Biobanking Throwdown: 2nd Round

We had posted earlier about the ongoing debate on the ethics of DNA databasing -- here is round two in the debate. Our poll is still open, let us know where you stand!

Is this anyway for a medical journal to behave?

Reprinted in part from the The Chronicle of Higher Education:

'JAMA' Orders Whistle-Blowers to Blow Their Whistles in Private

The longstanding ethical principle of medical students and physicians — “First do no harm” — appears to be taking on a new meaning at one of the world’s top medical journals.

The Journal of the American Medical Association, in an editorial published on Friday, has warned that anyone raising a conflict-of-interest complaint about one of its authors should do so in private to the editors, without telling any outsiders.

JAMA’s warning stems from a case involving Jonathan Leo, an associate professor of neuroanatomy at Lincoln Memorial University, in Tennessee, who found problems in a study published in JAMA by a University of Iowa psychiatry professor, Robert G. Robinson, about the use of antidepressants in stroke patients. Dr. Robinson, according to Mr. Leo, also didn’t disclose a financial relationship with the maker of the drug involved in the study.

Mr. Leo reported his concerns to JAMA in October. Finally, this month, he publicly revealed his complaint in a letter published in the BMJ (formerly known as the British Medical Journal). One week later, JAMA published a correction and a letter from Dr. Robinson conceding he had in fact been paid by the drug company and had failed to report that.

In its editorial, JAMA affirmed the need to guard against conflicts of interest. Yet JAMA said that, in the future, anyone suspecting a conflict involving one of its authors should tell JAMA and “should not reveal this information to third parties or the media while the investigation is under way.” JAMA said it could be trusted to handle the matter fairly.

“A rush to judgment may spark heat and controversy,” it said, “but rarely sheds light or advances medical discourse.”

JAMA editors denied suggestions by Mr. Leo and his university dean that the journal had threatened to damage the reputation of the university over Mr. Leo’s decision to publicly reveal his allegation against Dr. Robinson. JAMA did not say, however, what it would do if a whistle-blower behaved similarly in the future, in violation of JAMA’s new policy. JAMA also did not say how long whistle-blowers should expect the journal to take to look into their complaints.

Full article plus comments can be found here.

BiobankingThrowdown: The Ethics of DNA Databasing

Do you agree or disagree with the following proposition? (take our poll and we'll compare it with the Economist's poll results) :

People's DNA sequences are their own business, and no one else's.

Art Caplan and Craig Venter go toe-to-toe on this issue, with Art Caplan defending the privacy of DNA and Craig Venter arguing for public access. An excerpt of the discourse:

Art Caplan: "There are, it is increasingly said, plenty of reasons why people you know and many you don't ought to have access to your DNA or data that are derived from it. Have you ever had sexual relations outside a single, monogamous relationship? Well then, any children who resulted from your hanky-panky might legitimately want access to your DNA to establish paternity or maternity" ...to read more, click here.

Craig Venter: "As we progress from the first human genome to sequence hundreds, then thousands and then millions of individual genomes, the value for medicine and humanity will only come from the availability and analysis of comprehensive, public databases containing all these genome sequences along with as complete as possible phenotype descriptions of the individuals"...to read more, click here.

Let us know what you think!

Why I Love Designer Babies, Part Deux

Last month, Kathryn Hinsch started a lively discussion in her post, "Why I Love Designer Babies" -- this month, New Scientist editor Michael LePage adds fuel to the debate on genetic selection:

Fears over 'designer' babies leave children suffering

MADELINE Kara Neumann, age 11, died of diabetes because her parents prayed rather than taking her to doctors. Caleb Moorhead, age 6 months, died after his deeply religious vegan parents refused a simple vitamin injection to cure his malnutrition. The list of children killed by their parents' superstition or wilful ignorance is a long one.

Most people are rightly appalled by such cases. How can parents stand by and let their children die instead of doing all in their power to get the best medical care available?

Yet this is precisely what society is doing. We now have the ability to ensure that children are born free of any one of hundreds of serious genetic disorders, from cystic fibrosis to early-onset cancers. But children continue to be born with these diseases.

All would-be parents should be offered screening to alert them to any genetic disorders they risk passing on to their children. Those at risk should then be offered IVF with pre-implantation genetic diagnosis (IVF-PGD) to ensure any children are healthy.

Why isn't it happening? Because most people still regard attempts to influence which genes our children inherit as taboo. When a fertility clinic in Los Angeles recently offered would-be parents the chance to choose their child's eye colour, for instance, it provoked a storm of criticism that forced the clinic to reconsider

Such fears are misplaced: IVF-PGD is little use for creating designer babies. You cannot select for traits the parents don't have, and the scope for choosing specific traits is very limited. What IVF-PGD is good for is ensuring children do not end up with disastrous genetic disorders.

Nearly 150 years after Darwin unveiled his theory of evolution, we have yet to grasp one of its most unsettling implications: having diseased children is as natural as having healthy ones. Every new life is a gamble, an experiment with novel gene combinations that could be a brilliant success or a tragic failure.

Thanks to technology, we are no longer entirely at the mercy of this callous process. Rather than regarding this ability with suspicion, we should be celebrating it and encouraging its use. Instead, we continue to allow children be born with terrible diseases because of our collective ignorance and superstition. That makes us little better than the parents of Madeline and Caleb.

-- Original article can be found here, subscription may be required.

Healthcare, Guaranteed

Over the last decade we have filled our libraries with treatises written on reforming health care. Yet, our health care system remains largely unchanged. Many of these volumes are overly complex or duplicative, quoting the same figures about the shocking percentage of GDP spent on healthcare (close to 17%) and the poor results achieved (well behind almost all industrialized countries). In this sea of undifferentiated policy work, Ezekiel Emanuel’s book Healthcare, Guaranteed: A Simple, Secure Solution for America stands out for its clarity of approach. If we were President for a day (or maybe even Ezekiel’s brother, who is Obama’s Chief of Staff, Rahm Emanuel), we would mandate that Healthcare, Guaranteed be required reading for all members of Congress. Check out the great review written by the newest member of the Women's Bioethics Project advisory board, Margaret Lane.

NeuroNews on Wired

Another driveby post: Wired Science has two stories in Neuroscience the last two days that will be sure to be of interest to bioethicists:

Modafinil May Be Addictive:

The alertness drug developed as an addiction-free alternative to amphetamines might be addictive after all.

Researchers have found that people taking modafinil experience a surge of dopamine, an important cognitive neurotransmitter. Such dopamine upswings are seen in people taking Ritalin, and are considered a chemical signature of possible addictiveness. [Link to full article here.]

AND

MRI Lie Detection to Get First Day in Court

Defense attorneys are for the first time submitting a controversial neurological lie-detection test as evidence in U.S. court.

In an upcoming juvenile-sex-abuse case in San Diego, the defense is hoping to get an fMRI scan, which shows brain activity based on oxygen levels, admitted to prove the abuse didn't happen. [Link to full article here.]

The Emotional Fallout No One Talks About

Hilde Lindemann, President of the ASBH and WBP Board member asks us to take a look at what some brave blogger just posted at Shakesville. Moved her (and me) to tears:

Breaking the Silence: On Living Pro-Lifers' Choice for Women

Giant Crabs: The Onion Has some fun with GMOs

In a quick and driveby post:


Experts Agree Giant, Razor-Clawed Bioengineered Crabs Pose No Threat

Female Condoms to Prevent HIV?

From my understanding, male condoms and other contraceptives warn that these products may not prevent sexually transmitted diseases, pregnancy, or HIV/AIDS. But the article, “FDA approves inexpensive female condom,” touts that the new female condom, made with less expensive materials, will be targeted to “women in Africa and other areas where AIDS is a major concern.” According to the article, “Female Health’s initial Female Condom was approved in 1993 to prevent pregnancy, as well as sexually transmitted diseases, but has not been widely used in the United States, which made up just 10 percent of its 34.7 million unit sales in 2008.” The company hopes that the reduced costs “will help more groups offer more condoms in the hope of preventing HIV/AIDS and other STDs.”But is it probable to believe that women in Africa will be able to not only have access to this product, but will be able to use it? How logical is it to believe that a female condom will reduce the occurrence of HIV/AIDS in Africa? If this was possible, would it be safe to assume that men in Africa had access to male condoms, and yet did not use them? According to AVERT, “Relative to the enormity of the HIV/AIDS epidemic in Africa, providing condoms is cheap and cost effective. Even when condoms are available, though, there are still a number of social, cultural and practical factors that may prevent people from using them. In the context of stable partnerships where pregnancy is desired, or where it may be difficult for one partner to suddenly suggest condom use, this option may not be practical.”AVERT also mentions that, “the distribution of condoms to countries in sub-Saharan Africa has also increased: in 2004 the number of condoms provided to this region by donors was equivalent to 10 for every man, compared to 4.6 for every man in 2001. In most countries, though, many more condoms are still needed. For instance, in Uganda between 120 and 150 million condoms are required annually, but less than 40 million were provided in 2005.”So, based on these statistics, would making female condoms accessible to females in Africa make a difference in the HIV/AIDS epidemic? Would these condoms have an impact on the US population affected by HIV/AIDS? Although condoms may reduce the risk of STDs, HIV/AIDS, and pregnancy, if not used properly, their effectiveness decrease. According to AVERT, “The main reason that condoms sometimes fail to prevent HIV/STD infection or pregnancy is incorrect or inconsistent use, not the failure of the condom itself. Using oil-based lubricants can weaken the latex, causing the condom to break. Condoms can also be weakened by exposure to heat or sunlight or by age, or they can be torn by teeth or fingernails. Also, remember to check the expiry date of your condom!”The article reports that the FDA allows the United States Agency to distribute the female condom to global programs dedicated to preventing the spread of the virus that causes AIDS. My question is that if male condoms have always been available in the US and other countries, why is the numbers for AIDS, teen pregnancy, and STDs still continually rising? Shouldn’t we try to educate on these issues, rather than just developing and selling products that may or may not reduce the risks of attracting these diseases or unexpected pregnancies? Don’t we have an ethical responsibility to prevent these risks through knowledge than through profit?

The Promise of Advancing Neurotech

[Hat tip to Adam Kolber of the Neuroethics and Law Blog] Worth the nine minutes it takes to watch through to the end:



World Builder from Bruce Branit on Vimeo.

Moral Outrage of the Week: Excommunication in Brazil

In a very sad and disturbing case from Brazil, Yahoo news reports:

“A senior Vatican cleric has defended the excommunication of the mother and doctors of a nine-year-old girl who had an abortion in Brazil after being raped…."It is a sad case but the real problem is that the twins conceived were two innocent persons, who had the right to live and could not be eliminated," he said. The girl was apparently raped by her stepfather since she was six; he also allegedly sexually abused the girl's physically handicapped 14-year-old sister -- but the stepfather is not being excommunicated -- he is still a Catholic in good standing (at least if he ‘confesses’). The doctors who carried out the abortion did so for fear that the slim girl would not survive carrying the fetuses to term; President Lula da Silva said "in this case, the medical profession was more right than the church."

As one of my colleagues commented, 'Surely, the Vatican is pursuing a foolish consistency." Couldn't the Church have acknowledged that this was a case of self-defense, like an ectopic pregnancy? (Ideally, the Church could have considered its pre-Vatican Council I [1860s] position that abortion is permitted prior to the ‘quickening,’ but I don’t see that happening any time soon). And what happens if the mother and doctor ‘confess’, like the stepfather? Will the excommunication be lifted? Or will politics outweigh morality?

Ethics on the chopping block

[Cross posted from the Research Ethics blog] Two related stories came to my attention this week. Reading the first one, I was worried. But when I came across the second story, I thought, this needs to be talked about! In two places, both affected by the now globally worrisome economy, strict budget cuts are being made. And the first thing on the chopping block? Ethics.

The University of Tenneessee is considering closing down The Department of Human Values and Ethics in the College of Medicine along with a number of other science and medicine programs. Here's the story from the AAPR Bulletin Today: Possible University of Tennessee job cuts will draw protest.

Across the globe in New Zealand, the government will sign off on disbanding the country's Bioethics Council on Monday. The Bioethics Council was created in 2002 in response to public concern that the government was making decisions — in an ad hoc and unadvised manner — on complex and controversial biotech and genetic issues without considering the unique ethical, cultural and spiritual demographics of the country. Here is the story, from the Radio New Zealand newsfeed: Bioethics Council to be Disbanded

So what does this have to do with research ethics and ethics review boards? Well, plenty.

We should be concerned that the first cuts insitutions and governments want to make are on what they apparently consider to be highly expendable programs, like ethics. Seems to me that in perilous times, we just might need ethics a little more.

Ethics review boards, in either academic or medical settings, should be doing more than reviewing protocols, providing approvals and monitoring ongoing research in a silo somewhere, unconcerned that these kinds of cuts, as they don't name "research ethics" explicitly, have nothing to do with them. While reviewing research takes up a tremendous amount of time and energy, as I well know chairing an ethics review board myself, there is a certain amount of advocacy, outreach and education that an ethics review board must be committed to doing, on an ongoing and iterative basis.

So a few words on each of the three things I've identified here that ethics review boards should be committed to doing:

Advocacy for what? For strong ethics programs that are ideologically and financially supported by the administrators of the institution, situated logically within broader programs that have a commitment to research ethics; for fair, transparent and ethical processes in any context; and for fair treatment of not only participants — yes, that is our mandate — but also novice and experienced researchers, ethics review board members and others involved in research processes without whom researchers couldn't do their work. In these two cases, I would hope that those involved in research ethics at the University of Tennessee and from across NZ would speak out against the discontinuation of these broader ethics programs.

Outreach? Yes, outreach. Ethics review board members can do a great deal of outreach in their own departments and schools by articulating and clarifying what it is an ethics review board does, the kinds of principles upon which we base our deliberations and decisions, the challenges as well as the kinds of rewards that this work affords those who are dedicated to it and the kinds of broader values that ethics review boards, at their best, should be committed to upholding — things like autonomy of persons, voluntariness, maintaining dignity and integrity of persons and facilitating ethically sound research.

Outreach also implies making strong connections between ethics review boards, bioethicists and clinical ethicists, educators and other persons and programs within and between institutions.

Finally, education. As ethics review board members and those who are committed to research ethics in perhaps other ways, it's important, perhaps imperative, that we educate people not only about "what it is we do" but also why it's important to have people, who are concerned with ethics, hanging around. Bioethicists, clinical ethicists, research ethicists, those concerned with environmental ethics, business ethics...the list goes on. Usually most institutions don't think a great deal about these kinds of programs — and the associated dedicated people — until something goes wrong and suddenly, the institution turns to the same programs and people for help, advice and guidance. Seems that UT and NZ might not have anywhere to turn soon.

posted by Nancy Walton, Ph.D. at 6:10 PM

Feminization of HIV & Macroeconomic Policies

The Appignani Bioethics Center, Guttmacher Institute and Population Council are co-sponsoring a panel discussion on "Feminization of HIV & Macroeconomic Policies." under the auspices of the fifty-third session of the Commission on the Status of Women, at the United Nations headquarters in New York, from 2 to 13 March 2009.

Date & Place: Tuesday, March 10, 2009, 6.00-8.00 PM, 777 UN Plaza, 10th floor - Conference Room, NY 10017

The feminization of HIV relates to gender discrimination and social restrictions. These result in women's lacking access to education and employment as well as decision-making power. Victims of gender violence, women are deprived of sexual and reproductive rights. International agreements and decisions on gender equality must be translated into national legal frameworks and action plans. The focus of this panel is the social, economic, cultural and legal aspects of the epidemic, but to truly understand its feminization we need to consider how macroeconomic policies might improve women's access to resources and political influence.

Our very own Sean Philpott (blogger extraordinaire and Science and Ethics Officer for the Global Campaign for Microbicides, based at PATH) will be presenting on a panel with Helen Epstein (author of the recent book AIDS in Africa: The Invisible Cure), Heather Boonstra (our colleague from the Guttmacher Institute), and Anrudh Jain (from the Population Council).

He'll be talking about research and development of new user-controlled HIV prevention technologies that women can use to protect themselves, focusing on the need for sustained economic investment and ways to increase private industry involvement through novel licensing agreements, priority review vouchers, and advance market commitments. Kudos and thanks!

On Wisdom: Remoralizing Work and Celebrating Moral Exemplars

Quote of the Day, by Barry Schwartz in his TED talk: "Acknowledge when you go to law school, that a little voice talks to you about Atticus Finch, no ten-year-old goes to law school to do mergers and acquisitions...People are inspired by moral heroes.... The truth of the matter is that any interaction you have that involves other people is moral work and any moral work depends on practical wisdom. As teachers, we should strive to be ordinary heroes, the moral examplars to the people we mentor. The thing we have to remember is that we are always teaching, someone is always watching, the camera is always on."

Full talk is accessible here.

Conference on Food, Famine and Future Technologies

Appignani Bioethics Center

in collaboration with

The University of Montreal: Bioethics Programs present:

Food, Famine, and Future Technologies:

Ethical Dilemmas in a Hungry World

May 22-23, 2009 in NYC

Cocktail Reception: Friday, May 22, 2009, 6:00 PM - 9:30 PM

Location: Tudor Hotel at the United Nations, New York City, 304 E 42nd St. (between 1st and 2nd Ave), New York, NY 10017. Mediterranean food and wine will be served. Featured at the reception will be an Argentinean Tango performance by Laura Real., www.lauratango.com at www.tudorhotelny.com

Conference: Friday and Saturday, May 22-23, 8:30 AM-6:30 PM, 6:30 PM-9:30 PM cocktail reception

Conference room: 777 UN Plazas, 2nd Floor, (44th St and 1st Ave), New York 10017

Taking a broad and cross-disciplinary approach to addressing ethical dilemmas raised by genomic applications in agriculture, conference topics include agri-genomic innovations and their impact on society as a whole and environmental, economic, ethical, and social issues within agri-genomics.

The Conference will cover the following topics:

• Genomics research in agriculture (agri-genomics) and its diverse applications

• Consumers' perception and the media

• How to benefit human health and the food supply using genomic crops

• Environmental, economic, ethical, and social impacts within agri-genomics applications

• Lessons learned from genetically modified organisms for health and development

• Environmental safety and sustainability

• Development of sustainable nutrition for growing populations

• How to optimize stakeholder competition and cooperation

These topics will be addressed through paper presentations and panel discussions. The deadline for the submission of abstracts (no more than 150 words) is April 15, 2009. Send them electronically to: alita@americanhumanist.org or beatrice.godard@umontreal.ca.

Accepted papers will be peer-reviewed and published in our conference proceedings. Virtual registrations will also be available for those unable to attend the conference-this allows you to submit a paper for review and possible publication. The conference is open to the general public.

The address for the submission of abstracts/papers, registration and inquiries is:

P.O. Box 4104, Grand Central Station, New York, NY 10162

Phone: (212) 687-3324 analita@americanhumanist.org

Registration forms and other details are posted at www.humanistbioethics.org and www.omics-ethics.org

Registration fee is $100 and students' fee is $50. All fees are payable by check to the address above by April 15, 2009 or at the conference desk. Registration fees include participation in all sessions, conference kit, refreshments and coffee breaks, and cocktail reception.

*One can attend the cocktail reception only and pay at the door, for a fee of $55.

For more details about the conference please check: www.humanistbioethics.org or

www.omics-ethics.org

Conference Announcement: Living in the Genetic Age

SAINT LOUIS UNIVERSITY SCHOOL OF LAW

21st Annual Health Law Symposium

Friday, March 20, 2009
8 a.m. to 4 p.m.
William H. Kniep Courtroom

Advances in genetic technology raise a broad range of legal, social and ethical concerns. Fear of genetic discrimination remains an issue, as evidenced by the passage of GINA, the Genetic Information Nondiscrimination Act of 2008, which limited the use of genetic information by employers and health insurance providers. Other concerns include the meaning and uses of genetic knowledge in the face of uncertain choices; the significance of genetic information for ideas of self, family and community; and the challenges of genetic enhancement and personalized genomic medicine. This Symposium gathers leading experts and scholars from fields including law, medicine and anthropology to discuss these and
other challenges of living in the genetic age.

Details and registration:

Call: Mary Ann Jauer (314) 977-3067
Click: law.slu.edu/genetics
Write: jauerma(at)slu.edu