Quote of the Day: "rats and mice get greater protection as research subjects in the United States than do humans"

“In many ways, rats and mice get greater protection as research subjects in the United States than do humans,” said Arthur L. Caplan, chairman of the department of medical ethics at the University of Pennsylvania. Dr. Caplan is quoted in the NY Times today, in response to a report due to be released Friday by the inspector general of the Department of Health and Human Services, Daniel R. Levinson. The report finds that Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials.

Art points out that "Animal research centers have to register with the federal government, keep track of subject numbers, have unannounced spot inspections and address problems speedily or risk closing, none of which is true in human research."

"Because no one collects the data systematically, there is no way to tell how safe the nation’s clinical research is or ever has been."

To read the full article, click here.

[Editor's note: Art has written an MSNBC column about the report -- here's an excerpt:
"When a bridge collapses in an American city or a mine implodes, it does not take long before government gets in motion to figure out what to do about the problem. We see the carnage and demand action.

When a federal agency charged with protecting your health and safety is found grossly deficient, the response, sadly, is mainly talk.

When a bridge collapses in an American city or a mine implodes, it does not take long before government gets in motion to figure out what to do about the problem. We see the carnage and demand action.

When a federal agency charged with protecting your health and safety is found grossly deficient, the response, sadly, is mainly talk.

That is because it is hard to see where the victims are and, without them, it is hard to get the problem fixed. But when it comes to the Food and Drug Administration, we had better demand repairs.

A new report from the inspector general of the Department of Health and Human Services paints a very grim picture as to how well the FDA protects Americans who are subjects in human experimentation. The FDA is called on the carpet for not knowing how many experiments are actually being done in the United States. The report also faults the FDA for inadequate audits of research sites and a failure to ensure compliance with its orders when FDA inspectors find something amiss at a research site.

The problems discussed in the report are not new. They have been festering for years. Who is to blame?" The rest can be read here.

'Sexy' Issues in Health Care (or Let's Talk About Sex)

[Hat tip to R. Alta Charo for this] Slate is running their Sex and more sex issue, and prurient curiosity aside, there are very several interesting articles that might be of interest to bioethicists:

In the article Cancer Sluts, Meghan O'Rourke examines the proposition that a cervical-cancer vaccination would "promote promiscuity" among teenage girls.

In the article Naughty Nursing Homes, Daniel Egber examines the potential benefits of more sex for the elderly in nursing homes vs. the administrative nightmare of protecting a patient that isn't able to consent to sex at all, which could amount to a new elder version of 'gray rape'.

And from Juliet Lapidos (aka 'the Sexplainer'), an article asking Is Mad Cow an STD? , and explaining that the government seems to think it is, when it comes to FDA ban on sperm from all European countries with exposure to mad cow.

Happy reading~!

Testing Your Sanity

The NY Times is chockablock full of goodies this morning, including this little gem: A new web site helps you figure out just how mentally stable you are: www.sanityscore.com. Full article and explanation here.

Another Quote Worth Noting

“All I knew before was that you could get cancer from it,’’ she said. “I didn’t know you could get very ugly."-- talking about smoking, in a NY Times article about how Tyra Banks and America’s Next Top Model are going smoke-free.

Of Animal Eggs and Human Embryos

We've blogged several times about issues with the donation of eggs before, but this week the NY Times has an unusual editorial about a possibly 'elegant solution to the vexing egg donor problem.':

"Stem cell research in the United States has been hobbled for years by severe and misguided restrictions on federal funding. But now a vexing additional problem is slowing even privately financed research. There are distressingly few women willing to donate their eggs for experiments at the frontiers of this promising science..."

To read the rest, click here.

Was John Paul II Euthanized?

From Time magazine this week, an article that made raise my eyebrows:

"In a provocative article, an Italian medical professor argues that Pope John Paul II didn't just simply slip away as his weakness and illness overtook him in April 2005. Intensive care specialist Dr. Lina Pavanelli has concluded that the ailing Pope's April 2 death was caused by what the Catholic Church itself would consider euthanasia. She bases this conclusion on her medical expertise and her own observations of the ailing pontiff on television, as well as press reports and a subsequent book by John Paul's personal physician. The failure to insert a feeding tube into the patient until just a few days before he died accelerated John Paul's death, Pavanelli concludes. Moreover, Pavanelli says she believes that the Pope's doctors dutifully explained the situation to him, and thus she surmises that it was the pontiff himself who likely refused the feeding tube after he'd been twice rushed to the hospital in February and March. Catholics are enjoined to pursue all means to prolong life."

To read on, click here.

The Healing Power of Playfulness

We've blogged about laughter being the best medicine before and now, one of our readers brought this extraordinary and tender audio slide show about play, to our attention. The slide show and podcast were put together by Stuart Brown, MD, the director of the National Institute for Play. Dr. Brown and his board of advisors say that "pleasurable, purposeless activity prevents violence and promotes trust, empathy, and adaptability to life's complication." The Institute studies the cutting-edge science of human play, and draws on a rich universe of study of intelligent social animals.

It reminds of a novel I read not too long ago, by Dean Koontz, called One Door Away From Heaven. And although I think Dean Koontz has the wrong impression about 'bioethicists', he does get dogs right -- towards the end of the book, he talks about dogs and their connection to a "playful Presence." Here's the quote:

"Every world has dogs or their equivalent, creatures that thrive on companionship, creatures that are of a high order of intelligence although not of the highest, and that therefore are simple enough in their wants and needs to remain innocent. The combination of the innocence and their intelligence allows them to serve as a bridge between what is transient and what is eternal, between the finite and the infinite.

"...For those who despair that their lives are without meaning and without purpose, for those who dwell in a loneliness so terrible that it has withered their hearts, for those who hate because they have no recognition of the destiny they share with all humanity, for those who would squander their lives in self-pity and in self-destruction because they have lost the saving wisdom with which they were born, for all these and many more, hope waits in the dreams of a dog, where the sacred nature of life may be clearly experienced without the all but blinding filter of human need, desire, greed, envy, and endless fear. And here, in dream woods and fields, along the shores of dream seas, with a profound awareness of the playful Presence abiding in all things..."


So take a deep breath and think, when was the last time you played?

Discounts on IVF for Egg Donors in UK

Newcastle Fertility Centre is offering women in northeastern England a £1500 discount on their IVF bills if they donate some of their eggs for therapeutic cloning and stem-cell research purposes. A spokesperson for the Centre commented that this will reduce the cost of IVF for some women, and that the donation poses no risks beyond those that accompany the IVF procedure; critics call the scheme "lunacy" and worry that it will pressure less wealthy infertile women into research donation. Britain's Human Fertilization and Embryology Authority has approved the practice, and the BBC reports that the Centre is receiving Medical Research Council funding for its "egg-sharing" scheme. The BBC report appears here.

Vatican Says Vegetative patients have moral right to food, hydration

[Cross-posted from blog.bioethics.net]

The Vatican has released a ruling clarifying the Catholic position on food and hydration to patients in persistent vegetative states who are not expected to recover from their injuries.

The Vatican said that patients in a vegetative state, with few exceptions, have a moral right to artificial food and hydration. “In this way suffering and death by starvation and dehydration are prevented,” according to a statement released by the Vatican and approved by Pope Benedict XVI.

Nutrition and hydration support are not obligatory when such care becomes “excessively burdensome” or when patients cannot assimilate food and liquids “so that their provision becomes altogether useless,” the Vatican’s Congregation of the Doctrine of Faith wrote in a statement.

At the basis of the ruling is the moral belief that tube-feeding those near death is an "ordinary" state, and that the basic human dignity of the patient means that care should not stop.

The clarification becomes important because although Catholic doctrine does oppose euthanasia, it allows for the cessation of heroic, futile (extraordinary, and potentially painful) efforts. At question, then, has been whether or not tube-nourishment constitutes extraordinary or heroic efforts that are therefore optional under Catholic doctrine.

Ultimately, this affects more than "just" Catholics - many hospitals around the world are run by Catholic organizations who will feel bound by the ruling, and will enforce the decisions stemming from it regardless of whether or not the patient themself is Catholic.

-Kelly Hills

"Autonomous Killing Machines"

This post is in response to "Engineering Politics" by Christopher Csikszentmihalyi in the Sep/Oct 2007 issue of Good Magazine

http://www.goodmagazine.com/section/Provocations/engineering_politics

I liked this article because it is why I got involved with the IEET in the first place. I think the author's concerns are valid, I held similar ones myself, but his understanding of the effort to communicate to the general public comes up a bit short. (DARPA excluded from this, what they are doing, well, only those involved know). Christopher refers to the military’s drive to come up with "autonomous killing machines”, and while I don’t doubt that somewhat (always err on the side of caution), the military drives quite a bit of the emerging technologies that we have in our lives today. Hummer’s were not made for the suburbs or driving to the mall, they were made for combat, like Jeeps. The military had a need and the scientists, engineers and thinkers fulfilled that need. Once it became commonplace for the military and they worked most of the kinks out, they sell commercially, because some people fell the need to drive a ginormous tank of gas to take their kids to school.

I don’t necessarily have a problem with the military pushing for "autonomous killing machines”, ok, so I have a problem with the “killing machines” part. But after this summer, I have a more belief in the engineers behind it, and those that I don’t, again that’s why the IEET is around. It’s for the “Ethics and Emerging Technologies” to think and do for the technology and society, to talk about it openly and question things beforehand. Christopher writes that “Progressives need to get involved in research, design, and production” we are, the general public on the other hand, may not be interested in paying attention however.

For one, the websites that I have been too are full of open information; anyone who is interested can read about, say, what happened this weekend at the Singularity Institute for Artificial Intelligence about the Singularity. It’s not a secret. Jamais Casico put out his transcripts from his speech on his blog, not just what he thought he would say, but what he actually said, because he went back to revise it and repost. This is open. After Transvision 2007, George Dvorsky took and wrote reflections on several of the speakers on his blog, and got quite a response to it all.

What I see is that there is an effort to disseminate what information is available to the public. If the public was interested they could've went to two very affordable conferences, Human Rights for the 21^st Century (East Coast) and SIAI conference (West coast), and TV07 (Midwest, whoo!), which was more expensive, but worth the price for the celebrity speakers and numerous other notable presentations, not to mention other speeches out there that have been available across the country and globe from the fine people that are part of the think tanks and engineers of the emerging technologies. They travel a lot to give speeches and disseminate what they spend the rest of their time learning and knowing, primarily knowing. They are the doers, not those sent on their behalfs.

Christopher's conclusion in the article is “But such changes will only take place if we work to connect models of a just society to specific technical directions. And if we find more progressives who aren’t afraid of a little math.” I’m honestly afraid of a little math, but that isn’t enough to stop me from caring about all of this and becoming involved. I disagree that it is the engineers alone who “determine whether a product abets democracy or totalitarianism, whether it treats its user as a worker or as a human being.” True they are the creators, but there is interest before the creation, in the conceptual stages when ideas are being tossed around, while the technology is in process of being created.

If anyone was interested in the engineering stages, they had opportunities this summer to get up to a microphone and question the creator of their choice, which was taken advantage of by several in the audience at TV07. Or, if these same questioners sat in the audience and listened to the speeches that were given and heard what I heard they may have a different understanding of those out there making this technology reality. What I didn’t hear was that the technology was being created to destroy ourselves in the future. And if this was the case, they put on a pretty good show of convincing me of the opposite. I heard that they were aware of this concern and talked about it and included it as part of the discussion. As a skeptic of “autonomous AI” I understand other’s fears of the technologies on a personal level, however, becoming an engineer isn’t happening for me in the near future, and this is what Christopher didn’t include in his discussion, options. That just knowing, being aware of the conversations, or in them, is also an option that may help change and affect the overall larger picture.

Don't think me too harsh, I must applaud him for hopefully starting a dialogue for the magazine’s audience. The audience appears to be a younger and more open-minded group. This is the type of press that is both helpful and hurtful to communicators within the emerging technologies community. Referring to my above statement of information being out there and open, it happens mainly on the internet. Eventually, the discussion needs to be viewed by the general public which means off the net and into the mass media and popular culture, and I know that this may irk some of you, since it is an academic arena. Again, as someone, who is submersed in learning more about this daily, I need to learn more. The article tells others, unfortunately not that the IEET is out there, but that the technological evolution is.

Most people I speak with are not completely comfortable about all of this. It is unfortunate, but the only comfortable place there is to discuss is online, thus my urge to franticly type this. If I talked to anyone else there is an eye roll and a “uh-huh” complete lack of interest. It is troubling that the general public is not aware, but the technology is sneaking in to their daily lives. I read Our Molecular Future by Douglas Mulhall last year and was fascinated by the future technologies he discussed. And then I went to the dreaded Wal-mart last week, another topic for another day in itself, in the make-up aisle, what did I see?? Why the electronic paper I thought I wouldn’t see for quite awhile. It was on a L’Oreal or Revlon section (not too effective as I didn’t remember that part). I stood and stared and looked behind it for the plugs, cables, etc. and none. I was astonished that it was moving and just like a screen from a computer and as thin as a coin. I watched and no one else that I saw took pause, it was another ad in a sea of make-up.

I guess overall, the communication is out there, just not in the way that people notice, the technology is out there, again, just not in a way to notice, the problem is that when they do notice, as things will evolve, there will be questions. Maybe not on the small things that are the build-up to the greater technologies, but to the "autonomous killing machines” that, like the Hummer will eventually make to a commercial state where they can protect ones home. Or there will be questions when something happens in a negative manner, a mistake or a learning curve, if you will, like how we learned about the Hindenburg or Titanic. This is what causes me to be involved. Everything has trials and tribulations. I like to think however that, with people like those in the IEET, the discussion of the ethics will go out to the public before the commercialization.

Brain implants relieve Alzheimer’s damage (in rats, anyway)

More cool news from the Harvard Gazette:

Genetically engineered cells implanted in mice have cleared away toxic plaques associated with Alzheimer’s disease.

The animals were sickened with a human gene that caused them to develop, at an accelerated rate, the disease that robs millions of elderly people of their memories. After receiving the doctored cells, the brain-muddling plaques melted away. If this works in humans, old age could be a much happier time of life.

Alzheimer’s involves a protein called amyloid-beta, which makes up gooey clots or plaques that form in the brain. These toxic clumps, along with accessory tangled fibers, kill brain cells and interfere with memory and thinking. The situation has been compared to a build-up of cholesterol in coronary arteries.

“Delivery of genes that led to production of an enzyme that breaks up amyloid showed robust clearance of plaques in the brains of the mice,” notes Dennis Selkoe, Vincent and Stella Coates Professor of Neurologic Diseases at Harvard Medical School. “These results support and encourage further investigation of gene therapy for treatment of this common and devastating disease in humans.”

The first published report of the experiments, done by Selkoe and other researchers from Harvard-affiliated Brigham and Women’s and McLean hospitals, appeared Aug. 27 on the Web site of the Public Library of Science.

To read on, click here.

Girl's heart regenerates thanks to artificial assist

Cool news from the Canadian Broadcasting Company today (CBC) today:

A 15-year-old girl has become the first Canadian to have an artificial heart removed after her own heart healed itself.

Melissa Mills arrived at Edmonton's Stollery Children's Hospital last year after a sudden illness made her critically ill and a candidate for a heart transplant.

Doctors at the hospital implanted the Berlin Heart, a portable mechanical device that keeps blood pumping in an ailing heart, so she could survive until a transplant became available.

But over the next few months, Melissa's overall condition improved dramatically, and her heart muscle regained much of its strength. After 146 days on the Berlin Heart, Melissa underwent surgery to have the device removed.

Full article access here.

Savaging Spears

Continuing my somewhat thematic coverage of obesity/weight/perception and the media, this morning everyone but me apparently woke up to newspapers around the country savaging Britney Spears for her "comeback" performance at MTV's Music Video Awards last night.

And while her performance is part of the talk, the big bit is not what she did, but what she wore - or, rather, didn't wear, and the body she displayed.

A sampling of the headlines: Chubby Britney Fails, Britney's Mommy Pack, Please Don't Give Me More, Bump in the Night, and perhaps my 'favourite', Lard and Clear.

The Seattle PI is asking whether or not it's fair to attack Spears for her shape. Her performance certainly seems up for grabs, but her body - in its imperfect size ten, after bearing two children - is that a target, too? Did she "ask for it" by wearing a revealing black bikini? Or is she just following the suit in fashion in Hollywood now - criticizing Angelina Jolie for her stick like limbs, and embracing America Ferrara for her soft, shapely form.

The PI story continues,

Talk of Spears' physique comes amid an increasingly critical focus on overly skinny actresses in Hollywood, who've largely replaced supermodels as the world's fashion plates. It's hard to pick up a celebrity magazine without a critical photo of, say, Angelina Jolie's birdlike arms. And curvy actresses are getting positive attention, from Oscar-winner Jennifer Hudson of "Dreamgirls" to Golden Globe-winner America Ferrara of TV's "Ugly Betty."

In the fashion industry, there's been an effort to promote healthier-looking models. "Girls aren't looking as skinny this season as they did," said Suze Yalof Scwhartz, executive editor-at-large for Glamour Magazine. "There's food backstage. They're looking sexier." At Glamour, she noted, a model won't be featured "if she shows too much clavicle."

The nastier headlines about Spears are uncalled for, Schwartz said, but at the same time, "when you walk around the stage in a black bikini in front of millions of viewers, people are going to notice." She added that though Spears doesn't have the perfect body she once did, "Most women would die for the body she has now."

Frankly, if this is fat, sign me up!

Federal Judge To Hear Arguments on Missouri Law re Abortion Clinics

U.S. District Judge Ortrie Smith on Monday is scheduled to hear arguments in a case concerning the constitutionality of a new Missouri law (SB 370) that would upgrade facilities in the state that perform some abortions, the Kansas City Star reports (Kansas City Star, 9/10).

The law designates facilities performing second- or third-trimester abortions or more than five first-trimester abortions each month as "ambulatory surgical centers," which are subject to increased regulation from the state Department of Health and Senior Services. It also requires that hallways at the facilities be at least six feet wide and doors at least 44 inches wide. The clinics must also have separate male and female changing rooms for staff and a recovery room with space for a minimum of four beds with three feet of clearance around each bed. The health department has said the law requires that three clinics in the state be licensed.

Planned Parenthood of Kansas and Mid-Missouri last month filed a lawsuit that asks a federal court to block enforcement of the law. The suit alleges that the new regulations are unnecessary and are not meant to improve safety, but rather to interfere with a woman's constitutional right to abortion. PPKM in the suit also is asking that its Columbia and Kansas City clinics be exempt from the law because they were open before the law was passed. Smith last month issued a temporary restraining order blocking implementation of the law, which was scheduled to take effect Aug. 28. Smith last week ruled that physician Allen Palmer -- who operates the Women's Care Gynecology clinic in Bridgeton, Mo. -- can join the lawsuit (Kaiser Daily Women's Health Policy Report, 9/5). According to the City Star, Monday's hearing could lead to a preliminary injunction against the law (Kansas City Star, 9/10).

Comments
Planned Parenthood argues that the law is burdensome because standards required under it would drive abortion providers out of business and make abortions less accessible to women in the state, the Los Angeles Times reports. The law is "ludicrous," PPKM President and CEO Peter Brownlie said, adding, "There's a desperate quality to it." Michelle Trupiano, a lobbyist for Planned Parenthood, asked, "How is expanding the doorway size [in the clinics] going to improve women's health?"

Supporters of the law argue that women seeking abortions should receive treatment in modern facilities with doors wide enough to accommodate gurneys and paramedics in case of emergencies. "We're applying the same standards of health care to abortion clinics as we are to other medical facilities," Pam Fichter, development director of Missouri Right to Life, said.

Although Smith is "bound" by a 1992 U.S. Supreme Court ruling that prohibits states from putting an "undue burden" on women seeking abortions during the first trimester, there is "a lot of room for judicial interpretation," according to the Times. Carl Tobias, a law professor at the University of Richmond, said, "What may be an undue burden for one judge may not be for another," adding, "It's a very flexible standard" (Simon, Los Angeles Times, 9/10).

Reprinted with permission from kaisernetwork.org. You can view the Kaiser Daily Reports online, search the archives, and sign up for email delivery at www.kaisernetwork.org/dailyreports/. The Kaiser Daily Reports are published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2007 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Denying Children's Health Care

There's a reason that the movie Sicko had such an impact when it was released and there is a reason that we've blogged about Sicko and universal health care so much previously -- the issue resonates with the public and it is a major concern of many Americans - so, it's not surprising to see this scathing editorial in the New York Times today:

"The Bush administration reached a deplorable, preordained verdict yesterday when it denied New York State permission to expand a valuable health insurance program to help cover middle-class children. The administration, which makes no effort to disguise its disdain for government insurance programs, imposed new, excessively stringent requirements last month that not only guaranteed New York’s denial but will make it nearly impossible for any state to expand coverage.

The denial shows the White House at its most ideological and intransigent. Unfortunately, tens of thousands of children in New York — and many more nationally — will end up paying the price." To read the rest of the article, click here.

So time for a reminder -- Let's push for all candidates, from county seats to presidential, to seriously address this issue, and lead us toward a new health care system.

Breaking Up is Hard to Do

From Science Daily: — “Breaking Up is Hard to Do” is advice from a popular 1970s song, but older women going through a relationship breakup may have health problems to go along with their broken hearts, a University of Alabama researcher has found.

Dr. Bronwen Lichtenstein, UA assistant professor of criminal justice who specializes in women’s issues, recently completed a study of the health risks women over age 35 faced when they returned to the dating scene after the breakup of a long-term relationship. To read on, click here.

Biological Difference in Tumors Likely Cause of Black Women's Increased Mortality for Breast Cancer, Study Finds

Black women are more likely than other women to develop tumors that do not respond to common hormone-based treatments, according to a study to be presented at an American Society of Clinical Oncology conference that begins on Friday, the AP/Los Angeles Times reports (Marchione, AP/Los Angeles Times, 9/5).

The study, led by M. Catherine Lee, a clinical lecturer at the University of Michigan Comprehensive Cancer Center's department of surgery, is the largest to indicate a biological factor as the cause of black women's increased mortality from the disease, according to the Newark Star-Ledger. Previous research has attributed fewer mammograms and less aggressive treatment to the racial disparity (Stewart, Newark Star-Ledger, 9/6). Black women are less likely than white women to develop breast cancer but are more likely to die from the disease.

For the study, Lee and colleagues analyzed data on more than 170,000 breast cancer diagnoses from 1998 that were included in the American College of Surgeons' National Cancer Data Base. Ten percent of the cases were among black women.

Researchers focused on 95,500 women whose cancers were invasive rather than confined to a milk duct. They found that roughly 39% of such tumors in black women were estrogen receptor-negative, or ER-negative, compared with 22% of tumors in white women. ER-negative tumors are resistant to common hormone-based therapies like tamoxifen and are more difficult to treat, according to the AP/Times (AP/Los Angeles Times, 9/5). The high prevalence of ER-negative tumors among black women was consistent regardless of the age or stage at which they were diagnosed, the study found (Newark Star-Ledger, 9/6).

The study also found that black women were diagnosed at an average age of 57, compared with 62 for white women. Black women's tumors also were more advanced than white women's, with 29% of black women having stage 1 tumors that had not yet spread, compared with 42% of white women.

Lee said, "Differences in tumor biology have a significant impact on survival," adding, "The fact that breast cancers in black women are more aggressive biologically suggests that we need to focus more of our research energy on developing better treatments targeting ER-negative tumors." She said the "findings also point to a need for improved cancer education and screening in black women, particularly those in younger age groups" (Fox, Reuters, 9/5).

Reprinted with permission from kaisernetwork.org. You can view the Kaiser Daily Reports online, search the archives, and sign up for email delivery at www.kaisernetwork.org/dailyreports/. The Kaiser Daily Reports are published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2007 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Mind Matters: Beliefs, Emotions & Self Identity

Check out our new series, Mind Matters --

Women should care about neuroethics because advances in neuroscience are going to pose some of the most important ethical questions yet about what it means to be human—challenging our concepts of free will, gender and genetic determinism, and what sets us apart from other species. To help us address those issues, we have developed a new program called Mind Matters: Beliefs, Emotions & Self Identity, which will include interviews, podcasts, recommendations for essential readings and the latest in neuro-news.

For more info, click here.

Requiring the Meningitis Vaccine for Students

Our friend and colleague, Art Caplan, has a new column at msnbc.com on requiring meningitis vaccines for students as he fittingly points out, Americans hate to be told what to do, but we hate losing our kids more:

COMMENTARY

By Arthur Caplan, Ph.D.

Which is scarier to you - coming down with deadly bacterial meningitis or being required to get a vaccination against it? The disease itself should scare the living daylights out of you, especially if you are an adolescent or the parent of one. Yet it is the idea of mandatory vaccination that strikes fear in many.

We need to get our priorities straight when it comes to mandating or requiring vaccines. When there is a fatal disease that is easily prevented by a safe vaccine, the shot ought to win out every time over our dislike of being told what to do.

Bacterial meningitis, an infection of the fluid in the spinal cord or the tissues that surround the brain, can kill within hours. One in 10 victims dies and up to 20 percent of those who survive suffer hearing loss, deafness, brain damage, amputations or other serious complications. Around 3,000 people a year get the disease and it can kill within hours. Almost all of that is preventable with a vaccine.

Teens and young adults ages 15 to 24 are at especially high risk for bacterial meningitis since it can be spread by coughing, sneezing, kissing, sharing drinking glasses and other behaviors where people are in very close contact. College students are particularly at risk since they live in tight quarters and often have weakened immune systems due to lack of sleep.

In January 2005, the Food and Drug Administration approved a new vaccine against bacterial meningitis. The MCV4 Meningococcal Conjugate Vaccine, marketed under the name Menactra, protects against four very common bacterial strains and is longer lasting and more effective than earlier meningitis vaccines. The Centers for Disease Control recommends that everyone ages 11 to 18 should get it, as well as those headed off to live in college dorms or going into the military. But in 2006, only 12 percent of teenagers got the vaccine.

So why isn't everyone in this age group getting vaccinated? The answers are the same ones that continue to haunt vaccines - unjustified safety concerns, resistance to mandates and cost.

When Menactra first appeared, some cases of Guillain-Barre syndrome were reported. This is a serious disease in which the body's immune system attacks nerves and leads to gradual, temporary paralysis.

Those opposed to vaccination - and there are many in the United States and other countries - quickly pointed to the 20 cases that were reported as a reason not to get vaccinated. But, Guillain-Barre occurs in about one in 100,000 people in the United States. Vaccination is almost never the cause. In fact, when the 20 cases cited by vaccine critics were closely examined, none were associated with the meningitis vaccination.

23 states require shots
Today, 23 states mandate the vaccine for college freshmen.
Americans are generally leery of requiring or mandating vaccines. They value informed choice. But do you really want to leave an issue as important as vaccination left up to busy college freshmen to think about? Menectra is safe, so it's hard to know why anyone living in a dorm or close quarters would not want to get vaccinated.

And if you don't get vaccinated then you are not only putting yourself at risk but others whom you come in contact with on and off campus as well.

What is really startling is that mandating vaccines really only means strongly urging young people to get them. Most states recognize the right of anyone to refuse a vaccine on religious grounds. And even the states that have required or mandated vaccination allow someone not to do so if they sign a statement saying they have seen information about meningitis vaccine but still don't want the shot.

Getting insurance to pay
The real reason to mandate meningitis vaccine is to get it into the heads of kids and parents that this is an important thing to do and to help force government and insurance companies to pay the cost. If you don't mandate vaccines then insurers often won't pay for them. In our screwy world of health care, mandates have more to do with reimbursement then they do the police blocking access to the dorm until you show your vaccination card.

Americans do love choice. But they also hate to lose a child, a sister or a granddaughter. Sometimes choice ought to yield to common sense and evidence. We ought be doing all we can to get young people vaccinated against meningitis and to make sure that the costs of doing so are covered.

We're Not Monkeying Around (or are we?)

[Cross-posted from blog.bioethics.net]:

After what it calls "a series of detailed deliberative sessions", Britain's Human Fertilisation and Embryology Authority gave the go ahead Wednesday for the creation of embryos that would contain both human and animal cells. Such research is banned in Canada and President Bush has called for it to be forbidden in the US*. Here's more from HEFA's statement:

Having looked at all the evidence the Authority has decided that there is no fundamental reason to prevent cytoplasmic hybrid research. However, public opinion is very finely divided with people generally opposed to this research unless it is tightly regulated and it is likely to lead to scientific or medical advancements.

This is not a total green light for cytoplasmic hybrid research, but recognition that this area of research can, with caution and careful scrutiny, be permitted. Individual research teams should be able to undertake research projects involving the creation of cytoplasmic hybrid embryos if they can demonstrate, to the satisfaction of an HFEA licence committee, that their planned research project is both necessary and desirable. They must also meet the overall standards required by the HFEA for any embryo research.

There are already two applications for human animal chimeric embryo research before the regulatory panel. The applications include proposals to inject human DNA into the embryos of cows or rabbits, ultimately in an effort to produce stem cells.

The May 2007 AJOB Neuroscience featured a target article about the proposed human neuron mouse. This summer Hank Greely, one of the target article's authors, and Francoise Baylis, who authored a peer commentary, both appeared on a bioethics.net podcast to talk about the ethical implications of human-animal chimeras.

-Greg Dahlmann

*Or, at least, we think he did. In the State of the Union Address, Mr. Bush used the term "hybrid" which isn't the same thing as a chimera. US Senator Sam Brownback (R-KS) has proposed legislation to ban human animal chimeras (the bill actually uses the word) and apparently the President supports this legislation.

Of Mice and Men and Chimeras and Hybrids and more

"Some believe the greatest emerging threat to the human race can be found in the Middle East, where terrorists seek weapons of mass destruction. Others point to melting glaciers, adamant they have discovered proof of environmental doom.

I suspect a far greater threat to our species emerged this month in a politely worded report issued by a British parliamentary committee..." [rest of the article here]

(from an article in the Washington Times)

The British parliament is contemplating what types of human-animal hybrids should be permitted and what rules should govern their creation and destruction.

***New*** Take our poll and let us know what you think!

The Current Chaotic State of Patent Law

My friend and colleague, Gerry Elman, was recently quoted in a NY Times article on patent law about a Texas court ruling that applied a new standard regarding "obviousness" when applying for an intellectual property patent. Gerry was quoted as saying that he believed that the rulings would have a negative impact on small business and that the implications of raising the bar for inventors are 'huge'. In an email interview, I asked Gerry to explain a little further about the implications of the recent changes in patent law, which is of concern to many lawyers who are interested in biomedical ethics. Here is his thought-provoking response:

One such development is a series of regulations issued by the U.S. Patent and Trademark Office (“PTO”) on August 21, 2007, that are scheduled to take effect November 1^st. Patent applications pending on the effective date will become subject to the new rules, which will also affect any applications filed thereafter. The rules require an extensive prior art search and mandate a prior art analysis in unprecedented detail for inventions exceeding a certain threshold number of claims, namely either 5 independent claims or a total of 25 claims. This requirement cannot be avoided merely by submitting two or more applications for related subject matter, as the regulations aggregate the number of claims in such related cases (unless a Restriction Requirement separating “patentably distinct” inventions is issued by a patent examiner).

A separate provision withdraws the previously-unlimited opportunity to file continuation patent applications and requests for continued examination (RCEs). Those provided inventors an escape hatch from ill-conceived rejections by the patent examiner and the possibility of keeping a pending patent application alive for fine-tuning of patent claims even after a first patent on the subject matter had issued. The new rules allow two continuations and one RCE to be based on a given patent application. And they provide an option to petition for an exception to that limitation if the applicant proves why the continuation could not have been filed earlier. We anticipate that many patent prosecutions that at some point previously would have involved the simple expedient of filing a continuation or RCE will now require the more time-consuming and delay-invoking step of generating and briefing an appeal to the PTO’s Board of Appeals.

This drastic change in PTO practice comes at the same time as we experience a variety of court decisions with seismic effect on the previously-stable patent landscape. As mentioned in the New York Times article, on April 30^th, the U.S. Supreme Court recalibrated the test for unpatentability of a new combination of parts or steps because it is “obvious” from the prior art. KSR v. Teleflex. The Supreme Court has also revised the rules as to how soon a challenge to a patent can be filed in court (which will affect how license negotiations are conducted) Genentech v. MedImmune; and whether a patent owner can expect to get an injunction when a court finds that a patent has been infringed. eBay v. MercExchange. And on August 21^st, the Court of Appeals for the Federal Circuit made it more difficult for a patent owner to receive enhanced damages due to “willful infringement” of the patent. Seagate Technology.

It would be appropriate to argue that these changes in the aggregate amount to a massive “taking” of property by the government, intellectual property which should be protected pursuant to Article 1, sec. 8, clause 8 of the Constitution. If the weakening of the patent system means that in the future there will be less protection for innovations, then will there not also be less investment in the new businesses that would have commercialized them? And if that happens, will the existing large companies fill the innovation gap by ramping up their development activities, or would they tend to rest on their laurels without the gadflies of startups buzzing around?