Thursday, December 29, 2005
This incident is the latest to raise troubling questions about selective disclosure of data in industry sponsored clinical trials. To be sure, there will always be risks and contraindications with any medication, but health care regulators, providers, and patients can't assess those risks if they aren't given all the information. (See the latest regulatory contibution, note this registry is voluntary.) Important questions that emerge in this case are ones that Jerry Avorn asks us to think of as “pharmacoepistemological”. Epistemological questions are those that involve the nature and the scope of knowledge, truth, and justification of claims. Thus pharmacoepistemological questions have to do with how it is that we-- regulators, patients, and providers-- know that a drug is effective and safe enough to use. How do we --regulators, patients, and providers--get drug information and how can we determine if the information is trustworthy? It is the norm that the most trustworthy sources are scientific articles written in prestigious peer-reviewed journals by experts in the field who work at accredited institutions of higher learning. But in this procedure there is the assumption that people who submit the manuscripts will be telling the truth and not fudging data.
The fraudulent data announcing the creation of human embryonic stem cell lines that were submitted to and published by the world respected journal Science again reminds us that we get to know about empirical data as they are presented to us by trustworthy sources. But all along the chain of transmission of data, from lab investigator to department chair to external funding agency to the editorial board of the journal, we find human beings. And human beings have interests. Bias and interest are not the same thing. Bias can occur because of some interest or other that is contrary to the interest of the truthful and full transmission of data. The problem is not that there are values and interests inherent in the scientific project. This in itself does not make science “subjective." The values of truth telling and full disclosure are essential to good science. Thus, it is the kinds of values and human interests that affect the process that invite scrutiny. We have to ask what values are being advocated and whose interests are being served.
Tuesday, December 27, 2005
Friday, December 23, 2005
However, not everyone is excited by such prospects. Many religious groups that value abstinence until marriage say hymen repair is a deception. Devout Roman Catholics consider sex before marriage sinful and equate female virginity with near divinity. Hymen replacement is "misleading and misguided," says Kathleen Raviele, a gynecologist and vice president of the Catholic Medical Association in Needham, Mass. "The best thing is to remain chaste until marriage and then have that genuine experience on your wedding night."
For many Muslims, sexual purity, especially for women, is a way of maintaining the family’s sanctity. But Islamic law also prohibits lying and frivolous cosmetic surgery, says Uzma Mazhar, a St. Louis psychotherapist known for her Web site, CrescentLife.com, which provides Islamic perspectives on Western issues. "What people forget is that Islam teaches us to be honest and fair,"Ms. Mazhar says. "A family should think about this before they present a woman as a virgin when she's not."
Other criticisms of hymenoplasty include questions of the procedures legitimacy and safety. The ethics committee of the American College of Obstetricians and Gynecologists, concerned about the marketing of revirgination, has not taken a formal position on the matter, but has expressed concern over the lack of information in the medical literature regarding the procedure, a fact that may mean performers of the procedure are improperly trained. Marco Pelosi II, an obstetrician and gynecologist in Bayonne, N.J. had this to say about hymenoplasty: "no one used to talk about it, but that's changing," "Really, it's not like a heart transplant-it’s a very simple procedure."On the contrary, Thomas G. Stovall, a recent president of the Society of Gynecologic Surgeons, says "hymen repair is a totally bogus procedure." In general, he says, surgery marketed to improve one's sex life rarely works. As for hymen replacement, "most importantly, it doesn't make you a virgin again."
Despite this fact, women are enticed by the ability to tighten their vaginal walls and even redesign the look of their private parts; participating women often indicate that such measures were meant to boost their own confidence levels or please their partners. A 51-year-old patient-a Manhattan attorney and mother of three-had her hymen reattached her hymen and her vaginal walls tightened in 2003. "I thought it would add that extra sparkle to our marriage," says the woman. However, a 26-year-old Latin American woman who lives in New York's Queens who had a hymen repair in 2001 says it took almost two months for her to feel comfortable again. It took even longer for her to enjoy sex. Despite her discomfort, the married mother of two says she’s still glad she had the surgery. She says her husband wanted to experience intercourse with a virgin, explaining that "if a woman isn't a virgin when she gets married, a man can always put her down for that."
Such attitudes irk feminists, who say hymen repair is a manifestation of bigger social pressures that keep women subservient to men. "It comes with a whole set of norms of a macho culture," says Silvana Paternostro, Colombian-born author of "In the Land of God and Man: Confronting Our Sexual Culture." Some feminists liken hymenoplasty to female genital mutilation, a procedure that often forces women to endure genitalia alterations that Western women now pay for.
Read more: “U.S. Women Seek A Second First Time Hymen Surgery Is on the Rise And Drawing Criticism", AMY CHOZICK, THE WALL STREET JOURNAL; December 15, 2005
Thursday, December 22, 2005
Point number one: It's going to be a disaster. The people it's supposedly helping are being asked to choose from a bewildering number of plans, which can differ in cost by thousands of dollars, depending on a given person's (current!!) medications. The NPR story features an interview with a woman who does this for a living--and it takes her about an hour and a half to figure out what is the best choice for a particular person. Oh, and the tools people are supposed to use for this? The Internet. . . and while many of us know tech-savvy elders, it's simply irresponsible for the Internet to be positioned as the primary resource here. There are toll-free numbers set up for assistance, to be sure, but reports indicate that it's hard to get through to a live person. And we're not even talking yet about the actual implementation of this behemoth. Why did we do this, again? Oh, yeah--so that pharmas would have an opportunity to maximize profits. What part of "safety net" don't we understand?
Point number two: Given the inadequate support being provided for elders, guess who is supposed to leap in to fill the gap? The "adult children" of these folks, that's the plan. Let's be honest, folks: that's daughters and daughters-in-law. Just one more example of uabsolutely essential work (unpaid, "caring-centered," time-consuming, and invisible) that ends up on women's plates by fiat and assumption. Externalized costs, anyone?
Friday, December 16, 2005
Embryonic stem cell research might now be more potentially viable for the UK Stem Cell Bank, which learned that samples from 150 random human embryos, far fewer than previously thought, might be able to generate materials beneficial for two thirds of the population. Embryonic stem cells can mature into various types of tissue that can potentially be used to replace “diseased or damaged tissue in conditions such as diabetes and neurodegenerative disorders.” A
Displeased opponents say "false hope" is being raised among "desperate patients". Disregarding such criticisms, many scientists welcome stem cell research from spare IVF embryos as offering the possibility of a more cost-effective and practical alternative to therapeutic cloning. The scientific team calculated that cells from 150 random embryos would be enough to provide the best possible match for 13% of recipients, a favourable level of match for 65%, and some use for as many as 85%. Surprisingly, just 10 types of specifically selected genetic material would be enough to provide a favourable level of match for 78% of recipients.
At present the UK bank contains stem cells suitable only for research. Professor Pedersen told the BBC News website that “this research tells us is that the number of lines needed to achieve a significant clinical value is in the practical realm.” Professor Pederson also said that researchers were already working from spare IVF embryos. Dr Glyn Stacey, director of the UK Stem Cell Bank, acknowledged the importance of recent findings, but admitted researchers were still “a long way away in terms of establishing the basic cell culture methods” and do not know “whether all stem cell lines will give the full range of tissues." The charity Life argues that research had shown adult stem cells preferable to embryonic stem cells fro the purposes of treating disease. Spokesman Matthew O'Gorman said: "The
Sunday, December 11, 2005
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) claims that almost 18 million people in the USA abuse or are addicted to alcohol. According to BusinessWeek, this abuse and addiction costs the USA around $185 billion a year in medical services, lost wages, and law enforcement resources. The NIAAA also claims that alcohol affects women differently than men. “Women become more impaired than men do after drinking the same amount of alcohol, even when differences in body weight are taken into account. This is because women's bodies have less water than men's bodies. Because alcohol mixes with body water, a given amount of alcohol becomes more highly concentrated in a woman's body than in a man's. In other words, it would be like dropping the same amount of alcohol into a much smaller pail of water. That is why the recommended drinking limit for women is lower than for men… In addition, chronic alcohol abuse takes a heavier physical toll on women than on men. Alcohol dependence and related medical problems, such as brain, heart, and liver damage, progress more rapidly in women than in men.” For information on alcoholism science go here.
Awards will be announced on Wednesday, January 25, 2006. Check it out and vote.
Friday, December 09, 2005
Interesting Slate article and blog.bioethics.net post about how a young economist at the University of Virginia found that a woman in her 20s will increase her lifetime earnings by 10 percent if she delays the birth of her first child by a year. Part of that is because she'll earn higher wages—about 3 percent higher—for the rest of her life; the rest is because she'll work longer hours. For college-educated women, the effects are even bigger. For professional women, the effects are bigger yet—for these women, the wage hike is not 3 percent, but 4.7 percent.
Saturday, December 03, 2005
Nora Newcombe, a professor of psychology, says that while there is evidence of differences, there's no evidence of one sex being smarter than the other (overall). In general, women are better at writing, at memory tasks, some fine motor tasks, and speech. Men tend to be better at spatial imagery,. In general, women tend to do better with "book learning" type tasks, and men do better with "fluid tasks," meaning extracurricular learning and novel problem-solving.
Friday, December 02, 2005
Eager to progress with its stem cell project, the newly implemented California Institute of Regenerative Medicine pleaded with a judge to dismiss lawsuits that have impeded it from borrowing $3 billion to be used to fund research grants. Newly created by Proposition 71, the stem cell institute has been hindered by two lawsuits that have challenged its constitutionality and intimidated potential leaders. Filed by politically conservative groups, these lawsuits have delayed the agency’s work, according to deputy attorney general Tamar Pachter. For example, rising interest rates since the agency was first prepared to borrow have cost the state an estimated $15 million. The lawsuits question the authority and intentions of the agency’s managers, many of whom, they allege, are not state officials but employees with individual agendas. The agendas of the filers of such lawsuits have been questioned as well. One of the filers, the People's Advocate and the National Tax Limitation Foundation, which opposes abortion and the “right-to-die,” has admitted its disapproval of stem cell research, but claims its motivations are moral, not religious. The group maintains that only state officials should be able to dole out public funds.
The second lawsuit was filed by a newly created nonprofit called the California Family Bioethics Council, self-described as a “stem cell research watchdog group.” Bioethics lawyer David Llewellyn claims that the selection process, whereby elected officials and college administrators select members of the institute's Independent Citizens Oversight Committee, creates a “conflict of interest.” Human embryonic stem cells are created in the first days after conception and give rise to all the organs and tissues in the human body. Scientists hope to someday use stem cells to replacement diseased tissue. Such prospects anger many social conservatives, including President Bush, because embryos are destroyed during research. President Bush’s 2001 restriction on the use of federal money to fund stem cell work has kept the field infantile, according to scientists.
The pending litigation discourages potential leaders, fearful of the potential futility of their investments. The agency has been kept afloat and has opened a permanent headquarters thanks to a $5 million charitable donation from sound pioneer Ray Dolby and a $3 million loan from the state. Even though it has little money, the agency in September awarded 16 grants totaling $39.7 million to universities and nonprofit medical organizations in