This is not your typical blog. We have recruited scholars and public policy analysts from around the world to provide daily news and commentary on the implications of bioethical issues for women. We hope you’ll bookmark this page and let us know what you think: just click on the comment link at the bottom of each post to join the discussion. To sign up for the WBP newsletter, visit our homepage at www.womensbioethics.org or follow us on Twitter at http://twitter.com/khinsch
Disclaimer: The opinions expressed on this blog are solely those of the individual contributors and do not necessarily reflect the official policy positions of the Women's Bioethics Project.
As the readers of this blog know, both myself and several of our bloggers have posted about universal health care coverage many, many times as an ethical and moral imperative. In the last year, my hopes (along with many other bioethicists, I'm sure ) of attaining universal coverage have gone up, down and sideways, like a roller-coaster ride, exhilarating and frightening, with emotions ranging from inspiration to resignation. Now that the US House of Representative has finally passed a health reform bill, I've requested several bioethicists (and friends of the WBP) to share their thoughts on the ethical implications of the passage of this bill:
Art Caplan of UPenn: "The passage of this bill, flaws and all, represents the elimination of the single greatest failure in American health care -- a lack of universal insurance coverage. With this legislation in place America can finally say after decades of failure that it has honored its responsibility to create equal opportunity for every citizen."
The “universal participation” piece was not fully accomplished, but very significant progress was made. Already today, however, news reports say that it will be under attack in several states. We will have to see whether it survives.
Perhaps the least appreciated aspect of the legislation is the set of strategies to make stewardship a reality (most commentators lump it under “cost containment”). Ezra Klein offers a very useful, brief summary here."
Ruth Faden, Executive Director of Johns Hopkins Berman Institute of Bioethics and Philip Franklin Wagley Professor in Biomedical Ethics says: "This historic legislation for the first time enshrines a national commitment to guarantee that all of us in this country have meaningful access to appropriate medical care. As a consequence, our society is now more just. Our people have a greater prospect of securing for themselves and their families not only more health, but also more of everything that is essential to human well-being, including personal security, respect and self determination."
"Can one be happy and angry at the same time? The passage of the health care reform package is cause for rejoicing: it helps the poor and dispossessed—a disproportionate number of whom are women and children--gain access to health care. But it was achieved at the cost of both parties’ affirming in very loud tones that if a woman is pregnant unwillingly, she has recourse to abortion only if she can pay for it privately. That so much of the rhetoric surrounding reform was given over to underscoring what has been the case since the Hyde Amendment was passed many years ago, leaves me furiously frustrated."
I am waiting for several other bioethicists to respond to my inquiries, and will post them upon receipt.
"So I'm a progressive, and I don't consider this bill, or Dennis Kucinich (D-Ohio), or anyone who supports this legislation to be "selling out" because it doesn't go far enough. The bottom line is 30 million more people will get health care coverage, and that will save lives now. Voting "yes" gets a foot in the door.
Change takes serious effort, but progress happens. The fight for women's rights didn't end when we got the right to vote in 1920; the Lily Ledbetter Fair Pay Act signed just last year was another move toward true gender equality. Civil rights didn't end with the Emancipation Proclamation or the Voting Rights Act of 1964.
HR 4872 is a crucial first step, and can be amended and improved, but doing nothing is not an option. Health care should be a basic human right. And no one should be uninsured, or underinsured, or go broke paying their medical bills in the richest country in the world."
I couldn't attend the ASBH meeting in DC this year, but apparently, Ezekiel "Zeke" Emanuel gave quite a controversial speech. While I don't have the text of the original speech, my guess is that it will be posted on the ASBH website at some point. But what I do have is Art Caplan's response, from which you can glean certain aspects of Zeke's speech -- I'll be interested to see/hear what kind of reaction this gets:
Facts alone won’t suffice for the field of bioethics
When you get old enough as a practitioner in any field young people seek your advice about what they should do if they want to do what you do. Given that my age seems to be increasing exponentially this has been happening to me with increasing frequency. Undergraduates, high school students, medical students, those pursuing degrees in law and nursing and even those interested in a mid-career change have been asking me what they need to do if they want to pursue a career in bioethics.
I have thought about their question quite a bit. I have come to realize that the answer is not the same for everyone who presents the questions. But, the core of the answer is pretty much the same; pursue masters level training in bioethics, acquire familiarity with key social science methods and tools, learn something about a particular sub-area of the health sciences or life sciences and, seek out every opportunity to fine tune your analytical and rhetorical skills by working with others on projects, research, consulting, or teaching activities. At its heart bioethics is an interdisciplinary activity and knowing how to work with others who do empirical, historical, legal and normative work is a must.
I had thought that advice to be sound until I heard Zeke Emanuel’s plenary address to open the most recent annual meeting of the American Society of Bioethics and the Humanities. Zeke espoused a vision for future bioethicists that I think is narrow, misguided and wrong. Now I say that in the spirit that Zeke himself enjoys—vigorous debate about a matter that both of us consider of the gravest importance.
Zeke Emanuel, a physician with a degree in political science as well, is one of the best and brightest scholars in the field of bioethics. His writings are solid and exemplify how best to integrate empirical inquiry with normative analysis. And the ‘shop’ he has run at the NIH Clinical Center for many years prior to moving into the Office of Budget and Management to work on health reform has done an outstanding job training younger scholars in the ins and outs of bioethical inquiry. These facts are precisely why Zeke’s recent plenary address to the American Society of Bioethics and the Humanities was so disappointing.
Zeke began his speech by joking that he knew much of what he had to say would annoy his audience. He then proceeded to argue that the future of bioethics and of bioethicists depended upon the field moving away from its high public profile in political, media and policy debate. What bioethics needs, he argued, is a beefing up of the shabby empirical foundation it now relies upon for its normative and policy claims.
The only way for bioethics to flourish, to paraphrase Zeke’s key contention, is if bioethicists spend less time in public places, more time mastering quantitative methods and publishing empirically grounded research on topics such as informed consent and surrogate decision-making at the end-of-life in peer-reviewed journals. He also went on to add that he did not find any merit in masters programs or PhDs in bioethics since without a more robust empirical foundation there could be little value in such training.
A young, wanna-be bioethicist, Zeke contended, would be best served seeking training in behavioral economics, psychology, decision theory or perhaps, he grudgingly conceded, sociology. Those armed with these tools could be expected to create the rigorous empirical foundation that bioethics now sorely lacks. Moreover, Zeke predicted, those willing to enter bioethics by heading down his prescribed path can expect generous financial support in the form of a pot of gold provided by a National Institutes of Health poised and eager to provide funding for rigorous research.
Before any prospective bioethicists answer Zeke’s clarion call for rigor by dusting off their applications to departments of economics and the behavioral sciences let me try to point out why Zeke’s vision about what bioethics should be is severely myopic as well as inadequate.
Zeke’s call for bioethics to take a sharp empirical turn has power because it is embedded in his talk of the importance of data and rigor. Both are indeed important for bioethics for a variety of reasons. But, neither will get bioethics where it needs to be if it is to serve health care providers, patients, policy makers or the public.
Bioethics, in my view, has a duty to engage the public with bioethical questions. The topics that bioethics grapples with—how to manage dying, the use of reproductive technologies, what to do to maximize the supply of transplantable organs and tissues, how best to promote clinical and animal research, what information you should expect to receive as a patient about your diagnosis and treatment—are of keen importance and legitimate interest to everyone, rich and poor; young and old around the globe. Part, albeit part, but nonetheless a crucial part of the bioethicists role is to alert, engage and help to illuminate ethical problems and challenges both old and new in the health and life sciences. Note I do not say to solve them nor to be seen as an authoritative source to whom bioethical issues ought be assigned. Rather bioethics’ role is both Socratic and prophetic—challenge, probe, question, warn, chastise, alert, and, as Zeke appreciates, irritate the powers that be when necessary.
In this role of moral diagnostician bioethicists must be responsible and strive for clarity in provoking public attention and debate. However, in this role data is often absent, in dispute or woefully poor. In addition questions loom large and pressing, passions run deep and fear and ignorance are omnipresent companions to doing bioethics with an eye toward helping the public understand issues and options. To engage in the public role that bioethics has and should enthusiastically continue to play in the media, policy, education, legislation and the law more tools are needed then empirical data no matter how rigorous or precise that data and the means used to generate it may be.
One must be able to present a cogent argument, know the areas of consensus that have been established about ethical issues over the history of medical ethics and bioethics, have a familiarity with health law, the infrastructure of policy and a grasp of political, cultural, literary, historical and social dimensions of what makes morality tick in various cultures. In the absence of these skills and knowledge data is completely and utterly blind, even useless. That is why it is precisely this skill set that the aspiring bioethicist should expect a masters program or a PhD program in bioethics to provide in order to gain the analytical and argumentative skills to competently and responsibly carry out the crucial public role bioethics has.
At the end of the day bioethics is a public activity which uses empirical inquiry and information as a tool. Admittedly empirical data are the most important of the tools in the bioethicists toolbox but still they are only one of the types of tools that are used.
Zeke’s vision of bioethics completely confuses the instrument—compiling reliable empirical information relating to normative issues—with the job—informing the public about problems, options and suggesting possible avenues for their resolution.
Zeke’s vision makes a bit more sense if one focuses on the role that bioethics plays within health care for professionals and institutions. There bioethicists often act as consultants or help formulate policy in ethically contentious areas working with providers and administrators and sometimes even payers. But even in this setting, while data is often essential it is never sufficient. Much of what occurs in doing an ethics consultation, for example, has as much to do with knowing how to mediate a dispute as it does a recitation of the facts of a case or having at hand well-supported information about the consequences of various courses of action. In many other situations the ‘facts’ are not known and won’t be known—ever because the human interactions are too complex. Bioethics at the bedside is very much an ethical, social and personal activity and while data has a part to play it has about as much a part to play as it does in our everyday lives and decisions which is to say—sometimes it matters, often it does not.
Before the young bioethicist is told to follow Zeke’s path of empirical positivism consider one other fact. We will not in our lifetime or that of our children ever achieve the kind of empirical certitude about much of anything of the sort that Zeke suggests will help future generations of bioethicists do their work. For every ethical problem for which sufficient data exists to point toward an answer a hundred blossom for which the data don’t. For every ethical problem for which sufficient data have been assembled to make an answer rational, sensible, or even self-evident there are many where behavior, policy and practice do not and cannot be made to conform to that data. Sometimes data alone can point toward an answer. Almost always, however, it is a prior moral argument that points toward the use to which data will, could and ought be put whether that be in medical practice or in medical ethics. And more often then not moral and value arguments simply moot data and that situation cannot be rectified by appeals to more data.
Zeke ended his remarks that day by acknowledging he was not really trying to end the public role or policy dimension of bioethics. Rather he was just trying to reorient the field’s priorities. I would suggest Zeke be heeded but only half-heartedly.
More data is needed in bioethics. More scholars with empirical quantitative skills are needed. That said, if the goal of bioethics is not simply to produce every-increasing amounts of NIH funded empirical data but rather to make a difference for the better in the lives of patients, their health care providers, scientists, and the general public then what we need and will continue to need are bioethicists who know their history, understand the power of cases, stories and analogical reasoning, can mount cogent, coherent arguments based on the best information at hand, who are comfortable talking with a state legislator, an NIH institute director, a TV talking-head, an athletic coach, a small town family doctor and a minister. Aspiring bioethicists would be well served to develop that full skill set and to seek out bioethics programs that can teach them to meet all of those needs.
Arthur Caplan, PhD
Sidney D. Caplan Professor of Bioethics
and
Emanuel & Robert Hart Director
Center for Bioethics
University of Pennsylvania
In an earlier related post on biobanking, we asked our readers if they thought whether or not one's DNA should be private or publicly banked; the response was overwhelmingly in favor of privacy. Similarly, the notion of property rights in application to genes and genetic information presents serious challenges, as the Council for Responsible Genetics has long argued; their Genetic Bill of Rights includes a section that states "All people have the right to a world in which living organisms cannot be patented, including human beings, animals, plants, microorganisms and all their parts."
Now this issue is going before the courts: A group of patients, genetic researchers, and professional associations have filed a lawsuit against Myriad and the US Patent Office for patenting the genes known as BRCA1 and BRCA2. From the NY Times this morning:
"When Genae Girard received a diagnosis of breast cancer in 2006, she knew she would be facing medical challenges and high expenses. But she did not expect to run into patent problems.
Ms. Girard took a genetic test to see if her genes also put her at increased risk for ovarian cancer, which might require the removal of her ovaries. The test came back positive, so she wanted a second opinion from another test. But there can be no second opinion. A decision by the government more than 10 years ago allowed a single company, Myriad Genetics, to own the patent on two genes that are closely associated with increased risk for breast cancer and ovarian cancer, and on the testing that measures that risk.
On Tuesday, Ms. Girard, 39, who lives in the Austin, Tex., area, filed a lawsuit against Myriad and the Patent Office, challenging the decision to grant a patent on a gene to Myriad and companies like it. She was joined by four other cancer patients, by professional organizations of pathologists with more than 100,000 members and by several individual pathologists and genetic researchers.
The lawsuit, believed to be the first of its kind, was organized by the American Civil Liberties Union and filed in federal court in New York. It blends patent law, medical science, breast cancer activism and an unusual civil liberties argument in ways that could make it a landmark case. "
The complete article is accessible here; stay tuned as we follow this case, which could change the landscape in the field of genes and patents.
[Editor's note, added at 7:55pm, EDT: Colleague and WBP Supporter Art Caplan comments on this topic in his regular MSNBC column here, commenting that it is not always a bad thing when patent lawyers feel queasy. :>) ]
Colleague and WBP supporter Art Caplan explains that the 1918 offers some lessons for us today and that all of us have a responsibility to keep swine flu from spreading:
When faced with the threat of disease, the impulse of most Americans is to think about medical technology and miracle drugs. These are not likely to be much help in the battle against swine flu — but the history books might.
As history has proven, the best way to halt a deadly virus is to keep infected people away from others. In 1918, an influenza pandemic caused by a strain of flu similar to the one identified in Mexico killed more people than died in all of World War I. Up to 50 million people died worldwide. The greatest number of deaths occurred among young adults between the ages of 15 and 35.
At the time, young American men were being mustered into military camps from all corners of the country to prepare for the war. A few brought to those cramped quarters a new strain of flu. They quickly infected one another at an astonishing rate. As they were ordered to ship out, the epidemic spread along the train lines they used, with the flu jumping into the civilian population at every stop, right up to the harbors and port cities where they departed. Many experts think the flu followed these troops on their convoys into Europe, causing millions more to die.
We risk making that same fatal mistake this time around.
The Obama administration has developed plans to send National Guard troops from all over the U.S. to the Mexican border to help contain the violence from the bloody drug war raging there. I hope that by now the White House has realized this is a really, really bad idea. Sending the Guard right now to battle drug war lords could accelerate the spread of the swine flu among a high-risk group while giving the virus a free pass to travel all over the United States as the troops rotate home.
The 1918 pandemic offers additional stark lessons. While an effective vaccine may be found against this rare strain of swine flu, it will take many months to produce in large amounts. The best weapons we have right now are not glamorous and have little to do with doctors, drugs and hospitals: They are isolation, hygiene and controlling large gatherings of people.
New Zealand just quarantined a group of students who had flown back from Mexico. We may need to do the same thing.
Americans are not used to giving up individual liberty in the name of the common good. But that attitude is exactly what diseases such as the swine flu virus thrive on.
Heading out to church, the movies, restaurants, subways, supermarkets, day care centers, schools and other places where large numbers of people gather is a recipe for spreading the virus. What if infected people and those who have close contact with them won’t stay home? What if people with symptoms slog in to work anyway? Will we intrude on their basic rights and make them stay home? Are we willing to cancel public events and close schools, museums and churches until the infection passes, no matter how loud the protests?
Good hygiene — washing your hands frequently; wearing a filtering mask; keeping doorknobs and surfaces clean; being careful about sneezing, spitting and coughing — is helpful in controlling the spread of nearly all infectious diseases, swine flu included.
Each of us needs to take responsibility for stopping the spread of the flu.
What the nation needs is not to send an army to sit in the path of a deadly virus. Instead, we need to prepare for a short period of time when individual rights to go where we want, spend time with who we want and assemble as we want yield to the necessity of protecting the common good.
Reprinted from MSNBC website, original article can be found here.
We had posted earlier about the ongoing debate on the ethics of DNA databasing -- here is round two in the debate. Our poll is still open, let us know where you stand!
Do you agree or disagree with the following proposition? (take our poll and we'll compare it with the Economist's poll results) :
People's DNA sequences are their own business, and no one else's.
Art Caplan and Craig Venter go toe-to-toe on this issue, with Art Caplan defending the privacy of DNA and Craig Venter arguing for public access. An excerpt of the discourse:
Art Caplan: "There are, it is increasingly said, plenty of reasons why people you know and many you don't ought to have access to your DNA or data that are derived from it. Have you ever had sexual relations outside a single, monogamous relationship? Well then, any children who resulted from your hanky-panky might legitimately want access to your DNA to establish paternity or maternity" ...to read more, click here.
Craig Venter: "As we progress from the first human genome to sequence hundreds, then thousands and then millions of individual genomes, the value for medicine and humanity will only come from the availability and analysis of comprehensive, public databases containing all these genome sequences along with as complete as possible phenotype descriptions of the individuals"...to read more, click here.
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."
Friend and colleague Art Caplan comments on the ethical issues surrounding Venezuelan beauty pageants on Bloomberg.com:
"Eva Ekvall says she was 17, a little overweight and dreaming of winning enough to buy a car when she entered her first beauty contest. Plastic surgery was the last thing on the young Venezuelan's mind.
Then she met Osmel Sousa, the Pygmalion of her country's beauty industry. Three months later, weighing 10 kilograms (22 pounds) less, her nose reshaped, and with breast implants, Ekvall was crowned Miss Venezuela...
Cuban-born Sousa, 60, who has run the Miss Venezuela franchise since 1981, is responsible for most of the country's five Miss Universe, five Miss World and five Miss International titles. He openly encourages surgery.
``This isn't a nature contest,'' Sousa said in an interview as contestants in swimsuits and high heels practiced choreography for the 2008 Miss Venezuela pageant, which took place in Caracas on Sept. 10. ``It's a beauty contest, and science exists to help perfect beauty. There is nothing wrong with that.'...
Arthur Caplan, director of the University of Pennsylvania's Center for Bioethics questions Sousa's endorsement of aesthetic surgery.
``No surgeon can say that giving breast implants to a 17-, 18-year-old for beauty reasons is ethical,'' Caplan said by phone from Philadelphia. ``It's terrible that these pageants are turning into plastic surgery competitions and are no longer about real beauty.''
Surgical enhancement is permitted and is common among contestants, said Paula Shugart, president of the Miss Universe Organization, a joint venture between billionaire real estate developer Donald Trump and NBC Universal Inc...." [Full article can be accessed here.]
A commentary by friend and colleague Art Caplan in his MSNBC column:
'Change' was the horse that Barack Obama's presidential campaign rode to victory. Indeed the 2008 election will be remembered not only for Obama becoming the first African-American president, but also for its impact on core bioethical topics that have long dominated American domestic politics.
Divisive issues such as abortion bans failed to gain traction on state ballot initiatives, while newer bioethical concerns that are likely to dominate American politics for years to come, including physician-assisted suicide, emerged.
The past eight years of the Bush White House have seen stem cell research and the status of embryos at the center of the moral values debate. Obama's election has brought the fight over embryonic stem cell research in the U.S. to an end.
Loosening stem cell research The state of Michigan passed Proposal 2, loosening restrictions on embryonic stem cell research. This means that in Michigan - whose universities such as Michigan State in East Lansing are major biomedical research powerhouses - scientists will be able to use the excess embryos created at in-vitro fertility clinics as a source of stem cells for research, as long as they have the written consent of the parents who sought treatment.
There are now 10 states that have laws permitting embryonic stem cell research. These 10 are likely to be the recipients of an executive order that the new president will undoubtedly sign shortly after taking office, freeing up federal funds for embryonic stem cell research while laying out new regulatory guidelines.
One of the main arguments against embryonic stem cell research is that all embryos are persons from the moment of conception. The voters of Colorado were given the chance to put that view into law with the proposed Amendment 48. The so-called "Personhood Amendment" sought to define fertilized eggs as human beings, extending them constitutional rights. Coloradoans defeated this amendment by a margin of three to one.
Many, including myself, would argue that the ongoing debate over the morality of stem cell research is really just a stalking horse for the abortion debate. But efforts to further restrict abortion did not fare well at the ballot box, either. California voters rejected a proposition that would have required doctors to notify parents before performing an abortion on a minor. The initiative also would have required a two-day waiting period before minors could get abortions.
In South Dakota a measure that would have banned abortions - except in cases of rape, incest and serious health threat to the mother - also lost. An even tougher version, without the rape and incest exceptions, was defeated two years ago. The 2008 initiative went down to a resounding defeat of 55 percent to 45 percent.
Taken all together this series of votes represents an important moment in public bioethics in America. Like it or not - and I am well aware that many are not ready to let go of these issues - the nation may be starting to move past the endless battles over stem cells, embryos and abortion. Stem cell research in all forms is proceeding. Embryos are not going to be given legal status as persons. Further restrictions on abortion are unlikely.
There will still be plenty to fight over! The most important topic to emerge from this election is how Americans die and treat painful medical conditions.
Michigan became the 13th state to enact an amendment legalizing marijuana use for medical purposes. Proposal 1 passed by a margin of 63 percent to 37 percent. It allows patients with "debilitating medical conditions" to register with the state and, with the permission of a physician, legally buy, grow and use small amounts of marijuana to relieve pain, nausea and appetite loss, among other symptoms. Massachusetts decriminalized possession of one ounce or less of marijuana, shifting the penalty to a $100 fine.
Help for terminally ill Americans are clearly telling Washington that they want dying people to have access to whatever helps make that process less burdensome. It will be interesting to see how the new administration grapples with that message. If no one listens, then a much more controversial option may emerge - physician-assisted suicide.
Perhaps the most startling measure to pass at the state level was in Washington's Initiative 1000, offering terminally ill people the option of physician-assisted suicide. Washington voters decided that adults who are deemed competent and have been given less than six months to live by a physician can legally request and self-administer lethal prescription medicine. The measure passed by a margin of 59 percent to 41 percent. This surely will not be the last state-level effort to legalize physician-assisted suicide if other policies aimed at minimizing the suffering of the dying are not enacted. While I have my doubts about the wisdom of offering help in ending one's life before offering them health insurance, I suspect it will become a political hot potato in a number of states in the next few years. An aging population, the increasing cost of medical care and a lack of high-quality palliative and nursing-home care almost guarantee it.
The pundits will spend the next few months analyzing the election, pontificating on what led to the Obama victory and the Democrats taking greater control of Congress. They won't find the answers if they do not pay attention to the clear messages Americans sent concerning critical bioethical questions.
Art Caplan brings us all up to speed in his latest MSNBC column:
Last week, a newly released study showed that half of all American doctors who responded to a nationwide survey say they regularly prescribe placebos to patients. This news captured a lot of media attention and elicited a round of ethical hand-wringing with many experts wondering if systematically deceiving patients by giving them placebos without telling them was right. But ironically, there is a paper out this week in Public Library of Science Journal that is getting nowhere near the same attention as the placebo study, but raises a far more serious concern: Doctors prescribing off-label medicines that may not work.
In 2001, the last year for which data is available, American physicians wrote 150 million prescriptions off-label to treat conditions for reasons other than the ones for which the drugs were approved. This represents 21 percent of all prescriptions written for 160 of the most common medications used in the United States. About three-quarters of all off-label prescriptions were written for conditions for which there was little or no scientific support to show that they worked.
The manufacturers of these drugs apparently believe the practice is ethical. In the article, two physician researchers, Dr. Adriane Fugh-Berman and Dr. Douglas Melnick, say that despite the fact that it is illegal for pharmaceutical companies to promote drugs for off-label uses, drugmakers still find ways to do so — primarily because there is so much money to be made from the practice.
Drug companies sometimes seek approval from the U.S. Food and Drug Administration for an obscure use for a new drug knowing that it is likely it will be picked up for much wider use off-label. A “decoy” indication for a rare or unusual condition may get a drug approved quickly while the company gears up a subtle campaign to suggest off-label uses for which no data has been given to the FDA.
Doctors not bound by same rules The key to encouraging off-label use is to make sure no one working for the company suggests any such thing. But if prominent, respected physicians can be recruited to give talks for the company concerning a drug, they are free to say what they want about possible off-label uses.
Flooding medical meetings with abstracts, posters and other additions to programs that are not obviously sponsored by industry creates more buzz for possible off-label uses. These practices are so lucrative that some drug companies pursue them even at the risk of huge fines. In the past few years, Schering Plough, Cell Therapeutics, Purdue-Pharma, Cephalon and many other companies have paid billions in fines even as the practice of surreptitiously promoting off-label uses flourishes.
What we now have is a huge amount of money being spent on what are often placebos. The system for regulating off-label use is not working and needs to be toughened. And it makes sense for the next presidential administration to consider creating an agency that can serve as an independent, publicly funded source of data on the safety and efficacy of off-label use of drugs.
Until changes are made, what you really need to know from your doctors is not whether they are using placebos but whether the drugs they prescribe for you are off-label and why.
In the NY Times, a number of bioethicists comment on a plan to deploy a special ambulance to collect the bodies of people who have died suddenly from traumas or heart attacks and try to preserve their organs: "The organ team would wait five minutes after EMTs give up on resuscitation, to create a clear demarcation between efforts to save lives and those to preserve organs. 'The process of resuscitation would be very distinct from the process of organ recovery so that we would be sure that, ethically, there's no potential for an overlap or misconstruing of what's going on,' said Bradley Kaufman, a top medical director for the New York City Fire Department, which operates ambulances."
However, a number of bioethicists, such as Michael A. Grodin, Robert Truog, Art Caplan,Leslie Whetstine, and Nancy Dubler, who is helping vet the plan, have expressed concerns that the plan may undermine public trust in emergency medical care and the organ donor system and aggravate fears of disadvantaged groups that already harbor deep distrust of the medical system.
Over at MSNBC, Art writes that he's not so sure that Pistorious should be allowed to compete in the Olympics:
Should anyone who must run on prosthetic legs be allowed to compete in the Olympics or other sporting events?
Oscar Pistorius, a college student from South Africa, has been told he can compete in the Beijing games this August, in either the 400-meter or the 1600-meter relay race as a member of the South African team, if he can reach a qualifying time.
The decision has been greeted around the world with approval. Some see it as a triumph for the disabled. It is easy to see why. Pistorius, known as the Blade Runner, is a very appealing, articulate young man who trains hard and sincerely wants a chance to compete. But I am not sure letting him run is the right decision.
Pistorius was born with major bones missing in both his lower legs. His legs were amputated at the knees when he was a child. He runs using artificial limbs made of carbon fiber, known as Cheetah blades. The controversy over whether Pistorius should be allowed to compete has focused exclusively on whether his Cheetah blades give him an unfair advantage.
Last January the International Association of Athletics Federations (IAAF) said, based on a report from a German scientist, that mechanical legs give anyone using them an advantage in a race. They are more energy efficient than human legs, ultra-light, springier and do not fatigue. The IAAF said since the Cheetahs helped athletes perform better, it would ban their use. That decision meant no Olympics for Pistorius.
Pistorius appealed the ban to the Court of Arbitration for Sport (CAS) in Lausanne, Switzerland. Scientists at six universities in three nations took a look at Pistorius’ artificial legs. They concluded that the available evidence about the advantages of the Cheetah blades was insufficient. Last week the court said that, until more evidence was produced, Pistorius was eligible. The IAAF backed down and Pistorius can now compete.
What if further study does show that Pistorius can run faster because his artificial Cheetah blades work better than legs? Should he or others be kept out of competitions involving able-bodied persons?
