blog.bioethics.net

Hard Data Doesn't Represent the Best Medicine

An article in the late February issue of Time Magazine on evidence-based medicine and why it might be a bad thing for doctors to fully rely on it reminded me of what has to be my hands-down favourite journal article, ever. Now four years old, it's critique of evidence-based medicine is still one of the sharpest I've ever seen. From the BMJ website: Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials.

A Dr. Gordon Smith and Ms. Jill Pell decided to "determine whether parachutes are effective in preventing major trauma related to gravitational challenge," utilizing prominent sources to analyze the data available, sans any actual randomized trial. Their conclusion is an argument I've heard against evidence-based medicine many times now, but never quite so succinctly as this:

As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomised controlled trials. Advocates of evidence based medicine have criticised the adoption of interventions evaluated by using only observational data. We think that everyone might benefit if the most radical protagonists of evidence based medicine organised and participated in a double blind, randomised, placebo controlled, crossover trial of the parachute.

- Kelly Hills
[ed: please welcome guest blogger Kelly Hills, student in the Alden March Bioethics Institute MS in Bioethics program and doctoral student in the AMBI joint degree program being "taught out" by Albany Med/UGC and UAlbany Department of Philosophy; Kelly blogs for the Women's Bioethics Project blog as well as keeps her own blog about 'academia as an extreme sport', chronicles of the [mis]adventures of an academic in training to work in bioethics. She is also working at AMBI in the Scholar slot and recently co-authored a Nature Medicine review essay on transplantation in the black communities of America. Welcome Kelly, who joins Stuart Rennie, John Robertson and others along with your editors.]

Do You Know the Mutton Man?

For many years a team of researchers led by Esmail Zanjani at the University of Nevada at Reno have been trying to grow ‘humanized sheep’. Their goal is to create sheep that have organs such as the liver that could be transplanted into humans without being rejected.

To get xenograftable organs the scientists inject extracts stem cells from adult bone marrow into a sheep fetus while it is still in the womb. These cells are integrated into the developing fetus. Zanjani’s team has announced it has now made a sheep with roughly fifteen percent human cells. The sheep have a much higher percentage in their livers.

The goal of this form of genetic engineering is laudable. Produce transplantable organs. But the ethical objections are likely to be loud and heated.

The creation of chimeras is not something that has received sufficient attention and public debate. Groups sponsored by the European Union and the President’s Council on Bioethics have taken a look but the public is still not really tracking this issue.

Some animal rights activists are not going to like the idea of creating animals to harvest their parts. Some are going to find the risks associated with carrying animal viruses into humans ethically daunting. And many are going to give ‘mutton men’ are very high score on the ‘yuk’ scale.

Making animal/human hybrids makes sense. But, in this case those with ethical concerns are right. We need some international standards in place before ‘lambination’ becomes a standard part of transplantation.

-Art Caplan

Labels: cloning, reno, sheep, xenotransplantation

South Carolina to Require Women View Ultrasounds Prior to Abortion

South Carolina appears poised on the brink of approving legislation that will require women to view ultrasound images prior to abortion. While all three (yes, that's right, all three) abortion clinics in South Carolina perform ultrasounds to determine the age of the fetus, the law would require women to view the images, with the probable exemption of rape and incest victims.

Why? According to the bill's sponsor, Republican Rep. Greg Delleney,

She can determine for herself whether she is carrying an unborn child deserving of protection or whether it’s just an inconvenient, unnecessary part of her body and an abortion fits her circumstances at that time.

South Carolina law already requires the ultrasound, as well as doctor counseling of the age and development of the fetus, as well as alternatives to abortion. This is nothing more than a bald-faced attempt at intimidation and emotional manipulation of someone who is already in a vulnerable position.

The thing that baffles me the most is, what? You're going to suddenly see an ultrasound image and decide that no, all the reasons you have for an abortion have flown out the window, and really it's a great time to be a mother, hooray? Are we suddenly going to see social services increase in funding? Are we going to have outstanding health care, job retraining, free and good state-sponsored child-sitting services? Is South Carolina going to suddenly take away every single obstacle that exists to bearing and caring for a child, so that the only barrier remaining is whether or not a woman thinks this is the right time for her, without consideration to financial/economic concerns?

Yeah, that's what I thought.
-Kelly Hills

Labels: abortion, south carolina

is there a case for Bible study in secular education?

This week, Time's senior religion writer David Van Biema looks at whether or not there is a case to be made for secular education of the Bible and whether or not there is a place for Biblical literacy, especially in our high schools.

Van Biema interviewed Boston University's Stephen Prothero, who gives one of the more convincing reasons why it actually would be a good idea to have this secular edudcation:

In the late '70s, [students] knew nothing about religion, and it didn't matter. But then religion rushed into the public square. What purpose could it possibly serve for citizens to be ignorant of all that?

The ignorance - ignorance that Van Biema notes is as problematic with self-described evangelicals as it is with anyone else - leads us to a place where people are unable to critically examine public policy platforms for their hidden religious agenda. This has been on my mind lately, given that a lobbyist for a large and influential religious group freely admitted to me and the students we were talking to that part of her job is to remove the religion from the policy she lobbies for - that is, she (and many people with the same job across this country) is specifically trying to advance her religious group's beliefs via secular language.

It's a hidden agenda, one that favours secrecy to get what one wants, couched in language that tries to mask religious belief for social concern and looking out for the best interest in society. And we need to give people the critical skills to examine platforms for these hidden agendas - and without a familiarity in the religious texts that are driving the agenda, the goal seems lost.

-Kelly Hills

Labels: evangelism, religious texts

Genetic testing in the media spotlight

The implications of genetic testing have gotten some high profile media coverage in the last week. NYT produced a package of multimedia content around Amy Harmon's Sunday article about a young woman's decision to get tested for the Huntington's gene. Here's a snip:

The test, the counselor said, had come back positive.

Katharine Moser inhaled sharply. She thought she was as ready as anyone could be to face her genetic destiny. She had attended a genetic counseling session and visited a psychiatrist, as required by the clinic. She had undergone the recommended neurological exam. And yet, she realized in that moment, she had never expected to hear those words.

"What do I do now?" Ms. Moser asked.

"What do you want to do?" the counselor replied.

"Cry," she said quietly.

Her best friend, Colleen Elio, seated next to her, had already begun.

Harmon reports that clinicians in the Huntington's field say they're seeing an increasing number of young adults stepping forward to be tested. I wonder if this is at all indicative of an evolving generational gap in how we look at genetics.



NPR also devoted some significant time to genetic testing this week. Wednesday's All Things Considered featured a report by Julie Rovner about efforts in Congress to pass a law against genetic discrimination by employers and health plans. The Senate has passed such a bill in previous sessions and President Bush has indicated a willingness to sign one. Rovner reports that it's now looking likely that the House will move forward on the issue. ATC also talked with Kathy Hudson from the Genetics and Public Policy Center and Hopkins about her support of the legislation. Hudson argues that genetic information will be vital to healthcare in the future, but the specter of discrimination is blocking the path.

-Greg Dahlmann

Survey says... you've come to the end

A paper in the recent edition of PLoS Medicine proposes a radical idea: a computer might be better at making end-of-life decisions than a patient's family. A trio of researchers led by NIH's David Wendler created a "population-based treatment indicator" from already-published surveys of patient preferences in end-of-life cases. Wendler and company then compared the predictive accuracy of the indicator against that of surrogate decision makers in hypothetical situations. The result: the decisions made by both surrogates and the algorithm matched that of patients about 78 percent of the time. The authors hypothesize that as more specific data on patient preferences are added to the indicator formula, it could become even more accurate at predicting a patient's wishes than his or her family.

But if such a system were to show up in clinical settings -- and that, of course, is an enormous if -- would it really be used to shed light on patient preferences? Or would its real use be as a way of making family members feel better about their decisions? The authors suggest such a possible use: "This approach might help to relieve some of the burdens associated with making decisions for incapacitated patients, while allowing family and loved ones to retain final decision-making authority." The converse could also be true. What happens if a family's decision conflicts with the computer? Should the clinician tell them? Has the family made the "wrong" choice?

Scientific American has more on the "population-based treatment indicator."

-Greg Dahlmann

Labels: end of life, health services research

Upgrade now for longer-lasting lowered latent inhibition

G. Pascal Zachary used some of the New York Times' ink (and bandwidth) this past weekend to toss together a whole bunch of ideas about enhancing human capacity for creativity. The piece is kind of all over the place, but he essentially sorts the many efforts into two general categories of assistance: computational and pharmaceutical. So far, the computer geeks have made the most explicit progress. They keep getting tripped up, though. Said one Intel researcher to Zachary, "We don't have a link structure for your personal stuff. We’re not getting at the content." Or to look at the challenge a bit differently, computer scientists don't have much experience hacking the human body (if only we came with an Ethernet jack and an API). But you know who does? That's right. Drug companies. Which prompts Zachary to ask, "Might we be heading, however fitfully, toward a new industrial age when Microsoft buys Merck to better compete with Google?"

Just think for a moment about that potential family of brands. Introducing extended-release, extra-strength Creativity XP -- from the people who brought you Windows ME and Vioxx!
-Greg Dahlmann

Bring Out Your Dead

Gizmodo tells the story of this device, the dead and dormant remover, which is after 10 years really going to make its way into the Japanese streets. Supposedly. Where it will somehow sort out the people who cry out "I'm not dead yet!"

What Happens with Stem Cells After 2008? More of the Same.

David Jensen, whose California Stem Cell Report remains the authoritative source for anything going on around stem cells in California, has been reporting on the proceedings of a stem cell conference being put on by Stanford and Burrell and Company. Several speakers have been apparently saying something we’ve been arguing for a while now--- regardless of who wins, the presidential election of 2008 is not likely to produce any major changes in what one speaker called the “bizarre patchwork” of state funding and regulation of embryonic stem cell research. While many stem cell advocates would like to see a set of uniform federal standards and a big uptick in NIH funding, the likelihood of either of those things happening anytime soon after 2008 seems increasingly remote. While a new president, especially a Democratic one, might well sign the bill President Bush has vetoed once and is threatening to veto again to expand the number of stem cell lines eligible for federal research support, that’s likely to be all that happens. A major increase in NIH funding for ESC seems unlikely—one speaker at the conference even raised the possibility that NIH might even try to steer money away from ESC research because of all the state and private money already in play. Even if there’s a sizeable increase in stem cell funding, it would only make NIH one funder among many, and not likely the biggest one at that. NIH would have to increase its ESC funding roughly by a factor of eight to be competitive with California’s budget, and that doesn’t even include the funding in play from other states and private donors. While Congress could independently pass a law preempting individual state laws and establishing a uniform set of ESC research standards, the odds of that happening are less than slim. There’s no clear national consensus around a whole host of issues that would have to be addressed in such a bill, and the possibility that Congress could unify itself around one approach seems too remote to contemplate.
What seems likely to happen instead is more of what we’ve got now—more states weighing in with ESC funding programs of widely varying sizes (look particularly at what New York and Wisconsin wind up doing) and ESC research being heavily supported in some states and illegal in some others. There will be increasingly vocal debates over royalties and product pricing that will be resolved in a wide range of ways, and conflicts between the rules that apply to collaborating researchers located in different states. This “bizarre patchwork” is markedly less efficient and more administratively difficult than a single funding source and set of rules would be, but it’s an accurate reflection of conflicting and diverse public views about ESC that don’t show any sign of going away anytime soon.
- Jim Fossett, Director, States and Bioethics Program of AMBI & The Rockefeller Institute

Kill Him Quick, His Organs Are Souring

Police in Southern California and the state Medical Board are investigating whether a transplant surgeon prescribed drugs to hasten the death of a 26-year-old patient in order to harvest his organs more quickly to ensure they would be transplantable. What the doctor is alleged to have done is wrong and, if proven, merits strict punishment.

The public needs to be able to trust doctors to make dying as painless and dignified as possible. And to trust that they'll follow patients' wishes about medical care at the end of their lives. That is why a proposed change in state laws governing organ donation is not a good idea.

Many Americans, while supporting organ donation, have doubts about whether they will receive appropriate care if they identify themselves as organ donors. The frightening story from San Luis Obispo was being joked about on a sports radio station in Philadelphia just the other day. The message: Don't sign an organ donor card or check your driver's license to be a donor because doctors may kill you to get your parts!

We agree with the 85 percent of Americans who respond in polls that organ donation after death is a good thing. Donation helps provide some redemptive value to death, makes grieving less burdensome for family members and, of course, saves lives. But causing death to maximize organ donation is violating all ethical standards governing organ procurement. Fear of this may cause people to revoke or not provide
consent, and that jeopardizes thousands of lives.

Recently, a private but influential legal group, the National Conference of Commissioners on State Laws, revised the Uniform Anatomical Gift Act (UAGA), which is the model that many states have followed to legislate organ donation. The commissioners know there are too few organs available for those in need. Their proposal, which is under consideration by states, is that organ donation consent (on a driver's license, for instance) be allowed to override a person's living will, advance directive or even physician orders. The proposed language in the revision states, "measures necessary to ensure the medical suitability of an organ for transplantation or therapy may not be withheld or withdrawn from the prospective donor." What this means is that if you say you are willing to donate your organs, your advance directive, living will and physician's orders are in trouble.

The revised UAGA, which is under review by the California Department of Health Services and the state Legislature, in one fell swoop nullifies the advance directive of people who have consented to organ donation. If California and other states adopt the revised UAGA as written, advance directives will have to make clear whether the person gives more importance to organ donation or to directions about their end of life care. That is too much to ask.

People have clear opinions on their end-of-life care, including preferences for advanced life support and palliative medications, but also, organ donation. When making organ donation consent at a motor vehicles licensing office in San Jose, Los Gatos or Hollister, people are not asked whether the organ donation should nullify their living will. To assume otherwise makes no sense.

The commissioners may further revise their published recommendations to acknowledge their position that quality end-of-life care is as important as organ donation. They are thinking of adding language that organ-procurement professionals work with critical care physicians and families to try to find a course that promotes both excellent care as patients die and the opportunity to donate organs.

That collaboration is important, but it is essential that the line between caring for the dying and obtaining organs for those in need remain sharp and bright. One of the biggest barriers to obtaining consent for organ donation in California and around the nation is the fear that the consent will lead doctors to make end-of-life decisions based on what is best for organs rather than patients. That is what is troubling about the death in Southern California of Reuben Navarro. That fear should never become the law in California or any other state.
-Art Caplan [from San Jose Mercury News]

Evangelical Bioethics and the Web - washingtonpost.com

That's the title of today's story in the Washington Post about Joe Carter, evangelical blogger read by zillions, and his role on in bioethics debates. The blog is lauded by mainstream religious blog beliefnet.com and ranks up there among awards for blogdom. Conservative bioethics folks are out in force in the piece (as usual) to support absolutely anyone who isn't liberal, and I get spun as loving the site for its window to the evangelical "world:"

"When you read it, you get the sense that this is someone who has thought this out," said Matthew Eppinette, assistant director of the Center for Bioethics and Human Dignity, an evangelical bioethics think tank in Illinois that hired Carter in 2005. At the time, Carter was based in Fort Worth, repairing computer systems on fighter jets by day and blogging by night. Eppinette read the blog and called Carter in for an interview.

Glenn McGee, director of the Alden March Bioethics Institute in Albany, N.Y., and editor of the mainstream American Journal of Bioethics, said he checks Carter's blog not for scholarly reasons -- "most people in this field don't read blogs and are incredibly luddite" -- but more as cultural research.

"I'll go to his site to see, 'What are evangelicals saying about [the sexually transmitted human papilloma virus]?' I think he's a good mirror of what people are saying; he's plugged in," McGee said.

Considering Consanguinity (Inbreeding)

Writes our contributing editor Ricki Lewis:

In the Star Wars saga, George Lucas took great pains to keep Luke and Leia from kissing, knowing (when the audience didn't) that they were twins. Similarly, on the Young and the Restless, when newlyweds Billy and Mac discovered they shared a grandparent just seconds before they were to consummate their union, they backed away from each other in horror. Annulment followed.

gGenetics provides sound reasons for avoiding procreation with a blood relative. Consanguinity ("shared blood") can team up recessive genes inherited from shared ancestors, creating the curious situation of an otherwise extremely rare disorder striking more than one family member. Such families have led geneticists to many interesting genes - a search of the American Journal of Human Genetics for "consanguinity" in article titles yields nearly 4,000 hits. Within families, though, consanguinity can have tragic results. But for such personal behaviors as partner choice and having children, should outsiders intervene, even if their motives are to prevent suffering?

The "Ick" Factor

In a small, isolated town in northern Pakistan, a 10-year-old boy entertained crowds by stabbing knives through his arms and walking on hot coals - until one day at age 13 he jumped off a roof and died. At least six others in the community had the same strange pain insensitivity. Researchers studying the complexly connected families in the area discovered a mutation that blocks pain messages from entering nerve cells. DNA sequencing revealed that the errant gene had spread through shared ancestors.

A fictional victim of consanguinity is Calliope Stephanides, the hero/heroine of the Pulitzer-prizewinning "Middlesex", by Jeffrey Eugenides. The protagonist, raised as a girl, reached puberty and grew a penis - all because his paternal grandparents, isolated and frightened during wartime in a remote Greek village, united in their desperation. They were brother and sister.

The "ick factor" associated with consanguinity is perhaps why Patrick Stuebing and Susan Karolewski, the parents of four young children in Leipzig, Germany, recently made headlines. They, too, are brother and sister, and according to reports, two of their offspring have unspecified disorders. But Patrick was adopted, and didn't meet his biological family until age 23, when he and Susan fell in love. The government has placed three of the children in foster care and Patrick has already served one jail term, because incest is illegal.
But sibling pairings are rare; more common are cousin couples. In the U.S. 24 U.S. states ban first cousin marriages. The birth defect risk for all types of consanguinity is about 8 percent, compared to 3 percent for all births.

Consanguinity to Conserve Resources

Genetics is only part of the inbreeding story. For Calliope's grandparents and for the German couple, love trumped DNA. In some times and places, consanguinity was actually encouraged, usually to keep resources within a family.
Consider Egypt's Ptolemy dynasty. From 323 B. C. to Cleopatra's death in 30 B. C., the clan had one cousin-cousin pairing, four brother-sister unions, and an uncle-niece duo. Cleopatra herself wed her 10-year-old brother. Their pedigree (family tree) reflects this inbreeding. The term "pedigree" is from the French for "pie de grue", which means "crane's foot", because the typical chart widens with each generation, shaped like a bird's foot. The Egyptian pedigree resembles a ladder.

Marrying within the family to sequester resources persists. Today, 20 to 50 percent of marriages in some parts of the Middle East, Africa, and India are between cousins or uncles and nieces. In families unfortunate enough to keep their bad genes along with their wealth, results are heartbreaking. NPR recently ran a report, "Syrian Village Hobbled by Years of Inbreeding", about a community of 5,000 where 800 children have inherited a combination of blindness, mental retardation, and physical disabilities such as short limbs. The condition remains undiagnosed, but almost surely comes from more than 100 years of cousin-cousin marriages - encouraged to avoid paying a dowry. A teacher in the village is trying to attract outside attention to their plight, but he is outnumbered by those who do not wish to challenge "God's will".

Unknowing Consanguinity

Inbreeding undoubtedly occurs without people knowing it, especially in tight knit communities where few people leave or enter. This has happened with the Ashkenazi Jews, whose numbers plummeted so sharply during various periods of history that marriages of blood relatives were almost inevitable. Genocide has left a legacy of a dozen recessive disorders that are much more common among Jews than other population groups. But the Jewish people have done something about it. Thanks to genetic screening begun in the 1970s, the few cases of Tay-Sachs disease occurring in the U.S. today are notably not in Jewish people, in whom carrier-carrier couplings have been identified and steps taken to avoid the matching up of deleterious alleles. (The Law and Order: Special Victims Unit rerun on TV as I write this was wrong in portraying Tay-Sachs as a Jewish-only disease.)

The success of screening for Tay-Sachs disease carriers inspired a program that could serve as a model for other populations. The brainchild of an orthodox rabbi in Brooklyn who had lost four children to Tay-Sachs, Dor Yeshorim was founded in the early 1980s to test young people for the "Jewish genetic diseases". Results are stored in a confidential database, and when two people wish to marry, the information is unblinded. Couples who carry the same recessive disorder may alter their plans, either to marry or to have their own children. More than 100,000 people have been screened, and many families have avoided genetic disease.

So what should be done, if anything, to combat the health consequences of inbreeding? It might be a tough battle, since worldwide about 960 million couples are related, and know it. I'd vote for education - informing people of how and why marrying relatives sets the stage for disease - but not go so far as to disrespect long-held local customs and dictate who people can marry. Genetic medicine is largely about choice, and that should hold true for countering consanguinity.

Labels: consanguinity, inbreeding, star wars

South Carolina Learns from China About Organ Transplantation

Are we now taking lessons from the Chinese about where to look for transplantable organs. And good luck to those who get organs from populations known to be rife with infectious diseases. Wesley Smith drew this to my attention
-Art Caplan

Asimov would be pleased

South Korea has announced that they are drawing up a code of robot ethics, to prevent humans from abusing robots, and robots from abusing humans. Asimov would be so pleased!

While it's unclear if the code of ethics will follow Asimov's laws of robotics (an idea their convened panelists of scientists and sci-fi authors have not ruled out), Park Hye-Young of the Ministry of Information and Communication has indicated that a major concern is that people will be interacting with their robots like spouses, or become addicted to them (as many people appear to be addicted to cyberspace in general). And according to the BBC, "key considerations would include ensuring human control over robots, protecting data acquired by robots and preventing illegal use."

-Kelly Hills

Selling Bodies at UCLA

Cadavers for sale at UCLA? That's the charge:

The Los Angeles County district attorney's office announced criminal charges today against two men who allegedly ran a cadaver-trafficking scheme at UCLA's medical school, capping a three-year investigation that led to the temporary closure of the school's body donor program.

Henry Reid, 57, an embalmer who was director of the willed-body program from 1997 to 2004, was charged with conspiracy and grand theft for allegedly funneling donated bodies to a middleman, who then sold them to others for profit.

The middleman, Ernest Nelson, 49, was charged with conspiracy, grand theft and tax evasion. He has acknowledged cutting up about 800 cadavers and selling them to large medical research companies, including Johnson & Johnson; Nelson says the school authorized the sales, but UCLA officials say he was acting on his own.

Both Reid and Nelson were arrested today by UCLA police and are being held in lieu of $1 million bail each. Neither man could be reached for comment. They could be formally arraigned in a downtown criminal courtroom as early as Thursday.

-Art Caplan

Labels: stealing cadaver tissue, UCLA

Baby Drop-off Zone

Italy has made a policy matter of creating hatches for people to abandon their children, on what the Family Affairs Minister describes as the "modern-day foundling wheels" plan. Better lives for the children in many cases of course. But the process and its broad adoption (no pun intended) begins to edge toward sanctioning the abandonment of children by those who should be required to put them up for adoption, and the fact that often such parents would (ala the New Jersey Dumpster Baby Epidemic) literally leave their children to the elements or kill them outright doesn't change that reality. These "windows of mercy" are a poor substitute for public assistance to poor parents.
[Hat tip: Bill Soucy, Mac Genius and the Brains of the AMBI Computer Network]

Labels: adoption, child abandonment, Italy

further details on how not to procure organs

The LA Times has a follow-up on the organ procurement/transplant case that Ina's Sporula mentioned a few days back. Some intrepid soul at the paper decided to request the originally referred to report via the Freedom of Information Act, and received a 76-page document from federal investigators that reads like a litany of 101 things to not do when procuring organs for transplant.

As more comes out about this case, it's likely that the transplant surgeon will be the one made an example of, the over-zealous doctor that pushed too far. It is, after all, a nightmare scenario I hear repeated as the basis for why so many people are not organ donors, even though they would want an organ transplant themselves if it were necessary. But what is so interesting, in a "if you can't be a good example you'll be a horrible warning" sort of way, is reading the summary of the full report in the LA Times and realizing how many medical personnel (nurses and doctors) were present in the room, uncomfortable with what was going on, and said nothing until days, days, later. This seems a much more systemic problem than one over-zealous surgeon, to something endemic within the culture of the hospital itself.
-Kelly Hills

Labels: behaving ethically, internal oversight failures, Sporula, transplantation, UNOS, what were they thinking?, where's the bioethicist?

A Hostile Environment for Documents:
Why is the EPA's Library Being Decimated?

In The Scientist I argue that the destruction of huge amounts of material at the EPA is not only unwarranted it is downright dangerous:

Like most US agencies charged with the oversight of the public's health, the Environmental Protection Agency (EPA) relies on accumulated wisdom as it navigates new and varied problems. So imagine the information it stores at 27 libraries: books, journals, reports, and documents numbering in the millions. According to agency statistics, in 2005 EPA library staff fielded more than 134,000 database and reference questions and distributed tens of thousands of documents to researchers and the public. The library is the institutional memory of the EPA.

Like most libraries, EPA libraries have not scanned most holdings into electronic format. So librarians and location- or specialty-specific repositories are important to the EPA and those who consume its information. You'd think that the agency responsible for, say, all clinical information on the effects of pesticides would do anything to keep those systems of information fully operational and to modernize. But in fact, the greatest environmental disaster of this decade may be the amnesia that the White House and EPA seem hell-bent on causing.

In February of 2006, the White House proposed cutting $2 million of the $2.5 million budget for EPA libraries. It is a huge cut to the libraries, but a blip against the $8 billion EPA budget. Incredibly, EPA did not wait for the budget to be approved, but instead began decimating libraries and trashing materials including at three regional libraries, a library for research on the effects and properties of chemicals, and its headquarters.

Senators Barbara Boxer, (D, Calif.) and Frank Lautenberg, (D, NJ) and associations representing thousands of EPA scientists, engineers and other staff cried foul, pointing to the fact that EPA shutdowns depleted reference materials that might be indispensable in an emergency. In the EPA's library, for example, are at least 50,000 one-of-a-kind primary source documents. The EPA's own Office of Enforcement and Compliance Assurance (OECA), said last year that the agency has failed to adequately maintain critical information and accessibility. OECA "fears that dispersal of [the libraries' information important to specific regions... and unique data on industrial processes and analytical methods] without proper tracking and access could undercut rulemaking and the ability to substantiate and support findings, determinations and guidance."

Representatives Henry Waxman, (D, Calif.), Bart Gordon, (D, Tenn.), and John Dingell, (D, Mich.), called on EPA Administrator Steve Johnson to stop the process and the General Accounting Office to investigate. EPA says it has stopped. But it has failed to make available a good plan for access to stored materials. They just disappear. How? I find an image from the 1981 film Raiders of the Lost Ark helpful: scientist Indiana Jones is told by bureaucrats that the ark is being examined by "top people" and will be available later. The camera fades to the ark fading into a massive warehouse. EPA ought not to become a shell, or shill, manipulating its identity or even recreating itself as every administration relegates to "top people" the documents that are necessary to ensure public health.

Some have alleged that the EPA is shredding not just journals and documents, but files that may specifically damage the agency. No one has provided any proof of that yet, but if it turns out to be true, it may deserve a column of its own. My point is more mundane, but perhaps just as important. We just have to look to history to see the effect of destroyed libraries. Take the loss of the Library of Alexandria, founded in the 3rd century BC, to fires likely set by scoundrel politicians...

[Read the Rest of this essay by clicking here for The Scientist March Issue]

Labels: Bart Gordon, EPA, Henry Waxman, libraries, pesticides

Grey Goo

The regulation of nanotechnologies—products and processes which incorporate extremely small particles ( a nanometer is one billionth of a meter, and nanoparticles are usually described as those between 1 and 100 nanometers) – has popped into public visibility in the last year or so. Both federal and state governments have been promoting these technologies in a big way over the last several years—the multiple federal agencies that are part of the National Nanotechnology Initiative (NNI) have been spending close to a billion dollars a year to research and promote these technologies, and states have been avidly chasing the firms which do the research and produce the products. Products have been moving out of the lab and into the marketplace at an increasingly rapid rate—inventories maintained by the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars currently list over 300 products incorporating these particles and that’s almost certainly on the low side.

All of this development has happened without much attention to the consequences of large scale use of these products, particularly in the short run. Beginning with a book by futurist Eric Drexler in 1986 and continuing through a widely cited article by Bill Joy and Michael Crichton’s book Prey, there have been vivid dystopian scenarios of self-replicating nanobots covering the earth with “grey goo” which could annihilate the biosphere. More prosaically, there appears to have been little systematic effort to assess the environmental and health risks associated with nanoparticles. Recent reports by the British Royal Society and a distinguished largely American group which published an article in Nature a couple of months ago have noted this lack of attention. There is at least some evidence that these risks are not trivial— substances which are not reactive at larger scales may be so at nanoscale, but other factors besides size also come into play. The Nature article calls for a fifteen year research program to reduce the current uncertainty about the consequences of widespread use of these products.

The immediate question is what we do in the meantime. There have been calls for a moratorium on nanotechnological products until risks are better understood, but this seems unlikely to materialize. Federal regulatory agencies such as the FDA and EPA are beginning to regulate nanoproducts under their existing statutes—the EPA just announced a couple of months ago that that manufacturers of products which use nanosilver products to kill bacteria in such products as washing machines and shoe liners must now submit data showing these products have no adverse environmental or public health impact. How readily nanoproducts can be regulated under existing law isn’t really clear---some commentators have noted regulatory holes in the statutes authorizing federal action, which were written before nanomaterials came on the scene. Given the holes in the science and in the law, it may be a while before we have a coherent federal regulatory framework in place. It’s not difficult to imagine a scenario in which legal challenges limit federal agencies’ ability to regulate nanoproducts and Congress is reluctant to support expanded funding for risk research, increases in the budgets of regulatory agencies, or changes in regulatory legislation.

Given this potentially slow pace in Washington, it wouldn’t be surprising if the first serious attempts to regulate nanotechnologies come from state or even local governments. In fact, it’s already started---Berkeley, California has recently adopted an ordinance which requires users of nanomaterials to file an inventory and safety plan similar to those required for users of hazardous materials. This isn’t the first time local governments have acted to regulate cutting edge technology—since the late 1970’s, for example, anybody wishing to use recombinant DNA within the borders of Cambridge, Massachusetts has been required to secure a permit from the city health department that covers a wide range of biosafety issues. States typically have broad constitutional powers to protect the public health, and there may be fewer legal obstacles to state or local action than to federal. Even if federal action proceeds relatively rapidly, individual states or localities may wish to adopt additional health and environmental protection requirements for nanoproducts, and it’s far from clear that these would be pre-empted or invalidated in any way by federal regulatory action.

The major determinant of the future of nanoregulation in this country is likely to be political. The Cambridge ordinance had its origins in a rancorous spat between the city and Harvard in which the university basically blew off residents’ concerns. Similar conflicts over nanotechnology products are a real possibility. While “grey goo” scenarios are implausible, the real scientific uncertainty about how safe nanoproducts are, as well as the increased activism around these issues by environmental groups, may make some communities cautious about the conditions under which they allow research or manufacturing using these materials within their borders. Public opinion polls show considerable distrust of the ability of industry to regulate itself and support for governmental regulation of nanoproducts. Nanotech industry groups claim to get this, and have promoted “responsible development” of nanotechnology with appropriate acknowledgement of risks and uncertainties. What this means in particular circumstances, however, is still very much an open question.
- Jim Fossett, AMBI/Rockefeller Institute Federalism and Bioethics Initiative
(With thanks to Summer Johnson)

Labels: nanotechnology, state bioethics