Isn't this a repeat of the mid-nineties? Didn't the healthcare sector pay the republicans to help quell the banshee that was Hillary Rodham Clinton? Weren't they afraid of her influence in turning the industry on its head? (Weren't they successful in doing this?)
Apparently this is a reversal of things, and times. Mrs. Clinton has on her plate a different plan than she was considering in the nineties, less ambitious, and less effective. Though she claims to have plans to be a "healthcare president" (which would mean being strictly adherent to your philosophies), by taking the money from the industry, she is allowing herself admission into a gigantic conflict on interest. What it seems to be amounting to is the industry buying Clinton's compliance into their preferred style of medicine - private and costly. Clinton, and for that matter, anybody who is interested in healthcare for Americans should not fear the industry or worry about having their permission. The United States government has the ability to regulate the industry, or to the extreme, shut it down. No private insurance. Thus, there is no real reason for Hillary to fraternize with the enemy.
Not to say this is extremely important, but some of her fellow Presidential hopefuls address financial concerns through donations and non-questionable sources. Frankly, I expected more from her, as in not providing a place for her to be attacked by her opponents and the population she is trying to enchant. This may, in the long run, damn her campaign.
http://www.nytimes.com/2007/10/29/us/politics/29health.html?_r=1&ref=health&oref=slogin
Monday, October 29, 2007
Sunday, October 28, 2007
HIV Immunization Research Continues in Light of STEP Study Disappointment
The latest in a series of failed developmental pursuits of an effective HIV vaccine comes from Merck, who has discontinued its STEP study for ineffectiveness. The announcement was made today by the co-sponsors of this clinical trial, Merck & Co., Inc., and the HIV Vaccine Trials Network (HVTN), which is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health. The study evaluated two primary efficacy endpoints: whether the vaccine prevented HIV infection and whether the vaccine reduced the amount of virus in those who developed infection. Results suggest the vaccination may have made recipients more susceptible to infection, in the midst of one of the world's most rampant epidemics.
The Merck trials took place in 15 cities in the US, including Los Angeles, New York and Boston. Three Canadian cities and research sites throughout Peru, Brazil Haiti, the Dominican Republic and Jamaica also participated in the study. These trials began December 2004 and included 3,000 participants, determined to be high-risk for infection. Enrollment and vaccination in a second Phase II trial of this vaccine being conducted by the HVTN in South Africa called Phambili, and two additional Phase I trials, have been discontinued. The DSMB for the Phambili trial will evaluate the available data. Researchers in Soweto, Cape Town, Durban and two other sites began contacting South Africa's 801 trial participants on Tuesday, mainly by cellphone text message. The goal is to tell each one individually whether he or she had received a placebo or the vaccine, a process called "unblinding" the trial. Researchers are telling the roughly half who received the vaccine that it might have increased their risk of contracting HIV.
Among those who received at least two doses of the vaccine during the STEP study, 19 contracted HIV, compared to 11 of those given placebos. Therefore, the vaccine did not prevent infection in the 741 volunteers who received at least one dose of the three-dose vaccine series, 24 cases of HIV infection were observed, compare to 21 cases of HIV infection observed in 762 participants who received the placebo. Investigators insist the vaccine could not have caused infection as subjects were injected with a killed, adenovirus serotype 5 (Ad5) virus structured in the likeness of the HIV virus. The vaccine could have, however, caused immunological changes that made it easier for the virus to take hold during a later exposure. Investigators found RNA levels of vaccinated-infected individuals were higher than those in the placebo group, who were subsequently infected. "HIV RNA levels in the blood of infected individuals, the standard measure of ongoing HIV replication, were approximately 40,000 copies/mL in the vaccine group and approximately 37,000 copies/mL in the placebo group."1 Results suggest vaccinated subjects with a previous exposure to the virus's structure may acquire more copies of the of virus if infected.
Development of an effective AIDS vaccine remains one of the most challenging pursuits of modern medicine. One positive aspect of the Merck's vaccine (MRKAd5) research cannot be denied; it showed that the Phase IIb test-of-concept trial design can yield earlier results with fewer volunteers than a full Phase III trial. "[This] probably saved us all waiting another 2 or 3 years, and the cost," an investigator says. Such trials may be beneficial over the full 10,000-person Phase III trial as research toward the HIV vaccine continue.2
1. Vaccination and enrollment are discontinued in phase II trials of Merck's investigational HIV vaccine candidate. Available at: http://www.merck.com/newsroom/press_releases/research_and_development/2007_0921.html. Accessed October 28, 2007.
2. Disappointment dominated the responses to the halting of immunizations in the STEP trial, but many agree it could hold important lessons for future vaccine strategies. Available at: http://www.iavireport.org/Issues/Issue11-4/Analyze.asp. Accessed October 28, 2007.
Saturday, October 27, 2007
Dr. Norwood.
http://www.phillymag.com/home/articles/did_dr_norwood_go_too_far_part_one/
http://www.phillymag.com/home/articles/did_dr_norwood_go_too_far_part_two/
Above are links to a two part article on Dr. William Norwood. Although he is an incredibly brilliant surgery and has invented three cardiac surgeries that have saved thousands of children with congenital heart defects, he is being accused of failing to obtain a complete, informed consent from parents of his patients. After reading these articles, you will understand why the waters are muddied and a definite answer cannot be reached. I must also state that I am one of the children that Dr. Norwood saved by operating on my heart when I was 4. Although I did not receive one of the procedures he invented and I regret any children who might have been harmed or died while he was perfecting his techniques, I cannot caste a stone at this man as I would not be here without his exceptional brilliance and skilled surgical hand.
However, these articles do raise several ethical points. I can tell you from personal experience that when a doctor tells you there is something wrong with your heart, you are thereafter unable to comprehend what s/he is talking about, even for someone with some degree of medical understanding. I cannot imagine how difficult it would be for a parent to hear about their child’s heart defect, in addition to not having a basic understanding of the medical jargon. Though the parent may sign a consent form, is that really informed consent? What can a doctor do to help a non-medically educated parent understand complex terminology, especially when the parent is extremely emotional distressed? And while this may not necessarily be the circumstances Dr. Norwood is accused of, when an unexpected complication arises during surgery, should the doctor stop the surgery to speak to the parents to make sure they understand the implications of this complication and obtain consent to use further and perhaps more extreme measures to save the child’s life? In the situation where a mother claims she did not know the stent used in her daughter was still experimental, would that have really changed the mother’s decision? Would she have opted not to have a surgery that her daughter needed in order to live? Would she have chose to go against the doctor’s recommendation of a new, improved, better, but still experimental stent? I completely agree that the issue is that the mother did not have an opportunity to make the choices that were hers to make (if that did occur), but I also believe Dr. Norwood was doing what he thought was best for the child. Also remember, that without Dr. Norwood, this child would not have lived as long as she did. Without the procedure he invented, she would have died within days after birth.
Another issue brought to light by Dr. Norwood’s situation is the question of experimentation. While many codes exist to protect and regulate experimentation, the fact remains that medicine cannot advance without experimenting with new procedures. This article lists tons of surgeons who went against laws and hospital policies to perform procedures that were unethical and illegal. However, these “illegal procedures” are now considered routine procedure and lifesaving. I believe patients have rights, including the right to know exactly what a physician is doing to them and the right to refuse treatment. Perhaps Dr. Norwood took the idea of utilitarianism ethics to the extreme in that experimenting on a few kids will certainly benefit the greater good. He had to experiment in some form to perfect three surgeries that save the lives of thousands of kids (each year since the 1980s) with a congenital defect who otherwise would die within a few days of birth.
Where do we set the boundaries of punishment for pushing or overstepping ethical boundaries? Dr. Norwood’s intentions are good – he is trying to make these kids better. He is not a surgeon who is harming his patients by rushing through a surgery to make his golf game as in the case of a Hawaiian surgeon who replaced FDA-approved titanium spinal rods that hadn’t arrived yet with something he found in the operating room that had the same dimensions (patient is now paralyzed).
http://www.phillymag.com/home/articles/did_dr_norwood_go_too_far_part_two/
Above are links to a two part article on Dr. William Norwood. Although he is an incredibly brilliant surgery and has invented three cardiac surgeries that have saved thousands of children with congenital heart defects, he is being accused of failing to obtain a complete, informed consent from parents of his patients. After reading these articles, you will understand why the waters are muddied and a definite answer cannot be reached. I must also state that I am one of the children that Dr. Norwood saved by operating on my heart when I was 4. Although I did not receive one of the procedures he invented and I regret any children who might have been harmed or died while he was perfecting his techniques, I cannot caste a stone at this man as I would not be here without his exceptional brilliance and skilled surgical hand.
However, these articles do raise several ethical points. I can tell you from personal experience that when a doctor tells you there is something wrong with your heart, you are thereafter unable to comprehend what s/he is talking about, even for someone with some degree of medical understanding. I cannot imagine how difficult it would be for a parent to hear about their child’s heart defect, in addition to not having a basic understanding of the medical jargon. Though the parent may sign a consent form, is that really informed consent? What can a doctor do to help a non-medically educated parent understand complex terminology, especially when the parent is extremely emotional distressed? And while this may not necessarily be the circumstances Dr. Norwood is accused of, when an unexpected complication arises during surgery, should the doctor stop the surgery to speak to the parents to make sure they understand the implications of this complication and obtain consent to use further and perhaps more extreme measures to save the child’s life? In the situation where a mother claims she did not know the stent used in her daughter was still experimental, would that have really changed the mother’s decision? Would she have opted not to have a surgery that her daughter needed in order to live? Would she have chose to go against the doctor’s recommendation of a new, improved, better, but still experimental stent? I completely agree that the issue is that the mother did not have an opportunity to make the choices that were hers to make (if that did occur), but I also believe Dr. Norwood was doing what he thought was best for the child. Also remember, that without Dr. Norwood, this child would not have lived as long as she did. Without the procedure he invented, she would have died within days after birth.
Another issue brought to light by Dr. Norwood’s situation is the question of experimentation. While many codes exist to protect and regulate experimentation, the fact remains that medicine cannot advance without experimenting with new procedures. This article lists tons of surgeons who went against laws and hospital policies to perform procedures that were unethical and illegal. However, these “illegal procedures” are now considered routine procedure and lifesaving. I believe patients have rights, including the right to know exactly what a physician is doing to them and the right to refuse treatment. Perhaps Dr. Norwood took the idea of utilitarianism ethics to the extreme in that experimenting on a few kids will certainly benefit the greater good. He had to experiment in some form to perfect three surgeries that save the lives of thousands of kids (each year since the 1980s) with a congenital defect who otherwise would die within a few days of birth.
Where do we set the boundaries of punishment for pushing or overstepping ethical boundaries? Dr. Norwood’s intentions are good – he is trying to make these kids better. He is not a surgeon who is harming his patients by rushing through a surgery to make his golf game as in the case of a Hawaiian surgeon who replaced FDA-approved titanium spinal rods that hadn’t arrived yet with something he found in the operating room that had the same dimensions (patient is now paralyzed).
Friday, October 26, 2007
Jumping Rope with Abe Lincoln and a Groundhog
We've all seen the commercials and print ads for Rozerem, and you must admit how clever you think they are. Also, we've probably all encountered difficulty with sleeping, sometimes days-sometimes a few weeks at a time. I would be hard pressed to ever consider taking any sort of sleeping aid, prescription or OTC (with the exception of an occasional dose of Nyquil), but I have definetely experienced those bouts of poor sleeping. As our lives become increasingly busy and hectic, I think perhaps cutting back on caffeine and engaging in more physical activity (two things which are beneficial in more ways than just as sleep aids) are more healthy and desirable alternatives to help get to sleep at night.
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 a Valium.
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 a Valium.
Wednesday, October 24, 2007
Misperceptions regarding HIV protection in vaginal microbicide clinical trials
A number of vaginal microbicides that could decrease the rate of HIV transmission are currently under development and in different clinical trial phases. There are a number of different issues with how to run these trials, ranging from the women who participate being perceived as sex workers or ‘loose,’ to whether it is ethical to stop providing treatment once a trial is over for people who sero-convert during the trial, to whether including contraceptive properties as part of the microbicide will affect the utilization, and finally to whether the use of microbicides will cause a drop in condom use.
One of the reasons for developing vaginal microbicides is to provide women with a tool for protecting themselves when their partners refuse to use condoms. One of the difficulties in developing vaginal microbicides is addressing many different cultures’ requirements; people in some countries prefer ‘dry sex’ (little lubrication), others prefer more lubricated sex; some would avoid a vaginal microbicide that includes contraception, while others would welcome it. A number of different studies have been performed, just to examine and address preferences like these.[1],[2],[3]
In a study that evaluated participants’ perceptions of a candidate microbicide product, a disturbing trend was noted.[4] In this study, though the participants were counseled on what the microbicide could do and did not do, and how important it was to use condoms, the participants’ perception was that by using the gel, they were doing something for their health, regardless of the microbicide’s actual efficacy. In fact, in this particular trial, the microbicide was demonstrated to be ineffective, but there was a persistent belief that it was effective nonetheless, leading to a decreased reliance on condoms.
In many of the cited studies, preferences have been expressed that participants would rather use the microbicide than a condom, even when it has been explained that both are needed for optimum safety.
This is something that people who are running current and future trials need to be intimately aware of; the perception that the gel is so efficacious that condoms do not need to be used, even when it has been carefully explained otherwise, is so strong that if careful steps are not taken, the participants may endanger themselves more than the microbicide can protect them.
[1] Bentley ME, et al. Acceptability of a microbicide among women and their partners in a 4-country phase I trial. Am J Public Health. 2004; 94(7): 1159 – 1164.
[2] Braunstein S, van de Wijgert J. Preferences and practices related to vaginal lubrication: Implications for microbicide acceptability and clinical testing. J Women’s Health. 2005; 14(5): 424 – 433.
[3] Ramjee G, et al. Accetability of Carraguard, a candidate microbicide and methyl cellulose placebo vaginal gels among HIV-positive women and men in
[4] Mantell JE,
Study reports ties between academia and drug companies
The relationships between physicians and drug companies have been under scrutiny. It is widely known that pharmaceutical companies have given community clinicians gifts, trips, CME funding, and/or lunch for many years. However, the extent to which academic physicians and medical schools have such relationships with drug makers was previously unknown. The October issue of JAMA includes an article reporting results of a study by Campbell et al that examined institutional academic-industry relationships.
The authors surveyed the department chairs of 125 accredited medical schools and the 15 largest independent teaching hospitals in the
A MedlinePlus news release regarding the publication quotes
Sources: 1. Campbell EG et al. Instituational academic-industry relationships. JAMA. 2007;298:1779-1786; 2. U.S. medical schools, drug makers share strong ties. MedlinePlus Web site. Available at: http://www.nlm.nih.gov/medlineplus/news/fullstory_56236.html. Accessed October 17, 2007.
Monday, October 22, 2007
Legalizing not the drug, but the place where it is shot into forearms...?
I have heard of the needle exchange program, and I think it is a good idea, wherein IV drug users can acquire clean, sterile needles on the tab of the municipal government. Although the ultra-conservative Americans would regard it as defiling the fiber of the US, the fact is the drug users will seek whatever means necessary for their next fix. Rather than allowing the transmission rate of HIV and Hepatitis C among others to skyrocket, the public health sector provides clean needles to avert transmission. It has been successful, despite the controversy.
A new program, originated in San Fransisco, California takes this concept to another dimension. In addition to supplying the conventional "clean needle", this institution provides medical assistance in the form of a nurse, as well. Additionally, this is all being set in a "private booth" framework, where these IV drug users will have confidentiality and protection. It should be noted that the staff will not assist, nor condone the activities, but merely to safeguard the lives of the participants should an overdose or some other eventuality occur. After their session of IV drugs, the user will be able to "chill out" in a small cafeteria of sorts and have crumpets and coffee.
What has to be very carefully treaded is the line of condoning activity. Though the mission statement includes the public health department's standpoint, attaching a small breakfast hall adds creature comforts that should not be associated with the lifestyle. Having a nurse may even be excessive, perhaps, because it makes the lifestyle more socially normal. While I think the idea of a safe area to do this activity is good, it may attract more homeless people to utilize drugs if they haven't already. For the homeless person, this is a free meal and a quick medical exam. Thus, the problem then becomes curbing homelessness - and that is a big problem to handle.
As far as "recruiting" new users of drugs, almost every study shows that rate of people becoming new drug users - hard drug users - is mutually exclusive of regulations. The people will do it whether the law wants them to or not. It seems to be the case with habitual marijuana users, cocaine users, heroin users and so on - and it makes sense; those people with addictive type personalities very easily adapt the lifestyle. Those who do not have that personality usually do not. California's ambitions do not encourage the lifestyle, they make it safer - albeit at a social cost to the homeless perhaps.
http://hosted.ap.org/dynamic/stories/S/SUPERVISED_INJECTIONS?SITE=CASRP&SECTION=HOME&TEMPLATE=DEFAULT
A new program, originated in San Fransisco, California takes this concept to another dimension. In addition to supplying the conventional "clean needle", this institution provides medical assistance in the form of a nurse, as well. Additionally, this is all being set in a "private booth" framework, where these IV drug users will have confidentiality and protection. It should be noted that the staff will not assist, nor condone the activities, but merely to safeguard the lives of the participants should an overdose or some other eventuality occur. After their session of IV drugs, the user will be able to "chill out" in a small cafeteria of sorts and have crumpets and coffee.
What has to be very carefully treaded is the line of condoning activity. Though the mission statement includes the public health department's standpoint, attaching a small breakfast hall adds creature comforts that should not be associated with the lifestyle. Having a nurse may even be excessive, perhaps, because it makes the lifestyle more socially normal. While I think the idea of a safe area to do this activity is good, it may attract more homeless people to utilize drugs if they haven't already. For the homeless person, this is a free meal and a quick medical exam. Thus, the problem then becomes curbing homelessness - and that is a big problem to handle.
As far as "recruiting" new users of drugs, almost every study shows that rate of people becoming new drug users - hard drug users - is mutually exclusive of regulations. The people will do it whether the law wants them to or not. It seems to be the case with habitual marijuana users, cocaine users, heroin users and so on - and it makes sense; those people with addictive type personalities very easily adapt the lifestyle. Those who do not have that personality usually do not. California's ambitions do not encourage the lifestyle, they make it safer - albeit at a social cost to the homeless perhaps.
http://hosted.ap.org/dynamic/stories/S/SUPERVISED_INJECTIONS?SITE=CASRP&SECTION=HOME&TEMPLATE=DEFAULT
Sunday, October 21, 2007
The Widening Gap in Chicago’s Healthcare
A recent study, released by the Metropolitan Chicago Breast Cancer Task Force, indicates Chicago has a serious issue with uniformity throughout its healthcare system. In March, the task force set out to uncover why the city's African-American women who acquire breast cancer are dying a much higher rates than white women are. As it stands, Chicago's mortality rate for African-American women battling breast cancer is 68% higher compared to their Caucasian counterparts.1 This gap has widened over the years under the auspices of a "de facto segregated health-care system."
The task force has formulated three major hypotheses for explaining the breast cancer disparities in Chicago: "1) African American women receive fewer mammograms; 2) African American women receive mammograms of inferior quality; and 3) African American women have inadequate access to quality treatment once breast cancer is diagnosed."2 There is a desperate lack of mammogram accessibility and capacity in the areas with the most need. "The institutions with the best quality care are not in the neighborhoods where the need is greatest -- neighborhoods inhabited by poor, minority women."1
The task force has outlined 37 recommendations for a system overhaul of Chicago's healthcare system. The force admits, "some can be implemented immediately, while others will require a longer-term investment, further development and collaboration, additional study and statewide policy changes." Recommendations handed down by the team include, the implementation of a universal, transparent quality control system for mammograms, whereby the collection of quality data, such as the number of cancers detected per 1000 screen mammograms and the rate of false-positive results are shared with the public. In addition, the implementation of an electronic network established between "minority neighborhoods" to central diagnostic hubs, where experts interpret mammograms. The task force conjointly recommends the use of specialized imaging for earlier detection at local mammogram facilities.
The racial gap exists on a national level as well. The national death rates for African-American women are 37% higher than that for white women. No significant answers can be found with genetic influence. The racial gap in New York City is 11%.1 Its well-established network of public hospitals and clinics contribute to the limiting of racial differences in the city's healthcare. Healthcare systems and institutions that participate in quality assessments have proven better for it. Patients live longer with extended to quality of life. Without an overhaul of Chicago's healthcare system, communities will continue to lose their mothers, daughters, sisters and wives. Traditionally, the role of the African-American woman is crucial, particularly to her community, where she is not uncommonly a sergeant to several children, not of her own bearing. A community without mothers and with children left to raise themselves is frightening and never ideal, to say the least.
- System overhaul key to reducing breast cancer deaths for black women. The Chicago Tribune. 18 October 2007. Available at: www.chicagotribune.com/news/local/chi-cancer_bothoct18,0,2735430.story. Accessed 21 October 2007.
Clinical trials on vaginal microbicides
[1] Potts M. Thinking about vaginal microbicide testing. Am J Public Health. 2000 Feb; 90(2): 188-190.
Birth Control for Seventh Graders
A school district in Portland, Maine this week approved access to prescription birth control--without notifying parents in its middle school health center. The health center will also provide immunizations and STD counseling for the students.
Middle school students? As in 6th to 9th graders? Wow! This was my initial reaction to reading the article in the Times this morning. But I suppose the reality is that some students are sexually active at very young ages, the school district reporting that 5 out of the 500 students polled admitted to being sexually active. Wow again!
Is this a violation of parents' rights? Is this a case of something being legal, but not ethical? I must note that I am not a parent, but I would hope that parents of 13-year-olds should be in the know if their children are engaging in any sort of sexual activity.
I understand that the school is being proactive in the face of a harsh reality, attempting to prevent STDs and pregnancy in their young students, as well as providing sex education, which may not be present at home. But I feel that this is a parental responsibility, and that parents should know that their children are engaging in these behaviors. I'd be interested to learn how others in the class feel about this.
Middle school students? As in 6th to 9th graders? Wow! This was my initial reaction to reading the article in the Times this morning. But I suppose the reality is that some students are sexually active at very young ages, the school district reporting that 5 out of the 500 students polled admitted to being sexually active. Wow again!
Is this a violation of parents' rights? Is this a case of something being legal, but not ethical? I must note that I am not a parent, but I would hope that parents of 13-year-olds should be in the know if their children are engaging in any sort of sexual activity.
I understand that the school is being proactive in the face of a harsh reality, attempting to prevent STDs and pregnancy in their young students, as well as providing sex education, which may not be present at home. But I feel that this is a parental responsibility, and that parents should know that their children are engaging in these behaviors. I'd be interested to learn how others in the class feel about this.
Supervised injections
This link will take you to the article I based today's discussion on:http://www6.comcast.net/news/articles/health/2007/10/19/Supervised.Injections/
While officials are waiting to see the results of a similar program in Canada, San Francisco is considering offering a location where drug addicts can inject their drugs with the supervision of nurses in order decrease the number of overdoses.
While the nurses will not be assisting anyone with the injection, I took from the article that nurses would be on site to answer questions about how much of a particular drug would be a lethal dose and where would be a good injection site. So far, in the Canadian program, 800 people have died of overdoses onsite. Doesn’t this defeat this purpose of such a program?
Needle exchange programs, where drug addicts can turn in used needles for clean needles, have decreased the transmission rates of HIV and Hepatitis C. In addition, fewer overdoses would lighten the workload of the San Francisco Fire Department, where approximately 14% of all emergency calls are overdoses. In addition, the Canadian program states that some drug addicts who come into the program end up seeking treatment for their addiction.
With the positive aspects of this program, providing a safe haven to help addicts get high, with the funding of city government, implies that San Francisco condones illegal drug use. The ideal of completely eradicating illegal drug use in our society will most likely never become a reality, but do we want to encourage it? The funding will come out of San Francisco’s residents’ and workers’ tax dollars. How do we justify using tax dollars to encourage illegal drug use?
While officials are waiting to see the results of a similar program in Canada, San Francisco is considering offering a location where drug addicts can inject their drugs with the supervision of nurses in order decrease the number of overdoses.
While the nurses will not be assisting anyone with the injection, I took from the article that nurses would be on site to answer questions about how much of a particular drug would be a lethal dose and where would be a good injection site. So far, in the Canadian program, 800 people have died of overdoses onsite. Doesn’t this defeat this purpose of such a program?
Needle exchange programs, where drug addicts can turn in used needles for clean needles, have decreased the transmission rates of HIV and Hepatitis C. In addition, fewer overdoses would lighten the workload of the San Francisco Fire Department, where approximately 14% of all emergency calls are overdoses. In addition, the Canadian program states that some drug addicts who come into the program end up seeking treatment for their addiction.
With the positive aspects of this program, providing a safe haven to help addicts get high, with the funding of city government, implies that San Francisco condones illegal drug use. The ideal of completely eradicating illegal drug use in our society will most likely never become a reality, but do we want to encourage it? The funding will come out of San Francisco’s residents’ and workers’ tax dollars. How do we justify using tax dollars to encourage illegal drug use?
Monday, October 15, 2007
Whose Organs are They Anyway...?
The shortage of available and viable organs for transplant both in the U.S., and across the globe, is at a critical mass stage.
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?
http://tinyurl.com/3bheem
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?
http://tinyurl.com/3bheem
Deinstitutionalisation... Was it a good idea?
Last night, at about 0-dark-30 hours, on a PBS station, I observed a show documenting the life of a mentally retarded 18 to 19 year old. Apparently, the mother knew somewhere in the middle of her pregnancy that her son in the womb was in all likelihood have extreme deficiencies. Rather than undergoing an abortive procedure, she kept the child, to term. With her husband, she raised this child to about 14 years or so. (To be clear, there seems to be a problem with this child in terms of perception of the signals from his sense organs. In other words, as an example, Wernicke's and Broca's do not function; however, the sensory pathways from skin and sight are firing, with the exception that they do not then communicate to the integrative areas. The boy cannot feed himself, speak, or really do anything productive.) At this point, caretakers were recruited to spend all their waking hours tending to this child, feeding, wiping, and cleaning up after. Gradually, the parents came to a consensus with the caretakers, wherein they would take the child and move him to a separate house to live permanently with the caretakers. The parents responded as if a mountain had been lifted from their shoulders.
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?
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?
Sunday, October 14, 2007
A doctor's everyday ethics
Randy Cohen is a writer with an ethics column (“The Everyday Ethicist” or “The Ethicist,” depending on what source you get the column from). Last week, a doctor wrote in with a difficult situation he was presented with.[1] The short of it is that the doctor is Muslim, and a patient came into the emergency room and refused to be seen by the Muslim doctor. At the time, there was only one other doctor available, who also happened to be Muslim. The first doctor tried to reach the patient’s primary care physician but was unable to. The physician’s assistant offered to complete the exam, but the doctor refused to allow this and discharged the patient without a complete evaluation. The first doctor wondered if he did the right thing.
I found myself wondering what I thought was the ‘most right’ thing to do in this situation. Certainly, the doctor as an individual is allowed to feel indignant if not downright angry in the face of senseless bigotry. But as a doctor, his Hippocratic Oath leads him to ‘first, do no harm,” and to keep the good of the patient as his highest priority. These two things are in conflict for this doctor.
Finally, we don’t know anything about what the patient came into the ER for. If it were a life-and-death emergency, the answer might be different than momentary discomfort, and we do not have information as to which this situation is closer.
In this case, does the right of one individual outweigh the rights of the other? Does the doctor, given his oath to society, have to treat the bigot, regardless of the way he is treated in turn? And in fact, can this doctor treat this patient against his will? Which takes precedence, the patient’s desire to be treated by a non-Muslim, or the patient’s need to be treated?
[1]Cohen R. Patient Prejudice. The New York Times, 14 Oct 2007. Found at: http://query.nytimes.com/gst/fullpage.html?res=9C07E3DD163EF934A35753C1A9619C8B63
Google to Obey State’s Privacy Laws
"Google it!" A new verb to the English language, officiated by its entry to the Merriam Webster Collegiate Dictionary and the Oxford English Dictionary in 2006. It's meaning, "to use the Google search engine to obtain information on the Internet"2 has revolutionized the way American's obtain information for personal and work related inquiries. Since its incorporation in 1998, Google, Inc. has expanded its web-searching services to include image searching, Google News, Google Finance, Google Docs and Spreadsheets, and Google Maps. Google Maps has changed the way America's cities are explored by tourists and residences, alike.
Google's pursuit, "to organize the world's information and make it universally accessible and useful,"2 has awarded the company great success. But, has Google, Inc. applied its mission too literally with thev recent launch of Street View? The innovation provides 360° panoramic street-level images of fifteen major US cities, including Chicago, Las Angeles, Las Vega, New York City, Miami, Orlando, Philadelphia, San Francisco, Huston and surrounding metropolitan areas. Google plans to expand Street View by adding seven US cities and Canada. As expansion grows northern, Canada's authorities on privacy have expressed concern with the application of Google's Street View to Canada. Privacy Commissioner, Jennifer Stoddart expressed in a statement, "if the Street View application were deployed in Canada, it might not comply with our federal privacy legislation." 2 Canada's current privacy laws require knowledge, consent, and limited collection and use of personal information. Personal information such as license plate numbers, physical identities and locations are clearly visible and widely published on Google's Street View without the consent of individuals depicted and identified.
US privacy laws are less strict; Google's practices are completely legal in this country. Luckily, the corporation used good sense and removed photos of domestic violence shelters before Street View's launch earlier this year. Also, people may request review of a questionable image with inappropriate or sensitive imagery. If claims are founded, Google removes or alters the image. That is, after and if the subject is aware of an intrusion.
Recently, Google has promised to adhere to the local privacy laws where Street View is available. The corporation released a statement assuring its compliance and its willingness to blur images to adhere to privacy regulations. "The service will look different in Canada than it does in the United States. And that probably means blurring identifiable faces and license plates."1 But, is PhotoShop the answer? People are identifiable by other means such as clothing and location. Furthermore, what is "unidentifiable" to one may easily be downloaded and clarified to another. It may be impossible for Google to guarantee the protection of Canadian citizen identities. Fortunately, Canada is more interested in whether or not Google takes reasonable actions to protect personally identifiable information.
- CDS News. Street View will comply with Canada's privacy laws: Google. http://www.cbc.ca/technology/story/2007/09/25/tech-google-streetview.html
- Wikipedia-Google. http://en.wikipedia.org/wiki/Google
- Wikipedia-Google Street View. http://en.wikipedia.org/wiki/Google_Maps#_note-25
Assisted reproduction and risks of multiples
There are numerous concerns in assisted reproduction. One of the biggest concern and most known to the general public is the risk of multiples or 2 or more fetuses in one pregnancy. By the time a women is using assisted reproduction, she has gone through great disappointment through trying for several cycles (as, on average, it takes a women 1-12 months to become pregnant once beginning to try) without a successful pregnancy, some have suffered miscarriages, and invasive and expensive tests to determine the cause infertility. These women are desperate for a baby and want to utilize all possibilities to have baby. Therefore, many women will agree to transfer several embryos, with the hope that at least one will implant into their uterus and continue on to a successful pregnancy. Although there are many times when none of the implanted embryos attach to the uterus, there are also several times when 2-6 embryos implant, and the women is faced with a multiple pregnancy.
The greatest risk in a multiple pregnancy is premature delivery, which causes other serious complications. While a full term pregnancy is considered 37 to 42 weeks, twin pregnancies deliver at an average of 35 weeks, triplets average 33 weeks, and quadruplets average 29 weeks. The risk of premature delivery is 50% for twins, 90% for triplets, and 100% in quadruplets and higher multiples.1
Prematurity first leads to respiratory distress syndrome as the baby’s lungs are often not developed enough to breathe without assistance until 37 weeks. Infections and damage to other organs are also prevalent. Death is also a greater possibility as are development problems, such as cerebral palsy.1
To avoid the risks of multiple pregnancies, patients and doctors will perform a “selective reduction” if more than two embryos implant into the uterus. The doctor will perform an abortion on the fetus or fetuses that are selected to be “reduced.” However, women who have gone through so much to get pregnant and have a successful pregnancy are hesitate to abort some of their babies. However, reports show a risk of 4-6% and higher that an entire pregnancy will be lost after a selective reduction. In addition, these higher multiples are often only reduced to a twin pregnancy; therefore, the risks associated with a multiple pregnancy, thought reduced, still apply as the pregnancy is still considered a multiple pregnancy.2
The media has fueled the idea that multiples of assisted reproduction is safe. The country was awed by the birth of America’s first surviving sextuplets, the Dilleys, born in 1993. While I don’t remember the full extent of the coverage, Diane Sawyer of ABC visited the family each year on the sextuplets’ birthday to see how they were developing and growing. Though I cannot find any specific details, I believe one or two of the Dilley sextuplets suffer from mild cerebral palsy. More recently, Discover Health has given a reality TV show to a couple who had twins and sextuplets through assisted reproduction (Jon and Kate plus 8). This set of sextuplets have no medical consequences, though as they enter school, learning disabilities may present themselves. These two cases are media-worthy because they are remarkable and miraculous because the medical consequences have been so minimal compared to what the risks are.
However, a more recent birth again highlights the ethical concerns and very real risks of high order multiples. Ryan and Brianna Morrison had sextuplets on June 10, 2007, 4 ½ months early. Four of the 6 Morisson sextuplets died within a week, with a fifth baby dying in July.3 Mom was also treated for heart failure.4 The Morrisons were offered selective reduction but declined.4
While medical ethics have approved various methods of assisted reproduction, there are many very negative consequences to multiple pregnancies, which are often considered a guarantee of assisted reproduction. Therefore, perhaps the more ethical method would be to limit the number of embryos transferred. If only 2 embryos were transferred, at the most, a woman and her doctor is only looking at a twin pregnancy, which has a much greater risk of a successful, term pregnancy without disastrous consequences to mom and babies.
1. American College of Obstetrics and Gynecology and March of Dimes. Multiple pregnancy and birth: considering fertility treatments. Available at: http://www.acog.org/departments/resourceCenter/2006ModAcogAsrmMultiplePregnancyAndBirth.pdf. Accessed on October 14, 2007.
2. ACOG Committee on Ethics. Multifetal pregnancy reduction. Available at: http://www.acog.org/from_home/publications/ethics/co369.pdf. Accessed October 14, 2007.
3. 5th Minnesota sextuplet dies. Available at: http://wcco.com/topstories/local_story_204133943.html. Accessed October 14, 2007.
4. Minnesota sextuplets highlight risks of multiple births. Fox News. Available at: http://www.foxnews.com/story/0,2933,286889,00.html. Accessed October 14, 2007.
The greatest risk in a multiple pregnancy is premature delivery, which causes other serious complications. While a full term pregnancy is considered 37 to 42 weeks, twin pregnancies deliver at an average of 35 weeks, triplets average 33 weeks, and quadruplets average 29 weeks. The risk of premature delivery is 50% for twins, 90% for triplets, and 100% in quadruplets and higher multiples.1
Prematurity first leads to respiratory distress syndrome as the baby’s lungs are often not developed enough to breathe without assistance until 37 weeks. Infections and damage to other organs are also prevalent. Death is also a greater possibility as are development problems, such as cerebral palsy.1
To avoid the risks of multiple pregnancies, patients and doctors will perform a “selective reduction” if more than two embryos implant into the uterus. The doctor will perform an abortion on the fetus or fetuses that are selected to be “reduced.” However, women who have gone through so much to get pregnant and have a successful pregnancy are hesitate to abort some of their babies. However, reports show a risk of 4-6% and higher that an entire pregnancy will be lost after a selective reduction. In addition, these higher multiples are often only reduced to a twin pregnancy; therefore, the risks associated with a multiple pregnancy, thought reduced, still apply as the pregnancy is still considered a multiple pregnancy.2
The media has fueled the idea that multiples of assisted reproduction is safe. The country was awed by the birth of America’s first surviving sextuplets, the Dilleys, born in 1993. While I don’t remember the full extent of the coverage, Diane Sawyer of ABC visited the family each year on the sextuplets’ birthday to see how they were developing and growing. Though I cannot find any specific details, I believe one or two of the Dilley sextuplets suffer from mild cerebral palsy. More recently, Discover Health has given a reality TV show to a couple who had twins and sextuplets through assisted reproduction (Jon and Kate plus 8). This set of sextuplets have no medical consequences, though as they enter school, learning disabilities may present themselves. These two cases are media-worthy because they are remarkable and miraculous because the medical consequences have been so minimal compared to what the risks are.
However, a more recent birth again highlights the ethical concerns and very real risks of high order multiples. Ryan and Brianna Morrison had sextuplets on June 10, 2007, 4 ½ months early. Four of the 6 Morisson sextuplets died within a week, with a fifth baby dying in July.3 Mom was also treated for heart failure.4 The Morrisons were offered selective reduction but declined.4
While medical ethics have approved various methods of assisted reproduction, there are many very negative consequences to multiple pregnancies, which are often considered a guarantee of assisted reproduction. Therefore, perhaps the more ethical method would be to limit the number of embryos transferred. If only 2 embryos were transferred, at the most, a woman and her doctor is only looking at a twin pregnancy, which has a much greater risk of a successful, term pregnancy without disastrous consequences to mom and babies.
1. American College of Obstetrics and Gynecology and March of Dimes. Multiple pregnancy and birth: considering fertility treatments. Available at: http://www.acog.org/departments/resourceCenter/2006ModAcogAsrmMultiplePregnancyAndBirth.pdf. Accessed on October 14, 2007.
2. ACOG Committee on Ethics. Multifetal pregnancy reduction. Available at: http://www.acog.org/from_home/publications/ethics/co369.pdf. Accessed October 14, 2007.
3. 5th Minnesota sextuplet dies. Available at: http://wcco.com/topstories/local_story_204133943.html. Accessed October 14, 2007.
4. Minnesota sextuplets highlight risks of multiple births. Fox News. Available at: http://www.foxnews.com/story/0,2933,286889,00.html. Accessed October 14, 2007.
Tuesday, October 9, 2007
Me, too
Several pharmaceutical companies sell what are known as "me too" drugs, which are copies of drugs that are already proven effective and on the market. This cuts the cost of the clinical trial R&D time, and are cash cows for the pharmaceutical company. Most Americans love new stuff. While I completely understand the desire for the companies to do this, mainly to recoup the millions of dollars lost on fail clinical trials per year, the ethical side of this is questionable. Zyprexa is a drug for schizophrenics that is not much more effective than the more affordable generic drugs prescribed for schizophrenia that have been around for years. We are talking a difference of and $8000/year prescription for Zyprexa versus less than an tenth of that cost for a generic. (Note: this article may make some very leery of generics, however).
Some argue that me too drugs are another black eye for Big Pharma-greed-driven, profit-driven tactics to squeeze more money out of those in a vulnerable state of requiring a medication. Prilosec and Nexium are another terrific example of this theory.
However, one class of me too drugs that I don't mind and many women ages 15-35 may agree with me on is birth control. Me too birth control drugs are numerous, I can't venture to guess how many there are available. Television and any fashion magazine or other magazines targeted fo women are filled with ads for different types of these me too drugs. Ordinarily I cringe at the sight of all the pharmaceutical ads in magazines. But you can talk to many women who have been on several different prescriptions for birth control throughout their life and you may be alarmed at how many different kinds they have tried over the years, trying to find out which is the best match for their chemistry and lifestyle. I'd be interested to hear others thoughts on me too drugs.
Some argue that me too drugs are another black eye for Big Pharma-greed-driven, profit-driven tactics to squeeze more money out of those in a vulnerable state of requiring a medication. Prilosec and Nexium are another terrific example of this theory.
However, one class of me too drugs that I don't mind and many women ages 15-35 may agree with me on is birth control. Me too birth control drugs are numerous, I can't venture to guess how many there are available. Television and any fashion magazine or other magazines targeted fo women are filled with ads for different types of these me too drugs. Ordinarily I cringe at the sight of all the pharmaceutical ads in magazines. But you can talk to many women who have been on several different prescriptions for birth control throughout their life and you may be alarmed at how many different kinds they have tried over the years, trying to find out which is the best match for their chemistry and lifestyle. I'd be interested to hear others thoughts on me too drugs.
get a load of this!
Texas Investor Eyes Space Station as Orbiting Pharma Lab
By Alexis Madrigal 
10.08.07 | 12:00 AM
10.08.07 | 12:00 AM 
MOFFETT FIELD, California -- A swaggering Texas investor with a famous name wants Big Pharma to pick up the tab for the International Space Station when NASA eases off.
Thomas Pickens III thinks the pharmaceutical industry and the space station need each other.
Drug discovery is an arduous and extremely expensive project. But in space, molecules do miraculous things. Disease-causing proteins crystallize so well -- growing larger and clearer -- that finding a drug to stop the protein's damaging activities could happen months, if not years, faster.
Scientists have known for decades that some science works better in space -- but it hasn't been easy to get experiments up there. Now, with NASA planning to reduce its $2.6 billion annual investment beginning in 2015, the agency is throwing the space station open for private enterprise. And the Texas financial scion and multimillionaire is ready to transform space science with an injection of capitalism.
"If people knew what I already know, the International Space Station would be considered one of the most valuable resources our world possesses," Pickens said at the ISS National Laboratory Workshop last week. "There are things you can only do in microgravity that will eventually lead to products that could save millions of lives."
Pickens is chairman of the board of Spacehab, a company that provides equipment and services for scientists who want to send experiments into space. He has an obvious vested interest in getting scientists, and the entities that fund them.. But all the bias in the world doesn't matter, if there are experiments worth doing in space.
Scientists have sent all kinds of things into space with unique results. One 2000 experiment found that 1,600 kidney-cell genes were expressed differently in space than on the ground. Another found colon-cancer cells showed unique metabolic changes in microgravity. But with so many possible avenues of discovery, it has been difficult for scientists to make much progress, given how limited time in space has been.
Still, one area of research has had results that can lead scientists down a clear path of drug discovery: protein crystals.
"Up in space, the crystals grow bigger and better," said Tim Osslund, who specializes in protein formulation at Amgen. "The end result is higher resolution." And that resolution is a very valuable thing.
Osslund sent some of the company's proteins to the Mir space station in 1998. His crystals grew 32 times larger in space than in an earth-grown control environment. Larger, better crystals allow scientists to see a protein at the atomic level. That kind of detail can significantly accelerate drug discovery.
Pickens, who also manages a $100 million nanotechnology fund, believes that getting paid to grow these proteins in space will be the killer app for keeping the $130 billion International Space Station alive. Increased traffic to the ISS could drive down the cost of space flight and open up the station to all kinds of commercial applications, which would come in handy as NASA's financial support wanes.
Pickens' father made a fortune in oil, became a corporate raider, and now runs a hedge fund. He's worth $2.5 billion. No wonder his son looked to the heavens to make his fortune. Spacehabpenny stock firm has a market cap of about $5 million. recruited the younger Pickens earlier this year to turn the company around. The 20-year-old
You'd never imagine his company's modest finances watching Pickens interact with scientists at the ISS workshop. Pickens is a tall, charismatic Texan. He talks as if every period is a walk-off homerun.
The scientists seemed wary of him, which is perhaps appropriate. After all, he is prone to saying, "I am Wall Street." But they are transfixed when he talks about bringing big money into outer space. They're listening, because Pickens and other businessmen are the new variables in the space equation. The science has been there; the salesmanship has been missing.
Given the opportunity, biotech and pharmaceutical companies would likely be eager to buy crystals like the ones Osslund grew. Here's why: Treating disease often boils down to two proteins. One is generating the disease and the other blocks the first protein from working. If you know the shape of the disease protein -- let's say it's a wine bottle shape -- it's much easier to stick a cork into its mouth. The higher the resolution of your picture, the faster you can find the cork. And with some proteins, without the highest resolution, it's simply too difficult to find a cork.
Without a protein structure, scientists resort to blasting the protein with millions of molecules, hoping that one of them will stick. Pharmaceutical companies call the process screening, and it takes a long time and it costs a lot of money, even though there have been many improvements in the process. A new drug costs $800 million to get to market and takes 10 years to develop. But the payoff is huge. A report (.pdf) found the top-selling blockbuster drug Lipitor raked in $12.2 billion for Pfizer in 2006.
Space-grown crystals won't just speed drug discovery: They could also help companies find more precise drugs that cause fewer side effects.
"Conceptually, better crystals grown in space could improve our hit rates," said Dr. Kam Zhang, director of structural biology at Plexxikon, a biotech firm that's solved over 3,000 protein structures and created novel drugs. Two are in clinical trials, including one potential cancer treatment (.pdf).
Today, of course, everything space-related is still too expensive, especially getting there. NASA is working on reducing the cost with its Commerical Orbital Transportation Services program, which funded Elon Musk's SpaceX.
But one thing is sure: The space station needs private money, and lots of it. As Allan Marty, a former NASA consultant, told a mostly agency crowd at the ISS workshop last week, "It's not a given that the Space Station will be sustainable, unless we find a way to attract private capital over the next eight years."
Sitting with Pickens in what used to be an officer's lounge, the conversation ranges from space to energy and his theory that fusion will eventually replace oil (he used to build power plants).
Big pharma supporting space? Fusion? You can take Pickens out of Texas, but you can't take the Texas out of Pickens. It's easy to be skeptical when it comes to ideas that are science-fiction big. But what if he can transform a sleepy company into a bleeding-edge biotech and space-logistics hybrid?
"One day, I think you’ll see the space station completely occupied by commercial entrepreneurs," said Dr. Larry Delucas, a former astronaut and director of the Center for Macromolecular Crystallography at University of Alabama-Birmingham who sits on the scientific advisory board of Spacehab.
Pickens could make millions, save lives and commercialize space. That would make dad proud.
Sunday, October 7, 2007
Artificial life... already?
J. Craig Venter believes he has a functioning artificial chromosome based of Mycoplasma genitalium, giving it a label of M. laboratorium. Yes, it is significantly more synthetic compared to other cultured and transgenic species, but that is not the problem. What is objectionable in the situation is the fact that Dr. Venter plans on patenting the organism that he has created. I can understand certain specific genes being protected - they are the result of labor and development - manhours. However, this organism is a much more than a sum of its parts. Indeed, it has a cluster of reproductive genes, genes for metabolism and others. What happens when that species conjugates with another bacterial species? Can Dr. Venter still say M. laboratorium is still "his"?
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.
http://www.guardian.co.uk/science/2007/oct/06/genetics.climatechange
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.
http://www.guardian.co.uk/science/2007/oct/06/genetics.climatechange
Increased premiums for bad lifestyles
In most types of insurance, your premiums are based on how much of a risk you are, which is determined by your lifestyle choices. For example, if you have several vehicle accidents, you are deemed as a risky driver and given higher premiums. If this practice is typical, why is the idea of raising insurance premiums for those who make unhealthy lifestyle decisions so surprising?
With the rising costs of health care, companies need to find ways to cut costs. One easy way of cutting costs is to decrease costs of the most expensive patients. While it would be extremely unethical to charge people who did not cause their diagnosis, insurance companies are beginning to charge smokers and people who are overweight more than those who do not smoke and are not overweight.
Smoking can cause a variety of diseases, including several cancers, heart disease, and stroke1; being overweight can also cause a variety of diseases including hypertension, dyslipidemia, type 2 diabetes, coronary heart disease, stroke, gallbladder disease, osteoarthritis, sleep apnea, respiratory problems, and some cancers.2 Treatments for these diseases cost a great deal. With employers paying a large percentage of these costs, I think they are entitled to charge more for those who make decisions that put them at risk for such high-costing treatments. Many people feel this is unfair because it is another way for “big brother” to watch over us and control our lives. However, it is not the government making these policies – it is private corporations who are paying millions of dollars to cover treatments. In addition, the increase premiums are only for those who are putting themselves at risk by something they are doing, not simply by the medical history they are born with.
1. Smoking and Tobacco Use. Centers for Disease Control and Prevention. Available at: http://www.cdc.gov/tobacco/health_effects/index.htm. Accessed October 7, 2007.
2. Overweight and obesity. Centers for Disease Control and Prevention. Available at: http://www.cdc.gov/nccdphp/dnpa/obesity/ Accessed October 7, 2007.
With the rising costs of health care, companies need to find ways to cut costs. One easy way of cutting costs is to decrease costs of the most expensive patients. While it would be extremely unethical to charge people who did not cause their diagnosis, insurance companies are beginning to charge smokers and people who are overweight more than those who do not smoke and are not overweight.
Smoking can cause a variety of diseases, including several cancers, heart disease, and stroke1; being overweight can also cause a variety of diseases including hypertension, dyslipidemia, type 2 diabetes, coronary heart disease, stroke, gallbladder disease, osteoarthritis, sleep apnea, respiratory problems, and some cancers.2 Treatments for these diseases cost a great deal. With employers paying a large percentage of these costs, I think they are entitled to charge more for those who make decisions that put them at risk for such high-costing treatments. Many people feel this is unfair because it is another way for “big brother” to watch over us and control our lives. However, it is not the government making these policies – it is private corporations who are paying millions of dollars to cover treatments. In addition, the increase premiums are only for those who are putting themselves at risk by something they are doing, not simply by the medical history they are born with.
1. Smoking and Tobacco Use. Centers for Disease Control and Prevention. Available at: http://www.cdc.gov/tobacco/health_effects/index.htm. Accessed October 7, 2007.
2. Overweight and obesity. Centers for Disease Control and Prevention. Available at: http://www.cdc.gov/nccdphp/dnpa/obesity/ Accessed October 7, 2007.
DNA Testing Without Consent
An article by Lori Andrew in this week’s Parade magazine[1] discusses the science and ethics of DNA testing on historic or popular figures. Scientists have already performed DNA testing on a number of famous deceased persons, such as Albert Einstein (potential genetic predisposition to aneurysm), Beethoven (possible lead poisoning), Francesco Medici (arsenic, rather than malaria, was the likely cause of death), and Thomas Jefferson (paternity of a child of one of his slaves).
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[2].
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?
Medical Dramas- the New Reality TV?
We touched on this topic briefly during a class session. Linda mentioned her experiences with doing some writing for television medical programs, and the amount of challenge involved in trying to provide accuracy as a knowledgeable professional, while dealing with television producers whose job it is to provide drama and excitement for the viewer. Often accuracy goes out the window. After 25 years of dealing with the same myself on the news side, I can relate personally.
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"?
http://www.forbes.com/health/2007/09/19/tv-health-missteps-forbeslife-cx_avd_0919health.html
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"?
http://www.forbes.com/health/2007/09/19/tv-health-missteps-forbeslife-cx_avd_0919health.html
Saturday, October 6, 2007
Mom versus NBME
Recently I have been following the case of an MD who has been fighting the National Board of Medical Examiners (NBME) to be afforded an extra 60 minutes of break time to pump breast milk for her new born. Sophie Currier, who has received an MD and PhD from Harvard, has already been given extra time to take the medical licensing exam since she has dyslexia. She attempted to take the exam a few weeks before giving birth to her second child, only to fail by a few points.
The NBME explains the time allotted for the exam as follows: "A computerized exam, Step 2 CK consists of eight testing blocks of up to one hour each, plus 45 minutes of break time and an optional 15-minute tutorial. Examinees may use their break time throughout the day as they choose (e.g., take multiple short breaks between blocks of the test or fewer breaks of longer duration)."
NBME defends their decision to deny Dr. Currier's request by stating that several other mothers have taken the exam with the allotted break time with no problems. That is probably because these women didn't want to ruffle the proverbial feathers and have to deal with the situation Dr. Currier is currently in. And who would want to? The pressures of taking the exam and being a mother to a newborn, mixed in with ongoing court appeals? Its too much for someone to deal with at once. Reading over NBME's position on the web site linked above, the organization claims Dr. Currier is already given exemption by being permitted:
"a variety of comfort measures and personal item exceptions, such as permission to bring multiple, assembled pumps to eliminate the time involved in cleaning, assembling, and disassembling them; permission to pump milk while taking the test and on break time, with privacy within the constraints of exam security, in the individual testing room that she receives on account of her ADA disability. We also provided her with a sample schedule demonstrating how an examinee can flexibly manage the time to take a 20- to 30-minute break every three hours."
I don't know that I can really call any tools related to pumping breast milk as "comfort measures."
I am most interested in Dr. Currier's situation because I feel that once again the odds are stacked against a successful woman, who wants both a family and a successful career. While I recognize NBME's committment to consistency and fairness to all MD's taking the exam, I feel Dr. Currier is just taking a stand for her rights, on account of both her dyslexia and her need to pump milk for her child. Is she being punished for being a mother?
The NBME explains the time allotted for the exam as follows: "A computerized exam, Step 2 CK consists of eight testing blocks of up to one hour each, plus 45 minutes of break time and an optional 15-minute tutorial. Examinees may use their break time throughout the day as they choose (e.g., take multiple short breaks between blocks of the test or fewer breaks of longer duration)."
NBME defends their decision to deny Dr. Currier's request by stating that several other mothers have taken the exam with the allotted break time with no problems. That is probably because these women didn't want to ruffle the proverbial feathers and have to deal with the situation Dr. Currier is currently in. And who would want to? The pressures of taking the exam and being a mother to a newborn, mixed in with ongoing court appeals? Its too much for someone to deal with at once. Reading over NBME's position on the web site linked above, the organization claims Dr. Currier is already given exemption by being permitted:
"a variety of comfort measures and personal item exceptions, such as permission to bring multiple, assembled pumps to eliminate the time involved in cleaning, assembling, and disassembling them; permission to pump milk while taking the test and on break time, with privacy within the constraints of exam security, in the individual testing room that she receives on account of her ADA disability. We also provided her with a sample schedule demonstrating how an examinee can flexibly manage the time to take a 20- to 30-minute break every three hours."
I don't know that I can really call any tools related to pumping breast milk as "comfort measures."
I am most interested in Dr. Currier's situation because I feel that once again the odds are stacked against a successful woman, who wants both a family and a successful career. While I recognize NBME's committment to consistency and fairness to all MD's taking the exam, I feel Dr. Currier is just taking a stand for her rights, on account of both her dyslexia and her need to pump milk for her child. Is she being punished for being a mother?
Friday, October 5, 2007
Patient-Reported Outcomes vs Empirical Evidence in Clinical Trials
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.Tuesday, October 2, 2007
Letting Kids Drink Early Reduces Bingeing
Stanton Peele, psychologist and author of "Addiction-Proof Your Child", advocates parents reconsider how they teach their kids about alcohol. His position is that by allowing them to drink early (the author's own daughter was allowed to drink at home at 14), they learn to drink responsibly--thereby lessening the chance to become alcohol addicted later in life. His contention is that by forbidding it, parents make the temptation to binge more attractive and therefore more likely. A major defense he uses is that other cultures already practice this, and underage drinking is not a problem in many other nations. I personally don't subscribe to such a notion, and raised my own daughter to be very analytical in her thoughts and observations about alcohol. She's 23 now and drinks very little, only socially, and will absolutely not drink in situations where she needs to get behind the wheel of a car. Every parent's process with their own children is different, and it's an individual decision, but I personally do not advocate giving alcohol to 14 year-olds.
The full story from CNN appears below:
http://www.cnn.com/2007/HEALTH/09/27/kid.drinking/index.html
The full story from CNN appears below:
http://www.cnn.com/2007/HEALTH/09/27/kid.drinking/index.html
Monday, October 1, 2007
What defines a medical emergency?
An article in the New York Times on September 22 discusses the recent move by the federal government to remove coverage for chemotherapy through the Medicaid program for illegal immigrants seeking emergency cancer services. The existing provision for illegal immigrants through Medicaid allows for emergency coverage only, however up until now, the definition of “medical emergency” was left up for the individual states to decide. The statute clearly states that routine care for nonresidents and illegal immigrants is not covered, but the only procedures that are specifically excluded are transplantations.
Some states define a medical emergency as when it is not possible to schedule an appointment for treatment of an injury, illness, or disease. Other states define it as any condition that may lead to an emergency or lead to death without treatment.
But where is the line for emergency coverage to be drawn and is it worth excluding chemotherapy coverage when it is only a small portion of the state’s Medicaid budget? The article mentions that the majority of state Medicaid cost stems from care for pregenant women, labor, and delivery. A study of emergency Medicaid services in
Wall Street Journal Article
Hey everyone. This is an interesting Wall Street Journal article I came across, which serves as a bit of a wake up call for people who analyze data and journal articles. But honestly, I know this information doesn't really surprise those of us in research!
Most Science Studies
Appear to Be Tainted
By Sloppy Analysis
September 14, 2007; Page B1
We all make mistakes and, if you believe medical scholar John Ioannidis, scientists make more than their fair share. By his calculations, most published research findings are wrong.
Dr. Ioannidis is an epidemiologist who studies research methods at the University of Ioannina School of Medicine in Greece and Tufts University in Medford, Mass. In a series of influential analytical reports, he has documented how, in thousands of peer-reviewed research papers published every year, there may be so much less than meets the eye.
These flawed findings, for the most part, stem not from fraud or formal misconduct, but from more mundane misbehavior: miscalculation, poor study design or self-serving data analysis. "There is an increasing concern that in modern research, false findings may be the majority or even the vast majority of published research claims," Dr. Ioannidis said. "A new claim about a research finding is more likely to be false than true."
The hotter the field of research the more likely its published findings should be viewed skeptically, he determined.
Take the discovery that the risk of disease may vary between men and women, depending on their genes. Studies have prominently reported such sex differences for hypertension, schizophrenia and multiple sclerosis, as well as lung cancer and heart attacks. In research published last month in the Journal of the American Medical Association, Dr. Ioannidis and his colleagues analyzed 432 published research claims concerning gender and genes.
Upon closer scrutiny, almost none of them held up. Only one was replicated.
Statistically speaking, science suffers from an excess of significance. Overeager researchers often tinker too much with the statistical variables of their analysis to coax any meaningful insight from their data sets. "People are messing around with the data to find anything that seems significant, to show they have found something that is new and unusual," Dr. Ioannidis said.
In the U. S., research is a $55-billion-a-year enterprise that stakes its credibility on the reliability of evidence and the work of Dr. Ioannidis strikes a raw nerve. In fact, his 2005 essay "Why Most Published Research Findings Are False" remains the most downloaded technical paper that the journal PLoS Medicine has ever published.
"He has done systematic looks at the published literature and empirically shown us what we know deep inside our hearts," said Muin Khoury, director of the National Office of Public Health Genomics at the U.S. Centers for Disease Control and Prevention. "We need to pay more attention to the replication of published scientific results."
Every new fact discovered through experiment represents a foothold in the unknown. In a wilderness of knowledge, it can be difficult to distinguish error from fraud, sloppiness from deception, eagerness from greed or, increasingly, scientific conviction from partisan passion. As scientific findings become fodder for political policy wars over matters from stem-cell research to global warming, even trivial errors and corrections can have larger consequences.
Still, other researchers warn not to fear all mistakes. Error is as much a part of science as discovery. It is the inevitable byproduct of a search for truth that must proceed by trial and error. "Where you have new areas of knowledge developing, then the science is going to be disputed, subject to errors arising from inadequate data or the failure to recognize new matters," said Yale University science historian Daniel Kevles. Conflicting data and differences of interpretation are common.
To root out mistakes, scientists rely on each other to be vigilant. Even so, findings too rarely are checked by others or independently replicated. Retractions, while more common, are still relatively infrequent. Findings that have been refuted can linger in the scientific literature for years to be cited unwittingly by other researchers, compounding the errors.
Stung by frauds in physics, biology and medicine, research journals recently adopted more stringent safeguards to protect at least against deliberate fabrication of data. But it is hard to admit even honest error. Last month, the Chinese government proposed a new law to allow its scientists to admit failures without penalty. Next week, the first world conference on research integrity convenes in Lisbon.
Overall, technical reviewers are hard-pressed to detect every anomaly. On average, researchers submit about 12,000 papers annually just to the weekly peer-reviewed journal Science. Last year, four papers in Science were retracted. A dozen others were corrected.
No one actually knows how many incorrect research reports remain unchallenged.
Earlier this year, informatics expert Murat Cokol and his colleagues at Columbia University sorted through 9.4 million research papers at the U.S. National Library of Medicine published from 1950 through 2004 in 4,000 journals. By raw count, just 596 had been formally retracted, Dr. Cokol reported.
"The correction isn't the ultimate truth either," Prof. Kevles said.
Email me at ScienceJournal@wsj.com9.
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