Friday, February 29, 2008
What this new silicon womb is, is actually a vaguely IUD looking tube that allows fertilized embryos to be matured inside a silicon tube placed inside the woman's womb, rather than a test tube incubator, before being removed after 2-5 days and then transferred back into the uterus.
The hope seems to be that a more natural maturation environment will lead to more successful implantations with fewer embyros needed for implantation, reducing the risks associated with multiple births that often accompany IVF treatment. It also is a partly practical move; test tube embryos need to have their growth medium changed every few hours. By moving the embryos to a more natural growth environment, there is no need for artificial growth medium; the body is instead naturally primed to generate nutrients and remove wastes for the developing embryos.
Of course, the silicon tube insert is only approximating a more natural environment - the uterus is an equally foreign place to embryos that are only a few days old; they would typically be floating their way lazily through a fallopian tube at this stage of development. Still, there's no arguing the point that, so far as mimicing natural goes, a uterus is probably a lot closer than a laboratory incubator.
I am, perhaps not surprisingly, a little more interested - and concerned - about the ethical concerns around this. There is already a large debate about what to do with IVF embryos that are leftover from a successful implantation cycle, with debates about their personhood and agency and whether they should be utilized for stem cell research or adopted out as snowflake children, or disposed of as human waste. What sort of attachment is a woman (and/or her partner) going to develop to a bunch of embryos that are actually being housed and growing inside of her, before being removed to be sorted and determined which should continue growing inside of her? While I've never had a child myself, I have heard many of my parent-friends talk about the incredible attachment and overwhelming love that they develop upon realizing they've conceived. Will those feelings be muted or mitigated by this artificial conception? Or will they develop stronger ties towards multiple embryos that cannot possibly be carried to term at the same time? From the sounds of it, the tubes can carry anywhere from 4-12 fertilized eggs; what happens to the unused, and what's the emotional ramification?
The medical implications are interesting, but it's the ethical ones that are fascinating - and sadly, don't appear talked about in any of the literature I've found about this new way of IVF embryo maturation.
images from Anecova
The plan credited in WWZ with saving humanity involves the sacrifice of isolated communities: these unfortunates are left behind, as a distraction for the swarm of zombies, while the rest of the population flees. Once the communities have been completely "zombified," the army moves in mows them down. It's not an especially realistic scenario--or at least, one hopes not! But it does raise some interesting questions about what kinds of measures can, or should, be taken in the case of public health emergencies, and whether we all become utilitarians under such circumstances.
Camus' The Plague is, of course, the classic. Geraldine Brooks' Year of Wonders is also very good. And I just picked up a copy of The Last Town on Earth by Thomas Mullen, which is another quarantine story, this one set here in the Pacific Northwest. You'll probably get a review of it here one of these days ... when I have time for leisure reading again!
Thursday, February 28, 2008
For those of you who may have already read this book—this review comes as no surprise. But for those of you new to this author, one thing comes across quite clearly when you read what she has to say is this: Devra Davis knows a thing or two about cancer. And she did her homework when researching the data for this book.
Davis, who holds a Ph.D and a M.P.H., is the Director of the Center for Environmental Oncology at the
In “War”, she paints a grim and compelling portrait of the health care industry, and how the leaders of the industries that made cancer-causing products, sometimes profited from the drugs and technologies created to fight the disease. According to
In her essay, “Deadly Secrets” she outlines an unintentional web of lies, and half-truths, perpetuated by our world industries, in both exposing and contaminating the world and our bodies with cancer-causing agents, and then covering up or suppressing the knowledge and information from the public for many years—even by health care industry scientists. According to
Again, a good, gripping read.
It would seem that the newest thing in anti-aging is nanosomes. Nanospheres. Buckyballs. Some of the ingredients are just smaller versions of chemicals that have been used for years, like nano-particles of zinc oxide, but others are genuinely new, like buckyball enhanced day cream; apparently the buckyballs are an anti-oxidant that prevent skin aging?
The concern, however, isn't minor. No one knows for sure what nano-particles will do; in many cases chemical compounds that are familiar at a larger level take on new properties when they become so small (this is, after all, part of the appeal of nanotechnology). Another concern is one that admittedly sort of freaks me out with it's unknown-ness: can nano-particles penetrate your skin? Is that day cream really seeping into your tissues, oozing into your blood and muscle and ick? (It's like the beginnings of a Robin Cook horror novel...) And this isn't just some random, too much horror-scifi reading as a kid concern; Sally Tinkle, a researcher at the National Institute of Environmental Health Sciences in North Carolina, has shown in her lab that at least some nano-particles can seep through the skin, which means they could potentially get into our blood stream or interfere with our immune system. (I have the sudden urge to check all my cosmetic products for nanoanything...)
Of course, cosmetic companies point out that if what they were using in their products wasn't safe, the FDA wouldn't let it go on the market. But the FDA typically only investigates cosmetics if safety issues come up after the product is on the market; unlike drugs, there is no safety level testing, studies, or trials that have to be done on cosmetics, and no final approval or rejection process prior to marketing.
But at least some people are making an effort to track the claims of nanotech on the market. The Woodrow Wilson International Center for Scholars has a Project on Emerging Nanotechnologies where they track all of the supposed nanotech out and about in our products, in everything from iPhones to face cream. They make this information available to the public, via their website, and it's incredibly easy to lose a few hours of time there browsing and marveling at all of the nanotech that has quietly become part of the marketplace.
In the meantime, I think I have something else to add to my labels watch list aside from high fructose corn syrup - it might be a slightly luddite reaction, I'll grant you that, but the idea of unknown nano-particles being a part of my beauty routine just makes me hesitant in a way that only being raised on a lot of science fiction can probably explain.
Wednesday, February 27, 2008
You can read an earlier story from the Washington Post, including commentary from Art Caplan, here. Roozrokh is pleading not guilty.
Tuesday, February 26, 2008
Rather than point to the legal failures to provide recourse for these and other people in such tragic circumstances, I'd like to focus on the shortcomings of the hospital. While it is certainly important to respect patient privacy, does the Hippocratic Oath and the physician's humanity not demand that all reasonable measures be taken to obtain information that could save a patient's life? There was no conflict here, other than possibly with an administrative policy barring non-family from seeing a patient or providing information for the protection of the patient, but when weighed against the chance of saving a patient's life and the opportunity to act with a certain level of compassion, I don't see how any physician could look him or herself in the mirror after such a failure as this.
As I am not a part of the medical community, I am unfamiliar with the professional perspective on this. It is my hope, however, that if there is not yet consensus by the medical community on how to humanely address cases like these in a consistent fashion (because they are not going away and will become more prevalent) that some can be reached to demonstrate that the medical community can and will rise to a higher standard of humanity than what is dictated by the law.
Update: Alicia Ouellette has provided a link with information on the lawsuit being filed on the patient's behalf by Lamda Legal.
Prozac, the bestselling antidepressant taken by 40 million people worldwide, does not work and nor do similar drugs in the same class, according to a major review released today.Kirsch and company go on to emphasize that counseling should be the first choice, and medication a very last recourse. But the researchers also go on to emphasize that this raises broad questions about drug data reporting and drug licensing; in an article at BBC News, Dr. Tim Kendall argues that drug companies should be forced to publish all their data, regardless of conclusion - something that many people have been arguing for years, and has come up in this blog recently.
The study examined all available data on the drugs, including results from clinical trials that the manufacturers chose not to publish at the time. The trials compared the effect on patients taking the drugs with those given a placebo or sugar pill.
When all the data was pulled together, it appeared that patients had improved - but those on placebo improved just as much as those on the drugs.
The only exception is in the most severely depressed patients, according to the authors - Prof Irving Kirsch from the department of psychology at Hull University and colleagues in the US and Canada. But that is probably because the placebo stopped working so well, they say, rather than the drugs having worked better.
Part of the reason that this is a new, and believed to be groundbreaking study (at least by the researchers) is that Kirsch and colleagues requested the full set of trial data on four drugs (prozac, seroxat/paxil, effexor, and serzone) from the FDA via the freedom of information act; two newer drugs (celexa and zoloft) were excluded because the full information wasn't yet available via the FOA. They argue that this additional and unpublished research shows that there is simply no benefit to the drugs.
Now it should go without saying that this is a research study, and anyone taking these drugs shouldn't decide to stop taking them without first consulting your prescribing physician. That said, while I take an anti-depressant that's not on the list, under the theory that it will decrease the pain I experience by increasing the dopamine in my brain, I think I'll be printing out the PLoS Medicine report and taking it in for a discussion with my own doctor.
Perhaps most to the point, I do agree with the researchers and commentators who say that this, more than anything, emphasizes that all research collected on a medication should be reported - positive, negative, or neutral. It's becoming obvious that we can't trust the FDA to make decisions on the effectiveness of these drugs; that doctors and patients are going to have to become the experts, or at least have all the data at their fingertips in order to make their own informed decisions.
And with that, I ought to get back to midterms. See you all in another day; I've got a collection of things to bring up once I'm out from under this epistemological cloud.
Monday, February 25, 2008
Are Those Workplace Wellness Programs a Good Idea?
It happened yesterday in our department head meeting. The nice lady who represents our “WOW” council, “Works on Wellness”, was presenting yet again about the benefits of signing up, and encouraging/coercing our staffs to do so. It is “perfectly safe and confidential,” she said. Then she said, “Chris, as our Privacy Officer, what do you think?”
Well, I had already decided I was going to take the moral low ground and not opine publicly about my reservations. I had attended some of these presentations before, read Arthur Caplan’s great piece (which a colleague forwarded to me) about these programs (http://blog.bioethics.net/2007/08/art-caplan-on-msnbc-privacy-is-true-price-of-healt/) and had shared with my boss, the CFO, my concerns. This is a big initiative involving at least 15 hospitals, and I knew our CEO was heavily invested in our participation. I still have some interest in avoiding professional suicide. But now I was on the spot. I tried to hedge with, “you don’t really want to know”, making a joke, but she insisted.
For those of you who aren’t familiar, and many of you soon will be if you are not, this program, like many others nationally, has the stated goal of making employees more healthy. Employees are encouraged to go on line to a website, enter in their personal information, sign up for classes, even get a wellness coach. They enter in when their last physical was, and get points for doing all those screenings we should all be doing—cholesterol, mammograms, colonoscopies, etc. etc. They get points (and discounts) for exercise classes and joining Weight Watchers. Why? Aside from all the free/discounted education and the chance to track your health “quotient” in comparison to your peers, participants get a reduction in their insurance premiums for participating, and the more they participate, the more dollar credits they get. Not only that, but the organization gets an overall premium reduction too, based on the percentage of employees who participate. No wonder the top management sends regular emails encouraging staff to sign up, and now wants to enlist the department heads in doing the same type of 'encouraging'. Discounts for health insurance are a pretty powerful incentive.
“Perfectly safe and confidential”. Mmmm…. That is a tough one. Not a month goes by that there isn’t some famous security breach concerning PHI (Protected Health Information in HIPAA-speak) involving some pretty big organizations--- VA, Pentagon, Anthem—who you would expect to be current on technological ways to protect privacy. And, as Dr. Caplan points out, some organizations are already substituting a stick for the financial carrot—now you may have to pay more than your colleague if you are unlucky (or is it really your fault?) enough to have a high cholesterol level, still be addicted to nicotine, or, perhaps, carry a gene that will predispose you to expensive cancer treatment at some point in the future.
You might argue, and some in the room did, that it is only fair that those of us who don’t work to be healthy pay more than our exercising non red meat eating colleagues. What about those who don’t wear helmets or seat belts? Surely we shouldn’t have to pay for your care when you get into that wreck that could have been avoided. And of course our organization, even though a non profit, needs to stay afloat and provide care for our patients. Why not “tax” our employees to our benefit. The whole concept is, in a way, a bit like “sin taxes”--- taxes on alcohol and cigarettes and those other things we know we shouldn’t be doing. And what about if we elect to have children knowing that they may have an inherited disorder? Well, who wants to pay for that?
So, I looked around the room at my colleagues, some of whom are friends, and put in my two cents, quoting the Caplan article. As a result, I have been trading emails with the WOW coordinator all morning to defend/explain my position. So far, I haven’t gotten into any real trouble with my bosses.
HIPAA has been cursed and touted for all kinds of things. Even though it was not the intent of the federal law, which originally had to do with moving insurance from one employer to another, Privacy and Security became two of the three pillars of the statute, which at least requires “covered entities” to notify patients about what is happening to their PHI (Notice of Privacy Practices). Yet, even I, who do this for a living, toss these flyers in the trash when I get them, and quickly “agree” to explanations about the security of the websites I visit without reading the fine print. The law hasn’t really helped much, since there are so many loopholes that allow the courts and others to get information without the permission of patients.
A friend of mine’s mother was recently diagnosed with breast cancer, and all of the daughters sought genetic counseling. The doctor performing the testing and counseling advised my friend not to go through her insurance to get it paid for, warning her that the repercussions could be anything from refusal to provide life insurance to some future employer just deciding that another candidate, without the potential illness ahead, is better qualified. Studies show that 1 out of 4 docs deliberately exclude sensitive information from patient records at their request, and I would guess that number to be higher in truth.
For now, I am going to forgo the extra dollars in my paycheck and take care of my health because it is right for me and my family, not because my employer wants me to. And, I am going to advise anyone who asks me to do the same.
Researchers at the University of Alabama (UAB) and the University of Pittsburgh School of Medicine say an experimental anti-HIV gel being tested in Phase II trial studies is safe for women to use on a daily basis. The gel, called tenofovir, was successfully applied by non-HIV infected women patients, daily, over 6 months, as a prevention for HIV infection. The drug is being tested in trials conducted under the authority of a consortium of researchers, exploring and evaluating anti-HIV microbicides. The researchers are a part of the U.S. National Institutes of Health-funded Microbicide Trials Network.
200 sexually active HIV-negative women were included in the study. Participants were age 19 to 50, and 64 percent were married. The goal was to determine the drug's safety if used daily, and the woman's willingness to apply it according to directions.
Results from the tenofovir study comes as welcome news to this segment of the HIV/AIDs prevention research community, following on the heels of unsuccessful late-stage trial testing of other drugs, including another gel, carraguard, (which our blogger Sean Philpott had blogged about earlier this month) which failed to prevent HIV infection in 6,000 South African women tested. That study ended in 134 new HIV infections in the carraguard group, and 151 new infections in the placebo group. A year ago, two other late-stage drug trials for similar preventative gels were stopped due to fears the drugs would accelerate a women's chances of infection instead of decreasing it. Researchers acknowledged that low use of the gel by participants may have played a role in adversely affecting the results.
In South Africa, some 8,000 women develop HIV infection each day.
If the common goals between the public and the pharmaceutical giant Merck in the controversy over compulsory HPV vaccination were long-term cost containment and public safety by reduction and prevention of widespread disease (HPV and cervical cancer, in this case), and GARDASIL is supposed to achieve both objectives; then, mandatory GARDASIL vaccinations for young women is worth investigating.
Compulsory HPV vaccination for girls before they become sexually active is said to cut long-term costs in their healthcare (especially costs related to cervical cancer). However, these costs may be outweighed by long-term costs that are unknown at this time. According to Merck's website, GARDASIL has only been tested for over a decade, which is not sufficient in considering the long-term effects of a drug on a young woman's reproductive system. Currently, GARDASIL has not been evaluated for the potential to cause carcinogenicity or genotoxicity... it is not known whether GARDASIL can affect reproductive capacity (Merck 2007). Because a little over a decade is arguably insufficient time to recognize all of the implications that the drug may have on a woman of childbearing age who received the vaccine prior to, or during puberty, we do not know the long-term costs of what may result from the use of GARDASIL. And, we cannot assume that GARDASIL is cost efficient. We cannot consider this vaccine to be an effective one in reducing or preventing long-term, perhaps costly health problems.
As the second most common cause of cancer death in women worldwide, resulting in nearly a half-million diagnoses and 240,000 deaths each year (Merck 2007), and because 6 million people in this country become infected with HPV every year, and nearly 10,000 women are diagnosed with cervical cancer (Colgrove 2006), HPV and cervical cancer are undeniably very serious threats to public health. Compulsory HPV vaccination for girls before they become sexually active is said to significantly reduce or even prevent widespread cervical cancer. Because there is some evidence of its success in preventing four types of HPV, two of which are leading causes of cervical cancer, the fact that there are at least short-term benefits to GARDASIL is undeniable. However, the vaccine should be made accessible without mandating its use. From a moral standpoint, it seems that the use of the GARDASIL should be accessible at least for those at high risk (i.e., with family history of cervical cancer, etc.). Without long-term evidence of its efficacy and safety, it seems irresponsible (on the part of government, as well as Merck) to mandate its use, but also to deny its access completely.
The best possibility at this point is to wait until further, more conclusive and long-term research has been conducted. Given more time, competition will likely increase, which will inevitably reduce the cost to the consumer (or government), as well as provide more sound evidence regarding its long-term efficacy and safety.
Merck. 2007. CDC Finalizes Advisory Panel Recommendations for GARDASIL®, Merck Cervical Cancer Vaccine. http://www.merck.com/newsroom/press_releases/product/2007_0322.html (accessed September 25, 2007).
Colgrove, J. 2006. The Ethics and Politics of Compulsory HPV Vaccination. http://www.natap.org/2006/newsUpdates/121106_05.htm (accessed February 20, 2008).
A spokesman for America's Health Insurance Plans, formerly the American Association of Health Plans, is quoted as saying that insurers have "no interest" in discriminating against health plan members on the basis of genetic information. Well, that's swell, then--no need to worry, right?
Wrong. Insurers absolutely are interested in individuals' genetic predisposition to disease: that's why if you try to buy individual coverage you will be asked for a very complete family history, in addition to lots of other super-specific information. The industry's position is that their actuaries need this data in order to come up with accurate risk calculations ... but certainly not to discriminate. They might raise your premiums to a point you can't afford, or refuse to cover treatment for your pre-existing condition, or deny you coverage altogether. They'd be making business decisions, and those decisions would be based on clinically relevant data, not some unethical, irrational value judgment. But they would never, ever discriminate.
If you're not already behind the Genetic Information Non-Discrimination Act, get on board!
The ideal doctor-patient relationship is a partnership. Ultimately, both parties need to agree to participate in the care rendered. Patients should hold up their end of the bargain and refrain from suing their doctors at the drop of a syringe. Tort reform regarding medical practice would provide significant relief. For example, an ombudsman-like system of board review could be implemented. If a physician's actions were deemed to have met the standards of care in her specialty, a potential lawsuit against her could not go forward. Such a system could address both malpractice and negligence.
Cost savings would be enormous and would impact bottom lines across a broad spectrum of agents and agencies. Federal, state, and local resources would be freed-up from costly courtroom expenditures on wasteful medical litigations.
In a groundbreaking example of high-level support for such proposals, the U.S. Supreme Court ruled on 2-20-08 that "makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the FDA approved the device before it was marketed".
A case involving similar preemption for FDA-approved drugs will be heard by the Court in its next term.
This is a welcome trend, both economically and socially. The concept of personal responsibility has been battered and broken-down in the U.S. for many decades. "It's not my fault", people claim. "Twinkie's made me do it." Yes, a doctor prescribed a drug. Yes, a medical device was used. Yes, that drug or device had a manufacturer. But the patient agreed to treatment. Medicine is an art. There are frequent unexpected outcomes. Of course, we want to uphold best practices. Given best practices, lawsuits in medicine are inappropriate and need to be reined-in.
Manufacturers of defective products will still be liable. However, quality control is not a 100% guarantee. One malfunctioning device in an otherwise successfully deployed lot should not be grounds for a multimillion dollar lawsuit. Risks need to be shared. Full disclosure and informed consent are the tools to make these lawsuits go away.
Likewise for drugs. It seems obvious that the bottom line for global pharmaceutical companies is stock price and shareholder value rather than patient welfare. It may be that ultimately, in many cases, reliance on pharmaceuticals is misguided. In Global Pharmaceuticals: Ethics, Markets, Practices, Adriana Petryna and Arthur Kleinman describe the American "fetishization of pharmaceuticals" and the "pharmaceuticalization of certain disorders".
On 2-15-08 the FDA proposed new guidelines that "would allow drug and device makers to provide doctors with copies of medical journal articles" that discuss off-label product uses. The rules also say "drug companies do not have to promise to adequately test the unapproved use discussed in the article".
These proposed guidelines represent a radical sea change in policy. On the surface, they seem to pander to the desires of big pharma. This seems very problematic. On the other hand, FDA approval is not a guarantee of development of significant side-effects, as with the COX-2 inhibitors such as Vioxx.
The reality is that most drugs are not magic bullets. The playing field has shifted. Patients need to be protected, and that protection is best offered by regulation and information. But our regulatory system seems badly broken, and off-label usage may provide great benefit. Or it may not.
Medical risks need to be shared. Patients are not merely consumers. They are obligated to do their best to make informed choices. On the other hand, physicians need to clean-up their questionable relationships with drug manufacturers and drug representatives.
We want a health care system based on best practices, not based on most money.
Sunday, February 24, 2008
Saturday, February 23, 2008
Grandin explains in a separate commentary "the basic disagreement between the authors and me arises from the concept of details--specifically how details are perceived by humans, who think in language, compared with animals, who think in sensory-based data. Since animals do not have verbal language, they have to store memories as pictures, sounds, or other sensory impressions... As a person with autism, all my thoughts are in photo-realistic pictures," she explains. "The main similarity between animal thought and my thought is the lack of verbal language."
But you don't have to be autistic or an animal to think in pictures -- according to Wikipedia, "Research by Child Development Theorist Linda Kreger Silverman suggests that less than 30% of the population strongly uses visual/spatial thinking, another 45% uses both visual/spatial thinking and thinking in the form of words, and 25% thinks exclusively in words. According to Kreger Silverman, of the 30% of the general population who use visual/spatial thinking, only a small percentage would use this style over and above all other forms of thinking, and can be said to be ‘true’ “picture thinkers”. All of which suggests that perhaps the differences in cognition are not as great as we might think.
However, in the second article "What Is The Cognitive Rift Between Humans And Other Animals?" Harvard scientist Marc Hauser presents a new hypothesis on what he thinks defines the cognitive rift between humans and animals: "He identifies four key differences in human thought that make it unique. Animals, for example, have 'laser beam' intelligence, in which a specific solution is used to solve a specific problem. But these solutions cannot be applied to new situations or to solve different kinds of problem. In contrast, humans have 'floodlight' cognition, allowing us to use thought processes in new ways and to apply the solution of one problem to another situation."
Of course, neither of these settle the debate, however, both studies provide substantial food for thought.
(Photo Credit: iStockphoto/Jurie Maree)
So what's this got to do with bioethics? Well, we're primates ... and we, like the baboons of Sapolsky's troop, live in social settings in which some of us fare better than others ... and guess what? We have massive health disparities that track along socioeconomic gradients, which themselves track closely with race in this country. Coincidence? Mmmmm ... maybe not, huh? Of course, there are also lots of implications for self-care, like making sure we have social connections, etc. etc.
You can hear Sapolsky's take on stress and heart disease in women in this archived podcast from NPR's Science Friday, or a more general explanation of the relation between stress and health on the Scientific American Frontiers program "Worried Sick," or a talk about the effects of stress on memory here. There's also an interview with The Atlantic here. Want the more technical version? Here's the abstract for "The influence of social hierarchy on primate health." There are lots more--the guy's published something like 170 academic articles. But for the full-on Sapolsky experience (yes, ok, full disclosure: geek girl has a tiny crush), you've got to see him in person.
Friday, February 22, 2008
"The New York Times reports on the Supreme Court's decision in which the Justices ruled "that the manufacturer of a federally approved medical device cannot be sued under state law if the device causes an injury." The Times reports,
The 8-to-1 ruling in favor of Medtronic, the Minneapolis-based maker of cardiovascular devices, made it much more difficult for patients and their families to sue makers of medical devices that have been granted federal approval.
In 1996, a balloon catheter burst and severely injured Charles R. Riegel while he was undergoing an angioplasty. Mr. Riegel and his wife, Donna, sued the company in federal court, contending that the catheter had been designed, labeled and manufactured in a way that violated New York state law, and that those defects had caused severe and permanent injuries to Mr. Riegel.
But a federal district court and the United States Court of Appeals for the Second Circuit, in Manhattan, dismissed the Riegels’s suit on the ground that the catheter had been given pre-market approval by the Food and Drug Administration, thus protecting the manufacturer from liability under state law. (The case of Riegel v. Medtronic was tried in federal court because the plaintiffs and defendant were based in different states.)
The Supreme Court upheld the lower federal courts on Wednesday, with Justice Antonin Scalia writing for the majority that Medtronic and other manufacturers were protected under the Medical Device Amendments of 1976, which in its section on pre-emption bars states from imposing on medical devices “any requirement which is different from, or in addition to, any requirement applicable under this chapter.”
But the justices’ ruling was hardly the last word on when F.D.A. approval bars patients from suing. They are already considering at least three cases involving drugs and drug-labeling.
In 1996, when there was a different lineup of justices, the Supreme Court ruled that medical devices approved by the F.D.A. under a different, more expedited process were not shielded from state liability. At the time, the federal government took that position.
But in 2004, the Bush administration reversed the government’s position and began to take the side of manufacturers. In the Medtronic case, the administration argued that there would be “serious undermining of F.D.A.’s approval authority and its balancing of the risks and benefits” if juries could second-guess the agency.
Justice Ruth Bader Ginsburg was the lone dissenter on Wednesday, asserting that the majority had adopted an unnecessary “constriction of state authority.” Justice Ginsburg said she did not believe that Congress had intended to bring about “a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.”
But, will the Supreme Court have the last word on this topic . . . we discover that perhaps not -
If I had a better feeling about how the people running our government, I probably wouldn't be upset by this decision but it doesn't appear that everyone is playing on a level field. With all the stories in the news about recalls for tainted products and food, I am a bit concerned about the regulators being influenced too greatly by those they are supposed to be regulating."
“The Supreme Court’s decision strips consumers of the rights they’ve had for decades,” said Representative Henry A. Waxman of California, the chairman of the House Committee on Oversight and Government Reform. “This isn’t what Congress intended and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”
Senator Edward M. Kennedy of Massachusetts, the chairman of the Senate Health, Education, Labor and Pensions Committee, agreed, saying: “Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices. Congress obviously needs to correct the court’s decision. Otherwise, F.D.A. approval will become a green light for shoddy practices by manufacturers.”
I couldn't have said myself, Elizabeth -- thank you for posting this.
Steinbock outlines the purposes of prenatal testing in general: (1) prospective parents who are willing to consider abortion may wish to make an informed decision about continuing a pregnancy; (2) prospective parents, including those who would not terminate, may wish to have information available to help them prepare for the birth of a baby with health problems or special needs; (3) society may reduce the prevalence of genetic diseases; or (4) prospective parents may seek testing "for the good of the child."
As Steinbock points out, the predictive value of tests differs (meaning that some tests provide definitive information about whether a person will develop a given condition, as in the case of Huntington's, while others offer much less certainty). Some conditions are preventable or treatable, and others are not (this is the clinical utility piece I've blogged about recently). And even for conditions that are not treatable today, prospective parents might still hold out hope for a future treatment.
Botom line: Steinbock doesn't buy the argument that prenatal genetic testing for untreatable adult-onset diseases can be justified on the grounds that it is for the good of the child. She rejects the wrongful life concept in this context, noting that "in almost cases the child, once born, will have a life worth living. This is so even in the case of severe disability at birth, and much more so in the case of adult-onset disorders." This isn't to say that Steinbock opposes selective abortion--she defends it elsewhere--but justifications other than the benefit of the child must be marshaled to support it.
Thursday, February 21, 2008
The 10 minute reprise on Oprah can be found at this link, where Randy reminds us of the importance of such things as keeping your sense of fun and wonder, working and playing well with others, and showing gratitude.
I am reminded of Don Juan’s counsel in one of Carlos Castaneda’s books: that death is our constant companion, that it travels on our left shoulder, and that our task must be to make it our 'ally.' I would say that Randy Pausch has done an admirable job of doing just that.
Wednesday, February 20, 2008
The performances may include any of the following: dance, dramatic performance, poetry recitations, short films, music, & readings from fiction. The presentations will be followed by a brief statement by some of the presenters on their intentions & the power of their chosen medium in presenting the issue(s) inherent in their work.
You are invited to send an expression of interest in offering a performance.
Works of art: such as paintings, photos, posters and installations, are also sought for display in Congress venues throughout the Congress. The artists will be invited to discuss their work during the Congress at specified times.
Please send, by 31st March 2008, expressions of interest in offering a performance piece or presenting a work of art, with a brief description (1 page max) of your work & any supporting
material* (e.g. photos &/or videos) as Email attachment, to Arts Bioethics Network Coordinators: firstname.lastname@example.org and email@example.com
The statement should describe the work and its relation to human rights and/or bioethics, your intentions, and the power of your chosen medium in presenting the issue(s) inherent in your work. For performance: specify duration of performance (max. 10 mins). For work of art: any requirements for presenting.
Please include: Name of Presenter(s) or Artist(s); Contact Person; Institutional Affiliation; Contact E-mail; Contact phone number(s). *Supporting material not to exceed 8 MB. The Co-ordinators of the Arts Bioethics Network have established a process for identifying a representative selection of the performance pieces and works of art from those that are offered. The criteria for selection include: works that have a bioethics and/or human rights theme; and works that express the challenge of ethics and human rights in an increasingly cross-cultural world. You will be advised, by 30th April 2008, if you work has been selected.
For more information, please go to http://www.bioethicsworldcongress.com.
"Following a surprisingly unscientific line of reasoning, the editors at the most renowned and prestigious of science journals have rationalized away the need to fix an ailing peer-review system.
Increasing skepticism about the effectiveness and integrity of single-blind peer review—the process by which most academic papers submitted for publication are accepted or rejected—has prompted empirical evaluation of the system.
Standard practice is: reviewers—selected for their expertise and fluency in the chosen discipline—are aware of all authors’ names and affiliations, while authors are kept in the dark about the identity of their reviewers (although some journals allow them to request specific referees).
The growing argument against this lopsided method is that knowledge of authors’ identity—gender, nationality, research institution, level of experience in the field—can (and does) bias reviewers’ opinions on the merit of the research.
The most vocal critics of the current system are those who believe their submissions do not get fair consideration—women, early-career scientists, people with foreign-sounding names—when matched up against authors who sail through the submission process on the status of their lab or the history of their career. And in an environment in which research funding, hiring, tenure, salary, and academic reputation are massively dependent on publishing record, one can easily imagine the ripple effects such a disadvantage would bring."
Full commentary in SciAm can be accessed here. Nature has posted the editorial on their blog page, opening it up to the public for commentary, so let them know what you think.
Personally, I think the first commenter on the Sciam Blog got it right on the money: "Effectively, they're saying: "eliminating gender (or other) bias in the peer review system simply isn't our priority."
The film is set in the not-too-far-distant future, in a prisonlike facility that (we are told) is one of only two safe places left on the planet following The Contamination. It's a highly regulated environment, in which individuals' sleep, diet, and bodily functions are monitored 24x7. "Proximity rules"--men and women aren't allowed to get too close--and other regulations are enforced by omnipresent security guards. The other safe place on the planet is The Island--a beautiful tropical paradise that has somehow escaped contagion. It is the dream of everyone in the place to go there. The only way to get a ticket is to win the lottery.
Our hero, Lincoln Six-Echo, is a nonconformist in an environment that requires absolute compliance. He breaks out of the facility, briefly, only to discover the truth: he and his compatriots are being used as biological raw materials -- "insurance policies" -- for the rich and famous in the outside (uncontaminated!) world. The supposed lottery "winners" aren't really winners after all. You can imagine, probably, how the action bits of the story unfold from this point.
There are lots and lots of interesting themes at work here, among them:
- The use of a public-health threat to control a population
- The creation of clones to serve as a source of transplant organs
- The creation of clones to serve as gestational carriers
- What makes clones different from humans (if anything), and what makes humans "persons" (in the philosophical sense of "one of us")--there is a great scene in which Steve Buscemi tries to explain to McGregor and Johansson that they're not like him
- The role of medical personnel in this operation--should physicians and nurses participate in this kind of thing?
- How language frames our ability to discern right from wrong (to their creators and their customers, the clones are "insurance policies," "products," or "Agnates"--not clones, not individuals, and certainly not people)
- How visual images shape our ethical intuitions--some very graphic depictions of how the clones develop and are "extracted," how they are treated by medical professionals and guards
- What it might mean that this film was released in 2005, as the stem-cell debate was heating up in the US
- Clones as human chattel, and connections with slavery (or sex trafficking, though the latter is not part of the film)
Tuesday, February 19, 2008
The article quotes a few experts who basically say that as the technology has improved, the need to implant "extra" embryos has diminished; but this raises the question of just what a successful IVF result looks like. Is one baby? More than one baby? All the babies the woman wants? And what about the health status of the infant(s)? If carrying multiple fetuses increases the health risk to mom and babies, but the woman wants to "maximize her investment" in the painful and expensive IVF cycle by shooting for triplets, can/should physicians try to dissuade her? On what basis?
It will be interesting to see how this plays out, particularly since fertility medicine is largely a consumer-driven affair. Infertility treatment generally isn't considered medically necessary by insurers and therefore isn't a covered benefit. People who pursue it are paying thousands of dollars--per cycle--out of pocket. Given all that, I wonder whether "the customer is always right" will be the governing rule.
Technology Review has come out with their annual list of the top 10 most exciting, cutting -edge technologies and I can't wait to hear what our colleagues have to say about the ethical, legal, and societal implications (especially my personal favorites, 7, 4, and 3):
10.) Peering into Video's Future Is the Internet about to drown in digital video?
9.) Nanocharging Solar
8.) Invisible Revolution Artificially structured metamaterials could transform telecommunications, data storage, and even solar energy
5.) A New Focus for Light - light-focusing optical antennas that could lead to DVDs that hold hundreds of movies.
4.) Neuron Control – a genetically engineered "light switch," which lets scientists turn selected parts of the brain on and off, may help improve treatments for depression and other disorders.
3.) Nanohealing -Tiny fibers will save lives by stopping bleeding and aiding recovery from brain injury, says Rutledge Ellis-Behnke.
2.) Digital Imaging, Reimagined - compressive sensing could help devices such as cameras and medical scanners capture images more efficiently.
Which ones are your favorites? Which ones do you have the most hope for?
Monday, February 18, 2008
WHO was quick to say that Dr. Kochi's views are not those of WHO as a whole. Good thing, too: whatever one might think of Microsoft and its business practices, the Gates Foundation has done incalculable good in addressing health problems that afflict a large proportion of the world's poor. Many of these conditions--such as infectious diarrhea and parasitic disease--are unattractive drug targets for corporations. If the Foundation has made these conditions higher priorities in the research community, I think that's got to be a good thing...and if they've also managed to bring some business discipline to decision making, emphasizing outcomes and return (in health trems) on investment, so much the better. And there's no reason, at least in principle, that you can't make concrete, if incremental, improvements in health today at the same time as other research efforts focus on more long-term, systematic improvement of the public health infrastructure. Both are needed.
Kochi's criticism does raise an interesting point, though, about the way science works. His assertion that centralized funding puts too much power in the hands of the Gates Foundation could just as easily be said about the Federal government--which funds an awful lot of research in the United States. But the bottom line is, the science that gets funded is the science that gets done, and 'twas ever thus. So ... what's on tap for 2009?
Federal funding of research and development for the 2009 fiscal year will be directed much more heavily toward the physical sciences and Homeland Security, and away from the life sciences. The NIH budget award will be the same as for this year--ie, it won't keep up with inflation, which amounts to a net reduction of funds. You can learn more from Science here, or from ScienceProgress here.
Twenty-seven years after AIDS was first diagnosed among gay men in
The disproportionate impact of HIV on women is due to a variety of biological and socioeconomic factors. Many of those factors make today’s HIV prevention options – condoms, mutual monogamy, and male circumcision – inaccessible to women at greatest risk of infection. Many women do not have the social or economic power necessary to insist on condom use and fidelity or to abandon partnerships that put them at risk, and a recent study from
This morning, the Population Council posted the results of a phase III effectiveness study of a candidate microbicide called Carraguard, an odorless, clear gel made from carrageenan. Over 6,000 women in
Unfortunately, trial results showed that the product was safe and acceptable to women, but did not reduce their risk of acquiring HIV.
Twelve other candidate microbicides are currently in human trials, and a new generation of antiretroviral-based products is entering the development pipeline. But developing and testing these compounds is a time- and resource-intensive process, and many policymakers have begun to question whether or not limited public health resources are better used to promote proven prevention technologies like condoms.
This, I believe, is short sighted. For the reasons mentioned above, proven HIV prevention technologies will not protect at-risk women. Furthermore, drug development is always a long term struggle, with dozens of failed products for every one that makes it to market.
As disappointing as these results are, the fact that the trial reached completion is itself a breakthrough. Successful completion of the Carraguard trial is a testament not only to the commitment of the study investigators but also to the dedication of the trial participants themselves.
Regardless of the results, this trial will yield important information about microbicide effectiveness, safety, use, and acceptability, and will help researchers design and test new HIV prevention technologies.
Sunday, February 17, 2008
Most support the theory of the city’s health commissioner that forcing chain restaurants to list the calories alongside menu items — flagging that a Double Whopper With Cheese has 990 calories, for example — will make patrons think twice about ordering one. The rules are set to take effect at the end of March."
However, in a court affidavit seeking to block implementation of the regulations, Dr. David B. Allison, the incoming president of the Obesity Society, argues that more harm could be done than good -- either by contributing to the 'forbidden-fruit allure of high-calorie foods or by sending patrons away hungry enough that they will later gorge themselves even more.'Whether or not the injunction filed will be successful remains to be seen: The new labeling rules by NYC's Board of Health have support from a number organizations, such as Center for Science in the Public Interest, the American Medical Association, the American Academy of Pediatrics, the American Diabetes Association and the American Heart Association.
Full article and PDF link to the court filings here.
Friday, February 15, 2008
Anyway: FactCheck has just posted a nice analysis of how the Clinton and Obama health plans stack up, as well as a review of how accurately the candidates' respective campaign claims reflect their actual plans. You can check it out here.
The decision to do so, as well as the necessity of it, is ultimately in the hands of those choosing to be tested, based upon their own personal situations. But to what degree--is the testing--and the expense--justified? And would you really want to know what manner of disease and possible genetic defects lurk in your gene pool, dormant for now, but awaiting that deadly trigger down the road, certain to release havoc in your body?
ABC Nightline with Martin Bashir, on Wednesday night, profiled a genetic testing firm, called 23andme that obviously believes that we all deserve and need to know the truth, at a time when there's still a chance to correct it.
Among the impacts: a reduced lifespan, greater vulnerability to disease due to higher testosterone exposure during pregnancy, daughters who were less likely to reproduce, and smaller subsequent children. Additionally, having a grandmother around was more helpful than having a grandfather (probably because she helped with childrearing while he just sat around and ate food).
While modern reproductive technologies have mitigated a lot of the effects seen in pre-industrial families, it is still intriguing to consider these impacts in light of the strong cultural bias favoring the bearing of sons. Perhaps it is a type of "peacock effect", whereby the individuals who still thrive in the face of handicapping or indulging in risky behavior are considered stronger and more robust. Or, as my mother asserts, the value balances out an apparent difference in general robustness and health between male and female young, where males often are weaker to start with.
Of course, having too many sons can be evolutionarily disadvantageous too...
The experimenters used functional magnetic resonance imaging (fMRI) to scan the brains of Harvard and other Boston-area students while showing them pictures of other college-age people whom the researchers randomly described as either liberal northeastern students or conservative Midwest fundamentalist Christian students. The categories were a ruse.
Heightened activity in the ventral mPFC was associated with mentalization of self-similar people, whereas dorsal mPFC activity was associated with mentalization of self-dissimilar people. But when the participant pondered the subject in situations where an outsider was believed to behave in the same way as the participant would, activity in dorsal and ventral mPFC was equivalent.
With continuing advancements in the field of neuroscience, this study presents some excellent data to help us better understand the roots of prejudice and stereotyping. This study also poses potential challenges for the future since humans have a tendency to follow up discovery with manipulation - how long until someone posits the use of treatment to suppress activity in the parts of the brain responsible for prejudice, discrimination and bigotry? Are these "diseases" to be cured, deficiencies born of ignorance, or simply a part of being human?
Thursday, February 14, 2008
- Love is a powerful drug: “Love is a drug,” says Helen Fisher, an anthropologist at Rutgers University and author of “Why We Love: The Nature and Chemistry of Romantic Love.” “The ventral tegmental area is a clump of cells that make dopamine, a natural stimulant, and sends it out to many brain regions” when one is in love. “It’s the same region affected when you feel the rush of cocaine.”
- From the Situationist Blog: "It’s all about dopamine, baby, this One Great True Love, this passionate thing we’d burn down the house and blow up the car and drive from Houston to Orlando just to taste on the tip of the tongue.
You crave it because your brain tells you to. . . .Dopamine. God’s little neurotransmitter. Better known by its street name, romantic love. Also, norepinephrine. Street name, infatuation."- Valentine's Day stories from NPR.
- And for those who prefer to celebrate, ahem, 'privately' or putting it another way, celebrate privacy, a little Valentine's Day gift from a federal court in Texas: A federal appeals court has struck down a Texas law that makes it a crime to promote or sell sex toys, stating that "Whatever one might think or believe about the use of these devices, government interference with their personal and private use violates the Constitution." Full opinion here.
Wednesday, February 13, 2008
So go ahead, have a laugh! Who said bioethicists don't have a sense of humor?
See one perspective on a controversial ethics issue here.
Monday, February 11, 2008
I'll just warn you right up front: election season is getting to me.
We Americans may all be created equal, but substantial -- and shameful, in my view -- disparities in health status exist in the United States. Racial and ethnic minority groups, as well as rural and other underserved populations, bear a disproportionate burden of cancer, heart disease, and myriad other health problems. They have less access to health care, and when they do manage to get care, it's of lower quality.
Yes, it's complicated, and yes, there are lots of factors that contribute. But there's just no getting around the hard numbers on this one. Just to give you an idea of what we're talking about, according to the 2006 National Healthcare Disparities Report:
- Hispanics received poorer-quality care than non-Hispanic Whites* for 77% of core measures. Blacks* received poorer care than Whites* for 72% of core measures. American Indians and Alaska Natives are behind by a mere 41%. What are the "core measures"? Oh, silly little things like whether a woman gets breast cancer screening, or whether kids get dental care.
- Here's a shocker: across the board, poor people had worse access to care than the well-off. You really should check out the graph--it's a plain solid bar, representing 100%.
- Health care providers were less likely to inform obese Blacks and Mexican Americans, along with people with less than a high-school education, that they were overweight. These are populations with a higher prevalence of Type 2 (adult-onset) diabetes--perhaps those who could most benefit from a little counseling on this point.
When you hear people say that we don't, and won't, and can't allow health care rationing, and that choice is the most important thing, please remember these statistics. We absolutely do ration health care in this country. We just don't talk about the criteria we use to decide who gets it and who doesn't. People who are on the "don't" list don't have any choices at all.
*That's the Feds' classification.