hypocrisy? We are sad to see to which not at all the legislator denies himself to work on important bioethics problems.

Seen the current state of the French lawful texts, we think that research authorization on the embryo will have to be given, after reflection, that when the legislator will have done « the housework » in its texts. What it will have given again coherence and moderation to his legislation. It is necessary to add that France has not any clear position concerning the embryo statute, which does not reduce the problem.


In conclusion, we think that regarding stem cells, France must not be afraid of there to reflect as all the others imminent bioethics problems, as euthanasia or gene therapy...




In French

La France est un pays un peu en retard et en retrait dans le domaine de la bioĂ©thique, spĂ©cialement en matière de nouvelles thĂ©rapies. Concernant les cellules souches, bases de la thĂ©rapie cellulaire, la France a une position qui n’est pas toujours claire.

Les cellules souches adultes
Il n’y a pas de problèmes majeurs les concernant vu leur origine de prĂ©lèvement (placenta, cordon ombilical tissus adultes)
Nous pensons, toutefois, qu’il serait important de gĂ©nĂ©raliser la collecte de cellules souches de cordon ombilical ou de placenta, en respectant des règles d’hygiènes et de respect des individus stricts. Leur efficacitĂ© est rĂ©vĂ©lĂ©e Ă  chaque nouvelle greffe par thĂ©rapie cellulaire.

Les cellules souches embryonnaires
La loi du 6 aoĂ»t 2004 relative Ă  la bioĂ©thique interdit la recherche sur l’embryon. Par voie de consĂ©quence, elle empĂŞche la possibilitĂ© de prĂ©lèvement de cellules souches embryonnaires (stade morula, blastocyste).
La position de la France est hypocrite, nous n’avons pas peur de le reconnaĂ®tre et de le dire.
Car cette mĂŞme loi permet l’importation de lignĂ©es de cellules souches embryonnaires sur le territoire français, et tel a Ă©tĂ© le cas après l’entrĂ©e en vigueur de la loi.

Autrement dit, le législateur de 2004 se donne bonne conscience vis à vis des citoyens landa et des médecins chercheurs.
Il interdit la recherche sur l’embryon pour contenter les uns et il satisfait les autres pour ne pas les empĂŞcher de faire leur travail en important des lignĂ©es de cellules souches.
L’interdiction de la recherche sur l’embryon en France ne tient pas car le lĂ©gislateur de 2004 la prĂ©conise dans les autres pays et in fine sur son territoire en important des lignĂ©es de cellules souches embryonnaires obtenu par ce biais lĂ©galement interdit.

Quelle frilosité? Quelle hypocrisie?
Nous sommes triste de voir à quel point le législateur se refuse de travailler sur des problèmes bioéthiques importants.

Vu l’Ă©tat actuel des textes juridiques français, nous pensons que l’autorisation de la recherche sur l’embryon devra ĂŞtre donnĂ©e, après rĂ©flexion, que lorsque le lĂ©gislateur aura fait le mĂ©nage dans ses textes. Qu’il aura redonnĂ© cohĂ©rence et pondĂ©ration Ă  sa lĂ©gislation.
Il faut ajouter que la France n’a pas de position claire concernant le statut de l’embryon, ce qui n’allège pas le problème.


En conclusion, nous pensons qu’en matière de cellules souches, la France ne doit pas avoir peur d’y rĂ©flĂ©chir comme tous les autres problèmes bioĂ©thiques imminents, comme l’euthanasie ou la thĂ©rapie gĂ©nique...





Special Thanks to Linda MacDonald Glenn for the collaboration in the writing of this text.

Saturday, February 14, 2009

FDA Approves Depressant Drug For The Annoyingly Cheerful

[Hat tip to Jay Vos at Blazing Indiscretions for bringing our attention to this parody] At last, Big Pharma has come out with a drug designed to treat the symptoms of excessive perkiness. For those with an annoyingly chipper attitude towards life:




Cool Beans!

Give Free Love for Valentine's Day


Rather than caloric candy and soon-to-wither flowers, consider giving your loved ones a gift of heartfelt love this Valentine’s Day. Valerie Tarico, director of the Wisdom Commons, has developed these fun (and free) bioethically inspired gift alternatives:

Print a love quote or poem as a poster – over 150 selections.
Leave it on your kid's bed or your lover's desk or the kitchen counter. Or print out several and use them for placemats on Valentine's morning. Just click the printer icon after any quote. Here's what the posters look like.

Email a last minute Valentine wish.
Click on the mail icon after any quote or poem, say what you want to say, and send it off! A great option for your mom, or sister or nephew or anyone else who you remember (every year) at the last minute.

Forward the Daily Wisbit
Start the day right. Receive a bit of wisdom daily sent to your email address. For the next two weeks they're all about love. Sign up or see recent Daily Wisbits here.

The Wisdom Commons is a Women’s Bioethics Project initiative devoted to exploring, elevating and celebrating our shared moral core. Join us.

Friday, February 13, 2009

Health Literacy – A Cry for Universal Health Care

Health care is now a business that rivals the industrial complex. Its major consumers are victims of lopsided capitalist principles that exploit weaknesses within our educational systems – mainly literacy. If literacy is at an all-time low in this country, health literacy must be virtually non-existent. But what does this mean? And more importantly, why should anyone care? These questions are made complicated by arguments that weave a moral blanket of hypocrisy which does not provide comfort – let alone security - to those most impacted by a poor health infrastructure. That is, too often we blame the sick for having sickness and the uneducated for not knowing when the real cause of either or both is mis-education combined with quests for power and, ultimately, control.

Literacy is not merely the act of reading and comprehending fragments of generic knowledge. It is a tool for understanding the constellation of knowledge that shapes our views of the world and defines our positions in it. Understanding who we are in terms of how our bodies work optimally is essential to securing a competitive advantage – particularly in a free-market economy. However, large swatches of the US population are disproportionately denied basic health needs such as potable water, adequate shelter, and access to basic health care - they do not have insurance or they have inadequate insurance which is poorly defined and, therefore, subject to intricate loopholes. The health literature is replete with epidemiologic data illustrating the link between access to basic health needs and illness while the health economic literature highlights the impact of sickness to the work force and societal growth. So wouldn’t it make sense to promote and support a healthy society if for no other reason than the well-being of our economy and securing a prosperous future? It does to me.

However, in order for this to happen we need to eliminate the barriers to access which includes class-based health insurance and, more importantly, advance a comprehensive education about the relationship of personal health to societal development. Yet, too often, we exert power by enacting laws on the basis of a sense of moral superiority; and we use oppressive means to control basic needs. This is best exemplified by the gross amounts of narcotics and pharmaceuticals that act to subdue harmless physiologic impulses and abolish the most basic human right – the right to health (as defined by the World Health Organization). Or, perhaps it is the intention of the powers-that-be to keep certain people ignorant and weak from poor health. What better way to control people than to continuously exploit their vulnerabilities while making them dependant on small acts of welfare disguised as generosity?

Thursday, February 12, 2009

Moral Distress

When Doctors and Nurses Can’t Do the Right Thing

The writer, a physician, Pauline W. Chen, M.D, describes her experiences of witnessing what an ethics consultant she knew called “moral distress.” The ethics consultant, also a medical doctor, stated that this was a growing concern at her hospital. Moral distress is the feeling of being trapped by competing demands from bureaucracy, family, and professional peers that forces doctors and nurses to compromise their commitment to what is best for patients.

Dr. Chen described a scenario that involved a very talented nurse who possessed tremendous perspicacity regarding clinical situations. She noticed over the years, however, that this nurse’s communication style devolved from sharp insight to vague non-commitment when communicating with doctors and supervisors. One situation in particular provoked the writer of the article to question the nurse about her change in attitude.

An intensive care unit (ICU) patient who appeared beyond help was taken into the operating room repeatedly over a period of a month. The patient’s abdomen was riddled with an unrelenting bacterial infection that was refractory to treatment. The nurse’s concern for the welfare of her patient as well as her questions regarding the futility of the surgeries were repeatedly ignored by the surgical team. She began to resort to sarcasm and, ultimately, resigned herself to silence whenever she was asked to take the patient in for yet another unsuccessful surgery.

The nurse shared her frustration over not being able to advocate for her patients. She was faced with the moral dilemma of choosing to do what was right for the patient or protecting herself from being criticized by doctors or warned by her superiors. This frustration is shared by many nurses. A recent study found that 15 percent of nurses leave their jobs because of moral distress. Doctors grapple with their own version of moral distress but not to the same extent as nurses.

According to Ann B. Hamric PhD, RN, the lead author of a University of Virginia study of ICU nurses and physicians, moral distress may stem from a variety of situations, but it is, in large part, a product of the work environment. Doctors and nurses both suffer from feelings of a lack of autonomy and threatened integrity, fearfulness, and lack of respect. Doctors feel that lawyers and risk managers are dictating patient care over and above the physicians’ professional judgement. The United States has had a nursing shortage for years and a primary care shortage is pending. Dr. Hamric believes that the first step to dealing with moral distress is to recognize it as an issue and then to make a point of discussing it in the health care setting. If health care providers are unable to maintain their professional integrity and do what is right for their patients, the shortage will inevitably become a crisis.

I feel that respect, fairness, and autonomy are at the core of this issue. At the heart of nursing is the imperative to advocate for the patient. The nurse is the liaison between the physician, the social worker, the family, and the patient. No one is more intimately involved in the patient’s care than the nurse. This caregiving role distinguishes nursing from medicine and gives nurses a unique and valuable perspective. Patient hospital ratings are often directly proportional to the quality of nursing care received. Yet nursing professionals continue to feel undervalued and disrespected.

When healthcare providers work as a team of dedicated professionals rather than in the constraints of an outmoded hierarchy, everyone benefits. I was lucky enough to work with an amazing group of doctors and nurses (there were some bad apples, of course). I felt respected by the doctors, my colleagues supported me, my insights and recommendations were valued, and many of my patients appreciated the care I provided them. However, the manpower shortage confronted us on a daily basis. Mandated overtime was the norm. Burnout was common, resentment over not being able to give patients the full attention they deserved was an underlying theme, and safety was an overriding concern. Turnover was high as, week after week, my supervisor tried to balance the schedule, deal with upper management who had no clue about the realities of working on a hospital floor, and, somehow, appease the increasingly disgruntled troops. She too eventually left.

We were paid well and raises came often. But there was no life outside of work. We were required to work every other weekend. That meant working for two weeks at a time before getting two days off in a row. That, in addition to overtime. Days off had to be requested at least a month in advance and weren’t always granted. Sick days were offered but nurses who called out more than two days in a year were denied a raise. Some nurses did feel disrespected. On-call doctors were rude and imperious. The buck always stopped with the RN: Whatever the nurses aides didn’t get to or didn't feel like doing was dumped on the nurse; if social work wasn’t able to do something the nurse picked up the slack; doctors talked down to the nurses and some had the frightening reflex of blaming the nurse for their own mistakes. There were more patients than nurses to care for them.

Numerous studies, analyses, task forces and questionnaires later, nothing much has changed to improve the nursing shortage. The answers seem obvious to nurses but there seems to be a conspiracy of ignorance among the powers that be. The problem is systemic and one that is confronting professionals everywhere. Money is more important than people, timelines are more important than quality, the status quo is more important than teamwork, and upper management everywhere have their own agenda. There is no single solution to this problem but it doesn’t appear that any real efforts have been made to resolve it. If we were living in a different time, place, and culture, there would have been a revolution by now. But there seem to be too many competing interests for anyone to unify for a common goal and purpose. I don’t know the answer. I left nursing too for another job that has its own challenges with moral distress. That’s life in America I guess.