April 2008
Can you buy changes in health behaviors?
By Stuart Rennie
And the girl behind the counter has a tattooed tear
One for every year he's away she said
Such a crumbling beauty,
Ach there's nothing wrong with her
That a hundred dollars won't fix
Those are lyrics from Tom Waits' song '9th and Hennepin.' They slipped involuntarily into my consciousness when I read about a World Bank study that is being planned in Tanzania. According to the report in the Financial Times, the study involves 'incentivizing' sexual behavior change by means of cold hard cash. Participants, if they do not pick up sexually transmitted infections during the study period, are told that they will receive $45 for their efforts. The study also will have a comparative control arm in which participants will also be tested for STIs, but will not receive any money. One of the researchers from the University of California-San Francisco is reported as saying: “We hope this ‘reverse prostitution’ will make people think hard about the long-term consequences of their short-term behaviour.” An intriguing statement, since it implies that the problem with Tanzanians, in regard to sexually transmitted infections, is that they are just not thinking hard enough. Nothing like 45 dollars to get you to think straight. If the question is -- as the accompanying Editorial puts it -- "Are the funders saying young Tanzanians cannot be trusted to do what is good for them without a bribe?", it looks like the answer is a resounding yes.
The 5 most popular Bioethics News stories from the week of April 21
Here are the most popular Bioethics News items from last week based on average clicks per day:
1. "Untouchable" woman dies after being denied treatment
(AFP) An Indian woman died after giving birth when several doctors refused to touch her or provide treatment because of her caste status.
2. Congress close to passing GINA
(New York Times) A deal in the Senate opened the way for passage of the Genetic Information Nondiscrimination Act. (See the next story.) The bill would make it illegal to deny health coverage to someone on the basis of genetic information. It would also bar employers from hiring or firing on such info.
3. Senate passes GINA
(LA Times) The Genetic Information Nondiscrimination Act passed on a 95-0 vote.
4. Life expectancy declining in some parts of US
(New York Times) A study in PLoS reports that men and women in pockets of the Midwest and South are seeing life expectancy declines. One of the study's authors says this type of decline is unheard of in other developed countries.
5. Employer suspends 39 for lying about smoking
(AP) The suspended workers at a Whirlpool factory had signed insurance forms claiming they didn't use tobacco. Their jobs are now in jeopardy after they were caught smoking or chewing on company property.
The top five stories from two weeks ago.
Art Caplan on living forever
Over at MSNBC, Art writes that concerns over research into life extension are overblown:
Is it right to want to try to live forever? This ethical question is being kicked around quite a bit these days.
As the science of regenerative medicine using stem cells inches forward, as more is understood about how lifestyle influences longevity, as organ and tissue transplants become routine and as geneticists begin to unravel the secrets of why we age, the prospect of living forever — or at least until the Cubs win a pennant — makes the question something more than an exercise in science fiction.
What is particularly interesting is that many of those raising the question of the ethics of immortality do so with an answer already in mind — “No, it’s not right!” Both conservative and liberal writers alike are expressing a lot of moral angst in recent books, articles and opinion pieces about the prospect of people hanging around long, long after the last broadcast of "The Price Is Right" has aired, which could be an eternity.
Here's GINA
By Ricki Lewis
The human genetics community is eagerly awaiting imminent passage of the Genetic Information Nondiscrimination Act in the Senate. The law, in the works since 1995, prohibits health insurance companies and employers from using private genetic information in coverage and hiring decisions; from requiring genetic screens or tests; and from collecting such information without consent.
If the bill passes, it will add to the meaning of April 25. The date is already designated National DNA Day in honor of the publication of Watson and Crick’s famous DNA paper in 1953 and the unveiling of the official human genome sequence half a century later. Last year on DNA Day, the House passed GINA.
The noise gets louder
Writing in the Washington Post this week, David Shaywitz highlights some of the unintended consequences of the newer mass-scale approaches to studying genes:
A pioneer of this era, MIT geneticist Eric Lander, speaks eloquently of the "global view of biology," meaning that scientists now have extraordinary tools to study not only individual genes, but also multiple genes at the same time. Rather than immediately investing all their resources in a few favorite genes (the traditional approach), modern researchers first can survey thousands of initial candidates, then identify and ultimately direct their attention to the most important players and pivotal networks.
But we are increasingly discovering that this global perspective comes at an unexpectedly steep price: We're making a lot more mistakes. Or, at least, we seem to be having a lot of trouble picking out the rare, meaningful signal from the deafening noise in the background.
Typically, scientists accept a result as significant if there is a 95 percent chance it is real rather than random. But the catch is that as you start to make a large number of comparisons by examining thousands of genes, the possibility of a result appearing by chance becomes progressively more likely, to the point where such false positive results are all but guaranteed.
The consequence has been a boon for scientists -- most experiments yield enticing (read: publishable) results -- but a bane (of sorts) for science.
Scientific journals are littered with studies reporting "disease genes" or "molecular signatures" that are likely red herrings. To make matters worse, these results are typically packaged together as a tidy narrative, a post-hoc rationalization explaining how the newly identified genes fit perfectly into the biological process under investigation.
Shaywitz is quick to point out that despite the increased level of noise in the system, "more is more." We just to have to adjust our filters accordingly.
-Greg Dahlmann
Corn, oil and hunger
A trio of recent dots from the news stream that practically yell out to be connected:
+ The UN reported this week that rising food prices are pushing 100 million people even deeper into hunger. In response, Gordon Brown called hunger a "moral challenge."
+ Prices are starting to get so high that traditionally GM-food-phobic markets such as the EU are starting to warm to biotech crops.
+ Oil prices rose to a record high of almost $120 a barrel on Tuesday. As oil prices go up, ethanol becomes more attractive. And where does almost all of the ethanol in the US come from? Corn. In fact, about a third of US corn now goes to ethanol production, a trend which analysts say is pushing up food costs around the world.
-Greg Dahlmann
Art Caplan on Ben Stein's "Expelled"
Over at MSNBC, Art writes that Ben Stein's intelligent design documentary is not just bad -- it's immoral:
Rarely has a movie subtitle so capably assessed a movie’s content as does "Expelled: No Intelligence Allowed." There is not a shred of intelligence on display in this just released "documentary" purporting to be a careful examination of the fight over teaching creationism and evolution in America.
The movie seeks to explain why, as a matter of freedom of speech, intelligent design should be taught in America’s science classrooms and presented in America’s publicly funded science museums. But what is really on display in this film is a toxic mishmash of persecution fantasies, disconnected and inappropriate references to fallen communist regimes and their leaders and a very repugnant form of Holocaust denial from the monotone big mouth Ben Stein.
The 5 most popular Bioethics News stories from the week of April 14
Here are the most popular Bioethics News items from last week based on average clicks per day:
1. Formula could aid preemie decisions
(New York Times) The formula is based on a study published in NEJM that looked at which factors contribute to the success of very premature babies. About 40,000 of these babies are born each year in the US.
2. Regrowing lost limbs
(AFP) The Pentagon is participating in a $250 million research institute focused on regenerating tissues and whole limbs. The Army's surgeon general says he can see a future in which stem cells taken from soldiers will be used to replace limbs lost during combat.
3. Yale student's abortion art was faked
(Washington Post) Word that the senior's art project used tissue from her own abortions sparked outrage on and off campus. The work is now being described as "creative fiction." (This drama took another turn after the student called the university's denials "ultimately inaccurate.")
4. Feds expand DNA database
(Washington Post) The federal government will soon begin collecting DNA samples from all citizens arrested for involvement with a federal crime. Samples from detained illegal immigrants will also be collected. The new policy is projected to increase the federal DNA database by one million people a year.
5. Genetic testing goes retail
(New York Times) A company offering tests of a person's DNA for genes related to 18 diseases has opened up a storefront in Manhattan's SoHo neighborhood. One catch (or one of many): New York residents can't actually be tested just yet.
Looking ahead to "artificial" sperm and eggs
The possibility of sperm or eggs being created from pluripotent stem cells has been a hot topic of discussion in Britain over the last few months. The subject's come up as part of the broader debate about the upcoming vote on the UK's Human Fertilisation and Embryology bill. (The Britsh press has tagged these stem-cell-derived gametes with the modifier "artificial.") Sperm and eggs created in this manner could potentially open new avenues for treating infertility. They also could allow same-sex couples to produce children biologically related to both partners. But skeptics warn the technique could also lead to what one British interest group called "the ultimate incest": one person supplying both egg and sperm for a child.
The Hinxton Group, "an informal collection of individuals interested in ethical and well-regulated science," released a consensus statement (pdf) recently about sperm and eggs derived from pluripotent stem cells. The paper includes a look at some of the social implications of these gametes, as well as a handful of recommendations. Here's one of them:
Societies have the authority to regulate science, and scientists have a responsibility to obey the law. However, policy makers should refrain from interfering with scientific inquiry unless there is substantial justification for doing so that reaches beyond disagreements based solely on divergent moral convictions. Any interference with scientific inquiry should be derived from reasonable concerns about demonstrable risks of harm to persons, societal institutions, or society as a whole. In the case of PSC-derived gametes, as with all science, it is important to target policy specifically to those dimensions of the research or its applications that have proved to be unacceptable, and that these policies be proportionate to the magnitude of what is morally at stake.
The heart of the paper is only three pages long and it's a quick way to get up to speed on this topic.
-Greg Dahlmann
Pulling the sheet off ghostwriters
By Ricki Lewis
A report in the April 16 Journal of the American Medical Association exposes and laments the use of “guest authors” and ghostwriters on medical journal reports and review articles. A “guest author” is a researcher paid, such as by a pharmaceutical company, to lend her or his name when she or he has not actually done any of the reported work. We all know what ghostwriters are – the folks who write the tomes that celebrities without any experience in writing churn out, seemingly overnight.
An accompanying editorial calls for oversight of the guest author practice, but ignores the ghostwriter issue. Having been a ghostwriter, albeit rarely, I thought I’d comment.
The gap is widening on genetic testing, too
By Ricki Lewis
Yesterday, Ricki examined the growing gap between science and the public on stem cells. Today, she turns her attention to genetic testing.
Marketing tests based on whole genome association (WGA) studies were perhaps inevitable, for the approach makes theoretical sense. Scan genomes of people who share a particular disorder for single nucleotide polymorphisms (SNPs, or single base differences) that they have but unaffected controls do not. Then translate the population odds ratios of the telltale DNA patterns into individual disease risk statements, stressing such words as “variant” and “wellness” and censoring use of “disease.”
Consumers submit DNA-bearing saliva, and algorithms based on published WGA studies spit back risk stats. The tests are exempt from FDA scrutiny because they aren’t medical, according to the language. Load up the website with an intro genetics course, assemble an advisory board, and the FTC is satisfied, too.
But some people think it is too soon to hawk these WGA-based tests. The truth is, and the direct-to-consumer company websites actually say so in the fine print, we just don’t know yet whether an association seen in a population can provide meaningful information for an individual. The many calculations of WGA studies produce some false positives, and associations have been known to dissipate as data accumulates. Consumers may not be aware of these limitations, nor realize that “link,” “marker,” and “association,” have precise scientific meanings. It is all too easy to see slick company websites and assume that tests based on results of association studies have been validated. They have not.
The gap between science and society widens on stem cells
By Ricki Lewis
This is the first of a two-part post. Tomorrow, Ricki will examine how this gap is widening on genetic testing.
The disconnect between what biomedical scientists know and what health care consumers believe is growing, particularly for stem cell treatments.
The ability to send a skin cell back in developmental time to reinvent itself is a giant step forward, if expected since cell biologists started cataloging “stemness” genes years ago, George W. Bush’s partial claim to the idea notwithstanding. Even the glitch that some of those reprogramming genes cause cancer will vanish with refined recipes for making the coveted induced pluripotent stem (iPS) cells.
Researchers have also quietly coaxed pluripotent cells from the likes of testes, teeth, fat, and bone marrow, as well as from the medical trash heap, including placenta and umbilical cord membranes and even menstrual blood. Stem-like cells also hail from fetal cells lingering in women’s bloodstreams and self-fertilized eggs.
So far the new contenders in the human embryonic stem (hES) cell stakes seem to be the real deal – iPS cells have normal chromosomes, surfaces like those of true hES cells, and they can self-renew while also giving rise to all tissue layers of the embryo. However, because appearances can be deceiving, the International Society for Stem Cell Research warns that “a great deal of work remains before these methods can be used to generate stem cells suitable for safe and effective therapies.” In just a few months, though, iPS cells have proven themselves able to recapitulate more than a dozen diseases in vitro, providing unprecedented glimpses of the genesis of pathology. Their potential is staggering. Still, they are not quite ready for prime time in the clinic.
You’d never know it from the Web.
Can Plato pay the bills?
According to an article earlier this week in NYT, philosophy has become a hot major on college campuses:
Once scoffed at as a luxury major, philosophy is being embraced at Rutgers and other universities by a new generation of college students who are drawing modern-day lessons from the age-old discipline as they try to make sense of their world, from the morality of the war in Iraq to the latest political scandal. The economic downturn has done little, if anything, to dampen this enthusiasm among students, who say that what they learn in class can translate into practical skills and careers. On many campuses, debate over modern issues like war and technology is emphasized over the study of classic ancient texts.
Unfortunately for these students, employers don't seem to share the enthusiasm. A WSJ article a few days later included this chart:
But, with more jobs than candidates, maybe students of bioethics will fare a little better.
-Greg Dahlmann
Accepting placebos
Over at the Neuroethics and Law Blog, Adam Kolber argues that we should embrace the use of placebos:
Should a doctor stop prescribing antidepressants to a particular patient when the doctor believes that antidepressants will be no better for the patient than placebos? After recent changes in the American Medical Association’s Code of Medical Ethics, the doctor may have little choice but to stop. In November 2006, the AMA prohibited doctors from intentionally administering substances that they believe will only have placebo effects, unless they disclose to patients that they are doing so.
To most effectively use placebos in clinical practice, however, doctors cannot reveal their placebo nature. While placebo deception is a gray area of the law, the AMA’s prohibition makes it increasingly likely that doctors risk professional sanctions and legal liability when they use placebos without obtaining informed consent to do so.
Given our limited knowledge of placebo effects and patient preferences, the AMA prohibition is premature. While placebo deception should be rare, it sometimes promotes patients’ best interests. A rational patient might very well prefer to be deceived in some cases, if it means receiving a cheap and effective therapy with little risk of side effects. Even if a doctor believes that antidepressants will have no more than a placebo effect on a patient, we ought to allow the doctor to continue the therapy as before.
A "placebo positive" practice might face interesting challenges in getting informed consent -- if "informed" is the right word to use in this case. A patient would be consenting to possibly being lied to in the future. That's a lot of trust to place in your doctor.
And one more thing: if a doctor successfully treats a patient with a placebo, would it be ethical to eventually tell the patient that, yes, what you've been taking is just a sugar pill (or its equivalent)? Revealing that info could render the "treatment" ineffective and deprive the patient of whatever relief he or she has enjoyed.
-Greg Dahlmann
The 5 most popular Bioethics News stories from the week of March 31
Here are the most popular Bioethics News items from last week based on average clicks per day:
1. DNA evidence on the sly
(New York Times) Law enforcement agencies are increasingly collecting DNA evidence without the knowledge of suspects. The samples are often collected from discarded coffee cups, cigarette butts or, as in one case, saliva used to seal an envelope.
2. Drug co-pays straining budgets
(USA Today) Experts say co-pays are rising, but incomes aren't. One out of three people who got help last year from a foundation that aids people struggling to pay medical bills said drug co-pays were their top medical-debt problem.
3. Report: many populations routinely excluded from research
(HealthDay) Researchers at Baylor report that conversations about diversifying study patient populations have yet to result in widescale, real changes. The team also reports that many IRB members lack adequate training.
4. McCain's health care plan
(Boston Globe) John McCain says the country must provide health care to all citizens. He'd also like to reduce the government's involvement in health care and ease regulation of health plans.
5. UK researchers say they've created human-animal embryo
(The Times (UK)) A team from Newcastle University announced it had created embryo using cow eggs and DNA from human skin cells. Scientists hope to eventually extract stem cells from the embryos in order to model diseases.
The top 5 from last week.
The global scramble for ready-to-consent populations
By Stuart Rennie
Last year, Jill Fisher at Arizona State University wrote a very interesting article on the concept of 'ready-to-recruit' populations for biomedical research for the journal Qualitative Inquiry (subscription required, goddammit). The term 'ready-to-recruit' is a concept used in the pharmaceutical industry to describe populations that do not really have an attractive alternative to joining a clinical trial, because they live in circumstances of poverty, where there are few doctors, where local medical care is sub-standard and so on. Fisher prefers the more ethically charged term 'ready to consent' to describe these populations, because they are not just easy to access, but gaining their consent is a piece of cake. Practically all you need to do is ask. Socio-economic forces do the rest. Which is to say: the whole consent process is a bit of a farce.
The pregnant transgender man talks to Oprah
From a recap on Oprah's site:
Thomas [Beatie] says the desire to have children doesn't make him feel like less of a man. "I have a very stable male gender identity. I see pregnancy as a process, and it doesn't define who I am. It's not a male or female desire to want to have a child…it's a human desire," he says. "I'm a person, and I have the right to have my own biological child."
Beatie's obstetrician also appeared on the show and said, according to Reuters, "This baby is totally healthy. This is what I consider a normal pregnancy."
-Greg Dahlmann
Earlier on blog.bioethics.net:
+ A pregnant father
photo: Harpo Productions
Stray genetic material and expectations of privacy
Popular Mechanics recently ranked what are, in its opinion, the 10 most prophetic sci-fi movies ever. Number 1? The genetics-focused drama Gattaca. As the mag notes, "The technology on display in the movie is still years away, but the central message—that genetic oppression can become institutionalized before anyone notices—is increasingly relevant."
One of the plot elements in Gattaca is that a person's stray genetic material -- hair, saliva, whatever -- could be picked up by someone else and used as evidence against them.
And, as it turns out, that's actually happening.
Art Caplan on children's medical care and prayer
In his latest column for MSNBC, Art takes on cases where parents don't seek medical care for their children because of religious objections:
Ava Worthington is dead. She was only 15 months old when she died. The people responsible are her parents, who relied only on prayer as their child expired before their eyes. The question is whether they deserve to be put on trial for doing so. I think they do.
The 5 most popular Bioethics News stories from the week of March 24
Here are the most popular Bioethics News items from last week based on average clicks per day:
1. Charges considered for parents who didn't seek medical care before death of teen
(ABC News) The Wisconsin couple's daughter died from a diabetic condition. There's evidence the family has a religious objection to medical intervention, though the parents said they have nothing against doctors.
2. Lilly settles Alaska Zyprexa suit
(NYT) The state had accused the drug maker of sitting on information that linked the schizophrenia drug to diabetes. If Alaska's $15 million settlement is a benchmark, Lilly could be in for billions of dollars in settlements with other states.
3. Direct-to-consumer paternity test goes on sale
(AFP) The DNA test, which had already been available in test markets, went on sale last week in thousands of drug stores across the country. Test results are available in three to five days. They're not allowable as evidence in court, though.
4. Doubts raised about drugs based on RNAi
(AFP) The promise of drugs based on small-interfering RNA was that they would be able to very specifically "turn off" genes to treat a range of diseases. Researchers report in Nature, though, that these molecules actually are much more broadly acting and could have unintended side effects.
5. Ventilators and pandemics
(NYT) A report issued by a New York State task force says health care providers need to start thinking about how they would go about removing ventilator care from some patients during a flu pandemic.
The top 5 from last week.
