blog.bioethics.net

Who Owns the Embryo?

Marks and Clerk news, the update of a major patent law firm, shows that even with regulatory barriers, stem cell research is taking off in the patent world - with many new patents. My research group argued in Who Owns Life that patents in stem cell research have already changed the entire nature of the bioethics debate for that field, and indeed it appears that the stem cell patenting field has taken off. In our essay in that book we reviewed all of the patent activity to date in human stem cell research and identified the basic problems with those patents. But we couldn't have begun to anticipate this level of "progress."

People assert claims to owning the embryo itself now, for all intents are purposes. If you thought gene patents were alarming, you ain't seen nothing yet.

Not Guilty by Reason of Genes

In this week's New England Journal, Mark Rothstein takes up the question of forensic DNA testing:

On December 21, 2004, Brandon Moon was released from prison in El Paso, Texas, after having served 16 years of a 75-year sentence for three counts of aggravated sexual assault. Moon, who was 43 years of age at the time of his release, had been convicted in 1988 on the testimony of the three victims, who had had only a fleeting or partial view of their assailant. In 2004, after undergoing DNA testing, Moon was excluded as the contributor of the DNA collected after all three rapes. As a result, Moon became the 154th person in the United States to be exonerated on the basis of DNA evidence that came to light after the person was convicted for a crime...

irst, do these cases of wrongful conviction represent the tip of the iceberg, indicating the existence of deeper structural problems in the criminal justice system? As a study by Gross et al. revealed,2 most of the exonerations that have occurred since 1989 involved faulty eyewitness testimony, as in the case of Brandon Moon, coerced or false confessions, or perjurious testimony by prison inmates. Other cases involved poor crime-scene processing or poor evaluation of evidence by forensic laboratory workers, ineffective defense counsel, or even police and prosecutorial misconduct. Studies of errors in these cases often indicate the presence of systemic problems in forensics, law enforcement, or the criminal courts.3 For example, officials in several states ordered the review of hundreds of convictions after they determined that state and local crime laboratories might have made numerous errors in handling and testing evidence or, worse, might have deliberately falsified the results or interpretations of forensic testing.

Second, aside from those already exonerated, how many other innocent people have been convicted of serious crimes and have served, or are now serving, long prison sentences or are facing execution in one of the 38 states that permit capital punishment? Although there may not always be crime-scene evidence available for DNA testing, new federal legislation should make DNA testing more widely available to those who have been convicted. On October 30, 2004, President George W. Bush signed the Justice for All Act of 2004, which grants any inmate convicted of a federal crime the right to petition a federal court for DNA testing to support a claim of innocence. The law provides funding to the states to preserve evidence and to make DNA testing available to those who have been convicted by the state as well. It also increases the financial compensation of wrongfully convicted federal prisoners. Under Texas law, Brandon Moon is eligible for up to $25,000 for each year he was wrongfully imprisoned. Many states, however, have no provision for compensation.

Third, what is the proper role of DNA evidence in criminal investigations? DNA has the power not only to exculpate but also to inculpate. Forensic DNA analysis was first used in the United Kingdom in 1985 to solve two related sexual homicides. The use of such evidence soon became internationally accepted as a method for linking suspects with crime-scene evidence. In 1990, the Federal Bureau of Investigation established a series of federal–state forensic DNA data banks, called the Combined DNA Index System, or CODIS. In every state, certain convicted felons are required to submit a sample of DNA to be typed and the profile entered into a computerized data bank. Law-enforcement officials can then compare the DNA profiles obtained from evidence from a crime scene with all the DNA profiles in the local, state, or national system.

[subscription required; thanks Alta Charo]

Craig Venter Creates a Company to Create Synthetic Life

Boing Boing covers Craig Venter's newest venture; he will "now use his deep DNA knowledge to build new organisms. Synthetic Genomics, launching today, aims to engineer modular genetic components that can be snapped together to build biological systems that don't exist in nature."

Home Testing to Determine Fetus' Sex

Alta Charo notes:

The Boston Globe on Monday profiled a test launched earlier this month that allows pregnant women in the United States to determine the sex of their fetus as early as five weeks gestation. The $25 Baby Gender Mentor test, marketed by Mommy's Thinkin' and available exclusively at pregnancystore.com, includes a finger prick kit for pregnant women to collect a blood specimen. Women then can send the blood sample to a laboratory based in Lowell, Mass., which analyzes fetal DNA in the pregnant woman's blood for an additional charge of $250. Lab technicians test the blood for the presence of a Y chromosome, which would indicate the fetus is male, or the absence of the chromosome in the case of a female fetus. The pregnant woman receives the test results in two to three days. Although the test is aimed at "the type of woman who can't wait to open Christmas presents," some ethicists and physicians are concerned the new test could lead to sex-selective abortion, especially among cultures that favor male children, according to the Globe. Most pregnant women have the opportunity to learn the sex of their fetus during a routine ultrasound around 16 weeks gestation, though the results are not 100% accurate (Goldberg, Boston Globe, 6/27).

[thanks Andrea Kalfoglou]

Jeb Bush, Scientist

Kristen Philipkoski is a great Wired magazine writer, and reports from the Biotechnology Industry Organization meeting (now easily the most important meeting in biotechnology) that Florida Gov. Bush has decided to give loads of credence to our favorite neo-con William Hurlbut's bogus theory that embryonic stem cells can be derived from what the right-to-life folks have described as "handicapped embryos." We've written at such great length here about how mind-boggling this theory is - and noted that it went down in flames in Massachusetts after being embraced by Mitt Romney there.

But Wired magazine has something invested in Hurlbut, having published what amounts to a puff piece about him last month, and in so doing having essentially been suckered into what is becoming a hillarious snake oil road show, orchestrated by Hurlbut, but gaining momentum as it acquires signatures - a bit like Jeremy Rifkin's zillion signature petition in the late 1990s against gene patenting, in that it is being signed by folks who will later realize what they are signing and come to regret it. The best evidence of this of course is the fact that no significant stem cell researcher will give Hurlbut the time of day, nor have any senior scientists said anything about the Hurlbut proposal other than "who is that guy, again?"

In any event, Bush, who lends considerable expertise in bioethics, particularly in end of life issues, opines that Hurlbut is the "bright person" who can solve the big ethics problem about stem cell research:

"I think taking of human life to create life is a huge contradiction morally," Bush said. "But ... there are other really bright people in this issue who share that view who are trying to find an alternative that would not retard the advancement of science."

The Godly Doctor

Kansas City's paper reports on a study about to come out in the Journal of General Internal Medicine that demonstrates that religious physicians are in the majority these days. In fact,

In the survey of 1,044 doctors nationwide, 76 percent said they believe in God, 59 percent said they believe in some sort of afterlife, and 55 percent said their religious beliefs influence how they practice medicine.

The study's lead researcher notes that 83% of the U.S. population as a whole believes in God, so this figure isn't out of accord with the more general population. But the fact that 55% believe that their religion impacts their practice is certainly worthy of further study.

An Up Move for Physicians Who Do Lethal Injections

New York Times asks the time honored question at Gitmo: should doctors torture people. Apparently,

Military doctors at Guantánamo Bay, Cuba, have aided interrogators in conducting and refining coercive interrogations of detainees, including providing advice on how to increase stress levels and exploit fears, according to new, detailed accounts given by former interrogators.

I'm less worried than I might be because the real ethics experts are on the case: "Pentagon officials said in interviews that the practices at Guantánamo violated no ethics guidelines, and they disputed the conclusions of the medical journal's article, which was posted on the journal's Web site on Wednesday."

But others worry, particularly about physicians in so-called Biscuit Teams, who have as their job description the management of behavioral science consultation to the military, are basically in the same kind of conflict of interest as sports medicine docs in football teams, in that their commitment to health can be directly at odds with the team's immediate interest. Or, thinking about it, perhaps they really don't have any conflict at all, having accepted a job that amounts to reducing medicine to a skill in the service of other ends.

Either way, if you need a shrink, don't go to Gitmo.

But They Put it On a Lollipop!

Hartford Courant staff writer Thomas Williams does a nice job reviewing the rapidly ballooning scandal concerning an NIH plan to test an anthrax vaccine on children.

The trial will test and compare the reactions in humans to the vaccine manufactured by BioPort Corp. of Lansing, Mich., and another being developed by NIH. Bob Bock, an NIH spokesman, said the trial planned for 100 children in first and second grade will not occur until the vaccines are fully tested on 350 adults and shown to be safe for them.

"The results in this study," says an NIH announcement, "will help in the development of improved vaccines for anthrax." The NIH and U.S. Health and Human Services Department are calling for development of the vaccine to protect civilians from terrorist or other attacks.

Critics, however, are appalled.

"This vaccine is totally inappropriate for children, because the [exposure] threat is so remote," said Barbara Loe Fisher, president of the National Vaccine Information Center. "They will likely never be exposed to anthrax either through contamination by animal products or inhalation of weaponized anthrax."

"Children are involved in trials of vaccines that benefit children," she said, "but this vaccine will not do so." Fisher said based on the NIH announcement of "rare severe reactions" to BioPort's vaccine, she fears the parents of children used in the experiments will not be given proper warnings of the vaccine's potential for adverse reactions.

While You Were Sleeping:
New York Likely to Offer "Almost Over the Counter" Morning After Contraception

New York Times reports that in Albany, the NY State Senate have voted to make that state a leader in shifting the ground on the contraception and abortion debate - by making morning after contraception available to women without a prescription.

Passed in the middle of the night with the assent of the state's most powerful Republican lawmakers, the bill had already passed the Assembly and will now make its way to Governor Pataki. The Governor, who still seems interested in thinking about a bid for the Presidency or to return as Governor, was noncommittal on the question of his signing the bill into law.

Of course there is always the problem of the Fed:

The federal Food and Drug Administration has declined to allow the pill to be sold over the counter, even though two of its advisory committees voted in 2003 that it should be ... The bill would allow pharmacists and registered nurses who choose to participate to obtain blanket prescriptions from doctors, naming no individual patient, for the morning-after pill. The pharmacists and nurses could then dispense the pills to women and girls of any age. Proponents say the measure will help women get the pill early enough to be effective on weekends, when seeing a doctor can be difficult.

[Republican] Senator Spano, who argued on the floor that the bill would reduce unwanted pregnancies and therefore abortions, said afterward that it was "the most difficult and controversial bill" that he had sponsored in his 27 years as a legislator.

Dear "Mom": Get Lost.

You think your relationship with your son-in-law is rough? The Washington Post describes the way you know definitively that your son-in-law does not like you:

Michael Schiavo angered his late wife's family Monday by not notifying them about the burial beforehand and by inscribing on her bronze grave marker the words "I kept my promise." Schiavo, who said he promised his wife he would not keep her alive artificially, also listed Feb. 25, 1990, as the date his wife "Departed this Earth."

Amputee Wannabes: the Data About the Desire to Lose Limbs

In large part as a result of the oft cited article by Carl Elliot entitled "A New Way to be Mad" from Atlantic Monthly, there is considerable debate these days about a condition called body integrity identity disorder or BIID. Those with the condition seek, to put it simply, to have part of their body removed, most typically a limb. Reviewing a philosophy article today, Australian Broadcasting Corporation discusses a study that hasn't even been accepted for publication but which is interesting fodder for conversation:

The first person to use the term BIID was US psychiatrist Associate Professor Michael First from Columbia University, who interviewed 52 wannabes as part of a recent study which has been submitted for publication.

He found that 15% of wannabes identified sexual arousal as a reason for amputation, 63% wanted to be restored to their "true identity" and 37% said the limb "felt different".

Thirteen percent said the limb didn't feel like their own and six people had tried to perform their own amputation, including using a chainsaw.

The authors of the philosophical article make the claim that clinical amputations are not morally problematic. The nub root of their claim is that persons with BIID are not by definition irrational, and are thus capable of giving informed consent for removal. Given the damage that those who want amputation can do to themselves while waiting for surgical help, this gives enough moral weight in the minds of Bayne and Levy (the authors of the article, published in The Journal of Applied Philosophy), neglect to make any kind of argument as to why it is incumbent on physicians to offer the treatment (as opposed to the more ordinary sense of "autonomy", in which physicians are obliged only to acquiese to a patient's request to forego a treatment).

Attention Menopausal Women: Get Used to It

NIH has been pushing its new standard on hormone replacement therapy, driven in part as a result of data obtained since the fallout from fabricated data on hormone replacement therapy. The guidelines include the following incredible suggestion: women should begin to recognize menopause as a natural part of life rather than a disease state. This to buttress the claim also made in that report that hormone replacement therapy should be reserved for the most severe symptoms of menopause. That claim comes from safety concerns. But the broader claim - the one about how women need to learn to deal with aging, is hillariously sexist and dangerous and will fuel a gender debate within and outside the beltway.

Pharmaceutical Company Punished: "You Must Pay for an Ethics Professorship"

From the AP:

Bristol-Myers Squibb Co. agreed to pay $300 million in a deal to defer federal prosecution of a conspiracy charge stemming from an accounting scandal, the U.S. Attorney's Office in New Jersey said Wednesday. Two of its former executives also were indicted for their alleged roles in the same scandal. Frederick Schiff, Bristol-Myers former chief financial officer, and Richard Lane, former executive vice president and president of the company's worldwide medicines group, were indicted on charges of conspiracy and securities fraud. The company said that it would record an additional reserve of $249 million in the second quarter related to the settlement. Its shares fell 26 cents to close at $25.20 in trading on the New York Stock Exchange, near the high end of the 52-week range of $22.22 to $26.60. With Wednesday's payment, Bristol-Myers has doled out about $800 million to settle lawsuits and investigations tied to the incentives it paid wholesalers to stockpile inventory, inflating sales and earnings. In March 2003, Bristol-Myers restated $900 million in profits and $2.5 billion in revenue reported from 1999 through the first half of 2002.

The punishment? Big changes in its internal structure plus:

The company must also endow a chair at Seton Hall University Law School in Newark dedicated to teaching business ethics and corporate governance. The person holding that position will conduct an annual seminar for Bristol-Myers executives.

- Art Caplan

This Product Recall Will Hurt a Lot

Defective heart devices already implanted in lots of folks - devices made by Guidant Corporation, a company soon to be acquired by Johnson & Johnson (unless J&J decides that uh, maybe these guys might be very expensive as a subsidiary...) - are defective, or at least many of them may be, according to recent releases. The devices are internal defibrilators, and the problem is that they can short-circuit when they are called on to restore cardiac rhythym. If they do, you can die.

Writes the Times:

Guidant did not tell doctors for over three years about the electrical flaw in one model, the Ventak Prizm 2 DR Model 1861, that it has recalled. It also kept selling older versions of it after developing a version not prone to short-circuiting ...

The surgery to replace a defibrillator, which is the size of a pager and is implanted under the skin of the upper chest near the shoulder, takes an hour, and many people go home immediately afterwards. Full recovery takes about 7 to 10 days. But like any surgical procedure, the surgery carries a risk of infection.

About 17,000 people, 13,900 of them in the United States, are still implanted with the affected Prizm 2 DR devices, which are those made before April 2002, when Guidant fixed the problem. Another 11,900 people, 6,700 of them in this country, still have the affected Renewal devices, made before last August. The Renewal devices - more complex defibrillators intended for patients with severe heart failure - have pacemaker functions for both sides of the heart.

This isn't the first such device to be recalled. But it is definitely one of the more invasive procedures for removal, and the question of safety trade-off will be enormous, as will the question of who pays for what sort of injury and prevention.

An Exchange You Will Never See in America: The Archbishop Blesses Korean Stem Cell Cloning

This decade's Ian Wilmut, Hwang Woo-suk, whom Korean news outlets have taken to describing as a "star," is making the rounds in stem cell research. Early in the week he described to the major media the reasons why American stem cell laws are awful. On Tuesday and Wednesday, again talking about his big article on cloned human embryos (which we have blogged over and over again, and for which Magnus and Mildred Cho wrote an accompanying editorian in Science), he very publically signed up to help out with the next-generation version of Gerry Schatten's "ethics for stem cell researchers" course, which is moving to Stanford from Pitt.

But today's news is hillarious. The folks around the news scene are trying to figure out what to make of the meeting between Hwang and Seoul Archbishop Nicholas Cheong Jin-suk, at which they discussed the question of whether or not what Hwang is doing is unethical. According to the Digital Chosunilbo (English Edition) , Hwang laid out his claim to the Archbishop quite simply: these are not viable embryos, and therefore there is no abortion and no moral issue:

According to Ahn and the Seoul Diocese public information office, Cheong explained that he did not oppose all of Hwang’s research but could not countenance cloning lives such as human fetuses to harvest stem cells. Cheong in a press release distributed to major Catholic newspapers on June 11 said stem cell research “is an act premised on destroying human life.”

Hwang responded the research team’s stem cells used eggs that were not fertilizers, and because there was no chance they could become implanted in the uterine wall, there was no scientific evidence that they could develop into life.

This is the part where if it had been an American conversation, someone from the National Council of Bishops would have castigated Hwang for mincing words or for acting inappropriately by creating an abomination. But that isn't what happened:

After the meeting, Hwang expressed palpable relief. “I came to get scolded, but instead received blessings and teachings,” he said. “Since my understanding may be a little poor in dealing with precious life, I will follow the teachings and guidance of the archbishop."

The two also issued a joint statement saying they were “in total agreement that no matter what the case, scientists must respect human life, and agreed that the talk was a valuable opportunity to promote and establish a direction for mutual understanding between the scientific and religious worlds.”

Rome is a long way from Korea, and further still is Washington.

Dr. Maren Grainger-Monsen in San Francisco Chronicle

Maren Grainger-Monsen is amazing. Her film "Hold Your Breath" is the story of the care give to Afghan immigrant Mohammed Kochi. But that doesn't begin to get at the depth of the film, by bioethicist and Stanford "bioethics in film" program director Grainger-Monsen. I met Maren when she and I were figuring out how our respective Greenwall Foundation-funded projects would overlap. From my point of view, anything anybody else can do in bioethics and film, Maren can (and will) do better. She's just amazing.

Maren's Breath film left a roomful of stodgy bioethics professors weeping (well, it did me anyway), and from the tone of this SF Chronicle review she will likely see Breath make its way to some major awards in the non-fiction independent film awards (whatever those are).

She is well into a big program that has developed several films and other products and among her films are some that are used by most major medical schools in the English-speaking world. Here's the piece on her work in the SFChron.

Why This Blog Might Die

Not much point trying to keep up with William Saletan, the eloquent ironist from Slate, now that the writes about bioethics virtually every day - and usually does such a great job of it. Today he actually has a fabulous review of some amazing news in bioethics - worth taking ten minutes to surf his links about tall IVF kids, monogamy genes, overdiagnosis of mental illness, and virginity pledges. Dude. Stop please. We like writing our blog. Or at least share your research assistant with us.

Black Drugs

Karama Neal, of So what can I do? fame - and one of our fav bloggers, points out that race-based pharma marketing is here, for better and worse. NitroMed's BiDil is a medicine aimed at the treatment of cardiovascular disease in African Americans. On the 16th it went before an FDA panel for approval. Karama asks, though, who is ...

"African-American." Does Tiger Woods qualify? Teresa Heinz-Kerry? Barack Obama? Michael Jackson? How will physicians know how to prescribe this drug. A better approach would be to identify the (presumably) genetic factors that affect BiDil's function. It's easier to just use race instead, but it's sloppy and not good medicine.

There's money at stake here.

In the Lab Again, I Just Can't Wait to Get in the Lab Again

The coolest school on earth, the University of Texas, has just announced maybe the neatest name for an endowed chair ever. You know you want to be the Willie Nelson Professor of Stem Cell Research. Heck I'd even work in Dallas, where embryonic stem cell research might get you killed, if I could be named for Willie. Then again, there are the tax consequences. [thanks Art Caplan]

When is it OK to Refuse to Deliver Care?

This week's New England Journal includes this amazing piece by Alta Charo, examining the question of whether any of the new rash of claims by health professionals to "conscientious objections" to providing health care are valid.

Did the Government Cover Up Mercury Data on Autism?

In a joint Salon and Rolling Stone investigation, Robert F. Kennedy Jr. asks whether or not there was a kind of systematic effort to suppress data about the possible correlation between mercury (in the form of thimerasol, a preservative in vaccines) and autism.

My Mother, Host

Quite a story today concerning a 26-year-old pregnant woman with cancer, whose brain function ceased last month. She is being kept alive with a respirator in hopes she can have a premature baby who may have a chance to survive. Susan Torres, a researcher at the National Institutes of Health, lost consciousness early last month when an undiagnosed brain tumor caused a stroke. Her husband, Jason Torres, says doctors told him Susan's brain functions have stopped, but decided to keep his wife on life support even after doctors at Virginia Hospital Center determined that she would not recover. The baby Susan Torres was carrying when she had her stroke appears to be thriving after nearly 21 weeks of gestation. Her husband says if she can stay alive another month, and the cancer stays away from her uterus, the baby could be delivered and have a chance of surviving. The couple has a 2 year old son.

Schiavo Autopsy

Bloomburg has the first report on the release today of the autopsy findings for Terri Schiavo. Her brain, it was reported, was

"profoundly atrophied'' and weighed half the size of a normal brain when she died on March 31, Medical Examiner Jon Thogmartin said during a press conference in Largo, Florida. No amount of therapy would have reversed her trauma, he said.

There is also a report that contrary to claims that she had been abused in some way by her husband, resulting in injury to her neck or back, there were "no signs of trauma or neck injury."

But as The Guardian and AP note, she was blind. The autopsy looked for but found no evidence of an eating disorder, interestingly.

As to whether the feeding tube was helping her, in terms of providing therapy akin to what a respirator would need to provide in order that it would be continued, there is again no ambiguity:

He said that after her feeding tube was removed, she would not have been able to eat or drink if she had been given food by mouth, as her parents requested.

``Removal of her feeding tube would have resulted in her death whether she was fed or hydrated by mouth or not,'' Thogmartin told reporters.

He went on to say that "The balance of the brain consisted of . . . scar tissue."

Attorney Felos said of the blindness:

"The public sees a picture and has an impression," he said. "But it's a hard fact . . . that Terri Schiavo was blind. She couldn't see her mother and obviously couldn't react to the sight of her mother."

UPDATE: Senator Frist has acknowledged that she was in PVS. Meaning the treatment was futile. He says that he only wanted to be certain of that. No word on what he thinks could possibly have been done to be more certain than everyone already was. But it is important that he didn't continue to maintain that she should have been kept afloat in PVS forever.

STILL MORE UPDATE: The family disputes the autopsy findings. And Michael Schiavo plans (perhaps illegally) to release some of the photos of the brain to the general public. The best news account to date of the post-mortem post-mortem is here.

iRobot

engadget, one of the blogs I read when I should be finishing that article about therapeutic misconception my lunch, reports on a new kind of threat from computers in healthcare settings: robots that attack patients.

nobody is quite sure what prompted poor, mild-mannered Waldo (who gives robots named like Waldo?) — a lowly medicine-delivering bot — to run amok and terrorize the cancer ward. Waldo apparently blazed past the pharmacy and blew into the radiation oncology examining room where a physician was treating a cancer patient — and wouldn’t leave (wouldn’t leave? Don’t these things have an off switch?). It was enough to prompt the patient to flee the room in terror. What could disturb a robot so deeply? Messy breakup with Emma the nursebot?

The American Journal of Bioethics
Special Issue: Neuroethics

Our special issues on neuroethics has been released online by Taylor and Francis and mails this week. The topic is ethics and the brain, and the collection is the best summer beach reading we could muster great, if we can be permitted some pride.

Led by a guest editorial from Alan Leshner, the target articles include "Imaging or imagining? A neuroethics challenge informed by genetics," with open peer commentary by Science editor Don Kennedy, Ben Wilfond and colleagues, Lynette Reed et al, Paul Ford, Ray DeVries, Jocelyn Downie, Chris Buford, Bartha Knoppers and others.

Paul Root Wolpe, our own, Kenneth Foster and Daniel Langleben author "Emerging neurotechnologies for lie-detection: promises and perils," an authoritative treatment of a set of issues surrounding forensic use of brain sciences. Open peer commentators include Hank Greely, Jon Moreno, Ronald Green, Ruth Fischback et al, Joe Fins, Tom Buller, Linda Glenn and others.

The authors of both target articles respond to their critics in (freely accessible) letters to us as well.

Other features in 5:2 include an In Focus piece on bulimia in the Terry Schiavo case, and reviews of Tim Murphy's new research ethics book and of Jerome Kassirer's attack on complicity with big business within medicine.

It is all available at bioethics.net.

Using Soldiers to Win the Stem Cell Debate: Don't

Those of us who support embryonic stem cell research often cringe when the claims in favor of that research are embellished. During the Presidential election, of course, that reached its apex with arguments by a number of folks including Sen. Kerry himself to the effect that Christopher Reeve might have been cured has stem cell research been funded sooner. Today, dozens of children and others who argue - like us - for stem cell research are held up as potential recipients of embryonic stem cell-derived therapy, as though the big worry is that they will not receive their embryo pills next year and will suffer as a result. You don't have to have a long memory to see how dangerous these views can be. Just think back to gene therapy, and the clamor of folks to enroll in early, non-therapeutic trials because of the perceived magic of anything genetic. The very idea of "gene therapy research" is an oxymoron, if you think about it, as was argued by Nancy King and others.

Well, in California the arguments in favor of stem cell research are often a big more, um, dramatic than other places, and as a consequence the infractions of the "do not promise therapies to subjects who will not be getting them yet" rule are more problematic. And it doesn't get worse than this one, by A Scientist In Irvine, who writes the San Francisco Chronicle to let us know that among the victims of unenlightened stem cell research are the soldiers in Iraq, who won't get their stem cell therapies and will die as a result. It isn't that the argument is wrong, and it certainly isn't that the argument isn't creative, it's that the argument is premature - and in some ways the point to make about stem cell research is that it will transform medicine entirely, including producing therapies that one day will not require the use of embryos, therapies that could never have been produced without the use of this research. Yes that will one day help soldiers. But the promulgation of this "get it now or else" thing just makes it easier for the opponents of stem cell research to paint stem cell researchers as over-eager salesmen of therapeutic misconception.

In the Spotlight: Robert Orr

Baptist Press isn't usually a place where you'd see a profile of a bioethics scholar, let alone one whose work is coherent and thoughtful work has included making difficult and subtle decisions with patients at the end of life. But Tammi Reed Ledbetter, on the scene at Criswell College in Dallas where the Southern Baptist Convention is holding a big bioethics shin dig this week, has interviewed Bob Orr, physician and long-time clinical ethics scholar.

Orr, who has taught at Loma Linda and U. Vermont, is a clinical ethicist - a bioethics person who does ethics consults and is well trained in that practice. He trained at McGill in medicine and U. Chicago in clinical ethics - and is now the clinical director of the Center for Bioethics and Human Dignity in Chicago and a board member of the anti-stem cell research group "Do No Harm." He is also one of the best known clinical ethicists in the history of that practice, and arguably one of the most skilled.

In the profile, Orr laments that

“Sadly, over time, the voice of the theologian has gotten weaker and weaker and less listened to as the baton was handed over -- first to philosophers. Then clinicians —- the physicians, nurses and social workers who deal with patients daily -- became involved and engaged.”

And he's also incredibly ecumenical, doubtless something Tammi Reed would have suppressed could she have spelled it:

“Under the shadow of forgiveness, difficult decisions are possible.”

Orr said he is distressed “when I see two Christians going at each other” instead of engaging in a discussion that leads to responsible action."

Among those in bioethics who are genuinely interested in the relationship of medicine and faith, Bob Orr is one of the most thoughtful, quietly working carefully on dozens of interesting projects. This isn't the ideal profile of Orr, but it made us think of him and his good work.

Scientists Behaving Badly

Some scientists may avoid studies they think are likely to cause ethical controversy, but one third of scientists say that they've engaged in at least one behavior that they believed would probably get them into trouble during the past three years. Coverage of this forthcoming Nature piece has already begun, and among the findings are these

Of the 10 practices that Martinson’s study described as the most serious, less than 2 percent of respondents admitted to falsifying data, plagiarism or ignoring major aspects of rules for conducting studies with human subjects. But nearly 8 percent said they’d circumvented what they judged to be minor aspects of such requirements. The survey questions didn’t name those specific points.

Nearly 13 percent of those who responded said they’d overlooked “others’ use of flawed data or questionable interpretation of data,” and nearly 16 percent said they had changed the design, methods or results of a study “in response to pressure from a funding source.”

This data is going to be very very powerful.
[thanks Sean]

Don't Worry About that Health Privacy Thing, Unless You Are One of the 50% of Americans Who Will Have Mental Illness

Most Will Be Mentally Ill at Some Point, leads the New York Times headline concerning a comprehensive study of mental health among a broad cross-section of Americans. The study will appear in the June issue of Archives of General Psychiatry. Depression, alcohol abuse and phobias led the list, and most of those studied had developed their problem(s) at a young age, particularly those with impulse-control and anxiety problems.

HIPPAA Gutted Again - the Sound and Fury of Patient Privacy Laws in the U.S.

From the Health Privacy Project:

Yesterday, the U.S. Department of Justice issued a ruling that significantly weakens the enforcement provisions of the HIPAA (Health Insurance Portability and Accountability Act) Privacy Rule (see R. Pear, New York Times, 6/7/05). Under the new ruling, only covered entities (such as hospitals, doctors, and health plans)and not necessarily their employeescan be held accountable and prosecuted for criminal penalties under the Privacy Rule. This is a disturbing reversal and a stunning contradiction to the first criminal conviction under the Privacy Rule, whereby an employee of a consortium of cancer hospitals admitted to wrongful disclosure of a patients personal health information. Outside of that one criminal conviction and despite more than 13,000 complaints, the Department of Health and Human Services (HHS) has never issued a penalty for violations of the HIPAA Privacy Rule. The complaint-driven enforcement process of the Privacy Rule is already inadequate, but this ruling dramatically weakens the impact of the law and significantly limits the recourse patients have when their health information is illegally accessed, used, or disclosed.

This ruling is particularly distressing as the Bush administration
continues to press for the development of a National Health Information
Network (NHIN)with HHS Secretary Leavitt yesterday announcing the
creation of a new advisory panel to set federal standards for a national
electronic medical record (EMR) system. On the heels of the Secretarys
announcement, the administrations ruling only continues to undermine the
force of the first federal law protecting individuals sensitive health
information. Given the administrations track record and the lack of any
real commitment to ensuring that Americans personal health information
will be protected, the Health Privacy Project (HPP) is seriously
concerned that consumer and privacy advocates will not be fully
represented on the advisory panel. The public is more concerned than ever
about the privacy of their most sensitive information, especially in
light of well-publicized privacy and security breaches at major financial
and marketing firms.

Our fundamental concern is that without a strong and enforceable federal
health privacy law, patients will continue to take steps to protect
themselves from discrimination and stigma by limiting what they tell
their doctors and avoiding health care. Such privacy-protective behavior
is likely to increase if the government presses for an electronic health
network that does not adequately safeguard the privacy and security of
peoples sensitive health information.

[thanks Darby Penney]

Let Them Smoke Tobacco

My new favorite law professor Alicia Ouellette summarizes the impact of yesterday's court decision,

which held that Congress has the power to outlaw medical marijuana, even in states that have made its use legal. The case is disturbing because it validates federal oversight of sensitive questions of medical decisionmaking , an area previously reserved to the individual States.

The decision does not bode well for supporters of Oregon's PAS law in the case initiated by John Ashcroft (and now carried on by Alberto Gonzalez), which will be before the Court next fall. The issues in the Oregon PAS case are not identical to the issues in the medical marijuana case, but both involve the reach of the same law (the federal Controlled Substances Act) and state power in medical decisionmaking. Six justices (including the 5 most liberal members of the court), have now interpreted the reach of the Federal government to be broad and superior to that of the States.

Justice O'Connor, who wrote in Quill that PAS is the kind of issue that should be decided by the States, not the federal government, dissented in yesterday's decision. She lamented that the decision allows federal encroachment where previously the law promoted "innovation by allowing for the possibility that 'a single courageous State may, if its citizens choose, serve as a laboratory; and try novel social and economic experiments.'" The Oregon PAS statute is clearly such an experiment. It may very well be at risk.

High Intelligence and Ashkenazi Genes

Of the new research indicating that there is a correlation between Ashkenazi genes found in that Jewish population and intelligence, many are asking whether or not it might be possible to enhance intelligence using whatever genetic advantage nature has given to Ashkenazi Jews. Jay Hughes writes to the bioethics chat line thusly:

Fortunately we will soon have far faster and more ethical ways of enhancing intelligence than persecuting people for several thousand years. But it would certainly be deliciously ironic if gentiles started upgrading themselves with Ashkenazim genes. An anti-Semite's nightmare.

Drugs and the Environment: Time for 'Phase 5' Trials?

Milwaukee Journal Sentinel's Susanne Quick pens a great story that really should be picked up more widely. She follows U. Wisconsin researchers who drop miniscule amounts of widely prescribed medicines - those known to pass right through the human body and, unaltered by waste water processing systems, right into the fresh water in nature. The effects, of dosing that is roughly the same as what is found in many fresh water environments, are scary:

They are investigating the effects of common drugs ... because they are designed to affect the biology of a living organism - to reduce headaches, control seizures or suppress coughs - [the] researchers think they could have an impact on fish and other wildlife.

Standing in her lab at the WATER Institute, an old tile warehouse on the banks of the Kinnickinnic River, Klaper reviewed the minnow experiment. She pointed to the fishes' gills, which were straining open and shut in a desperate attempt to filter oxygen in the deadly murk surrounding them.

"The water was cloudy by the time we got in the next morning," said Chris Rees, a research assistant, recalling the day after a lipid regulator was introduced into their tank.

But the milkiness wasn't from the drug itself, Klaper said. It was the physical manifestation of the stressed and dying fish - a cloudy stew of mucous and other piscine secretions.

It wasn't as if Klaper had heavily dosed the fish. She had diluted the drug to one part per billion, or the equivalent of a drop in a railroad tanker. That's a concentration that has been detected in waters from Europe to South America, and as close to home as Lake Ontario and the Detroit River ... "We're really just at the beginning" of understanding the effects of these drugs on wildlife, she said.

But if her drug-exposed fathead minnows are any indicator of the future, it's not looking good

[thanks S Faye]

Abuse by Terri Schiavo's Husband? What Abuse?

St. Petersburg Timesreports:

As the day approached in which Terri Schiavo's feeding tube was to be removed, Gov. Jeb Bush claimed there were new and compelling allegations of abuse or neglect that the state Department of Children and Families had to investigate. That effort led to a dramatic showdown between the governor and the Pinellas-Pasco circuit judge who ordered Schiavo's feeding tube removed on March 18. Bush and DCF continued to seek its reinsertion, claiming the 30 or so new complaints had to be probed. But documents released by DCF Friday reveal few fresh allegations that Schiavo was abused or neglected. Investigators wrote that there were "no indicators" of abuse in any of the cases. "The preponderance of the evidence shows that Michael Schiavo followed doctors' orders (regarding) Ms. Schiavo's diagnosis of being in a persistent vegetative state and that he provided her with appropriate care," one investigator wrote.

DCF released nearly 70 pages of documents Friday in the Schiavo case after the St. Petersburg Times sought their release in court. Perhaps the only allegation in the batch not heard before: A March 7 complaint that accused a nursing assistant at Schiavo's Pinellas Park hospice of using an "air freshener substance" in her bath water in July, which caused a rash. DCF investigators learned the substance was an aromatherapy oil that the assistant placed in a spray bottle, not in Schiavo's bath.

Another complaint, made on March 8, said Schiavo was moaning because she was in pain from recent dental work. But other complaints allege that Schiavo received no dental work for years. Some people called to complain that the blinds in Schiavo's room weren't open wide enough.

Others just repeated allegations that had been made for years: That Schiavo's husband, Michael, abused her. That he didn't seek rehabilitation for her. That he failed to properly care for her. Pinellas-Pasco Circuit Judge George Greer, who ordered Schiavo's feeding tube removed, had previously found no credibility in those accusations either. Greer issued an order Thursday requiring DCF to release the latest records by Monday.

-Art Caplan

Um, Dave, What Was That About "Adult Stem Cells Made Her Walk Again?"

Wired News has an extraordinary allegation by

a spinal-cord patient [who] has charged that Rep. Dave Weldon (R-Florida) used her image without permission and misled Congress and the public by suggesting that her case offers evidence that adult stem cells can help severely injured people walk again.

Susan Fajt, who suffered a spinal-cord injury in a car accident in November 2001 that left her with little sensation from her chest down, e-mailed Weldon, who is also a physician, on Wednesday detailing her complaints and requesting an apology.

On May 24, as Weldon tried to persuade members of the House of Representatives that embryonic stem-cell research was not only unethical but unnecessary, he held up a poster-size image of himself standing beside Fajt, who is clutching a walker in the photo.

Topol Refutes Ethics Charge, Sort of

Seattle Times follows the interesting twist on the story of Cleveland Clinic's top doc Eric Topol. Topol was accused, more or less, of conflict of interest in December, as we noted in this blog on the 5th of that month. Specifically, it was alleged that he advised a hedge fund (for a fee) about concerns about a drug in which it invested, and about which he had written.

As a result of the allegations, Topol was, it is fair to say, lambasted in the media as an example of docs being bought out by investment firms and pharma.

Topol's reaction? Well according to the Seattle times story, Topol promptly published on the matter - but not defending himself. Instead, he did a quick study that showed how frequent the behavior has become. Hmm. Everybody's doing it.

Lawmakers Give Stem Cell Research a Push

WaPo today covered the efforts of Connecticut and Massachusetts to put money, power and state sanction on the table to retain and grow stem cell research in those states. $10 million per year for Connecticut is awaiting a signature from an eager Governor M. Jodi Rell, who has promised to sign.

The Massachusetts legislature has stomped on Governor Mitt Romney's veto of the bill there, which will now give the state health regulatory officials the power to control research in Massachusetts. Frankly I cannot figure out how the Massachusetts legislation works, but apparently it will at least prevent overzealous district attorneys from preventing embryonic stem cell research with their own independent interpretation of what counts as a violation of the law there against destruction of embryos.

The big news is Connecticut's effort, reviewed here by The Scientist.

Dutch Euthanasia of Severely Ill Newborns

This week's New England Journal carries a very well researched attack on the increasingly prominent practice in Holand of euthanasia involving newborns whose prognosis is grim.
[thanks Bob Baker; subscription required]

Language Matters

Even the archconservative Dallas Morning News can't resist mocking Washington ethicist-in-chief Tom DeLay's use of the phrase "dismemberment of embryos" to describe stem cell research. The paper went looking for debate about whether or not DeLay was in some sense justified for describing stem cell research as a deliberate torture and slaughter of little people. But what's to discuss? Nobody could defend the choice of "dismemberment" as a metaphor to describe embryonic stem cell research, right? Well, there is one guy who will. Just when I was ready to believe he might not be completely without shame,

William Hurlbut, a Stanford University bioethicist who sits on the President's Council on Bioethics, defended Mr. DeLay's description. 'The point he is trying to get at is conceptually correct. He is trying to make vivid the realization that even though they are very tiny, they are integrated organisms, not 'inchoate clumps of cells' as some scientists have misleadingly said,' Dr. Hurlbut said. ... 'the truth is that even though it is very tiny, the blastocyst-stage embryo from which ES [embryonic stem] cells are harvested does have distinct parts. To disaggregate it to get the ES cells is to pull apart a human body in its incipient but unfolding form.'

Yes, Bill, I'm sure Rep. DeLay worked hard dumbing down his sophisticated sense of embryonic dismemberment, and was only "trying to make vivid the realization that even though they are very tiny, they are integrated organisms, not 'inchoate clumps of cells.'" Just checking, but did DeLay work on his position about "inchoate clumps of cells" while he was riding in some corporate jet? Or maybe it was while he was up late at night worrying about Terry Schiavo? I'll give you $50,000 if you can find a single instance of Tom DeLay using the word inchoate in a sentence. Though I am sure that he has given the deepest of thought to stem cell research. Ethics are on his mind.

Lakoff's fellow linguist Deborah Tannen has another interesting interpretation of the rationale for DeLay's comment, one not hatched (like Hurlbut's) on the moon:

Deborah Tannen, a Georgetown University linguistics professor, said that by using the word dismemberment, Mr. DeLay and others opposed to embryonic stem cell research are trying to associate it with the controversial late-term abortion, which critics also refer to as "partial-birth" abortion.

"That was such a successful campaign because it gave the impression that they were dismembering a child," Dr. Tannen said. "They are trying to create an association with babies, and they want to push it back earlier and earlier. I guess stem cells would be the extreme of that, but they're just cells. In order to dismember something, it has to have limbs, and cells don't have limbs."

So, oddly, the question of language has become front burner in the stem cell debate. New York Times science writer Gina Kolata, for example, points out that the uses and abuses of the terms 'cloning' and 'embryo' in particular have become very important to the debate over stem cells - with both sides arguing that their description of the term is based on science and the other's based on politics, religion or some other such superstition:

... cloning opponents are disturbed by the way stem cell scientists these days almost always speak of "somatic cell nuclear transfer" rather than "cloning." "The most important thing to be said is that the language is changing and it seems to have an agenda behind it to make things more acceptable," said Dr. John Kilner, the president for the Center for Bioethics and Human Dignity, which opposes cloning and destroying human embryos to extract their stem cells.

"I'm concerned," he added. "People ought to debate the scientific issues on the merits."

Ah yes, the merits.

The truth is that the abuses of the language game are in fact on both sides. I'm not sure that it could ever have seemed truly reasonable to describe the product of a procreative process as a "clump of cells;" the language is truly loaded and deliberately uses science to confuse the listener. However, the abuses of science by proponents of stem cell research pale by comparison to the abuses of the right wing, including many who use their pretentious language to obscure the fact that they have no idea whatsoever what they are talking about:

Dr. Leon Kass, the [President's Commission on Bioethics'] chairman, argued last week that the South Koreans' feat should not be disguised by jargon.

"The initial product of their cloning technique is without doubt a living cloned human embryo, the functional equivalent of a fertilized egg," Dr. Kass wrote in an e-mail message.

"If we are properly to evaluate the ethics of this research and where it might lead," he continued, "we must call things by their right names and not disguise what is going on with euphemism or misleading nomenclature."

The silky language doesn't disguise a simple claim: the product of reproductive nuclear transfer is "without doubt a living cloned human embryo, the functional equivalent of a fertilized egg." Find me one stem cell researcher, indeed one embryologist, who would agree that "without a doubt" that is true. Having studied embryologists' perceptions of stem cell research, I can tell you there's no such person out there. Find me a scientist who will speak of the "functional equivalent" of an embryo. Get started now, though, because no scientist has used the language of function in basic biology in 50 years, and because nobody - and I mean nobody - in science would argue that embryos have a clearly defined "function." What would the function of a fertilized embryo be? To develop into a baby. The Korean cells can't.

Both sides of the stem cell debate want to control language - but neither can really claim to have accessed facts or even "scientific reality." In this debate, the politics - resulting in socially accepted language - really will determine the science.
[updated 6/1]