Tuesday, October 30, 2007
But I did appreciate how some may feel inclined to take a sleep aid. Until now. The New Times published an article this week reporting that sleeping pills are really just mildly effective, that the newer drugs tested cut the time it took to fall asleep by only 12.8 minutes, and increased total sleep time by only 11.4 minutes. Is taking a prescription and ingesting more chemicals worth that? I don't think so.
And that is not all. The same article also reports that older prescription sleep aids such as Halcion and Restoril accounted for signicantly better results than the newer drugs. Yet another case of unneccessary "Me-too" drugs being overly marketed and preying on people who may be in a vulnerable state, in this case, sleep-deprived. As I mentioned above, most people find the Rozerem ads charming; they may march into the doctor's office and specifically request Rozerem. Note the Times article reports Americans spent $4.5 billion dollars on sleep aids last year.
Basically, sleeping pills don't really work, or rather, just aren't as effective as the American consumer is led to believe, according to the analysis. Pharmaceutical companies are latching onto our weaknesses and trying to tell us once again that it can all be solved in a little pill. And if Americans are spending that much money every year on sleeping pills, then it appears physicians are also throwing in the proverbial tower by prescribing these pills. Too bad these physicians can't be like the doctor in Fight Club who tells Tyler Durdan to "get more exercise and chew some valerium root, " instead of prescribing sleeping pills.
After speaking with Hinsch, Kohl writes: "Hinsch also voiced concern over the long term health implications of carrying another person's genetic matter, pointing to the fact that women who gestate even genetically-related multiple boys have increased risks for autoimmune problems, the genetic difference between the male and female of the species being enough to upset our natural physical make up. So what is the physical impact of carrying a non-related fetus? How is that risk compounded when carried out repeatedly which may happen at a place as well-managed as Akanksha in a developing region like Gujarat, India?"
Kohl has immense stores of sympathy for infertile couples and recognizes that there is a cost-effectiveness that is appealing to these couples -- I like the way she concludes, proceeding with caution, taking nothing for granted: "The act of bringing forth life, no matter whose constituent parts, no matter whose uterus or birth canal, is far too complicated to isolate it from history or the world as it is."
Sunday, October 28, 2007
My alter ego, Halle, received this email/phone message from her friends in LA, as a part of publicity push for the opening premiere of Nip/Tuck Tuesday evening, presumably as a joke. Neither of us is sure whether to laugh or be insulted.
Admittedly, the images are alluring -- the mythic fallen angel with her wings clipped -- although it is not the most intellectually stimulating fare on cable (it is, like House M.D., an oh-so-bad-but-I-can't-look-away drama), I can tell you a lot of students are going to be doing pop culture analysis on the ethics of plastic surgery and enhancements. Oh well, it's one way to get them to think about the issues. [Hat tip to Jay Hughes for the EurekaAlert article.]
Friday, October 26, 2007
The panel's report is available at http://www.chicagobreastcancer.org.
Thursday, October 25, 2007
You can listen in here.
First, from the Washington Post: Researchers have had to shut a South African AIDS vaccine trial developed by Merck & Co; they started warning hundreds of clinical trial volunteers that a highly touted experimental vaccine they received in recent months might make them more, not less, likely to contract HIV. The full article here.
Secondly, another reason to become a vegetarian -- from Wired, the inside scoop on how cloned meat (and milk) is filtering its way into the food chain and onto on your dinner table. The author talks to one of the farmers about the health problems that his cloned pig offspring have suffered: "Within weeks of delivery in September 2002, the first piglet got sick and died. Another dropped dead two months later. A few days before Christmas, Earnhart walked into his heated barn at feeding time and spotted his last two piglets belly-up in the straw. The cause of death was apparently their identical, adult- size ulcers...[The demise] may have resulted from a well-known, poorly understood side effect of somatic-cell nuclear transfer called sudden death syndrome." Access the rest of the article here.
Let's hope the rest of the week brings better news.
Tuesday, October 23, 2007
However, Ginsburg told the crowd of 500 people that if Roe were overturned, she does "not believe" it would "prevent women of means from accessing an abortion" but would "have a devastating impact on poor women" (AP/International Herald Tribune, 10/21). According to the Journal-Constitution, if Roe were overturned, middle-class women would be able to travel to states that allow the procedure, just as women who could afford to travel to California, Hawaii and New York -- where abortion was legalized prior to Roe -- did so to obtain an abortion (Atlanta Journal-Constitution, 10/21).
Ginsburg added that divisive issues such as abortion demonstrate the need for a strong, vigorous minority in the court, particularly in light of the more conservative court. She said she hopes the latest court term, which began this month, will be less divided than the last term. One-third of the cases during the last term -- including the case that upheld a ban on so-called "partial-birth" abortion -- were decided by one vote, the AP/Herald Tribune reports. Ginsburg said, "I will continue to dissent if in my judgment the court veers in the wrong direction when important issues are at stake" (AP/International Herald Tribune, 10/21).
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/dailyrepo
One of my students sent me a link to this article on a grad student doing a thesis on "Intimate Relationships with Artificial Partners" -- David Levy, a grad student in artificial intelligence at University of Maastricht in the Netherlands, speculates that robots will become so human-like in appearance, function and personality that many people will fall in love with them, have sex with them and even marry them. He predicts that Massachusetts will be the first jurisdiction to legalize marriages with robots, circa 2050.
Several things come to mind:
First, AI has to attain the status of legal personhood before any such thing as marriage (or any other contractual relationship for that matter) is recognized.
Secondly, as Glenn McGee wrote in an article in the Scientist and on blog.bioethics.net earlier: "As humans build robots that learn what their owners desire, the dilemma of the robots of Blade Runner emerges: What do humans owe “purpose-built” machines who begin to reach awareness, or to so resemble awareness that it becomes a selling point? Should laws be written to protect robots from us, by requiring robot makers to stop short of, say, robosexual devices that learn to be incredibly intimate with humans and yet are owed nothing? If so, do we create such laws in the interest of robots, or to preserve our own human dignity by choosing not to create a new kind of slave, whether or not that slave is fully aware?"
Thirdly, would these robots be sentient -- capable of experience pleasure and pain? Because the act of creating potentially sentient beings carries with it the corresponding responsibility for their actions and for the impact on the human community, the biosphere of the earth and the universe as a whole.
Fourthly, will it ever be possible to 'upload' your thoughts and memories to create a robot version of you? Some organizations are striving to do this -- and if they succeed, it will certainly have an impact on the previous questions.
Monday, October 22, 2007
From the Washington Post, the provocative Replaceable You:
As the tail end of the enormous 78 million-member baby boom generation enters middle age, Americans are living longer and expecting to enjoy better fitness and health than previous generations. The human body can't necessarily do at 50 what it did at 25, but when a part wears out from age or overuse or both, older Americans increasingly expect that it can be fixed or replaced.
Sign me up! ~
Just back from the ASBH meeting in Washington, D.C., it was a fantastic meeting and neuroethics played a very prominent role in the panel presentations this year. Some of the speakers included Walter Glannon and Roberta Bondar on issues of neuroenhancement, Thomas I. Cochrane and Julie A. Tannenbaum, on how neuroscience is shaping our conceptions of moral personhood, and WBP's Robin N. Fiore and James Giordano about why neuroscience needs naturalized ethics (which brought on a very intense discussion about is there such a thing as a 'male' or 'female' brain). Pair this up with the latest in the Washington Post about how to keep an aging brain a healthy one, and you could have easily have several years worth of interesting reading and contemplation. The Women's Bioethics Project is looking forward to collaborating with the newly established Neuroethics Society and the Law and Neuroscience Project!
Friday, October 19, 2007
Obviously, as Holden points out, the inherent misogyny of the comment is unarguable. But also something you can’t really argue with is the fact that movies with female leads are tanking. Have people suddenly stopped enjoying women? Looking at Nicole Kidman? (The last time I saw a total, her latest movie, co-starring Daniel Craig, hadn’t even made back its $80 budget.) And while that might strike you as a misandrist comment – consider the utter box office failure of all romantic movies, regardless of the gender of the lead, or the fact that, again as Holden notes, the female target audience has largely disappeared. (Maybe they’re all in grad school, like me, and have only had the time and spare money - $12 for a movie?! – for one movie a year?)
But what is truly interesting to me is something I haven’t seen mentioned anywhere but in this piece, and what I suddenly find myself wondering about in other settings. Rabinov blamed the box office failure on the leading role being a woman - not bad marketing, or bad writing, directing, or anything else. Roles typically taken by men in the movie industry, and that clearly have much more control over the quality of the movie, or the ability to draw an audience. It’s convenient to scapegoat the women, something my women’s studies friends would probably say is an attempt to subvert the strides women have made in gaining equality. Put her back in the kitchen – or at least the role of the helpless romance interest.
The academy has some similar gender concentrations, for lack of better concept, with women newly (and massively, by general statistics) emerging in all fields, but men still being in many, if not most, of the positions of authority. I wonder, then, just how much scapegoating of women in our own field has occurred because of faulty assumptions, blaming her gender rather than other circumstances around the failure (or perceived reason to scapegoat).
So I toss it out to you, at a sleepless 4am, and wonder if you know of any experiences like this for women in our (vastly defined) field, or if you think it’s happened to you? Is this, in your opinion, an isolated instance, or do you think it’s more common to reach for blaming the woman involved? It’s genuinely something that’s never crossed my mind, and I’d like to hear your thoughts.
The researchers from the James Hogg iCapture Center for Cardiovascular and Pulmonary Research – and what a fabulous name is that for a center? – have suggested that perhaps women’s hearts and surrounding blood vessels are simply physiologically different, making the functional properties of aspirin (which prevent clots from forming) moot.
Of course, the critique has been coming fast and furious, with experts disagreeing on the report and findings, and cautioning against women who are taking an aspirin a day to keep the heart attack away from stopping.
But as anyone who’s taken aspirin continually knows, there are risks to it damaging the stomach lining and causing its own issues – and for that reason, if it’s not necessary or medically of benefit for women to take a daily aspirin, it’s certainly worth knowing! The research will undoubtedly continue, and be worth keeping an eye on.
[cross-posted from the AJOBlog]
Thursday, October 18, 2007
The report card, titled "Making the Grade on Women's Health: A National and State-by-State Report Card," measured women's health in all 50 states and Washington, D.C., by using 27 health benchmarks designated by HHS' Healthy People 2010 campaign. According to the report, the U.S. overall fails to meet 12 of the 27 benchmarks, up from nine in 2004 (Bartolf, CQ HealthBeat, 10/17). Only three of the 27 benchmarks -- women receiving regular dental care, women ages 40 and older receiving mammograms and women ages 50 and older receiving colorectal cancer screening -- were met, Michelle Berlin, an associate professor at OHSU, said.
None of the states received a "satisfactory" grade in women's health. Three states -- Massachusetts, Minnesota and Vermont -- received a grade of "satisfactory minus," a decrease from 2004, when eight states were considered "satisfactory minus." Eleven states and the district received failing grades in women's health status, compared with six states in 2004. The 11 states are: Alabama; Arkansas; Indiana; Kentucky; Louisiana; Mississippi, which ranked last; Oklahoma; South Carolina; Tennessee; Texas; and West Virginia. The remaining states received "unsatisfactory" grades, Reuters reports (Steenhuysen, Reuters, 10/17).
The report found that several benchmarks -- including the percentage of women receiving prenatal care, infant mortality and the percentage of uninsured women -- varied significantly by race. American Indians and Alaska Native women were twice as likely as white women to be uninsured, the report found. Among white women, 16.9% were uninsured, compared with 22.7% of black women and 37.8% of Hispanic women, according to the report. The percentage of uninsured women increased by 1.7% since 2004, according to the report (CQ HealthBeat, 10/17). Minnesota had the lowest percentage of uninsured with 9.1%, and Texas had the highest percentage at 28.1%, the report said (Reuters, 10/17).
The report found 85.7% of white women received prenatal care, compared with 70.8% of American Indians, 75.9% of blacks and 77.5% of Hispanics. According to the report, the percentage of women nationwide who received prenatal care increased by 5% since 2004 but is still unsatisfactory. The report found that white women have an infant mortality rate of 5.7 deaths for every 1,000 live births, compared with 13.5 deaths per 1,000 live births for blacks and 5.6 per 1,000 live births for Hispanics. The overall infant mortality rate has remained the same since 2004.
The percentage of obese women increased in all states and the district (CQ HealthBeat, 10/17). Hawaii had the lowest percentage of obese women at 16.7%, and Mississippi had the highest percentage at 31.5%. The percentage of women ages 40 and older who received mammograms improved in all states (Reuters, 10/17).
The number of states with parental notification policies for minors seeking abortion decreased, as did the number of states that have mandatory waiting periods for abortions, the report found. The number of states that provide public funding for abortion for low-income women has remained constant since 2001, according to the report.
"The outlook for women's health is nowhere near approaching the nation's goals for 2010" set by the Healthy People campaign, Berlin said, adding, "Failing to meet these goals undermines not only the health and well-being of women, but the well-being of our country as well." Judy Waxman, vice president for health and reproductive rights for NWLC, said, "It's nothing to cheer when only a handful of states are meeting at least half of the policy goals" (CQ HealthBeat, 10/17).
Waxman called on states to implement policies to improve women's health (Reuters, 10/17). "It is evident that our health system needs mending," Waxman said, adding, "Lawmakers must take a comprehensive, long-term approach to meeting women's health needs" (CQ HealthBeat, 10/17).
The report is available online.
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/dailyrepo
Wednesday, October 17, 2007
I’m kidding, of course. It’s wrong and we should not permit gifts (large or small) to physicians by pharmaceutical companies and I support Stanford’s recent decision to ban such things. Yet, I find the simple solution of “let’s ban the pens and food along with the vacations and lucrative consulting fees” naïve and not recognizing the bigger problem of the weakening of physicians’ duty to keep their patient’s health primary.
The WJS recently did a series of articles on two disturbing trends. One described how more and more physicians have a financial interest in the laboratories they refer patients to for tests. The other is on the trend of primary care physicians offering services such as Botox and liposuction that have nothing to do with a patient’s health but everything to do with the physician’s bottom line.
These practices undermine patients' confidence in their doctors to have their best interests as a top priority. Now that is a moral dilemma bioethicists need to speak out against, not just pens and pizza.
Excerpts from the WSJ articles cited:
Medicare Moves to Cut 'Self Referral' Practice
Proposed New Rules Target The Rise in Doctors Sending Patients to Centers They Own
By DAVID ARMSTRONG
WJS September 12, 2007; Page B1
In recent years, many physicians have become wealthy by investing in magnetic resonance imaging, or MRI, facilities, surgery centers and diagnostic sites -- and then sending their patients to them. A recent McKinsey & Co. study pegged doctors' profits from this practice, known as self-referral, at $8 billion a year. Critics say self-referral fuels the ordering of unnecessary exams or procedures as the doctors stand to profit from the increased business. Supporters say that doctors' investment in new facilities improves medical services, especially outside metropolitan areas, where patients might not otherwise be able to access the latest technologies.
Small Firms Are Taking On Second Jobs: FranchisesAdd-On Business Fills
Gap During Slow TimesAnd Expands Clientele
By RAYMUND FLANDEZ
WJS October 16, 2007; Page B5
Brian Fox wanted to give his general-practice clinic, Fox Medical Center, a face lift by providing additional services to patients. So he added a scaled-down version of a Dermacare Laser & Skin Care Clinics franchise. Patients can make regular medical appointments as well as schedule treatments like Botox, laser hair removal and skin resurfacing. He says the franchise brings in about $35,000 to $60,000 per month, on average doubling his monthly intake. There's little new overhead or inconvenience since Dr. Fox and his staff use the same exam rooms for laser and injectable services and medical examinations."The benefit that I've been able to develop out of this is not just from the financial end," Dr. Fox says. He says he finds the Dermacare procedures fun and a break from attending to sick patients or dealing with insurance companies.
Monday, October 15, 2007
We're all aware of the efforts enacted by various states across this country, designed to encourage consistent organ donation on a voluntary basis. In these instances, potential donors have to consent to having their organs harvested. However, the medical community in the United Kingdom is seeking to change that, by moving to an "opt-out" system.
Under the new system doctors would assume that everyone wants to be a donor after death, unless a request has been made ahead of time, either in writing or by notifying relatives, requesting to opt-out.
What do you think? Whose organs are they anyway?
Before the mid 1960's, most likely the child would have been brought to a psychiatric hospital. After the 60's, however, there was a movement to deinstitutionalise the hospitals. Most likely it was related to the advent of the phenothiazine class of antipsychotic drugs (e.g. thorazine). It is almost as if once they transitioned, they never looked back at the benefit of what the hospitals had to offer. As an example, Pennsylvania Hospital here in Philadelphia had a psychiatric hospital up on 48th and Haverford. What was interesting is that it was technologically interesting -- each patient room had huge windows, an individualized heating and cooling vent, and most importantly, there was custom treatment for individuals of all tiers of mental deficiency. This means that individuals who suffered from Down syndrome would have all the medical staff and psychiatric staff as necessary.
I'm not suggesting that progress has not been made in treating some individuals - in fact, we have come far with the atypical antipsychotics. However, not everybody is deserving of medication. Realistically, the boy being discussed will never be able to receive medication to palliate his symptoms. Rather, the fundamental wiring is incomplete. Would it be a bad idea to have a trained staff of professionals interacting with this child in a Hospital setting? Barring any corruption (which happened in a few hospitals (e.g. molestation of patients)) I think he may be able to benefit. Look at the situation he is in now, wherein he is removed from his home and has "caretakers". Would it not be more prudent to have trained professionals to deal with the child instead?
Friday, October 12, 2007
In what my friend Mickey would call "whattya know, water is wet" news, a new study released in The Lancet's current issue, which focuses on the health of women and mothers worldwide, shows that abortion rates have declined worldwide. According to the Guttmacher Institute, one of the authors of the report, abortion rates fell most significantly in Eastern Europe, "a trend that corresponds with substantially increased contraceptive use in the region." Also of note is that the abortion rate fell the most in the regions where abortions are safe and broadly legal.
When thinking of maternal health, especially in developing countries, abortions must be taken into account. Dr. Paul F.A. Van Look, the director of WHO’s Department of Reproductive Health and Research, says that "nearly half of all induced abortions are unsafe, putting the lives and health of women at major risk. Each year, about 70,000 women die due to unsafe abortion and an additional five million suffer permanent or temporary disability."
Echoing Dr. Sharon Camp, we know that the best way to reduce abortion is to reduce unwanted pregnancies, which is easiest done by the simple method of increasing access to contraception. And the only way to improve the health of women who do have abortions is to make them safe, and provided by a skilled professional.
Thursday, October 11, 2007
AP Article (via Google).
I have concerns about this technology, just as privacy and civil liberties advocates do; also the irony of making such explicit imagery a routine part of security measures calls into question many conventions in our society on modesty, nudity, and privacy, especially when women are being banned from airplanes for dressing "indecently" and a little cleavage on a politician provokes outcry. While I do not believe that women are delicate flowers who need to be protected, I have to wonder if this technology was developed and advocated by heterosexual men who have never known what it is like to be leered at, harassed, or surreptitiously photographed from compromising angles. I recommend we send those officials through the scanner and tell them that their scans were being carefully scrutinized by Larry Craig or Mark Foley. Then let us see if they are as excited about this breakthrough.
The lead physician, Dr. Daniel Gunther, died of carbon monoxide poisoning on Sept. 30. It was recently ruled a suicide.
More chilling, a family in Britain is considering removing their disabled daughter's uterus to "spare her the pain, discomfort and indignity of menstruation."
I agree with the findings of the ethics committee reviewing Ashley's case that it was unethical on many levels. And I am disturbed that this type of procedure is being considered again. While I do not believe that hypothetical reproductive viability ought to outweigh one's health, the drastic measures taken (removal of organs) for ease-of-care purposes was an example of poor judgment and skewed priorities.
Wednesday, October 10, 2007
Proposed new testing includes Abraham Lincoln’s blood, looking for Marfan syndrome, and the body of what is allegedly Billy the Kid. There is also a cottage industry of selling celebrity locks of hair and other artifacts (gum chewed by Arnold Schwarzenegger, a pumice stone used by Britney Spears). The collection of locks of hair has long been a tradition among some collectors, but the other artifacts have been disallowed by Ebay, as part of their ban on the trade of body parts.
Regarding still-living celebrities and popular figures, it seems to me to be a direct invasion of privacy to test discarded items for DNA, as these could show genetic mutations that could affect insurance or the celebrity’s standing, or they could demonstrate illicit drug use. This one seems like an easy call to make for most reasonable human beings, especially if they consider being in that position themselves .
However, regarding long-dead historical figures, should there be a statute of limitations, after which it’s okay to perform genetic testing? Should it only be in cases where there is a legitimate scientific inquiry? But what constitutes ‘legitimate’? And what if descendants are unhappy with the perceived invasion of privacy? Can you invade the privacy of someone long dead? And what about grave-robbing and testing of mummies and other remnants of long-dead cultures? Is it okay if no one complains and not okay if descendants are uncomfortable with the perceived desecration of the remains? When does scientific inquiry and curiosity trump individual or cultural concerns, and does the passage of time shift this continuum?
Tuesday, October 09, 2007
- "Heart Health: Panic Attacks Seen as Risk in Postmenopausal Women": Women ages 51 to 83 who have panic attacks are four times more likely to have coronary heart disease than postmenopausal women who do not have such attacks, according to a GlaxoSmithKline-funded study of 3,300 women enrolled in the Women's Health Initiative and published in the October issue of the Archives of General Psychiatry, the Times reports. The study found that compared with women who did not have panic attacks, women who had such attacks had a 75% higher mortality rate and were more likely to smoke and have high blood pressure, diabetes, a history of cardiovascular conditions and symptoms of depression (Bakalar, New York Times, 10/9).
- "In the Battle Against Cancer, Researchers Find Hope in a Toxic Wasteland": Two compounds discovered in a hole filled with toxic waste in Butte, Mont., by Don Stierle, a professor at Montana Tech of the University of Montana, and Andrea Stierle, a chemistry researcher at MTUM, have shown initial success in killing NIH-developed breast and cervical cancer cell lines, according to two papers recently published in peer-reviewed organic chemistry journals, the Times reports. Although Andrea Stierle said the research is at an early stage, she and Don Stierle have been negotiating with a pharmaceutical company to possibly develop new cancer medications from the compounds (Maag, New York Times, 10/9).
- "Antidepressants Emerge as Coolant for Hot Flashes": An increasing number of women are taking antidepressants to treat hot flashes and other symptoms of menopause as more women and doctors are seeking alternatives to hormone replacement therapy, the Times reports. According the Times, studies are highlighting a "wide variation" of responses among women taking the drugs to treat hot flashes (Parker-Pope, New York Times, 10/9).
Kurdish Officials Seek To End 'Honor' Killings Related to Out-of-Wedlock Pregnancies, Sex Outside Marriage
Officials in the Kurdish region of Iraq are seeking to end so-called "honor" killings, the murder of a woman by a relative to protect the family's honor because she became pregnant while unmarried, or engaged in premarital or extramarital sex or other actions that could affect the family, the AP/Miami Herald reports. According to the AP/Herald, honor killings are an ancient tradition in the Kurdish areas of Iraq, Iran and Turkey, as well as in tribal areas of Pakistan and some Arab societies.
Kurdistan's Parliament in 2002 revoked Iraqi laws that dismissed charges or allowed leniency in cases involving honor killings. The British government earlier this year arranged for a delegation of Iraqi Kurds to meet with Pakistani officials to discuss their experiences in combating the practice. "Killing under the pretext of protecting honor is murder," Nechirvan Barzani, the region's prime minister, said in July.
Advocates against honor killings have welcomed the regional government's efforts to halt the custom by publicly condemning it and warning about harsh penalties for those who commit the act. Runak Faraj -- head of the Rewan Women's Center in Sulaimaniyah, one of Kurdistan's main cities -- said that the attitude toward honor killings could be changing in part because of an increased Western influence in the region. "Western culture is growing here and is in contradiction with the old tradition that honor is something sacred," she said. Some advocates added that more education about the custom, as well as law enforcement, is needed.
According to officials who attended the meeting with Pakistani officials, there are several hundred honor killings and related suicides annually in Iraqi Kurdistan, but reliable statistics are not available because of ineffective law enforcement and a lack of cooperation among tribal communities. The number of women who committed suicide by setting themselves on fire increased from 36 in 2005 to 133 in 2006, and the number of women murdered increased from four to 17 in the same time period, according to a report by Kurdistan's Human Rights Ministry. The report did not specifically mention honor killings (Torchia, AP/Miami Herald, 10/7).
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/dailyrepo
An article in The Scientist discusses the FDA’s decision to require patient-reported outcomes from some pharmaceutical companies during the drug development process. Over the last few years, the FDA has moved to require patient-reported outcomes such as results of validated patient questionnaires from more drug developers. In 2006, the FDA issued a 32-page draft guidance for designing questionnaires, capturing patient feedback, and analyzing data.
Patient-reported outcomes are measurements of responses during the clinical trial that cannot be obtained through other types of clinical testing or questioning, such as reduction of pain or fatigue and quality-of-life improvement. While the FDA director for the study of end points and label development states that a patient-reported outcome can be more reliable and less variable than a clinician’s assessment, others argue that the questionnaires are subjective and a perception of “pain” can vary widely from patient to patient. In addition, when questionnaires are completed on behalf of children or elderly patients, how can validity of the results be guaranteed? Who would monitor the investigator and ensure that he/she does not complete questionnaires on “behalf” of patients, thereby potentially skewing the results of the study?
The potential burden on the drug developers to add patient-reported outcomes if requested by the FDA may add a year or more to the drug development process. It is also an additional financial consideration, as development and validation of a questionnaire can cost $500,000 or more. On the other hand, there is a strong advantage to having validated data with positive patient outcomes in the drug’s product labeling. The drug developer has a valuable opportunity to use the patient-outcomes data for promotional purposes in promotional and educational materials and also in reimbursement negotiations with managed-care payers or government agencies.Source: Silverman E. Whether drug companies like it or not, the FDA is pushing patient-reoprted outcomes in trials. So what are they good for? The Scientist. 2007;21:64. Available at: http://www.the-scientist.com/article/print/53617.
Monday, October 08, 2007
This article, from Forbes.com, addresses the issue of how these programs frequently make mistakes in the information ultimately shared with viewers, despite their reliance on any number of experts and consultants there to provide accurate representations of diseases, and medical procedures. With a more sophisticated consumer/viewer, there's little concern that these shows are seen as nothing more than entertainment. However, a number of studies have published data that this perception may be far from reality.
It's no secret that many lay people get and rely more and more on information gleaned from popular media, and less from reliable sources. These studies, published in several scholarly journals, presented findings that showed viewer perceptions and beliefs about procedures such as cosmetic surgery, to organ donation, that were directly attributable to these programs.
So what do you think?
Is this unfolding trend the result of blatant disregard for the facts on the part of TV networks, who use creative license beyond its purpose--in other words taking entertainment too far--or are the studies over dramatizing the issue and "making something out of nothing"?
The same issue will be faced with truly artificial life in the form of a learning, electronic neural network. When that object becomes much more than what it was when it was created, and begins the process of sentience, can it be labeled as property? (See Star Trek:The Next Generation, Season 2, Episode 9 - "The Measure of a Man" for a fantastic depiction of this scenario)
The fact is, even in this minuscule scale, this confronts humanity with very fundamental questions, and will lay framework regarding our values. Some things, especially when it concerns life even in the smallest sense cannot be held for profit's sake. Granted, the patenting process allows credit and respect where due for certain processes or products made. It does not, however, allow a human being to claim ownership on an organism, no matter its scale.
Full article here.
Tuesday, October 02, 2007
3D Images You Can Touch
(Which leads to the question 'can virtual intimacy be far behind?')
The first time you gazed at a high-definition display, you may have thought to yourself, “Wow, that image looks so real; I feel like I could reach out and touch it!” What if, one day, there was a display that let you turn that perception into reality?
Researchers at NTT Comware in Japan have developed a prototype of just such a system, called the Tangible-3D display...the glove provides a tactile sensation that makes you feel like you’re touching solid objects. [Full article here.]
Pfizer faces $8.5 billion suit over
Connecticut Catholic Bishops Agree To Comply With Law Requiring Hospitals To Dispense EC To Rape Survivors -- Connecticut's Roman Catholic bishops on Thursday said that the state's four Catholic hospitals will comply with a law (SB 1343) that takes effect Monday and requires all hospitals in the state to dispense emergency contraception to rape survivors, the Hartford Courant reports...[Full article here]
The Pill, For Men: Two kinds of oral contraceptives and a sperm blocker are being developed - With condoms and vasectomies, men take responsibility for a third of contraception in the
Americans Seek Common Ground on Abortion
(MSNBC/Newsweek) Long a black-and-white issue, abortion is now seen more as an argument to be fostered, not settled -- Although plenty of people are passionate about abortion, few of them would spend 16 years and $7 million of their own money making a movie about it, especially one that tries not to take sides. [Full article here]
Judge had no right to ban homeless couple from procreating,
Exoneration Using DNA Brings Change in
All but eight states now give inmates varying degrees of access to DNA evidence that might not have been available at the time of their convictions. Many states are also overhauling the way witnesses identify suspects, crime labs handle evidence and informants are used. [Full story here.]
Woman Suing IRS Over Sex-Change Tax Claims
Has Artificial Beauty Become the New Feminism? [hat tip to James Hughes of IEET.org] This spring, Sideways star Virginia Madsen became a spokesperson for Allergan Inc., the maker of Botox." Quoted in People magazine, Madsen asserts that she's made "a lot of choices" to keep herself "youthful and strong": "I work out. I eat good foods. And I also get injectables." [Rest of the story here.]
The pill: new evidence shows it helps protect against cancer
The contraceptive pill actually protects women against cancer in later life, according to the largest study ever set up to evaluate the risks and benefits. [Full story here]
The scientists, at Harvard-affiliated Boston Children’s Hospital, grew the valves from a type of stem cell that normally gives rise to the inner lining of blood vessels. They used a biodegradable scaffold to give the cells shape and a mix of proteins and growth factors to stimulate the cells to grow into the proper tissue type. [Full story here]