A Prescription for Trouble

Those of you who attended the ASBH conference in Denver last week may have come to the mock trial of the Law and Bioethics Affinity Group which included marvelous performances by Erin Egan, Judy Illes, Peter Cohen and Katie Watson. Also, a sense of courtroom decorum was greatly enhanced by our two judges, Terry Tomsick and Alice Herb, who did a wonderful job with the rulings, too! The fact pattern involved the use of neuroimaging for purposes of lie detection in a product liability case against a major drug company who marketed a COX-2 inhibitor that increased the chances of serious heart problems.

The irony is that just yesterday, the Managing Editor of Boston magazine, Jennifer Johnson, sent me a link to this article in Boston (about the Vioxx scandal) with an intriguing summary:

Its reports on new drugs put billions in pharmaceutical company profits and untold lives at stake. So it’s a very big deal when the New England Journal of Medicine gets something wrong. With the powerful publication still reeling from a scandal it can’t seem to shake, editor Jeffrey Drazen’s plan for fixing things is less a sure-fire cure than a leap of faith.

It just goes to show what a small world it is (especially when it comes to bioethics)! Thanks, Jennifer

Universal Health Care Ethics

One of the largest health problems facing the nation today is access to medical care. With around 50 million people uninsured, our country struggles with providing health care to many individuals. Because the scope of this problem penetrates all facets of life, it needs to be tackled at many different levels. Deciding our values as a society about health care requires answering difficult ethical questions. The means by which we begin to create and implement a national health care system necessitate that we define what those values are. Addressing the challenges of providing national health care is inherently part of the discussion around this dilemma.
One initial question that must be asked is: How responsible is an individual for the status of their health? Factors that contribute to one’s health include their environment, genetics, socioeconomic status, behavior, and the actual health care obtained. Because of the variability of these factors for each person and the unpredictable nature of individual health, responsibility should ultimately be shared among families, communities and society. It is known that approximately 10% of the population accrues 70% of total health care costs. The financial burden this poses on individuals with acute, chronic, or terminal illness is substantial. Do we want to live in a society where access to health care is determined by socioeconomic status? Aside from social responsibility, we have personal interest in creating a system where the burdens of this financial risk are spread across the population; our health circumstances are just as uncertain as everyone else’s.
The costs of health care are significantly rising at an unsustainable rate. Maintaining a healthier population not only benefits the individuals but also the payers (insurance companies, employers, government) of the expenses. How do we incorporate individual responsibility into the equation? What financial contribution should individuals make? Should it be experience based; should individuals pay premiums based on their health care history? Or should the payments be based on a community rating, where everyone pays the same regardless of their health status? Or should it solely be based on ability to pay, a tax financed system? How do we promote healthier lifestyles while recognizing the injustices that exist? It is less likely that someone living in poverty would have access to a fitness center. This person may also live in an unsafe area, making it difficult to take walks after work. This person may not be able to afford healthier foods, relying on foods with less nutritional quality to feed him or herself. The more we recognize the barriers that exist, the more responsibility we feel to help create a system that provides for everyone.
Even once we recognize that universal health care is essential, there are more questions to be answered. How would we go about implementing universal health care? What role should government play? The current structure allows for minimal governmental regulation and relies highly on free-market economics to regulate the system. Increasing governmental regulation would inevitably decrease our choice (as it has been observed in countries where it has been implemented such as Canada). We must decide that we value access for all over choice for those privileged enough to have this conversation.
Increasing access of information to individuals, determining what values as a society we have, implementing a system that insures health care to all individuals, and deciding how to finance this system are significant challenges regarding this issue. However, recognizing that access to health care is an ethical issue is a critical step in the process.

For more information: http://www.everybodyinnobodyout.org/FAQ/fqIndResp.htm

Fox and Counter-Fox

[Hat tip to R. Alta Charo for the title]...

Making Stem Cell Issue Personal, and Political

Alessandra Stanley does a great job of teasing out the fact from fiction in her column in the NY Times this morning about the contentious comments of Rush Limbaugh regarding Michael J. Fox's ads about stem cell research:

The plea is as disturbing — and arresting — as a hostage video from Iraq. In a navy blazer and preppy Oxford shirt, the actor Michael J. Fox calmly asks viewers to support stem cell research by voting for several Democratic candidates in Maryland, Missouri and Wisconsin, while his body sways back and forth uncontrollably like a sailor being tossed around in a full-force gale...
In short, Mr. Fox’s display of the toll Parkinson’s disease has taken on him turned into one of the most powerful and talked about political advertisements in years.
Rush Limbaugh rushed in to discredit Mr. Fox, though he mostly hurt himself. Rush Limbaugh, the conservative radio talk show host, told his listeners that the actor either “didn’t take his medication or was acting.” Mr. Limbaugh later apologized for accusing Mr. Fox of exaggerating his symptoms, but said that “Michael J. Fox is allowing his illness to be exploited and in the process is shilling for a Democrat politician.”

Republicans cobbled together a response ad attacking the ethics of embryonic stem cell research, including testimonials by the actress Patricia Heaton (“Everybody Loves Raymond”) and James Caviezel, who played Jesus in Mel Gibson’s “Passion of the Christ.” At least in the advance version shown on YouTube last night, Mr. Caviezel’s introduction seemed either garbled or to be in Aramaic.


Michael J. Fox

Fox Stem Cell Video

Live from Denver! ASBH

Kathryn Hinsch and I will be blogging from the annual ASBH conference in the Mile High City of Denver -- let us know what you'd like to hear about!

Genetic Guilt

There was an interesting article about genetic testing and breast cancer today in The Independent, profiling a family and their decisions to undergo mastectomies.

http://news.independent.co.uk/uk/health_medical/article1880078.ece

Aside from the fact that this is an important tale of both the benefits and difficulties of discovering your own genetic susceptibility to cancer, what caught my eye was this quote:

Despite all this, Julie was devastated when her 29-year-old daughter, Jenny, was found to have the mutated gene. She will undergo a double mastectomy in January. Julie says: "I feel guilty, which I know is not rational. But it is my fault. I passed it on to her."

As if “mommy guilt” wasn’t multi-faceted enough! It’s not hard to imagine that many women (and men) may feel compelled to do whatever it takes to eliminate genetic abnormalities in their children, provided the opportunity to do so.

(Thanks to Dr. Hsien Hsien Lei’s “Genetics and Health” blog for pointing me in the direction of this article.) Published by Emilie Clemmons.

Bioethics for the Rest of Us?

Can you recommend a good book on bioethics for a beginner? I am often asked that question and until now I haven’t had a very satisfying answer. As much as I love it, I don't feel comfortable recommending the American Journal of Bioethics with its grim graphics and complex cover stories (this month’s: “Damage Compounded: Disparities, Distrust, and Disparate Impact In End-of-Life Conflict Resolution Policies” and "Altruistic Discourse in the Informed Consent Process for Childhood Cancer Clinical Trials.") Not exactly layperson friendly. Fortunately, Art L. Caplan has come along to save the day. His recently published book titled “Smart Mice, Not So Smart People: An Interesting and Amusing Guide to Bioethics” is a great introductory book which covers a stunningly wide range of topics. It is easy to read, doesn’t pretend to be “objective” and helps the reader ponder the key bioethics issues of our time. I'll be giving it out as Christmas presents this year.

Calling all Bioethics Bloggers

Are you a bioethics blogger and attending the American Society for Bioethics and Humanities annual meeting next week in Denver? We are planning a special bloggers meeting to discuss, well, blogging and bioethics. Not sure of the time nor venue yet but we'll opt for an open slot in the conference schedule (and hopefully we'll scrounge up some pizza and beer.) Interested in participating? Please contact me for further details.

The Scientist & the Ethicists Podcast Series: Nerd Girrrrls Rule!

In an effort to help the public make sense of an escalating number of news stories about “designer babies,” genetic engineering and cloning, the Women’s Bioethics Project launchs it's first series of podcasts, titled “The Scientist & the Ethicists.” Check it out.

The Breastfeeding Rodeo

The U.S. Department of Health and Human Services and the Office on Women’s Health have been actively promoting an ad campaign over the past few years to increase awareness about the benefits of breastfeeding.

http://www.womenshealth.gov/breastfeeding/index.cfm?page=adcouncil

Educating women about the benefits of breastfeeding—getting that information out there (because many were unaware)—is an extremely important endeavor and the DHHS and OWH should be commended for their efforts…for the most part.

Their print and radio ads are generally informative and amusing and (I feel) effective in that they provide important scientific information about the benefits of breastfeeding without criticizing the actions or choices of mothers.

Their TV spots, however, have generated some controversy. Each depicts pregnant women (fictionally) engaging in a dangerous activity, including log rolling and riding a mechanical bull, then equates the activity with failing to breastfeed your child.

This approach seems counterproductive on at least two fronts: 1) it falsely implies that feeding your baby formula is as dangerous to its health as bull-riding while pregnant and thus feeds misinformation to its audience and 2) it serves to criticize and alienate women who choose not to or cannot breastfeed for a variety of reasons.

Let’s give women the best information we have on breastfeeding and on other women’s health topics to help them make the best decisions for their families. Frightening them with false analogies is both unethical and counterproductive.

Lastly, if the U.S. government is truly interested in breastfeeding for our children and for public health, they need to encourage our workplaces and the general public to support breastfeeding and to provide women with comfortable places to nurse their children. Many moms I know (myself included) have plenty stories to share about breastfeeding or pumping while sitting on the toilet in a workplace or public bathroom, or stories about being heckled for discreetly breastfeeding in public.

Currently, the womenshealth.gov website information appears to address workplace breastfeeding solely by encouraging women to make it work. They say:

“Let your employer and/or human resources manager know that you plan to continue breastfeeding once you return to work. Before you return to work, or even before you have your baby, start talking with your employer about breastfeeding. Don't be afraid to request a clean and private area where you can pump your milk. If you don't have your own office space, you can ask to use a supervisor's office during certain times. Or you can ask to have a clean, clutter free corner of a storage room.”

Thanks for the tips, but I want to know: do DHHS and OWH have a plan to educate our workplaces or maybe that man on the airplane who was so “disgusted” by my breastfeeding that he asked to change seats?

Emergency Contraception for those under 18

Student blogger Kirti Shah comments on a previous post re emergency contraception:

Recently the Government of Chile announced that they are going to provide emergency contraception to any one over 14 at no cost. What a revolutionary idea from a Catholic country. We in the U.S. now have made it available over the counter to anyone over 18 but they still have to pay. This was blocked on political grounds ( religious grounds) a number of times by questioning its safety ( rejecting all the evidence) and the usual abortion arguments.

The current law permits the pharmacist to sell it to anyone over 18. Any person over 18 can then give it to a person under 18 but a pharmacist cannot. This makes the pharmacist a policeman and potentially liable in case of some kind of a mistake. This can potentially introduce a third party in the distribution chain. We need to change this law to accommodate any minor and this would at the very least allow a health professional to advise the patient on the proper use of this medication.. The “ morning after” pill has a 89% efficacy if taken within 72 hours of unprotected sex and is more effective if taken in the first 24 hours. Reducing the waiting time should be of utmost importance.

We should clarify what emergency contraception is. It is a backup method of preventing pregnancy or reducing chances of pregnancy after unprotected sex. Examples of unprotected sex would be a broken condom, if one forgot to take birth control pill for 2 or more days ( which happens a lot) , or if one was sexually assaulted. Plan B is not RU-486 ( the abortion pill) because plan B is used to prevent pregnancy. It will not work if you are already pregnant and it will not affect an existing pregnancy. Plan B is also safe and it is a larger dose of normal birth control pill. Plan B will decrease the chances of pregnancy by 89% if taken within the first 72 hours of unprotected sex. It works better if taken within the first 24 hours after unprotected sex. When birth control pills first came out their doses were very high almost similar to plan B.

Arguments have been and will be used against plan B with misleading and false arguments and a conscious effort has to be made to educate the public. Condoms were once sold behind the counter and today they are available all over and serve a useful purpose. We cannot deny services to people who need it using false arguments and we need to loosen up the law that will free up the pharmacist or any other health care professional to be able to provide these services in good faith.

Vaccines on Trial

[Guest post by Amrita Desai]

I came across a very interesting article on One of the largest ever vaccine studies which is underway in Kolkata, India. Paroma Basu, who is a freelance writer based in Madison, Wisconsin, uncovers the benefits and difficulties of inoculating 60,000 people against cholera and typhoid fever out of population of 14 million. In the poorest areas of this city, residents live in homes jammed together along winding sewage-littered pathways and rely on shared toilets and drinking water. Typhoid fever and cholera are endemic in India, and are chronic problems in Kolkata. This state of West Bengal is often called as “homeland of cholera”.

The vaccine industry has always been reluctant to commit resources to the development of vaccine for world’s poorest people. But a grant of US$40 million from Bill & Melinda Gates Foundation is helping to introduce affordable vaccines to cities like Kolkata. The money has funded the five-year Diseases of the Most Impoverished Program (DOMI). DOMI is studying the social, economic, and clinical effects of introducing vaccines. Since 2000 it has launched two cholera studies, six projects investigating typhoid fever.

In a unique research effort 60,000 Kolkata slum-dwellers will participate this summer in phase III trials of an oral cholera vaccine. Last November researchers injected the same population with vaccine against typhoid fever. Typhoid vaccine was donated by GlaxoSmithKline and cholera vaccine by Dukoral.

The road blocks encountered during this trial in Kolkata are an example of the difficulties of caring out such a program from political and religious tensions and burocratic delays to mistruths spreading like wild fire among the largely illiterate trial participants. The institute had to get an endless list of clearances from National health ministry committee, local councilors, ethics and human right groups, Hindu priests, Muslim imams and community thugs. During the typhoid vaccine trials rumors were spreads that the scientists were injecting cancer cells in to people. Others believed that they were being sterilized. There was mass panic.

About 65% of the targeted study group eventually gave their consent and receive the typhoid jab. A big reason for this level of success was Dipika Sur, director of epidemiology who employed 250 slums, dwellers as community health workers, field supervisors and sample collectors. The strategy paid of largely because of staggeringly high unemployment levels in the slums. Today a health worker goes door to door sending patients with persistent symptoms of diarrhea or fever to one of seven “health outpost”, where patients received free blood test and medicines if diagnosed with cholera or typhoid. Here people can see a doctor and be treated right away. Families who share a room with 11 members are aware how important it is to keep the bathroom clean and not to drink polluted water.

India is becoming an increasingly appealing location for undertaking clinical trials. A trial in India costs half as much as in the United States, and India has a high prevalence of diseases, such as diabetes and heart disease, that predominantly affect the developed world. But India's future as a centre for 'outsourced' clinical trials could be in jeopardy. Despite its advanced hospitals, the country is struggling to find enough trained staff to run the clinical trials and lacks a central database to track them once they are underway. There are several recent cases where researchers did not comply with ethics regulations. Trial participants were, without their knowledge, given drugs that had not been approved by the health ministry or been tested adequately in animals.
If the government fulfils its promise to tighten regulations, India could benefit greatly not just from the revenue generated by these trials, but also from the new drugs being tested in its population. At least 2 million persons succumb annually to enteric infection, and in countless other patients, diarrhea disease aggravates malnutrition and susceptibility to other infections. Prevention of enteric illness by virtue of improved hygiene and provision of sanitation and water treatment is impractical in most developing countries, where morbidity and mortality rates are highest. For this reason my opinion is that development of vaccines against the most important gastrointestinal infections remains a high priority.

The biotech companies from whole world should unite and help each other by eliminating the spread of deadly diseases and bring awareness among people and live life in a clean environment.

Marijuana may stave off Alzheimer's

Another news item in the category of "needs rigorous clinical trials"~ From Reuters this morning:

Good news for aging hippies: smoking pot may stave off Alzheimer's disease.

New research shows that the active ingredient in marijuana may prevent the progression of the disease by preserving levels of an important neurotransmitter that allows the brain to function.

Researchers at the Scripps Research Institute in California found that marijuana's active ingredient, delta-9-tetrahydrocannabinol, or THC, can prevent the neurotransmitter acetylcholine from breaking down more effectively than commercially marketed drugs.

THC is also more effective at blocking clumps of protein that can inhibit memory and cognition in Alzheimer's patients, the researchers reported in the journal Molecular Pharmaceutics.

The researchers said their discovery could lead to more effective drug treatment for Alzheimer's, the leading cause of dementia among the elderly. To read on, click here.

Photo: (AFP/Getty Images/Ron Wurzer)

The Feminization of Medicine

[Hat tip, Sean Philpott] From the Boston Globe, an article about the changing face and character of medicine:

Over the last quarter-century, women have entered the field of medicine in unprecedented numbers, changing not only its face but its character...

Nearly half of medical school students nationwide are now female, and as they enter the profession, they are making patient care friendlier and therefore may be less likely to get sued than male physicians. Women physicians also are more likely to serve minority, urban, and poor populations and are twice as likely to go into primary care....The implications for the physician workforce are significant. .. To read on, click here.

(Boston University Alumni Medical Library photo)

Organ "Donations" from Chinese Prisoners

The darker side of bioethics. This video is heart-retching and could not argue louder for a Universal Declaration on Bioethics and Human Rights. Watch it and weep.


http://www.youtube.com/watch?v=TklqtWzNn_A

From the BBC:

Organ sales 'thriving' in China

Chinese officials say the prisoners volunteer to donate their organs. The sale of organs taken from executed prisoners appears to be thriving in China, an undercover investigation by the BBC has found. Organs from death row inmates are sold to foreigners who need transplants. One hospital said it could provide a liver at a cost of £50,000 ($94,400), with the chief surgeon confirming an executed prisoner could be the donor. China's health ministry did not deny the practice, but said it was reviewing the system and regulations.

'Present to society'

The BBC's Rupert Wingfield-Hayes visited No 1 Central Hospital in Tianjin, ostensibly seeking a liver for his sick father. Officials there told him that a matching liver could be available in three weeks.

Thanks to bioethics.net for bringing this to our attention.

Google Results for Bioethics Penis: 79,700

Now for the lighter side of bioethics:

I spent much of the day working on optimizing the Women’s Bioethics Project blog and website to increase our readership. (Yes, the glamorous life of running a public policy think-tank.) My husband, who is a software engineer, suggested that rather than the tedious process of linking to appropriate websites or writing content that will be picked up by widely read newsgroups, I should just add “penis” to my keyword list and be done with it.

Rather than indulge in such a gratuitous attempt to increase our Google ranking, I did some crack research so I could offer two recent postings from the prestigious American Journal of Bioethics and the venerable Hastings Center on the topic:

Penis Transplants in China
http://blog.bioethics.net/2006/09/insert-penis-here.html

Proof that I Like Penises
http://www.bioethicsforum.org/20060310adreger.asp

I think that about covers (or uncovers it.) Back to neuro-ethics.

Call for Papers: Women's Health Conference

The Pennsylvania Hospital, Philadelphia, will host its second annual
History of Women's Health Conference on Wednesday, April 11, 2007. We invite interested persons to send a two page proposal or abstract of your topic by Wednesday, November 15, 2006 for consideration. The History of Women's Health Conference focuses on women's health issues from the late 18th century to the present. This conference encourages interdisciplinary work. Topics of interest include, but are not limited to, obstetric and gynecology issues (fertility, infertility, birth control methods, menopause), adolescence (health, cultural influences, body image), mental health topics, geriatric concerns, overall women's health, access to health care, minority health and more.

Please submit your proposals/abstracts to:

Stacey C Peeples
Lead Archivist, Pennsylvania Hospital
3 Pine East, 800 Spruce St.
Philadelphia, PA 19107
(215) 829-5434 (v)
(215) 829-7155 (f)

Where the Rubber Meets Roe

William Saletan argues that the abortion debate is morphing: Either you're for reducing the numbers or not:

The issue that never changes is finally changing.

If you're one of the millions of Americans who don't like abortion but also don't like the idea of banning it, good news is on the way. In the last three weeks, two bills have been filed in the House of Representatives. Without banning a single procedure, they aim to significantly lower the rate of abortions performed in this country. Voluntary reduction, not criminalization or moral silence, is the new approach.

How do you stop abortions without restricting them? One way is to persuade women to complete their pregnancies instead of terminating them. The other is to prevent unintended pregnancies in the first place. And there's the rub—or, in this case, the rubber. The two House bills used to be one proposal, backed by an alliance of pro-life lawmakers and organizations. The alliance split because one faction wanted to fund contraception and the other didn't. Read on.

The Value of Life: War vs Embryos

[Hat tip to Josh Perry for this alert] Scathing Slate article on Bush's faulty reasoning on embryonic stem cell research by Michael Kinsley:

It was, I believe, Rep. Barney Frank, Democrat of Massachusetts, who first made the excellent, bitter, and terribly unfair joke about Ronald Reagan: that he believed in a right to life that begins at conception and ends at birth. This joke has been adapted for use against various Republican politicians ever since. In the case of President George W. Bush, though, it appears to be literally true.

Bush, as we know, believes deeply and earnestly that human life begins at conception. Even tiny embryos composed of half a dozen microscopic cells, he thinks, have the same right to life as you and I. That is why he cannot bring himself to allow federal funding for new stem-cell research, or even for other projects in labs where stem-cell research is going on. Even though these embryos are obtained from fertility clinics where they would otherwise be destroyed anyway, and even though he appears to have no objection to the fertility clinics themselves, where these same embryos are manufactured and destroyed by the thousands, the much smaller number of embryos needed and destroyed in the process of developing cures for diseases like Parkinson's are, in effect, tiny little children whose use in this way constitutes killing a human being and therefore is intolerable.

But President Bush does not believe that the deaths of all little children as a result of U.S. policy are, in effect, murder. He thinks that some are, while very unfortunate, also inevitable and essential.

You know who I mean. Close to 50,000 Iraqi civilians have died so far as a direct result of our invasion and occupation of their country, in order to liberate them. The numbers are actually increasing as the country slides into chaos: more than 6,500 in July and August alone. These numbers are from reliable sources and are not seriously contested. They include many who were tortured and then killed, along with others blown up less personally by car bombs and suicide bombers. The number does not include the hundreds of thousands who have died prematurely as a result of a decade and a half of war and embargos imposed on the Iraqi economy. Nor does it include soldiers on both sides, most of whom are innocent, too. Last week the number of American soldiers killed in Iraq and Afghanistan surpassed the number of people who died in the terrorist attacks of Sept. 11, 2001.

To read on, click here.