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05/15/2017

A review of Table 19: Reinforcing the dominant cultural narrative that all unintended pregnancies are wonderful and wanted

A friend and I recently watched the movie Table 19 because we were looking for a fun comedy. Unfortunately, the movie was neither fun nor funny. Indeed, the movie did not deliver on a number of fronts, which is why I do not recommend it. I want to focus on a specific plot line that this movie employed—one that is common in movies and books—and that I find problematic. In case you are interested in watching this movie despite my warnings, there are spoilers ahead.

The basic plot is that Eloise McGarry, played by Anna Kendrick, ends up sitting at the table of “rejects” at a wedding. She was originally the maid of honor to the bride, but she and the bride’s brother, Teddy, broke up after two years of dating and she was consequently demoted from the bridesmaids’ table to the “loser” table, Table 19. As the movie progresses, we find out that the reason Eloise and Teddy broke up is because of an argument surrounding an unintended pregnancy. Eloise was upset with Teddy when she told him she was pregnant because he did not immediately respond positively. Instead, he asked her what she wanted to do about the pregnancy. His lack of enthusiasm enraged her and she told him that they would be ridiculous parents, which angered him, causing him to break up with her via text message. Because this is a typical Hollywood movie, it has a happy ending with Eloise and Teddy getting back together and happily welcoming their baby into the world.

Unintended pregnancies account for almost half of all pregnancies in the United States so it is not surprising that they are used as a plot twist in many movies and books. What is problematic is that many movies and books expect both members of the heterosexual couple to respond joyfully to the news of an unintended pregnancy and there is shock and discord if this is not the response. This is precisely what happened in Table 19. While some unintended pregnancies are wanted pregnancies (perhaps they are mistimed or the couple didn’t think they could conceive but they always wanted to), many unintended pregnancies are not wanted pregnancies. Just because a couple is now pregnant does not mean that they automatically switch from not wanting to become pregnant to being thrilled that they are pregnant. The dominant cultural narrative that all pregnancies are wonderful and wanted is harmful to women, men, and couples.

Eloise and Teddy are a couple in their 20s who seem somewhat irresponsible and lacking direction. They are trying to figure out what to do with their lives individually and as a couple. Given their circumstances, it is understandable that they may not be ready for a baby. Their inability to have a mature and reasoned conversation about their unintended pregnancy further buttresses that they might not be ready for a baby. But according to the dominant cultural trope, they are supposed to be able to pull it all together in order to be an intact heterosexual couple who are excited to have a baby. While this is how the movie Table 19 ends, not all stories have happy endings and it is important to recognize that there is a diversity of responses to unintended pregnancies.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.  

 

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05/05/2017

Rethinking The Obligation To Provide Universal Healthcare Coverage: The need for moral imagination

Healthcare is indeed complicated, in case anyone with a speck of knowledge about it ever thought otherwise. There are many ways to organize a healthcare system, as is evident from all the various ways advanced industrial societies around the globe provide healthcare to their citizens. Questions about the extent to which the private insurance system versus the government is involved brings us back to protracted debates about the legitimate role of government and whether or not citizens have a basic right to healthcare, or should healthcare be assumed to be one more market service which individuals may elect to use or not? Sadly, in the United States these questions often are framed in abstract terms appealing to general ideological values and goals that shape and limit the range of viable policy options. What I want to emphasize in my blog today is the need for moral imagination—what’s it like to be in the shoes of those who are suffering, and often without health insurance, and without a job?  This is a first step we all must take before we can weigh our moral obligations to provide healthcare to everyone.

Before the passage of the Affordable Care Act (ACA) there were over 45 million uninsured Americans who did not have access to a primary care physician. That number has been reduced by about 18 million, but now we at risk of seeing this number rise again with the possibility of a repeal of the ACA and passage of a GOP led alternative. The Congressional Budget Office (CBO), a politically independent agency, estimated that if the American Health Care Act had past would eventually lead to 24 million people loosing their health care insurance by 2026. That means the total number of uninsured citizens will be back close to the 50 million mark. This number is not just a statistic in the abstract—it’s a compelling measure of human suffering. Imagine you, the reader of this blog, become one of those unfortunate souls included in that number, which you and I could? What will that feel like?

Most of us, who have the good fortune of spending our days working in academic medical centers and many other professional settings, have access to not just good healthcare, but to excellent, state of the art, healthcare. Just think about it—have you or members of your family ever been sick or injured and is urgent need of seeing a competent physician? How long did it take you to get your appointment and receive the medical attention you needed? Most of us who have been in situations of need are amazingly fortunate to get what we need reasonably soon, so it is easy for people like us to take healthcare for granted.  Imagine having a troubling medical condition—news from a test, or a worrisome new symptom, or what may be worse, your family, being is serious need and not having health insurance. How would you feel? What would you do? What if you applied for insurance coverage and your premiums were exorbitant, beyond what you could afford, because of a preexisting condition?

Jimmy Kimmel did a remarkably good deed on his show recently by describing the scare he had with his newborn son who required urgent surgery to repair a heart condition. He was among the lucky—to have health insurance but also to be rich. His family’s needs are not at risk of not being met. But he showed moral imagination—empathy for others—when he prompted us to imagine what it would be like to have a baby who needed life saving medical interventions and not have access to medical care. When we ponder healthcare at this level, aren’t we all in agreement, as he said:

“We were brought up to believe that we live in the greatest country in the world, but until a few years ago, millions and millions of us had no access to health insurance at all,” Kimmel said. “If your baby is going to die, and it doesn’t have to, it shouldn’t matter how much money you make. I think that’s something now, whether you’re a Republican or Democrat, or something else, we all agree on that, right?”

 

 There are many Americans today who have gone without healthcare coverage for years after losing a job that never came back, which mean getting sick or injured puts them a great risk of personal bankruptcy, the number one reason individuals file for bankruptcy. Can you imagine what’s like to be out of job, no money, and have serious healthcare needs for yourself or your family? Sadly too many Americans know first hand exactly what that experience is like. And it is all the sadder because the United States of America is the richest nation on earth and the only advanced nation without universal healthcare. How can a nation be so rich and not provide basic healthcare to all of its citizens?

One barrier seems to be the necessary means by which universal healthcare would be made possible: government involvement. Our lack of moral imagination also limits our options. For decades the so-called conservative mantra has been the demonization of government programs, which perpetuates the myth that government is totally inept to effectuate any important social goal. But there is no other way to provide for the healthcare needs of our population than through government involvement. Individual action, local communities, religious institutions and organizations, NGO’s, etc., etc., alone will never solve this problem. Only the collective action of “we the people”, as an expression of our social and moral goals and values, can accomplish such a mammoth task. So how can we the people start thinking differently about this problem?

We need to be thinking with fresh interest and robust moral imagination about how we are going to fulfill our obligation provide healthcare to all Americans. This starts with first imagining and allowing yourself to feel what it’s like to be sick and without healthcare, and experience your or your family member’s illness getting worse and worse, with the only option at some points to go to a hospital emergency department. If we would not want this for ourselves or for those we care about, we shouldn’t want it for anyone else.


The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our 
website.  

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05/01/2017

Increasing Access to Biosimilar Drugs

The development of ‘specialty drugs’ in the health care industry has created legal, ethical, and public policy issues because patients are not able to get access to their prescribed medications based on the expense.  Specialty drugs are usually biologicals, treat serious conditions, and  are very expensive with no cheap alternatives.[1] Although there is debate about how much finances should influence medical decision making, it is a conversation that can not be ignored when patients can not get access to treatment based on ability to pay. There should be increased access to these drugs but how to increase access is up for debate.

One posed solution has been the creation of biosimilar which are the generic version of a specialty drug. A biological medication is different from a traditional drug in molecular make up.[2]  “A biologic drug is ‘a substance that is made from a living organism or its products[,]’”[3]  while a traditional prescription drug is made up of simple molecules.[4]  This difference means that biologicals are scientifically more difficult to produce because a more elaborate research is necessary.[5]  This also means making a generic form, known as a biosimilar, is more expensive and harder to make.[6] Generally, a biological is “twenty times more expensive per patient than traditional small-molecule pharmaceuticals.”[7] There also are patent infringement concerns when making biosimilar.

 

From ethics perspective, one of the key aspects of justice is ensuring equal access to healthcare or at least fairly allocating available resources. For biosimilar drugs, it truly depends on what insurance company, what insurance plan, and what pharmacy benefit manager the patient has as to whether the patient will even have a chance to get these drugs. One could argue that it is hard to say we have a fair allocation system when it dependent on what backroom deals pharmaceutical companies have with insurance companies. On the other side, fairness includes ensuring that pharmaceutical companies are properly compensated for their time, energies, and resources used to develop these drugs. Yes, they are cheaper than brand name biologics but they are still expensive and arguably unaffordable. Competition has been the suggested method for decreasing prices to ensure better access. However, patents exclusivity and the Food and Drug Administration approval process make competition slow.

 

On April 27, 2017, The United States Supreme Court heard a case that addresses exactly this issue of access. The Court heard oral arguments in regards to an appeal by Novartis, Swiss pharmaceutical company, requesting the time for biosimilars to be on the market be sped up.[8] Amgen, a California pharmaceutical company who makes the name brand version Neupogen, had challenged the early release. The lower court decision had ruled in favor of Amgen, preventing Novartis from releasing its biosimilar until six months after the Food and Drug Administration approved it. The case revolves around a provision in the Affordable Care Act which aimed at creating an expedited path for approval of biosimilar drugs. The goal was to increase access of new innovations to the public as well as increase competition to decrease price. Zarxio, the biosimilar version of Neupogen, is projected to cost 15 percent less than Neupogen, which is a decrease in cost but not a substantial in cost. Part of the issue is health insurance companies expect biosimilar drugs to work like generic medications and they do not. Biosimilars themselves are still innovation and companies charge for the research and development that goes into innovations. The final decision is due to come in June and this case could determine whether justice will be respected in regards to how quickly consumers can get access to biosimilars.

 



[1] Joseph J. Hylak-Reinholtz & Jay R. Naftzger, Is it Time to Shed a “Tier” for Four-Tier Prescription Drug Formularies? Specialty Drug Tiers May Violate HIPAA’s Anti-Discrimination Provisions and Statutory Goals, 32 N. Ill. U.L. Rev. 33, 35 ? 36 (2011); Jim Sabin, How the U.S. Rations “Specialty Drugs,” Health Care Org. Ethics (Saturday, April 26, 2008) http://healthcareorganizationalethics.blogspot.com/2008/04/how-us-rations-specialty-drugs.html.

[2] Michael Callam, Who Can Afford it?: The Patient Protection and Affordable Care Act’s Failure to Regulate Excessive Cost-Sharing of Prescription Biologic Drugs, 27 J.L. & Health 99, 103 (2014).

[3] Id.

[4] Id.

[5] Id. at 104.

[6] Id.

[7] Callam, supra note 2, at 105.

[8] Andrew Chung, U.S. Top Court Grapples Over Making Copycat Biologics Available Sooner, Reuters (Apr. 26, 2017), http://mobile.reuters.com/article/idUSKBN17S2BF.

 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

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04/27/2017

When is Non-Existence Better than being Alive?

If bioethics has central or recurring questions, this is surely one of them.  And, of course, the problem, or question, often is restated to: who decides if this life is worth living?  The confounding elephant in the room is that families often have more hope than care providers, and the evidence is mixed on whether either party is particularly accurate in projecting the future.

Hannah Arendt in her book The Human Condition described in detail how humans must make choices without knowing outcomes.  Everyone (except neurologists) loves the stories about people coming out of comas and persistive vegetative states.  Neurologists are not fans because it admits to an inability to predict—even being right 98% of the time isn’t enough. 

Obstetricians face this problem constantly, but with different stakes.  We know fetal heart rate monitoring is far from perfect, but none of us would ignore a bradycardia of several minutes.  Maybe this baby is actually dying, and we aren’t going to take the chance.  When is non-existence acceptable in my specialty?  Only when the pregnant woman has decided it is so.

At both ends of life, non-existence, the ultimate existential question, is left to patient and family values, because there is no cultural/societal consensus.  Inuit tribes expected the elderly and infirm to walk out into the ice when times got tough, and food was scarce.  Our culture rejects this, but medical students often question why we keep alive an individual with no hope of recovery and little or no awareness of their surroundings or condition.

I am not a utilitarian, and I am not defending any of Peter Singer’s views.  But I still wish that we did not prolong suffering, or pour resources into a life without awareness of its own self.  Families struggle with these decisions, and often choose the conservative choice thinking that hope is better than non-existence.  Those of us in medicine tasked with keeping these fragile physiological flames burning often ask ourselves whether we are doing harm or good.  Until we reach (if ever) a societal consensus, we should share with decision makers our moral ambiguity and sense of regret when we support their loved ones against our better judgment.  Is this enough?  Perhaps not, but we are not yet even doing this with consistency.  

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

 

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04/24/2017

Fetuses and Full Disclosure

Medicine has a notoriously long history of paternalism, particularly with regards to reproductive health. The past century has seen everything from forced sterilization of people of color and those with intellectual disabilities to nondisclosure of sexually transmitted diseases. Physicians have fought to regain the trust of the community through disclosure of key medical information and shared decision making, both of which are essential underpinnings of the bioethical principle of autonomy. Given the incredible emphasis on these concepts in contemporary medical training, it is surprising that the following law has now passed Texas Senate approval:

SB 25. A cause of action may not arise, and damages may not be awarded, on behalf of any person, based on the claim that but for the act or omission of another, a person would not have been permitted to have been born alive but would have been aborted. (b) This section may not be construed to eliminate any duty of a physician or other health care practitioner under any other applicable law.

In short, there can be no legal penalty against physicians who knowingly choose to withhold information from pregnant patients if the physician thinks it will prevent an abortion. This does not absolve the physician in question from professional consequences, like action from the Texas Medical Board. However, it does set an important precedent – namely, that the belief structure of the physician takes precedence over the rights of the patient. From a bioethical standpoint, this is an inexcusable violation of autonomy. Disclosure of all relevant information is critical to informed decision making, which is the bedrock of autonomy in the complex, jargon-laden world of modern medicine. One of our key roles as clinicians is to promote patient autonomy by translating this jargon into information that can be easily understood by the patients, family members, or anyone with medical power of attorney. Her decisions about the future of her pregnancy hinge on information about fetal status, whether she decides to terminate or simply wants to be able to prepare for the effects of an abnormality. Clearly, allowing one’s own beliefs surrounding abortion to supersede a patient’s right to know about the status of her fetus is an obvious ethical transgression.

Furthermore, legal actions that protect doctors who fail to disclose important information to their patients harm the medical community at large. These laws undermine the trusting relationship between doctor and patient that we continue to build, particularly in vulnerable populations that have historically been ignored or exploited by medical professionals. Trust is especially important in sexual and reproductive healthcare as patients entrust their physicians with some of the most intimate details of their lives when seeking treatment in these matters. SB 25 is akin to codifying mistrust into law. 
Patients’ values may differ drastically from our own and the decisions they make may not reflect what we would do in similar situations. Almost all physicians have had patients make decisions with which they disagree thoroughly. However, it is our duty to behave in an ethically responsible way and to help patients make these decisions in a way that is consistent with their own belief structure, regardless of our own feelings. This means providing all relevant information in a nonjudgmental way and respecting the informed, autonomous decision of the patient. Passing a law exempting physicians from the legal consequences of paternalism doesn’t change what is right. Rather, it serves only to further divide patients from their providers in a way that harms us all. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

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04/20/2017

Dueling BRCA Databases: What About the Patient?

The news release Monday morning grabbed my attention:

“Study finds wide gap in quality of BRCA1/2 variant classification between Myriad Genetics and a common public database.”

Myriad Genetics had been exclusively providing tests, for $3000+ a pop for full BRCA gene sequencing, for 17 years before the Supreme Court invalidated key gene patents back in 2013. Since the ruling a dozen or so competitors have been offering tests for much lower prices. Meanwhile, Myriad has amassed a far deeper database than anyone else, having been in the business so much longer. And it’s proprietary.

CLASSIFYING GENE VARIANTS

(NHGRI)

Public databases of variants of health-related genes have been around for years too. The best known, ClinVar, collects and curates data from the biomedical literature, expert panels, reports at meetings, testing laboratories, and individual researchers, without access to Myriad’s database. ClinVar uses several standard technical criteria to classify variants as “pathogenic,” “benign,” or “of uncertain significance.” (“Likely pathogenic” and “likely benign” were used more in the past.)

ClinVar lists 5400 variants just for BRCA1. The criteria come from population statistics, how a particular mutation alters the encoded protein, effects on the phenotype (symptoms), and other information. Bioinformatics meets biochemistry to predict susceptibility. The BRCA1 protein acts as a hub of sorts where many other proteins that control DNA repair gather. DNA Science discussed the genes behind breast and ovarian cancers here.

As gene sequences accumulate in the databases and troops of geneticists and genetic counselors annotate them, the proportion of pathogenic and benign entries will increase as that of the unsettling “variants of uncertain significance” — VUS — will decrease. Knowing will outpace not knowing. In the meantime, a woman with a VUS for a gene that confers susceptibility to develop breast and/or ovarian cancer, concerned that her DNA sequence isn’t “normal,” might have her at-risk organs removed. And then she might learn, as the databases grow, that her variant is really benign after all, because while she was being treated for a disease that she didn’t actually have, more patients emerged who have the gene variant but not the related cancers.

The reclassification of a VUS as something more meaningful depends on access to as much information as possible.

How many unnecessary surgeries are happening? Have happened? Myriad estimates hundreds to thousands.

DISCOVERING DISCORDANCE

The news release announced a paper from Myriad just published in The Oncologist that compared 4,250 unique BRCA1 and BRCA2 gene variants in the company’s database to entries in ClinVar, and found that 26.7% of the ratings do not fully agree. (ClinVar lists multiple sources for many of the variants, and 14.5% didn’t agree on all counts and 12.3% on only some.) According to Myriad, most of the VUS listings were in ClinVar. In fact, only 0.5% of Myriad’s BRCA1 sequences and 1.1% of their BRCA2 sequences are VUS. They’re clearly ahead of the game.

 

A breast cancer cell (NHGRI).

The discordance isn’t really news. It echoes earlier reports both from Myriad researchers for the BRCA genes and from a  non-Myriad, multi-center group that also found 26% discordance, but their analysis included several cancer predisposition genes; the most conflicting were CHEK2 and ATM. And another recent study found that about half of women with VUS undergo bilateral mastectomy, concluding that “many surgeons managed patients with BRCA1/2 VUS the same as patients with BRCA1/2 pathogenic mutations.” That’s terrifying. It means that the problem isn’t due just to overanxious patients, but also to surgeons who might not be genetics-savvy.

The news release doesn’t go to the obvious conclusion, that privatization of the database may be fueling inappropriate surgeries, or at least not preventing them, a point that Sharon Begley made elegantly in Stat News. Many of her expert sources countered the implication that variant classifications from ClinVar are just accepted and delivered to patients without further and often intense research and validation by health care providers.

MOTIVES

In the news release, William Gradishar, MD, from the Feinberg School of Medicine at Northwestern University and lead author on the new study from Myriad, provided the company view (slightly edited):

“The high degree of discordance seen in this study signals a cautionary note … it means that different labs are providing different results to patients for the same genetic mutation … some patients are receiving incorrect results that may have life-changing or -threatening implications… Although efforts are underway to resolve the quality problems within public databases, it is unlikely the issue will be resolved soon and users of public databases likely will continue to encounter discrepancies. At this time, labs should not use public databases in any way in clinical variant classification.”

Actress and activist Angelina Jolie had her breasts and ovaries removed to lower her risk of BRCA1-associated cancers.

Ron Rogers, spokesperson for Myriad, wrote in an email that the company provides database access for certain scientific collaborations, but then provided the business view:

“Myriad has invested hundreds of millions of dollars to develop our database over two decades, which is used to classify variants as part of the Company’s specific process. We encourage other commercial labs to make their own investments, which are required to offer a quality product. The problem is that some other commercial labs refuse to make the needed investments. Instead, they are trying to short cut the process by relying on inaccurate public databases, which has the potential to deliver inaccurate results and harm real people.”

If anyone remembers the race to sequence the first human genome, which pitted NHGRI and their public database against Celera Genomics and their proprietary one, the battle over BRCA is a little deja vu all over again.

Rogers added that if patients who have had bilateral mastectomies following a report of a VUS had come to Myriad, “we could have provided many of them with definitive answers and helped to prevent a significant number of these life-changing procedures.” About 85% of the BRCA testing market indeed uses Myriads products.

Myriad’s tests as well as their support (genetic counseling) are excellent. The company helped a friend of mine interpret and confirm BRCA1 test results from 23andMe, which her son had taken on a whim but the unexpected finding of a mutation had sent her family into a tailspin. 23andMe, the direct-to-consumer genetic information company, coaxes customers to provide their results for research (“Be part of something bigger”) and charges investigators for access to the data. Like Myriad, 23andMe also suffered a setback in 2013. FDA yanked some of their health-related carrier tests, but the agency reversed the ban on April 6, 2017.

23andMe and Myriad serve different types of individuals. Many of 23andMe’s customers, like my friend’s son, aren’t distraught over cancer, just curious and acting on their own. So here’s another comparison: Is Myriad’s protecting of their data similar to my reaction to people downloading my books for free? No. I’m just losing royalties.

My mother’s lost battle with breast cancer can’t help but influence my view that impeding accurate diagnosis for profit, to protect assets, may make sense in the business world but is not the right thing to do. I have trouble commoditizing patient tests and sequestering information that might help, and the many rock stars of genetics who have joined the Free the Data movement would agree.

Because the entire discussion makes me queasy, I thought instead I’d illustrate the distinction between a harmful mutation and a VUS, by comparing the BRCA1 gene sequence to the English language.

THE HANDMAID’S TALE

Most genes are thousands of DNA bases long, and therefore can vary in many ways. Gene variants – mutations – can affect health or not depending upon how they disrupt the proteins that they encode.

BRCA1 (the gene) is 125,951 bases long, only 5,589 of which are represented in the protein. Mutations near its ends are more damaging than those in the middle. One of the two Ashkenazi (Jewish) “founder” mutations, 185delAG, removes an A and a G at position 185, near the beginning. Because a gene sequence is read in triplets – every 3 DNA bases encodes an amino acid – adding or deleting a number that isn’t 3 or a multiple of it devastates the protein’s function. 185delAG is, then, a gene variant of very high significance. (My analogy below is not quite on target because the words in a sentence vary in length.)

I entered 125,951 letters into a publishing calculator that translates numbers of alphabet characters into a book of a particular size, and wound up with a 6” by 9” volume of 265 pages. That view of the BRCA1 gene’s enormity corresponds to approximately the length of Margaret Atwood’s dystopian masterpiece “The Handmaid’s Tale.” I’m rereading it, inspired by the “Make Margaret Atwood Fiction Again” signs at the March on Washington January 21.

I took a sentence about as far into the book as the 185delAG mutation is in the BRCA1 gene:

Everything except the wings around my face is red: the color of blood, which defines us.

Removing two adjacent letters – the “ex” in “except” – and then moving the other letters into the word-sizes, clearly disrupts the meaning:

Everything ceptth ewi ngsar oundmy fa ceis re dth: eco lorof bl oodwh ichde finesus

Gibberish, and it would continue to the end of the book. In a gene, the offset sequence would likely lead to a stunted protein, halted when reaching a “stop” signal in the mRNA. And when a BRCA1 gene loses meaning, control of DNA repair falters and other mutations go unchecked. Cancer results.

A VUS would do something less drastic, such as replacing a letter in a way that doesn’t obscure the overall meaning of the sentence (or gene). Substituting the “g” in “everything” with a “j,” for example, doesn’t alter the meaning. And many changes to a DNA sequence have no effect on the encoded amino acid sequence at all.

So that’s what a VUS is, a DNA sequence of a particular gene of interest that’s rather rare in a population, and that may or may not mean something. And their numbers will decline and then vanish as the databases build and their entries are annotated and validated. But until they do, I think that sharing all that we know about variants of possibly disease-causing genes, to prevent unnecessary treatments, is the only ethical path to take.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

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04/12/2017

Rape, disability, and gender: A response to McMahan and Singer’s op-ed on the Anna Stubblefield case


Unfortunately, there have been numerous cases of sexual harassment and sexual assault in academia and particularly in more male-dominated fields, including my home field of philosophy. In these cases, professors use their position of prestige and power to sexually harass and abuse their students. UC Berkeley philosophy professor John Searle is just the most recent example. To my knowledge, all of these cases have involved male professors victimizing female students. The lone exception is Anna Stubblefield, a former professor of philosophy at Rutgers. Here is a summary of her case from Current Affairs


At issue is the case of Anna Stubblefield, a Rutgers University philosophy professor convicted of sexually assaulting her mentally disabled pupil, and sentenced to 12 years in prison. The case is, to say the least, extremely unusual. The student, D.J., was a severely impaired 30 year old man with cerebal palsy, who had never spoken a word in his life and communicated through “screams” and “chirps.” Stubblefield acted as his personal tutor, using a discredited pseudoscientific technique to elicit what she insisted were complex communications from D.J. Eventually, based on what she believed D.J. wanted, Stubblefield began engaging in sex acts with him, having become romantically attracted to him over the course of her time assisting him.  

Stubblefield’s case is not only different because she is a woman and her victim is a man, but also because she is one of the few professors to go through the legal system and be convicted.

There are many complexities to Stubblefield’s case and I don’t have the space to address them all here. Instead, I want to discuss a particular point Jeff McMahan, philosophy professor at University of Oxford, and Peter Singer, bioethics professor at Princeton, made in an op-ed piece in the New York Times regarding Stubblefield’s case. They argue that because D.J. is cognitively disabled, the sexual assault did not harm him in the same way or to the same degree as it would an individual who is not cognitively disabled because D.J. “cannot understand the normal significance of sexual relations between persons or the meaning and significance of sexual violation.” Not surprisingly, this op-ed piece has upset individuals in the disability community and advocates for individuals with disabilities. People such as Nathan J. Robinson have responded eloquently to the main argument of McMahan and Singer’s article.

I want to look more closely at a smaller point they make as part of their larger argument. They state, “It seems reasonable to assume that the experience was pleasurable to him [D.J.].” The assumption that sexual activity was pleasurable for D.J. even though he was not able to consent to it is troubling and reinforces problematic gender norms. There is a dominant cultural narrative that men are always interested in sex and that sex is always pleasurable for them. This narrative contributes to the popular perception that men cannot be raped by women because an erection is a sign of their consent. Yet, men can indeed be raped by women and an erection can occur even if men are not aroused or consenting to sexual activity. If D.J. were a woman and Stubblefield were a man, I doubt McMahan and Singer would argue that we could assume the experience was pleasurable for the victim. Yet because of our dominant cultural norms regarding gender and sexuality – namely that men always want sex and that sex is always pleasurable for them – McMahan and Singer seems to assume that this is the case even when DJ does not have decision-making capacity.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

 

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03/28/2017

Mandatory Reporting of Pharmacy Prescription Errors?

Following the widely-reported 2014 case of a Cincinnati pharmacist incorrectly filling a prescription which led to a serious patient injury, the Ohio State Board of Pharmacy is now poised to promulgate a new regulation requiring pharmacists to report errors and to the board. This may be the first attempt by a US state board of pharmacy to require dispensing error reporting. (However, about six years ago, the Canadian province of Nova Scotia instituted a required reporting system that has resulted in over 20,000 reports of errors and “near-misses” each year.)

The facts of the 2014 case are direct: A pharmacist was responsible for mistakenly filling a prescription written to supply labetalol but instead dispensed lamotrigine. As a result, the patient suffered permanent kidney damage requiring long-term dialysis. However, because of more in-depth news reporting, an investigator for a local television station made the claim that pharmacists deal with mistakes in “secrecy” and recommended that prescription errors reporting be mandated.

Regrettably, dispensing errors are an unfortunately fact of a pharmacist’s life. In a 2003 observational study attempting to assess prescription dispensing accuracy in 50 pharmacies in six US cities, pharmacy researchers Elizabeth Flynn, Kenneth Barker, and Brian Carnahan showed that the error rate was 1.7% for the 4481 prescriptions reviewed. Of the 77 identified mistakes, the team considered five to “clinically important.” (J Am Pharm Assoc. 2003;43:191-200). Interestingly, the accuracy rate did not vary significantly by pharmacy type or city.

In a 1998 report, a national pharmacist liability carrier provided information to authors Walter Fitzgerald and Dennis Wilson that 85% of its claims resulted from “mechanical errors,” including dispensing the wrong drug or dose, or labeling the prescription incorrectly. [Drug Topics. 1998 (Jan. 19):84-86.] In an earlier dispensing errors study in California and Oregon, author Andrea Rock reported that each pharmacy made an average of 324 dispensing mistakes every year: almost one per day! (Money. 1998 (Apr.):114-117).

Look-alike/sound-alike (LASA) mistakes – such as the one noted in the 2014 Cincinnati case – are common and well-known in pharmacy practice circles. Despite decades of alerts and warnings and safeguards instituted (including placing the name of the medication on the label, mandatory counseling, automation and redundancies, double- and triple-checks, national and international safety campaigns, and numerous others), the errors persist. (PharmacyToday. 2016 (Feb.):32).

It will remain unclear for some time as to whether any new approach involving mandating that pharmacists report dispensing mistakes will have a positive impact on improved safety. Clearly both pharmacists and patients rightfully fear the possibility of a significant error with life-changing impact. However, given our track records at reducing errors it appears highly unlikely that such mistakes will be eliminated entirely. Perhaps a different tactic might be better here: no-fault insurance for dispensing errors? [Wallis KA. Learning from no-fault treatment injury claims to improve the safety of older patients. Ann Fam Med. 2015 (Sep.); 13(5): 472-474.]

Some may consider this an unnecessary a departure from traditional fault-based liability thinking. After all, dispensing errors are very often clearly negligence: the pharmacist failed to do something that a reasonably prudent pharmacist should have done to avoid injury to the patient. However, the same could be said of automobile accident insurance: a driver failed to do something that a reasonably prudent motorist should have done to avoid injuring another. And yet, some states allow no-fault motorist insurance. The underlying bottom line is the same for both driver no-fault insurance and pharmacist dispensing error liability: it’s an activity that involves human beings making decisions, and human beings will make errors, and sometimes that errors lead to severe injuries which financially impact all of society directly or indirectly. Of course, as with no-fault motor vehicle insurance, if the actor is “grossly negligent” or “recklessly” disregards reasonable safety precautions, then the individual responsible will still be held financially accountable for injuries and losses as under the traditional tort system.

A no-fault system to compensate persons injured from dispensing errors will not eliminate mistakes – something that is not possible – but it will shift the liability focus from identifying the persons or persons to blame to the goal of avoiding errors in the first place. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

Full Article

This entry was posted in Health Care, Pharmaceuticals and tagged , . Posted by Bioethics Today. Bookmark the permalink.

03/28/2017

Mandatory Reporting of Pharmacy Prescription Errors?

Following the widely-reported 2014 case of a Cincinnati pharmacist incorrectly filling a prescription which led to a serious patient injury, the Ohio State Board of Pharmacy is now poised to promulgate a new regulation requiring pharmacists to report errors and to the board. This may be the first attempt by a US state board of pharmacy to require dispensing error reporting. (However, about six years ago, the Canadian province of Nova Scotia instituted a required reporting system that has resulted in over 20,000 reports of errors and “near-misses” each year.)

The facts of the 2014 case are direct: A pharmacist was responsible for mistakenly filling a prescription written to supply labetalol but instead dispensed lamotrigine. As a result, the patient suffered permanent kidney damage requiring long-term dialysis. However, because of more in-depth news reporting, an investigator for a local television station made the claim that pharmacists deal with mistakes in “secrecy” and recommended that prescription errors reporting be mandated.

Regrettably, dispensing errors are an unfortunately fact of a pharmacist’s life. In a 2003 observational study attempting to assess prescription dispensing accuracy in 50 pharmacies in six US cities, pharmacy researchers Elizabeth Flynn, Kenneth Barker, and Brian Carnahan showed that the error rate was 1.7% for the 4481 prescriptions reviewed. Of the 77 identified mistakes, the team considered five to “clinically important.” (J Am Pharm Assoc. 2003;43:191-200). Interestingly, the accuracy rate did not vary significantly by pharmacy type or city.

In a 1998 report, a national pharmacist liability carrier provided information to authors Walter Fitzgerald and Dennis Wilson that 85% of its claims resulted from “mechanical errors,” including dispensing the wrong drug or dose, or labeling the prescription incorrectly. [Drug Topics. 1998 (Jan. 19):84-86.] In an earlier dispensing errors study in California and Oregon, author Andrea Rock reported that each pharmacy made an average of 324 dispensing mistakes every year: almost one per day! (Money. 1998 (Apr.):114-117).

Look-alike/sound-alike (LASA) mistakes – such as the one noted in the 2014 Cincinnati case – are common and well-known in pharmacy practice circles. Despite decades of alerts and warnings and safeguards instituted (including placing the name of the medication on the label, mandatory counseling, automation and redundancies, double- and triple-checks, national and international safety campaigns, and numerous others), the errors persist. (PharmacyToday. 2016 (Feb.):32).

It will remain unclear for some time as to whether any new approach involving mandating that pharmacists report dispensing mistakes will have a positive impact on improved safety. Clearly both pharmacists and patients rightfully fear the possibility of a significant error with life-changing impact. However, given our track records at reducing errors it appears highly unlikely that such mistakes will be eliminated entirely. Perhaps a different tactic might be better here: no-fault insurance for dispensing errors? [Wallis KA. Learning from no-fault treatment injury claims to improve the safety of older patients. Ann Fam Med. 2015 (Sep.); 13(5): 472-474.]

Some may consider this an unnecessary a departure from traditional fault-based liability thinking. After all, dispensing errors are very often clearly negligence: the pharmacist failed to do something that a reasonably prudent pharmacist should have done to avoid injury to the patient. However, the same could be said of automobile accident insurance: a driver failed to do something that a reasonably prudent motorist should have done to avoid injuring another. And yet, some states allow no-fault motorist insurance. The underlying bottom line is the same for both driver no-fault insurance and pharmacist dispensing error liability: it’s an activity that involves human beings making decisions, and human beings will make errors, and sometimes that errors lead to severe injuries which financially impact all of society directly or indirectly. Of course, as with no-fault motor vehicle insurance, if the actor is “grossly negligent” or “recklessly” disregards reasonable safety precautions, then the individual responsible will still be held financially accountable for injuries and losses as under the traditional tort system.

A no-fault system to compensate persons injured from dispensing errors will not eliminate mistakes – something that is not possible – but it will shift the liability focus from identifying the persons or persons to blame to the goal of avoiding errors in the first place. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

Full Article

This entry was posted in Health Care, Pharmaceuticals and tagged , . Posted by Bioethics Today. Bookmark the permalink.

03/28/2017

Mandatory Reporting of Pharmacy Prescription Errors?

Following the widely-reported 2014 case of a Cincinnati pharmacist incorrectly filling a prescription which led to a serious patient injury, the Ohio State Board of Pharmacy is now poised to promulgate a new regulation requiring pharmacists to report errors and to the board. This may be the first attempt by a US state board of pharmacy to require dispensing error reporting. (However, about six years ago, the Canadian province of Nova Scotia instituted a required reporting system that has resulted in over 20,000 reports of errors and “near-misses” each year.)

The facts of the 2014 case are direct: A pharmacist was responsible for mistakenly filling a prescription written to supply labetalol but instead dispensed lamotrigine. As a result, the patient suffered permanent kidney damage requiring long-term dialysis. However, because of more in-depth news reporting, an investigator for a local television station made the claim that pharmacists deal with mistakes in “secrecy” and recommended that prescription errors reporting be mandated.

Regrettably, dispensing errors are an unfortunately fact of a pharmacist’s life. In a 2003 observational study attempting to assess prescription dispensing accuracy in 50 pharmacies in six US cities, pharmacy researchers Elizabeth Flynn, Kenneth Barker, and Brian Carnahan showed that the error rate was 1.7% for the 4481 prescriptions reviewed. Of the 77 identified mistakes, the team considered five to “clinically important.” (J Am Pharm Assoc. 2003;43:191-200). Interestingly, the accuracy rate did not vary significantly by pharmacy type or city.

In a 1998 report, a national pharmacist liability carrier provided information to authors Walter Fitzgerald and Dennis Wilson that 85% of its claims resulted from “mechanical errors,” including dispensing the wrong drug or dose, or labeling the prescription incorrectly. [Drug Topics. 1998 (Jan. 19):84-86.] In an earlier dispensing errors study in California and Oregon, author Andrea Rock reported that each pharmacy made an average of 324 dispensing mistakes every year: almost one per day! (Money. 1998 (Apr.):114-117).

Look-alike/sound-alike (LASA) mistakes – such as the one noted in the 2014 Cincinnati case – are common and well-known in pharmacy practice circles. Despite decades of alerts and warnings and safeguards instituted (including placing the name of the medication on the label, mandatory counseling, automation and redundancies, double- and triple-checks, national and international safety campaigns, and numerous others), the errors persist. (PharmacyToday. 2016 (Feb.):32).

It will remain unclear for some time as to whether any new approach involving mandating that pharmacists report dispensing mistakes will have a positive impact on improved safety. Clearly both pharmacists and patients rightfully fear the possibility of a significant error with life-changing impact. However, given our track records at reducing errors it appears highly unlikely that such mistakes will be eliminated entirely. Perhaps a different tactic might be better here: no-fault insurance for dispensing errors? [Wallis KA. Learning from no-fault treatment injury claims to improve the safety of older patients. Ann Fam Med. 2015 (Sep.); 13(5): 472-474.]

Some may consider this an unnecessary a departure from traditional fault-based liability thinking. After all, dispensing errors are very often clearly negligence: the pharmacist failed to do something that a reasonably prudent pharmacist should have done to avoid injury to the patient. However, the same could be said of automobile accident insurance: a driver failed to do something that a reasonably prudent motorist should have done to avoid injuring another. And yet, some states allow no-fault motorist insurance. The underlying bottom line is the same for both driver no-fault insurance and pharmacist dispensing error liability: it’s an activity that involves human beings making decisions, and human beings will make errors, and sometimes that errors lead to severe injuries which financially impact all of society directly or indirectly. Of course, as with no-fault motor vehicle insurance, if the actor is “grossly negligent” or “recklessly” disregards reasonable safety precautions, then the individual responsible will still be held financially accountable for injuries and losses as under the traditional tort system.

A no-fault system to compensate persons injured from dispensing errors will not eliminate mistakes – something that is not possible – but it will shift the liability focus from identifying the persons or persons to blame to the goal of avoiding errors in the first place. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

Full Article

This entry was posted in Health Care, Pharmaceuticals and tagged , . Posted by Bioethics Today. Bookmark the permalink.