blog.bioethics.net

Sporula on Organ Donation

Ina's blog comments on a case of transplantation:

Well, I used to make up a case like this one about Kaiser transplant surgeons to get students to think carefully about the consequences of various facets of our organ donation system and alternatives (e.g. paying donors, etc). People (see for example Art Caplan’s position have often suggested that our current system (donation rather than payment) would prevent people from pushing friends/relatives/patients over the “brain-dead” boundary, but I’ve never been convinced, and now, here’s potential proof.

I have to say that I always assumed these cases would be found in developing countries and specifically that subset of developing countries where medicine isn’t well-regulated. It just goes to show you huh? (Insert Annie Oakley singing “anything you can do I can do bettttteeeeerrrrrr!”). Of course, I don’t want to prejudge this particular doc, but I have to say I doubt that this is the first time a U.S. transplant surgeon’s pushed things a little - just the first time that someone might have gotten caught…

For more of Ina's Sporula, whatever that is Ina, because it is interesting stuff, go here.

Labels: Sporula, transplantation

HPV Fights - Once Again, the States Decide!

It ain’t over, said Yogi Berra, until it’s over, and the debate over what to do about Gardasil, the vaccine developed by Merck against the strands of the human papilloma virus (HPV) that cause cervical cancer. is still raging hot and heavy in many states. While the vaccine has been recommended for routine use by the CDC’s vaccine advisory committee and a number of professional groups such as the American Cancer Society and the American Academy of Pediatrics, the question of whether states should mandate the vaccine for school girls has been more controversial. Only one state—Texas—has formally mandated the vaccine to date, but over 30 states are reportedly considering some form of mandate.

As frequently happens in politics, the debate over mandating has in many places been about things other than the merits of the vaccine. HPV’s are sexually transmitted, and many conservative groups have complained that mandating the vaccine will encourage sexual activity and promiscuity. Other groups have complained about the intensity of Merck’s campaign to sell the mandate. The company has mounted strong lobbying campaigns in favor of a mandate in a number of states and has financed a major cervical cancer awareness and pro-mandate initiative by Women in Government, a advocacy group of women state legislators. Merck is charging $360 for the three shot vaccine regimen, and there have been charges that the company is trying to secure market share before a competitive vaccine being brought out by GlaxoSmithKline hits the market later this year, which will almost certainly cause the price to come down. The backlash against these activities has been so severe that Merck has announced it is terminating its lobbying efforts.

All this political flap seems unfortunately likely to divert attention from the vaccine’s merits, which seem considerable. Cervical cancer is not the problem in this country than it is elsewhere, because most women get regular PAP smears, but there are some 10,000 new cases a year and over 3,500 fatalities. The CDC’s most recent prevelance estimates (published in this week’s JAMA) for HPV infection detected the two strands of the virus that cause cervical cancer in over two percent of the women in the United States, with an additional 10 percent or so being infected with other “high risk” forms of the virus. Gardasil also vaccinates against two “low risk” HPV’s which are associated with genital warts and other low level cervical changes. Overall, HPV infection and cervical cancer are most common among low income women who may have trouble accessing or affording regular PAP smears. In clinical trials, Gardasil demonstrated close to 100 percent efficacy in preventing the precursors of cervical cancer, and side effects appear infrequent and mild.

The case for mandating is weaker, but still reasonable. Typically vaccine mandates take a longer time to roll out after there has been more experience with the vaccine in the general population and side effects or other problems have had time to emerge. The professional groups that have endorsed the vaccine have typically not taken a position on mandating. The vaccine is currently very expensive, but the price may come down once the competing vaccine hits the market. Federal vaccination support programs typically cover younger children, but not the teenagers and young women who are also major targets for a vaccination effort, so insuring adequate access remains an issue. Absent a mandate, access to the vaccine will remain limited to those who know about it and can afford it, which are not those groups at greatest risk who need the vaccine the most. Past mandates do appear to have been relatively successful in expanding vaccination rates and equalizing access to vaccines, but additional funding would be required. Medicaid and CHIP are obvious possible funding sources for girls under 18.

What seems likely to happen is that different states will do different things—some states will mandate with a variety of different conditions and some will not, and there will be significant disparities across the states in who does and doesn’t have access to the vaccine. I know we’re getting boring about this, but what happens in state capitals is more important than what’s happened in Washington.

Jim Fossett
AMBI/Rockefeller Institute
Federalism and Bioethics Initiative

Labels: hpv vaccine, state bioethics

The Definitive List of Undergraduate Internships in Bioethics Around the Nation

For years students have wondered where they could study bioethics for the summer. If I had a nickel for every time a college student asked me where she could go to do some summer research in the field, I'd have a lot of nickels, or whatever the expression is. Well, Paul Root Wolpe changed all that with his new survey of undergraduate summer internship programs in bioethics for undergraduates, which you can download here as a PDF.

Labels: ethics education, internships, undergraduate bioethics

In Retrospect: What the Media Did Wrong in Covering Ashley X

She is the 9 year-old who will "never grow up," and Art Caplan does an excellent job for the Poynter Institute in pointing out what the media can do to cover stories like this better - and what went wrong in this social debate that the media could have fixed. It's a great interview with lots of links - definitive if you are searcing for the comprehensive source of coverage of Ashley X's case.

Labels: Art Caplan, Ashley X, Poynter Institute

Ten Years Since Dolly...

Art Caplan writes in MSNBC:

Ten years ago today, the birth of the first cloned mammal - a sweet-faced sheep named Dolly - was announced to the world. Her creators, a team of veterinary scientists at Scotland's Roslin Institute, approached their landmark scientific achievement with a sense of humor: They named the lamb after Dolly Parton. (The DNA they used to clone her came from a breast cell.) Much of the rest of the world, however, was not amused.

Dolly's creation set off a storm of fear, confusion, misunderstanding, pandering and double-talk that culminated in the greatest fraud ever perpetrated in the history of biomedicine - the false claim that a South Korean scientist had cloned human embryos and made stem cells from them.

Dolly's creators were so giddy because they had demonstrated it was possible to reactivate all the genes in a cell taken from an adult mammal. They made a grown-up cell act like a kid again.

At the time, almost no scientist thought cloning was possible from the DNA of adult animals. Cloning had already been accomplished in tadpoles and by using embryonic cells, but science dogma held that once a cell had grown up and become specialized - by turning into a skin cell, a hair follicle or a breast cell, for instance - its DNA was through. There was no way to get that DNA to switch on again and act like an embryo.

What intrigued scientists about Dolly had little to do with what captivated the rest of humanity. The main preoccupation of religious, philosophical and social commentators 10 years ago was how rapidly Dolly would be followed by the creation of a human clone who would destroy the world.

So, where are these clone armies?

In the weeks following Dolly's announcement, mainstream media reports were full of irresponsible speculations by all sorts of experts and "authorities" on what Dolly's birth meant for you and me.

Some worried that cloning would lead fiendish dictators to create armies of clones bred for war. Others fussed that the rich and egomaniacal would seek to create clones of themselves so they could live forever. Still others warned that clones would serve as mobile spare-parts farms. Need a liver or a kidney? Just carve out your clone's and off you go, good as new. And what about cloners resurrecting the dead from bits of DNA found at museums, graveyards and churches?

All this nutty speculation led to a worldwide panic about biological engineering as seen before only in Hollywood films from the 1950s such as "Invasion of the Body Snatchers" and "Attack of the 50 Foot Woman." Presidents, popes and potentates across the globe went bonkers warning us against human cloning. Laws forbidding human cloning - which were premature at best, since the chances of producing a human clone hard on the heels of Dolly's birth were, as I tried to point out at the time, next to nothing - were proposed left and right.

Then it got truly scary. Because that's when the cavalcade of cloning kooks came out.

Bring in the clowns

The parade was led by the felicitously named Richard Seed, a physicist who announced in December 1997 that he intended to clone the first human being. Anchors and talking heads everywhere granted Seed a worldwide platform to babble on about his plan to use cloning to bring humans closer to God.
Seed was soon followed in his "I will clone and you cannot stop me" mania by Kentucky fertility expert Panayiotis Zavos and maverick Italian fertility doctor Severino Antinori, best known for helping a 62-year-old woman become pregnant. For a time these two teamed up and proposed setting up a cloning operation on a boat in international waters.

These characters did their best to convince the world that they held the bottle in which the genie of cloning resided. The media and politicians lapped it up. But this gaggle of kooks paled in comparison to the arrival of the group forever linked in the minds of the world with human cloning: the Raelians.

The Raelians, a religious cult that believes extraterrestrials used genetic engineering to create life on Earth, secured a worldwide audience with their cloning threats.

In 2002, Dr. Brigitte Boisselier, a college chemistry professor, Raelian bishop and CEO of the sci-fi start-up Clonaid, along with Rael, the founder of the Raelians and a former French pop singer and race-car aficianado, announced to an aghast world press that Clonaid had successfully cloned a human being. Boisselier said that the mother delivered by Caesarean section somewhere outside the United States, and declared that both the mother and the little girl, Eve, were healthy.

Despite loads of fanfare and claims of a slew of additional clones, no DNA proof was ever offered up.

Why anyone would think that a chemist with a bad hair-dye job and a cult leader parading around in a Starfleet uniform had the scientific know-how and skills required for human cloning was not apparent. However, these two took over the airwaves for weeks. They also appeared as witnesses testifying about cloning in the U.S. Congress and before the National Academy of Sciences!

A perfect storm of nutty professors, kooky cultists and shameless self-promoters used the media to get their screwball message out: Human cloning was not only possible, it had been done and the frightening power of cloning resided perilously in the craziest hands on the planet.

Mainstream madness

Things were not going all that much better in mainstream science. The scientists who created Dolly got into a nasty dispute over who deserved credit for her creation.

Dolly herself got sick, was euthanized and wound up stuffed for a display at a museum in Scotland in 2003. Scientists worldwide managed to clone other species including mice, goats, pigs, cattle and rabbits but at a terrible price in terms of stillborn, sick and deformed animals.

But the biggest blow - to scientific integrity - was still to come.
Scientists quickly recognized that cloning might be a useful way to take advantage of the embryonic stem cell discovered shortly after Dolly's birth, but with much less fanfare. Cloned embryos made from adult human cells might hold the key to technology capable of replacing worn-out or damaged human cells.

The drive to be the first to show that cloning human embryos was possible led to dubious announcements by a few scientists that they had made cloned embryos. The cloning race culminated in the whopping lie told to the world by South Korea's Hwang Woo-suk. In a fabricated paper published in May 2005 in the prestigious journal Science, he claimed to have cloned many human embryos and extracted stem cells from them.

Those who hated the prospect of any form of cloning - animal or human - and those who were morally horrified by the prospect of human embryonic stem cell research, including President Bush, Sen. Sam Brownback, R-Kan., Rep. Dave Weldon, R-Fla., and Rep. Ron Paul, R-Texas, among others, proposed bills that would stop the strategy of "clone and kill." The tactics, incredibly, worked.

Public funding for embryonic stem cell research foundered on the legacy of fear built by nuts, the media, scientists bickering amongst themselves, fabricators and politicians who played the cloning card again and again.

So where does this dismal history leave cloning today?

Animal cloning has proven incredibly difficult. There are noises being made about introducing meat or milk from cloned animals into the food supply, but the economic practicality of that happening given how hard and expensive it is to clone animals makes this all talk. The huge risk of creating a dead or deformed baby has put all talk of human cloning firmly on the back burner. The fact that there still has been no successful cloning of a primate using Dolly-style techniques shows just how hard - or maybe, impossible - human cloning is.

Cloning for research is still of interest to scientists around the world, but no one has been able to make it work reliably.

The place where cloning continues to thrive is in Hollywood, TV and science fiction. There, clones are still mined for body parts, mad scientists can still gin up a possessed clone kid and evil dictators still create their clone armies to conquer the galaxy.

Ten years after the announcement of Dolly's creation, cloning is a subject that still scares most of us when all it really is is a new, very difficult, very inefficient and very tricky way to make a lamb.

Labels: Brigitte Boisselier, Brownback, Dolly, embryonic stem cell research, human cloning, Hwang, Ian Wilmut, Raelians, Richard Seed, South Korea

Promoting Male Circumcision for Hindus

This blog has dealt with ethical questions about male circumcision and HIV before, but somehow the assumption crept in that this is a distinctively African controversy. Maybe it was because of the high HIV prevalence in that part of the world. Maybe its was because of the longstanding interest -- especially among anthropologists -- with circumcision rituals in Africa. Let us make a confession here: the author of this post has co-authored an article in the Journal of Medical Ethics called Male Circumcision and HIV Infection: Ethical, Medical and Public Health Tradeoffs in Low-Income Countries. And it too is guilty of identifying the issue a bit too much with sub-Saharan Africa.

Whatever way this came about, the ethical questions concerning the promotion of male circumcision to lower risk of HIV transmission have to embrace India. For one thing, the number of new HIV infections has rising in India dramatically over the last years. For another thing, male circumcision is a highly charged matter, both politically and religiously, when Hindus do not traditionally circumcise and Muslims do.

An article in the Times of India today gives an indication of just how sensitive the question is. The National AIDS Control program in India will not even think of conducting randomized controlled trial to test whether being circumcised lowers a man's risk of getting HIV infected: not because three such studies have been done before, but the whole idea seems too hot to handle. When Richard Feachem, Director of the Global Fund to Fight AIDS, Tuberculosis and Malaria, said that he expected that Hindus would increasingly have more HIV infections because their men do not get circumcised, his inbox was inundated by hate mail. The issue is inseparable from the larger relationship between mainly Hindu India and its Muslim neighbor and rival, Pakistan. The foreskin has geopolitical significance.

The question is: when circumcision acts as a religious/cultural marker from neighboring groups, will men still agree to do it, to reduce their chances of getting HIV? A World Health Organization/UNAIDS meeting in Switzerland on March 6 is set to tackle these tradeoffs between cultural identity and public health, among others. When HIV infections globally are increasing, vaccines are probably at least 10 years away, and the once-promising microbicides are crashing and burning, the ancient practice of male circumcision is strangely enough carrying the torch in the fight against HIV/AIDS.
-Stuart Rennie

Labels: circumcision, Haiti, HIV, Journal of Medical Ethics

Pope Speaks Against the Perfect Baby

Ok I'm no big fan of preposterous notions of The Perfect Baby, but I've got nothing on the hardball position that we and lots of others predicted would come out of the Vatican once this Pope was named. MSNBC/Reuters reports that he is on the warpath where reprotech is concerned:

ROME - Pope Benedict XVI on Saturday condemned genetic engineering and other scientific practices that allow people to select so-called “designer babies” by screening them for defects.

In a speech to the Pontifical Academy for Life, a Church body of experts, the Pope also attacked artificial insemination and the widespread use of medical tests that can detect diseases and inherited disorders in embryos.

“In developed countries, there is a growing interest for the most sophisticated biotechnological research to introduce subtle and extensive eugenics methods in the obsessive search for the ‘perfect child’,” the Pope said.

Clearly no one has apprised the Pope that the critical bioethics issue these days is the fate of the body and child of Anna Nicole Smith, which has turned MSNBC into a 24/7 soap opera. But thank goodness he's protecting us from reproductive technology even in this time of crisis.
[hat tip: Art Caplan]

Labels: anna nicole smith, artificial insemination, perfect baby, pre-implantation genetic diagnosis, the Pope

South Carolina Reverts to its Earlier, Medieval Approach to Drugs and Pregnancy

From AP [and that handy Google cache] via Art Caplan:

AIKEN - A 24-year-old Bath woman pleaded guilty in Aiken County Court recently to using cocaine while pregnant. That is not unusual, but her sentence was: She has to go on birth control. Julie Ann Horton became the first woman in Aiken County ordered to take birth control as part of a plea deal, a stipulation she agreed to so she could avoid jail time. She might not be the last.

Solicitor Barbara Morgan said her office is planning to offer plea deals to drug-addicted women that include birth control requirements, a decision that is being criticized as infringing on a woman's reproductive rights.

"That's like playing God when all you are is a judge," said Charleston attorney Susan Dunn, who has represented women charged with using drugs while pregnant.

However, Ms. Morgan said the new effort is about getting help for a woman's drug problem that has already resulted in her giving birth to a baby who tested positive for those illegal narcotics. It's not about sterilization, she said; the birth control is temporary and as of now, a voluntary part of plea deals.

An expectant mother who is using drugs cannot make the appropriate decisions for the health of her unborn child, she argued.

"Given a choice between drugs and a baby, the drugs always trump," Ms. Morgan said.

In South Carolina, women who deliver drug-positive babies are charged with unlawful conduct by a legal custodian, a felony punishable by up to 10 years in prison.

Ms. Morgan said her office has prosecuted women who have had multiple babies test positive for drugs when they're born, and she predicts many women would agree to go on birth control if offered it as part of a plea deal.

Labels: drug addiction, mary faith marshall, pregnancy, south carolina

Denied Tenure, African-American MIT Stem Cell Researcher Starts a Hunger Strike

Boston Globe reports on the highly unusual strategy of Professor James Sherley, one of only 28 black faculty at MIT at the time of his tenure decision, whose denial of tenure seems irreversible. He opposes (quite prominently) embryonic stem cell research.

Labels: adult stem cell research, hunger strike, James Sherley, MIT, tenure

Art Caplan on the New PHRMA Statement on Gifts: Nonsense on Stilts

The movement, begun at Penn, to restrict access to sales representatives and gift-giving behavior on academic health center campuses and facilities has triggered a surprising response from PHARMA. Basically they are arguing that a well-trained sales force has a key role to play in educating physicians about drugs and devices and that sometimes this can and should involve free meals.

I disagree. Sales reps do not have the background or the training to provide sound advice to physicians. They have a background in marketing and selling products--the science of which I would doubt they understand in any real way. I am surprised to see this unconvincing rationale come forward and hope that it will be a tiny speed bump in the effort to minimize the influence of marketing and sales people at academic medical centers, hospitals, and doctor's offices.
- Art Caplan

Labels: Conflict of Interest, marketing, medical schools, PHRMA

The ASRM - cough - I Mean HFEA Set to Enact Payment-for-Eggs Plan in Britain

The Observer in London points to a shocking move by the HFEA to increase the supply of eggs for embryonic stem cell research, following on the suggestions of the initial report by the new stem cell research association ISSCR:

Women who go through the medical procedure to harvest the eggs from their ovaries, which doctors describe as 'invasive' and possibly dangerous, will be paid 250 Pounds plus travel expenses, the existing maximum compensation for any egg or sperm donor. Anyone agreeing to donate will have to show that they are acting for altruistic reasons, for example because they have a close relative suffering with one of the conditions scientists are trying to develop new treatments for with the aid of human eggs.

What a fabulous decision, in light of the fact that HFEA was the last governmental organization to hold out for conservative policies with regard to this matter, against such outliers as the South Korean Hwang group, where payment for egg donation worked out so well that it resulted in the obvious oppression of women, including the most obvious donors - those who work in labs that need eggs.

Thankfully there were ethicists in the Hwang lab. Not so thankfully, they published a report claiming beyond a shadow of a doubt, on the basis of their very close observation of the egg donation process, that the Hwang group was doing a fabulous job, and that no coercion occurred, only to later back up a little bit, then retract their claim. Even less thankfully, the loudest claim to date by an ethicist to the effect that payment for eggs is a great idea is the same author of that article, whose observations led him to conclude that he was - quoting here - 100% certain of the ethical propriety of the Hwang group's procurement group. The group - remember them - that coerced at least one team member to donate eggs because she knocked a petri dish containing eggs onto the lab floor. Obviously it was a popular view among the ISCRR crowd who lack funding for stem cell research or a good supply of eggs - but a shortsighted view to say the least, and informed by zero research - except for that lovely article retracted from AJOB.

There are those who have suggested that perhaps there might be problems with payment:

There were also warnings last night that poor women could be tempted or coerced into taking part for the money. 'The HFEA could be unwittingly opening the door to barter or sale of eggs, including women in Britain as well as abroad, even though it is saying that women doing this would do so for purely altruistic reasons,' said Donna Dickenson, emeritus professor of medical ethics and humanities at the University of London and one of Britain's leading experts on the issue.

'The sum of £250 would still be enough of an inducement for women from eastern Europe, for example, to come to Britain to sell their eggs. That's clearly turning eggs into an object of trade and that's disturbing. Once the principle of egg donation for research is established, it will become harder to prohibit paid egg donation.'

But at the end of the day, HFEA will ignore the several leading stem cell researchers who begged it to reconsider on moral grounds despite the scientists support for embryonic stem cell research:

The HFEA, chaired by Shirley Harrison, is set to approve the policy despite a host of leading scientists voicing a range of concerns during the consultation process.

Some argued that the putative benefits of stem cell research had been exaggerated, while others highlighted the medical dangers to women who undergo the painful and invasive three-stage process to remove the eggs.

So a stunning move by Britain into the wild wild west of egg donation, and without data or careful regulations or a provision to re-examine the policy in short order on the basis of the experiences of women and clinics. At least it is stunning to me based on the work of our research group concerning the disposition of the Brits toward this sort of issue. To say nothing of the outstanding work by AAAS commissions chaired by among others Jonathan Moreno and Alta Charo, which counseled quite clearly of the issues here.

Labels: Britain, egg donation, embryonic stem cell research, HFEA

Bush: "[Electronic Health Records Must Be] Secure & Private
(Except When They Aren't)

The Times warns that Bush administration policy of promoting and supporting electronic health records - promoted by the President under the aegis of preventing mistakes, reducing costs and improving care - is not backed up by the privacy protections the President promised. The times refers to the GAO report which makes this claim:

In the report, the Government Accountability Office, an investigative arm of Congress, said the administration had a jumble of studies and vague policy statements but no overall strategy to ensure that privacy protections would be built into computer networks linking insurers, doctors, hospitals and other health care providers.

... the G.A.O. said the administration had taken only rudimentary steps to safeguard sensitive personal data that would be exchanged over the network.

Senator Daniel K. Akaka, Democrat of Hawaii, who requested the investigation, said it showed that “the Bush administration is not doing enough to protect the privacy of confidential health information.” As a result, Mr. Akaka said, “more and more companies, health care providers and carriers are moving forward with health information technology without the necessary protections.”

... Mark A. Rothstein, the chairman of a panel that advises the government on health information policy, essentially agreed with the accountability office. “Health privacy has not received adequate attention at the Department of Health and Human Services,” said Mr. Rothstein, a professor of law and medical ethics at the University of Louisville School of Medicine. “A sense of urgency is lacking.”

Mr. Rothstein said “time is of the essence” because “the private sector is racing ahead” to establish medical record banks and health information exchanges. In December, he noted, Wal-Mart, Intel and other companies announced they were creating a huge database that could store the personal health records of more than 2.5 million employees and retirees. The companies promised they would have “stringent privacy policies and procedures.”

Mr. Rothstein said Congress should not provide more money for a nationwide health information network unless the administration did more to protect the privacy of electronic medical records.

Perhaps medical privacy protections are unnecessary, because after all we are protected by the Patriot Act. That helps ensure privacy, yes?

Labels: Bush, electronic health records, privacy advocates

Pharmacy Says Happy Valentine's, Have Some Viagra

Valentine's Day. Hearts, candy, chocolates, roses; if your car isn't buried under a snowdrift somewhere in the Northeast, maybe a nice dinner out or a movie. It can get costly. And in Britain, as of the 14th of February, men can add another USD100 to the total Valentine's price: the cost of a pharmacist provided pack of Viagra.

That's right, a British pharmacy chain has decided to sell small samples of Viagra over-the-counter. If you're between 30 and 65, male, and are willing to sit through an hour long consultation with the pharmacist, take a blood pressure, glucose, and cholesterol test, you too can buy four pills of Viagra.

The theory behind all of this, launched on Britain's National Impotence Day (a shared date with Valentine's), is that some men are just too shy to talk to their doctor about erectile dysfunction, and so are suffering in silence. This may very well be the case - but is an hour long visit with a pharmacist going to be easier than a doctor's visit? Is it going to be so easy that it suddenly makes going to the doctor a walk in the park? (If you decide you like the effects of the Viagra, you've to see a physician for a 'script.) For that matter, should pharmacists even be prescribing medications?

And does anyone else marvel at the fact that for USD100, you can have an hour of a pharmacist's time, several tests on your health done, and a mini-prescription filled? It's more time than most people ever spend with their physician, for a lot less money!

Woops: Another quick search of the news sites before posting shows that it really was just a big marketing push. The pharmacy isn't actually offering the OTC pills 'til Monday, and you have to schedule your appointment in advance. Sort of takes the spontaneity out of that one...
-Kelly Hills

Labels: Britain, erectile dysfunction, Valentine's, Viagra

More State Bioethics: HPV Vaccine Proposals Snowball

Kaiser Network really lays it out: states matter at least as much as what feds do—even in red states…and the HPV situation proves it.
- Jim Fossett

Labels: hpv vaccine, state bioethics, women and bioethics

Scaring Off Science: Missouri Anti-Stem Cell Research Crowd Takes a Page from the New Jersey Playbook and Tries to Kill Construction

Although they don't mention it, Jonathan Moreno and Sam Berger are ripping on New Jersey pro-life tactics as well as those in the Show Me State. This in their new web piece about Missouri on the CAP site, a nice review of the problems in that state, and a clear indication that people are taking seriously the importance of moving from federal to state examination of bioethics problems.
hat tip: Art Caplan

Labels: Center for American Progress, embryonic stem cell research, state bioethics

Owning Ancestry: DNA Commerce

Kathy Hudson's Genetics and Public Policy Institute has really got something with this one: a conference to bring public attentiont to the real issues associated with commerce in human DNA, understood in a rich way with attention to the problems that anthropologists, including Sandra Soo-Jin Lee, one of my favorite rising scholars, have identified. The event is at the National Press Club, and you can register online.

Labels: anthropology, commercializing DNA, GPPI, ownership of body, Sandra Lee

"My Father Was an Anonymous Sperm Donor"

I had completely forgotten that Jon Merz shared this all-too-predictable but very poignant story with me in December. It is the story of the future of sperm donation: lots and lots and lots of kids out looking for the guys who were told "here's some cash for your sperm and don't worry, the kids will never know who you are." The guys, in other words, who are their biological parents. It is a story in the Washington Post that contains quite a rant, amounting to this:

When she was 32, my mother -- single, and worried that she might never marry and have a family -- allowed a doctor wearing rubber gloves to inject a syringe of sperm from an unknown man into her uterus so that she could have a baby. I am the result: a donor-conceived child.

And for a while, I was pretty angry about it.

I was angry at the idea that where donor conception is concerned, everyone focuses on the "parents" -- the adults who can make choices about their own lives. The recipient gets sympathy for wanting to have a child. The donor gets a guarantee of anonymity and absolution from any responsibility for the offspring of his "donation." As long as these adults are happy, then donor conception is a success, right?

Not so. The children born of these transactions are people, too. Those of us in the first documented generation of donor babies -- conceived in the late 1980s and early '90s, when sperm banks became more common and donor insemination began to flourish -- are coming of age, and we have something to say.

I'm here to tell you that emotionally, many of us are not keeping up. We didn't ask to be born into this situation, with its limitations and confusion. It's hypocritical of parents and medical professionals to assume that biological roots won't matter to the "products" of the cryobanks' service, when the longing for a biological relationship is what brings customers to the banks in the first place.

We offspring are recognizing the right that was stripped from us at birth -- the right to know who both our parents are.

And we're ready to reclaim it.

I grow tired of saying that we told you so, but we did. Now let's get this straight: any clinic that provides donor insemination without insisting that in order to be candidates for the procedure, prospective parents promise to tell their offspring about the donation, is engaging in malpractice. Period. Wake up, ASRM. These kids are not kidding.

Labels: adoption, ASRM, gamete donation, malpractice, sperm donation, truth telling

The End of the World by Pandemic: The Dance Remix

Greg Dahlmann hosted Northeast Public Radio's Weekly Rundown, a great program that died too soon but lives in spirit by podcast, and is the genius-in-progress working on the complete redesign of the blog you are reading right now. He noticed that an admirer of the program from London and musician, Rav Casley Gera, decided to turn my interview with Dahlmann into an apocalpytic song called Memorial Warning. I'm featured as "some guy." Which I guess beats being called a wannabe. Anyway it sounds like Phillip Glass, but on light propofol sedation. If you listen all the way through you will look like this guy.

Labels: bioethics music, Glenn McGee, potential pandemics

Nanotechnology & Medicine: Summer Johnson's Take

Science and Society asked our Summer Johnson, director of the Ethics in Novel Technologies, Research and Innovation Program (ENTRI) at Alden March Bioethics Institute, to talk about ethical issues in nanotechnology.

Caplan on Vaccines and Autism

Art, who runs a vaccines and ethics project at Penn, is really going after the continuing claims that vaccines are linked to autism in any scientifically validated way. In the Philadelphia Inquirer he argues as much:

What must it be like to spend a huge amount of time every waking day trying to change public health practice - only to find out that you were wrong? That is precisely what has happened to the proponents of the theory that mercury in vaccines - contained in the preservative thimerosal, which once was used (and is used no longer) in vaccines - is responsible for a nearly 20-year explosion in autism and other neurological disorders among American children.

This urban legend has had very real - and terrible - consequences. It has led, and continues to lead, many parents to avoid getting their kids and themselves vaccinated against life-threatening diseases. The failure to vaccinate has caused many preventable deaths and avoidable hospitalizations from measles, whooping cough, diphtheria, flu, hepatitis and meningitis. And fear of vaccines puts each one of us at risk that we, our children or grandchildren will become part of a deadly outbreak triggered by someone whose parents avoided getting their child vaccinated for fear of autism.

Recent research on many fronts in medicine and science has nailed the coffin shut on the mercury-in-vaccines-causes-autism hypothesis. The connection is just not there. Perhaps the key fact, which has garnered little attention, is that thimerosal has been removed from vaccines in this and other countries for many years, with no obvious impact on the incidence of autism. The most recent data point toward a correlation with nothing at all to do with vaccines: the increasing age at which people (particularly men) have children seems to be associated with an increase in autism and other neurological problems.

Still, some of the most fervent anti-vaccine critics cannot let go. They continue to tell devastated parents of children with autism that vaccines are to blame. Others are still out on the lecture circuit peddling books and articles that bash vaccines and invoke mercury as a problem. Still others pepper the Internet with the false message that vaccines and autism do go hand in hand - it is just that the government, or the pharmaceutical companies, or organized medicine, or all of them, are keeping the truth from us all.

Less than two years ago, Robert Kennedy Jr. published an article in Salon.com alleging that the government knew of and covered up the autism-vaccines connection. Thimerosal was, Kennedy told large audiences and many media reporters, to blame.

Kennedy was hardly alone in fingering vaccines as the cause of the epidemic of autism affecting American children. David Kirby's 2005 best-selling book, Evidence of Harm, and many other articles, newsletters and advocacy blogs fanned the flames. Some continue to do so.

Proponents of the thimerosal/mercury-causes-autism theory have had a powerful impact on public opinion. When one of my students recently conducted a pilot study of attitudes about the new cervical-cancer vaccine, fears about autism were prominent among the reasons many respondents gave for being wary of the vaccine. Friends of mine continue to tell me of parents in Lafayette Hill, Voorhees, Greenville and Downingtown who won't have their children vaccinated because of the risk of autism. States continue to allow parents to opt out of vaccines on "philosophical" grounds - perhaps the only arena in American public life where "secular philosophy" is given legal standing in public policy. And even some young health-care workers report that they don't get important vaccines that would protect them, their families and their vulnerable patients against death because of worries about autism and vaccines.

Science and medicine have not bought the thimerosal/mercury-autism link. For years the Centers for Disease Control and Prevention, the American Academy of Pediatrics, the Children's Hospital of Philadelphia's Vaccine Education Center, the National Academy of Sciences, the Food and Drug Administration, and countless other prestigious organizations and scientists have said the data do not support mercury in vaccines as the cause of autism.

Now, with the mercury long out of vaccines, what is there left to say? Why won't the slandering of vaccines as the cause of autism stop?

There has always been a great deal of antipathy toward vaccines - in part because vaccines do have a tiny chance of causing death or other serious side-effects. Parents who have been through that hell have a hard time hearing or sending any other message other than "vaccines are bad." And those who made careers out of peddling the vaccine-autism link - in the face of a lack of evidence - have really been motivated by a distrust of medicine, science, government and experts, a distrust that has little to do with scientific studies or expert opinions. Even government officials have never really cared enough about public health to do much to counteract the incredible damage the autism-vaccine proponents have done. That is not acceptable.

Our nation is spending a fortune on plans to cope with the prospect of a bioterror attack. State, city and federal agencies are trying to figure a plan if avian flu mutates into a form in which it can start killing people. Hospital officials are worrying over how to cut back on preventable deaths in our hospitals and nursing homes. Those in charge of keeping disease transmission in hospitals, schools and public spaces to a minimum are fretting over what steps to take. The answer to every one of these challenges involves - vaccines.

This nation's future, its national security, the safety of its health-care institutions, and the safety of its citizens depends upon vaccination. It is way past time that message got heard by parents, teachers, nurses, doctors, hospital administrators, the media and politicians. If there has been a more harmful urban legend circulating in our society than the vaccine-autism link, it is hard to know what it might be. At a time when vaccines may be our last best hope in facing some of the greatest challenges we and our children face, this legend needs to be put to rest. Vaccination, not vaccine-bashing, is what this nation needs.

Labels: autism, vaccination, vaccines

'Shroom Science: Safe & Effective? Smart?

In my column in this month's issue of The Scientist I argue that perhaps we are moving just a bit too fast in bringing back research on hallucinogens, and that learning the lessons of history about how that research led to pseudoscience and then to broader and dangerous abuse is very, very important - particularly given the effects should a media explosion lead to the impression that large and important medical institutions are engaged in drug pushing of psilocybin and other compounds (like LSD):

In the August issue of Psychopharmacology, Johns Hopkins researchers published a study in which some subjects were given psilocybin and then asked to relate their experiences. Francisco Moreno of the University of Arizona published in the November issue of the Journal of Clinical Psychiatry his patients' reports that psilocybin helped them with migraine headaches. Harbor-UCLA Medical Center psychiatrist Charles Grob told the Chronicle of Higher Education that he is giving the compound to patients dying of cancer to see whether it eases pain by relieving anxiety.

The study of so-called magic mushrooms isn't new; it could be argued that it is celebrating its 50th anniversary this year. It began, as best anyone can tell, when Wall Street banker R. Gordon Wasson documented his trip to a healer in Oaxaca, Mexico, whose brew, he claimed, enabled him to see the reality of ideas and concepts. His 1957 essay in Life magazine excited the imaginations of scientists around the world. Sandoz patented the two active chemicals in the mushrooms, calling the compounds psilocin and psilocybin. Chaos ensued as researchers struggled to do excellent scientific work using a family of substances whose effects - to put it mildly - were not easily measurable using the tools of the time.

The scientists who used psilocybin in their research in the 1960s poked at the nature of consciousness, but this particular compound just refused to be caged by ordinary scientific conventions. Paper after paper stabbed at descriptions of the effects and utility of psilocybin, but scalar measures of transcendence just could not capture its effects, or side effects. A few of the leading scientists engaged in its study, most notoriously Harvard psychologist Timothy Leary, simply abandoned the strictures of scientific research as insufficient to grasp the power of psilocybin.

By the time the FDA banned hallucinogenic drugs in 1970, the majority of those experimenting with mushrooms were not in universities...

[Read the full article]

Labels: hallucinogens, human subjects, Johns Hopkins, psilocybin

International Society for Stem Cell Research Releases Guidelines for Stem Cell Research. Yawn.

Our David Magnus writes in the Mercury News that the new guidelines by ISSCR are pointless or worse:

The International Society for Stem Cell Research (ISSCR) has announced its recommended guidelines.

For many of us who work on oversight committees for stem-cell research, this report is too little, too late.

The prestigious National Academy of Sciences has already issued an extremely influential report on stem-cell research, and here in California, we already have a set of laws, regulations and guidelines (mostly based on the NAS report) that governs research. Do we really need another set of guidelines?

There are three important points that these guidelines raise:

• We have seen a growing number of organizations coming up with guidelines for stem-cell research, and most cover the same issues. It gets hard for oversight committees to know who to listen to. Here in California, stem-cell research is governed by the regulations from the California Institute for Regenerative Medicine if it is funded by Proposition 71 money. If such research is privately or federally funded, it falls under a law that mandates several issues and additionally directs the state health department to issue guidelines. Clearly, the law comes first -- but to what extent do we need to pay attention to other guidelines? At this point, less is more.

• The one really novel stand the ISSCR group has taken concerns payment of women who agree to donate their eggs for research. This is a difficult ethical issue. Many argue that creating a market in eggs for research will lead to the exploitation of poor women to develop treatments for the wealthy. Others argue that failure to provide compensation means that women are exploited as they are exposed to risk for no benefit.

We are inconsistent in the way we approach payment. Women are allowed to take large sums of money in exchange for ``donating'' their eggs for infertility treatments, but people cannot legally take money to donate their bone marrow for transplantation, although the risks are similar and the procedures similarly invasive.

The ISSCR group says local oversight committees should determine the appropriate policy: no payment, reimbursement of direct expenses, or substantial compensation for time and suffering. The problem with this recommendation is that it seems to fly in the face of virtually every law in place. The NAS guidelines call for a prohibition on payment of egg donors beyond direct expenses. Proposition 71 has a similar ban in place. Many other states and countries have made it unlawful to pay women more than a token amount or to pay anything beyond their direct expenses.

Many researchers are worried that they will have a difficult time getting access to the eggs they need. But offering standards that cannot be followed by any of the major players in stem-cell research is a recipe for irrelevance.

• The final issue raised by the guidelines is what is missing. The ISSCR group missed a real opportunity to address many new challenges that stem-cell researchers and oversight committees face -- challenges that have had little attention.

All of the guidelines to date focus on bench research. But Menlo Park biotech company Geron has already announced that it intends to start clinical trials using differentiated embryonic stem cells for patients with acute spinal cord injury. Yet we have almost no guidance on how oversight committees should evaluate these trials or what should go into informed consent forms. Astonishingly, neither the NAS nor ISSCR has said anything about the right of subjects who may oppose stem-cell research to know that the cells placed in their bodies for research come from embryonic stem cells.

The California Stem Cell Research Oversight Committee has come up with the first guidance on this issue, but much more needs to be done. There are many other pressing issues that have received little attention. It is time for groups to stop going over the same ground and to try to break new ground.

Art Caplan on Switzerland's Decision that the Mentally Ill May Be Helped to Take Their Own Lives?

This is an incredibly momentous and controversial court decision by the highest court of Switzerland:

Switzerland already allows physician-assisted suicide for terminally ill patients under certain circumstances. The Federal Tribunal’s decision puts mental illnesses on the same level as physical ones.

“It must be recognized that an incurable, permanent, serious mental disorder can cause similar suffering as a physical (disorder), making life appear unbearable to the patient in the long term,” the ruling said.

Assisted suicide has always been linked to the challenge of allowing the terminally ill a choice in managing their inevitable death. That is the policy in the state of Oregon which has had legalized assisted suicide for the terminally ill for many years.

Linking the right to assistance in dying from physicians to the quality of someone's life or their suffering is an enormous and, in my view, very dangerous shift in thinking about assisted suicide.

IF this policy were to be put into place in Switzerland or elsewhere it would put physicians in the position of trying to distinguish 'competent' requests from persons with mental illness alleging emotional despair from 'incompetent' or 'temporarily desperate' persons with mental illness alleging emotional despair --something psychiatry and psychology are not always adept at doing.

Moreover, this policy opens the door to anyone who says they have unbearable psychological or emotional suffering to request help in dying--people with terrible burns, those who are severely disfigured, those who are emotionally bereft at the loss of a child, partner or loved one and even those suffering from career setbacks and failures.

I think the policy is both difficult to enforce and dangerous to apply since it is hard to see how it will not lead to a very slippery slope. Once assisted suicide is extended to those who claim or state that their quality of life is not worth living it puts medical professionals in the very difficult role of trying to figure out if such a claim is valid. It then puts them in the even more difficult role of trying to decide why it is their responsibility to alleviate the suffering, even the most miserable suffering, that people may face through the prescription of lethal doses of drugs.

-Art Caplan

Labels: disability, euthanasia, mental illness