Thursday, January 31, 2008
All month long, you'll be able to buy products that have gone red, from a variety of sources that pledge to donate a percentage of the sale to women's heart health. While this is a great concept, make sure you check it out before you commit to buying a red product. As with any other product/donation campaign, different companies donate different amounts and have different rules for how they donate - and some are surprising. This isn't to discourage people from buying red - only to encourage smart shopping!
And as for tomorrow, I'll definitely be one of the ladies in red. (I don't know what it is with the musical references today, so sorry!)
This would be alarming news to receive about any major pharma company, regardless of their involvement in the import/export industry, but the fact that Shanghai Hualian is the sole supplier of mifepristone (RU-486) for the United States raises even bigger concerns.
So far, the contaminated medications have been isolated to a factory about an hour away from the one that makes RU-486, but obviously when a company has one manufactoring problem, concern spreads to the entire system.
The United States Food and Drug Administration declined to answer questions about Shanghai Hualian, because of security concerns stemming from the sometimes violent opposition to abortion. But in a statement, the agency said the RU-486 plant had passed an F.D.A. inspection in May. “F.D.A. is not aware of any evidence to suggest the issue that occurred at the leukemia drug facility is linked in any way with the facility that manufactures the mifepristone,” the statement said.
When told of Shanghai Hualian’s troubles, Dr. Sidney M. Wolfe, a leading consumer advocate and frequent F.D.A. critic, said American regulators ought to be concerned because of accusations that serious health risks had been covered up there. “Every one of these plants should be immediately inspected,” he said.
The director of the Chinese F.D.A.’s drug safety control unit in Shanghai, Zhou Qun, said her agency had inspected the factory that produced mifepristone three times in recent months and found it in compliance. “It is natural to worry,” Ms. Zhou said, “but these two plants are in two different places and have different quality-assurance people.”
And while I do see this point, and agree with it to a degree, but given recent concerns both about the FDA and it's process, as well as China covering up manufacturing and health issues... I would certainly feel a lot better if the FDA released something more concrete than a no comment. That the FDA won't reveal what other medications are made/imported by the company also is worrisome. Again, on the one hand, I can understand not wanting to run consumers off by fear - but on the other hand, a lot of pets died because of contaminated food. Do we want to see the same health risks in our medications?
(*And as an aside, apologies to anyone else who now has Soft Cell's Tainted Love spinning 'right round in their head.)
You've likely heard about plans -- some in place (as in Massachusetts), some proposed (like the one just rejected this week in California) -- to require that individuals purchase health insurance. It being an election year, we're likely to start hearing more, soon, about the candidates' plans for fixing the health care "system." Such individual-mandate approaches may be part of that picture.
Just in time, here's a chance to learn more: you can tune in to a live webcast today at 1:30 ET, sponsored by the Henry J. Kaiser Family Foundation. It should be an informative session, featuring a panel of well-known experts in health policy and finance.
If you can't tune in today (sorry for the short notice!), the archived webcast will be available online afterward.
A little different approach than the previous post we had on Gender: Love it or Kill it?.
The full article can be accessed here, subscription required.
Wednesday, January 30, 2008
Our friends at RH* Reality Check just posted that they've named this blog--along with several others--"Excellent."
Thanks to RH Reality Check, and congratulations to WBP and to the blog contributors!
....*that's for Reproductive Health
Tuesday, January 29, 2008
Indeed. In a study published this month in the Journal of General Internal Medicine, of 466 physicians surveyed at medical schools in the Chicago-area, 45% admitted to prescribing placebos to patients without the patient's knowledge, a practice striking at the very heart of Western medical ethics: informed consent.
Even more startling, one in five doctors admitted to actually lying to patients, claiming the placebos were medication, in clear violation of American Medical Association (AMA) guidelines, which directs its members to use placebos only if the patient is aware of and agrees to it.
Perhaps some might argue that the issue is not that significant--since placebos are viewed as harmless--but just how important is it? Particularly in terms of the doctor-patient relationship? Others might argue it raises major trust issues, and even a violation of patient rights.
See the full Time.com article here.
The father, James Boldt, converted to Judaism in 2004 and wants the boy to be circumcised as part of the faith. The mother, Lia Boldt, appealed to the high court, saying the operation could harm her son physically and psychologically.
The state Supreme Court ruled that earlier court decisions failed to determine whether the boy wanted the circumcision, as his father contended, or opposed it, as his mother alleged.
The Supreme Court sent the case back to the trial court to answer that question.
If the trial court finds the child agrees to be circumcised, the Supreme Court said, it should deny the mother's requests. But if the trial court finds the child opposes the circumcision, the court has to determine if it will affect the father's ability to care for the child.
The custody dispute began when the child was 4 and the circumcision issue began three years ago when he was 9.
We have several interesting issues impacting this case. First: informed consent of the patient. Is a 12 year old mature and competent enough to make a decision about this permanent operation? There is a precedent in our society that denies non-medically indicated permanent procedures. For reference, most physicians deny elective sterilization operations to women even if they are of legal, consenting age (depending on the state, 25 is often used as a "no questions approval" cutoff).
Second, what is the nature of the circumcision procedure? Ought it be considered a ritual fully protected by free exercise of religion, or an elective permanent surgical procedure for non-health related reasons, thus violating the non-maleficence clause of the Hippocratic Oath? Note the sliding scale of the perceived magnitude of circumcision - from something akin to a piercing to mutilation of one's body and bodily function.
Third, the dispute between the parents should be considered carefully, and both parties' motives must be separated from what is in the best interest of the teenager. However, the "father's ability to care for the child" should not be used as a factor, as it should be categorically seen as a sign of unfit parenting to abuse or neglect one's child for not conforming to religious practice.
In my opinion, a case would be made for supporting such a procedure on someone not legally competent only if 1) there were a medical indication or 2) there were a time-sensitive factor to the procedure in terms of reducing side effects or discomfort. Thus, there is potential for supporting circumcision of infants over children or teenagers because some believe less pain is felt at that time (I do not endorse this position, I simply present it for argument) than would be felt later on. And there are rare cases where a circumcision is medically indicated in a child or a teenager due to developmental or other impairments.
However, this situation does not fulfill either criterion - a 12 year old does not have time-sensitive reasons for seeking a circumcision, there is no medical indication, and even the religious argument falls short due to the father's recent conversion. I do not see a reduction in suffering that would result from the operation occuring now or occuring six years from now, but the difference legally, cognitively, and ethically would be significant. Therefore, while I applaud the court's intent to look to the teenager's wishes, I do not feel that he is able to ethically consent to such a procedure at this time, and there should not be a circumcision until he comes of legal age of consent.
Addendum: Upon further reflection, I suspect that this is an attempt by the court to foist responsibility for the act (or non-act) onto the teenager so they do not have to risk appearing to be anti-religion. If so, that is an irresponsible course of action.
Professor Julian Savulescu, director of the centre of practical ethics at Oxford University: "To fail to do beneficial research is as harmful as doing harmful research," he says. The whole article is available here.
And oh, yeah -- and James Hughes of the IEET quips: "When I get enhanced I want to look like Julian. Oh, and be tenured at Oxford also."
The new ABC show Eli Stone, which I have quite been looking forward to - the premiere has George Michael as prophet singing Faith - is by the same producer who's given us Brothers & Sisters and Dirty Sexy Money. So I was thinking "how in the world could this go wrong, it'll be fabulous!"
Well, apparently the world likes to make a point sometimes. The American Academy of Pediatrics wants the first show either pulled or substantially re-edited, because the opening scene involves a woman suing a pharmaceutical company over the supposed autism/vaccine link, saying that it's the reason her child is autistic. The link we know doesn't exist. Where the lead researcher involved was charged with misconduct in an effort to put the link/controversy to rest. The lawyers settle, after the woman makes your typical heartwarming by a wronged mother speech.
Given the description, you would think that the pharma companies would be going after ABC, but instead it's the pediatricians. They're worried that the heavy promotion ABC has been giving Eli Stone (a new show in a sea of repeats due to the writer's strike), and the likelihood of high viewership, will result in frightening more parents away from vaccinating.
The sad thing is, it's clear from the entire set-up that the scenario is supposed to make us dislike Eli, the main character, so that at his redemption we feel something for him. But it would have been completely possible to make him an utter bastard of a lawyer - and not propagate medical misinformation in the process.
ABC's response, to run a website for the CDC at the end of the show, isn't going to alleviate fears - it's not even going to address them. It's the difference between using scare tactics to get a message across versus a mass mailed flyer. And ultimately, they're counting on popular misconception and fear to tell their story for them, which is plain lazy writing.
But don't take my word for it, make your own decision. You can see for yourself. The first seven minutes of the show are available at ABC. Just select Eli Stone from the left side menu, and then select the sneak peak episode.
Monday, January 28, 2008
Today's example is researchers who are working to find ways of reducing the use of animals in research (AP story). Contrary to what some critics seem to believe, it's simply not true that researchers who work with animals don't care about the animals' welfare. You can listen to a pretty powerful story that illustrates what I mean here--the link you want is the first one, "Don't Fall in Love with Your Monkey."
Research that aims at reducing the number of animals used in research by finding technological substitutes, research that tries to find ways of reducing the pain and distress animal subjects experience when they are used in research--these are not super-high priorities for federal funding. (You can learn more about protections and guidelines that govern the use of animals in research here.)
It's worth noting that the push for the research referenced in the news tag above is partly a response to help corporations deal with the upcoming EU ban on animal testing. There's a lesson here: when financial incentives exist to build a better mousetrap (sorry for the unfortunate metaphor), science will focus on the problem...whether the funds come from the feds, from corporations, or from abroad.
According to the Times, Shaping Youth http://www.shapingyouth.org founder and bloggger contacted the retailer to complain that ad was demeaning and was reported told that the retailer does not respond to “nontraditional media;” the Times concludes by saying that the retailer “does not plan to change it’s ads.”
The crotch shot is indeed repugnant, but hiding behind the source of the criticism rather than taking it on raises the ante on this one. The traditional media are of course the ones who are tone deaf to this sort of issue. If you have not been reading the inside back cover of MS. Magazine, check out their “No Comment” feature, a roundup of “traditional” advertising that is depicts women in sexual and/or degrading ways in order to sell ordinary sort products and services completely unrelated to sex. http://www.msmagazine.com/spring2005/nocomment.asp
It is noteworthy that the male version of the ad mentioned here depicts him skating across the logo. The focus on the woman’s crotch distracts from less obvious problems with this and other ads: women are depicted as immobilized, passive, pinned while men are active, dominant, in control. For me, this is the more disturbing element since it flies under the radar and is less accessible to criticism yet arguably has a greater role in maintaining the conceptual underpinnings of women’s subordination. I have benefited in thinking about these issues by Jane Caputi’s powerful work on “The Pornography of Everyday Life” from her book _Goddesses and Monsters: Women, Myth, Power and Popular Culture_. [Full Disclosure: Caputi is my colleague and friend.]
Now, what shall we do about this retailer and others who do not take the dignity of women seriously?
Sunday, January 27, 2008
The reason for this isn't as gruesome, nor as forensic show plot-y as it sounds. It's actually rather simple; when preparing a brain, during an autopsy, it typically takes longer to prepare the brain for viewing than it does to release the rest of the body for burial/cremation. Once the examination of the brain is done, and final cause of death has been determined, the brain is disposed of like most other medical waste - incineration.
But it raises a host of ethical, legal and social issues. Many people, backed by many different religions, believe that the body must be returned to the ground whole, for various reasons involving religious tenants and the afterlife/Resurrection. Others, perhaps fueled by media reports of wrongdoing on the part of funeral directors and the like, simply fear what is happening to those body parts - are they being used for research without permission? Unauthorized grafts or transplants? They want accountability for the whole of their loved one's body, and feel that it is well within our cultural history to demand it.
The defendants argue that this will severely harm their practice, of forensics and crime scenes, of autopsies, and perhaps more. After all, they point out, when a body dies, fluids - blood and more - are lost at the scene, and this is not collected for return. Likewise, there are times when the entire body simply cannot be returned, due to the natural of the death itself. Or most simply, as attorney Mark Landes has pointed out, it is a definitional impossibility to both do an autopsy and return the entire body.
Unfortunately, this is a situation of cultural and social beliefs hitting up against practical considerations and laws - we need to know how people died, particularly when it is a suspicious death, but we want to respect the religious and cultural beliefs of the people involved. And there are times when the two simply cannot be reconciled - and in those cases, what do you do?
I know what my decision would be - what's yours?
her body achieved what doctors said was the holy grail of transplant surgery. “It’s kind of hard to believe.” Brennan’s body changed blood group from O negative to O positive when she became ill while on drugs to avoid rejection of the organ by her body’s immune system.Her doctors are now, of course, looking in to how to repeat this success.
Her new liver’s blood stem cells then invaded her body’s bone marrow to take over her entire immune system, meaning the teen no longer needs anti-rejection drugs.
Just goes to show, eh?
Saturday, January 26, 2008
According the Daily Mail, British neuroscientists found that exposing middle-aged mice to infrared light for six minutes a day help to improve their performance in a cognitive tasks. The prototype cognitive helmet, a futuristic looking headset, is scheduled to be tested in the human trials starting this summer. The rest of story here.
Friday, January 25, 2008
The second one reports on a research study published in Archives of Surgery (abstract). The NYT article reports, accurately, that the study found that women whose post-mastectomy reconstruction used silicone implants instead of women's own tissue were twice as likely to acquire infections. But there are a couple of interesting things you might notice, if you go look at the abstract.
One is that the absolute risk of infection in these procedures is 12.4% for women with implants, and 6.2% in women whose reconstructions don't involve implants. Double, yes, fair enough. But the abstract also notes and that women who had mastectomies without reconstruction had a 4.4% risk. So...a fairly substantial increase in relative risk occurs between women who forego reconstruction and those who have it, with still higher risks for those who also choose implants. But if you look at the news reports, no-reconstruction, interestingly, is not even reported on as a possible choice. How come? (No hate mail, please: I don't in any way mean to imply that women should or shouldn't have reconstructive surgery, only that the way this particular study has been reported in the popular press is somewhat misleading.)
If you look at the abstract yourself, you might notice a few other things that might give you pause. The study included only 50 women in total--not a very substantial sample size. And the finding that was picked up by the media was incidental to the primary finding of the project, which focused on the economic costs associated with such infections. Also, the study sample was women on their initial hospital admission for the mastectomy/reconstruction procedure, and women who were readmitted...which could conceivably leave out women who *didn't* experience infections as a result of these surgical procedures.
Given how much of our health information comes to us through media filters, we need to be savvy consumers of that information. We need to understand how research works, so that we don't uncritically accept the media spin of research reports. Something happens to research results when they are morphed into news bites...and if we're basing health care decisions for ourselves and our families based on that information, we've got to know how to read critically. It's my hope that we can educate ourselves about how to be more critical consumers of media products. At the same time, I'd like to see women apply judicious pressure on the media to step up to the educational role, and not just pursue the latest bright shiny object.
This genome is more than 10 times as long as the longest piece of DNA ever previously synthesized. What it means is the possibility of scientists to be able to one day design an organism on a computer, press the “print” button to have the necessary DNA made, and then put that DNA into a cell to produce a custom-made creature, a possibility certain to raise many ethics questions in the minds of scholars and laymen alike.
See details of this emerging technology in this from the NY Times.
The plan combines ideas to improve general population health, with a focus on shifting to preventive medicine, and tax credits to encourage people to buy coverage.
Blue Cross did not name specific levels for its proposed tax credits but said they would go to low-wage workers in small businesses, people whose health premiums represent a large share of their income, people without access to employer coverage and those who have lost a job.Of significant interest, given recent conversations and posts regarding the FDA and Big Pharma here on the Women's Bioethics Blog, is the Blue Cross proposal to create "an independent institute to back research comparing the effectiveness of new and existing drugs, devices and medical procedures."
The association also proposed helping states find and enroll people who are eligible for existing public health insurance programs but are not using them.
The Blue Cross and Blue Shield Association said the tax credits envisioned would cost the U.S. government $50 to $100 billion per year, but the overall proposal also would yield other savings as uninsured people get coverage and cut down, for example, on hospital emergency room costs.
I haven't had a chance to read more than the media coverage of the proposal itself, but if you're interested, the BBC has a link to the proposal pdf for download.
What started out as a course of 8 students, with 2 dropping, has turned into an 800 person mega-course - so putting it on the internet was an obvious next choice. Of course, Harvard isn't the only school offering courses on happiness - it's a growing trend.
To learn more about the Harvard Extenion course, click here. And to see Dr. Ben-Shahar talk about the class, and his related book, Happier: Learn the Secrets to Daily Joy and Lasting Fulfillment, click the embedded link below, of his interview on The Daily Show with Jon Stewart.
Thursday, January 24, 2008
Read details of the pioneering research, from the Washington Post
Well, if you look at the blogging universe, all indications are yes. And it's important to note that these bloggers, many of whom see nearly 4,000 unique pageviews a day, aren't just arguing that 'big is beautiful'. They're actually arguing that the medical experts are wrong and there's no obesity epidemic, that people come in all shapes and sizes, and as long as you exercise, eat sensibly, and are healthy (a philosophy known as 'Health At Every Size'), it shouldn't matter what your physical measurements are, or what size clothing you fit into.
The bloggers argue that changes in definitions over time, along with flaws in the body mass index formula, have pushed more Americans into the “fat” and “obese” categories, and they point to provocative studies suggesting that there may be benefits to being overweight, including a large study that found that underweight Americans are more likely to die than those who are moderately overweight.These are certainly complicated and often sophisticated arguments coming from people who are both vested in their interest, and are lay people who've done a remarkable job at educating themselves in a subject that many medical professionals don't full understand. But I see several inherent dangers in the fat-acceptance movement in the blogging universe.
Several other recent studies on heart patients and dialysis patients have also reported higher survival rates among heavier patients, suggesting that the link between body size and health may be more complex than generally acknowledged. Another study of people over 60 found that being fit has more bearing on longevity than simply being thin.
The bloggers’ main contention is that being fat is not a result of moral failure or a character flaw, or of gluttony, sloth or a lack of willpower. Diets often boomerang, they say; indeed, numerous long-term studies have found that even though dieters are often able to lose weight in the short term, they almost always regain the lost pounds over the next few years.
First and foremost is a tendency to not separate out the difference between overweight and obese - and these are terms that, in medical parlance anyhow, do have different meanings. And while these bloggers have gone and educated themselves, their issue with the concept of BMI to determine health of weight has led them to lump the reports they cite, the ones that indicate being moderately overweight might have health benefits, with those who are morbidly obese. And there is a big difference to your health and body between being 20lbs overweight and being 100lbs overweight.
I'll be the first to agree that there is a problem with the BMI scale - but also the first to point out that you'd be hard pressed to find someone whose health would not improve if they were to lose 100lbs of extra weight.
The second, and perhaps more serious, problem I see with this fat-acceptance movement is that people are notoriously bad at underestimating the amount of food they eat. It is because of this typical tendency to underestimate the calories we consume that the New York City health commissioner, Dr. Thomas Frieden, is once again pushing to have calorie information clearly labeled on menus in the City. He believes (and I tend to agree) that people will quickly stop ordering their favourite appetizers when they realize that appetizer has 2500 calories.
It's very easy to say that you eat right and exercise and cannot lose weight - but in my experience, at least, I've found that most people who make this claim (myself included) tend to "forget" a lot of the calories they consume over the course of the day, or overestimate how many calories their exercising should burn. And without a strict log of what you're eating, and the help of a nutritionist, it's often difficult to know both of these numbers.
We do need to be careful that there is not a moral judgment when talking about people's weight. Shaming doesn't work as a weight loss tactic, and people shouldn't be shunned or ostracized for weighing more than normal. But at the same time, most people who are overweight are, at least in the eyes of people who work in this field for a living, like Dr. Walter C. Willett, professor of nutrition and epidemiology at the Harvard School of Public Health, overweight because of their lifestyle and not their genetic predispositions. I think we're doing a disservice to everyone by coddling feelings and pretending that weight doesn't have the ability to negatively impact health.
Now to be clear, I don't think everyone should be a size 6, nor do I think being ultra-thin is any better than being seriously overweight. But the condemnation of the so-called "thinspiration" blogs is pretty universal; no one seems to think they are a healthy concept, no one seems to think that they are standing up against some great medical conspiracy or anti-thin hysteria. In fact, just about everyone seems to think they are very unhealthy mentally and physically, and something should be done about them. I just wonder why blogs on the other side, making the argument from a "fatspiration" rather than "thinspiration" point of view don't receive the same critiques.
The question being asked is: Are you an obnoxious patient? I wonder how many of us can admit it if we are. In my case it becomes especially difficult to be objective since I feel like I have a vested interest in getting better, unlike my doctor to whom I may be just a patient. I also feel like I have learned a lot about my specific condition and I know which symptoms specifically apply to me. Yet, on the flip side, it is important to realize that the physician has probably seen a thousand patients like me and probably knows more about the progress of the condition and what I should expect. I guess its difficult being a partner... and trusting your partner.
If we can figure out how to do gradual and safe reperfusion of the cells, will this change the definition of death? This would be a incredible advance, similar to when CPR became standard practice.
In a similar vein, the International Network for the Definition of Death, an affiliate of the International Association of Bioethics, is having its 5th International Symposium, and is devoted to the discussion of the ethical and medical issues associated with:
|diagnosis and differentiation of brain death, coma, and persistent vegetative state|
|differentiation of anencephaly and other severe neurological deficits from brain death|
|organ transplantation and termination of treatment decisions for the brain-dead and neurologically impaired|
|philosophical issues of personhood and rights related to the status of the brain dead and neurologically impaired.|
For more information on this, click here.
Wednesday, January 23, 2008
As promised (or warned--I guess it depends on whether you think this is an interesting issue), here is another thing to think about with regard to genetic biobanking studies.
So: say you've agreed to participate in a research study that is trying to identify whether there is a genetic contribution to breast cancer. In this particular study, the researchers will follow a cohort of women who have not developed breast cancer at the time of enrollment. The researchers will take blood samples and do physical exams periodically. They will also sequence your DNA. As time goes on, some number of women in the study cohort will develop breast cancer, and some won't. The researchers will look at the DNA sequences to see whether there are different patterns in the genetics of the women who develop cancer as compared with those who don't. If they find such patterns, they'll go on to investigate what those specific mutations do.
This kind of research, which is called a genome-wide association study, GWAS for short--because it's looking for associations between genetic patterns and disease--is a lot like a fishing expedition. (You can learn more about these studies in this archived Science Friday audio panel with Ira Flatow.) How GWAS's work has a couple of important implications. One is that, for such studies to work at all, researchers need really big datasets to sift through. Another is that the same dataset could be used for lots of different purposes.
For these reasons, and for efficiency and cost-effectiveness reasons as well, the National Human Genome Research Institute (NHGRI) is trying to develop plans to pool or share such datasets across different projects.
Think back to our breast cancer study example. If you'd consented to participate in that study at your local research university, how would you feel about your (de-identified) information being used by researchers somewhere else? Would you feel that you needed to be offered the chance to opt out of this "wide data sharing?" Or would you feel that your original consent covered such subsequent uses?
Here's another permutation to think about. Say the researchers did the breast cancer study, and in the course of that work they noticed that there seemed to be a correlation between certain genetic patterns and alcoholism or schizophrenia. Would it be ok with you for them to pursue this line of inquiry using your genetic information? Would you feel that you needed to be offered the chance to opt out?
You can read about the NHGRI policy, and the scientific community's reaction, in The Scientist, here. Salon.com ran an article a few years ago about a much smaller open-source approach to genetics, here (which is where the nifty kitty photo came from).
Tuesday, January 22, 2008
The experiments, using a technique called somatic cell nuclear transfer (SCNT), provide key steps toward the development of patient-specific embryonic stem cells for use in developing new treatments for conditions such as Alzheimer's disease, Parkinson's disease, and spinal cord injury, among others. The lead author was Andrew J. French, Ph.D., of Stemagen Corp., a private company headquartered in La Jolla, Calif.
In the experiments, the researchers removed the nuclei of mature oocytes from healthy young women who had previously donated eggs for successful infertility treatments. The SCNT technique was then used to insert DNA from an adult male donor into the oocytes. The DNA was derived from a type of cell called fibroblasts, obtained from skin biopsies.
Subsequently, several of the reconstructed oocytes continued to develop as normal embryos, to the blastocyst stage. Extensive and carefully documented genetic tests were performed to confirm the genetic identity of the cloned embryos. In three embryos, tests showed the same DNA as the male fibroblast donor.
In one of the three cases, additional tests showed that the embryo had another type of DNA, called mitochondrial DNA, from both the female oocyte donor and the male DNA donor.
Mitochondrial DNA testing is viewed as an essential proof of successful human cloning -- particularly after previous fabricated reports from a South Korean research group.
The ability to generate stem cells using the patient's own DNA is significant in the treatment of currently incurable degenerative diseases, as well as for cell-based drug discovery. Previous studies reporting the development of cloned human embryos have used embryonic stem cells as the DNA donors.
While the study is an important step toward the development of stem cells for therapeutic cloning, much more research will be needed to confirm and extend the results.
news this past week about the death of chess champion Bobby Fisher – I had to ask the same question: Would you have allowed Bobby Fisher to be born?
While we don't know for sure, Fisher's outrageous and at times hateful and bigoted behavior may have been caused by Asperger's syndrome which is part of the autistic spectrum . Or perhaps Fisher suffered from having an "extreme male brain" as characterized by Simon Baron Cohen, PhD, MPhil, a professor of developmental psychopathology in the departments of psychiatry and experimental psychology, a Fellow of Trinity College, Cambridge, and director of the Autism Research Centre at the University of Cambridge, in the United Kingdom, and author of the book "The Essential Difference: The Truth about the Male and Female Brain".
We may never know the truth but it would be tragic if he were simply remembered as a hateful, reclusive genius and not for the many accomplishments he brought to the world.
Dr. Caplan captures the key bioethical challenge these new genetic technologies and our understanding of the brain pose:
As genetic testing moves into the world of mental health, we are going to face some very tough questions. Will medicine suggest that any and every variation from absolute normalcy is pathological? How can we draw lines between disabling diseases such as severe autism and
more mild differences such as Asperger's, which may give society some of its greatest achievers? Will parents have complete say over the kind of children they want to bear? And what sorts of messages will doctors and genetic counselors convey when talking about risks, probabilities and choices that involve not life and death but personality and sociability, genius and geekiness?
Neither medicine nor the general public are at all ready to deal with the emerging genetic knowledge about autism, Asperger's or other aspects of mental health. But the future of our society may well hinge on how we answer these questions.
Bobby Fisher: May you rest in peace.
Monday, January 21, 2008
The ultimate aim of this work will be to develop personalized stem cells that can be used to cure disease. The researchers will clone individuals with serious illnesses by inserting their DNA into enucleated cow and rabbit eggs, resulting in hybrid embryos from which stem cells can be extracted. The hybrid embryos are to be destroyed no later than 14 days after they are created. It is hoped that using patients' own DNA in this process will reduce (or, better still, eliminate) the risk of transplant rejection (graft vs. host disease) when the stem cells, or organs grown from them, are implanted in the patient's body.
The UK's approach sidesteps at least two issues that have been problematic for scientists in the US: (1) the destruction of human embryos question (because they're hybrids, not solely human), and (2) the problem of gathering a sufficient number of donated human ova for research purposes. It's at least a little bit interesting to note that public opinion in the UK generally favors this approach, even as the rejection of genetically modified "Frankenfoods" continues to be reported in the news there.
However, US opinion has been quite strongly against such transgenic experimentation, generally because of concerns of developing chimeras with human (or human-like) consciousness. Additionally, the requirement that the chimera embryos be destroyed within 14 days of creation is probably pretty close to unenforceable-which gives rise to the kinds of nightmare scenarios Margaret Atwood contemplated in Oryx & Crake ("baby orchards" for organ transplants).*
So: Does the HFEA's approach create more problems than it solves? Talk amongst yourselves.
News here: The Guardian, Financial Times
*And yes, that's another WBP Book Club selection! Go here for more info.
Sunday, January 20, 2008
Of particular interest to me was Christine Vestal's analysis of states attempting to attract prominent stem cell researchers to grow their hESC research facilities into world class research labs. Once the fear was federal stem cell research laws would create a brain drain of science talent, as American scientists picked up and moved to countries more open to doing hESC. Now, the concern is the state next door, as California, Connecticut, Illinois, Maryland, New Jersey, New York and Wisconsin have awarded nearly $250 million in grants, which is three times more than the federal government spent in the same time frame.
While some states consider how to keep up with the funding next door (Iowa, Massachusetts and Missouri), others have simply bowed out of the stem cell race (Arkansas, Indiana, Louisiana, Michigan, North Dakota and South Dakota).
The State of the States 2008 document appears to be a great resource, full of interesting information. For example, did you know that 100 bills both for and against hESC research were considered in 39 states, but only three laws actually enacted? (New York State approved its hESC research funding, Iowa repealed a ban, and Illinois confirmed an executive order.)
While the ethics of the research are briefly mentioned (and Jonathan Moreno is quoted, albeit in another section of the article), overall they are given rather short shrift. That flaw aside, however, this appears to be a valuable addition to any researchers stack of pdfs.
It seems to me that Art says it all when he says "Don't ask, don't tell is bad policy for cloned food" (or any food, I might add) and that consumers will have the last word.
This is only the latest in a series of revelations about the way that pharmaceutical companies (“Big Pharma”) control the data about new drugs which they make available to the FDA in seeking approval and then to the public. No one disputes that these failures to disclose are harmful to the public’s health. Doctors prescribing drugs and using medical devices must have complete information in order to make the best treatment decisions. However, what is lost amidst the hand-wringing is that there is a very simple way to end this pattern and to make this information available to those who need it: require that all information, positive and negative, about drugs submitted for approval to the FDA be made available to a public data base. Current regulatory changes to require greater disclosure are inadequate because if there are any places left to hide negative data, Big Pharma will find a way to get there. Moreover, the arguments that it is somehow unfair to require companies to benefit from information about what doesn't work makes no sense because companies would only have to disclose AFTER they decide it is worth submitting the drug for approval.
Pharmaceutical companies are businesses like any other and are entitled to make a profit and to keep business information private—but only to the extent that it does not harm the public’s health. Having a drug approved for sale in the United States by the FDA is a privilege and it should come with the responsibility of making available all the available information—not just the information which the company chooses to disclose.
While it has always been the case that pharmaceutical companies were able to hide negative results in studies they conducted themselves, the need is much greater following a recent Supreme Court decision, Garcetti v. Cebalos, which held that government employees do not have First Amendment protection for divulging information—even information vital to the public’s safety-which they learn at work. Most people do not know that a growing number of research companies conducted by pharmaceutical companies are channeled through academic medical centers. While Garcetti v. Cebalos, did not involve research scientists it clearly suggests that a medical researcher at a state university which conducts drug trials for pharmaceutical companies could put his or her job at risk by divulging negative results. This silencing of whistleblowers means that without specific legislation that requires the disclosure of all data, wherever acquired, companies can continue to shield negative results from public view.
Of course is o.k. for pharmaceutical companies to make a profit, just as it is for auto companies, but when the product is one that can endanger the public’s health there must be a requirement of full disclosure.
Jennifer S. Bard, J.D., M.P.H.
Alvin R. Allison Professor of Law and Director, Health Law Program Texas Tech University School of Law Associate Professor (Adjunct) Texas Tech University School of Medicine
1802 Hartford Avenue
Lubbock, Texas 79409-0004
806.742.3990, ext. 349
Anyhow, the UCSF researchers actually appeared to realize the damage done, and are waging a media war of their own to undo the inaccurate media reports, misconceptions of what their study said, and undermine groups who are trying to twist their study for other agendas. On Friday, the university and its researchers issued an apology, saying
their release had “contained some information that could be interpreted as misleading.”
“We deplore negative targeting of specific populations in association with MRSA infections or other public health concerns,” it concluded. Dr. Henry Chambers, one of the report’s authors and a professor of medicine at the university, said he was surprised by how the report had been spun.
“I think we were looking at this from a scientific point of view and not projecting any political impact,” he said. “We were focusing on the data. You want to make sure it’s as right as possible and written up in a form that reviewers would understand what you’re trying to say, and do it in a clear manner so it’s not subject to misinterpretation. Which is what happened later, it appears.”
What is interesting about this is the acknowledgment by Dr. Chambers that they did not think outside their own discipline when writing their report or releasing the study. While that limited view and hyper-focus was a common and accepted part of a pre-internet academic community, which relied on published journals to transmit information - guaranteeing that at least the media would have to wait to attempt to stir up sensationalist claims. These days of electronic media, however, lead to a situation of electronic publication of paper results, which is how the UCSF MRSA USA300 report was made public. With that comes instant reporting, instant response, and the emphasis moves away from accuracy and towards sensationalism, an effort to attract the viewer eye. How do you compete with that?
The answer, it seems, is simple. You play the same game. Instead of ignoring the potentials of the internet for rapid information dissemination, for instant response, you do what Dr. William H. Parker, clinical professor of obstetrics and gynecology at the University of California, Los Angeles School of Medicine did. You fight fire with fire, create your own email messages with accurate information you encourage people to forward on, and make sure when you release your research results to the public, you consider both your academic peers and the lay people who will see the research. This might mean writing a "dumbed down" or accessible version of your report for release to general media outlets - but isn't that preferable to having your research misinterpreted and misreported?
Saturday, January 19, 2008
Alas, I could not attend the North Carolina Science Blogging Conference because of a conflict, but I am so pleased to see that I can attend virtually at the this web site. As fellow blogger Jennifer Ouellette says on her blog, "Blogging can be a somewhat isolated activity. Sure, there's comments and linkages and fostering online conversations and such, but generally I just plug along, cranking out my two or three posts a week on whatever topic captures my whimsy that day. Honestly? Sometimes I forget that I'm not blogging in a void. Today was a nice reminder that I'm part of a large, vibrant community that is changing the face of science, science journalism, science education, and science communication in some very exciting ways."
So far, the sessions are very informative and interesting -- check it out! What science blogger do you know who has cocktail recipes on their blog, like this one?:
The Black Hole
So called because after one of these, you have already passed the event horizon of inebriation.
1 oz. Kahlua
1 oz. vodka.
.5 oz. Cointreau or Triple Sec.
.5 oz. dark rum
.5 oz. Amaretto
Pour into an old-fashioned glass over (scant) ice. Stir gently.
Watch time slow.
Next year, I have to go this!
Imagine this scenario: you're a healthy person, no major complaints. You go for your annual physical exam, and you have a couple of blood tests--standard stuff, checking to make sure your cholesterol's ok, you're not anemic, etc. A couple of weeks go by, you get a card in the mail that says everything's fine. End of story, right?
Now imagine that the hospital or clinic has retained the blood left over from the tests your dcotor ordered. And further imagine that the hospital or clinic has what's called a biobank or biorepository--that is, a collection of stored tissue for use in research. Your DNA is extracted from the blood sample and sequenced--which means that some piece of your genotype is now known to some researcher (but not to you). In some institutions, this couldn't happen without your explicit (written) informed consent; but in others, it's standard practice that "waste tissue" from blood tests, pathology samples, etc. becomes the property of the hospital or clinic. Should informed consent be required, or is an opt-out model more appropriate?
Generally speaking, biobank participants' DNA samples aren't associated with their name, Social Security Number, street address, or other information traditionally considered "identifying"--but the reality is, nothing is a more precise identifier of who you are than your so-called genetic fingerprint. Is this worrisome?
I'd be interested to hear what others think about this--and, fair warning, I am likely to be asking more questions along these lines, as the DNA biobanking issue is on my mind a lot these days!
While I'm at it, here are two references for further reading, if you are so inclined. The Stored Tissue Issue, from Robert Weir, Robert Olick, and Jeffrey Murray, is an academic treatment of the issues. Michael Crichton's Next is an entertaining look at some of these questions--and it just happens to be a WBP Book Club selection.
Yet another indication to revisit and enlarge our moral universe.
Friday, January 18, 2008
I dont disagree with the concept necessarily. The health industry has long been known for losing money on certain patients, and making up money on others. This seems like a way to fix the leakiness problem.
On the other hand, this sounds like a really bad idea from the perspective of a patient, especially because of the multitude of ways it can be expanded. Today, they talk about ability to pay. However, once enough data has been accumulated, the data can be mined to see what was being paid for. What health risks does this patient inherently have? If this patient has risks, maybe we can view her as a "repeat customer." This can lead to targeted ads on one end, and lack of treatment for chronic sufferers on the other end.
I worry about the slippery slope!!
The Abigail Alliance makes a stirring argument: none of us would want to feel that we were unable to get access to the "silver bullet" that would make our loved one (or ourselves) well again or extend life because of some bureaucratic requirement. And certainly the story of Abigail Burroughs--by all accounts a lovely young woman, who died of a rare form of cancer when she was just 21--is terribly sad.
But does it mean FDA is wrong to deny access to unproven drugs? I don't think so. The FDA's mission is to ensure that the medicines and devices we use to improve human health are safe and effective. This is a vital function and one that must be preserved.
We--by which I mean the general public--have a tendency to assume that drugs are good, that they work, and that they generally don't make people sicker. This is not a great assumption: check out the news earlier this week about Zetia and Vytorin (cholesterol drugs that could actually increase atherosclerosis), or the Vioxx settlement (a pain-reliever that caused heart attacks and strokes in some patients), or reports that suggest that several common drugs for schizophrenia may increase diabetes risk, or fen-phen (an off-label use for weight loss caused permanent heart damage in some patients). These are just a few examples. Drugs can be dangerous. They can make people sicker, and in some cases, they can give people worse problems than they started out with.
"Aha!" the advocates say, "But what about if somebody is already dying? They're as sick as they're going to get. Surely they should be granted access!" Still, in general, I think not. Patients who are terminally ill are the very last people we should be treating with unproven agents. Clinical trials aren't all beer and skittles: If you doubt that drugs can be dangerous, check out reports of the TeGenero trials last summer, in which 6 previously healthy young men ended up in the ICU with permanent immune system damage. These were Phase I safety trials, not Phase II--the category the Alliance wants to make available--but my point is, should we really subject patients to such an ordeal in the pursuit of what is likely an understandable, but unrealizable, dream of a cure?
A key point to understand is that research is different from treatment. Research is directed toward the development of new solutions, and it may or may not benefit those individuals who volunteer to participate. It sounds harsh, but helping volunteers isn't the point of research. Treatment, on the other hand, is all about managing symptoms and effecting cures. It's just plain wrong to represent one as the other.
The legal questions are more subtle: argument in the original case focused on whether terminally ill patients have a Constitutional right to drugs that have passed Phase I clinical testing. Our very own Linda Glenn did a nice overview here.
Thursday, January 17, 2008
None of this in itself is particularly new or newsworthy; it is a continuing debate of what constitutes emergency care, standard care, informed consent, and what it means to have decision making capacity. These debates have been going on for years, and will likely continue for as long as any of us can envision.
No, the interesting thing actually comes from the commentary at City Room, the NYTimes local blog. Reading through the comments gives an eye-opening view into the way the general public perceives medicine, emergency medical care, and doctors. The most fascinating, and oft-repeated claim, is that if the patient (plaintiff) could be be arrested for assault, then he was obviously competent to decide his medical care - that, as one commenter put it,
if the patient’s competence is questioned regarding his ability to make an informed decision, then it’s inconsistent to charge that same incompetent person with assault.
Of course, the best retort to that (also brought up in comments) is that a drunk person is not competent to make decisions - yet is still responsible for the actions they take while drunk. (Also of note is that no one claiming specific background and training in medical ethics has spoken up in the thread. For those of you reading this, with the limited information available, what's your take on the situation?)
Obviously the message of personal autonomy and the basic idea of informed consent has permeated our society, but at a very simplistic level that might actually cause more misunderstanding and difficulty when treating emergency medical cases than potential good. The question becomes then, how do we increase the general knowledge level of the lay person while still emphasizing autonomy, while simultaneously acknowledging the education and superior knowledge of the physician without falling back on paternalism?
For anyone interested in this line of thought, the comments in that thread are well worth the read, and the contemplation.
Wednesday, January 16, 2008
I'm spending some time with my husband, Kim, in Timor Leste, where he is working on a land tenure property rights program; it is a poor but naturally beautiful country, struggling to regain its independence after a long term occupation. During his pre-dawn jogs, Kim is amused to encounter herds of goats clustered in twos and threes, nestled together in road determined to enjoy last few moments of their nights' rest. They barely flick an ear as he weaves between them, appearing to be no more than darker shadows in the dim morning light; they know the road belongs to them, at least until the break of day. This pre-dawn sedentary determination belies their youthful exuberance during the day. I think of their american cousins in the CAFOs, the FDA's approval of the sale of cloned meat, and it prompts me to consider the relative quality of life of the livestock in Timor Leste as compared to the livestock in the Industrial Food Chain in the US.
What strikes me is that we, in the US, while priding ourselves in the humane treatment of our companion animals, turn a blind eye towards the cruelty of the livestock in our industrial food chains, our CAFOs -- the CAFOs that feed the fast food, cheap food, sugary food industry, arguably the food industry chain that is eroding the quality of life of humans in the US.
My observation is that the goats, pigs, cows, and chickens in Timor Leste have a much more interesting, satisfying, and likely, longer lives than their supposedly "free range" US cousins.
While not meaning to diminish the extreme poverty of the human condition in Timor Leste, the everyday presence of the goats, pigs, cows, and chickens are a reminder that we can learn something about importance of recognizing our interconnectedness and the potential dangers of disconnection and disassociation -- and about the infinity diversity of living things with which we share the planet.
[Addendum, Jan 20, 2008: Colleague Art Caplan writes that Don't ask, don't tell is bad policy for cloned food. -- I might add I think it's bad policy for food in general. Also, Chris MacDonald at the Business Ethics Blog gives a different perspective. ]
Tuesday, January 15, 2008
Up until now, hospitals have been the tried and true mode of infection with any of the multiple drug resistant bugs in our environment, and for decent reason: hospitals, for all their efforts at sterility, house the sickest of the sick, and prove to be breeding grounds for antibiotic resistance.
What's noticeable about USA300 is two things. First is the fact that it's transmitted in the community, by skin to skin contact. While this is generally sexual contact, any sort of prolonged contact with another's skin is enough for transmission, and there is already evidence that this high contact no sex transmission has taken place.
The second interesting thing is that reporting of MRSA USA300 has reminded me of the initial reporting of HIV/AIDS back in the 1980s, albeit on a larger scale. And it might just be my memory of the San Fran/Bay Area reporting filtered through multiple books, novels, and movies, but the tone of the articles - "new outbreak in San Francisco gay community", "gay men affected by new skin to skin disease", etc - is eerily familiar. And I can't decide how I feel about this. On the one hand, it's only responsible to make sure it's clear everyone knows whether or not they're in a vulnerable population group. But on the other hand, it seems like it's walking dangerously close to stigmatization, again. This is alleviated by the acknowledgment of casual, non-sexual skin to skin transmission, but that seems overshadowed by the general tone of the articles I've been reading.
Perhaps most of all, it's disappointing. I would have hoped that these 20-odd years later, people would have learned how to write about an emergent infectious disease without creating, intentionally or otherwise, a stigmatized population group to go with it.
I'm editing this some six hours after the initial post, because I wanted to put up a picture of the kinds of headlines I'm referring to, as well as a link to the Google News collection of these stories - all of which have a disturbingly similar theme in their headlines. Click on the image above to see them all.
Monday, January 14, 2008
Today's NYT reports that Pfizer has begun direct-to-consumer advertising for their drug, Lyrica. It's not a new medication, having been approved for some time for the treatment of nerve pain (as experienced by some people with diabetes or shingles).
What's news is that the advertisements are for a new indication: fibromyalgia. Fibromyalgia is a condition for which no definitive diagnosis exists, and its cause and mechanisms are not understood by medical science. People who have it, most of whom are middle-aged women, complain of chronic, widespread pain and tenderness, as well as extreme exhaustion.
But whether fibromyalgia really exists is a contentious issue. Those who suffer from fibromyalgia insist that it is a real, and debilitating, problem. Numerous advocacy and support groups exist online and offer individuals the chance to compare notes with fellow sufferers. Skeptics charge that it is essentially a psychosomatic complaint--i.e., "it's all in their heads."
A few features of this story are worth comment (in my view, anyway). One is that we should be aware of the long-standing tendency of the medical establishment to minimize symptoms it can't explain by saying they are psychological--i.e., not "really real," and outside the purview of "real medicine." Many of these conditions (like irritable bowel syndrome, multiple chemical sensitivity, and chronic fatigue syndrome) tend to affect middle-aged women more than other groups. Coincidence? Maybe. But maybe not. Either way, it's worth thinking about whether these issues are being too easily dismissed.
Another is the influence that pharmaceutical companies have in our society over what "counts as" illness or disease. On one view, if there's a drug for it, then it's a disease. Thus shy people may actually suffer from social anxiety disorder and require Paxil; short people might have idiopathic short stature and need human growth hormone; and the list goes on. Is this trend toward medicalization a good thing? What does it mean, in practical terms, when we move a condition from the "some people are like this" (normal human variation) column into the "people who are like this have a disease" (illness) column? Who benefits from those effects?
One more thing to consider: the challenge of pain. As a subjectively experienced phenomenon, it's tough for medicine to deal with. Most medical problems are objectively measurable in one way or another, but pain is particularly tough to pin down. People have different pain thresholds, experiencing more or less pain in response to the same stimulus. It's been the standard view for a while now that women experience pain differently from men, though whether these differences are biological or social (or both) is still unclear. And the data source for pain? We mainly have to rely on self-report--and as a general rule, science doesn't like self-reported data. But the flip side could mean denying needed relief to people who are suffering ... and who wants to do that?