sign me up for a sugar pill

It's midterms, which means my awareness of the world has shrunk to the space between my coffee pot and desk, but a friend insisted that I pay attention to this story right now - and I'm glad he did. PLoS Medicine has just published a report titled Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration; granted, it's one of those titles that doesn't immediately tell you what it's about (and since I'm in the middle of preparing a few abstracts, as well, my brain is itching to red pencil it, but I digress). So what is this unwieldily-titled paper about? According to the succinct title The Guardian gave their report of the issue, it's simple: prozac, used by 40 million people, does not work. From that article,

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.

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.

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.

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.
-Kelly

Are Those Workplace Wellness Programs a Good Idea?

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.

HIV Preventative Significant Boost for Women

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.

Is GARDASIL® a responsible mandate?

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.

References:

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).

Genetic discrimination: in the eye of the beholder?

Yesterday's NYT ran a front-page article by Amy Harmon about genetic discrimination. Some people who could potentially benefit from genetic testing are deciding not to be tested (or to be tested "off the books" using direct-to-consumer vendors) to avoid the possibility of discrimination in insurance or employment.

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!

Patient Responsibility for Medical Outcomes

Universal health care in the U.S. would be a step in the right direction toward solving some of our many problems in the area of costs and delivery. One of the numerous pressures on costs are malpractice and negligence lawsuits. Physicians pay astronomical liability premiums. A significant portion of hospitals' budgets is spent on in-house legal departments. All health care providers and facilities are at risk in our litigation-happy society.

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.

Embracing the HPV Vaccine -- Warts and All?

We've posted before here and here about the HPV vaccine and debated whether or not it should be 'mandated' for girls; today in the NY Times an article in the Fashion and Style section (??) asks whether or not the parents would encourage their boys to get the vaccine. Currently, Gardasil is only FDA approved for girls and is marketed as preventing cervical cancer; but boys could benefit too, because the vaccine also protects against genital warts. Currently the vaccine is already approved for boys in Australia, Mexico and countries in the European Union; Merck will seek FDA approval for boys later this year. The question is, will the parents of young boys and girls in the USA buy it? Full article accessible here.

Animal and Human Cognition: Are the differences that great?

Two articles in the Science Daily news examine the differences in human and animal cognition -- the first, an article linked to the Public Library of Science (PLoS) Biology Journal that asks the question, "Do Animals Act Like Autistic Savants?: When Temple Grandin argued that animals and autistic savants share cognitive similarities in her best-selling book Animals in Translation (2005), the idea gained steam outside the community of cognitive neuroscientists. Grandin, a professor of animal science whose best-selling books have provided an unprecedented look at the autistic mind, says her autism gives her special insight into the inner workings of the animal mind. She based her proposal on the observation that animals, like autistic humans, sense and respond to stimuli that nonautistic humans usually overlook."

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)

Does social inequality leads to health problems?

Stanford University neurobiologist and primatologist Robert Sapolsky says yes. In a number of interesting and very funny books, including A Primate's Memoir, Why Zebras Don't Get Ulcers, and The Trouble with Testosterone, Sapolsky explores the hypothesis that social dominance hierarchies and stress reactions play a large role in primate health.

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.

Supreme Court Ruling Favors Medical Device Firms

Professor Elizabeth Malloy over at the Health Law Professors Blog sums up my reaction to the recent Supreme Court on medical devices manufacturers being shielded from liability:

"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 -

“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.”

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."


I couldn't have said myself, Elizabeth -- thank you for posting this.

Who benefits from prenatal testing for adult-onset disease?

I recently stumbled across this article (free, but registration required) by SUNY Albany's Bonnie Steinbock. The paper examines the growing practice of prenatal testing and considers who benefits from such testing for adult-onset conditions (such as breast cancer, schizophrenia, and Huntington's disease).

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.

The Last Lecture

Those of you who know me, know that it was end of life issues that brought me originally into the field of bioethics. Dealing with death and dying is not something I did willingly. So when a friend sent me this link to The Last Lecture, I wasn't sure if I wanted to watch it. But this man, Randy Pausch, deals with his mortality in a such beautiful, positive way and helps give meaning to all of our lives, I felt compelled to share it with our readers:





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.

Arts and Bioethics: Challenging Ideas and Cultures

The Arts Bioethics Network will be launched at the 9th World Congress of Bioethics in Croatia in a 2-hour session of performances in which artists from various genres will present work that has a bioethics &/or human rights theme.

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: c.kuppuswamy@sheffield.ac.uk and pmacneill@med.usyd.edu.au

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.

KaiserEDU essay contest

Attention students! KaiserEDU.org, a project of the Kaiser Family Foundation, has announced an essay contest for college undergraduates and graduate-level students. The prize is $1,000, the deadline is March 17, and the topic is healthcare reform. Learn more here.

Nature: eliminating gender bias in the peer review system simply isn't our priority

A scathing article in Scientific American and very dismaying news about how Nature editors rejected a peer review process that would reduce gender bias:

"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."

Bioethics and "The Island"

Like most of America, you probably haven't seen Michael Bay's The Island (2005), starting Ewan McGregor and Scarlett Johansson. It's not a cinematographic masterpiece. It is downright goofy in spots, there is a lot of stuff blowing up (this is the team that brought us Transformers and Armageddon, after all), and it has the most intrusive product placement I've ever seen in a movie. But if you're interested in bioethics, and particularly if you're interested in how the mass media depicts biotech, you should get your hands on the DVD. If you teach bioethics, the film could provide a nice springboard for discussion. Plus, for the first third or so, it's got Steve Buscemi, which is always a plus in my book.



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)
  

It might also be interesting to consider similarities to (and differences from) other media depictions of cloning and organ-harvesting. Oryx & Crake, Never Let Me Go, and Coma (also a 1978 movie) come to mind, but there are lots more out there.

Too many twins? Says who?

Today's NYT ran a piece that describes calls to reduce the number of multiple births resulting from in vitro fertilization efforts. Since the introduction of IVF in 1980, multiple births in the United States have increased by a whopping 70 percent--in no small part due to the fact that many prospective parents choose to implant multiple embryos in the hopes of increasing the odds of a successful pregnancy and birth. Several of us have blogged on other issues re multiples before, too... here, here, here, and here.

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.

Top Ten Technologies to Watch For in 2008

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

7.) Personalized Medical Monitors

6.) Single-Cell Analysis

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.

1.) Augmented Reality

Which ones are your favorites? Which ones do you have the most hope for?

Science: money = influence

According to the NYT, a memo critical of the role of the Gates Foundation's increasing role in global health research and policy was recently released to the media. The World Health Organization's chief of malaria research, Dr. Arata Kochi, is worried that the Gates Foundation's business-minded focus on best practices and leveraged investment is at odds with the way scientific research should be done and the way international health policy should be developed.

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.

(Still) Wanted: A Female-Controlled Method to Prevent HIV

Twenty-seven years after AIDS was first diagnosed among gay men in California and New York, HIV/AIDS has become a health threat borne disproportionately by women in the developing world. Globally, there are twelve HIV-positive women for every ten HIV-positive men. In the hardest hit countries in sub-Saharan Africa, young women are three times more likely than their male peers to become infected.

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 Uganda shows that circumcision does not protect female receptive sex partners. There thus is a desperate need to develop new tools to enable women to protect themselves, including microbicides.

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 South Africa volunteered to be part of this clinical trial, in which participants were randomly assigned to either receive Carraguard or a comparator gel. Trial participants were instructed to use the gel plus condoms every time they had sex, and asked to return to the study clinic repeatedly over a two-year period. During this time, they were provided with condoms and received comprehensive risk reduction counseling, HIV testing, and screening and treatment for STIs.

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.

Food Wars, Part XIV: Conflict on the Menu

We've been posting a lot about food ethics in the last couple of months, so it is fitting that from the NY Times today: "New York City’s new rules for menu labels at chain restaurants have set off a food fight among the nation’s obesity experts.

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.

Need a scorecard on healthcare reform?

FactCheck.org, a project of the Annenberg Public Policy Center (APPC) at the University of Pennsylvania, is a great source for nonpartisan information about how what the candidates say matches up with what they do (or have done in the past). Plus, APPC is headed by Kathleen Hall Jamieson, who is a really terrific scholar, writer, and advocate on behalf of the public interest.

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.

Yes or No to In Vitro?

The Women's Bioethics Project recently had the opportunity to work with web TV hosts and producers Whitney Keyes and Wyatt Bardouille.  They interviewed one of our book club non-fiction authors, Beth Kohl, about her personal experience with assisted reproductive technologies.  With engaging humor and wit, Whitney, Wyatt and Beth explore the reality of the ART process as well as some of the ethical implications.  Sometimes we get lost in the complexity of ethical debates and forget that these issues affect real people with real stories. Narrative matters.

 

You can watch the segment "Yes or No to In Vitro?" here.  

23 & Me...Cracking the Code

The issue of genetic screening and analysis--the value and expense of it--and whether the testing is necessary or worthwhile--has been raised and discussed on this blog site time and time again.

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.

Boys Suck: Science Proves It

Evolutionary biologist Virpi Lummaa has discovered that Finnish women in previous generations suffered a variety of adverse effects when they bore and raised sons.

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...

Prejudice and Mentalism: It's All In Your mPFC

Scientific American reports on a study that shows difference in medial pre-frontal cortex activity when distinguishing between people who are part of one's group and who are not.

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?

A Valentine's Day Gift to our Readers...

Whether you have a special someone with whom to celebrate today or whether you just are a special someone, we wish you a Happy Valentine's Day! And here are just a few links to stories that popped up when I googled Valentine's Day + bioethics:

- 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.

Grocery Store Wars, featuring Cuke Skywalker and Obi Wan Cannoli

Ok, in light of all the recent food ethics posts here, other bioethics blogs, and references to Michael Pollan, someone was bound to make a YouTube video that makes fun of the 'ways of the farm' -- you know, the field that gives rise to all things edible. It pits the lovely organic rebel Princess Lettuce against the 'evil' genetically modified Darth Tater:



So go ahead, have a laugh! Who said bioethicists don't have a sense of humor?

The Logic or Rationale of the DNR Order

Whether we've discussed it or not, we've all thought about the prospect of Do Not Resuscitate Orders (DNRs). In most instances the need for them is no mystery nor does it require rocket science to understand when they become necessary. But now, in 21st century medical science comes the question: when do they not make sense?

See one perspective on a controversial ethics issue here.

Reality check: health disparities

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.
  

The list goes on. Those who want to learn more can check out the National Partnership for Action To End Health Disparities. Meanwhile, here's a question you might want to keep in mind as we learn more about the candidates' plans for health care reform: Is it really acceptable for the richest country in the world to allow this kind of inequity?

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.

Pain and personhood

Yesterday's NYT Magazine ran a long article about whether fetuses feel pain. The author, Annie Murphy Paul, is working on a book about how our early experiences shape development, and she asks some interesting questions about what effects pain and stress might have on fetuses. The pain question is an interesting one, and experts disagree about whether, to what degree, and at what point in time fetuses can experience pain.

If fetuses can experience pain, it seems not only reasonable but morally necessary that they receive sufficient anesthesia when they undergo painful procedures (such as blood transfusions or surgical interventions--which, believe it or not, can actually be done in utero in certain specialized centers in the U.S.). Such a claim doesn't rest on assertions of personhood, only of sentience. I would never let a veterinarian do surgery on my dog without anesthesia, but that doesn't make him a person.

As Paul notes, some anti-abortion activists have seized on research that shows fetuses displaying a physiological response to painful stimuli. They want to use this information as an emotional weapon, making sure that women know that if they have an abortion, the fetus will feel pain. Therefore, the argument goes, they should not abort. But while such a statement might make a woman feel worse, I have a hard time imagining that it would really change the mind of a person who'd made a firm decision to abort. It might cause her to ask that anesthesia be provided, though, which seems like a good thing.

Setting aside the abortion debate, pain is awfully tricky. We tend to understand pain as a subjective phenomenon: two people exposed to the same painful stimulus might well have different responses. So what does it mean to talk about pain for the fetus, who can't rate pain on a scale from 1 to 10, or even point at a frowny face? What do measures of cortisol or other stress hormones, or changes in blood flow, tell us about what the fetus is experiencing?

If we say that increases in certain metrics or decreases in others correlate with pain, what would it mean if we saw similar indications in a person in a persistent vegetative state? Paul comments that it might cause one to reconsider active euthanasia in such a situation, as a means of sparing suffering. But the connection between pain and suffering, between objective physiological measures and life as experienced, forces us to think about consciousness, about personhood, about respect for living beings (human and not), and about mercy. I can't do the article justice here, but it's definitely worth a read.

Endocrine Disruptors Skewing Birth Ratio in US and Japan

From the polar ice cap to the middle of the world, comes study after study linking synthetic chemicals and their lethal properties, to a reported steady decline in the number of boys born each year.

In an article written by Elizabeth Barker for the February 2008 issue of Whole Life Times, a recent report from the National Institute of Environmental Health Sciences determined a significant decline in the ratio of male-to-female births in the US and Japan, resulting in 250,000 fewer boys being born since 1970.

Last year, a team of Scandinavian researchers in the Arctic reported twice as many girls as boys being born in that region, identified as a "pollution sink" for the rest of the planet. Both studies blamed environmental pollutants as the most likely causal factors in the male birth shortages.

Read the entire article here.

Embryonic Stem Cell Trials in Humans Could Begin in Months

If all goes as planned, a California biotech firm will begin human testing using human-based embryonic stem cells by Spring of 2008.

Dr. Thomas Okarma, CEO of Geron, said the firm plans to conduct embryonic stem-cell studies in subjects with spinal cord injuries, involving up to 40 patients. The planning, of course, is pending the greenlight to proceed from the FDA, which is said to be setting a "high bar" on regulations governing what is certain to be one of the most significant pioneering research procedures of the century. Economic analysts predict the regulatory process alone will be daunting, and time-consuming because these are uncharted waters. It will be the first time that the FDA reviews a human embryonic stem-cell application.

Controversy has raged on both sides over the debate of stem cells and the ethical use in human therapeutic applications. In 2001 President Bush placed limits on federal funding of experiments involving then-existing human-derived stem cell lines, and in 2007 vetoed an attempt by Congress to lift those restrictions. No doubt the impending research will only raise more ire, questions and a major regulatory conundrum of the likes never witnessed before.

Some News Items Worthy of Taking Note

A quick summary of some of the newsworthy items that appeared in the news in the past week:

Alexis Madrigal of Wired's Science blog writes about a report published by the Committee for Economic Development, a nonprofit, nonpartisan thinktank in San Francisco, that prescribes openness in medicine, including open-access publishing of research data, as a means for improving the healthcare system. For a copy of the full report, click here. For more on Alexis' article, click here.


Sara Robinson does a great job of blasting the straw bogeymen in her first of her series, Mythbusting Canadian Healthcare, where she refutes the ten biggest myths about Canadian health care. [Hat tip to Mike the Mad Biologist, who blogged about it first and commented in his blog: "Despite conservative claims to the contrary, we do ration healthcare: many lower middle-class and unemployed people don't get to have any."]. Full article here.


Want to learn more about what makes you unique? Check out New Scientist's Personality Factors: "[F]ive key thermostats account for most of the variation in personality. These big five - extroversion, neuroticism, conscientiousness, openness and agreeableness - define five axes along which all individuals fall. Your personality, as measured by one of the many available questionnaires, consists of five different scores. Since each axis is continuous and they are independent of one another, there are countless unique personality configurations." For the whole enchilada, click here. (Subscription required)

And although, this article from New Scientist isn't related to healthcare ethics, it does bring up some fascinating philosophical questions: Will 2008 be the year of time travel? , like if you had a chance to go back in time and stop horrific things from happening (the classic example is eliminating Hitler to avoid WW II), should you? (Subscription required).

Happy Reading!

JUST SAY ‘NOETIC”

Earlier last week, we featured a delicious (if dubious) little item titled “The Mind-Body Connection via Intentional Chocolate.” According to The Institute of Noetic Sciences, a recent study found that adding positive intentions to chocolates resulted in significantly enhanced mood in those subjects who ate the “intentional’ confection compared to the controls.

Leaving aside the question of whether this actually works (and if so, how I can get my hands on some?!), I have a question for you:

Off the top of your head, do you know what “noetics” means? At dinner Saturday evening, someone stumped me with this. None of us, all post-college educated, reasonably literate people, could do more than guess. Now I was curious. I decided to look into it, and here’s what I found out. First of all, the dictionary definition of noetic (adj.): “of, relating to, originating in, or apprehended by the intellect. [Greek noetikos , from noesis , understanding].” And then, an interesting extension noted in the Online Medical Dictionary: “noetic anxiety: In existential psychotherapy, anxiety caused by confusion or loss of meaning in life.” (Or perhaps not enough chocolate? But I digress…)

And as for the Institute of Noetic Sciences (or IONS, the evocative acronym they often use):

“IONS is a non-profit research and education institution dedicated to advancing the science of consciousness and human experience to serve individual and collective transformation. Founded in 1973 by astronaut Capt. Edgar Mitchell, IONS was created to explore the interface of science and spirituality and to promote forms of consciousness that shift humanity from separation and conflict to collaboration, forgiveness and inter-connectedness.”

I’m feeling better already!

Informed Consent in Clinical Medicine as a Concern for Ethicists

The always excellent Kaiser Foundation's Daily Health Report http://www.kaisernetwork.org/daily_reports/rep_index.cfm calls attention to a startling new research finding--apparently "most patients don't read the forms they sign before undergoing surgery or medical treatment." What I find interesting, though, is that the Wall Street Journal Article that Kaiser quotes from concludes that hospitals are studyng this in an effort "to improve their informed consent processes amid 'mounting concern about patient safety and lawsuits arising from botched communications.'" At least the priorities are in that order. As a lawyer/bioethicist is is always interesting to me to see that despite the visceral hatred doctors have for the concept of civilian oversight (which is an accurate description of the current medical malpractice system which relies on lay juries for final decision making)combined with a reflexive support of any "tort reform" legislation which makes it harder for patients to sue. This support is unrelated to realities that medical malpractice litigation is not a factor in rising medical malpractice rates.

And this is of special interest to women how? Because of two phenomena. First, because women are still battling for true informed consent when it comes to issues such as breast conservation surgery and caesarian sections http://blog.healthcommunicationresearch.com/search?q=women
and second because efforts to make it harder to sue for medical malpractice ("tort reform") are harmful to women. See Professor Linda Finley (Lucinda M. Finley, Female Trouble: The Implications of Tort Reform for Women, 64 Tenn. L. Rev. 847 (1997) [hereinafter Finley, Female Trouble]; Lucinda Finley, The Hidden Victims of Tort Reform: Women, Children, and the Elderly, 53 Emory L.J. 1263 (2004) .

While bioethicists think more about the ethical issues in the informed consent process of clinical research, in fact the informed consent issues in day to day medical treatment are just as important. Although it may seem as if consent for medical treatment is less problematic because unlike areas of clinical research where the interventions may not benefit the patient these interventions seem designed only for the patient's benefit, in fact medical care is not so simple. There is always a range of options when it comes to medical treatment and one of the least understood of these options (to patients at least) is the option of doing nothing. Another frequent problem is that patients are not informed of the range of options but only those options available through their doctor or health care center.

There is an entire field devoted to communicating with patients and this blog http://blog.healthcommunicationresearch.com/search?q=women
provides many interesting examples of how the way women receive information can impact their health care decisions.

It would be ideal if the kind of improvements to informed consent such as moving away from handing over sheets of typed paper to sign towards a more interactive process that included different ways of presenting information, could be made without any need for the penalties of either civil litigation or administrative fines. However, there is nothing in recent history to show that informed consent is such a basic good that it would always be a priority without these incentives.



I would encourage all of us interested in informed consent to think more about its role in medical treatment in general and women's health care in specific from the ethics or human rights perspective rather than just to see this as yet another imposition of the legal system on the already over-burdened health care system.


Wall Street Journal Examines Efforts by U.S. Hospitals To Improve Informed Consent Processes[Feb 06, 2008]
The Wall Street Journal on Wednesday examined how U.S. hospitals have begun to improve their informed consent processes amid "mounting concern about patient safety and lawsuits arising from botched communications." According to the Journal, researchers have found that "most patients don't read the forms they sign before undergoing surgery or medical treatment." In addition, more than "half of those who do read the forms don't understand them, and only a quarter of forms include all of the data patients need to make an informed decision," the Journal reports.In response, some hospitals have begun "offering explanatory videos and diagrams" to patients when they complete consent forms, as well as "translating medical lingo into simple English" and "offering materials in other languages" to explain medical procedures and provide information about alternative treatments, according to the Journal. Some hospitals also have begun to use new technologies, such as online databases that calculate the risk of medical procedures for patients before they complete consent forms and electronic forms to address problems with lost paper forms that can delay procedures and increase costs.CMS recently issued new guidelines that require hospitals to develop "patient-friendly" informed consent processes, and facilities that do not comply could lose their eligibility to participate in Medicare. The Joint Commission, which accredits hospitals nationwide, also has advocated improvements to the informed consent processes used by the facilities (Landro, Wall Street Journal, 2/6).

A Gourmet Q&A

We're unashamed fans of Michael Pollan around here, so it when I came across this Q&A with him on Gourmet's website, sharing it was a no-brainer. Pollan is doing the interview rounds talking about his new book, In Defense of Food (currently sitting on my nightstand awaiting a few hours of spare time), and in this particular interview talks about the inspiration for the new book, why cliche's about food matter, and uh... apparently how to survive on a diet of primarily whale blubber. Well worth the read - after all, you never know when you'll be stuck in the arctic wilderness with nothing but a whale carcass.
-Kelly