Saturday, May 31, 2008
For the right price, a California biotech startup will clone dogs for five lucky bidders in the world’s first commercial dog cloning program. BioArts International opens a series of online auctions June 18, when people around the world can bid to have their four-legged friends “duplicated.” Bidding starts at $100,000.
BioArts chief executive Lou Hawthorne, who recently succeeded in a decade-long quest to clone his family dog, spearheads the program. Hawthorne (pictured with his cloned dogs) partners with Hwang Woo-suk, a South Korean scientist who led the effort to produce the world’s first canine clone in 2005. Hwang is also known for a series of embezzlement and bioethics law violations linked to fake stem cell research.
News of the BioArts auction is sure to spark debate among dog owners for both its controversy and opportunity. One one hand, the Humane Society argues that commercial pet cloning has no social value and may lead to increased animal suffering. On the other, Hawthorne views biotechnology as path to happiness for pet owners.
But can the scientists at BioArts duplicate an animal’s personality? When I was young, my family’s dog passed away after a long battle with cancer. I was devastated; I had grown up with Sam around, and his unique personality was a big part of our family. Even if cloning were possible at the time, I doubt the process could have replicated Sam the way we knew him.
The debate over pet cloning also raises the issue of homeless animals. The Humane Society makes a strong case for animal adoption over animal replication. Wouldn’t pet owners be doing society (and the animals involved) a favor to adopt animals from shelters rather than pour hundreds of thousands of dollars into an attempt at producing a genetic duplicate?
Will Hawthorne and his team at BioArts oversee an international bidding war of dramatic proportions in June? Or will the price of cloning prove to be too high for an untested market? Whether pet owners have $100k to spare or not, the auction will surely get people thinking—and arguing—about the ethics of pet cloning.
Friday, May 30, 2008
[Hat tip to Carl Zimmer]
Under the old system, drugs were categorized into one of five categories - A, B, C, D and X – based on the amount of animal and human safety data available. Only a handful of currently marketed drugs fall into category A: safe for use based on extensive animal and human safety data. More drugs fall in category X: conclusive animal and human data demonstrating fetal risk.
The problem is that the vast majority of drugs fall into categories B and C. For most these compounds, there may or may not be data from animal models to suggest that the drug is safe and no good human studies to confirm these pre-clinical results. Use of these drugs by pregnant or lactating women is thus a crap shoot, with women and their physicians given little guidance to help them weigh the risks and benefits of these treatments. The new labeling rules would provide more information about the potential risks and benefits to pregnant or lactating women and their children or fetuses.
Still, I wonder whether the FDA realizes the Catch-22 that many researchers face regarding pregnant and lactating women. In the HIV prevention field, for example, microbicide and PrEP (pre-exposure prophylaxis) studies generally exclude pregnant and lactating women from enrolling, and study participants who become pregnant must discontinue product use. However, in the resource-poor countries when many of these trials take place, women spend approximately one-third to one-half of their reproductive years pregnant or breastfeeding. Not only do unexpected pregnancies adversely impact the power of these studies to detect a protective effect, but these restrictions also mean that a large number of women in the developing world who want to participate in these HIV prevention trials cannot. Alternatively, they be required to use a limited number of contraceptive methods that might otherwise be unacceptable to them.
Finally, it is unclear how HIV prevention researchers can collect the necessary data to demonstrate that these products are safe and effective for pregnant and lactating women to use. Most of these data come from pregnancy exposure registries, in which women who use category B, C and D drugs are monitored for the effect of these compounds on fetal development. But does it make sense to rely on such “natural experiments” rather than collect the necessary safety data in a controlled clinical trial using fully informed and willing participants? … particularly for compounds like topical microbicides and PrEP which, if effective, will be used primarily in countries in which collecting data for pregnancy exposure registries is likely to be difficult at best?
Thursday, May 29, 2008
Warning: The body parts you are about to see may have come from Chinese prisoners who were tortured and executed.
The NY Times Cityroom blog writes that the exhibition has been the object of persistent criticism from medical ethicists and human rights advocates, who have questioned whether the remains were legally obtained.
You can access the full story here.
When a pharmaceutical company discovers or develops a promising new compound, they apply for and receive patent approval, which provides for 17 years of patent protection and exclusivity. This gives them the sole right to sell the drug while the patent is in effect. However, as the patent nears expiration, other pharmaceutical companies are able to applications to the Food and Drug Administration to obtain approval to market generic versions of the brand-name drug.
The pharmaceutical companies claim that the period of market exclusivity enables them to recoup the cost of developing the new drug. However, pharmaceutical companies often try to extend the period of exclusivity by obtaining approval for their own generic version of the branded drug, which provides an additional 6-month marketing exclusitivity period. Also, they may try to obtain an extension on exclusivity by targeting special populations such as children.
The ethical dilemma raised here is how this marketing exclusivity for the pharmaceutical company affects the patients, those individuals with medical condition who need the drug. The availability of generic equivalents for brand-name drugs makes it easier for patients with low incomes or no health insurance to get the medications that they need. Very often, brand-name drugs are priced well beyond their means.
My mother had deep vein thrombosis and a pulmonary embolism 7 years ago and consequently has been on daily anticoagulation therapy ever since. She is at high risk for having another pulmonary embolism and approximately 30% of people who have pulmonary emboli die. When she was recently scheduled to have a hysterectomy, her hematologist recommended that she transition to Lovenox (enoxaparin, Sanofi-Aventis) during the week before her surgery and the week after the surgery. Subcutaneous Lovenox has a much shorter onset of action and half-life (12 hours) compared with the oral anticoagulant warfarin (4 to 5 days). So, this would enable her to receive anticoagulation therapy up to 12 hours before her surgery and again within 2 days after the surgery, reducing the amount of time that she'd be at risk for developing deep vein thrombosis or pulmonary embolism.
The real surprise came when my mother tried to fill her prescription for Lovenox. She is retired, but she does have prescription drug coverage. However, her co-payment for a 10-day supply of Lovenox injections was $900. That's right, $900. The insurance company was also paying $900. It turns out that Sanofi-Aventis does provide assistance for some patients who are unable to afford needed medication. However, when I downloaded the forms and helped my mother complete them, it turned out that her annual income was $1500 too much to qualify for assistance. So, she had to pay the $900 for the Lovenox. In her case, the risk was too great to go without the medication. However, now that she's had the surgery, she doesn't know how she's going to manage to pay her co-payment for all of the other related expenses--the hospital, the surgeon, the operating room, the anesthesiologist. She hadn't expected one medication to take all the money that she'd been setting aside in preparation for the surgery expenses.
So, I was pleased to read the news article about Sanofi-Aventis and to learn that generic versions of Lovenox might soon be available. Lower-priced generics will make it easier for patients like my mother to obtain the medication that they need for anticoagulation.
Hopefully, fewer patients will have to take pause to consider whether or not the risk of dying is worth the price of the drug.
Although the jet lag is murder, as are the 11pm conference calls with colleagues back in DC, trips like this often give me the opportunity to catch up with all of the journal articles, news reports, and blog postings that have gone unread over the past couple of weeks.
In reviewing my RSS feeds, I was particularly struck by a recent post on The Root, looking at the often neglected problem of obstetric fistula in resource-poor regions of the world. Over 2 million women in the developing world suffer from obstetric fistula - a rupture of the tissue separating the vagina from the rectum or the bladder that occurs as a result of prolonged labor or sexual trauma. If uncorrected, this tear results in pain, incontinence and frequent genital tract infections. Affected women live in physical and psychological agony, and are frequently cast out of their homes and stigmatized within the larger community because of their inability to control the urine or feces that drip down their legs as a result of this condition.
Of course, the surgical procedure to repair a fistula has been around for over 100 years, and costs a mere $300 in a country like Kenya. That's less than the amount that most American taxpayers received as part of the recent economic stimulus package, and is much less than that Zegna Sport pullover I've been eying at Saks. But it's equivalent to the yearly income of most of the affected women in the developing world.
Just think of the positive impact on our dismal world standing if the US government was willing to set aside the necessary funds to provide treatment to all women suffering from fistula across the world: $600 million. Of course, that will never happen ... but individuals can still help by donating to groups like the Campaign to End Fistula.
Cost to repair a fistula: $300
Restoring a young woman's confidence and dignity: Priceless.
Tuesday, May 27, 2008
Hormone Replacement Therapy (HRT) came into the picture as a safe treatment for menopausal symptoms in 1942 with the marketing of Premarin™, followed by other treatments such as Prempro™. These medications contain one or more synthetic female hormones, commonly known as estrogen and progesterone. Premarin holds the crown for being the most widely prescribed drug in the United States because of its effectiveness in making menopausal women happy again.
The Women's Health Initiative (WHI) was a national health study launched in 1991 during the heyday of HRT prescriptions. According to the study, the clinical trials were designed to test the effects of HRT, diet, and supplementation on prevention of heart disease, fractures, and breast and colorectal cancer. The 15-year project involved over 161,000 women ages 50-79, and is considered one of the most definitive, comprehensive programs of women's health research ever done in the United States. Participants in the WHI trials were randomly assigned hormone medication or placebo. However, the NIH halted the study early because the health risks participants experienced outweighed the health benefits. Women taking the hormones did see some benefits, but they greatly increased their risk for breast cancer, heart attacks, strokes, and blood clots.
Menopausal women and their physicians felt betrayed. How could something with such a long standing history as being the women's miracle menopause cure now be proven to be unsafe? The results of the study compelled many physicians and women to abandon HRT and try to come up with alternatives with little to no avail. Think about trying to explain to a menopausal woman in mid-hot flash that if she dresses in layers and refrains from caffeine and alcohol, she'll feel back to her pre-menopausal self in no time...hide the knives!
Now, a recent ABC News article reports that an international panel of experts are giving the green light for HRT again. This change of heart comes after researchers revealed that the WHI was flawed. Participants in the trials did not accurately represent the menopausal population, with the majority being relatively old and suffering from other conditions that all boosted risk. The panel has agreed that HRT is safe and effective for short term use in early menopause.
With all the swings HRT is going through, what’s a menopausal woman to do? Hopefully, women won't become too hot and bothered and lose sleep over their decision to use HRT for some sought after relief.
I lived 27 years of my life oblivious to the hell of allergy sufferers. Now that I have settled down, bought a home in the desert, and started to grow roots, my world has turned upside-down. Juniper is my nemesis, and Albuquerque is surrounded by it. In an attempt to survive, I followed the same path millions of allergy suffers take: two months of Alavert (to no avail), two months of Claritin (complete waste of time), four months of Zyrtec (you’re joking, right?), and even three months of a self-prescribed cocktail of Benadryl and Sudafed, all of which proved pointless. These “remedies” might as well have been sugar pills. So, I went out on a limb and tried the “alternative medicine” tract. I tried Chinese herbs and acupuncture, I even dreadlocked my hair, burned strange candles, and prayed to my living room papa-san chair (I mistook Wicca for wicker). HAA-CHU!
I investigated allergy shots, but was quickly rejected as an ineligible candidate. To add salt to my wound, I am immunodeficient. When immune B cells and T cells are activated by an invader, they replicate into more antigen-fighting cells and something called long-lived memory cells. Long-lived memory cells are responsible for remembering exactly how the invader was destroyed, so the next time he comes around looking for some action—SMASH! WHAM! KABOOM! The long-lived memory cells knock him out of the picture. My immune system suffers from having “no anamnestic response,” or rather, no short-term memory. I lack the adaptive quality that healthy immune systems boast. My body cannot recall how to fight off the diseases and infections it has already conquered. So, every winter I catch a cold, take an unusually long amount of time to get over it, and then quite often catch the same cold again a week or so later. This same scenario is what prevents allergy shots from working in my body. The allergen is injected, my B and T cells do a little dance, and then…HAA CHU!
One blessed day, Providence led me behind the counter to something marvelous. Heralding angels rejoiced as the register tallied my bill, a $10.79 purchase of Drixoral. Schering-Plough Healthcare Products are the makers of Drixoral, an over-the-counter allergy and cold medicine that contains dexbrompheniramine (antihistamine) and pseudoephedrine (decongestant). Amidst the worst of juniper season, I finally found relief—as well as a little drowsiness (so what if I sleep from March until July? At least I can finally sleep). One pill allowed me to function in the world—albeit in a misty stupor. I was no longer sneezing. The irritated, itchy roof of my mouth went back to being unnoticed. My lungs also joined the land of the breathing, finding relief from asthma. Just like Moses and the Red Sea, my seemingly endless mucous parted, allowing my sinuses the forgotten sensation of inhalation. And, last but not least, the dark circles under my blood-shot eyes returned to a healthy pink.
All was fine and dandy until I took the last pill in my Drixoral package today. I stopped by Walmart’s local pharmacy on my way home from work and wasn’t worried that they were out of stock. I tried Walgreens—also out of stock, another Walgreens, then another and another. Six stores later, I realized Drixoral no longer existed within Albuquerque anymore—at least not in pharmacies (we have a rather large population of meth houses). The rumor circulating around town and beyond (my friend’s step-father is a pharmacist in St. George, UT) was that the Drixoral has been discontinued to prevent the illegal manufacturing of crystal methamphetamine.
A few startling quick facts about the people ruining my life:
1. One gram of their meth costs about $260, a price that has raised since last year’s $160 per gram…price gougers. Per pound, it costs $12,000 to $16,000 at the wholesale level.
2. It is a nationwide law that a valid I.D. and signature are required to buy cold and flu medications containing pseudoephedrine. Pharmaceutical companies compensated by introducing a string of new cold remedies containing phenylephrine instead, which can’t be used to make meth.
3. Some of the effects of meth abuse include: paranoia, brain damage, hallucinations, hypothermia, convulsions, cardiovascular collapse, and a condition called “tweaking.” Tweaking is when the abuser cannot sleep for days, is extremely irritable, and becomes violent without provocation.
4. A few of the warning signs that there is a meth house near you include: odor of solvents, blacked out windows, activity late at night, iodine-stained kitchen or bathroom, and excessive trash. Cleaning up a meth lab can cost the government up to $10,000.
Had I been privy to the memo forecasting the removal of Drixoral from the market, I would have loaded up on the product—even at the risk of appearing like a junkie myself. Is it fair to take such a needed product off the market because of a handful of drug dealers and producers?
So, I took to my next weapon—the internet—and searched for Drixoral for hours (this is a matter of life or death, you realize). I found nothing on Scherling-Plough’s website (http://www.schering- plough.com/schering_plough/pc/allergy_respiratory.jsp) claiming they were taking the drug off the market, but there were no links to order the product either. I finally decided to bite the bullet and call Schering-Plough to get the low-down on Drixoral myself. Straight from the horse’s mouth: Drixoral will be off the market for one year as Scherling-Plough relocates their manufacturing plant. I made them promise they would not discontinue the product. We spit on our hands and pinky swore…well, as best as two people can do over the phone. They took an oath and a Bible was involved. I think I promised the pharma company one of my future children... But, at least I know Drixoral, my saving grace, will return.
I guess I don’t have to hate meth heads anymore…
A lot of discussion has been going around regarding Pistorius. Should he or shouldn't he be allowed to compete for a spot in the Beijing Olympics? If he makes it, should he or shouldn't he be allowed to compete. There’s concern over what this will do to sports in general; what kind of message is it sending out to others; and how it could throw off future comparisons within the sport, making some sports records incomparable.
In Art Caplan’s Opinion piece, he discusses Tiger Woods' laser eye surgery and how he now has better than 20/20 vision. This surgery allows him to continue to compete with vision, not just without glasses or contacts, as with the first surgery, but better than that. Caplan says, "That's why it cannot just be "advantage" that determines whether someone can use technology to compete. The deciding factor is whether something confers a significant, not a slight advantage."
But what about the other sports, like Major League Baseball? What about those players who have gotten the Tommy John surgery? Have these individuals been enhanced, do they have an unfair advantage to those that have not have the surgery? Or what about those players who like Tiger Woods have gotten the laser eye surgery, and are able to tell the difference between a curve ball and a fast ball better than others.
Caplan goes on
"We don’t expect to compare the performances of today to those of the ancient Greeks, but we do expect some ability to compare what happened today to be compared with what happened yesterday, a year ago, a decade ago or even 50 years ago.
It may be fascinating to see who can go the fastest on rocket-powered legs or throw a heavy weight the farthest using performance-enhancing drugs, or genetically engineered muscles. But what you have then is an exhibition or a show, not a sport. In some ways, this is what the professional wrestling and no-rules body building already are.
To be a sport you need something approximating a fair playing field, some boundaries on the attributes of those who compete so they are comparable to one another and some ability to compare today’s performance with those in the not-so-distant past.
That is why I am not sure Oscar Pistorius should compete.
He may not have a marked advantage, but his artificial limbs make him too different from those he competes against, and too unlike those who have raced before. It's not about giving him an opportunity. The issue is that Pistorius risks destroying exactly what he wants to do — compete in a sport."
The previously mentioned surgeries also offer advantages over both today and yesterday’s competitors. Situations arise where an athlete seriously injures himself and, with modern technology, instead of having to retire they are put back together. By putting them back together, and in some cases, back on the playing field as they were before or even better, technology is playing a part in the sports world. A search for 'surgery' on CBSsports.com produced 47,500 results, I acknowledge that not all of these individuals were undergoing corrective or elective surgery to return to the game, but it is still quite a lot.
There is discussion because he has an unfair significant advantage. He’s disabled and he can keep up, maybe not yet qualify, but he can keep up, regardless of his disability. The concern mimics the perspective I had of the American Gladiator. An average guy breaks the boundaries and competes, but hope is that the next competitor will be above average with potential to blow everyone else out of the water. Then, there is the potential for an unfair competition with not everyone being able to get or, rather, need the legs. It’s better to keep the competitors separate, the Paralympians and the Olympians, so they are on a level playing field.
The significant advantage everyone’s examining is still there for those willing to play regardless of the competition in the Olympics. Pistorius and others like him can still compete in the Paralympics with their “advantage”. Will the athletes of the Paralympics also be comparable within the past 50 years? Can the artificial limbs of 50 years ago be comparable to those of today in competition? Is the Paralympic committee ok with all of this lack of comparison or are their records already taking into account the differences in technology?
I have two scenarios; granted there could be more, please share them.
Pistorius competes in the Beijing Olympics, he places whatever. Others like him are inspired and also try out. Not guaranteed a position based on sympathy, but on capability, like everyone else. Those who can meet the competition minimums will compete, those who can’t won’t.
Pistorius competes in the Beijing Paralympics, he places whatever. Others like him are inspired by his attempt to participate in the Olympics as a result try out for the Paralympics. Not guaranteed a position based on sympathy, but on capability, like everyone else. Those who can meet the competition minimums will compete, those who can’t won’t.
Technological advances are driven by demand. Those who are already amputees are going to want better ones. Those who compete are going to want faster ones. Where will these individuals be competing? I go back to
“It may be fascinating to see who can go the fastest on rocket-powered legs or throw a heavy weight the farthest using performance-enhancing drugs, or genetically engineered muscles. But what you have then is an exhibition or a show, not a sport. In some ways, this is what the professional wrestling and no-rules body building already are.” (Emphasis added)
The Paralympics is an arena to compete in sports, even though they allow Cheetah Flex Foot for competition. Maybe they have an interesting show in their future.
“To be a sport you need something approximating a fair playing field, some boundaries on the attributes of those who compete so they are comparable to one another and some ability to compare today’s performance with those in the not-so-distant past”
The Paralympics offer a fair playing field for those with artificial limbs like Cheetah Flex Foot; where the Olympics offer a fair playing field for those with limbs (oh, and the special external technological advances they have, i.e. special swimsuits, clothing, shoes, and equipment. Which with the demand to be better will also advance)? Knowing that we aren’t going to get rid of artificial limbs like Cheetah Flex Foot, and knowing they are going to make an impact somewhere, which competitive arena will they be allowed to affect and advance?
"It’s less sensational news than skyrocketing food and oil prices, but the beloved yellow banana may soon disappear forever. Bananas are even more heavily consumed in many parts of the world than rice or potatoes, but now a fungus called Panama Disease is turning them brick-red and inedible. Here’s the worst part: There is no cure for Panama Disease and it is spreading very quickly. Experts surmise that within the next three decades, the sweet and creamy food staple will be nonexistent."
You can access the full post here.
It's hard to imagine a world without bananas...
[Apologies to all those who now have Gwen Stefani's Hollaback Girl stuck in the heads.]
Mary Ann Mott, National Geographic News
According to Reuters UK ( “Factbox: Human Fertilisation and Embryology Bill” ), controversial medical research innovations are being debated in Parliament’s House of Commons this week. The Human Fertilisation and Embryology Bill raises several interesting bioethical issues, one of which would allow the creation of human-animal hybrid embryos to be used for medical research.
Interspecies embryos would be created by taking a cell from a patient and inserting it into an enucleated animal ovum. An electric shock would fuse the two cells together allowing the formation of an embryo. Because the genetic material from the animal has been removed, the resulting embryo would be 99.9% human and an excellent model for medical research. The proposed legislation mandates that these embryos must be destroyed before 15 days, and they must not be implanted into the uterus of a woman or another animal.
The advantage of creating mixed-species embryos is that they can be a powerful research tool for developing stem cell models without the use of human eggs. Embryonic stem cells would be taken from the new hybrid embryo and injected into specialized human tissues, giving researchers insight on understanding the progression and possible treatment of medical conditions such as Alzheimer's disease, cystic fibrosis, Parkinson’s disease, diabetes, and other inheritable diseases. Stem cells could also be used to repair human tissue by allowing new tissue that is genetically matched to the individual to be cultivated for damaged body parts without the risk of rejection.
Scientists and researchers are excited about the medical possibilities that may unfold, and supporters of this bill are convinced that these techniques are “an inherently moral endeavor” that could eventually save millions of lives. There is, however, a great deal of public anxiety about the ethics of experimenting across species boundaries. Many critics find it unnatural and morally wrong to combine human and animal genetics. They also question the benefits of hybridization, claiming that there is no evidence that this will help cure diseases and that other research methods are more effective. They find it both misleading to the public and an abomination to nature. “There are other ways to advance medicine besides going into the strange, brave new world of chimeric animals.”
Even scientists are divided on this issue. Although there may seem to be medical advances to be gained from human-animal hybridization, we really need to make sure that these benefits outweigh the possible risks. In the words of William Cheshire, associate professor of neurology at the Mayo Clinic’s Jacksonville, Florida branch,
“We must be cautious not to violate the integrity of humanity or of animal life over which we have a stewardship responsibility. Research projects that create human-animal chimeras risk disturbing fragile ecosystems, endanger health, and affront species integrity.”
[Photo courtesy of goatboyfilms.com/.]
Monday, May 26, 2008
The first decoding of DNA in a female was done in The Netherlands, reports DutchNews.nl. A red-haired, 34-year-old Dutch woman has become the first woman in the world to have her compete DNA unraveled, genetic scientists at Leiden University Medical Centre announced on Monday.
[T]he sequencing data of a female provides more insight into the X chromosome. 'Because the X chromosome has to do all the work in one half of the population - the males - selection has been tougher during human evolution,' according to Van Ommen. 'This means the X chromosome is less variable.'
Male sequencing data has already been unraveled from Jim Watson, co-discoverer of the double helix structure of DNA, from researcher Craig Venter and from two Yoruba Africans. 'It was time to balance the genders a bit,' news agency AP reported Van Ommen as saying.
Decoding the DNA took six months, but the scientists point out they could only use the sequencing equipment when it was not being used for other projects.
Sunday, May 25, 2008
1. Culture - Read the original article: Culture shock (24 March 2001)
2. Mind Reading - Liar! Liar! (14 February 1998)
3. Tool Use - Look, no hands (17 August 2002)
4. Morality - Virtuous nature (13 July 2002)
5. Emotions - Do animals have emotions? (23 May 2007)
6. Personality - Critters with attitude (3 June 2001)
Do you think humans are unique? Take our poll!
Full article accessible here.
However, a number of bioethicists, such as Michael A. Grodin, Robert Truog, Art Caplan, Leslie Whetstine, and Nancy Dubler, who is helping vet the plan, have expressed concerns that the plan may undermine public trust in emergency medical care and the organ donor system and aggravate fears of disadvantaged groups that already harbor deep distrust of the medical system.
Access to the full article here.
Saturday, May 24, 2008
In response to the ruling, Senator Barbara Boxer (D-CA) introduced a bill last week that would bring greater accountability and transparency to the Food and Drug Administration’s (FDA) regulation of all medical devices. Millions of Americans are implanted with devices ranging from pacemakers to breast implants, yet don’t realize that medical devices are not rigorously approved like pharmaceuticals. The bill (S.3020), the Food and Drug Administration Accountability and Transparency Act, will provide the FDA with several tools to help ensure the safety of these devices.
Because of less stringent safety approval mechanisms, the FDA allows manufacturers to conduct post-approval studies. But in many cases these studies are altered or not completed and consumers are left in the dark about safety problems.
Medical device manufacturing is a $75 billion industry, with considerable lobbying power, which enables them to secretly waive or alter post-approval agreements with the FDA, without informing consumers. This bill would end this practice by requiring such changes to be placed in the Federal Register.
Senator Boxer also stated: “If the Secretary of Health and Human Services determines that a manufacturer’s failure to conduct post-market surveillance is a risk to public health, this legislation give the Secretary the authority to notify health professionals that have been using these devices about any safety concerns.”
Sybil Niden-Goldrich, a long-time advocate of the breast-implant issue, applauded Senator Boxer: “More than 360,000 women received breast implants last year—a 40% increase over the last five years. Yet none of these women knew silicone implants were approved on the basis of post-approval studies that subsequently were watered down by FDA and aren’t being conducted. Senator Boxer’s bill would correct these grave injustices.”
Selmer Bringsjord, director of the Rensselaer Artificial Intelligence and Reasoning Laboratory at Rensselaer Polytechnic Institute, spends a lot of time in Second Life, but not for recreation or entertainment -- he and his team at RPI (RPI) are the creators of synthetic agent Edd Hifeng, who they have endowed with a limited ability to converse and reason.
See the rest of the article here.
Do difficult times call for deep brain stimulation?
Brain-stimulation devices for treating depression have faced unexpected setbacks. To serve the 40 million or so sufferers who fail to respond to antidepressant drugs, a few companies have tried to treat the disorder with electronic implants and electromagnets. These therapies, however, have stumbled en route to the doctor's office.
To take a crack at those intractable cases, experiments exploring five device therapies will start this year. In total, nine different technologies are now under investigation in at least 27 human trials.
Full story here.
A Superhighway to Bliss
JILL BOLTE TAYLOR was a neuroscientist working at Harvard’s brain research center when she experienced nirvana.
But she did it by having a stroke.
On Dec. 10, 1996, Dr. Taylor, then 37, woke up in her apartment near Boston with a piercing pain behind her eye. A blood vessel in her brain had popped. Within minutes, her left lobe — the source of ego, analysis, judgment and context — began to fail her. Oddly, it felt great.Access the rest of the story here.
Concerns about carbon nanotubes as carcinogenic
Nanotechnology experts are calling for prompt government action to ensure that carbon nanotubes are properly regulated, after researchers discovered that some carbon nanotubes can cause precancerous growths in the same way that asbestos does.
the lung's outer lining, called the mesothelium.
Full article accessible here.
How Our Brains are Wired for Belief
From the Pew Forum on Religion and Public Life, transcripts from a discussion about how recent advances in neuroscience and brain-imaging technology have offered researchers a look into the physiology of religious experiences. The whole article and transcripts accessible here.
Friday, May 23, 2008
Over at MSNBC, Art writes that he's not so sure that Pistorious should be allowed to compete in the Olympics:
Should anyone who must run on prosthetic legs be allowed to compete in the Olympics or other sporting events?
Oscar Pistorius, a college student from South Africa, has been told he can compete in the Beijing games this August, in either the 400-meter or the 1600-meter relay race as a member of the South African team, if he can reach a qualifying time.
The decision has been greeted around the world with approval. Some see it as a triumph for the disabled. It is easy to see why. Pistorius, known as the Blade Runner, is a very appealing, articulate young man who trains hard and sincerely wants a chance to compete. But I am not sure letting him run is the right decision.
Pistorius was born with major bones missing in both his lower legs. His legs were amputated at the knees when he was a child. He runs using artificial limbs made of carbon fiber, known as Cheetah blades. The controversy over whether Pistorius should be allowed to compete has focused exclusively on whether his Cheetah blades give him an unfair advantage.
Last January the International Association of Athletics Federations (IAAF) said, based on a report from a German scientist, that mechanical legs give anyone using them an advantage in a race. They are more energy efficient than human legs, ultra-light, springier and do not fatigue. The IAAF said since the Cheetahs helped athletes perform better, it would ban their use. That decision meant no Olympics for Pistorius.
Pistorius appealed the ban to the Court of Arbitration for Sport (CAS) in Lausanne, Switzerland. Scientists at six universities in three nations took a look at Pistorius’ artificial legs. They concluded that the available evidence about the advantages of the Cheetah blades was insufficient. Last week the court said that, until more evidence was produced, Pistorius was eligible. The IAAF backed down and Pistorius can now compete.
What if further study does show that Pistorius can run faster because his artificial Cheetah blades work better than legs? Should he or others be kept out of competitions involving able-bodied persons?
(read the rest)
Thursday, May 22, 2008
Scientific advances that alter minds and bodies in novel ways can make people uneasy. The President's Council on Bioethics has become a forum for the airing of this disquiet, and the concept of "dignity" a code word for addressing it. This body recently released a 555-page report, and what it reveals should alarm anyone concerned with American biomedicine and its promise to improve human welfare. The May 2008 issue of The New Republic spells it out: this brand of government-sponsored bioethics does not want medical practice to maximize health and flourishing; it considers that quest to be a bad thing, not a good thing.
Although the Dignity report purports to be based on universal moral concerns, it springs from a movement to impose a radical political agenda, fed by fervent religious impulses, onto American biomedicine. How did the United States, the world's scientific powerhouse, reach a point at which it grapples with the ethical challenges of twenty-first-century biomedicine using Bible stories, Catholic doctrine, and woolly rabbinical allegory? Read the article, note the credentials (better, the incredentials) of the report’s contributors, and laugh…or weep.
Among the articles is “Facing Life with a Lethal Gene” detailing the experience of Katharine Moser, an occupational therapist who has tested positive for the Huntington Disease gene and who has yet to develop symptoms. Another article, “Cancer Free at 33, but Weighing a Mastectomy” follows the struggle of Deborah Lindner, a woman who has tested positive for the gene which leaves her at high risk for BRCA-related breast and ovarian cancer. Ms. Lindner decides to have a double mastectomy to avoid breast cancer.
Two related articles in the series, “Prenatal Test Puts Down Syndrome in Hard Focus” and its follow-up, “Genetic Testing + Abortion = ???” brought national attention to the complex subjects of prenatal testing, abortion, Down syndrome, parental advocacy, and the ethical dilemma of many liberals who are both pro-choice and pro-disability rights.
For a full description of this Pulitzer Prize category, Ms. Harmon’s autobiography, and all of the prize-winning articles, see the Pulitzer website. All of Ms. Harmon’s DNA Age articles can be viewed here.
Congratulations Amy! Posting thanks to blog reader Nancy Iannone.
For more info, check out the website BiggerStrongerFastermovie.com,
Older Brain Really May Be a Wiser Brain
When older people can no longer remember names at a cocktail party, they tend to think that their brainpower is declining. But a growing number of studies suggest that this assumption is often wrong.
Instead, the research finds, the aging brain is simply taking in more data and trying to sift through a clutter of information, often to its long-term benefit.
The studies are analyzed in a new edition of a neurology book, “Progress in Brain Research.”The rest of the article can be accessed here.
Blogger and disability rights activists Greg Wolbring has some interesting stuff to say about the ruling in his blog:
1) The ruling I assume will be interpreted to be a ruling against the scientific data claiming that the cheetah legs lead to an unfair advantage. The ruling leaves the door open that one could exclude a runner with prosthetics from competing in a ‘natural leg’ running event if it can be proven that the ‘artificial’ legs lead to an unfair advantage. This makes sense. So far the process of investigating theses new ‘artificial’ legs is not developed enough to be called a golden standard so its open for interpretations. Once tests are developed that are accepted as the golden standard and they show an unfair advantage one can see that that runner won’t be allowed to run against the ‘biological leg’ runners.2) However the ruling seems to give the answer to another question. Are the Olympics about athletes who have a body adhering to the norm of the homo sapient species? In other words is the Olympics about athletes with a ‘normal biological body’? The ruling cements the view that the Olympics are not about biological bodies per se. So one can compete in the Olympics independent of whether certain biological parts are replaced by artificial parts.
If the replacement does not lead to a competitive advantage athletes with artificial body parts can compete against athletes where the body part in question is biological and not artificial.
If the replacement does leads to a competitive advantage one could see the ruling opening the door for the scenario where the athletes with artificial body parts compete against each others in the Olympics whereby the artificial body parts are treated like a pole used in pole vaulting…
Greg's blog can be found here.
Wednesday, May 21, 2008
Yesterday, a federal appeals court overturned Virginia's ban on late-term abortion, passed in 2003 as the "Partial Birth Infanticide Act". Although the US Supreme Court upheld a federal ban on late-term abortion in 2007 (Gonzales v. Carhart), the Richmond-based US Court of Appeals for the 4th Circuit concluded that the Virginia ban was overly restrictive in comparison. In particular, unlike the federal ban, the Virginia law provided no legal protection for physicians who "accidentally" perform an intact dilation and extraction while performing a second-trimester abortion.
Across the pond, the British Parliament voted to keep an upper limit of 24 weeks for elective abortion, rebuffing critics who sought to lower the limit to 12 weeks. A very small number of infants born after only 24 weeks of gestation survive, but a majority of British MPs felt that the small chance of survival did not justify further restrictions on a woman's right to choose.
-- DIGNITY AND AGING
In the most recent issue of THE NEW REPUBLIC, Steven Pinker has an article on "The Stupidity of Dignity," in which he attacks the uses of the idea of dignity by Leon Kass and other members of the President's Council on Bioethics. Kass is the author of LIFE, LIBERTY AND THE DEFENSE OF DIGNITY: The Challenge for Bioethics. Pinker, it seems, has little respect for the concept of dignity in bioethics. On the contrary, he sides with Ruth Macklin, author of a
2003 article titled "Dignity Is a Useless Concept." Pinker, like Macklin, believes that "dignity" is a squishy, subjective notion. Above all, Pinker sees dignity as an insidious application of what he terms "theocon bioethics," associated with Kass and his allies.
This is a debate in which I am interested party, since I am co-editor of the book DIGNITY AND OLD AGE, which contains two chapters where I question the hegemony of the ideal of autonomy, so prominent in bioethics today. I do argue that dignity can and should play a critical role in thinking about ethics and the lived experience of old age, precisely because it captures elements of the world not captured by the ideal of self-determination. Pinker, by contrast argues that dignity is relative, fungible, and sometimes harmful, saying that "dignity is a trivial value, well worth trading off for life, health, and safety." Yet even Pinker is compelled to admit that "people generally want to be seen as dignified. Dignity is thus one of the interests of a person, alongside bodily integrity and personal property, that other people are obligated to respect."
Is it really true that dignity "is just another application of the principle of autonomy?" I think not, but the argument is too long for the space of this newsletter. Still, as Kant well understood, there are certain ideas that are impossible to escape. Suffice it to say that, like "freedom" and "happiness," the idea of "dignity" will not soon go away. It is an intrinsically contested concept and one that deserves our attention in all of the stages of life.
-- JUSTICE AND DEMENTIA
The Report "Achieving Care and Social Justice For People With Dementia" explores the issue of caring for people with dementia. It not only defines what "care" is but goes on to explain what "good care" should be. They authors examine the theory and practice of good care, using the moral categories of: Attentiveness, Responsibility, Competence, Responsiveness and Trust. The key point is that good care requires a continual negotiation between those providing and those receiving care. If caregivers adopt an ethic of care, patients will be assured of fundamental human rights.
For a related upcoming event, note the conference on "Creativity, Communication and Dementia" scheduled for May 30 - 31, 2008 in Vancouver, British Columbia. This event
is sponsored by the Society for the Arts in Dementia Care and the Canadian Institute of Health Research. For details contact: Dr. Dalia Gottlieb-Tanaka at (604) 986-6408 or email at: email@example.com.
-- IS PNEUMONIA THE OLD MAN’S FRIEND?
Physician William Osler once described pneumonia as “the old man’s friend:” that is, a relatively convenient way of dying. But what if we deliberately withhold cheap and effective treatment-- say, antibiotics-from older people with dementia? Dr. Gregory Rutecki has pushed this question: "Do [the elderly] die from complications contingent on the antibiotics themselves-- violating primum non nocere? Induction of bacterial resistance as well as
the impact thereof on society is not of primary concern. If the question of resistance is not being asked in other often younger cohorts, it cannot be asked solely with respect to the physically-marginal, demented elderly. They cannot be punished for their so-called biological tenacity."
From "Revisiting an Ethical Conundrum: An Older Person’s Friend
or a Renewed Assault on the Biologically Tenacious?" by Gregory W. Rutecki, MD.
Tuesday, May 20, 2008
In an era in which most cases of cervical cancer can be prevented or detected early and treated, the study – sponsored by the Sabin Vaccine Institute, the Pan American Health Organization, and the US CDC, among others – concluded that cervical cancer-related deaths are likely to double in Latin America in the next 20 years. Fewer than five per cent of women in Africa, Asia and Latin America are screened for cervical cancer, as compared to 70% of women in North America and Europe. Most of these women also lack access to newly-approved HPV vaccines.
Does this truly have to be the case? Must we continue to needlessly condemn 250,000 poor women to death every year? Even if we accept the argument that current screening and treatment technologies – Pap smears and the HPV vaccine – are too costly to be used widely in resource-poor countries like Haiti and Nicaragua, what about lower cost screening technologies like VIA (visual inspection of the cervix using acetic acid)?
For almost a decade, it has been known that clinicians, usually nurse-midwives, can detect more than three-fourths of pre-cancerous and cancerous cervical lesions simply by wiping a patient's cervix with acetic acid (white vinegar) and examining it visually. That this method is not more widely used, particularly in light of a recent Lancet study showing that VIA is as effective as traditional screening methods in India, is shameful.
It's time to wake up and smell the vinegar ...
Friday, May 16, 2008
Wednesday, May 14, 2008
The comments inside were intriguing: "...he [Hugh Herr] doesn't want his human legs back because soon they'll be archaic", "Technology...is quickly outpacing evolution, and few know how to respond", "Others will fret that some athletes might cut off a limb to gain a prosthetic advantage." This last quote has been a debate between a close friend and I for months now. I think this is a probability in the future, people are very competitive and those who were not born to compete may pay to be able to do so at any cost. She, only the other hand, is appalled at the idea, she is very open-minded about things, but this one crosses her line of what people would subject themselves to. The difference in opinions is understandable, we come from different experience and backgrounds, she had a mother who had to have her legs amputated for medical reasons and saw firsthand what life is like without limbs. Me I only know from what I read and imagine. We therefore amicably agree to disagree.
My other favorite quote however, and the one I saw on American Gladiators this week, was, "Shed a tear for the 'disabled' today. Tomorrow they might pity you." I wish I would've written this. I thought of it Monday evening when I was watching American Gladiators. This is a requirement in my home, my son is enamored with the Gladiators as any almost 9 year old should be. They showed the next competitors and who did they have...a leg amputee...a bionic athlete, John Siciliano.
My first thoughts were good for him, and my second was good for NBC or whoever in the company selected him to compete. The show, with it's overly muscular Gladitors, typically has competitors that are also overly muscular and look as if they're training for, well, to take on a Gladiator. This guy, however, was different. He wasn't overly muscular, he was a Para-Olympian Gold Medalist, he had endurance and a great determination took to take them all on. I watched and rooted for him. He didn't win, but it wasn't without a fight. The last challenge was tough and I must be honest, it was a bit sad and disheartening. No matter what his determination was, his leg was not outfitted for the Eliminator. The water challenge made the leg wet, the leg was the J-shaped Flex Foot version not good for ropes, tight-rope walking or going down the pipe, also not good with the wet leg. When it came to the end, he fought hard while the crowd cheered, he finished with pride.
Honesty again, this made me tear up, seeing him and knowing that he won't be the first, hoping others out there built like a Gladiator will want to compete also, as an equal to the Gladiators and to show up the first bionic competitor. Except the next time, they will be outfitted with prosthetics to take on the ropes, water, and the evil travelator. Bionic athletes are not going away any time soon,and as was mentioned in ESPN magazine, "Thousands of vets will return to the U.S. without limbs, and they will want the best replacements...and those vets will take their prosthetics to the blacktop and the field. Disabled athletes will get only more competitive."
So I say, good luck to the next competitor and welcome to the mainstream. We're going to be seeing a lot more of you in the future and I hope that we will all benefit from your determination and continual drive for best technologies.
Dr. Welch is also the author of a wonderful book, Should I Be Tested for Cancer? Maybe Not and Here's Why that provides lots more information about the ways in which "predictive" testing and population-level screening can create problems for patients.
Tuesday, May 13, 2008
By Michael LaTorra
Harvard's Michael Sandel argues in his book The Case Against Perfection: Ethics in the Age of Genetic Engineering that life is a gift and that we should accept the unbidden nature of this gift, working toward acceptance and solidarity with others rather than seeking unbridled mastery over human biology.
But is life properly viewed as a gift?
The claim that life is a gift automatically entails a responsibility on the part of the recipient of that gift to respond with gratitude and without taking issue with the precise attributes and characteristics of what has been given and received. One is supposed to live by the aphorism "Don't look a gift horse in the mouth" (or you might see a lot of rotten teeth). So to accept Sandel's premise that life is a gift is also to accept that one is obliged to respond in a certain way and without closely scrutinizing the actual conditions of what has been received.
But is life a gift at all? The alleged giftedness of life is not inherent in life itself. Something can be given and received without that something being a gift. Communicable diseases are given and received, yet we do not usually consider diseases to be gifts. In some cases, some individuals will say that they learned valuable lessons from their struggle with a disease. In that sense, perhaps we could deem a disease to be a gift. A better term for such an event, however, would be a test.
A test is given and received, just like a gift. However, a test may properly be viewed as fair or unfair, depending on whether the test is appropriate to the skill and knowledge level of the person being tested, and whether the test is free from trickery or deception. We are not expected to have any sense of social obligation to be grateful for being tested. We are not expected to overlook unfairness, bias or deception in the test itself. Indeed, we have a duty to evaluate the fairness of the test so that neither we nor other test-takers should be badly affected by an unfair, biased, deceptive or inappropriate testing instrument.
Life as we currently live it has many undesirable features, such as sickness, old age, too-short duration, painful death, and other limitations. To represent life as a gift without recognizing these negative attributes is to bias the discussion of how life might be improved. If life were merely a gift, one would have to wonder about the motives or competence of whomever chose to give such a gift. If you were shopping for the perfect gift to give someone you loved, would you give them spinal bifida and Huntington's disease?
Life is not always or only a gift. Life is also a test. A crucial element of this test is how life itself might be improved so as to lessen suffering, improve capacity, enhance abilities, and extend the duration of every desirable aspect of life itself. This is the lesson of life. This is how the test is well-met. The true gift of life is to make it better than it was when first received.
Scientists have created the first genetically modified human embryo.
What does this mean to you?
Led by Nikica Zaninovic, researchers at Cornell University added a green fluorescent protein to an embryo left over from assisted reproduction. They destroyed the embryo five days later. It is believed to be the first documented genetic modification of a human embryo." Rest of the article can be accessed here.
Sunday, May 11, 2008
It shows a woman peering gooily into a shop window, mooning over a warm and wriggling litter of--wait for it--not puppies, but diapered babies. Meanwhile, her male companion tries to drag her away from the window, eyes rolled heavenward in the universal male posture of "Not this again!"
There's a lot to unpack here, beginning with the idea that women view motherhood the same way they view a new pair of shoes; that men view women's desires to become mothers with the same exasperation as they view the shoe-buying habits some of us have; that babies are like puppies (warm, fuzzy, commodities)....
You can play too! What other assumptions and analogies are implied here?
You don't have to have a child to feel like a mother, or be motherly, or motherlike or maternal. We can be mothers to our ideas, our passions, to our pets, to our extended families -- being a mom can also be about being a nurturing caregiver, a protector of life and liberty, a guardian of the weak and the fragile, and a steward of the earth and all of its living creatures.
So, from all of us at the Women's Bioethics Project, we wish you a Happy and Joyful Mother's Day!
Friday, May 09, 2008
"Whether you'd prefer a new and improved reproductive system installed as a replacement for your own or external to yourself (say, next to the washing machine), there are a few recent advancements bringing it a step closer to reality. An emulsified liquid blood substitute called perflubron has had some success used as a replacement for amniotic fluid for premature babies in respiratory distress. It's not a complete replacement for the complex stew of hormones, lipids, and proteins normally present in the amniotic fluid, it is at least a promising way to get oxygen into developing lungs."
He concludes, "we're still many decades away from a safe, human uterine replicator that can bring an embryo from conception to zeroeth birthday party. Even once we've sorted out the technical aspects of the womb itself, we'll have to deal with what the rest of the mother's body contributes to development. Hormones have already been mentioned, but baby also borrows mommy's disease-fighting machinery. Our replicator will require nearly complete endocrine and immune systems, too.
All in all, I'd take a serious look at adoption."Full article accessible here.
Thursday, May 08, 2008
Conference: New Dilemmas in Medicine, co-hosted by the IHEU-Appignani Bioethics Center & Bioethics International
Where: 777 United
To Have the Best Child Possible: The Coming Age of “Procreative Beneficence?”
. Arthur Cooper, M.D., Director of Trauma & Pediatric Surgical Services,
· Jennifer Kimball, Executive Director Culture of Life Foundation
· Eva Kittay, Ph.D. SUNY Stony Brook
· Barbara Katz Rothman, Ph.D. CUNY Baruch College
· Udo Schuklenk, Ph.D. Queen's
· Panel Moderator: TBD
Ethics and Pharmaceutical R&D: Who Should Be Responsible for Tomorrow’s Drugs?
· Angela Ballantyne, Ph.D.,
· Chalmers C. Clark, Ph.D., Associate Professor, Department of Philosophy,
· Paul Howard, Ph.D., Director of the Manhattan Institute's Center for Medical Progress
· Wilmot James, Ph.D., Executive Director of the Africa Genome Education Institute
· Jason L. Schwartz, Ph.D., Researcher, University of
· Panel Moderator: Jason Lott, M.D.,
Saying “No” to Patients: Medical Professionals as Conscientious Objectors
- Robert Baker, Ph.D. Director & Professor of Bioethics, The
of Medicine Union Graduate College-Mount Sinai School
- Thomas Berg, L.C., Ph.D., Executive Director, Westchester Institute for Ethics & the Human Person
- Laura Katzive, Deputy Director, International Legal Program, Center for Reproductive Rights
- Mark Mercurio, M.D., M.A.,
of Medicine, Director of the Yale Pediatric Ethics Program, and Co-Chair of the Hospital Ethics Committee Yale University School
- Rosamond Rhodes, Ph.D., Professor & Director Medical Education, Bioethics Education,
of Medicine Mount Sinai School
- Girija Nandan Singh , Ph.D., University Professor & Head of Geography at R. D. & D. J. College Munger, Bihar, India
- Panel Moderator:
Dacey, Ph.D., Center for Inquiry, NYC Austin
Following the conference there will be a cocktail reception featuring an Argentinean Tango performance by Laura Real. This will be from 7:00 PM to 9:30 PM at the Consulate General of Romania, located nearby at 200 East 38th Street @ Third Ave
Registration Fees (includes cocktail reception):
General Public - $65
Students - $30
One can attend the cocktail reception only for $30.
Pay at the door, or send your check to:
IHEU-Appignani Center for Bioethics
P.O. Box 4104
Grand Central Station
New York, NY 10162
Contact person: Ana Lita: (212) 687-3324 AnaLita@iheu.org