Bioethics Rumble? Let's Roll!

A recent AJOB blog cites the building anticipation for a potential “bioethics rumble” at the ASBH Summer Conference: Bioethics and Politics: The Future of Bioethics in a Divided Democracy,” to be held July 13-14, 2006 at the Crowne Plaza in Albany, NY. Linda MacDonald Glenn and I will be blogging live from the conference and will report any bloodshed.

We were delighted that WBP’s soon to be published whitepaper was selected to be presented at the conference. Below is the abstract:

Bioethics and Public Policy:A Competitive Analysis of Americans United for Life

How does an established, pro-life advocacy group reshape itself into a self-proclaimed “non-profit, public interest bioethics law firm” using bioethics to drive its political agenda? Bioethics and Public Policy: A Competitive Analysis of Americans United for Life examines the strategies and tactics of one of the most prolific and active conservative organizations that is working to shape bioethics public policy through legislation, pro bono legal counsel, and public opinion. Analysis of Americans United for Life’s programs—such as model state legislation on bioethical issues, whereby they provide everything a state legislator would need to draft, defend, publicize and push through legislation—illustrates how an organization’s ability to focus at a state level to promote a conservative bioethics agenda fits in to the bigger picture of conservative politics. Americans United for Life also has important connections to influential D.C. based conservative think tanks and bioethics centers. It’s a fascinating look at how political influence directly shapes bioethics in the world today.

For more information on the conference: http://politics.bioethics.net/

Diagnosing The Right Depression

Seeking help for depression is the first step. But there are different types of depression, which need their own specific treatments. Learn the differences and what you can do to get better.

Such Obscenity!

From guest blogger, Peter J. Cohen, MD, JD, Adjunct Professor of Law, Georgetown University Law Center and Chair, Physician Health Committee, Medical Society of the District of Columbia:

I breathed a profound sigh of relief when I learned that the Congress had passed legislation increasing penalties for broadcast indecency as I am now assured that my eyes will no longer be assailed by “wardrobe malfunctions.” However, I wonder when our lawmakers will see fit to deal with the far more significant indecencies—nay obscenities—which we observe in our daily newspapers and TV news broadcasts every day. Just a few examples come to mind:

• Deplorable infant mortality, a disgrace to our nation
• Our impoverished people who suffer and die every day for lack of even basic health care
• Our society—far more concerned with the “legality” of immigrants than with their humanity
• A volunteer army that allows the overwhelming majority of our population to remain completely unaffected by our wars
• A system of lobbying, campaign financing, and influence peddling that make a mockery out of the democratic process

That is enough—Time and respect for the rain forests that produce our newsprint do not permit a complete listing.

Women's Bioethics Blog

Routine HIV testing in the District of Columbia

I have often wondered if blood samples taken for laboratory tests or during hospitalization are screened for human immunodeficiency virus (HIV). One could argue that routine screening of blood samples would be a good laboratory safety precaution; or that it could help catch infections in unsuspecting individuals, allowing early treatment and slowing the spread of the disease overall. A battery of questions flows: Could it also be argued that routine lab and hospital screening is too costly to be practical? Are there a set of guidelines for when HIV screening is performed? Are HIV screenings only performed when they must be ruled out as part of an explanation for a set of symptoms? Was my blood screened for HIV when I was hospitalized? Would I have been told only if my test was positive? Would routine hospital screening for HIV be considered a violation of privacy or other rights without patient consent?

Now the city of Washington, DC, which is believed to have the highest rate of HIV infection in the country (179.2/100,000 people), is urging mandatory HIV testing as part of routine health screening for all patients between the ages of 14 and 84. The Centers for Disease Control (CDC) has been pushing for physicians to routinely screen patients, but this is the first local effort of its kind. Starting tomorrow, the city will distribute 80,000 tests to community groups, doctors' offices, emergency rooms, and STD clinics. These are oral swab tests that produce results in twenty minutes, as opposed to blood tests that can take two weeks to process. According to Jason DeParle of the New York Times, this is "significant because many people who underwent the earlier tests never returned to learn the results, meaning those with the virus remained unaware of the risk they posed to others." I would take a guess that any test that can be processed in twenty minutes is also much less costly than one that gets sent to the lab for two weeks.

While the practicality of an oral test and the idea of routine testing potentially dissolve a few barriers toward HIV detection, there are still many questions to be addressed. Firstly, in a city of more than 550,000, how far will 80,000 tests go, and what happens when they run out? Susan Levine of the Washington Post reported on Saturday that the aim is to use up that supply by the end of the year, "which would mean reaching a fifth of their key population in the next six months." Both Patricia Nalls of the Women's Collective in Northwest Washington and Walter Smith of the DC Appleseed Center for Law and Justice expressed concerns about not having heard any detail about planning for necessary counseling and follow-up care for a newly diagnosed HIV-positive population.

It is also unclear as to whether routine screening does present a privacy issue. Alan Cross reported that the "recommendation met with some resistance from privacy advocates who felt that such a testing might end up stripping HIV-positive people of their privacy and a breach of confidentiality would make it difficult for them to lead normal lives."

Sources and further reading:

Deparle, Jason, "District of Columbia Urges Routine HIV Testing." New York Times, 25 June 2006, http://www.nytimes.com/2006/06/25/us/25hiv.html.

Levine, Susan, "DC Wants HIV Testing for All Residents 14 to 84." Washington Post, 24 June 2006, A01, http://www.washingtonpost.com/wp-dyn/content/article/2006/06/23/AR2006062301685.html.

Cross, Alan, "DE's new campaign to test 14 to 84 year-olds for HIV." Earthtimes.org, 25 June 2006, http://www.earthtimes.org/articles/show/7331.html.

Drug Maker Calls for Limiting Risk Information in Drug Ads

At a time when many are calling for more risk information in direct-to-consumer pharmaceutical ads, a new study from AstraZeneca puts a cap on the number of risks mentioned in TV spots before the consumer is overloaded.

Three is optimal. Four is good. Five is OK. Anything more than that, said the drug maker, and you start wandering into too-much-information territory.

But this runs contrary to counter to what the rest of the industry has discussed. The Food and Drug Administration has repeatedly asked for more risk information, and in remarks earlier this year the director of its drug marketing, advertising and communications division, Thomas Abrams, noted that 82% of pharmaceutical company violations in the past year were related to inadequate presentation of risk information.

Test may help "which came first" question in Alzheimer's

A new test may help scientists answer a perplexing "which came first" question about the development of Alzheimer's disease, possibly pointing the way to earlier diagnosis or even treatment.

Brain deposits of a small protein known as amyloid beta long have been associated with Alzheimer's. But scientists have been unable to determine whether the body begins producing too much of the protein or loses the ability to clear it away.

Now, a research team led by Dr. Randall J. Bateman at Washington University in St. Louis is poised to find that answer with a test that for the first time can monitor the protein.

An initial test of the new technique on six healthy volunteers determined that the protein is quickly produced and quickly cleared, keeping it in balance in the central nervous system, the researchers report in Monday's online issue of the journal Nature Medicine.

Does Anyone Remember what happened to the goose who laid the golden eggs?

In the Boston Globe:

Drowning in credit-card debt and student loans, young women are selling their eggs for big payoffs. But can they really make the right medical and moral decisions when they're tempted with $15,000?

Womb transplants may be possible in 5 years

My question is, how will this affect the moral and legal status of embryos and fetuses?

St Kitt's or the Island of Dr. Moreau?

On the sun-splashed Caribbean island of St. Kitts, Yale University researchers are injecting millions of human brain cells into the heads of monkeys afflicted with Parkinson's disease.
In China, there are 29 goats running around on a farm with human cells coursing through their organs, a result of scientists dropping human blood cells into goat embryos.
The mixing of human and animal cells in the name of medicine has been going on for decades. People are walking around with pig valves in their hearts and scientists have routinely injected human cells into lab mice to mimic diseases.
But the research is becoming increasingly exotic as scientists work with the brains of mice, monkeys and other mammals and begin fiddling with the hot-button issue of cloning. Harvard University researchers are attempting to clone human embryonic cells in rabbit eggs.
Such work has triggered protests from social conservatives and others who fear the blurring of species lines, invoking the image of the chimera of Greek mythology, a monstrous mix of lion, goat and serpent.
During his State of the Union speech in January, President Bush called for a ban on "human cloning in all its forms" and "human-animal hybrids," labeling it one of the "most egregious abuses of medical research."
He didn't elaborate, but scientists working in the field believe that by "hybrids," the president meant creating living animals with human traits - something they say they aren't doing.
Other critics are calling for stricter regulations on the research.

Man's (and Woman's) Best Friend Saves Life

From the Washington Post: A Bite and Bark That Saved a Life -- Cellphone Chomp Called 911 for Beagle's Owner:

Belle Weaver is flying into the nation's capital today to receive an award for saving a family member's life. Before she leaves town, she'll meet with her congressman, accept a certificate autographed by a football great and bow her head to receive a medal. Stories such as hers, of heroism and quick thinking, are always inspiring. But this one has a twist, and not just because Belle is 3 years old -- she's a beagle. And she used her owner's cellphone to call 911. Her owner, Kevin Weaver, 34, was in the throes of a diabetic seizure, lying unconscious on his kitchen floor in Ocoee, Fla., when Belle located his phone and chomped down on the keypad, triggering a call.

The only thing emergency dispatchers heard was barking, but it was enough cause to send help, they reasoned. Weaver, a former flight attendant, woke up hours later in the hospital, weak and disoriented. Belle was there by his side, having finagled a ride in the ambulance.

Are we unable to let go of our fears?

Blood shortages have been a problem in this country for some time now. There are always blood drives that try to entice and encourage people to donate blood for a good cause. From my point of view, I always found these blood drives to be a success, however the drives are not enough to lift the blood shortage to a sufficient status. According to an article written by Arthur Caplan, there seems to be an increasing shortage in blood supply owing to the fact that men who engage in same sex relationships are not permitted by law to donate blood. Apparently, since the AIDS epidemic became a threat in the mid 1980s, gay men have since not been allowed to even give their blood owing to their vulnerability to the disease. The government placed this law in effect when the epidemic was new and treatment was not available. Caplan feels that the shortage is owed to the fact that our government is still holding on to old fears by not allowing gay men to donate blood. With the advancement of medicine allowing for people to live longer and to combat the disease more efficiently, Caplan maintains that it is time for all people to give their blood by choice, and not be denied to do so just because of their sexual orientation. With the ever changing advancement of technology, AIDS and HIV can be detected earlier according to Caplan...so what should we be worried about? The government should realize that things are progressing at a positive rate in the medicine field. If we want these blood shortages to stop, the government should make some changes.Read more: http://www.msnbc.msn.com/id/13106365/

Combatting Obesity

Obesity has been on the rise since the late 1980’s. Today, approximately 65% of Americans are overweight, and over 30% of Americans are obese. The number of overweight children has also doubled. “According to some estimates, obesity results in thousands of deaths a year and accounts for $117 billion in U.S. health care expenses annually.”1
In an effort to combat the growing rate of obesity in the U.S., the FDA recently released the Keystone Report. In a world in which all of our portions are “super-sized,” the Keystone Report offers some solutions for controlling caloric intake, especially when eating outside the home. “Americans spend approximately 46 percent of their food budget on food prepared away from home and take in 32 percent of their calories from such foods.”1
The Keystone Report offers recommendations about how to change consumers eating behaviors. Specifically, the Report suggests increasing the marketing of lower calorie foods like fruits and vegetables and providing consumers with nutritional information. Although there has been an increase in the amount of nutritional information available to consumers, more improvements are possible. Most dining establishments still do not provide such nutritional information.
I agree that the FDA and other government agencies should continue to educate the public about health and dietary issues. However, because obesity rates are still on the rise, perhaps the government should also try to promote the benefits of eating more balanced meals at home. We will not see substantial improvements in the obesity rates until more education comes from within the home. Parents have to education themselves and their children about the benefits of eating healthy and exercising. Children sitting in front of the television hearing about exercising and eating more fruits and vegetables are not going to make any changes on their own. Unless parents talk to their children and lead by example, government initiatives will not make the improvements that they could.
Sources:
1http://www.fda.gov/bbs/topics/NEWS/2006/NEW01379.html
http://www.cnn.com/2006/HEALTH/diet.fitness/06/02/restaurants.obesity.ap/index.html

FDA Approves Thalidomide

The ratio of benefits vs. risks of a potential new drug is a main factor in deciding to approve a new drug. However, the acceptable ratio depends on the targeted condition or disease. For instance, numerous adverse effects are often associated with cancer treating medications. Due to the high mortality associated with cancer, these side effects are deemed acceptable compared to the death rates and other serious complications of cancer.
I read an article on CNN.com entitled “Thalidomide Approved for Cancer Treatment.” On May 25, 2006, the FDA approved the use of thalidomide in treating patients recently diagnosed with multiple myeloma. Thalidomide, in combination with dexamethasone, is to be used in treating multiple myeloma.
In the early sixties when thalidomide was used by pregnant women, it was discovered that thalidomide caused numerous birth defects. Specifically, it stunted the growth of fetal arms and legs and caused eye, ear, heart, and kidney defects. As a result, the use of thalidomide was banned worldwide in 1962.
Even today, with its FDA approval, thalidomide is being marketed under a “restricted distribution program.” Thalidomide labels display multiple warnings about the risk of birth defects. There is also a warning for male patients stating that it is unknown if thalidomide is present in semen. Due to the severe risks associated with thalidomide even the FDA provides information on its website about thalidomide and warns about the drug’s effects: “Do not take this drug if there is any possibility that you are, or may become, pregnant. Just one dose can cause severe birth defects.”
In addition to myeloma, thalidomide is also being examined in clinical trials as a treatment for a variety of solid tumors and blood cancers.
I found it interesting, and concerning, that a drug with such serious side effects will be used in hopes of prolonging the life of multiple myeloma patients. My concern is based on the CNN article’s suggestion that the success of the clinical trials is somewhat questionable and unknown. For the sake of those multiple myeloma patients that will take this medication in hopes of treating their condition, I hope that the efficacy of the drug outweighs the side effects.
Sources:
http://www.cnn.com/2006/HEALTH/conditions/05/25/thalidomide.cancer.ap/index.html
http://www.fda.gov/cder/news/thalidomide.htm
http://www.multiplemyeloma.org/treatments/3.04.html

Too Much Information -- DNA Home Kits

Imagine being able to order a genetic test over the Internet -- to see if you have inherited a predisposition to cancer or whether there might be a genetic component to your infertility -- without having to get approval from your doctor, consult a genetic counselor or risk the fallout that might result from filing an insurance claim.

Now imagine sitting alone at your home computer and receiving devastating news: test results that will forever change your life -- and your family's -- in ways you never anticipated.
Those are the promises and perils of the nascent, growing and largely unregulated phenomenon of direct-to-consumer (DTC) genetic tests. For the price of a mail order test kit containing swabs to scrape cells inside the cheek, nearly a dozen companies now offer curious consumers the chance, without ever seeing a doctor, to learn whether they carry genes for cancer, blood disorders or other diseases. Some companies are marketing personalized diet or skin care recommendations based on DNA analysis using tests that are not widely accepted in the scientific community.

For more, read on...

Hawking Says We Must Sail Beyond the Sunset To Survive

In a manner reminiscent of "To Sail Beyond the Sunset" (both the poem of Ulysses by Alfred Tennyson and the book by science fiction author Robert Heinlein), world reknowned astrophysicist Stephen Hawking has said that the survival of the human race depends on its ability to find new homes elsewhere in the universe because there's an increasing risk that a disaster will destroy the Earth.

Humans could have a permanent base on the moon in 20 years and a colony on Mars in the next 40 years, the British scientist told a news conference. "We won't find anywhere as nice as Earth unless we go to another star system," added Hawking, who arrived in Hong Kong to a rock star's welcome Monday. Tickets for his lecture planned for Wednesday were sold out.

He added that if humans can avoid killing themselves in the next 100 years, they should have space settlements that can continue without support from Earth.

"It is important for the human race to spread out into space for the survival of the species," Hawking said. "Life on Earth is at the ever-increasing risk of being wiped out by a disaster, such as sudden global warming, nuclear war, a genetically engineered virus or other dangers we have not yet thought of."

UN hears about HPV Vaccine

I am pleased to have been invited to speak at the UN Department of Economic and Social Affairs, Division for the Advancement of Women on June 6, 2006. The meeting was chaired by Ms. Rachel Mayanja, UN Assistant Secretary General and Special Advisor to UN Secretary General Kofi Annan on Gender Issues and Women's Advancement (OSAGI). Over 20 high-ranking UN officials attended the meeting. Novel developments of particular concern to women include human egg and other tissue markets, as well as the recently announced vaccine for cervical cancer, a disease which kills approximately 300,000 women each year--mostly in the developing world. I argued that it is vital for women, who have a special stake in bioethical issues, to come together to promote a thoughtful application of biotechnology to improve the status of women's lives, to safeguard women's bodies from harm, and to ensure that social policies regarding women are appropriately recognized and incorporated into public policy.
Read more about:www.iheu.org/bioethics

The Capitalization of Medical Services?

One morning last week I was rudely awakened by the blaring news report coming from my radio alarm about a private medical practice offering, for an extra charge, preferential patient treatment that would include services such as next-day appointments, three-minute return phone calls, and real-time access to a doctor by cell phone or email. I was horrified. If some patients pay extra fees for priority service, isn't response time and level of service for patients who can not pay extra fees necessarily de-prioritized and slowed? My jaw dropped a little further when I heard the doctor speaking for the practice rationalize the idea by explaining that without the extra revenue derived from premium services, his practice would be out-of-business within the next year or two.

I was immediately reminded of an issue I worked on when I was an advocate for artists and cultural organizations. In 2001, the United States Immigration and Naturalization Service (now the U.S. Citizenship and Immigration Services) implemented a $1000 premium processing fee for non-immigrant visa applications. This service worked in favor of businesses who could pay the fee to have the applications of new foreign employees processed in 15 days, but it significantly lengthened the time it took to process non-premium application (to as much as 120 days). As a result, the visa applications of international artists who could not pay the fee were delayed enough that some missed their own performances in the U.S. and many cultural institutions experienced booking difficulties.

I was a little groggy when I heard this news and I had missed the first half of the story, so I later Googled around for a matching news article with the information I missed. I didn't find an exact match, but I did find a number of other articles about the phenomenon—that is, concierge medicine or “pay-for-care” services. Concierge-style medical practices charge an annual fee of anywhere from $700 to $6000 for the patient conveniences mentioned above, and additional per-visit fees of $50 to $200 depending on the service provided. Many patients who utilize concierge medical services claim that these fee-based conveniences save them aggravation in obtaining care, provide them with better quality health care, and save them money and time in the long-run. Many of these patients also keep their regular health insurance to cover major and emergency medical needs.

I couldn't help but wonder, if I as a patient could pay the extra fees, why should I, on principle, have to pay anything on top of what I'm already shelling out for health insurance and copays, just to get decent service? Furthermore, would it not be selfish of me to opt for premium service knowing that medical care resources are limited and I would in effect be taking away a level of service from patients who can not afford extra costs?

Should a line be drawn between different kinds of services, those for which premium service is stratified by cost and those for which levels of service must be prioritized by something else? I thought to myself, it's one thing to charge extra fees for a service that does not directly infringe on the rights of an individual. I don't have a problem with the idea of stratefying cost according to speed of package delivery, as it is unlikely to affect any critical aspect of my life (like my health), and the use of premium services do not strain the resources of the delivery company. Health care services are sometimes prioritized by urgency of medical need, for example, in the emergency room, or when my physician will give me a same-day appointment because I have been running a high fever for several days. But once someone else can out-prioritize me by paying more, medical urgency goes out the window.

It then occurred to me that it may be more ethical to run a purely pay-for-service practice, as opposed to a practice that offered fee-based services for those who could afford them but still accepted patients who could not. (I'm not sure exactly how the practice on the news operated.) Some doctors who run concierge-style medical practices in fact claim that they are better able to care for their patients because they see fewer patients without sacrificing revenue and save time by not having to submit health insurance claims for patients. Declining rates of insurance reimbursements for providers was also cited as incentive to run concierge practices.

Still, the existence of a few concierge-style medical practices creates the potential for skew in who gets the better medical care and an environment of “you get what you pay for.” I can imagine that as things currently stand only a very small percentage of the population could or would be willing to pay several thousand more dollars a year for medical care. I am reminded of a conversation I had with a Philadelphia-based psychotherapist about the administrative and cost issues of insurance supplementation for mental health services: she told me that many of her colleagues had chosen to move their practices to Main Line areas, where patients would be likely pay for services not covered by insurance. This was not to suggest that those therapists were not aware that they were potentially contributing to an overall situation of better care for the “haves,” but that they had perhaps had made a very difficult personal choice, an ethical leap, that the benefits to perhaps themselves or their families or the future of their practices outweighed the issues (and their abilities to operate within them) presented in today's landscape of psychological and medical care in the United States. Though I certainly do not believe that the idea of concierge medical practices or psychological services available only in economically advantaged areas is a viable solution to the critical issues of a medical care coverage system that is groaning under its own weight, I do believe that it is worthwhile considering the idea that concierge medical practices are a valid development, or an ethical/pragmatic response to the current landscape of medical care coverage. This also forces consideration of the fact that, as things now stand, U.S. citizens are hardly on a level playing field in terms of medical coverage and quality of care, and I can't help but wonder that if pay-for-care medical service was the norm, things might not be that much different than they are now.

Some interesting news stories about concierge medicine:
http://www.bradenton.com/mld/bradenton/news/nation/14477842.htm
http://cbs2chicago.com/health/local_story_125141203.html
http://www.msnbc.msn.com/id/6885323/site/newsweek/

and from the Miami Herald.

The DaVinci Code and Women's Bioethics

Maybe it's a little bit of stretch, but what does the book and the movie The DaVinci Code have to do with Women's Bioethics? How about this for arguments: "...the latest challenge to women's lowly status in religion. The female place in sacred history, according to a group of researchers, goes beyond wife, mother and follower." The pro-life movement sees it this way: 'The Da Vinci Code is a piece of propaganda which follows the same pattern as the revolution that gave us abortion and the rest of our promiscuous culture. The fallout of that revolution ... could lead to the spiritual deaths of millions more."


What are your thoughts? Does anybody else see more connections? Or is this too much of stretch?

Human Papillomavirus (HPV) Recombinant Vaccine Approved by FDA

U.S. Food and Drug Administration (FDA) today approved a Quadrivalent Human Papillomavirus Recombinant Vaccine. It is the first and only vaccine to prevent cervical cancer and vulvar and vaginal pre-cancers caused by HPV types 16 and 18 and to prevent low-grade and pre-cancerous lesions and genital warts caused by HPV types 6, 11, 16 and 18 and is developed by Merck and will be marketed under trade name Gardasil.

Arthur Allen does a nice job of discussing some things we should be thinking about in his Slate article: And Now, the HPV Vaccine: Warts and all (http://www.slate.com/id/2143304/) :

"...how to get the vaccine to the women and girls who need it most—poor, uneducated women and those in the developing world. "None of us are going to be happy if the only women who get the vaccine are the same women who are already getting regular screens for cervical cancer," John Schiller, one of the vaccine's inventors, told me at his National Institutes of Health laboratory. The Vaccines for Children program, a Clinton-era entitlement, will probably make the vaccine available for free to poor children in the United States. But social conservatives like Focus on the Family leader James Dobson have opposed making vaccination mandatory, believing vaccination might lower barriers to teen sex.In a roundabout way, this prudery may keep the vaccine out of reach of poor girls. Research and experience have shown that only mandatory-vaccination laws—which typically increase vaccination rates by 10 to 15 percent—get even cheap vaccines to the poor. Given the politics, state legislatures and public health boards may shy from requiring HPV vaccine for middle-school entry."

And Justice Healthcare for All....

This falls under the category of 'no big surprise' : The federal government should guarantee that all Americans have basic health insurance coverage, says a committee set up by Congress to find out what people want when it comes to health care.

"Assuring health care is a shared social responsibility," says the interim report of the Citizens' Health Care Working Group, a 14-member committee that went to 50 communities and heard from 23,000 people.

The committee describes its recommendations as a framework. The recommendations don't say who would pay for universal health coverage or how much it would cost. The concept of government-guaranteed coverage runs counter to the Bush administration's position that consumers should bear more responsibility for their initial medical expenses.