Racial health disparities in the United States have been repeatedly measured, demonstrated, and presented to the point where their existence is no longer in question. But still up for discussion is how to fix them, whether through sweeping legislation like this year’s federal health care reform, local efforts to improve health care access or social determinants of poor health, and/or by customizing care to better serve minority populations. But what about that time-honored American way of dealing with injustice and unfairness - why not tell disparities “I’ll see you in court!”?

The idea is not so far-fetched, said Anup Malani, a professor of law and medicine at the University of Chicago, in his lecture to the MacLean Center for Clinical Medical Ethics in early December. After all, the Civil Rights Act of 1964 was created to address segregation and inequality in schools, employment, and other important aspects of life, so why not medicine? History shows that Title VI of the Civil Rights Act, which forbids racial discrimination by any body that receives federal funds, was one of the most effective strategies ever in reducing racial health gaps. After its passage, hospitals and other medical providers (nearly all of whom receive federal funding in the form of Medicare/Medicaid), could no longer legally segregate patients into different wards or treat them with different personnel. The result was a rapid improvement of health care for black populations, and a brisk narrowing of the disparity in measures such as infant mortality, Malani said.

“It was a huge, huge success,” Malani said. “We spend a lot of time in law school thinking about the great civil rights successes in education, and we’re studying the wrong thing. In four months, you got 1,000 hospitals to integrate. This is unbelievable…One would like to achieve that sort of result again.”

But the rapid integration of American hospitals in the 1960’s only reduced the gap, it didn’t eliminate it. Some hospitals also exploited a loophole in Title VI and simply moved to more affluent, predominantly white communities, a strategy that turned out to be difficult to litigate in Title VI court cases. Because hospitals could plead at least one legitimate reason for the move - usually the argument that they would no longer be financially viable in the inner city - the charges of civil rights violation were denied. Other limitations of civil rights cases, including federal limits on damages, high cost, slow pace, and inadequate penalties, also make Title VI the wrong weapon to use in fighting today’s racial disparities, Malani argued.

Those loopholes may have even created a major driver of health gaps, Malani’s research has found, in that a disproportionate number of minority (and poor) patients receive their treatment from the country’s worst-performing hospitals. This dynamic creates what Malani called a “between” disparity, where minorities receive care from lower-quality providers than white patients, rather than receiving poorer care from similar-quality providers. Statistics have supported that observation, showing that hospitals and ambulatory care centers that treat more minorities have lower scores on measures such as mortality.

Therefore, though it hurt Malani to admit it (”it’s awkward for me as a lawyer to say I’m not the solution,” he joked), the most effective strategy may not be litigation but policy efforts to help the low-performing hospitals. Improve the statistics of these health care providers, and you hopefully reduce the racial gap by reducing “between” disparities.

“Let’s send funds to these hospitals,” Malani said. “If you just target the worst hospitals in America, you’re going to disproportionately help minorities.”

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The bacteria that started it all.

When scientist/entrepreneur J. Craig Venter announced that his company had created “synthetic life” in March, a predictable tsunami of media hype followed. Though the discovery was more accurately an important step in synthetic biology, rather than the creation of life from scratch in a laboratory, the story provoked rampant speculation about what this new field might be capable of. Interest in the promise and dangers of synthetic biology went up to the very top - the White House, where President Obama ordered his Presidential Commission for the Study of Bioethical Issues to look at this new science as their first item of business.

Today, seven months later, the commission’s report [pdf] is being released, with recommendations on what the federal government should do - and not do - about the growing field of synthetic biology. Our own Daniel Sulmasy, professor of medicine and ethics at the University of Chicago Medical Center and the Divinity School, is one of 13 members of the commission, and was kind enough to walk ScienceLife through the highlights of the report. The over-arching theme is one of “prudent vigilance,” Sulmasy said.

“We rejected the position that progress is so good, let’s just forget about any kind of regulation,” Sulmasy said. “But we also rejected the very cautious ‘precautionary principle,’ that says until something is proven safe we shouldn’t do it. I think that would cripple scientists and the potential of progress here that may be of significant benefit.”

Someday, synthetic organisms may provide renewable fuel sources, efficient vaccines, new ways of fighting pollution, and improved agriculture. While those applications are a long way off, Sulmasy said now was the right time for the commission to start a conversation about the ethics of such scientific breakthroughs, even if it is decades before they come to fruition. There’s a danger in being too early, he said: ethicists discussed the possibility of cloning organisms as early as the 1970’s, yet those discussions were largely unacknowledged, leaving policymakers unprepared for the ramifications of Dolly the Sheep in 1997. But open the ethical conversation too late, and it’s “like trying to put the cat back in the bag,” Sulmasy said.

“I hope that we can take a look early enough that we can have the ethical debate before the science is being done in widespread fashion and it’s impossible to regulate,” Sulmasy said.

Still, not knowing where synthetic biology may lead left the commission in a tough spot. Of the 18 recommendations listed in their report, the majority suggest using public funding organizations such as the National Institutes of Health, the Department of Energy, and NASA to share lifeguard duties over the field, without proscribing any specific restrictions. The agencies should fund promising research projects in synthetic biology, the report says, and make sure that adequate testing is done before the products of thatresearch are released beyond the laboratory.

Keeping scientists at academic institutions and private research companies in line should be possible under this structure, but the report identifies a newer, less predictable group of experimenters: DIY scientists. Shrinking costs of genome sequencing and scientific tools have led to a community of hobbyists doing synthetic biology research at home, Sulmasy said.

“There already is a lot of regulation and oversight on the academic and industrial side, so we didn’t think there was a need to create an independent commission or mechanism for assuring the safety of this work there,” Sulmasy said. “Where we did discover a gap is in a small number of people who are doing this kind of work at home and are very intrigued by it. For those who fall outside of the usual communities, we want to bring them into the fold without causing resistance.”

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“In this sense, we may indeed say that medicine has saved the life of ethics, in that it has given back to ethics a seriousness and relevance which it seemed to have lost for good.”

-Stephen Toulmin, 1982

“The emergence of medical ethics in the latter half of the 20th century helped revive medicine, saved it…from its narrow focus on science and technology to restore to it its former human dimensions of care, compassion and case focus.”

-Mark Siegler, 2010

Did medicine save the life of ethics? Toulmin , a professor in the University of Chicago Department of Philosophy and Divinity School until 1986, argued that it did in his 1982 essay. But at the 22nd Annual Dorothy J. MacLean Fellows Conference - dedicated to the memory of Toulmin - his former colleague Mark Siegler, the director of the MacLean Center for Clinical Medical Ethics, said the opposite might also be true. His argument found support in the sessions of the conference’s second day, which examined medicine’s present and future from the angle of ethics, and occasionally recommended applying the brake to the runaway train of science.

The first session of the day focused on the genetic testing of newborns, the kind of medical concept that sounds great on paper, but loses some of its luster with close, careful scrutiny. In theory, the ability to quickly screen a baby for disease immediately after birth should be a medical wonder, allowing physicians to quickly react and treat the child for medical conditions. But the history of such screening is far from ideal, as Norman Fost of the University of Wisconsin presented.

Consider the case of phenylketonuria (PKU), a nutritional deficiency that can cause mental retardation in around 1 of every 10,000 births. Spurred by John F. Kennedy’s call to action against the causes of mental retardation, scientists developed a cheap, simple test for PKU in newborns that was made mandatory. However, the test was “one of the worst tests ever devised,” Fost said, with a 95 percent false positive rate. To make matters worse, the special diet used to treat PKU turned out to be as harmful to children as the original disorder. As an isolated case, that story is frightening enough, but the pattern of unreliable tests and ill-considered treatments has repeated itself several times over, Fost said.

“Santayana said, ‘Those who do not study history are not doomed to repeat it,’” Fost said. “In newborn screening, it doesn’t really matter if you study history, it just keeps getting repeated anyway.”

Rather than slowing down to correct these flaws, the field of newborn screening is poised to expand using the latest genetic technology. Lainie Ross, professor of pediatrics at the University of Chicago Medical Center, talked about the near future where all 3 billion base pairs of a newborn baby can be sequenced from a single blood spot. That data can then be matched against the library of all known genetic disorders and markers of disease risk, giving parents an avalanche of information about their child’s current and future health.

But can anything be done with that information? Will an inability to treat genetic disorders produce unnecessary anxiety in parents? How do you determine who should have access to that child’s information? What if the child, when they reach adulthood, wants that information withdrawn? How should that information be used by insurers, employers, or law enforcement, if at all? In light of all these questions, genetic testing appears more and more inadvisable, even if the science to do so is nearly there.

“Clearly many issues need to be addressed before newborn genetic profiling should become routine,” Ross said.

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Anyone who dares make predictions about the future of the U.S. health care system in 2010 is standing on shaky ground. With the passing of the Patent Protection and Affordable Care Act (PPACA)- the legislative product of the health care reform debate - everyone knows that the rules are about to change in this country, but nobody is quite sure how. The changes included in the act will not be fully phased in until 2014, and the complicated business of determining exactly how those changes are implemented is currently underway in the bureaucratic halls of Washington. Throw in the Republican gains in this month’s election - won at least in part on promises to repeal aspects of PPACA - and uncertainty is rampant about the most important overhaul to American health care since the creation of Medicare.

That foggy vision of the future dominated discussion on the opening day of the 22nd Dorothy J. MacLean Fellows Conference, this year’s edition of the MacLean Center for Clinical Medical Ethics annual event. Though the topic of Friday’s sessions was nominally health disparities on the local, national, and global stages, the discussion was magnetically drawn again and again to PPACA, which was designed in part to narrow notorious health care gaps in the United States.  The physicians, ethicists, and social scientists at the conference unsurprisingly agreed that it was imperative that those disparities be reduced, but less consensus was reached on whether PPACA would be the magic bullet to do so.

On its face, the legislation makes several sweeping moves that would appear to directly confront health disparities in America. No PPACA component is more significant for underserved populations than the expansion of medical coverage for the country’s 47 million people without insurance, the majority of whom are minorities, said A. Eugene Washington, the dean of the David Geffen School of Medicine at UCLA. The other major aims of the bill, improving quality and reducing cost, may produce more mixed results for disparity reduction, as new payment measures based on outcome, rather than volume, could push health care providers to avoid communities with poor health at baseline. Much relies upon how the broad goals of the bill are truly implemented by federal and state agencies, he said.

“The legislation is really a framework, and it’s going to get shaped,” Washington said.

The (mostly) pessimistic view of that shaping process was provided by Harold Pollack, professor of social service administration at the University of Chicago. Pollack said the legislation, as written, is the most important AIDS and drug addiction policy ever passed in the United States and that expanded coverage will help address some disparities. But he was also critical of the slow roll-out of policies because it makes them contingent upon “bipartisan goodwill,” a scarce resource lately in Washington.

“We’re in for a wild ride, and it’s going to be a wild ride in a time of fiscal crisis and political gridlock in the short run, when the most difficult implementation challenges in our health care system will have to be resolved,” Pollack said.

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When long-hidden information about U.S. syphilis experiments on Guatemalan prisoners in the 1940’s surfaced last week, the shocking case contained echoes of the infamous Tuskegee study. Conducted from 1932 to 1972, the Tuskegee syphilis experiment followed African-American sharecroppers with the disease, and gained notoriety for withholding antibiotic treatment from the men in order to study the disease’s “natural progression.” The damage left by this unethical research persists to this day as an example frequently cited by minority communities distrustful of medical research.

“Most folks in the black community who know very little about research know about the Tuskegee study,” said Rick Kittles, in his Sept. 29 MacLean Center seminar “Race, Biomedical Research, and the Politics of Trust.” “It’s as if it was imprinted in our genes. There’s no Sunday morning breakfast discussion about it, but we know about it. We know something bad happened. We know that we were exploited. It has some serious implications still today.”

Indeed, the shadow of Tuskegee looms large over modern efforts to reduce the growing health disparities in the United States between Caucasian and minority populations, said Kittles, an associate professor at the University of Illinois School of Medicine. Many factors contribute to health gaps on parameters such as obesity, diabetes, and cancer: genes, socioeconomic status, environment, behavioral and cultural practices, and discrimination. But attempts to study any of these factors in the hope of reducing disparities must face the troubled history of research on the undeserved. As researchers find new ways to improve health, from advanced genetic medicine to improving access to fresh food with weekend farmers markets, community involvement is essential for such measures to close the disparity gap instead of further widening the distance between haves and have-nots.

“As this new technology and information is emerging - new treatments and intervention that could hopefully eliminate disparities - if [the community] is not involved, they’re not going to accept it. You have to bring them into the mix,” Kittles said.

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In 1994, Italy’s Roberto Baggio was widely considered to be the best soccer player in the world. Having led his country to the final of the World Cup, played before over 100,000 people in the Rose Bowl, Baggio was the obvious choice to take his team’s critical fifth penalty shot in the shootout that would determine the championship. All he had to do was kick the ball past the goalkeeper from 12 yards away, something a star such as Baggio could probably do in his sleep. But at the biggest moment on the biggest stage in world sports, he flubbed it, skying his penalty shot over the crossbar and giving Brazil the World Cup.

Sportswriters and fans love to label such failures as abstract incidents of “choking,” and worse, often use them as evidence of an athlete’s lack of character and resolve. But research from the lab of Sian Beilock, associate professor of psychology at the University of Chicago, has found that choking actually results from information overload in the brain, with active thought overwhelming the more reflexive working memory. That research is the centerpiece of her new book, called  Choke: What the Secrets of the Brain Reveal About Getting it Right When You Have To, released just this week.

ScienceLife has written about Beilock’s research in the past, when her laboratory looked at how hockey players’ brains process active language differently from non-athletes. But Beilock hasn’t restricted herself to the NHL; she’s also invited golfers into the lab for putting experiments and tested how the attitudes of female teachers toward math affects the performance of their female students. Taken together, her work is less about the sports fans’ concept of “choking” and more about how external and internal factors keep the brain from performing optimally, knowledge that you don’t have to be a world-class soccer player to use.

Coverage of the book has run this week at Time, US News & World Report, and NPR.

Elsewhere…

An experiment published in Science this week demonstrates a central tenet of Einstein’s theory of relativity, by showing that a clock on the floor runs slightly slower than a clock one meter above it. Wired and Discover both offer blogs explaining why that’s important for everything from clock calibration to air travel. Quote the paper’s first author in Wired: “It’s interesting to think about - are frequent flyers getting younger [because they move so much] or aging faster [because they spend so much time in the air]?”

How has mad scientist research changed over the years? Gawker blog io9 made a graph.

The MacLean Center for Clinical Medical Ethics at the University of Chicago is oldest such program in the United States, has trained scores of physicians in ethical matters, and administers an excellent seminar series that has provided ample material for this here blog. Mark Siegler, the center’s first and so far only director, will receive a lifetime achievement award next month from the American Society for Bioethics and Humanities.

Many people take pride in never missing a day of work, and fighting through what they perceive as a minor illness to put in a full shift at the office. But what if your office is a hospital ward? Doctors who show up for work sick run the risk of spreading their illness to patients, further complicating their health issues. But with the tight schedules and long hours of the hospital, there’s even more pressure to get out of bed and fight through your sniffles (or worse).

Medical residents, physicians in their first few years out of medical school, have the tightest schedules and longest hours of all, and a study by University of Chicago and Massachusetts General Hospital researchers found that population to be especially guilty of “presenteeism.” In the wake of last year’s H1N1 flu epidemic, concerns about this bad habit have grown, and Vineet Arora, Anupam Jena and colleagues surveyed residents from 12 medical centers. In a study published in the Journal of the American Medical Association, they found that 60 percent of residents surveyed showed up to work sick at least once in the academic year 2008-09.

“Hospitals need to build systems and create a workplace culture that enables all caregivers, not just residents, to feel comfortable calling in sick,” Arora said of the results. “Their colleagues and their patients will thank them.”

See coverage at CNN, Scientific American, and AP.

Elsewhere…

How many species bear your name? If your name is Robert F. Inger, the answer is more than 50, ranging from Calamalaria ingeri to Ingerna charlesdarwini. That’s the kind of list you rack up when you’ve spent seven decades studying amphibians and reptiles in Borneo, Thailand, Malaysia, India, and China. Last week, Inger - a graduate of the University of Chicago and curator emeritus at the Field Museum in Chicago - celebrated his 90th birthday, and his colleagues put together a website to celebrate the occasion.

The official opening of the University of Chicago Center in Beijing was celebrated this week, a space designed to foster collaboration between our faculty and Chinese researchers and experts. As this feature describes, many such partnerships are already underway, including the AIDS education efforts of professor of medicine Renslow Sherer and fossil-hunting projects by paleontologist Paul Sereno. By a stroke of luck, ScienceLife will write about another Sino-UofC research collaboration next week - stay tuned!

Our contribution to President Obama’s Commission for the Study of Bioethical Issues, physician/bioethicist/friar Daniel Sulmasy, was profiled in the Chicago Tribune.

Another genetic sequencing race, this time between…Mars and Hershey’s? The Snickers maker struck the first blow with Wednesday’s online public domain publication of the Cacao Genome Database, while a group funded by Hershey’s hopes to publish their sequence in a journal soon. The competition is both delicious and beneficial, experts said, and may someday yield more efficient cocoa famring as well as chocolate that is both healthier and better-tasting. Yes, please.

There aren’t too many tabloid stories that have implications for science and medical ethics. But in January 2009, the sensational saga of Nadya Suleman, the mother of octuplets crudely dubbed Octomom, simultaneously lit up the TMZs and National Enquirers of the world and posed tough questions to the field of assisted reproduction. Methods such as in vitro fertilization and artificial insemination have been a miracle for many families who would not otherwise have been able to conceive their own children. But B.O. (Before Octomom) little attention had been paid, at least publicly, to the question of when assisted reproduction should and should not be offered to a patient.

Suleman, who was a single mother of six even before in vitro fertilization led to the rare occurrence of octuplets, was an extreme example, to be sure. Many physicians spoke out against the use of assisted reproduction in Suleman’s case, and the Beverly Hills doctor that provided the treatment was charged with gross negligence by the Medical Board of California. But what about cases that are less clear-cut? How many pre-existing children are too many for a doctor to approve of further assisted reproduction? Does it matter whether the mother seeking artificial insemination is married or single? What about if the couple looking to conceive is homosexual?

Obstetrician-gynecologists are the physicians closest to the nexus of these questions, and Pritzker School of Medicine student Ryan Lawrence and Farr Curlin, associate professor of medicine, decided to take the temperature of the field on these issues. In a paper published this month in Obstetrics & Gynecology, Lawrence and his colleagues report on the results of a survey filled out by more than 1,000 ob-gyns. The doctors were asked whether they morally or ethically object to commonly-used reproductive technologies and given seven scenarios to test whether they would discourage or refuse to offer those methods to particular women:

• the patient is not married to their sexual partner
• the patient will raise the child or children as a single parent
• the patient’s partner is female
• the patient is HIV positive
• the patient is 56 years old and postmenopausal
• the patient already has five biological children
• the patient has a 25 percent risk of dying from a heart condition during pregnancy

As you might expect, the survey results showed widespread acceptance of assisted reproduction technologies, with less than 5 percent of ob-gyns objecting to IVF or artificial insemination. Slightly more objections were found when the procedures were conducted with donor sperm or eggs, rather than sperm or eggs taken from the intended parents. Physicians who self-identified as strongly religious were more likely to balk at the use of donor cells, which the authors speculated may have to do with Roman Catholic beliefs against separating sexual intercourse from procreation and Jewish or Muslim concerns over lineage and legitimacy.

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Please welcome Ankur Thakkar, who works in our Publications Department, with this fine post on the controversy over paid compensation for organ donation.

The economic crisis over the last three years caused many Americans to change their lifestyles to make ends meet. They turned to second jobs, second mortgages and tighter budgets. They sold the possessions they could live without. What else could they part with to make money? What if they could sell their organs?

Organ selling has polarized physicians and bioethicists since the beginning of clinical transplantation, but year after year it gains steam. This makes sense when there are 80,000 people in the United States waiting for a kidney and more than 5,000 of them will die this year, according to the Organ Procurement and Transplantation Network. Most people who need organs have to wait for donors they’ve never met to pass away, with the chances for a successful outcome deteriorating the longer they have to wait. There aren’t enough kidneys to go around.

“One reason for this is that modern medicine can now keep people alive long enough for their kidneys to fail,” said medical ethicist Lainie Ross, MD, PhD, associate director of the MacLean Center for Clinical Medical Ethics. “This means the waiting list for organs grows, while the number of usable organs from deceased donors is reduced.”

A 2010 study by researchers from the University of Pennsylvania and the Pennsylvania Veterans Affairs Medical Center found that when people were offered money for their organs, it made them more willing to donate. The researchers concluded that creating a financial incentive would increase the national supply of organs, resulting in saved lives.

Ross isn’t convinced. An outspoken opponent of opening the organ market, she believes it is socially irresponsible to allow people to make money from their organs. Far too many donors will assume that selling their organs will lift them out of poverty, without understanding the risks to their health.

The Pennsylvania study, conducted on Philadelphia commuters, found the opposite. The participants rated their willingness to donate their organs with and without payment. The responses were similar despite the participants’ incomes, suggesting that offering money for organs did not disproportionately change the minds of poorer people.

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The newborn. (courtesy: J. Craig Venter Institute)

The biggest science story of the year may have broken yesterday, though it’s hard to say either the topic or the source was a surprise. J. Craig Venter, one of the driving forces of the Human Genome Project, announced via the Institute that bears his name the creation of the first synthetic cell - a bacterium with DNA entirely constructed in the laboratory. Mycoplasma mycoides JCVI-syn1.0 might not have the catchiest of names, but it’s a landmark of scientific achievement: the first time man has moved beyond studying life to creating it.

The paper, published yesterday in Science, is a technical marvel of laboratory perseverance. It turns out creating a genome from scratch isn’t as easy as just sticking a bunch of nucleotides together; the final string of more than 1 million base-pairs had to be laboriously constructed from hundreds of smaller cassettes, and even the tiniest errors could be catastrophic. “Our success was thwarted for many weeks by a single pair deletion in the essential gene, dnaA,” the article reports (and you can almost feel the frustration). “One wrong base out of over one million in an essential gene rendered the genome inactive.”

There’s no doubting the magnitude of the achievement, but is Venter’s creation truly “synthetic life,” as many media outlets are ready to claim? Some interesting perspectives are provided in Science’s rival Nature, who asked several scientists and ethicists to write essays on the meaning of the announcement. Steen Rasmussen from the University of Southern Denmark argues that it is not truly synthetic life, because the Venter’s team created only the DNA, which was placed into a pre-existing, natural cell. Another expert, Jim Collins from Boston University, calls the synthetic genome a “stitched-together copy of the DNA of an organism that exists in nature, with a few small tweaks thrown in.” Indeed, the Venter genome is built from 300+ bacterial genes the group determined to be the minimal amount necessary to create a functional cell, with the only significant addition being “watermarks” left by the researchers (including quotes from Richard Feynman and James Joyce).

But if science is like crossing the Atlantic Ocean one lily pad at a time, Thursday’s announcement was still a pretty damn cool lily pad. The ultimate dream - of creating new life that can generate fuel, clean up pollution and produce faster, better vaccines - may still be years if not decades away from reality. So too, may be the ultimate fear of human-created organisms running wild in the natural ecosystem. As Carl Zimmer wrote in 2007, with just the right mixture of awe and caution, about the future of synthetic biology, someday “out of a million garages, a million new species may bloom.”

Blog founding father Jeremy Manier covered Venter’s project back in 2008 for the Chicago Tribune.

Elsewhere…

I never get tired of hearing about the story of Phineas Gage, the 1800’s railroad worker who suffered a particularly gross brain injury and came away with a radically altered personality. The damage to his frontal lobe helped scientists figure out the role of that brain region in controlling impulses and behavior. But a new article, highlighted on Mind Hacks, finds evidence that Gage showed signs of recovery from his injury later in life, adding both a new chapter to a favorite psychology-class story and testimony to the brain’s ability to adapt after even the most extreme injury.

Speaking of brain trauma, A new JAMA article reports that patients who have suffered a traumatic brain injury are almost 8 times more likely to experience depressive symptoms after the injury. Joseph Fink, an assistant professor of neuropsychology at the University of Chicago Medical Center, weighed in on the findings with MedPage Today. The study reminded me of a poster I saw just last week presented by medical student Maxwell Rovner at the Pritzker Senior Scientific Session, where a smaller study of epilepsy patients found very high rates (88%) of depression in the 72 hours after a seizure. Clearly, any shock to the brain can lead to severe psychiatric consequences on top of the more direct neurological issues; if the mechanism for those disturbances could be unraveled, it could say a lot about the origins of mental illness.

I can barely wrap my mind around the scale of the Gulf oil spill disaster, so I’ve taken refuge in stories that emphasize the scientific angles of this environmental story. Here’s a nice NatureNews piece on the use of dispersant chemicals, a strategy I’ve seen a lot of skepticism about on my news feed. An AP story explains why it has been so hard to get a firm grasp of the size and spread of the oil spill. Of course, even the science surrounding the oil spill gets political, as yesterday’s New York Times reported.

Nothing like a good scientific explanation for a paranormal phenomenon. In this case, it’s ball lightning, which two physicists theorize could be the result of stroke-induced tiny magnetic fields that produce hallucinations.

This is the second day of our coverage of the 2010 BIO International Convention, a massive biotechnology conference being held this week at McCormick Place in Chicago. Come back all day for reports from panels, lectures, and the exhibit floor on how scientists, government leaders, and industry hope to use the combined forces of science and technology to tackle some of the world biggest problems. For day one of our coverage, click here.

5:30 PM - Regulators, Mount Up!

The boogeyman of the BIO conference has been those faceless regulators, the bureaucracy that speakers have often blamed for the bulk of the slowdown that occurs between scientific innovation and its debut on the marketplace and in the clinic. Though never named directly, the big boss of those regulators in the United States is the Food & Drug Administration, whose stamp of approval is required for each and every new treatment or device. And as much as the biotechnology and patient advocacy choruses cry “more and better drugs, faster!,” one must remember the importance of government oversight in monitoring new products for safety and efficacy - illustrated again today in the FDA-directed recall of 200,000 medical infusion pumps. Late afternoon Tuesday, the industry finally got to hear from the woman at the head of that regulatory boogeyman, in the form of Margaret Hamburg, commissioner of the FDA.

Appearing at a session sponsored by the pharmaceutical company Merck, the reception for Hamburg was of course, polite and gracious - everyone knows not to bite the hand holding that magical FDA stamp. But Hamburg’s speech appeared to be quite reassuring as well, a promise to the assembled drug companies and scientists that President Obama’s FDA was committed to science and new, better, faster ways of approving medical technology. In fact, Hamburg argued for no less than a new field - regulatory science - that would study how best to judge drugs in an era where older models of clinical trials may be obsolete.

“Just as biomedical research evolved in the past decade, regulatory science must also evolve,” Hamburg said. “We cannot use 20th century science to review products using 21st century science.”

If regulatory science sounds like the dullest thing ever, Hamburg doesn’t blame you. In the Q&A session, she said the FDA looked for a different, punchier name, saying that regulatory science “sounds like such a snooze,” and conjures images of bureaucracy and intrusive government. But in the end, Hamburg said, they decided “you can only put so much perfume and fancy clothes” on the concept of improving the country’s regulatory processes. The trick now is to attract promising scientists to a field that is considered to lack the creativity of other scientific realms, and to expand the FDA workforce to keep up with the active pipeline of biotechnology

Such regulatory scientists will have some big problems to tackle. The new world of biomarkers and potentially personalized medicine have complicated the clinical trial process, which has previously relied on lumping large numbers of patients together despite individual differences in disease. New kinds of trials, such as the “adaptive” format pioneered in the BATTLE trial at MD Anderson Cancer Center, will be needed to match the best drug to the best patient in a way that can be regulated, Hamburg said. New devices, such as software that will connect glucose monitors to insulin pumps to produce automated control in diabetes patients, will also need inventive study design to quickly and properly weigh the benefits and safety risks for patients.

“We want the FDA to serve as a gateway, not a barrier, for products people need every day,” Hamburg said.

(Apologies to Warren G - ed.)

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Taxation With Neural Representation

Hopefully, all of you reading remembered that yesterday was that least enjoyable of holidays, the deadline to file taxes. If you didn’t remember, um, sorry. The act of filling out and paying taxes is known anecdotally to produce feelings of nausea, panic, and in some cases, language deficits. But is there any scientific evidence for an actual effect of taxation upon physiology?

Actually, there is! In 2007, University of Oregon scientists in the field of neuroeconomics, a relatively young discipline devoted to studying how financial decisions are encoded by brain activity, published in Science an experiment on how our brains react to taxation vs. donation. Using fMRI to take live images of neural activity, William Harbaugh and colleagues gave subjects $100 and ran them through trials where they either had the choice of donating money to a food bank or were “taxed” in the form of a mandatory donation. People reported that they were 10 percent more satisfied with the voluntary donation compared to the mandatory donation - not a big surprise. But the brain also reflected these different reactions; even though the money went to the same place (the food bank), a voluntary donation more strongly activated brain areas usually associated with reward such as the striatum, nucleus accumbens, and caudate nucleus.

I wrote about the study when it came out for the Chicago Tribune, but focused mostly on the “warm glow” effect of altruism as a potential motivator for the seemingly self-injurious process of donating money. But one could also turn it around the other way and say that the mandatory donation, or taxation, was significantly less rewarding, both in subject’s lower self-reported satisfaction and reduced brain activity. It’s likely that the aversive experience of taxation was even under-measured by this study, where subjects knew where those mandatory taxations were going: to a food bank, hardly a politically controversial cause. Presumably, if money was merely taken away from subjects’ accounts without a subsequent bump in the food bank’s accounts, the response would have been even more negative.

Checking Harbaugh’s site (where you can watch a video of the 3rd James Bond explaining this study), it doesn’t appear that any followup studies have been published as of yet that could better illustrate the brain’s response to taxation. The lessons for real life are also unclear; presumably it would make us all feel better to make voluntary donations rather than have to fill out tax forms every April, but that seems to rely a bit too much on the honor system to keep government services funded. Perhaps the IRS can borrow a portion of the study’s findings and blunt the pain of taxes just a bit by being more clear about where taxes are going - an educated taxpayer may find the experience at least marginally less miserable.

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Daniel Sulmasy is used to wearing many different figurative outfits, from the white coat he wears as a physician at the University of Chicago Medical Center to the brown robe he dons after work as a Franciscan friar. Now, Sulmasy will have another important role in his wardrobe as a member of President Obama’s Commission for the Study of Bioethical Issues. The 12-member committee was formed by Obama last fall to replace the Bush Administration’s Presidential Council on Bioethics, and will advise the president on forthcoming issues in science and medicine.

“This is quite an honor and a pleasant surprise,” Sulmasy said of the appointment. “I testified in 2006 to a previous presidential ethics council, but I never expected to become a member of such a group.”

Sulmasy, the associate director of the McLean Center for Clinical Medical Ethics, becomes the latest University faculty member to moonlight as ethical advisor to a president. The Medical Center’s Leon Kass and Janet Rowley both played prominent roles on the panel assembled by President George W. Bush, that most famously informed his decision to limit federal funding on stem cell research. On Obama’s panel, announced today, Sulmasy’s unique background as doctor and friar stands out among a panel made up of scientists, doctors, lawyers, and Muhammad Ali’s wife (an advocate for Parkinson’s disease). With experience in both religious and medical spheres, and an accomplished ethics background, Sulmasy should be a valuable voice for a panel that will have to wrestle with the difficult questions orbiting scientific advances in genomics, biotechnology, stem cell research and health care in the coming years.

One issue that may immediately be put before the panel is Sulmasy’s area of expertise: end-of-life care. The decision-making process between terminally-ill patients and their doctors was distorted through the political funhouse mirror during the health care reform debate into the fictitious concept of “death panels,” but that polarized discussion only obscured a legitimately important medical topic. Many of Sulmasy’s over 140 published journal articles deal with this very topic, some studying how well patients are informed of their options when their prognosis is poor and some considering the ethical boundaries for doctors between withdrawing care for a dying patient and assisting that patient in ending their life.

Wrestling with such a difficult topic requires an ethicist’s strong stomach for navigating the uncomfortable - best characterized by the title of a 1998 Sulmasy paper: “Killing and allowing to die: another look.” Discussing how doctors can best help their patients exert control over their own death requires blunt language; in a 2001 position paper for the American College of Physicians, Sulmasy (with co-author Lois Snyder) wrote that “Our societal emphasis on ‘cure’ and the medical emphasis on intervention have sometimes been a the expense of end-of-life care.” With studies showing that the vast majority of a person’s health care expenditures are made in the last year of their life, these are decisions that stretch beyond medicine into financial, ethical and spiritual zones.

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Just a few things from around the world of science this week…

Addiction researchers often speculate that abused drugs such as cocaine and nicotine hijack the brain systems responsible for the more natural pursuits of food and sex. Many studies have shown that food, particularly delicious food, can activate brain reward areas, but a new paper by Paul Johnson and Paul Kenny at Scripps Research Institute in Florida made one of the most convincing arguments yet for “food addiction” resembling drug addiction. Rats given unlimited access to a “cafeteria diet” (bacon, cheesecake, frosting and more - yum!) showed not only the expected weight gain, but also a reduced sensitivity to reward. In other words, when rats got fat, the usual good stuff wasn’t quite as rewarding, requiring them to seek even more reward to reach satisfaction.

This reduced sensitivity correlated with a reduction in one type of receptor (D2) for the neurotransmitter dopamine, a reduction seen in drug-addicted animals and people. When researchers used a virus to artificially reduce those receptors, only animals that had previously been exposed to the cafeteria diet showed overeating behavior and reduced reward, suggesting an environmental role also contributes to “food addiction.” It also makes a convincing argument to stay out of the cafeteria.

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A very cool study, but another paper published this week, by scientists from England, Australia and The Netherlands in PLoS Biology, shone a harsh spotlight on the elephant in the room of animal research. Scientific publications are almost always about laboratory or clinical successes, trials or experiments that produced an effect - even if it isn’t always the effect that was expected at the outset. But wherefore the negative results, those experiments where after the dust has settled from statistical analysis, nothing really happened? Only rarely are such non-effects published, a practice that led Emily Sena and colleagues to hypothesize a “publication bias” in animal studies looking at stroke interventions.

Reviewing 16 review studies (papers that aggregate dozens to hundreds of individual research findings), the authors found that only 1 out of 50 papers in those review studies reported negative results. Anyone who has worked in a lab knows that far fewer than 98 percent of all experiments show an effect, leading the authors to believe that many negative results go unreported. That’s kind of a big deal. For one, animal studies that didn’t work may be needlessly replicated by scientists who didn’t realize they’d already been tried out, wasting time, money, and laboratory animals’ lives. For two, when that research is translated from animals to humans, researchers may overestimate the efficacy of those interventions - a potential explanation for why the jump from lab rat to patient is so often unsuccessful. Obviously, if this is a problem for stroke interventions, one can imagine it affecting biomedical research of all stripes. But until more journals are willing to publish negative results and scientists willing to check their ego and publish those experimental duds, it’s an issue that’s not going away.

A lengthier analysis of this paper and similar efforts to self-police science is recommended reading at Respectful Insolence.

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Much has been written this week about the potentially landmark legal decision to revoke the patents held by a private company on BRCA-1 and BRCA-2, genes that signal a predisposition to breast or uterine cancer. I got the most information on the case from Genomics Law Report, a blog run by lawyer Daniel Vorhaus - particularly this post on the legal nitty-gritty and what happens next. Deborah Shelton of the Chicago Tribune (my former newsroom cubicle neighbor) also had a more accessible write-up in today’s paper.

Who says scientists don’t have a sense of humor? Check out this roundup by Nature News of the best science-related April Fool’s gags, including the new journal pictured above (I chuckled at “Evolution: Why Won’t It Stop?”).

University of Chicago internal medicine resident Shantanu Nundy is currently in rural Uganda working at a clinic for pregnant mothers, and he’s blogging about it here. Nundy, who apparently does not sleep, also wrote a book called Stay Healthy at Every Age: What Your Doctor Wants You to Know that is due to be released soon.

Finally, don’t get your medical information from twitter. Save it for Justin Bieber news.

fMRI on Trial

Last year, one of the most-followed trials in the Chicago area was the first-degree murder case against Brian Dugan, who was accused of murdering a 10-year-old Naperville girl in 1983. The Dugan trial was interesting for many reasons, most notably for coming at the end of a 26-year process during which two other men were falsely convicted and sentenced to death for the crime. But it wasn’t until I read this week’s issue of Nature that I realized the scientific precedent set during the trial, one that signaled a new intersection of science and law that could be very important in coming decades.

During the sentencing portion of the trial, after Dugan had been convicted of the murder, testimony for both the defense and prosecution was provided by neuroscientists. This occurrence in and of itself is not unusual, as scientific evidence is more and more frequently used to argue whether a criminal suffers from mental illness that contributed to the crime. But as reporter Virginia Hughes summarizes nicely, this courtroom science debate was different, as it hinged upon new evidence for mental illness: an fMRI brain scan.

Through his defense team, Dugan had been volunteered for a study conducted by Kent Kiehl from the University of New Mexico on the brains of psychopaths, people who lack a sense of moral behavior. According to Hughes’ article, Kiehl has conducted fMRI scans - which create a live movie of brain activity - on more than 1,000 criminals over 16 years, including many that used a mobile scanner located at a prison in New Mexico. Dugan, already in police custody for two other murders, was scanned by Kiehl at Northwestern Memorial Hospital during his trial and interviewed by Kiehl for a diagnosis of psychopathy.

But when defense lawyers attempted to introduce the results of the scan and interview into court as a “mitigating factor” that could save him from the death penalty, prosecutors objected. Hughes writes that DuPage County State’s Attorney Joseph Birkett argued in court that the scans would prejudice the jury due to “bright colors and statistical parameters…chosen by the researchers.” A hearing held outside the jury’s presence led the judge in the trial to rule that the results of Dugan’s scan could be discussed, but not shown in the trial. After some more legal oddness unrelated to the brain scans, Dugan was eventually sentenced to death in November 2009.

Though somewhat irrelevant to the details of the case, the role that fMRI scans played in Dugan’s sentencing could open the floodgates of a phenomenon speculated about for quite some time: the use of brain imaging in courtrooms. Hughes’ article does a great job of rounding up scientist opinions about this use - both against and, perhaps surprisingly, for - so I won’t recapitulate those here. But the central argument against brain scan “diagnosis” of mental illness is worth remembering for all brain scan studies - most such research uses average pools of data from multiple subjects that can’t always be applied on an individual basis. As Hughes reports Jonathan Brodie, a psychiatrist from New York University, said in the trial, “If you look at professional basketball players, most of them are tall…but not everyone over six foot six is a basketball player.”

There’s a nice overview of this article and some other research into brain imaging of mental illness by Vaughan Bell at Mind Hacks.

Elsewhere…

In another crossover of science and law enforcement, a PNAS study suggested that the thriving worlds of bacteria present on everyone’s skin (gross but true) could be employed as a forensic tool. Specifically, the authors proposed that by testing the bacteria present on a computer mouse or keyboard, they could identify people who had recently used those devices - a useful police tool for determining who hacked into a system or deleted incriminating data. And as Ars Technica and Wired report, it worked, putting the old-fashioned fingerprint duster on notice.

Science-writing kerfuffle! I normally think that the science writers at UK newspaper The Guardian are some of the best around (and their sportswriters are the best), but boy is this article wrongheaded. I just wrote about epigenetics on the blog recently, and will do so again many times in the future, but nowhere will I ever claim that it proves Darwin wrong, because that’s just, well, wrong. Jerry Coyne, Carl Zimmer, and another Guardian reporter have already torn it to shreds, it’s worth reading like a car accident is worth gaping at.

Should people be allowed to donate their organs to strangers in exchange for money? A recent survey from the University of Pennsylvania said that payment for organ donation would increase supply without drawing disproportionately from the poor, but the University of Chicago’s Lainie Ross criticized their conclusions.