Class action lawsuits are a fairly decent way of finding out what the latest government scandal is. This month, it's related to claims that the government in Texas has been keeping samples of blood from newborns, and then making them available to researchers without the consent of the parents.
Normally, these blood samples are used to check for a variety of serious medical conditions, including cystic fibrosis. According to the Texas Department of Health Services, this program will allow doctors to identify children with these conditions early in life, and allow them to be treated effectively from a younger age.
Normally, these samples would be kept, but not used without explicit permission. However, do to a loophole in the law, the state government has sold the samples to different companies, without asking for permission from the parents. This is clearly unethical behavior, and the class action lawsuit seeks compensation for those parents who had samples of their child's blood used, without their consent.
But this is not enough. The publicity surrounding the case might make the government more likely to refrain from selling these samples in the future, but it is no guarantee. What is really needed is for the government to follow the policies that are standard in research and medicine when it comes to informed consent. We have an established right to privacy, and the use of newborn blood samples in this manner is a clear violation of this right.
http://www.kxan.com/dpp/news/local/class-action-filed-over-newborns-blood
http://www.kxan.com/dpp/health/government-taking-newborn-dna-samples
http://www.dshs.state.tx.us/LAB/newbornscreening.shtm
Wednesday, December 22, 2010
Monday, December 13, 2010
Hippocrates, or Gregory House?
Discussions about bioethics, as with anything else, are too often confined to the realm of theory, in which academics debate various hot-button issues without considering the equally important practical concerns. The fact of the matter is that academics do not conduct their lives and make their decisions according to bioethical guidelines, doctors do, and hence doctors’ perspectives on these controversial issues are equally if not more important than those of academics.
As a first example, 46% of doctors reported being in favor of physician-assisted suicide, while 41% were opposed. Such a divide is inevitable and understandable—there are very strong arguments to be made on both sides of this issue, and lay people are equally torn and unsure about it. The fact that even doctors, who presumably understand most of the medical details surrounding physician-assisted suicide, have not come even close to a consensus suggests that this is truly an issue with no clear solution.
In response to another question, 58% of doctors said that it is not ethical to prescribe a placebo to a patient who wants treatment, but 24% said that it is. Although there is a case to be made for giving placebos without informing the patient (it is, after all, the only way that they can work), the lack of informed consent inherent in lying to a patient about the drugs that they are being given sways the pendulum of ethicality firmly in one direction. Perhaps some of the 24% are truly prescribing placebos with the best interests of their patients in mind, but I suspect that some are doing so simply in the hopes that the placebo will miraculously work and they will have something cool to write a paper about.
Many of the other results, however, are not at all acceptable or understandable, and point not to any inherent ethical conundrum but rather to the fact that doctors are just as selfish, greedy, and self-protecting as the rest of us. 40% of doctors said that it is acceptable in some cases to cover up mistakes they have made that will not cause their patient any harm, and 39% said that it is sometimes alright to perform procedures that are not medically necessary simply to protect against future litigation. These statistics reveal that that in a large number of cases, doctors are willing to compromise their ethics to protect themselves. They are of course in a very tough spot in terms of malpractice suits, but this still does not make it okay.
Moving beyond the realm of self-protection and into that of greed, only 47% of doctors said that gifts and perks from pharmaceutical companies should be refused, while 37% said that it is okay to accept them and 16% said “it depends”. Accepting gifts from drug companies is a clear conflict of interest—it incentivizes doctors to prescribe drugs made by those companies, even when their patients might not need them or be able to afford them—and the fact that so many are willing to overlook this in favor of fancy cars and tropical getaways is a dark stain on the image of the infallible physician. We must never lose sight of the fact that doctors are just as human as the rest of us, and we must always frame our ethical debates taking this often-overlooked variable into account.
Sunday, December 12, 2010
Weight Loss Pills: A Form of Enhancement?
The FDA is currently on the verge of approving the first diet pill in over a decade. Contrave, made by Orexigen Therapeutics, combines two existing drugs: Bupropion, the popular antidepressant and smoking-cessation medication, and naltrexone, used to counter alcohol addiction. This combination aims to boost metabolism and decreases appetite in order to help people lose weight.
Given that we are in the midst of an obesity epidemic here in the United States, an effective diet pill is certainly something that society could use. But the FDA has been wary to approve many diet pills, because they are risky in terms of side effects. The justification for Contrave comes from observation of its component drugs over a prolonged period of time, and the fact that a lot of data has been gathered from research already.
While Contrave is certainly not going to revolutionize weight loss, as it is only a tiny bit more effective than the traditional diet and exercise regime, it will certainly become very widely used if approved.
But are commercially available diet pills really what America needs right now? Yes, certain people are obese for clinical and medical reasons, and so pills are a valid method for these people, who played no hand in their condition. However, most of the obese became that way due to poor choice of lifestyle and diet. Thus, pills are for most people a quick, easy and painless way to lose weight and 'fix' some fault, while allowing them to continue indulging themselves. But what if we take the situation to the extreme: for example, what if incredibly effective pills were to become available, and their usage became commonplace (a very likely scenario given how drug-happy the population already is)? Everyone would simply indulge their greed and laziness and take the diet pills as a tool to indulge these other moral vices. By using diet pills in order to improve ourselves aren't we somehow compromising our sense of respect for ourselves, and the moral value of hard work and self disciple (Or even, Sandel's "giftedness")? Perhaps diet pills are a form of enhancement that ought to be treated with wariness for reasons other than just the risk of bad side effects.
http://theweek.com/article/index/210159/will-contrave-revolutionize-dieting
Given that we are in the midst of an obesity epidemic here in the United States, an effective diet pill is certainly something that society could use. But the FDA has been wary to approve many diet pills, because they are risky in terms of side effects. The justification for Contrave comes from observation of its component drugs over a prolonged period of time, and the fact that a lot of data has been gathered from research already.
While Contrave is certainly not going to revolutionize weight loss, as it is only a tiny bit more effective than the traditional diet and exercise regime, it will certainly become very widely used if approved.
But are commercially available diet pills really what America needs right now? Yes, certain people are obese for clinical and medical reasons, and so pills are a valid method for these people, who played no hand in their condition. However, most of the obese became that way due to poor choice of lifestyle and diet. Thus, pills are for most people a quick, easy and painless way to lose weight and 'fix' some fault, while allowing them to continue indulging themselves. But what if we take the situation to the extreme: for example, what if incredibly effective pills were to become available, and their usage became commonplace (a very likely scenario given how drug-happy the population already is)? Everyone would simply indulge their greed and laziness and take the diet pills as a tool to indulge these other moral vices. By using diet pills in order to improve ourselves aren't we somehow compromising our sense of respect for ourselves, and the moral value of hard work and self disciple (Or even, Sandel's "giftedness")? Perhaps diet pills are a form of enhancement that ought to be treated with wariness for reasons other than just the risk of bad side effects.
http://theweek.com/article/index/210159/will-contrave-revolutionize-dieting
Wednesday, December 8, 2010
Kids, Your Mother and I Have Something to Tell You...
Adopted and donor-parented children fare much better when they are told the news early in life. Waiting only delays the inevitable - a child will find out, and the sooner they do, the better. Why do parents so often wait then?
Recently, Robert Klitzman wrote an article in the Huffington Post about the importance of giving children the news about their origins as soon as possible, because the psychological consequences of waiting are worse as time goes on. Keeping the information a secret only satisfies parents' selfish desires to remain the ultimate parent figures, and saves them the stress of breaking the news. This is more important now than ever, when 1% of childbirths use the assistance of reproductive technologies.
The situation seems to be even more complex now than ever, since donor children are not quite the same as adopted children. Before, it was simple enough to phrase, "we are not your real parents." Now, more thought-out wording is required to explain to a child that another individual donated their sperm or eggs to aid parents in using reproductive technologies to essentially "create" a child.
This, of course, is going to be a necessity, as the percentage of reproductive technology use only increases. However, the most pressing question on my mind is: what kind of implications does this have for future cloning practices? How do you describe to a child what kind of process conceived them?
This will further complicate things to a level that is yet unprecedented. Parents will need to explain more than ever, and the psychological consequences may be worse than any information regarding parenting has ever been. It seems as though most clones will undoubtedly face some sort of identity crisis trying to grapple with the concept of their being, and rates of depression would skyrocket. Suicide rates in clones would be much higher in relation to the rest of the population, and finding an effective way to handle clones and their psyches will not be easy.
Right now, we are struggling to find a safe method to protect the physical safety of clones, but once we solve this, an equally important problem waits in the shadows. When physical safety is provided for, mental safety is next. Will we be able to rise to the challenge?
http://www.huffingtonpost.com/robert-klitzman-md/in-vitro-fertilization-families_b_782690.html
Recently, Robert Klitzman wrote an article in the Huffington Post about the importance of giving children the news about their origins as soon as possible, because the psychological consequences of waiting are worse as time goes on. Keeping the information a secret only satisfies parents' selfish desires to remain the ultimate parent figures, and saves them the stress of breaking the news. This is more important now than ever, when 1% of childbirths use the assistance of reproductive technologies.
The situation seems to be even more complex now than ever, since donor children are not quite the same as adopted children. Before, it was simple enough to phrase, "we are not your real parents." Now, more thought-out wording is required to explain to a child that another individual donated their sperm or eggs to aid parents in using reproductive technologies to essentially "create" a child.
This, of course, is going to be a necessity, as the percentage of reproductive technology use only increases. However, the most pressing question on my mind is: what kind of implications does this have for future cloning practices? How do you describe to a child what kind of process conceived them?
This will further complicate things to a level that is yet unprecedented. Parents will need to explain more than ever, and the psychological consequences may be worse than any information regarding parenting has ever been. It seems as though most clones will undoubtedly face some sort of identity crisis trying to grapple with the concept of their being, and rates of depression would skyrocket. Suicide rates in clones would be much higher in relation to the rest of the population, and finding an effective way to handle clones and their psyches will not be easy.
Right now, we are struggling to find a safe method to protect the physical safety of clones, but once we solve this, an equally important problem waits in the shadows. When physical safety is provided for, mental safety is next. Will we be able to rise to the challenge?
http://www.huffingtonpost.com/robert-klitzman-md/in-vitro-fertilization-families_b_782690.html
Tuesday, December 7, 2010
Take .00132086 Gallons of Liquid Tylenol Every 4 to 6 Hours
One week ago, a study came out in the Journal of the American Medical Association indicating that approximately half of all adults who give medicine to their children end up giving them the wrong dosage. This often happens either because of confusing instructions on the medicine box or bottle, because the devices provided to measure the medicine have markings in units which do not match the units in the instructions, or because no measuring devices are provided at all. As reported in Dr. Sanjay Gupta’s blog on cnn.com, about 25% of medicines do not come with a measuring device, and of the 75% that do, a whopping 99% have inconsistencies between the dosing instructions on the label and the dosing markings on the measuring device.
In response to reports last year of children overdosing because their parents provided them with the wrong doses of medicine, the FDA issued a series of voluntary guidelines to drug companies suggesting steps by which they might decrease the risk posed by this fundamental flaw in their products. The steps they suggested are quite obvious: “The FDA recommends that all OTC liquid products include a measuring device and that the same units of measurement and abbreviations appear on the device and in the written label instructions. It also recommends limited marking on the dosing cups or devices—only those needed to get the right dose. The FDA also recommends standardizing abbreviations.”
Surely it didn’t take a genius to figure those ones out. Putting aside the fact that it was wrong for drug companies to even think of releasing drugs with inconsistent units of measurement, the most glaring atrocity in this whole situation is that the FDA has not made their guidelines mandatory. The FDA has a duty to ensure that all drugs which are released on the market, and especially ones that are OTC and not regulated by a doctor, are safe to be used. Safe means not only that taking the recommended dosage will not do undue harm, but also that the packaging and measuring devices are designed in such a way as to ensure that it is very easy for the average person, and even those of subpar intelligence, to take the correct dose.
Going back to the CNN blog post, the author writes, “In some cases the directions used terms such as teaspoon or tablespoon while the cup or dropper listed doses only in milliliters. Rarely were there instructions to convert from one form of measurement to another, according to the study.” While this would technically be enough information to calculate the correct dosage, even providing conversion factors is still, I think, not good enough. Health is a universal right, and the ability to multiply should not be a prerequisite. I suspect that drug companies like the lack of regulation because it allows them to manufacture a generic measuring cup for all the different products which they produce, and the fact that the FDA has allowed them to get away with this for so long (and is still allowing them to do so) is a fundamental failure on the part of the government to protect its people.
Syntes Surgeons Test Bone Cement on Spinal Surgery Patients W/O Consent
Synthes Incorporated and its subsidiary, Norian Corporation are responsible for orchestrating a series of “unauthorized tests of its bone cement on about 200 spinal surgery patients” that resulted in a few deaths. The use of bone cement had already been approved to be used in the arm, but had not yet been approved to be used in the spine. Synthes “had trained surgeons to use it ‘off-label’ so the company could gather data to support its expanded use.” Company members pleaded guilty and are reportedly aware of the unlawfulness of their actions. Apparently Synthes company members and surgeons had been warned previously that the tests they were performing were considered “human experimentation.” Although the surgery was not the cause of the deaths of the patients- it was most definitely a contributing factor. “The patients who died suffered severe hypotension, or low blood pressure, following injections of Norian bone cement,” which leads one to believe that perhaps the injection of bone cement was a primary instigator of death. What other medical observers, such as Dr. Kassirer, professor of medical ethics at Tufts University Medical School find absurd is that not only is it unusual that the Synthes employees immediately pled guilty and sought jail time, but also that with this “off-label marketing…companies view these settlements of $300 million, $400 million, even…$1 billion, as almost spare change.” Rather than paying off expensive fines for illegal and immoral surgeries, this money could be invested wisely such as in cancer research or something of the sort. What’s startling to believe is that these surgeries were conducted from 2002 to 2004 and they are just now being brought to justice. I believe it was guilt that forced the Synthes employees and surgeons to immediately plead guilty—I imagine it’s a terrible feeling to know that you caused another’s death. If there’s one thing I have observed from the medical and scientific world, it’s that patience does indeed pay off and it’s especially important to respect this law when one’s health is at hand.
And so if companies are so willing to pay off their fines and hardly sweat at doing so, is this proper punishment? There must be a way to firmly bring ill-acting companies to justices so that they learn that putting patients’ lives in danger for the sake of experiment is absolutely not okay. Human experimentation, especially human experimentation without consent is never acceptable—and these larger companies must learn this in a way that truly makes an impact.
http://www.latimes.com/business/nationworld/wire/sns-ap-us-medical-devices-fraud,0,6267730.story
Sunlight and Sneaky Incentives
Drug companies are currently paying doctors in sneaky ways in order to get them to prescribe the drugs they produce. They have been treating doctors to meals at expensive restaurants, sending gifts, and even writing them checks. As public criticism mounted, an pharmaceutical industry trade group began to crack down on these payments, the drug companies found even sneakier ways to give incentives to doctors. These disclosed payments can cause conflicts of interest.
Perhaps what is needed to keep these in check is to make all the undisclosed payments to come to light. To this effect, a national sunshine law that takes effect in 2013 would require all pharmaceutical companies to disclose the money that they are paying doctors. However, social psychological theories suggest that informing the public about how much doctors are receiving from drug companies might actually cause more doctors accept the incentives from drug companies. By exposing the widespread nature of a problem, doctors may become influenced to think that accepting financial incentives from drug companies is a common practice and therefore acceptable. Furthermore, doctors who disclose to their patients that they are receiving benefits from drug companies become more biased in their recommendations to their patients, and ironically, patients are also more likely to trust them. This casts doubts on whether the sunshine law would really help to reduce the negative effects of the doctors' bias on patients.
To add to this drama, an independent investigative journalism group, ProPublica, has recently put up a searchable database on their site. This database, “Dollars for Docs”, allows anyone to check how much money their doctors are being paid by drug companies. Would this then worsen the effects of biased prescriptions? It appears so. While exposure of statistics and high-profile case by news agencies would only cause doctors to get a general sense of how many doctors are getting incentives, “Dollars for Docs” allows the doctors to actually find out how much their peers are getting paid. This acts as an even stronger social proof, since a doctor would likely be able find someone he/she knows as a decent person who is receiving much more money than he/she is. This may cause even more doctors to accept incentives from drug companies.
Does this mean that ProPublica is doing a disservice to the public? Not necessarily. It allows the government to see the problem as what it is, and tackle it accordingly with the right kind of legislation and enforcement. If government officials are given to authority to act on this information to impose penalties on doctors who receive incentives, then disclosure is the right step to go.
Monday, December 6, 2010
A Cure For Traumatic Experiences?
Tragedy. It happens. It is a part of human life that we all may face one day. Yet what occurs when the negative and painful experiences from such tragic events become so overwhelming that they impair us in our everyday lives? The mind has its own way of protecting itself from trauma by repressing memories of such events, but neuroscience researchers at Johns Hopkins University are taking matters into their own hands and conducting research that may lead to a drug where doctors can selectively erase painful memories from the minds of human beings.
Research began by administering electric shocks to a group of a hundred or so mice while playing a sound (classical conditioning- so that the mice can associate the pain they received with the sound they heard). “They also administered a drug to some of the mice that kept their brains flooded with AMPARs. Those mice retained the fearful memories of the sound long after the initial jolt, while the drug-free group gradually became inure to it, eventually forgetting the painful experience”. This suggests that AMPARs are essential to the brain’s formation of memory and researcher Joseph E .LeDoux at NYU remarks that “It’s a huge step forward” in developing a drug that serves to block AMPARs and potentially eliminate harmful memories. Dr. Richard Huganir, director of the Neuroscience Department at Johns Hopikins believes that this could serve as a treatment for the 8 million American citizens who suffer from PTSD. People living with PTSD have already contacted Huganir eager to take part in drug trials. While all this seems good and well as a miracle treatment for traumatic experiences, there is a serious underlying ethical issue these researchers seem to be neglecting. Though this drug will no completely erase the painful memories, it will eliminate the strong emotional attachment people have, something that I feel is eerily unnatural.
Humans are, as many people believe, the sum of our experiences. We are shaped by both the positive an negative experiences in our lives. In truly traumatic experiences, I believe a humanistic approach to treatment where individuals can learn and grow from their experiences is perhaps the best way to recover from a traumatic experience. I acknowledge the severity of disorders such as PTSD that result from traumatizing moments in life, yet questions will arise in the future over what constitutes an experience as being traumatic enough to warrant the use of such a drug. There is something slightly inhuman about eliminating emotional attachment to our experiences, and these neuroscientists must be wary of such ethical concerns as the continue with their research.
Sources:
1) http://www.businessweek.com/magazine/content/10_50/b4207050515280.htm?campaign_id=rss_null
Friday, December 3, 2010
Diagnosis of Alzheimer's: Ignorance Is Bliss?
Alzheimer's is a mental degenerative disease which, though common, is still not at all well understood. Currently, the leading hypothesis for the cause of Alzheimer's symptoms (memory loss and a progressive inability to care for one's self) is the "amyloid hypothesis" which says that the disease occurs when a toxic protein, beta amyloid, accumulates in the brain. The bulk of drug research has been based on this hypothesis, focusing upon the idea is that if beta amyloid levels are reduced, the disease might be slowed, halted or even prevented if treatment starts early enough.
Many drugs have been developed, however very few have been effective. For example, the "Lilly" drug at first seemed promising, and was among the first shown to breach the blood-brain barrier and reduce levels of beta amyloid in the brain. But while it did slow down amyloid production, it did not have any prolonged effect of reducing symptoms in Alzheimer's patients. In fact, it even proved detrimental to their health because of other side effects that were originally not expected.
The "Lilly" example demonstrates the tension between our current lack of knowledge about the workings of the disease, and our desire to develop drugs in order to alleviate suffering. This tension has been intensified by the improvement in detection technologies, which are able to pick up even slight levels of plaque build up in the brain and allow for accurate predictions of Alzheimer's disease before its full onset later on.
But even though we have these technologies, is there really any benefit to the average individual for getting tested early on for Alzheimer's, if there are still no drugs which can help later? Simply knowing that you will develop Alzheimer's, while there is no available cure, has almost no benefit to the patient - it might simply produce feelings of hopelessness and depression while potentially complicating other aspects of life such insurance and employment. Once the world knows that you are soon doomed for mental incompetency, they will treat you differently.
Right now, the only benefit from this highly sensitive testing is for drug companies and researchers, who will be able to identify test subjects and carry out better trials on patients who do not already have advanced Alzheimer's. Usually, we like to focus upon relieving suffering, and to be aware of our own states of health. But perhaps ethically, in this case it would be better right now to focus upon understanding of the disease rather than finding a cure. Given our current state of knowledge and lack of a cure, perhaps ignorance is bliss for the general population when it comes to Alzheimer's?
http://www.nytimes.com/2010/08/19/health/19alzheimers.html?_r=1&ref=the_vanishing_mind
Many drugs have been developed, however very few have been effective. For example, the "Lilly" drug at first seemed promising, and was among the first shown to breach the blood-brain barrier and reduce levels of beta amyloid in the brain. But while it did slow down amyloid production, it did not have any prolonged effect of reducing symptoms in Alzheimer's patients. In fact, it even proved detrimental to their health because of other side effects that were originally not expected.
The "Lilly" example demonstrates the tension between our current lack of knowledge about the workings of the disease, and our desire to develop drugs in order to alleviate suffering. This tension has been intensified by the improvement in detection technologies, which are able to pick up even slight levels of plaque build up in the brain and allow for accurate predictions of Alzheimer's disease before its full onset later on.
But even though we have these technologies, is there really any benefit to the average individual for getting tested early on for Alzheimer's, if there are still no drugs which can help later? Simply knowing that you will develop Alzheimer's, while there is no available cure, has almost no benefit to the patient - it might simply produce feelings of hopelessness and depression while potentially complicating other aspects of life such insurance and employment. Once the world knows that you are soon doomed for mental incompetency, they will treat you differently.
Right now, the only benefit from this highly sensitive testing is for drug companies and researchers, who will be able to identify test subjects and carry out better trials on patients who do not already have advanced Alzheimer's. Usually, we like to focus upon relieving suffering, and to be aware of our own states of health. But perhaps ethically, in this case it would be better right now to focus upon understanding of the disease rather than finding a cure. Given our current state of knowledge and lack of a cure, perhaps ignorance is bliss for the general population when it comes to Alzheimer's?
http://www.nytimes.com/2010/08/19/health/19alzheimers.html?_r=1&ref=the_vanishing_mind
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