blog.bioethics.net

A comment from Paul Gelsinger on gene therapy and informed consent

In a guest post earlier this week Alan Milstein, the attorney who represented Jesse Gelsinger's family, wrote about his reaction to a recent editorial by James Wilson about gene therapy and informed consent in the journal Human Gene Therapy. The guest post prompted a number of comments, including one from Paul Gelsinger -- Jesse's father. Here's Mr. Gelsinger's comment in full:

To clear the air about what really happened, let me take you back nearly 9 years to the meeting we had with the principal investigator 3 months before Jesse's actual participation in the "gene theray" clinical trial. Understanding the information regarding the gene therapy that Jesse was to receive wasn't all that difficult for me, since I had extensive experience in science. The risks were fairly well spelled out. There was the possibility that he would have an immune response, that his liver could be seriously damaged, that a liver biopsy to be done a week after the vector infusion had the risk of serious side effects. When I questioned this investigator as to whether they had seen any ill effects, he stated that they had only had to deal with flu like symptoms. In further conversation, he remarked that the liver was a remarkable organ, the only organ in the body capable of regenerating itself. The risks were downplayed. There was no mention by the investigator or the consent form of any animals having died in the research.

A month later, a call from the expert on Jesse's disorder, another of the principal investigators, led us to believe that the most recent patient had benefited from the vector infusion. He stated that she showed a 50% improvement in her ability to excrete ammonia following the gene therapy. When I said, "Wow, this really works", he stated yes and that it would be for those for whom this therapy was designed, not kids like Jesse with mild otc, but newborns with the almost always fatal form. We totally dropped our guard and Jesse made arrangements to participate.

(read the rest)

The medical marijuana vending machine

A few dispensaries have rolled out the "prescription vending machine" in, where else, California. This isn't like buying a can of soda, though. From an AP story:

Mehdizadeh said he spent seven months to develop and patent the black, armored box, which he calls the "PVM," or prescription vending machine.

A sliding fence protects the tinted windows of his dispensary, barely distinguishing it from a busy thoroughfare of strip malls, automobile dealers and furniture shops. A box resembling a large refrigerator stands inside the nearly empty shop, near a few shelves stocked with vitamins and herbs.

A guard in a black T-shirt emblazoned with the word "Security" on the front stands at the door. A poster of Bob Marley decorates a back room.

The computerized machine requires fingerprint identification and a prepaid card with a magnetic stripe. Once the card and fingerprint are verified, a bright green envelope with the pot drops down a slot.

Mehdizadeh says any user approved for medical marijuana and registered in a computer database at his dispensaries can pre-purchase the drug and then use the machine to pick up.

It would seem that these machines could be used for other prescriptions, as well -- maybe the morning-after pill? It's come up in comments here on the blog-dot that one way to resolve the emergency contraception pharmacist objection problem is to just figure out a way to dispense the pills without a pharmacist.

Maybe a machine like this is a way to do that. (Of course, if the guy who stocks the machine starts objecting we're right back to where we started.)

-Greg Dahlmann

Unfortnately, this isn't the plot from a bad horror movie

There's a story in NYT today about an illegal transplant operation just outside New Delhi that's been forcing people to "donate" their kidneys:

As the anesthetic wore off, Naseem Mohammed said, he felt an acute pain in the lower left side of his abdomen. Fighting drowsiness, he fumbled beneath the unfamiliar folds of a green medical gown and traced his fingers over a bandage attached with surgical tape. An armed guard by the door told him that his kidney had been removed.

Mr. Mohammed was the last of about 500 Indians whose kidneys were removed by a team of doctors running an illegal transplant operation, supplying kidneys to rich Indians and foreigners, police officials said. A few hours after his operation last Thursday, the police raided the clinic and moved him to a government hospital.

Many of the donors were day laborers, like Mr. Mohammed, picked up from the streets with the offer of work, driven to a well-equipped private clinic, and duped or forced at gunpoint to undergo operations. Others were bicycle rickshaw drivers and impoverished farmers who were persuaded to sell their organs, which is illegal in India.

-Greg Dahlmann

On gene therapy and informed consent

By Alan Milstein

January’s issue of Human Gene Therapy offers some intriguing commentary on the issue of informed consent in gene transfer trials. I became aware of the articles when a writer for TheScientist Blog called for my reaction to the Editorial by James Wilson, because I had represented the Gelsinger family after the death of their son in the experiment sponsored by Dr. Wilson and because I currently represent the family of Jolie Mohr, whose recent death renewed the debate over the informed consent process in this field of research.

My initial reaction reported by the caller reflects my surprise that Dr. Wilson would thrust himself into the debate when the informed consent process he used during his trial was so deficient.

(read the rest)

The label on the synethic genome

Wired Science, with the help of a few scientists, has decoded the "watermarks" placed in the synthetic genome recently constructed by the Venter Institute. So, what were the no-doubt profound messages tucked inside the first synthetic genome:

VENTERINSTITVTE
CRAIGVENTER
HAMSMITH
CINDIANDCLYDE
GLASSANDCLYDE

Yep. The names of people who worked on the genome. It makes sense, though. The Venter Institute is aiming to create designer organisms. And what designer item is complete without a logo? These kinds of watermarks could become the "LV" or "Intel Inside" of synthetic biology.

Of course, they'll be a little harder for Jessica Simpson to flaunt on the red carpet.

-Greg Dahlmann

Earlier on blog.bioethics.net:
+ Wired: three smart things about genomics
+ What do Bacteria have to do with Albert Einstein's Theory of Relativity?
+ On Human Genomes and "Rewriting the Textbooks"

What President Bush said about stem cells in the State of the Union

Here's the section (whole speech transcript), which also includes mentions of cloning and intellectual property:

On matters of life and science, we must trust in the innovative spirit of medical researchers and empower them to discover new treatments while respecting moral boundaries. In November, we witnessed a landmark achievement when scientists discovered a way to reprogram adult skin cells to act like embryonic stem cells. This breakthrough has the potential to move us beyond the divisive debates of the past by extending the frontiers of medicine without the destruction of human life. (Applause.)

So we're expanding funding for this type of ethical medical research. And as we explore promising avenues of research, we must also ensure that all life is treated with the dignity it deserves. And so I call on Congress to pass legislation that bans unethical practices such as the buying, selling, patenting, or cloning of human life. (Applause.)

The president's comments about expanding funding for research on induced pluripotent stem cells aren't surprising. Back in November, an official from NIH's Stem Cell Task Force was quoted by the San Francisco Chronicle saying that the agency would "be quite enthusiastic" about funding iPS cell research.

The president's call to ban "the buying, selling, patenting, or cloning of human life" also isn't too surprising, but the intellectual property part of that statement is a little vague. Was he referring to patenting the entire genome of an individual person? Because if he was just talking about parts of the human genome, we're already pretty far down that road.

-Greg Dahlmann

Synthetic bacterial genome coverage roundup

Here's a quick scan of the reaction to Thursday's news that the Venter Institute has created a synthetic bacterial genome:

+ Some researchers were skeptical of the relative importance of the Venter's Institute's achievement, noting that the research team didn't use the genome to actually run a cell. Said Stony Brook's Eckard Wimmer to NYT, "No matter how they praise the quality of the synthetic DNA, they have no idea whether it is biologically active." Added Harvard's George Church, also in NYT, "Right now, all they’ve done is shown they can buy a bunch of DNA and put it together." And in the Washington Post, Church questioned the economics of the Venter Institute's approach, "The question is: Is it faster or cheaper than other methods? But they don't lay out their economics. They missed an opportunity there."

+ Other researchers were more impressed. Harvard Medical School's Pamela Silver told the Baltimore Sun that the Venter Institute's work was a "technological tour de force." And the University of Chicago's Daphne Preuss described the work as a "seminal achievement" to Chicago Tribune.

+ David Magnus in a Bloomberg News article: "It's a wonderful breakthrough that could change the way we think about gene therapy. It would allow us potentially to create chromosomes exactly the same as a patient's chromosome but with genes that have been corrected. This could be a future treatment for disease."

+ The ethics of synthetic biology came up in a lot of the coverage. "Venter is claiming bragging rights to the world's longest length of synthetic DNA, but size isn't everything. The important question is not 'How long?' but 'How wise?'" said the ETC Group's Jim Thomas in a press release. The group also expressed worries about sufficient oversight. In the San Jose Mercury news, David Magnus noted that the field is moving ahead quickly, but "It shouldn't be discarded because of the pitfalls. We just need to make sure we stay on top of the pitfalls. As a society, we're taking a gamble that we can put enough protections in place so that by the time it is widespread, the damage can be mitigated." And in the Chicago Tribune, the Catholic Theological Union's Rev. Thomas Nairn said the field doesn't necessarily raise fundamentally new ethical questions: "From a religious point of view the creation of new viruses or bacteria would not necessarily create a huge problem, depending on how they're used. The two major principles are to do no harm, and do the work respectfully."

+ Carl Zimmer in Wired:

There is a lot we don't understand about life, of course, but Venter's project isn't going to answer all the questions. We are a long way from playing God. The scientists didn't assemble the fragments of DNA by themselves, nor did they program robots to do so. Instead, they injected the fragments into E. coli, and let the bacteria do the job themselves. Eventually, it turned out that E. coli could only build up a quarter of the genome. The scientists don't quite know why. So they injected those big chunks of Mycoplasma DNA into yeast. Lo and behold, the yeast were able to finish up the job for the scientists. They don't quite know how the yeast did their own biochemical magic either. I would assume that God would have this kind of stuff figured out.

Earlier blog.bioethics.net coverage of synthetic biology and Craig Venter.

-Greg Dahlmann

Academic journal deja vu

Mounir Errami and Harold Garner -- both of the University of Texas Southwestern Medical Center -- report in a Nature commentary this week that duplication and plagiarism appear to be on the rise in biomedical academic publishing. After using a text analyzer on a sample of Medline abstracts, they found that as many as 200,000 articles in the Medline database could be duplicates. (They've posted a large group of the potential duplicates in a database so that others can pick over them.) Errami and Garner report that many of these duplicates appear to be articles that were submitted to different journals at the same time. And they also found that the people who appear to be ripping off other academics often seem to be serial offenders.

This may seem like a problem that only concerns academia, but as Errami and Garner note, there are implications for the general public:

In general, duplicates are often published in journals with lower impact factors (undoubtedly at least in part to minimize the odds of detection) but this does not prevent negative consequences — especially in clinical research. Duplication, particularly of the results of patient trials, can negatively affect the practice of medicine, as it can instill a false sense of confidence regarding the efficacy and safety of new drugs and procedures. There are very good reasons why multiple independent studies are required before a new medical practice makes it into the clinic, and duplicate publication subverts that crucial quality control (not to mention defrauding the original authors and journals).

So, what should be done about this problem? Errami and Garner call for more vigiliance by journal editors and better use of technology:

If journal editors were to use more frequently the new computational tools to detect incidents of duplicate publication — and advertise that they will do so — much of the problem is likely to take care of itself. We find it odd that automated text-matching systems are used regularly by high schools and universities, thereby enabling us to hold our children up to a higher standard than we do our scientists. In our view, it would be fairly simple to fold these tools into electronic-manuscript submission systems, making it a ubiquitous aspect of the publication process.

Although text-comparison algorithms have come a long way in the last decade, they are still in their infancy, and experience with student software shows that as tools to detect duplicate publication improve, determined and skilled cheats will find ways to defeat them. But as in any arms race, the winners are usually determined by the cost–benefit balance, and the costs entailed in unethical duplication practices will quickly rise to a level that makes them prohibitively expensive to all but the most desperate (or most skilled) practitioners.

(via)

-Greg Dahlmann

Earlier on blog.bioethics.net:
+ Is your professor juicing?
+ Glenn McGee in The Scientist: Me First!

Not yet a synthetic organism, but closer

A team from the Venter Institute is reporting this week in Science that it has successfully constructed a synthetic genome for the bacterium Mycoplasma genitalium, which they call the "M. genitalium JCVI-1.0 genome." In the paper, the team describes how it assembled "cassettes" of base pairs (basically chunks of DNA made up of about 5000 base pairs) into ever larger sections of the genome before finally assembling the whole sequence in yeast.

So what? Well, theoretically you could use a synthetic genome to act as the "operating system" for new types of organisms. Here's how the Venter Institute's Hamilton Smith describes the next step on the Science podcast:

I like the analogy with the computer. You have an operating system, which by itself doesn't do anything. But when you install it on a computer, then you have a working computer system. It's the same with the genome. The genome is an operating system for a cell and the cytoplasm of the cell is the hardware that's required to run that genome. The two together make a living reproducing cells. So, when we chemically synthesize the genome, it's of no use sitting in a test tube. You have to transplant it into a receptive cytoplasm. Once you do that, then genome is expressed and you have a divided cell ... that's the next big step.

Smith says the Venter team is now focused on stripping the synthetic Mycoplasma genome down to only the genes essential for the microbe's basic function. Then they'll try transplanting that stripped down synthetic genome into cells to see if it works.

-Greg Dahlmann

Earlier on blog.bioethics.net:
+ Craig Venter on the "DNA-driven world"
+ Craig Venter on Stephen Colbert
+ Craig Venter on the ethics of creating synthetic organisms

Doctors and the death penalty

What role, if any, should doctors have in executions? That's the focus of an editorial in this week's NEJM by Gregory D. Curfman, Stephen Morrissey and Jeffrey M. Drazen that looks ahead to a decision in the Supreme Court case Baze v. Rees. They contend that lethal injection has led to the medicalization of executions -- and medical professionals have been drafted to lend the event "apparent moral legitimacy." The authors conclude:

We are concerned that, regardless of its decision in Baze v. Rees, the Court may include language in its opinion that will turn again to the medical profession to legitimize a form of lethal injection that, meeting an appropriate constitutional standard, will not be considered "cruel and unusual punishment." On the surface, lethal injection is a deceptively simple procedure, but its practical application has been fraught with numerous technical difficulties. Without the involvement of physicians and other medical professionals with special training in the use of anesthetic drugs and related agents, it is unlikely that lethal injection will ever meet a constitutional standard of decency. But do we as a society want the nation's physicians to do this? We believe not.

Physicians and other health care providers should not be involved in capital punishment, even in an advisory capacity. A profession dedicated to healing the sick has no place in the process of execution. On January 7 in oral arguments in Baze v. Rees, the justices asked many important and thoughtful questions about a potential role for physicians and other health care professionals in executions. In their fuller examination of Baze v. Rees, the justices should not presume that the medical profession will be available to assist in the taking of human lives. We believe that, like the anesthesiologists in the Morales case, all responsible members of the medical profession, when asked to assist in a state-ordered execution, will remember the Hippocratic Oath and refuse to participate. The future of capital punishment in the United States will be up to the justices, but the involvement of physicians in executions will be up to the medical profession.

-Greg Dahlmann

Earlier on blog.bioethics.net:
+ Is lethal injection cruel and unusual punishment?

Is New York's stem cell agency sidestepping ethics?

That's the accusation made by Daniel Sulmasy, a member of the Empire State Stem Cell Board's ethics committee. In an opinion piece this week in the NY Post, he writes that the ethics committee was first rushed to make interim recommendations -- and then essentially ignored:

Ethics-committee members hold diverse views on the controversial kinds of stem-cell research. Nonetheless, the committee unanimously recommended that the board hold off on funding these practices for six months so that the committee could examine these thorny ethical issues carefully and recommend guidelines.

The ethics committee thought that ethics mattered.

But perhaps ethics doesn't matter much in New York. The board's funding committee, composed almost exclusively of scientists and advocates for embryonic-stem-cell research, agreed on ambiguous guidelines that permit all the controversial practices noted above: cloning, chimeras, parthenogenesis and creating human embryos solely for research.

The ethics committee's sensible plan of ethical due diligence proved intolerable to the funding committee. It argued that even temporary limits would "send the wrong message to scientists."

On Jan. 7, Gov. Spitzer held a press conference to announce that the first round of funding had been awarded: $14.5 million.

This precipitous funding decision sends the wrong message - namely, that the discussion of research ethics should never encumber scientists' work. That's a dangerous premise for any society to hold. Was a six-month delay to allow ethical review really too much to ask? It's preposterous to propose that this would've had a "chilling effect" on science.

-Greg Dahlmann

Earlier on blog.bioethics.net:
+ New York's stem cell program picks up speed

Out with them, out with them all!

The Minneapolis Star Tribune reports that a health care group got an early jump on Spring cleaning:

Administrators at SMDC Health System saw them as virulent, insidious and cause for an all-out eradication campaign in its four hospitals and 17 clinics throughout northern Minnesota and Wisconsin.

Germs?

No, pens and note pads.

Nexavar pens. Combivir note pads. Vioxx mouse pads. Advair and Levitra clipboards A disembodied stuffed nose from Allegra that exclaims, "That's snot funny!"

As part of a new policy that experts say is one of the toughest in the nation blocking pharmaceutical companies from influencing doctors, the Duluth-based health system recently got rid of nearly every freebie with a drug company name on it.

"We're part of a leading trend that's trying to get away from the pharmaceutical companies essentially controlling what's prescribed in this country," said Dr. Kenneth Irons, chief of community clinics for SMDC. "This shows people we're not in the pharmaceutical companies' back pockets."

OK, so you get a few boxes and drop the stuff into the trash, right? It turns out the job was a little bigger than that (emphasis added):

In all, SMDC employees have turned in more than 18,700 items, including clocks, mugs, surgical caps, calculators, tape dispensers, and a stress-relieving squeeze toy made to look like a red blood cell.

Administrators plan to donate the 20 shopping carts full of stuff to a hospital in Cameroon, where supplies of all types are desperately needed -- and most of the advertised drugs aren't available.

Presumably, the "That's snot funny!" nose won't be making the trip to Cameroon. Transporting such an item might violate international humor laws.

Later in the article a PhRMA VP called the Minnesota sweep "a bit draconian." Maybe he's just miffed this his industry's now stuck with a bunch of tchotckes and pens they can't give away.

(via Jim Fossett and the WSJ's Health Blog)

-Greg Dahlmann

Earlier on blog.bioethics.net:
+ One more time -- should docs take freebies from drug companies?
+ OK, who hasn't taken money from drug companies?
+ Days of styrofoam cups and M&Ms
+ Stanford: No More Small Gifts
+ No More Free Lunch

From AJOB:
+ All Gifts Large and Small

AJOB article at center of focus on hospital ethics consultation

American Medical News, an AMA publication, recently took a look at the state of ethics consult services in hospitals -- and it found a lot of unease. Doctors are hesitant to call for ethics consults. Ethics consultants often lack the training and resources to effectively address situations. And among bioethicists, there's uncertainty about whether ethics consults even help. From the article:

The use of ethics consultation services varies widely from hospital to hospital, but physician experts and ethicists agree that they frequently are underused. That leads, they say, to increased medical costs and ugly disputes among physicians, patients and families.

Physicians' reluctance to seek aid when dilemmas arise is partly grounded in the notion that a call for help is equivalent to hauling in the "ethics police." But the problem, experts say, goes far deeper.

Too often, ethics consultants lack the resources, training and mediation skills necessary to resolve disputes and address dilemmas in a timely and effective manner. In addition, the journal article pointed out that fewer than half of consultants have any formal training, and only one in 20 has a bioethics certification or graduate degree.

Moreover, the evidence that ethics consultation actually improves patient outcomes is thin. Many experts are at a loss on how even to go about measuring its impact.

"If ethics committees were a drug," said Howard Brody, MD, PhD, director of the University of Texas Medical Branch's Institute for Medical Humanities, "they would not be approved."

The AMNews piece builds around the February 2007 AJOB cover article "Ethics Consultation in United States Hospitals: A National Survey" by Ellen Fox, Sarah Myers and Robert A. Pearlman. In that article, the authors reported that only 41 percent of ethics consultants had formal training. Ellen Fox, who's director of the VA's National Center for Ethics in Health Care, is now involved in an effort to standardize and measure the work of ethics consultants. From the AMNews piece:

... The VA began the initiative in May 2007. By September of this year, it will record electronically all consultations and their outcomes.

The VA has developed a 63-page primer and two-hour instructional video for its consultants. Ethics coaches will visit VA medical centers to train consultants on consistently following a step-by-step process when handling cases. They will be expected to evaluate their own performance and skills, and physicians and other health professionals will be surveyed for their feedback, said [Ellen Fox] ...

"It is concerning to me that almost 20 years after the Joint Commission mandate, there still are not widely agreed-upon standards for quality," she said. "That's why in the VA we've issued these standards and will hold people accountable for meeting them."

Dr. Fox, lead author of the study in The American Journal of Bioethics, said proof of ethics committees' effectiveness is still largely anecdotal.

"The way to ensure that ethics consultation is utilized at an appropriate level is to ensure that the quality of ethics consultation is very high," she said. "Our strategy is to prove the value of it on the ground."

-Greg Dahlmann

Cloned human embryos coverage roundup

Here's a bit of the reaction to the report in the journal Stem Cells (pdf) that Stemagen, a California company, has successfully created cloned human embryos by fusing an adult skin cell with an egg (a process called somatic cell nuclear transfer or SCNT).

+ Stemagen didn't produce stem cells from the embryos, which has led to a somewhat skeptical reaction from other researchers. ACT's ACT's Robert Lanza tells the Washington Post, "I'd really like to believe it, but I'm not sold yet." Harvard's Douglas Melton tells the Boston Globe that Stemagen's results are "nothing substantially new." And George Daley, also of Harvard, tells the New York Times that he found Stemagen's data "pretty convincing," but that the skepticism would only go away after stem lines were created. But Tulane's Donald Phinney tells the Globe that Stemagen's results are "pretty important" and "This paper takes proof of principle work in nonhuman primates and applies it to humans."

+ According to the San Diego Union Tribune, the reaction from the Center for Genetics and Society's Marcy Darnovsky when she heard the news yesterday, "Yikes." The California stem cell funding initiative allows this kind of research, but Darnovsky tells the the Union Tribune that "[Somatic cell nuclear transfer] isn't a good use of that public money” because of cost and the ethical concerns related to getting the necessary eggs. And Darnovsky tells the Washington Post that the iPS cell developments from late last year make cloning-based stem cell research "less justified than ever."

+ Stemagen's approach to obtaining eggs -- asking women who were already donating for reproductive treatments -- drew some praise. Wisconsin's Alta Charo in the Washington Post: "The protocol entailed no marginal increased health risks to the egg donors, as they were already undergoing hormonal stimulation for non-research purposes."

+ The Westchester Institute's Fr. Thomas Berg in the San Diego Union Tribune: “We're manipulating and using human embryonic life as material for research. The only intent here would be to destroy the embryo once it's been cloned. That just opens up a huge issue.” Of Stemagen's claims, the US Conference of Catholic Bishop's Richard Doerflinger told the Washington Post: "It does not answer the ethical or social questions about the mass-production of developing human lives in order to destroy them. ... It only tells us that these questions are more urgent than ever." Doerflinger in Newsday: "We've been objecting to human cloning for any purpose for many years. We think there should be laws against it as there are in other countries, and as the United Nations has called for."

+ About reproductive cloning, Stemagen's CEO tells the Washington Post, "It's unethical and it's illegal, and we hope no one else does it either."

Earlier on blog.bioethics.net:
+ Art Caplan on cloned human embryos
+ Where the presidential candidates stand on cloning

Flashback: where the presidential candidates stand on cloning

Back in November when news of cloned monkey embryos surfaced, we surveyed the leading presidential candidates' stands on cloning human embryos to produce stem cells for potential therapies. The issue was roughly split between Republicans and Democrats -- the Republicans generally against, the Democrats generally supportive. But the candidates have different histories on this topic, so the full breakdown is worth checking out again after Thursday's news of cloned human embryos.

Earlier on blog.bioethics.net:
+ Art Caplan on cloned human embryos

Art Caplan on cloned human embryos

Over at MSNBC, Art puts the news that a company has cloned human embryos into context:

Stemagen, a private company in La Jolla, Calif., has published a paper in which its scientists claim they have successfully created cloned human embryos. If you think you have heard this announcement before, you are right.

Just about two years ago, a team of scientists at Seoul National University in Korea announced in the journal Science that they had cloned human embryos and had gotten stem cells to grow from them. The Korean work could not be replicated. Eventually Hwang woo-suk, the lead scientist involved, admitted he had lied. There were no cloned embryos. He resigned his university position in complete disgrace.

So, two questions arise about today’s human cloning news. Did Stemagen scientists really do what they are saying they did? If they did, what does it mean for the future of human cloning and stem cell research?

(read the rest)

Zetia situation demonstrates need for a more open clinical trial process

By Alan C. Milstein

The news about Zetia and Vytorin once again raises a major problem in the way the FDA allows drug companies to control the information about the clinical trials they conduct, often to the detriment to public health. Apparently, Merck and Schering-Plough had completed the trial which has just hit the media back in April of 2006. While analyzing the results of the 720 human subjects might have taken some time, the data hardly could have been as complex as the two companies claimed in explaining the continued delay in reporting the information which will undoubtedly cost them sales of their drugs.

Meanwhile, there was little reduction in the direct advertising the companies did for the products. We still repeatedly had to witness the actors pretending to be med students on rounds discussing the advantages of Zetia with their mentor and the cute morphing of Aunt Meg and hard-boiled eggs in the Vytorin commercials.

Merck, of course, faced similar criticism about delaying the release of clinical trial data about Vioxx. And all the major players in BigPharma faced tough questioning from Congress over their failure to report the results of clinical trials they conducted which revealed that SSRIs increased the likelihood of suicide and suicide ideation in adolescents while showing no efficacy in the treatment of childhood depression. A long-delayed Black Box warning was the result

This is not a new problem. A few years back, I was investigating the systemic and institutional failures which caused the death of 18 year old Jesse Gelsinger. The Recombinant DNA Activities Committee had previously rejected a call for a Gene Therapy Information Network which would house the adverse events of all gene therapy trials so other investigators and human subjects would have access to the information. A prior trial at a different institution had yielded results which might have predicted Gelsinger’s reaction to the adenovirus but had been marked proprietary by the research team. In an off the record conversation, Phil Noguchi, FDA Director of Cellular and Gene Therapy and a member of the RAC, told Jesse’s father and me that had the network been approved Jesse would not have been killed. A sobering thought, to say the least.

While that network is now in place, more needs to be done to make the clinical trial enterprise in this country transparent and to eliminate the ability of pharmaceutical companies to withhold or delay the results of their clinical trials. The companies will cry that millions are at stake. But those are of lives not just dollars.

Alan C. Milstein is a nationally recognized litigator in the areas of insurance law, products liability, bioethics and clinical trials litigation.

Art Caplan on food from cloned animals

In his latest column for MSNBC.com, Art calls for transparency in the marketing of food from cloned animals:

The Food and Drug Administration has spoken: meat, milk, cheese and other products from cloned animals are safe to eat. And the federal agency won't require any special labels identifying these products.

There is no reason to doubt the FDA's science. It is as careful a review as possible. The agency reviewed dozens of studies from around the world without finding any evidence that meat or milk from cloned animals is in any way biologically distinguishable from meat and milk from any other animal.

So is the debate over the use of cloned animals for food now over? Hardly.

(read the rest)

Should consent for organ donation be presumed?

Gordon Brown, the British prime minister, set off a bit of row this past weekend with an op-ed calling for hospitals in the UK to adopt an "opt-out" policy for organ donation. That is, hospitals would presume that a person was willing to be an organ donor unless that person had explicitly declared otherwise. Here's a clip from Brown's piece in the Sunday Telegraph:

We know that transplant surgery is one of the great advances of medical science, and has saved the lives of thousands. Yet the organ donation on which it depends remains a difficult and sensitive issue on which feelings can be strong. Many of us will have friends and family members who have benefited from transplant surgery, or - tragically - who have endured the agonising wait for a life-saving organ that did not become available in time.

That is an avoidable human tragedy we can and must address. There are currently more than 8,000 people in the UK awaiting organ donation but only 3,000 transplants are carried out each year. Sadly, that means that more than 1,000 people die each year waiting for transplants. So we need to do more to ensure that organs are available to those who need them. This week, the Organ Donation Taskforce will report on how we can improve the management of transplant services and organ donations, and will set out a series of recommendations.

However, we may need to do more to encourage more of us to donate. In Britain we have 14.9 million people on the organ donor register - which is around 24 per cent of the population. In terms of actual donors (not just people willing to give, but those whose organs are actually used) we have a rate of about 13 donors per million in our population. This compares with about 22 per million in France, 25 per million in America and around 35 per million in Spain - the best in the world.

That is why I want to start a debate in this country about whether we should take steps to move towards a new system designed to enable far more of us to benefit from transplant surgery - one that better reflects survey findings that around 90 per cent of us are in favour of organ donation.

Brown appears to have been successful in starting a debate, though it might not end the way he had hoped. Officials from the Church of England have raised doubts, a rep from a patient group declared that "presumed consent is no consent at all," and others question whether Brown even has a handle on the problem.

But Brown isn't out by himself on this issue. The UK's chief medical officer supports the plan and The Observer (a sister publication of the Guardian) has started a campaign to change the system.

-Greg Dahlmann

How's that "Methods in Bioethics" submission coming along?

The entry deadline for the Methods in Bioethics Competition will soon be here (February 1). The contest is a collaboration among AJOB, Bioethics, Cambridge Quarterly of Healthcare Ethics, Journal of Medical Ethics, Kennedy Institute of Ethics Journal, Nursing Ethics, and Theoretical Medicine and Bioethics. The winner will be published in all of those journals at the same time. So, if you haven't already, now is the time to get started on your 500 word essay answering the question: "What are the methods of theoretical bioethics?" Need more info? Check out all the details.

Steven Pinker on "The Moral Instinct"

Yesterday's NYT Mag included an article by Steven Pinker about the science of morality:

... Illusions are a favorite tool of perception scientists for exposing the workings of the five senses, and of philosophers for shaking people out of the naïve belief that our minds give us a transparent window onto the world (since if our eyes can be fooled by an illusion, why should we trust them at other times?). Today, a new field is using illusions to unmask a sixth sense, the moral sense. Moral intuitions are being drawn out of people in the lab, on Web sites and in brain scanners, and are being explained with tools from game theory, neuroscience and evolutionary biology.

“Two things fill the mind with ever new and increasing admiration and awe, the oftener and more steadily we reflect on them,” wrote Immanuel Kant, “the starry heavens above and the moral law within.” These days, the moral law within is being viewed with increasing awe, if not always admiration. The human moral sense turns out to be an organ of considerable complexity, with quirks that reflect its evolutionary history and its neurobiological foundations.

These quirks are bound to have implications for the human predicament. Morality is not just any old topic in psychology but close to our conception of the meaning of life. Moral goodness is what gives each of us the sense that we are worthy human beings. We seek it in our friends and mates, nurture it in our children, advance it in our politics and justify it with our religions. A disrespect for morality is blamed for everyday sins and history’s worst atrocities. To carry this weight, the concept of morality would have to be bigger than any of us and outside all of us.

So dissecting moral intuitions is no small matter. If morality is a mere trick of the brain, some may fear, our very grounds for being moral could be eroded. Yet as we shall see, the science of the moral sense can instead be seen as a way to strengthen those grounds, by clarifying what morality is and how it should steer our actions.

The whole thing is definitely worth reading. Pinker's take on the subject includes discussions of neuroscience, psychology, philosophy, altruism, repugnance and many other topics that come up here on the blog-dot frequently. Pinker ultimately argues that the scientific study of morality can actually help us to become better people.

-Greg Dahlmann

Earlier on blog.bioethics.net:
+ Evolution and morality
+ Steven Pinker on "dangerous" ideas
+ Weekend reading: experimental philosophy

Following up: "no destruction" embryonic stem cells, cocaine vaccine

Here are a few updates and extensions to earlier posts on blog.bioethics.net:

New development on creating human embryonic stem cells; same answer from NIH
ACT's Robert Lanza talked with MSNBC's Alan Boyle about ACT's claim this week that it had created embryonic stem cell colonies without harming the embryos from which the cells were derived. Boyle asked Lanza about some the ethical questions this technique might prompt:

Since this still involves extracting cells from an embryo, I suppose people might ask the ethical question about what happens to those embryos that are sampled. Could you get into a situation where you’re creating life to save a life, then have an open-ended fate for that life that you’ve created and frozen?

Actually, we’re rescuing embryos, because these embryos would be slated to be destroyed, and we’re not harming them so they’re frozen down. By generating these lines, those embryos will be protected and will not be harmed. Period.

That’s one thing. But the other thing to consider here is if you just look at PGD [preimplantation genetic diagnosis], these are couples who will have one of the cells from an embryo sent off to the lab to be tested. And of course when it goes off to the lab, that cell is destroyed.

What we could do is, before you send that cell off for testing, just let it divide overnight. Then send one cell off for testing, and you create a stem cell line from the rest of those cells. So you then have a genetically matched line for that child without any additional risk to the embryo. In other words, it has no impact on the clinical outcome of that procedure - but yet, there’s a benefit in that you have a line that matches the child. And that line can also be used by the whole world.

The ACT claim seems to have elicited little more than a shrug from the political world. NIH already said it wouldn't get on board. And Democratic Congresswoman Diana Degette, who's been a sponsor of bills that would expand federal funding for embryonic stem cell research, didn't seem to think the ACT paper would change anything.

And in a follow up flashback, here's Art Caplan's skeptical take from when ACT announced an earlier version of this technique in 2006.

The cocaine vaccine
The announcement from researchers at Baylor that they were looking to do final round trials of a vaccine that would blunt the high from cocaine prompted Time to talk with The Hastings Center's Tom Murray about some of the ethical questions:

Should we be concerned about giving the vaccine to children?

In general, parents will want to use any tools at their disposal to help their children, and a vaccine that prevents cocaine addiction could well fall into this category. There are a couple of problems, however: The vaccine as currently designed is not for prevention of addiction, but for use by current or former addicts who want to guard against relapsing. The drug is not likely to be tested in children, but if trials in cocaine-addicted adults lead to FDA approval, the vaccine will be available for "off-label" use — meaning that doctors will be free to prescribe it for anything they want.

Plenty of drugs that are not specifically approved for use by children are nevertheless given to them off-label, but medically speaking, children are not merely tiny adults, and scientists cannot predict how children will respond to a drug that has been tested only in adults. Without solid research confirming that the vaccine works in children as a preventive against addiction — without damaging side effects — parents who decide to give it to their children will be exposing them to unknown and possibly serious risks. At a minimum, if children are given the vaccine, doctors should follow them carefully in order to pick up any evidence of side effects.

The interview also takes up questions about cost, informed consent and discrimination.

-Greg Dahlmann

New development on creating human embryonic stem cells; same answer from NIH

A team from Advanced Cell Technologies (and other research centers) reports in Cell Stem Cell today that they have created colonies of human embryonic stem cells without harming the embryos from which the cells were derived. (ACT reported an earlier version of this technique, which involves removing one cell from an embryo, last year -- today's paper seems to describe a more efficient version.) The yardstick they used for harm in this case was fertility clinic embryos, which also often have one cell removed, though it's usually for genetic testing (preimplantation genetic diagnosis, or PGD, is the technical term). As Rick Weiss reports in the Washington Post, the embryos used by ACT to generate the stem cell colonies had a survival rate as good as or better than that of fertility clinic embryos -- whether they were underwent PGD or not.

So, given the seeming lack of harm, NIH should be able to fund this kind of research, right? Actually, no. From that Washington Post article:

That means the work should be eligible for federal financing under President Bush's six-year-old policy of funding only stem cell research that does not harm embryos, said study leader Robert Lanza, chief scientific officer at Advanced Cell Technology in Worcester.

But that is not likely, said Story Landis, who heads the National Institutes of Health stem cell task force, which oversees grants for studies on the medically promising cells.

The embryos Lanza used, which were donated for research, appear not to have been damaged, Landis acknowledged. However, she said, "it is impossible to know definitively" that the embryos were not in some subtle way harmed by the experiment. And "no harm" is the basis of the Bush policy, she said.

Landis said the only way to prove that the technique does not harm embryos would be to transfer many of them to women's wombs and see if the resulting babies were normal. But it would be unethical to do that experiment, she said, so the question cannot be answered.

That standard has Lanza fuming. By all scientifically recognized measures, he said, the embryos -- currently frozen in suspended animation because they were donated for research and not to make babies -- are normal, he said.

"I think the burden of proof lies with the NIH and the Bush administration to show that an embryo was harmed," Lanza said.

-Greg Dahlmann

(via Jim Fossett)

New York's stem cell program picks up speed

We’ve got to say it every so often -- state stem cell programs are moving ahead, while the feds continue to languish. The most recent state to put money on the table is New York. Having gotten up and running in record time, the New York Stem Cell agency (NYSTEM) has just made its first set of awards. The state plans to spend $600 million on stem cell activities over 10 years, which makes it a sizable player among states, though not in California’s league.

NYSTEM has also released an interesting and useful snapshot of on-going stem cell research in New York. Based on surveys and interviews with stem cell principal investigators, this paper inventories researchers and their major research interests, reports on the types of stem cells currently in use in New York, and aggregates scientific opinion on appropriate funding priorities and mechanisms. Check it out.

Meanwhile, inside the Beltway, grass is still growing and paint is still drying and watching either of those things happen is more exciting than watching federal stem cell policy proceed.

-James Fossett

Men and abortion

The LA Times recently reported on a "burgeoning movement" (statistics aren't cited) of activism among men who are "post abortive" -- that is, they contributed to a pregnancy that ended in abortion. As one Christian counselor tells LAT, "We had abortions."

There seem to be two motivations behind this movement. The first is to provide counseling and support to men who experience grief or guilt after an abortion. And the second is to use that grief in the political fight over this issue. From the LAT article:

Since the concept of post-abortion syndrome first emerged in the early 1980s, some women have recounted similar stories -- and learned to leverage them into political power. They speak at legislative hearings and rallies organized by the Silent No More Awareness Campaign. They write affidavits detailing their years of emotional turmoil, which the Justice Foundation, a conservative advocacy group, submits to lawmakers and courts nationwide.

Last spring, the Supreme Court cited these accounts as one reason to ban the late-term procedure that opponents call "partial-birth" abortion. The majority opinion suggested that the ban would protect women from a decision they might later regret.

Women's testimony was also used to justify a sweeping abortion ban passed in 2006 in South Dakota. (Voters overturned the ban before it could take effect.)

"It's a rule of thumb that if you want to get a law passed, you have to tell anecdotes that grab people," said Dr. Nada Stotland, president-elect of the American Psychiatric Assn. Antiabortion activists have done that well, she said. "They've succeeded in convincing a lot of the American public" that abortion leaves women wounded.

Now, those activists see an opportunity to dramatically expand the message.

The Justice Foundation recently began soliciting affidavits from men; one online link promises, "Your story will help legal efforts to end abortion." Silent No More encourages men to testify at rallies.

Therapist Vincent M. Rue, who helped develop the concept of post-abortion trauma, runs an online study that asks men to check off symptoms (such as irritability, insomnia and impotence) that they feel they have suffered as a result of an abortion. When men are widely recognized as victims, Rue said, "that will change society."

Abortion rights supporters watch this latest mobilization warily: If anecdotes from grieving women can move the Supreme Court, what will testimony about men's pain accomplish?

"They can potentially shift the entire debate," said Marjorie Signer of the Religious Coalition for Reproductive Choice, an interfaith group that supports abortion rights.

The article includes a number of anecdotes from men about their experiences with abortion -- and at times it seems that the movement might need better representation:

In the end, Aubert says his moral objection to abortion always wins. If he could go back in time, he would try to save the babies.

But would his long-ago girlfriends agree? Or might they also consider the abortions a choice that set them on a better path?

Aubert looks startled. "I never really thought about it for the woman," he says slowly.

-Greg Dahlmann

The health care price tag

The Centers for Medicare and Medicaid Services released figures this week about health care spending in the United States for 2006 (pdf). The total amount: $2.1 trillion. That's 16 percent of GDP. Or a little more than $7,000 per person. A few details and thoughts:

+ If you're concerned about government taking over health care... you may be too late. Spending by governments accounted for 40 percent of that $2.1 trillion. That's the largest single slice of the "who's paying" pie. Households were next at 31 percent, followed by businesses at 25 percent. The ranks of people 65 and older are going to swell in the next few decades (pdf), so government's slice of that pie almost surely will increase as more people go on Medicare.

+ For all the attention they get about their cost, prescription drugs are still only the third largest expenditure by category ($216.7 billion). We spend roughly three times that much on hospitals, and a little more than twice that on physicians and clinical services.

+ So what are getting in return for those trillions? On an individual level some of us are probably doing very well, but as a country maybe we should be looking for a partial refund. Or at least, have a stern conversation with someone on the customer service line. A study published in Health Affairs this week reported that the US ranks last among the 19 leading industrial countries in preventable deaths from treatable diseases. The number one country in the study was France, which spends roughly half what the US does on health care per person.

-Greg Dahlmann

Drawing the line on genetically engineered pets

Catching up on the last little bit of year end list-making, here's Wired's "Top 10 New Organisms of 2007." The collection includes quite a few organisms that you might call useful or productive -- vaccine-producing button mushrooms and mice that model schizophrenia, for example. But a few of the organisms on the list are what might be considered "entertainment" organisms: the now infamous glow-in-the-dark cats, the hypoallergenic cat, and tadpoles engineered to be fluorescent for the purposes of art (that's an image created from one of them above).

Reading about these organisms got me thinking about a comment posted by SabrinaW about the glow-in-the-dark cats. Here's what she wrote in December:

It is the commercialization of such "designer pets" that bothers me about this. Coming from a negative utilitarian standard (avoid doing harm), this development appears frivolous, potentially harmful, and disrespectful to the dignity of animals. We are treating them like robots or a product rather than as a living being with needs and an interest in being treated humanely. I worry about the shifts in how we will view animals in the wake of this "new exciting feature!" and what that will inspire in us as we find ourselves unable to understand more while still maintaining respect for the dignity of life.

I am allergic to pet dander (dogs and cats), and love cats dearly. But I cannot bring myself to consider a "made to order" hypoallergenic cat - such a "feature" brings no benefit to the cat itself and could hold potential dangers for it.

I wonder about where we should draw the lines here. Sabrina draws it at the genetically engineered "designer" pet. But humans have been breeding certain characteristics into and out of our pets for a long time. What makes a hypoallergenic cat different? At $27,000 a cat, it will almost surely be prized and well cared for. Isn't that all a cat can ask for? Or is there something about the act of genetic engineering that pushes these kinds of organisms over the line?

Update: Check out Sabrina's further thoughts on this in the comments.

-Greg Dahlmann

Earlier on blog.bioethics.net:
+ South Koreans clone cats that glow in the dark
+ About those glow in the dark cats
+ Looking for cats that glow in the dark

photo: Dmitry Bulatov, Kaliningrad Branch of the National Centre for Contemporary Art in Russia

Weekend reading: shifting attitudes, House, climate change sadness

NYT: We Agreed to Agree, and Forgot to Notice
Looking at the recent surges by Barack Obama and Mike Huckabee, Kirk Johnson wonders if the United States is on the verge of a cultural turning point:

But there’s no doubt that for one night, in one state, Americans dramatically changed the subject. Race didn’t matter — even though Mr. Obama was an African-American running in a nearly all-white state — but talk of unity and common ground did, as Mr. Obama galvanized his supporters by promising to toss historical and political division aside.

How far rhetoric and passion can take a man, or a nation, is another question, and there’s plenty of reason to doubt we’re anywhere near a transformative era in 2008. Look around today, Dr. Bunzl and other social theorists say, and it’s easy to see nothing but cynicism, apathy, polarization and political gridlock.

But if you listen closely, you might hear something — a faint but persistent tapping at the window that economists, criminologists and biologists say is the sound of change arriving anyway. From capital punishment to global warming to homosexuality to abortion, many of the social issues that divide us are shifting and evolving — perhaps even in some instances into a new consensus, or at least, and no less profoundly, toward a reframing of the old debates.

POLITICS might be stuck in the slow lane, but science, capitalism and American culture and society are decidedly not, and all are making creative end runs around the gridlock. Mr. Obama’s call in his Iowa victory speech — for “a coalition for change that stretches through red states and blue states” — evokes an earlier time in America, but it also suggests a future that may be unfolding no matter what politicians like him say or do.

Blogcritics: The Metaphorical Medicine of House
Diane Kristine talks with Lisa Sanders, NYT's "Diagnosis" columnist and technical advisor to the TV show House:

"I have never broken into any of my patients' houses," she added dryly. "I have on occasion made house calls, but I ring the doorbell and if they're not home, I come back later."

Yet she brings this up not simply as a critique, but rather a way of illustrating the show's metaphorical take on medicine.

"One of the things we do, one of the great pleasures of being a doctor, is you get to ask all these incredibly nosy, intrusive questions," Sanders said. "People can feel extremely violated with intimacy. Of course, it's part of a trusting relationship, you hope, but you probe into the inner recesses of their personal life as if you were breaking into their house."

"Their propensity to break into houses is a perfect visual representation, a psychological representation, of what we're doing," she continued. "I love that."

Wired: The Next Victim of Climate Change Will Be Our Minds
Clive Thompson looks at climate change induced sadness, a phenomenon Glenn Albrecht -- a philosopher by training -- calls solastalgia:

Everyone's worrying about resource management and the spooky, unpredictable changes in the ecosystem. We fret over which areas will get flooded as sea levels rise. We estimate the odds of wars over clean water, and we tally up the species — polar bears, whales, wading birds — that'll go extinct.

But we should also be concerned about the huge toll climate change will inflict on our mental health. In the modern, industrialized West, many of us have forgotten how deeply we rely on the stability of nature for our psychic well-being. In a world of cheap airfares, laptops, and the Internet, we proudly regard mobility as a sign of how advanced we are. Hey, we're nomadic hipster capitalists! We love change. Only losers get attached to their hometowns.

This is a neat mythos, but in truth it's a pretty natural human urge to identify with a place and build one's sense of self around its comforts and permanence. I live in Manhattan, where the globe-hopping denizens tend to go berserk if their favorite coffee shop closes down. How will they react in 20 or 30 years if the native trees can't handle the 5-degree spike in average temperature? Or if weird new bugs infest the city in summer, fall shrinks to a single month, and snow becomes a distant memory? "We like to think that we're cool, 21st-century people, but the basic sense of a connection to the land is still big," Albrecht says. "We haven't evolved that much.

-Greg Dahlmann

December 2007 AJOB

The December 2007 issue of AJOB is now online and it includes two target articles:

Clash of Definitions: Controversies About Conscience in Medicine
by Ryan E. Lawrence, Farr A. Curlin

Defining the Scope of Implied Consent in the Emergency Department: Defining the Scope of Implied Consent in the Emergency Department
by Raul B. Easton, Mark A. Graber, James Hughes, Jay Monnahan

As always, each target article is accompanied by a group of peer commentaries. December's issue also features two editorials: "Mandating Vaccination: What Counts as a "Mandate" in Public Health and When Should They Be Used?" by Matthew K. Wynia; and "Playing with God: Prayer is Not a Prescription" by Glenn McGee. The full text of the latter is available for free. Here's a selection:

Despite some very vocal advocates, the idea that prayer is a cure for disease just doesn't have a prayer. Harvard researchers and the Templeton foundation poured nine years and $2.4 million into the sixth and most comprehensive study to date of the effect of prayer by strangers ("intercessory prayer") on patients' health. And this month they announce, as have those who led the other five studies, pretty definitive results: prayer by strangers across thousands of miles had no effect on side effects for 1,802 heart bypass patients. There's just no getting around the evidence that there is no meaningful correlation between prayer by strangers and patients' health.

Those who continue to preach for remote control prayer are undeterred in the struggle to turn religion into biomedical research. The studies just haven't been done correctly, they argue. Perhaps people didn't get the prayer right, or did not know how much to pray. Or maybe patients were scared (which may very well explain why heart patients who were told they were the subject of prayer did more poorly than those who were unaware).

But the problem with patients putting their faith in intercessory prayer is that it tries to turn religion into biomedical science, at great cost to both.

Even the winners eventually lose

Art Caplan recently popped up over at SI.com as part of a piece looking at some of the occupational health concerns of professional athletes. As Art points out, most pro athletes rely on team doctors. And those doctors often have a conflict of interest:

"The doctors work for the clubs, their duty is to maximize the ability of the player to get the job done," he says. "It's the 'double agent' problem. They're expected to do what's good for the club, not necessarily the player. And that may mean clearing a player to play when he's carrying an injury or telling him to play through the pain."

"A medical doctor should protect the long-term health of the player. But the club is only interested in the player's health as it relates to his playing career. The athletes are often young and stupid and they don't know any better, they don't think about getting their own doctor for a second opinion. And the clubs prey upon the relative ignorance of the athlete. In fact, they milk those images of courage and virtue. As for the public, they don't care what a player's body might be like once they retire."

The long-term physical toll exacted by playing a professional sport -- and who should pay for the consequences -- has been a very contentious issue lately for the National Football League. A few months back the NFL announced it would add $10 million to its medical fund for retired players in order to help pay for joint replacements, cardiovascular screening and assisted living. The NFL's contribution follows years of criticism that the league hasn't done enough to address the medical needs of former players. The fight has gotten nasty at times, pitting retired players against both the league and the players' union. There were threats of neck breaking and invocations of Upton Sinclair.

The retired players' main argument has been that a lot of people -- the league, owners, today's players -- are now rich because guys back in the day sacrificed their bodies each Sunday for wages that would now be considered relatively small. That argument seems to have connected with some people. A group of current players recently announced they would make donations to a fund for retired players. One current player called it a " humanitarian issue."

So what part -- if any -- do sports fans play in all this? Art stated in that SI piece that fans "don't care what a player's body might be like once they retire." Some people would argue that today's players are very well compensated for the physical sacrifices they make. But if we're going to heartily cheer the often violent action on the field and support this multi-billion dollar industry built in part on the destruction of its workers' bodies, I wonder if we as fans bear some responsibility, too.

-Greg Dahlmann

The cocaine vaccine

You might have seen the stories floating around recently about the development of vaccine that can blunt or eliminate the high from cocaine. Researchers at Baylor are now looking to get approval to start Phase III trials of the vaccine sometime during the next year. From a Houston Chronicle article:

The vaccine also could raise interesting ethical questions involving who should get inoculated and what happens if confidential information about those receiving it becomes known. Although developed for therapeutic purposes — the number of cocaine addicts in this country is estimated at more than 2 million — the vaccine eventually is expected to be used for prevention, as well.

The questions include whether parents would be allowed to have their children inoculated; whether it would amount to coercion to make it a condition for lighter criminal sentences; whether employers might happen upon such information and use it discriminatorily; and whether to use it on pregnant addicts to protect the fetuses.

The questions don't just reverberate about this vaccine: Tom Kosten also is at work on vaccines for methamphetamine, heroin and nicotine. Two other nicotine vaccines are being investigated by other scientists.

A 2004 report from the National Academies looked at the issues surrounding immunotherapy for treating addiction. From the report:

Enthusiasm for the new medications should not obscure the fact that fully informed and voluntary consent is necessary under any and all circumstances. These medications can produce long-lasting biological markers (raising issues of confidentiality and potential for discrimination) and might interfere with drug-testing methods. The free and informed nature of consent is of special concern if the medications are used in settings and circumstances that are inherently coercive. These therapies may offer great benefit, even when used in such settings. However, any such benefit needs to be balanced against the rights to privacy and liberty that have long been recognized in the provision of medical care. Particular complications may arise in obtaining consent from persons in the criminal justice system, from pregnant women, from women who are already parents and involved with the child welfare system, and from adolescents and children whose parents or guardians seek to administer these medications for “protective” use.

That last situation highlighted by the report -- about children -- seems especially interesting. Would you give such a vaccine to your children? Would you want to, in a sense, take that choice away from them? Every parent wants to protect their children from serious harm and there's little doubt that narcotic addiction falls into that category. So, sure, maybe a vaccine against cocaine and heroin is an easy choice. But, if such a vaccine existed for marijuana or nicotine, how about those?

Update: Over at the MindHacks blog, Vaughn Bell has more about vaccines against addiction and raises the possibility of an "arms race" between illicit drug producers and vaccine developers.

-Greg Dahlmann

The robots of 2007

Congratulations, Robot(s) M-430iA, you're the Robot of the Year, according to Japan's Ministry of Economy, Trade and Industry. Sure, you're just an arm. And you effect a manner not unlike that of a pecking chicken. But you beat out a field that included competitors with seemingly much flashier functions such as firefighter, human body simulator and delivery with a smile. And as your manager said to the AP of your job in pharmaceutical and food plants, "The trend these days is to try to avoid having human workers at all. People can get dirty and introduce unwanted objects." And, of course, people taste like bacon.

Speaking of robots, SciAm's Larry Greenemeier rounds up the year in robots. And about sex with robots... Joel Achenbach says we should hold on to the flesh-and-blood option, you know, for back-up.

-Greg Dahlmann

(via)

photo: Fanuc LTD

Sleep as a choice

I have cursed my body's need for sleep. And, I have cursed when my body needed sleep but my mind refused to turn off. I'll admit that at times I've turned to the pharmaceutical industry to help me cope, but this one scares me: a nasal spray with a drug that helps your mind compensate for lost sleep. I get that it's being developed for military pilots on long-range missions, but talk about a potential market. The drugstore might replace Starbucks. My cynical side says there's no way this could actually work long-term without serious side effects, but desperate people trying to compete in our capitalist society may not care. It seems to me that we ought to hold this drug to a very high safety standard and control its distribution like other prescription drugs that are easily abused.

-Andrea Kalfoglou

Check out my brain!

The new blog io9 pointed out something recently that was a bit surprising to us -- and maybe it will be to you, too: people seem to be really into posting images of their brains on the photo sharing site Flickr. A lot of the images seem to be of the "hey, check out my brain!" variety, like the one above from Flickr user Liz Henry (on the image's Flickr page, check out the annotations made by Henry and her friends). But other images seem to be a way for people to share intimate details about themselves -- about brain tumors or a diagnosis of MS, for example.

Maybe this shouldn't be surprising, though. As our culture becomes more aware of neuroscience and the role of the brain, the sending of postcards from our brains just becomes another way of connecting with other people. As io9's Annalee Newitz comments, "... I like any trend that leads us closer to a day when people flirt online by exchanging MRIs of their brains."

-Greg Dahlmann

image from Flickr user Liz Henry re-posted under a CC license

Art Caplan's predictions for 2008

In his first MSNBC column of the new year, Art's readying himself for what could be a disappointing year:

This is the time of year when, optimism firmly in hand, we anticipate all the great things that await us.

Not gonna happen, at least when it comes to scientific and medical progress. I arrive bearing bad news about the coming year. Plenty of it.

(read the rest)