Monday, April 8, 2013

Major roadblock possibly cleared for stem cell research


Researchers at the University of California, San Francisco have found rare stem cells extracted from cells in lactating breast tissue and breast milk that are capable of becoming most of the different cell types. This is an amazing research breakthrough as it was previously thought that there were no pluripotent cells in the body after the embryonic stage of human development. When these cells were put into mice or in cell culture, the cells differentiated to produce multiple cell types, including those for the heart, intestine, brain, pancreas, even cartilage.

These stem cells have the potential to generate new tissues and could essentially be a “patch kit”, healing wounds and reconstructing damaged or missing organs. They could also be used as a resource to study how cells become pluripotent, leading to more research and potentially better and more accessible “patch kits”. This discovery has also led scientists to hypothesize that pluripotent cells are actually scattered throughout the bodies of men and women in other organs.

However, some scientists are not fully convinced that these cells are truly pluripotent because they fail one widely accepted test for embryonic cells: when injected into mice, they don't form a type of tumor called the teratoma. For many, this failure is a deal-breaker.

Nevertheless, if the research can continue on, and if breast stem cells are found to be truly pluripotent, this could potentially solve the key issue that surrounds the medical use of stem cells. Historically, the ethical quandary rose with the destruction of human embryos for stem cell derivation. On the grounds that the human embryo is a human life with moral value justifying its protection, the extraction of embryonic stem cells is unethical.  The use of adult stem cells and umbilical cord blood stem cells has generally been considered to be free of any particular ethical issues.  In fact they have been applauded as ethically superior alternatives to the use of embryonic stem cells. If we can add breast milk stem cells to this list, the road to stem cell research and improved medicine will be cleared of a major obstacle.

http://www.bioethics.org.au/Resources/Resource%20Topics/Stem%20Cells.html
http://www.newscientist.com/article/mg21729084.800-are-breast-milk-stem-cells-the-real-deal-for-medicine.html
http://www.bioedge.org/index.php/bioethics/bioethics_article/10436

Sunday, April 7, 2013

We need the placebo treatment


In class we talked about the controversy behind the AIDS treatment in the developing countries. In the United States, the 076 regimen has been tested with a control, and was determined that it can decrease the transmission rate of AIDS from mother to child. This treatment requires the injection of intravenous drugs, some oral regimens, and the refrainment from breast feeding. However, this treatment is expensive, and many people in the developing country cannot afford it. Thus, there are other treatments that have been developed for these countries, but the treatments have not been tested with a placebo experiment. The debate is then whether or not we should test the treatments on these countries.
According to the Declaration of Helsinki, physicians should not conduct experiments on patients if there is known to be a better treatment. Here, the 076 provides such proven treatment. Is it then ethical to give placebos to people?
It is suggested in class that it's possible to data mine, and we can estimate the actual transmission rate in the country. Therefore, without the use of placebo, we can still guess at the effectiveness of the drug based on the evidence that we have. Because data shows that there is a decrease in transmission rate with the use of the drug in the countries we have data for, it is very plausible that people in Uganda will also respond to the drugs in the same way. However, what happens if there are significant side effects to the drugs?
Suppose that we base on the current data and only provide drugs to the people without first testing with placebo. Then, if significant side effects were to occur after using the drugs, who should be responsible? I believe we should have an experiment to make sure the drug is effective first. Perhaps the climate in Uganda is different from the other countries, or maybe its society works in a way such that the drug is ineffective. There are many reasons why a treatment can have different results because we simply do not know the full extent to how our bodies work, and there are too many factors that can complicate the treatment. Therefore, I support the use of a placebo experiment using this drug, with the consent of the people, and only after the drug is shown to be effective in Uganda should it be administered.

Cognitive enhancing drugs - just because we can, should we?

In a discussion forum last month, leading bioethicists expressed support for the use of cognitive enhancing drugs. Researchers have claimed that drugs used to treat ADHD (Ritalin, Adderall) and narcolepsy (Provigil) are widely used in the healthy to improve focus and memory. Bennett Foddy, deputy director of the Institute for Science and Ethics at the University of Oxford, foresees many benefits of making cognitive enhancers acceptable in society. “So far as we can tell, cognitive enhancing drugs have a higher effect on people with lower intelligence,” said Foddy. “So it’s actually an equalizing force. Far from giving some people an unfair advantage, it’s a way of minimizing the unfair advantage which comes about because of differences in people’s genetic endowment” (qtd. in Chinthapalli). Another speaker claimed that there seems to be no moral problem with enhancing ourselves, since it is difficult to judge the boundary between therapy and enhancement in medicine. In regard to the issue of addiction, it was argued that the same problem comes up with many drugs—including alcohol—and that the “benefits outweigh the risks.” The speakers agreed that more studies on the effects of these drugs in healthy people should be performed (Chinthapalli).
But in this case, are the opinions of bioethicists reliable? First of all, the claim that cognitive enhancement is widespread may not be valid. The only evidence of common nonprescription use of Ritalin and Adderall by college students is surveys, which rarely ask specifically about the use of the drugs as enhancers. For instance, the 2009 National Survey of Drug Use and Health asked about the use of a stimulant “without a prescription of the individual's own or simply for the experience or feeling the drugs caused” (qtd. in Lucke et al.). However, students who report nonmedical use of these drugs could be using them to “get high” or to stay alert during late night parties. The same holds true for reported nonmedical use of stimulants in adults. While some adults may be using the drugs to enhance cognitive function at work, others could actually be using them to self-treat symptoms of ADHD (Lucke et al.). If cognitive enhancers aren’t as common as researchers believe, then attempts to facilitate the use of these drugs would be met with more hostility than anticipated. Secondly, the risk of addiction is of far greater importance than these researchers realize. A person taking Ritalin in acceptable doses and with medical supervision may not be likely to become addicted. But in large doses, stimulant drugs cause dependence and have a high potential for abuse.
If cognitive enhancing drugs miraculously improved brain function in healthy people, perhaps we could be willing to dismiss other concerns as secondary. After all, the prospect of reducing disparities in intelligence may seem attractive. But the extent to which enhancers improve cognitive functioning in people with neurological diseases and intellectual disorders is unclear (Lucke et al.). Moreover, recent scientific reviews draw attention to the limited evidence that stimulant drugs improve cognitive performance in healthy individuals. For instance, a recent study on the effects of Ritalin in healthy young men found increased activity in the region of the brain affecting attention. However, these findings did not correspond to “improved accuracy in working memory or visual attention tasks” (Lucke et al.). In addition, research showing the positive influence of cognitive enhancing drugs has important limitations. All evidence for the enhancing effect of Provigil, for example, is based on short-term trials in the laboratory (Lucke et al.). However, such results do not reflect on the practical benefits of long-term use of the drugs. No evidence exists to show that cognitive enhancers work over extended periods of time or in real-world situations. 
Everyone acknowledges that more research is needed to assess the benefits and harms of cognitive enhancing drugs in healthy people. But it is worth questioning whether these types of studies are even worth the investment. Contrary to media opinion, it seems unlikely that cognitive enhancers offer any true advantage for individuals and for society. The positive effects of these drugs over a long period of time in practical situations, if any, are probably minimal. Making stimulant drugs more accessible to healthy people would increase rates of substance abuse, offsetting any small advantage we might gain from enhancement. Bioethics researchers will have difficulty defending cognitive enhancers to a society that has also seen the effects of cocaine and the amphetamines. Not everything that is ethical is always acceptable. 

http://www.bmj.com/content/346/bmj.f1743
http://www.tandfonline.com/doi/full/10.1080/21507740.2011.611122#tabModule

Tuesday, April 2, 2013

Your Turn to Sacrifice


Fifty years later, some experiments involving human subjects are still garnering controversy in the bioethics community. Unlike the Tuskegee syphilis scandal, in which impoverished African-American with syphilis were observed for decades even though a cure existed, that has become almost universally recognized as repugnant and the black mark on the record of human experimentation, the Milgram experiment is still hotly debated today. In 1960, professor of psychology Stanley Milgram of Yale developed a study famous for its cleverness—and its tiptoeing the line of respect for human dignity. The question at hand is the trickery necessary for the experiment: in Milgram’s study, the “subjects” were actually researchers . . . and the “research aides” were actually the subjects, unbeknownst to them. Milgram gathered ordinary participants from the New Haven community under the pretense of helping him in his research. He ordered them to administer electric shocks to test “subjects” (really just pre-recorded voices of fellow researchers) who were supposedly in another room answering questions via an intercom. Every time the “subject” answered a question incorrectly, the “aide” raised the amount of voltage to the next level and pressed a button to shock him. In response, the sound of a scream was played, which the “aide” believe belonged to the actual “subject.” The study, which found that 65% of “aides” administered even the highest level of shock (450 volts, marked “XXX” and higher in intensity than lower levels marked things like “Danger: severe shock”), to show the compliance of those under authority and how they shifted their moral responsibility to superiors.

Many today are quick to condemn this form of experimentation. One harm of the experiment on its subjects is the psychological trauma induced by causing pain to “subjects” and hearing corresponding screams. Another problem in the study to which critics point is the lack of informed consent by the actual subjects; so much so was this lack of consent that the subjects didn’t truly understand their function as subjects of the study (by necessity of the study’s nature). This notion of informed consent is a bedrock of practically every code of ethics, so the revulsion of onlookers is understandable. But while some press their criticisms with words like “the days when experimenters could do what they want are gone,” there exist defenders of such practices in high places even today. For instance, more than half of the standing committee that reviews human experimentation at Harvard today says that they would approve of Milgram’s research (slightly modified, but largely intact). One reason is that most medical codes of ethics allow for lack of full knowledge on the part of the subjects in cases when knowing everything would defeat the point of the research. In addition, goes their refrain, how will we progress in important fields of science? “Human experimentation limits the classic unfettered freedom of academic research.” Harvard professor Regina Yando on the Harvard experimentation committee puts this another way by saying that she would approve of Milgram’s research if “there was serious, important research to be obtained” that “outweighed” the harm to the subjects. The problem with this line of thinking, though, is that employs a utilitarian calculus so pure that even most staunch utilitarian adherents will shy from it. While the benefit of the knowledge may far outstretch the pain suffered by the subjects in some ways, modern ethics considers these questions in more than just a simple calculation of net gain for humanity. Regardless of the benefit, there are certain lines that we all agree must not be crossed: and sacrificing someone else’s livelihood, however small it may be, for the greater good can never be used as justification.

Sources:

Treating a Five Year Old With..... Medical Marijuana?


Jayden David has suffered from a rare form of epilepsy, Dravet syndrome, which is so severe it essentially left him incapacitated. His father described his condition when he said “If he wasn't sleeping, he was seizing.” Before Jayden turned five he had tried more than a dozen different medications to try and at least reduce the severity of the seizures if not eliminate them. None of these treatments worked, and as a last resort Jayden’s father turned to a new and controversial treatment, medical marijuana.
             While drastic the treatment seems to be working. Jayden now only takes four prescription pills a day, eats solid food, sings and dances, and the frequency and intensity of his seizures has been greatly reduced.
            It should also be noted that Jayden does not take any medication that contains THC, the psychoactive portion of the drug that gives users a high. The drugs he takes only contain cannabidiol, which has no psychoactive effects.
            The question that becomes apparent is how appropriate is it to treat a five year old boy with medical marijuana? Medical marijuana, while legal in California where Jayden lives, is still illegal according to federal law. Even more importantly there has been no research into the effect of cannabidiol on the developing brain. Although there are known changes in brain structure that occur in adult brains of marijuana users no testing has been done in children. If the same types of changes occur in children’s developing brains there can be huge long-term negative side effects. However, with all this being said it’s hard to argue with the success of the treatment so far.

http://www.latimes.com/news/local/la-me-customized-marijuana-20120914,0,7012444.story?page=1

Monday, April 1, 2013

Stem cell therapy and the need for greater governmental involvement


On 18th July 2011, Dr. Arthur Caplan, Director of the Center for Bioethics at the University of Pennsylvania, reported in an article that despite the fact that the therapeutic use of stem cells outside of bone marrow transplants is not yet proven to be safe, a large number of clinics around the world are offering stem cell therapies as treatments for conditions including, but not limited to, multiple sclerosis, spinal cord injury, osteoarthritis, rheumatoid arthritis, heart disease, autoimmune diseases, cerebral palsy and autism. According to the article, one such clinic has claimed on the Internet that it has treated more than 800 patients for the above conditions, without stating how many of these treatments have been successful and to what extent.

Moreover, Heidi Ledford, one of the editors of Nature (the leading international weekly journal of science), reported on 28th June 2011 that the International Society for Stem Cell Research (ISSCR) has been threatened by a group of lawyers representing industry clinics established in countries with relatively weak governmental medical oversight. The ISSCR is a not-for-profit organization that brings together over 3500 scientists from across the world and facilitates stem cell research. It had a website that used materials already published in the scientific community to provide correct information about the reliability of the stem cell therapies proposed by the above described clinics. It was also going to upload on this website additional information useful for potential patients, such as which of these clinics had ethics committees for the oversight of unconventional medical procedures and which of these ethics committees adhered to the rules of legal agencies like Food and Drug Administration or the European Medicines Agency. However, the ISSCR was forced to bring down this website because they did not have enough funds to fight the above lawsuits, even if they were to win in the end.

This example raises important questions: How essential is it to increase awareness about novel medical technologies amongst the common masses? Is it possible that some doctors would take unfair advantage of the lack of knowledge of their patients by offering them risky, expensive medical procedures? How 'informed' were the consents that the above mentioned 800 patients gave before they were treated with untested stem cell procedures? The very fact that the ISSCR was threatened with lawsuits by these clinics indicates that these clinics were not revealing all the information to their patients and were afraid of losing potential patients should the website go up.

According to me, the onset of medical technology (and stem cell technology in particular) does provide an opportunity for the cure of diseases that were previously thought to be incurable but it also provides an opportunity for the misuse of the lack of knowledge of the public to fill the pockets of doctors and clinics. Hence, I think it is important that this technology is allowed to grow just like any other technology in the past, but with a significant amount of involvement from the government with the prime purpose of protecting the common man from exploitation. More money needs to be spent to make sure that every medical institution that offers unconventional medical procedures to its patients does have an established ethics committee for review, and the cases approved/disapproved by this committee can be periodically evaluated by governmental agencies and appropriate action taken. The government can also provide funds to legitimate organizations such as the ISSCR which would enable them to spread more medical knowledge, thereby helping patients make better decisions. If we are to ensure that people are greatly benefited but not harmed at all from this new and powerful technology, I think the government must play an extremely active role. 

Sources: 
1. http://www.nbcnews.com/id/43760409/ns/health-health_care/#.UVnKV1HVDZs
2. http://www.nbcnews.com/id/3035344/