To the team’s knowledge, it is the first to ask research participants’ opinions about the need for informed consent for sharing their own information. The team explored participants’ preferences while collaborating on the Electronic Medical Records and Genomics (eMERGE) Network. The Network involves volunteers enrolled in the joint Group Health-UW Adult Changes in Thought (ACT) study. ACT is a longitudinal cohort study that tracks aging-related changes in thousands of older Group Health patients over time.

When the team asked Group Health patients who participate in ACT whether their “de-identified” (anonymous) genetic and medical record information could be shared in the database, 86 percent said yes. Then the team surveyed 365 ACT study participants who had agreed to let their genetic information be shared, mostly because of a “desire to help others.” In the survey, 90 percent of participants said they thought it was important to have been asked for this reconsent.

Reconsent means getting additional informed consent from research participants before using their information for a purpose beyond what they agreed to originally. Alternatives to reconsent — including opting out, being notified, or neither individual permission nor notification — were unacceptable to 40 percent, 67 percent, and 70 percent of the surveyed participants, respectively.

“We were surprised that so many people felt it was important for us to ask them, even though they decided to give their consent,” said lead author Evette Ludman, PhD, a senior research associate at Group Health Research Institute. “This indicates that even if most of a study’s participants would agree to data sharing, it’s still crucial to ask them.”

Since 2008, the National Institutes of Health (NIH) has strongly encouraged many studies to submit genetic information to the federal database of Genotypes and Phenotypes (dbGaP). The reason is that genomic research on large numbers of people can yield insights that aren’t possible with smaller numbers.

For new studies that will enroll participants prospectively, informed consent can — and should — address such sharing. But sharing genetic data raises ethical questions for longitudinal cohort studies, including ACT, which started long before dbGaP was established in 2006. Few existing informed consents address data sharing through this new mechanism. Ideally, Dr. Ludman suggested, research grants would include funding and time to pursue reconsent. In this study, it cost around $50 for each participant who was asked.

“Trust is a two-way street, and human research requires lots of trust,” Dr. Ludman said. “People have an understandable feeling of ownership over their bodies and medical records, including their genetic information,” she added. “Researchers show we’re worthy of trust when we ask research participants for permission to use their information in a way that they haven’t already agreed to.”

Recent high-profile legal cases have highlighted the issue of consent and trust in research, including the Havasupai tribe vs. Arizona State University and parents vs. the Texas health department over storing newborn blood samples without parental consent. So too has the bestselling book, The Immortal Life of Henrietta Lacks, about the history surrounding the HeLa cell line, the world’s most widely grown human cells.

With funding from the National Human Genome Research Institute (NHGRI), Dr. Ludman’s co-authors were Research Associate Leslie Spangler, VMD, PhD, Executive Director Eric B. Larson, MD, MPH, and Project Manager Monica M. Fujii, MPH, of Group Health Research Institute; Wylie Burke, MD, PhD, UW professor and chair of bioethics & humanities and affiliate investigator at Group Health Research Institute; and Gail Jarvik, MD, PhD, UW professor of medicine and head of the division of medical genetics, Stephanie M. Fullerton, PhD, UW assistant professor of bioethics & humanities, and Susan Brown Trinidad, MA, UW research scientist in bioethics & humanities.

The eMERGE Network

The Electronic Medical Records and Genomics (eMERGE) Network is a national consortium formed to develop, disseminate, and apply approaches to research that combine DNA biorepositories with electronic medical record (EMR) systems for large-scale, high-throughput genetic research. The Network brings together researchers with a wide range of expertise in genomics, statistics, ethics, informatics, and clinical medicine from leading medical research institutions across the country: Group Health Cooperative with the UW; Marshfield Clinic; Mayo Clinic; Northwestern University; and Vanderbilt University.

Group Health Research Institute

Founded in 1947, Group Health Cooperative is a Seattle-based, consumer-governed, nonprofit health care system. Group Health Research Institute changed its name from Group Health Center for Health Studies on September 8, 2009. Since 1983, the Institute has conducted nonproprietary public-interest research on preventing, diagnosing, and treating major health problems. Government and private research grants provide its main funding.

UW Medicine

The UW Medicine health system includes UW Medical Center, Harborview Medical Center, Northwest Hospital, the UW School of Medicine, UW Medicine Neighborhood Clinics, UW Physicians, Airlift Northwest, and the UW’s partnership in the Seattle Cancer Care Alliance with Seattle Children’s and Fred Hutchinson Cancer Research Center. UW Medicine has major academic and service affiliations with Seattle Children’s Hospital, Fred Hutchinson Cancer Research Center, and the Veterans Affairs Puget Sound Health Care System in Seattle and the VA Hospital in Boise. The UW School of Medicine is the top public institution for biomedical research in funding received from the National Institutes of Health. For more information about UW Medicine, visit www.uwmedicine.org.

Fifty-seven percent (57%) say funding for such research should be left to the private sector.

While 55% of voters who identify themselves as pro-choice support government funding of stem cell research, 83% of pro-life voters are opposed.

In March of last year, 52% of all voters agreed with President Obama’s decision to lift the ban on federal funding of embryonic stem cell research, but 38% were opposed.  A federal judge this week blocked that decision, but the Obama administration intends to appeal the ruling. The issue at hand is whether the research destroys living human embryos.

Only 24% of voters now believe embryonic stem cell research is morally wrong. That’s down five points from March 2009. Fifty-four percent (54%) say it is not morally wrong, unchanged from the previous survey. Twenty-one percent (21%) are not sure.

Fifty-two percent (52%) of pro-life voters think embryonic stem cell research is morally wrong.  Seventy-nine percent (79%) of pro-choice voters disagree.

The survey of 1,000 Likely Voters was conducted on August 25-26, 2010 by Rasmussen Reports. The margin of sampling error is +/- 3 percentage points with a 95% level of confidence. Field work for all Rasmussen Reports surveys is conducted by Pulse Opinion Research, LLC. See methodology.

Virtually unchanged since January 2007 is the finding that 69% of voters believe it is at least somewhat likely that embryonic stem cell research has the potential to lead to cures to previously incurable diseases. That includes 39% who say it is Very Likely.

Just 18% say it is not very or not at all likely that such research will help find cures for diseases that are presently incurable.

Pro-choice voters overwhelmingly believe that stem cell research will lead to such cures. Those who are pro-life are more narrowly divided on the question.

Seventy-eight percent (78%) of Republicans and 62% of voters not affiliated with either major party oppose taxpayer funding of embryonic stem cell research. Fifty-five percent (55%) of Democrats favor such funding.

The Political Class is even more supportive of government funding of this kind of research.  While 70% of Mainstream voters oppose taxpayer funding of stem cell research, 73% of the Political Class think it’s a good idea.

But then Political Class voters are twice as likely as those in the Mainstream to say such research is not morally wrong.

Seventy-one percent (71%) of all voters say they have followed the issue of stem cell research at least somewhat closely, with 23% who are following Very Closely.

Nearly half (48%) of voters continue to believe that an abortion is too easy to obtain in this country.

Forty-six percent (46%) now describe the U.S. health care system as good or excellent.  Just 22% view the current system as poor.

Fifty-six percent (56%) of voters continue to favor repeal of the national health care bill passed by Congress in March and signed into law by the president.  That includes 46% who Strongly Favor repeal.

Please sign up for the Rasmussen Reports daily e-mail update (it’s free) or follow us on Twitter or Facebook. Let us keep you up to date with the latest public opinion news.

The court ruled in favor of a suit filed in June by researchers who said human embryonic stem cell research involves the destruction of human embryos.

Judge Royce Lamberth granted the injunction after finding that the lawsuit would likely succeed because the guidelines violated law banning the use of federal funds to destroy human embryos.

“(Embryonic stem cell) research is clearly research in which an embryo is destroyed,” Lamberth wrote in a 15-page ruling. The Obama administration could appeal his decision or try to rewrite the guidelines to comply with U.S. law.

The unusual suit against the National Institutes of Health, backed by some Christian groups opposed to embryo research, argued that the NIH policy violates U.S. law and takes funds from researchers seeking to work with adult stem cells.

The U.S. Department of Justice and NIH had no immediate comment.  

RULING:  https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv1575-44

October 15 & 16, 2010, Princeton University - Open Hearts, Open Minds & Fair Minded Words - A Conference on Life & Choice in the Abortion Debate 

The conference is inspired by President Obama’s call for those on different sides of the abortion issue  to work together where we agree and engage in “vigorous debate” with “open hearts, open minds, and fair minded words”

Cosponsors:  University Center for Human Values & James Madison Program, Princeton University; Department of Theology, Fordham University; Center for Bioethics, University of Pennsylvania; Bioethics International

Cochairs:  Charles Camosy, Fordham University; Frances Kissling, University of Pennsylvania; Jennifer Miller, Bioethics International; Peter Singer, Princeton University

For more information and to register visit:  http://uchv.princeton.edu/Life_Choice/

Goals and Values of the Conference

1. Explore new ways to think and speak about abortion. Recognizing the divisive nature of the debate, and its larger effect on public discourse, we wish to explore new words, ideas, categories, arguments and approaches for engaging with each other
2. Approach issues related to abortion with open hearts and open minds. We wish to make a concerted effort to engage with each other with the kind of humility and quiet necessary to really listen and absorb the ideas of someone who thinks differently.
3. Define more precisely areas of disagreement and work together on areas of common ground. Some sessions are intended to cut through the confusion and fog of the public abortion debate, by clarifying more precisely areas of disagreement, potentially highlighting areas where we can move forward.
4. Get to know those on multiple sides of the issues more personally. In part because it is often easier to take seriously and listen to those one knows personally, we will self-consciously promote social interaction at this conference through lunches, cocktail hours and breaks.

[WSJ] When CEO Mark Hurd resigned from Hewlett-Packard last week in light of ethics violations, many people expressed surprise. Mr. Hurd, after all, was known as an unusually effective and straight-laced executive.

But the public shouldn’t have been so shocked. From prostitution scandals to corruption allegations to the steady drumbeat of charges against corporate executives and world-class athletes, it seems that the headlines are filled with the latest misstep of someone in a position of power. This isn’t just anecdotal: Surveys of organizations find that the vast majority of rude and inappropriate behaviors, such as the shouting of profanities, come from the offices of those with the most authority.

Psychologists refer to this as the paradox of power. The very traits that helped leaders accumulate control in the first place all but disappear once they rise to power. Instead of being polite, honest and outgoing, they become impulsive, reckless and rude. In some cases, these new habits can help a leader be more decisive and single-minded, or more likely to make choices that will be profitable regardless of their popularity. One recent study found that overconfident CEOs were more likely to pursue innovation and take their companies in new technological directions. Unchecked, however, these instincts can lead to a big fall.

But first, the good news.

A few years ago, Dacher Keltner, a psychologist at the University of California, Berkeley, began interviewing freshmen at a large dorm on the Berkeley campus. He gave them free pizza and a survey, which asked them to provide their first impressions of every other student in the dorm. Mr. Keltner returned at the end of the school year with the same survey and more free pizza. According to the survey, the students at the top of the social hierarchy—they were the most “powerful” and respected—were also the most considerate and outgoing, and scored highest on measures of agreeableness and extroversion. In other words, the nice guys finished first.

This result isn’t unique to Berkeley undergrads. Other studies have found similar results in the military, corporations and politics. “People give authority to people that they genuinely like,” says Mr. Keltner.

Of course, these scientific findings contradict the cliché of power, which is that the only way to rise to the top is to engage in self-serving and morally dubious behavior. In “The Prince,” a treatise on the art of politics, the 16th century Italian philosopher Niccolo Machiavelli insisted that compassion got in the way of eminence. If a leader has to choose between being feared or being loved, Machiavelli insisted that the leader should always go with fear. Love is overrated.

That may not be the best advice. Another study conducted by Mr. Keltner and Cameron Anderson, a professor at the Haas School of Business, measured “Machiavellian” tendencies, such as the willingness to spread malicious gossip, in a group of sorority sisters. It turned out that the Machiavellian sorority members were quickly identified by the group and isolated. Nobody liked them, and so they never became powerful.

There is something deeply uplifting about this research. It’s reassuring to think that the surest way to accumulate power is to do unto others as you would have them do unto you. In recent years, this theme has even been extended to non-human primates, such as chimpanzees. Frans de Waal, a primatologist at Emory University, has observed that the size and strength of male chimps is an extremely poor predictor of which animals will dominate the troop. Instead, the ability to forge social connections and engage in “diplomacy” is often much more important.

Now for the bad news, which concerns what happens when all those nice guys actually get in power. While a little compassion might help us climb the social ladder, once we’re at the top we end up morphing into a very different kind of beast.

“It’s an incredibly consistent effect,” Mr. Keltner says. “When you give people power, they basically start acting like fools. They flirt inappropriately, tease in a hostile fashion, and become totally impulsive.” Mr. Keltner compares the feeling of power to brain damage, noting that people with lots of authority tend to behave like neurological patients with a damaged orbito-frontal lobe, a brain area that’s crucial for empathy and decision-making. Even the most virtuous people can be undone by the corner office.

Why does power lead people to flirt with interns and solicit bribes and fudge financial documents? According to psychologists, one of the main problems with authority is that it makes us less sympathetic to the concerns and emotions of others. For instance, several studies have found that people in positions of authority are more likely to rely on stereotypes and generalizations when judging other people. They also spend much less time making eye contact, at least when a person without power is talking.

Consider a recent study led by Adam Galinsky, a psychologist at Northwestern University. Mr. Galinsky and colleagues began by asking subjects to either describe an experience in which they had lots of power or a time when they felt utterly powerless. Then the psychologists asked the subjects to draw the letter E on their foreheads. Those primed with feelings of power were much more likely to draw the letter backwards, at least when seen by another person. Mr. Galinsky argues that this effect is triggered by the myopia of power, which makes it much harder to imagine the world from the perspective of someone else. We draw the letter backwards because we don’t care about the viewpoint of others.

Of course, power doesn’t turn everyone into ruthless, immoral tyrants. Some leaders just end up being tough, which isn’t always a bad thing. The key is keeping those qualities in balance.

Anthony Russo

At its worst, power can turn us into hypocrites. In a 2009 study, Mr. Galinsky asked subjects to think about either an experience of power or powerlessness. The students were then divided into two groups. The first group was told to rate, on a nine-point scale, the moral seriousness of misreporting travel expenses at work. The second group was asked to participate in a game of dice, in which the results of the dice determined the number of lottery tickets each student received. A higher roll led to more tickets.

Participants in the high-power group considered the misreporting of travel expenses to be a significantly worse offense. However, the game of dice produced a completely contradictory result. In this instance, people in the high-power group reported, on average, a statistically improbable result, with an average dice score that was 20% above that expected by random chance. (The powerless group, in contrast, reported only slightly elevated dice results.) This strongly suggests that they were lying about their actual scores, fudging the numbers to get a few extra tickets.

Although people almost always know the right thing to do—cheating is wrong—their sense of power makes it easier to rationalize away the ethical lapse. For instance, when the psychologists asked the subjects (in both low- and high-power conditions) how they would judge an individual who drove too fast when late for an appointment, people in the high-power group consistently said it was worse when others committed those crimes than when they did themselves. In other words, the feeling of eminence led people to conclude that they had a good reason for speeding—they’re important people, with important things to do—but that everyone else should follow the posted signs.

The same flawed thought processes triggered by authority also distort our ability to evaluate information and make complex decisions.

In a recent study led by Richard Petty, a psychologist at Ohio State, undergraduates role-played a scenario between a boss and an underling. Then the students were exposed to a fake advertisement for a mobile phone. Some of the ads featured strong arguments for buying the phone, such as its long-lasting battery, while other ads featured weak or nonsensical arguments. Interestingly, students that pretended to be the boss were far less sensitive to the quality of the argument. It’s as if it didn’t even matter what the ad said—their minds had already been made up.

This suggests that even fleeting feelings of power can dramatically change the way people respond to information. Instead of analyzing the strength of the argument, those with authority focus on whether or not the argument confirms what they already believe. If it doesn’t, then the facts are conveniently ignored.

Deborah Gruenfeld, a psychologist at the Stanford Business School, demonstrated a similar principle by analyzing more than 1,000 decisions handed down by the United States Supreme Court between 1953 and 1993. She found that, as justices gained power on the court, or became part of a majority coalition, their written opinions tended to become less complex and nuanced. They considered fewer perspectives and possible outcomes. Of course, the opinions written from the majority position are what actually become the law of the land.

It’s not all bad news for those in authority. Mr. Galinsky has found that under certain conditions, power can lead people to make fewer mistakes on tedious tasks, such as matching a color with its correct description. After all, if you’re powerless, why bother?

There is no easy cure for the paradox of power. Mr. Keltner argues that the best treatment is transparency, and that the worst abuses of power can be prevented when people know they’re being monitored. This suggests that the mere existence of a regulatory watchdog or an active board of directors can help discourage people from doing bad things.

However, people in power tend to reliably overestimate their moral virtue, which leads them to stifle oversight. They lobby against regulators, and fill corporate boards with their friends. The end result is sometimes power at its most dangerous.

That, at least, is the lesson of a classic experiment by the economist Vernon Smith and colleagues. The study involved the dictator game, a simple economic exchange in which one person—the “dictator”—is given $10 and asked to divide the cash with another person. Although the dictators aren’t obligated to share—they are in a position of pure power—a significant majority of people act generously, and give away $2 or more to a perfect stranger.

There is one very simple tweak that erases this benevolence. When the “dictators” are socially isolated—this can occur, for instance, if the subjects are located in separate rooms, or if they’re assured anonymity—more than 60% of people keep all of the money. Instead of sharing the cash with someone else, they pocket the $10. Perhaps the corner office could use a few more windows.

—Jonah Lehrer is the author of “How We Decide” and “Proust Was a Neuroscientist.”

Genetically modified cows and goats can produce proteins in their milk that can be extracted as a drug component. Cloning animals to create living drug factories could lower the costs of medicines used to save lives.

Examples include cows that pump pharmaceutical proteins and antibodies in their milk and blood; chickens that lay drug-producing eggs; and pigs that grow human-ready organs. Making perfect copies of these animals, through cloning, could speed up the drug-making process, according to scientists.

“Once you create a genetically engineered animal, you want to make copies,” said David Andrews, director of animal biotechnology at the Biotechnology Industry Organization, a trade association that represents 1,200 companies.

In Dane County, a now-closed biotech firm created cloned pigs that had human-friendly, transplantable organs.

The same firm, Infigen, created a herd of cloned cows with drug-making capabilities.

Infigen wanted to produce proteins for the treatment of hemophilia, an affliction that causes uncontrolled bleeding, and Pompe’s disease, a rare genetic disorder that can lead to muscle degeneration.

The science was proven, but the firm ran out of money and closed in 2004.

“Because we were breaking new ground, where the FDA approval process was not fully developed, investors were hesitant. That became the stumbling block,” said Michael Bishop, Infigen’s former president.

“We knocked the science out and achieved some very amazing things,” he said. “And the interesting thing is I don’t think the technology has advanced very much since then. As a matter of fact, I think Infigen enjoyed better success than anybody else in the business.”

Preventing blood clots

Currently, a Massachusetts biotech firm is using genetically engineered dairy goats to make a human protein that prevents dangerous blood clots from forming. GTC Biotherapeutics extracts the protein from the goats’ milk for a drug that helps prevent strokes, pulmonary embolisms and other life-threatening conditions.

The FDA-approved drug, called ATryn, could be followed by other medicines made from the milk of genetically engineered animals. Cloning would be an efficient way to create them, said Yann Echelard, GTC vice president of corporate and technology development.

There are ways to do this without cloning, but it’s a more predictable process, he said.

Now that the FDA has said it’s safe to consume the milk and meat from cloned animals, it could help pave the way for creating drugs.

“As scientists, we can do this stuff,” said Mark Cook, an animal sciences professor at the University of Wisconsin-Madison.

“The big issues that came up were more regulatory than science based. Just to get a drug through FDA clearance can take 10 to 15 years and cost a billion dollars.”

A herd of 150 dairy goats could produce enough of a life-saving drug to meet the needs of thousands of people.

The mammary gland in cows and goats was designed by nature to make proteins, Echelard said.

Not everyone agrees

But some people are wary of the use of genetically engineered animals, saying a mating between one escaped animal and a natural one could trigger a chain of events that could contaminate a species.

“What we have learned from the genetic engineering of crops is that nature finds a way” to reproduce, said George Kimbrell, an attorney with the Center for Food Safety, a nonprofit group focused on food issues.

“I am dubious, at best, of claims that if we produce these transgenic animals there are not going to be some accidental escapes that will impact the environment and, potentially public health, through the food chain,” Kimbrell said.

Genetic engineering raises animal cruelty questions, said Pete Shanks with the Center for Genetics and Society, a nonprofit group that encourages responsible use of genetic technologies.

Last year in New Zealand, a government-owned company created four genetically engineered calves intended to produce a hormone for treating infertility. Three of the calves developed huge ovaries, the size of tennis balls rather than the usual thumbnail size, and two of them died unexpectedly at the age of 6 months, according to Shanks.

“There are many possible responses to this debacle,” said Shanks, author of “Human Genetic Engineering: A guide for activists.”

“But we should start by noting the callous response of the scientists involved, who did not see the deaths as a big deal and called it part of the learning process.”

Sponsored by Sens. Sherrod Brown (D-Ohio), Sam Brownback (R-Kan.) and Al Franken (D-Minn.), the Creating Hope Act aims to solve a nagging problem inherent to the market-driven world of pharmaceutical manufacturing: how to encourage the creation of expensive-to-develop drugs that few patients need?

The lawmakers hope to do so by offering expedited FDA approval of potentially popular drugs to pharmaceutical companies that develop treatments for rare pediatric diseases. The idea is that the financial incentive associated with bringing “blockbuster” drugs to the market sooner will encourage companies to work harder researching the lesser needed treatments.

The proposal expands on a 2007 law that offers “priority review vouchers” to companies that develop new drugs for neglected tropical diseases. Drugs yielding vouchers, under the bill, must meet the definition of “rare” established by the Orphan Drug Act, and must not have previous approval from the FDA.

The bill would also prohibit companies from getting vouchers under the 2007 law for drugs already on the market abroad. Closing that loophole would force the companies to create new treatments, rather than simply bringing old ones to market in the U.S.

The National Institutes of Health estimates that there are more than 6,000 diseases qualifying as rare under the Orphan Drug Act, a vast majority of which get little or no drug company research money because the return on investment would be so small.

“We are falling woefully and inadequately short in our efforts to cure and treat rare and neglected pediatric diseases and conditions,” Brown said in a statement announcing the bill. 

Kids’ healthcare advocates agree. 

“This legislation aligns government and private sector interests and will be a major step forward in addressing the unmet needs of children with devastating illnesses, including life-threatening cancer,” said Nancy Goodman, executive director of Kids v Cancer

[Nature] In the ethically fraught field of human-embryo research, Britain’s Human Fertilisation and Embryology Authority (HFEA) has long been regarded as a world leader in regulating and advising scientists.

But now the HFEA faces the axe, and researchers and politicians are chorusing their discontent. “I’m absolutely astonished at this,” says Ruth Deech, an independent member of the House of Lords and former chair of the HFEA. “I think our standing in the world will be reduced.”

Since it was created by the Human Fertilis­ation and Embryology Act in 1990, the HFEA has regulated fertility treatment and research involving human embryos in the United Kingdom (see ‘The development of an embryo agency’). Its work involves inspecting and licensing centres, as well as providing ethical and legal advice to scientists and the public. Scientists have generally applauded the HFEA for providing a clear set of boundaries for what research is permissible. “It’s looked upon as an organization that is often the first to make decisions that define scientific and clinical barriers,” says Justin St. John, director of the Centre for Reproduction and Development at the Monash Institute of Medical Research in Melbourne, Australia. Countries such as Australia and Canada have established similar agencies using the HFEA as a model. “It is the envy of American researchers and biotech companies,” adds Paul Wolpe, director of the Emory Centre for Ethics in Atlanta, Georgia.

The HFEA is threatened because Britain’s new coalition government has pledged itself to a “radical simplification” of the regulatory landscape for public health and medical research. Health secretary Andrew Lansley announced last week that the number of health agencies will be reduced from 18 to “between eight and ten”, to reduce overlap between the bodies and save £180 million (US$285 million). The move is part of a bigger push to make public spending cuts by closing ‘quangos’ — quasi-autonomous non-governmental organizations — many of which perform regulatory functions on behalf of the government.

The government says that the HFEA’s regulatation of fertility treatments will move to the Care Quality Commission, one of the health quangos to survive the cull. But its research licensing work will probably move to a new super-regulator that would also absorb the functions of the Human Tissue Authority (HTA), which oversees organ donation and the use of human tissues in research and teaching. The government says the HFEA and the HTA will be abolished by April 2013.

“I think amalgamation would be a loss,” says St. John, who held an HFEA licence for research using ‘cybrid’ embryos — created by putting human DNA into an empty animal egg — when he worked at the University of Warwick, UK. “You might lose expertise and considerable knowledge.”

If the clinical and research aspects of embryology were divided, “it would risk spreading the available expert advice thinly across two bodies”, says Martin Bobrow, emeritus professor of medical genetics at the University of Cambridge, UK.

After Britain’s previous government mooted similar reforms in 2004, research charities and academics queued up to decry plans to merge the HFEA, the HTA and parts of the Medicines and Healthcare Products Regulatory Agency into a new Regulatory Authority for Tissue and Embryos. Some said the bodies’ functions were too different for a merger to work; others feared the loss of specialist expertise that might result.

The plans were abandoned after a cross-party parliamentary inquiry held in 2007 concluded that the case against a merger was “overwhelming and convincing”. The inquiry heard evidence that the HFEA’s remit was fundamentally different from, and more ethically complex than, the HTA’s. Many of those consulted warned that losing the HFEA as a discrete body could undermine public confidence in the regulations it enforced; and that even as part of a larger organization, it would still need the same resources to operate effectively, limiting any cost savings. Deech, who was on that inquiry committee, says that the merger plan “was comprehensively demolished three years ago for very good reasons, which are just as good today”.

Health hazard

A more immediate casualty of the ‘bonfire of the quangos’ is likely to be the Health Protection Agency (HPA), which provides advice and guidance on infectious diseases and environ­mental hazards. The government says that the HPA’s work will migrate into the Department of Health by April 2012. This has raised alarm bells with some scientists. “Will the new service be able to give advice that is in the best interests of public health, whether or not it conflicts with policy and interests of whatever government is in power?” asks Paul Hunter, a professor of health protection at the University of East Anglia in Norwich, UK. “The HPA currently does a lot of good research that ultimately benefits the public health,” he adds. “Will this still continue in the new service, or if not, how will the gap be filled?” Further details on the reforms are expected after a wide-ranging review of medical-­research regulation by the Academy of Medical Sciences, commissioned by the previous government, is completed this autumn.

George, 61, of Old Tappan, New Jersey, pleaded guilty before United States Magistrate Judge Patty Shwartz on January 26, 2010, to an Information charging him with one count of importing falsely labeled goods into the United States and one count of selling falsely labeled fish in the United States with the intent to defraud. United States District Judge Faith S. Hochberg imposed the sentence today in Newark federal court.

According to documents filed in this case and statements made in court: From January 2003 to June 2006, George maintained a business relationship through Sterling Seafood with a seafood distribution company located in Vietnam. As part of that business relationship, Sterling Seafood regularly purchased fish in the catfish family, Pangasius hypophthalmus, sometimes referred to as Vietnamese catfish. Sterling Seafood would then resell the fish in the United States.

In the interest of fairly regulating commerce in the U.S., the U.S. Department of Commerce establishes anti-dumping duties or tariffs on certain imported products – taxes imposed to increase the price of goods so they do not provide unfair competition to comparable goods produced locally. In January 2003, an anti-dumping duty or tariff was placed on all imports of Vietnamese catfish into the United States because catfish was being marketed at a significantly lower price than was market rate at that time. That initial anti-dumping order imposed a duty of up to 63.88 percent on all catfish subject to the order, and was adjusted based on market conditions.

At his plea hearing, George admitted that from 2004 to 2006, he agreed with the Vietnamese distribution company to engage in a scheme to falsely identify and declare the purchase and importation of the Vietnamese catfish in order to evade the applicable anti-dumping duties. George stated that he specifically instructed the Vietnamese company to fraudulently identify the Vietnamese catfish as “grouper” on commercial contracts, purchase orders, and other documents because grouper was not subject to any anti-dumping duties. Additionally, George admitted that from 2004 to 2005, he purchased over $500,000 of similarly misbranded Vietnamese catfish that was imported from Vietnam by a Virginia corporation and then sold that misbranded Vietnamese catfish throughout the United States.

George’s 22-month sentence represents 18 months on Count One and 22 months on count two, to run concurrently. In addition to the prison term, Judge Hochberg sentenced George to a year of supervised release and ordered him to pay restitution in the amount of $64,173,839.16. George also paid a $50,000 community service payment to the National Fish and Wildlife Foundation to be expressly earmarked for research into the identification of fish and other marine organisms. This sentence does not preclude him from facing additional civil penalties.

U.S. Attorney Fishman credited special agents with Immigration and Customs Enforcement’s Homeland Security Investigations in Newark, under the direction of Special Agent in Charge Peter T. Edge; the Department of Homeland Security’s Customs and Border Protection, under the direction of Director of Field Operations Robert E. Perez; the Department of Commerce National Oceanic and Atmospheric Administration’s Fisheries Office of Law Enforcement, Northeast Division, under the direction of Special Agent in Charge Andrew Cohen; and the Food and Drug Administration Office of Criminal Investigations, under the direction of Special Agent in Charge Thomas P. Doyle, Metro Washington Field Office with the investigation of this case. The Department of Justice’s Environmental Crimes Section, under the direction of Ignacia S. Moreno, Assistant Attorney General for the Environmental and Natural Resources Division, also handled the prosecution.

The government is represented by Assistant U.S. Attorney Zahid N. Quraishi of the United States Attorney’s Office Criminal Division in Newark and Elinor Colbourn of the Department of Justice’s Environmental Crimes Section.

The study results are striking. By surveying 46 healthcare professionals, Rottman and co-authors highlight that hospital clinicians are unaware of the general and ethical challenges that occur during a pandemic. Moreover, the study shows that when hospital clinicians are made aware of the potential challenges, including triage and resource allocation decision scenarios, they are “quickly overwhelmed” and unable to reason through the scenarios and/or draw upon cohesive and consistent response action plans. This study is immensely helpful in that it demonstrates the acute preparedness and knowledge gaps regarding ethical decision- making, although the results would be statistically stronger with a larger respondent pool. This information is highly relevant because a failure by the clinical community to make ethical decisions in a pandemic not only exposes the clinician and his or her hospital to legal liability, but also is likely to lead to a failure to save the most amount of lives possible. For example, without preparedness in ethical decision-making, a clinician may decide to allocate resources and provide care on a first-come, first-served basis or lottery system. Although these two systems might seem superficially fair, this type of decision-making is not likely to maximize the total number of lives saved. Additionally, because select survey responses extend beyond pandemics to include bioterrorism and disasters generally, the study results may be applicable for consideration in multiple hazard disaster planning.

Continue reading editorial and study results at the journal of Prehospital and Disaster Medicine.