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 bioéthique, spécialement en matière de nouvelles thérapies. Concernant les cellules souches, bases de la thérapie 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 prélèvement (placenta, cordon ombilical tissus adultes)
Nous pensons, toutefois, qu’il serait important de généraliser la collecte de cellules souches de cordon ombilical ou de placenta, en respectant des règles d’hygiènes et de respect des individus stricts. Leur efficacité est révélée à chaque nouvelle greffe par thérapie cellulaire.
Les cellules souches embryonnaires
La loi du 6 août 2004 relative à la bioéthique interdit la recherche sur l’embryon. Par voie de conséquence, elle empêche la possibilité de prélèvement de cellules souches embryonnaires (stade morula, blastocyste).
La position de la France est hypocrite, nous n’avons pas peur de le reconnaître et de le dire.
Car cette même loi permet l’importation de lignées de cellules souches embryonnaires sur le territoire français, et tel a été le cas après l’entrée 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 empêcher de faire leur travail en important des lignées de cellules souches.
L’interdiction de la recherche sur l’embryon en France ne tient pas car le législateur de 2004 la préconise dans les autres pays et in fine sur son territoire en important des lignées de cellules souches embryonnaires obtenu par ce biais légalement 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’état actuel des textes juridiques français, nous pensons que l’autorisation de la recherche sur l’embryon devra être donnée, après réflexion, que lorsque le législateur aura fait le ménage dans ses textes. Qu’il aura redonné cohérence et pondération à sa législation.
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 réfléchir comme tous les autres problèmes bioéthiques imminents, comme l’euthanasie ou la thérapie génique...
Special Thanks to Linda MacDonald Glenn for the collaboration in the writing of this text.
Sunday, February 15, 2009
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!
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 quot
e. 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?
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.
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.
Sweet, Soft Matter: Candy Cotton for the Regeneration of Blood Vessels
I love interdisciplinary journals, but I had not stumbled across Soft Matter, where physics meets chemistry meets biology for fundamental soft matter research, until today when the following story caught my eye:
(Via Red Orbit)
"Scientists are turning to cotton candy as a novel tool to help grow replacement tissues for people. It seems the long-time favorite treat may provide an ideal way to generate a network of blood vessels within lab-grown skin, bone, muscle or fat for breast reconstruction, researchers say.
Dr. Jason Spector of New York-Presbyterian Hospital/Weill Cornell Medical Center in New York and Leon Bellan of Cornell University conducted the research on the new technique.
It works by first pouring a thick liquid chemical over the cotton candy, and waiting for the liquid to solidify into a chunk. The chunk is then put in to warm water to dissolve the cotton candy, leaving small channels where the strands of cotton candy used to be. Eventually, what is left is a piece of material containing a network of fine channels.
These channels are then lined with cells to create artificial blood vessels. The solid chunk can be seeded with immature cells of the type of tissue scientists wish to make.
Since the block is biodegradable, as it disappears it is slowly replaced by growing tissue. Ultimately what remains is a piece of tissue permeated with tiny blood vessels."
Assuming this technique will be refined, it would have incredible implications for organ transplantation, regenerative medicine, artificial wombs, as well as other medical uses.
What can I can say but "Sweet!"?
U.S. Court of Claims Denies Claim of Vaccine/Autism Link
A specially convened vaccine court, part of the process required to seek compensation under the Vaccine Injury Compensation Program, has ruled against parents saying that the MMR vaccine caused autism in their children. The court specifically said that there was absolutely no compelling scientific proof of the claim, and that the "petitioners' theories of causation were speculative and unpersuasive."
This was one of three test cases going before the court, and the court has yet to rule on the claim that thimerosal alone is the culprit. However, the language the court used in this case is very telling: "The petitioners have failed to demonstrate that thimerosal-containing vaccines can contribute to causing immune dysfunction."
-Kelly Hills
This was one of three test cases going before the court, and the court has yet to rule on the claim that thimerosal alone is the culprit. However, the language the court used in this case is very telling: "The petitioners have failed to demonstrate that thimerosal-containing vaccines can contribute to causing immune dysfunction."
-Kelly Hills
Why I Love Designer Babies
Perhaps I should say I love the topic of designer babies, which is why I was pleased to read Gautam Naik’s provocative article, “A Baby, Please. Blond, Freckles -- Hold the Colic” in the Wall Street Journal today. Naik points out that this technology is nearer than we think; he reports on a Los Angeles clinic which will soon help couples select both gender and physical traits in a baby when they undergo a form of fertility treatment. Researchers from Harvard to Stanford and around the world are working hard to make genetic modification a reality. Are we ready?
Genetic modification and selection raises a number of issues that we at the Women’s Bioethics Project believe should be at the forefront of any good bioethics discussion. Here’s why:
1) It’s a hive of ethical issues
Genetic modification and selection raises a whole slew of ethical issues: how we view our children; where we draw the line at enhancement v. therapeutic applications of the technology; the issues of safety, access, and social justice; and the potential eugenic applications, just to name a few.
2) The technology isn’t here yet
Because the technology isn’t available yet, there is still a chance to consider the implications before wide-spread use. A tremendous amount of scientific progress in the area of cloning has been made since the 1997 announcement that a sheep had been successfully cloned; cloned primates and pets and the creation of induced pluripotent stem cells and human-nonhuman chimeras are just a few of the scientific discoveries that get us closer every day to the prospect of a genetically modified child.
3) We all have a stake in the issue
The ability to radically alter human reproduction raises fundamental questions regarding the nature of our humanity and the character of our society. All of us, whether we choose the use the technology or not, have a stake in the genetic modification of children and we need to engage in conversation on these issues now.
4) Questions raised go beyond designer babies
I love the topic of designer babies because difficult questions need to be asked about all kinds of emerging technologies from nanotechnology to therapeutic and reproductive human cloning. It can be overwhelming, but the only thing we can count on is change–that the nature of the technology will evolve while the challenges remain.
Moving forward
As we discuss genetic modification, we must remember that this not just an interesting a moral philosophical exercise—our elected representatives will be developing a national science policy on the use of genetic modification technologies in the next few years. As citizens, we’ll be asked to vote on the use of these technologies. What factors do we want policy makers to keep in mind as they decide the future of genetic engineering? There are several policy options to consider:
Banning - Should we ban it? The use of this technology is currently not prohibited in the US, Russia, and China. While many countries are currently considering legislation that would ban genetic modification of children, it has been fully banned in 44 countries around the world, including Germany, France, Italy, Australia, Canada, Brazil, Costa Rica and Japan.
Regulating - Should we regulate the technology to allow only certain applications? Many believe there may be acceptable uses of genetic modification in the future, but want to be sure that appropriate limitations are set, through government or other oversight, to ensure safe and ethical use. Should we regulate any proposed form of genetic engineering if, when widespread, it has a harmful effect on individuals and society? If so, who determines what that threshold is?
Promoting – Should we promote the widespread use of this technology? Some believe that genetic modification holds tremendous promise for preventing genetic diseases and that society should pursue policies to promote or encourage its use in the future, despite what other sideline “designer” applications are developed as a result.
It’s time to get the conversation going. What are your thoughts?
Genetic modification and selection raises a number of issues that we at the Women’s Bioethics Project believe should be at the forefront of any good bioethics discussion. Here’s why:
1) It’s a hive of ethical issues
Genetic modification and selection raises a whole slew of ethical issues: how we view our children; where we draw the line at enhancement v. therapeutic applications of the technology; the issues of safety, access, and social justice; and the potential eugenic applications, just to name a few.
2) The technology isn’t here yet
Because the technology isn’t available yet, there is still a chance to consider the implications before wide-spread use. A tremendous amount of scientific progress in the area of cloning has been made since the 1997 announcement that a sheep had been successfully cloned; cloned primates and pets and the creation of induced pluripotent stem cells and human-nonhuman chimeras are just a few of the scientific discoveries that get us closer every day to the prospect of a genetically modified child.
3) We all have a stake in the issue
The ability to radically alter human reproduction raises fundamental questions regarding the nature of our humanity and the character of our society. All of us, whether we choose the use the technology or not, have a stake in the genetic modification of children and we need to engage in conversation on these issues now.
4) Questions raised go beyond designer babies
I love the topic of designer babies because difficult questions need to be asked about all kinds of emerging technologies from nanotechnology to therapeutic and reproductive human cloning. It can be overwhelming, but the only thing we can count on is change–that the nature of the technology will evolve while the challenges remain.
Moving forward
As we discuss genetic modification, we must remember that this not just an interesting a moral philosophical exercise—our elected representatives will be developing a national science policy on the use of genetic modification technologies in the next few years. As citizens, we’ll be asked to vote on the use of these technologies. What factors do we want policy makers to keep in mind as they decide the future of genetic engineering? There are several policy options to consider:
Banning - Should we ban it? The use of this technology is currently not prohibited in the US, Russia, and China. While many countries are currently considering legislation that would ban genetic modification of children, it has been fully banned in 44 countries around the world, including Germany, France, Italy, Australia, Canada, Brazil, Costa Rica and Japan.
Regulating - Should we regulate the technology to allow only certain applications? Many believe there may be acceptable uses of genetic modification in the future, but want to be sure that appropriate limitations are set, through government or other oversight, to ensure safe and ethical use. Should we regulate any proposed form of genetic engineering if, when widespread, it has a harmful effect on individuals and society? If so, who determines what that threshold is?
Promoting – Should we promote the widespread use of this technology? Some believe that genetic modification holds tremendous promise for preventing genetic diseases and that society should pursue policies to promote or encourage its use in the future, despite what other sideline “designer” applications are developed as a result.
It’s time to get the conversation going. What are your thoughts?
Tuesday, February 10, 2009
Finally, some good news for women at risk of HIV
Women and girls are the new face of HIV/AIDS. Globally, there are twelve HIV-positive women for every ten HIV-positive men. In the hardest hit countries of sub-Saharan
The disproportionate impact of HIV on women is due to a variety of biological and socioeconomic factors, factors that also make current HIV prevention tools – including condoms and mutual monogamy – inaccessible to those most at risk. For example, many women do not have the social or economic power necessary to insist on condom use and fidelity, or to abandon partnerships that put them at risk.
Thus, there is a desperate need to develop new user-controlled tools to enable women to protect themselves, such as vaginal microbicides. Over the past two years, a series of flat findings and trial closures have shaken public confidence in research to develop safe and effective microbicides. But now there’s a glimmer of hope.
Yesterday, at the 16th Conference on Retroviruses and Opportunistic Infections in Montreal, a team of researchers funded the US National Institutes of Health announced the results of HPTN 035, a clinical trial of PRO2000 and BufferGel, two candidate vaginal microbicides.
This study enrolled over 3000 at-risk women in
Although the decrease in HIV infections among women using PRO2000 did not quite achieve statistical significance, this is first large-scale clinical trial showing that a candidate microbicide might actually work in women. A second trial of PRO2000, enrolling more than 9000 at-risk women in
Saturday, February 07, 2009
Octuplets Mother Speaks Out
Nadya Suleman, mother of the recent octuplets born in California, has done her first interview with a major news outlet. (Although Suleman was seeking USD 2 million for the interview, NBC maintains that they did not pay her. However, that doesn't rule out "compensation" in other forms.)
Unfortunately, Suleman's interview has continued to raise, rather than answer, questions. Foremost among them, for me, is her claim that she had six embryos implants per IVF procedure. This... simply does not ring true. Or at least plausible, if she was using a US fertility expert.
Consider this: in order to have done so, this means Suleman would have needed to find, at age 26, a fertility doctor who would implant six embryos. ASRM guidelines are no more than 3 embryos for a woman under the age of 35, and that's if she has a history of problems with conception. With a 'clean' history, only 2 embryos are recommended. Now, it sounds like Suleman might have qualified as having difficulty conceiving, with several ectopic pregnancies and miscarriages prior to IVF. But even accounting for that, it's double the recommended standard. For each pregnancy.
But stop to do the math. While one vial of donor sperm would be more than enough for all of this, it means that they collected at least 36 eggs from Suleman, and that all of those eggs were viable enough to implant once fertilized. Realistically, not every egg retrieved is going to be mature, and not every egg is going to fertilize (unless you're using something like ICSI). Realistically, you're looking, at the very least, at 1/3rd more eggs than that being pulled out (and even that is a very, very low number - remember, they're saying that there were six viable eggs to implant per cycle. A quick web search shows that 1/3 of the eggs removed at any time are not mature, and of the ones that are mature, only half reach the point of being "good enough" to implant).
Now let's go over to CDC stats. While the last data is from 2005, which was going on 5 years ago, Suleman started her IVF course in 2001, so some of this data is specifically applicable (and some of it only extrapolation). According to the CDC, only 35% of ART cycles resulted in a pregnancy, and of those, 82% resulted in a live birth. So again, Suleman seems to have defied the odds. A lot. And as the CDC says about frozen eggs, "[b]ecause some embryos do not survive the thawing process, the percentage of thawed embryos that resulted in live births is usually lower than the percentage of transfers resulting in live births." While only 15% of embryos transferred were frozen, of those 15%, only slightly more than 1/4 ended up in live births.
Again, the odds make this seem incredibly unlikely.
Finally, fertility clinics are required by law to report their ART data, under the Fertility Clinic Success Rate and Certification Act. This gives us a decent way of tracking ART results - and also who is doing ART. In 2005, eleven clinics in California did not report their ART data (which would include embryo transfers/live birth data/etc). Of those eleven places, it looks like seven were within an hour of her home (keeping in mind her back injury likely limited the distance she could travel). Of the clinics that did report their data, 35 are within an hour of Whittier, California. However, given these clinics are compliant with reporting their data, it seems safe to eliminate them from immediate suspicion. (As for the potential Mexcio connection, Tijuana is approximately two hours away. Certainly not out of the question; an hour was a random number drawn from thin air. Suleman has certainly shown herself to be willing to go to significant length, and pain, to achieve her goals.)
All in all, what does this mean? Not much. Over 300 pages of records on Suleman have been released to the press, under a public records request to California's Division of Workers' Compensation. While it doesn't appear that the fertility clinic (or doctor) that treated her is in those records, there is ample evidence to support that she did have problems conceiving, and that she had known psychiatric issues, including what was diagnosed as either postpartum depression or PTSD. Issues that should have limited, if not prevented, future implantations.
Ultimately, until Suleman names her doctor, or said doctor speaks out, little will be conclusively known. But the facts remain simple: the facts do not add up.
-Kelly Hills
Unfortunately, Suleman's interview has continued to raise, rather than answer, questions. Foremost among them, for me, is her claim that she had six embryos implants per IVF procedure. This... simply does not ring true. Or at least plausible, if she was using a US fertility expert.
Consider this: in order to have done so, this means Suleman would have needed to find, at age 26, a fertility doctor who would implant six embryos. ASRM guidelines are no more than 3 embryos for a woman under the age of 35, and that's if she has a history of problems with conception. With a 'clean' history, only 2 embryos are recommended. Now, it sounds like Suleman might have qualified as having difficulty conceiving, with several ectopic pregnancies and miscarriages prior to IVF. But even accounting for that, it's double the recommended standard. For each pregnancy.
But stop to do the math. While one vial of donor sperm would be more than enough for all of this, it means that they collected at least 36 eggs from Suleman, and that all of those eggs were viable enough to implant once fertilized. Realistically, not every egg retrieved is going to be mature, and not every egg is going to fertilize (unless you're using something like ICSI). Realistically, you're looking, at the very least, at 1/3rd more eggs than that being pulled out (and even that is a very, very low number - remember, they're saying that there were six viable eggs to implant per cycle. A quick web search shows that 1/3 of the eggs removed at any time are not mature, and of the ones that are mature, only half reach the point of being "good enough" to implant).
Now let's go over to CDC stats. While the last data is from 2005, which was going on 5 years ago, Suleman started her IVF course in 2001, so some of this data is specifically applicable (and some of it only extrapolation). According to the CDC, only 35% of ART cycles resulted in a pregnancy, and of those, 82% resulted in a live birth. So again, Suleman seems to have defied the odds. A lot. And as the CDC says about frozen eggs, "[b]ecause some embryos do not survive the thawing process, the percentage of thawed embryos that resulted in live births is usually lower than the percentage of transfers resulting in live births." While only 15% of embryos transferred were frozen, of those 15%, only slightly more than 1/4 ended up in live births.
Again, the odds make this seem incredibly unlikely.
Finally, fertility clinics are required by law to report their ART data, under the Fertility Clinic Success Rate and Certification Act. This gives us a decent way of tracking ART results - and also who is doing ART. In 2005, eleven clinics in California did not report their ART data (which would include embryo transfers/live birth data/etc). Of those eleven places, it looks like seven were within an hour of her home (keeping in mind her back injury likely limited the distance she could travel). Of the clinics that did report their data, 35 are within an hour of Whittier, California. However, given these clinics are compliant with reporting their data, it seems safe to eliminate them from immediate suspicion. (As for the potential Mexcio connection, Tijuana is approximately two hours away. Certainly not out of the question; an hour was a random number drawn from thin air. Suleman has certainly shown herself to be willing to go to significant length, and pain, to achieve her goals.)
All in all, what does this mean? Not much. Over 300 pages of records on Suleman have been released to the press, under a public records request to California's Division of Workers' Compensation. While it doesn't appear that the fertility clinic (or doctor) that treated her is in those records, there is ample evidence to support that she did have problems conceiving, and that she had known psychiatric issues, including what was diagnosed as either postpartum depression or PTSD. Issues that should have limited, if not prevented, future implantations.
Ultimately, until Suleman names her doctor, or said doctor speaks out, little will be conclusively known. But the facts remain simple: the facts do not add up.
-Kelly Hills
Friday, February 06, 2009
More on the Octuplets
Our friend and supporter, Art Caplan, sheds some more light on the ethical implications of the octuplets in his Philly op-ed:
"Something has gone terribly wrong when a 33-year-old single woman - who has no home of her own, no job, and a mother who worries her daughter is "obsessed" with having children - winds up with 14 of them. And all are under age 8, including eight newborn babies now in a neonatal nursery in various states of prematurity.
Examining what exactly went wrong may shed some light on what ought to be done. If doctors cannot prevent such a shambles from recurring, then society must.
The woman in question, Nadya Suleman, lives with her parents in a small home near Los Angeles. She has had infertility problems linked to blocked Fallopian tubes. She can make eggs, but they cannot be fertilized naturally because of the blockage.
Suleman apparently used donated sperm and in vitro fertilization to create all the embryos that became her children. She underwent treatment to cause her to produce many more eggs than the normal one per month, and they were surgically removed from her body and fertilized in lab dishes. Some of the resulting embryos were put back into her body, and that is how her first six children were made.
Unhappy with only six, Suleman sought further fertility treatment and had an additional eight of her embryos defrosted and implanted. They produced the now famous octuplets who, after a Caesarean section, are in intensive care at Kaiser Permanente Medical Center in Bellflower, Calif. Sadly, there is no known case of octuplets in which all escaped severe disabilities.
The most obvious questions raised by this sad saga include: How did Nadya Suleman become a fertility patient? And how did she get eight embryos implanted when she already had six young children to care for in a tiny house, with no partner and no income?
Some fertility doctors would answer that it's not their job to decide how many children a person can have. Jeffrey Steinberg, medical director of the Fertility Institutes, which has clinics in Los Angeles, Las Vegas and New York City, was quoted as saying: "Who am I to say that six is the limit? There are people who like to have big families."
James Grifo, a renowned fertility specialist at New York University, had little time for those wondering why Suleman was a patient. "I don't think it's our job to tell them how many babies they're allowed to have," he reportedly said. "I am not a policeman for reproduction in the United States."
With all due respect, the idea that doctors should not set limits on who can use reproductive technology to make babies is ethically bonkers.
If someone comes to a clinic with a history of child abuse, active drug addiction, and a rap sheet with serious felonies, should the doctor simply say: "If you have the money, I will make all the babies you want"? That gives cash and carry a whole new meaning.
Doctors have an obligation to consider patients' requests for treatment, but they do not have to honor them. One very good reason not to do so is if a doctor believes that what the patient wants would put children at grave risk.
Putting eight embryos into a woman is exactly that - putting kids at grave risk. Putting eight babies into the family of a single mom already trying to cope with six other young kids, with no money and little help, is putting kids at grave risk. The doctors who allowed Nadya Suleman to receive multiple embryos engaged in grossly unethical conduct.
The other major ethical problem raised by this story is the hijacking of health-care dollars by someone acting irresponsibly.
Suleman had to know that starting a pregnancy that might create eight tiny lives was to risk killing herself, as well as killing or severely disabling one or more of the babies. Fortunately, she made it through the pregnancy. But the cost of neonatal care for her eight new children probably will exceed $1 million.
When they are discharged from intensive care, more millions of dollars in medical costs likely await, not to mention the help Suleman will need just to handle all of her children's basic needs.
Society needs to discourage mega-multiple births. And it is clear what needs to be done to accomplish that.
If the medical profession is unwilling or unable to police its own, then government needs to get involved. We already have rules governing who can get involved with adoption and foster care. Shouldn't these minimal requirements be extended to fertility treatment? And shouldn't some limit be set on how many embryos can be implanted at one time, along with some rules about what to do with embryos that no one wants to use?
Other nations, such as Britain, keep a regulatory eye on reproductive technologies and those who wish to use them, knowing their use can put kids at risk in ways that nature never envisioned. We owe the same to children born here."
Original article here.
"Something has gone terribly wrong when a 33-year-old single woman - who has no home of her own, no job, and a mother who worries her daughter is "obsessed" with having children - winds up with 14 of them. And all are under age 8, including eight newborn babies now in a neonatal nursery in various states of prematurity.
Examining what exactly went wrong may shed some light on what ought to be done. If doctors cannot prevent such a shambles from recurring, then society must.
The woman in question, Nadya Suleman, lives with her parents in a small home near Los Angeles. She has had infertility problems linked to blocked Fallopian tubes. She can make eggs, but they cannot be fertilized naturally because of the blockage.
Suleman apparently used donated sperm and in vitro fertilization to create all the embryos that became her children. She underwent treatment to cause her to produce many more eggs than the normal one per month, and they were surgically removed from her body and fertilized in lab dishes. Some of the resulting embryos were put back into her body, and that is how her first six children were made.
Unhappy with only six, Suleman sought further fertility treatment and had an additional eight of her embryos defrosted and implanted. They produced the now famous octuplets who, after a Caesarean section, are in intensive care at Kaiser Permanente Medical Center in Bellflower, Calif. Sadly, there is no known case of octuplets in which all escaped severe disabilities.
The most obvious questions raised by this sad saga include: How did Nadya Suleman become a fertility patient? And how did she get eight embryos implanted when she already had six young children to care for in a tiny house, with no partner and no income?
Some fertility doctors would answer that it's not their job to decide how many children a person can have. Jeffrey Steinberg, medical director of the Fertility Institutes, which has clinics in Los Angeles, Las Vegas and New York City, was quoted as saying: "Who am I to say that six is the limit? There are people who like to have big families."
James Grifo, a renowned fertility specialist at New York University, had little time for those wondering why Suleman was a patient. "I don't think it's our job to tell them how many babies they're allowed to have," he reportedly said. "I am not a policeman for reproduction in the United States."
With all due respect, the idea that doctors should not set limits on who can use reproductive technology to make babies is ethically bonkers.
If someone comes to a clinic with a history of child abuse, active drug addiction, and a rap sheet with serious felonies, should the doctor simply say: "If you have the money, I will make all the babies you want"? That gives cash and carry a whole new meaning.
Doctors have an obligation to consider patients' requests for treatment, but they do not have to honor them. One very good reason not to do so is if a doctor believes that what the patient wants would put children at grave risk.
Putting eight embryos into a woman is exactly that - putting kids at grave risk. Putting eight babies into the family of a single mom already trying to cope with six other young kids, with no money and little help, is putting kids at grave risk. The doctors who allowed Nadya Suleman to receive multiple embryos engaged in grossly unethical conduct.
The other major ethical problem raised by this story is the hijacking of health-care dollars by someone acting irresponsibly.
Suleman had to know that starting a pregnancy that might create eight tiny lives was to risk killing herself, as well as killing or severely disabling one or more of the babies. Fortunately, she made it through the pregnancy. But the cost of neonatal care for her eight new children probably will exceed $1 million.
When they are discharged from intensive care, more millions of dollars in medical costs likely await, not to mention the help Suleman will need just to handle all of her children's basic needs.
Society needs to discourage mega-multiple births. And it is clear what needs to be done to accomplish that.
If the medical profession is unwilling or unable to police its own, then government needs to get involved. We already have rules governing who can get involved with adoption and foster care. Shouldn't these minimal requirements be extended to fertility treatment? And shouldn't some limit be set on how many embryos can be implanted at one time, along with some rules about what to do with embryos that no one wants to use?
Other nations, such as Britain, keep a regulatory eye on reproductive technologies and those who wish to use them, knowing their use can put kids at risk in ways that nature never envisioned. We owe the same to children born here."
Original article here.
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